Global Regulatory Update for March 2022

EVENTS:

Register Now For “UK REACH, What’s Happened And What’s Next?,” On March 23, 2022: Companies worldwide must be aware of the significant implications for chemical regulatory compliance under the United Kingdom (UK) REACH regulation as the UK has completed its first year of complete separation from the European Union (EU). Companies should act quickly to understand their rights and obligations under UK REACH to maintain continuity of their supply chains and market access. “UK REACH, What’s Happened and What’s Next?” will delve into these important issues with The Acta Group (Acta^®) professionals who have decades of experience to help evaluate what to expect in 2022.

CHEMUK 2022, May 11-12, 2022, Birmingham, UK: CHEMUK 2022 brings together all the stages of chemical and chemical product development, specification, and processing/manufacturing communities with crucial supply chain supplier groups. Acta is a proud sponsor, and Steven P. Brennan, Ph.D., Senior Manager, REACH and Emma Louise Jackson, CBiol MSB, Regulatory Consultant will be at Acta’s exhibit table on May 11 and 12, 2022. Sign up now for complimentary registration at https://chemuk22.smartreg.co.uk/Visitors/Visitors/register?promoid=TAG, courtesy of Acta.

“What To Expect In Chemicals In 2022” Webinar Recording Available Now: Acta affiliateBergeson & Campbell, P.C.’s (B&C^®) January 26, 2022, webinar “What to Expect in Chemicals in 2022” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/864194569862780944. During the one-hour webinar, Lynn L. Bergeson, President, Acta; Richard E. Engler, Ph.D., Director of Chemistry, Acta; and James V. Aidala, Vice President, Policy and Government Affairs, Acta, offered their best informed judgment as to the trends and key developments chemical industry stakeholders should expect to see from the U.S. Environmental Protection Agency (EPA) in 2022. We encourage you to view the webinar and read our comprehensive Forecast for U.S. Federal and International Chemical Regulatory Policy 2022 to learn more about the key trends for which companies should now prepare.

NEW PODCAST EPISODES:

The “PIPing” Point — A Conversation With Kelly Scanlon, DrPH, Director Of EHS At IPC: Lynn L. Bergeson and Kelly Scanlon, DrPH, CIH, Director of Environmental Policy & Research, Global Government Relations, at IPC sit down for this episode of All Things Chemical^® to discuss IPC’s work on environment, health, and safety (EHS) policy, enhanced regulation of articles under TSCA, and other challenges the electronics industry faces.

Toxics And Human Rights — A Conversation With Baskut Tuncak, Director Of TURI: On this episode of All Things Chemical, Lynn L. Bergeson and Baskut Tuncak discuss Baskut’s goals as Director of the Toxics Use Reduction Institute (TURI) at the University of Massachusetts, Lowell, one of three agencies implementing the Massachusetts Toxics Use Reduction Act, and his prior role of United Nations (UN) Special Rapporteur on toxics and human rights. Listen now.

B&C’s 2022 Forecast: Lynn L. Bergeson, James V. Aidala, and Richard E. Engler, Ph.D. discuss what to expect in 2022 with regard to industrial and agricultural chemical regulation in the United States during this episode of All Things Chemical. Listen now.

How Can Battery Production Be Greener? — A Conversation With Mathy Stanislaus: During this episode of All Things Chemical, Lynn L. Bergeson and Mathy Stanislaus cover a broad range of issues, including the mission of the Global Battery Alliance (GBA), Mathy’s new role as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, GBA’s fascinating and potentially transformational Battery Passport project, and other interesting topics. Listen now.

NEW ARTICLES:

Lynn L. Bergeson Authors “PFAS: Making Sound Investment Decisions,” Financier Worldwide: The ubiquity of per- and polyfluoroalkyl substances (PFAS) and the manufacturing sector’s decades-long reliance on them to impart functionalities in a dizzying array of products put the investor between the proverbial rock and a hard place. PFAS’s varied chemical properties make the broad categorization of “PFAS” into a monolithic category of “forever chemicals” chemically and scientifically questionable. For better or worse, however, that is exactly what is happening today, and distinguishing between commercially promising and commercially risky PFAS chemicals is challenging. Yet, the ability to make this distinction could be the difference between a great investment and a commercially disastrous one. This article explores this difficult assessment, provides essential information on PFAS, and offers some suggestions to avoid making bad investment decisions.

