Deoxyarbutin ban and dihydroxyacetone regulations

Summer is in full swing, and the European Commission doesn’t laze around and introduces further changes to the cosmetic law. Thus, the Commission Regulation (EU) 2021/1099 of 5 July 2021 amending Annexes II and III to the Regulation (EC) No 1223/2009 was published. The changes concern two ingredients: Deoxyarbutin (INCI: Tetrahydropyranyloxy Phenol) and Dihydroxyacetone (INCI: Dihydroxyacetone). Details below.


Deoxyarbutin

Deoxyarbutin (INCI: Tetrahydropyranyloxy Phenol) has been used as a skin lightening agent so far, e.g. in face creams. It is a derivative of ß-arbutin, obtained by removal of hydroxyl groups from the glucose side-chain of ß-arbutin.

This compound has not been covered by the Regulation (EC) No 1223/2009 so far. However, the SCCS Scientific Committee concluded that, due to safety concerns, the use of deoxyarbutin in face creams up to 3% cannot be considered safe (opinion no. SCCS/1554/15). This is due to the fact that deoxyarbutin releases Hydroquinone. On the other hand, Hydroquinone is a prohibited substance for use in cosmetics (Annex II of the Regulation 1223/2009, item 1339), with the exception of position 14 in the Annex III (it may be used only in artificial nail products under certain conditions).

All this made Tetrahydropyranyloxy Phenol (deoxyarbutin) included in the Annex II, under entry 1657. In brief, this substance will be banned for use in cosmetic products from July 26th, 2021.

Link to the SCCS opinion: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_183.pdf


Dihydroxyacetone

Another substance that will be regulated is Dihydroxyacetone (INCI: Dihydroxyacetone). It is a well-known tanning compound with a long history of use in self-tanning products. Every sun-kissed skin lover knows it for sure 😉

So far, the use of dihydroxyacetone has also not been regulated by cosmetic law. In opinion SCCS/1612/19, the SCCS Committee considered dihydroxyacetone safe to use as a hair colouring ingredient in leave-on (non-oxidative) applications at a maximum concentration of 6.25%. In addition, the use of dihydroxyacetone (in hair dyes) described above together with the use of self-tanning lotion and face cream containing dihydroxyacetone at a maximum concentration of 10% was also considered safe.

Based on the conclusions of the SCCS, dihydroxyacetone will be added to the Annex III of the Regulation (EC) No 1223/2009 in a new position – 321. The conditions of use of dihydroxyacetone in cosmetics will be limited to those described in the SCCS opinion, i.e. it will only be used in:

– non-oxidative hair dye products, up to a maximum concentration of 6.25%;

– self-tanning products, at the maximum concentration = 10%.

The regulation provides for a 6-month transition period for the introduction and a 9-month period for making products with this component available on the market. From 26 January 2022, products containing that substance and not complying with the restrictions shall not be placed on the Union market. Afterwards, from 22 April 2022, those products cannot be made available on the market in the Union.

You can read the SCCS opinion on dihydroxyacetone at the link: https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_234.pdf


As you can see, the changes in the cosmetic law are still progressing. Looking at the intensive works of the SCCS and the European Commission, it can be concluded that there will be more and more of them 😉 And finally, I encourage you to read the new regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1099&from=EN

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