Global Regulatory Update for December 2022
The Acta Group and Bergeson & Campbell, P.C. extend our best wishes to our clients and many friends. We wish you and your family a safe and healthy New Year. As we have for many years, the firms have made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.
WEBINAR — Registration Is Open For “Two Years Later: How Has The Chemicals Strategy For Sustainability Changed REACH And CLP Regulations?”: Registration is now open to join Meglena Mihova, Managing Partner, EPPA; Thomas Petry, Ph.D., Managing Director, ToxMinds; Jane S. Vergnes, Ph.D., Vice President, The Acta Group (Acta®); and Lynn L. Bergeson, Esquire, President, Acta, as Bergeson & Campbell, P.C. (B&C®) affiliate Acta presents “Two Years Later: How Has the Chemicals Strategy for Sustainability Changed REACH and CLP Regulations?” on January 17, 2023, 10:00 a.m. – 11:00 a.m. (EST). This webinar will explore exactly how the Chemicals Strategy for Sustainability is fundamentally reshaping the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and the Classification, Labeling and Packaging (CLP) regulations in ways that are resetting the global stage in terms of identifying new hazard classes and New Approach Methodologies (NAM) for identifying them. Register now.
PODCAST — Biotech’s Emergence In The EU And Globally — A Conversation With Dr. Claire Skentelbery:Lynn L. Bergeson and Dr. Claire Skentelbery, Director General, EuropaBio — The European Association for Bioindustries, discuss evolving perceptions of biotechnology in the European Union (EU), how biotechnology is advancing the EU’s commitment to sustainability and circularity, and what’s next for biotech advocacy in the EU. Listen now.
PODCAST — Keeping Up With CLP Changes — A Conversation With Karin F. Baron: Lynn L. Bergeson and Karin F. Baron, MSPH, Senior Regulatory Consultant, Acta, return to the studio to discuss the controversial changes proposed by the European Commission (EC) to the CLP. Listen now.
Acta & B&C To Publish Forecast 2023: Start 2023 with the information you need — Acta and B&C will publish our Forecast for U.S. Federal and International Chemical Regulatory Policy 2023 early January 2023. In the Forecast, our legal, scientific, and regulatory professionals distill key trends in U.S. and global chemical law and provide their best informed judgment of key developments likely in the coming year. Save the date for our companion webinar, “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023,” scheduled for January 31, 2023, 11:00 a.m. – 12:00 p.m. (EST).
Canada Publishes NOI On The Labeling Of Toxic Substances In Products, Including Toxic Flame Retardants: On October 29, 2022, Canada published in the Canada Gazette a notice of intent (NOI) announcing that it intends to propose actions under the Canadian Environmental Protection Act, 1999 (CEPA) to require the labeling of certain substances that are listed on the CEPA Schedule 1 List of Toxic Substances in certain products, such as cosmetics, cleaning products, and flame retardants in upholstered furniture. Comments and feedback on the NOI will inform a strategy on labeling and supply chain transparency for substances in products. Comments on the NOI are due January 12, 2023.
Canada intends to propose labeling requirements for some of the substances listed on CEPA Schedule 1 in circumstances where providing information to consumers on the presence of those substances would help reduce risks to the environment or human health. The government will develop criteria to guide decision-making. Criteria where labeling of substances listed on CEPA Schedule 1 would be required may include:
- The substance could be associated with potential concerns to the environment or human health at any stage of its life cycle;
- Labeling can help in achieving the risk management objective;
- The substance is subject to a phasedown and will continue to be found in products for a period of time before being fully restricted or eliminated;
- There are substance concentration limits for products; and
- There is a need to provide disposal guidance that relates to the presence of the substance.
According to the NOI, criteria indicating where labeling of substances listed on Schedule 1 of the Act would not be required may include:
- When a toxic substance is entirely prohibited in products under regulations under a federal law;
- When another federal act is best placed to manage the risks identified for a toxic substance; and
- When a substance is considered toxic under CEPA but would not pose environmental or human health risks when contained in a certain product or when the product is disposed of (e.g., carbon dioxide in soda and other beverages).
