EU Delegated Regulation 2024/2564 (ATP 22): Key Changes to the Classification of Dangerous Substances

EU Delegated Regulation 2024/2564 (ATP 22): Key Changes to the Classification of Dangerous Substances

Delegated Regulation (EU) 2024/2564, also known as ATP 22 (technical adaptation to progress), is a major amendment to the CLP Regulation on the classification and labelling of dangerous substances. This regulation introduces 27 new classifications: amending 16 existing ones and deleting 7. Its implementation will affect different sectors, including the cosmetics industry, and will require adaptations to the labelling and packaging of chemicals.

Context of Delegated Regulation (EU) 2024/2564

The evolution of chemicals regulation in the European Union has been constant and significant, always seeking to improve the safety of both people and the environment. Within this regulatory framework, the Delegated Regulation (EU) 2024/2564, which allows adaptation to respond to new needs, is included.

Main changes to ATP 22

  • •Introduction of 27 new harmonised classifications: aligning hazardous substances with their corresponding risk levels, providing a clearer framework for manufacturers and importers:
  • 005-022-00-4, 005-023-00-X, 005-024-00-5, 005-024-00-5, 029-026-00-0, 047-004-00-9, 047-005-00-4, 047-006-00-X, 603-247-00-8, 605-042-00-9, 605-043-00-4, 606-156-00-1, 606-157-00-7, 606-158-00-2, 607-770-00-2, 607-771-00-8, 607-772-00-3, 607-773-00-9, 607-774-00-4, 607-775-00-X, 609-074-00-4, 611-182-00-1, 612-299-00-0, 613-350-00-X, 613-351-00-5, 616-243-00-6, 617-024-00-8
  • •Amendments to 16 existing classifications: Substances that previously had a harmonised classification which has been updated by a new one:
  • 005-005-00-1, 016-022-00-9, 016-094-00-1, 029-019-01-X, 601-037-00-0, 604-020-00-6, 605-001-00-5, 607-001-00-0, 607-043-00-X, 607-094-00-8, 607-198-00-3, 607-315-00-8, 607-432-00-4, 613-272-00-6, 616-127-00-5, 617-008-00-0.
  • •Deletion of seven harmonised classifications: These decisions are the result of a re-evaluation of the substances that had harmonised classification and which have been deleted.
  • 005-017-00-7, 005-017-01-4, 005-018-00-2, 005-018-01-X, 005-019-00-8, 005-019-01-5, 029-024-00-X.

Impact on the Cosmetics Industry: CMR substances

Among the entries included in ATP 22, there are substances widely used in cosmetic formulations. Some of them, with the harmonisation of classifications, have become CMR (Carcinogenic, Mutagenic or Toxic to Reproduction). CMR category 1 substances are completely banned for use in cosmetic products, while category 2 substances need the approval of the Scientific Committee on Consumer Safety (SCCS) to be considered safe. As a result, certain substances may not be used in cosmetics, forcing manufacturers to look for viable alternatives.

Substances included in ATP 22 used in cosmetics and which have become CMR are the following:

  • •Hexyl salicylate (CAS No. 6259-76-3) – Repr. 2, Skin Sens. 1
  • •O-phenylphenol (CAS No. 90-43-7) – Carc. 2, Skin Corr. 1, Eye Dam. 1, Skin Sens. 1B
  • •N,N'-methylenebisisrylamide (CAS No. 110-26-9) – Muta. 1B
  • •Silver powder [particle diameter > 100 nm < 1 mm] (Nº CAS 7440-22-4) – Repr. 2
  • •Silver nanoparticles [particle diameter > 1 nm ≤ 100 nm] (Nº CAS 7440-22-4) – Repr. 2

Key Dates of the Regulation

The date of adoption of the regulation was 19 June 2024. While the entry into force of the new rules is scheduled for 20 October 2024. From that date, the countdown of the implementation period will start, until 1 May 2026, which is the date of mandatory compliance with Delegated Regulation (EU) 2024/2564 (ATP 2022).

The burden of ensuring compliance falls primarily on manufacturers and importers, who will have to inform themselves about the new regulations and adapt their business practices accordingly. This includes adapting the labelling of affected products and other documents such as SDS. At SIAM we facilitate the process by keeping the substance database of our CHEMETER, software up to date, so that our customers can comply with their obligations within the set period.