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EU Regulates the Use Requirements of Deoxyarbutin and Dihydroxyacetone

In July 2021, the EU released the amendments to the annexes of Regulation (EC) No 1223/2009, of which 1) deoxyarbutin (tetrahydropyranyloxy phenol) is newly prohibited for use in cosmetics, and 2) dihydroxyacetone is newly allowed for a restricted use:

Substance

Product type, body parts

Maximum concentration in ready use preparation

Transitional Measures

Dihydroxyacetone (1,3-Dihydroxy-2-propanone)

Hair dye substance in non-oxidative hair dye products

6.25%

  • From 26 January 2022 hair dye and self-tanning products containing that substance but not complying with the restrictions shall not be placed on the EU market.

  • From 22 April 2022 hair dye and self-tanning products containing that substance but not complying with the restrictions shall not be made available on the EU market.

Self-tanning products

10%

Both the two substances were not regulated in Regulation (EC) No 1223/2009 before. The reasons for the ban on deoxyarbutin are as follows:

  1. It results in the release of Hydroquinone, which is a prohibited ingredient in cosmetic products listed in the Annex II of Regulation (EC) No 1223/2009.

  2. According to Scientific Committee on Consumer Safety (SCCS)’s opinion adopted on 25 June 2015, due to safety concerns raised with regard to the life-cycle of products containing deoxyarbutin, the use of deoxyarbutin up to 3% in face creams cannot be considered as safe.

Dihydroxyacetone is added as a new entry in Annex III based on SCCS's opinion as well. Its opinion adopted on 3-4 March 2020 indicates that dihydroxyacetone in non-oxidative hair dye products and in self-tanning products with a maximum concentration of up to 6.25% and 10% respectively is considered safe.

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