Register Now For “TSCA Reform – Nine Years Later” Virtual Conference, 8:30 a.m. – 4:30 p.m. (EDT), June 25, 2025: Complimentary registration is now open for this dynamic virtual conference providing updates and insights regarding the current state of Toxic Substances Control Act (TSCA) implementation, ongoing and emerging issues, and related developments. As with our previous TSCA anniversary events, a stellar faculty of speakers from government, non-governmental organizations, industry, and academia will convene to inform, analyze, discuss, and debate the most pressing issues related to TSCA with regulatory practitioners and other stakeholder attendees. Presented by The Acta Group (Acta^®) affiliate Bergeson & Campbell, P.C. (B&C^®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health.

Register Now For “Regulation Without Borders: The EUDR and the New Era of Global Due Diligence” Webinar, August 5, 2025, 10:00 a.m. – 11:15 a.m. (EDT): Acta and B&C; EPPA; and Preferred by Nature (PBN) are pleased to present “Regulation Without Borders: The EUDR and the New Era of Global Due Diligence,” a complimentary webinar providing a detailed exploration of the European Union Deforestation Regulation (EUDR) and how it applies to manufacturers, suppliers, operators, traders, processors, and exporters or importers.

Register Now For “Loper Bright: Has the Demise of Chevron Deference Mattered?” Webinar, July 15, 2025, 11:00 a.m. – 12:00 p.m. (EDT): B&C is pleased to present “Loper Bright: Has the Demise of Chevron Deference Mattered?,” a complimentary webinar reviewing changes to TSCA determinations in light of Loper Bright. During this webinar, Kelly N. Garson, Senior Associate, B&C, and Regulatory Consultant, Acta, and James V. Aidala, Senior Government Affairs Consultant, B&C, and Vice President, Policy and Government Affairs, Acta, will discuss the basis for the U.S. Supreme Court’s decision in Loper Bright, the impacts on administrative law, and observations on how Loper Bright may shape current and future chemical safety or TSCA and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) policy development and litigation.

EUROPEAN UNION (EU)

EC Holds Public Consultation On Upcoming EU Bioeconomy Strategy: The European Commission (EC) began a public consultation on March 31, 2025, on the upcoming EU Bioeconomy Strategy. The EC states in its March 31, 2025, press release that the Strategy will focus on reinforcing circularity and sustainability, while contributing to the decarbonization of the EU economy. It will also “set the framework conditions to enable bioeconomy startups, entrepreneurs and new business models to thrive.” According to the call for evidence, the Strategy’s main aims include:

• Ensuring the long-term competitiveness of the EU bioeconomy and investment security;
• Increasing resource-efficient and circular use of biological resources, by creating an efficient demand;
• Securing the competitive and sustainable supply of biomass, both domestically and from outside the EU; and
• Positioning the EU in the rapidly expanding international market for biobased materials, biomanufacturing, biochemicals, and agri-food and biotechnology sectors.

The EC encourages all stakeholders to participate in the online consultation. Comments are due June 23, 2025. More information is available in our April 1, 2025, blog item.

Council Of The EU And EP Agree On Updated Toy Requirements: The Council of the EU announced on April 10, 2025, that it reached a provisional agreement with the European Parliament (EP) on a regulation that will update the safety requirements for toys sold on the EU single market. The agreement expands the ban on carcinogenic, mutagenic, and toxic for reproduction chemicals (CMR) to include other hazardous substances like endocrine disruptors. The agreement prohibits skin sensitizers and toys treated with biocidal products (except for toys intended to be always kept outdoors). The agreement limits the use of preservatives and prohibits the use of fragrance allergens in toys intended for use by children under the age of three or in other toys intended to be placed in the mouth of children. The agreement also introduces a limited ban on the intentional use of per- and polyfluoroalkyl substances (PFAS) in toys, allowing exemptions for toy components necessary for electronic or electric functions of the toy where the substance or mixture is inaccessible. The agreement provides 4.5 years for industry to implement the new requirements.

EC Adopts Working Plan For Regulations For Ecodesign For Sustainable Products And Energy Labeling: The EC announced on April 15, 2025, that it adopted the 2025-2030 working plan for the Ecodesign for Sustainable Products Regulation (ESPR) and Energy Labeling Regulation. According to the EC, the working plan provides a list of products that should be prioritized to introduce ecodesign requirements and energy labeling over the next five years. The priority products for ecodesign and energy labeling requirements are steel and aluminum, textiles (with a focus on apparel), furniture, tires, and mattresses. The EC notes that these were selected based on their potential to deliver on the circular economy. The EC based the selection of products included in the working plan on an inclusive process with stakeholders, reflecting input from both stakeholders and EU member states. The EC states that future ecodesign and energy labeling requirements for the selected products will cover two elements:

• Product performance, such as minimum durability, minimum energy and resource-efficiency, availability of spare parts, or minimum recycled content; and/or
• Product information, including key product features such as the products’ carbon and environmental footprint. Product information will mainly be made available via the Digital Product Passport or, for products with energy labels, via the European Product Registry for Energy Labelling (EPREL).

