Revisited Draft Technical Guidance Document on requirements for substances in articles 1

Transcription

1 REVISITED RIP 3.8 FINAL REPORT DRAFT Revisited Draft Technical Guidance Document on requirements for substances in articles 1 Reach Implementation Project 3.8 On 3 December 2007, B-Lands Consulting released on its website [ the revisited version of RIP3.8 on requirements for substances in articles. The obsolete numbering [2005] from the original RIP3.8 on chapters, articles, paragraphs, workflows and annexes, was entirely reviewed to match the final version of Regulation (EC) No 1907/2006 (REACH). [Conversion Table]. This revisited RIP3.8 is a temporary fix to get going until ECHA releases the long awaited "GUIDANCE ON REQUIREMENTS FOR SUBSTANCES IN ARTICLES". 1 Disclaimer: The content of this report expresses the views of the contractors and may not reflect the position of the Commission. The Commission will at a later stage update the guidance in line with the final political agreement on the REACH regulation

2 REVISITED RIP 3.8 FINAL REPORT DRAFT Preface Within the context of the proposed EU Chemicals policy, REACH 2, the European Commission has initiated REACH Implementation Projects (RIPs) with the intention of developing tools and guidance for the new legislation. REACH Implementation Project No. 3 covers a suite of individual projects all aimed at developing guidance for industry on various aspects of REACH. Under the RIP 3.8, a Draft Technical Guidance Document on requirements for substances in articles shall be developed. This report is part of the deliverables from the Technical Guidance Document in support of the New EU Chemicals Legislation (REACH)-III: Technical Guidance Document on fulfilling the requirements for articles under REACH (REACH Implementation Project 3.8; 2005/ of 21/01/2005) The study was co-ordinated by DHI Water & Environment (the contractor) and carried out by experts from DHI Water & Environment; Danish Toxicology Centre; Ökopol GmbH; Umweltbundesamt, Austria; Federal Environmental Agency, Germany; Swedish Chemicals Inspectorate; Danish Environmental Protection Agency and the Norwegian Pollution Control Authority within the time frame of May 2005 to May During the preparation of this report, the Consortium received valuable input from members of the Stakeholder Experts Group nominated by the European Commission to discuss the progress and outcome of the project. 2 The Presidency Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC. This TGD was initially based on the draft text as agreed by the Competitiveness Council at its meeting on 13 December 2005 and as amended in Document No /05 of 19 December While the official Guidance on requirements on substances in articles is being worked out by the European Commission, B-Lands Consulting has updated the numbering on all chapters, articles, paragraphs, and annexes from the original RIP 3.8 to match numbering in the adopted Regulation (EC) 1907/2006 (REACH)[18 December 2006]. 2

3 REVISITED RIP 3.8 FINAL REPORT DRAFT CONTENT 1 GENERAL INTRODUCTION Who is addressed by this guidance? What is an article? Legislative background for substances in articles General introduction to REACH requirements for substances in articles The phase-in scheme Time scheme for substances to be notified Other relevant legislation Why this guidance is needed and how to use it General approach to documentation INFORMATION VIA THE SUPPLY CHAIN Obtaining standardised information from suppliers Requesting non-standardised information up the supply chain WHEN IS REGISTRATION OR NOTIFICATION REQUIRED? First checking whether any of the requirements under Articles 7 and 33(1,2) might apply to the (substances in the) article Checking content of SVHC according to Articles 7(2) or 33(1,2) Screening for substances intended to be released from the article according to Article 7(1) CHECKING IF REGISTRATION IS REQUIRED ACCORDING TO ARTICLE 7(1) Obligation according to Article 7(1) Workflow 2 - Checking whether registration is required (Article 7(1)) Checking whether the total volume of articles > 1 t/a First screening if the total amount of a substance > 1 t/a Identification of substances intended to be released Checking whether the substances are exempted from registration Checking for existing registration for that specific use Determination of the total amount of each substance intended to be released Registration of substances intended to be released from articles CHECKING WHETHER COMMUNICATION OF INFORMATION UNDER ARTICLE 33(1,2) AND NOTIFICATION UNDER ARTICLE 7(2) ARE REQUIRED Obligation according to Article 33(1,2) Obligation according to Article 7(2) Overall approach to obtaining information about SVHC

4 REVISITED RIP 3.8 FINAL REPORT DRAFT 5.4 Determining whether the article contains substances of very high concern (WF 1) Identification of SVHC and their amounts through supply chain communication and branch knowledge Identification of substances through chemical analysis Workflow for checking whether forwarding information and notification are required Determination of the concentration of identified SVHC Check for an intended release of the SVHC Check for existing registration for that specific use Determining whether the total amount of SVHC is > 1 t/a for the produced and imported articles with SVHC concentration > 0.1% (w/w) Check if exposure can be excluded during normal or reasonably foreseeable conditions of use Use and function of the substance and the article Potential for release Exposure of humans and the environment Appropriate instructions for use and disposal (Article 33(1,2)) Instructions for use and disposal Transferring the information Notification of a substance in articles CHECKING WHETHER A SUBSTANCE IN AN ARTICLE HAS BEEN REGISTERED FOR THAT SPECIFIC USE Checking registration of substances falling under Art. 7(1) and Art. 7(2) Special conditions during phase-in for substances falling under Art. 7(1) How to decide if a use has been registered for SVHC?...39 ANNEX ANNEX 1 Abbreviations, Definitions and Explanations...40 ANNEX 2 Article 7 and Article 33(1,2) on REACH...60 ANNEX 3 Article 57 and Article 59 of REACH...63 ANNEX 4 General information requirements for registration of substances with regard to substance identity...65 ANNEX 5 Information to be used in relation to check if notification is required...68 ANNEX 6 Illustrative cases for cheking if requirements under Article 7 and article 33(1,2) may apply...73 ANNEX 7 Information sources on substances in articles...98 ANNEX 8 Information sources on restrictions and methods for determination of substances released from articles101 TABLES Table 1 Requirements on standard information further to Article 10 and Annex VI information to be submitted for registration according to Article 12 of REACH are based to the substance to-tal quantity

5 REVISITED RIP 3.8 FINAL REPORT DRAFT Table 2 Categories of products based on main function of the product and release of chemicals during use. (The objects market with a in the table = Current DG ENT/DG ENV conclusion on borderline cases brought up by the consortium of RIP 3.8)...50 Table 3 Examples illustrating the borderline between preparations and metallic semi-finished products (from Eurofer Stainless Steel Producers Group)...54 Table 4 Information to be delivered and requested for substances used by an article producer and identified as a SVHC on the candidate list of eventually inclusion in Annex XIV or on Annex XIV of REACH (Agency website).69 Table 5 Information to be delivered and requested for preparation used by an article producer when the preparation has a potential content of SVHC...70 Table 6 Information to be delivered and requested for articles used by an article producer (for further processing) or imported...72 Table 7 Substances with intended release in NN polishing cloth and Polishing cloth for silver...74 Table 8 Substances with intended release in NN polishing cloth and Polishing cloth for silver...78 Table 9 Quantification of substances intended to be released...79 Table 10 Substances with intended release from a permanent marker...82 Table 11 Some important properties of some of the PAHs in HA oil...91 Table 12 Calculation of the amount of PAHs in an average passenger car tyre for the EU market...92 FIGURES Figure 1 EU producer and EU importer of articles...6 Figure 2 The phase-in scheme for registration and notification of substances in articles...11 Figure 3 Explanation of the symbols used in the workflows (WF 1, WF 2 and WF 3)...14 Figure 4 Information to be obtained from actors in the supply chain...17 Figure 5 Workflow for checking if requirements under Articles 7 and 33(1,2) may apply...18 Figure 6 Workflow for checking if registration is required...erre ur! Signet non défini. Figure 7 Workflow for checking if Art. 33(1,2) applies and if notification is required (Art. 7(2))...31 EXAMPLES Example 1 Preparation intended to be released - felt tip pen...22 Example 2 Substance intended to be released - cleaning sponge...23 Example 3 Identification of substances intended to be released - felt tip pen...24 Example 4 Reduction of substance volume to be registered...25 Example 5 Registration of same substance in more articles...25 Example 6 Registration of substance intended to be released...26 Example 7 Calculation of a concentration...33 Example 8 Calculation of the amount of a SVHC

6 REVISITED RIP 3.8 FINAL REPORT DRAFT 1 GENERAL INTRODUCTION 1.1 Who is addressed by this guidance? This draft Technical Guidance Document (TGD) applies to all European article producers and importers of articles into the EU 3. It describes ways to check whether an article producer or importer has to fulfil any requirements under Article 7 and 33(1,2) of the European chemicals regulation REACH related to substances contained in articles. Other REACH requirements of article producers under REACH are not considered in this guidance but will be addressed in other TGDs of REACH. The European Commission will develop an overall guidance with links to the series of TGDs developed for the implementation of REACH and how to use them. Figure 1 EU producer and EU importer of articles It is only the first EU producer 4 or EU importer of an article who potentially has the obligation to register or notify. However, the obligation to deliver information when required according to Article 33(1,2) applies to the entire article supply chain. When determining whether an article is subject to REACH requirements or not, the first step is to check whether the produced or imported objects are considered articles under REACH. 3 See Annex 1 for abbreviations and definitions. 4 I.e., the manufacturer first transforming the substances/preparations into an article or incorporating additional substances/preparations in an existing article 6

