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.

*Source

On 10 December 2025, the European Chemicals Agency published the results of an EU-wide enforcement project under the Enforcement Forum. The project identified significant non-compliance with REACH req...

On 10 December 2025, the European Chemicals Agency published the results of an EU-wide enforcement project under the Enforcement Forum. The project identified significant non-compliance with REACH requirements in imported substances, mixtures, and consumer products. These findings are based on the Forum REF-12 project, which focused on the registration, restriction, and authorisation obligations for imports entering the European Economic Area (EEA).

Background

The REF-12 project aimed to strengthen REACH enforcement at EU borders by improving cooperation between enforcement authorities and customs, and by developing more effective, risk-based targeting methods. The inspections focused on products where non-compliance was anticipated; therefore, the results do not reflect the overall compliance rate of all imports into the EEA.

Extensive EU-Wide Controls on Imports

Inspectors in 29 EEA countries carried out 2,603 targeted inspections of imported substances, mixtures, and articles. The inspections were conducted in close cooperation with customs authorities and focused on products considered at higher risk of non-compliance. Almost all non-compliant products identified before being released for free circulation were either denied entry to the EEA market or allowed entry only after corrective measures had been taken.

Registration Failures in Imported Mixtures

Checks on REACH registration obligations revealed a particularly high non-compliance for substances imported as part of mixtures.

• 32% of substances in mixtures lacked the required REACH registration.
• For substances imported on their own, registration was missing in 7% of cases.

The Enforcement Forum noted that many importers were not fully aware of their REACH obligations and, in some cases, were unaware of the substances present in the mixtures they were placing on the EU market.

Restricted Hazardous Substances Still Common in Consumer Goods

Inspectors also examined more than 1,300 imported mixtures and consumer products for compliance with REACH restrictions.

• 16% of the products checked contained restricted hazardous substances above the permitted limits.
• Most inspections targeted imported jewellery, with a particular focus on nickel, cadmium, and lead.
• Controls also covered toys, textiles, and footwear.

The results confirm persistent non-compliance in imported jewellery, especially with regard to nickel, and show little improvement compared to earlier enforcement projects.

Gaps Identified in Authorisation Compliance

Enforcement authorities also checked compliance with REACH authorisation requirements for imported substances of very high concern listed in Annex XIV. Out of the 21 relevant cases, authorisation was missing or had expired in four cases, highlighting the ongoing challenges of monitoring authorised substances at the import stage.

Strengthened Cooperation with Customs

The project demonstrated the importance of targeted sampling strategies and the systematic use of customs import data. Enhanced cooperation between customs and national REACH enforcement authorities was identified as a key factor in improving the detection of non-compliant imports and ensuring more efficient future controls.

On 10 December 2025, the European Commission presented the Environment Omnibus, a package of five legislative proposals intended to simplify environmental legislation and reduce administrative burdens...

On 10 December 2025, the European Commission presented the Environment Omnibus, a package of five legislative proposals intended to simplify environmental legislation and reduce administrative burdens for businesses and public authorities. This forms part of the Commission’s wider efforts to boost competitiveness while maintaining EU environmental and health protection standards.

Purpose and Scope of the Omnibus

According to the Commission, the objective of the Omnibus is to streamline procedures, modernise reporting obligations, and improve the efficiency of environmental implementation. The proposals focus on areas where administrative requirements have become complex or outdated, including environmental assessments, industrial emissions, and waste and circular economy legislation.

Overview of the Five Legislative Proposals

The Environment Omnibus contains the following five proposals, each introducing targeted simplification measures:

