Europe Regulatory News

On 16 September 2025, the European Chemicals Agency (ECHA) announced the expansion of its ECHA CHEM database to include regulatory data on chemicals. The upgrade means that, in addition to substanc...

On 16 September 2025, the European Chemicals Agency (ECHA) announced the expansion of its ECHA CHEM database to include regulatory data on chemicals. The upgrade means that, in addition to substance information, users can now access details on regulatory processes and legal obligations under several EU laws.

Integration of Key EU Regulations

In this release, ECHA CHEM incorporates regulatory processes and lists from the following chemicals regulations and directives:

• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)
• CLP (Classification, Labelling and Packaging) Regulation
• POP (Persistent Organic Pollutants) Regulation
• Drinking Water Directive

Under REACH, the update covers the list of restricted substances and the restriction process, the Authorisation List and ECHA’s recommendations for inclusion, substances of very high concern (SVHC) and the Candidate List, as well as dossier and substance evaluation.

This integration provides a single point of access to chemical identity data, classification and labelling information, REACH registration details, and other regulatory lists.

Drinking Water Directive Positive Lists

On 24 September 2025, ECHA further announced that the European positive lists under the Drinking Water Directive are now available in ECHA CHEM. The information is searchable, can be filtered by material type, and is linked with relevant data collected under REACH and CLP.

Improved Access and Transparency

The expanded system aims to improve transparency and efficiency by centralising regulatory and substance data. Companies, regulators, and other stakeholders can now more easily assess compliance obligations, restrictions, and potential risks related to chemical use.

Webinar Recording Available

ECHA presented the new features in a webinar on 23 September 2025. The session is now available for viewing and includes demonstrations of the platform and explanations of the first set of regulatory process and obligation lists. The recording can be accessed here.

ECHA has removed the harmonised classification of titanium dioxide (TiO₂, CAS 13463-67-7) from the C&L Inventory and updated the registry of intentions, following the Court of Justice of the Euro...

ECHA has removed the harmonised classification of titanium dioxide (TiO₂, CAS 13463-67-7) from the C&L Inventory and updated the registry of intentions, following the Court of Justice of the European Union (CJEU) ruling of 1 August 2025 annulling the classification. Related guidance documents on classification and labelling have also been deleted from ECHA’s website.

Annex VI to CLP Amended

The Court’s judgment directly amends Annex VI to the Classification, Labelling and Packaging (CLP) Regulation. The following entries no longer apply to titanium dioxide:

• Carc. 2 (H351: inhalation) classification
• Supplemental hazard statements EUH211 and EUH212
• Notes V, W, and 10

Immediate Effect for Businesses

Because the ruling has direct legal effect, the removal of the titanium dioxide entry does not require a further amendment (ATP) to CLP. Companies can already update safety data sheets (SDS) and labels to reflect the deletion of the harmonised classification.

Implications for Industry

The removal has significant implications for manufacturers and importers of paints, coatings, plastics, and other products containing TiO₂. Labelling requirements are now simplified, and suppliers can base hazard communication on their own product assessments rather than the harmonised entry.

The full text of the ruling of the European Court of Justice on the classification of titanium dioxide can be found here.

The European Chemicals Agency (ECHA) announced on 9 September 2025 that it is continuing to verify the company size of registrants who declared themselves as micro, small, or medium-sized enterpris...

The European Chemicals Agency (ECHA) announced on 9 September 2025 that it is continuing to verify the company size of registrants who declared themselves as micro, small, or medium-sized enterprises (SMEs) at the time of their REACH registrations.

Correct declarations to avoid charges

Companies are advised to review their declared company size in REACH-IT. If the declared size is smaller than the actual company size at the time of submission, registrants should proactively inform ECHA’s Helpdesk. Early correction avoids the administrative charge, leaving only the requirement to pay the difference to the correct registration fee.

If ECHA discovers an incorrect size declaration during the verification process, companies will be required to pay both the difference in fees and an administrative charge of up to EUR 19,900.

Supporting documents required

Registrants must upload documents supporting their SME status in REACH-IT and regularly check their accounts for new messages and tasks. ECHA also reminds companies to keep their registrations and contact details up to date. Guidance on how to determine company size is available on ECHA’s website here.

From 1 July 2026, the European Chemicals Agency (ECHA) will begin publishing the names of companies that have submitted classification and labelling (C&L) notifications under the CLP Regulation. Th...

From 1 July 2026, the European Chemicals Agency (ECHA) will begin publishing the names of companies that have submitted classification and labelling (C&L) notifications under the CLP Regulation. The name of every notifier will be made publicly available in the C&L Inventory in accordance with the amended Article 42 of the CLP, introduced by Regulation (EU) 2024/2865 published in the EU Official Journal on 20 November 2024.

Confidentiality Requests Before June 2026

Companies wishing to keep their name confidential must update their dossiers and submit a justification by 30 June 2026. Unless confidentiality is granted, ECHA will make notifier names publicly accessible from 1 July 2026. ECHA also released an updated CLP notification manual in June 2025 to guide companies through the process.

CLP Notification Requirements

Manufacturers and importers placing hazardous substances on the EU market are required to notify ECHA within a month of placing the substance on the market. Article 40 (1) of the CLP (Classification, Labelling and Packaging) Regulation outlines the data that must be included in the Substance dataset. The following details are needed for CLP notification (relevant IUCLID section in brackets):

·       Notifier details: Name and contact information (from REACH-IT).

·       Confidentiality request (notifier name): Justification and category must be provided.

·       Notifier contact person: To be specified in section 1.1.

