Polymers: Global Notification Procedures

Transcription

1 Polymers: Global Notification Procedures - US - Canada - Japan - Australia - China (Peoples Republic) - Korea - Philippines - Taiwan - Switzerland Not going to cover: EU (in any detail) Malaysia New Zealand Turkey John Moore Regulatory Consultant

2 Manufacturing & Marketing of New Polymers Many of the regulatory principles for new polymers have been taken from the rules developed for new non-polymeric substances: Exemption/applications for Exemptions Research & Development Reduced datasets for low volume chemicals Simplified Notification Notifying new polymers is not that difficult. CHALLENGE: Minimise testing hence reduce costs and resources Compile a dataset to satisfy all regions and meet MSDS/CLP responsibilities Gain early market access

3 Manufacturing & Marketing of New Polymers Planning is key: Do not rush into testing, consider your options and then plan carefully and accordingly. Questions to consider: In which regulatory controlled regions do you wish to market your new polymer? Is your polymer a true regulatory polymer in those regions? Understand polymer chemistry, chemical & structural features, & key properties - Is your polymer really new globally, could it be an existing polymer? - Apply inventory rules (especially exemption rules) - Benefits of assessing monomers - Is your new polymer one of Low Concern? - PLC - RRR - RTP - Do exemptions from notification apply? (application?) - Simplified/reduced/limited/abbreviated notifications? Special provisions for REACH EU & Switzerland Goal: Establish minimum data / information requirements Global perspective

4 Early Planning Consideration EU Use Monomers and Other Reactants present in your polymer in combined form that are REACH compliant within your supply chain no regulatory action required. SWITZERLAND, CHINA, US, CANADA & PHILIPPINES Offer exemptions/reduced testing facilities for Regulatory Polymers produced from Inventory listed monomers/reactants

5 What is a Regulatory Polymer? Polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. MW spread sufficient to ensure no more than half the species present have the same MW, and consist of at least 50% (w/w) of molecules which consist of a chain of 3 (or more) monomer units linked to at least one other unit i.e. 50% of a polymer must be of 4 units or more, but it does not matter how many monomer types are present Adopted by US, Canada, Australia & Switzerland EU (REACH) - slightly truncated version China, Korea, Taiwan & Philippines - very similar Japan additionally require Mn >1000

6 Polymer, Structure Chemistry & Key Properties Chemical identification, purity, structure, molecular formula - world wide regulatory status Chemical characteristics (polyester, dissociation, functionality) GPC understand MW properties - low Mw species, residual monomer(s) content Stability especially under conditions of use Biodegradable? Physico-chemical properties (water solubility / extractivity, particle size) Information for MSDS, CPL worker & customer safety Basic Core Information set useful across most regulatory controlled regions.

7 New or Existing Polymer? In-depth knowledge of polymer chemistry EU, Switzerland, China & Philippines: Monomers are key US (TSCA) Canada (DSL/N-DSL) Philippines (PICCS) Australia (AICS) Japan (ENCS & ISHL) China (IECSC) Taiwan Korea (ECL) In-depth knowledge of inventory rules CAS Number listed which fully describes your new polymer: No further actions required. Unrestricted manufacture & import Japanese ENCS. Many generic listings. Not fully CAS# indexed. Expertise needed to search. Do not assume a new polymer is not represented

8 Inventory Conforming: Inventory Exemption Rules <2% monomer rule Utilise inventory listings that do not include monomers present <2% US, Canada, Australia, Philippines, Taiwan, EU (REACH), Switzerland Korea China >99% & >98% listed rule Japan Top 2 monomer rule Philippines Monomers listed Philippines, Switzerland China Reduced testing US, Canada China special simplified notification Graft & Block co-polymer rule Japan Taiwan Korea Special Salt rule Japan Not as simple as obtaining a CAS# and checking inventory listing. Use of these rules can lead to significant savings (money & resource)

9 Polymers of Low Concern If you have a new polymer, endeavour to meet Polymer of Low Concern (PLC) criteria in as many regulatory controlled regions as possible and take advantage of the reduced testing facilities these offer Save: Time to market Capital Resource

10 Criteria for PLC - General US, Canada, China, Australia, Taiwan Polymers : Mn >10,000 Species of MW <1000 limit : <5% < 500 limit : <2% Other terms for PLC: Canada: RRR Switzerland: RTP Polymers Mn > <10,000 Species of MW <1000 limit : <25% < 500 limit : <10% Taiwan: Polymers classified (GHS) CMR or Env haz do not qualify MW and oligomer content are not the only considerations. Korea PLC covers: Non-ionic polymer Mn >10000 Other polymers with Mn >1000 if: of which all starting monomers /reactants are listed in KECI and not listed on the toxic chemicals (except inorganic compound) listing specified/published by NIER. Philippines Switzerland Japan China Other common features which apply to some but not all the regions: inventory listed reactants; stability; solubility / extractivity / absorbivity; functionality; non-hazardous (to human health) classification; special considerations for polyesters

