Neil Plumridge (Chair of the Environmental Working Party) has provided the following summary of recent Chemical Watch developments. In order to access links, you will need an account with Chemical Watch.
CLP revision proposal published Dec 2022, includes new delegated acts as well as changes to the regulation. The delegated acts introduce new hazard classes (Endocrine Disruptors, PBT/vPvB & PMT/vPvM. EU intends to submit these to the UN for inclusion in GHS at the same time that it implements them in EU law.
New chemicals – Sustainable substances by design (SSBD) – proposal starts with hazard assessment, however this first gate would prevent progress to the next steps, which include the assessment of risk to Human Health from Manufacturing and Production processes, risk to Environment from Manufacturing and Production Processes, then Risk to Human Health during the application processes (i.e. end use of the product), and risk assessment of the life cycle impact on environment. There have been calls to add a further SEA (Social and Economic assessment). Challenges so far encountered in using the model so far include:
• Challenges in obtaining or generating required data.
• Identifying required internal and external expertise.
• Having tools to complete the evaluation.
The proposal has been pushed back to Q4 2023 (was due Q4 2022), NGO’s not happy and demanding immediate publication. Impact is that because of the delay with REACH, Review of RoHS and other legislation dependent upon REACH are also delayed.
Essential Use Concept
Was due Q4 2022, now due Q2 2023. Essential use still to be defined, but must be essential for Health and Safety, or critical for the operation of Civil Society, and for there to be no substitute substance available (does not require that any substitute has similar technical performance, just that there are alternatives).
Proposal to restrict PFAS in the EU covers not just the original 4000+ substances, but now includes over 10,000 substances. It includes the restriction of imports of PFAS substances including PFAS substances in articles. Several options for consideration are included in the proposal:
1. Complete ban/restriction – the transition period being 18 months
2. The preferred option is a ban/restriction with a transition period of 18 months, but with certain specific derogations, time limited to transition periods of 5 to 12 years. – Dialysis membranes are one such area where suitable alternatives have not yet been identified.
Its expected that the proposals will be published and open for 6 month consultation from 22nd March. Final publication is due in 2024 with implementation by the EU in 2025.
The ECJ has dismissed PlasticsEurope’s second appeal concerning endocrine-disrupting effects on the environment in its entirety, rejecting its five grounds as unfounded or inadmissible, and bringing to an end a series of three legal challenges the trade group has mounted over BPA’s inclusion in the REACH candidate list. The EU Court of Justice has ruled that Echa was right to identify bisphenol A (BPA) as an SVHC based on its endocrine-disrupting effects on the environment, dealing another blow to PlasticsEurope in its second appeal case against the agency for this specific reason for inclusion on the candidate list.
A major enforcement project has found 40% of companies inspected in the European Economic Area (EEA) to be non-compliant with at least one REACH authorisation requirement, with complex legislation and unclear rules cited as reasons behind the widespread breaches.
As pressure mounts on the European Commission to bring forward its delayed REACH revision proposal, two NGOs have suggested ways to fast track the legislative process by amending the law’s Annexes separately through an implementing Act. The idea was mooted in a report from the European Environmental Bureau (EEB) and CHEM Trust under a scenario whereby the Commission fails to publish the proposal by June, which is seen as the latest possible time for its consideration in the current term of the EU Parliament before elections in May 2024.
EPA Review under TSCA of the first 10 substance controls is due to be completed. The Biden Administration requested the review of the assessments conducted under the Trump administration. The Assessment of unreasonable risks is designed in three stages
- Prioritisation of chemicals for review
- Risk Evaluation
- Risk Management
Biden administration has changes the risk evaluation to move away from evaluation of risk by individual uses, to now consider the risk posed by the whole chemical approach. The risk review can also no longer presume that PPE is worn correctly. So far only 1 risk management rule has been published (asbestos), however it can be expected that the rules associated with the next 10 chemical reviews will be published soon following the publication of the risk evaluation, but will differ in approach compared with the rule published for asbestos. Management rules (unlike risk evaluation), will take use of PPE and established industry best practice into consideration, and will also take occupational exposure limits into consideration. EPA could publish the first rule anytime now. EPA also due to publish on unreasonable risks.