·       Substance identity: According to Annex VI sections 2.1–2.3.4 (sections 1.1, 1.2, 1.4).

·       Confidentiality request (IUPAC name): Provide a publishable name for the C&L inventory and justification.

·       Classification: As required under the CLP Regulation (section 2.1).

·       No classification justification: Required if the substance is not classified under all hazard classes.

·       Reason for classification: Based on supporting data.

·       Concentration limits, M-factors, acute toxicity estimates: Where applicable, with justification referencing Annex I (section 13).

·       Label elements: Hazard pictograms, signal words, hazard statements.

Update: On 27 August 2025, ECHA clarified that there will not be sector-specific evaluations for the newly introduced PFAS use categories. Instead, all uses will be considered collectively when the E...

Update: On 27 August 2025, ECHA clarified that there will not be sector-specific evaluations for the newly introduced PFAS use categories. Instead, all uses will be considered collectively when the European Commission decides on possible derogations. See the details here.

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On 20 August 2025, the European Chemicals Agency (ECHA) announced that an updated Background Document for the proposed restriction of per- and polyfluoroalkyl substances (PFAS) under the REACH Regulation has been published. The update follows extensive stakeholder input on the original 2023 proposal and provides additional details on the scope and possible derogations.

Expanded Scope of the Restriction

The revised document incorporates feedback from over 5,600 consultation comments and now covers additional uses beyond the initial proposal. Newly addressed sectors include:

• Printing applications
• Sealing materials
• Machinery and equipment
• Technical textiles
• Explosives
• Military uses
• Certain medical applications, such as immediate packaging and pharmaceutical excipients
• Industrial uses including solvents and catalysts

Options for Continued Use under Conditions

The updated proposal introduces possibilities for time-limited or use-specific derogations in critical sectors where alternatives are not yet technically feasible. These could apply, for example, to semiconductors, energy technologies, or certain medical uses, provided strict conditions for controlling emissions are met.

Next Steps

ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) will review the updated document and issue their opinions before the European Commission and EU Member States decide on the final restriction.

The updated Background Document can be found here.

On 8 August 2025, the European Commission adopted a regulation amending Annex XVII to REACH (Regulation (EC) No 1907/2006) concerning carcinogens, germ cell mutagens and reproductive toxicants (CMR...

On 8 August 2025, the European Commission adopted a regulation amending Annex XVII to REACH (Regulation (EC) No 1907/2006) concerning carcinogens, germ cell mutagens and reproductive toxicants (CMRs). This update reflects recent changes to the EU’s harmonised classification and labelling of chemicals.

New Substances Added to Annex XVII

The amendment incorporates substances newly classified as CMR category 1B under Commission Delegated Regulation (EU) 2024/1973. These substances are now listed in Appendices 2, 4, and 6 of Annex XVII, meaning that they cannot be supplied to the general public above the set concentration limits.

Among the substances included are:

• Diuron (CAS 330-54-1)
• Tetrabromobisphenol-A (CAS 79-94-7)
• N,N-dimethyl-p-toluidine (CAS 99-97-8)
• 4-nitrosomorpholine (CAS 59-89-2)
• 4-methylimidazole (CAS 822-36-6)
• Several phosphonium salts and diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
• Dibutyltin compounds, including dibutyltin maleate and dibutyltin oxide

Derogation for Cumene in Aviation Fuels

The Commission also clarified the status of cumene (CAS 98-82-8). Although cumene had already been included in Annex XVII in 2023, the restriction had created practical issues for aviation fuels used by non-professional pilots. The new regulation introduces a derogation permitting the use of cumene in kerosene and gasoline for aviation that meet recognised international standards (e.g. Jet-A, Jet-A1, JP-x, DEF STAN, ASTM, EN 228).

Entry into Force and Application

The Regulation will enter into force 20 days after publication in the Official Journal of the EU. The restrictions related to the newly classified CMRs will apply from 1 September 2025, in line with the implementation of the updated CLP classifications. The full text of the Regulation and the Annex can be downloaded here. 

On 1 August 2025, the European Commission launched a public consultation and Call for Evidence for the upcoming Circular Economy Act, marking a key step in its impact assessment. The initiative is pl...

On 1 August 2025, the European Commission launched a public consultation and Call for Evidence for the upcoming Circular Economy Act, marking a key step in its impact assessment. The initiative is planned for adoption in 2026, and aims to strengthen the EU’s circular economy by improving market conditions for secondary raw materials, enhancing recycled material supply, and increasing demand for high-quality recyclates. The Act also supports broader EU objectives on competitiven.

Purpose and Focus of the Circular Economy Act

The Commission highlights that circularity is essential for economic security, resilience, competitiveness, and decarbonisation, and it is widely supported by the public as a key solution to environmental challenges. However, progress has been limited, prompting renewed calls for action from European industry, institutions, and recent policy reports. In response, the European Commission has committed under its 2024–2029 Political Guidelines and related initiatives to adopt the Circular Economy Act by 2026.

The Circular Economy Act aims to strengthen the EU’s economic resilience and competitiveness while driving sustainable production, circular economy practices, and decarbonisation. It will support the smooth trade of circular products, secondary raw materials, and waste across the EU. Additionally, the Act seeks to boost the availability of high-quality recycled materials and encourage greater demand for them within the Union.

The initiative aligns with existing EU strategies, including the Competitiveness Compass and Critical Raw Materials Act, and is part of the Commission’s commitment to doubling the EU circularity rate by 2030.

Feedback period

Stakeholders are invited to take part in the online consultation through the Have Your Say portal. The feedback window remains open until 6 November 2025.