(14)The substance Polyhexamethylene biguanide hydrochloride (PHMB), with the INCI name Polyaminopropyl Biguanide, is currently listed as a preservative in entry 28 of Annex V to Regulation (EC) No 1223/2009 with a maximum concentration of 0,3 %. It has been classified as a CMR substance of category 2 by Commission Regulation (EU) No 944/2013note. The classification became applicable on 1 January 2015. On 18 June 2014, the SCCS adopted an opinionnote which concluded that on the basis of the data available, PHMB is not safe for consumers when used as a preservative in all cosmetic products at a maximum concentration of 0,3 %. However, the SCCS opinion also concluded that the safe use could be based on a lower use concentration and/or restrictions with regard to cosmetic products' categories and that dermal absorption studies on additional representative cosmetic formulations are needed. On 7 April 2017, the SCCS adopted a new opinionnote which concluded that, based on the data provided, the use of PHMB as a preservative in all cosmetic products up to 0,1 % is safe but that its use in sprayable formulations is not advised. In light of the classification of PHMB as a CMR substance of category 2 and of the new SCCS opinion, PHMB should be authorised as a preservative in all cosmetic products, except in applications that may lead to exposure of the end-user's lungs by inhalation, with a maximum concentration of 0,1 %. The conditions set out in Annex V to Regulation (EC) No 1223/2009 should be adapted accordingly.