Recent regulatory changes concerning preservatives

European Annex V updates:


The group of chemicals known as parabens make up an important part of the preservatives which could be used in cosmetics. In addition to propylparaben and butylparaben, other parabens, like methylparaben and ethylparaben, are safe, as repeatedly confirmed by the Scientific Committee on Consumer Safety (SCCS). They are also some of the most efficient preservatives.

However, with the adopted measures the Commission limits the maximum concentration of two preservatives, propylparaben and butylparaben, from currently allowed limit of 0.4% when used individually and 0.8% when mixed with other esters, to 0.14%, when used individually or together.

Also, they are being banned from leave – on products designed for the nappy area of young children below the age of three.


Current Status: Methylisothiazolinone (Sharomix MTI) is currently authorized as a preservative in rinse-off cosmetic products at a concentration up to 0,01 % weight/weight (100 ppm) through entry 57 of Annex V to Regulation (EC) No 1223/2009.

The new allowed concentration will be reduced to 0,0015 % (15 ppm) max, in rinse-off products.

This means that, as of 27 April 2018, MIT must not be found as a preservative in rinse-off cosmetic products at a concentration exceeding 15 ppm.

Polyaminopropyl Biguanide (PHMB)

Polyaminopropyl biguanide Poly (hexamethylene) biguanide hydrochloride has been classified as Carc. 2 by Regulation (EU) No. 944/2013 (5th ATP). This classification came in to force on 1 January 2015. Poly (hexamethylene) biguanide hydrochloride (INCI name: Polyaminopropyl Biguanide) is a preservative listed in Annex V (entry 28) of Regulation (EC) No. 1223/2009 and may be used up to a maximum concentration of 0.3% in cosmetic products.

Recent SCCS opinion on Polyaminopropyl biguanide (PHMB) Allowed for all cosmetic applications at 0.1% (0.5% final product) – instead of 0.3% (1.5% in the final product). No date yet for this amendment.

Other restrictions which should be pointed out –

Chlorphenesin – allowed to use up to 0.3%
DMDMH – allowed to use up to 0.6% active
Benzyl Alcohol – allowed to use up to 1.0%

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