ABA And B&C Announce Release Of “Chemical Product Law and Supply Chain Stewardship” Book: The Acta Group (Acta^®) and Bergeson & Campbell, P.C. (B&C^®) are pleased to announce the release by American Bar Association (ABA) Publishing of Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA, edited by Acta President Lynn L. Bergeson and authored by Ms. Bergeson and members of Acta and B&C’s highly experienced Toxic Substances Control Act (TSCA) practice group. This invaluable guide provides a road map to navigate efficiently the transformational changes in chemical product law, identifies the practical business and product stewardship implications of the new normal in product regulation, and explains the urgent need for supply chain awareness so that the business community and others can make informed and compliant business decisions. Please note: A 20% off discount code will be provided to Acta clients and friends via e-mail later this month — so keep watch for that.

Recording Available For “What’s New with New Approach Methodologies: A Webinar,” Featuring EPA CCTE’s Katie Paul Friedman, Ph.D., And PETA Toxicology Specialist Adam Bettmann, MS, DABT^®: A recording is available for B&C and Acta’s webinar featuring experts in the toxicology field discussing the state of play as stakeholders take advantage of new approach methodologies (NAM). Adam Bettmann, MS, DABT^®, a Toxicology Specialist representing PETA Science Consortium International e.V., navigates the current state of NAMs and their use for submissions to the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) by providing an overview of some of the relevant guideline and non-guideline testing approaches, the process of vetting NAMs for readiness, and available training and educational opportunities. Katie Paul Friedman, Ph.D., Acting Director for the Biomolecular and Computational Toxicology Division in the Center for Computational Toxicology and Exposure (CCTE) in EPA’s Office of Research and Development (ORD), provides an overview of the TSCA New Chemicals Collaborative Research Program (NCCRP) as the lead within the ORD. An overview of the proposed research plan and its components (as presented to the U.S. EPA ORD Board of Scientific Councilors in late 2022) is followed by descriptions of early works in progress and publications related to this effort. Richard E. Engler, Ph.D. wraps up these issues with an overview of TSCA Section 4 authority and chemical testing issues. Watch now.

AUSTRALIA

Australia Seeks Comment On Information Requirements For “Designated Fluorinated Chemical” Assessments: The Australian Industrial Chemicals Introduction Scheme (AICIS) has begun a public consultation to obtain comments on the clarity of the information requirements that will be added to the form for an AICIS assessment certificate application for a chemical that is a “designated fluorinated.” Designated fluorinated chemicals are a subset of per- and polyfluoroalkyl substances (PFAS) that capture the PFAS chemicals of highest concern to human health and the environment, including longer chain PFAS chemicals that are similar to perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and perfluorohexanesulfonic acid (PFHxS). AICIS assesses the health and environmental risks of designated fluorinated chemicals that are not on the Australian Inventory of Industrial Chemicals (the Inventory) after an application for an assessment certificate is submitted through the form in AICIS Business Services. The chemical can be manufactured or imported into Australia only if AICIS issues an assessment certificate. At this time, to obtain the full set of information requirements for assessment certificate applications for designated fluorinated chemicals, potential applicants must contact AICIS for guidance about the information needed for their application. According to AICIS, this has led to requirements being communicated to an applicant as an information request after a certificate application has been submitted. Before improving transparency by adding the requirements to the application form and publishing them, AICIS seeks comment on whether an applicant will be able to understand them clearly. AICIS states that it expects the updated application form to affect a very small number of applicants. There have only been two applicants for assessment certificates for designated fluorinated chemicals since AICIS began in July 2020. Comments on the information requirements are due April 8, 2025.

CANADA

Canada Releases Final State Of PFAS Report And Proposed Risk Management Approach, Proposes To Add PFAS To CEPA Schedule 1, Part 2: On March 5, 2025, Environment and Climate Change Canada (ECCC) announced the availability of its final State of Per- and Polyfluoroalkyl Substances (PFAS) Report (State of PFAS Report) and proposed risk management approach for PFAS, excluding fluoropolymers. The State of PFAS Report concludes that the class of PFAS, excluding fluoropolymers, is harmful to human health and the environment. To address these risks, Canada proposed on March 8, 2025, to add the class of PFAS, excluding fluoropolymers, to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA). ECCC states that it will prioritize the protection of health and the environment while considering factors such as the availability of alternatives. Phase 1, starting in 2025, will address PFAS in firefighting foams to protect better firefighters and the environment. Phase 2 will focus on limiting exposure to PFAS in products that are not needed for the protection of human health, safety, or the environment. ECCC notes that this will include products like cosmetics, food packaging materials, and textiles. ECCC states that it will publish a final decision on the proposed addition of 131 individual PFAS to the National Pollutant Release Inventory (NPRI) with reporting to take place by June 2026 for PFAS releases that occurred during the 2025 calendar year. ECCC states that these data will improve its understanding of how PFAS are used in Canada, help it evaluate possible industrial PFAS contamination, and support efforts to reduce environmental and human exposure to harmful substances. Comments on the proposed risk management approach and the proposed order to add the class of PFAS, excluding fluoropolymers, to CEPA Schedule 1 Part 2 are due May 7, 2025. More information will be available in a forthcoming memorandum.

