Are you up to date with 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.
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.
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%