March Regulatory Updates


BPC Updates

During its February meeting, the Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA) endorsed opinions on a range of active substances and Union authorisations. The session, held in Helsinki on 7 March 2024, concluded with the committee supporting the approval, renewal, and authorization of various substances and product families for use within the EU.

Key outcomes include:

  • Endorsement for the approval of prallethrin for use in product-type 18, which includes insecticides, acaricides, and products aimed at controlling other arthropods. The committee noted that the assessment of prallethrin covered only indoor use, indicating a need to evaluate the safety of outdoor applications based on established parameters.
  • Support for the approval of silver zinc zeolite across multiple product-types, such as disinfectants not intended for direct application to humans or animals (type 2), film preservatives (type 7), and preservatives for fibre, leather, rubber, and polymerised materials (type 9).
  • Recommendation for the renewal of cholecalciferol for product-type 14 (rodenticides), emphasizing the substance’s safety and efficacy.

Additionally, the BPC approved opinions on Union authorisations for:

  • A biocidal product family containing L-(+)-lactic acid for veterinary hygiene disinfectants (product-type 3).
  • A biocidal product family with hydrogen peroxide for disinfectants used in the food and feed area (product-types 2 and 4).
  • A biocidal product containing N-cyclopropyl-1,3,5-triazine-2,4,6-triamine (cyromazine) for product-type 18.

The European Commission, in collaboration with EU Member States, will make the final decisions based on the BPC’s recommendations. This process underscores the importance of safety and efficacy assessments for biocidal products and their active substances, ensuring protection for humans, animals, and the environment.


ECHA Proposes Guidance for Protecting Bees from Biocide Risks

The European Commission has clarified that ECHA’s new guidance on assessing the risk of biocides to bees will not impact the evaluation of active substances currently under review in the biocides programme. Competent authorities for biocides have decided to limit the guidance’s effect on ongoing applications, aligning with the objective to conclude the review programme, which was recently extended by six years. It was agreed that no new guidance or updates to existing guidance would apply to the approval of existing active substances starting 1 January 2024. The bee risk assessment guidance will only affect approvals for active substances and biocidal products with applications submitted from 1 February 2026.

ECHA’s guidance, finalized after five years of work and published in February, provides a detailed assessment framework for evaluating the risk to bees, including both lower-tier and higher-tier assessments, risk mitigation measures, and usage instructions.

The application of similar guidance on the impact of water treatment processes on residues in drinking water produced mixed opinions among the competent authorities, leading to a lack of agreement on its implementation timeline. The issue will be revisited in the next meeting scheduled for 19-21 June.

Furthermore, the competent authorities have approved a list of guidance documents ECHA is requested to prioritize in the coming year, including revisions on in situ-generated active substances, human health information requirements, and efficacy guidance on resistance to antimicrobial substances and products.



Updates on PFAS Restrictions

The European Chemicals Agency (ECHA) is advancing its evaluation of the proposal to restrict per- and polyfluoroalkyl substances (PFAS) in the EU. This move, part of the REACH chemicals regulation, aims to address the vast feedback received during the consultation phase.

ECHA’s Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) committees are set to review the proposed restriction and consultation comments in stages, focusing on the impacts across various sectors. The evaluation process will incorporate updates from the five national authorities responsible for the proposal, refining the initial report based on public input.

The review will unfold over three committee meetings throughout 2024, addressing specific sectors and concerns at each stage:

  • In March, discussions will center on consumer mixtures, cosmetics, ski wax, the hazards of PFAS (RAC only), and the general approach (SEAC only).
  • The June session will explore issues related to metal plating, the manufacture of metal products, and additional hazards discussions (RAC only).
  • The September meeting will tackle textiles, upholstery, leather, apparel, carpets, food contact materials and packaging, and the petroleum and mining sectors.


EU to Introduce First REACH Restriction Proposal on PVC and Additives

The European Commission is preparing to introduce its first REACH restriction proposal targeting polyvinyl chloride (PVC) and its additives by September, as announced by Giuseppe Casella, head of DG GROW’s unit, during a debate in the European Parliament on 19 March. This initiative follows the European Chemicals Agency’s (ECHA) recommendation from a November report, which identified REACH restrictions as the most appropriate measure to mitigate the health and environmental risks associated with PVC. The debate saw calls from MEPs across the political spectrum for the Commission to safeguard public health from these risks, echoing the demands of over 60 environmental NGOs for a PVC phase-out by 2030.

