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Expert opinion

Polyaminopropyl Biguanide (PHMB) - Submission III

Final Opinion

Details

Publication date
7 April 2017
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic ingredients
SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Duus-Johansen, J. Ezendam, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1581/16
Adopted on: 7 April 2017

Conclusion of the opinion:

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 maximal concentration of 0.3%. The safe use could be based on a lower use concentration and/or restrictions with regard to cosmetic products' categories. In order to ensure the safe use of PHMB at a lower concentration than 0.3%, the applicant presented new dermal absorption studies on additional representative cosmetic formulations.
Based on the data provided, the SCCS is of the opinion that the use of Polyaminopropyl Biguanide (PHMB) as a preservative in all cosmetic products up to 0.1% is safe.

2. Alternatively, taking into account the EU market data available, does the SCCS consider Polyaminopropyl Biguanide (PHMB) safe when used as preservative up to a maximum concentration of 0.1% in all cosmetic products with the exclusion of those products categories (body lotion, hand cream and oral care) in which this ingredient is seldom used?

Not applicable.

3. According to the data available, does the SCCS consider Polyaminopropyl Biguanide (PHMB) safe for use in sprayable formulations up to a maximum concentration of 0.1%?

As no new safety data on inhalation is available on PHMB, its use in sprayable formulations is not advised.

4. Does the SCCS have any further scientific concerns with regard to the use of Polyaminopropyl Biguanide (PHMB) in cosmetic products?

/

Keywords:

SCCS, scientific opinion, Polyaminopropyl Biguanide (PHMB), Regulation 1223/2009, CAS 32289-58-0 / 27083-27-8 / 28757-47-3 / 133029-32-0, EC: 608-723-9 and 608-042-7

Opinion to be cited as:

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Polyaminopropyl Biguanide (PHMB) - Submission III, SCCS/1581/16, 7 April 2017.

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sccs_o_204.pdf
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