Europe Regulatory News

The national authorities of Denmark, Germany, the Netherlands, Norway and Sweden have released a 20-page summary explaining the updates to their proposal to restrict per- and polyfluoroalkyl substa...

The national authorities of Denmark, Germany, the Netherlands, Norway and Sweden have released a 20-page summary explaining the updates to their proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the REACH Regulation in the EU/EEA.

Purpose and Key Updates

The document, titled “What You Need to Know About the Updated PFAS Restriction Dossier,” provides an overview of the key changes made since the original proposal was submitted to ECHA in January 2023. It aims to help stakeholders navigate the broad and technically complex proposal and to clarify how consultation feedback and scientific evaluations have been incorporated.

Scope and Derogations

The updated dossier refines the definition of PFAS, includes revised or new derogations for specific uses where alternatives are not yet available, and outlines transitional periods. It also updates the socio-economic analysis and clarifies analytical and reporting requirements.

Next Steps

ECHA’s expert committees, the Committee for Risk Assessment (RAC) and the Committee for Socio‑Economic Analysis (SEAC), are expected to issue their draft opinions in spring 2026, followed by a formal public consultation (more details here).

The dossier submitters emphasise that the summary is not a substitute for the full updated restriction dossier but serves as guidance to support industry and other stakeholders in understanding the forthcoming decision-making process.

The full summary can be accessed here.

On 21 October 2025, the European Parliament adopted three legislative resolutions forming the core of the One Substance, One Assessment (OSOA) initiative. The package aims to simplify and harmonise...

On 21 October 2025, the European Parliament adopted three legislative resolutions forming the core of the One Substance, One Assessment (OSOA) initiative. The package aims to simplify and harmonise the evaluation of chemicals across the EU by improving data accessibility, strengthening coordination among EU agencies, and transferring certain scientific and technical tasks to the European Chemicals Agency (ECHA).

Common Data Platform on Chemicals

The first regulation (P10_TA(2025)0235) establishes a common data platform on chemicals to consolidate information on hazard properties, uses, emissions, presence in the environment, and human exposure. The platform will also include data on safer alternatives and will apply the FAIR principles (findable, accessible, interoperable, and reusable) to ensure consistency and transparency in chemical data. It also establishes a monitoring and outlook framework to support the early identification of emerging chemical risks.

Re-attribution of Tasks to ECHA

The second act (P10_TA(2025)0236) reallocates specific scientific and technical tasks from the European Commission and other bodies to ECHA. These include assessing exemption requests under the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU, coordinating technical reviews, and publishing non-confidential application information. A twenty-month transition period is foreseen to enable the transfer of responsibilities and resources.

Strengthened Inter-Agency Cooperation

The third text (P10_TA(2025)0237) amends several existing EU regulations to strengthen cooperation among EU agencies involved in chemical safety, food safety, environmental protection, and product regulation. These include:

• Regulation (EC) No 178/2002 (General Food Law Regulation)
• Regulation (EC) No 401/2009 (European Environment Agency Regulation)
• Regulation (EU) 2017/745 (Medical Devices Regulation)
• Regulation (EU) 2019/1021 (Persistent Organic Pollutants Regulation)

The amendments introduce mechanisms for data exchange, coordinated scientific assessments, and the resolution of divergent scientific opinions.

Next Steps

These measures aim to eliminate the duplication of chemical assessments, improve regulatory efficiency, and enhance the scientific coherence of EU chemicals legislation. This is in line with the objectives of the Chemicals Strategy for Sustainability and the zero-pollution ambition of the European Green Deal.

Following Parliament’s approval, the package awaits formal adoption by the Council of the European Union before entering into force. Each act will enter into force following publication in the Official Journal of the European Union, typically twenty days after publication, unless otherwise specified.

On 15 October 2025, the European Commission adopted Implementing Regulation (EU) 2025/2067, amending Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency (EC...