Canada Posts Guidance Materials For Reporting To The Federal Plastics Registry: On April 20, 2024, Canada published a Canada Gazette notice that will require companies (including resin manufacturers, service providers, and producers of plastic products) to report annually on the quantity and types of plastic they manufacture, import, and place on the market. Reporting will begin in September 2025 for Phase 1, requiring reporting on plastic placed on the market in three categories for the 2024 calendar year. ECCC has posted the following guidance materials and resources on its web page on the Federal Plastics Registry (FPR):

• Guide for Reporting to the FPR — Phase 1: ECCC has prepared a guidance document to provide assistance in responding to the notice. ECCC notes that this version of the document is focused on Phase 1 reporting requirements (reports due in 2025 on 2024 data). It provides a general overview of the reporting requirements, as well as additional guidance materials that include tools such as calculation methods and other aids.
• Foreign Supplier Letter: When responding to the notice, reporters are required to provide information that their organization possesses or to which they may be reasonably expected to have access. ECCC notes that more detailed information on the plastic composition in products and packaging may be available from the supply chain. According to ECCC, suppliers may have information of which reporters are unaware. Any person requiring more detailed information on the plastic composition of their products is required to contact their suppliers. To that end, a Government of Canada letter for communicating with foreign suppliers is available. The letter may help reporters obtain information from foreign suppliers to respond to the notice. The letter is available in English, French, Chinese (simplified), and Spanish. To receive a copy of the letter, e-mail RFP-FPR@ec.gc.ca with the subject line “Foreign Supplier Letter” and include the languages of the letters requested.
• User guides for using the online reporting platform: ECCC states that several user guides have been prepared to help users use the FPR’s new reporting platform. These user guides are available on the new reporting platform or upon request. To obtain copies, submit a request by e-mail to RFP-FPR@ec.gc.ca.

ECCC has also posted frequently asked questions (FAQ) regarding the FPR.

CHILE

Chile Releases List Of Hazardous Substances For Industrial Use, Begins Notification For Hazardous Substances For Non-Industrial Use: Chile has released a list of hazardous substances for industrial use that were notified by the September 30, 2024, extended deadline. The list is the first of a four-part national inventory of chemicals under Decree 57/2021, which approves the regulations on the classification, labeling, and notification of chemical substances and mixtures, established a national chemicals framework, and implemented the seventh revision of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The regulations apply to manufacturers and importers of chemical substances and mixtures that are not already regulated by other regulations, exempting pharmaceutical products, food products for human or animal consumption, cosmetic products, pesticide residues in food, and hazardous waste. Hazardous substances for industrial use that are not listed on the national inventory are considered new substances and must be notified. The list is available on the Ministry of Environment’s (MMA) chemical substances notification platform website. Access is available upon request to MMA. On February 9, 2025, Chile began accepting notifications for hazardous substances for non-industrial use. Notifications are due August 30, 2025.

CHINA

China Holds Public Consultation On Draft Law On Safety Of Hazardous Chemicals: China’s National People’s Congress began a public consultation on December 26, 2024, on the draft Law on the Safety of Hazardous Chemicals. The draft law would apply to the production, transport, storage, use, operation, and disposal of hazardous chemicals. It would define hazardous chemicals as substances with highly toxic, explosive, flammable, or combustion-supporting properties that pose risks to humans, facilities, or the environment. If enacted, it will replace Decree 591, which establishes a hazardous chemicals information management system, implements electronic identification, and initiates whole lifecycle information management of hazardous chemicals. Comments on the draft law were due January 23, 2025.

EUROPEAN UNION (EU)

CLP Amendments Entered Into Force In December 2024: Amendments to the EU’s Classification, Labelling and Packaging Regulation (CLP) entered into force on December 10, 2024. According to the European Commission’s (EC) website, the revisions are intended to enhance chemical safety and information transparency:

• Online stores will have to display hazardous properties clearly on their websites;
• Labeling will be made simpler by allowing more flexible use of fold-out labels, introducing digital labeling, and improving the legibility of labels;
• Advertisements and online offers will have to contain information on chemical hazards, facilitating informed choices by consumers and the development of a market for sustainable consumer chemical products;
• For the first time, there will be clarity on the safe sale of household chemicals via the refill stations, contributing to reducing packaging and packaging waste;
• There will be a more user-friendly inventory of substances notified by industry, benefiting small and medium-sized enterprises (SME);
• Explicit rules for classifying complex substances (those containing more than one constituent) will be introduced, while taking account of the specificities of natural complex substances, such as essential oils; and
• Poison centers will receive more comprehensive information for medical emergencies, especially from cross-border distribution.

