Technical assistance related to the review of REACH with regard to the registration requirements on polymer Final report

Transcription

1 Technical assistance related to the review of REACH with regard to the registration requirements on polymer Final report 17 February 2015

2 Document information BIO by Deloitte is a commercial brand of the legal entity BIO Intelligence Service. Since 26 June 2013 the legal entity BIO Intelligence Service is a 100% owned subsidiary of Société Fiduciaire Internationale d Audit which is owned by Deloitte. CLIENT European Commission DG ENV REPORT TITLE Final report PROJECT NAME Technical assistance related to the review of REACH with regard to the registration requirements on DATE 17 February 2015 PROJECT TEAM BIO by Deloitte (BIO), Pólo de Inovação em Engenharia de Polímeros (PIEP) AUTHORS Ms Arianna De Toni (BIO) Ms Nada Saïdi (BIO) Ms Liliana Rosa Santos (PIEP) Mr Shailendra Mudgal (BIO) KEY CONTACTS Shailendra Mudgal +33(0) shmudgal@deloitte.fr Or Arianna De Toni +33(0) adetoni@bio.deloitte.fr DISCLAIMER The project team does not accept any liability for any direct or indirect damage resulting from the use of this report or its content. This report contains the results of research by the authors and is not to be perceived as the opinion of the European Commission. Please cite this publication as: BIO by Deloitte (2014). Technical assistance related to the review of REACH with regard to the registration requirements on Final report prepared for the European Commission (DG ENV), in collaboration with PIEP.

3 Table of contents 1. INTRODUCTION Background Objectives Terminology Registration and notification Existing substances and new substances 8 2. METHODOLOGY The country approach Collecting information on the approaches: bibliographical review Reporting information on the approaches: factsheets and reporting table Country factsheets The reporting table Mapping the approaches Assessment of third countries approaches Hazard assessment Cost-effectiveness Development and assessment of new PLC and grouping approaches GENERAL REGISTRATION REQUIREMENTS FOR POLYMERS Reporting information on third countries Selected countries Data availability Country factsheet and reporting table Competent Authorities feedback Overview of requirements Mapping of the different approaches Definition of a polymer among the studied countries Exemption and reduced requirements for REGISTRATION APPROACHES FOR POLYMERS OF LOW CONCERN Approaches adopted in third countries Definition of a PLC Rationale for establishing a PLC approach Requirements for PLCs Amount of PLCs registered or exempted Hazard assessment of Criteria for determining potential hazard: theoretical framework Hazard assessment applied by Competent Authorities Proposal of a EU PLC approach Discrimination using hazard information available in REACH and CLP dossiers _ Eligibility criteria 46 3

4 Criteria on average molecular weight and oligomer content Criteria on Reactive Functional Groups (RFGs) Exception: polyesters Cost effectiveness of PLC approaches (third countries and new approach) Equations Required data for numerical application Calculation of reduction factors for third countries Conclusion on third countries approaches Cost reduction for the EU with the proposed PLC approach REGISTRATION APPROACHES FOR GROUPING POLYMERS Approaches adopted in the DSD and in third countries Definition of a group of polymer and process for determining similarity Amount of groups registered Assessment of grouping approaches with regards to environmental and health risks of Criteria for assessing grouping approaches Assessment of grouping approaches from the studied jurisdictions Proposal of a EU grouping approach Grouping with the same constituents Grouping with different constituents Cost effectiveness of grouping approaches (third countries and new approach) Equations Required data for numerical application Calculation of reduction factors for third countries Cost reduction for the EU with the proposed grouping approach CONCLUSION Third countries PLC and grouping approaches Proposed approaches for the EU ANNEXES 81 Annex 1. Country factsheets 82 Annex 2. Supporting data 196 Annex 3. Determination of FGEWs 225 Annex 4. Proposed PLC approach Reactivity of functional groups 227 Annex 5. Glossary 233 4

5 List of Tables Table 1: Structure of the reporting table Table 2: List of Competent Authorities in the studied countries Table 3: Overview of the characteristics of all studied countries Table 4: Correspondence between number-average molecular weight and composition criteria in USA, Canada, Australia, China, South Korea (K-REACH) and Taiwan Table 5: Scoring of the criteria for determining potential hazard Table 6: Inclusion of hazard assessment criteria in the different strategies Table 7: Proposed list of approved polyesters reactants for an EU PLC approach Table 8: Required data for estimating cost effectiveness of PLC approaches Table 9: Estimated cost-effectiveness of PLC in Australia, Canada and the USA Table 10: Grouped registrations in the studied jurisdictions Table 11: The different processes for determining similarity Table 12: Justification elements for read-across and their relevance for grouping Table 13: Rationale for categorisation of read-across analogues and relevance for grouping Table 14: Assessment of the Australian grouping approach with regards to environmental and health risks Table 15: Example of structure and functional groups in the category of Alpha olefins, from the OECD HPV (high production volume) Programme Table 16: Required data for estimating cost effectiveness of grouping approaches Table 17: Provisions for exemption or reduced requirements in third countries (except from PLC and grouping approaches) Table 18: Types of excluded from the PLC category (and hence subject to registration), per country Table 19: Reactivity constraints in terms of reactive functional groups (RFGs), for candidate PLCs with Mn between 1,000 and 10,000 Da Table 20: Polyesters considered as PLCs Table 21: Reduced requirements for PLCs in Canada, Australia, China and Taiwan

6 List of Figures Figure 1: Number of generic parameters used by each country Figure 2: Types of certificates available for synthetic and bio in Australia Figure 3: Routes to the Reduced Test Package (RTP) Figure 4: Number of PLCs registered/exempted per year, as compared to the total number of Figure 5: An isocyanate group allows a polymer to bind to proteins Figure 6: The relationship between Mn, oligomer content and health concern. (A) <1000 Da and (B) <500 Da oligomer content data. The low health concern are represented by open circles, and the potential health concern by filled circles Figure 7: Decision tree for determining if a polymer is a PLC Figure 8: Eligibility in a PLC approach Figure 9: The narrow range in which a group of AB co can be considered as one substance (first case) Figure 10: The narrow range in which a group of AB co can be considered as one substance (second case) Figure 11: Example of a homologous series of end-groups Figure 12: Main reasons for exemption or reduced requirements in the studied countries Figure 13 : The Polymer Flow Scheme test ( ) Figure 14: Attack of a conjugated olefinic group by a nucleophile. This is not occurring in unconjugated olefinic groups Figure 15: Activation of an olefin by a sulfone group (left) and a vinyl ether group (right) Figure 16: Synthesis of a blocked isocyanate from a free isocyanate. Thanks to the blocking agent (e.g. a ketoxime), the carbon loses its reactivity Figure 17: Illustration of the reactivity of a free isocyanate with a protein. This re action cannot occur with a blocked isocyanate. 228 Figure 18: Equilibrium between hemiacetals and aldehydes (top); equilibrium between methylolamides and formaldehyde (bottom) Figure 19: Allyl ethers and free radicals Figure 20: Alkylation of a nucleophile (NuH) by an epoxide Figure 21: The aziridine functional group Figure 22: Reactivity of the ortho and meta positions in phenol hydroxyl groups: electrophilic addition Figure 23: Hydrolysis of a cyanate group into a carbamate group Figure 24: Nucleophilic addition on pendant acrylate and methacrylate groups Figure 25: Example of lactones reactivity: binding to the N-end of a protein Figure 26: Reaction of a vinyl sulfone group with a protein cysteine residue

7 1. Introduction 1.1. Background When REACH 1 was developed, requesting registration for was deemed too difficult, because of the complexity of the polymer market, in terms of size and variability of chemical substances on the market. Therefore, the REACH provisions set out in Title II (Registration) and Title VI (Evaluation) do not apply to (Article 2(9)). The approach adopted then was to base the assessment of on monomers, and therefore register monomers only. In this regard, Article 6(3) of the REACH Directive specifies that any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that have not already been registered by an actor up the supply chain, if both the following conditions are met: the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s); the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year. This current approach to the control of is being reviewed, as Article 138(2) of the REACH Regulation specifies that the European Commission (EC) may propose, as soon as possible, a legislative proposal aiming at registering a range of selected. This legislative proposal shall be presented once a practicable and costefficient way of selecting for registration could be established 2, and after reviewing the need to register them, taking into account innovation and competitiveness and the one hand and protection of human health and the environment on the other. The Dangerous Substances Directive (DSD) 3 shares with REACH the aim to protect the environment and public health. It intended to harmonise national measures on classification, packaging and labelling of dangerous substances. Although the DSD is being progressively replaced by the CLP Directive, its provisions on are still relevant. It establishes the concept that may be grouped together into so-called families, in order to reduce testing costs and avoid unnecessary testing duplication. In third countries, national legislative schemes for chemical control often include provisions for the registration of. These provisions, as noted during the Expert Group Meeting on held by the OECD Task Force on New Chemicals Notification and Assessment in 2009, often integrate the concept of Polymers of Low Concern (PLC) 4. PLCs are deemed to have insignificant environmental and human health impacts and should therefore, according to the OECD, be submitted with reduced regulatory requirements. On the basis of a previous study 5, which aimed to evaluate the possibility of registering certain types of, the EC identified two registration approaches to be further investigated: grouping for registration and defining a category (or categories) of of low concern. The purpose of this contract is to analyse precisely the existing 1 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). 2 Article 138(2) of the REACH Directive 3 Directive 67/548/EEC on Classification, Packaging and Labelling of dangerous substances 4 OECD (2009) Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern 5 Risk & Policy Analysts Ltd, Review of REACH with regards to the registration requirements on, Part A: Polymers (Final report),

8 approaches (outside EU) and, based on this analysis, to propose one or more alternative options which could be used in the EU and to preliminarily assess these options in terms of feasibility and cost-effectiveness. This objective is in line with the recommendation of the 2013 General Report on REACH 6 to explore the need and feasibility of registering in the EU Objectives The project aims at determining other possible approaches than the current one implemented in EU for registering under REACH. The support that is to be provided by the study covering the technical and scientific aspects of the issue will allow the EC to: Prepare and publish the next general report required by Article 117 on the operation of REACH, due in 2015 and which shall include a section on and their potential registration based on article 138(2); and Determine if some should to be registered under REACH and build a legislative proposal to ensure their appropriate registration. In order to establish a practicable and cost-efficient proposal for the registration of, the EC opted for two approaches to be investigated and assessed during this project: grouping for registration and defining a category (or categories) of PLCs. The specific objectives for this project are to identify and assess the strategies relative to these two approaches, adopted in non-eu jurisdictions. The project also aims to develop alternative approaches for registering based on this analysis Terminology Registration and notification Registration refers to the submission of a dossier to a Competent Authority, by manufacturers or importers of a substance, containing information of the identity of the substances and data used to assess the risks related to this substance. Registration of a substance under a jurisdiction allows the circulation of this substance on the internal market of this jurisdiction 7. Notification refers to the fact of submitting to the Competent Authority, under specific provisions, a limited amount of information about the substance. The information provided should allow the Competent Authority to check that the substance effectively falls under the abovementioned specific provision. Notification is used in some countries in the same sense than registration. In the EU and under the DSD, the term notification is used. In this report, the term registration is used, except when discussing the practices of jurisdictions where the term notification is used Existing substances and new substances Existing substances in a specific jurisdiction refer to substances which are already registered in this jurisdiction or which were circulating on the market before the entry into force of the registration legislation. New substances are all substances which are not existing ones. 6 European Commission, Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions (General Report on REACH), This definition is in line with (19) of the REACH regulation 8

9 The non-eu obligations described in this report refer to new 8, while REACH obligations refer to all substances (both new and existing). 8 In Australia and Canada, existing may be subject to requirements if for a specific polymer, circumstances arise that may warrant reassessment of its hazards and risks. These requirements are substance-specific and are not a systematic process. They are discussed in the factsheets of Annex 1 but are not under scrutiny in the core report. Canada has launched an initiative reviewing its assessment of existing. 9

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11 2.Methodology 2.1. The country approach The team collected information by country to identify if their legislation included either a grouping or a PLC approach (or both). The selection process of relevant countries began by identifying the countries belonging to the OECD Working Group on Polymers. This step was followed by a browsing of developed and emerging countries belonging to the OECD: countries having a regulation on the manufacture/import of chemicals were analysed to determine whether were tackled. Those which specifically included provisions for were selected. The results of the country selection process are presented in section Collecting information on the approaches: bibliographical review Key sources of information on the approaches for in non-eu jurisdictions were identified, including notably two key documents: John Moore Regulatory Services (2011). Handling on a global scale: A world-wide regulatory review Paper prepared by J H Moore for ChemCon Asia (Session 7 Horizontal Issues); and OECD (2009). Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern. Based on the preliminary information available in the aforementioned documents, a deskbased search was performed with keywords such as polymer registration [name of country], polymer notification [name of country], polymer regulation [name of country], chemical programme [name of country]. The following types of documents were targeted: Texts of Acts or Regulations on management of chemicals/: these texts set out the different types of defined in the selected jurisdictions and what requirements are associated with them. They are our reference documents, but are sometimes difficult to analyse. This is why most countries have issued guidance documents along with their regulation; and Guidance documents issued by the national Competent Authorities: these documents explain the Regulations implemented in the countries and give examples. They are sometimes based on questions submitted by companies Reporting information on the approaches: factsheets and reporting table Two means for reporting the collected information were used: individual country factsheets and a reporting table summarising the collected information Country factsheets A country factsheet was drafted for each jurisdiction, describing the polymer registration scheme currently implemented there. Each factsheet is a Word document of around 10 pages containing information collected as outlined in section 2.2and structured as follows: 11 Main aspects of the scheme: this section specifies the pieces of national legislation relevant to the registration of chemicals and and

12 describes the different registration categories (types of chemicals/, review periods, etc.); Decision tree for registering a polymer under the legislation: this flow chart shows the different steps followed by a manufacturer/importer of a polymer to determine which registration category applies to his case. If a PLC or a grouping approach is supported by the legislation, the corresponding parts of the decision tree are highlighted; Generic legal requirements for not concerned by grouping or PLC approaches: this section details the data requirements for belonging to registration categories which are neither PLCs nor grouping; Principal criteria used in PLC approaches, if any: this section presents the criteria for defining a PLC under the legislation and the data requirements associated with the registration of a PLC; Principal criteria used in grouping approaches, if any: this section presents the different methods for grouping, as well as the criteria those groups shall comply with; Key points: this sections presents the advantages/disadvantages of the strategy and its transferability in the EU); Questions for the Competent Authority, asking for: o o Precisions on aspects covered by the factsheet, Information on costs, evaluation of efficiency, and motivations behind the legislation, as this information cannot be found on the Internet; and Sources of information. The Country factsheets were sent to the Competent Authorities along with a letter from the Commission in order for them to check the validity of the retrieved information and answer the questions included in the factsheet. The factsheets can be found in Annex The reporting table The reporting table is a separate Excel document to this report which aims at reporting parameters and criteria used in the studied countries in order to identify or group (including the PLC approach) for registration. The table is organised in 5 sets of columns: registration requirements, identification information, grouping approach, PLC approach and additional information. Table 1 details the information provided for each set of columns: 12

13 Table 1: Structure of the reporting table COLUMN HEADER DESCRIPTION Registration requirements Identification information Parameters Category Specific to polymer identification? Tonnage for which it is required Method of determination required? Grouping approach Parameters used for grouping Advantages Limitations PLC approach Is registration required for newly manufactured only, or is it extended to already present on the market? Sub-columns under this header, list and characterise parameters required to properly identify a polymer under the regulation Lists all parameters required for identification Specifies the category to which a parameter belongs to : structural properties, composition, physico-chemical properties, reactivity, stability, hazard properties, potential for high exposure Indicates whether a parameter is common to the identification of all regulated chemicals, including (e.g. nature of impurities) or specific to (e.g. number average molecular weight) Specifies for which quantities placed on the market a parameter is required Specifies whether the regulation requires in the submission dossier, a mention/description of testing method(s) used to determine a parameter Does the regulation use a grouping approach for registering? If yes, sub-columns must be filled. Specifies which identification parameters are used in the grouping approach Advantages associated with the grouping approach Limitations associated with the grouping approach Sub-columns under this header, aim to characterise the PLC approach implemented by the regulation 13

14 COLUMN HEADER DESCRIPTION Type of registration Criteria for exemption / reduced requirements Presence in the inventory of End use Production volumes Molecular weight Composition Physico-chemical properties Hazard Number of PLC categories? Advantages Limitations Additional information Specifies which type of registration is required for of low concern : exemption, exemption with notification or reduced requirements Specifies which criteria a polymer must fulfil to be called "low concern" Is the presence of any reactant in the existing inventory taken into account? Is the end use of the polymer taken into account? Are production volumes of the polymer taken into account? What is/are the range(s) of molecular weight used to determine if a polymer is of low concern? What is the maximum percentage of oligomeric and functional groups content in a polymer, for it to be called low concern? This is often coupled with criteria regarding molecular weight (see above) What are limit values of ionic density and water solubility for a polymer of low concern? Which hazard properties are taken into account when defining of low concern? Are they available by default, i.e. routinely determined by manufacturers? Are there more than one PLC category, with different requirements, in which a polymer could fit? Advantages associated with the PLC approach Limitations associated with the PLC approach Practical information about the regulation 14

15 COLUMN HEADER DESCRIPTION Currently implemented? Regulatory text Other sources Comparison with the OECD definition Specifies whether the regulation is currently implemented or not Title of the regulation, date of implementation Title and date of complementary documents that were used to fill the reporting table : manuals, guidance, scientific papers, etc. Is the country definition the same as the OECD definition of polymer? 15

16 The reporting table compiles all the information in a systematic manner and provides the basis for further assessment of individual approaches and for cross-analyses Mapping the approaches Using the reporting table, it is possible to map the approaches in terms of categories of parameters used to identify, in terms of type of approaches and in terms of criteria used to define PLCs. In order to map the approaches, generic parameters and an associated legend were defined, to avoid overlaps between identical parameters which are named differently among different jurisdictions. For instance, country A and country B may require Gel Permeation Chromatography (GPC) data to be submitted. Country A may ask for GPC data while country B may ask for permeation chromatograms : these two parameters refer to the same identification item but are named differently. A generic parameter could then be GPC data. Through these generic parameters, diagrams were developed, showing trends in the use of these parameters in the different countries. Furthermore, based on the factsheets, a comparative analysis was performed along the following axes: the OECD definition, as defined during the Second Meeting of the OECD Expert Group on Polymer Definition held in Paris, France (October 1991) : A 'POLYMER' means a substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a 'MONOMER UNIT' means the reacted form of a monomer in a polymer." The definition of a PLC and requirements to determine PLCs; Other approaches than PLC for exemption or reduced requirements; Grouping approaches; Rules for joint submissions or grouped registrations; and How monomers are considered during the registration process. This macroscopic analysis allowed to identify trends in the approaches applied in countries implementing a regulation on polymer registration. Furthermore, the answers to questionnaires from the various Competent Authorities allowed a better understanding of the rationale of their national legislation and provided some elements for the cost-benefit analysis. The results of the mapping exercise are presented in section 3.3 and detailed in section 4.1 (PLC approaches) and 5.1 (grouping approaches). This work of analysis is the basis to develop one or more alternative approaches for polymer registration in EU Assessment of third countries approaches The third countries approaches were assessed in terms of hazard assessment and in terms of costeffectiveness Hazard assessment The primary aim of the approaches used in third countries for registering is to address potential polymer hazard, in order to minimise risks they could pose to human health and the environment. It is therefore important to evaluate the extent to which and how the different countries address polymer hazard. First, a set of criteria characterising polymer hazard was defined 16

17 thanks to a literature search on Google and Google scholar and thanks to already identified documents: the OECD study 4 and a publication by Lithner et al 9. These criteria were scored by relevance (with scores such as high, medium, low, for instance). The framework developed during this step is presented in section An additional framework was developed in section in order to assess grouping approaches with regards to the similarity in terms of environmental and health risks among all members of a group. The third countries approaches were then assessed against these criteria. The assessment of the overall approaches, with a link to PLC approaches, is presented in section The assessment of grouping approaches is presented in section Cost-effectiveness This step is meant to assess how PLC and grouping approaches allow for a reduction of costs of registration versus a full registration. Thanks to data on costs of registration and on the number of registered, one can evaluate the reduction factor of these approaches. Data was collected from the Competent Authorities, as questions asked at the end of the factsheets. A calculation methodology for assessing cost-effectiveness was developed and conclusions were drawn. The calculation methodology is presented in section (PLC approaches) and (grouping approaches). The assessment of cost-effectiveness of the countries strategies is presented in section (PLC approaches) and (grouping approaches) Development and assessment of new PLC and grouping approaches New PLC and grouping approaches were developed thanks to in-house expertise and to third countries information which was gathered and assessed during the course of the project. The PLC approach was developed with the aim to ensure no reasonable hazard is associated with qualifying as PLCs. The hazard criteria defined for assessing the third countries approach (see previous section) were used: the scores assigned to each one of them helped in the design of a hazard assessment framework (which parameters should be prioritised for determining hazard in a decision framework). The new proposed PLC approach is detailed in section 4.3. The grouping approach was developed with the aim that similar be registered with one application. It is based on approaches implemented in third countries and on the approach implemented in the EU under the DSD. The new proposed grouping approach is detailed in section 5.3. The newly developed PLC and grouping approaches were assessed with regards to the cost reduction they could allow in the EU as compared to a situation in which all would be registered individually and with the same requirements, using the cost-effectiveness analysis conducted for the third countries. The results are presented in section (PLC approach) and (grouping approach). 9 Delilah Lithner, Åke Larsson, Göran Dave, Environmental and health hazard ranking and assessment of plastic based on chemical composition, Science of the Total Environment, 409, 2011,

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19 3.General registration requirements for The non-eu approaches described in this section refer to new, while REACH obligations refer to all substances (both new and existing) Reporting information on third countries Selected countries The list of countries/jurisdictions on which country factsheets were drafted is the following; USA, Australia, Canada, Japan, California, China, New Zealand, Philippines, South Korea and Taiwan. USA 10, Australia, Canada, Japan were selected because they belong to the OECD Working Group on Polymers. China, New Zealand, Philippines, South Korea and Taiwan have regulations on the manufacture/import of chemicals, which specifically include provisions for, and were therefore included in the list. Switzerland, Mexico and Turkey were also initially analysed but finally considered not relevant because their regulation does not tackle Data availability Reliable information (i.e. from official sources) on registration schemes for and associated data requirements were generally available on the Internet. However, for some Asian countries, no translations (or only partial ones) of official documents were available, so, most of the time, sources are consultancies providing services to manufacturers/importers for them to comply with the legislation which published analysis on the web Country factsheet and reporting table The country factsheets (one for each jurisdiction) can be found in Annex 1. On the basis of the key characteristics of each scheme, notably with regards to reduced requirements for certain types of (PLCs, R&D, low volume, etc.), five countries were identified as particularly interesting and are considered a priority for further analysis: Australia, Canada, Japan, South Korea, and the USA. The reporting table summarising the approaches from the selected countries can be found as a separate document Competent Authorities feedback Competent Authorities (CAs) were asked for feedback on the factsheets and for information useful for the analysis (cost-benefit, reduction in the number of registration, rationale for implementation). All CAs have answered, except for China, the Philippines and South Korea. 10 it was noticed that California voted a regulation for a safer use of chemicals in addition to the national framework regulating chemicals at US level, the Toxic Substances Control Act (TSCA). Therefore, California was added to the list of the jurisdiction of interest. 19

20 Table 2: List of Competent Authorities in the studied countries Country Competent Authority USA Australia Canada Japan US EPA Australian Government Department of Health Health & Environment Canada Ministry of Economy, Trade and Industry (METI) National Institute of Technology and Evaluation (NITE) California China New Zealand Philippines South Korea Switzerland California s Department of Toxic Substances Control (DTSC) Ministry of Environmental Protection Environmental Protection Agency (EPA) of New Zealand Environmental Management Bureau of the Department of Environment and Natural Resources (EMB-DENR) Ministry of Environment (MoE) Department of the Environment, Transport, Energy and Communications (DETEC) Taiwan Environmental Protection Administration (EPA) Executive Yuan, R. O. C. Taiwan 3.2. Overview of requirements Under all jurisdictions in third countries, existing are not subject to registration (see section for a definition of existing substances). Only new have to be registered. However, in Canada and Australia, existing may be subject to requirements on the Competent Authority s request. The number of parameters used for polymer submission in the studied jurisdictions amounts to a total of 473 (see reporting table). However, some countries use the same parameter, but name it differently, so that a list of parameters cannot be directly drawn from the reporting table. A correspondence table was established between the raw list of parameters and a list of so-called generic parameters, defined in order to avoid duplication of similar parameters (see the sheet Definition of generic parameter of the Reporting Excel file). The list has been reduced to 162 generic parameters (see the sheet List of generic parameters of the Excel file). These parameters are those required by at least one of the Competent Authorities of the studied jurisdictions when a polymer is submitted. Parameters required for submission of a polymer are identification parameters, information on quantity and use and information on potential hazard. The generic parameters that are the most used in the studied countries (i.e. which are used by more than 5 countries) are the following: Identification: o o o CAS number Other identity code than the CAS number Chemical name 20

21 o o o o o o o o o o o o o o Molecular formula Number-average molecular weight Weight-average molecular weight Structural formula Molecular weight distribution Analytical data (spectra, GPC, HPLC) w% of polymer components below 1,000 absolute molecular weight w% of reactants Water solubility Octanol-water partition coefficient Melting point Boiling point Physical state Purity Quantity and use: o o o Modes of transportation and storage Estimated annual quantity to be manufactured/imported Uses Potential hazard o o o o o o o o Expected exposure (number of people, circumstances, pattern) Biodegradability Eye irritation Skin sensitisation Toxicity by inhalation Skin irritation Oral toxicity Acute toxicity test for aquatic species The above list of parameters includes basic identification information such as CAS number and molecular weight, as well as information on the structure and composition of the polymer. Common physico-chemical properties are also often required (water solubility, octanol-water partition coefficient, melting point), as well as information of potential hazards. A detailed graph showing the number of countries using each parameter is available in the sheet Number of countries using each parameter 11 of the Excel file and is not included in the report because of its large size. The studied countries use an average of 35 parameters when submitting for registration (Figure 1). However results presented in the graph must be considered with caution because for some countries such as Japan or Taiwan, little information was available. 11 Abbreviated Nb of countries using each pm in the Excel file 21

22 Number of generic parameters 100 Figure 1: Number of generic parameters used by each country Mapping of the different approaches This section establishes a macro-level comparison between law provisions of the studied countries when it comes to notifying, i.e. the legal requirements for registration. The axes of analyses underlying the comparison are presented in Table 3. The Californian scheme is not considered in this analysis because of the specific nature of the jurisdiction and of the regulation: it aims at complementing the US notification program and does not include any specific notification process or submission of information. 22

23 Table 3: Overview of the characteristics of all studied countries Country Use of OECD polymer definition PLC approach Other approaches than PLC for exemption or reduced requirements Grouping approach Joint submissions or grouped registrations Monomer consideration in registrations Australia Yes Yes 2% rule Manufactured/imported inferior to certain limits volume Number average molecular weight above certain thresholds Yes "group assessment" The presence of monomers in the inventory is cause for exemption or reduced requirements (including the PLC approach) Not hazardous according to the GHS 12 Exists in other regulatory controlled regions Canada Yes Yes 2% rule Use for R&D purposes Presence of all reactants in one of the inventories Yes "matched notification" "consolidated notification" The presence of monomers in the inventory is cause for exemption or reduced requirements (including the PLC approach) Presence in the non-domestic inventory Exposure USA Yes Yes 2% rule Manufactured/imported inferior to certain limits volume Yes joint submission "consolidated notice" The presence of monomers in the inventory is cause for exemption or reduced requirements (including the 12 GHS or UN GHS, is the Globally Harmonized System of Classification and Labeling of Chemicals created by the United Nations 23

24 Country Use of OECD polymer definition PLC approach Other approaches than PLC for exemption or reduced requirements Grouping approach Joint submissions or grouped registrations Monomer consideration in registrations Use for R&D purposes PLC approach) Low release and exposure Japan Yes, with an additional criterion Yes 2% rule Yes% rule Onium rule Manufactured/imported inferior to certain limits volume No No The presence of monomers in the inventory is cause for exemption or reduced requirements (including the PLC approach) Presence in the inventory of monomers or other reactants Number average molecular weight above certain thresholds Certain properties physico-chemical South Korea Yes Yes 2% rule Presence in the inventory of monomers or building blocks Manufactured/imported inferior to certain limits volume No joint submission The presence of monomers in the inventory is cause for exemption or reduced requirements (including the PLC approach) China Yes Yes 2% rule 24 Presence in the inventory of monomers or building blocks Manufactured/imported volume No joint submission The presence of monomers in the inventory is cause for exemption or reduced requirements (including the

25 Country Use of OECD polymer definition PLC approach Other approaches than PLC for exemption or reduced requirements Grouping approach Joint submissions or grouped registrations Monomer consideration in registrations inferior to certain limits PLC approach) Taiwan n/a Yes 2% rule No joint submission - Occurs in nature without physical and chemical process Manufactured/imported inferior to certain limits volume Not hazardous according to the GHS Philippines Yes No 2% rule Presence in the inventory of monomers or other reactants Presence in the inventory of in which 2 or more of the top (by weight) monomers are included No No The presence of monomers in the inventory is cause for exemption or reduced requirements (including the PLC approach) Exists in other regulatory controlled regions New Zealand Yes No Non-hazardous using HSNO criteria No No Monomers are notified under a specific regime 25

26 Definition of a polymer among the studied countries All countries are using the OECD definition of a polymer: The Second Meeting of the OECD Expert Group on Polymer Definition held in Paris, France (October 1991) confirmed the definition 13 of a polymer as developed during the First meeting in 1990: A 'POLYMER' means a substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a 'MONOMER UNIT' means the reacted form of a monomer in a polymer." South Korea, China, Canada, USA and Japan transposed this definition into more quantitative terms (the other countries use the OECD definition as is). The phrase a simple weight majority of molecules containing at least three monomer units was adapted as more than 50 % of the molecules must contain at least three monomer units and the phrase [ ] consists of less than a simple weight majority of molecules of the same molecular weight was transposed as no single molecular weight molecule can be more than 50 % (w/w) of the total distribution. Furthermore, Japan adds to the OECD definition a number average molecular weight criterion: the number average molecular weight (Mn) of a polymer must be 1,000 Da Exemption and reduced requirements for All jurisdictions propose approaches (including for some of them, PLC and/or grouping approaches) for exemption of reduced requirements for. Provisions for reduced requirements/exemption are presented in Table 17 of Annex 1 (except for PLC and grouping approaches) and discussed below Exemption for existing Some are not considered new and are therefore not subject to any regulatory requirement. In all jurisdictions but New Zealand, a polymer is not considered as new if it is manufactured by modifying the formulation of an existing one by adding existing reactants, none of which constitutes more than 2% w/w of the polymer. This criterion is commonly called the 2% rule, and is used in REACH for the registration of monomers. Japan defined an additional 1% rule, allowing a polymer manufactured by modifying the formulation of an existing one by adding reactants, none of which constitutes more than 1% w/w of the polymer, to be considered as an existing polymer. The 1% rule differs from the 2% rule by allowing the presence of reactants that may not be existing ones. Japan and South Korea (TCCA) also consider as existing the following : block whose unit are existing substances and graft whose stem and branch are existing substances Exemption or reduced requirement for low volumes Polymers can be exempted from registration on grounds related to the manufactured/imported volume of said polymer. The USA grant exemptions for manufactured/imported at less than 10 tons/yr, while Japan and Taiwan exempt those manufactured at less than 1 ton/yr. Additionally, an exemption is available for the 1 10 ton/yr range in Japan, provided the polymer is non-degradable and non-accumulative. Other countries provide reduced requirements for low volumes. For instance, Australia has a set of permits allowing the manufacture/import of chemicals

27 (including ) at low volumes with reduced requirements: the Low volume chemical (LVC) has a limit of 100kg/y, or 1000kg/y if hazard criteria are met, while the Controlled Use (Export Only) Permit (EOP) has a limit of 10t/y. Provisions for low volumes are often associated with other criteria, such as the nature of the polymer, the number average molecular weight, the use or the presence in the national inventory of monomers or other reactants. For instance, different types of certificate notifications are possible in Australia based on the nature of the polymer, the tonnage, molecular weight and use (Figure 2). Figure 2: Types of certificates available for synthetic and bio in Australia LTD: Limited notification; STD: standard notification Manufacturers of bio and synthetic can apply for a Limited notification certificate (LTD) the less stringent certificate if the production volumes are below 1 tons/yr. The limit is higher if the polymer is site-limited (10 tons/yr). Manufacturers of synthetic with Mn above 1,000 Da can also apply from an LTD for higher volumes: with higher molecular weights are commonly regarded as less hazardous. However, bio cannot benefit from the 1,000 Da provision for LTD because they are generally considered more hazardous than synthetic 14. Reduced requirements are also built on an exposure basis: the higher the quantity produced, the higher the exposure; moreover, if a polymer is site-contained, its exposure is low. Here, the rationale for reduced requirements is therefore a combination of hazard and exposure. 14 Another example is Canada, which provides for additional requirements for bio, depending on their use. 27

28 Exemption or reduced requirement for R&D Polymers used for R&D purposes often benefit from exemptions or reduced requirements, because they are manufactured/ imported in small volumes and are mostly site-contained (low exposure). The USA exempt all R&D from registration, while in Japan and Australia, they must be manufactured/imported at less than 1 ton/ yr to be exempted. In Canada, R&D benefit from reduced requirements. Other exemptions or reduced requirements exist in the studied jurisdictions, but are more anecdotal. For instance, Australia and New Zealand provide reduced requirements and exemptions (respectively) for they consider as non-hazardous. Australia uses the GHS criteria to determine if the polymer is not hazardous, while New Zealand developed its own criteria (HSNO criteria). Australia also allows specific treatment for existing in other regulatory controlled regions (Canada and USA), as their regulations are similar Exemption or reduced requirement linked to the status of registration of monomers In all countries but New Zealand, monomers are registered as any other chemical substance. In New Zealand, a specific regime for monomers was set up. In all countries but Taiwan, Switzerland and New Zealand, the presence of monomers in the inventory is cause for exemption or reduced requirements, notably because they appear in the criteria for qualifying as a PLC. In Australia, Canada and the USA, polyesters synthesised from an approved list of existing monomers can be notified as PLCs (see section 4.1.1), and thus benefit from reduced requirements. The extent of this practice could not be evaluated in Canada and the USA because they do not track the various criteria each notification meets: if a polymer is notified as a PLC, the Competent Authority does not report in its database whether the polymer is an approved polyester or a PLC of another nature (for details on criteria making a polymer a PLC, please see section 4.1.1). In Australia, there have been 3 assessments of PLCs utilising the polymer criterion (for 3 separate companies) since This represents 1% of all PLC notification (301 PLCs were notified the same period) 15. Furthermore, in Japan, a PLC must fulfil one of three sets of criteria to be considered as PLC; one of these sets of criteria specifies that all the monomer(s) must be existing chemical substance(s). Likewise, in South Korea, a non-ionic polymer with number average molecular weight Mn 1,000 Da can be a PLC if all starting monomers/reactants are listed in KECI (Korean Existing Chemical Substances Inventory) and not listed on the toxic chemicals listing (excluding inorganic compounds) specified/published by NIER (National Institute of Environmental Research). In Japan, from April, 2013 till December, 2014, 8 consisting of existing monomers were notified as PLCs, which represents 11% of PLCs notified during the same period (total number: 74) 16. The status of registration of monomers (i.e. if they are listed on the national inventory or not) also leads to other specific provisions. In Canada, requirements differ regarding whether the polymer is on the NDSL 17 (or their reactants, including monomers, are on the DSL or the NDSL), or if it is not on the NDSL. Polymers manufactured/imported at volumes between 1 ton and 10 tons and with all their monomers on either list, have less requirements (this not the case for manufactured/imported at less than 1 ton). As of December 2014, 301 have benefited from reduced requirements in Canada because their monomers were registered in the DSL or NDSL. This represents 31% of the total number of manufactured/imported at volumes between 1 ton and 10 tons and notified during this period (957 of that category were notified during the same period). Although Environment Canada did not assess the actual reduction of costs, it can be 15 Personal Communication from NICNAS 16 Personal Communication from METI 17 The NDSL (Non- Domestic Substances List) and the DSL (Domestic Substances List) are the two Canadian inventories 28

29 said that companies benefitting from reduced requirements experience a reduction of costs because they have less data requirements 18. Therefore, the study of third countries strategies regarding synthesised from existing monomers shows that this is not an option frequently used by companies. Nevertheless, jurisdictions of Australia, Canada and the USA are looking into making registration of polyesters synthesised from existing (and approved) monomers a more favourable option for companies. This will involve extending the list of approved monomers: see section PLC and grouping approaches Seven out of ten jurisdictions have adopted a PLC approach: Canada, China, Australia, USA, Taiwan, South Korea, and Japan. The approaches are discussed and assessed in section 4. USA, Australia and Canada allow submission of a single registration for similar, under the names consolidated notice, group assessment and consolidated notification respectively. The approaches are discussed and assessed in section Personal Communication from Environment Canada 29

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31 4.Registration approaches for Polymers of Low Concern 4.1. Approaches adopted in third countries National approaches are described in the country factsheets. This section presents a comparative analysis. The approach adopted in the DSD for Reduced Test Package is also briefly presented Definition of a PLC The OECD Polymer Working Group agreed on a general definition of a PLC (OECD, 2009): Polymers of low concern are those deemed to have insignificant environmental and human health impacts. Therefore, these should have reduced regulatory requirements. However, no specific criteria were defined by OECD, as criteria used to establish a polymer as a PLC are not harmonised among studied countries; however, strong similarities exist in this regard. A review of the requirements in the seven countries having a PLC approach shows that some are not eligible to qualify for being a PLC and are de facto excluded from any PLC category. Criteria for exclusion include: containing certain elements: for instance, Canada does not accept that have any atomic elements other than carbon, hydrogen, nitrogen, oxygen, silicon, sulphur, fluorine, chlorine, bromine or iodine covalently bound to carbon; cationic ; water-absorbing ; degradable ; and hazardous : for instance, in Taiwan, the polymer must not be classified according to the GHS 12 as a carcinogenic, reprotoxic, or environmentally hazardous. Table 18 of Annex 1 details how those criteria are applied in each country of study. Assessment of those criteria from a hazard point of view is provided in section Once confirmed that it is not excluded from qualifying as a PLC, the candidate polymer must fulfil a set of criteria in order to be defined as a PLC. Those criteria differ depending on its number-average molecular weight (Mn): candidate with Mn in the 1,000 10,000 Da range must comply with more stringent criteria than those with Mn superior to 10,000 Da, because they are more likely to be reactive; at 10,000 Da, data show that are essentially inert 19. Closely linked to the Mn criteria are restrictions on oligomer 20 content: USA, Canada, Australia, China, South Korea (K- REACH 21 ) and Taiwan set strict conditions on the composition of the polymer in terms of low molecular species (Table 4). 19 Feedback from US EPA 20 Oligomer: a low molecular weight species derived from the polymerization reaction 21 Presently, in South Korea, chemicals and are subjected to the Toxic Chemicals Control Act (TCCA), but starting on 1 January 2015, this regulation will be divided into the Act on Registration and Evaluation of Chemicals of Korea (also commonly known as AREC or K-REACH that focuses on registration and evaluation of substances) and the Chemicals Control Act (CCA that focuses on the control of hazardous substances and response to chemical accidents). 31

