Europe Regulatory News

On 12 December 2025, the European Union formally established a Common Data Platform on Chemicals by publishing Regulation (EU) 2025/2455 in the Official Journal of the European Union. This creates a c...

On 12 December 2025, the European Union formally established a Common Data Platform on Chemicals by publishing Regulation (EU) 2025/2455 in the Official Journal of the European Union. This creates a central digital infrastructure for the collection, sharing and reuse of chemicals-related data across EU institutions, agencies and Member States. The European Chemicals Agency (ECHA) has been designated as the platform’s operator.

Adopted on 26 November 2025, the regulation represents a key step in strengthening transparency, regulatory efficiency, and scientific coherence in EU chemicals management. It supports the ‘One Substance, One Assessment’ principle under the Chemicals Strategy for Sustainability.

Centralising Chemicals Data Across EU Legislation

The common data platform is designed to centralise chemicals-related information currently dispersed across multiple EU databases and authorities. By improving data accessibility, interoperability, and reuse, the platform will support more consistent and scientifically robust regulatory decision-making across EU chemicals legislation while making non-confidential information available to the public.

The platform will also underpin a monitoring and outlook framework for chemicals, enhancing the EU’s ability to track chemical pollution, emerging risks, and sustainability-related indicators across environmental and human health domains.

Scope of Data Included in the Platform

The regulation defines the broad scope of chemicals-related data to be integrated into the common data platform, consolidating regulatory, study and monitoring information generated under Union law. The platform will aggregate datasets provided by various EU bodies, each with responsibilities aligned to their respective mandates.

Datasets managed by ECHA will include, among others, information under REACH and the CLP inventory, as well as data on biocidal products and chemicals under the Drinking Water Directive. Contributions from the European Food Safety Authority (EFSA) will cover toxicological and chemical monitoring data related to the food chain. Datasets provided by the European Environment Agency (EEA) will include data on environmental emissions and chemical occurrence data. Data relating to human and veterinary medicinal products, managed by the European Medicines Agency (EMA), will be integrated in a stepwise manner, subject to applicable sector-specific rules.

In addition, the platform will incorporate study-related data, particularly notifications of studies commissioned to meet regulatory obligations, alongside metadata that will enable authorities to identify existing studies and reduce duplication of testing. Environmental and human monitoring data, including information currently hosted through IPCHEM, will form a core component of the platform.

Further datasets will cover hazard, exposure and risk information, regulatory process status and outcomes, and reference values used in human health and environmental protection. Where available and non-confidential, information on alternatives to substances of concern and sustainability-related indicators will also be accessible through the platform. All data will be made available in line with existing confidentiality provisions under Union law.

Early Warning and Study Notification Mechanisms

The regulation introduces an early warning and action system for emerging chemical risks. This system is intended to strengthen the EU’s capacity to identify and respond to potential threats at an early stage. The European Environment Agency will compile early warning signals based on monitoring data, targeted research, and inputs from agencies including ECHA, EFSA, EMA, and the European Agency for Safety and Health at Work (EU-OSHA). The first annual report under this system is due by 2 July 2027.

The regulation also establishes mandatory study notification requirements for operators commissioning new scientific studies for regulatory purposes. Notifications must be submitted without undue delay after a study is commissioned. A dedicated database of study notifications, managed by ECHA and integrated into the common data platform, must be operational by 2 November 2027.

Key Dates and Implementation Timeline

• Publication in the Official Journal: 12 December 2025
• Entry into force: The regulation will enter into force 20 days after publication in the Official Journal, on 1 January 2026.
• Commission implementation plan: By 2 July 2026, the European Commission must adopt an implementation plan identifying the datasets to be included in the platform and setting out the timetable for their integration.
• Study notification obligation: From 2 November 2027, operators commissioning studies to meet obligations under EU chemicals legislation must notify these studies to the common data platform, with the aim of improving transparency and avoiding duplication.
• Operational platform deadline: By 2 January 2029, the common data platform on chemicals must be fully established and operational, integrating all required datasets and services.
• Regulation review: By 2 January 2032, the Commission must carry out a review of the regulation and assess whether amendments are needed.
• Integration of historical data: All chemical data generated prior to the platform’s establishment must be incorporated by 2 January 2036.

Implications for Regulators and Industry

The platform is expected to improve the consistency and scientific robustness of hazard and risk assessments across chemicals legislation for EU authorities. For industry, the new study notification requirement and improved data visibility are intended to reduce redundant testing and improve regulatory predictability.

The regulation marks a significant step toward a more integrated, data-driven EU chemicals management system, laying the groundwork for closer cooperation between agencies such as ECHA, EFSA, EEA and EMA.

