Europe Regulatory News

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.

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 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.

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.

On 17 September 2025, the European Chemicals Agency (ECHA) launched a call for evidence to support a study on substances of concern (SoCs) in packaging and packaging waste, as required under the Pa...

On 17 September 2025, the European Chemicals Agency (ECHA) launched a call for evidence to support a study on substances of concern (SoCs) in packaging and packaging waste, as required under the Packaging and Packaging Waste Regulation (PPWR). The consultation is open until 28 October 2025.

Legal Basis and Objectives

The PPWR, in force since 11 February 2025, tasks the European Commission, assisted by ECHA, with preparing a report on substances in packaging that may pose risks to human health or the environment, or that hinder recycling and the safe use of secondary raw materials. The mandate given to ECHA requires the study to assess such substances and propose possible regulatory follow-up measures, including restrictions.

Scope of the Study

The background note to the call for evidence highlights that the study will focus on:

• Substances that contaminate recycled materials or reduce recycling efficiency.
• Chemicals of concern that may be released from packaging during use, disposal, or recycling.
• Waste management practices and recycling technologies relevant for mitigating risks.

Stakeholders Invited to Contribute

Input is sought from companies across the packaging supply chain, including manufacturers, importers, distributors, formulators, and recyclers, as well as NGOs, Member State authorities, and scientific organisations. Non-EU stakeholders may also contribute where relevant. Information can be submitted confidentially.

Consultation Timeline

• Start date: 17 September 2025
• Deadline for contributions: 28 October 2025
• Submit contributions via: EU Survey

Further details are available in the European Commission’s mandate to ECHA and the background note.

All fees under the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012) have increased by 19.5% to reflect inflation, following Commission Implementing Regulation (EU) 2025/1490.The revi...

All fees under the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012) have increased by 19.5% to reflect inflation, following Commission Implementing Regulation (EU) 2025/1490.

The revised fee schedule entered into force on 14 August 2025 and applies to a broad range of procedures, including applications for active substance approval, biocidal product authorisation (single products and families), renewals, amendments, technical equivalence assessments and annual fees.

Impact on Companies

The increase affects all companies placing biocidal products on the EU market. While SME reductions remain available, the inflation-linked adjustment represents a significant rise in regulatory costs, especially for businesses planning new submissions or renewals in 2025.

The full text of the Biocides Fee Regulation can be found here.