11 PLC: Japan Since April , to be a polymer of low concern, the polymeric material must either meet all the conditions 1-4 1) Stability tests at various phs: - including the various criteria stipulated 2) No weight change (<2 wt.%) in solubility tests in acidic and alkaline conditions or the basic structure of the substance has no positive charge. 3) <2 wt. % soluble in water and organic solvents. may not need to meet this 4) No metals other than Na, Mg, K or Ca are contained in the structure. OR..

12 PLC: Japan (cont) Polymers meeting conditions 1, 2, 4, (but not condition 3), can attain PLC status, by fulfilling conditions 5 and 6 and either 7i or 7ii. 5) Oligomer (MW 1000) content is <1%, and no concerns for bioaccumulation. 6) As or Se are not contained in the structure. 7) i. Mn is >10,000 ii. Polymers with Mn <10,000 consisting of existing chemical substances, with no C-C, C-N double or triple bonds and containing no designated functional groups in the structure. Designated functional groups are: Aziridyl-, Amino-, Epoxy-, Sulfonic acid-, Hydrazino-, Phenolic hydroxyl, or Fluoro-groups. ISHL requirements: MW & chemical characteristics

13 PLC: China Simplified Notification MW criteria same as US, Canada, Australia etc. Simplified Notification i. average molecular weight of polymers is 1,000-10,000 Daltons, oligomers with molecular weight less than 500 Daltons have less than 10% content, and oligomers with molecular weight less than 1000 Daltons have less than 25% content. Low concern polymers shall not contain high concern or high activity groups, such as heavy metal, cyan group, acrylic ester, aziridine, isocyanate, thio-isocyanate and vinyl sulphone. ii. average molecular weight of polymers is not less than 10,000 Daltons, oligomers with molecular weight less than 500 Daltons have less than 2% content, and oligomers with molecular weight less than 1000 Daltons have less than 5% content. iii. Polyesters which contain at least two carboxylic ester bonds in polymeric molecules and at least one carboxylic ester bond combined with internal monomers. Still have another chance to attain PLC

14 PLC: China Simplified Notification Structural /phys-chem assessment: Heavy metals or cationic No Water solubility Not soluble General/Typical Notification Solvent solubility Not soluble ph stability Stable October 2010, a simplified notification system replaced the former annual application procedure. Conclude as PLC

15 PLC: Taiwan Simplified Notification of Polymers (a) Mn with no active functional groups MW <500, <10% and MW <1000, < 25% (b) Mn >10,000 with no active functional groups MW <500, <2% and MW <1000, <5% (c) If the blocks and branch chains of your new polymer are all listed in the soon to be published existing chemical substances inventory - Regarded as a PLC - Notified via the simplified notification scheme

16 US: Using the PLC exemption route Annual submission to EPA Structural Representation Identity of reactants/monomers and verification of TSCA listings Analytical Data Note No PMN no inventory listing, therefore re-importation may be restricted. Assessment criteria difficult Benefit: no 90 day review period Alternative: File PMN & NOC

17 Canada: Using the PLC route PLC= Reduced Regulatory Requirement (RRR) Schedule 9 Highest Schedule for RRR polymers (Unlimited quantities) and other polymers at <10MT/annum Mainly bibliographic & polymer specific MW information. 30-day review period. Supports DSL listing

18 Japan: Using the PLC route In Japan if you meet and decide to take the PLC route, it is said that formal notification is no longer required... However you do need to: Obtain approval from the Ministries by submitting the appropriate application form Submit test results and information that confirms PLC

19 Australia: Using the PLC route PLC Conforming: Dossier submission to NICNAS is required 90-day review period (permit available after 28-days) Listed on AICS after 5 years, or earlier at notifier s request Self assessment available for PLCs which are non-hazardous (human health) Benefits: No study reports. 28 day review period. Reduced fee Data is required to confirm PLC status Data is required to confirm non-hazardous

20 Korea: Using the PLC route Information requirements for application for exemption from notification of PLC Non-ionic polymer Mn >10000 Other PLC Mn >1000 Chemical name and CAS No of the Polymer Structure (if defined) GPC - molecular weight information Non-GLP lab testing data are acceptable but it must include molecular distribution curve, slice table, test method/condition, etc in a formal report form signed by responsible person with the name/address of test lab OECD TG 118. Chemical name/cas No of each monomers/reactants demonstrating they are neither new chemical substances i.e. all listed on KECI nor toxic chemicals (except inorganic compound) defined by NIER under the TCCA Information requirements for application for exemption from notification of PLC Non-ionic polymer Mn >10000 Other PLC Mn >1000 Chemical name and CAS No of the Polymer

21 China: Using the PLC Simplified Notification Route Routine Simplified Notification Complete simplified notification form Information to demonstrate that the polymer meets the PLC criteria Chemicals notified via the simplified scheme are not listed on IECSC Non PLC: notify as a non-polymeric substance..