On 17 December 2025, the European Commission published a formal Note for Guidance clarifying the implementation of Commission Regulation (EU) 2024/3190, which bans the use of bisphenol A (BPA; 80-05-7...

On 17 December 2025, the European Commission published a formal Note for Guidance clarifying the implementation of Commission Regulation (EU) 2024/3190, which bans the use of bisphenol A (BPA; 80-05-7) and restricts other hazardous bisphenols and bisphenol derivatives in certain food contact materials and articles.

Scope and materials covered

The guidance confirms that the Regulation applies to the material groups listed in Article 1(2) of Regulation (EU) 2024/3190. These groups include plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins, silicones and rubber. Paper and board are not within the scope of the regulation, although the rules apply where regulated materials form part of a multi-material food contact article. Enamel, where it constitutes a glass-based material melted onto substrates, is also excluded.

Recycled food contact materials are considered outside the scope of the ban where BPA or other bisphenols are present only as unavoidable adventitious contamination and are not intentionally used in the manufacturing process.

Other bisphenols and current allowances

The guidance explains how the Regulation applies to bisphenols other than BPA and their derivatives. While salts of BPA are banned, certain BPA derivatives, such as bisphenol A diglycidyl ether (BADGE; CAS 1675-54-3), may still be used provided that residual BPA is not present. The use of other hazardous bisphenols with harmonised CMR or endocrine-disrupting classifications is prohibited unless authorisation is granted.

Use of bisphenol S (BPS; CAS 80-09-1) remains permitted for now, subject to existing limits, until the European Food Safety Authority (EFSA) publishes guidance on the data required for risk assessment. Once this guidance has been issued, businesses will have a defined timeframe in which to apply for derogations to continue placing affected materials on the market.

Compliance documentation, testing and declarations

The Commission clarifies that a Declaration of Compliance is required for all food contact materials within scope, including intermediate materials, even where BPA has not been used. All bisphenols and bisphenol derivatives used in the manufacturing process must be listed in the declaration.

While analytical testing is not mandatory in all cases, it may be required where BPA is permitted under specific derogations or where other bisphenols are used and residual BPA must be excluded. A detection limit of 1 µg/kg has been identified as feasible for both migration and residual content testing, pending further work by EU reference laboratories.

Transitional timelines through 2026 to 2029

The guidance provides detailed explanations of the transitional provisions, including the differences between intermediate materials and final food contact articles. In general, final food contact articles may first be placed on the EU market 18 or 36 months after the provisions come into force, depending on the use case. Additional sell-through periods apply for filled packaging and repeat-use articles, with timelines extending to January 2029 in some cases.

The Commission emphasises that transitional deadlines primarily apply to final food contact articles, while intermediate materials may only continue to circulate insofar as is necessary to complete compliant final products before the relevant deadlines.

Who is affected

The guidance is particularly relevant for manufacturers, converters, brand owners and importers involved in food contact materials, especially where BPA or alternative bisphenols such as BPS, BADGE or bisphenol AF (BPAF; CAS 1478-61-1) are used in materials, coatings, inks or adhesives. The guidance is intended to support consistent enforcement and compliance planning across the EU during the transition to BPA-free food contact materials.

The complete Note for Guidance can be accessed here.

On 12 December 2025, the European Union published Directive (EU) 2025/2456 in the Official Journal, amending the Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU) to transfer specific ...

On 12 December 2025, the European Union published Directive (EU) 2025/2456 in the Official Journal, amending the Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU) to transfer specific scientific and technical responsibilities from the European Commission to the European Chemicals Agency (ECHA).

Adopted on 26 November 2025, the Directive introduces amendments affecting both the substance restriction framework under Annex II and the procedures for exemption applications under Annex V, with different application dates.

Changes to Substance Restrictions Under Annex II

The Directive amends the framework governing substance restrictions set out in Annex II of the RoHS Directive. Under the revised provisions, ECHA is assigned a formal role in the preparation of restriction dossiers. Restriction proposals may be prepared either by a Member State or by ECHA acting at the request of the European Commission.

The Directive also introduces a requirement for the Annex II list of restricted substances to be reviewed periodically, at least every four years. The provisions related to Annex II will apply from 13 August 2027.

Key Changes to RoHS Exemption Procedures Under Annex V

The Directive revises the procedural rules governing RoHS exemption applications set out in Annex V, transferring responsibility for the scientific and technical assessment of applications to ECHA.

