Commission Regulation (EU) 2022/1176: Changes in the limits of use of Benzophenone-3 and Octocrylene.
On the 7th of July 2022, the European Commission published an amendment to the EU Cosmetics Regulation, amending Annex VI, the list of UV filters allowed in cosmetic products. The modification applies some changes in the limits of use of Benzophenone-3 and Octocrylene.
Benzophenone-3 and Octocrylene were analysed by the Scientific Committee on Consumer Safety (SCCS) suspected of having endocrine-disrupting properties. Hence, the SCCS evaluated them and released their opinions in March 2021 — SCCS 1625/20 and SCCS 1627/21.
The amendment of the Regulation aims to implement the SCCS’ findings in the EU cosmetics regulatory framework.
Benzophenone-3
Benzophenone-3 (CAS 131-57-7) is an organic compound used as a UV filter in cosmetic products up to a maximum concentration of 6% and up to 0.5% to protect the cosmetic formulation.
According to the amendment, Benzophenone-3 will remain as follows, the entry of Annex VI will be modified to match the new SCCS concentrations:
- Up to 6% in face, hand, and lip products, excluding propellant and pump spray products.
- Up to 2.2% in body products, including propellant and pump spray products.
- Up to 0.5% in other products.
If used at 0.5% to protect the product formulation, the levels used as UV filter must not exceed 5.5% for face products, hand products, and lip products and the levels used as UV filter must not exceed 1.7% when used for body products.
As stated in the Regulation already, when the substance is present in a concentration higher than 0.5%, the warning ‘contains Benzopenone-3’ must be affixed on the label of the cosmetic product.
Octocrylene
Octocrylene (CAS 6197-30-4) is an organic substance used as a UV filter in cosmetic products. Also, it is used as a light stabilizer.
Currently, it is allowed to use Octocrylene as a UV filter up to a maximum concentration of 10% in finished cosmetic products. Now, the amendment modifies the concentration depending on the presentation of the product:
- Up to 9% in propellent spray products.
- Up to 10% in other products.
Dates of applicability
The European Commission allows the companies a one-year period to adapt to the new requirements, as brands will need to reformulate their products.
Therefore, the Regulation amending Annex VI will enter into force on 28th July 2022, after 20 days from its publication in the Official Journal of the European Union.
From that moment, cosmetic products containing Benzophenone-3 and Octocrylene in concentrations in compliance with the old restrictions can still be placed on the EU market, until 23rd January 2023, and the products will have six months more, until 28th July 2023 to be made available on the EU market.
From 28th July 2023, non-compliant products must be withdrawn from the market.
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References:
- COMMISSION REGULATION (EU) 2022/1176 of 7 July 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of certain UV filters in cosmetic products. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1176&from=EN
- REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009R1223&qid=1657631728773