More information is available in our November 4, 2022, memorandum.
Canada Proposes To Align TDGR With Latest International Codes: On November 26, 2022, Canada proposed to amend the Transportation of Dangerous Goods Regulations (TDGR) to incorporate changes and new requirements adopted in the 22nd edition of the United Nations (UN) Model Regulations on the Transport of Dangerous Goods (UN Recommendations) and the 2020 edition of the International Maritime Dangerous Goods Code (IMDG Code). The proposed amendments would revise the dangerous goods safety marks, classification information, shipping names, and packaging requirements, as well as update the Canadian standards that are incorporated by reference to align better with the UN Recommendations for the design, manufacture, and use of means of containment. The proposed amendments would also allow the use of dangerous goods safety marks prescribed under Title 49 of the U.S. Code of Federal Regulations and special permits issued in the United States for the transportation of dangerous goods across North America by road and railway vehicles. Finally, the proposed amendments would rewrite Part 12 of the TDGR to clarify air transportation requirements and update provisions for transport to remote locations and exemptions for medical, scientific, industrial, aerial, and enforcement activities to reflect current domestic needs. Comments are due February 9, 2023.
Canada Begins Public Consultation On NOI For Proposal To Remove The Consumer Product Exclusion From The HPA: On December 15, 2022, Canada began a public consultation on an NOI regarding potential amendments to remove the consumer product exclusion from the Hazardous Products Act (HPA). According to Canada, the main objective of the proposal is to require that suppliers communicate and provide workers and employers with hazard and safety information required under the HPA and the Hazardous Products Regulations (HPR) for consumer products that are hazardous products intended for use, handling, or storage in a workplace in Canada to inform workers and employers of hazards associated with these products. Canada is considering potential regulatory amendments that would:
- Remove the consumer product exclusion from Schedule 1 to the HPA;
- Exempt suppliers of consumer products from the labeling requirements of the HPA and the HPR; and
- Require that suppliers of consumer products that meet the definition of a hazardous product under the HPA provide a safety data sheet (SDS) upon request.
Comments are due February 23, 2023. Canada will use the comments received to inform its next steps, including a cost-benefit analysis of the proposal.
EC Begins Consultation On Revising FCM Regulations: On October 5, 2022, the EC began a public consultation on its initiative to modernize the food contact material (FCM) regulations. The EC intends to address the following shortcomings identified with the current legislation:
- Lack of clarity regarding safety and functioning of the EU market in the absence of specific EU harmonized rules for FCMs “other than mainly plastics”;
- Weaknesses and limitations of legislation relying primarily on a list of authorized starting substances and lack of sufficient focus on the final FCM article;
- Lack of prioritization of the most hazardous substances in all FCMs;
- Poor quality, availability, and transparency of information in the supply chain, hampering the ability to ensure compliance and undertake official controls; and
- Insufficient support for small and medium-sized businesses (SME) and the development of safe and more sustainable alternatives.
The public consultation consists of two sets of questions:
- Citizen Part: Questions for all citizens as consumers of food in food packaging and users of kitchenware and tableware such as plates, cutlery, cups and glasses, pans, storage containers, foil, and film wrap, as well as appliances such as refrigerators and other articles that may foreseeably come into contact with food (e.g., napkins). The EC states that no knowledge of FCMs or the legislation is required; and
- Stakeholder Part: Questions for businesses, representatives of businesses, consumer organizations, scientific institutions, and those involved in compliance and enforcement of FCMs. The target group includes manufacturers, importers, distributors, and other businesses, including SMEs, consumer and industry associations, conformity assessment bodies, non-governmental organizations (NGO), as well as Member State authorities, including control bodies. Some background and knowledge of the regulatory field of FCMs is needed.
Comments are due January 11, 2023.
