July 8, 2022 – On October 13, 2021, the European Commission submitted to the World Trade Organization (WTO) the draft of the Regulation amending Annex VI to the EU Cosmetics Regulation — namely, the list of UV filters allowed in cosmetic products. The modification concerns two substances, Benzophenone-3 and Octocrylene.
The commenting period lasted until December 13, 2021, and the Act’s adoption is expected in the second quarter of 2022.
Both Benzophenone-3 and Octocrylene were suspected of having endocrine-disrupting properties and were included in the list of substances to be assessed with high priority (Group A). Hence, the Scientific Committee on Consumer Safety evaluated them and released the related scientific opinions in March 2021 — SCCS 1625/20 and SCCS 1627/21.
The draft Regulation aims to implement the Scientific Committee‘s findings in the EU cosmetics regulatory framework.
Benzophenone-3 (CAS 131-57-7) is an organic aromatic ketone found in some flowering plants. At the moment, in cosmetics, it is used as a UV filter up to a maximum concentration of 6% and up to 0.5% to protect the cosmetic formulation.
According to the draft, BP-3 entry in Annex VI to the EU Cosmetics Regulation will be amended as follow:
- Up to 6% in face products, hand products, and lip products, excluding propellant and pump spray products. If used at 0.5% to protect the product formulation, the levels used as UV filter must not exceed 5.5%;
- Up to 2.2% in body products, including propellant and pump spray products. If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 1.7%;
- Up to 0.5% in other products.
As a reminder, when it is present in a concentration higher than 0.5%, the additional warning ‘contain Benzopenone-3’ must be affixed on the label.
Octocrylene (CAS 6197-30-4) is a soluble oil that absorbs UVB and short UVA (UVA-II, between 315 nm and 340 nm) radiations. That is why it is used in cosmetics as a light stabilizer and a UV filter.
Currently, it is allowed to be used as a UV filter up to a maximum concentration of 10% in the finished product. Conversely, the draft foresees the following restrictions:
- Up to 9% in propellent spray products;
- Up to 10% in other products.
The European Commission should grant a reasonable time for the industry to adapt to the new requirements, especially as brands will need to reformulate their products in some cases. Therefore, the Regulation amending Annex VI will enter into force after 20 days from publication in the Official Journal of the European Union. From that moment, cosmetics containing Benzophenone-3 and Octocrylene in concentrations compliant with the old restrictions can still be placed on the EU market for additional six months and be made available on the EU market for 12 months.
Update from 08/07/2022
Commission Regulation (EU) 2022/1176
On July 7, 2022, the European Commission issued the Commission Regulation (EU) 2022/1176, which foresees new limits for the UV filters Benzophenone-3 and Octocrylene as specified above. The Regulation will enter into force on July 28, 2022, 20 days after its publication in the Official Journal of the European Union (OJEU).
As for the application deadlines, starting from January 28, 2023, beauty brands can place on the EU market cosmetic products that comply with these restrictions only. On the other hand, manufacturers that place cosmetic products on the EU market in compliance with the previous requirements until January 28, 2023, have until July 28, 2023, to make those available on the EU market. This is to give reasonable time to the industry to adapt to the new requirements and withdraw non-compliant products from the market.
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- European Commission. (2022). 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. Retrieved on 08/07/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1176&from=EN
- European Commission. (2021). Commission Regulation (EU) …/… of XXX 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. Retrieved on 16/12/2021 from https://members.wto.org/crnattachments/2021/TBT/EEC/21_6560_00_e.pdf
- European Commission. (2021). Annex to the Commission Regulation (EU) …/… of XXX 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. Retrieved on 16/12/2021 from https://members.wto.org/crnattachments/2021/TBT/EEC/21_6560_01_e.pdf
- World Trade Organization. (2021). Regular notification G/TBT/N/EU/843. Retrieved on 16/12/2021 from http://tbtims.wto.org/en/RegularNotifications/View/174842?FromAllNotifications=True