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
|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||17th||September 2022 (expected)||December 17, 2022||14 new ingredients banned & Methyl Salicylate restricted|
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- ECHA. (2022). Harmonized classification and labeling (CLH). Retrieved on 01/03/2022 from https://echa.europa.eu/regulations/clp/harmonised-classification-and-labelling
- Cosmetics Business. (2021). The big 23: Which ingredients are facing EU bans? Retrieved on 10/02/2022 from https://cosmeticsbusiness.com/news/article_page/The_big_23_Which_ingredients_are_facing_EU_bans/197800