Opinion of the scientific committee on consumer safety (SCCS) – 2nd Revision of the safety of the use of poly(hexamethylene) biguanide hydrochloride or polyaminopropyl biguanide (PHMB) in cosmetic products

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Conclusion of the opinion: On the basis of the data available, the SCCS concludes that Polyaminopropyl Biguanide (PHMB) is not safe for consumers when used as a preservative in cosmetic spray formulations and in all cosmetic products up to the maximum concentration of 0.3%. The safe use could be based on a lower use concentration and/or restrictions with regard to cosmetic products' categories. Dermal absorption studies on additional representative cosmetic formulations are needed.

PHMB is used in a variety of applications other than cosmetics. General exposure data from sources others than cosmetics should be submitted for the assessment of the aggregate exposure of PHMB.

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