Regulatory changes concerning PHMB

Polyaminopropyl Biguanide (PHMB) – Brief history

Polyhexamethylene biguanide hydrochloride (PHMB), with the INCI name Polyaminopropyl Biguanide, was 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 944/2013 (15) and this classification became applicable on January 2015.

June 2014 – SCCS first regulatory update

On June 2014, the SCCS adopted an opinion 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.

April 2017 – SCCS second regulatory update

On April 2017, the SCCS adopted a new opinion 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.

Changes in the level of use – PHMB

In light of the classification of PHMB as a CMR substance of category 2 and of the SCCS opinion, PHMB level of use changed during the end of 2019 officially.

It is still approved 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 %.

Practically speaking – this means PHMB which available in the market as 20% active + 80% water, should be used up to the level of 0.5%, instead of 1.5% as in the past.

See below the full listing taken from the updated version of Annex V (the recent PHMB full update was on December 2019) – Page 5

Written by Mr. Lee-Or Tsvilling, Global Technical Manager.

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