32 Table 4: Correspondence between number-average molecular weight and composition criteria in USA, Canada, Australia, China, South Korea (K-REACH) and Taiwan Mn criteria (Da) Composition criteria 1000<Mn<10,000 Mn>10,000 The polymer must contain less than 10% oligomer content of molecular weight below 500 Da and less than 25% oligomer content of molecular weight below 1,000 Da The polymer must contain less than 2% oligomer content of molecular weight below 500 Da and less than 5% oligomer content of molecular weight below 1,000 Da In this regard, Japan and the South Korean TCCA 22 adopted different approaches. Japan has a single weight % <1000 Da oligomer content cut-off of <1%, while under TCCA, no conditions on oligomer content are set. Candidate belonging to the 1,000 10,000 Da range must also comply with criteria directly addressing hazard concerns. In all countries but South Korea, they consist of criteria on the amount of reactive functional groups, as measured by the Functional Group Equivalent Weight (FGEW) present in the candidate polymer: a FGEW is the weight of polymer that contains one equivalent of the functional group; or the ratio of Mn to the number of functional groups in the polymer. A method for calculating FGEWs is provided in Annex 3. Table 19 in Annex 1 shows which functional groups are concerned in each country, and which restrictions apply. Functional groups such as carboxylic acid groups, aliphatic hydroxyl groups, ordinary un-conjugated olefinic groups, halogens or blocked isocyanate are considered of low concern, because they generally lack reactivity in biological settings. Groups of higher concern have evidence of human health hazard adverse effects in humans or conclusive evidence of severe effects in animals: e.g. aziridine, isocyanate or thioiscyanate groups. In South Korea, hazard concerns are not addressed considering functional group content. According to TCCA, with Mn between 1,000 Da and 10,000 Da must comply with the following criteria: All starting monomers/reactants should be listed in KECI (Korean Existing Chemical Substances Inventory) and not listed on the toxic chemicals listing23 (excluding inorganic compounds) specified/published by NIER (National Institute of Environmental Research); Polymers should not be synthesised from toxic chemicals, observational chemicals or new chemicals, and epoxy-compound; and The PLC s water solubility should be less than or equal to 5 mg/g at ph 2, 7 and 9. According to K-REACH, with Mn between 1,000 Da and 10,000 Da must not contain more than 2% w/w of the following monomers: hazard chemical substances, epoxy compound, aziridine compound or new chemical substance. Furthermore, it was determined from toxicity data that indicated polyesters made from certain specific alcohols and acids and meeting the eligibility criteria would be considered PLC regardless of MW or oligomeric content. Therefore, in Australia, Canada, USA and China, all the aforementioned criteria (Mn, oligomer content, amount of reactive functional groups and other hazard concerns) do not apply if the candidate polymer is a polyester from an approved list (see Table 20 in Annex 1). In this case, the polymer is considered a PLC by the mentioned jurisdictions regardless of number average molecular weight or oligomeric content. The Polyester List was created and amended once by the US EPA for use in the administration of TSCA and has been adopted in full by the jurisdictions of Canada and Australia. The monomers/reactants were proposed by industry and were accepted to the Polyester List if they did not pose a concern to human health and the environment. This is based on the assumption that polyesters will eventually degrade to the monomer units; hence the toxicity of the monomer/reactants will be most relevant for environmental considerations. Similarly, since the 22 Toxic Chemicals Control Act, 23 Toxic chemicals listing from National Institute of Environmental Research: 32

33 polyesters on the list do not need to meet molecular weight requirements (and could therefore be relatively low molecular weight ) the hazard properties of the monomers/reactants serve as an indicator of the toxicity of the parent polyester to human health. The monomers are considered a worst-case indicator of toxicity given absorption is necessary to cause effects and this will be reduced for the larger polyester molecules. Feedback from industrial stakeholders indicated they wanted additional monomers on the approved list. A project currently being run multilaterally through the OECD Clearing House on New Chemicals is seeking to do this in a harmonised way (since the US, Canada and Australia all have an approved polyester monomers list) 24. The approach adopted in the EU under the DSD is sensibly different from the approaches of the priority countries (in particular, USA, Canada and Australia). Under the DSD, a polymer for which a Reduced Test Package is acceptable must meet the following criteria: It must be "non-readily degradable" Have a high number-average molecular weight (Mn). The extractivity in water must be <10 mg/l, excluding any contributions from additives and impurities Less than 1 % of species with a molecular weight <1000. There is no eligibility criteria, although there are restrictions on degradability and water solubility (which are parameters included in eligibility criteria of third countries). The restriction on oligomer content is the same as in Japan and stricter than in Australia, Canada and Australia. The concept of RTP has been extended post-annex VII D such that where a polymer does not comply with one of those criteria, it may still be possible to reach RTP or similar status by balancing the presumed, but still low, bioavailability that is implied from knowledge of the properties of the component monomers (Figure 3) Personal Communication from NICNAS 25 EC (2002) Manual of decisions for implementation of the sixth and seventh amendments to directive 67/548/EEC on dangerous substances (directives 79/831/EEC and 92/32/EEC) 33

34 Figure 3: Routes to the Reduced Test Package (RTP) Notably, the restrictions on oligomer content are less stringent than in the original definition 26, as containing up to 10% species with Mn less than 1,000 Da can be RTP. Furthermore, a polymer can enter the route to RTP as described in Figure 3 only if does not contain some reactive functional groups: acid halides; acid anhydrides; aldehydes; hemiacetals; methylolamides,-amines or -ureas;alkoxysilanes (> C2); allylethers; conjugated olefines; cyanates; epoxides; imines; substances with unsubstituted ortho or para positions to phenolic hydroxyl, pendant acrylates and methacrylates; aziridines; carbodiimides; halosilanes; hydrosilanes; hydrazines; isocyanates; isothiocyanates; alpha or beta lactones; methoxy or ethoxy silanes; vinylsulfones or analogous compounds. These groups correspond to the moderate and high concern groups in the Australian, US and Canadian PLC approaches (see Table 19 in Annex 1). 26 In the original version of Annex VIID, RTP- had less than 1 % of species with M < 1,000 (the percentage refers only to molecules (components) directly derived from and including monomer(s), excluding other components e.g. additives or impurities). 34

35 Rationale for establishing a PLC approach The criteria for defining PLCs, as described above, were first developed by US EPA for the US PLC approach (the so-called Polymer Exemption ). The rationale was to identify characteristics which could precisely define, in a rule, that US EPA had seen whose risk was minimal. This resulted in identifying three distinct types of which US EPA felt met the risk criteria (shall not present an unreasonable risk) under section 5(h)(4) of the TSCA statute (see USA factsheet for more information). Although the other jurisdictions do not define the exact same types of PLCs, the criteria remain sensibly similar. In the EU, RTP Polymers were defined because it was recognised that some are not able to cause systemic effects which are toxicologically and/or ecotoxicologically relevant Requirements for PLCs Exemption USA, South Korea and Japan exempt PLCs from registration. In South Korea and Japan, the manufacturer/importer of a PLC must submit an application to the Competent Authority, proving that the new polymer is indeed a PLC. In the USA, no application is necessary, but manufacturers/importers must keep all relevant documents in case of an inspection. They must also submit information once a year, telling US EPA how many they manufactured/imported that year through the Polymer Exemption Postcard Notifications which allows the US EPA to estimate that around 200 /yr are exempted 27. However, US EPA receives around 200 polymer pre-manufacture notifications (PMNs) per year (29% of polymer PMNs), called "Eligible Drops", that meet the criteria of PLC but are nonetheless submitted to EPA as PMNs. US EPA suspects that they may have been first manufactured/imported under the Polymer Exemption Rule, and that the manufacturer/importer now wants the polymer on the TSCA Inventory: manufacturers say customers prefer knowing the polymer is on the Inventory Reduced requirements In Canada, Australia, China and Taiwan, the manufacturer/importer of a PLC must submit a notification, but requirements are reduced compared to regular. Differences exist between these four countries in terms of the amount of data required a PLC registration: while Canada and Australia have quite extensive registration forms, China and Taiwan do not require much information (see Table 21 in Annex 1). Required data include proofs that the polymer is a PLC (thanks to test results) as well as information on hazards: for instance, human health and environmental implications must be reported in Australia Amount of PLCs registered or exempted The Competent Authorities (CAs) of the studied countries were contacted in order to gather information on the implementation of their PLC approach, for further discussion (see section 3.1.4). Only Japan, Australia, Canada and the USA provided data. Based on the Polymer Exemptions reported to the US EPA annually as postcards, there are approximately 200 benefiting from the PLC exemption in the USA. In Australia, an average of 55 PLCs is notified per year. Moreover, manufacturers/importers of a PLC can apply for a self-assessment certificate (SAPLC), for which they must provide an assessment report detailing specific information: an average of 10 PLCs is self-assessed per year. In Canada, the regulatory term for PLCs is RRR (Reduced Regulatory Requirements Polymers). Around 116 RRR are notified per year. 27 Feedback from US EPA 35

36 Number of notifications/registration/reported exemptions, per year In Japan, according to the Ministry of Economy, Trade and Industry (METI), the number of that benefited from the PLC exemption is 230 cases in total from FY 2011 to March, 2014 (which amounts to around 71 per year). Figure 4 below presents the number of registrations/reported exemptions related to PLCs, as compared to the total number of, in USA, Australia Canada and Japan. Figure 4: Number of PLCs registered/exempted per year, as compared to the total number of PLC Other USA* Australia Canada Japan * In the USA, other notifications include the 200 Eligible drops ( meeting the criteria of PLC but nonetheless submitted to EPA as PMNs). The figure shows that the country where the number of polymer registrations (PLC or non-plc) is the highest is the USA. This is probably due to the fact that the US market is much bigger than the Australian, Canadian or Japanese market. The figure also shows that around half of the registered/exempted are PLCs. In Australia and Canada, there are more PLCs being notified than regular, which shows that there are less high-concern than low-concern and that it is beneficial for companies to notify a low concern polymer as a PLC Hazard assessment of The primary aim of the approaches used in third countries for registering is to address potential polymer hazard, in order to minimise risks they could pose to human health and the environment. After laying out the criteria for determining potential hazard as identified in the literature this section looks at how the different countries apply them in their regulations. This gives information on the extent to which the different countries cover hazard assessment of Criteria for determining potential hazard: theoretical framework Polymers are generally not reactive and their large size prevents them from crossing biological membranes. Polymer hazard might however be brought by non-polymeric substances within the 36

37 polymer product (residual monomers, impurities from the polymerisation process or degradation products) 28. There are only few recent scientific or technical papers on hazards of : the OECD study 4, the Lithner 29 paper (2011), the US EPA Assessment of Polymers 30 and the Toxicology Excellence for Risk Assessment (TERA) Decision Tool 31. It must also be mentioned that the OECD publication and the TERA report include information reported by the US EPA and other competent authorities. The review of those publications showed that the main criteria for determining the potential hazard of are the following: Information on health and environmental hazards. This includes hazard classification according to the UN GHS or any relevant national legislation and/or toxicity results from tests on the polymer. Polymer class. Experimental work conducted by the OECD and the modelling exercise performed by Lithner (2011) show that belonging to some chemical classes are potentially hazardous: namely polyacrylates, polyurethanes, polyvinyls, epoxy resins and polyacrylonitriles. The main reason leading to classifying those as potentially hazardous is the presence of unreacted toxic monomers (e.g. vinyl chloride or isocyanate), the range of Mn, and oligomer content. However, as stressed by the OECD study, no systematic correlation has been established between polymer class and hazard. One notable exception relates to the polyester family: polyester synthesised from a wide range of reactants (see Table 20 for examples) have been determined as being nonhazardous. Low average molecular weight. Polymers with smaller average molecular weights are more likely to cross biological membranes. They are therefore more likely to be hazardous: the OECD study notes that with Mw 1000 Da are more likely to pose health and environmental concern. Therefore, the presence of oligomers 20 in a polymer increase the probability of its being hazardous, as oligomers can migrate from the polymer material to biological media. Presence and content of reactive functional groups (RFG). Polymer toxicity can be brought by the presence of some specific functional groups present at the surface of the polymer material. These reactive functional groups of concern are mostly alkylating agents (they bind with DNA and/protein and denatures them, leading to adverse effects in biological organisms) and electrophilic groups (leading to DNA damage). The most hazardous functional groups include acrylates, isocyanates, aziridines, hydrazines and vinyl sulfones. Presence, content and properties of residual monomers. Polymerisation reactions used in industrial processes rarely proceed to completion, thus leading to the presence of unreacted residual monomers in the polymeric material 32. Some of these monomers, such as vinyl chloride, acrylonitrile and isocyanate are toxic and therefore bring hazard to the polymer material. According to industry information, most concern regarding polymer hazard seem to lie with unreacted monomers, especially when the polymer is intended for further polymerisation (RPA, 2012). Indeed, such are intermediates and 28 Substance intentionally added to the polymer, such as additives, are not considered part of the polymeric substances and must be treated separately. 29 Delilah Lithner, Åke Larsson, Göran Dave, Environmental and health hazard ranking and assessment of plastic based on chemical composition, Science of the Total Environment, 409, 2011, Boethling, Robert S. and Nabholz, J. Vincent, Environmental Assessment of Polymers under the U.S. Toxic Substances Control Act, pp , in Ecological Assessment of Polymers Strategies for Product Stewardship and Regulatory Programs, Hamilton, John D. and Sutcliffe, Roger (eds.), (1997) Van Nostrand Reinhold. 31 Gadagui et al (2013) A Decision Tool for Assessing Polymers and Polymeric Substances with Potential Hazards to Human Health 32 Araújo (2002): Techniques for Reducing Residual Monomer Content in Polymers: a Review, Polym Eng Sci, Vol 42, pp

38 therefore do not undergo residue removal as thoroughly as other. Furthermore, they are intended to be easily reactivated for polymerisation. Those parameters are not completely independent; for instance, correlations exist between the class of polymer and the presence of toxic unreacted monomers. In the current state of knowledge and to have a complete picture of polymer hazards, it is necessary to take into account all these criteria. The criteria were scored with regard to their relevance in determining potential hazard (Table 5). Table 5: Scoring of the criteria for determining potential hazard Criteria Information on health and environmental hazards of the polymer Polymer class Low average molecular weight Presence and content of reactive functional groups (RFG) Presence, content and properties of residual monomers, impurities and degradation products Score of relevance High Low Medium Medium Medium-High Direct information on health and environmental hazards was given the highest score because it provides data from standardised experimental tests: hazard parameters such as LC50 or LOAECs are the most relevant for saying whether a substance is hazardous or not. This criterion also includes information from the UN GHS, the internationally recognised classification system of chemicals. All the other criteria are not a direct measurement of hazard but indirect ways to determine hazard thanks to specific properties of. They cannot be assigned a high score, but some are more relevant than others. Thus, the lack of systematic correlation between polymer class and polymer hazard lead to a low score for this criterion. On the other hand, the criterion related to the presence of unreacted monomers was given a score of medium-high : it is a known fact that the presence of residual monomer (e.g. carcinogenic vinyl chloride in PVC) may create hazards as a result of longterm exposure, such that polymer producers strive for reducing residual monomer content in 32. The presence and content of RFGs in a polymer is a good clue as to whether the polymer may be hazardous: one can tie, at molecular level, reactivity of some groups to adverse effects on DNA or proteins. For instance, a polymer containing an isocyanate reactive group (e.g. situated at the surface of the polymer) can bind to a protein to form a conjugate (Figure 5). One can then predict that some proteins may be denatured by the isocyanate reactive groups and cause hazard. Figure 5: An isocyanate group allows a polymer to bind to proteins R N C O H 2 N R R H O HN N C R Isocyanate group Protein Protein conjugate Tests were performed, trying to link the presence and content of RFG to polymer hazard. Those performed by US EPA during their polymer assessment study allowed them to classify RFG according to three categories of concern (see section and Table 19), while the OECD study could not conclude because of insufficient available data on reactive functional groups to carry out detailed analyses Thus, the complexity of chemical interaction and the lack of experimental data tying the content of RFGs to potential hazard is the main flaw of this criterion. It was given a score of medium relevance. The OECD study investigated in details the links between molecular weight, oligomer content, and hazard (Figure 6). 38

39 Figure 6: The relationship between Mn, oligomer content and health concern. (A) <1000 Da and (B) <500 Da oligomer content data. The low health concern are represented by open circles, and the potential health concern by filled circles Data show that the with potential health concern are mainly grouped at combinations of higher oligomer content and lower Mn when compared with the low health concern. Most, but not all, potential health concern have Mn <10000 Da and oligomer content >1%. The US EPA assessment also identified low average molecular weight and high oligomer content as a cause for concern. However, it should be noted that the OECD study did not cross-link low average molecular weight of with their content in RFG: it would have been interesting to know whether those are genuinely hazardous because of their size only, or because they contain RFG. The criterion was given a medium score. In the end, the two criteria with the most straightforward link to hazard ( Information on health and environmental hazards and Presence, content and properties of residual monomers were given the highest scores (High and Medium High, respectively). The criteria which can predict, to a certain extent (limited by the lack of data and literature), hazard of were given a Medium score: they are Low average molecular weight and Presence and content of reactive functional groups (RFG). The criterion for which correlation with hazard is the thinnest (i.e. Polymer class ) was given a low score Hazard assessment applied by Competent Authorities The registration dossiers provided by companies to Competent Authorities allow an identification of the and its potential hazards. The registration requirements 33 differ from one jurisdiction to another, notably regarding parameters related to hazard and the aforementioned criteria (see section 4.2.1). How the studied countries integrate the hazard criteria is reported in Table See section 3 and reporting table 39

40 Table 6: Inclusion of hazard assessment criteria in the different strategies Australia Canada China Japan New Zealand Philippines South Korea Taiwan USA Information on health and environmental hazard Polymer class Low average molecular weight Presence and content of reactive functional groups Presence, content and properties of residual monomers 40

41 Information on health and environmental hazard All countries use information from hazard tests (acute dermal toxicity, acute toxicity test for aquatic species, 14-day extended toxicity study in fish, etc. 33 ) in order to evaluate potential polymer toxicity. In all countries but Japan and South Korea, applicants can submit existing information of polymer hazard, such as the hazard class of the polymer (according to UN GHS), Material Safety Data Sheets (MSDS) and a list of available toxicology and ecotoxicology published studies. Depending on the nature of the polymer (e.g. PLC or non-plc), a range of toxicity tests also have to be performed. In Japan and South Korea, applicants submit the results of an extensive list of toxicity tests 33. It is interesting here to discuss the case of New Zealand and the Philippines, which use only straightforward information on hazard (i.e. existing hazard information and toxicity tests and not indirect information such as the content of residual monomers) for registration of. In New Zealand, only hazardous are to be registered and the assessment of hazard is based on toxicity tests only: New Zealand does not accept other criteria (such as content of residual monomers or presence of RFG) for justification of low or high concern of. In Philippines, benefit from separate registration from other chemicals but there are no specific tests for : are subject to the same testing as non-, except for some exemption cases based on the 2% rule. Therefore, no criteria specific to are taken into account (e.g. low average molecular weight, oligomer content, etc.). Polymer class Using polymer class to gain information on hazard is not much used. It can be justified by the absence of a systematic correlation between polymer class and hazardous properties. However, scientific evidence show that polyesters manufactured from some monomers (see the list of approved monomers developed by US EPA, for instance, available in Table 20) are of low concern. The USA and Canada both consider that such polyesters are not likely to pose environmental and health threats (see section 4.1.1). Low average molecular weight In all countries but Philippines and New Zealand, a polymer with an average molecular weight of less than 1000 Da in considered likely to be hazardous. In Japan, such are not even in a regulatory point of view, and are registered as regular chemicals. Furthermore, in all countries but Philippines and New Zealand, criteria on the presence and content of oligomers are implemented. This criterion is used for defining of low concern, for which the content of oligomers is strictly regulated (see section 4.1.1). Presence and content of reactive functional groups (RFG) Reactive functional groups (sometimes classified in low/medium/high concern categories) are considered to be cause of potential hazards in in Australia, Canada, China and Japan. South Korea and Taiwan, although they include the concept of PLC in their regulation, do not use information on presence and content of RFG to discriminate between PLC and other. Presence, content and properties of residual monomers As discussed before, the presence (and quantity) of any residual monomer is the primary source of concern when it comes to potential hazard. All countries but New Zealand, Philippines and Japan, use this criterion for hazard assessment. However, Japan includes implicitly the potential presence of residual monomer as a cause of concern: although the applicants do not submit the content of any residual monomers, synthesised from monomers containing RFG are considered as hazardous enough for a full registration (they cannot be PLCs). As a conclusion to this review, it can be said that the implementation, or not, of a set of identified hazard criteria is closely related to the adoption, or not, of a PLC approach. New Zealand and the Philippines, which do not have a PLC approach, only rely on direct information of hazard. However, the other countries need a wider range of criteria indicating potential concern in order to have a comprehensive framework for their PLC 41

42 approach. Among the countries with a PLC approach, Australia, Canada, China and the USA use all criteria with medium, medium-high and high relevance. Japan does not consider the presence or content of residual monomers but does specify that the monomers used to synthesise a PLC must not be toxic. South Korea and Taiwan do not take into account the presence or content of reactive functional groups. It appears that among the countries considered a priority for the analysis 34, the ones that integrate the most hazard criteria in their PLC approach are Australia, Canada and the USA. The development of new PLC approaches will therefore integrate elements and rationales from these three countries Proposal of a EU PLC approach The proposed approach is based on elements presents in third countries' approaches which have been chosen as relevant in the EU context since they take into account EUspecific elements (e.g. the CLP regulation, the fact that a monomer registration currently exists, etc.). According to the OECD definition of a PLC, posing low hazard to human health and the environment should benefit from reduced requirements. The proposed approach includes all hazard criteria defined in the previous section (information on health and environmental hazard; polymer class; low average molecular weight; presence and content of reactive functional groups; presence of oligomers and presence, content and properties of residual monomers), organised in the following assessment framework: 34 Australia, Canada, Japan, South Korea, and the USA, see section Error! Reference source not found. 42

43 Potential Hazard Concern: non-plc Figure 7: Decision tree for determining if a polymer is a PLC Candidate polymer Is the polymer classified under the CLP Regulation? No Yes Are its monomers/reactants registered under REACH? Yes Does the polymer comply with criterion H 1? No Yes No Limited Hazard Concern: PLC Yes Does the polymer comply with criterion H 2? No On elemental limitations: criteria EL 1 and EL 2 and EL 3 and EL 4 AND On cationicity: criteria C 1 and C 2 AND On degradability: criteria D 1 and D 2 AND Does the polymer comply with all eligibility criteria? On water absorption: criteria WA No Yes Yes Is it an approved polyester? No Does the polymer comply with PLC criteria on M w and oligomer content? No Criterion M w /OC 1 OR Criterion M w /OC 2 Yes Yes Does the polymer comply with PLC criteria on RFG? No Criterion RFG 1 As shown in Figure 7, all criteria were given a code (e.g. C 1, EL 2) in order to refer to them more easily. The first part of the decision tree considers classification under the CLP regulation and (eco)toxicological information available in the REACH dossiers of monomers and other substances in the polymer, if they are registered under REACH (see section 4.3.1). Then, the organisation of the decision tree takes Australia, Canada, China and the USA as references. First, it has been extensively discussed 35 that some are likely to pose an unreasonable risk and should be excluded from the PLC category: they are called ineligible and are discriminated by eligibility criteria. This does not mean that 35 Inter alia during the polymer assessment conducted by US EPA prior to implemented the US PLC approach 43

44 eligible are of low concern: they merely qualify to be assessed against the next criteria of the decision tree. Figure 8 below illustrates the concept of eligibility in a PLC approach: among a sample of containing PLCs and non-plcs, only the most hazardous ones will be ruled out and the set of eligible will include PLCs and non-plcs. Figure 8: Eligibility in a PLC approach Eligible Will be excluded from the PLC category after further assessment Hazard Polymers of Low Concern Polymers of Concern An eligible polymer which is a polyester should be assessed against the polyester criterion before being assessed against the oligomer content criteria. Indeed, US EPA hazard assessments showed that some polyesters (those synthesised from an authorised list of monomers, see section 4.3.5) are of low concern regardless of their oligomer content or RFG nature or content. However, hazard assessment results also show that approved polyesters not fulfilling eligibility criteria were not of low concern (see section for details on the potential toxicity of polyesters). Therefore, applicants should first check for eligibility criteria, before considering the polyester provision. The third and fourth steps of the decision tree deal with oligomer and reactive functional group contents. Criteria on RFGs are considered after the criteria on oligomer content in the decision tree because for some complying with the criteria on oligomer content 36, there are no restrictions on RFG content. The following subsections describe in details the criteria referred to in the decision tree and therefore document each step of the proposed PLC approach Discrimination using hazard information available in REACH and CLP dossiers H 1 For candidate for which information on hazard classification under the EU CLP regulation is available: the candidate polymer should not be classified as any of the following classes: Acute toxicity (Acute Tox. 1 to Acute Tox. 4); Germ cell mutagenicity (Muta. 1A, Muta. 1B and Muta. 2); Carcinogenicity (Carc. 1A, Carc. 1B and Carc. 2); Reproductive toxicity (Repr. 1A, Repr. 1B, Repr. 2, Lact.); Aspiration hazard (Asp. Tox. 1); Respiratory/skin sensitization (Resp. Sens. 1 and Skin Sens. 1); Specific target organ toxicity single exposure (STOT SE1 to SE3) 36 Polymers with Mw 10,000 Da must contain less than 2% oligomer content of molecular weight below 500 Da and less than 5% oligomer content of molecular weight below 1,000 Da, see in section

45 Specific target organ toxicity repeated exposure (STOT RE 1 and STOT RE 2); Hazardous to the aquatic environment (Aquatic Acute 1, Aquatic Chronic 1 to 4); Hazardous for the ozone layer (Ozone). Furthermore, the polymer should not be identified as PBT or vpvb. If no information is available on hazard classification of the candidate polymer, then the H 1 criterion does not apply. H 2 One or more monomers or other substances in the candidate polymer should not be classified or thought likely to be classified, on the basis of its REACH registration dossier, as any of the following classes: Acute toxicity (Acute Tox. 1 to Acute Tox. 4); Germ cell mutagenicity (Muta. 1A, Muta. 1B and Muta. 2); Carcinogenicity (Carc. 1A, Carc. 1B and Carc. 2); Reproductive toxicity (Repr. 1A, Repr. 1B, Repr. 2, Lact.); Aspiration hazard (Asp. Tox. 1); Respiratory/skin sensitization (Resp. Sens. 1 and Skin Sens. 1); Specific target organ toxicity single exposure (STOT SE1 to SE3) Specific target organ toxicity repeated exposure (STOT RE 1 and STOT RE 2); Hazardous to the aquatic environment (Aquatic Acute 1, Aquatic Chronic 1 to 4); Hazardous for the ozone layer (Ozone). Furthermore, the monomers or substances contained should not be identified as PBT or vpvb. If no monomers or other substances in the polymer are classified under the CLP or registered under REACH, then the H 2 criterion does not apply. Rationale Although some jurisdictions do not include criteria on hazard classification of or monomers for defining PLCs (e.g. USA or Canada), it seems important to rule out hazardous before considering any other criteria. Considering the EU CLP for hazard classification of and the REACH dossiers for monomers and other reactants, comes from an effort to integrate the proposed PLC approach in the EU context while keeping international standards. Indeed, the EU CLP is aligned with the provisions of the UN GHS. The hazard classes considered for H 1 and H 2 are the most serious for health and the environment, among all classes listed in the CLP regulation. A polymer classified under these classes cannot, by definition, be considered a PLC. Therefore, such are ruled out from the PLC category at this level of the decision process (see decision tree, Figure 7). Polymers in accordance with H 1 (or which are not classified under the CLP regulation), and whose monomers/reactants are not toxic according to the parameters listed in H2, can be considered PLC without further analysis. This step of the decision tree is adapted from the routes for the Reduced Test Package of the DSD (see Figure 3). According to these routes, if monomers/substances in the polymer: 45

46 Are not classified (or likely to be classified) as T, T+, C, Xn, Xi 37 ; and Do not have a positive mutagenicity test; and Have a value for acute aquatic toxicity above 10 mg/l; they qualify for a Reduced Test Package. For the purpose of developing a PLC approach for the EU, this rule was adapted with consideration to the CLP classification and if necessary, the pieces of information available in REACH dossiers (which formalise the likely to be classified provision) Eligibility criteria Before determining if a polymer meets the PLC criteria, it should be first reviewed to determine if it is eligible for qualifying as a PLC. The polymer which is reviewed for eligibility is named candidate polymer in the following subsections. Upon assessment of criteria implemented in non-eu strategies, the following eligibility criteria should be applied: Elemental limitations EL 1 The candidate polymer must not contain less than two of the following elements: C, H, N, O, Si, and S. EL 2 The candidate polymer must not contain other elements than the following, covalently bound to carbon: F, Cl, Br and I. It must not contain perfluoroalkyl moieties consisting of a CF3 or longer chain length. EL 3 The candidate polymer must not contain other counter-ions than the following: Cl -, Br -, I -, Na +, Mg 2+, Al 3+, K + and Ca 2+. EL 4 The candidate polymer must not contain more than 0.2%w of the following elements: Li, B, P, Ti, Mn, Fe, Ni, Cu, Zn, Sn and Zr. Any other element is not allowed. Rationale Limiting the nature and contents of some elements in is an early step in ensuring low hazard. Criteria EL 1, 3 and 4 are common for ensuring low hazard from an elemental point of view. Criterion 2 on the presence of halogens bound to carbon is also common, but a provision on perfluoroalkyl moieties was added, in line with hazard assessment conducted by US EPA Cationicity C 1 The candidate polymer must not be a cationic polymer, i.e. a polymer containing net positively-charged atom(s) or associated group(s) of atoms covalently linked to its polymer molecule (e.g. ammonium, phosphonium and sulfonium cations). Exceptions are: Solid, not dispersible or soluble in water, not dispersible in air (i.e. not sprayed or processed into powders) and only intended to be used in a solid phase; Polymers with a low cationic density, i.e. a polymer whose cationic group has a combined equivalent weight greater than daltons. C 2 The candidate polymer must not be expected to become a cationic polymer, i.e. it must not contain groups reasonably anticipated 38 to become cationic (e.g. amines and isocyanates) and/or be cationic in a natural aquatic environment (4 < ph < 9). Exceptions are: 37 These codes are from the DSD and are being replaced by the codes from the CLP regulation 38 Reasonably anticipated means a knowledgeable person would expect a given physical or chemical composition or characteristic to occur, based on factors such as the nature of the precursors used to manufacture the polymer, the type of reaction, the type of manufacturing process, the products produced in the polymerisation, the intended uses of the substance and associated use conditions. 46

47 Solid, not dispersible or soluble in water, not dispersible in air (i.e. not sprayed or processed into powders) and only intended to be used in a solid phase; Polymers with a low cationic density, i.e. a polymer whose cationic group has a combined equivalent weight greater than daltons. Rationale Aquatic toxicity and adverse human health effects (mainly inhalation concerns) surfaced for cationic during the polymer risk assessment conducted by US EPA. According to this assessment, some cationic present a hazard concern and can become environmentally toxic because they contain a net positively charged atom or contain groups that can reasonably be anticipated to become cationic in water. Cationic atoms of concern include (but are not limited to): nitrogen, phosphorus, and sulphur - nitrogen is the cationic group in 99% of cases. Examples of groups that are anticipated to become cationic in water are for instance, aliphatic primary, secondary and tertiary amines. For polycationic to be considered of concern, they have to be either water soluble or dispersible in water as either micro- or macro- dispersions 30,39. Therefore, the US EPA recommended ineligibility for this category of, with the exceptions mentioned in both criteria above. These exceptions are meant to include the candidate which are the least hazardous for aquatic environment, as the highest concerns were seen with cationic with FGEW < 5,000 Da. The exceptions also include cationic with the lowest health hazard: concerns with cationic are linked with chronic inhalation issues, as it is likely that they irreversibly bind to the anionic lung membranes causing acute and chronic lung toxicity. For instance, US EPA has one acute inhalation test where polymer particles were not small enough to get into deep lung; however, during autopsy membranes of bronchi were bloody (damaged and lost some of their integrity) as predicted. By allowing cationic that are solid material and therefore not sprayed or processed into powders, actual risk from the eligible is reduced Degradability D 1 The candidate polymer must not be designed to substantially 40 degrade, decompose or depolymerise, i.e. it must not be designed to convert into smaller, simpler substances through oxidation, hydrolysis, attack by solvents, heat, light or microbial action, or through other processes. D 2 The candidate polymer must not be reasonably anticipated 38 to substantially 40 degrade, decompose or depolymerise after manufacture or use, even though it is not intended to do so. Rationale When degrading, suffer chemical changes which result in undesirable changes in their physical properties, like for instance chain scission leads to loss of molecular weight. Therefore, degradable can convert into smaller compounds, able to cross biological membranes and cause environmental and/or health hazard Water absorption WA The candidate polymer must not be a water-absorbing polymer (i.e. a polymer capable of absorbing its own weight in water) with Mw 10,000 Da. Rationale 39 Interpretive Assistance Document for Assessment of Polymers Sustainable Futures, Summary Assessment, Updated June US EPA, june2013.pdf 40 Substantially means 'considerably', 'meaningfully' or 'to a significantly large extent'. It is not intended to include the slow, natural biodegradation that occurs during processes such as the weathering of paint. Readily biodegradable, on the other hand, fall under this criterion. 47

48 Cancer concerns were associated with high-mw water-absorbing following a two-year inhalation study on rats 41 ; therefore, these should not be eligible for being PLCs. It is important to refer that only water-absorbing are considered to be of concern, water-soluble and water dispersible are not considered to be water absorbing and are not expected to be of concern, because it is assumed that the lungs are prepared to clear the particles of these after inhalation. The water-absorbing of concern are those called super-absorbents that can absorb extremely large amounts of water (a mass equivalent to their weight or greater). Examples of these are those used in disposable nappies and paper towels Criteria on average molecular weight and oligomer content M w/oc 1 Polymers with 1000 < Mw < 10,000 Da must contain less than 10% oligomer content of molecular weight below 500 Da and less than 25% oligomer content of molecular weight below 1,000 Da. There are also restrictions on the nature and content of reactive functional groups (see section 4.3.4). M w/oc 2 Polymers with Mw 10,000 Da must contain less than 2% oligomer content of molecular weight below 500 Da and less than 5% oligomer content of molecular weight below 1,000 Da. There are no restrictions on the nature and content of reactive functional groups. Rationale Data from the studied countries as well as results from the OECD study show that a high oligomer content in a polymer is a cause of environmental and health concern. In particular, the OECD study noted that the distribution of potential health concern showed an increased incidence of high oligomer content beginning at 5% for <1000 Da and 2% for <500 Da oligomeric content. Therefore, one would be inclined to set oligomer contents at a lower cut-off for all oligomer species under 1,000 Da. For instance, Japan decided to have a 1% cut-off for all oligomer species under 1,000 Da and this cut-off was also established in the DSD 43. The fundamental idea of this concept, as explained by ECHA, was the assumption that <1% of species with M<1000 and low water extractivity are not able to cause systemic effects which are toxicologically and/or ecotoxicologically relevant. However, data from the OECD study also shows that a lot of low concern have a Mw between 1,000 and 10,000 Da with oligomer content reaching sometimes 30%: by applying the Japanese cut-off for oligomer content to the OECD sample, 83% of low health hazard and 88% of low environmental hazard would not be considered PLCs. Keeping in mind that criteria on average molecular weight and oligomer content should rule out the most potentially hazardous while including as much low-hazard as possible, it can be recommended that in the 1,000 10,000 Da range should benefit from higher cut-offs but be further tested for reactive functional groups, in order to ensure they do not pose unreasonable concern. Cut-offs of 10% for oligomers with molecular weight below 500 Da and of 25% for oligomers with molecular weight below 1,000 Da as applied in the USA, Canada, Australia, China, South Korea and Taiwan seems a reasonable choice. On the other hand, eligible of more than 10,000 Da are mostly inert, so criteria on RFG are not needed. However, to avoid any risk, the 5% and 2% cut-offs should not be raised. 41 US EPA (2007) US Rationale For Criteria Defining Polymers and Polymers of Low Concern, Presentation of Anna Coutlakis (March 2007, Tokyo) Although the cut-off values have been amended and updated since the DSD times, see section

49 In conclusion, the proposed cut-offs are based on expertise from the various polymer related registrations and assessments and ECHA believes these will ensure adequate protection also for EU Criteria on Reactive Functional Groups (RFGs) RFG 1 For a polymer with 1000 < Mw < 10,000 complying with criterion Mw/OC 1, the following restrictions regarding the content of Reactive Functional Groups (RFGs) apply: No restrictions on low-concern functional groups; If the polymer contains only moderate-concern groups, these groups should have a FGEW above 1,000 Da each and a combined FGEW over 1,000 Da; If the polymer contains high-concern and moderate-concern groups (or highconcern groups only), the combined FGEW of these groups should be over 5,000 Da. Furthermore, each high-concern group should have a FGEW over 5,000 Da and each moderate-concern group should have a FGEW over 1,000 Da The categories of RFGs are defined as follows. For moderate- and high-concern groups, the main toxicity concerns are indicated in brackets, are based on considerations detailed in Annex 4 and on work of the US EPA 45 : Rationale Low-concern groups: carboxylic acid groups; aliphatic hydroxyl groups; ordinary unconjugated olefinic groups; butenedioic acid groups; conjugated olefinic groups present in naturally occurring fats, oils and carboxylic acids; blocked isocyanates; thiols; unconjugated nitrile groups; halogens (except reactive halogen containing groups such as benzylic or allylic halides); Moderate-concern groups: conjugated olefinic groups not contained in naturally occurring fats (genotoxicity), oils and carboxylic acid; alkoxysilanes with alkoxy groups >C2 (lung toxicity, ecotoxicity); High-concern groups: pendant acrylates and methacrylates (genotoxicity, skin irritation); aziridines (genotoxicity, skin irritation); carbodiimides (genotoxicity, skin irritation); halosilanes (lung toxicity, ecotoxicity); hydrosilanes (lung toxicity, ecotoxicity); hydrazines (genotoxicity, skin irritation, ecotoxicity); alpha or beta lactones (genotoxicity, ecotoxicity); vinyl sulfones or analogous compounds (genotoxicity, ecotoxicity); acid halides (genotoxicity, skin irritation); acid anhydrides (lung toxicity); aldehydes (genotoxicity, ecotoxicity); hemiacetals (genotoxicity, ecotoxicity); methylolamides (genotoxicity, ecotoxicity); methylolamines (genotoxicity, ecotoxicity); methylolureas (genotoxicity, ecotoxicity); methoxy- and ethoxysilanes (lung toxicity, ecotoxicity); allyl ethers (genotoxicity, cytotoxicity); cyanates, iso(thio)cyanate (genotoxicity, skin irritation); epoxides (genotoxicity, skin irritation); imines (genotoxicity); unsubstituted positions ortho or para to phenolic hydroxyl (genotoxicity); any other RFG not in low or moderate concern groups. Polymers complying with Mw and oligomer content of criterion Mw/OC 1 could still pose concern due to their potential reactivity. The criteria presented in this section aim at addressing this issue and rule out which are alkylating agents and of an electrophilic nature: some reactive functional groups are believed to be capable of reacting with tissues or with other chemical constituents, and cause sufficient irritation to disrupt normal cell membrane barriers and therefore facilitate penetration 46. Furthermore, 44 Feedback from ECHA. The cut-off levels might be adjusted once more data on assessment has been collected in EU Feedback from ECHA 49

