New amendments brought by Regulation 2019/1966 on CMR Omnibus

- Focus on salicylic acid -

Generally, the use of CMR substances (classified as carcinogenic, mutagenic, or toxic for reproduction) in cosmetics products is prohibited by the EU cosmetics legislation.

This type of substances are included in the List of prohibited substances in Annex II to the EU Cosmetics Regulation.

On 27 November 2019, the European Commission published the Regulation (EU) 2019/1966, which amends and corrects Annexes II, III and V to the EU Cosmetics Regulation and will apply from 1 May 2020, except for the substances with CAS numbers 148-24-3 and, respectively, 134-31-6 for which the restrictions already apply since 11 June 2019.

One of the most known and used substances in cosmetic products reviewed due to its CMR characteristics is salicylic acid.

Salicylic acid and its salts are currently listed as:

·  Preservatives allowed in cosmetic products in a concentration of up to 0,5 % (acid) [Entry 3 of Annex V to the Regulation (EC) No 1223/2009]

·  Restricted substance only allowed, when used for purposes other than preservative, in rinse-off hair products in a concentration of up to 3,0 % and in other products, except for body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant applications [1], in a concentration of up to 2,0 %.[2][Entry 98 of Annex III to the Regulation (EC) No 1223/2009]

The above restrictions were already mentioned in the Scientific Committee on Consumer Safety (SCCS)’s opinion published in December 2018, with the additional mention that the opinion is not applicable to any oral product (such as toothpaste and mouthwash) with the exception of lipsticks.[3] The SCCS also concludes that salicylic acid is an eye irritant and extends the restriction and condition of not being used also in products for children under the age of 3, except for shampoos. [4]

Other substances facing restrictions are listed in paragraphs 14, 15 and 16 of the Regulation (EU) 2019/1966. For more details, please access this link.

Additionally, on 13 December 2019, a Corrigendum to the Commission Regulation (EU) 2019/1966 has been published with additional amendments to Annexes II, III and V to the EU Cosmetics Regulation. The document can be accessed at this link.

Obelis Expert Consultants, with more than 30 years of experience with EU Regulations, will gladly answer any question you may have and will assist you in safeguarding your products’ compliance.


[1] SCCS/1601/18 Final Opinion Corrigendum of 20-21 June 2019, p.55

[2] COMMISSION REGULATION (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products

[3] SCCS/1601/18 Final Opinion Corrigendum of 20-21 June 2019, p.55

[4] SCCS/1601/18 Final Opinion Corrigendum of 20-21 June 2019, p.6


Bianca Sofian

Junior Consultant, Regulatory Affairs & Quality Assurance Department

6th February 2020


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