Europe Regulatory News

The European Chemicals Agency (ECHA) has announced the launch of the B-risk for biocides online tool. This new resource is designed to support the assessment of the risks that biocidal products pose t...

The European Chemicals Agency (ECHA) has announced the launch of the B-risk for biocides online tool. This new resource is designed to support the assessment of the risks that biocidal products pose to bees. It is intended to assist businesses, scientists, and authorities in evaluating the hazards that biocidal agents pose to bees. It was developed as a joint effort under the "one substance, one assessment" concept.

Extending the Reach of Bee Risk Assessment

The European Food Safety Authority's (EFSA) popular B-risk tool, initially created for plant protection products (pesticides), has been modified to create the B-risk for biocides tool. By customizing it to the unique demands of biocidal products, particularly insecticides, the new tool directly assists users in conducting complete risk assessments under the Biocidal Products Regulation (BPR).

This initiative aligns with broader EU initiatives aimed at reversing the decline in pollinator populations. It is essential for promoting bee health and biodiversity throughout Europe.

Key Benefits and Alignment with New Guidance

The new tool is meant to ensure compliance with the ECHA Bee Guidance, which was published in 2024, and will be essential for biocides evaluations submitted from February 2026 onwards.

Key features and benefits of the B-risk for biocides tool include:

• Biocide-Specific Exposure Assessment: Tailored to mimic the unique ways bees may be exposed to biocidal products.
• User-Friendly Interface: A step-by-step layout that automates intricate calculations.
• Scientific Alignment: Fosters a common understanding of risk and is in line with the scientific principles outlined in EFSA's 2023 Bee Guidance for pesticides.
• Integrated Support: An integrated user handbook gives clear guidance throughout the evaluation process.

Access and Platform Details

The B-risk tool is available to users via ECHA's Support pages and is hosted on EFSA’s R4EU site. It is web-based and does not require installation. Registration on the R4EU portal and acceptance of EFSA’s conditions of usage are mandatory to access the tool.

The development of the B-risk for Biocides tool is a significant step in preparing for ECHA's 2024 Guidance on assessing risks to bees from the use of biocides, published in February 2024. This guidance will apply to new biocide evaluation applications submitted from February 2026 onwards. However, it will not apply to active chemicals currently included in the review process.

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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 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.

Update 13 November 2025:The Council of the European Union has today formally approved the One Substance, One Assessment (OSOA) legislative package, marking the final political step before publication ...

Update 13 November 2025:
The Council of the European Union has today formally approved the One Substance, One Assessment (OSOA) legislative package, marking the final political step before publication in the Official Journal. Once published, the three acts will enter into force 20 days later. The package introduces a harmonised assessment process across EU chemicals legislation and foresees the creation of a common data platform, which must become operational within three years of entry into force.

Original News:

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 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.