50 alkylating agents can denature DNA and/or proteins and electrophilic moieties can lead to DNA damage. Three categories of RFG were defined in order to estimate polymer hazard with as little under- or overestimation as possible. The proposed categorisation is based on work conducted in the USA, EU, Australia and Canada and further justified by a study of reactivity at molecular level (details and references reported in Annex 4) The proposed categorisation was submitted to ECHA which received it favourably, with eminent toxicologists considering it is in line with the EPA learnings and that the approach in SAR (structure-activity relationship, see Annex 4) on which the proposal is based is sound. The list of RFG included in each category is made of types of which are common and on which the most data was available in the studied jurisdictions. The low-concern groups are the least reactive in biological and/or aquatic media, and they are neither alkylating agents nor electrophilic groups. Their low reactivity is described in Annex 4. These groups are considered of low concern in Australia, Canada and in the USA. The moderate-concern group includes two types of RFGs: olefinic groups which do not belong to the category of low concern because they are conjugated and not naturally occurring; and alkoxysilanes which are not hazardous enough to be in the high concern category. The reactivity of moderate concern groups is presented in Annex 4. These groups are considered of moderate concern in Australia, Canada and in the USA. The high-concern category regroups RFGs which are the most reactive and are known to pose health and/or environmental concerns. They are alkylating agents and electrophilic groups. Their reactivity is presented in Annex 4. This category regroups all functional groups defined as reactive in the EU 25 and defined as high concern in Australia, Canada and the USA. Nevertheless, the high concern category includes RFG which are considered of moderate concern in the USA and Canada (acid halides; acid anhydrides; aldehydes; hemiacetals; methylolamides; methylolamines; methylolureas; methoxy- and ethoxysilanes; allyl ethers; conjugated olefins; cyanates; epoxides; imines; unsubstituted positions ortho or para to phenolic hydroxyl). Although the USA did test over 10,000 and identified moderate concern or these groups, it is more precautionary to put them in the high concern category: NICNAS (the Australian Competent Authority) noted that they had no data that these RFG were of moderate concern and the OECD study shows that epoxides and unsubstituted positions ortho or para to phenolic hydroxyls are cause for health concerns. The FGEW cut-offs defined in criterion RFG 1 were chosen as the most stringent of those used in the studied countries. The lack of data on FGEWs in the OECD study did not allow to have additional information to support an alternative choice Exception: polyesters If the candidate polymer is a polyester from an approved list, it is considered a PLC regardless of number average molecular weight or oligomeric content. A proposal for an approved list is presented in Table 7. 50

51 Table 7: Proposed list of approved polyesters reactants for an EU PLC approach Monobasic Acids and Natural Oils [ ] Heptanoic acid [ ] Nonanoic acid [ ] Hexanoic acid [ ] Dodecanoic acid [ ] Hexanoic acid, 3,3,5-trimethyl- [ ]* Tung oil [ ]* Sunflower oil [ ]* Soybean oil [ ]* Safflower oil [ ]* Linseed oil [ ]* Cottonseed oil [ ]* Corn oil [ ]* Coconut oil [ ]* Fats and glyceridic oils, menhaden [ ]* Fats and glyceridic oils, oiticica [ ]* Palm kernel oil [ ]* Oils, walnut [ ]* Fatty acids, coco [ ]* Fatty acids, vegetable-oil [ ]* Fatty acids, C18-unsatd., dimers [ ]* Fatty acids, castor oil [ ]* Fatty acids, dehydrated castor oil [ ]* Fatty acids, tall-oil [ ]* Fatty acids, C16-18 and C18- unsatd. [ ]* Glycerides, C16-18 and C18- unsatd. [ ]* Oils, perilla [ ]* Fats and glyceridic oils, herring [ ]* Fatty acids, soya [ ]* Fatty acids, linseed oil [ ]* Fatty acids, sunflower-oil [ ]* Linseed oil, oxidized [ ]* Fatty acids, sunflower-oil, conjugated [ ]* Fats and glyceridic oils, babassu [ ]* Fatty acids, safflower-oil [ ]* Fats and glyceridic oils, sardine [ ]* Canola oil [ ]* Fats and glyceridic oils, anchovy [No Registry #]* Fatty acids, tall-oil, conjugated [No Registry #]* Oils, cannabis Dibasic and Tribasic Acids and Esters [ ] Butanedioic acid, dimethyl ester [ ] Decanedioic acid, dimethyl ester [ ] Butanedioic acid [ ] 2-Butenedioic acid (E)- [ ] Decanedioic acid, diethyl ester [ ] Heptanedioic acid [ ] Decanedioic acid [ ] Butanedioic acid, diethyl ester [ ] 1,3-Benzenedicarboxylic acid [ ] Nonanedioic acid [ ] Dodecanoic acid [ ] Octanedioic acid [ ] 1,2,4-Benzenetricarboxylic acid [ ] Nonanedioic acid, diethyl ester [ ] Dodecanedioic acid [ ] 1,3-Benzenedicarboxylic acid, dimethyl ester [ ] Heptanedioic acid, dimethyl ester [ ] Octanedioic acid, dimethyl ester [ ] Nonanedioic acid, dimethyl ester [ ] Undecanedioic acid [ ] Fatty acids, C18-unsaturated, dimers * 51

52 Polyols [ ] 1,2,3-Propanetriol [ ] 1,3-Butanediol [ ] 1,3-Pentanediol, 2,2,4-trimethyl- [ ] 1,3-Propanediol, 2-(hydroxymethyl)-2- [ ] 1,4-Butanediol [ ] 1,3-Propanediol, 2-methyl methyl- [ ] Ethanol, 2,2 -oxybis- [ ] 2-Propen-1-ol, polymer with [ ] 1,3-Propanediol, 2-ethyl-2- (hydroxymethyl)- [ ] 1,3-Propanediol, 2,2- bis(hydroxymethyl)- ethenylbenzene [ ] 1,2,3-Propanetriol, homopolymer [ ] 1,4-Cyclohexanedimethanol [ ] 1,3-Propanediol, 2,2-dimethyl- Modifiers [ ] Acetic acid, 2,2 -oxybis- [ ]* Methanol, hydrolysis products [ ]* Siloxanes and silicones, di-me, [ ] 1-Hexanol with trichlorohexylsilane and methoxy Ph, with Ph silsesquioxanes, [ ] Ethanol, 2-(2-butoxyethoxy)- trichlorophenylsilane methoxy-terminated [ ] 1-Phenanthrenemethanol, [ ]* Silsesquioxanes, Ph Pr [ ]* Siloxanes and silicones, Me Ph, tetradecahydro-1,4a-dimethyl-7-(1- methylethyl)- [ ]* Siloxanes and silicones, di-me, di- methoxy Ph, with Ph silsesquioxanes, [ ] Phenol, 4,4 -(1- Ph, with Ph silsesquioxanes, methoxy- methoxy- and Ph-terminated methylethylidene)bis-, polymer with 2,2 -[(1- terminated methylethylidene)bis(4,1- phenyleneoxymethylene)]-bis[oxirane] * Designates chemical substances of unknown or variable composition, complex reaction products, or biological materials (UVCB substances). The CAS Registry Numbers for UVCB substances are not used in Chemical Abstracts and its indexes. 52

53 Rationale It was shown from toxicity data that polyesters made from certain specific alcohols and acids would be considered PLC regardless of Mw or oligomeric content. Therefore, it is simpler and less time-consuming to consider them as PLC from the start. The proposed list is based on the US, Canadian and Australian lists (see Table 20 in Annex 1). All reactants from these lists are included in the proposed approach except for the following chemicals, because they can be considered toxic (although their toxicity is low): [ ] Benzoic acid, [ ] 1,2-Benzenedicarboxylic acid, [ ] Pentanedioic acid [ ] 1,4-Benzenedicarboxylic, [ ] 1,4-Benzenedicarboxylic acid, dimethyl ester [ ] Hexanedioic acid [ ] Hexanedioic acid, diethyl ester [ ] Hexanedioic acid, dimethyl ester [ ] 1,4-Benzenedicarboxylic acid, diethyl ester [ ] Pentanedioic acid, diethyl ester [ ] Pentanedioic acid, dimethyl ester [ ] 1,2-Propanediol [ ] 1,2-Ethanediol [ ] 1,6-Hexanediol [ ]1-Butanol [ ] Cyclohexanol, [ ] Cyclohexanol, 4,4 -(1-methylethylidene)bis- The US, Australian and Canadian list are currently static, meaning that there is no process in place in those countries by which a company can petition to add a permissible ingredient. Nevertheless, a project currently being run multilaterally through the OECD Clearing House on New Chemicals is seeking to do add monomers to the approved list in a harmonised way (since the US, Canada and Australia all have an approved polyester monomers list) 4.4. Cost effectiveness of PLC approaches (third countries and new approach) This analysis of costs aims at assessing how PLC approaches allow for a reduction of costs of registration. Reviewing the different countries schemes for registration of and, above all, receiving information from some Competent Authorities, gave information in this regard. The cost of a registration includes user fees to be paid to the Competent Authority and additional costs (such as staff time for preparing submissions and generating data, consultancy work, etc.). While information on user fees is available, estimation of additional costs is generally not (they are sometimes calculated during the review of the relevant regulation, as was the case in Australia). 53

54 Equations Reduction of costs for 1 polymer Let x be the registration cost of a non-plc and y the registration cost of a PLC. Then the reduction factor of costs for 1 polymer r PLC is such as: y = (1 r PLC ). x The cost of a registration includes user fees and additional costs (such as staff time for preparing submissions and generating data, consultancy work, etc.). Fees and additional costs are different for a non-plc and for a PLC, so that: x = x fee + x add. y = αx fee + βx add. While information on user fees is available, estimation of additional costs is generally not, because it requires consultations with industry stakeholders, for instance as part of the review of the registration strategy. Therefore, estimations of β are bound to be difficult. In Australia, where the additional costs have been considered recently as part of the review of NICNAS 47, α and β are of similar value. Let us then assume that α = β. Under this hypothesis, the reduction factor r PLC can be defined as: r PLC = 1 α Reduction of costs for N Let N PLC be the number of PLC notifed by a company per year and N the total number of notified per year. Then the cost for notifying these N is: Cost Total,incl.PLC approach = N PLC. y + (N N PLC ). x If no PLC approach was implemented, then the cost for notifying these would be: Cost no PLC approach = N. x The reduction factor of costs for N polymer, R PLC, is such as: Which gives: Cost Total,incl.PLC approach = (1 R PLC ). Cost no PLC approach R PLC = N PLC N. r PLC The ratio N PLC for one company can be estimated as being, on average, the ratio for all N companies notifying in the country that year. Therefore, country-wide data can be used to estimate R PLC The case of exemption of PLCs If PLCs are exempted from registration, then α = 0 but additional costs remain (the manufacturer must prove that the polymer is indeed a PLC). In order to assess r PLC in the case of exempted, one must know βx add.. No realistic assumptions can be done regarding the value of those parameters, if there is a lack of data (which is expected). Analogies with other countries will be necessary Required data for numerical application In order to estimate R PLC, the following data is necessary: 47 NICNAS (2013) Options for reforming the National Industrial Chemicals Notification and Assessment Scheme Regulation Impact Statement 54

55 Cost of a registration for a non PLC or, if lack of data, fee for a non PLC Cost of a registration for a PLC or, if lack of data, fee for a PLC Number of PLC registrations per year in the country of interest Total number of polymer registrations per year in the country of interest Calculation of reduction factors for third countries The assumptions are the following: As compared with a regular polymer, the reduction in fees and the reduction in additional costs are the same when notifying as a PLC (except for exemptions, where the reduction in fees is 100%). The proportion of PLCs and grouped registrations are the same, on average, for a company as country-wide. The required data to assess cost-effectiveness are compiled in Table 8 below. Table 8: Required data for estimating cost effectiveness of PLC approaches Country Cost of a registration for a non PLC or, if lack of data, fee for a non PLC Cost of a registration for a PLC or, if lack of data, fee for a PLC Number of PLC registration s per year in the country of interest Total number of polymer registration s per year in the country of interest Australia $51,400 $26, Canada $3,500 (fee) $1,500 (fee) China 30,000 RMB 48 No data No data No data Japan $92,470 $23, South Korea n/a n/a No data No data Taiwan Not available Not available Not available Not available USA No data No data 200 (postcards) Australia Available data allows for an estimation of both α and β, so that it is not necessary to use the hypothesis α = β. In Australia: So: x = $51,400 and y = $26,100 r PLC = Notifying a polymer as a PLC rather than as a regular polymer allows a reduction of 49% of the costs of registration. Furthermore, the average number of notified per year is: N PLC = 65 and N =

56 So: R PLC = N PLC N. r PLC = R PLC = In Australia, a company reduces its costs by 31% as compared with a situation in which no PLC approach is implemented Canada In Canada, fees for PLCs are of $1500 and for non-plcs of $3500, so the reduction of costs can be estimated as: r PLC = Furthermore, the average number of notified per year is: N PLC = 116 and N = 202 So: R PLC = N PLC N. r PLC = R PLC = In Canada, a company reduces its costs by 33% as compared with a situation in which no PLC approach is implemented (only registration fees considered based on data available) USA PLCs are exempted from registration and no information is available on testing costs, so the reduction of costs will be assessed thanks to data from Australia. Assumption: β.x add x is the same for both countries. Then: Moreover: r PLC = N PLC = 200 and N = 514 So: R PLC = N PLC N. r PLC = R PLC = In the US, a company reduces its total costs by an estimated 23% as compared with a situation in which no PLC approach is implemented Japan The Japanese authorities provided total costs for registration/application for the PLC exemption, along with the number of registered/exempted. This allows a straightforward calculation of reduction factors. Costs for PLC applications amount to 2-3 million Japanese Yen (JPY), which represents an average of $23, For a normal registration (non-plc), costs amount to 10 million JPY, which represents $92, So: 49 Value of 2.5 million JPY in US dollars, conversion rate of October 3 rd,

57 r PLC = Furthermore, around 80 are registered per year and 230 benefited from the PLC exemption from 2011 to March 2014, which gives an average of 71 PLC per year. So: N PLC = 71 and N = 151 And: R PLC = N PLC N. r PLC = R PLC = In Japan, a company reduces its costs by 35% as compared with a situation in which no PLC approach is implemented Conclusion on third countries approaches The results of the cost-effectiveness analysis are compiled in Table 9 below. Table 9: Estimated cost-effectiveness of PLC in Australia, Canada and the USA Country Reduction factor: 1 polymer Proportion of registered/exempted PLC per year Reduction factor: Total Australia 49% 64% 31% Canada 57% 57% 33% China No data No data No data Japan 75% 47% 35% South Korea No data No data No data Taiwan No data No data No data USA 60% 39% 23% Based on data from four countries, the adoption of a PLC approach allows for a reduction of costs by 31% on average. Japan, Australia and Canada have a similar reduction factor (respectively 35%, 31% and 33%) while the reduction factor for the USA is lower. This difference is due to a lower proportion of exempted PLC per year in the USA (39%) than registered per year in the other countries. The US EPA notes that 200 more could be notified as PLC every year, but that companies prefer not to, in order for their polymer to be put on the Inventory Cost reduction for the EU with the proposed PLC approach Conclusion on the reduction of costs for the EU as compared to a situation in which all not falling under other specific requirements (volume, R&D, etc.) would be registered individually and with the same requirements depends on the type of registration which would be used for PLCs in the EU. In light of what is done in third countries, three options are considered: Option 1 Exemption from registration, with notification: the PLC is not registered, but the manufacturer must submit an application proving that the 50 Value of 10 million JPY in US dollars, conversion rate of October 3 rd,

58 polymer is indeed a PLC. As done in: Japan and South Korea; Option 2 Exemption from registration, without notification: the PLC is not registered nor does the manufacturer need to submit an application. However, he must keep all relevant documents proving the polymer is a PLC, and report the volumes manufactured once a year. As done in: the USA. Option 3 Registration with reduced requirements: the PLC is registered but with a lighter dossier than regular. As done in Canada, Australia, China and Taiwan. By considering the cost-effectiveness of PLC approaches in third countries implementing the different options, one can roughly evaluate the cost reduction in the EU. Option 1 Cost data is only available for Japan. However, the approach for defining a PLC in Japan is different than the one proposed for the EU: the proposed EU PLC definition (see section 4.3) is similar to the Australian, Canadian and US definition and less so to the Japanese one (see section 4.1.1). Therefore, defined as PLCs in Japan, and benefiting from the exemption, may not all be the same as those which would be considered as PLCs in the EU. Thus, it is not possible to apply the Japanese reduction factors to the proposed EU approach. It is not possible to conclude for Option 1 with regards to cost reduction in the EU. Option 2 The proposed PLC approach for the EU resembles the US criteria and overall strategy for defining a PLC. Therefore, the reduction factor of 23% would be applicable also for the EU, should Option 2 be chosen to tackle PLCs, with the limitation that the EU and US market may differ. However, this option may not be the most relevant for the EU, as it relies on inspections of manufacturers by the Competent Authority (e.g. ECHA). Option 3 This option was adopted in the EU for reduced test package under the DSD and is currently implemented in Australia and Canada for PLCs. The reduction factor of those two countries PLC approach, which resembles the one proposed for the EU, was evaluated at 31% and 33% (for Australia and Canada, respectively). Therefore, an average cost reduction of 30-35% can be associated to a PLC approach with reduced requirements and a set of criteria similar to what is implemented in Canada and Australia. Thus, should option 3 be chosen for the EU, a reduction factor of 30-35% might be expected. 58

59 5.Registration approaches for grouping 5.1. Approaches adopted in the DSD and in third countries Definition of a group of polymer and process for determining similarity The USA, Australia and Canada allow submission of a single registration for similar, under the names consolidated notice, group assessment and consolidated notification respectively. Grouping provisions also existed for under Annex VIID to the DSD (narrow range and wide range 51 ). The grouping approaches are summarised in Table The wide range is also named the family approach 59

60 Table 10: Grouped registrations in the studied jurisdictions Jurisdiction Name Size of group Criteria for sameness / similarity USA Consolidated Notice 2 to 6 Similar in terms of exposure, environmental release, and test data Canada Consolidated Notification 2 to 6 Substances of the same class. The CA does not provide guidelines explaining how to assess similarity. Australia Group Assessment 2 or more For that are similar and have a similar use. Similar polymer -the notified polymer contains one polymer constituent less than the primary polymer; -the notified polymer contains a polymer constituent which is similar to a polymer constituent in the primary polymer with all other polymer constituents the same. In this case all but one polymer constituent should be the same. Where there is a difference in a polymer constituent, the substituted one must meet the criteria for similar chemical. The notifier needs to provide data on the original and substituted polymer constituent to demonstrate this; -the notified polymer is structurally identical to the primary polymer. In some cases, a polymer may be manufactured by different reaction pathways and, in some cases, using different reactants. This can lead to the identification and naming of a particular polymer in more than one way, with different CAS registry numbers, although the may be structurally identical (that is, contain the same linkages and functional groups). The notifier needs to provide information to support this. In addition, the identity and physicochemical criteria (given below) must be met: -contain the same linkages and functional groups, and -water solubility within the range of 50% to 200%. Similar use -industry sector in which the chemical is used 60

61 Jurisdiction Name Size of group Criteria for sameness / similarity Australia (cont.) -routes of human exposure -types of workers exposed and the extent to which they are exposed -routes of environmental release -potential for public exposure -volume range <1 tonne, 1 3 tonnes, 3 10 tonnes, tonnes, tonnes and tonnes. (Note: a use would not be considered similar if the increase in volume would lead to a change in the original risk assessment). -the mode of introduction (for example, import or manufacture). EU (DSD) Narrow range and wide range 2 or more The narrow range: a narrow group of (co) of similar composition and/or similar Mn is considered a substance and is therefore subject to one notification. This means that small variations are allowed: o o For homo 52, Mn can vary up to three-fold; For co, the two following cases are allowed: Mn remains approximatively constant ( approximatively meaning a variation up to 2- fold is allowed) while the composition varies by ± 10 % absolute (Figure 9 illustrates this case for an AB copolymer 53 ); The composition remains approximatively constant ( approximatively meaning a variation up to 3 % absolute is allowed) while Mn can vary up to 3-fold (Figure 10 illustrates this case for an AB copolymer) Figure 9: The narrow range in which a group of AB co can be considered as one substance (first case) 52 Homo are synthesised from only one type of monomers. Therefore, their composition cannot vary. 53 A polymer synthesised from two different monomers, named A and B 61

62 Jurisdiction Name Size of group Criteria for sameness / similarity EU (DSD) (cont.) %A Narrow group of AB co (%A) nominal + 10 % (%A) nominal (%A) nominal 10 % M n, min 2 M n, min M n Figure 10: The narrow range in which a group of AB co can be considered as one substance (second case) %A Narrow group of AB co (%A) nominal + 3 % (%A) nominal (%A) nominal 3 % M n, min 3 M n, min M n 62

63 Jurisdiction Name Size of group Criteria for sameness / similarity EU (DSD) (cont.) The wide range (also called the family approach): the family approach is used when a group of is too wide in composition or in Mn to be considered a substance (and therefore cannot be notified using the narrow range approach). A family is defined by a group of in which one parameter (e.g. Mn) is fixed (i.e. confined in a narrow range) while the other (e.g. composition) is allowed to vary over a large range. The principle of the family approach is to allow the notification of a group of having a similar hazard potential. In order to ensure that, representative members of the family must be tested: o For homo: let us consider a group of homo with Mn extending over more than a 3-fold range, the lowest Mn polymer being named P1 and the highest Mn polymer P2 (they are the two representatives of the group).the full-test package (as defined in Annex VIID to the DSD) must be performed on P1: If no toxicological/ecotoxicological effects are observed for P1, then no testing is required for P2: toxic effects normally decrease from the low to the high Mn, so that if no effects are seen on P1, none are expected for P2; If toxicological/ecotoxicological effects are observed for P1, then P2 must be tested for endpoints which were positive for P1: If toxicological/ecotoxicological effects are seen on P2, then the group is submitted with testing results on P1 and P2 in the dossier. The dossier is valid for homo from the Mn of P1 to three times the Mn of P2; If no toxicological/ecotoxicological effects are seen on P2, then 2 notifications are necessary: (1) one notification for with Mn ranging from the Mn of P1 to three times the Mn of P1; and (2) one notification for with Mn ranging from the Mn of P2 to three times the Mn of P2. For co: the principle of testing both ends of the group (in terms of Mn if composition is fixed or in terms of composition if Mn is fixed) is applied (see above). However, if effects are seen for the lowest end of the group and no effects for the highest end, then additional tests must be performed on other representative members of the group. 63

64 The rationale behind grouping approaches is that having similar molecular structure, composition or use, present a similar physical and chemical behaviour which eliminates the need to distinguish each one of the individual for the assessment required during the registration. The advantage of this read-across is thus to reduce the number of submissions (there is only one submission for a family of rather than for each type of polymer), which reduces the number of tests required, and will save time and money to companies that have to perform the submission. The process for determining similarity for the purpose of grouping is different among the studied countries (Table 11). Table 11: The different processes for determining similarity Jurisdiction Process for determining similarity USA Canada Australia EU (DSD) Expertise of CA staff Expertise of CA staff The company must ensure that the submitted group complies with a set of criteria The company must ensure that the submitted group complies with a set of criteria Australia defines a set of criteria and parameters, which applicants for a Group Assessment must use to justify the similarity between all notified. These criteria deal with the similarity of the structure and physicochemical properties of the polymer, as well as similarity with regards to the use of the. For instance, notified must have an identical structure; therefore, grouping parameters include linkages and functional groups. Furthermore, notified under the same procedure must be in the same volume range, have the same potential for exposure and the same toxicity (applicants assess acute oral toxicity and acute aquatic toxicity). If read across data is used, its suitability for the other of the group must also be assessed and reported in the application for a Group Assessment. On the other hand, US EPA has not developed specific criteria to determine similarity. Instead, the US procedure relies on the expertise of EPA technical staff: if they expect, from their knowledge of the review process, that the differences between the substances in the proposed consolidated submission are such that they would require substantial different analyses during the review process, the request is rejected (or partially rejected). The same approach is adopted in Canada. The EU approach is different from the US one because the responsibility of determining if a group of can benefit from only one registration falls on the company and not on the Competent Authority. It is however similar to the Australian approach, as in both the EU and in Australia there is a set of criteria on structure and composition for determining groups. Nevertheless, the EU approach seems to encompass more cases of polymer grouping, through the narrow and wide range strategies Amount of groups registered In the USA, 3553 consolidated notices for were approved since 1996: this represents an average of around 208 consolidated notices per year, grouping 2 to 6. As US EPA receives around 514 polymer notifications in total per year, the consolidated approach allows for a reduction in the number of notifications by a factor of The most common grouping issue deals with variation of the monomers used in the polymer manufacture (methacrylate / acrylate; unspecified monomer vs specific class 1 substance; salt counter-ions {Na +, K +, NH 4+, Mg 2+ }, different initiators used) to name but a few examples of possible consolidations. Other consolidation types are rarely claimed. In the USA, the consolidation process was always primarily meant to reduce the burden on the notice submitters, and secondarily reduce resource expenditures at US EPA to 64

65 review substances that are expected to have similar assessments and decisions. Qualitatively, US EPA is confident that grouping for registration reduced the costs on their end. Furthermore, industry has strongly supported well-defined consolidated testing approaches versus testing each chemical substance individually. The Australian Group Assessment option was used for 8 in the timeframe - 1 PLC and 7 others over a total of around 200. No data was available for Canada. In the EU, only 1 family (of 6 ) was notified under the family approach of the DSD, among 265 'polymer' notifications. The reason why industry did not start using polymer notifications or the family approach to a larger extent was that the guidance on was considered as 'complex' and later efforts to simplify the guidance by the NCD Working Group were not successful due to too many discrepant opinions about the polymer notification package requirements inside the group 54. There is therefore a great discrepancy regarding the actual use of grouping approaches in the studied jurisdictions: while it is popular among industrials in the USA, it is seldom used in the EU (DSD) and in Australia. The reason for such a difference may lay in the responsibility for determining similarity: while in the USA, the US EPA determines if a group of can benefit from only one registration following a request, in the other jurisdictions the companies must prove the similarity based on predefined criteria Assessment of grouping approaches with regards to environmental and health risks of Criteria for assessing grouping approaches The common concept behind all third countries' grouping approaches is that members of a group must not differ in terms of environmental and health risks. They must have similar hazardous properties and present similar exposure scenarios. Hazard Hazards of chemicals, including, are characterised by different hazard endpoints: Ecotoxicity: o o o Aquatic Terrestrial Sediment Human health hazards: o o o o o o o o Carcinogenicity Reprotoxicity Teratogenicity Genotoxicity Immunotoxicity Neurotoxicity Irritation Sensitisation Saying that two have the same hazard means that they show toxicity for the same endpoints. This means that ensuring identical hazard for all members of a group 54 Communication from ECHA 65

66 would imply that for every endpoint, all members of a group be tested, or at least that for every endpoint, some members of the group be tested and read-across methods be used for the others. This represents a lot of work and would not allow a grouping approach to reduce the burden on companies in terms of costs. Here enters the concept of similarity of with regards to their potential hazard. The idea is that all members of a group have comparable types and levels of hazard, so that the review of individual dossiers by the CAs, should these members have been registered individually, would not have been sensibly different, and would have had the same outcome with regards to their circulation in the market. Therefore, assessing grouping approaches includes checking whether they ensure that members of a group have comparable types and levels of toxicity. This can be done by checking if criteria developed for grouping (if any) are in line with read-across techniques for predicting similar behaviour of chemicals. A grouping approach can then be seen as an application of the read-across concept. The OECD has developed read-across methods for read-across justification and for constituting so-called categories of chemicals, which can be used for predicting the toxicity of one substance using available information on the toxicity of other substances of the category (analogues) 55. The authors have identified elements for justification of readacross which are relevant for grouping : they are presented in the following table. Table 12: Justification elements for read-across and their relevance for grouping General element Relevant? Detailed description for grouping Chemical structure Yes The size of the polymer Type of linkages Linear vs branched Composition Yes Same monomers used to synthesise the polymer Impurities Yes Content of residual monomers and oligomers Functional groups Yes RFGs Physical-chemical properties and other molecular descriptors 56 Yes The charge (ionicity) of Particle size Swellability Kinetics: Absorption, distribution, metabolism and excretion No. The previous basic elements are sufficient to evaluate the overall toxicity of 55 Guidance on Grouping of Chemicals, Second Edition: 56 Molecular descriptors are numerical quantities describing the chemical structure and can be divided into two categories: Classical physical chemical properties (e.g. solubility, log P, molar refractivity, dipole moment, polarizability), and theoretical molecular descriptors derived from a symbolic representation of the molecule (0D, 1D, 2D and 3D, e.g. counts of structural fragments and atoms, connectivity indices and other graph invariants, HOMO/LUMO, surface area, volume). 66

67 General element Relevant? Detailed description for grouping Mode/Mechanism of action or adverse outcome pathways (MOA/AOP). Chemical / biological interaction Responses found in alternative assays Not applicable Information obtained from other endpoints/species/routes Not applicable Furthermore, the OECD has proposed a rationale including some of the above elements and others, for categorising chemicals for read-across. The table below shows which are relevant, according to the authors, for assessing grouping approaches for (with regards to hazard). Table 13: Rationale for categorisation of read-across analogues and relevance for grouping Elements of the rationale for categorisation Relevant? Detailed description for grouping Common functional group(s) (e.g., aldehyde, epoxide, ester, specific metal ion) Yes, see previous table A common mode or mechanism of action or adverse outcome pathway No, see previous table Common constituents or chemical classes, similar carbon range numbers. (for UVCB substances) No. Specific to UCVB substances The likelihood of common precursors and/or breakdown products via physical or biological processes that result in structurally similar chemicals No. Polymer degradation products are closely linked to their structure, so this element is tackled by structural considerations. An incremental and constant change across the category (e.g., a chain-length category) Yes. This allows that inherent variability of (in terms of structure and size) be taken into account. Incremental addition of carbons in a polymer backbone Polymer with a homologous series of end-groups The use of the read-across principle for assessing grouping approaches for can be formalised in a simple framework including these questions: Does the approach involve provisions related to similar structure? Does the approach involve provisions related to composition? 67

68 Does the approach involve provisions related to content of residual monomers and/or oligomers? Does the approach involve provisions related to common functional groups? Does the approach involve provisions related to physical-chemical properties and other molecular descriptors? Does the approach involve provisions related to an incremental and constant change across the group? The analysis of potential hazard of conducted in section 4 allows for a prioritisation of those assessment questions: the analysis showed that the most relevant hazard criteria (other than direct knowledge of toxicity) were related to the size of the polymer, the nature and content of reactive functional groups and the content of residual monomers, impurities and degradation products. Therefore, the assessment concludes that a grouping approach ensures that all members have similar hazard if the following three elements are included: Criteria for similar structure AND Criteria for common functional groups AND Criteria for similar content of residual monomers, impurities, etc. The other elements are optional. Exposure Similarity in terms of exposure can be evaluated with regards to the following framework: Does the approach require information on: The entities which are exposed (the public, workers, aquatic compartments, terrestrial compartments, etc.)? OR The routes of exposure (dermal, inhalation, etc.)? OR The intended use of the polymer (toys, bottles, nappies, etc.)? OR The manufactured volumes? Assessing grouping approaches with regards to exposure consists in evaluating the amount of information which is required by the CAs on the above-mentioned elements Assessment of grouping approaches from the studied jurisdictions The USA, Australia and Canada are currently implementing a grouping approach. Under the DSD, it was also the case in the EU. USA In the USA, no criteria are provided to companies for them to comply with in case they want to use the grouping approach. Guidance provided by the US EPA states that members of a group must be similar in terms of exposure, environmental release, and test data. Then, US EPA staff uses its expertise to determine whether the differences between the substances in the proposed group are such that they would require substantial different analyses during the review process and in such a case, reject the request. 68

69 The approach implemented in the USA relies on internal expertise at US EPA, using internal databases of chemicals. Appropriate assessment is ensured by staff specialised in polymer toxicology, e.g. Vince Nabholz, author of Environmental Assessment of Polymers under the U.S. Toxic Substances Control Act, in Ecological Assessment of Polymers Strategies for Product Stewardship and Regulatory Programs 30. Australia NICNAS provides criteria for similarity of and similar use (see section 5.1.1). The evaluation of the assessment framework is provided below. Table 14: Assessment of the Australian grouping approach with regards to environmental and health risks Question Answer for the Australian approach HAZARD - Does the approach involve provisions related to: Similar structure? Yes: two similar must contain the same linkages Furthermore, structurally identical, but manufactured with different reaction processes can be grouped together. Composition? Content of residual monomers and/or oligomers? Common functional groups? Physical-chemical properties and other molecular descriptors? An incremental and constant change across the group? Yes: two similar must not differ by more than one constituent Yes: a PLC and a non-plc cannot be members of the same group. This implies that with low content of residual monomers and oligomers cannot be grouped with with higher content of residual monomers and oligomers. Yes: two similar must contain the same functional groups Yes: two similar must have similar water solubility (within the range of 50% to 200%) No EXPOSURE: Does the approach require information on: The entities exposed? The routes of exposure? The intended use of the polymer? Yes: One of the similar use criterion requires that the types of workers exposed and the extent to which they are exposed, as well as the potential for public exposure be the same. Yes: One of the similar use criterion requires that routes of environmental release, routes of human exposure, and the mode of introduction (for example, import or manufacture) be the same Yes: One of the similar use criterion requires that industry sector in which the chemical is used be the same 69

70 Question The manufactured volumes? Answer for the Australian approach Yes: One of the similar use criterion requires that the volume range of all members of a group be the same: <1 tonne, 1 3 tonnes, 3 10 tonnes, tonnes, tonnes and tonnes The Australian grouping approach aims to ensure that environmental and health risks are similar within one group. However, the constraints on the variability of structure and composition of of one group do not allow the Australian grouping approach to accommodate for the inherent variability of. Indeed, with similar structure but with sizes distributed over a wide range of Mn (e.g. three fold) may have similar hazard and may be relevant to be grouped together. However, such a case is not provided for in the Australian approach. Canada The Canadian grouping allows only small differences in the structure of for grouping them. Therefore, it can be assumed that similar environmental and health risks are ensured, but the inherent variability of may not be taken into account. EU (DSD) The grouping approach, including the narrow and the wide range approaches, is assessed in the table below: Question Answer for the approach of Annex VIID of the DSD HAZARD- Does the approach involve provisions related to: Similar structure? Composition? Content of residual monomers and/or oligomers? Yes: There are criteria of similar size (similar Mn) Yes: Definition are provided regarding the meaning of similar for composition No Common functional groups? Physical-chemical properties and other molecular descriptors? Yes No An incremental and constant change across the group? Yes: This is provided by the wide range approach EXPOSURE- Does the approach require information on: The entities exposed? The routes of exposure? The intended use of the polymer? The manufactured volumes? No No No No The DSD grouping approach does not comply with all criteria for ensuring similar environmental and health hazard within a group. However, the DSD grouping approach 70

71 includes direct testing of representative members of the family, so that it is understandable that other elements for predicting hazard are not used in the framework. The concept of testing representatives aims to ensure that environmental and health hazard are similar within one group. However, no elements relative to similar exposure was identified in the DSD grouping approach. Conclusion The US and Canadian approaches do not provide much guidance for grouping for registration. The responsibility falls on the Competent Authority to determine whether the members of the group show similar hazard and exposure. Companies submit information on similarity based on their knowledge of their products. One can hardly conclude on the efficiency of those approaches, other than say that similarity is in the end determined by experts, thus ensuring a similar environmental and health risk among all members of a group. The Australian and the DSD approaches provide criteria for companies to properly group : in these strategies, the responsibility for evaluating the similarity falls on companies. The analysis of the grouping assessment method shows that the Australian approach ensures that all members of a group have similar environmental and health risks. However, the Australian approach fails to take into account the inherent variability of, and allows only grouping of which are almost identical. The DSD approach ensures that all members of a group have similar hazard, but the exposure aspect is not tackled. The DSD approach allows a variable composition of in one group, thus taking into account the inherent variability of Proposal of a EU grouping approach The proposed grouping approach is based on the Australian approach and includes elements from the DSD approach and the OECD categorisation to take into account the inherent variability of. In order to ensure that members of a group have a similar degree of purity, PLC and non- PLC are not allowed to belong to the same group (see Table 14). Furthermore, all members of a family must have the same functional groups. The proposed approach is divided into two main categories: Groups of with the same constituents, i.e. the same monomers and other substances belonging to the polymer structure, e.g. counter-ions; and Groups of with different constituents. The following subsections detail the different cases included in the proposed approach Grouping with the same constituents The term same constituents includes monomers and other substances belonging to the polymer structure, e.g. counter-ions. Case 1: Structurally identical 57 Polymers manufactured by different reaction pathways and possibly with different reactants have different CAS numbers. Instead of being registered individually, they can be registered in one group, if they are structurally identical. Justification includes proof that the structures are identical (e.g. with chromatographs, NMR spectra, etc.). 57 As done in Australia 71

72 Case 2: Polymers which were considered as one substance under the DSD (narrow range) Polymers with similar composition and similar Mn, meaning that small variations are allowed: For homo, Mn can vary up to three-fold; For co, the two following cases are allowed: o o Mn remains approximatively constant ( approximatively meaning a variation up to 2-fold is allowed) while the composition varies by ± 10 % absolute; The composition remains approximatively constant ( approximatively meaning a variation up to 3 % absolute is allowed) while Mn can vary up to 3-fold Case 3: Polymers with incremental and constant change across the group This allows homologous series of to be grouped together for one registration. Example 1: homologous series of alpha-olefins (see Table 15) Each category member differs by a methylene group ( CH2 unit) 55. In this case, there may be a trend of increasing acute aquatic toxicity with increasing chain length from C3 up to a carbon chain length of C12, after which no acute aquatic toxicity is seen because the water solubility has decreased with increasing chain length. Thus the applicability domain for aquatic toxicity would be C3 to C12. 72

73 Table 15: Example of structure and functional groups in the category of Alpha olefins, from the OECD HPV (high production volume) Programme Category Structural Relationship Functional groups Number of Major justification for category Reference between category substances in members the category Alpha olefins Even-numbered, alpha- Olefin 5 Category members are olefins bearing a single medium-length (C6 SIDS Initial unbranched aliphatic chain(c6 C14) with no CxH2x C14), even numbered, unbranched aliphatic chain with no other functional groups. There is an increasing or decreasing trend or Assessment Report, OECD other functional groups pattern from the shortest category member (C6) to the longest category member (C14) for various physical- properties and ecotoxicity but there appears to be no difference across category members for biodegradation and health endpoints. Melting point, vapour pressure, and water solubility decrease with increasing chain length while boiling point and octanol:water partition coefficients increase with increasing chain length. Measured and predicted acute aquatic toxicity data indicate that 1-hexene, 1-octene, and 1- decene exhibit acute effects to aquatic organisms at levels at or below their water solubility, but 1-dodecene and 1-tetradecene are not likely to be acutely toxic. 1-hexene may be less toxic than the rest of the category members and 1-octene, 1-decene, and 1- dodecene are expected to be similarly toxic. Modelling could not predict the chronic aquatic toxicity of 1-tetradecene. No apparent difference regarding biodegradability. Data indicate no differences among the five category members for acute toxicity, repeat dose toxicity, genotoxicity and reproductive/developmental toxicity. 73