• Submission of exemption applications: Under the revised framework, all future RoHS exemption applications, including renewals, must be submitted directly to ECHA rather than to the European Commission. This change applies to exemptions listed in Annex V of the RoHS Directive. Once an application is deemed complete, ECHA will manage the subsequent assessment steps.
• Scientific and socio-economic assessment: As part of the new procedure, ECHA must seek the opinions of both the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) when evaluating exemption applications.
• Renewals and decision timelines: The Directive does not amend the existing deadline for submitting renewal applications. Applications for renewal must continue to be submitted no later than 18 months before the expiry of the relevant exemption.

Following receipt of the committees’ opinions, the European Commission has nine months to adopt a decision. Existing exemptions will remain valid until a renewal decision has been made.

ECHA is also tasked with developing a harmonised format and guidance for exemption applications. The revised Annex V procedures will apply from 27 August 2027.

Broader Shift in EU Chemicals Governance

The reassignment of responsibilities under RoHS reflects a broader EU policy trend of consolidating scientific and technical assessments within ECHA to strengthen consistency across EU chemicals and product legislation. This approach aligns with the EU’s ‘One Substance, One Assessment’ framework, which aims to streamline chemical risk assessments by centralising scientific expertise within ECHA and reducing duplication across regulatory regimes.

On 10 December 2025, the Council of the European Union agreed its position on a proposed regulation to establish a standalone legal framework for the European Chemicals Agency (ECHA). This is a signif...

On 10 December 2025, the Council of the European Union agreed its position on a proposed regulation to establish a standalone legal framework for the European Chemicals Agency (ECHA). This is a significant step in the legislative process, confirming the support of EU Member State for the creation of a dedicated regulation to govern ECHA’s mandate, governance, and financing.

Establishing a Dedicated Legal Framework for ECHA

The proposed regulation aims to provide ECHA with its own legal basis, separate from the REACH Regulation, under which the agency was originally established. This initiative reflects the significant expansion of ECHA’s responsibilities in recent years, which now include tasks relating to chemicals, biocides, prior informed consent, persistent organic pollutants and other EU legislation.

Under the proposal, the new framework would:

• Define ECHA’s role and tasks in a single horizontal regulation, consolidating provisions currently spread across REACH and other EU chemicals legislation and clarifying ECHA’s responsibilities across multiple regulatory regimes.
• Update governance arrangements, including the roles and functioning of the Management Board and the Executive Director. The aim is to improve oversight, transparency, and decision-making efficiency in light of ECHA’s expanded mandate.
• Address ECHA’s long-term financial sustainability, including the structure of fees, charges and EU budget contributions. This would respond to the declining fee income under REACH and the increasing workload across EU chemicals legislation.
• Strengthen the functioning of ECHA’s scientific committees, notably by reinforcing the obligations of Member States to nominate experts, increasing the flexibility of committee composition, and improving ECHA’s capacity to deliver timely scientific opinions.

Council Position and Next Steps

By agreeing its position, the Council has established its negotiating mandate for discussions with the European Parliament under the ordinary legislative procedure. The Council’s approach broadly follows the European Commission’s original proposal, presented in July 2025. The file will now move forward once the European Parliament adopts its position, after which interinstitutional negotiations are expected to begin.

If adopted, the regulation would represent a structural change in EU chemicals governance, providing ECHA with a consolidated legal and operational framework aligned with its expanded role under EU chemicals policy.

On 27 November 2025, the European Commission notified the World Trade Organization (WTO) of a draft Commission Delegated Regulation proposing amendments to Annex VI of the Classification, Labelling an...

On 27 November 2025, the European Commission notified the World Trade Organization (WTO) of a draft Commission Delegated Regulation proposing amendments to Annex VI of the Classification, Labelling and Packaging Regulation (EC) No 1272/2008 (CLP Regulation). The draft measure introduces new and revised harmonised classification and labelling entries for 48 substances or substance groups, based on opinions adopted by the ECHA Risk Assessment Committee (RAC).

According to the notification (G/TBT/N/EU/1172), the proposal represents a forthcoming adaptation to technical progress (ATP) to the CLP Regulation. The Commission indicates a proposed adoption in Q1 2026, following completion of the consultation process. The draft regulation will take effect 20 days after publication in the Official Journal of the European Union, with a deferred application date to give suppliers time to update their labelling and packaging.

The detailed classification proposals are set out in the annex to the draft regulation and cover both new harmonised classifications and updates to existing Annex VI entries.

New Proposed Harmonised Classification Entries

The draft ATP proposes introducing new entries in Annex VI, mainly covering reproductive toxicity, carcinogenicity, environmental hazards and sensitisation. The table below summarises the substances, CAS numbers and main hazard classes proposed.

Updated Existing Harmonised Classification Entries

The draft ATP also proposes updates to existing Annex VI entries, revising hazard classes and categories for several substances already subject to harmonised classification.

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 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.