ECHA Will Propose EU-Wide Restrictions On Certain Hexavalent Chromium Substances: The EC requested that the European Chemicals Agency (ECHA) assess the risks posed by certain hexavalent chromium substances. ECHA announced on April 29, 2025, that it has concluded that an EU-wide restriction for hexavalent chromium substances is justified because the substances “are among the most potent workplace carcinogens and pose a serious risk to workers’ health.” ECHA states that it expects to begin a six-month public consultation on a ban on hexavalent chromium substances, except in the following use categories when defined limits for worker exposure and environmental emissions are met:

• Formulation of mixtures;
• Electroplating on plastic substrate;
• Electroplating on metal substrate;
• Use of primers and other slurries;
• Other surface treatment; and
• Functional additives/process aids.

ECHA states that this restriction could replace the current authorization requirements under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, ensuring that the risks associated with hexavalent chromium substances are effectively controlled once they are no longer subject to REACH authorization. ECHA notes that it included barium chromate in the scope of the restriction to avoid regrettable substitution. More information is available in our May 8, 2025, blog item.

EC Calls For Evidence For Impact Assessment Of European Biotech Act: The EC began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the biotechnology sector in the EU while maintaining high safety standards. The new European Biotech Act will aim to ensure that the EU makes the most of the biotechnology revolution for the benefit of society, the environment, and the economy, while making it easier to develop and bring to market products across all biotechnology sectors in the EU. Comments were due June 11, 2025. The EC plans a public consultation on the draft legislation in the fourth quarter of 2025, and to adopt final legislation in the third quarter of 2026. More information is available in our June 6, 2025, blog item.

ECHA’s Redesigned C&L Inventory Is Available In ECHA CHEM: ECHA announced on May 20, 2025, that the redesigned Classification and Labeling (C&L) Inventory is now available in ECHA CHEM, ECHA’s public database containing information from all REACH registrations received by ECHA. According to ECHA, the C&L Inventory includes information on more than 4,400 EU-level harmonized classifications and seven million classifications notified or included in REACH registrations. ECHA states that altogether, the C&L Inventory includes data on approximately 350,000 substances. More information is available in our May 23, 2025, blog item.

EC Announces Low- And High-Risk Countries Under The EUDR: The EC released on May 22, 2025, the identity of the countries that present a low or high risk of deforestation in producing seven commodities (cattle, cocoa, coffee, palm oil, rubber, soy, and wood) that are “the most relevant in terms of driving global deforestation and forest degradation” under the EUDR. The classification takes into account other criteria as listed in Article 29(4) of Regulation (EU) 2023/1115. The Regulation is scheduled to enter into force on the third day following its publication in the Official Journal of the European Union. More information is available in our May 23, 2025, blog item.

Council Of The EU Agrees On Position For Pharma Package: The Council of the EU announced on June 4, 2025, that it is ready to begin negotiations with the EP on new rules that aim to make the EU’s pharmaceutical sector fairer and more competitive. According to the press release, the Council’s mandate for negotiations introduces key amendments to the proposed legislation:

• Regulatory data protection: Companies producing innovative medicines will be able to prevent competitors from accessing the data used to develop those medicines for eight years;
• Regulatory market protection: Producers of innovative medicines will benefit from one year of regulatory market protection, extendable to two years if certain pre-defined key objectives are achieved;
• Obligation to supply: A new article (56a) has been added to the directive, giving EU member states the power to require the marketing authorization holder of a medicinal product to make that product available in sufficient quantities to cover the needs of patients in the member state;
• Transferrable exclusivity voucher: The Council has introduced a new clause stipulating that a transferred voucher can be used only in the fifth year of the regulatory data protection period and only if the marketing authorization holder demonstrates that the annual gross EU sales of the product have not exceeded €490 million in any of the preceding four years; and
• Intellectual property exemption for generic medicines: To support earlier market entry of generic and biosimilar medicinal products, the Council’s mandate further clarifies the scope of the so-called “Bolar exemption” and expands it to include submissions for procurement tenders.

Council Of The EU And EP Reach Provisional Agreement On Regulating Detergents And Surfactants: On June 10, 2025, the Council of the EU announced that it reached a provisional agreement with the EP on the update to the regulation on detergents and surfactants. According to the press release, the update will simplify the placement and free movement of these products in the internal market, while accompanying market developments in terms of product innovation (such as microbial cleaning products or detergents containing microorganisms) and consumer habits (such as bulk detergent sales and refills). The update will also enhance the compliance and safety of imported products made available on the market by requiring non-EU manufacturers to appoint an authorized representative to support compliance and liaise with local authorities in case of need. The press release notes that the provisional agreement must be endorsed and formally adopted by both institutions.