74 Example 2: homologous series of end-groups (from Annex I of the Manual of Decisions for implementation of the sixth and seventh amendments to the DSD) 25 This family consists of a group of molecules in which the polymer entity is the same and a homologous series of end-groups is attached; e.g.: Figure 11: Example of a homologous series of end-groups C C10 Fixed polymer C C C Grouping with different constituents Case 4: Change in counter-ion (if the polymer is a salt) Feedback from grouping in the USA shows that one of the most common grouping request deals with variations of the counter-ion, if the polymer is a salt. As done in Australia, all other structural properties being the same, salts can be grouped if the counter-ions are similar, for instance: Salts formed when the hydrogen of an acid is replaced by an alkali metal or a cation of equivalent solubility (for example, NH 4+ ) is suitable for grouping. Na + salts can be grouped with K + salts (all other structural properties being the same) and other salts Case 5: change with a similar monomer Feedback from grouping in the USA shows that one of the most common grouping request deals with variations of the monomer. The following variations are accepted within a group: Monomers which are isomers (positional and stereoisomers, except if the isomery is known to change the toxicity profile) done in Australia. Monomers with a slight change in structure, e.g. acrylate/methacrylate done in the USA 5.4. Cost effectiveness of grouping approaches (third countries and new approach) There is an actual reduction of costs from a grouping approach if the cost of determining similarity is lower than the regular cost of registering a polymer Equations Reduction of costs for 1 polymer Let x be the cost of a standard registration and x grp the cost of registering one polymer in a grouped registration. Then the reduction factor of costs for 1 polymer r grp is such as: x grp = (1 r grp ). x A simple way to consider a grouped registration is the following: 1 polymer undergoes all the necessary tests (costing x), while the others are evaluated for similarity with the first polymer. Let x sim be the cost of determining similarity and n is the number of in a grouped registration, then: So that: x grp = 1 n n 1. x + n. x sim 74

75 r grp = (1 1 n ) (1 x sim x ) Reduction of costs for the total number of registrations Let N s be the number of single registrations and N grp the number of grouped registrations. Then the total cost is: Cost grouping approach = N s. x + N grp. n av. x grp Where n av is the average number of in a grouped registration. If no grouping approach was implemented, then the cost for notifying these would be: Cost no grouping approach = (N s + n av. N grp ). x The reduction factor of total costs, R grp, is such as: Which gives: Cost grouping approach = (1 R grp ). Cost no grouping approach R grp = 1 + r grp N s n av.n grp The ratio N s for one company can be estimated as being, on average, the ratio for all N grp companies notifying in the country that year. Therefore, country-wide data can be used to estimate R grp. Alternate equation If the number of grouped registrations is not available but instead the number of benefiting from a grouped registration N pols grp is known, then: Cost grouping approach = N s. x + N pols grp. x grp If no grouping approach was implemented, then the cost for notifying these would be: Cost no grouping approach = (N s + N pols grp ). x The reduction factor of total costs, R grp, is then: R grp = 1 + r grp N s N pols grp Required data for numerical application In order to estimate R grp, the following data is necessary: The number of in a grouped registration The number of grouped registrations or the number of benefiting from a grouped registration; The number of single registrations the cost of determining similarity (x sim ) The required data to assess cost-effectiveness are compiled in Table 16 below. 75

76 Table 16: Required data for estimating cost effectiveness of grouping approaches Country The number of in a The number of grouped registrations The number of benefitting from a grouped The number of single registrations x sim grouped registration (per year) registration per year (average) Australia 2 or more No data 4 (LTD) 1 (PLC) 33 (LTD) 55 (PLC) Savings are of $9,800 for an LTD or $3,200 for a PLC: (in 2012/2013: 1 PLC and 2 LTD; in 2013/2014: 0 PLC and 5 With: x x sim = $9,800 (LTD)or $3,200(PLC) LTD) x = $34,000 (LTD) or $19,600 $ 32,000 (PLC) So: x sim = $24,200 (LTD) or $16,400 $ 28,800 (PLC) Canada China Japan South Korea Taiwan USA 2 to 6 No data No data No data No data n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 2 to No data 306 No data 76

77 Calculation of reduction factors for third countries As seen in Table 16 above, not enough data was collected from third countries to allow an assessment of the reduction factors. Attempted calculations needed too many assumptions could not accurately reflect the situation in third countries. Therefore, the cost-effectiveness of grouping approaches could not be assessed Cost reduction for the EU with the proposed grouping approach Available data does not allow for a quantitative assessment, but the approach to which the new approach is the closest is the Australian one. In this jurisdiction, only three benefitted from the grouping approach in 2012/2013 and five in 2013/2014. Furthermore, the DSD approach, applied previously in the EU, only saw one family being notified. The cost reduction for the proposed approach is likely to be low. 77

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79 6.Conclusion 6.1. Third countries PLC and grouping approaches The studied countries implement approaches allowing for reduced requirements or exemptions for certain types of. These approaches include PLC and/or grouping approaches as well as the status of registration of monomers. Figure 12 below summarises which country applies which (main) reason for reduced requirements/exemption. Figure 12: Main reasons for exemption or reduced requirements in the studied countries A majority of the studied countries have a PLC or a grouping approach. Australia, Canada and the USA are the only countries which have both. Countries implementing a PLC approach do it based on the fact that some are less hazardous and should therefore benefit from reduced requirements. There is no standardised set of criteria for defining a PLC: the OECD definition of a PLC remains general. Nevertheless, there are trends in the sets of criteria defined by the different countries using the PLC concept. Ineligibility criteria, criteria on molecular weight, oligomer content and reactive functional groups are used by most countries. The criteria used by the USA, Australia and Canada are those which abide the most with polymer hazard characteristics as identified in the literature. Furthermore, the implementation of a PLC approach allows a reduction of registration costs for companies: reduction factors range from 23% (the USA) to 67% (Japan). Only three countries implement a grouping approach (Australia, Canada, USA). The size of the groups often range from 2 to 6 : an internal study at US EPA found that the biggest consolidated group of chemicals that actually were commercialised was six chemicals per consolidation. Determining similarity among the of one group is an issue which is dealt with differently among the countries: in the USA, an applicant proposes a group and the US EPA relies on the expertise of their technical staff to validate the group; while in Australia applicants must justify similarity using a predefined set of criteria and parameters. It is difficult to reach a conclusion for the cost-effectiveness of grouping approaches, because of lack of data. 79

80 6.2. Proposed approaches for the EU A PLC and a grouping approach are proposed for the EU. The PLC approach is based on a decision tree for determining whether a polymer can be considered of low concern or not (Figure 7). The elements included in the decision tree are the following: Eligibility criteria on: hazard classification, presence of only selected elements, cationicity, degradability and water absorption; Criteria on molecular weight and oligomer content; Criteria on Reactive Functional Groups; and Criteria on polymer class (polyesters). The implementation of this approach, with reduced requirements for PLCs (option 3 in section 4.4.5), would allow a cost reduction factor of 30-35% for a company. The proposed grouping approach was developed in the aim to ensure that all members of a group have similar environmental and health risks. It includes provisions for groups of with the same constituents and groups of with different constituents. The cost effectiveness of the grouping approach could not be well predicted based on available data on similar grouping approaches implemented in third countries but is expected to be lower than with the PLC approach. 80

81 7. Annexes ANNEX 1. COUNTRY FACTSHEETS 82 ANNEX 2. SUPPORTING DATA 196 ANNEX 3. DETERMINATION OF FGEWS Method 1 - End-group analysis Method 2 - Per cent charged method 225 ANNEX 4. PROPOSED PLC APPROACH REACTIVITY OF FUNCTIONAL GROUPS Low concern Moderate-concern High concern 228 ANNEX 5. GLOSSARY

82 Annex 1. Country factsheets Australia Regulatory text: The Industrial Chemicals (Notification and Assessment) Act Competent Authority: Australian Government Department of Health Contacts: Dr Sarah Rumble Aim and structure of this sheet This factsheet describes the polymer notification scheme currently implemented in Australia. After a first section outlining the main aspects of the scheme and a decision tree showing its different steps, the sheet details the principal criteria used in grouping and PLC approaches. Key points raised by the document (advantages/disadvantages of the strategy, transferability in the EU) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the Australian Government Department of Health. Context and general description The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is a statutory scheme administered by the Australian Government Department of Health. NICNAS was established in July 1990 under the Industrial Chemicals (Notification and Assessment) Act The Australian Inventory of Chemical Substances (AICS) lists the chemicals available for industrial use in Australia (known as existing chemicals, including ). Therefore, an industrial polymer not included in the AICS is regarded as a new polymer. In two specific cases can an industrial chemical listed in the AICS be nevertheless considered as new : If it is introduced in the Australian market beyond the scope of the conditions for which it is subjected; If it is a synthetic polymer* not abiding by the 2% rule (see grouping approach ). New industrial chemicals (including ) are subject to notification, for which two categories exist: permits and assessment certificates. Notification under one category or the other depends on the type of chemical/polymer, its production/import volume, its use and period of use, as well as the manufacturer specific business needs (see table below). Applying for a permit allows for a reduction of costs and data requirements, but authorised volumes and duration are lower. In addition, only chemicals assessed under an assessment certificate are eligible for entry onto the AICS. Therefore, a company may choose, even if the new chemical qualifies for a permit, to apply for an assessment certificate. Data requirements under the certificate category are specified in so-called Schedules, which are documents compiling information to be provided to NICNAS. In particular, Schedule D specifies the information a company must provide to characterise a polymer, polymer mixture, its additives and adjuvants. Table 1 lists the various forms and schedules in which requirements are stated; details about those requirements are presented in the relevant sections of this factsheet. 82

83 Table: Overview of permits and certificates Definition Data requirements Permits Commercial The Commercial Evaluation Chemical (CEC) permit Form 1-CEC evaluation allows to use the chemical for a specified chemical (CEC) performance or product trial only (for example, to test a new polymer in a surface coating when a large quantity is required to fill paint lines or to evaluate a new process that requires a new industrial chemical). Data listed in 6(a)(i) to 6(N), 7,8, 11 and 12 of Part B of the Schedule This type of permit is not issued for chemicals in retail products such as cosmetics. Low volume A Low Volume Chemical (LVC) permit allows a LVC permit application chemical chemical to be introduced at a maximum quantity of form (LVC) 100 kg per year, or 1000 kg where certain criteria are met (polymer or hazardous criteria), for a maximum of three years. (Form1-LVC and Form LVC-1R) Controlled Industrial chemicals will be eligible for the Controlled Form EOP-1 Use (Export Use (Export Only) Permit (EOP) if the entire quantity Only) Permit (EOP) of the new chemical: imported into Australia will be exported imported into Australia for use in formulating products will be exported manufactured in Australia will be exported manufactured in Australia for use in formulating products will be exported. For introduction volumes exceeding 10 tonnes per year, the notifier needs to provide all available toxicological and ecotoxicological data with An EOP is available where you can demonstrate the your application. chemical is low risk. Under the highly controlled NICNAS may ask for criteria, you must have sufficient control measures in additional toxicological place to prevent exposure to workers and the public and eco-toxicological and release to the environment. information to An EOP lasts for a maximum of three years. determine 'no unreasonable risk'. Controlled CUPs are issued for the introduction of low-risk new Form CUP-1 Use Permit chemicals used in highly controlled circumstances for (CUP) a maximum of three years (note: certain prescribed criteria apply). There is no volume restriction. A CUP can be renewed any number of times, provided certain criteria are met. 83

84 Early introduction permit An Early introduction permit (EIP) allows introduction of a chemical into Australia before the assessment certificate is issued. The notifier can apply for one under certain circumstances, in conjunction with a certificate notification. Section 30A EIPs are for new industrial chemicals meeting certain hazard or use criteria and Section 30 permits are for new chemicals where it can be shown their immediate introduction is in the public interest. May be eligible: Form EIP-1 Polymer of low concern (PLC) non-hazardous chemicals or chemicals and meeting low-hazardous criteria low-risk,highly controlled chemicals or. Certificate Polymer of low concern (PLC) notification Limited (LTD) notification Standard (STD) notifications Selfassessment certificate PLC notifications are for that meet the PLC criteria LTDs are for chemicals fitting one of these categories: small-volume chemicals, bio, and low MW synthetic (NAMW <1000 Da) that is, chemicals to be imported or manufactured at a rate of up to 1 tonne/12-month period site-limited chemicals, bio, and low MW synthetic (NAMW <1000 Da) that is, chemicals restricted to their manufacturing site and manufactured at a rate of not more than 10 tonnes/12-month period synthetic with NAMW >1000 Da that do not meet the PLC criteria. No volume restriction. STDs are for chemicals, bio and low MW synthetic (NAMW<1000 Da) imported or manufactured at greater than 1 tonne/year that do not fulfill the requirements of any other category Self-assessment certificate categories allow industry to self-assess low regulatory concern chemicals against specified criteria and provide an assessment report which is screened and amended by NICNAS in consultation with the notifier if necessary before publication. Self-assessment certificates are available for PLCs and non-hazardous chemicals or. The assessment time frame is shorter than for non self-assessment categories (28 days as opposed to 90 days) and the fees you pay are lower. Selfassessment certificates cannot be extended. Form PLC-1 any other information about the polymer available to the notifier the completed application form for an assessment certificate (Form-1), including the information about the chemical comprising parts A, B and C* of the schedule (* for STD only, unless available for LTD), Part D for synthetic polymer or biopolymer, and Part E for an ultraviolet filter used in a cosmetic and applied to the skin PLC Self Assessment (Form 1 - PLC) Non PLC Self Assessment (Form 1 - Non PLC) In general, NICNAS completes a certificate assessment for a new industrial chemical within 90 calendar days from the date the complete notification package (application) is received. This review period is shorter for permits (see Table). 84

85 Table: Application details for permits and certificates Permits and certificate Chemical amount Duration of Assessment Fees in $, as of categories introduced certificate or timeframe June 2014 permit Commercial evaluation chemical (CEC) < 4tonnes Up to 2 years Usually within 14 days 4,100 Low volume chemical (LVC) < 100 kg/year 3 years 20 days 4,100 Low volume chemical (LVC) Controlled Use (Export Only) Permit (EOP) >100 but 1000 kg/yr1 Unlimited 3 years 20 days 4,100 3 years Usually within 4, days Permits Controlled Use Permit Unlimited 3 years Usually within 28 4,100 (CUP) days Early introduction permit As for PLC, LTD or Until certificate 28 days 2,400 STD issued, or permit rescinded Permit renewal As for previous 3 years 20 days 2,100 LVC, CEC, CUP, (LVC/CUP/EOP) (LVC/EOP), and EOP and up to 2 years usually 28 days (CEC) (CUP) and 14 days (CEC) Polymer of low concern (PLC) notification Unlimited 5 years 90 days 5,800 Limited (LTD ) notification <1 tonne/yr <10 tonne/yr for site limited chemicals Unlimited for synthetic with Mn> years 90 days 12,400 Certificates Standard (STD) notifications >1 tonne/yr 5 years 90 days 17,400 Self assessment As for PLC, LTD or STD 5 years 28 days 4,000 for PLC 10,000 for non hazardous polymer 10,800 for non hazardous chemical Application for Extension As for PLC, LTD or 5 years from 45 days 5,300 of Assessment Certificate STD granting of original certificate As NICNAS function is also to maintain the AICS, five years after a certificate has been issued following the 85

86 assessment of a new industrial chemical, NICNAS authorises the chemical for wider use by listing it on the AICS. Under specific conditions, new chemicals (including ) can be exempted from notification: New chemical introduced for research, development or analysis purposes only if it is manufactured in a specific location or imported or manufactured at a maximum of 100 kg in a 12-month period. New chemical introduced under the transhipment category; new chemical subject to the control of the Australian Customs and Border Protection Service and leaving Australia less than 30 days after the day it was introduced. New chemical intended for non-cosmetic and cosmetic use that does not exceed 100 kg in any 12-month period and that poses no unreasonable risk to occupational health and safety, public health or the environment. Non-hazardous new chemical intended for cosmetic use introduced at less than 1% Nevertheless, these exempted new chemicals must be self-assessed and they are subject to an annual reporting obligation. In addition, some require the submission of a form to NICNAS before market entry. For the reporting year, at least* 558, which represent 7.6% of total reported chemicals (395 distinct - 8% of distinct chemicals) were present in the NICNAS database reporting exemptions. Notification of a new industrial chemical (including ) leads to an assessment by NICNAS, before it is authorised for manufacture or import. Under certain conditions, a company can perform the risk assessment itself and submit a report to NICNAS for notification. This process is named self-assessment and, when it comes to, is possible for two types: Polymers of Low Concern and non-hazardous **. NICNAS has a number of modular notification categories with reduced fees: a previous (or concurrent) assessment can be utilised in the NICNAS assessment, if: the notified chemical or polymer is similar to a chemical or polymer previously assessed by NICNAS; or the notified chemical or polymer is being notified at the same time as a similar chemical or polymer, and for a similar use; or an assessment of the notified chemical or polymer in Canada, USA or the EUis available; or an assessment of the notified chemical or polymer by another Australian Agency is available. The modular notification categories strategy is discussed in the grouping approach section. Existing chemicals Manufacturers or importers of an existing chemical/polymer do not need to notify said chemical, but they need to register to NICNAS as an importer or manufacturer. Due to the large number of chemicals listed on the AICS, NICNAS assesses existing chemicals as a priority in response to concerns about occupational health and safety, public health or environment effects. These may be assessed as single chemicals or groups of chemicals. NICNAS will conduct different types of assessments depending on the circumstance. The Priority Existing Chemical (PEC) assessment is the most detailed. A PEC is an industrial chemical for which NICNAS requires investigation in detail because there are reasonable grounds to believe it gives rise, or may give rise to, adverse occupational health and safety, public health and/or environmental effects either through manufacturing, handling, storing, using or disposing it.nominations for a PEC assessment may come from a company, union, industry body, individual, government department or non-government organisation. NICNAS may nominate a chemical listed on the AICS for assessment as a PEC at any time. In addition, NICNAS has called for nominations of chemicals as potential PECs from the public and wider community.. NICNAS then screens nominated chemicals against set criteria including volume of use, potential exposure and severity of occupational health and safety, public health and environmental effects. Once the NICNAS Director has considered all information available and consulted with interested parties, the Director decides if there are reasonable grounds for whether the manufacturing, handling, storing, using or disposing of the chemicals might give rise to adverse health or environmental effects. If so, the Director recommends to the Minister that the chemical should be declared a PEC.. 86

87 Once a chemical has been declared a PEC, anyone who wants to import or manufacture it while it is a PEC must first apply to have NICNAS assess the chemical. The information you need to supply with your application varies for each assessment but could include: the physical and chemical properties of the chemical, the occupational health and safety, public health and environmental effects of the chemical, including known effects the quantity, or proposed quantity, of the chemical imported or manufactured, the uses or potential uses of the chemical, names of customers to whom the importer/manufacturer have supplied or intend to supply the chemical information on procedures relating to manufacturing procedures, handling (including transportation) and storing the chemical information about occupational health and safety, public health and environmental matters, particularly exposure matters, as outlined in paragraphs 6 to 8, Part B of the Schedule copies of labels and (M)SDSs of the chemical and products containing the chemical a description of procedures in place to deal with emergencies involving the chemical. No have been declared as a PEC to date. As part of the reform regarding assessment of existing chemicals, NICNAS has implemented a new framework known as the Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework (see Assessment methodologies) for the accelerated assessment of industrial chemicals in Australia. From July 2012, NICNAS began assessing around 3,000 existing chemicals which had been identified as 'Stage One' chemicals, using the IMAP framework. The Stage One chemical list contains a number of. More information on the IMAP Framework including the polymer assessment methodology utilised (Appendix B of the IMAP framework document) is available on the NICNAS website ( Whilst there are no statutory obligations under the ICNA Act relating to the introduction of chemicals being assessed through the IMAP framework NICNAS has welcomed the voluntary provision of information for chemicals on the Stage One List. IMAP assessments also make recommendations on regulatory controls for safe use made to the relevant standard setting body where applicable. Secondary Notification requirements Assessed PEC and new chemicals/ are subject to further requirements if a person who introduces the chemical, or NICNAS, becomes aware of circumstances that may warrant reassessment of its hazards and risks, they must report it to NICNAS, who will call for a Secondary Notification in the Chemical Gazette (special edition of the Commonwealth Government Gazette covering important matters, regulatory issues and requirements for chemical introduction). Notifiers of such a substance will be required to provide specific information about the chemical (for example, its health and environmental effects). All manufacturers/importers of this chemical will need to comply with the new data requirements detailed in the Secondary Notice. Monomers of existing and new are not subject to any specific requirements (i.e. they are only subject to notification if themselves are new chemicals). * No exact number is available. However, NICNAS was able to interrogate the database for those chemicals which had polymer as part of their chemical name (noting that not all entries will have a full CAS name inputted). This number is therefore likely to be an underestimation **See the Definition of a polymer section 87

88 Decision tree *Whilst there are no statutory obligations under the ICNA Act relating to the introduction of chemicals being assessed through the IMAP framework NICNAS has welcomed the voluntary provision of information for chemicals on the Stage One List. IMAP assessments also make recommendations on regulatory controls for safe use made to the relevant standard setting body where applicable. Definition of a polymer NICNAS has adopted the OECD definition of a polymer: A polymer is a chemical consisting of: molecules that are: o characterised by the sequence of one or more types of monomer units, and o distributed over a range of molecular weights for which differences in molecular weight can be primarily attributed to differences in the number of monomer units, and comprising a simple weight majority of molecules containing at least three monomer units covalently bound to at least one other monomer unit or other reactant, and comprising less than a simple weight majority of molecules of the same molecular weight. Definition of a biopolymer: a polymer directly produced by living or once-living cells or cellular components, or synthetic equivalent of such a polymer, or derivative or modification of such a polymer in which the original polymer remains substantially intact. Definition of synthetic polymer: A synthetic polymer is defined as any polymer other than a biopolymer. There is a specific definition for a new synthetic polymer, which is a polymer: including a combination of monomers and other reactive components, each representing at least 2% by weight of the polymer, being a combination not listed in the AICS, or of weight at least 2% is attributable to a monomer or other reactive component that is not listed in the AICS as a 88

89 component of a synthetic polymer. Definition of a non-hazardous polymer: A non-hazardous polymer must comply with the four following points have one of these characteristics: o dissolves in water without dissociation or association and is not surface active and the partition coefficient (n octanol/water) at 20oC as log Pow does not exceed 3 o solubility in water is >1 mg/l o number average molecular weight (NAMW) is >1000 AND be readily biodegradable AND have a very low aquatic toxicity to fish, aquatic invertebrates and algae, that is, LC50 or EC50 100mg/L or greater AND Is not a hazardous chemical with regards to adverse effects on health, as described in the UN's Globally Harmonised System of Classification and Labeling of Chemicals, 3rd edition (GHS), as adopted for workplace chemicals in Australia (some hazard categories or subcategories under the GHS are not used in the definition used by Safework Australia) AND Is not a Dangerous Good according to the Australian Code for the Transport of Dangerous Goods by Road and Rail Generic requirements for not concerned by grouping and/or PLC approaches Existing or in their 5 year certificate period Existing are listed in the AICS, while in their 5 year certificate period are those for which a certificate was issued at least 5 years before. Indeed, after an assessment certificate has been issued, but before the polymer is listed on the AICS, additional manufacturers/importers can apply for the certificate to be extended to them (with the permission of the original notifier). When applying for an extension of an original assessment certificate, applicants must furnish any new information on occupational, public and environmental procedure and on new health and environmental effect. Other requirements for existing are related to the secondary notification: the Secondary Notification of a chemical previously assessed by NICNAS may be required if a person who introduces the chemical, or NICNAS, becomes aware of circumstances that may warrant reassessment of its hazards and risks. Manufacturers or importers must do so within 28 days of becoming aware of such a change. Relevant changes requiring a Secondary Notification are those that may increase occupational health and safety, public health or environmental risks, including but not limited to: A significant new use of the chemical which may: o increase the potential for human exposure (for example, increased concentrations in consumer products) o increase environmental exposure o change the type of exposure (for example, from dermal exposure to inhalation or a chemical initially used as a catalyst in a chemical reaction may later be used as a metal cleaning agent). A significant increase in the quantity of chemical imported or manufactured (for example, a tonnage increase from 1 to 10 tonnes/year or from 50 to 500 tonnes/year). Apart from potentially increased exposure, a significant increase in quantity may lead to a change in the type of exposure (for example, the method of disposing large quantities may be different from the method of disposing small quantities). Production in Australia may have begun for a chemical initially assessed as an imported chemical. A change from less than 1 tonne to more than 1 tonne for a chemical originally notified as a LTD (<1 tonne). A polymer originally notified as a PLC that no longer meets the PLC criteria. A change in manufacturing method, which may lead to increased risk by: o changing from a closed process to an open system o using different raw materials o using different processing conditions o increasing the number of workers required to deal with the chemical 89

90 o changing the type of exposure o changing the method of waste disposal o increasing the environmental exposure. New information on the chemical's potential hazardous properties that have been identified since initial assessment (for example, it may become known that the chemical is carcinogenic). Secondary notification of chemicals not yet listed on AICS, but which have been assessed by NICNAS (i.e. those still in the 5-year certificate period) are assessed under the new chemicals process. The procedure for secondary notification is well documented, but there are no specific additional requirements. The applicant has to furnish a new application that takes into account the changes, on a case-by-case basis. The data required for the re-assessment is stipulated by NICNAS in the Chemical Gazette notice calling for the Secondary notification assessment. For prior to listing on AICS (ie during their 5 year certificate period), there have only been 2 requiring secondary notification. For existing, there have been 3 requiring secondary notification. New New which are not concerned by the PLC approach can be divided into two types: those meeting the definition of a non-hazardous polymer, and those not meeting it. These two types of are subject to the same requirements; the only difference is the possibility, for manufacturers of non-hazardous, to perform a selfassessment. This section begins by describing data requirements related to non-plcs (non-hazardous or not) and then focuses on the process of self-assessment for non-hazardous. Non-PLCs are notified under the permit or the assessment certificate (LTD/STD). If they qualify for a permit, they have to provide the following data (costs of notification (fee + additional costs) under a permit range from $11,000 to $18,000): CEC Chemical identity( name, classification, molecular structure, spectral data) Description of operation and exposure (nbr of exposed worker, safety procedure...) Summary of health and environmental effects Environmental: site location, storage, release to the environment, public exposure Any information on toxicity/ hazard effects with supporting studies Previous use in Australia Notification in other countries Label and (M)SDS ((Material) Safety Data Sheet) 7 were notified under a CEC in 2013/14 LVC Chemical/polymer identity Composition if polymer Physical/chemical properties (if available) Description of chemical/polymer use Occupational exposure Public exposure All available (eco)toxicological information Environment exposure Previous use in Australia Notification in other countries Label and (M)SDS ((Material) Safety Data Sheet) 5 were notified under a LVC in 2013/14 CUP: Identity of chemical/polymer 90

91 EOP EIP: Composition for polymer Occupational exposure Physical and chemical properties (if available) Description of chemical/polymer use Occupational exposure Public exposure Human health effects information Environmental release Environmental fate/effect (Eco)toxicological information available Label and (M)SDS ((Material) Safety Data Sheet) Identity of chemical/polymer Import/export information/aim Process description Summary of health and environmental effects (brief) MSDS and label The data required for an EIP is dependent on the type of EIP and is required to demonstrate that the relevant criteria have been met. Note that an EIP application must accompany a certificate application and so much of the data would already be supplied as part of the certificate application. For all chemicals/, notifiers must provide relevant health effects information to demonstrate the criteria have been met (i.e. full toxicological data for non-hazardous with NAMW<1000, but only acute oral, skin irritation and genotoxicity (and skin sensitisation if a structural alert present) for a non-hazardous polymer with NAMW>1000) For all chemicals/, notifiers must provide relevant environmental effects information to demonstrate the criteria have been met (i.e. ecotoxicological data for three trophic levels for a non-hazardous polymer, unless accompanying a LTD application in which case ecotoxicological data are not required if certain release criteria are met) Non-hazardous chemical/polymer and polymer with NAMW >1000: notifiers must provide some Physical/chemical property (Molecular weight, solubility...) Non-hazardous chemical/polymer and chemicals including with number average molecular weight (NAMW) <1000: notifiers must provide other physical and chemical property (Flammability, Explosive property...) Non-hazardous chemical/polymer: notifier must provide information on ready biodegradability For controlled use chemical/, notifiers must provide information on operation, control, exposure and disposal. If the manufacturer has to notify the non-plc under an assessment certificate (or if he chooses to), four factors are to be taken into account: the nature of the polymer, the number average molecular weight, the tonnage and the use (sitelimited or not). The two graphs below present which certificate is required for each condition. 91

92 For bio, there is no possibility of applying for an LTD on molecular weight criteria: application for an LTD or an STD is conditioned solely to the tonnage. For synthetic however, if the threshold of 1,000 Da is met, the manufacturer can apply for an LTD, no matter the tonnage. Data requirements for LTD and STD are more stringent than for permits. The application form is common to both certificates (Form-1) and asks for the following requirements The type of certificate the company applies for: LTD or STD. Information on chemical: name, notification overseas Chemical identity Composition, impurities, additives, polymer constituent Physical and chemical properties Introduction and use information (imported/manufactured, Volume per year, operation description) Human health implication (worker and public exposure, toxicological data*...) Environmental implication (release, fate, ecotoxicological data*) Label and MSDS An average of 33 are notified under a LTD per year, and 4 under a STD Costs of notification (fee+additional costs) under LTD/STD range from $34,000 to $67,800 If the non-plc is non-hazardous, the manufacturer can apply for a self-assessment certificate and send an assessment report to NICNAS. Indeed, NICNAS allow industry to self-assess low regulatory concern chemicals against specified criteria and provide an assessment report which is screened and amended by NICNAS in consultation with the notifier if necessary before publication. This report must contain the following information and can be audited by NICNAS: Chemical/polymer identity Composition Physico/chemical information Human health implications Environmental implication The material Safety data sheet Recommendations *Toxicological and ecotoxicological data is only a legislated requirement for the STD category, but if data is available on the notified polymer, it should be submitted (even for a LTD). Grouping approach Australia allows the 2% rule to be applied: a synthetic polymer is considered as new and needs notification, only if it meets the definition specified in the Definition section. Furthermore, NICNAS has a number of modular notification categories with reduced fees: a previous (or concurrent) assessment can be utilised in the NICNAS assessment, if: the notified chemical or polymer is similar to a chemical or polymer previously assessed by NICNAS; or the notified chemical or polymer is being notified at the same time as a similar chemical or polymer, and for a similar use; or 92

93 an assessment of the notified chemical or polymer in Canada (under a comparable schedule) is available; or an assessment of the notified chemical or polymer by another Australian Agency is available: o the Therapeutic Goods Administration (TGA), under the Therapeutic Goods Act 1989, is available, or o the Australian Pesticides and Veterinary Medicines Authority (APVMA), under the Agricultural and Veterinary Chemicals Code Act 1994, is available, or o Food Standards Australia New Zealand (FSANZ), under the Food Standards Australia New Zealand Act 1991, is available, or a chemicals notification and assessment scheme from the USA, EU (pre-reach), Canada (where the criteria for the Approved Foreign Scheme category are not met), or OECD member country, is available. Modular notification (with reduced fees) are available for STD, LTD and PLC certificates, but not for self-assessment certificates. The average number of for which a modular notification is used per year is 18: 8 PLC (on a total of 55/yr) and 10 LTD (on a total of 33/yr). Similar Polymer: For NICNAS to regard one polymer as similar to another, the polymer must be assessed in the same notification category. In addition, the change in polymer identity must not be known to affect the toxicity profile of the polymer. The notified polymer must be covered by one of these situations: o the notified polymer contains one polymer constituent less than the originally assessed polymer or primary polymer o the notified polymer contains a polymer constituent which is similar to a polymer constituent in the originally assessed polymer or primary polymer with all other polymer constituents the same. In this case all but one polymer constituent should be the same. Where there is a difference in a polymer constituent, the substituted one must meet the criteria for similar chemical. The notifier needs to provide data on the original and substituted polymer constituent to demonstrate this. o the notified polymer is structurally identical to the originally assessed polymer or primary polymer. In some cases, a polymer may be manufactured by different reaction pathways and, in some cases, using different reactants. This can lead to the identification and naming of a particular polymer in more than one way, with different CAS registry numbers, although the may be structurally identical (that is, contain the same linkages and functional groups). The notifier needs to provide information to support this. In addition, the identity and physicochemical criteria (given below) must be met: o contain the same linkages and functional groups, and o water solubility within the range of 50% to 200%. Application should consist of: o a completed modular attachment to the relevant STD or LTD or PLC form, as appropriate o the assessment reference for example, STD/XXX for the chemical or polymer that has been previously assessed (included in the attachment) o justification of why the chemical or polymer meets the 'similar' criteria (included in the attachment) where the original notification used read across data the suitability of the read across data for the notified chemical should also be demonstrated o a list of other available information (for example, toxicity or environmental test data) on the previously assessed chemical or polymer that was not provided in the original NICNAS assessment (included in the attachment) you must provide a copy of this data as part of the notification o consent for you to use the data on company letterhead from the notifier(s) and any other owners of data supplied in the original assessment (if you are not the original notifier). Savings compared to non-modular assessment are $2300(PLC) and $4900 (LTD) For the period, the Similar Polymer modular notification was used for 7 PLCs and 3 LTDs Group Assessment: This certificate category is for a chemical or polymer notified at the same time as one that is similar and has a similar use. This category applies if two or more chemicals or both meet the similar criteria (see previous section), and are notified for a non-self-assessed certificate at the same time. You pay the full fee for one application, and a reduced fee for the others. A similar use is one in which the following must be the same: o industry sector in which the chemical is used o routes of human exposure 93

94 o o o o o types of workers exposed and the extent to which they are exposed routes of environmental release potential for public exposure volume range <1 tonne, 1 3 tonnes, 3 10 tonnes, tonnes, tonnes and tonnes. (Note: a use would not be considered similar if the increase in volume would lead to a change in the original risk assessment). the mode of introduction (for example, import or manufacture). For the application, the notifier must follow the normal procedures for a STD, LTD or PLC notification for the chemical or polymer considered to be the primary one. The secondary notifier must demonstrate that the criteria for similar use and similar polymer is met: o information on the identity and composition of the chemical or polymer o information on use o information on introduction and use concentrations o estimated manufacture and import volume o matters affecting occupational health and safety, environmental impact and public health o label and (M)SDS for the chemical or polymer in the form that it is introduced o melting(or boiling) point, particle size, and partition coefficient in the case of chemicals o particle size and water solubility in the case of o acute oral toxicity (typically for STD notifications) o acute aquatic toxicity for the most sensitive organism (typically for STD notifications) Different data are required for inseparable mixtures of similar. Savings compared to non-modular assessment are $3200(PLC) and $9800 (LTD) For the period, the Group Assessment modular notification was used for 1 PLC and 7 LTDs There are five arrangements in place for NICNAS to consider overseas assessments conducted elsewhere (see Table 3) Approved Foreign Scheme (see Table): Applications under the Approved Foreign Scheme category can be made for a chemical that was notified and assessed in Canada as a new chemical under a comparable schedule to a STD, LTD or PLC notification in Australia. Savings compared to non-modular assessment are $2200 (PLC) and $3100 (LTD) For the period, the Approved Foreign Scheme modular notification was used for 5 PLC and 3 LTDs Modular Notification (Comparable Agency) Canada, United states, European Union Applications under this modular notification category (STD, LTD or PLC) are for new chemicals previously notified and assessed in Canada, European Union or the United States. Notifiers apply under the Approved Foreign Scheme or the Modular Notification (comparable agency) categories for the STD, LTD and PLCs. Moreover they must furnish all available information provided by comparable agency and any other available data (especially regarding Australia) Savings compared to non-modular assessment are $1100 (PLC) and $2500 (LTD) For the period, the Approved Foreign Scheme modular notification was used for 2 PLC and 6 LTDs OECD Parallel Process (see Table): The Organisation for Economic Co-operation and Development (OECD), through its Clearing House for New Chemicals, has encouraged efforts to maximise work-sharing arrangements in notifying and assessing new industrial chemicals, with a goal of Mutual Acceptance of Notifications. The Parallel Process reduces the time required for notifying new industrial chemicals to multiple jurisdictions. A company notifies a new chemical to multiple jurisdictions (of their choice), providing an agreed set of data to all participating countries, namely, a lead country and secondary countries. After they receive the final hazard assessment, they supply national notification forms and the completed collective hazard assessment to all secondary countries, with fees required by them. Comparable Agency (Australian agencies): This modular notification is available but has not yet been utilised by notifiers, and no specific guidance has been developed. As for now, notifiers must follow the normal notification procedures for a STD, LTD or PLC 94

95 notification, address all NICNAS schedule data requirements for the relevant assessment category, and provide all available data on the notified chemical or polymer as part of your submission. Notifiers can contact NICNAS if they wish to apply for this notification option. Table: Description of options for modular notifications using overseas assessments (foreign scheme, comparable agency and OECD parallel process) Approved Foreign Scheme Canada only Modular Notification (comparable agency) Canada Modular Notification (comparable agency) United States Modular Notification(comparable agency) European Union OECD Parallel Process (worksharing) Status of chemical overseas Previously assessed as a new chemical in Canada (Environment Canada) Previously assessed as a new chemical in Canada (Environment Canada) Previously assessed as a new chemical in the United States (US EPA) Previously assessed as a new chemical in EU (ELINCS) Does not apply to REACH Planned to be notified in two or more OECD countries Linkage with company in overseas country Required Canadian notifier authorises release of Canadian reports to NICNAS Required Canadian notifier authorises release of Canadian reports to NICNAS Required United States notifier authorises release of US EPA information to NICNAS Required EU notifier provides assessment report and letter of validation from EU authority to NICNAS Required conotification involves relevant government and industry representatives NICNAS assessment category STD, LTD or PLC STD, LTD or PLC STD, LTD or PLC Usually STD or LTD STD, LTD or PLC Timing Request to Environment Canada 60 days before notification to NICNAS Request to Environment Canada 60 days before notification to NICNAS Report provided to NICNAS before the start of NICNAS assessment Report and validation letter to be provided to NICNAS at time of notification Depends on preparation of hazard assessment by lead country 95