Lynn L. Bergeson Authors “Isn’t It Ironic?,” American College Of Environmental Lawyers (ACOEL) Blog: The Biden Administration’s EPA is laser focused on achieving several “whole-of-government” priorities: addressing climate change, identifying and giving environmental justice greater consideration in decision-making, and following the science wherever it may lead. Knowing and respecting leadership in the Office of Chemical Safety and Pollution Prevention (OCSPP) tasked with achieving these laudable yet daunting objectives shows that there is no question the commitment is genuine. It is ironic, however, that EPA is applying the Toxic Substances Control Act (TSCA) in ways that are counterproductive to achieving these goals. The full article is available on the ACOEL Blog.

Lynn L. Bergeson Authors “Toxic Substances: EPA Targets Asbestos,” Chemical Processing: TSCA has long been considered the “poster child” of failure as a chemical control law when it comes to asbestos regulation. EPA in its latest approach to regulating “legacy” uses may well invite heightened scrutiny. EPA announced in December the availability of the Draft Scope of the Risk Evaluation for Asbestos, Part 2. In it, the Agency will evaluate conditions of use of asbestos that were excluded from Part 1 as legacy uses and associated disposals, and conditions of use of asbestos in talc and talc-containing products. This article summarizes EPA’s approach.

AUSTRALIA

AICIS Begins Comment Period On Draft Evaluations Covering More Than 1,000 Industrial Chemicals: On January 31, 2022, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced that it has completed ten draft evaluations covering 1,417 industrial chemicals that:

• AICIS identified as possibly posing a risk to human health and/or the environment;
   
• Are unlikely to require further regulation in Australia to manage environmental risks; or
   
• Are not considered for in-depth evaluation because they are not commercially active in Australia.
   

The evaluations open for comment are:

• 1,3,5-Triazine-2,4,6-triamine (melamine);
   
• 1,6-Octadiene, 7-methyl-3-methylene-(Myrcene);
   
• 2,5,8,11,14-Pentaoxapentadecane (tetraglyme);
   
• 2-Phenylphenol and salts;
   
• Chemicals not considered for in-depth evaluation — not commercially active in Australia;
   
• Chemicals that are unlikely to require further regulation to manage risks to environment;
   
• Compounds of dimethyltin;
   
• Ethanone, 1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)-, [3R-(3.alpha.,3a.beta.,7.beta.,8a.alpha.)]- (acetyl cedrene);
   
• Octynoic and nonynoic acid esters; and
   
• Trimellitates (high molecular weight).
   

Comments are due March 28, 2022.

CANADA

Canadian Government Introduces Bill Intended To Modernize CEPA: Environment and Climate Change Canada (ECCC) announced on February 9, 2022, that the government introduced in the Senate the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), intended to modernize the Canadian Environmental Protection Act, 1999 (CEPA) and make related amendments to the Food and Drugs Act (FDA). The bill was initially introduced in the 43rd Parliament in April 2021 as Bill C-28, but it was not considered due to the federal election in September 2021. ECCC states that the bill would “encourage businesses to transition to the production and use of chemicals that are safer for the environment and human health.” Under the bill, ECCC would develop a new plan of chemical management priorities and would propose a new regime to manage toxic substances of highest risk. Canada would create a publicly available “Watch List” of substances determined to be capable of becoming toxic under CEPA to inform Canadians and businesses of substances that they may wish to avoid. Our February 22, 2022, memorandum provides a summary of the amendments and new measures in the bill.

Canada Begins Public Consultation Process For Development Of Regulations Regarding Recycled Content For Certain Plastic Manufactured Items: On February 12, 2022, Canada published a notice of intent to inform, and seek early feedback from, interested parties regarding the development of regulations under CEPA to require minimum recycled content in certain plastic manufactured items. Canada also published a technical issues paper outlining details of the proposed regulations. Comments are due March 14, 2022. The Department of the Environment will consult stakeholders and interested parties on the proposal through early 2022, including through virtual engagement sessions. Parties interested in attending these sessions are asked to contact the Department at ContenuRecycleRecycledContent@ec.gc.ca. The Department intends to publish the proposed regulations as early as the end of 2022. There will be a comment period following the publication allowing interested parties an opportunity to provide feedback.

