ECHA provides advice on new hazard classes for substances and mixtures

The new rules are in force as of 20th April 2023.  From this day on, the Member States can make proposals for harmonised classification and labelling (CLH) with the new hazard classes and manufacturers, importers, downstream users and distributors can self-classify their substances and mixtures accordingly.

There are transitional periods from the entry into force of the Delegated Regulation, during which manufacturers, importers, downstream users and distributors are not yet required to classify their substances or mixtures according to the new hazard classes.  During these periods, the new hazard classes can be applied on a voluntary basis.

At the end of the transitional periods, all manufacturers, importers, downstream users and distributors must apply the new hazard classes.

Separate transition times apply for mixtures. New hazard classes apply from 1st May 2026 to new mixtures, whereas companies have until 1st May 2028 to update the classification and labelling for existing mixtures.

Obligations For Companies

Manufacturers, importers, downstream users and distributors should consider the following tasks in order to comply with their duties.

The exact order and timing will depend on the specific scenario of each operator: if they place on the market substances or mixtures; if they are members of a joint submission or not; if their substance or mixture is already placed on the market or not, etc.  The list is not exhaustive but lists the main tasks triggered by the new legal text.

1. Review the classification and labelling of the substances and mixtures in their portfolio against the criteria of the new hazard classes. They should use all available information for self-classification.
2. Take note of the transitional periods for substances and mixtures that apply to them and make sure they have fulfilled their duties at the latest by those dates. Transitional periods allow to comply earlier and avoid last-minute difficulties.
3. If they are part of a joint submission under REACH, initiate the discussion to agree on the classification and labelling of their substances. Update the registration dossier without undue delay, as outlined in the Implementing Regulation 2020/1435.
4. If they are part of a group of manufacturers/importers for the purpose of C&L notification, initiate the discussion to agree on the classification and labelling of their substances. Update the notification to the inventory accordingly.
5. Contact the other notifiers for the same substance to agree on the new classification and labelling. The leader of the joint submission, or the leader of the group of manufacturers/importers, if the operator is a member of either, can help in such communication.
6. Revise their labels, for both substances and mixtures.
7. Update, when relevant, any poison centre notification they have already made, with the new hazard information.
8. Consider whether a new poison centre notification is needed. Mixtures previously not classified for human health nor physical hazards may have to be classified for the new human health hazards from 1 May 2026.
9. Update their safety data sheets (SDS) with the new classification and labelling, and all relevant new information that is needed to reflect the new hazards. They may need to compile an SDS for substances or mixtures which were previously not classified.
10. Prepare to compile and provide an SDS upon request if their mixtures are not classified but contain a substance in 0,1% or more of an endocrine disruptor Category 2 and is not intended for the general public.