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HomeOpinion on potassium hydroxide (KOH) as callosity softener/remover
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Potassium hydroxide (KOH) CAS n. 1310-58-3 is regulated in Annex III/15a - List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down- to Cosmetics Regulation (EC) n. 1223/2009. According to the Cosmetics Regulation (EC) n. 1223/2009 the use of Potassium Hydroxide as cosmetic ingredient must be limited as follows: (a) Nail cuticle solvent: 5.0% by weight (b) Hair straightener: 2.0/ 4.5 % by weight (general/professional use) (c) pH adjuster - depilatories: up to pH 12.7 (d) Other uses as pH adjuster: up to pH 11 Industry requested the amendment of Annex III of the European Cosmetics Directive (76/768/EEC) in order to allow the use of Potassium hydroxide (KOH) as callosity softener/ remover with a concentration up to 1.5% by weight. The Commission asked the EMA Agency for opinion as to whether “a topical product to be applied on the skin and containing Potassium hydroxide (KOH) at a concentration up to 1.5% by weight might fall under the definition of a pharmaceutical product by function”. In October 2013 the Commission received the opinion of EMA on Potassium hydroxide (KOH) with the following conclusion: In conclusion, a topical product applied on the skin and containing Potassium hydroxide (KOH) at a final concentration up to 1.5% by weight, and used as a keratolytic agent, has no metabolic, immunological or pharmacological mechanism of action, and therefore the presented product does not meet the criteria of a medicinal product as specified in the Article 1(2) of Directive 2001/83/EC.
- Offentliggjort:
- Forfatter(e): Generaldirektoratet for Sundhed og Forbrugere (Europa-Kommissionen)
- Emner: Farmaceutisk og kosmetisk industri , Videnskabelig og teknisk forskning
- Emne: direktiv (EU) , forbrugerbeskyttelse , kemisk forbindelse , kosmetisk produkt , offentlig sundhed , toksikologi , uorganisk kemikalie
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| ISSN 1831-4767 | ISBN 978-92-79-35649-0 | DOI 10.2772/56132 | Katalognummer ND-AQ-14-002-EN-N |
- Released on EU publications website:
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