Europe Regulatory News

On 1 December 2025, the Council of the European Union agreed its position on the sixth update of the Carcinogens, Mutagens and Reprotoxic Substances Directive (CMRD). The revision introduces new bindi...

On 1 December 2025, the Council of the European Union agreed its position on the sixth update of the Carcinogens, Mutagens and Reprotoxic Substances Directive (CMRD). The revision introduces new binding occupational exposure limits, updates Annex I and reflects the latest scientific advice in order to strengthen the protection of workers exposed to hazardous substances.

New Substance Limits and Additions

The Council’s position confirms new or updated limits for several substances and processes. These include:

• Cobalt and inorganic cobalt compounds
• Polycyclic aromatic hydrocarbons (PAHs), measured as benzo[a]pyrene
• 1,4-dioxane, including a biological limit value
• Isoprene, with a new EU-level occupational exposure limit
• Welding fumes containing category 1A or 1B carcinogens, mutagens or reprotoxic substances

The revision also updates the definitions of carcinogens, mutagens and reprotoxic substances, reflecting scientific developments and accommodating the inclusion of welding fumes as a process covered by the directive.

Next Steps

The file will now move to the European Parliament, which will establish its position before the start of the trilogue negotiations. Transitional periods are planned for sectors where immediate compliance may be difficult. According to the Council, the revised limits and updated rules could prevent approximately 1,700 lung cancer cases and 19,000 other serious health conditions over the next 40 years.

On 26 November 2025, the European Chemicals Agency (ECHA) published the Reporting Guidelines for Synthetic Polymer Microparticles (SPMs) to support companies in preparing the annual emission reports r...

On 26 November 2025, the European Chemicals Agency (ECHA) published the Reporting Guidelines for Synthetic Polymer Microparticles (SPMs) to support companies in preparing the annual emission reports required under the EU microplastics restriction (Regulation (EU) 2023/2055). The guidance clarifies who must report, what information must be submitted, and how to prepare dossiers using the IUCLID reporting template prior to submission through REACH-IT.

Who Must Report and Key Deadlines

The reporting obligation applies to manufacturers, importers, industrial users, and suppliers who place SPMs on the market for uses that remain exempt from the restriction. The guidelines distinguish between two groups, each with a different start date for reporting.

• For manufacturers and industrial downstream users of SPMs in pellet, flake, or powder form, used as feedstock in plastic manufacturing at industrial sites, reporting begins in 2026. These companies must submit the required information to ECHA by 31 May each year, starting in 2026, and report on emissions from the previous calendar year.
• For other manufacturers of SPMs and other industrial downstream users using SPMs at industrial sites, reporting begins in 2027. These companies must also submit their information by 31 May each year, starting in 2027, based on emissions from the preceding year.

Although certain uses of SPMs remain exempt from the ban on placing on the market, are still subject to the annual reporting requirement.

Information Required in the Report

According to the guidelines, companies must provide comprehensive information on each relevant use of SPMs. This includes:

• Identification of the polymer, using generic names and available codes.
• Description of the use, including the sector, product category, technical function, and where applicable, site information.
• Quantities placed on the market and estimated emissions or potential releases to the environment.
• A description of containment or loss-prevention measures.
• Justification for any claimed derogations.

All reports must be completed using the dedicated IUCLID template. This template is designed to ensure traceability and consistency across sectors, particularly where the same SPM may be used in several applications. Submission takes place through REACH-IT, where the annual reporting window will open.

Preparing for Compliance

ECHA encourages companies to start preparing early by mapping their portfolios and determining whether SPMs are used in any exempted applications. Setting up internal systems to collect volume data, emissions estimates, and use descriptions will help ensure timely submission. The aggregated reporting data will support EU authorities in assessing environmental releases and monitoring the effectiveness of the microplastics restriction.

The guidelines can be accessed here.

On 25 November 2025, the European Parliament adopted an own-initiative report (2025/2086(INI)) calling for faster approval and authorisation procedures for biological control agents used in agricultur...

On 25 November 2025, the European Parliament adopted an own-initiative report (2025/2086(INI)) calling for faster approval and authorisation procedures for biological control agents used in agriculture.

The Parliament emphasises the important role of biocontrol products, which include living organisms, microorganisms and naturally derived substances in reducing reliance on chemical plant protection products. However, developers currently face lengthy and complex procedures that were originally designed for conventional pesticides. The Parliament therefore believes that more efficient processes are needed to help farmers access safer and more sustainable pest management solutions.