7 REVISITED RIP 3.8 FINAL REPORT DRAFT 1.2 What is an article? "Article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition;" (REACH, Article 3(3)). An article is composed of one or more substances or preparations, and it may contain one or more materials. The materials may be of natural origin, such as wood or wool, or they may be processed such as polyvinyl chloride (PVC) or steel. Specific substances or preparations may be added to give the article special properties. A well known example is the addition of dyes to textiles. Most of the commonly used products in private households and industries are articles, e.g. furniture, clothes, vehicles, books, toys, kitchen equipment, and electronic equipment. The elements of the article definition under REACH are interpreted in the following: The function of an object is determined by the purpose of its use ("Why is the object used?") For example, the function of a pen is to write and the function of a battery is to provide energy. The shape of an object is its two- or three-dimensional form (depth, width and height). Surface means the outmost layer of the object. Design means the arrangement of the elements of design in such a way as to best accomplish a particular purpose. The design of a textile may be determined by the twist of fibres in the yarn, the weave of threads in a fabric and the treatment of the surface of the textile. An object is an article when the shape, surface and design are more important for the normal use than its chemical composition. The type of user of an article, e.g. private consumers or industrial enterprises, does not have any influence on its status as article. The Commission had no intention to change the current interpretation of substances and preparations vis-à-vis articles. What has been currently regarded as an article under the chemicals legislation should continue to be regarded as an article under REACH. In some cases, it may, however, be difficult to decide if the chemical composition or the physical appearance of an article is more important for achieving the desired end use function. Some borderline cases are objects, which consist of a container 5 containing substances or preparations. Other cases of doubt occur when substances/preparations are solids, with a specific shape such as metal bars, plates of alloys and plastics pellets, which may be further processed to an article or a part of an article. As an example a sheet of a metal will sometimes be used directly as it is for roofing and sometimes the same type of metal sheet will be processed further into another shape. For these cases of doubt, no simple decision criteria can be given. In Annexes 1b and 1c, examples of such cases are listed and it is explained if they are articles or not. If the object is an article according to the REACH definition and/or the cases in Annexes 1b and 1c, the requirements of Article 7 and 33(1,2) apply to the article producer or importer. If the object is a substance or a preparation, the substances have to be registered under Article 6 of REACH 6 by the manufacturer/importer of these substances. 5 The container is in itself an article. 6 Guidance for registering substances on their own, in preparations or in articles is developed in RIP

8 REVISITED RIP 3.8 FINAL REPORT DRAFT 1.3 Legislative background for substances in articles The new regulation REACH aims to maintain and enhance the competitiveness of the EU chemicals industry as well as at the protection of human health and the environment. It contains rules of chemical substances on their own, in preparation and articles. Under REACH, it is up to the manufacturers, importers and downstream users of substances to ensure safe use of the chemical substances that they produce, import and use. It must be noted that a producer of articles is a downstream user when he incorporates a substance in an article and has to fulfil the obligations of downstream users 7. When a substance is manufactured/imported at a volume of 1 tonne per year or more, manufacturers/importers of that substance have an obligation to gather information on the properties of the chemical substance, list the identified uses of the substance and give guidance on safe use. The information has to be submitted to the European Chemicals Agency in order to register the substance. Also producers and importers of articles have under certain circumstances an obligation to submit information about certain substances in their articles to the Agency with the aim to register or notify these substances. When receiving a registration, the Chemicals Agency will check its completeness and EU Member States experts may evaluate the information. As stated in the preface this Technical Guidance Document is based on the draft text as agreed by the Competitiveness Council at its meeting on 13 December The REACH Articles of particular importance for article producers and importers are as follows: Article 3(3): Article definition. Article 6: General obligation to register substances on their own or in preparation. Article producers may import substances on their own or in preparations for the production of their articles. In that case the article producer is also a substance importer and will have to make a normal REACH registration for substances imported in volumes above 1 tonne/a (substances on their own or as part of preparations). (Guidance on REACH Article 6 is not part of the current document 6 ). Article 7: Defines under which circumstances article producers and importers are to register or notify substances in articles under REACH and details the notification requirements. Article 23, 28-30: Deadlines for pre-registration and registration of phase-in substances and participation in Substance Information Exchange Forum (SIEF). Article 33(1,2): Duty of actors in the supply chain for articles containing substances of very high concern (SVHC) to communicate information down the supply chain. Article 57 and 59: Criteria for identifying substances of very high concern that will be placed on a candidate list. Article containing substances on this list are subject to Article 33(1,2) (and may be subject to authorisation if included in REACH Annex XIV). The authorisation (Title VII) may apply to European article producers and importers but is explained in the Technical Guidance Document for Downstream Users 8 and the Technical Guidance 7 See RIP 3.5: Technical Guidance Document on requirements for Down Stream Users. Preliminary study. 8 RIP 3.5 is expected to start in June

9 REVISITED RIP 3.8 FINAL REPORT DRAFT Document for preparing an Application Dossier for Authorisation. Restrictions on substances (Title VIII) may apply to article producers and importers and is not further explained here General introduction to REACH requirements for substances in articles Article 7 of REACH sets a conditioned obligation for article producers and importers to register or notify substances in articles: The registration is obligatory only for substances in articles and for which the following conditions are met: The substance is intended to be released during normal and reasonable foreseeable conditions of use The total amount of the substance present in the articles exceeds 1 t/a per producer or importer (Article 7(1)) The substance has not yet been registered for that use (Article 7(6)) Notification is required for substances of very high concern (SVHC) 10 present in articles and for which the following conditions are met: The substances are present in those articles in a concentration above 0.1% (w/w); and The total amount in those articles exceeds 1 t/a per producer or importer (Article 7(2)). It is not obligatory, however, to notify if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal of the article (Article 7(3)) or if the substance has already been registered for that specific use (Article 7(6)). When an article contain a substance of very high concern in a concentrations above 0.1% (w/w) it is obligatory to inform the recipients of the article as a minimum about the chemical names of these substances and how the article can be safely used (Article 33(1,2)). Finally, it should be noticed that the Agency may decide that an article producer or importer must submit a registration for any substance in the article if all the conditions stated in Article 7(5) are met (cf. Annex 2). This may apply to SVHCs as well as other substances (not already required to be registered according to Article 7(1)). 9 How to comply with restrictions as an article producer is discussed in the RIP 3.5 on guidance for downstream users. Restrictions for importers are already part of current legislation and no further guidance is thus provided. 10 CMRs category 1 or 2, PBTs, vpvbs or substances of equivalent concern (Art. 57) included in the candidate list for Annex XIV (Art. 59) 9

10 REVISITED RIP 3.8 FINAL REPORT DRAFT The phase-in scheme The obligation to register substances in articles meeting the Article 7(1) criteria described above applies already 12 months after REACH enters into force (Article 141(2)), unless the article producer/importers take benefit of the phase-in scheme by making a pre-registration. An existing substance can be pre-registered 11 at the Agency starting 12 months and ending 18 months after entry into force of REACH (Article 28(2)). If a substance has been pre-registered it is a so-called phase-in substance (see Annex 1A) and the deadline for the actual registration depends on the total volume contained in the article produced or imported and on the classification of the substance: Registration within 3 years from entry into force (EIF) of REACH: Substances in quantities of 1,000 t/a or more per manufacturer or importer Substances in quantities of 100 t/a or more per manufacturer or importer, which are classified as very toxic to aquatic organisms and may cause long-term effects in the aquatic environment (R50-53). Substances in quantities of 1 t/a or more per manufacturer or importer, which are classified as carcinogenic, mutagenic or toxic to reproduction (CMR), categories 1 and 2. Registration within 6 years from EIF of REACH: All substances in quantities of 100 t/a or more per manufacturer or importer Registration within 11 years from EIF of REACH: All substances in quantities of 1 t/a or more per manufacturer or importer Missing the deadline for registration means that the articles cannot longer be manufactured in the Community or imported - until the registration obligations have been fulfilled. 11 Guidance on how to pre-register is provided in the TGD of preparing the Registration Dossier (RIP 3.1) and the guidance on SIEFs is covered by RIP 3.4 (TGD of Data sharing) and RIP

11 REVISITED RIP 3.8 FINAL REPORT DRAFT Deadline Year ½ Action Enter into force of REACH, Art. 33(1,2) information Registration of non-phase in substances starts Pre-registration of existing substances ends 3 3 ½ Registration of phase-in substances 1000 t/a or class. as R t/a or class. as CMR Cat. 1 & 2 1 t/a Notification of phase-in substances in articles starts (candidate list) 6 Registration of phase-in substances 100 t/a 11 Registration of phase-in substances 1 t/a Figure 2 The phase-in scheme for registration and notification of substances in articles Substances intended to be released from articles are to be registered according to the same deadlines as the general substance registration according to Article 6. The pre-registration allows article producers and importers to benefit from the phase-in scheme described above and to participate in SIEFs. According to Article 29(1), importers shall be participants in a SIEF whereas it is optional for article producers to join. The aim of the SIEFs is to facilitate the exchange of information with the purpose of avoiding the duplication of studies Time scheme for substances to be notified The notification of substances in articles (Article7(2-4)) shall not apply until 6 months after a substance has been identified and included in the specific candidate lists of substances of very high concern (same substances which may be subject to authorisation under REACH (Title VII)). The first deadline however for notification of substances in articles will be 3½ years (as a minimum) after entry into force of REACH (Article 7(7)). Information on substances of very high concern (SVHC) included in the candidate list (article 59(1)) for inclusion in Annex XIV and contained in articles is to be forwarded to the professional users of the article (Article 33(1,2)) directly after a substance is included in that list. The candidate list will be updated continuously when substances have been identified as meeting the SVHC criteria of Article 57. Criteria for identifying substances as CMR, PBT, vpvb or of equivalent concern is developed in the RIP

12 REVISITED RIP 3.8 FINAL REPORT DRAFT 1.4 Other relevant legislation The restriction on the marketing and use of certain dangerous substances and preparations (consolidated text: CONCLEG: 1976L /2004) in the existing Annex I of Directive 76/769/EEC will be repealed by Annex XVI (in Volume VI) of the REACH Regulation: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles. This means that these existing restrictions such as the ban of certain azo colorants in textiles will be included in the Annex XVII and apply instantly after EIF of REACH. However, one should be aware that other of the existing directives concerning restriction or reduction of the use or risk of certain hazardous substances in articles will still apply separately after EIF of REACH. Examples are the General Products Safety Directive 2001/95/EEC and product specific legislation such as: Directive aiming to restrict the use of certain hazardous substances in articles: Directive 2002/95/EC on the Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS). Directive aiming to reduce the amount of hazardous substances in waste from articles: Directive 2000/53/EC on End of Life Vehicles (ELVs) Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE) 1.5 Why this guidance is needed and how to use it The aim of this guidance is to assist producers and importers of articles in assessing which requirements have to be complied with related to the production and import of articles. It guides article producers and importers to answers to the following questions: Do I need to pre-register and register substances under REACH? Do I need to notify substances under REACH? Do I need to forward information on substances in the articles to my customers? The approach of the guidance is based on workflows supplemented by explanations and practical advice, which are illustrated by examples. The workflows give the overview of the steps to take and questions to ask. Explanations give further details to understanding and make references to other documents or helpful tool. The examples are given in order to illustrate the work process. The procedure of the assessment is as follows: 1. Start always by deciding whether the objects in question are considered to be articles under REACH or not (c.f. Chapter 1.1 of this guidance). Only producers and importers of articles have to proceed to the workflows in the subsequently chapters of the guidance. 2. Workflow 1 (WF 1) Checking if requirements under Article 7 or 33(1,2) may apply in Chapter 3. From this workflow, you may be directed further to 3. Workflow 2 (WF 2) Checking if registration is required (Art. 7(1)) in Chapter 4, and 12