EPA due to complete risk evaluation of the next 20 priority chemicals by June 2023, however it’s unlikely that it will be in a position to publish all 20, having had to review the initial 10 risk evaluations. But some will indeed be published. The 20 substances were originally prioritised ad submitted for review in 2019, and where due to be completed in 2023. The results will have to take into consideration the outcome of the first test evaluations that the EPA ordered manufacturers/importers to complete under TSCA.
TSCA Accumulative risk approach to be applied to the evaluation of phthalates.
TSCA Pre-market reviews, continue to be delayed with 90% missing the 90 day review deadline. EPA have been working on this, and have allocated new senior staff, implemented updated IT, and introduced new tools and chemicals assessment processes, as well as implementing training and guidance to companies making submissions to reduce rework on submission files, to improve the turnaround of submissions.
EPA TSCA final PFAS reporting rule due to be published March 2023, 1 year transition for reporting, it’s the first step to notifying manufacture, import and uses of PFAS. It includes import of articles containing PFAS. 1,300 PFAS substances are identified to be reported on. The one off disclosure requires reporting of all PFAS manufacture, import and uses since 2011. Reporting will be via the EPA CDX Portal. Also implements 5 year record keeping requirement for PFAS containing products. Requires detailed data on uses, end of life treatment of products e.g. waste handling, and on health impacts etc. Companies should actively start probing supply chains regarding the presence of PFAS is supplied goods etc.
Federal action by EPA to produce more TSCA test orders. 45 PFAS test orders are likely, also expect 150 (30 have been so far proposed) SNURS to be raised for PFAS substances.
Final rule on PFOA / PFAS likely in 2023.
PFAS – 139 Bills have been raised in the US (including at state level, in many states) regarding restriction of PFAS, 20 New laws have actually been past in the last year. State action is continuing, mainly aimed at consumer and fire fighting foam, however Maine is looking to introduce disclosure rule, intended to lead to a ban of all non-essential uses of PFAS. Draft rule is due late 2023., with the intention of the ban being in place by 2030.
California and New York state are introducing PFS Packaging restrictions, as well as phase out of PFAS in other products.
The US EPA is ‘reimagining’ the way it conducts TSCA risk evaluations, with plans to move towards a ‘leaner’ and more expedited process, Michal Freedhoff announced at Chemical Watch’s TSCA Developments 2023 conference this week. The chemicals office head also pledged to try to preserve important uses of chemicals as the agency shifts toward risk management rulemaking.
Industry requests for corrections (RFCs) to the final TSCA risk evaluations of carbon tetrachloride and n-methylpyrrolidone (NMP) will be addressed in the risk management rulemaking process for the substances, the EPA has told Chemical Watch. This means that a pair of industry challenges to certain agency determinations around workplace risks will probably remain unresolved until late summer 2024, when final rules for the substances are expected. The EPA spokesperson said that any correction requests will be dealt with in the rulemaking because it “completes the risk management regulatory development process”.
Transport Canada – revision of dangerous goods legislation, consultation is open. Proposal includes alignment with international requirements, and alignment with US hazardous substance transport rules to aid cross border trade.
CEPA (Canadian Environmental Protection Act) – Last updated 1999, but more recently reviewed, it was decided that it was about time that it was updated. A Proposal was drafted in 2022, and voted through in 2022 as the S5 Bill. It’s due final changes and the final vote. It introduces an approach similar to the EU hazard focused approach. The current list of hazardous substances would be split into two parts, with Part one holding higher risk substances, and part two containing the other hazardous substances. It would also introduce a watch list, which industry is not happy about. It would also set a much higher bar for justification of confidential business information. Risk assessments would also have to consider accumulative risk, and the impact on at risk communities, with the inclusion of a right to a healthy environment as part of the update.
