Polyamiopropyl biguanide (PHMB) is a preservative listed under Annex V (28) of the European Cosmetic Regulation EC 1223/2009. Until recently the regulatory future of PHMB was in a very tenuous position. It was subject to an unfavourable opinion by the Scientific Committee on Consumer Safety (SCCS) from June 2014 which deemed the previous limit of 0.3% to be unsafe in all products and was unable to provide a safe limit for use with the available data (viewable here). To compound this, PHMB is classified as a category 2 carcinogen (CMR 2) by ECHA (European Chemicals Agency) under the CLP Regulation EC 127/2009 (you can view the classification here).
Given these two positions, PHMB’s legality in cosmetic products was the subject of much discussion, including the Danish authorities considering action against companies selling products containing PHMB. This argument culminated in the European Commission confirming that ingredients are not banned based on their CMR categorisation without first having their Annex classification updated. This clarification meant that PHMB was on a ‘waiting list’ to either have its classification changed from Annex V to Annex II or have a new lower limit provided by the SCCS.
Fortunately for formulators the latter has happened. In a new opinion (SCCS/1581/16 – viewable here) the SCCS have deemed PHMB to be safe for use in all cosmetic products, except in sprayable formulations, up to a maximum concentration of 0.1%. This would reduce the existing 0.3% limit but prevent the need for an outright ban.
The opinion is currently open for comment and the deadline for submissions is the 10th March 2017.