13 REVISITED RIP 3.8 FINAL REPORT DRAFT 4. Workflow 3 (WF 3) Checking if Art. 33(1,2) applies and if notification is required (Art. 7(2)) in Chapter 5. The symbols used in the workflows are explained in Figure 3. Guidance of more general nature in relation to the work with checking the requirement for substances in articles are presented in the following sections of the guidance: General approach to documentation in relation to enforcement of requirements to article producer or importer is given in Section 1.6. The information to be expected from the suppliers in general and communication within the supply chain are explained in Chapter 2. Identification via chemical analysis, which may be an option in some cases, is presented in Section (substances intentionally released) and Section (SVHC). Chapter 6 explains how to check for existing registration of a substance for that specific use in an article. Annex 1 to this document lists the common abbreviations and definitions of REACH applied in the document. The annex includes further explanation of some of the definitions and terms related to articles in the REACH proposal. The legal text of relevance for this guidance document are copied into Annexes 2 and 3. Annex 4 explains substance identification and presents an extract of the ongoing work in RIP 3.10 on substance identity within pre-registration and inquiry prior to registration. Information to be used when checking if notification is required is included in Annex 5. The use of the workflows (WF1, WF2 and WF3) is illustrated by different cases in Annex 6. 13

14 REVISITED RIP 3.8 FINAL REPORT DRAFT Key to workflows NO Decision point YES Process or action Information source Links to other workflows or guidance Name of the procedure Company etc. in the process End point Figure 3 Explanation of the symbols used in the workflows (WF 1, WF 2 and WF 3) 1.6 General approach to documentation There are no specific record-keeping requirements within the Article 7 of the REACH proposal for producers/importers of articles besides registration and notification. However, the producer/importer of articles should consider documenting the results obtained completing the workflows of this guidance even if no duties under REACH have been identified. Documentation may facilitate demonstrating REACH compliance towards customers and (inspecting/enforcing) authorities. It is recommended that each producer/importer establishes routines to ensure high quality of documentation. Possible approaches could be: 14

15 REVISITED RIP 3.8 FINAL REPORT DRAFT Producers/importers of articles with implemented management systems could incorporate REACH conformity as a quality criterion accepted by the authorities with clear indications of how conformity will be secured and documented. Importers (e.g. SMEs) without a management system may follow a kind of good importing practice for articles, which could be developed by the respective industrial associations in cooperation with the responsible authorities. This might include: Following the workflows of this guidance Describing whether registration/notification is required Supporting documents including letters from suppliers, certificates, results of analysis etc. Short considerations on how the above could be done are given in relation to the cases in Annex 6. 2 INFORMATION VIA THE SUPPLY CHAIN During the assessment process of requirements for substances in articles it may be necessary to gather specific information about substances contained in articles as explained for the different steps of the assessment process in Sections 4.2.2, 5.3 and 5.4. Supply chain communication is the most important way of gathering information on the identity, property and quantity of substances contained in an article. The manufacturer or importer of a substance on its own or in a preparation, which is part of an article is the actor who in the first place has to know its identity and properties. Hence, he should be the first choice in identification of the substances in the articles. 2.1 Obtaining standardised information from suppliers Manufacturers, importers and suppliers of substances on their own or in preparation have obligation to communicate information according to Article 32 or a SDS/eSDS (extended SDS). Article suppliers (producers/importers/distributors) are, however, not legally required to communicate information on substances contained in the articles apart from the obligation in Article 33(1,2) under REACH. Therefore, in order to obtain information about substances in articles, it may be necessary to identify the manufacturer/importer of the substance. A SDS or an esds from an EU supplier will generally contain information on: The registration numbers of the substances, if registered (when substance volume 1t/a per manufacturer/importer) The identity of the manufacturer/importer/distributor responsible for placing the substance/preparation on the EU market The chemical names and ID numbers of the substances The concentration ranges of dangerous substances contained in the preparation 15

16 REVISITED RIP 3.8 FINAL REPORT DRAFT The classification of the dangerous substance(s) and information on authorisation and restriction where applicable Important and common use(s) of the substances Exposure Scenarios if the substance volume > 10 t/a per M/I including identified use(s) (see Annex 1) Information on registered, non-classified substances might not be supplied. Information according to Article 32 will be forwarded if a registered substance is subject to authorisation or restrictions. So will any other information, which is needed to enable safe use (e.g. appropriate risk management measures). In these cases, also the registration number is to be given and in addition substance identity when authorisation or restrictions apply. 2.2 Requesting non-standardised information up the supply chain In case no standard information is supplied and neither registration numbers nor substance identities are known, the manufacturer/importer 12 of the substance has to be identified through communication up the supply chain. The same procedure could apply for an EU producer and an EU importer of articles. Contact the actors in the supply chain in the following order: If known, the substance manufacturer or importer (placer on the market) should be contacted directly, requesting information on the substance name, registration number etc. for establishing its identity 13 If known, the producer of a preparation or an article should be contacted, requesting information on substances contained herein or on the identity of their suppliers The nearest suppliers up the supply chain should be contacted, requesting information on substances in their own or in preparations or article components used in the production of the article. 12 This could be the original registrant under REACH if it is an EU manufacturer/importer. 13 For determining whether or not a registration / notification is required, it may still be necessary to identify the actor producing the preparation contained in the article and the article producer in order to find out the total amount of a substance contained in the article. 16

17 REVISITED RIP 3.8 FINAL REPORT DRAFT Figure 4 Information to be obtained from actors in the supply chain For pre-registration and/or participation in a SIEF, it is enough to have some knowledge on the substance identity (see Annex 4). For checking if registration/notification is required, more information needs to be collected. The manufacturer/importer can be identified and asked about information on the substance identity, its properties and for which uses, it was registered. If a preparation is incorporated in the article, the formulator of that preparation can be asked for the substance concentration or concentration range 14. The article producer himself knows the amount of the preparation contained in the article and the total amount of the article produced. If the substance manufacturer or importer cannot be identified or is not willing to co-operate, the article producer/importer has to use other means to identify the substance e.g. a combination of publicly available information in data bases, branch knowledge and conclusions from chemical analysis. 3 WHEN IS REGISTRATION OR NOTIFICATION REQUIRED? 3.1 First checking whether any of the requirements under Articles 7 and 33(1,2) might apply to the (substances in the) article Workflow 1 (WF1): Checking whether requirements under Articles 7 or 33(1,2) may apply guides the user through the first basic questions to be answered and leads him to more specific workflows on: 14 This is possible when the formulator is making the preparation from substances. If the formulator is mixing preparations or mixing substances and preparations, he might have to request information further up in the supply chain. 17

18 REVISITED RIP 3.8 FINAL REPORT DRAFT Checking whether registration might be required for substances in the article (Workflow 2) Checking whether notification might be required for substances in the article and if information has to be communicated (Workflow 3) Explanation for decision-making is provided in the supplementary text to the workflow. To illustrate the work processes, examples are presented in Annex 6. Both routes of WF1 have to be checked, i.e. both the content of SVHC and the intended release. Note that it is possible that an article produced/imported: May have an intended release of a SVHC (Article 7(1) applies) or May have an intended release of one substance (not a SVHC) and, at the same time a content of a SVHC not intended to be release (both Article 7(1) and Article 7(2) apply) WF 1 Checking if requirements under Article 7 or 33(1,2) may apply Check if Article 7 or Article 33(1,2) may apply Producer or importer of articles Definition of intended release Annex 1 Is there an intended release from the article? NO Does the article Contain SVHC? SVHC Definition Annex 1 Identify in article Chapter 5.4 YES No further action needed YES Check if registration is required Check if Article 30(4) applies and if notification is required WF 2 WF 3 Figure 5 Workflow for checking if requirements under Articles 7 and 33(1,2) may apply Checking content of SVHC according to Articles 7(2) or 33(1,2) In order to check if the requirements of Articles 7(2) or 33(1,2) apply, it must be examined whether the article contains any substance of very high concern (SVHC), which is identified and included in the candidate list for inclusion in Annex XIV. Respective guidance is given in Chapter 5. 18

19 REVISITED RIP 3.8 FINAL REPORT DRAFT Screening for substances intended to be released from the article according to Article 7(1) Intended release of substances is closely related to the function or the quality of an article. If one of the following questions can be answered with yes, the release of substances from the article is intended: Does the article function by releasing substances or preparations (e.g. felt tip pens releasing ink for writing)? Does the function of the article depend on substances or preparations that are emitted or lost during use (e.g. impregnated textile cloths for cleaning)? Does the article have a secondary function or quality, which is achieved through the release of substances or preparations during use (e.g. a scented eraser)? A working definition of intended release from articles is given in Annex 1. Producers or importers of articles, from which substances are intended to be released, may have to register these substances. Respective guidance is given in Chapter 4. 4 CHECKING IF REGISTRATION IS REQUIRED ACCORDING TO ARTICLE 7(1) 4.1 Obligation according to Article 7(1) Registration of substances in articles is required when all conditions listed under Article 7(1) are fulfilled: The substance is intended to be released under normal or reasonably foreseeable conditions of use The total amount of the substance present in all articles with intended release produced or imported by one actor exceeds 1 t/a The substance has not been registered for that use (cf. Chapter 6) 4.2 Workflow 2 - Checking whether registration is required (Article 7(1)) WF 2 suggests a tiered checking, which sorts out the cases, in which registration is not required, with as little information as possible. However, it may be more efficient to perform the steps in a different sequence, e.g. if certain information is available already. Sections and describe an initial assessment, which is solely based on: The total volume of the articles produced or imported The total or the maximum volume of the preparation incorporated in the article 19

20 REVISITED RIP 3.8 FINAL REPORT DRAFT If the need to register cannot be excluded, each unidentified substance intended to be release from the article as described in Section must be identified. Having identified the substances, it is possible: To check if any of the substances are exempted from registration in Annexes IV and V of REACH To check whether the substances have already been registered for that specific use (Chapter 6) To pre-register, join a SIEF and participate in joint registrations To determine the total amount of each identified substance Guidance on determination of the total amount of a substance intended to be released is given in Section Checking whether the total volume of articles > 1 t/a If the total volume of articles per importer or producer is 1 t per year the substances intended to be released will definitely also be 1 t per year and the obligation to register substances in the articles will clearly not apply even if the articles were composed solely of dangerous substances. If, however, the total volume is > 1 t/a, the answer to the question at the Article level in Figure 6 is yes and checking must continue. 20

