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Wednesday, April 12, 2017Regulation

Preservatives PHMB and HEPB: final Opinions of the SCCS

© CosmeticOBS-L'Observatoire des Cosmétiques

The SCCS has just published its final Opinions on the safety of two cosmetic preservatives, the Polyaminopropyl biguanide (PHMB) and the Ethylzingerone - Hydroxyethoxyphenyl butanone (HEPB). They were adopted by written procedure on 23 December 2016, and were open for comments until March 10, 2017.

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Polyaminopropyl biguanide (PHMB)

Background

This Opinion has been subject to a commenting period of a minimum eight weeks after its initial publication (from 12 January until 10 March 2017). Comments received during this time were considered by the SCCS.

For full background information, see the articles
SCCS: 7 requests for scientific Opinions (April 24, 2014)
SCCS 6th plenary meeting: 4 Opinions open for comments (July 7, 2014)
SCCS: 1 Opinion, 1 Addendum, 3 Revisions (December 30, 2014)
Four requests for Opinion to SCCS (October 19, 2016)
Preservatives PHMB and HEPB: two Opinions of the SCCS (January 16, 2017 )

Final Opinion

For this Opinion, comments received resulted in the following changes: sections 3.2. and 3.6 Function and uses as well as a reference to the EU Regulation on biocides in the section 3.5 Safety evaluation and the list of references (section 6).
The conclusion remained unchanged.

Conclusion

 1. In light of the new data provided, does the SCCS consider Polyaminopropyl biguanide (PHMB) safe when used as preservative in all cosmetic products up to a maximum concentration of 0.1%?

In the previous Opinion, the SCCS stated that the Polyaminopropyl biguanide (PHMB) is not safe up to …

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