EC Publishes Guidance For Safe And Sustainable Chemicals And Materials: On October 26, 2022, the EC’s Directorate-General for Research and Innovation (DG RTD) announced publication of a Strategic Research and Innovation Plan (SRIP) that is intended to accelerate the shift to safe and sustainable chemicals and materials. According to DG RTD, to protect against hazardous substances, the SRIP “highlights crucial research and innovation [R&I] needs for this transition and guides funders in their investments.” In addition to listing the R&I needs for the whole life cycle of such chemicals and materials, the SRIP also provides guidance on how to make the most of such R&I activities. The EC’s aim is to encourage and guide funders in EU, national, and private financial programs. DG RTD states that the SRIP reflects the priorities of authorities, scientists, and companies alike.
ECHA Calls For Evidence On PVC And Its Additives: The European Chemicals Agency (ECHA) has opened a call for evidence on polyvinyl chloride (PVC) and its additives. ECHA states that with this call, it seeks to obtain an understanding on the use volumes at the EU level per sector and for as many end uses as feasible, but company-specific information is also welcome. ECHA notes that it does not seek use and volume information on the industrial life-cycle stages nor exposures in this call. ECHA will use submitted information to prepare an investigation report on PVC and its additives that the EC has requested. The call for evidence will close January 6, 2023. More information is available in our November 3, 2022, blog item.
ECHA Announces EU-Wide REACH Enforcement Project Will Focus On Imported Products: ECHA announced on November 16, 2022, that the Enforcement Forum agreed that the next REACH enforcement project will investigate how companies fulfill the registration, authorization, and restriction obligations for products and chemicals they import from outside the EU. According to ECHA, the project will be done in 2023-2025 and “will require close cooperation between REACH enforcement and national customs authorities in the Member States.” ECHA states that the project “was triggered by high levels of non-compliance in imported goods detected in previous Forum projects, including a recent pilot project” that found that 23 percent of inspected products were non-compliant with EU requirements and that further controls are necessary. More information is available in our November 16, 2022, blog item.
European General Court Annuls Harmonized Classification And Labeling Of Titanium Dioxide: On November 23, 2022, the Court of Justice of the EU announced a decision of the General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. According to the press release, the EC first “made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer.” It is unclear if the EC and/or member states will appeal. If not, the ruling will take effect at the expiration of a two month and ten-day period from the notification of the judgment (i.e., approximately February 10, 2023). More information is available in our December 6, 2022, memorandum.
EFSA Publishes Protocol Assessing The Hazards Of Plasticizer Substances: The EC requested that the European Food Safety Authority (EFSA) re‐evaluate the risks to public health related to the presence of plasticizers such as phthalates, structurally similar substances, and replacement substances as a consequence of migration from FCMs. In the first part of the two‐part mandate, EFSA was tasked with drawing up a protocol for assessing the hazards of plasticizer substances. On November 24, 2022, EFSA published a hazard assessment protocol that describes how the two central questions on hazard identification and hazard characterization will be addressed. EFSA states that the protocol aims to describe the strategy for retrieving, selecting, and extracting the data, appraising the relevant evidence, and summarizing, analyzing, and integrating that evidence to perform hazard assessments that will be used for the risk assessment of the prioritized substances. EFSA will publish separately outputs addressing the following related tasks in the mandate: identifying and prioritizing those substances used or potentially used as plasticizers in FCMs that may warrant further data collection and risk assessment; drawing up a protocol for the exposure assessment of the prioritized substances; and setting up calls for data and other information on the occurrence of the prioritized substances.
