title: 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.
abstract: 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.
authors.affiliation: Federal Institute for Risk Assessment (BfR), Berlin, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Bernauer
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D001645:Biguanides / Q000008:administration & dosage / Q000009:adverse effects*; D003257:Consumer Product Safety / Q000592:standards*; D003358:Cosmetics / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D001645:Biguanides; D003358:Cosmetics; C031233:polihexanide
keywords: CAS no. 32289-58-0 or 27083-27-8); Poly(hexamethylene) biguanide hydrochloride; Polyaminopropyl biguanide (PHMB); Regulation 1223/2009; SCCS; Scientific opinion