The regulatory framework for the classification, labelling, and packaging of substances and mixtures continues to evolve.
The two most significant updates of the last year are Regulation (EU) 2024/2865 (CLP) and Commission Delegated Regulation (EU) 2023/707, which introduce significant changes with direct consequences on the design of safety data sheets (SDSs).
What is CLP Regulation (EU) 2024/2865 and Commission Delegated Regulation (EU) 2023/707?
Regulation (EU) 2024/2865: entered into force on December 10th, 2024 and applies for 18 months from that date, with some exceptions. It is designed to update Regulation (EU) 1272/2008. The main changes introduced include adapting CLP to new online sales methods, introducing new provisions for the classification of complex mixtures and updating the classification criteria for certain hazard classes to ensure a more accurate risk assessment.
Commission Delegated Regulation (EU) 2023/707:
Introducing new criteria for the classification of hazardous substances and mixtures with a focus on endocrine disruptors, a diverse group of substances that can alter the normal balance of hormones by activating, deactivating or modifying the signals sent by hormones, causing adverse effects in the body, its offspring or a subset of the population.
In addition to endocrine disruptors, Commission Delegated Regulation (EU) 2023/707 introduces four additional hazard classes for PBT, vPvB, PMT and vPvM substances and mixtures. Products that are slowly degradable are toxic and tend to bioaccumulate in living organisms (PBT, vPvB) or have a high mobility in the environment, allowing them to enter the water cycle and travel long distances (PMT, vPvM). Greater attention is paid to the fate and hazards of products for the environment.
Therefore, manufacturers, importers, downstream users and distributors will have to review the classifications of marketed substances and mixtures, with different timelines between the two.
For substances, companies must comply with the new legislation from May 1st, 2025, for new market entries, i.e. substances placed on the market for the first time and for new production batches, while those already on the EU market, i.e. already in the supply chain, will have a deadline of November 1st, 2026.
Special transition periods apply for mixtures. The new hazard classes will apply to new mixtures (mixtures placed on the market for the first time and new production batches) from May 1st, 2026, while companies must update the classification and labelling of mixtures already in the supply chain by May 1st, 2028.
Updating SDSs and labels of hazardous substances and mixtures is necessary to ensure compliance with the new legislation and to protect human health and the environment.