96 Other requirements Conditions apply, including that the chemical must have been assessed in Canada in a comparable assessment category to that of the NICNAS notification Can be used if requirements for Canada Approved Foreign Scheme are not met (for example, if notification is not in a comparable assessment category) Of most benefit if assessed in a comparable assessment category Dataset acceptable to all countries agreed during the process Fee benefit Specific Approved Foreign Scheme upfront fee applies Specific modular (comparable agency) upfront fee applies Specific modular (comparable agency) upfront fee applies Specific modular (comparable agency) upfront fee applies Usual upfront fee applies if Australia is the lead country. Otherwise a reduced fee applies (contact NICNAS for details) PLC approach The PLC category was developed in 1993 to encourage industry to introduce less hazardous into Australia. Polymers of Low concern are to be notified thanks to a PLC certificate: an average of 55 PLCs is notified per year. Costs of notification range from $19,600 to $32,600 (fee + additional costs). Moreover, manufacturers/importers of a PLC can apply for a self-assessment certificate (SAPLC), for which they must provide an assessment report detailing specific information: an average of 10 PLCs is self-assessed per year. This report is globally the same as for non- PLC, except for some composition and toxicological criteria. The Australian PLC category and criteria were revised in 1997 in order to align the criteria with the US TSCA. The Australian criteria are also very similar to those in Canada, although minor differences do exist. A PLC is defined by NICNAS as a polymer that: either has a number average molecular weight that is: o >1000, or o <1000, and is a polyester manufactured from approved monomers / reactants, and has a low cationic charge density is not a hazardous chemical does not dissociate readily is stable under the conditions in which it is used, and has such other characteristics as are prescribed by the regulations. These characteristics are detailed in the following criteria: Reactive functional groups (RFGs): RFGs are categorized into low, moderate and high concern groups. Polymers must have a minimum Functional Group Equivalent Weight (FGEW) to be classified as PLC: o Low concern: no limitation 96

97 o Moderate concern: > 1000 o High concern: > 5000 If a polymer does not meet the cut-off for moderate or high concern RFGs to meet the PLC criteria, it could still be considered a PLC if sufficient additional information is provided to negate concern caused by the RFGs present As opposed to Canada, where RFGs are taken into account for defining PLCs but no classification is established, the Australian Regulation groups RFGs according to their concern. Molecular weight: The NAMW (Number average molecular weight) must be superior to 1000 Da (exception for polyester) and must meet the percentage of low molecular species requirement. The low molecular weight species in a polymer includes the oligomer content with NAMW <1000 Da, where oligomer is defined as the low molecular weight species derived from the polymerisation reaction: o For with NAMW >10000 the allowable low molecular weight species is 2% under 500 AND 5% under 1000 o For with NAMW between 1000 and 10000, the allowable low molecular weight species is 10% under 500 and 25% under 1000 Molecular weight criteria are identical to those defined in Canada. Cationic : To be eligible as a PLC, a polymer must have a low charge, or cationic, density. NICNAS provides a set of definitions: o A polymer is a low charge density polymer if it is: not a cationic polymer or is not reasonably anticipated to become a cationic polymer in a natural aquatic environment (4<pH<9), or a solid material that is not soluble or dispersible in water and will only be used in the solid phase (for example ion exchange beads), or cationic (or potentially cationic) and the combined (total) FGEW (functional group equivalent weight) of cationic groups is 5000 or above (. o A cationic polymer is a polymer containing a net positively-charged atom/s or associated group/s of atoms covalently linked to its polymer molecule. Examples are the ammonium, phosphonium and sulfonium cations. o A potentially cationic polymer is a polymer containing groups reasonably anticipated to become cationic. Examples are all amines (primary, secondary, tertiary, aromatic, etc.) and all isocyanates (which hydrolyse to form carbamic acids, then decarboxylate to form amines). o Reasonably anticipated means a knowledgeable person would expect a given physical or chemical composition or characteristic to occur, based on factors such as the nature of the precursors used to manufacture the polymer, the type of reaction, the type of manufacturing process, the products produced in the polymerisation, the intended uses of the substance and associated use conditions. Canada also provides restrictions on the cationic nature of. Hazard classification: A polymer can only be a PLC if it is not classified as a hazardous chemical according to the UN's Globally Harmonised System of Classification and Labeling of Chemicals (health and environmental criteria), as adopted for workplace chemicals in Australia Canada does not refer to the UN GHS classification for the definition of a PLC. Elemental criteria: A PLC must contain, as an integral part of its composition, at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon and sulphur. Excluding impurities, a PLC must only contain: o carbon, hydrogen, nitrogen, oxygen, silicon and sulphur o sodium, magnesium, aluminium, potassium, calcium, chlorine, bromine and iodine as the monatomic counter-ions Na+, Mg2+, Al3+, K+, Ca2+, Cl-, Br- or I- o fluorine, chlorine, bromine or iodine covalently bound to carbon o <0.2%(by weight) of any combination of the atomic elements lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin and zirconium. No other elements are allowed, except as impurities. 97

98 These elemental criteria are taken into account by Canada. Degradable or unstable : o A PLC must be a stable polymer o A polymer is not eligible to be a PLC if it is designed or reasonably anticipated to degrade, decompose or depolymerise substantially. This includes that could substantially decompose after manufacture and use, even though they are not intended to do so. The degradability and stability of a polymer is taken into account in the PLC definition in Canada Water absorbing : Water absorbing with NAMW and greater meaning a polymer capable of absorbing its own weight in water do not qualify as PLCs. This restriction on water-absorbing is not applied in Canada. Polyester: Polyesters manufactured from an approved list of monomers or other reactants are eligible for notification as PLCs, provided they satisfy all other PLC criteria. This provision is independent of the NAMW. Polyesters that will not be eligible for notification as PLCs: o biodegradable polyesters, which do not meet the degradation criterion o water-absorbing polyesters o polyesters manufactured from any monomer or other reactant not on the list of allowable reactants, including such a reactant at <2%. Likewise, A polyester polymer made only from reactants specifically listed in the Canadian regulations can be regarded as a PLC in Canada In Australia, there have been 3 assessments of PLCs utilising the polymer criterion (for 3 separate companies) since This represents 1% of all PLC notification (301 PLCs were notified the same period). Requirements for PLC, as described in the relevant form, are: Identity of polymer Information on polymer (composition, reactive groups, cationic..) Matching criteria for PLC Physical/chemical property Introduction and use Human health implication Environmental implication MSDS In particular, (eco)toxicological data is not required for either PLC or self-assessment PLC but must be provided if available. The PLC definition and associated requirements were modelled on the US EPA's polymer exemption criteria. The polymer exemption criteria was essentially fully adopted apart from a couple of differences which are: 1. In Australia, there is a further requirement that the polymer should not be classified as a hazardous chemical under the GHS. This criterion has proven useful on rare occasions in eliminating hazardous from the polymer of low concern category that would have otherwise been eligible based on meeting the other criteria. 2. Based on limited supporting evidence NICNAS has considered all moderate concern functional groups under the US EPA's polymer exemption criteria as high concern functional groups, except for the following moderate functional group: "conjugated olefins, except those in naturally occurring fats, oils, and carboxylic acids" Key characteristics of the strategy In order for new to become "existing", i.e. to be listed in the AICS, manufacturers have to notify them under an assessment certificate. Only after 5 years, with the expiration of the certificate, is the polymer considered "existing". Manufacturers of "existing" substances do not have to provide information, unless NICNAS publishes a secondary notification. Two secondary notifications were issued for in their 5 year certificate period and three secondary notifications for existing. 98

99 Since 2012, NICNAS has furthermore been conducting a reassessment of all existing chemicals, including, under the IMAP framework. Within the IMAP program, which is reliant on existing data sources, there was a lack of available data to identify new toxic effects of the. The framework did however provide an appropriate methodology for focussing risk assessment on with a higher likelihood of posing risks to human health (in Appendix B of the IMAP Framework document). A particularity of NICNAS lies in the existence of two types pathways for notification: permit and certificate. Permits do not lead to the polymer being listed in the AICS, but fees and data requirements are lower. The total costs for industry (fee + cost of effort + industry consultant) are 2 to 5 times lower for a permit than for a LTD/STD certificate ($11,000-18,000 Vs $34,000-67,800). 12 have been notified Furthermore, of low concern are to be notified under a specific certificate category for assessment by NICNAS. The cost of notification of a PLC is lower than for the other certificates ($19,000-32,000 Vs $34,000-67,800). However, manufacturers have the possibility to assess PLCs themselves and then provide a report to NICNAS. The definition of a PLC is similar to other jurisdictions (US& Canada for instance). The number of notified according to the various types of certificates are summarised in the graph below: Around 100 are notified per year using certificates, half of them being PLCs. Self-assessment of PLCs began in 2011 and the number of notifications under this specific certificate has been increasing since. Very few are notified under an STD certificate. NICNAS takes into great consideration the use of in the different types of notification - and exemption thereof - they propose. Export, R&D and use on site are among the types of use for which specific provisions are available. Reduced exposure, in the form of low production volumes, may also warrant specific provisions (e.g. application for an LTD instead of an STD). In Australia, four types of grouping approaches are available under the "modular notification" scheme. Around 9 per year are notified using a modular notification (see figure below): PLCs as well as other can qualify for this notification. GA Group Assessment (Savings compared to non-modular assessment are $3200(PLC) and $9800(LTD)) 99

100 SC Similar to Chemical Previously Assessed (Savings compared to non-modular assessment are $2300(PLC) and $4900(LTD)) FS Approved Foreign Scheme (Savings compared to non-modular assessment are $2200(PLC) and $3100(LTD)) CA Assessed by Comparable Agency (Savings compared to non-modular assessment are $1100(PLC) and $2500(LTD)) Half of the PLCs notified under a modular notification use the Similar Polymer option. The Group Assessment option is not very popular for PLCs, although it is much more used in the case of LTDs. Modular notifications are not possible for self-assessment certificates. The Approved Foreign Scheme and Comparable Agency modular categories are not appropriate for self-assessment as the assessment reports from the overseas agencies are shared directly with NICNAS and not disclosed to the notifier (as the US and Canada do not publish their assessment reports). For the other modular categories an important part of the assessment for these categories is the decision on whether the chemicals are similar enough and where different how this might affect the hazard assessment. This is therefore a decision that is best made by NICNAS rather than the notifier. There may also be third party issues in that a previous notifier may have given permission for a new notifier to use their previous NICNAS assessment, but may not necessarily want that new notifier to have access to the primary source material previously submitted to NICNAS. The Australian Government is currently undertaking a review of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The purpose of the review is to examine the role of NICNAS within the broader institutional and regulatory framework for chemicals regulation. The review is investigating how the regulatory settings may be improved to enhance both the competitiveness of the Australian chemical industry, and public health and environmental outcomes. As part of this review the current new chemicals notification and assessment framework is under review in order to better align NICNAS regulatory effort with the risk of the industrial chemical. The proportionality principle is an underlying concept that was considered when the legislation was drafted and when any legislative changes resulting from reforms have been developed. It is clearly reflected in the different categories of notification that are set out in the Act, as well as the accompanying fees structure. Sources The NICNAS website (handbook) NICNAS (June 2013) Options for reforming the National Industrial Chemicals Notification and Assessment Scheme Regulation Impact Statement NICNAS answers to the following questionnaire: What is the number of exempted from notification? What is the average number of notified per year, for each available notification type (permit, selfassessment certificate, LTD, STD, PLC) for standard cases (i.e. no modular notification)? What is the average cost of notification for under each available notification (permit, self-assessment certificate, LTD, STD, PLC) for standard cases (i.e. no modular notification)? What is the average number of for which a modular notification is used? What is the associated reduction of costs? Did reassessment of existing substances under the IMAP framework allow the identification of new hazardous properties of, as of yet? How frequent is it that a Secondary Notification for is issued? How is the proportionality principle applied? What are the motivations behind the different legislative choices made by NICNAS? For instance: o Why aren t modular notifications possible for self-assessment certificates? o At which stage of development is the Comparable Agency Modular Notification? Why develop such a notification?. o How did NICNAS establish the definition of PLC and associated requirements? Did NICNAS evaluate the the efficiency of the legislation: outcomes, monitoring system, costs, quality of data? 100

101 101

102 California Regulatory text: The Safer Consumer Products Regulations (chapter 55 to division 4.5 of title 22 of the California Code of Regulations) Consumer-Products-Regulations-2.pdf Competent Authorities: California s Department of Toxic Substances Control (DTSC) Contacts: Karl Palmer (kpalmer@dtsc.ca.gov ) Debbie Raphael draphael@dtsc.ca.gov Aim of this sheet This factsheet describes shortly the strategy under implementation in California and aiming to remove toxic chemicals from commerce and prompt industry to provide safe alternatives. The factsheet contains few elements on but rather points out the key features of the strategy and how could be concerned. Context and general description The DTSC adopted the Safer Consumer Products Regulations in October 2013 in order to implement the Californian environmental law named the Green Chemistry Initiative (GCI). The GCI aims to reduce or eliminate the use of hazardous materials through an all-inclusive approach that considers how hazardous substances can be reduced or eliminated during product design, development, and manufacture; consumer product use; and ultimate product reuse, recycling, and disposal. The Safer Consumer Products Regulations establish a four-step regulatory process in which the DTSC: i. Identifies, within 30 days after the effective date of the regulations (October 1, 2013), candidate chemicals of concern ( Candidate Chemicals ): ii. This list is composed of chemicals listed by 23 authoritative bodies on the basis of exhibiting at least one of eight hazard traits: carcinogenicity, reproductive toxicity, mutagenicity, developmental toxicity, respiratory sensitivity, endocrine disruption, neurotoxicity, and/or persistent bioaccumulative toxicity. The list, available from the following link comprises chemical substances used in as monomers or additives, e.g., styrene, isocyanates potentially used in polyurethane-based adhesives, MDA potentially used in epoxy resins, tetrahydrofuran potentially used in varnish and adhesives; Develops, by April 2014, a list of Priority Products (see below) containing those Candidate Chemicals; alternatives assessments must be conducted for these Priority Products. When establishing a Priority Product, DTSC must find that (1) there must be potential exposure to the candidate chemical in the product and (2) there must be the potential for exposures to contribute to or cause "significant or widespread adverse public health and/or environmental impacts." Once the Candidate Chemical becomes the basis for the listing of a Priority Product, it becomes a "chemical of concern" for that particular product. DTSC announced that they will conservatively begin with an initial list no more than five Priority Products, and finally selected only three classes of Products: Children s foam padding sleeping products containing the flame retardant TDCPP ( example of products include polyurethane foams (polyurethane is a polymer); Spray polyurethane foam systems containing unreacted diisocyanates, which are 102

103 commonly used in home insulation ( ); and Paint strippers, varnish removers, and industrial-strength surface cleaners containing methylene chloride ( ); It is interesting to notice that two of the three Priority Products are closely linked to a polymer material: polyurethane. The polymer in itself in not regarded as hazardous, but potential additives (flame retardant TDCPP) or unreacted monomers (diisocyanates) make this polymer material a cause of concern. iii. Requires manufacturers of Priority Products to notify DTSC that their product has been listed as a priority product and analyse possible product alternatives (not yet implemented). To support implementation of this step, the DTSC plans to develop: alternatives analysis guidance documents a data system including, for example, chemical and product information, notifications and reports submitted to or prepared by DTSC, and guidance documents. For instance, when looking for alternatives to polyurethane foam systems (one of the identified Priority Products), non-isocyanate based polyurethanes (NIPUs) could be considered. Indeed, research efforts have been dedicated to minimizing the use of isocyanates to synthesize polyurethanes and NIPUs have recently been developed as a new class of polyurethane to mitigate health and environmental concerns. iv. imposes a regulatory response designed to protect public health and/or the environment (not yet implemented). DTSC's response may include (1) requiring supplemental information from the responsible party; (2) requiring addition information be provided to consumers; (3) imposing product use restrictions; (4) banning the product; (5) requiring engineering or administrative controls; (6) requiring an end-of-life management program; and (7) when no viable safer alternative is found, requiring the manufacturer to initiate a research and development project or fund a related challenge grant design to find a safer alternative. Figure: The Safer Consumer Products Regulations, How It Works (Karl Palmer, 2012) 103

104 Legend: OEHHA: office of environmental health hazard assessment; COC: chemical of concern Key characteristics of the strategy California considered chemical safety legislation in 2013 in response to concerns about the safety of chemicals in consumer products. California moved ahead against the backdrop of long-running delays in revamping the federal Toxic Substances Control Act meant to protect consumers from toxic substances. The Act, passed in 1976, grants the Environmental Protection Agency power to require testing of dangerous compounds. Yet some four decades later, the EPA has rarely used that power (it has only been able to require testing on a little more than 200 existing chemicals and banned five) as Congress has been tied up in a protracted effort to reform TSCA. One of the key points of the Californian strategy is that notification is based on a list of products of concern defined by DTSC on hazardous grounds. The important feature of this notification is that it must be accompanied with an alternatives assessment, as the industry is prompted to provide safe alternatives. Another key point is the presence of polymer materials in the Priority Products list published in April Polyurethane is mentioned in two of the three Priority Products as a material of concern because of its additives and unreacted monomers. Questions for DTSC How do you expect to be tackled in the context of the Safer Consumer Regulations? How do you see synergies with provisions from the TSCA, notably regarding Polymers of Low Concern? What is the percentage of polymer substances you expect will be notified? Have you received notifications from the industry as of yet? What are the expected costs for the industry (notification and assessment of potential alternatives), and especially SME? What would be the frequency of notification update from the industry? How are conditions of use/exposure affecting regulatory obligations? Are other than polyurethane expected to be in the priority products? If a polymer identified as a Priority Products, are there specific requirements for monomers? Or is it only when they are unreacted? How will new be taken into account? The strategy only seem to tackle existing substances. 104

105 How is the proportionality principle applied? Could you tell us more about the motivations behind the legislative choice of California? How do you expect to evaluate the legislation efficiency: outcomes, monitoring system, costs, quality of data? Sources

106 Canada Regulatory text: New Substances Notification Regulations (Chemicals and Polymers), Competent Authorities: Environment Canada & Health Canada Contacts: Idris Berhanu Aim and structure of this sheet This factsheet describes the polymer notification scheme currently implemented in Canada. After a short introduction outlining the main aspects of the strategy and a decision tree showing its different steps, the sheet details the principal criteria used in the grouping approach and the Reduced Regulatory Requirement (RRR, application of the concept of Polymer of Low Concern) approach. Key points raised by the document (advantages/disadvantages of the strategy, transferability in the EU) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the two Competent Authorities, Environment Canada and Health Canada. Context and general description Since July 1994, in Canada have been regulated under the Canadian Environmental Protection Act (CEPA) and its various amendments. Under this Act, the New Substances Notification Regulations (Chemicals and Polymers) [the Regulations] was promulgated, which sets out the information that a person must provide to Environment Canada and Health Canada before manufacturing or importing a chemical, biochemical, polymer or biopolymer that is not on the Domestic Substances List (DSL). The latest amendment of the Regulations dates back to Substances on the DSL were either notified under the NSNR or grandfathered (i.e. nominated to be on the DSL without prior risk assessment) for manufacture or import: these substances are called existing substances. The DSL is the determining factor as to whether a substance is new to Canada and needs to be notified. Furthermore, Canada applies the 2% rule: a polymer manufactured by modifying the formulation of an existing polymer on the DSL by adding reactants, none of which constitutes more than 2% w/w of the polymer, is not considered as new. The name of the polymer may, or may not, include monomers or other reactants. These substances must be included in the description of the polymer composition. Monomers or other reactants present in combined or reacted form at less than 2% w/w can be ignored in the name of the polymer, but the information must still be provided in the notification. After submission of information, the assessment period is between 30 and 60 days. Then, updates to the DSL are published in the Canada Gazette within 120 days following the determination that a substance is eligible for listing. The Non-Domestic Substances List (NDSL), however, includes substances which are not on the DSL but are believed to be in international commerce. In particular, a new substance listed in the US inventory (TSCA Inventory) is eligible for a listing on the NDSL. The substances on this list require notification as they are new to Canada but the trigger limits are higher and the amount of information to submit is less than if the substance is not on the NDSL. After a notification is completed and after assessment decisions show that eligibility criteria are met, the substance appears on the DSL. The Regulations divide into three major categories, which have different regulatory requirements: and bio used for special categories (e.g. R&D), RRR, and and bio used for any other purpose or belonging to any other category. The first category has reduced reporting 106

107 requirements; the second category is similar to the adopted US concept of Polymers of Low Concern and needs fewer requirements than the ones of the third category. The Regulations are organised into Schedules, which set out data requirements for notifying new substances (including ); these requirements are called items. The Schedule required for a substance depends on the type of substance involved, and the annual amount of substance intended to be manufactured in or imported into Canada. Some Schedules do not provide data requirements, but rather act as annexes listing specific definitions. The table below provides further details about NSNR Schedules and items targeting : Table: Schedules dealing with and their content Schedule number Content Items 2 Information regarding biochemicals and bio 1. The identification of the organism, hereinafter referred to as production organism, and the organ, if applicable, from which the biochemical or biopolymer is isolated, including (a) synonyms and common and superseded names, if known; and (b) its source and history. 2. A description of any known adverse environmental or human health effects associated with exposure to the production organism. 3. The concentration of the viable production organism in the biochemical or biopolymer and, if known, in end-use products. 4. A description of the method used to separate the production organism from the biochemical or biopolymer. 5. The identification of the encoded products, if known. 6. A description of any known biological activity or adverse environmental or human health effects associated with the nucleic acid or with the encoded products specified under item 5. 3 Information regarding and bio that are research and development substances, contained sitelimited intermediate substances or contained export-only substances 1. The type of substance: research and development substance, contained site-limited intermediate substance or contained export-only substance. 2. The new substances pre-notification consultation number if it has been assigned, and if known. 3. The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. 4. The trade names of the polymer and the synonyms of its chemical name, if known. 5. The CAS registry number of the polymer, if such a number can be assigned. 6. The molecular formula of the polymer. 7. The structural formula of the polymer, if possible, or else a partial structural formula. 8. For contained site-limited intermediate substances and contained export-only substances: (a) its number average molecular weight (Mn); and (b) the maximum concentrations, expressed as a percentage, of all residual constituents having molecular weights of less than 500 daltons and of all residual constituents having molecular weights of less than daltons. 9. For research and development substances, the target number average molecular weight (Mn) of the polymer. 10. The known impurities present and their concentration by weight. 11. The composition of the polymer including constituents such as monomers and other reactants, additives, stabilizers and solvents which constituents are present when the polymer is tested, and their concentration by weight. 12. A material safety data sheet in respect of the polymer, if available. 107

108 13. The physical state of the polymer. 14. Whether the polymer is formulated for dispersal in water. 15. The following exposure information respecting the polymer: (a) the anticipated annual quantity to be manufactured, if applicable; (b) the anticipated annual quantity to be imported, if applicable; (c) the anticipated uses; (d) its anticipated concentration in products and, if known, in endues products; (e) a description of the expected modes for its transportation and storage; (f) a description of the size and type of container used for its transportation and storage; (g) an identification of the components of the environment into which it is anticipated to be released; (h) its anticipated releases into municipal wastewater systems; (i) a description of the methods recommended for its destruction or disposal; (j) whether the public is anticipated to be significantly exposed to the polymer in a product taking into account factors including its concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure and, if not, information substantiating that the public is not anticipated to be significantly exposed; and (k) for site-limited intermediate substances, the location of use. 16. A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer or to which they ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer. 17. The identification of the other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the polymer and, if known, the agency s file number, the outcome of the assessment and the risk management actions imposed by those agencies. 7 Types of 9 Information regarding reduced regulatory requirement and other and bio The different types of considered in the context of the NSNR. They are presented in the Definition of a polymer section, on page The type of polymer: (a) a reduced regulatory requirement polymer; (b) a polymer on the NDSL; (c) a polymer with all of its reactants on the DSL or the NDSL; or (d) a polymer with one or more reactants not on either the DSL or NDSL. 2. The new substances pre-notification consultation number if it has been assigned and if known. 3. The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. 4. The trade names of the polymer and the synonyms of its chemical name, if known. 5. The CAS registry number of the polymer, if such a number can be assigned. 6. The molecular formula of the polymer. 7. The structural formula of the polymer, if possible, or else a partial structural formula. 8. The reaction scheme if the polymer is a reduced regulatory requirement polymer, unless it is a polymer referred in paragraph 9(c) of these Regulations. 9. The following physical and chemical data in respect of the polymer: (a) its number average molecular weight (Mn); and (b) the maximum concentrations, expressed as a percentage, of all residual constituents having molecular weights of less than 500 daltons and of all residual constituents having molecular weights of less than daltons. 10. The known impurities present and their concentration by weight. 108

109 11. The composition of the polymer including constituents such as monomers and other reactants, additives, stabilizers and solvents which constituents are present when the polymer is tested, and their concentration by weight. 12. A material safety data sheet in respect of the polymer, if available. 13. The following exposure information respecting the polymer: (a) the anticipated annual quantity to be manufactured, if applicable; (b) the anticipated annual quantity to be imported, if applicable; (c) the anticipated uses within Canada; and (d) if the polymer is not a reduced regulatory requirement polymer, (i) the anticipated concentration of the polymer in products and, if known, in end-use products, (ii) the anticipated degree of direct human exposure to the polymer, including concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure, (iii) whether the polymer is anticipated to be used in products intended for use by or for children, and (iv) if known, the three sites in Canada where the greatest quantity of the polymer, manufactured or imported by the person, is anticipated to be used or processed and the estimated quantity by site. 14. A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer. 15. The identification of the other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the polymer and, if known, the agency s file number, the outcome of the assessment and the risk management actions imposed by those agencies. 10 Information regarding other and bio on the NDSL or all of whose reactants are on the DSL or NDSL 1. The information specified in Schedule 9 or, if that information has been previously provided, the date (year, month, day) of the submission of that information and, if they are known, the new substances pre-notification consultation number, if it has been assigned, and the new substances notification number. 2. The following physical and chemical data in respect of the polymer: (a) its physical state; (b) whether it is formulated for dispersal in water; (c) its water extractability measured at (i) ph 7 for anionic and neutral, (ii) ph 2 and 7 for cationic, or (iii) ph 2, 7 and 9 for amphoteric ; (d) its octanol-water partition coefficient; and (e) if water extractability is determined to be greater than 2%, its hydrolysis rate as a function of ph and, if known, an identification of the products of the hydrolysis. 3. Unless the polymer has a water extractability at ph 7 of less than or equal to 2%, an acute toxicity test of the polymer for the most sensitive species: fish, daphnia or algae or, if the sensitivity of these three species is unknown, an acute algae toxicity test. * 4. Data from one acute mammalian oral toxicity test of the polymer and the following information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the route by which the polymer is administered and the conditions under which the test is conducted; and (c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. * 5. The following exposure information respecting the polymer: (a) a description of the expected modes for its transportation and storage; (b) a description of the size and type of container used for its transportation and storage; (c) its anticipated releases into municipal wastewater systems; 109

110 (d) a description of the methods recommended for its destruction or disposal; (e) its historical and other likely uses; (f) any factors that may limit environmental exposure; (g) whether it is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment and, if the release is less than or equal to 3 kg per day, per site, the data substantiating the quantity released; and (h) whether the public is anticipated to be significantly exposed to the polymer in a product taking into account factors including the concentration of the polymer, duration, frequency and circumstances of exposure and factors that may limit direct human exposure and, if not, information substantiating that the public is not anticipated to be significantly exposed. 6. A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer or to which they ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer. 11 Information regarding other and bio not on the NDSL 1. The information specified in Schedule 9 or, if that information has been previously provided, the date (year, month, day) of the submission of that information and, if they are known, the new substances pre-notification consultation number, if it has been assigned, and the new substances notification number. 2. The following physical and chemical data in respect of the polymer: (a) its physical state; (b) whether it is formulated for dispersal in water; (c) its water extractability measured at (i) ph 7 for anionic and neutral, (ii) ph 2 and 7 for cationic, or (iii) ph 2, 7 and 9 for amphoteric ; (d) its octanol-water partition coefficient; and (e) if water extractability is determined to be greater than 2%, its hydrolysis rate as a function of ph and, if known, an identification of the products of the hydrolysis. 3. Data from a ready biodegradation test on the water-soluble portion of the polymer, unless the polymer has a water extractability at ph 7 of less than or equal to 2% or is a branched silicone or siloxane polymer. * 4. Unless the polymer has a water extractability at ph 7 of less than or equal to 2%, the following tests: (a) if the sensitivity of the three species is known, an acute toxicity test of the polymer for each of the two most sensitive species: fish, daphnia or algae; (b) if the sensitivity of only one species is known and that species is not algae, an acute algae toxicity test and either a fish or daphnia acute toxicity test selected on the basis of the most sensitive of these species; or (c) if the sensitivity of only one species is known and that species is algae or if the sensitivity of the three species is unknown, an acute algae toxicity test and either a fish or daphnia acute toxicity test. * 5. Data from one acute mammalian oral toxicity test of the polymer. * 6. Information sufficient to assess skin irritation in respect of the polymer. * 7. Data from a skin sensitization test in respect of the polymer. * 8. Data from one repeated-dose mammalian toxicity test in respect of the polymer, of at least 28 days duration, which test is selected on the basis of the most significant route of potential human exposure to the polymer, namely, oral, dermal or inhalation. * 9. For the tests referred to in items 5 to 8, the following additional information: (a) the age, sex, number, species, strain and source of the animals tested; (b) the route by which the polymer is administered and the conditions under which the test is conducted; and (c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. * 10. Mutagenicity data obtained from each of the following tests of the polymer: 110

111 (a) one in vitro test, with and without metabolic activation, for gene mutations; (b) one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells; and (c) one in vivo mammalian test, for chromosomal aberrations or gene mutations or another indicator of mutagenicity that, together with data substantiating that the tissue investigated was exposed to the polymer or its metabolites, permits an assessment of in vivo mutagenicity. * 11. The following exposure information respecting the polymer: (a) a description of the expected modes for its transportation and storage; (b) a description of the size and type of container used for its transportation and storage; (c) an identification of the components of the environment into which it is anticipated to be released; (d) its anticipated releases into municipal wastewater systems; (e) a description of the methods recommended for its destruction or disposal; (f) its historical and other likely uses; and (g) any factors that may limit environmental exposure. 12. A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer or to which they ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer. The current Schedules are from the 2005 amended version of the Regulations, and are different from the previous versions. More about reasons of such changes is expected to be known from interviews with Environment Canada & Health Canada (see Questions for Environment & Health Canada"). Information corresponding to the relevant Schedule has to be submitted, in the form of a notification, to Environment Canada a number of days (30 or 60) before reaching an annual or projected quantity threshold, according to the category of the new polymer (see the decision tree for more details). There is no possibility of joint submission; however, there are two similar processes applicable to : A Matched Notification takes place when a notifier requests that information previously provided by another notifier for the same substance is used for assessment by Environment Canada & Health Canada. Such information may include test requirements or additional information. The notifier who is providing the information must submit a letter of authorization indicating his or her New Substances Notification (NSN) reference number as well as the name of the notifier whom he or she is supporting, together with the latter notifier s NSN reference number, if known. When files are matched, there may be a price reduction in the required fees. Consolidated Notifications take place when a notifier simultaneously provides two to six NSN packages for substances of the same class and where the technical information provided for one substance is used to address the technical information requirements for the remaining substances. Once a polymer is added to the DSL after notification (either regular, matched or consolidated) and assessment, it can be subject to new submission of information. Indeed, if specific new activities for instance incorporation in a new product may result in an increase of toxicity of the polymer, a Significant New Activity (SNAc) may be published in the Canada Gazette, which triggers new submission of information. When a SNAc is issued, those implicated in the SNAc shall submit the information specified within the SNAc before the use, import or manufacture of that substance under the conditions specified in the SNAc. If a SNAc is issued for a new substance and is in force when the substance is added to the DSL, the substance is added with a SNAc flag. Over the course of the New Substances Program, a SNAc Notice has been issued for approximately 35, out of approximately 215 SNAcs. Monomers are treated as individual substances under the Regulations, and may require separate notification (if they are new, as any other chemical). A new polymer whose monomers (or other reactants) are listed in the DSL or the NDSL is subject to less requirements. Decision tree 111

112 Definition of a polymer The substance must comply with the OECD definition of a polymer, namely: Molecules must be distributed over a range of molecular weights > 50 % of the molecules must contain at least three monomer units covalently bound to at least one other monomer unit or other reactant No single molecular weight molecule can be > 50 % (w/w) of the total distribution Definition of a biopolymer According to the Regulations, biopolymer means a polymer that is produced by a micro-organism or a protein or a nucleic acid derived from a plant or an animal. Types of, according to Schedule 7 1. A cationic polymer or a polymer that is reasonably expected to become cationic in a natural environment, except: (a) a polymer whose cationic group has a combined equivalent weight greater than daltons; or (b) a polymer that is a solid material, that is not soluble or dispersible in water and that will be used only in the solid phase, such as that can be used as ion exchange beads. 2. A polymer that is designed, or can be expected, to substantially degrade, decompose or depolymerize, 112

113 including that could substantially degrade, decompose or depolymerize after manufacture and use, even though they are not intended to do so. Degradation, decomposition and depolymerisation refer to the types of changes that convert a polymeric substance into simpler, smaller substances, through processes including but not limited to oxidation, hydrolysis, attack by solvents, heat, light and microbial action. 3. A polymer that has, as an integral part of its composition, only one or none of the following atomic elements: carbon, hydrogen, nitrogen, oxygen, silicon and sulphur. 4. A polymer that has 5. A polymer (a) any atomic elements other than carbon, hydrogen, nitrogen, oxygen, silicon, sulphur, fluorine, chlorine, bromine or iodine covalently bound to carbon; (b) any monoatomic counterions other than chlorine ion, bromine ion, iodine ion, sodium ion, divalent magnesium, trivalent aluminum, potassium ion or divalent calcium; or (c) 0.2% or more by weight of any atomic element or combination of the following atomic elements: lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin or zirconium. (a) that has reactive functional groups other than carboxylic acid groups, aliphatic hydroxyl groups, unconjugated olefinic groups that are considered ordinary *, butenedioic acid groups, blocked isocyanates including ketoxime-blocked isocyanates, thiols, unconjugated nitrile groups, halogens excluding reactive halogen groups such as benzylic or allylic halides, and conjugated olefinic groups present in naturally occurring fats, oils and carboxylic acids, in combined equivalent weights of less than daltons; or (b) in which the only reactive functional groups present are part of acid halides, acid anhydrides, aldehydes, hemiacetals, methylol-amides, methylol-amines, methylol-ureas, alkoxysilanes with alkoxy greater than C2-alkoxysilanes, allyl ethers, conjugated olefins, cyanates, epoxides, imines, unsubstituted positions ortho or para to phenolic hydroxyl, in combined equivalent weights of less than daltons. *Not specially activated either by being part of a larger functional group, such as a vinyl ether, or by other activation influences, for example, strongly electron-withdrawing sulfone group with which the olefinic groups interact. Generic requirements for not concerned by the PLC/RRR approach For which are neither R&D/contained-site-only/contained-export-only nor RRR (see next section for those ), requirements differ regarding whether: they are on the NDSL, or their reactants are on the DSL or the NDSL, or they are not on the NDSL. Schedules, thresholds and time-frames associated with each case are presented in the decision tree above. This section aims to discuss this description. In both cases, information corresponding to Schedule 9 (as well as information corresponding to items 1 to 3 of Schedule 2 for bio) is required when the polymer is manufactured or imported at a quantity of more than 1,000 kg/year. If or when this quantity exceeds 10,000 kg/year, further information is requested by Environment Canada & Health Canada: if the polymer is not on the NDSL, information specified in Schedule 11 has to be provided if the polymer is on the NDSL (or its reactants are on the DSL or the NDSL), information specified in Schedule 10 has to be provided in both cases, information corresponding to items 1 to 4 of Schedule 2 is requested for bio, as well as items 5 & 6 if the biopolymer is a nucleic acid. The level of requirement is higher in Schedule 11 than in Schedule 10: the differences and similarities between the two schedules are presented in Table below. Tests included in Schedule 11 but not in Schedule 10 include biodegradability, skin toxicity, repeated-dose mammalian toxicity, and mutagenicity tests. An overview of test data requirements for Schedules 9 to 11 is presented in Table 2. Table: Comparison between NDSL (schedule 10) and non-ndsl (schedule 11) requirements 113

114 Item Number in Schedule 10 Number in Schedule 11 Comparison Information of the schedule The same. Physical and chemical data 2 2 The same. Acute toxicity for water species Acute mammalian oral toxicity test 3 4 In Schedule 10, only a test on the most sensitive species is needed. In Schedule 11, according with the data of toxicity, tests on several species are asked In Schedule 10, the Item 4 asks for toxicity data and some information. In Schedule 11, the Item 5 asks for toxicity data, and the Item 9 asks for the same information than in Item 4. Consequently, the same is asked. Exposure information 5 11 Several requirements are the same. However, in Schedule 11 an identification of the components of the environment into which the polymer is anticipated to be released is asked. In Schedule 10 have to be provided 60 days before reaching 50,000 kg/yr: -the data substantiating the quantity released if the releases are higher than 3kg/day/site, -information of public exposure (including the concentration of the polymer, duration, frequency, circumstances of exposure and factors that may limit direct human exposure) Summary of other hazard information 6 12 The same. Ready biodegradation N.A. 3 Only present in Schedule 11. Skin irritation N.A. 6 Only present in Schedule 11. Skin sensitization N.A. 7 Only present in Schedule 11. Repeated dose mammalian toxicity test N.A. 8 Only present in Schedule 11. Additional information for toxicity tests N.A. 9 Only present in Schedule 11. Mutagenicity N.A. 10 Only present in Schedule 11. Box: Presentation of schedule 10 and schedule 11 items, for understanding of Table 1 Schedule Items

115 (information of the schedule 9) (Physical and chemical data) (acute toxicity test for water species) (acute mammalian oral toxicity test) (exposure information) (summary of other hazard information) (information of the schedule 9) (Physical and chemical data) (ready biodegradation) (acute toxicity test for water species) (acute mammalian oral toxicity test) (skin irritation) (skin sensitization) (repeated dose mammalian toxicity test) (additional information for toxicity tests) (mutagenicity) (exposure information) (summary of other hazard information Table: Overview of test data requirements (Source : John Moore, 2011) TEST SCHEDULE Chemical name Trade name CAS number Molecular formula Structural representation Polymer constituents (composition)/ Reaction scheme Polymer impurities (composition) MSDS Number Average Molecular Weight % Low Molecular Weight 1000 and 500 Exposure information Water solubility/extractability Octanol Solubility/Log P Hydrolysis as a function of the ph Acute Aquatic Toxicity (fish/daphnia/algae) Biodegradation # * * 115

116 Acute Oral Toxicity Skin Irritation Skin sensitisation 28-day Sub-Acute Ames Chromosome Aberration Use Profile Test Required Test not usually required ^ ^ The need for hydrolysis study depends on extractivity characteristics * The need for the aquatic tests depends on water extractability and sensitivity of species. Only one acute ecotox test on the most sensitive species is required for a Schedule 10 notification. A Schedule 11 requires two ecotox tests on the two more sensitive species. If there is uncertainty, it is recommended to conduct an algae test. ^ If the polymer is considered a high release/high exposure chemical, a repeated-dose mammalian toxicity test, Ames and Chromosome Aberration may be required. If the manufactured or imported quantity of a polymer listed on the NDSL (or whose reactants are on the DSL or the NDSL) exceeds 50,000 kg/year, additional information may be required: if releases to the environment exceed 3kg/site/day: (a) the data from a repeated-dose mammalian toxicity test of the polymer of at least 28 days duration, using the most significant route of potential human exposure to the polymer, namely, oral, dermal or inhalation, plus (i) the age, sex, number, species, strain and source of the animals tested, (ii) the route by which the polymer is administered and the conditions under which the test is conducted, and (iii) the dose of the polymer, the vehicle by means of which the polymer is administered and its concentration in that vehicle; and (b) the mutagenicity data obtained from an in vitro test, with and without metabolic activation, for gene mutation or chromosomal aberrations in mammalian cells. if there is significant human exposure: (a) as described above (b) the mutagenicity data obtained from an in vitro test, with and without metabolic activation, for gene mutation; and (c) the data obtained from an in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells or the data from a previously existing in vivo mammalian test for chromosomal aberrations that, together with data substantiating that the tissue investigated was exposed to the polymer or its metabolites, permits an assessment of in vivo clastogenicity. Polymers not listed on the NDSL are not subject to those additional requirements, because they are already provided for in Schedule 11. The graph below illustrates the requirements discussed above, depending on the manufactured or imported quantity of and their nature (on the DSL or not). 116