Council Of The EU Gives Final Approval To CSRD: The Council of the EU announced on November 28, 2022, that it gave its final approval for the corporate sustainability reporting directive (CSRD). The CSRD introduces more detailed reporting requirements and ensures that large companies and listed SMEs are required to report on sustainability matters such as environmental rights, social rights, human rights, and governance factors. The new sustainability reporting rules will apply to all large companies and to all companies listed on regulated markets except listed micro undertakings. The Council notes that these companies are also responsible for assessing the information applicable to their subsidiaries. For non-European companies, the requirement to provide a sustainability report applies to all companies generating a net turnover of 150 million euros in the EU and that have at least one subsidiary or branch in the EU exceeding certain thresholds. These companies must provide a report on their environmental, social, and governance (ESG) impacts, as defined in the CSRD. The European Financial Reporting Advisory Group (EFRAG) will be responsible for developing draft European standards. The EC will adopt the final version of the standards as a delegated act, following consultations with EU member states and a number of European bodies. Application of the CSRD will take place in four stages:
- Reporting in 2025 on the financial year 2024 for companies already subject to the non-financial reporting directive (NFRD);
- Reporting in 2026 on the financial year 2025 for large companies that are not currently subject to the NFRD;
- Reporting in 2027 on the financial year 2026 for listed SMEs (except micro undertakings), small and non-complex credit institutions, and captive insurance undertakings; and
- Reporting in 2029 on the financial year 2028 for third-country undertakings with net turnover above 150 million euros in the EU if they have at least one subsidiary or branch in the EU exceeding certain thresholds.
EC Adopts Recommendation For Safe And Sustainable Chemicals: On December 8, 2022, the EC adopted a recommendation intended to promote R&I for safer and more sustainable chemicals and materials. According to the DG RTD’s December 8, 2022, news item, the proposed “safe and sustainable by design” framework will encourage innovation to replace hazardous substances in products and processes, such as in FCMs like plastic wrap or food containers, textiles, or information and communications technologies products, such as laptops or tablets. It aims to develop new chemicals and materials and optimize or redesign production processes and the use of substances currently on the market to improve their safety and sustainability. The EC invites EU member states, industry, academia, and research and technology organizations to use the recommendations in their R&I activities “to lead the way for safer and more sustainable substances thus increasing their share on the EU market and globally.” The recommendation launches a testing period and a voluntary reporting mechanism. Based on the feedback, the EC will revise the framework. The news item notes that the testing period “counts on the engagement of industry, academia, research community and support from Member States.”
EP Announces Provisional Agreement With Council Of The EU To Revise EU Rules For Design, Production, And Waste Treatment Of Batteries: On December 9, 2022, the European Parliament (EP) announced that it reached a provisional agreement with the Council of the EU to update the EU rules on batteries. According to the EP, the agreed rules will cover the entire battery life cycle, from design to end-of-life, and apply to all types of batteries sold in the EU, including portable batteries, SLI batteries (supplying power for starting, lighting, or ignition of vehicles), light means of transport (LMT) batteries (providing power for traction to wheeled vehicles such as electric scooters and bikes), electric vehicle (EV) batteries, and industrial batteries. The provisional agreement includes the following provisions:
- Batteries to be easier to remove and replace, consumers better informed: A carbon footprint declaration and label will be required for EV batteries, LMT batteries, and rechargeable industrial batteries with a capacity above two kilowatt hours (kWh). To inform consumers better, batteries will carry labels and quick response (QR) codes with information related to their capacity, performance, durability, and chemical composition, as well as the “separate collection” symbol. LMT batteries, industrial batteries with a capacity above two kWh, and EV batteries will also be required to have a “digital battery passport” including information on the battery model as well as information specific to the individual battery and its use.
- Introduction of due diligence policy for the battery industry: All economic operators placing batteries on the EU market, except for SMEs, will be required to develop and implement a “due diligence policy,” consistent with international standards, to address the social and environmental risks linked to sourcing, processing, and trading raw materials and secondary raw materials.
- Other measures foreseen by the regulation:
- Collection targets are set at 45 percent by 2023, 63 percent by 2027, and 73 percent by 2030 for portable batteries, and at 51 percent by 2028 and 61 percent by 2031 for LMT batteries;
- Minimum levels of recovered cobalt (16 percent), lead (85 percent), lithium (six percent) and nickel (six percent) from manufacturing and consumer waste must be reused in new batteries;
- All waste LMT, EV, SLI, and industrial batteries must be collected, free of charge for end users, regardless of their nature, chemical composition, condition, brand, or origin; and
- By December 31, 2030, the EC will assess whether to phase out the use of non-rechargeable portable batteries of general use.