PVC, a widely used plastic containing numerous chemical additives, is found in various consumer products, including toys, packaging, and artificial leather. The Commission is also examining additional regulatory actions against specific substances highlighted in ECHA’s report, such as aromatic brominated flame retardants and ortho-phthalates. Future decisions, including potential restrictions on aromatic brominated flame retardants expected by early 2025 and an expansion of existing phthalate restrictions, will depend on the outcomes of ECHA’s further investigations and hazard classification procedures.


OECD Lacks Criteria for ‘Low Concern’ Fluoropolymers Amid PFAS Restriction Talks

The OECD has stated that it lacks agreed criteria to classify fluoropolymers as ‘polymers of low concern’ (PLC) for exemption from global PFAS restriction proposals. This clarification comes amid discussions on whether to include fluoropolymers in blanket PFAS restrictions, a debate fueled by industry claims that these substances differ from other PFAS and qualify as PLC under OECD guidelines. Eeva Leinala of the OECD’s Environment Directorate highlighted that no consensus was reached on PLC criteria during discussions in the 1990s and early 2000s, and no further work on fluoropolymers has been conducted since. Despite this, some countries have adopted their own criteria for PLC.

The issue of exempting fluoropolymers from PFAS restrictions is contentious. They are a significant subgroup of PFAS, used in various consumer and industrial products. The EU has included them in its initial restriction dossier, but is reviewing consultation comments, including demands for exemptions. The UK is considering authorizing certain fluoropolymers for production aids, while a recent study advocates for their inclusion in the EU proposal, allowing only essential uses.

Experts argue for limiting fluoropolymer uses and encourage companies to seek alternatives, stressing that many PFAS, including fluoropolymers, can be replaced. The debate continues on finding a balance between necessary uses and unfounded exemptions for these substances.


Disney Commits to Phasing Out PFAS and Other Harmful Substances by 2026

In a separate note, The Walt Disney Company announced plans to phase out PFAS, phthalates, and other substances from its products by 2026, aiming to eliminate intentionally added PVC from its packaging. This initiative is part of Disney’s 2023 Sustainability & Social Impact Report, which outlines commitments to reduce specific chemicals in its Disney-branded products. Disney’s chemical reduction targets include various substances, with the company also encouraging its licensees and vendors to seek safer alternatives for these chemicals.


Medical Devices:

SCHEER Public Meeting Cancelled

The public hearing scheduled by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) for 11 April 2024 in Brussels has been canceled. The hearing was intended to discuss the preliminary update of guidelines on the benefit-risk assessment of phthalates in certain medical devices, focusing on those with carcinogenic, mutagenic, reproductive toxic (CMR), or endocrine-disrupting (ED) properties.

Stakeholders had been invited to engage in the public consultation process to submit comments, suggestions, and scientific contributions for the update of these guidelines. Participants registering for the hearing were required to provide professional details and a brief technical justification for their contributions, emphasizing the scientific discussion surrounding phthalates in medical devices.

The criteria for participant approval included scientific or technical expertise in the field and the ability to present and understand scientific arguments related to phthalates. Despite the cancellation, the initiative highlights the importance of scientific input in assessing the risks and benefits of phthalates in medical devices. Further details and the draft program for the public hearing were available on the SCHEER website, along with the invitation for public comments.



Disagreement on Water Treatment Guidance Timeline

During discussions on implementing ECHA’s guidance for water treatment processes, competent authorities (CAs) could not reach a consensus on the timeline. The guidance, aimed at assessing the impact of water treatment on the residues of active substances and their metabolites in drinking water, saw differing opinions among CAs. While some advocated for its application to all submissions two years post-publication, others opposed its application to ongoing procedures. The matter is set for further discussion in the June 19-21 meeting.


Setting Guidance Priorities for ECHA

In a recent meeting, authorities agreed on prioritizing certain guidance documents for ECHA’s focus in the upcoming year. The list includes revising recommendations for in situ-generated active substances, slated for the second quarter of 2024, developing guidance on human health information requirements by the first quarter of 2025, and issuing guidance on antimicrobial resistance by the fourth quarter of 2024. These priorities underscore the commitment to refining regulatory frameworks for chemical substances.