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On 28 May 2021, the Official Journal of the EU published an amendment to the Cosmetics Regulation (EC) No. 1223/2009 regulating the use of carcinogenic, mutagenic, or toxic for reproduction (CMR) substances in cosmetics.The amendment will enter into force on 17 June 2021 and will go into effect on 1 October 2021.
Verisk 3E Review
Currently, Article 15 of the Cosmetics Regulation provides that substances that have been classified as CMR are prohibited from use in cosmetic products. However, CMR substances may be authorized under certain conditions.
The new Regulation (EU) 2021/850 regulates the use of several CMR substances, which have been classified as CMR by Delegated Regulation (EU) 2020/217.
Ban of CMR in Cosmetic Products
The new regulation introduces 12 new entries in Annex II of the Cosmetics Regulation, prohibiting them from use in cosmetics products.
Exceptional Authorization of Titanium Dioxide in Cosmetics
Titanium dioxide (TiO2) was classified as a CMR by Delegated Regulation (EU) 2020/217. However, an application for exceptional use was submitted, and the Scientific Committee on Consumer Safety (SCCS) examined the request and concluded in its opinion that TiO2 is safe when used in certain concentrations and for certain applications.
Therefore, TiO2 (in powder form containing 1% or more of particles with aerodynamic diameter ≤ 1μm) is included in Annex III of the Cosmetics Regulation and may be used in:
- Face products in loose powder form, in a maximum concentration of up to 25%
- Hair products in aerosol spray form, in a maximum concentration of up to 1.4%
- Hair products in an aerosol spray for professional use, in a maximum concentration of up to 1.1%
- Other products, provided that the applications do not lead to exposure of the end-user’s lungs by inhalation
Additionally, the existing requirements for TiO2 laid down in Annex IV, entry 143 (Authorized Colorants) and Annex VI, entry 27 (Authorized UV Filters) are revised in order to introduce requirements related to the non-exposure from inhalation.
Update of the Requirements for Salicylic Acid
The new Regulation (EU) 2021/850 updates the requirements related to the exceptional use of salicylic acid that had been introduced by Regulation (EU) 2019/1966. Thus, Annex III, entry 98 is revised in order to take into consideration the modified SCCS’s opinion that the substance is considered safe in body lotion, eye shadow, mascara, eyeliner, lipstick, and roll-on deodorant in a concentration of up to 0.5%.
Corrigendum to the Repeated Entry on Nickel Bis(tetrafluoroborate)
Regulation (EU) 2021/850 also modifies Annex II of the Cosmetics Regulation in order to correct the technical error related to nickel bis(tetrafluoroborate), which has been entered twice (under entries Nos. 1401 and 1427). Thus, the last entry No. 1427 is deleted.
Verisk 3E Analysis
The amendment will enter into force on 17 June 2021. All economic operators in the cosmetic industry (producers, importers, and distributors) need to update their internal database and assess if their products comply with the new requirements. As it concerns the newly added exceptional application for salicylic acid, the regulation does not provide a specific application date. Thus, the new exceptional used will become applicable as of 17 June 2021. Concerning the other changes related to the ban on the new CMR substances and the exceptional use of TiO2 in cosmetics, including as a colorant and UV filter, they all will start to apply on 1 October 2021.