Dated 24 May 2013, the European Regulation 483/2013 introduces restrictions for use for Laureth-9 (Polidocanol) and adds it to the Annex III of the Cosmetics Regulation. The industry has until April 1, 2014 to come into compliance.
In an opinion of 2 October 2007, the CSPC (now SCCS) concluded that Polidocanol was of low toxicity and did not pose a risk to the health of the consumer when used up to 3% in leave-on and up to 4% in rinse-off cosmetic products.
This opinion was confirmed by the SCCS on December 2011.
According to the opinion of the European Medicines Agency, Polidocanol used in topical products at these concentrations acts as detergent or ionic surfactant and these products do not present the characteristics of medicinal products.
Therefore, the European Commission has just modified the Annex III of the Cosmetics Regulation 1223/2009, the list of substances which cosmetic products must not contain except subject to the restrictions provided.
Laureth-9 (CAS: 3055-699-0) is added in this list on the reference number 257, with the following maximum concentrations:
• in leave-on products: 3%,
• in rinse-off products: 4%.
The application of these restrictions are deferred by 12 months to allow the industry to make the necessary adjustments to product formulations. Thus, this Regulation shall apply from 1 April 2014.
For further information
• See
the full text of Regulation 483/2013