1. Streamlined Environmental Assessments for Permitting
   This proposal introduces measures to simplify and accelerate environmental assessment and permitting procedures. It promotes the use of single points of contact, increased digitalisation and faster administrative timelines. It also includes a dedicated toolbox of accelerating measures is also included for projects in strategic sectors, such as digital infrastructure, critical raw materials and affordable housing, particularly those that contribute to decarbonisation or resource efficiency.
2. Simplified Industrial Emissions Standards
   The second proposal revises the requirements under the Industrial Emissions Directive (IED) to provide industry and farmers with greater flexibility. It simplifies the implementation of environmental management systems (EMS) by removing transformation plan obligations, extending preparation timelines, and eliminating the need for independent audits. Certain reporting requirements for farmers and aquaculture operators are also reduced, with additional simplifications for organic farming activities.
3. Replacement of the SCIP Database with Digital Solutions
   The third proposal concerns the reporting of hazardous substances in products. The Commission proposes replacing the SCIP database under the Waste Framework Directive, citing disproportionate costs. The SCIP database’s functions would be replaced by more effective digital tools, including the Digital Product Passport and elements of the One Substance One Assessment framework, while maintaining access to relevant information.
4. Simplification of Extended Producer Responsibility Obligations
   The fourth proposal targets Extended Producer Responsibility requirements across several waste streams, including batteries, packaging, electronic equipment, and single-use plastics. It temporarily suspends the obligation for EU-based producers to appoint authorised representatives in Member States where they are not established, pending the further streamlining of EPR schemes under the forthcoming Circular Economy Act.
5. Facilitated Access to Geospatial Data
   The fifth proposal aligns the technical requirements for geospatial data under the INSPIRE Directive with the horizontal EU legislation on high-value public-sector data. This alignment is intended to reduce compliance costs for public authorities and improve access to geospatial datasets for public and private users alike.

Future Simplification Initiatives

Beyond the current Environment Omnibus, the Commission has indicated that simplification efforts will continue in the coming years. This will include further stress-testing of existing environmental legislation, as well as additional guidance and measures to improve implementation at the EU and national levels.

As part of this ongoing work, the Commission intends to publish guidance to facilitate the timely and effective implementation of the Packaging and Packaging Waste Regulation (PPWR). This guidance will address issues raised during the call for evidence and promote a more harmonised application across Member States. In addition, the Water Framework Directive is scheduled for review and revision in 2026, alongside planned updates to the Marine Strategy Framework Directive, with the aim of improving coherence with EU freshwater legislation.

The Commission has also confirmed that the forthcoming Circular Economy Act, expected in 2026, will introduce simpler, more harmonised rules aimed at reducing the costs for cross-border circular economy activities.

Next Steps

The five proposals will now be examined by the European Parliament and the Council under the ordinary legislative procedure. Following adoption, the Commission plans to develop supporting guidance and digital tools to assist Member States and stakeholders with implementation.

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

The Council of the European Union has adopted a new regulation aimed at reducing the release of plastic pellets into the environment, following a provisional agreement with the European Parliament. Th...

The Council of the European Union has adopted a new regulation aimed at reducing the release of plastic pellets into the environment, following a provisional agreement with the European Parliament. The final text was published in the Official Journal of the European Union on 26 November 2025.

Plastic pellets are, widely used as a raw material in manufacturing but pose a significant pollution threat because they do not biodegrade once released. Instead, they accumulate in oceans, rivers, soil, marine life and, eventually, the human food chain. It is currently estimated that 52,000 to 184,000 tonnes of pellets leak into the environment each year, making them the third-largest source of unintentional microplastic pollution. The newly adopted rules introduce stronger controls across the entire supply chain to reduce pellet losses and tackle the broader issue of microplastic contamination.

Key Provisions of the Regulation

Regulation 2025/2365 on preventing plastic pellet loss in the EU introduces comprehensive obligations to eliminate plastic-pellet losses across the entire supply chain, with the clear goal of achieving zero leakage into the environment. The rules apply to companies handling five tonnes or more of pellets each year, as well as to operators responsible for cleaning containers and tanks, and to both EU and non-EU carriers transporting pellets within the Union. They also extend to shippers, vessel operators, agents and masters of seagoing vessels transporting pellet-filled freight containers to or from EU ports.

To ensure accountability, non-EU transporters must appoint an authorised representative within the EU, while operators handling more than 1,500 tonnes of pellets annually will need certification from an independent third party. Smaller businesses will follow simplified procedures, including self-declaration of compliance.

The regulation also sets out detailed requirements for the maritime transport of pellets, mandating safer packaging, handling and clear cargo information to prevent pellet losses at sea. These measures collectively represent a major step toward strengthening Europe’s response to microplastic pollution in both land and marine environments.

Next steps

The Regulation will take effect 20 days after its publication in the Official Journal of the European Union, meaning it will become legally effective on 16 December 2025. Most provisions will apply from 17 December 2027. However, several key articles, including those on general obligations and specific operational requirements, will apply earlier, from 16 December 2025.

Specific rules relating to shippers and operators of seagoing vessels will come into force at a later date, from 17 December 2028. Once in effect, the Regulation will be fully binding and directly applicable across all EU Member States.

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.