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23rd Amendment of Regulation (EC) No 1272/2008: 22 new entries
- Daniel Jiménez
- 6 hours ago
- 2 min read
On 20 June 2025, the Official Journal of the European Union published Delegated Regulation (EU) 2025/1222, which constitutes the 23rd Adaptation to Technical Progress (ATP) of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).
The regulation adds 22 substances to Table 3 of Annex VI and replaces 10 existing entries, incorporating the most recent opinions from ECHA's Risk Assessment Committee (RAC).
The regulation will enter into force on July 10, 2025, and will be mandatory from February 1, 2027, although providers may adopt it voluntarily from the date of entry into force.
Table of contents
1. Regulatory overview
Objective : To align the harmonized classification with current toxicological evidence, strengthening the protection of human health and the environment.
Legal basis : Articles 37(5) and 53 of the CLP Regulation.
Transition period : 19 months to consume stocks and adapt labels, SDS and UFI/PCN notifications.
2. Main technical innovations
Group of substances (examples) | Essential change in danger | Affected sectors |
Oxidants and industrial gases O₃ (ozone), N₂O (nitrous oxide) | New entries with multiple classes: Ox. Gas 1 , Acute Tox 1 , STOT RE 1 , Carc. 2 , Ozone 1 | Water treatment, semiconductors, hospitals |
Organic intermediates 1,1-dichloroethylene (vinylidene chloride) | Reclassification to Carc. 2 and STOT SE 3 | Barrier plastics, adhesives |
Agrochemicals / biocides Captan, Folpet, Dinotefuran, Pethoxamid | Inclusion or hardening of Carc. , Repr. or Aquatic Chronic 1 classes | Phytosanitary products, pest control |
Pigments and dyes Pigment Red 53:1 | Classification Carc. 1B (change from “suspected” to “alleged”) | Inks, artistic and signage paints |
Botanical extracts Chrysanthemum cinerariaefolium (pyrethrin) | New STOT SE 1 classification and specific limits (ATE, M-factors) | Natural cosmetics, gardening products |
3. Regulatory implications for companies
Classification and Labeling : Manufacturers and importers must relabel containers and update GHS pictograms by February 1, 2027.
Safety Data Sheets (SDS) : Revise sections 2, 9 and 11 to reflect new classes, specific limits and M-factors.
PCN/UFI Notifications : Any affected mixture requires new or amended submission to the national Poison Control Centres.
Supply chain transparency : communicating hazard changes to upstream and downstream customers, especially when formulations are linked.
Substitution : Initiate analysis of alternatives for substances classified as Carc. 1B / Repr. 1B to avoid future restriction or authorization scenarios.
4. Strategic recommendations from BELAB Services
Priority action | Aim | Suggested deadline |
Inventory audit | Detect impacted substances and mixtures in all centers and subsidiaries | Q3 2025 |
Contract management | Incorporate liability clauses and provide updated CLP data | Q4 2025 |
Internal training | Train R&D, regulatory affairs, and marketing on labeling changes | Continuous |
External communication | Proactively inform customers about the transition and benefits of early adoption | From July 2025 |
Our multidisciplinary team can assist you with:
Multilingual relabeling in compliance with CLP/GHS.
Comprehensive review of SDS and adaptation to IUCLID 6.
Replacement strategies and risk-benefit profile.
PCN communication and support in market inspections.
Request more information at consut@belabservices.com .
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