21 REVISITED RIP 3.8 FINAL REPORT DRAFT WF 2 Checking if registration is required (Art. 7(1)) Check if registration is required Article level Is the total volume of articles > 1t/a? NO No further action needed YES Preparation level First screening: Total amount > 1 t/a? NO No further action needed Substance level YES Determination of substance ID Section Identify each substance intended to be released from the article Substances exempted from registration? YES No further action needed NO Guide on how to check if specific use is registered Chapter 6 Check for existing registration for the specific use Registered? YES No further action needed NO Determination of substance content Section Determine the amount of each substance intended to be released Total amount of substance > 1t/a? NO No further action needed YES Workflow registration RIP 3.1 Figure 6 Workflow for checking if registration is required 21

22 REVISITED RIP 3.8 FINAL REPORT DRAFT First screening if the total amount of a substance > 1 t/a A first screening can be performed if either the volumes of substances/preparations incorporated in the articles or the volumes of articles placed on the market are available. If the volume of the preparation incorporated in the article is known, the critical market volume of the articles can be estimated as follows: Taking the maximum content in an article of a preparation intended to be released, the maximum amount of articles that can be placed on the market without triggering registration obligations can be determined by a simple backwards calculation: Vol article [t/a] < maxconc preparation 1[ t/ a] inarticle[%]0.01 or Number article [number/a] < max Conc preparation 1[t / a] in article[t / article] Example 1 Preparation intended to be released - felt tip pen Example: A felt tip pen contains ink to be intentionally released. Assumption: The maximum content of ink, which consists of several substances, in the pen is 20% by weight of the pen (1) or given as 2 g ink per pen (2). The producer/importer of the pen does not produce or import other articles. The maximum amount of the article not triggering the registration obligations is estimated: (1) Vol article [t/a] < 1[t / a] 20 % 0.01 = 5 t/a (2) Number article [number of pens/a] < 1[t / a] 2g / pen = 500,000 pens/a Conclusion: The estimation shows that as long as the article is produced or imported below 5 tonnes per year or the number of pens is below 500,000 per year, the amount of ink contained in the pen is below 1 t/a and thus none of the substances contained in the ink will exceed the threshold of 1 t/a. This is a minimum estimate based on the content of a preparation in one article as it was assumed that other articles were not produced or imported. However, care has to be taken if more articles, from which the same substance is intended to be released, are produced or imported. In that case, the amounts from all these articles must be summed up. If the market volume of the articles is known, the critical concentrations of substances in the preparations intended to be released can be derived as follows: Knowing the total market volume of the article and the maximum amount of the preparation included in the article (assuming that only one preparation with the specific substance is used and in one article only), the concentration limit, below which registration is not necessary, can be calculated for the substances: 1[t / a] Max. conc. of substance in preparation [%] < x100 Vol article[t / a]x Conc [%]/100 preparation 22

23 REVISITED RIP 3.8 FINAL REPORT DRAFT Information requests up the supply chain can then be focussed on substances exceeding the concentration calculated to be critical. Example 2 Substance intended to be released - cleaning sponge Example: A cleaning sponge contains cleaning agents that are released during use. Assumption: The sponge consists of maximum 15% cleaning agent. An importer sells 30 tonnes of these sponges on the European market every year: The importer of the sponge does not import or produce other articles. He imports 4.5 t/a cleaning agent (30 t/a sponges x 15/100) Maximum concentration of substance in the cleaning agent [%] < 1[t / a] 4.5[t / a] = 22% Conclusion: This means that registration is not necessary for substances contained in the cleaning agent below 22% by weight. As this may not apply to all substances in the cleaning agent, further information has to be sought. The supplier of the sponge can be asked by the importer whether the concentration of 22% is exceeded for any (or if known a specific) of the substances used in the cleaning agent. If the first screening shows that the threshold volume for registration is exceeded, the identification process as described below should be followed Identification of substances intended to be released The substance identity can be obtained from the article producer (relevant for article importer), from the manufacturers of the preparation intended to be released or the substance manufacturer as explained in Chapter 2. If is it not possible to obtain the substance identity via supply chain communication, it may be possible to identify the substance via a combination of knowledge of the article (databases, sector publications etc.) and chemical analysis. Taking substance samples for chemical analysis should be fairly easy as they are intended to be released from the article. If substances cannot be easily separated, e.g. the substance is absorbed into a matrix, extraction from the article can be made, followed by an analysis on the extract. Another possibility is to identify substances in the evaporated air from the article (e.g. perfumed/scented articles). In general, chemical analyses have to be planned carefully taking into account which information can be obtained with which methods. A strategy for testing should be developed in collaboration with testing laboratories and based on available methods and information collected from e.g. branch organisations, research institutions and/or accredited chemical analysis laboratories. In order to obtain information on substance identities and quantities intended to be released from articles through chemical analysis, the following approach is proposed: Consult branch experts or sector information sources to narrow down which substances to look for (both with regard to the tonnage threshold and groups of substances). Specific requirements to substances in articles are often linked with standard methods for analytical control of compliance (see Annex 7). 23

24 REVISITED RIP 3.8 FINAL REPORT DRAFT Identify from which part of the article to sample: Separated liquid (e.g. ink in a printer cartridge), extract from article matrix (e.g. felt material as matrix/carrier for ink in felt tip pens) or evaporation sample from the article (e.g. scent in an eraser) Develop a test strategy as a tiered process, i.e. broad screenings, narrow screenings and identification by e.g. semi-quantitative methods Perform the chemical analysis for the identification of substances 15 Example 3 Example: Felt tip pen Identification of substances intended to be released - felt tip pen A screening for organic compounds could be performed using e.g. GC-MS. The screening procedure would cover a scan of a broad range of organic compounds in order to get an overview of the number and amount of different compounds Checking whether the substances are exempted from registration The substance identities are compared with the exemptions from registration given in Annex IV and Annex V of REACH. If the substance is listed in Annex IV or fulfils any of the criteria of Annex V, no further obligations under Article 7(1) apply Checking for existing registration for that specific use When the substance intended to be released has been identified, it can either be pre-register or a check is made of whether the substance has already been registered for that specific use. Respective guidance is given in Chapter Determination of the total amount of each substance intended to be released If the former steps cannot exclude that registration is necessary, more information on the amount of the substances in the articles is needed. To check whether the threshold of 1 t/a is exceeded, the amount of each substance intended to be released in all articles with intended releases produced/imported within one calendar year must be summed up. Different methods or starting points may be chosen depending on the type of information available: The total volume of the articles placed on the market is known and the concentration ranges of substances in the preparations intended to be released have been obtained from e.g. supply chain, product specifications (on specific content in specific articles) or classification thresholds. 15 It is questionable whether chemical analysis is applicable to determine the substance identities for pre-registration and/or registration according to REACH. According to the preliminary results of RIP 3.10, the identities of the main substance component(s) have to be submitted for pre-registration but not information on e.g. impurities (Annex 4). The work of RIP 3.10 is not finished but it appears difficult to determine substance identities by analytical methods to the extent needed for a registration. 24

25 REVISITED RIP 3.8 FINAL REPORT DRAFT The exact concentration of the substance in the article can be obtained from e.g. mass balance (article producers), information through the supply chain, branches etc. or quantitative chemical analysis. Substance quantification by analytical methods Quantification of identified substances in an article by analytical methods is possible but may encounter difficulties when the substance/preparation is integrated in the article matrix 16. For analytical quantification of the content of substances in article matrices, it is relevant to know how those substances are included in the article. Extraction, sampling and measurement methods have to be appropriate for the article material and for the substance to be quantified. The same general approach may be used for quantification as for identification of substances intentionally released from articles (cf. Section 4.2.2). It should be noticed that it is the total amount incorporated in the article that has to be determined and not only the amount released from the article. Calculation of the total amount of a substance intended to be released If the maximum content of a preparation in an article and the maximum concentration of a specific substance in the preparation (e.g. from a SDS delivered together with the preparation) are known, the maximum amount of the substance in the produced/imported article can be calculated. The maximum amount or volume of the substance intended to be released is: Vol substance [t/a] = Weight article [t] (max.conc. preparation [%] 0.01) (max.conc substance [%] 0.01) (number of article/a) If, however, the loss of preparation during production (e.g. loss through evaporation, wash out or surplus substances) can be quantified, the substance volume to be registered may be reduced by the respective percentage. Example 4 Reduction of substance volume to be registered Example: If the producer can document that 10% of the solvent contained in the dye for a felt tip pen evaporates before the pen is finished and sealed, he may reduce the volume of the solvent to be registered by 10%. If the same substance is intended to be released from different articles of one producer or importer, the volumes of this substance in all those articles have to be summed up: Total Vol substance [t/a] = Vol substance [t/a] per article Example 5 Registration of same substance in more articles Example: The same solvent is used in pens and in cleaning tissues Total Vol substance t/a] = Vol substance [t/a] per article = Vol substance [t/a] Pens + Vol substance [t/a] Cleaning tissues The calculation of the total amount of a substance could be further improved by the use of specific concentration of a substance, e.g. obtained by quantitative chemical analysis. The total amount of 16 In the cases, in which the article is a container with a substance/preparation, the amount of substance intended to be released can easily be sampled. 25

26 REVISITED RIP 3.8 FINAL REPORT DRAFT substance contained in the article and intended to be released can be calculated when knowing the produced or imported amount of the article: Vol substance [t/a] = (Conc. substance [%] 0.01) Vol article [t/a] Example 6 Registration of substance intended to be released Example: A felt tip pen contains a solvent intended to be released. Assumption: The solvent constitutes 5% by weight of the pen produced within EU in an amount of 100 t/a and the solvent is not contained in other articles of the same producer and not contained in the casing of the felt tip. Vol solvent [t/a] = (Conc. solvent [%] 0.01) Vol pen [t/a] = (5 [%] 0.01) 100 [t/a] = 5t/a Conclusion: As the threshold of 1 t/a is exceeded, the producer of the pen must register the solvent for use in the pen. 4.3 Registration of substances intended to be released from articles When the registration obligation applies for substances intended to be released from an article, the producer or importer of the article shall submit a registration to the Agency. The registration must contain information according to Article 10, including Annex VI information. The amount of registration information is determined by the total quantity of the substance in all those articles of one actor. Information on inherent properties according to REACH Article 12 is required to be submitted. All available information as well as the standard information requirements described in Annexes VII to X of REACH (taking into account the general adaptation rules of Annex XI and the criteria of Annex III) shall be collected and submitted for the registration. RIP 3.3 develops guidance on these information requirements. A TGD for preparing the Registration Dossier will be developed in RIP

