Tuesday, April 26, 2016European Commission

Regulation 2016/622: Potassium hydroxide allowed as a callosity softener/remover

© CosmeticOBS-L'Observatoire des Cosmétiques

This regulation of 21 April 2016 introduces a new use for ingredient Potassium hydroxide, which will now be allowed as a callosity softener/remover. Annex III to Cosmetics Regulation 1223/2009 will be amended accordingly.

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The whereas of regulation 2016/622

(1) On 27 March 2014, the Scientific Committee on Consumer Safety (SCCS) issued a scientific opinion on potassium hydroxide , which concluded that potassium hydroxide is safe for use as a callosity softener/remover up to a maximum concentration of 1.5% w/w.

(2) The SCCS also concluded that the safe use of cosmetic products containing free potassium hydroxide in concentrations from 0.5% w/w depends on responsible risk management, through warnings and extensive guidance for use.

(3) Following the scientific opinion of the SCCS, the Commission considers that potassium hydroxide should be considered safe for use as a callosity softener/remover up to a maximum use concentration of 1.5% w/w.

(4) In light of the conclusion of the SCCS regarding responsible risk management with respect to products containing free potassium hydroxide in concentrations from 0.5% w/w, the Commission considers that cosmetic products containing potassium hydroxide for use as a callosity softener/remover should bear a warning referring to the directions for use.

(5) Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products.

The new entry in Annex III …

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