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The new amendment to Regulation (EC) No. 1223/2009, (EU) 2024/996, places the substances Arbutin (CAS# 497-76-7) and Alpha-Arbutin (CAS# 84380-01-8) in Annex III of the regulation, under reference numbers 378 and 377 respectively. The maximum limit allowed for Arbutin is 7%, which can only be used in face creams. For Alpha-Arbutin, the maximum limit is 2% in face creams and 0.5% in body lotion.
The functions of using Arbutin and Alpha-Arbutin substances in cosmetics are whitening, antioxidants and skin conditioning.
The SCCS highlighted on 27/05/2015 that the potential combined use of these substances and other hydroquinone-releasing substances in cosmetic products has not been evaluated and could be of concern. On 1/31/2023, the SCCS adopted an opinion on the safety of Alpha-Arbutin and Arbutin in cosmetic products, confirming its previous conclusion that Alpha-Arbutin used in facial creams up to a maximum concentration of 2 % and in body lotions up to a concentration of 0.5% is safe and Arbutin used in facial creams up to a maximum concentration of 7% is safe. The SCCS also concluded that aggregate exposure of Alpha-Arbutin with Arbutin is considered safe for consumers. The SCCS also highlighted that the presence of hydroquinone (CAS number 123-31-9) should remain as low as possible in formulations containing Alpha-Arbutin and Arbutin and should not exceed unavoidable trace levels.
This Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union 04/04/2024.
ELI: http://data.europa.eu/eli/reg/2024/996/oj
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