27 REVISITED RIP 3.8 FINAL REPORT DRAFT Table 1 Requirements on standard information further to Article 10 and Annex VI information to be submitted for registration according to Article 12 of REACH are based to the substance to-tal quantity Volume 1 t/a No registration required > 1 t/a Registration including information on inherent properties as specified in Annex VII, III and XI of REACH 10 t/a 100 t/a 1000 t/a Registration including information on inherent properties as specified in Annexes VII, VIII and Annex XI of REACH Registration including information on inherent properties as specified in Annex VII and VIII and testing proposals 17 for the provision of the information specified in Annex IX and XI of REACH Registration including information on inherent properties as specified in Annex VII and VIII and testing proposals for the provision of the information specified in Annex IX, X and XI of REACH 5 CHECKING WHETHER COMMUNICATION OF INFORMATION UNDER AR- TICLE 33(1,2) AND NOTIFICATION UNDER ARTICLE 7(2) ARE REQUIRED 5.1 Obligation according to Article 33(1,2) According to Article 33(1,2), producers and importers of articles containing substances of very high concern (SVHC) included on the candidate list for possible inclusion in Annex XIV in a concentration above 0.1% (w/w) have to provide the recipient of the articles with at least the name of the substance. This obligation applies also when there is no obligation to notify the substance as a consequence of Article 7(3). The candidate list will be published at the Agency s website and can be checked there. 5.2 Obligation according to Article 7(2) Notification of substances in articles is required when the conditions of Article 7(2) are met: The substance is included in candidate list (Article 59(1)) and The substance is present in all articles produced or imported by one actor in an amount totalling over 1 tonne per year (per producer or importer) The substance is present in articles above a concentration of 0.1% weight by weight (w/w) If, however, the conditions of Articles 7(3) or 7(6) are met, no notification of substances in the article is required: 17 As far as the information specified in Annexes IX and X is not available for the registrant, he is obliged to develop and submit a testing proposal describing how to determine the missing data. 27

28 REVISITED RIP 3.8 FINAL REPORT DRAFT The producer or importer can exclude exposure of the substances to humans or the environment during normal or reasonable foreseeable conditions of use including disposal (7(3)) The substance has already been registered for that specific use (7(6)) 5.3 Overall approach to obtaining information about SVHC Supply chain communication and which information can be obtained from which actors are explained above (cf. Chapter 2). Specific details for SVHC are summarised below: Substances and preparations SVHC are CMR substances classes 1 and 2, PBT/vPvB substances or substances of equivalent concern falling under the criteria of Article 57(f). The identity, classification and concentration ranges in preparations of such substances have to be stated in the respective SDS when the preparation meets the criteria for classification as dangerous and the substance/preparation is supplied by an EU manufacturer/importer. Moreover, substances subject to an authorisation or restriction shall be identified under Section 15 of the SDS or via information according to Article 32. SDSs of substances or preparations imported from non-eu Member States will often specify classified substances. Articles EU producers/importer of articles containing SVHC in concentrations exceeding 0.1% (w/w) must deliver information on at least the substance name to the recipients (industrial and professional users of the article) (Article 32 (4)). If SDS or Article 32 information is not delivered by the supplier of a substances contained in an article, the composition parts of an article or a finished article, information has to be sought by the EU producer/importer via request up his supply chain or in other data sources. An overview of the information, which should be delivered by suppliers of substances, preparations and articles in different situations, is presented in Annex 5 together with the additional information, which should be requested or looked for with the aim to answer the following questions: Does the article contain a SVHC included on the candidate list for possible Annex XIV inclusion? Has the substance already been registered for that specific use(s) or has an authorisation been granted for that use? Is the concentration of any SVHC > 0.1% (w/w)? Is the total amount of the SVHC in all your articles, in which the substance is contained in amounts exceeding 0.1% (w/w), > 1 t/a? Can exposure of humans or the environment during its life-cycle be excluded? 28

29 REVISITED RIP 3.8 FINAL REPORT DRAFT 5.4 Determining whether the article contains substances of very high concern (WF 1) At the first step, it is only necessary to know whether or not the article contains a SVHC. The information may be obtained via: Safety data sheets, Article 32 information 18, supply chain requests, chemical analysis etc. (see Chapter 2 and Section 4.2.3) Identification of SVHC and their amounts through supply chain communication and branch knowledge When no SDS or other standardised information is available or that information is insufficient, the following activities should be performed: Article producers Request the supplier of substances/preparations included in the article to provide the registration number, when available, identity and concentration range of any SVHC on the candidate list and Annex XIV contained therein. For article components, ask the supplier to either confirm that no SVHCs listed on the candidate list are contained in concentrations > 0.1% (w/w) in the article or to specify the identity and concentration of the SVHC in the article. Article importers Request the supplier to confirm whether or not an article contains any SVHC on the candidate list and Annex XIV in concentrations > 0.1% (w/w). If the supplier cannot confirm this, ask for the identity and the amount (or concentration) of these substances in the article. Article producers and importers Collect information from studies and surveys, if available, on the specific article made by e.g. EU Member States (e.g., Survey and migration of chemical agents in toothbrushes, Survey No. 42, 2004) and branch knowledge to confirm information from supply chain communication or to find information on the likelihood of an SVHC being contained in the article. Check if the article conforms to any specific requirements such as standards, labels or other legislation that ensures that the content of some SVHCs is below a certain threshold level, e.g. the TOXPROOF label/certificate of cars (Annex 7) Identification of substances through chemical analysis If no information is available through supply chain communication and branch knowledge for a specific product i.e. the substance, preparation or article, a chemical analysis may be performed in order to assess the content. When considering articles, knowledge about which parts and materials of the article that may contain a SVHC is an advantage. Use the overall approach to obtain information as described in Section 5.3 Narrow down the range of SVHC (the candidate list), which have to be analysed by collecting information from sector publications, product standards etc. 18 Note that SDS and Art. 32 information can only confirm the present of SVHC not exclude it. 29

30 REVISITED RIP 3.8 FINAL REPORT DRAFT Use a chemical screening analysis for identifying SVHC The analytical limit of detection of the SVHC in the analysed materials should be at least 0.05%. High competence in analytical chemistry is needed, and the analysis needs to be carefully planned on a case-by-case basis to obtain a sufficiently reliable result. Consult e.g. branch organisations, research institutions and/or accredited chemical analysis laboratories for information on available methods. 5.5 Workflow for checking whether forwarding information and notification are required If SVHC(s) have been identified in the article, the assessment must continue by use of Workflow 3: Checking whether forwarding information and notification are required (Art. 33(1,2) and Art. 7(2)). The workflow may be started at any point. As an example, it might be easier to calculate the total amount of the SVHC in the article than to check a registration for that specific use. The workload of notification is relatively low compared to that of registration but require some knowledge on the quantity of the substance (cf. Article 7(4)(f)). It is recommended to evaluate the costs before going into a more thorough assessment instead of just fulfilling a notification) 30

31 REVISITED RIP 3.8 FINAL REPORT DRAFT WF 3 Checking if Art 33 (1,2) applies and if notification is required (Art. 7(2)) Check if Art. 33(1,2) applies and if notification is required Determination of SVHC conc. Section 5.6 Determine the Concentration of the SVHC Conc above 0.1% w/w? NO No further action needed Guide on work process Instructions Section5.11 YES Communicate information according to Art. 32( 4 ) SVH30intended Released? YES Possible action under registration Guide on how to Check it that use is registered Chapter 6 NO Check for existing Registration for the Specific use Registered? YES No further action needed NO Determination of SVHC content Section 5.9 Determine the amount of the SVHC present in all articles Total amount > 1 t/a NO No further action needed YES Guide on work Process to exclude exposure Chapter 5.10 Can exposure be excluded? NO Workflow for notification RIP 3.1 Figure 7 7(2)) Workflow for checking if Art. 33(1,2) applies and if notification is required (Art. 31

32 REVISITED RIP 3.8 FINAL REPORT DRAFT 5.6 Determination of the concentration of identified SVHC For each article, it must be determined whether the concentration of the identified SVHC is > 0.1% (w/w) in order to know which information has to be communicated down the supply chain (Article 33(1,2)). A further continuation of the assessment is needed to find out the obligations under Article 7(2). Methods for obtaining information on the concentrations of SVHC in articles and the use of quantitative chemical analysis have been elaborated in previous chapters of this guidance (see Chapter 2, Sections and 5.4.2). However, it should be noticed that an article producer should consider the possibility of using mass balance for determining the concentration of SVHC in his articles and also be aware of the possibility of accumulating a SVHC through a process. This chapter is mainly focussing on how to determine the concentration of a SVHC in an article with different components. The SVHC may be contained in different concentrations in different components of the same article, e.g. one concentration in the chassis of a computer and another concentration in the transformer. The concentration threshold of 0.1% (w/w) refers to the average concentration of the entire article as produced or imported. The principle to be applied when calculating the concentration of a SVHC in an article of a producer/importer is illustrated by two cases: 1 You buy different components for a computer such as transformer, rectifier, mother board, memory, processor, hard drive, graphics card, network card, sound card and chassis. All these components are obtained from producers and importers within the EU and each of them have to have been notified if they contain SVHC > 0.1% (w/w). a) You are assembling the components to a computer at the end of the supply chain and place it on the market for both professional and private consumers. As the final producer of this computer, you do not have to notify any substance in the article given that you have not added any new substances yourself. (However, you may have article 33(1,2) requirements). b) In assembling the computer, you add a SVHC or a SVHC in its own or in a preparation to the computer, e.g. via a surface coating. You now have to make an assessment considering this SVHC: You need to sum up the individual amounts in all components and in the coating and divide it by the total weight of the computer. 2 You are importing a chair from Taiwan into the EU market. The chair consists of a wooden part and a plastic part. The producer of the chair informs you that both the wooden part and the plastic part contain xyz% and abc%, respectively of a SVHC included in the candidate list. Based on this information, you are obliged to check if the threshold of 0.1 % is exceeded. This could be done by calculating the concentration of this SVHC in the whole chair as described below and illustrated in the example box. The average concentration of a SVHC in an article is calculated as follows: 32

