REACH:
EU Member States Approve First-Ever REACH Ban on Entire PFAS Group in Firefighting Foams
Historic Step for REACH
EU Member States have voted to support the European Commission’s proposal to ban all PFAS in firefighting foams, marking the first time the entire PFAS group will be restricted under REACH for a specific sector. The decision was made at the REACH Committee meeting on 29 April.
The restriction sets a strict limit value of 1 mg/kg for PFAS in firefighting foam and aims to curb environmental contamination from these persistent and harmful substances.
Staggered Transition Periods
While the general transition period is five years, several sector-specific extensions apply:
- 18 months for fire drill training and testing
- 18 months for municipal fire departments
- Until 31 December 2030 for portable fire extinguishers
- 10 years for Seveso sites, offshore oil and gas, and military/civil vessels
- 5 years for civil aviation, new ships, and defence applications
Users benefiting from transition periods must submit a PFAS management plan within 12 months, outlining strategies to prevent environmental discharge.
Review Clause and National Action
The approved regulation includes a review clause: within five years, the Commission will reassess exemptions for PFAS foams used in cleaned legacy equipment to avoid unnecessary equipment replacement due to residual contamination.
Denmark, which has had a national PFAS firefighting foam ban at training sites since 1 July 2024, praised the EU measure. “With the EU ban, we now stop a major source of PFAS in the environment,” said Environment Minister Magnus Heunicke.
Part of Broader PFAS Controls
The firefighting foam restriction is part of a growing list of PFAS regulatory actions, including:
- PFHxA restrictions in food packaging and clothing (effective 2026)
- C9–C14 PFCA restriction (in place since 2023)
- Upcoming bans in toys and packaging under other EU regulations
- Anticipated universal PFAS restriction proposal covering 10,000 substances by 2026
This decision represents a significant milestone in REACH history, signaling a shift toward broad group-based restrictions to tackle persistent chemicals in a targeted and sector-specific way.
ECHA Proposes 2028 Ban on Chromium Trioxide Uses via REACH Restriction
From Authorisation to Restriction
ECHA has proposed a sweeping REACH restriction on all 11 chromium trioxide (Cr(VI)) substances currently covered by the authorisation list, with the aim of phasing out their use across the EEA by 2028. The move replaces the previous authorisation regime for these substances, which are known for their extreme carcinogenicity, especially in industrial and workplace settings.
The Annex XV restriction dossier, published by ECHA, will undergo a six-month consultation from 18 June 2025, after which it will be assessed by ECHA’s scientific committees and submitted to the European Commission for decision.
Scope and Exemptions
The proposal includes barium chromate to prevent regrettable substitution and covers mixture formulation, not substance manufacture. It also exempts specific industrial uses if exposure/emissions remain below defined thresholds. These uses include:
- Formulation of mixtures
- Electroplating on plastic and metal
- Use of primers/slurries
- Other surface treatment
- Functional additives and process aids
A proposed 18-month transition period would allow companies time to adapt.
Three Restriction Options
ECHA outlines three restriction options (RO1, RO2, RO3), each with increasing stringency:
- RO1: Based on the current EU binding occupational exposure limit (5 µg/m³); most cost-effective.
- RO2: Moderate stringency; 1 or 0.5 µg/m³, depending on use.
- RO3: Most stringent; 5 or 0.1 µg/m³.
Each option includes environmental limit values (ELVs) for air and water emissions, tailored to the level of worker protection offered.
Health and Environmental Benefits
ECHA estimates that the restriction could:
- Prevent up to 17 tonnes of Cr(VI) from entering the environment each year
- Avoid up to 195 cancer cases annually
- Yield benefits of up to €1.07 billion over 20 years, depending on the option selected
Why This Shift?
The proposal follows a 2023 Commission decision to move Cr(VI) substances from authorisation to restriction, after the EU General Court annulled an upstream authorisation, leaving hundreds of downstream users without clarity.
The shift also reflects a broader rethink of REACH’s authorisation process. ECHA has processed hundreds of Cr(VI) applications since 2015, far more than expected, creating a regulatory bottleneck. The Commission now favours using authorisation for narrower, high-volume substances, not widely-used substances like Cr(VI).
Alternatives and Economic Impact
According to ECHA, no “drop-in” substitutes exist for many uses of Cr(VI). Although alternatives are available, they are often:
- Less effective
- Not technologically mature
- Still hazardous, though less so
Switching could increase production costs by 10–20%, and significant investment would be needed. ECHA notes that widespread substitution is unlikely without stopping imports of Cr(VI)-treated articles from outside the EU.
What’s Next?
- Public consultation: June–December 2025
- Committee review and Commission decision: Expected in 2026
- Implementation: 18-month transition, leading to full effect by 2028
This restriction is poised to become one of the most significant and far-reaching workplace safety and environmental protection measures under REACH to date.
EU Extends PFOA Exemption in Firefighting Foams and Bans UV-328 under POPs Regulation
Extended Exemption for PFOA Use in Firefighting Foams
On 5 May 2025, the European Commission adopted a delegated act under the EU POPs Regulation, granting an additional five-month exemption for the use of perfluorooctanoic acid (PFOA) in firefighting foams.
- The deadline for removing PFOA-based foams is now 3 December 2025, extended from 4 July.