ECHA Updates Report On Key Areas Of Regulatory Challenge: On June 11, 2025, ECHA announced that it has updated its report on Key Areas of Regulatory Challenge with new topics in line with the EU’s Competitiveness Compass and the Clean Industrial Deal. ECHA states that specific scientific research is needed to protect people and the environment better from hazardous chemicals and to develop balanced and effective regulatory measures. The research needs include:

• Provide protection against most harmful chemicals: This chapter highlights the need for protection against harmful chemicals, focusing on gaps in identifying and understanding their effects for the immune, neurological, and endocrine system impairments.
• Addressing chemical pollution in the environment: According to the report, chemical pollution is one of the key drivers contributing to ecosystems degradation and biodiversity loss. One key element in the management of the risks posed by chemical pressure on ecosystems is the development of targeted new approach methods (NAM) that can efficiently address the manifold interactions between chemicals and ecosystems. This chapter also describes the need to understand better the sensitivity of non-bee pollinators to biocidal active substances and to monitor specific substances such as linear and cyclic siloxanes.
• Shift away from animal testing: For chemicals management processes to shift away from animal testing, NAM-based methods need to be developed to substitute or reduce the use of in vivo test methods currently in place to support hazard identification. This chapter covers different research areas, models, short-term and long-term fish toxicity, and carcinogenicity.
• Improved availability of chemical data: The sound management of chemicals in Europe depends on the ability to make decisions based on robust and relevant, up-to-date knowledge. According to the report, there is still a lack of comprehensive information on many substances, and polymers and nanomaterials deserve particular attention. The availability of analytical methods that ensure a proper assessment of the presence of restricted chemicals and chemicals falling under authorization is also critical.
• Promote circularity through safe materials: ECHA’s new responsibilities mean that its need for knowledge is expanding to new areas such as waste and recycling. According to ECHA, it needs more information to valuate economically the environmental impacts of harmful chemicals. By addressing these areas, ECHA can promote a circular economy that prioritizes safe materials, leading to healthier ecosystems and sustainable growth.

Council Of The EU And EP Agree On “One Substance, One Assessment” Legislative Package: The Council of the EU announced on June 12, 2025, that it reached a provisional agreement with the EP on the “one substance, one assessment” (OSOA) legislative package, “which aims to streamline assessments of chemicals across relevant EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks.” The package contains three proposals: a directive concerning the re-attribution of scientific and technical tasks; a regulation aimed at enhancing cooperation among EU agencies in the area of chemicals; and a regulation establishing a common data platform on chemicals. According to the Council, the co-legislators maintain the objectives of the EC’s legislative package but expanded the information available in the common platform to include scientific data submitted voluntarily, clarified the treatment of medical data, and ensured that the content of the platform will be publicly available. The provisional agreement will now be considered by the Council of the EU and the EP for formal adoption. More information is available in our June 13, 2025, memorandum.

EC Intends To Amend CLP In Fourth Quarter Of 2025: The EC intends to adopt a regulation amending the Classification, Labelling and Packaging (CLP) Regulation in the fourth quarter of 2025. According to the EC, the regulation will:

• Amend the CLP to bring it in line with the eighth and tenth revisions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), adopted in 2018-2022; and
• Partially implement the eleventh revision of the GHS (aerosols and skin sensitizers (mixtures)).

The draft amendment will be released for a public consultation.

UNITED KINGDOM (UK)

HSE Publishes UK REACH Report (2023 To 2024) And Work Programme (2024 To 2025): The UK’s Health and Safety Executive (HSE) announced on March 21, 2025, that it has published the following annual report and work program on activities under UK REACH:

• UK REACH Report, which outlines the relevant activities covering the 2023 to 2024 Work Programme; and
• UK REACH Work Programme, which describes operational work for 2024 to 2025.

More information is available in our March 21, 2025, blog item.

Defra Calls For Comments On Indicative Lists For LC-PFCAs, Their Salts, And Related Compounds: On June 2, 2025, the UK’s Department for Environment, Food & Rural Affairs (Defra) requested comment on a draft indicative list for long-chain perfluorocarboxylic acids (LC-PFCA), their salts, and related compounds. According to Defra, at the 20th meeting of the Persistent Organic Pollutants (POP) Review Committee of the Stockholm Convention on POPs, the Committee recommended listing LC-PFCAs, their salts, and related compounds in Annex A of the Convention, allowing for specific exemptions. Defra notes that the listing extends to compounds classified as substances capable of degrading or transforming into LC-PFCAs. Comments are due June 30, 2025. More information is available in our June 13, 2025, blog item.

Defra Publishes Interim Approach To The PMT Concept To Support UK REACH Risk Management Of PFAS: On June 4, 2025, the UK’s Defra announced the availability of an interim approach to address persistent, mobile, and toxic (PMT) or very persistent, very mobile (vPvM) concerns to support managing risks from PFAS under UK REACH. According to Defra, applying an approach to manage the risk associated with the PMT or vPvM concerns for PFAS will support chemical regulation in Great Britain (GB), including proposed restrictions under UK REACH. Defra notes that this builds on the HSE’s 2023 Regulatory Management Options Analysis (RMOA) for PFAS, which included discussion of the environmental hazards associated with persistence, bioaccumulation, mobility, and toxicity. This statement also provides a basis to prioritize:

• Research in addressing gaps in technical knowledge;
• Available data; and
• Appropriate test methods that limit the application of the PMT concept.

Defra notes that while the focus in the interim position statement is on PFAS, “a wider range of substances potentially have these properties of concern.”