Europe Regulatory News

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.

In a decisive move to protect human health and the environment, the European Commission has announced the final adoption of a regulation under REACH (Regulation (EC) No 1907/2006) to prohibit the u...

In a decisive move to protect human health and the environment, the European Commission has announced the final adoption of a regulation under REACH (Regulation (EC) No 1907/2006) to prohibit the use of per- and polyfluoroalkyl substances (PFAS) in firefighting foams across the EU.

The new Commission Regulation (EU) 2025/1988, published in the Official Journal of the European Union on 3 October, amends Annex XVII of REACH. This restricts the placing on the market and use of PFAS in firefighting foams from 23 October 2030 onwards. There will be phased transitional periods for specific applications.

Scope and Timeline

From 23 October 2030, firefighting foams containing PFAS in concentrations equal to or above 1 mg/l (sum of all PFAS) will no longer be permitted for sale or use, except in limited cases where substitution is not yet technically feasible. Transitional provisions apply to:

• High-risk and industrial installations under the Seveso III Directive, offshore platforms, certain ships, and military uses, where continued use is permitted until 23 October 2035 under strict conditions.
• Portable fire extinguishers and alcohol-resistant formulations may be used until 23 April 2027.
• Training, testing, and public fire services may use existing stocks with containment measures until 23 April 2027.

During these periods, operators must minimise releases to the environment, label PFAS-containing stocks, and ensure that waste is treated and destroyed properly, typically by incineration at temperatures above 1100 °C. Equipment that has contained PFAS foams must be thoroughly cleaned before being refilled with fluorine-free alternatives. A special derogation allows cleaned equipment (excluding portable extinguishers) to temporarily emit up to 50 mg/l of PFAS, subject to review by 2030.

Definition and Impact

The restriction applies to PFAS as defined by the OECD criteria; substances containing a fully fluorinated methyl (-CF₃) or methylene (-CF₂-) carbon atom without attached hydrogen or halogen atoms. According to the Commission’s assessment, firefighting foams are a major source of PFAS emissions, releasing around 470 tonnes annually across the EU.

The new restriction is expected to prevent around 13,000 tonnes of PFAS emissions over the next 30 years. The Commission highlights that the measure will also drive innovation in the development and deployment of fluorine-free alternatives.

The full text of Commission Regulation (EU) 2025/1988 can be accessed here. 

On 25 September 2025, the European Commission published Delegated Regulation (EU) 2025/1930 in the Official Journal, amending the Persistent Organic Pollutants (POPs) Regulation (EU) 2019/1021 to i...

On 25 September 2025, the European Commission published Delegated Regulation (EU) 2025/1930 in the Official Journal, amending the Persistent Organic Pollutants (POPs) Regulation (EU) 2019/1021 to include Dechlorane Plus (syn- and anti-isomers; CAS 13560-89-9, 135821-03-3, 135821-74-8). The regulation will enter into force on 15 October 2025, implementing the EU’s commitments under the Stockholm Convention. The Convention listed Dechlorane Pluas for global elimination in 2023 due to its persistence and bioaccumulative properties.

Thresholds for Unintentional Presence

• Until 15 April 2028, the substance is permitted at concentrations up to 0.1% (1 000 mg/kg) in substances, mixtures, and articles.
• After 15 April 2028, this is reduced to 0.0001% (1 mg/kg).

Specific Exemptions

The use of Dechlorane Plus is permitted under narrowly defined derogations, including:

• Aerospace, space, and defence; medical imaging and radiotherapy devices – until 26 February 2030.
• Spare parts and repair for vehicles, machinery, marine and outdoor equipment, aerospace and instruments – until the end of their service life or 31 December 2043, whichever comes first.
• Medical and in vitro diagnostic devices – until the end of their service life.

Review and Legacy Use

The Commission must review these exemptions by 1 April 2028, ahead of the next Stockholm Convention review, to determine whether extensions are needed. Products that have already been placed on the market under a valid exemption may continue to be used after the exemption has expired, and certain spare parts for aerospace and defence equipment may remain in use beyond 2043.

The full text of the delegated regulation can be accessed here.