33 REVISITED RIP 3.8 FINAL REPORT DRAFT Conc. of SVHC [%] [ g] Amount of SVHC 100 = Weight of the whole article [] g Example 7 Calculation of a concentration Example of calculating a concentration: A chair consists of a wooden part and a plastic detail. The weight of the chair is kg The wooden part of a chair contains 10 mg of a SVHC. The weight of the wooden part is 2 kg. A plastic detail of the chair contains 1 mg of the same SVHC and the weight of the plastic detail is 1 g. The SVHC concentration in the chair: 3 3 ( )g 100 % = % (w/w), which is < 0.1%. (2001)g Conclusion: The producer/importer has neither to communicate information down the supply chain according to Art. 33(1,2) nor to notify according to Article 7(2). If the exact concentration in the article or the article parts is not known, a first screening may be performed on the basis of the maximum amount or concentration in the whole article or the different parts. If this shows a concentration > 0.1%, a more precise determination of the SVHC amount or concentration should be made. 5.7 Check for an intended release of the SVHC If the SVHC is intended to be released, Workflow 2 is used. As previously described, notification according to Article 7(2) is not needed if a registration according to Article 7(1) is needed. Article 33(1,2) obligation may however still be applicable if the > 0.1 % criteria is met. 5.8 Check for existing registration for that specific use Substances in articles already registered for that specific use do not need to be notified according to Article 7(6). Respective guidance is given in Chapter Determining whether the total amount of SVHC is > 1 t/a for the produced and imported articles with SVHC concentration > 0.1% (w/w) Determination of the SVHC concentration in the articles has shown that the concentration is > 0.1% (w/w) in a number of the individual articles, e.g. a bag and a belt. This triggers Article 33(1,2) obligations. To see if also notification is triggered the amount of the SVHC of each of these articles must be determined and summed up. Calculate the total amount of a SVHC (g) in each article produced or imported per year with a concentration of the SVHC > 0.1% (w/w): 33

34 REVISITED RIP 3.8 FINAL REPORT DRAFT The volume for one article is: Vol SVHC 6 [ g / a] = (max. conc. of SVHC in article [%] 0.01) (weight of article [ g] 10 ) (number of article/a) The total volume is: Total Vol SVHC [t/a] = Vol SVHC [t/a] of each sort of article Example 8 Calculation of the amount of a SVHC Example of calculation of the amount of a SVHC: A company imports pairs of shoes, 3000 belts, and bags per year to the EU market. A pair of shoes contains 0.05% (w/w) of a SVHC, a belt contains 0.15% (w/w), and a bag contains 0.2% (w/w) of the same SVHC. The weights of the articles are 0.7 kg per pair of shoes, 700 g per belt and 1 kg per bag. The concentration in the belt and the bag > 0.01% (w/w) calculate the total volume of the SVHC for each of the articles. The total volume of the SVHC imported by the articles: Belts: Vol SVHC [t/a] = (0.15% 0.01) (700 [g] 10-6 ) 3000 = t/a Bags: Vol SVHC [t/a] = (2% 0.01) (1000 [g] 10-6 ) = 1.2 t/a Sum up the total volume for all sorts of articles with a concentration of the SVHC > 0.1%: Vol SVHC = ( ) t/a = t/a, which is > 1 t/a Conclusion: The company has to notify the SVHC in the bag and the belt. Furthermore, the company has to provide information for both the belt and the bag according to Art. 33(1,2) Check if exposure can be excluded during normal or reasonably foreseeable conditions of use 19 Notification is not required if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal (Article 7(3). Exposure to human or the environment can be excluded in the following situations: There is no release of the substance of concern during normal and reasonably foreseeable conditions of use(s) or disposal (see explanation of these terms in Annex 1). There is a release but the article is embedded during use(s) and the substance will not escape to the environment or get into contact with humans during use or disposal. A producer/importer needs to show that exposure can be excluded during normal and reasonably foreseeable conditions of use including disposal. He will have to consider whether information about uses supplied to him by downstream users could be considered to be reasonably foreseeable 19 Disclaimer, this chapter presents initial views on what to consider when checking if exposure can be excluded. Further principles on exposure and exposure waiving will be developed in RIP (TGD on preparing the Chemical Safety Report) 34

35 REVISITED RIP 3.8 FINAL REPORT DRAFT conditions of use. Methods and tools for communication within the supply chain with the aim to obtain information on uses are considered in the RIP 3.2 and RIP Use and function of the substance and the article The assessment of a possible exposure cannot be separated from the function (if any) or the use of the substance in the article 20 and the use conditions of the article. The article producer or importer needs to consider all normal and reasonably foreseeable conditions of use including disposal of the article and assess whether exposures can be excluded or not. It is recommended to document the considerations made on the normal and reasonably foreseeable conditions of use if the conclusion is that exposure can be excluded Potential for release The potential for release of a substance from a material in an article will depend on: The substance Physico-chemical parameters like vapour pressure and water solubility, stability in contact with air, water etc. and how the substance is combined into or onto the material. The material of which the article is made Structure and chemistry of the article matrix including physico-chemical parameters and the way in which the substance is incorporated in it (chemical bonding or not) The uses and disposal of the article Location of use and disposal (indoor or outdoor use, private homes, workplace etc.) Physical conditions at place of use (temperature, ventilation etc.) Some chemical substances are very firmly bound in the material, e.g. chromium in stainless steel, and the emission potential of chromium is therefore very low. Other substances are loosely incorporated in a matrix, e.g. softening additives in PVC. Such substances, like phthalates, are continuously emitting from the surface of the article. Another way, in which substances may be released, is through normal wear and tear of articles (abrasion). Here, the substances are released together with the article matrix, e.g. additives in car tires or outside surface coatings of the car underbody. A potential for emission may already have been identified if a material containing the specific SVHC has been used before REACH enters into force. Check in the supply chain, branch organisations and available data sources (see examples in Annex 7). 20 A brief description of the use(s) of the substance in the article has to be included when notifying (Art. 7(4)(e)). 35

36 REVISITED RIP 3.8 FINAL REPORT DRAFT Exposure of humans and the environment The next step is to assess whether exposure to humans or the environment can be excluded. The whole life cycle of the article must be considered. A: User groups Consider the user group (industrial users, professional users, consumers etc.). An industrial process may be performed in a closed system. For articles used close to the body, like clothes, shoes or jewels, the exposure of humans is obvious and cannot be excluded. B: Environment and disposal Exposure of the air, soil and water must be considered (cf. Guideline for exposure assessment develop in RIP 3.2). Can exposure be excluded? If yes supply appropriate instructions (cf. Section 5.11) If no notification is necessary (cf. Section 5.12) 5.11 Appropriate instructions for use and disposal (Article 33(1,2)) Instructions for use and disposal Appropriate instructions should be supplied to the recipient of an article containing SVHC in concentrations above 0.1% (w/w) (Art. 33(1,2)). The information should be sufficient to allow safe use and disposal of the article and should include as a minimum the name of the substance. Other information, which should be provided, is the classification of the substance (CMR or PBT/vPvB) as well as the registration number of the substance and information about authorization of the substance: Substance name The registration number of the SVHC Information about authorization of the SVHC The information needed by the recipient could be adjusted to the type of the intended use of the article and the user, e.g. industry, professional user. Be aware that the purpose of the information is to ensure safe use, i.e. to limit the risk associated with the use of the article. The level of the knowledge of the recipient should be decisive for the formulation and design of the instruction. For industrial users, additional information could be part of the information requirements stated in Annex IV 5 of REACH Guidance of safe use : Check list for additional information that might be needed Exposure controls/personal protection 36

37 REVISITED RIP 3.8 FINAL REPORT DRAFT Handling and storage Disposal consideration First aid measures Fire-fighting measures Transport information Branch specific guidance could be developed Transferring the information The information could be included in already existing information. The information may be transferred in various ways. Paper labels might in some cases be suitable but other techniques, e.g. electronic chips or EAN codes, could be developed Notification of a substance in articles The information to be notified according to Article 7(4) shall include the following items: The identity and contact details of the producer or importer (registrant) The registration number(s) for the substance, if available The identity of the substance(s) (cf. Annex 4). This information will be available on the candidate list The classification of the substance, which will be available from the Agency A brief description of the use(s) of the substance in the article and of the uses of the article(s) (cf. Section ) The tonnage range of the substance, i.e tonnes, tonnes etc. This information can be estimated as explained in Section 5.9. Guidance for preparing a notification dossier is part of the TGD on preparation of Registration Dossiers (RIP 3.1). 6 CHECKING WHETHER A SUBSTANCE IN AN ARTICLE HAS BEEN REGIS- TERED FOR THAT SPECIFIC USE 6.1 Checking registration of substances falling under Art. 7(1) and Art. 7(2) An identified substance falling under Articles 7(1) or 7(2) has to be registered or notified, respectively. If, however, the specific use of the substance in an article has already been registered, Article 7(6) of REACH will apply and the article producer or importer shall not register or notify the substance. There are two ways of obtaining information on a possible registration of an identified use(s) of substances: 37

38 REVISITED RIP 3.8 FINAL REPORT DRAFT 1. The supply chain 2. The Chemicals Agency Any EU manufacturer or importer of a substance in a volume 1 t/a has to submit information for registration in a technical dossier. The information has to include the identity of the substance (Annex 4) and the identified use(s) including the use(s) in the article. Once the registration has been completed, the Agency has to assign a registration number to the substance concerned (Art. 20(3)). The registration number will be available in the Agency database together with the registration dossier. As previously mentioned, the registration number should furthermore appear from the SDS of a substance/preparation or be communicated to the recipient of a registered substance if Art. 32 information is required (cf. Chapter 2). Identified use(s) will not necessarily appear from the SDS but must be included in the extended SDS (esds). However, the registration number on the SDS from EU suppliers can be applied when requesting information on identified use(s) either to the supplier or the Agency. 1) Information requests up the supply chain Request up the supply chain whether the use in the article has already been registered for the identified substance. Usually substances are used in preparations and the request may therefore have to be differentiated for the different substances contained therein. At each supply chain level, a request upstream may be forwarded to more actors as the different components of a preparation may be supplied by various actors. This option is open mainly for article producers but also importers may import articles containing substances or preparations, which have originally been produced within the EU. 2) Information requests to the Agency Look for the information on the Agency database or make a request to the Agency to find out if a specific use of a substance has been registered. For this step, it is a prerequisite that the identity of the substance is known (at minimum the ID number, such as CAS, EINECS, ELINCS. For substance identification, see Annex 4). On request, the Agency should be able to give a simple yes / no answer to the question: Do I have to register my substance in articles according to Article 7(1)? based on the use identifier given by the potential registrant. When the use identifiers have been further developed in RIP 3.2, specific guidance should be developed on how to address the Agency to find out whether Article 7(6) applies. 6.2 Special conditions during phase-in for substances falling under Art. 7(1) When REACH enters into force, no substance will be registered and no article producer/importer can make use of Art. 7(6). Thus, according to Art. 23, every article producer/importer should preregister substances intended to be released from their article in order to make use of the phase-in scheme and to be allowed to continue the production or import of the article. As a potential registrant, the producer/importer will get in contact with other registrants via the SIEFs and it will be possible to assess whether own registration is necessary; e.g. by having suppliers of that substance including the article use in the substance registration. If article producers/importers miss the pre-registration, they will have to register the substances for their specific use(s) before they can place their articles on the EU market. 38