117 As of December 2014, 301 have benefited from reduced requirements in Canada because their monomers were registered in the DSL or NDSL. This represents 31% of the total number of manufactured/imported at volumes between 1 ton and 10 tons and notified during this period (957 of that category were notified during the same period). Grouping approach Consolidated Notifications Consolidated Notifications take place when a notifier simultaneously provides two to six NSN packages for substances of the same class and where the technical information provided for one substance is used to address the technical information requirements for the remaining substances. Consolidated notifications are typically seen where there are only small differences between the substances being notified, such as an additional carbon in a long carbon chain, and the information for one substance can be used as an acceptable analogue to the others. Matched Notification A Matched Notification takes place when a notifier requests that information previously provided by another notifier for the same substance is used for assessment by Environment Canada & Health Canada. Such information may include test requirements or additional information. The notifier who is providing the information must submit a letter of authorization indicating his or her New Substances Notification (NSN) reference number as well as the name of the notifier whom he or she is supporting, together with the latter notifier s NSN reference number, if known. When files are matched, there may be a price reduction in the required fees. The Matched Notification process and third party notifications allow us to ensure that confidential business information is maintained. It also helps ensure fairness for notifiers. RRR/PLC approach and other reduced requirements The Regulations provide for reduced requirements for a wide range of, although the term PLC is not used in Canada. There are two grounds on which a polymer can qualify for reduced requirements: either specific low concern properties (so-called Reduced Regulatory Requirements ) or a particular scope of use (R&D, contained site-limited intermediate or contained export-only ). From , the average number of notifications are as follows: RRR 116/year Special Category (R&D, CSLI, CEO) 2/year Non-RRR 86/year 117

118 Schedules, thresholds and time-frames associated with each case are presented in the decision tree on page 6. This section aims to discuss this description. The definition of RRR combines composition and reactivity constraints (see box) and is close to the definition of PLC in the USA (Box). Special Category (R&D, CSLI, CEO) 2/year Box: Definition of a RRR polymer First, some are ineligible to qualify for reduced requirements: they are described in items 1 to 4 in schedule 7. In short, those ineligible are either: A cationic polymer or a polymer that is reasonably expected to become cationic in a natural environment; or A polymer that is designed, or can be expected, to substantially degrade, decompose or depolymerize, or A polymer that has, as an integral part of its composition, only one or none of the following atomic elements: carbon, hydrogen, nitrogen, oxygen, silicon and sulphur; or A polymer that has (a) any atomic elements other than carbon, hydrogen, nitrogen, oxygen, silicon, sulphur, fluorine, chlorine, bromine or iodine covalently bound to carbon; (b) any monoatomic counterions other than chlorine ion, bromine ion, iodine ion, sodium ion, divalent magnesium, trivalent aluminum, potassium ion or divalent calcium; or (c) 0.2% or more by weight of any atomic element or combination of the following atomic elements: lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin or zirconium. The US regulation also takes into account those criteria for eligibility for PLC. However, they do include 3 additional criteria: Polymers prepared from monomers and reactants not listed in the TSCA Inventory Water-absorbing with Mn>10,000 Da Polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3 or longer chain length In order to be qualified as a RRR, a polymer must be of one of the following type: Mn criteria (Da) Composition criteria Reactivity constraints Other 1000<Mn<10,000 The polymer must contain less than 10% oligomer 58 content of molecular weight below 500 Da and less than 25% oligomer content of molecular weight below 1,000 Da Not described in items 5 in schedule 7 (this item deals with reactive functional groups - Mn>10,000 The polymer must contain less than 2% oligomer 59 content of molecular weight below 500 Da and less than 5% oligomer content of Oligomer: a low molecular weight species derived from the polymerization reaction 59 Oligomer: a low molecular weight species derived from the polymerization reaction 118

119 molecular weight below 1,000 Da A polyester polymer made only from reactants specifically listed on Schedule 8, or an anhydrous form of these reactants other than the reactants or their anhydrous forms that include both 1-butanol and fumaric or maleic acid. Exemption criteria in the US and RRR criteria in Canada are essentially the same, although the US has made some amendments. The Mn and composition criteria for RRR are the same as those defined in the USA for PLC; furthermore, there are no reactivity constraints associated with RRR having an Mn superior to 10,000 Da, as is the case in the USA. The reactivity constraints regarding the type of RRR having an Mn between 1,000 Da and 10,000 Da deal with the type and equivalent weights of reactive functional groups in the polymer. However, the Canadian regulation does not define categories of reactive functional groups, unlike what is done in the USA with the low-concern, moderate-concern and high-concern categories. In Canada, polyesters manufactured from specific reactants qualify for reduced requirements. This is also done in the USA, where polyester made only from reactants specifically listed in the polymer exemption section of the TSCA can be exempted. Information corresponding to Schedule 9 (as well as information corresponding to items 1 to 3 of Schedule 2 for bio) is required when a RRR polymer is manufactured or imported at a quantity of more than 1,000 kg/year. No further information is required for higher volumes, unlike the case of discussed in the generic requirements section. Therefore, information from Schedule 9 is considered to be enough for of low hazard as well as for other manufactured/imported at a quantity less than 10,000 kg/year (Table below). Table: Conditions for which information of Schedule 9 is sufficient Type of polymer Conditions Type of reduced requirement RRR none Low hazard On the NDSL (or all reactants are on the NDSL or DSL) Quantity less than 10,000 kg/year Low volume Not on the NDSL Quantity less than 10,000 kg/year Low volume Furthermore, information corresponding to Schedule 3 is required when an R&D, contained site-limited intermediate or contained export-only polymer is manufactured or imported at a quantity of more than 10,000 kg/year. Additional requirements for bio differ depending on their use: 119

120 Below is a table comparing the Schedules associated with the two types of reduced requirements, Schedule 3 & Schedule 9: Table: Comparison between Schedule 3 and Schedule 9 requirements Item Schedule 3 Schedule 9 Comparison Type of polymer 1 1 Schedule 3 tells about R&D, site-limited And Schedule 9 about RRR, NDSL Pre-notification number 2 2 The same. Chemical name 3 3 The same. Trade names 4 4 The same. CAS number 5 5 The same. Molecular formula 6 6 The same. Structural formula 7 7 The same. For site-limited intermediates: Mn and maximum concentrations 8 N.A. Only present in Schedule 3. For R&D: targeted Mn 9 N.A. Only present in Schedule 3. Impurities The same. Composition The same. MSDS The same. physical state 13 Only present in Schedule 3. water dispersion 14 Only present in Schedule 3. exposure information Schedule 3: more information about storage and 120

121 transportation. Schedule 9: more information about exposure data, and applications. summary of other information Schedule 3: more complete. government agency notified The same. reaction scheme N.A. 8 Only present in Schedule 9. physical and chemical data N.A. 9 Only present in Schedule 9. Box: Presentation of schedule 3 and schedule 9 items, for understanding of Table 4 Schedule Items (type of polymer) (prenotification number) (chemical name) (trade names) (CAS number) (molecular formula) (structural formula) (For sitelimited intermediates: Mn and maximum concentrations) (for R&D: targeted Mn) (impurities) (composition) (MSDS) (physical state) (water dispersion) (exposure information) (summary of other information) (government agency notified) (type of polymer) (prenotification number) (chemical name) (trade names) (CAS number) (molecular formula) 9 (continued) 7 (structural formula) 8 (reaction scheme) 9 (physical and chemical data) 10 (impurities) 11 (composition) 12 (MSDS) 121

122 13 (Exposure information) 14 (summary of other information) 15 (government agency notified) Similar items are those dealing with identification information of the polymer (name, number, molecular formula), information on content (including name and proportion of impurities) as well as exposure. Key characteristics of the strategy One particularity of the Canadian scheme is the existence of two lists, the domestic one and the non-domestic one. The Canadian scheme provides lower requirements for the notification of a wide range of : RRRs, R&D, site-contained or listed on the NDSL. In particular, no toxicological data is to be submitted for RRRs. However, for all types of, the nature and content of all impurities must be provided. It is interesting to note that Canada, although providing for a lot of reduced requirements, does not allow any exemptions (this is different from the USA, where many exemption cases are defined and very little reduced requirements). The use/exposure issue is taken into account in two ways: For with low exposure, and whose use is contained in a restricted area, there are reduced requirements. On the other hand, if releases to the environment and/or public exposure are considered to be high, specific provisions are applied Around 204 are notified each year, 57% of them being RRR. Very few are notifed under a special category such as R&D (1% of notified ). Figure: Proportion of notified under each category The Canadian regulation is inspired from the US s, notably regarding the definition of an RRR, which resembles US PLC s. There is also a strong link between the US TSCA Inventory and the NDSL. No joint submission is possible in Canada, but the Matched Notification allows to use same data between notifiers of a same substance, with reduced fees. The Consolidated Notification process, by which a notifier can simultaneously provides two to six NSN packages for substances of the same class, also allows for a reduction in costs, as there is one notification made where there would have been several. Approximately 165 companies notify per year, and the majority of the notifications received are unique substances, i.e. few notifications are received for the same substance from different companies. For special category (contained site-limited intermediate or contained export-only), the average cost to submit the notification is $2000. For R&D under special categories, there are no fees ($0). For RRR, it is $1500. For non-rrr 122

123 it s $3500, whether it s on the NDSL or not. Note that these are the fees for notifying, and do not include the costs associated with obtaining the information requirements (e.g. toxicity testing). Also, it should be noted that small and medium-sized enterprises may be eligible for reductions in fees. Under the Regulations, if individual monomers are being imported or manufactured in Canada, they would require separate notification as they would be considered separate substances. In those instances, the monomer may be a chemical, or it may be a polymer (e.g. pre-polymer monomer), each of which has its own information requirements under the Regulations. The Minister is obligated to periodically review regulations. Experience with the Regulations to that point led to proposed and then realized amendments to the Regulations. The internal and external consultative processes followed prior to those amendments led to improvrcementsimporcements in the notification process. It should be noted that the fees did not change. The New Substances Program is constantly undergoing regular and continuous improvement. There are regular meetings with Industry and Stakeholders, and guidelines and policies are updated continuously as needed for the betterment of the New Substances Program. Sources New Substances Notification Regulations (Chemicals and Polymers), John Moore Regulatory Services (2011) Handling on a global scale: A world-wide regulatory review Paper prepared by J H Moore for ChemCon Asia 2011 (Session 7 Horizontal Issues) Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers, The New Substances Notification Regulations of the Canadian Environmental Protection Act, 2005 NSN Technical Document-Waiver Requests for Chemicals and Polymers, The New Substances Notification Regulations of the Canadian Environmental Protection Act, 2013 Health and Environment Canada answers to the following questionnaire: What are the criteria for grouping of in same class under the Consolidated Notification? There are provisions to allow manufacturers producing a same chemical to one in the DSL to have fewer requirements. Is it frequently done for? Same question for the Consolidated Notification? How do the provisions for monomer and polymer notification differ from each other? What is the average cost of notification for each category of (RRR, R&D and site-contained, in the NDSL, not in the NDSL)? What is the average number of notified per year, for each category (RRR, R&D, etc)? What is the average number of existing which information has to be updated each year? How many companies (approximately) and how many (approximately) falls under notification scheme?. How frequent is it that a SNAc notice for is issued? How is the proportionality principle applied? Could you provide more information on how R&D are dealt with? What are the motivations behind the different legislative choices made by Heath & Environment Canada? In particular: o Why did you conduct the reform with the change of Schedules? Does the amended regulation improve the notification process/costs? o For the 2005 amendments, did you discuss the option of introducing requirements for monomers? Why did you decide against? o The definition of RRR is the same as in the USA (PLCs) for the composition criteria (content of oligomers). However, the reactivity constraints laid out in Schedule 7 are different from the reactivity constraints for a PLC (US definition). It seems like it is a simplified version. Why this choice? o Under the NSNR, it is not possible for companies to submit a joint notification if they manufacture 123

124 similar. Why do you not allow that, but favor the process of Matched Notification? Did you evaluate the the efficiency of the legislation: outcomes, monitoring system, costs, quality of data? 124

125 China Regulatory text: Measures on the Environmental Management of New Chemical Substances (China Ministry of Environmental Protection (MEP) Order ) 60 Competent Authority: MEP-CRC (Ministry of Environmental Protection 61 -Chemical Registration Center) 62 Contacts: Jing Ye CRC- MEP New Chemical Substance Management Division of CRC-MEP : Nie Jinglei (niejinglei@mepscc.cn) Yang Li (yangli@mepscc.cn) Liu Chunxin (liuchunxin@mepscc.cn) Chen Lin (chenlin@mepscc.cn) Aim and structure of this sheet This factsheet describes the polymer registration strategy currently implemented in China. After a short introduction outlining the main aspects of the strategy, the factsheet details the main criteria used in PLC approach. Key points raised by the document (advantages/disadvantages of the strategy) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the MEP- CRC. Context and general description According to the Chinese Regulation Measures on the Environmental Management of New Chemical Substances, a new chemical substance is a substance that is not covered by the Inventory of Existing Chemical Substances in China (IECSC). IECSC covers the substances which have been placed on the market for commercial purposes between 1 January 1992 to 10 October 2003, and these are exempt from notification. In China the notification must be done before a new chemical substance can be manufactured, imported or placed in the market. If a polymer is already listed in IECSC, a new chemical substance notification is not required. Polymers for which monomers and reactants are not included in the IECSC are considered a new substance and for these, a simplified notification or typical notification is needed, depending on the volume of the polymer on the market and whether the polymer meets the criteria for Polymer of Low Concern (PLC). Domestic companies need to submit the notification documents of the new chemical substance to the Chemical Registration Centre of MEP-CRC prior to the manufacturing or importation, and foreign companies can notify the new substance by appointing a local Chinese agent. There are three types of notifications for new in China, which have different requirements associated: simplified notification under special conditions, simplified notification under basic conditions and typical notification. Chemical substance used in scientific research and development in very low quantities (<0.1 tonnes per year) can be notified via the Scientific Research Record Notification (SRRN), that has the lowest requirements among the notification types (its only necessary a SRRN Form). If there are impurities in the chemical substance or additives (in the time of marketing of the notified substance), they have to be 60 Measures on the Environmental Management of New Chemical Substances (China MEP Order ) A8%E7%94%B3%E6%8A%A5%E7%99%BB%E8%AE%B0%E6%8C%87%E5%8D%97.pdf 61 Ministry of Environmental Protection of the People's Republic of China: 62 Chemical Registration Center of MEP: 125

126 addressed and can be provided as an attachment; the information required for impurities is chemical name, molecular weight, CAS number and maximum percentage content and for additives is chemical name, CAS number, basic properties, percentage of content and additive effect. Joint Notification is available and after it is approved, each notifier receives an independent Registration Certificate. There are no requirements for existing chemical substances. Post-notification requirements are annual activity reports and updates of registration information. Decision tree The following diagram shows to how to determine the right type of notification for in China 63 : Definition of a polymer In coherence with OECD definition: yes Polymer is a chemical substance consisting of one or more than monomeric units in sequence and the molecular weight of such molecules shall be arranged within the certain scope and the differences of molecular weight mainly depends on number of monomeric units. Polymers shall simultaneously meet the following three conditions: (1) Molecular weight is not a fixed value but dispersedly distributed (2) Molecules with weight percentage more than 50% at least contain three monomeric units which are connected with at least one of other monomeric units or other reactants in covalent bonding (3) Molecules with same molecular weight shall not exceed 50% (weight percentage) of all molecules. Box: Definitions accompanying the polymer definition Monomer refers to a chemical substance capable of forming covalent bonds with two or more same or different molecules under specific polyreaction conditions. Monomeric unit refers to a form of monomers in after reaction. Sequence refers to one form of successive monomers of monomeric units connected by covalent bonds in molecules. Units of sequence cannot be broken by units other than monomeric units. 63 Polymer Regulations and Polymer Notifications Update Report 2011: 126

127 Reactant refers to a molecule that is connected to one or more sequences of monomeric units. Reactants cannot be repeating units in polymer structures under specific reaction conditions. Weight percentage refers to charge weight ratio of monomers or reactants in polyreaction or content ratio (by weight) of monomeric units or reactants combined in molecules after polyreation. Generic requirements for not meeting PLC criteria 1. Typical Notification All new commercially manufactured or imported in quantities of 1 ton per year that are not exempt have to be notified by typical notification. For typical notification the data required depends on the tonnage band, with 4 different levels, as follows: 1-10 t/y, t/y, t/y and 1000 t+/y. The requirements for the different levels are proportional with the volumes, only the physico-chemical testing is the same. This process takes 4-8 months. The general data requirements are: Regular Notification Form Classification and Labelling Risk Assessment report Eco-toxicological Properties Toxicological Properties Physico-chemical Properties Chinese Safety Data Sheet (SDS) In the case of, besides the requirements described above, applicants must also submit information on: Average molecular weight Molecular weight distribution Monomers/reactants list, names and CAS numbers (if known) Residual monomers/reactants Percentage of monomers/reactants in the polymer (if known) Percentage of oligomer content at a molecular weight of less than 1000 Molecular formula and/or structural formula (if known) Polymerization process and conditions (if known) Manufacturing process 2. Simplified Notification under special conditions Although the simplified notification under special conditions applies to of low concern (PLC) (if the polymer itself is not listed on IECSC) it also applies to: consisting of monomers or building blocks that are already listed in IECSC (if the polymer itself is not listed on IECSC); containing less than 2% of a new chemical substance weight by weight (if the polymer itself is not listed on IECSC). For simplified notification under special conditions there are no mandatory testing requirements, however, any existing or basic physic-chemical or toxicological properties and other information that could describe the properties of the substance shall be listed, and for, information regarding composition data about monomer, Gel Permeation Chromatography (GPC) data, and polymerization mechanism shall also be given. This notification process takes 2-3 months. 3. Simplified Notification under basic conditions For that are not listed on IECSC and are not eligible for simplified notification under special conditions, simplified notification under basic conditions shall be submitted if the volume of the is less than or equal to 1 ton per year. This process lasts approximately 3-4 months. The following information shall be submitted for the simplified notification under basic conditions for : 127

128 Composition information about the polymer and GPC data, which includes average molecular weight, molecular weight distribution, its monomers/reactants list, and names and chemical abstract numbers shall be specified (if known), the residual monomers/reactants, the percentage of monomers/reactants in the polymer (if known), the percentage of oligomer content at a molecular weight of less than1000, molecular formula and/or structural formula (if known), polymerization process and conditions (if known). Existing physico-chemical data (melting point, partition coefficient n-octanol/water and water solubility are mandatory). 1~3 of the following tests must be carried out in Chinese labs approved by MEP: ready biodegradability, acute toxicity study with Brachydanio rerio, acute toxicity test with earthworms depending on substance properties. PLC approach China has adopted the concept of PLC proposed by OECD (Organisation for Economic Co-Operation and Development) even though China is not a member of OECD. China s PLC criteria are also very similar to USEPA (United States Environmental Protection Agency) PLC criteria In China, that meet any one of the following three criteria will be regarded as PLC and they will only need a simplified notification: The average molecular weight (MW) of the polymer is between 1,000-10,000 Daltons. At the same time, the weight percentage of oligomer with MW<500 is less than 10%, and the weight percentage of oligomer with MW<1000 is less than 25%. Besides, the polymer shall not contain functional groups of high concern and highly reactive functional groups, like for example heavy metal, cyan group, acrylic ester, aziridine, isocyanate, thio-isocyanate and vinyl sulphone; The average molecular weight (MW) of the polymer is greater than 10,000 Daltons. At the same time, the weight percentage of oligomer with MW<500 is less than 2%, and the weight percentage of oligomer with MW<1000 is less than 5%; Polyester which contain at least two carboxylic ester bonds in polymeric molecules and at least one carboxylic ester bond combined with internal monomers. The main differences between PLC definition between China and USA are: o o In China, for with MW between 1,000-10,000 Daltons, the polymer shall not contain functional groups of high concern and highly reactive functional groups, like for example heavy metal, cyan group, acrylic ester, aziridine, isocyanate, thio-isocyanate and vinyl sulphone; For USA, the polyester eligible for PLC can only be made from reactants specifically listed in the polymer exemption section of the TSCA Box: Requirements for PLC PLC only need a special simplified notification, with the following requirements: List of monomer(s)/reactants, including the name, CAS number, the content of monomer(s)/reactants as well as whether if monomer(s)/reactants are listed in IECSC; Molecular weight of, weight-average molecular weight, number average molecular weight and molecular weight distribution, including GPC or other testing results to indicate molecular weight and its distribution; this information will be used to judge whether or not conform to polymer definition and meet the PLC criteria Description of the mechanism of polymerization process, manufacturing process or flow chart; Many new placed on Chinese market meet the criteria of simplified notification under special conditions. Box: Possible options to take when general PLC criteria is not met (according with the decision tree) In the case that the polymer does not fulfill the PLC criteria, in order to avoid a general/typical 128

129 notification, some actions that can be taken: Submit the same polymer identification as required for the simplified notification, plus information on residual monomer(s) content, and answer the following questions: 1. Does the polymer contain heavy metals or is it cationic? If yes, the notification proceeds according to the general/typical notification scheme. If no, then perform the next test. 2. Is it soluble in water? If the polymer is soluble, even without knowing the level of solubility, the notification proceeds according to the general/typical notification scheme. Method according to SEPA (State Environmental Protection Administration's) chemical testing method 105. If no, then perform the next test. 3. Is it soluble in organic solvents? If it is soluble in any of the lipotropy solvents (n-octanol and n-heptane), stop this test and perform notification based on data requirements of the corresponding quantity level in general notification; and if no, perform solubility test on general solvents. If it is soluble in over two general solvents (isopropanol, 1,2-dicloroethane, toluene, tetrahydrofuran, methyl isobutyl ketone and dimethyl formamide), stop this test and perform notification based on data requirements of the corresponding quantity level in general notification; and if no, perform the next test. 4. Is it stable in different ph solutions?. If the polymer is unstable under any of the conditions for ph stability tests (that must be performed on at ph 4, 7, 9 and 12, respectively) the notification proceeds according to the general/typical notification scheme. If not, the polymer is considered to be of low concern and only a special simplified notification is needed. Grouping approach Chinese chemicals legislation does not refer any grouping approach for polymer notification. Key characteristics of the strategy Advantages of the strategy: Only new must be notified; existing are exempt from notification requirements. PLC doesn t have requirements for mandatory toxicology or eco-toxicology data. The simplified notification has the advantage of needing only one-off submission, with no renewals required Disadvantages of the strategy: Notification of new that do not meet exemption criteria can be both costly and resource intensive Transferability at EU level : The definition for of low concern is according to OECD The existence of a chemicals substance list (IECSC) could facilitate the notification. We have a similar list in Europe (ELINCS European List of Notified Chemical Substances) and we could assume that, as in China, the substances present in this list, including, could be exempt from notification. The PLC approach. PLC have less requirements (only need a simplified notification) Existence of three types of notification with different requirements, according to the type of polymer 129

130 and tonnage band. China REACH cost 64 : o The administration fee is fixed and is charged by CRC (around RMB 200); this fee accounts for a very small portion of the total costs. o Total costs consist mainly of the testing fees, which depend on tonnage level, and are charged by certified laboratories. Typically the cost is several hundred thousand RMB s. o Service/consulting fee to the local agent. Questions for MEP-CRC Do you have any feedback from industry about the costs for notification of new that do not meet exemption criteria? What are the advantages for excluding existing form the notification requirements? What needs to be included in the post-notification requirements? Is this for all or just the ones who needed a typical notification? PLC Sources Why were three categories of PLC defined? Does the complexity of determining the compliance with the special simplified notification criteria discourage some manufacturers from building a PLC dossier? How has the PLC approach influenced the number of notifications? MEP Guidance Document on New Chemical Substance Notification (Chinese): B4%A8%E7%94%B3%E6%8A%A5%E7%99%BB%E8%AE%B0%E6%8C%87%E5%8D%97.pdf English translation for Provisions on the Environmental Administration of New Chemical Substances in China (2010), done by The Chemical Inspection and Regulatory Service (CIRS) : Inventory of Existing Chemical Substances Manufactured or Imported in China (IECSC): al_substances_2010.html Guidance Documents for New Chemical Substance Notification in China (China REACH): Guidance for New Chemical Substance Notification: pdf Polymers: Global Notification Procedures, John Moore Regulatory Consultant : df Polymer Regulations and Polymer Notifications Update Report 2011: 64 Environmental Legislation for Industry Chemicals in China, Tao Yao, Leihong Yao, Li Ying, Eija Tynkkynen, Produced by Finpro China for Teknologiateollisuus ry FP6533, May 14,

131 Case study: Are You Ahead or After Other Companies within Compliance Requirement in China REACH?, Crystal Yang, REACH24H Consulting Group, 12 June 2012, Germany: The guidelines for the testing of chemicals (HJ/ T ), SEPA, June 2004, in Chinese: Environmental Legislation for Industry Chemicals in China, Tao Yao, Leihong Yao, Li Ying, Eija Tynkkynen, Produced by Finpro China for Teknologiateollisuus ry FP6533, May 14,

132 Dangerous Substances Directive Regulatory text: Directive 67/548/EEC on Classification, Packaging and Labelling of dangerous substances, also called the Dangerous Substances Directive (DSD) 65 Competent Authority: ECHA Contacts:Mark Rosenburg Aim and structure of this sheet This factsheet describes the strategy for identification and classification of according to Annex VII D of the DSD. After a short introduction outlining the main aspects of the strategy, the sheet details the requirements for the notification process and the main criteria used in grouping approaches. Context and general description The Dangerous Substances Directive (DSD), in action since 1967, is the currently European Union Law that governs chemicals regulation. By 2016 the DSD will be replaced by the Classification, Labelling and Packaging (CLP) regulation, from The several amendments of the DSD introduced new requirements for chemicals, the most important amendments being the sixth and the seventh. The sixth amendment (79/831/EEC) 66 stated that all chemicals commercialized in Europe prior to 18 September 1981 had reporting requirements. These reported substances were then listed on the European Inventory of Existing Commercial Chemical Substances (EINECS), which allowed them to be commercialized in Europe without prior notification. The seventh amendment (92/32/EEC) 67, from 1992, stated that for a new substance (chemical substance not listed on EINECS) to be commercialized in Europe requires that a dossier of this new substance has to be submitted to the member country in which the substance will first be placed on the market. The seventh amendment also defines that for chemical substances imported to the EU, there are two option for notification: (1) a substance may be notified by the importer or (2) the substance may be notified by a person in the EU designated by the manufacturer as the manufacturer's only representative. The DSD provides guidance for the identification and classification of chemical substances, and in its Annex VII there is a particular section for (section D), that defines the specific requirements for. It also describes a grouping approach, denominated family approach that consists in grouping according to their families, in order to reduce testing costs and avoid unnecessary testing duplication. It also considers that are some that apply for a reduced test package (RTP). Under the seventh amendment of the DSD is defined the exemption for polymer notification under the 2% rule for notification of new, indicating that, with the exception of those which contain in combined form 2% or more of any substance which is not on EINECS, shall be considered as having been notified within the meaning of this Directive. Under the DSD, a polymer is subject to notification requirements if it falls under any of the categories: o o A substance produced by polymerisation of one or more non-einecs listed substance(s), present 2% or more in bonded form; A substance produced by post-reaction of an exempt polymer with non-einecs listed substance(s), present 2% or more in bonded form. Decision tree 65 European Directive on the classification, packaging, and labeling of dangerous substances (67/548/EEC), of 27 June 1967, OJ L 196/1 66 Sixth Amendment to the DSD, 79/831/EEC of 18 September 1979, OJ L 259/10 67 Seventh Amendment to the DSD, 92/32/EEC of 30 April 1992, OJ L 154/1 132

133 New polymer Meets exemption criteria? No Yes No Meets criteria of Annex VII D, para C2? Yes Exemption from notification Standard Test Package (STP) Reduced Test Package (RTP) PLC Approach Possibility of registering a family of Definition of a polymer In accordance with the OECD definition. Grouping approach "Polymer" means a substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. "Monomer unit" means the reacted form of a monomer in a polymer; Homopolymer is a polymer consisting of only one kind of monomer unit Copolymer is a polymer consisting of more than one kind of monomer unit. Generic requirements for not concerned by grouping approaches or Reduced Testing The polymer-specific requirements will vary depending on the amount of the polymer to be introduced into commerce. For lower quantities, there are reduced data requirements, and the amount and complexity of the data that must be submitted for a polymer, increases with volume. For a polymer notified as a Standard Test Package Polymer the standard testing program is to be followed, according with the amount commercialized, as follows: 1. Polymers placed on the Community market in quantities of 1 t/a or total quantities (cumulative) of 5 t In addition to the information and tests referred to in Annex VII A (see box 1), the following polymer-specific information is required: IDENTITY OF THE SUBSTANCE o Number-average molecular weight o Molecular weight distribution (MWD) o Identity and concentration of starting monomers and starting substances which will be bound in the polymer o Indication of end groups and identity and frequency of reactive functional groups: Identity of non-reacted monomers; Percentage of non-reacted monomers. INFORMATION ON THE SUBSTANCE 133

134 Statement, with relevant information, if the polymer has been developed to be environmentally degradable. PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE Water extractivity Further tests may be required additionally in certain cases, e.g.: o o light-stability if the polymer is not specifically light-stabilized, long-term extractivity (leachate test); depending on the results of this test, appropriate tests on the leachate may be requested on a case by case basis. 2. Polymers placed on the Community market in quantities of < 1 t/a or total quantities (cumulative) of < 5 t but 100 kg/a or total quantities 500 kg In addition to the information and tests referred to in Annex VII B (see Box 2), the following polymer-specific information is required: IDENTITY OF THE SUBSTANCE o Number-average molecular weight o Molecular weight distribution (MWD) o Identity and concentration of starting monomers and starting substances which will be bound in the polymer o Indication of end groups and identity and frequency of reactive functional groups: Identity of non-reacted monomers; Percentage of non-reacted monomers. INFORMATION ON THE SUBSTANCE o Statement, with relevant information, if the polymer has been developed to be environmentally degradable PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE o Water extractivity 3. Polymers placed on the Community market in quantities of < 100 kg/a or total quantities (cumulative) of < 500 kg In addition to the information and tests referred to in Annex VII C (see Box 3), the following polymer-specific information is required: IDENTITY OF THE SUBSTANCE o Number-average molecular weight o Molecular weight distribution (MWD) o Identity and concentration of starting monomers and starting substances which will be bound in the polymer o Indication of end groups and identity and frequency of reactive functional groups: Identity of non-reacted monomers; Percentage of non-reacted monomers. INFORMATION ON THE SUBSTANCE o Statement, with relevant information, if the polymer has been developed to be environmentally degradable Box 1: Annex VII A IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION OF THE PRODUCTION SITE IDENTITY OF THE SUBSTANCE o Name: Names in the IUPAC nomenclature; Other names (usual name, trade name, abbreviation); CAS number and CAS name (if available) o Molecular and structural formula o Composition of the substance: Degree of purity (%); Nature of impurities, including 134

135 isomers and by-products; Percentage of (significant) main impurities; If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude:... ppm... %, Spectral data (UV, IR, NMR or mass spectrum); HPLC, GC o Methods of detection and determination INFORMATION ON THE SUBSTANCE o Production: Technological process used in production; Exposure estimates related to production: working environment and environment o Proposed uses: Types of use (description of the function and the desired effects); Technological process(es) related to the use of the substance (where known); Exposure estimate(s) related to use (where known): working environment and environment; Form under which the substance is marketed (substance, preparation, product); Concentration of the substance in marketing preparations and products (where known); Fields of application with approximate breakdown: industries, farmers and skilled trades, use by the public at large; Where known and where appropriate, the identity of the recipients of the substance; Waste quantities and composition of waste resulting from the proposed uses (where known) o Estimated production and/or imports for each of the anticipated uses or fields of application: Overall production and/or imports in tonnes per year; Production and/or imports o Recommended methods and precautions concerning: Handling; Storage; Transport; Fire (nature of combustion gases or pyrolysis, where proposed uses justify this); Other dangers, particularly chemical reaction with water; If relevant, information concerning the susceptibility of the substance to explode when presented in the form of a dust o Emergency measures in the case of accidental spillage o Emergency measures in the case of injury to persons (e.g. poisoning) o Packaging PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE o State of the substance at 20 ºC and 101,3 kpa o Melting-point o Boiling-point o Relative density o Vapour pressure o Surface tension o Water solubility o Partition coefficient n/octanol/water o Flash-point o Flammability o Explosive properties o Self-ignition temperature o Oxidizing properties o Granulometry TOXICOLOGICAL STUDIES o Acute toxicity: Administered orally; Administered by inhalation; Administered cutaneously; Skin irritation; Eye irritation; Skin sensitization o Repeated dose: Repeated dose toxicity (28 days) o Other effects: Mutagenicity; Screening for toxicity related to reproduction (for the record); Assessment of the toxicokinetic behaviour of a substance to the extent that can be derived from base set data and other relevant information ECOTOXICOLOGICAL STUDIES o Effects on organisms: Acute toxicity for fish; Acute toxicity for daphnia; Growth-inhibitor test on algae; Bacterial inhibition 135

136 o Degradation: biotic and antibiotic o Absorption/desorption screening test POSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS o For industry/skilled trades: Possibility of recycling; Possibility of neutralization of unfavourable effects; Possibility of destruction (controlled discharge, incineration, water purification station and others) o For the public at large: Possibility of recycling, Possibility of neutralization of unfavourable effects, Possibility of destruction (controlled discharge, incineration, water purification station and others) REDUCED TEST PACKAGE FOR INTERMEDIATES AT QUANTITIES = 1 TONNE/ANNUM Box 2: ANNEX VII B IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION OF THE PRODUCTION SITE IDENTITY OF THE SUBSTANCE o Name: Names in the IUPAC nomenclature; Other names (usual name, trade name, abbreviation); CAS number and CAS name (if available) o Molecular and structural formula o Composition of the substance: Degree of purity (%); Nature of impurities, including isomers and by-products; Percentage of (significant) main impurities; If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude:... ppm,... %; Spectral data (UV, IR, NMR or mass spectrum); HPLC, GC o Methods of detection and determination INFORMATION ON THE SUBSTANCE o Production: Technological process(es) used in production; Exposure estimate related to production (working environment and environment) o Proposed uses: Types of use (description of the function and the desired effects); Technological process(es) related to the use of the substance (where known); Exposure estimate(s) related to the use of the substance (where known) (working environment and environment); Form under which the substance is marketed: substance, preparation, product; Concentration of the substance in marketed preparations and products (where known); Fields of application with approximate breakdown: industries, farmers and skilled trades and use by the public at large; Where known and where appropriate, the identity of the recipients of the substance o Estimated production and/or imports for each of the anticipated uses or fields of application: Overall production and/or imports in tonnes per year; Production and/or imports o Recommended methods and precautions concerning: Handling; Storage; Transport; Fire (nature of combustion gases or pyrolysis, where proposed uses justify this); Other dangers, particularly chemical reaction with water o Emergency measures in the case of accidental spillage o Emergency measures in the case of injury to persons (e.g. poisoning) o Packaging PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE o State of the substance at 20 ºC and 101,3 kpa o Melting-point o Boiling-point o Water solubility o Partition coefficient n-octanol/water o Flash-point 136

137 o Flammability TOXICOLOGICAL STUDIES o Acute toxicity: Administered orally; Administered by inhalation; Skin irritation; Eye irritation; Skin sensitization o Other effects: Mutagenicity ECOTOXICOLOGICAL STUDIES o Degradation: Biotic Box 3: ANNEX VII C IDENTITY OF MANUFACTURER AND THE NOTIFIER IF THESE ARE NOT THE SAME; LOCATION OF THE PRODUCTION SITE IDENTITY OF THE SUBSTANCE o Name: Names in the IUPAC nomenclature; Other names (usual name, trade name, abbreviation); CAS number and CAS name (if available) o Molecular and structural formula o Composition of the substance: Degree of purity (%); Nature of impurities, including isomers and by-products; Percentage of (significant) main impurities; If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude:... ppm;... %; Spectral data (UV, IR, NMR or mass spectrum); HPLC, GC o Methods of detection and determination INFORMATION ON THE SUBSTANCE o Production: Technological process(es) used in production; Exposure estimate related to production (working environment and environment) o Proposed uses: Types of use: description of the function and the desired effects; Technological process(es) related to the use of the substance (where known); Exposure estimate(s) related to the use of the substance (where known) (working environment and environment); Form under which the substance is marketed: substance, preparation, product; Concentration of the substance in marketed preparations and products (where known); Fields of application with approximate breakdown: industries, farmers and skilled trades, use by the public at large; Where known and where appropriate, the identity of the recipients of the substance o Estimated production and/or imports for each of the anticipated uses or fields of application: Overall production and/or imports in tonnes per year; Production and/or imports o Recommended methods and precautions concerning: Handling; Storage; Transport; Fire (nature of combustion gases or pyrolysis, where proposed uses justify this); Other dangers, particularly chemical reaction with water o Emergency measures in the case of accidental spillage o Emergency measures in the case of injury to persons (e.g. poisoning) o Packaging PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE o State of the substance at 20 ºC and 101,3 kpa o Flash-point o Flammability TOXICOLOGICAL STUDIES o Acute toxicity: Administered orally; Administered by inhalation. Grouping approach 137

138 The grouping approach proposed by the DSD allows notifiers of to submit one technical dossier which will cover several, avoiding unnecessary tests to be performed, by only testing selected representative members of a family. The proposed grouping approach can be divided in two categories, one covering a narrow range of variation and another covering a wide range: 1. Narrow range In this category, for the particular case of, the term substance means a narrow group of (co) of similar composition and/or similar number average molecular weight (Mn) values, even if the small variations are due to deliberate alterations to the process conditions, the process itself remaining unchanged. Small variations include the following: a) for homo, the Mn can vary by up to 3-fold; b) for co- where, a. the Mn remains approximately constant (variation up to 2-fold) while the composition varies by + 10% absolute. or b. the composition remains approximately constant (variation up to + 3% absolute) while the Mn can vary up to 3 fold. Each substance, as defined above, will be subject to one notification, with as a consequence, the cumulation of the tonnages, one entry in ELINCS etc. For (a) and (b) (ii), the tests are done on the polymer with lowest Mn and for (b) (i) that with the mean composition. 2. Family approach (wide range) When a group of to be marketed is too wide in composition or in number average molecular weight to be considered a substance, then it may be possible to consider the group as a family, and grouping in this way it is assumed that, in principle, the members of a family of have a similar hazard potential. In this category, family of is defined as a group of /substances (in the meaning of 1.), either homo or co, in which one parameter (e.g Mn) is fixed while one other (e.g. the composition) is allowed to vary, due to the differing ratios of monomer units, over a relatively large range. In this concept, fixed means confined to a narrow range consistent with the possibly wide variation of the variable parameter. Reduced Test Package Annex VII D of the DSD also establishes that for with high number-average molecular weight, a low content of low molecular weight species and a low solubility/extractivity a reduced test package (RTP) will be sufficient, because they are are not able to cause systemic effects which are toxicologically and/or ecotoxicologically relevant, denominating these RTP. The notified RTP must be labeled with the phrase Caution-substance not yet fully tested in addition to any label required by testing. A polymer for which a reduced test package is acceptable must meet some or all of the following criteria: It must be "non-readily degradable." Have a high number-average molecular weight (Mn). The extractivity in water must be <10 mg/l, excluding any contributions from additives and impurities Less than 1 % of species with a molecular weight <1000. The requirements for a RTP polymer will also vary depending on the amount of the polymer to be commercialized. 1. Polymers placed on the Community market in quantities of 1 t/a or total quantities (cumulative) of 5 t 138