Canada Launches Consultations On Mandatory Labeling For Chemicals In Consumer Products And Better Supply Chain Transparency: Canada announced on March 4, 2022, the launch of national consultations on improved and mandatory labeling for certain consumer products, including cosmetics, cleaning products, and flame retardants in upholstered furniture. The consultations will also seek views on how the government can improve information about chemicals in product supply chains. The consultations will take place through a series of workshops and interactive events between now and summer 2022. ECCC and Health Canada have engaged Wood Canada Limited to lead the consultations in a policy lab format. The policy lab will bring together experts and interested parties in broad discussions and focus groups and use digital tools to explore and test potential solutions as they are being developed. To participate in the consultations, interested parties are invited to identify themselves on the virtual consultation platform or by e-mail at policylab@woodplc.com no later than March 25, 2022.

EUROPEAN UNION (EU)

ECHA Adds Four Hazardous Chemicals To Candidate List: The European Chemicals Agency (ECHA) announced on January 17, 2022, that it added four substances to the Candidate List of Substances of Very High Concern (SVHC). The entries added to the Candidate List are:

Under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), companies have legal obligations when their substance is included — either on its own, in mixtures, or in articles — on the Candidate List. Any supplier of articles containing a Candidate List substance above a concentration of 0.1 percent (weight by weight) has to give sufficient information to their customers and consumers to allow safe use. ECHA notes that consumers have the right to ask suppliers whether products they buy contain SVHCs. Importers and producers of articles must notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list. Suppliers of substances on the Candidate List (supplied either on their own or in mixtures) must provide their customers with a safety data sheet (SDS). They also have to notify ECHA under the Waste Framework Directive if their products contain SVHCs in a concentration above 0.1 percent (weight by weight). This notification is published in the Substances of Concern In articles as such or in complex objects (Products) (SCIP) database on ECHA’s website.

EU Opens Consultation On Changes To REACH: On January 20, 2022, the European Commission (EC) launched a public consultation seeking comment on a proposed revision of the REACH regulation (No. 1907/2006). The consultation is the most extensive to date; it covers many elements of the legislation and, once changes are implemented, will have a significant impact on industry for the future. The consultation topics include:

• Revision of the registration requirements, including increased information requirements and establishing the obligation to register certain polymers;
   
• Introduction of mixture assessment factors (MAF);
   
• Simplification of communication in the supply chain;
   
• Revision of the provisions for dossier and substance evaluation;
   
• Reform of the authorisation and restriction processes, including the extension of generic approaches to risk management and the introduction of the essential use concept; and
   
• Revision of the provisions for control and enforcement.
   

The consultation will run until April 15, 2022. A link to the consultation survey is available here. More information is available in Acta’s February 2, 2022, memorandum.

ECHA Seeks Comment On Proposal To Add Eight SVHCs To Authorization List: ECHA announced on February 2, 2022, that it is considering recommending eight new substances for the EC to include in the Authorization List (REACH Annex XIV). The substances include:

ECHA invites further information on the uses of these substances, their possible exemptions from the authorization requirement, and on the structure and complexity of their supply chains. According to ECHA, the EC is also separately calling for information on the possible socio-economic consequences of including these substances in the Authorization List. ECHA states that it will pass the information directly to the EC and will not consider it. Comments are due May 2, 2022.

SCIP Database Includes Seven Million Article Notifications: ECHA announced on February 2, 2022, that the SCIP database has seven million searchable article notifications received from nearly 7,000 companies across the EU. The database is searchable by article name, brand, product category, type of material, chemical name, or SCIP number. According to ECHA, the information “helps consumers to make more informed and sustainable purchasing choices,” and waste operators can use the data to improve their current re-use and recycling practices. The data also increase knowledge about SVHCs in supply chains and can help drive their phase out. In 2022, ECHA intends to continue improving how information is displayed in the database, making the system more stable, and helping stakeholders through support materials, the ECHA Helpdesk, and events.

NGO Challenges Labeling Of Bio-Based Plastics And Chemicals: ClientEarth, an environmental non-governmental organization (NGO), announced on February 4, 2022, that it filed an internal review request to the EC for unlawfully labeling bioenergy, bio-based plastics, and chemicals used to make plastics as “sustainable” in the EU taxonomy. According to ClientEarth, the Climate Delegated Act, which has been applicable since January 2022, wrongly classifies bioenergy, bio-based plastics, and chemicals used to make plastics as activities that “contribute substantially to climate change mitigation or adaptation” and do no significant harm to the environment. ClientEarth maintains that the EC has infringed the Taxonomy Regulation by relying on flawed standards for biomass already provided under the recast Renewable Energy Directive, instead of assessing whether the available scientific evidence on biomass production is conclusive. ClientEarth is also challenging the labeling of bio-based plastics and of bio-based chemicals, such as ethylene and propylene, used to make plastics. The EC has 16 weeks to reply to the internal review request. If the reply does not fix the breaches of law, ClientEarth can challenge the decision before the European Court of Justice.