On 15 October 2025, the European Commission adopted Implementing Regulation (EU) 2025/2067, amending Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency (ECHA) under REACH. The regulation was published in the Official Journal of the European Union the following day. It introduces two major reforms: an inflation-based adjustment to standard REACH fees and a new system for verifying Small and Medium-sized Enterprise (SME) status.

Fee Adjustments

The amendment introduces a 19.5 % increase in standard REACH fees, reflecting the cumulative inflation recorded since 2021. This update ensures that the fees paid to ECHA continue to cover the costs of registration, evaluation, and other administrative processes under REACH.
However, in line with the European Commission’s SME Relief Package and the 2024–2029 Political Guidelines, small and medium-sized enterprises (SMEs) are excluded from this adjustment. The exemption is intended to maintain a fair balance between administrative sustainability and the financial capacity of smaller companies.

The revised fee structure will apply from 5 November 2025, the date the regulation enters into force. The exact fee amounts for each registration type and company size can be found in Implementing Regulation (EU) 2025/2067 which is available here.

New Approach to SME Status Verification

The amendment introduces a change to how ECHA verifies SME eligibility. Rather than reviewing SME claims after submission (the current ex post approach), ECHA will now verify SME status in advance (ex ante).

Under the revised system, companies wishing to benefit from reduced fees must obtain SME recognition before submitting their dossiers. This request must be submitted no later than two months before the intended submission date. Once granted, SME status will remain valid for three years and will cover all applications made during that period.
ECHA may charge an administrative fee to process SME recognition requests, but this fee will be waived if the company’s SME status is confirmed. 

The new SME verification system will apply from 5 February 2027, providing a 15-month transition period for companies to align their internal procedures. 

The European Parliament has backed draft measures, supported by 431 MEPs, to advance a circular economy in the automotive sector. This will be achieved by improving vehicle design, increasing the us...

The European Parliament has backed draft measures, supported by 431 MEPs, to advance a circular economy in the automotive sector. This will be achieved by improving vehicle design, increasing the use of recycled materials, and strengthening car recycling.

The initiative aims to make vehicles easer to dismantle and recycle, set ambitious recycled-content targets, and assign manufacturers greater responsibility for collection and treatment. The Parliament’s position is in line with the European Green Deal and the EU's circular economy objectives, and negotiations will now follow the Council's earlier position.

Circular Economy in the Automotive Sector

The rules apply to most vehicles, with the exception of those used for special purposes, military purposes, emergency services, and historically significant vehicles. New vehicles must be designed so that parts can be easily removed for reuse, recycling, remanufacturing, or refurbishing. MEPs propose that vehicles contain at least 20% recycled plastic within six years and 25% within ten years, with future targets set for recycled steel and aluminium.

Three years after implementation, manufacturers will be subject to extended producer responsibility, covering the cost of collecting and treating end-of-life vehicles, alongside an export ban for such vehicles. The co-rapporteurs emphasized that the Parliament’s aim to support resource security, environmental protection, and sustainability while ensuring realistic targets and fair competition.

These measures follow the Commission’s proposal in July 2023 and align with the European Green Deal and the circular economy action plan. With 14.8 million vehicles produced in 2023 and 6.5 million reaching end-of-life annually, interinstitutional negotiations are expected soon, following the Council’s earlier position in order to finalize the regulatory framework.

Further steps

As the European Council already adopted its position earlier this summer, interinstitutional negotiations are expected to start without delay.

The latest version of the OECD QSAR Toolbox version 4.8 has been released, introducing new functionalities and technical improvements to enhance usability, transparency, and data security. The QSAR ...

The latest version of the OECD QSAR Toolbox version 4.8 has been released, introducing new functionalities and technical improvements to enhance usability, transparency, and data security. The QSAR Toolbox is a freely available software that supports chemical hazard assessment and reduces the need for animal testing. It is developed jointly by the European Chemicals Agency (ECHA), the OECD Environment Directorate, and implemented by the Laboratory of Mathematical Chemistry.

