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% |
|
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:
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.
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.