- The exemption applies to liquid fuel vapour suppression and Class B fire scenarios in existing mobile and fixed systems.
- This decision follows concerns from authorities and stakeholders over delays in foam replacement, challenges in measuring PFOA-related substances, and an underestimation of quantities in use.
- The revised date aligns with the latest permissible deadline under the Stockholm Convention.
Ban on UV-328 with Limited Exemptions
The Commission also confirmed the ban of UV-328, a widely used UV stabiliser, with certain transitional exemptions.
- A limit value of 1 mg/kg applies to all substances, mixtures, and articles.
- Use in land-based vehicles, photographic paper, and a few other applications is allowed until 26 February 2030.
- UV-328 is typically used in automotive coatings, plastics, and outdoor products to prevent UV degradation and discoloration.
- The measure follows global agreements under the UN Stockholm Convention to restrict persistent organic pollutants.
Cosmetics:
EU Opens Public Consultation on Cosmetics Regulation Review
The European Commission has launched a public consultation on the Cosmetic Products Regulation, open from 5 May to 28 July 2025. This initiative forms part of a broader evaluation of the regulation, first implemented in 2013, and aims to gather feedback from stakeholders, industry, NGOs, and consumers.
The consultation seeks input on how well the regulation has achieved its goals, with particular focus on:
- The effectiveness of current risk assessment methods;
- The potential inclusion of environmental considerations for cosmetic ingredients;
- The future role and independence of the Scientific Committee on Consumer Safety (SCCS).
A previous call for evidence, closed in March, attracted 155 responses, revealing diverging views: while NGOs support a shift toward environmental risk coverage, industry stakeholders advocate preserving a risk-based approach focused on human health.
The Commission is also exploring a possible reallocation of SCCS responsibilities to another EU agency, which has raised concerns about maintaining scientific independence.
A draft revision of the regulation is expected in Q2 2026, after delays linked to the EU legislative calendar and the 2024 European elections. This will be the first major update since the law’s introduction, aligning with the goals of the Chemicals Strategy for Sustainability (CSS).
Biocides:
European Commission Extends BPR Approvals for 11 Biocidal Substances
The European Commission has extended the approval periods for 11 active substances under the Biocidal Products Regulation (BPR), as renewal decisions are still pending. The extensions were granted due to delays beyond the control of applicants and aim to ensure regulatory continuity.
The affected substances include:
- Nonanoic acid (PT 2),
- Iodine (PT 3),
- Octanoic acid (PT 4),
- Cu-HDO (PT 8),
- S-methoprene (PT 18),
- Medetomidine (PT 21),
- Decanoic acid (PT 4),
- DDACarbonate (PT 8),
- IPBC (PT 8),
- 1R-trans phenothrin (PT 18),
- Polyvinylpyrrolidone iodine (PTs 1 & 3).
New expiry dates range from 30 June 2026 (e.g., medetomidine) to 29 February 2028 for most substances. All implementing decisions were published in the EU Official Journal between 23–26 May and will enter into force 20 days after publication.
Medical Devices:
ISO Releases Final Draft of ISO 10993-1 on Biological Evaluation of Medical Devices
The International Organization for Standardization (ISO) has published the Final Draft International Standard (FDIS) 10993-1, outlining updated requirements and principles for evaluating the biological safety of medical devices as part of a risk management process.
Key Highlights
- Risk-Based Approach: The draft introduces a structured, risk-based framework for assessing biocompatibility based on the type, nature, and duration of body contact.
- Device Categorisation: Clarifies how devices are classified (e.g., short-term vs long-term) to better inform testing needs and risk assessment strategies.
- Minimising Animal Testing: Emphasises identifying data gaps and avoiding unnecessary in vivo testing in alignment with ethical standards and evolving regulations.
Scope of Application
Applies to all medical devices, including implantables, wearables, and single-use items like face masks and surgical gloves.
Industry Impact
Manufacturers and stakeholders in the medical device industry should begin aligning their biological evaluation procedures with the revised standard. This includes updating risk management practices and reassessing safety strategies in preparation for formal adoption of ISO 10993-1.
In parallel, the Commission has also granted approval for formic acid for use in in-can preservatives (PT 6). Backed by ECHA’s Biocidal Products Committee (BPC), the approval is valid until 30 September 2036.
Notified bodies survey on certifications and applications
The European Commission has released the 12th Notified Bodies (NB) Survey, providing insights into the implementation progress of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) as of 31 October 2024. This survey, conducted by the Austrian National Public Health Institute (GÖG) with support from Areté and Civic Consulting, achieved a 100% response rate from all 51 designated NBs.(health.ec.europa.eu)
Key Findings:
- MDR Certifications: A total of 28,512 applications were lodged under the MDR, resulting in 17,846 written agreements and 13,177 issued certificates.(ec.europa.eu)
- IVDR Certifications: Under the IVDR, 2,201 applications were submitted, leading to 1,273 issued certificates.(ec.europa.eu)
- Staffing Levels: There has been a steady increase in NB staffing, with a notable rise in full-time equivalents (FTEs) dedicated to MDR and IVDR assessments.
The survey highlights ongoing challenges, including the need for increased NB capacity and the importance of timely conformity assessments to ensure the availability of medical devices and in vitro diagnostics in the EU market.
For a comprehensive overview, you can access the full survey report here: (health.ec.europa.eu).