- Collection targets are set at 45 percent by 2023, 63 percent by 2027, and 73 percent by 2030 for portable batteries, and at 51 percent by 2028 and 61 percent by 2031 for LMT batteries;
ECHA Publishes Draft CoRAP For 2023-2025: ECHA has published the draft Community Rolling Action Plan (CoRAP) for 2023-2025. ECHA has listed 24 substances for evaluation by EU member states. Five are planned to be evaluated in 2023, and 19 are listed for evaluation in 2024 and 2025. ECHA will adopt and publish the CoRAP for 2023-2025 in March 2023, following the Member State Committee’s opinion. ECHA suggests that registrants review the draft list of substances planned for evaluation in 2023 and update their dossiers to include all relevant information before March 2023.
EC Adopts Rules Limiting Levels Of Four PFAS In Food: On December 7, 2022, the EC announced the adoption of new rules that limit the levels of four per- and polyfluoroalkyl substances (PFAS) — perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorohexane sulfonic acid (PFHxS) — in food. According to the EC, the EU member states unanimously supported the new rules, which will apply beginning January 1, 2023.
EC Proposes Revised CLP And Introduces New Hazard Classes For Endocrine Disruptors, PBTs, vPvBs, PMTs, And vPvMs: On December 19, 2022, the EC announced a legislative proposal that would revise the CLP to clarify rules on labeling and rules for chemicals sold online. According to the EC, the legislative proposal would provide:
- Better and faster processes for all actors to inform on hazards of chemicals placed on the EU market;
- Improved communication of chemical hazards, including online, through simpler and clarified labeling and advertising requirements, including a minimum font size for chemical labels;
- The right for the EC to develop classification proposals on potentially hazardous substances, in addition to EU member states and industry. According to the EC, “[t]his will speed up the pace at which hazardous substances are identified”; and
- The first specific rules for refillable chemical products, so consumers buy and use chemical products, such as home care chemicals, sold in bulk in a safe way.
The legislative proposal will now be subject to the approval of the EP and the Council of the EU as part of the ordinary legislative procedure. The EC has posted questions and answers on the legislative proposal.
The EC also announced the adoption of a delegated act to introduce new hazard classes for endocrine disruptors and substances that are persistent, bioaccumulative, and toxic (PBT); very persistent and very bioaccumulative (vPvB); persistent, mobile, and toxic (PMT); and very persistent and very mobile (vPvM). The EC notes that the new hazard classes are the result of “extensive scientific discussions” and will provide easier access to information to all users of such chemicals, notably consumers, workers, and businesses. According to the EC, the new hazard classes could allow further action to address and mitigate the risks of substances and mixtures under other EU downstream legislation, such as REACH, while taking account of socio-economic impacts. The EC expects the delegated act to enter into force in early 2023, after scrutiny by the EP and the Council of the EU. The EC states that the EU will chair a “new UN informal working group to develop global criteria for the newly adopted hazard classes.”
EC Begins Consultations On Proposed Restrictions Of BPA And Other Bisphenols And Creosote And Creosote-Related Substances: On December 21, 2022, ECHA began two public consultations:
- Bisphenol A (BPA) and other bisphenols: Germany has submitted a proposal to restrict the placing on the market of mixtures and articles containing bisphenol A, other bisphenols, and bisphenol derivatives with endocrine-disrupting properties for the environment; and
- Creosote and creosote-related substances: France has submitted a proposal to restrict the placing on the market, re-use, and secondary use of wood treated with creosote or creosote-related substances.
Comments on the proposals are due June 22, 2023. ECHA states that comments submitted by January 25, 2023, will be used by the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) in their first discussions of the proposals in March 2023.
