Revision of the opinion on the safety of poly(hexamethylene) biguanide hydrochloride (PHMB) or polyaminopropyl biguanide (INCI) in cosmetic products

WG on Cosmetic Ingredients
SCCS members:U. Bernauer (rapporteur), P.J. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, A. Luch, E. Nielsen, T. Platzek, S.C. Rastogi (chairman), Ch. Rousselle, J. van Benthem
Contact:SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1535/14
Doi: 10.2772/4883
Adopted on: 16 December 2014

Conclusion of the 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 out the genotoxic potential of PHMB. In the absence of a valid dermal absorption study, a 10 % dermal absorption might be taken as default according to SCCS Notes of Guidance. Deviation from the default assumption of 10 % dermal absorption would be possible if a valid dermal absorption study according to SCCS Notes of Guidance is submitted.

2. SCCS is requested to address any further scientific concerns on the ingredient Polyaminopropyl Biguanide (PHMB) in particular regarding its use in spray formulation. Neat PHMB is a respiratory irritant and exerts adverse effect to the respiratory system after acute and repeat exposure. As the vapour pressure is low, no respiratory irritation or toxic effects are expected from the evaporation of PHMB when present in 0.3% in cosmetic formulation. In the absence of additional information required to determine the toxic effects of spray products according to the SCCS Notes of Guidance, the use of PHMB in spray formulation is not recommended. PHMB is used in a variety of applications, not only in cosmetics. Therefore information on exposures from all possible sources is required for safety calculation as PHMB is a CMR substance.

Keywords:

SCCS, scientific opinion, poly(hexamethylene) biguanide hydrochloride, polyaminopropyl biguanide (PHMB), Regulation 1223/2009, CAS No. 32289-58-0 or 27083- 27-8

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of poly(hexamethylene) biguanide hydrochloride or polyaminopropyl biguanide (PHMB) in cosmetic products, 18 June 2014, SCCS/1535/14, revision of 16 December 2014.