EC Announces Increase In Availability Of Biological Pesticides: The EC announced on February 10, 2022, that EU member states have approved new rules to facilitate the approval of micro-organisms for use as active substances in plant protection products. According to the EC, the new rules “will provide the EU’s farmers with additional options to substitute chemical plant protection products.” The EC states that after the new rules take effect, the approval of micro-organisms and the authorization of biological plant protection products containing them will be “significantly faster,” ensuring that new biological solutions that can replace chemicals are put on the market more quickly. The EC notes that the new rules will put the biological and ecological properties of each micro-organism at the center of the scientific risk assessment, which needs to demonstrate safety before the micro-organisms can be approved as active substances in plant protection products. More information is available in the EC’s questions and answers (Q&A).

EP Committee Approves Proposed Rules To Govern Design, Production, And Disposal Of Batteries: The European Parliament (EP) Committee on the Environment, Public Health and Food Safety announced on February 10, 2022, that it adopted its position on proposed rules to govern the battery product life cycle, from design to end of life. The Committee agreed with the EC’s approach to overhaul current legislation to take into account technological developments and amended provisions in several areas, including the introduction of a new category of “batteries for ‘light means of transport’ (LMT)”, such as e-bikes. The Committee approved the proposed rules on a carbon footprint declaration and label, a maximum value for the life cycle carbon footprint, as well as minimum levels of recovered cobalt, lead, lithium, and nickel from waste for reuse in new batteries. The Committee “want[s] the battery industry to follow internationally recognised due diligence standards across their entire value chain.” The Committee calls for more stringent collection targets for portable batteries, and the introduction of minimum collection rates for LMT batteries, and the collection of all waste automotive, industrial, and electric vehicle batteries. The Committee expects the report to be adopted by plenary in March 2022, and it will constitute the EP’s negotiation position with EU governments on the final shape of the legislation.

EP Approves Update To Carcinogens And Mutagens Directive: The EP announced on February 17, 2022, that it adopted an informal agreement reached in December 2021 on the fourth revision of the Carcinogens and Mutagens at Work Directive. The revision will include reprotoxic substances within the scope of the Directive for the first time. EP negotiators also secured an agreement that health-care workers who deal with hazardous medicinal products, half of which are reprotoxic, must receive sufficient and appropriate training on how to handle them safely. The revision will also provide for occupational exposure limits (OEL) for acrylonitrile and nickel compounds and revise the maximum limit for benzene downward. In addition, the EC will be required to present legislative proposals on OELs for 25 substances or groups of substances before the end of 2022. Pending the approval of the EU Council, the revision will enter into force on the twentieth day after its publication in the Official Journal of the European Union. EU member states will have two years to transpose the Directive after its entering into force.

EC Begins Public Consultation On Reducing The Release Of Microplastics Into The Environment: The EC announced on February 22, 2022, the launch of a public consultation on how best to reduce the amount of unintentionally released microplastics into the environment. According to the EC, the public consultation will support its initiative on Microplastics pollution – measures to reduce impacts on the environment, “a key deliverable of the Circular Economy Action Plan and the Zero Pollution Action Plan.” According to the EC, the consultation focuses on plastic pellets, synthetic textiles, and tires, the sources that are known to release the largest quantity of microplastics. Additional sources, such as paints, geotextiles, and detergent capsules for laundry and dishwashers, are also being evaluated. Responses are due May 17, 2022.

Proposal To Ban “Forever Chemicals” In Firefighting Foams Throughout The EU: ECHA progresses a REACH restriction proposal on all PFAS in firefighting foams. Five different restriction options to protect human health and the environment from PFAS have been assessed. The preferred option would ban the placing on the market, use, and export of all PFAS in firefighting foams. This option would also provide transition periods to allow industry to develop and implement safer alternatives without compromising fire safety. If enacted into law, the restriction would prevent release of an estimated 13,000 metric tons of PFAS to the environment; it is estimated to cost society €7 billion EUR over 30 years. A six-month public consultation on the proposal will start on March 23, 2022. ECHA will also host an online webinar on April 5, 2022, to explain the restriction process and support stakeholders.

In addition, five member states of the EU are working on a restriction proposal for PFAS in all other uses. It is anticipated that this proposal will be brought to the EC in January 2023. PFAS importers, manufacturers, and users should keep abreast of the developments regarding firefighting foams as a blueprint for restriction of other uses.