Canada looking to publish restrictions of Long Chain PFAS, removal of some existing exemptions from current rules, on the use of PFOA substances. Will also look to restrict the use of DBPE and DEHP flame retardants in products, with new legislation likely.
Ongoing chemicals legislative work as more countries join the OECD.
Draft law proposed 2022, would establish an industrial inventory, risk assessment and risk management., stalled under the previous administration, hope is that under the new administration it will eventually be passed. November 2022 it passed first committee stage, and has now (Q1 2023) passed to the next committee for review, then onto the upper house for vote into law.
National Inventory of Industrial Chemicals and associated risk assessment legislation. Applied to industrial chemicals from Feb 2022, and will apply to mixtures from Feb 2025, aligned to GHS, first LATAM country to pass legislation.
Ministry of Health, has a list of hazardous substances subject to import controls, expect to see updated procedure, the list is also being updated in line with GHS hazard categories. Update to the standard for non-Industrial chemicals was published 9th Feb 2023.
Expect to see an expansion of Chiles Extended Producer responsibility legislation.
National Inventory of Industrial Chemicals and associated risk assessment legislation. Published Nov 2022, there should be an industrial chemicals inventory by 2025. Establishment of a Department for risk assessment and risk reduction. Columbia is pushing to meet OECD requirements. It currently meets 9 out of 10 requirements for chemicals management. It’s updating it’s SDS requirements to align with GHS 7th Ed from April 2023.
Established Industrial Inventory, New Government Department for risk assessment.
Mercosur (Argentina, Brazil, Paraguay, Uruguay)
Aligning chemicals legislation. Argentina and Uruguay have implemented 4th Ed GHS, Brazil the 5th Ed, Paraguay so far has not implemented GHS. Expect GHS alignment and update to more recent edition across the trade body.
Latin American Regulatory Forum is promoting harmonisation of chemicals legislation across the region.
Federal Dangerous Goods Code, published by the National Transport Agency, applies from 1st April 2023, and is mandatory from 1st April 2024, however it’s subject to state implementation. It’s harmonised with the 22nd UN Road and Maritime regulations. Table 184.108.40.206 is updated. Published as ADG Version 7.8. Includes Lithium Batteries.
ADG 8.0 due for publication, and is a more fundamental review, hopefully aligning more with international regulation. It will include shipping requirements for infectious materials (for the first time).
Taiwan’s EPA has banned ten organotin compounds for use in the manufacture of biocides, antifouling paint and antifouling systems. They are now only permitted for use in research, experimentation and education, PU resins, plastic stabilisers and pharmaceuticals. Published on 20 February, the amendment to Categories and Management of Handling for Toxic Chemical Substances, a subsidiary regulation to the Toxic and Chemical Substances of Concern Control Act (TCSCCA), came into effect immediately.
UN Model Regulation on the Transport of Dangerous goods (Orange Book) updated Jan 2023.
New focus on Un Sustainability goals and how the transport of dangerous goods supports these. Ongoing work to update the regulations to address new green energy fuel transport requirements, as well as the need to develop regulation regarding the shipments of sodium ion batteries. Also looking to approve the use of electric vehicles for shipments of dangerous goods.
Latest Dangerous goods by air requirements apply from 1st Jan 2023.
IATA – Proposal to develop a risk based approach regarding Lithium batteries for shipments via air transport.
Discussion regarding development of Competence Based Training and Assessment requirements for those involved in shipping dangerous goods. Canada are also looking at similar requirements for shipping agent training and competence.
International Maritime Agency – Update of IMDG code for sea transport
Updated Road, Rail and Inland waterway requirements for shipments of dangerous goods – is mandatory (for signatories to the UN convention) from 1st July 2023
Update of ADR – Road Transport – This was originally specifically for cross border shipments, but is now also being cited in domestic legislation (UK, EU etc.) and applies as national transport requirements.