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  • Foto del escritorDaniel Jiménez

REGULATORY UPDATE, March 2023

1. New CMR substances (banned) The new draft of regulations amends Annex VI of the EU CLP Regulation and it includes new CMR classifications relating to the following cosmetics ingredients: - Trimethylbenzoyl diphenylphosphine oxide, reprotoxic 1B – currently found In Annex III entry 311 of the EU Cosmetics Regulation. It become to be banned and included in Annex II (prohibited substances) of the Cosmetics regulation 1223/2009 across the seventh CMR Omnibus Regulation.

It is important to note that this new legislation will not automatically be included within the Great Britain (GB) CLP Regulation. So currently, the announced bans will apply only in the EU. 2. Reminder of the upcoming new restrictions The Regulation 2022/2195 of 10 November 2022 made the following amendments: ANNEX III: 1) Butylated hydroxytoluene (BHT) is restricted for use in cosmetic products at · 0.001% in mouthwashes · 0.1% in toothpastes · 0.8% in other leave-on and rinse-off products

Deadline (placing on the market): 1 July 2023 Deadline (making available on the market – off shelf): 1 January 2024 2) Acid yellow 3 is restricted for use in non-oxidative hair dye products at · 0.5% (entry 82 of Annex IV still applies if the ingredient is used as a colorant). Deadline (placing on the market): 1 July 2023 Deadline (making available on the market – off shelf): 1 January 2024 Annex VI: 1) Homosalate is allowed for use at · 7.34% in face products, except for propellent spray products. Deadline (placing on the market): 1 January 2025 Deadline (making available on the market – off shelf): 1 July 2025 2) Bis-(diethylaminohydroxybenzoyl benzoyl) piperazine is included for use as a UV filter in cosmetic products at · 10%, both in the non-nano and nano forms · the nanoform is only allowed if: o purity ≥ 97 %, o median particle size D50 (50 % of the number below this diameter) ≥ 50 nm of number size distribution · the nano form cannot be used in applications that may lead to exposure of the end user’s lungs by inhalation. · In case of combined use of both the non-nano and nano forms, the sum concentration shall not exceed 10%.Homosalate is allowed for use at 7.34% in face products, except for propellent spray products. Deadline (placing on the market): 1 January 2025 Deadline (making available on the market – off shelf): 1 July 2025 2) Bis-(diethylaminohydroxybenzoyl benzoyl) piperazine is included for use as a UV filter in cosmetic products at · 10%, both in the non-nano and nano forms · the nanoform is only allowed if: o purity ≥ 97 %, o median particle size D50 (50 % of the number below this diameter) ≥ 50 nm of number size distribution · the nano form cannot be used in applications that may lead to exposure of the end user’s lungs by inhalation. · In case of combined use of both the non-nano and nano forms, the sum concentration shall not exceed 10%.


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