Current procedures for biological control substances and products fall under Regulation (EC) No 1107/2009 on plant protection products. In contrast invertebrate biological control agents are not covered by EU legislation, instead falling under diverse national rules.

Call for a Clear Definition and Adapted Data Requirements

The report calls on the European Commission to develop a clear and harmonised EU-wide definition of biological control agents. It stresses that the existing regulatory framework does not sufficiently reflect the specific characteristics and risk profiles of biocontrol products. The Parliament recommends adapting data requirements and risk assessment procedures, so that they are proportionate and better tailored to biological products. This would ensure that applicants, particularly small and medium sized enterprises (SMEs), face fewer administrative obstacles and greater predictability when submitting dossiers.

Measures to Speed Up Authorisation While Maintaining High Safety Standards

To accelerate market access, the report proposes fast-track approval routes for low-risk biological control agents, wider use of mutual recognition between Member States and the option of provisional authorisations under defined conditions. At the same time, the Parliament emphasises that these adapted procedures must continue to ensure a high level of protection for human health, non-target organisms, and the environment. Additional resources at the EU and national levels are recommended to prevent delays and to support the timely evaluation of applications.

The adopted text can be found here.

On 25 November 2025, the European Parliament adopted a new Toy Safety Regulation aimed at strengthening child health protection and updating safety requirements for all toys placed on the EU market.Ex...

On 25 November 2025, the European Parliament adopted a new Toy Safety Regulation aimed at strengthening child health protection and updating safety requirements for all toys placed on the EU market.

Expanded Restrictions on Hazardous Chemicals

The updated regulation broadens the existing bans on dangerous substances. In addition to carcinogenic, mutagenic and reproductive toxic chemicals, the rules now prohibit endocrine disruptors, substances that are harmful to the respiratory system, skin or other organs, per- and polyfluoroalkyl substance (PFAS) and the most hazardous bisphenols. Allergenic fragrances will no longer be permitted in toys intended for children under three years of age or in toys that children may put in their mouths.

Strengthened Safety Assessments and Digital Product Passports

Manufacturers will be required to carry out comprehensive safety assessments before placing toys on the market. These assessments must consider chemical, physical, mechanical and electrical risks, as well as flammability, hygiene and radioactivity. The rules also require manufacturers of connected or digital toys to assess potential risks to children’s mental health.

All toys will require a digital product passport (DPP), which is designed to support customs and market surveillance as well as giving consumers easy access to safety information via a QR code for example. Importers, distributors and online marketplaces will face stricter obligations, and toys that do not comply with the regulation will be treated as illegal.

Next Steps

The Toy Safety Regulation will apply 20 days after its publication in the Official Journal of the European Union. A transitional period of four and a half years will allow authorities and industry to adapt to the new requirements.

On 18 November 2025, the European Chemicals Agency (ECHA) made its 12th recommendation to the European Commission, that four additional substances be added to the Authorisation List (Annex XIV of the ...

On 18 November 2025, the European Chemicals Agency (ECHA) made its 12th recommendation to the European Commission, that four additional substances be added to the Authorisation List (Annex XIV of the REACH Regulation (EC No 1907/2006)). If the Commission proceeds with this recommendation, manufacturers, importers and downstream users of these substances will need to apply for authorisation if they wish to continue using them beyond the set transition deadlines.

The authorisation process is intended to manage chemicals that have already been identified as Substances of Very High Concern (SVHCs), by imposing strict requirements on their use and promoting the use of safer alternatives. The four substances targeted in this recommendation are already listed on the Candidate List of SVHCs and their proposed inclusion in Annex XIV signals heightened regulatory scrutiny.

Substances Proposed for Authorisation

Below is a summary of the proposed entries and key use/volume data.

ECHA notes that the volumes and uses of barium diboron tetraoxide within the scope of authorisation are limited. Nevertheless, the substance is recommended based on grouping considerations, as it could otherwise be used to replace other boron compounds that are already recommended, which would risk regrettable substitution.

The document also notes that the draft entry for bis(2-ethylhexyl) tetrabromophthalate, covering all isomers and combinations, was not included in the final recommendation. This substance is being addressed in a parallel restriction initiative under the Restrictions Roadmap.

