On October 27, 2026, the European Commission published two draft delegated regulations proposing amendments to Table 3 of Part 3 of Annex VI to the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008) for public consultation. 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 period ends 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.
ChemRadar 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.