139 IDENTITY OF THE SUBSTANCE o Name: Name in the IUPAC nomenclature; Other names (usual name, trade name, abbreviation); CAS number and CAS name (if available) o Molecular and structural formula: Number-average molecular weight; Molecular weight distribution (MWD); Identity and concentration of starting monomers and starting substances which will bebound in the polymer and Indication of end groups and identity and frequency of reactive functional groups o Composition of the substance: Degree of purity (%); Nature of impurities, including byproducts (Identity of non-reacted monomers); Percentage of (significant) main impurities (Percentage of non-reacted monomers); If the substances contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude:... ppm,... %, Spectral data (UV, IR, NMR or mass spectrum) o GPC o Methods of detection and determination INFORMATION ON THE SUBSTANCE o Production: Technological processed in production; Exposure estimates related to production (working environment, environment) o Proposed uses: Types of use: description of the function and the desired effects o Estimated production and/or imports for each of the anticipated uses or fields of application o Recommended methods and precautions concerning: Handling; Storage; Transport; Fire; Other dangers, particularly chemical reaction with water o Emergency measures in the case of accidental spillage o Emergency measures in the case of injury to persons (e. g. poisoning) o Packaging PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE o State of the substance at 20 C and 101,3 kpa o Melting range (e. g. from the thermal stability test) o Relative density o Water extractivity o Flammability o Explosive properties o Auto-flammability o Particle size: o Thermal stability o Extractivity with: water at ph 2 and 9 at 37 C and cyclohexane TOXICOLOGICAL STUDIES ECOTOXICOLOGICAL STUDIES (In particular, the following additional tests may be required: lightstability, if the polymer is not specifically light-stabilized and long-term extractivity (leachate test). POSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS 2. Polymers placed on the Community market in quantities of < 1 t/a or total quantities (cumulative)of < 5 t IDENTITY OF THE SUBSTANCE o Name: Name in the IUPAC nomenclature; Other names (usual name, trade name, abbreviation); CAS number and CAS name (if available) o Molecular and structural formula: Number-average molecular weight; Molecular weight distribution (MWD); Identity and concentration of staring monomers and starting substances which will be bound in the polymer; Indication of end groups and identity and frequency of reactive functional groups o Composition of the substance: Degree of purity (%); Nature of impurities, including by- 139

140 products (Identity of non-reacted monomers); Percentage of (significant) main impurities (Percentage of non-reacted monomers); If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude:... ppm,... %; Spectral data (UV, IR, NMR or mass spectrum); GPC o Methods of detection and determination INFORMATION ON THE SUBSTANCE o Production: Technological process used in production; Exposure estimates related to production (working environment and environment) o Proposed uses: Types of uses: description of the function and the desired effects; Technological process(es) related to the use of the substance (where known); Exposure estimate(s) related to the use (where known): working environment and environment; Form under which the substance is marketed: substance, preparation, product; Concentration of the substance in marketing preparations and products (where known) o Fields of application with approximate breakdown: industries, farmers and skilled trades, use by the public at large o Where known and where appropriate, the identity of the recipients of the substance o Waste quantities and composition of waste resulting from the proposed uses (where known) o Estimated production and/or imports for each of the anticipated uses or fields of application: Overall production and/or imports in tonnes per year; Production and/or imports o Recommended methods and precautions concerning: Handling; Storage; Transport; Fire (nature of combustion gases or pyrolysis, where proposed uses justify this); Other dangers, particularly chemical reaction with water; If relevant, information concerning the susceptibility of the substance explode when present in the form of a dust o Emergency measures in the case of accidental spillage o Emergency measures in the case of injury to persons (e. g. poisoning) o Packaging PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE o State of the substance at 20 C and 101,3 kpa o Melting range (e. f. from the thermal stability test) o Water extractivity o Flammability Key characteristics of the strategy The DSD establishes regulations on classification, packaging and labelling of dangerous substances within the European Union In 2016 will be replaced by a new regulation the Classification, Labelling and Packaging (CLP) regulation Possibility of a grouping approach (called family approach ) that allows the submission of one technical dossier covering several, reducing testing costs and avoiding test duplication Possibility for some to apply for a Reduced Test Package (RTP) Substances listed on EINECS can be marketed in the EU without notification The amount and complexity of data requirements increases as the commercialized volume increases Sources (1) European Directive on the classification, packaging, and labeling of dangerous substances (67/548/EEC), of 27 June 1967, OJ L 196/1 (2) Sixth Amendment to the DSD, 79/831/EEC of 18 September 1979, OJ L 259/10 (3) Seventh Amendment to the DSD, 92/32/EEC of 30 April 1992, OJ L 154/1 (4) "Manual of Decisions for Implementation of the Sixth and Seventh Amendments to Directive 67/548/EEC 140

141 on Dangerous Substances (Directives 79/831/EEC and 92/32/EEC), 141

142 Japan CSCL Regulatory text: The Chemical Substances Control Law (CSCL) Competent Authorities: Ministry of Economy, Trade and Industry (METI) Ministry of Health, Labour and Welfare (MHLW) The Ministry of the Environment (MOE) Contacts: Ms Uchino Erika Ms. Tomoko Aoyagi Aim and structure of this sheet This factsheet describes the polymer strategy currently implemented in Japan under the CSCL. After a short introduction outlining the main aspects of the strategy and a decision tree showing its different steps, the sheet details the principal criteria used in grouping and PLC approaches. Key points raised by the document (advantages/disadvantages of the strategy, transferability in the EU) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the Competent Authorities (the Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare, and the Ministry of the Environment (MOE). Context and general description Polymers are regulated by the Chemical Substances Control Law (CSCL), the amended version of which entered into force in April 2011 and by the Industrial Safety and Health Law (ISHL). This factsheet only deals with the CSCL. CSCL was conceived in order to prevent environmental pollution of persistent and toxic chemicals. The CSCL includes an inventory of chemicals, which consists of: Existing chemical substances, i.e. Chemical substances that were already manufactured/imported at the time of the promulgation of the CSCL in Newly announced chemical substances, i.e. If a notified chemical substance is classified, the name will be gazetted more than 5 years after the notification. Monitoring Chemical Substance, i.e. If a notified chemical substance is classified, it will be gazetted without any delay. Class I and II specified chemical substances: see Box 1 below. No polymer is classified in Class I or Class II. Priority Assessment Chemical (PAC) substances i.e. If a notified chemical substance is classified, it will be gazetted without any delay. (substances for which companies must provide more detailed information, such as the manufacturing amount by prefecture (district), the import amount by import country/region, and the shipment amount by prefecture (district) and by use category(sub use category), for annual notification). Box 1: Definitions of Class I and II specified chemical substances Class I specified chemical substance Class I Specified Chemical Substances are substances that are persistent, highly bioaccumulative and pose a risk of long-term toxicity to humans or predator animals at a higher trophic level, and that are specified in Article 1 of the Cabinet Order for Enforcement of the CSCL Class II specified chemical substance Class II Specified Chemical Substances are substances that may pose a risk of long-term toxicity to humans or to flora and fauna in the human living environment, and that have been, or in the near future are reasonably likely to be, found in considerable amounts over a substantially extensive area of the 142

143 environment. These substances are specified in Article 2 of the Cabinet Order for Enforcement of the CSCL. The inventories are generally called CSCL list However, under the CSCL, the following four designations refer to the same inventory: CSCL List, METI List, ENCS (Existing and New Chemical Substances) list and MITI* inventory. A chemical substance that is not on these inventories is regarded as new and may be subject to new chemical notification: under CSCL, notifications are sent to the three competent authorities. A new chemical substance is added to ENCS more than 5 years after notification. All existing chemical substances and notified substances are given METI numbers. For, a newly manufactured/imported substance may not be considered new under CSCL if it fulfils one of these conditions: a polymer manufactured by modifying the formulation of an existing one by adding reactants, none of which constitutes more than 1% w/w of the polymer ( >99% listed exemption rule ) a polymer manufactured by modifying the formulation of an existing one by adding reactants listed on the ENCS, none of which constitutes more than 2% w/w of the polymer ( >98% listed exemption rule ). A block polymer whose unit are existing substances A graft polymer whose stem and branch are existing substances Ammonium type salts, including complex salts, if the acid and base are both existing substances (the onium rule ). As a rule, manufacturers and importers in Japan are legally obliged to submit annual notifications of manufactured and/or imported quantities of the previous fiscal year of substantially all chemical substances by themselves under CSCL. Japan has a very detailed system of notification. Some types of exemption are: the small quantity permit, based on the tonnage (( 1 t/y throughout Japan), the low-volume exemption permit based on a combination of tonnage, biodegradability and bioaccumulation criteria (1-10 t/y throughout Japan, non-degradable, and nonaccumulative), and the PLC exemption, based on a series of screening tests named the Polymer Flow Scheme (PFS) (please see the PLC section for more information). In addition, other exemptions are for a new chemical for testing and research and intermediates, export only, used in a completely closed system. There is no monomers list under CSCL. Importers are required to notify each polymer. * MITI: Ministry of International Trade and Industry. This is the former name of the METI. 143

144 Decision tree Definition of a polymer A polymer is a sequence of one or more monomer units and meeting all of the following criteria: Molecules consisting of at least 3 monomer units must be 50% by weight Molecules of the same molecular weight is <50% by weight Number average molecular weight (Mn) is 1,000 This definition is the same as the OECD definition, except from the last criterion, which is an additional requirement. Generic requirements for not concerned by the PLC approach Polymers not concerned by the PLC approach are subject to full notification under CSCL, unless they qualify for exemption. Full notification involves (non-exhaustive list): o Chemical Identity of main component and impurities present at >1% o Water and solvent solubility o Melting point o Stability o PFS test or the following data set: evaluation of ready biodegradability (readily biodegraded substances may not require further testing) evaluation of potential for bioaccumulation (first determination of Kow; if log Kow =/>3.5 a fish bioaccumulation test is needed except for certain high-mw substances) mutagenicity tests (bacterial mutation (Ames) + chromosome aberration tests) 28-day oral toxicity study with recovery phase ecotoxicity testing (acute fish and Daphnia tests + algal growth test). Full notifications are submitted using a so-called Blue card ( and each final test reports (English or Japanese) and summary reports (Japanese only) must be provided the Competent Authorities. Screening exposure assessment are conducted according to use category and annual volume.. Each use category has emission factors 144

145 ( Some use categories have specific emission factors for. Exemptions under CSCL are possible on production volumes: Exemption Condition on volumes Condition hazard on Data to be provided Small volume exemption < 1t/yr none Structure characterization, structural formula, physical-chemical property. Low volume exemption < 10 t/yr Biodegradability bioaccumulation Same data as full notification, except mutagenicity tests, 28-day oral toxicity study and ecotoxicity testing. Furthermore, R&D are exempted from notification. Around 80 were notified in Japan FY2012. Test cost for normal registration In case the chemical substance cannot enjoy the PLC exemption, the normal registration is required. For this registration, depending on the category for which the company wish to apply on the Chemical Substances Control Law, (1)degradability, (2)accumulability, (3) toxicity to human beings, and/or (4) toxicity to fish and plants (ecological system) need to be tested. In case the required test is only for (1) and (2), the cost would be within the range of a few million JPY. However, in case the text is required for (3) and (4), the cost might go up to 10 million JPY. Grouping approach None PLC approach Once a manufacturer proves that its polymer is a PLC thanks to the Polymer Flow Scheme (PFS), the polymer is exempt for notification. A PLC must fulfill one of these three criteria. Criteria 1: o Found to be stable o Insoluble in water and organic solvents, acids and alkalis o Does not contain metals other than Na, Mg, K, and Ca Criteria 2: o Found to be stable o Does not contain As and Se in the chemical structure o Soluble in water or organic solvents, and molecular weight <1,000 is less than 1% and Mn is 10,000*2 o No knowledge indicating components with molecular weight <1,000 that are highly bioaccumulative o Does not contain metals other than Na, Mg, K, and Ca Criteria 3: o Found to be stable o Does not contain As and Se in the chemical structure o Soluble in water or organic solvents, and molecular weight <1,000 is less than 1% and Mn is 1,

146 o o o and <10,000 All the monomer/s must be of existing chemical substance/s and does not contain functional groups of concern. No knowledge indicating components with molecular weight <1,000 that are highly bioaccumulative Does not contain metals other than Na, Mg, K, and Ca Stability, Solubility, Molecular weights are confirmed by the Polymer Flow Scheme Test: Figure 13 : The Polymer Flow Scheme test ( ) According to METI, the number of that benefited from the PLC exemption is 230 cases in total from FY 2011 to March, 2014 In Japan, from April, 2013 till December, 2014, 8 consisting of existing monomers were notified as PLCs, which represents 11% of PLCs notified during the same period (total number: 74). Test cost for PLC application: In order to apply for the PLC scheme, three types of test results are required. The first type is to test physicochemical stability as well as alkali-solubility and acid-solubility The second type is to test water-solubility and organic-solubility The third type is to test molecular weight distribution. With all the three types together, it costs a company approximately 2-3million JPY. Key characteristics The Japanese strategy includes a PLC approach and provides reduced requirements for R&D and low volume. PLCs are exempted under Japan law. The approach adopted by Japan to include the PLC concept in their strategy is different from other countries. They defined a flow scheme which progressively rules out based on their hazard. Costs for registering regular and for notifying PLCs is high in Japan: averages of $92,470 for non PLCs and $23,100 for a PLC. 146

147 Sources NITE and METI answers to the following questionnaire Information about the notification scheme is very scattered, as we could not find a translation of the CSCL and ISHL. Could you check the accuracy of the factsheet? What is the average cost of a notification for polymer manufacturers/importers? (Full notification versus reduced notification requirements? How does it vary depending on the type of company (e.g. SME)? How many companies (approximately) and how many (approximately) falls under the notification scheme? Is there a possibility to notify groups of hazardous on the basis of similar endpoint toxicities? May companies provide a joint notification of a) a same polymer and/or b) a group of similar? How do the conditions of use influence to the information requirements on hazardous? How many, synthetized from the inventory listed monomers, are exempted from the notification? Could you possibly provide the exhaustive list of information requirement of the full notification? How do the provisions of full notification of monomers and hazardous differ from each other? Are there any in the class I or II categories? How are R&D tackled? Under the low volume exemption? How is exposure taken into account? Is Japan reassessing existing chemicals, including? If so, have any been reassessed as hazardous? How is the proportionality principle applied? What were the motivations behind the different legislative choices? In particular: What was the rationale for separating general public health from occupational health and developing two laws?why did Japan choose to add a criterion on number average molecular weight for the definition of a polymer, as compared to the OECD definition? What is the reasoning behind the ISHL hazard criterion of a carbon content of <32%? Did you evaluate the efficiency of the legislation: outcomes, monitoring system, costs, quality of data? How many benefit from the PLC exemption? What is the average cost of a notification for polymer manufacturers/importers? (Full notification versus reduced notification requirements and PLC? How does it vary depending on the type of company (e.g. SME)? 147

148 148

149 Japan (ISHL) Regulatory texts: The Industrial Safety and Hygiene Law (ISHL) Competent Authorities: Ministry of Health, Labour and Welfare (MHLW) Contacts: Ms Kitamura Makiko Aim and structure of this sheet This factsheet describes the polymer strategy currently implemented in Japan under the ISHL. After a short introduction outlining the main aspects of the strategy and a decision tree showing its different steps, the sheet details the principal criteria used in grouping and PLC approaches. Key points raised by the document (advantages/disadvantages of the strategy, transferability in the EU) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the Competent Authority (the Ministry of Health, Labor and Welfare (MHLW)). Context and general description Polymers are regulated by the Chemical Substances Control Law (CSCL), the amended version of which entered into force in April 2011 and by the Industrial Safety and Health Law (ISHL). This factsheet only deals with the ISHL. The ISHL regulates chemicals used in the workplace with the purpose of preventing workers from exposure to carcinogens and other harmful chemicals.. The ISHL each includes an inventory of chemicals, which consists of: a static part, the list of existing chemical substances, i.e. chemical substances that were already manufactured/imported at the time of the promulgation of the CSCL in By default, existing chemical substances under CSCL are also existing chemical substances under ISHL o a dynamic part: announced chemical substances by public notice from the three ministries: under ISHL, the name of a notified chemical substance will be published on the gazette within one year. The inventory is generally called ISHL list. A chemical substance that is not on these inventories is regarded as new and may be subject to new chemical notification: under ISHL, information is sent to MHLW only. A newly manufactured/imported substance may not be considered new under ISHL if it fulfils one of these conditions (listed on the reference website a polymer manufactured by modifying the formulation of an existing one by adding reactants, none of which constitutes more than 1% w/w of the polymer ( >99% listed exemption rule ) a polymer manufactured by modifying the formulation of an existing one by adding reactants listed on the ENCS, none of which constitutes more than 2% w/w of the polymer ( >98% listed exemption rule ). A block polymer whose unit are existing substances A graft polymer whose stem and branch are existing substances Ammonium type salts, including complex salts, if the acid and base are both existing substances (the onium rule ). Some substances are however exempted from notification under ISHL. There are no specific requirements for monomers. 149

150 Decision tree Definition of a polymer A polymer is a sequence of one or more monomer units and meeting all of the following criteria: Molecules consisting of at least 3 monomer units must be 50% by weight Molecules of the same molecular weight is <50% by weight Number average molecular weight (Mn) is 1,000 This definition is the same as the OECD definition, except from the last criterion, which is an additional requirement. Generic requirements for not concerned by the PLC approach Polymers not concerned by the PLC approach are subject to full notification under CSCL or ISHL (or both), unless they qualify for exemption. Full notification involves (non-exhaustive list), under ISHL: Chemical Identity of main component Water and solvent solubility Melting point Stability Ames test or Carcinogenicity Study GLP certification Production flow of a new chemical substance (manufactures only) ISHL allows exemption, the criteria are the following (listed on MW is 2000 The polymer is synthetized from existing (inventory listed) monomers and does not have any of the following features: o a positive electronic charge o a carbon content of <32%* o covalent bonds with elements other than S, Si, O, H, C, N o ionic bonds with metal (or metal complex) ions other than Al, K, Ca, Na, or Mg o a synthetic route which involves extraction or isolation from living organs, or derived from such by chemical reactions. This concept also extends to structurally similar analogues. o halogen or cyano or reactive functional groups** o degrades or depolymerizes at normal temperature under normal pressure ** The MHLW did not have enough evidence that containing carbon at a proportion above 32 percent were safe when they made the rule. ** The examples of reactive functional groups are: isocyanic acid groups,, branched acrylic acid groups, branched metacrylic acid groups, epoxy groups, anhydrides, halides, aldehydes, amines, phenols, thiophenols, acid groups containing sulfur and their derivatives, aziridines, blocked isocyanic acid derivatives, imine, isothiocyan acid groups, vinylsulphones, halosilanes, alkoxysilanes, and lactones with three- or four- membered rings. 150

151 Grouping approach None PLC approach There is no PLC approach under ISHL Key characteristics of the strategy The ISHL aims to protect the worker in his environment. The other legislation regulating in Japan is the CSCL, which was conceived in order to prevent environmental pollution of persistent and toxic chemicals. Some are considered as being safe in the workplace and are exempted from notification No PLC or grouping approach are implemented under ISHL Sources

152 New Zealand Regulatory text: Hazardous Substances and New Organisms (HSNO) Act Competent Authority: Environmental Protection Authority (EPA) 69 of New Zealand Contacts: Andrea Eng HSNO Committee: Dr Kevin Thompson (Chair) Helen Atkins, LLB (Deputy Chair) Aim and structure of this sheet This factsheet describes the polymer registration strategy currently implemented in New Zealand. After a short introduction outlining the main aspects of the strategy, the factsheet details the generic requirements for polymer notification. Key points raised by the document are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the EPA New Zealand. Context and general description The Hazardous Substances and New Organisms (HSNO) Act 1996 is the legislation adopted in New Zealand that includes a number of regulations to manage the risks associated with hazardous substances, with the main purpose being the protection of people, the environment, and the health and safety of communities, by preventing or managing the adverse effects of hazardous substances and new organisms introduced into the country. The HSNO Act has been in force for hazardous substances since 2 July 2001 and under this, all hazardous substances require a HSNO approval (the HSNO approval system covers all hazardous substances, which includes products containing hazardous substances). There are two types of approvals: individual substance approvals and group standard approvals. All the hazardous chemical components of products approved under group standards are collected in a database called the New Zealand Inventory of Chemicals (NZIoC) (non-hazardous chemicals are not required to be listed). Before any product is imported or manufactured in New Zealand for the first time, the NZloC must be checked to see whether the chemicals contained in that product are listed on the inventory. If the chemical is a component of a formulated product then it can be notified to the NZIoC and is added to the NZIoC. If the chemical meets the definition of chemical in the group standards then it cannot be notified and an application for approval is required. A notification to the NZIoC is not an approval for the chemical but allows the chemical to be used as a component in a formulated product covered by a group standard approval. An approval for the chemical is only required if the product is 100% of the chemical or a dilution in a solvent. The listings on the NZIoC are available for any importer or manufacturer to use. Notification to EPA New Zealand for a new chemical contained in a product must be done before its assignment to a group standard. After the EPA has been notified, the product can be assigned to the group standard, becoming a HSNO approved substance under that group standard. All chemical substances notified to EPA are then added to the NZloC so they can be used as components in products approved under a group standard. Under previous legislation hazardous substances, including, were required to be notified. These notifications were used to create the set of current group standard approvals. Information from these notifications was used in the creation of the New Zealand Inventory of Chemicals (NZIoC). Once a chemical/polymer is listed on the NZIoC there are no 68 Hazardous Substances and New Organisms (HSNO) Act 1996, 69 Environmental Protection Authority of New Zealand, 152

153 further notification requirements. New notifications are only required for that are not listed on the NZIoC. Most products are covered by group standards, like the Polymers group standards 70. These group standards can be used to provide an approval for either formulated products or individual (single-component) chemicals, and detail control measures including site and storage requirements, approved handlers, packaging, equipment, disposal and exposure limits. The polymer group standards are for used as components/raw materials in the production of a formulated or manufactured polymer product, and includes solvent-based polymer solutions, water-based polymer solutions and solid (beads/granules/pellets) that may or may not include additives. The polymer group standard is an approval for the polymer substances used to make the manufactured articles. The group standard is not designed to regulate the finished products. This is outside the current scope, therefore the final product use has not influenced the information requirement. Polymers are exempt from registration requirements if the polymer or formulated product is non-hazardous using HSNO criteria (Which are based on an early version of the GHS). Registration only applies to hazardous. A substance is considered to be hazardous when it has a level of hazard greater than the threshold(s) for one or more of the following intrinsic properties: explosiveness, flammability, oxidising capacity, corrosiveness, toxicity and ecotoxicity. A number of hazard endpoints have been designated as primary hazards all other hazard endpoints are considered as subsidiary hazards, The primary hazards are the physical hazards (explosive, flammable, oxidising, acutely toxic category A, B and C and carcinogenic category A and B. For the primary hazards are flammable liquids 3.1B and 3.1C, corrosive 8.2B and 8.2C, acutely toxic 6.1B and 6.1C and carcinogenic 6.7A.and 6.7B. A group standard may have one primary hazard or a combination of primary hazards. If assigned to a specific group standard the product must have only the primary hazards specified but may also have any of the subsidiary hazards listed. For example, a flammable and corrosive group standard a product must be either a.1b or 3.1C and a 8.2B or 8.2C. If only flammable it should use the flammable group standard not the flammable corrosive one. The Polymer Group Standards that have been created for hazardous imported or manufactured as components/raw materials for use in the production of a formulated or manufactured polymer product are as follows, with the respective approval number in brackets and the thresholds for each parameter (for more information see User Guide to the HSNO Thresholds and Classifications) 71 : Polymers - Combustible (HSR002640) 72 : o The substance must be a flammable liquid with a flashpoint of greater than 60 C and less than or equal to 93 C (HSNO 3.1D classification). Polymers - Flammable (HSR002641) 73 : (a) The substance must be a flammable liquid with a flashpoint of less than 23 C and an initial boiling point of greater than 35 C (HSNO 3.1B classification); or (b) The substance must be a flammable liquid with a flashpoint of greater than or equal to 23 C and less than or equal to 60 C (HSNO 3.1C classification). Polymers - Flammable, Corrosive (HSR002642) 74 : 70 Polymer group standards, 71 User Guide to the HSNO Thresholds and Classifications, Environmental Risk Management Authority (ERMA) New Zealand, 2008: 72 Polymers (Combustible) Group Standard 2006, 73 Polymers (Flammable) Group Standard 2006, 153

154 (a) The substance must be a flammable liquid i. with a flashpoint of less than 23 C and an initial boiling point of greater than 35 C (HSNO 3.1B classification); or ii. with a flashpoint of greater than or equal to 23 C and less than or equal to 60 C (HSNO 3.1C classification); and (b) The substance must be a skin corrosive (HSNO 8.2B or 8.2C classification). Polymers - Flammable, Toxic [6.7](or carcinogen as below) (HSR002643) 75 : (a) The substance must be a flammable liquid i. with a flashpoint of less than 23 C and an initial boiling point of greater than 35 C (HSNO 3.1B classification); or ii. with a flashpoint of greater than or equal to 23 C and less than or equal to 60 C (HSNO 3.1C classification); and (b) The substance must be a known or presumed human carcinogen (HSNO 6.7A classification) or suspected human carcinogen (HSNO 6.7B classification). Polymers - Subsidiary Hazard (HSR002644) 76 : A substance in this group must have one or more of the following (but only the following) hazards: (a) acute toxicity, HSNO 6.1D or 6.1E classification (including aspiration hazard); (b) skin irritancy, HSNO 6.3A or 6.3B classification; (c) eye corrosivity, HSNO 8.3A classification; (d) eye irritancy, HSNO 6.4A classification; (e) respiratory sensitisation, HSNO 6.5A classification; (f) contact sensitisation, HSNO 6.5B classification; (g) mutagenicity, HSNO 6.6A or 6.6B classification; (h) reproductive toxicity, HSNO 6.8A, 6.8B or 6.8C classification; (i) target organ toxicity, HSNO 6.9A or 6.9B classification; (j) ecotoxicity, HSNO class 9. Polymers Toxic, acute (HSR002645) 77 : o The substance must be an acute toxicant (HSNO 6.1B or 6.1C classification) Polymers Toxic, carcinogen (HSR002646) 78 : o The substance must be either a known or presumed human carcinogen (HSNO 6.7A classification) or suspected human carcinogen (HSNO 6.7B classification). Monomers are not included in the Polymer group standards, but are contained within the Additives, process chemicals and raw materials group standards 79, which is a group for products that are used in the manufacture or processing of other products. Small-scale use of hazardous substances in research and development (R&D) are exempt or excluded from the HSNO Act. Labelling of hazardous is the same as for other hazardous substances Polymers (Flammable, Corrosive) Group Standard 2006, 75 Polymers (Flammable, Toxic [6.7]) Group Standard 2006, 76 Polymers (Subsidiary Hazard) Group Standard 2006, 77 Polymers (Toxic [6.1]) Group Standard 2006, 78 Polymers (Toxic [6.7]) Group Standard 2006, 79 Additives, process chemicals and raw materials group standards, 80 Labelling of hazardous substances, 154

155 Box: Additional hazards possible for each Polymer Group Standards In addition to the hazard referred for Polymers Combustible, Polymers-Flammable, Polymers-Flammable,Toxic, a substance may have any of the following (but only the following) hazards: (a) acute toxicity, HSNO 6.1D or 6.1E classification (including aspiration hazard); (b) skin irritancy, HSNO 6.3A or 6.3B classification; (c) eye corrosivity, HSNO 8.3A classification; (d) eye irritancy, HSNO 6.4A classification; (e) respiratory sensitisation, HSNO 6.5A classification; (f) contact sensitisation, HSNO 6.5B classification; (g) mutagenicity, HSNO 6.6A or 6.6B classification; (h) reproductive toxicity, HSNO 6.8A, 6.8B or 6.8C classification; (i) target organ toxicity, HSNO 6.9A or 6.9B classification; (j) ecotoxicity, HSNO class 9. In addition to the hazard referred to for Polymers-Flammable,Corrosive, a substance may have any of the following (but only the following) hazards: (a) acute toxicity, HSNO 6.1D or 6.1E classification (including aspiration hazard); (b) metallic corrosivity, HSNO 8.1A classification; (c) eye corrosivity, HSNO 8.3A classification; (d) eye irritancy, HSNO 6.4A classification; (e) respiratory sensitisation, HSNO 6.5A classification; (f) contact sensitisation, HSNO 6.5B classification; (g) mutagenicity, HSNO 6.6A or 6.6B classification; (h) reproductive toxicity, HSNO 6.8A, 6.8B or 6.8C classification; (i) target organ toxicity, HSNO 6.9A or 6.9B classification; (j) ecotoxicity, HSNO class 9. In addition to the hazard referred to for Polymers Toxic,acute, a substance may have any of the following (but only the following) hazards: (a) aspiration hazard; (b) skin irritancy, HSNO 6.3A or 6.3B classification; (c) eye corrosivity, HSNO 8.3A classification; (d) eye irritancy, HSNO 6.4A classification; (e) respiratory sensitisation, HSNO 6.5A classification; (f) contact sensitisation, HSNO 6.5B classification; (g) mutagenicity, HSNO 6.6A or 6.6B classification; (h) reproductive toxicity, HSNO 6.8A, 6.8B or 6.8C classification; (i) target organ toxicity, HSNO 6.9A or 6.9B classification; (j) ecotoxicity, HSNO class 9. In addition to the hazard referred to Polymers Toxic,carcinogen, a substance may have any of the following (but only the following) hazards: (a) acute toxicity, HSNO 6.1D or 6.1E classification (including aspiration hazard); (b) skin irritancy, HSNO 6.3A or 6.3B classification; (c) eye corrosivity, HSNO 8.3A classification; (d) eye irritancy, HSNO 6.4A classification; (e) respiratory sensitisation, HSNO 6.5A classification; (f) contact sensitisation, HSNO 6.5B classification; 155

156 (g) mutagenicity, HSNO 6.6A or 6.6B classification; (h) reproductive toxicity, HSNO 6.8A, 6.8B or 6.8C classification; (i) target organ toxicity, HSNO 6.9A or 6.9B classification; (j) ecotoxicity, HSNO class 9. There is no special legislation for,all substances are treated the same. HSNO is based on GHS criteria so anything that falls within that criteria is included. If the substance falls outside this criteria it is not included. This means there is no regulation below the thresholds. In general, it is up to industry to make the determination as to what is nonhazardous. Section 26 of the HSNO Act allows industry to make an application to the Authority for a determination of whether or not a substance is hazardous. There have been a number of determinations made for HAZ03001 To determine whether certain fluoro are hazardous. Determined that fluoro, as defined in the application, are not hazardous HAZ03002 To determine whether certain polyethers are hazardous. Determined that polyethers, as defined in the application, are not hazardous HAZ03003 To determine whether certain polyamides are hazardous. Determined that polyamides, as defined in the application, are not hazardous. HAZ03004 To determine whether certain polyesters are hazardous Determined that polyesters, as defined in the application, are not hazardous. HAZ03005 To determine whether certain polyolefins are hazardous Determined that polyolefins, as defined in the application, are not hazardous. HAZ03006 To determine whether certain vinyl are hazardous Determined that vinyl, as defined in the application, are not hazardous. Decision tree The process to assign a product to a group standard can be divided in two paths, one for Single component (path A) and another for Formulated product (path B), as follows 81 : 81 Assigning a Product to a HSNO Approval: 156

157 Path A (Single Component): 157

158 Path B (Formulated): CMR: Carcinogenic, mutagenic or reproductive Definition of a polymer In coherence with OECD definition: Yes. New Zealand adopts the OECD definition of a polymer, as follows: Polymer means a chemical substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least 3 monomer units which are bound to at least one other monomer unit or other reactant and which consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. Monomer means a single molecule that can combine with itself and/or other chemical entities to form a polymer. Generic requirements for not concerned by grouping and/or PLC approaches The notification requirements for group standards (monomers and included) are the following: 158

159 the name of the substance; the HSNO approval number and/or title of the Group Standard under which the substance has a deemed approval; the name and CAS number of the new chemical not listed on the Inventory of Chemicals that is present in the substance; the concentration of that chemical in the substance; the hazardous properties of the chemical, including the provision of the relevant hazard data used to assign the substance to the Group Standard; the proposed use of the substance. A new chemical that is being imported as a single chemical is not allowed to be notified. Notification is only allowed for new chemicals that are components in a formulated product. Notification does not result in approval for the single component chemical to be imported ; this would require an application to get approval. EPA does not assess the data provided. Novel chemicals are not generally manufactured in New Zealand so they rely on information and assessments from other regulatory authorities. Approximately 350 notifications of have been made to the NZIoC since 1 July Approximately 50 companies have made these notifications. Key characteristics of the strategy Registration only applies to hazardous The NZIoC is a list of hazardous chemicals that are allowed to be used as components of products approved under group standard approvals. The NZIoC is annotated with the chemical status - either it can be used as a single chemical product under a group standard or it can only be used as a component in a product. The existence of the database NZloC with all hazardous chemicals approved under group standards Definition of polymer and monomer are according to OECD Costs relative to approval for new substances (New Zealand dollars, including tax) 82 (Substances under HSNO can be either chemicals or mixtures. For a polymer this would only be required for the single component polymer products): Type of approval Cost in New Zealand dollars, including tax Import or manufacture a new hazardous substance for release $3,450-$17,250 Release in an emergency/special emergency certain substances may be granted an approval only for use in an emergency $8,265 Rapid assessment where a new substance is less hazardous or similar in composition to a substance already approved $ New Zealand - Overview of Chemical Control Legislation, Andrea Eng, ChemCon Asia 2011, 1 July 2011, 159

160 Import of a new hazardous substance into containment or manufacture of a new hazardous substance in containment mainly for research, field trials, or substances intended for export only $575 Transhipments an approval is needed where a hazardous substance is in transit through New Zealand; imported solely for the purpose of export within 20 working days to another destination outside of New Zealand $287 Group Standards approval for groups of substances of a similar nature, type, or circumstances of use Negotiated Cost of notification is only the company time to submit the notification. There are no costs from the EPA. If a polymer requires an application then the costs above would apply. Most likely the application would be rapid or import and manufacture for release (at the low end of the cost for this type of application). This depends on the specific substance. As there are no criteria set for the acceptance of data, all the companies have to do is provide information in each category required. There is no assessment of the quality of the data provided. Companies generally find it very easy to meet the requirements. The only time they have difficulties is when the importer notifying is not the owner of the proprietary information. Once a chemical/polymer is listed on the NZIoC or approved that listing or approval can be used by anyone, it is not restricted to the original notifier or applicant. While there is no reason that a joint submission cannot be made there is no need as only one submission is required for a chemical. Available information can be used to comply with the requirements. The HSNO Act has been implemented in accordance with GHS. It should be noted that NZ manufacture of is generally limited to basic and most novel are imported from overseas. This means, that in general, EPA is reliant on information that has been generated for other regulatory authorities. Section 33 of the HSNO Act provides an exemption for small-scale research on hazardous substances. This allows for development of new substance without approval. The whole Act has been established using the proportionality principle. Firstly, the Act only covers hazardous substances which means there are no requirements for non-hazardous substances. The group standard approach where like substances are grouped based on different properties means that less hazardous substances have less controls compared to group standards for more hazardous substances. A substance is only approved once not by product. If there is already an existing approval this means a product is effectively pre-approved. The Act also requires monitoring of the effectiveness of the Act. Cost are compared to overseas regulators and have been found to be low in comparrison. The public right to know principle means that we cost recover approximately 20% on applications. The EPA rely on the quality of the data from overseas juristictions like the EUuropean Union. Sources Hazardous Substances and New Organisms (HSNO) Act 1996, Environmental Protection Agency of New Zealand, Polymers group standards, Assigning a Product to a HSNO Approval : HSNO Thresholds and Classifications : Overview: Global Industrial Chemical Control Laws and Regulations, GlobalChem 2010, Jeff Hafer, %20Hafer.pdf 160

161 User Guide to the HSNO Thresholds and Classifications, ERMA New Zealand, 2008: New Zealand - Overview of Chemical Control Legislation, Andrea Eng, ChemCon Asia 2011, 1 July 2011, EPA s answers to the following questionnaire What were the motivations behind the different legislative choices? In particular: o What are the main reasons for exempting non-hazardous from registration? Does the grouping of hazardous occur by endpoints or by most important hazardous property?how do the conditions of use influence to the information requirements on hazardous? Are there any requirements for existing? Do existing need any type of notification? If they do, what is the frequency of the update of notification and what is the information necessary for update? How do the provisions for monomer and polymer notification differ from each other? Are data requirements reduced for when their monomers are already notified to the authorities? How many companies (approximately) and how many (approximately) falls under the notification scheme? Do you have any feedback from companies if it is easy for them to comply with the notification obligations? Is it possible to do a joint submission of data (from 2 or more notifiers) for that have to be notified? What are the costs associated with the regulatory polymer notification requirements in general and for the various types of companies, including SME s? How are R&D tackled? Are there specific provisions? Can available information be used to comply with the requirements for hazardous properties of chemicals or is industry obliged to perform new tests? If so, what information is requested and is there any specificity for? How is the proportionality principle applied? Did you evaluate the efficiency of the legislation: outcomes, monitoring system, costs, quality of data? 161

162 Philippines Regulatory text: Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990 (Republic Act 6969) 83 Competent Authority: Environmental Management Bureau of the Department of Environment and Natural Resources (EMB- DENR) 84 Contacts: Chemical Management Section of EMB-DNR: Angelita T. Brabante, Chief Emmanuelita D. Mendoza, PCL & CCO Specialist (Expert) Josephine L. Monilla, PICCS Specialist Angelica Anne C. Nicolas, PCB Specialist Jose Joel D. Maleon, PCL Specialist Rechelle B. Andaya, PMPIN Specialist Aim and structure of this sheet This factsheet describes the polymer registration strategy currently implemented in the Philippines. After a short introduction outlining the main aspects of the strategy, the factsheet details the main criteria used in PLC approach. Key points raised by the document (advantages/disadvantages of the strategy) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the EMB-DENR. Context and general description The Toxic Substances and Hazardous and Nuclear Wastes Control Act was promulgated in 1990 to regulate and manage toxic chemicals before they enter Philippine s commerce, distinguishing between existing substances and new substances. A new substance is any chemical substance imported into or manufactured in the country after December 31, 1993 and which is not included in the Philippine Inventory of Chemicals and Chemical Substances (PICCS). Pursuant the provisions of the R.A. 6969, the DENR promulgate its implementing rules and regulations, by the Administrative Order No. 29 on Implementing Rules and Regulations of Republic Act Title II: Toxic Chemical Substances 85, that establishes a number of requirements and mechanisms for identifying, screening, and evaluating new chemicals before they become commercially available in the Philippines. The two main objectives are to: Take stock of all existing chemicals and chemical substances currently used, manufactured, and imported to the Philippines and develop the Philippines Inventory of Chemicals and Chemical Substances (PICCS) 86. Require prior notification of new chemical substances to be manufactured in or imported to the Philippines 83 Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990, 84 Environmental Management Bureau of the Department of Environnent and Natural Resources (DENR- EMB), 85 Administrative Order No. 29 on Implementing Rules and Regulations of Republic Act Title II: Toxic Chemical Substances, pdf 86 Philippines, and develop the Philippines Inventory of Chemicals and Chemical Substances (PICCS), 162