• Integration of metabolism data: Users can now import and visualise structural data and metadata from metabolism databases, strengthening the analysis of biotransformation processes.
• New and updated databases and profiles: The update adds new datasets and improves existing ones to expand chemical coverage and enhance predictive accuracy.
• Updated QSAR documentation: The documentation of QSAR predictions has been revised in line with the OECD QSAR Assessment Framework to ensure greater transparency and consistency.
• Improved security and support: Updated libraries and software components enhance system stability and data protection.

The release notes for QSAR Toolbox 4.8 are available here.

On 1 October 2025, the European Union notified the World Trade Organization (WTO) of two draft Commission Regulations revising the data requirements for active substances and plant protection produ...

On 1 October 2025, the European Union notified the World Trade Organization (WTO) of two draft Commission Regulations revising the data requirements for active substances and plant protection products under the EU’s pesticides legislation. Comments on both measures can be submitted until 30 November 2025.

Updates to Active Substance Data Requirements

Notification G/TBT/N/EU/1162, concerns updates to active substance data requirements in plant protection products. These updates are set out in a draft amendment to Commission Regulation (EU) No 283/2013.

The proposal seeks to adapt the existing data requirements in light of scientific and technical progress, incorporating new methodologies and guidance from the European Food Safety Authority (EFSA) and the OECD. It incorporates new approaches for risk assessment, introduces alternatives to non-animal testing, and brings testing requirements into line with other EU legislation, such as REACH.

This initiative forms part of a wider update package, which also includes revisions to Regulation (EU) No 284/2013 (product-level data requirements) and Regulation (EU) No 546/2011 (uniform evaluation principles).

Amendment to Product-Level Data Requirements

Notification G/TBT/N/EU/1164, proposes a corresponding amendment to Commission Regulation (EU) No 284/2013, which specifies the data requirements for the authorisation and renewal of plant protection products.

This update mirrors the objectives of G/TBT/N/EU/1162, ensuring coherence between active substance and product-level assessments. It introduces revised testing and reporting provisions for efficacy, residues, and risk assessments, taking into account recent EFSA guidance on birds, mammals, and bees, as well as the impact of water treatment processes.

Next Steps

Both measures are expected to be adopted by the European Commission in the second quarter of 2026 and will enter into force 20 days after publication in the Official Journal of the European Union. The provisions will apply from two months after they enter into force.

On 30 September 2025, the European Commission published its Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals for the period 2...

On 30 September 2025, the European Commission published its Synthesis Report on the Operation of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals for the period 2020–2022. The report reviews the implementation of the Prior Informed Consent (PIC) Regulation across the EU and outlines the latest changes to Annex I.

New substances and updates to Annex I

Several chemicals were added or reclassified under Annex I between 2020 and 2022, expanding the list of substances subject to export notification or explicit consent requirements. Newly listed entries include perfluorooctanoic acid (PFOA) and related compounds, decabromodiphenyl ether (decaBDE), and chlorinated paraffins (C10–C13).

Some existing substances were also moved from Part 1 (notification only) to Part 2 (notification and explicit consent) of Annex I, which further tightens controls on exports. These changes bring the EU Regulation into line with recent decisions under the Rotterdam Convention and strengthen oversight of the trade with hazardous chemical.

In addition, Annex V was expanded to include new export bans for substances such as dicofol, pentachlorophenol, PFOS, PFOA, and decaBDE, as well as certain mercury compounds and mercury-added products.

Implementation findings

The Commission concludes that the PIC system functions effectively, though national authorities continue to face resource constraints and administrative pressure from frequent updates to the annexes. ECHA processed around 10,000 export notifications in 2022 and continued to improve its ePIC system. Enforcement activities by Member States remained stable, focusing on preventing unauthorised exports and ensuring proper documentation.

Outlook

The report recommends the further simplification of annex amendment timelines, the enhancement of user guidance within the ePIC system, and the improvement of support for Designated National Authorities. Overall, the Regulation is considered to be meeting its objectives while adapting to evolving international obligations.

The full text of the report can be found here.