EU Proposes Amendments to CLP Regulation: Strengthening Classification and Labeling Requirements for Endocrine Disruptors and PBT Substances

At a Glance: The European Commission has launched a public consultation, ending November 24, 2026, on draft regulations amending Annex VI of the CLP Regulation. The proposed updates incorporate REACH, Biocides, and Plant Protection standards for Endocrine Disruptors, PBTs, and vPvBs into harmonized labeling, introducing new classification notes, additivity rules, and expanding covered substances, supported by an 18-month transition period.

On October 27, 2026, the European Commission opened a public consultation on two draft delegated regulations. The proposed measures would amend Table 3 of Part 3 of Annex VI to the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008). This revision aims to fully incorporate chemicals already identified as Endocrine Disruptors (EDs), Persistent, Bioaccumulative and Toxic (PBT) substances, or very Persistent and very Bioaccumulative (vPvB) substances under the REACH, Plant Protection Products, and Biocidal Products regulations into the CLP's harmonized classification and labeling system.

The public consultation window closes on November 24, 2026.

Key Highlights

1. New Notes Clarifying Classification Criteria

Draft Regulation 1 adds several key Notes to Annex VI of the CLP Regulation, providing clear compliance guidance for the industry:

• New Note Y: Specifically for Octamethylcyclotetrasiloxane (D4), it clarifies that if the D4 content in a substance is below 0.1% (w/w), a harmonized PBT classification is not required, shifting the assessment responsibility to the company. This provides a compliance exemption pathway for downstream products containing trace amounts of D4.
• New Note Z: When a harmonized classification entry name refers to a group of substances, suppliers are allowed to provide the specific substance name and identifier on labels and Safety Data Sheets (SDS), improving the precision of information transfer in the supply chain.
• New Notes 14-17 (Concentration Additivity Rules): For the classification of EDs, PBTs, and vPvBs, it is explicitly stated that if a single entry covers multiple substances in a mixture, their concentrations shall be added together to determine if a hazardous classification is triggered.
• New Notes 18-21: These further specify the entries and corresponding hazard classes to which the aforementioned additivity rules apply, ensuring accuracy and consistency in classification determination.

2. Expansion of Substances

Draft Regulation 2 significantly expands the list of harmonized classified substances in Annex VI of the CLP Regulation, involving the addition of approximately 30 new entries and the replacement/update of about 40 existing entries. The scope of substances covers a timeline from 2008 to 2025 and mainly includes:

• Industrial and Specialty Chemicals: Covering siloxanes (D4/D5/D6/L3/L4/M3T), various UV absorbers (UV-328/320/327/329/326/350), phosphate esters, benzotriazoles, perfluorinated compounds (such as PFOA and its salts), and Bisphenol A.
• Plasticizers and Intermediates: Various phthalates (DEHP/DBP/BBP/DIBP/DCHP), short-chain chlorinated paraffins, TBTO, anthracene, HBCDD, coal tar pitch, etc.
• Active Substances in Pesticides and Biocides: Including quinoxyfen, thiophanate-methyl, mancozeb, mefenacet, and various rodenticides.

These substances will be assigned corresponding hazard classes (PBT/vPvB/ED) and hazard statement codes (e.g., EUH440/EUH441/EUH430), along with specific concentration limits or M-factors.

CIRS Insights

This amendment to the CLP Regulation will have a profound impact on the chemical supply chain. Companies need to review the classification, labeling, and SDS documents of existing products, especially mixtures involving the above-mentioned substances, and must re-evaluate their hazardous properties according to the new concentration additivity rules. For substances containing D4, companies need to establish precise content testing and assessment mechanisms to apply Note Y.

To ensure a smooth transition for the industry, Draft Regulation 2 stipulates an 18-month transition period. During this time, suppliers should expedite internal compliance assessments, label updates, and supply chain information dissemination to ensure full compliance with the new harmonized classification and labeling requirements after the transition period ends.

What CIRS Can Do for You

CIRS Group is a leading provider of comprehensive regulatory compliance services and solutions for chemicals, cosmetics, food and food-related products, agrochemicals, and medical devices. Its chemical team consists of experts with extensive knowledge in chemistry, toxicology, environmental science, and related fields. They are well-versed in various international regulations, including but not limited to EU REACH, CLP, GHS, TSCA, and K-REACH. Our chemical compliance services in the EU cover:

CIRS Services

• EU REACH Registration (including OR services);
• EU REACH Evaluation Compliance Services;
• SVHC Testing;
• PPWR Compliance Services;
• EU CLP Compliance;
• EU Poison Center Notification;  
• EU BPR Compliance;
• EU PoPs Compliance;
• PFAS Testing
• Global GHS compliance

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further information

Draft Regulation 1

Draft Regulation 2