Amendment to CLP Regulation – New and Updated Harmonized Classification of Cosmetic Ingredients
The Commission Delegated Regulation (EU) 2022/692, amending the CLP Regulation, was published on May 3rd. It introduces new and updated classification of a list of chemicals, including classifications for 12 ingredients that are used in cosmetic products.


Regulation (EC) No 1272/2008, commonly called CLP Regulation, provides for a harmonized classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on an opinion prepared by the Committee for Risk Assessment of the European Chemicals Agency (ECHA). Depending on the level of evidence of their CMR properties, substances are classified as CMR substances of category 1A, 1B or category 2.

By default, the use of substances classified as CMR (under the CLP Regulation) is banned according to Article 15 of the European Cosmetics Regulation (Regulation (EC) No 1223/2009). Nevertheless, a CMR substance may be used in cosmetic products, by way of exception, if specific conditions are fulfilled.

With the aim of implementing the prohibition of CMR substances, ensure legal compliance (particularly for economic operators and national competent authorities) and to ensure a high level of protection of human health, these compounds are included in Annex II (list of substances prohibited in cosmetics products) or Annex III (list of substances which cosmetic products must not contain except subject to the restrictions laid down) of the EU Cosmetics Regulation. A CMR substance may also be deleted from Annexes III to VI of the Regulation for these purposes.


On May 3rd 2022, the Commission Delegated Regulation (EU) 2022/692 was published in the Official Journal of the European Union. It amends the CLP Regulation for the purposes of its adaptation to technical and scientific progress.

ECHA has received proposals to introduce harmonized classification and labelling of certain substances and to update or delete harmonized classification and labelling of other substances. Taking into those proposals and comments received from the parties concerned, RAC adopted several opinions on those proposals.

The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR). This means that these 7 ingredients may be prohibited or restricted in cosmetic products marketed in the EU in the future.

The ingredients used in cosmetics which are now classified as CMR are the following:

  • Benzophenone (CAS number: 119-61-9)
  • Teophylline (CAS number: 58-55-9)
  • Melamine (CAS number: 108-78-1)
  • Azadirachta Extracts (CAS number: 84696-25-3)
  • Trimethylolpropane Triacrylate (CAS number: 15625-89-5)
  • Pentetic Acid (CAS number: 67-43-6)
  • Pentasodium pentetate (CAS number: 140-01-2)

The Commission Delegated Regulation shall enter into force on the twentieth day following that of its publication and shall apply from 1 December 2023.

If you wish to get more information on the safety of cosmetic ingredients, feel free to contact us at


  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures


cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »
medical devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?

Read More »
medical devices

EUDAMED – update on timelines

EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.

Read More »
cosmetic products

UK OPSS call for data on six cosmetic ingredients

On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties. 

Read More »
cosmetic products

European Commission Recommendation on the Definition of Nanomaterial

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.

Read More »
cosmetic products

Expected Restriction on the Use of Methyl Salicylate

The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex III to Regulation will be amended, and the use of Methyl Salicylate in cosmetic products will be restricted.

Read More »