What you need to know about CMR substances in cosmetics

April 4, 2022 – If you work in the cosmetics industry, you will hear about CMR substances all the time.  In this article, you can find a summary of all the most important aspects of the matter.

What are CMR substances?

CMR substances are chemicals identified as carcinogenic, mutagenic, or toxic for reproduction. They are divided into three hazard categories:

  • Category 1A — substances that are known to be CMR mainly according to human evidence;
  • Category 1B — substances presumed to be CMR based on data from animal studies;
  • Category 2 — substances suspected to be CMR derived from limited evidence from humans or animal studies. Category 2 is selected when there is insufficient evidence to classify a substance as CMR of category 1.

The ECHA’s Committee for Risk Assessment (RAC) is responsible for assessing whether a specific substance shall be classified as a CMR. Then, based on the RAC’s opinions, the European Commission lists the CMR substances in Part 3 of Annex VI to CLP Regulation (Regulation (EC) No 1272/2008 on the classification, labeling, and packaging of substances and mixtures).

The European Commission regularly updates the CLP Regulation through the Adaptation to Technical Progress Acts (ATP). Usually, such acts apply 18 months after publication in the Official Journal of the European Union (OJEU). For instance, on May 28, 2021, the European Commission published the 17th ATP that will apply as of December 17, 2022.

How are CMR substances regulated in cosmetics?

Article 15 of the EU Cosmetics Regulation regulates CMR substances in cosmetics. Normally, they are prohibited in cosmetic products. Hence, the European Commission shall add all the new entries of the ATPs to Annex II to the EU Cosmetics Regulation (list of substances prohibited in cosmetic products). However, upon request of the cosmetic industry, the European Commission can allow their use by way of exception if they meet specific requirements. In such case, the substance will be added to Annex III to the EU Cosmetics Regulation (list of substances restricted in cosmetic products).

Therefore, a CMR substance of category 2 can be used in cosmetics if the Scientific Committee on Consumer Safety (SCCS) has evaluated it and found it safe (Article 15(1)). For example, the SCCS has recently identified some products and concentrations in which Salicylic Acid (CMR 2) is safe.  Thus, the European Commission added Salicylic Acid to Annex III.

Conversely, a CMR substance of category 1A or 1B can be used in cosmetics if it meets all the following conditions (Article 15(2)):

  • “They comply with the food safety requirements as defined in Regulation (EC) No. 178/2022;
  • There are no suitable alternative substances available, as documentedin an analysis of alternatives;
  • The application is made for a particular use of the product category with a known exposure;
  • They have been evaluated and found safe by the SCCS for use in cosmetic products” (EC, 2009).

The Omnibus Acts

Considering the above, the European Commission must add the CMR substances to Annexes II or III to the EU Commission Regulation. It does it through the so-called Omnibus Acts.

The Omnibus Act model was first introduced in 2018 to make sure CMR substances were added promptly to the EU Cosmetics Regulation. As a matter of fact, before 2018, the process was way longer, and it could take up to 36 months. Consequently, the Omnibus Act and the related ATP apply as of the same date.

Moreover, in the Omnibus Acts, there is no difference between placing and making available on the market. Hence, from the date of its applicability, manufacturers cannot place on the EU market cosmetics not compliant with the Omnibus restrictions. Furthermore, they must recall products already on shelves.

So far, the European Commission has published four Omnibus Acts, and one more is coming this year:

Omnibus Act / Law Related ATP Publication date Application date Ingredients concerned
I / Commission Regulation (EU) 2019/831 All CMRs classified until December 2018 (10th ATP) May 22, 2019 June 13, 2019 334 new ingredients banned & 2 restricted
II / Commission Regulation (EU) 2019/1966 13th November 27, 2019 May 1, 2020 12 new ingredients banned & Salicylic Acid restricted
III / Commission Regulation (EU) 2021/850 14th May 26, 2021 October 1, 2021 12 new ingredients banned. Salicylic Acid & Titanium Dioxide restricted
IV / Commission Regulation (EU) 2021/1902 15th November 3, 2021 March 1, 2022 23 new ingredients banned including Lilial & Zinc Pyrithione
V /  Commission Regulation (EU) 2022/1531  17th September 16, 2022  December 17, 2022 14 new ingredients banned & Methyl Salicylate restricted
VI / Commission Regulation (EU) 2023/1490 18th July 19, 2023 December 1, 2023 30 ingredients banned, including Benzophenone

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