Implications and next steps

The recommendation will now be considered by the European Commission and EU Member States. If the substances are added to Annex XIV, the latest application dates and sunset dates will be set out in the authorisation list.

Companies that manufacture, import or use these substances in the European Economic Area will need to check whether their uses fall within the scope of the entries. Where relevant, they will also need to prepare for authorisation applications or consider alternatives in view of the future sunset dates.

On 6 November 2025, the European Commissioner for the Environment, Water Resilience and Forestry, Jessika Roswall, presented an update on the European Commission’s chemicals policy agenda. She confi...

On 6 November 2025, the European Commissioner for the Environment, Water Resilience and Forestry, Jessika Roswall, presented an update on the European Commission’s chemicals policy agenda. She confirmed that the long-awaited revision of the REACH Regulation is still in preparation. The Commissioner outlined the ongoing efforts to reinforce EU chemicals legislation and encourage the development of safer and more sustainable materials.

REACH Revision Still Under Preparation

Roswall acknowledged that the REACH revision process is taking longer than initially planned, noting that the Commission is still updating its supporting analysis and impact assessments. She confirmed that no proposal date could yet be given, indicating that the draft would only be published once the analytical work was complete.
This effectively confirms that the REACH revision will not be presented in 2025, in line with previous indications of delay.

New Databases to Support One Substance, One Assessment

The Commissioner also outlined the upcoming measures under the ‘One Substance, One Assessment’ Regulation, including the establishment of two new EU databases. One database will collect environmental sustainability data to support lifecycle-based assessments of chemicals. The second database will compile information on alternatives to substances of concern, with the aim of facilitating substitution and reducing regulatory duplication.

These databases are intended to increase transparency, improve coordination across EU agencies, and promote the development of safer substances.

Revised Safe and Sustainable by Design Framework

Roswall announced that the Commission will soon adopt an updated Safe and Sustainable by Design (SSbD) Framework to guide research and innovation funding towards safer and more sustainable chemical and material solutions. The revised framework will also help companies to integrate sustainability criteria at an early stage in the development of products.

EU Innovation and Substitution Hubs to Address PFAS and Promote Safer Alternatives

To complement these efforts, the Commission is establishing EU Innovation and Substitution Hubs under the EU Chemicals Industry Action Plan. These hubs are designed to accelerate the development of safer and more sustainable alternatives as well as addressing key challenges such as the substitution of PFAS and other substances of concern.

Roswall noted that the design phase is already underway and invited stakeholders to provide input on how the hubs can best support industry and research collaboration.

Upcoming Bioeconomy Strategy and Circular Economy Act

The Commissioner also confirmed that the new EU Bioeconomy Strategy will be adopted on 25 November 2025. The strategy aims to scale up the production of bio-based materials, strengthen biotechnology research, and extend sustainable value chains across industrial sectors.

A Circular Economy Act, expected in 2026, will follow as part of the Commission’s broader environmental policy package. This act will focus on creating a single market for secondary raw materials and fostering circular solutions throughout EU supply chains.

Collaboration and Outlook

Roswall emphasised that the success of these initiatives will depend on cooperation between Member States, industry, and research partners. She emphasised that the Commission’s long-term goal is to maintain high health and environmental protection standards while strengthening the competitiveness and resilience of the EU chemicals sector.

The long-awaited revision of the EU REACH Regulation (EC) No 1907/2006 has been delayed again. The European Commission’s internal planning document (SEC(2025) 2543 final, 3 November 2025), outlining...

The long-awaited revision of the EU REACH Regulation (EC) No 1907/2006 has been delayed again. The European Commission’s internal planning document (SEC(2025) 2543 final, 3 November 2025), outlining possible agenda items for meetings between 12 November 2025 and 28 January 2026, does not list the REACH revision among the key legislative proposals. This confirms that the proposal will not be tabled in 2025 and is now expected in 2026, depending on progress with the revised impact assessment and inter-service consultation.

RSB Rejection Causes Further Delay

The delay also follows reports that the Regulatory Scrutiny Board (RSB) issued a negative opinion on the Commission’s impact assessment supporting the REACH revision in September 2025. The RSB reportedly requested further analysis from the Directorate-General for Environment before the proposal could proceed, contributing to the postponement of the legislative process.

Background and Objectives

Originally announced under the EU Chemicals Strategy for Sustainability, the REACH revision aims to strengthen data requirements, improve risk management for hazardous substances, and streamline administrative procedures.