Europe Regulatory News

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.

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.

On 1August 2025, the Court of Justice of the European Union (CJEU) delivered its final judgment on the classification of titanium dioxide (TiO2), upholding the 2022 General Court decision that an...

On 8 July 2025, the European Commission published a wide-ranging legislative proposal package aimed at simplifying the EU’s chemicals legislation. This includes significant proposed amendments to th...

On 8 July 2025, the European Commission published a wide-ranging legislative proposal package aimed at simplifying the EU’s chemicals legislation. This includes significant proposed amendments to the Classification, Labelling and Packaging (CLP) Regulation, the Cosmetics Regulation, and the Fertilising Products Regulation. The proposals also include a separate regulation that postpones key labelling obligations under the CLP Regulation until 1 January 2028.

Key Proposals: Greater Flexibility and Reduced Compliance Burden

The central legislative text (COM(2025) 531) proposes targeted amendments to three major regulations to address compliance challenges, reduce the administrative burden and enhance regulatory clarity across the chemicals sector. Accompanying the proposal is a detailed Annex outlining specific changes to the legal text, which is particularly relevant for compliance teams and legal counsel.

Highlights include:

• CLP Regulation (EC No 1272/2008):

  • Replaces rigid formatting rules (e.g. fixed font size and black-on-white labels) with readability standards, allowing for greater flexibility across product types.

  • Allows broader use of digital labelling to provide supplementary information online.

  • Revises Article 31 to simplify physical label requirements - label elements must be clear, indelible and contrasting with the background, but a fixed layout is no longer required.

• Cosmetics Regulation (EC No 1223/2009):

  • Removes the pre-notification requirement for nanomaterials.

  • Introduces clearer procedures for adding new UV filters, preservatives, and colourants to product annexes.

• Fertilising Products Regulation (EU 2019/1009):

  • Eliminates the need for extended REACH registration for certain component substances.

  • Simplifies the approval process for micro-organisms and introduces digital conformity documentation.

Postponement of CLP Amendments to 2028

In parallel, the Commission published a second legislative act (COM(2025) 526) which aims to postpone the implementation of certain controversial provisions introduced by Regulation (EU) 2024/2865. This includes changes to:

• Label layout and formatting

• Advertising rules

• Labelling for online and distance sales

The revised date for the entry into force of these provisions is now set for 1 January 2028, which gives industry more time to adapt.

Impact and Next Steps

According to the Commission’s impact assessment, the simplification measures are expected to save the chemicals sector up to €363 million annually without compromising health or environmental protection. These proposals form part of a broader effort under the EU’s Chemicals Industry Action Plan to promote competitiveness and innovation.

The simplification proposal (COM(2025) 531) and the postponement regulation (COM(2025) 526) will now proceed through the ordinary legislative procedure, involving review and potential amendment by the European Parliament and Council.