The SCCS had adopted 4 Opinions during its plenary meeting on 18 June 2014. On the agenda: Polyaminopropyl biguanide, Acid orange 7, HAA299 (a new UV-filter) and hydrolysed wheat proteins. These Opinions are open for comments until 18 August 2014.
Polyaminopropyl biguanide (PHMB)
This Opinion has been modified by the SCCS on December 16, 2014: see the article.
Background
PHMB is authorized as preservative in cosmetic products at a maximum permitted concentration of 0.3%.
It is classified as CMR2 according to the Commission Regulation 944/2013 and would be prohibited from 1st January 2015 as cosmetic ingredient according to art. 15(1) of Regulation 1223/2009.
In January 2014, the Commission received a submission from Cosmetics Europe on PHMB, intended to demonstrate the safety of the ingredient when used as a preservative in cosmetics products up to a maximum concentration of 0.3%.
For exhaustive background information, see the article:
• SCCS: 7 requests for scientific Opinions, CosmeticOBS, 24 April 2014
Opinion
1. Taking into account the scientific data provided, SCCS is requested to give its opinion on the safety of Polyaminopropyl Biguanide (PHMB) when used as a preservative in cosmetics products up to a maximum concentration of 0.3%.
The SCCS cannot assess the safety of Polyaminopropyl Biguanide (PHMB) as no firm conclusion on the genotoxic potential can be drawn based on the available data. Before any further consideration, adequate data (i.e. a properly performed gene mutation study) are required to rule …