39 REVISITED RIP 3.8 FINAL REPORT DRAFT 6.3 How to decide if a use has been registered for SVHC? For articles containing substances of very high concern, for which an exposure cannot be excluded, the process of checking whether a use has been registered starts after the publication of the first candidate lists according to Art. 59(1). After having identified a SVHC as described in the previous chapters of this guidance, the producer/importer may request either the Agency (database) or check in the supply chain whether his use of the SVHC in articles is registered and possibly authorised or subject to restrictions. Annex 6 gives examples of information on SVHC expected to be delivered through the supply chain and possible requests to make for further information. 39

40 REVISITED RIP 3.8 FINAL REPORT DRAFT ANNEX 1 ABBREVIATIONS, DEFINITIONS AND EXPLANATIONS Abbreviations /a Per year Art. CAS CMR Conc. EIF EINECS ELINCS ELVs ES esds ESIS EU F GC-MS ID-no ID number IUPAC max M M/I PBT P/I Prep. REACH RIP Article Chemical Abstract System Carcinogenic, mutagenic and toxic for reproduction Concentration Enter Into Force European Inventory of Existing Commercial Chemical Substances European List of Notified Chemical Substances End of Life Vehicles Exposure Scenario Extended Safety Data Sheet European chemical Substances Information System European Union Formulator Gas Chromatography Mass Spectrometry Identification number Identification number International Union of Pure and Applied Chemistry Maximum Manufacturer Manufacturer/Importer Persistent, Bioaccumulative and Toxic Producer/Importer Preparation Registration, Evaluation, Authorisation and Restriction of Chemicals REACH Implementation Project 40

41 REVISITED RIP 3.8 FINAL REPORT DRAFT RMM RoHS SCCNFP SDS SIEF SMEs Subst. SVHC TGD Vol vpvb WEEE w/w WF Risk Management Measures Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment Scientific Committee on Cosmetic Products and Non-food products intended for Consumers Safety Data Sheet Substance Information Exchange Forum Small and Medium-Sized Enterprises Substance Substances of Very High Concern Technical Guidance Document Volume very Persistent and very Bioaccumulative Waste Electrical and Electronic Equipment Weight per weight Workflow 41

42 REVISITED RIP 3.8 FINAL REPORT DRAFT Definitions and explanations Article according to Article 3(3) Definition According to Article 3, the article definition says: Article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. Explanation The article may be ready for final use but may also be combined with other articles as a complex article consistent of several sub-units e.g. as a computer and a car. Furthermore, the article may be further processed as e.g. woollen tread or aluminium alloy cast piece. Where to set the borderline between substance/preparation and article may vary depending of either the function of the article or the type of material. Examples of different families of articles and how to treat borderline cases between article and substance/preparation in a container are presented in Annex 1b, while examples of the transition from substance/preparation to article are shown in Annex 1c. Furthermore, powders giving a specific shape, e.g. metallic powder to be used as a reinforcing material in an adhesive, should not be considered as articles. Objects falling under the article definition are e.g.: Cars, cloths, furniture, children s play toy, glasses, utensils, pens, bolt etc. Identified use Definition Identified use means a use of a substance on its own or in a preparation, or a use of a preparation that is intended by an actor in the supply chain, including his own use, or that is made know to him in writing by an immediate downstream user (Article 3(26)). Intended release Explanation The release requirements in Article 7(1) relate to substances that are intended to be released during the service life of the articles. A release of substances from articles is intended when: The release is essential for the end use function of the article or vice versa, without the release of the substances, the article would not work sufficiently. Examples: Intended releases in this sense are: Release of ink from felt tip pens (function = writing, requires the release of the ink from the pen), release of detergents from cleaning wipes for glasses (function = cleaning, the release of detergents contributes to the cleaning function of the wipes) 42

43 REVISITED RIP 3.8 FINAL REPORT DRAFT The release contributes to a quality or minor function of the article, or, in other words the, release contributes to an added value of the article, which is not directly connected to the end use function. Example: Intended release in this sense is: Release of perfume from a perfumed eraser (function = to erase, added value / function for convenience = quality to smell good) A release is not considered to be an intended release in the following cases: A release occurs during removal of 'impurities' from a semi-finished or finished article during its production process (before marketing as a finished article). Example: A size is added to a fabric to improve its process ability. Sizes are released during further wet processing of the textile A release occurs during use or maintenance of the article and is meant to improve the product quality in a wide sense or the safety as a side effect but the released substances do not contribute to the function of the article. Example: Washing of clothes by the consumer where remnants of different chemicals (dye, softener, starch etc.) from processing are removed over some washing cycles A release of substances formed during chemical reactions Examples: Release of substances from articles catching fire and ozone released from copy machine A release of perfume during burning of scented candles or incenses is considered an intended release as the release is due to heating of the media rather than a chemical reaction. Manufacturer, producer or importer Definition Manufacturer means any natural or legal person established within the Community who manufactures a substance within the European Community (Article 3(9)). Importer means any natural or legal person established within the Community who is responcible for import (Article 3(11)). Explanation Producer as such is not defined in REACH but the term article producers is used. REACH differentiates between manufacturers of substances and producers of articles. Producers of articles are third parties according to Article 28(6) and are thus in the same situation as downstream users and manufacturers and importers of substances in volumes of less than 1 tonne (sometimes they are downstream users according to the definition of use). The producer/importer who is responsible of fulfilling the requirements of Article 7 and 33(1,2) is any natural or legal person established within the Community who is legally responsible for putting the (substances in the) article on the market within the EU. 43

44 REVISITED RIP 3.8 FINAL REPORT DRAFT Article producers are those actors manufacturing articles within the EU and article importers are actors importing articles manufactured outside the EU into the European market (EU). The article producer can be an importer of articles at the same time. Normal condition of use Explanation Normal condition of use means the conditions associated with the intended end use function. Normal conditions of use may be deducible by common sense (imagining someone using the article as it is supposed to be used) or can be derived from user manuals or instructions for use. Normal conditions of use for articles used by industrial or professional users may differ significantly from conditions that are normal for consumers. This may particularly be true for the frequency and duration of normal use as well as temperature, air exchange rates or conditions related to water contact. Recommendations on avoiding specific conditions during normal use or explicitly excluding a certain use may be given by the article producer or importer as part of the instructions for use. Those uses and connected conditions of use are not considered normal use if the article producer or importer clearly states this in writing, e.g. in the instructions or on the label of the article. Examples of the exclusion of specific conditions of use are care labels in textiles do not wash above 30 C and warning statements such as keep out of children's reach or do not expose to high temperatures. Per year Definition Per year means a calendar year unless stated otherwise (Article 3(30)). Phase-in substances Definition The definition of phase-in substances according to Article 3(20) Phase-in substance means a substance which meets at least one of the following criteria: (a) It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) (b) It was manufactured in the Community, or in the countries acceding to the European Union on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this regulation (c) It was placed on the market in the Community, or in the countries acceding to the European Union on 1 May 2004, and between 18 September 1981 and 31 October 1993 inclusive it was also placed on the market by the manufacturer or importer and was considered as having been noti- 44

45 REVISITED RIP 3.8 FINAL REPORT DRAFT fied in accordance with the first indent of Article 8(1) of Directive 67/548/EEC, as amended by Directive 79/831/EEC, but does not meet the definition of a polymer set out in Directive 67/548/EEC, as amended by Directive 92/32/EEC. Reasonably foreseeable conditions of use Explanation Reasonably foreseeable conditions of use mean conditions of use outside the use originally intended by the article producer (normal use) but which may be foreseen because of the form, shape or function of that article 21. The following conditions are considered reasonably foreseeable: Accidents of high likelihood, e.g. breakage of a fragile container releasing all of the content (wording is dependent on the article definition). These are to be considered as worst-case situations. Uses not in accordance with the function but which can be anticipated because function and appearance of the article also suggests other uses than the intended ones Extremely intensive use (e.g. a consumer working with a tool 12 hours a day for three months when building his own house) Excluded from reasonably foreseeable conditions in situations of professional and industrial uses are: Uses, which are clearly and noticeably excluded by the article producer or importer. These uses are to be regarded as use deliberately against the intention Uses, which have been clearly advised to be avoided by means of product design or warning labels 22 Clear misuse Children are a good example to illustrate how reasonably foreseeable conditions of use can be identified: It is commonly known that children do not always know the function of an article but still use it for any of their purposes and in a way that suits them best. Especially small children put anything into their mouth or, if the object is too big, bite it or lick it. Therefore, when defining conditions of reasonable foreseeable uses of an article, children s access to the article should be assessed. 21 The term is occurring in the General Product Safety Directive and in the guidance to the General Product Safety Directive, it is stated: What are reasonably foreseeable conditions must be judged in the individual case and will change with market developments where consumers increasingly use complex products, for example medical devices and machinery 22 An assessment of appropriateness of the design of a product to exclude such misunderstandings should be part of the considerations 45

46 REVISITED RIP 3.8 FINAL REPORT DRAFT The assessment of reasonably foreseeable conditions of use for articles solely used by industrial or professional users can mainly focus on evaluating the likelihood of breakage/accidents (see comment in Annex VII of REACH) as uses not foreseen by the article function can normally (but not always) be excluded. The assessment of reasonably foreseeable conditions of use should be targeted only to those situations where an increased exposure or an exposure via different pathways (inhalation, dermal contact or ingestion) as compared to the normal conditions of use occurs. Recipient of an article Definition Recipient of an article means an industrial or professional user being supplied with an article but does not include consumers. Registered for that use Explanation The registration of substances in REACH shall include the identified use of the substance. In addition to that, use and exposure categories may be used. These categories are not yet decided. Substances and preparations Definition According to Article 3(1), the definition of substances says Substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. According to Article 3(2), Preparation means a mixture or solution composed of two or more substances Explanation Substances or preparations are used in the manufacture of articles. Under REACH, substances and preparations need to be accompanied by either a safety data sheet according to Article 31 (if dangerous) or by information according to Article 32 (non-dangerous). These are important information sources on identity of substances present in articles as well as registered uses of te substances. 46