EC Adopts Proposal For Directive On Corporate Sustainability Due Diligence: The EC announced on February 23, 2022, that it adopted a proposal for a Directive on corporate sustainability due diligence. According to the EC, the proposal is intended to foster sustainable and responsible corporate behavior throughout global value chains. Companies would be required to identify and, where necessary, prevent, end, or mitigate adverse impacts of their activities on human rights, such as child labor and exploitation of workers, and on the environment, for example, pollution and biodiversity loss. The new due diligence rules would apply to the following companies and sectors:

• EU companies:
  
  • Group 1: All EU limited liability companies of substantial size and economic power (with 500+ employees and more than €150 million EUR in net turnover worldwide); and
     
  • Group 2: Other limited liability companies operating in defined high-impact sectors that do not meet both Group 1 thresholds, but have more than 250 employees and a net turnover of more than €40 million EUR worldwide. For these companies, rules would start to apply two years later than for group 1.
     
• Non-EU companies active in the EU with turnover threshold aligned with Group 1 and 2, generated in the EU.
   

The EC notes that small and medium enterprises (SME) would not be directly in the scope of the proposal.

This proposal would apply to the company’s own operations, their subsidiaries, and their value chains (direct and indirect established business relationships). According to the EC, to comply with the corporate due diligence duty, companies would need to:

• Integrate due diligence into policies;
   
• Identify actual or potential adverse human rights and environmental impacts;
   
• Prevent or mitigate potential impacts;
   
• Bring to an end or minimize actual impacts;
   
• Establish and maintain a complaint procedure;
   
• Monitor the effectiveness of the due diligence policy and measures; and
   
• Publicly communicate on due diligence.
   

The proposal would require group 1 companies to have a plan to ensure that their business strategy is compatible with limiting global warming to 1.5 °C, in line with the Paris Agreement. The proposal would also introduce directors’ duties to set up and oversee the implementation of due diligence and to integrate it into the corporate strategy. When fulfilling their duty to act in the best interest of the company, directors would have to consider the human rights, climate change, and environmental consequences of their decisions.

The EC will present the proposal to the EP and the Council for approval. Once adopted, EU member states will have two years to transpose the Directive into national law and communicate the relevant texts to the EC.

UNITED KINGDOM (UK)

Defra Surveys Retailers And Suppliers On UK REACH Article 33 Requirements: The Department for Environment, Food and Rural Affairs (Defra) has invited businesses that place articles on the Great Britain (GB) market to provide feedback on their current duties under Article 33 of UK REACH. The survey aims to assess awareness of the duties, understand businesses’ practical experience, and obtain perceptions on the scope of the requirements. The results will be used to inform the Secretary of State’s review of Article 33. It is unclear if the review will lead to a change in the obligations of suppliers and retailers.

Interested parties have until March 9, 2022, to respond to the survey. Note that there are separate surveys for suppliers and retailers based in England and in Wales.

UK HSE Opens Call For Evidence For Four Substances: The Health and Safety Executive (HSE), in conjunction with the Environment Agency, has assessed 11 substances and substance groups that were added to the EU REACH Candidate List. As a result, the agencies have identified the following four substances, or substance groups, that require regulatory management options analysis (RMOA):

This is the first time that the UK has initiated a public consultation on RMOAs. The UK agencies have leaned heavily on the work previously undertaken by the agencies of the EU and some EU member states. The UK lost access to the ECHA database when it left the EU in January 2021 and has a limited data set of its own. Stakeholders have until April 10, 2022, to submit their comments.

NPIS Reveals That Annex VIII Of The EU CLP Regulation (EC No. 1272/2008) Retrospectively Applies In The UK From January 1, 2021: Importers and downstream users placing hazardous mixtures for consumer or professional use on the UK market are required to submit a poison center notification (PCN) in the harmonized format. The details for the information are set out in Annex VIII in accordance with Article 45 of Regulation (EC) No 1272/2008 on the Classification, Labeling and Packaging of substances and mixtures (CLP Regulation). Previously these requirements did not appear to apply to the GB market because they entered into force in the EU after the UK’s exit. The National Poisons Information Service (NPIS) acts as the appointed body responsible for accepting the submissions.

Some companies completed voluntary submissions that may need to be resubmitted in the harmonized format. Transitional arrangements indicate that no further action is required for these companies until December 31, 2024. Annex VIII will be enforced starting January 1, 2025.

This communication from the NPIS was unexpected, and it contradicts previous guidance. Stakeholders should continue to track these developments and prepare to take action if required.