ECHA Adds Five Chemicals To The Candidate List And Updates One Entry: The European Chemicals Agency (ECHA) announced on January 21, 2025, that it added five chemicals to the Candidate List of substances of very high concern (SVHC) and updated one entry:

ECHA states that its Member State Committee confirmed the addition of these chemicals to the Candidate List, which now has 247 entries. ECHA notes that some entries are groups of chemicals, so the overall number of impacted chemicals is higher. Candidate List chemicals may be placed on the Authorization List in the future. If a substance is on that list, its use will be prohibited unless companies apply for authorization and the EC authorizes them to continue its use.

Under the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH), companies have legal obligations when their substance is included — either on its own, in mixtures, or in articles — on the Candidate List. Suppliers of articles containing a Candidate List substance above a concentration of 0.1 percent (weight by weight) must provide their customers and consumers information on how to use the article safely. ECHA notes that consumers have the right to ask suppliers whether the 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 on the list (January 21, 2025). EU and European Economic Area (EEA) suppliers of substances on the Candidate List, supplied either on their own or in mixtures, must update the safety data sheet (SDS) provided to customers.

Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain SVHCs in a concentration above 0.1 percent (weight by weight). ECHA will publish this notification in its database of substances of concern in products (SCIP). Under the EU Ecolabel Regulation, products containing SVHCs cannot have the ecolabel award.

EU Advocate General Recommends Overturning Decision Annulling Harmonized Classification And Labeling Of Titanium Dioxide: On February 6, 2025, the EU Advocate General (EU AG) recommended that the European Court of Justice (ECJ) overturn the 2022 decision of the General Court annulling the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court annulled the EC’s decision to classify titanium dioxide as a suspected human carcinogen. The French government and the EC appealed the decision, arguing that the court exceeded the limits of permissible judicial review of an EC decision and that the court incorrectly interpreted the concept of “intrinsic properties” as it appears in the CLP. The EU AG proposes that the ECJ:

• Set aside the November 2022 judgment in CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, EU:T:2022:725);
• Refer the case back to the General Court for the resolution of the remaining pleas in law; and
• Order that the costs be reserved.

The ECJ is expected to issue its decision later this year. More information is available in our March 11, 2025, blog item.

Packaging And Packaging Waste Regulation Enters Into Force: On February 11, 2025, the Packaging and Packaging Waste Regulation entered into force. According to the Council of the EU’s December 16, 2024, press release, the regulation sets 2030 and 2040 targets for a minimum percentage of recycled content (up to 65 percent for single use plastic bottles by 2040); minimizes the weight and volume of packaging and avoids unnecessary packaging; and minimizes substances of concern, including restricting placing on the market food contact packaging containing PFAS if they exceed certain thresholds. The Council notes that labeling, marking, and information requirements (e.g., on material composition or recycled content) should facilitate consumer sorting and consumer choices.

ECHA announced on February 11, 2025, that it will prepare a study identifying chemicals of concern in packaging and related components assessing how these chemicals affect their safety, reuse, and recycling. The EC’s request to ECHA states that it expects the study to support it in:

• Identifying chemicals of concern present in packaging and packaging components that negatively affect the reuse and recycling of materials and impact chemical safety. In addition, the study will investigate the need for future restrictions under REACH for the identified chemicals of concern that can impact chemical safety;
• Establishing labeling on packaging that marks the chemicals of concern to be adopted by January 1, 2030, in the form of an Implementing Act;
• Assessing the packaging recyclability on chemicals of concern that affect negatively the reuse and recycling of packaging and packaging components; and
• Assessing the need to modify the provisions related to PFAS content four years from the date of application of the Regulation.

Under the regulation, ECHA is to provide its input to the EC by the end of September 2026. Based on ECHA’s report, the EC will consider appropriate follow-up measures, including possible restrictions on the use of substances in packaging materials that pose health or environmental risks. According to ECHA, these restrictions “will follow the existing REACH restriction process.”

EC Calls For Evidence For Evaluation Of Cosmetic Products Regulation: The EC issued a call for evidence on February 21, 2025, for an evaluation/fitness check of the Cosmetics Products Regulation (CPR). According to the EC, the evaluation is expected to provide evidence of how the CPR has been applied, whether it has delivered on its objectives, and whether it remains fit for purpose. The EC states that the evaluation will investigate the current scope of the CPR, the definitions used, the application of the generic risk approach to ingredients with potentially higher risk for human health, and labeling provisions, as well as the main trends in international trade and the external competitiveness of the EU industry. It will also examine whether the CPR is fit to support and enable international convergence with other jurisdictions. The EC notes that the evaluation will include areas for improvement, including any potential for simplification and burden reduction, and will help the EC determine whether revision of the CPR is needed. Comments are due March 21, 2025.

