AMENDMENT OF THE REGULATION (EC) NO 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL REGARDING THE USE OF CERTAIN UV FILTERS IN COSMETIC PRODUCTS.
Benzophenone-3 and Octocrylene were allowed as UV filters in cosmetic products and listed in entries 4 and 10, respectively, of Annex VI to Regulation (EC) No 1223/2009.
In light of concerns related to potential endocrine disrupting properties of Benzophenone-3 and Octocrylene, when used as UV filters in cosmetic products, a call for data was launched in 2019.
The Commission requested the Scientific Committee for Consumer Safety (SCCS) to carry out a safety assessment of both substances.
Based on the assessment the SCCS concluded in its opinion in March 2021 and it can be synthesized as follows:
- Benzophenone-3 is not safe used as a UV filter up to the current maximum concentration of 6 % in sunscreen products, either in the form of body cream, sunscreen propellant spray or pump spray;
- Benzophenone-3 is safe for the consumer when used as a UV filter up to a maximum concentration of 6 % in face cream, hand cream, and lipsticks;
- Benzophenone-3 up to 0,5 % in cosmetic products to protect the cosmetic formulation is safe for the consumer;
- Benzophenone-3 as a UV filter is safe for the consumer up to a maximum concentration of 2,2 % in body creams, in propellant sprays and in pump sprays;
- BUT if Benzophenone-3 is also used at 0,5 % in the same formulation, the levels of Benzophenone-3 used as a UV filter should not exceed 1,7 % in body creams, in propellant sprays and in pump sprays.
- Octocrylene is safe as a UV-filter at concentrations up to 10 % in cosmetic products when used individually;
- Octocrylene is safe for a combined use of sunscreen cream or lotion, sunscreen pump spray, face cream, hand cream and lipstick at a concentration up to 10 %, but the use of Octocrylene at concentrations of 10 % or above in sunscreen propellant spray is not safe for the combined use;
- Octocrylene in sunscreen products – when used together with face cream, hand cream, or lipstick containing 10 % Octocrylene – is safe when its concentration does not exceed 9 %.
These measures should enter into force the 20th day after the publication in the Official Journal of the European Union, the 7th of July 2022, hence active starting from 27th of July 2022.
VINCENZO NOBILE R&D manager
ANDREA BURIOLI In Vivo Safety & Efficacy Technician
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