ECHA Will Investigate Presence Of CMRs In Childcare Articles: The EC has requested that ECHA collect and summarize information on the potential presence of carcinogenic, mutagenic, and reprotoxic (CMR) substances in childcare articles. According to ECHA, this work will support the EC in preparing a restriction proposal following the simplified restriction procedure for CMR substances (REACH Article 68(2)). ECHA expects that its report will be finished by the end of September 2023.
OECD Publishes Report On Government Risk Management Approaches Used For Chemical Management: OECD published a report entitled Government Risk Management Approaches Used for Chemicals Management that provides a synthesis of the various risk management approaches and options that are used by OECD member country government chemical regulatory programs to manage the risk of chemicals. The report focuses on the management of risks of industrial and consumer chemicals, i.e., chemicals that are not covered by specific legislations such as pesticides or pharmaceuticals. According to OECD, the synthesis can serve as a basis for future discussions of individual risk management approaches, either for particular types of chemicals or regarding particular risk management approaches, and facilitate international alignment. It can also promote the identification of areas where governments can additionally support better chemical management and serve as a resource for countries developing their chemical management programs.
HSE Publishes Upcoming GB Active Biocidal Substance Open Invitation Deadlines: The Health and Safety Executive (HSE) opened an invitation for companies to take over the role of participant for an active biocidal substance/product type combination in the Great Britain (GB) Review Programme when:
- The person, company, or task force/consortium currently supporting the active substance (the participant) decides to withdraw their support;
- An active substance is redefined (where, during the evaluation, it becomes clear that the identity of the substance being evaluated does not entirely match the substance that was initially supported and therefore it may not be appropriate to apply the conclusions of such an evaluation to the substance as it was initially identified); or
- A person, company, or task force/consortium makes a declaration of interest (to add an active substance/product type combination to the GB Review Programme where certain criteria can be met), and that declaration of interest is declared compliant by HSE.
HSE has posted the current list of open invitations. To support one of the active substances that is up for open invitation, a notification must be submitted to HSE by the deadline indicated. If HSE does not receive a notification to take over the role of participant, the active substance/product type combination will be subject to a GB non-approval decision. Biocidal products containing active substances with GB non-approval decisions for the relevant product types must be removed from the GB market.
HSE Announces Temporary Changes To GB Biocides Application Processing Times: The November 7, 2022, HSE Biocides ebulletin includes an item announcing temporary changes to GB biocides statutory application processing times. HSE notes that following the end of the EU exit transition period on December 31, 2020, businesses needed to resubmit product applications to HSE by various deadlines. According to HSE, due to the large number of resubmissions received, a new law is being introduced in GB to extend temporarily the statutory deadlines for processing product applications under the GB Biocidal Products Regulation (BPR) for a period of up to five years. According to HSE, the new law will allow biocidal products on the market in GB awaiting decision on their application to remain there legally until they are processed by HSE. After five years, the statutory deadline will revert to the existing length. The new law is planned to come into force on December 31, 2022, subject to parliamentary procedures.
Defra Will Propose Legislation To Extend UK REACH Deadlines For Three Years: As reported in our July 18, 2022, memorandum, in July 2022, Defra began a public consultation on extending the UK REACH submission deadlines for transitional registrations — the registrations under UK REACH of substances that were registered in the EU in accordance with EU REACH on or before December 31, 2020, the end of the Brexit transition period. Defra requested comment on two options to extend the current deadlines for registration, as well as a do-nothing option. On November 29, 2022, Defra announced that it will bring forward secondary legislation, subject to the consent of the Scottish and Welsh governments, to extend the UK REACH submission deadlines across all tonnage bands by three years. Defra also requested comment on extending the dates for HSE to carry out compliance checks on at least 20 percent of the registration dossiers. The UK government intends to introduce legislation, subject to the consent of the Scottish and Welsh governments, to extend the statutory dates for compliance checks so that they do not precede the data submission dates. More information is available in our December 6, 2022, blog item.