22 Taiwan: Using the PLC Simplified Notification Route Submission requires: Notifier s details Chemical name (English & Chinese) CAS Registry Number (if available) Appearance, colour, odour Safe use information (handling, storage, transportation etc) GHS classification & labelling Characterisation / identification data Physico-chemical properties Non-PLC: Full notification

23 Non-PLC: Other Alternatives Turkey to Full Notification If you do not meet PLC, there are other polymer specific facilities available which may lead to reduced testing

24 Canada Non-RRR : Reduced Notification based on MW and Volume Considerations If: N-DSL Polymer or polymer produced from DSL/N-DSL monomers reactants & Manufactured or imported at >10-<50MT/annum Schedule 10 : final for polymers that do not meet the high release/exposure category guidelines/. Mainly MW, phys-chem & basic tox & env information. 60 day review period Manufactured or imported >50MT/annum, requires a Schedule 10 update. Additional information needed Schedule 11 for other non-rrr polymers

25 Non-PLC: Australia Limited/Abbreviated Notification Schemes Australia: Non-PLC: Mn>1000 reduced data set Mn <1000 treat as a non-polymeric substance

26 Non-PLC: Korea Reduced Data Sets Reduced testing compared to full notification of non-polymers. General information (all substances): Plus: Polymer specific test data - Option 1 or Certain polymer specific information + mutagenicity & toxicity (acute oral) Option 2 or Certain polymer specific information + mutagenicity & ecotoxicity (acute fish) Option 3

27 Non-PLC: Philippines Abbreviated Notification Schemes Philippines: Abbreviated notification scheme for polymers listed on one other inventory No specific polymer tests Supply the information in your possession in a 16 section MSDS format

28 Switzerland Partially Revised ChemO Polymers produced from EINECS listed monomers/reactants do not require notification New polymer: not been previously notified contains in combined polymerised form >2% of non-einecs listed monomer(s). Notification required if the new monomer is placed on the market i.e. in combined form > 1MT/annum Notification according to REACH Registration for the new monomer(s) Information is based on vols of the monomer in Switzerland + EEA OECD regulatory polymers produced from EINECS listed monomers do

29 Full Notification: Data/Information/Testing Testing/Information Requirements for Global Notifications: Real Challenge for unlimited volumes in the absence of: PLC Reduced/simplified schemes being available

30 Planning Tests/Information Building Block Approach. 1. Basic Core Information ph Stability Chemical identity/purity Mw GPC etc Solubility Dissociation properties Functionality Biodegradability MSDS/ label ph stability 3. Higher Level Cationic/ionic props Classification Further extraction studies Further stability tests 2. Typical Basic Core information Set + Hydrolysis as a function of ph Solubility: water/solvents/acid alkaline Log P/Abs/desorption/diss const/ Charge density Particle Size Mpt/Bpt/ vapour Density Flammability/Explosivity/flash point Auto ignition/oxidising/reactivity Ames Oral toxicity Fish toxicity 4. Non-polymer substance Type Full battery of Tox / Env acute studies and mutagenicity tests Plus longer term studies

31 Testing Information: Regions Covered 1. Basic tests typically cover: US (PLC and other typical polymers) Canada (RRR & Schedule 9) China (PLC) Korea (PLC/Option 1) Taiwan (PLC) Australia (PLC but may fall short) 3. Higher Level Japan (PLC) Philippines Switzerland (RTP) Korea Options (2&3) 2. Typical tests additionally cover: Australia (Mn >1000) Canada (Schedule 10) 4 Non-polymer substance Type Canada (Schedule 11) Japan (non-plc) Australia (Mn <1000) China (non PLC) Switzerland (non-rtp) Monomers (REACH/Switzerland)

32 Final Message, Conclusion Plan well Understand your polymer chemistry If possible, design chemistry to provide alternatives to full notification Understand inventory rules Develop some basic information Make full use of all available exemptions & reduced testing facilities Develop a robust, cost effective, global testing plan Thanks for your kind attention