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 20^th day after the publication in the Official Journal of the European Union, the 7^th of July 2022, hence active starting from 27^th of July 2022.

 

 

 

VINCENZO NOBILE R&D manager

ANDREA BURIOLI In Vivo Safety & Efficacy Technician

 

 

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