47 REVISITED RIP 3.8 FINAL REPORT DRAFT Substances of very high concern (SVHC) Definition The following substances are considered substances of very high concern: Substances meeting the criteria for classification in accordance with Directive 67/548/EEC: Carcinogenic category 1 or 2 Mutagenic category 1 or 2 Toxic for reproduction category 1 or 2 Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vpvb) in accordance with the criteria set out in Annex XII of REACH Substances having endocrine disrupting properties and substances having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties giving rise to an equivalent level of concern to those substances listed above. Explanation Substances of very high concern (SVHC) are substances, which have properties of very high concern with regard to human health or the environment (see above). They may be selected for inclusion in Annex XIV of REACH or the candidate list for inclusion on Annex XIV. RIP 4.4 is developing criteria for identifying substances as CMR, PBT, vpvb or of equivalent concern. Use Definition Use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation (Article 3(24)). 47

48 REVISITED RIP 3.8 FINAL REPORT DRAFT ANNEX 1B NB! Information in this annex should be considered as work in progress as the details still needs to discussed with stakeholders and finally checked in relation to definitions. The Agency/Agency Forum is invited to work further on these lists. BASIC PRINCIPLES TO DECIDE WHETHER SUBSTANCES IN THEIR OWN OR IN PREPARATIONS IN A CONTAINER OR IN A MATRIX SHOULD BE REGISTERED UNDER ARTICLE 7(1) OR ARTICLE 7(2) (INTEGRAL PART OF THE ARTICLE) OR UNDER ARTI- CLE 6 In order to find out under which REACH Article substances are to be registered, the status of the object and the relation to its content need to be clarified: How is the object treated according to the current understanding at European level? E.g. consult the Manual of Decision for implementation of the sixth and seventh Amendments to Directive 67/548/EEC on dangerous substances (Directives 79/831/EEC and 92/32/EEC) of 23 January The object should be treated according to the common understanding whether it is an article or a substance in its own or in a preparation in a container or matrix. Examples: A printer cartridge should be considered an article, which is in accordance with the MoD, whereas substances/preparations in a spray can are considered substances/preparations to be registered under Article 6. Is the object a functional container with substances/preparations? Substances in their own or in preparations contained in functional containers are borderline cases and it has to be decided on a case-by-case basis whether the case falls under Art. 7(1)/Art. 7(2) or under Art. 6. The article definition should be used to decide whether the object is an article or a substance in its own or in a preparation in a container Consider which is most important for the function of the object: The shape and design of the container or the chemical content? If the container is designed especially for the end use function, the entire object is to be considered an article. If the function is mostly determined by the chemical content, the contained substances are to be registered under Article 6. Examples: The contained chemicals to be released from a firecracker do not determine the function to a higher degree than does the shape, surface or design. Both the contained chemicals and the form of the firecracker are important but the form is considered more important. Therefore, the firecracker containing gunpowder is falling under Article 7(1). 48

49 REVISITED RIP 3.8 FINAL REPORT DRAFT Consult the indicative list of article families to decide if a substance in a functional container is considered an integral part of an article falling under Art. 7(1)/Art. 7(2) or a substance/preparation falling under Art. 6. Is the object a matrix with substances/preparations? In most cases, substances in their own or in preparations incorporated in a matrix are considered to be articles falling under either Art. 7(1) or Art. 7(2). The article definition should be used to decide whether the object is an article or a substance in its own or in a preparation in a matrix Consider which is most important for the function of the object: The shape and design of the matrix or the chemical content? If the matrix is designed especially for the end use function, the object is to be considered an article. Examples: The chemicals remaining in textiles treated to achieve a water-repellent effect, e.g. textiles for outdoor furniture, do not determine the function of the textile to a greater extent than do the shape, surface or design. Therefore, the waxed textiles are falling under Article 7(2). Consult the indicative list of article families to decide whether a substance in a matrix is considered an integral part of an article falling under Art. 7(1)/Art. 7(2) or a substance/preparation falling under Art

50 Table 2 Categories of products based on main function of the product and release of chemicals during use. (The objects market with a in the table = Current DG ENT/DG ENV conclusion on borderline cases brought up by the consortium of RIP 3.8) FAMILY Substances in their own or in preparations falling under Art. 6 Substances in their own or in preparations as part of articles falling under Art. 7(1) Articles falling under Art. 7(2) Intended release Intended release No intended release Functional container with substances/preparations The chemical composition most important for the function The shape and design most important for the function The shape and design most important for the function S/P in spray can a Printer cartridge (ink or toner) a Thermometer a Air freshener with spray nozzle Pens Car battery a Soap in pump flasks Correction roller Cooling elements Fire extinguisher Correction pen Teeth cooler for small children Meter for costs in heaters Cooling bandage Firecracker a Articles with decorative liquids 50

51 FAMILY Substances in their own or in preparations falling under Art. 6 Substances in their own or in preparations as part of articles falling under Art. 7(1) Articles falling under Art. 7(2) Intended release Matrix with substances/preparations The chemical composition most important for the function Air freshener in a gel-matrix Soap bar Sizes in textiles during processing Brake linings (wear and tear during driving) Intended release The shape and design most important for the function Crayons Fade-out dyes in jeans Cosmetotextiles Typewriter ribbon Polishing cloth Cleaning wipes Cleaning sponge Shoe polishing sponge Diapers w. scent or lotion Wet wipes. scent or lotion Textile, films and sheets with a layer of adhesives: Adhesive tape Bonding sheet Self-adhesive patches Self-adhesive marks Plaster Scented articles: Clothes with scent Eraser with scent a Candles w. scent Play toys w. scent Books for small children w. scent CDs for children w. scent Paper w. scent No intended release The shape and design most important for the function Any textile where the natural or synthetic fibre is processed in a way that substances in their own or in a preparation are added and remained in the textile (e.g. biocide, fungicide, flame retardant, water repellents, anti-wrinkle) Objects treated so that substances in their own or in a preparation are remained in the object e.g. furniture (wood treated with e.g. biocides), electrical equipment (treated with flame retardants) and cars (treated with flame retardants). May 26 th

52 ANNEX 1C NB! Information in this annex should be considered as work in progress as the details still needs to discussed with stakeholders and finally checked in relation to definitions. The Agency/Agency Forum is invited to work further on these issues. EXAMPLES ON THE TRANFORMATION FROM SUBSTANCES/PREPARTIONS FALLING UNDER ARTICLE 6 OF REACH TO ARTICLES UNCER ARTICLE 7 OF REACH. The transition from preparation to articles is not always obvious and is may be difficult to set the border between preparation and article. Information on where to set the borderline for different materials, i.e. metal, textile, paper and plastic, has been obtained from the respective industrial sectors. Examples of where to set the borderline between preparation and article are presented on the following pages. The examples are not intended to be comprehensive or a definitive item of work but meant as illustration of the current and/or future situation of the presented objects. Furthermore, it has to be noticed that there is no intension of changing the current legal status of substances, preparations and articles. Furthermore, according to the industry (Eurofer), it might be desirable to continue to provide a SDS with some metallic semi-finished products instead of Article 33(1,2) information (Table 3). 52

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54 Table 3 Examples illustrating the borderline between preparations and metallic semi-finished products (from Eurofer Stainless Steel Producers Group) Product Form Pre-REACH After EIF Legal Status Information required Legal Status Information required Cast ingots 1 Preparation SDS Preparation SDS Remelt ingots Preparation SDS Preparation SDS Continuously cast billets and slabs Preparation SDS Preparation SDS Castings 2 - Centrifugal Article SDS may be available upon request from some suppliers Article Art. 33(1,2) - Die - Investment - Sand Bar 3 Preparation SDS Preparation SDS Blanks - Cut Article SDS may be available upon request from some suppliers Article Art. 33(1,2) - Machined Coil 3 Preparation SDS Preparation SDS Coated sheet and strip Article SDS may be available upon request from some suppliers Article Art. 33(1,2) Extrusions Preparation SDS Preparation SDS Forgings Article SDS may be available upon request from some suppliers Article Art. 33(1,2) Foil 3 Preparation SDS Preparation SDS Powder Preparation SDS Preparation SDS Powder metal and alloy compacts Article SDS may be available upon request from some suppliers Article Art. 33(1,2) 54

55 Product Form Pre-REACH After EIF Legal Status Information required Legal Status Information required Pipe and tube 4 - cast Article SDS may be available upon request from some suppliers Article Art. 33(1,2) - seamless Article SDS - welded Preparation Pipe and tube fittings Article SDS may be available upon request from some suppliers Article Art. 33(1,2) Sheet and strip 3 Preparation SDS Preparation SDS Stampings Article SDS may be available upon request from some suppliers Article Art. 33(1,2) Wire rod 3 Preparation SDS Preparation SDS Wire 3 Preparation SDS Preparation SDS Notes: 1. Cast ingots (sometimes referred to as sheet and wire ingots) undergo further processing that does not involve remelting (i.e. only their shape is changed). 2. Centrifugal, die, investment and sand castings are produced in a form close to their final shape and only require some degree of surface preparation and machining to generate the finished article. 3. After the EIF of REACH, bar, coil foil, sheet, strip, wire rod and wire could be regarded as articles because their shape or surface finish is more important than their chemical composition and they will not undergo a change of molecular structure (i.e. they will not be remelted). However, the European Commission has indicated that the REACH is not intended to change the status of substances, preparations or articles from that designated by existing EU legislation. Furthermore, (i) Article 2 of the Dangerous Substances Directive (67/548/ECC) states - For the purposes of this Directive: (a) "substances" means chemical elements and their compounds as they occur in the natural state or as produced by industry; (b) "preparations" means mixtures or solutions composed of two or more substances. (ii) Article 3 of Dangerous Preparations Directive (1999/45/EC) states Determination of dangerous properties of preparations 1. The evaluation of the hazards of a preparation shall be based on the determination of: - physico-chemical properties, - properties affecting health, May 26 th

56 - environmental properties. These different properties shall be determined in accordance with the provisions laid down in Articles 5, 6 and 7. Where laboratory tests are conducted, they shall be carried out on the preparation as placed on the market. 4. After the EIF of REACH, cast, seamless and welded pipe and tube should all be regarded as articles because their shape or surface finish is more important than their chemical composition. It should be noted that prior to REACH, welded pipe and tube have traditionally been supplied with a SDS based on the sheet material from which they are produced. 56

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