163 and develop a Pre-Manufacturing and Pre-Importation Notification (PMPIN) 87 process and procedure. PICCS includes chemical name in IUPAC nomenclature and the chemical abstract registry number of the chemical. Polymers not included in the PICCS, are considered a new chemical substance and cannot be manufactured, imported, distributed, or used unless the manufacturers and importers (proponents) follow the PMPIN notification assessment process whose objective is to screen harmful substances before they enter Philippines. Hence, proponents of a new chemical substance (in quantities >1000 kg per year) are required to notify DENR-EMB of their intent to manufacture or import the new chemical not sooner than 180 days and not later than 90 days before date of manufacture or importation and to submit the appropriate PMPIN forms. There are two kinds of PMPIN forms for notification, an Abbreviated Form and a Detailed Form, with different requirements (see p. 2 Generic requirements). Some chemicals are exempt from PMPIN. These are: Chemicals already included in the PICCS; Chemicals to be produced or used in small quantities ( 1000kg per year) for purposes of research and development; Reaction intermediates which do not leave the closed production system or undergo intermediate storage during the reac tion process; Chemicals regulated by laws other than RA 6969, e.g. radioactive substances, pesticides, drugs, foodstuffs, and consumer products. Impurities can be listed as by-product in the PMPIN Form. The first PICCS was published by DENR-EMB in 1995 and has been updated regularly (2000, 2002, 2005 and 2008), with the latest edition of 2011 which includes more than 44,000 chemical substances. Updating of the PICCS is done semi-annually and includes all new chemicals that have been issued a PMPIN Clearance Certificate. 87 Pre-Manufacturing and Pre-Importation Notification (PMPIN), 163

164 Decision tree The decision tree for polymer notification is the following: Definition of a polymer In coherence with OECD definition: Yes Polymers as defined in the Guidance Manual Implementing Rules and Regulations for Title II: The Management of Chemicals and Toxic Substances 88 are: Substances consisting of large molecules built up by the sequence of repetition of one or more types of monomer units in a linear or branched fashion. Such substances comprise a simple weight majority of molecules containing at least three monomer units that are covalently bound to at least one other monomer unit or reactant. Such molecules must be distributed over a range of molecular weights wherein differences in molecular weight are primarily attributable to differences in the number of monomer units. The reactants (monomers, cross linking agents, chain transfer agents and post-polymerization reactants i.e. neutralising agents) are included in the definition of the, if they are present at levels equal to or above two percent by weight of the polymer. Generic requirements for not concerned by PLC approaches Notification of Polymers must be done before a new polymer is placed on the market (manufacture or importation). There are no specific tests for, they are subject to the same testing as non-. There are two types of PMPIN notification: Abbreviated: o To be used when a new chemical is being used with no control in a country with a similar chemical regulatory process as the Philippines and sufficient information is submitted by a notifier that clearly 88 Guidance Manual Implementing Rules and Regulations for Title II: The Management of Chemicals and Toxic Substances, 164

165 exhibits that the chemical will not pose an unreasonable risk. Polymers which exist in other regulatory controlled regions (like USA, EU, Australia, Canada, Japan, Korea, etc.) can be registered via the Abbreviated Notification Scheme. o Only requires a summary of the toxicological data already in hand (actual test reports on the chemical substance, a formulation, SAR, QSAR), proof of listing on another inventory, and a good quality MSDS. Detailed: Is used when the manufacturer or importer cannot adequately document the safety of the new chemical or when DENR-EMB determines that the information submitted does not contain sufficient documentation to enable DENR-EMB to determine the safety of the new chemical. The requirements are: o Chemical name (CAS registry name, IUPAC and common name) o CAS number, if available o RTECS (Registry of Toxic Effects of Chemical Substances) number, if available o Molecular formula o Synonyms for the new polymer o Trade name of the new polymer o Regulatory status in other countries, if available o Physico-chemical characteristics (boiling point, melting point, specific gravity, vapour pressure, appearance, odour, purity, octanol/water partition coefficient, water solubility, solubility in organic solvents) o Toxicological data (carcinogenicity, mutagenicity, teratogenicity, sensitization, acute toxicity, chronic toxicity, irritation) o Environmental tests (acute and chronic toxicity to animals fish in particular, terrestrial plant toxicity, stability and incompatibilities) o Occupational exposure o Estimate environmental release and disposal o Name and address of nominating person o Anticipated volume per annum to be placed on the market and intended use PLC approach Although there is no definition for Polymers of Low Concern in the Philippines Act, there are some that qualify for exemption from notification. The exemptions from notification available from the PMPIN scheme are: Polymers listed on PICCS. All monomers and other reactants (including cross-linking, chain transfer agents and post polymerisation reactants) added at quantities of less than 2% (by weight) are exempt from PMPIN reporting requirements Polymers for which all monomers/reactants present at 2% are listed on PICCS. New in which 2 or more of the top (top by weight) monomers are included in the definition of another polymer already listed on PICCS. Key characteristics of the strategy There are no specific tests for, they have to be tested in the same way as non-polymeric substances, so the process can be onerous when compared to other regulatory regions with similar chemical regulations. There is a list with all existing substances (PICCS) that can be searched for free There is a system for notification of new substances (PMPIN) There are some (may be considered as PLC) that are exempt from notification 165

166 Notification must be filed not sooner than 180 days and not later than 90 days before date of manufacture or importation. The review period for all substances is 90 days. Once a chemical is listed in PICCS, it may be manufactured or imported with no control provided it is not included in the PCL (Priority Chemicals List) or not subject to CCO (Chemicals Control Order) The manufacturer or importer will bear the cost of all documentation and tests that EMB may require on the new chemical. After a clearance to import or manufacture is issued by EMB, the proponent must submit a Notice of Commencement to EMB. The processing fees 89 accompanied with Notification are reported in the table below and, in addition to these, applicants should carry the cost of all documentation and tests that may be required by the Chemical Review Committee. Targets Activities Processing fees Duration Existing Chemicals PICCS certificate (I) P450 ( $ 10) 15 working days New Chemicals > 1000 kg/y PMPIN (M/I) (Abbreviated Form) P2150 ( $ 48) working days PMPIN (M/I) P3750 ( $ 84) (Detailed Form) New Chemicals 1000 kg/y SQI Clearance (M/I) P500 ( $ 11) 20 working days Questions for EMB-DENR How many companies (approximately) and how many (approximately) falls under the notification scheme? What were the motivations behind the different legislative choices? In particular: o Why does the RA 6969 require the same registration information package as for any substance also for, rather than a reduced, specific set of tests for? o There are some exemptions from notification for. What is the main reason for allowing this exemption? Can these be classified as PLC (Polymers of Low Concern)? Do you have any feedback from industry regarding the notification processes? Are they easy to comply with? For that are not exempt from notification, do you think that some tests could be avoided for polymer registration, e.g. when monomers used for the synthesis of the polymer are already listed in the existing inventory? If so, which ones are considered less relevant for? Are there any requirements for existing? Do existing need any type of notification? If they do, what is the frequency of the update of notification and what is the information necessary for update? How are R&D tackled? Is a joint submission (by 2 or more proponents) possible for the notification of new? Is there a possibility to register groups of on the basis of similar endpoint toxicities? May companies provide a joint registration of a) a same polymer and/or b) a group of similar? How do the conditions of use influence to the information requirements on? Could you possibly provide the full list of information requirements under the notification? How do the notification provisions of monomers and differ from each other? 89 CIRS Webinar: An Introduction to New Substance Notification in Philippines, Ms Cloris Pan, nes_ms_cloris_pan.pdf 166

167 Sources Did you evaluate the efficiency of the legislation: outcomes, monitoring system, costs, quality of data? Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990, Environmental Management Bureau of the Department of Environment and Natural Resources (DENR-EMB), Guidance Manual Implementing Rules and Regulations for Title II: The Management of Chemicals and Toxic Substances, Philippine Inventory of Chemicals and Chemical Substances (PICCS), Practical Guide to Chemical Safety Testing: Regulatory Consequences, lymers&source=bl&ots=cz9px6vzjm&sig=ptdj85wepg8-ulab58h-5qynuoc&hl=pt- PT&sa=X&ei=ksnwUvWeKojQ7Abg8IHgBQ&ved=0CDoQ6AEwAg#v=onepage&q=new%20zealand%20hsno%20non %20hazardous%20&f=false Overview of the Chemical Control Legislation in the Philippines, Handling Polymers on a Global Scale, J. H. Moore, CIRS Webinar: An Introduction to New Substance Notification in Philippines, Ms Cloris Pan, 167

168 South Korea Regulatory text: Toxic Chemicals Control Act (TCCA) (actual legislation) 90 Act on Registration and Evaluation, Authorization and Restriction of Chemical Substances (commonly known as AREC, Korea REACH or K-REACH) 91 (enters in force in 1 January 2015) Competent Authority: Ministry of Environment (MoE) 92 National Institute of Environmental Research - NIER 93 (new substances), Korea Chemicals Management Association - KCMA 94 (existing substances) Contacts: Hyun Kyoung Kim ( ) Environmental Health Research Department Pil-je Kim ( ) Environmental Health Research Department Risk Assessment Division National Institute of Environmental Research (mhkim@korea.kr) K-REACH Helpdesk, Korea Chemicals Managements Association International Relation Team: Myung Jin Yun (dbsaw0906@kcma.or.kr) Hae Min Yeon (hyeo014@kcma.or.kr) Sun Young Lee (sylee@kcma.or.kr) Aim and structure of this sheet This factsheet describes the polymer registration strategy currently implemented in South Korea and the substitute legislation that will come into force in 1 January After a short introduction outlining the main aspects of the strategies, the sheet details the principal criteria used in the PLC approach for both legislations. Key points raised by the document (advantages/disadvantages of the strategies) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the MoE. Context and general description Presently, in South Korea, chemicals and are subjected to the Toxic Chemicals Control Act (TCCA), but starting on 1 January 2015, this regulation will be divided into the Act on Registration and Evaluation of Chemicals of Korea (also commonly known as AREC or K-REACH that focuses on registration and evaluation of substances) and the Chemicals Control Act (CCA that focuses on the control of hazardous substances and response to chemical accidents). TCCA TCCA does not regulate all chemicals, but only covers new chemicals, toxic chemicals, observational chemicals and restricted or banned chemicals. Existing, like those listed in the Korea Existing Chemicals Inventory (KECI 95 ) and commercialized prior to 2 February 1991, and those notified according to the previous provisions and TCCA and published since 2 February 1991, are exempt from notification. According to the TCCA, manufacturers or importers of new are required to submit a formal notification dossier to the relevant authorities (that needs to be approved) 90 Toxic Chemicals Control Act (TCCA) (actual legislation), 91 Draft version of the Act on Registration and Evaluation, Authorization and Restriction of Chemical Substances, and Regulations&itm=&txt=&pg=1&seq=3 (both in Korean original version, and in English unofficial translated version by Korea Testing and Research Institute) 92 Korean Ministry of Environment (MoE), 93 National Institute of Environmental Research (NIER), 94 Korea Chemicals Management Association (KCMA), 95 Korea Existing Chemicals Inventory (KECI), 168

169 before the polymer itself, or any product containing it, can be placed on the market, unless it complies with any of the exemptions from notification for new. The National Institute of Environmental Research (NIER) is responsible for the new chemical notification and the Korea Chemicals Management Association (KCMA) of MoE is responsible for accepting a declaration for details of other chemicals and application for the confirmation certificate. Justified amounts of chemicals used in Research and Development are exempt from notification. The assessment of the polymer dossier is normally complete in 60 days, unless if supplementary data is required. K-REACH K-REACH describes different requirements for registration and exemption to the current TCCA. K-REACH manages new chemical substances, existing chemical substances and downstream products by prescribing the requirements for registration, hazard evaluation and risk assessment, and is regarded as a REACH-style chemical regulation. K- REACH requires manufacturers and importers of chemicals to notify substances (i.e. submit data such as quantities of production or import in the previous year) to the MoE, which will then designate certain existing chemicals as chemicals subject to assessment for registration. For existing substances (including ) that have been designated as chemicals subject to assessment and that are already pre-registered, they will have a transitional period up to 8 years to register. The new chemical substances shall be registered prior to the manufacture or importation. Chemical substances used for Research and Development are exempt from registration. Decision tree The following picture shows, according to TCCA, how are regulated in Korea and how to comply with the regulation: The following picture shows the decision tree for PLC exemption, according to Korea REACH 96 : 96 K-REACH updates: The Presidential and Ministerial Decrees, Jun Ho Lee, Webinar, 6 March 2014, 9:30am GMT: 169

170 Definition of a polymer In coherence with OECD definition: yes The definition of polymer as it appears in the NIER Public Notice No (dated July ) is as follows: Polymer means a chemical substance which contains sequences built up from one or more types of monomer units, which shows a characteristic distribution of molecular weights primarily according to the number of repetitions of a monomer within each molecule, and it also contains three or more monomer units covalently linked to at least one other monomer unit or another reactant, and 50% or more of such molecules. Furthermore, the weight percentage of the molecules of the same molecular weight does not exceed 50%. Generic requirements for not concerned by PLC approaches TCCA The substances falling under the definition of polymer (as defined by OCDE) are subject to the Polymer Notification procedures. Under TCCA, when a new polymer is manufactured or imported, the examination of its toxicity (done by NIER) is required. The applicants of the Polymer Notification are responsible to choose under which one of the three available schemes they want to submit the notification, but additional tests can be required by NIER if the polymer safety is not completely assured. Joint submission is possible for companies registering the same polymer with other companies. The data requirements for Polymer Notification require less data than for non-, as follows 1. Polymer specific tests. The data on number-average molecular weight, composition of monomers, the content of residual monomers and stabilities of polymer, with no toxicity or ecotoxicity tests required. The following Items must be included: The test data showing the number-average molecular weight and the molecular weight distribution (e.g., GPC test data, etc.) The document on chemical name, CAS No., and composition (%) of monomers used in the manufacture of polymer. However, the composition (%) of each monomer can be calculated on the basis of its constituent ratio in the finally manufactured product The data on the content (%) of residual monomers The data on the content (%) of substances with molecular weight of 1,000 or less The data on stability in acidic and alkaline condition * The requirement of stability test depends on the water solubility of polymer. 170

171 * Test guideline for stability of polymer in acidic and alkaline condition (OECD 111, or under certain conditions OECD 120) 2. Polymer specific information + mutagenicity & toxicity. Must be given information with respect to: Number average molecular weight Molecular weight distribution GPC data Monomer identity The data on the content (%) of residual monomers The data on the content (%) of substances with molecular weight of 1,000 or less PLUS Acute oral toxicity and In-vitro bacterial reverse mutation test (Ames test) 3. Polymer specific information + mutagenicity and ecotoxicity. Must be given information with respect to: Number average molecular weight Molecular weight distribution GPC data Monomer identity The data on the content (%) of residual monomers The data on the content (%) of substances with molecular weight of 1,000 or less PLUS Acute fish toxicity and In-vitro bacterial reverse mutation test (Ames test) For all substances (polymeric and non-polymeric) general information requirements are also needed, as follows: Information about the chemical identity (chemical name, structure, CAS number if available, and empirical formula when appropriate) Proposed uses and use category Estimate amounts to be placed on the market per annum for the next three years Purity profile Physico-chemical properties (nature of the substance, melting/boiling point, vapour pressure, water solubility, solubility in common organic solvents Release pathway and environmental impact K-REACH Joint registration is possible, and the general data requirements for under K-REACH are: Number average molecular weight Monomer information Remaining monomers Content of oligomers with less than 1,000 Daltons Acid or base solution stability The other data requirements for under K-REACH depend on the tonnage band, and are as follows: Data requirements in K-REACH 1~10 tonnes 10~100 tonnes 100~1000 tonnes 1000 tonnes Physical state Water solubility Melting point Physical state Water solubility Melting point Physical state Water solubility Melting point Physical state Water solubility Melting point 171

172 Boiling point Vapor pressure Boiling point Vapor pressure Acute toxicity oral (inhalation) AMES test Short-term toxicity testing on fish Ready biodegradation Boiling point Vapor pressure Boiling point Vapor pressure Acute toxicity oral (inhalation) AMES test Short-term toxicity testing on fish Ready biodegradation Other Specific Exemptions besides PLC approach TCCA Besides PLC, falling under any of the following categories are exempt from the new chemical notification under TCCA: Polymers that contain less than 2% w/w reactants or monomers which are not listed on KECI; Graft polymer, if the stem and all branches are listed on KECI; Block polymer of which all blocks and stems are listed on KECI; PLC approach TCCA According to the TCCA, the definition of of low concern (PLC) covers: Non-ionic polymer with number average molecular weight Mn 10,000 Da; Non-ionic polymer with number average molecular weight Mn 1,000 Da, of which: o all starting monomers/reactants are listed in KECI (Korean Existing Chemical Substances Inventory) and not listed on the toxic chemicals listing 97 (excluding inorganic compounds) specified/published by NIER (National Institute of Environmental Research); o Polymers are not synthesized from toxic chemicals, observational chemicals or new chemicals, and epoxy-compound; o and the water solubility should be less than or equal to 5 mg/g at PH 2, 7 and 9. Box: Data requirements for PLC application Information requirements for application for exemption from notification of PLC Non-ionic polymer with Mn 10,000 Da Non-ionic polymer with Mn 1,000 Da Chemical name and CAS registry number of the polymer x x Structure (if defined) x x GPC analysis data including molecular weight distribution curve and slice data Number average molecular weight and weight average molecular weight Details of monomers/reactants for the polymer showing any of them are neither toxic chemicals, observational chemicals, new chemical substance defined by Korea TCCA nor epoxy compound x x x x x 97 Toxic chemicals listing from National Institute of Environmental Research: 172

173 Chemical name/cas number/wt%/keci listing number of each monomers/reactants Water solubility test report showing the results meets with following criteria: water solubility less than 5 mg/g at ph 2, 7 and 9 (refer test method OECD 120) x x K-REACH Polymers are exempt from the new chemical notification under K-REACH if they meet one of the following exemption criteria (PLC criteria): Exemption condition 1: Polymers with Mn>=10,000 Daltons whose molecular species with molecular weight (MW) below 1,000 are present at 5% or less, and species with MW below 500 are present at 2% or less; Not satisfying sub exemption condition 1 Exemption condition 2: Polymers with 1,000 Mn 10,000 whose molecular species with MW below 1,000 are present at 25% or less, and species with MW below 500 are present at 10% or less Not satisfying sub exemption condition 1 and 2 Sub exemption condition 1: o Not cationic polymer (except if in solid form not soluble or dispersible in water) Sub exemption condition 2: o o Polymer with monomer (of Hazard chemical substances, epoxy compound, aziridine compound or new chemical substance) over 2% by weight Number average molecular weight below 10,000 Daltons Box: Data requirements for exemption of PLC application To apply for a PLC exemption, applicants must submit the following information: Substance name, CAS number/ke number, tonnage Monomer names, CAS number/ke number, content % (2% only) Data showing number average molecular weight and molecular weight distribution Data on content percentage of molecular weight of oligomers less than 1,000 Da and 500 Da Data showing that sub exemption conditions are not satisfied Grouping approach None Key characteristics of the strategy TCCA: For most of the only basic physico-chemical and polymer stability test data are required. The definition of PLC, under TCCA, which is similar to other countries Some can be exempt, but with notification, and with reduced testing requirements Existence of three types of notification for, which require less data than for non- 173

174 K-REACH: The tonnage levels for registration of existing substances is the same as for EU-REACH (1-10 ton per annum, ton per annum, 100-1,000 ton per annum, and over 1,000 ton per annum) Under K-REACH, the existence of an authorization list of chemical substances is expected to be similar to the authorization list of EU REACH K-REACH requires new chemical substances manufactured and imported in quantities of less than one ton per year to be registered as well The testing requirements for substances that need to be registered are different depending on tonnage level The penalties for failure to report under K-REACH are: up to 3 years in prison or 50 million won ( USD 46,450) Questions for MOE What are the main reasons to substitute the actual chemicals legislation (TCCA) for a new one (K-REACH)? Under TCCA there are three options for Polymer Notification. What are the specific criteria used to choose which category for submission? Why are there three different options for polymer notification under TCCA? Do you have any feedback from industry about the costs for notification of new that do not meet exemption criteria? Do you have any idea if the costs for registering will be higher for K-REACH than for TCCA? How many notifications do you expect to need registration under K-REACH? In TCCA need to be notified, but K-REACH refers that need to be registered. Are these two words synonyms, used in the same manner in each legislation, or they have different meanings? The polymer definition, according to OECD definition, is the same for both legislations? Do monomers need to be notified under TCCA and registered under K-REACH? How the provisions for monomers and polymer differ? PLC Why are two categories of PLC defined under TCCA and under K-REACH? How has the PLC approach under TCCA influenced the number of notifications? What is the reason for the sub exemption conditions for PLC according to K-REACH? Under K-REACH, regarding the information required for exemption application of PLC, what are exactly the data necessary to show that sub exemption conditions are not satisfied? Sources Toxic Chemicals Control Act (TCCA) (actual legislation), Draft version of the Act on Registration and Evaluation, Authorization and Restriction of Chemical Substances, and Regulations&itm=&txt=&pg=1&seq=3 (both in Korean original version, and in English unofficial translated version by Korea Testing and Research Institute) Korean Ministry of Environment (MoE), National Institute of Environmental Research (NIER), Korea Chemicals Management Association (KCMA), Korea Existing Chemicals Inventory (KECI), Korea Toxic Chemicals Control Act (TCCA), Chemical Inspection and Regulation Service, Handling Polymers on a Global Scale, J. H. Moore, Polymer Regulations and Polymer Notifications Update Report 2011, Chemical Inspection and Regulation Service, New Chemical Notification, 174

175 Registration Strategies prior to Implementation of K-REACH, Nam and Nam International, K-REACH Helpdesk, Korea Chemicals Management Association (KCMA), Overview on Chemicals Control Legislation in Korea, Phil-Je KIM and Hyun-Kyung KIM, National Institute of Environmental Research, Korea, in ChemCon Asia 2011: K-REACH updates: The Presidential and Ministerial Decrees, Jun Ho Lee, Webinar, 6 March 2014, 9:30am GMT: Toxic chemicals listing from National Institute of Environmental Research: 175

176 Taiwan Regulatory text: Toxic Chemical Substances Control Act (TCSCA) 98 Competent Authority: Environmental Protection Administration (EPA) Executive Yuan, R. O. C. Taiwan 99 Contacts: EPA contacts page ( Dr. Jowitt Li, Director at Taiwan s Safety and Health Technology Center (SAHTECH) (joli@sahtech.org) Aim and structure of this sheet This factsheet describes the polymer registration strategy currently implemented in Taiwan. After a short introduction outlining the main aspects of the strategy, the factsheet details the main criteria used in PLC approach. Key points raised by the document (advantages/disadvantages of the strategy) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the EPA Executive Yuan. Context and general description The Toxic Chemical Substances Control Act (TCSCA) is the main legislation for industrial chemicals in Taiwan, it was firstly issued on 26 November 1986 and its last revision dates from 2007, after 5 amendments. A detailed implementation scheme is currently being developed and will be published for public consultation during The Act s objective is the management of manufacture, import, export, sale, use, storage, transport and disposal of toxic chemicals, requiring business operators to apply for handling permits for designated toxic chemical substances from the Environmental Protection Administration (EPA). The revised TCSCA creates a system for the registration, evaluation and control of chemicals (it s a REACH-like legislation, conceived to promote international harmonization), requiring companies to register new substances (90 days prior to manufacturing or importation) and register designated existing substances manufactured or imported above a given quantity (the list of designated substances subject to registration will be announced by authorities and a grace period will be given). Companies can only produce or import substances after EPA approves their applications. The detailed registration regulation is in the stage of drafting, followed by public consultation and pre-announcement by the end of Joint submission of the same substance is permitted, to avoid duplication of testing data, according to Article 7-1, Paragraph 4 (Share registration costs), registers apply for joint or consecutive registration of a same substance may share the costs to use the same information and avoid duplicated testing. Registers may negotiate to share the costs or the central government may intervene to determine cost sharing upon the request of the register(s). Relevant information can be used for registration only upon the cost share is paid and consent is made by the register(s). Monomers are subject to typical chemical substance requirements. Definition of a polymer No definition of a polymer under TCSCA was found. Decision tree The decision tree for the registration process is showed below : 98 English version of the fulltext of the revised TCSCA, 99 Environmental Protection Administration (EPA) Executive Yuan, R. O. C. Taiwan, 176

177 Generic requirements for not concerned by PLC approaches There are two types of substances that require registration: New chemical substances (a new substance, or a new polymer, is defined as a substance that is not listed in the Taiwan National Inventory of Existing Chemical Substances 100, published by a central competent authority) Designated Existing Substance at a given quantity or above For there are three exemptions from registration: A polymer that occurs in nature A polymer for which the 2 % rule is applicable Polymer of low concern below 1 t/y According to substance type and the tonnage of manufacturing or importing, there are 3 types of registration: standard registration, simplified registration and small volume registration. Registration information includes manufacturing or importing details, the physical, chemical, and toxicology data, exposure and hazard assessment data and other information designated by the central competent authority. However, guidance on data required for those three types of registration (data requirements, tonnage thresholds, exposure and risk assessment,) has not been released yet will be published for public consultation during The table below shows the three types of registration: Type of registration Volume / Year Review period (days) Small volume registration < 1 ton 10 Simplified registration 1 < 10 tons + certain National Existing Chemical Inventory in Taiwan, 177

178 Standard Registration 10 tons 90 * * The review period is reduced to 30 days if the substance is already listed on at least two Inventories from the following jurisdictions: US, EU, Japan, mainland China (PRC), Canada and Australia. However, full data entries accepted by these agencies as well as the approval documents should also be provided. If a polymer is classified according to the Globally Harmonized System (GHS) as carcinogenic, mutagenic, reprotoxic or environmentally hazardous, it will not qualify for the Simplified Registration procedure. There does not seem to be any requirements for monomers, or any specific provisions for made with existing monomers. Inputs from the Taiwanese competent authority will allow knowing more on the subject. The table below summarizes the requirements for each of the Registration Types: Information Small volume Simplified Standard Basic information of the registrant Basic information of substances identification (chemical name in English and Chinese, CAS registry number, if available) Substances manufacture and use information GHS hazards classification and labelling Safe use information Physical/chemical characteristics Toxicological information Ecotoxicological information Hazard assessment report* Exposure assessment report* * Additional information required for standard registration for chemicals over 10 t/y The detailed information on each registration type is given in the Draft Regulation made public on May 8th2014. And presented in the two tables below: Table: Simplified Registration of the New Chemical Substances- Information Requirements Section 1. Basic identification of the registrant and substances 2 Substances manufacture, use and exposure information Items 1.1Information of the registrant 1.2 Substance Identification 2.1 Manufacture and importation 2.2 Use information 2.3 Exposure information 178

179 3 Hazards Classification and Labelling 3 Safe use information 5 Physical and chemical properties 3.1 Physical hazards 3.2 Health hazard 3.3 Environmental hazards 3.4 Labelling 4.1 First aid measures 4.2 Firefighting measures 4.3 Accidental release measures 4.4 Handling and storage 4.5 Transport information 4.6 Exposure controls / personal protection 4.7 Stability and reactivity 4.8 Disposal considerations 5.1 Physical state 5.2 Melting / freezing point 5.3 Boiling point 5.4 Density 5.5 Octanol/water partition coefficient 5.6 Water solubility Table: Small Quantity Registration of the New Chemical Substances- Information Requirements Section 1. Basic identification of the registrant and substances Items 1.1 Information of the registrant 1.2 Substance Identification 2. Manufacture and use information 2.1 Manufacture and importation 2.2 Use information Table: Standard Registration of the New Chemical substances- Information Requirements Section 1. Basic identification of the registrant and substances Items 1.1 Information of the registrant 1.2 Substance Identification 2. Substances manufacture, use and exposure information 3 Hazards Classification and Labelling 2.1 Manufacture and importation 2.2 Use information 2.3 Exposure information 3.1 Physical hazards 3.2 Health hazards 3.3 Environmental hazards 3.4 Labelling 4 Safe use information 4.1 First aid measures 4.2 Firefighting measures 4.3 Accidental release measures 4.4 Handling and storage 4.5 Transport information 4.6 Exposure controls / personal protection 4.7 Stability and reactivity 4.8 Disposal considerations 5 Physical and chemical properties 5.1 Physical state 5.2 Melting / freezing point 5.3 Boiling point 5.4 Density 5.5 Octanol/water partition coefficient 5.6 Water solubility 5.7 Vapour pressure 5.8 Flash point 5.9 Flammability 179

180 5.10 Explosive properties 5.11 Oxidation properties 5.12 ph value 5.13 Auto-ignition temperature 5.14 Viscosity 5.15 Corrosive to metals 6 Toxicological Information 6.1 Acute toxicity: oral, dermal, inhalation 6.2 Skin corrosion/irritation 6.3 Eye irritation 6.4 Skin sensitization 6.5 Genetic toxicity 6.6 Basic toxicokinetics 6.7 Repeat Dose Toxicity : oral, inhalation, dermal 6.8 Reproductive/Developmental toxicity 6.9 Carcinogenicity 7 Ecotoxicological Information 7.1 Short-term toxicity testing on invertebrates (daphnia) 7.2 Toxicity to aquatic algae and cyanobacteria 7.3 Biodegradation in water: screening tests 7.4 Short-term toxicity testing on fish 7.5 Hydrolysis 7.6 Toxicity to microorganisms 7.7 Adsorption / desorption 7.8 Long-term toxicity testing on invertebrates (daphnia) 7.9 Long-term toxicity testing on fish 7.10 Toxicity to soil macroorganisms except arthropods 7.11 Toxicity to terrestrial organisms 7.12 Toxicity to soil microorganisms 7.13 Biodegradation in water and sediment: simulation test 7.14 Biodegradation in soil 7.15 Bioaccumulation: aquatic / sediment 7.16 Toxicity to sediment 8 Hazard assessment 8.1 Physicochemical-property-to-humanhealth hazard assessment summary 8.2 Health hazard assessment summary 8.3 Environmental hazard assessment summary 9 Exposure Assessment 9.1 Exposure scenarios description 9.2 Exposure estimation 9.3 Risk Characterization Furthermore, R&D are subject to exemption up to 1 tonne per year. Simplified registration applies to 1 tonne per year, and standard registration applies 10 tonnes per year of polymer. All tests must be performed in accordance with the methods described in CNS15030 or OECD (Organisation for Economic Co-operation and Development) announcements or the national standards set by the Bureau of Standards of the Ministry of Economic Affairs. Testing requirements can be waived if the company can provide scientific evidence or complete information of the contents in a way similar to QSAR (Quantitative structure activity relationship). Grouping approach 180

181 No grouping approach PLC approach Polymers of Low Concern (PLC) are those meeting any of the following criteria : (a) The number average molecular weight (Mn) is between 1000 and Dalton, no active function groups exists, of weight average molecular weight (MW) below 500 Dalton is less than 10% and of MW below 1000 Dalton is less than 25% ; (b) Mn is above 10,000 Dalton, no active function groups exists, of MW below 500 Dalton is less than 2% and of MW below 1000 Dalton is less than 5% ; (c) The blocks and branch chains are all in the existing chemical substances inventory. Points (a) and (b) of PLC definition are according to OECD definition for PLC. The substance priorly reviewed and verified by the central competent authority, as of low concern in annual quantities of less than 1 tonne is exempted from registration. The substance priorly reviewed and verified by the central competent authority, as of low concern in annual quantities of 1 tonne or more is subject to simplified registration. PLC definitions/criteria applied in the US, Canada Australia, in conjunction with solubility test are adopted under TCSCA. The motivations behind the decision are primarily based on the common international practices of working definitions and applicability to industries. Key characteristics of the strategy It s a REACH-like legislation with a system for the registration, evaluation and control of chemicals. PLC only require a Simplified Registration, with less requirements necessary. If it is manufactured at less than 1 ton a year, it is exempted from notification; The requirements for each type of registration are not exactly known, there is only a current understanding of what they are, but more details are required. Some aspects of the legislation may change when the final guidance is published. The Act doesn t exclude new substances with small volumes from registration. Testing requirements can be performed according to OECD test methods. The penalties for failing to register substances under revised TCSCA are the following: Category Failure to notify new substance Comments 1. Fine: NT$200,000 to NT$2,000,000; 2. Repeated infringement: business suspension or returned export. Failure to register designated existing substance 1. Fine: NT$30,000 to NT$300,000; 2. Repeated infringement: business suspension or returned export. Information on the number of notifications or the costs is not available yet, as the Regulation is not fully implemented yet. However, experts at SAHTECH predict there will be a significant portions of polymer registration is subject to simplified category. Furthermore, annual program reviews iare planned after the system is implemented commencing Sources English version of the full text of the revised TCSCA, 181

182 Environmental Protection Administration (EPA) Executive Yuan, R. O. C. Taiwan, Taiwan Chemical Substance Registration & Inventory Update, Dr. Jowitt Li, Chemical Watch Webinar, 26 February 2014 National Existing Chemical Inventory in Taiwan, Taiwan: Overview on Chemical Control Legislation, Mark Grenda: Toxic Chemical Substances Control Act : National Chemical Substance Register Office (NCSR) : Taiwan Overview on Chemical Contriol legislation (Labelling, MSDS, Existing and New Substances, etc.) and Aspects of GHS, Mark Grenda, Afton Chemical Corporation, USA, SAHTECH answers to the following questionnaire: What are the costs associated with each registration type for? Would it be possible to receive the list of information requirements under the standard registration? How many companies (approximately) and how many (approximately) falls under standard registration and simplified registration scheme? Polymers used in R&D need to be registered? If yes, what are the requirements? What are the polymer and monomer definitions under TCSCA? What were the motivations behind the different legislative choices? In particular: o Why were three categories of PLC defined? Are there any specific requirements for monomers or are monomers considered as a normal substance? Are there reduced polymer information requirements if the monomers are registered versus a polymer made with a new monomer? Can you specify what are exactly the requirements necessary for each type of registration? Do you have the numbers of registered under each category? And regarding the number of is the market? What is your position regarding Classification and Labelling requirements for? Is it exactly the same as for other substances or is there something specific for? Can you already say what aspects of the legislation, regarding, will change when the final guidance is published? Is there a possibility to register groups of hazardous on the basis of similar endpoint toxicities? May companies provide a joint registration of a) a same polymer and/or b) a group of similar? How do the conditions of use influence to the information requirements on hazardous? How many, synthetized from the inventory listed monomers, are exempted from the registration? Could you possibly provide the full list of information requirements under the standard registration? How do the provisions of standard registration of monomers and differ from each other? Did you evaluate the efficiency of the legislation: outcomes, monitoring system, costs, quality of data? 182

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184 USA Regulatory text: The Toxic Substances Control Act (TSCA) Competent Authority: US EPA Contacts: Anna Coutlakis Chemist/policy analyst Aim and structure of this sheet This factsheet describes the polymer notification scheme currently implemented in the USA, since the latest Exemption Rules were enacted in After a short introduction outlining the main aspects of the strategy and a decision tree showing its different steps, the sheet details the principal criteria used in grouping and PLC approaches. Key points raised by the document (advantages/disadvantages of the strategy, transferability in the EU) are gathered in a dedicated section, while questions deriving from those points are organised in a questionnaire for the US EPA. Context and general description Under the TSCA, manufacturers must submit to the US EPA a pre-manufacture notice (PMN) if they intend to manufacture (import is considered manufacture) any new chemical substance, i.e. a substance which is not on the TSCA Inventory (=list of existing substances) or otherwise excluded from notification. After PMN review has been completed (the review period is 90 days), the company that submitted the PMN must provide a Notice of Commencement of Manufacture or Import (NOC) to US EPA within 30 calendar days of the date the substance is first manufactured or imported for non-exempt commercial purposes. A chemical substance is considered to be on the TSCA Inventory and becomes an existing chemical as soon as a complete NOC is received by US EPA. Existing substances are not subject to any requirements. However, the US EPA is conducting risk assessment of existing chemicals in order to identify potential concerns with existing chemicals and possible actions for addressing those concerns. The US EPA established a set of exemptions (for which no PMN is required), based on: Use of the chemical/polymer: o Research and development (R&D) exemption -synthesis of new chemical substances for analysis, experimentation, or research on new or existing chemical substances, including product development activities. o Test-marketing exemption application (TMEA): for companies planning to manufacture or import a new chemical substance for test-marketing. Test-marketing involves the distribution of a predetermined limited amount of a chemical substance to specified number of customers to explore market acceptability before general distribution. The review process for this type of notice is 45 days. Production volume: the Low Volume Exemption (LVE) is available for substances manufactured in quantities of 10,000 kg or less per year. The US EPA grants a LVE notice (the review period for an LVE is 30 days) Release and exposure: the Low Release and Exposure (LoREX) Exemption. Eligibility for this exemption category is independent of production volume level. Performance standards for this 184

185 exemption include both absolute criteria (e.g., an upper limit on surface water releases) and goals (e.g., no worker exposure). The US EPA grants a LoREX notice (the review period for an LoREX is 30 days) Nature of the chemical: the polymer exemption rule, allowing some (so-called Polymers of Low Concern, or PLC) to be excluded from notification. In order to be exempted, have first to comply with the definition of a polymer according to the OECD and to fulfil eligibility criteria; in particular, they must not fit any of the criteria listed in (d) (1-6) of the regulation. If they follow these prerequisites, manufacturers can see if they meet the three exemption criteria mentioned in the TSCA and described in the Polymer Exemption Guidance Manual. If so, they are exempted from notification (with no user fee) and are authorised to begin immediate manufacture/import. Nevertheless, they must submit information once a year telling US EPA how many chemicals they manufactured/imported that year. This information is much abbreviated and is provided in a Polymer Exemption Postcard. Knowing who used the exemption allows US EPA's Enforcement group to go out and check if the data recorded under the recordkeeping provisions, regarding the chemicals, are correct. If a polymer is not eligible for exemption or does not meet any of the exemption criteria, a PMN must be submitted to the US EPA. Nevertheless, if this polymer is similar to others, a common notice can be built (called a consolidated notice ). There are no specific requirements for notification of monomers. Costs of a notification depend on characteristics of the filer, whether it be a big or small company. Choices are: PMN or Section 5 Exemptions. PMN User Fees are $2500 if a company has yearly sales over $40 million, $100 if sales are $40 million or below. Exemptions require no User Fee. Decision tree Definition of a polymer The substance must comply with the OECD definition of a polymer, namely: Molecules must be distributed over a range of molecular weights > 50 % of the molecules must contain at least three monomer units covalently bound to at least one other monomer unit or other reactant No single molecular weight molecule can be > 50 % (w/w) of the total distribution Generic requirements for not concerned by grouping and/or PLC approaches Section 5 of the TSCA requires anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose to provide US EPA with a notice (the pre-manufacture notice, or PMN) 185