EC Legislative Package Would Simplify Corporate Sustainability Reporting: The EC announced on February 25, 2025, that it has adopted a new package of proposals to simplify EU rules, boost competitiveness, and unlock additional investment capacity. The package brings together proposals in a number of related legislative fields, including sustainable finance reporting, sustainability due diligence, EU Taxonomy, carbon border adjustment mechanism, and European investment programs. Specifically, proposed revisions concerning sustainability reporting (Corporate Sustainability Reporting Directive (CSRD) and EU Taxonomy) include:

• Removing around 80 percent of companies from the scope of CSRD, focusing the sustainability reporting obligations on the largest companies that are more likely to have the biggest impacts on people and the environment;
• Ensuring that sustainability reporting requirements on large companies do not burden smaller companies in their value chains;
• Postponing by two years (until 2028) the reporting requirements for companies currently in the scope of CSRD and that are required to report as of 2026 or 2027;
• Reducing the burden of the EU Taxonomy reporting obligations and limiting it to the largest companies (corresponding to the scope of the Corporate Sustainability Due Diligence Directive (CSDDD)), while keeping the possibility to report voluntarily for the other large companies within the future scope of the CSRD;
• Introducing the option of reporting on activities that are partially aligned with the EU Taxonomy, fostering a gradual environmental transition of activities over time, in line with the aim to scale up transition finance to help companies on their path towards sustainability;
• Introducing a financial materiality threshold for the Taxonomy reporting and reducing the reporting templates by around 70 percent; and
• Introducing simplifications to the most complex “Do no Significant harm” (DNSH) criteria for pollution prevention and control related to the use and presence of chemicals that apply horizontally to all economic sectors under the EU Taxonomy — “as a first step in revising and simplifying all such DNSH criteria.”

Proposed changes in the area of sustainability due diligence include:

• Simplifying sustainability due diligence requirements so that companies in scope avoid unnecessary complexities and costs, e.g., by focusing systematic due diligence requirements on direct business partners and by reducing the frequency of periodic assessments and monitoring of their partners from annual to five years, with ad hoc assessments where necessary;
• Reducing burdens and trickle-down effects for SME and small mid-caps by limiting the amount of information that may be requested as part of the value chain mapping by large companies;
• Further increasing the harmonization of due diligence requirements to ensure a level playing field across the EU;
• Removing the EU civil liability conditions while preserving victims’ rights to full compensation for damage caused by non-compliance, and protecting companies against over-compensation, under the civil liability regimes of EU member states; and
• Giving companies more time to prepare to comply with the new requirements by postponing the application of the sustainability due diligence requirements for the largest companies by one year (to July 26, 2028), while advancing the adoption of the guidelines by one year (to July 2026).

The EC posted questions and answers (Q&A) on the legislative package.

ECHA Updates Annual Evaluation Statistics And Recommendations To Registrants On Improving Dossiers: ECHA announced on February 26, 2025, that it has updated its annual statistics on evaluation progress. According to ECHA, between 2009 and 2024, it checked the compliance of 15,500 REACH registrations, representing 23 percent of all submitted registration dossiers and covering 3,200 substances. For high-volume chemicals registered at quantities of 100 metric tons or more per year, ECHA has checked 34 percent of the registrations. ECHA notes that based on the evaluations, it updated its recommendations to registrants on how to improve their dossiers.

In 2024, ECHA carried out 313 compliance checks, covering almost 2,000 registrations and addressing 272 individual substances. ECHA notes that these checks focused on those registration dossiers that may have data gaps. As a result, ECHA sent 208 decisions to companies, requesting additional data to clarify long-term effects of chemicals on human health or the environment. ECHA states that it also examined 161 testing proposals and sent out 92 decisions, addressing the tests proposed by industry to ensure the safe use of the substance.

To follow up information requests sent to companies, ECHA states that it checks whether the provided information complies with the REACH requirements. In 2024, ECHA concluded this evaluation for 241 substances. According to ECHA, in about 70 percent of the cases, companies provided the requested information. ECHA notified the remaining 30 percent to EU member states for enforcement and will follow up. ECHA also adopted three substance evaluation decisions prepared by EU member states, requesting further information to assess the safety of substances of potential concern.

FRANCE

Parliament Passes Bill That Would Prohibit Intentionally Added PFAS In Certain Consumer Products: On February 20, 2025, the National Assembly passed legislation that would prohibit the following items containing PFAS as of January 1, 2026:

• Cosmetic products;
• Wax; and
• Textile clothing products, footwear, and waterproofing agents for textile clothing products and footwear intended for consumer use.

The bill would ban in 2030 any textile products containing PFAS, excluding textile products necessary for essential uses.