European Cosmetics Industry Discusses Safety of Fragrance and Preservative Ingredients

European Cosmetics Industry Discusses Safety of Fragrance and Preservative Ingredients

The World Trade Organisation has been notified by the European Commission of a draft Regulation to ban three fragrance allergens in cosmetics products.  The Scientific Committee on Consumer Safety (SCCS) also issued opinions on two cosmetics preservatives.

perfume-1433727__340The SCCS found the fragrance ingredients atranol, chloroatranol and HICC* to be unsafe for cosmetic products use. The Cosmetics Committee is expected to formally vote on the draft Regulation in March. The European Parliament and Council should adopt the Regulation shortly after.

The preservative PHMB** has been deemed safe for use at a concentration of 0.1% by the SCCS. The ruling is based on new dermal absorption studies on additional cosmetic formulations. PHMB is a category 2 carcinogenic, mutagenic and reprotoxic (CMR) substance, but in Europe these substances are not automatically banned under the cosmetics Regulation. This point is criticised by some countries, most notably by Denmark. Two years ago, the committee deemed PHMB use at levels up to 0.3% unsafe, with recommendations that lower use concentration or restrictions could ensure safety.

Although pleased with the conclusion, director general of Cosmetics Europe, John Chave expressed concern over the diminishing range of cosmetics preservatives. He also commented that the opinion issued by the committee indicated that a substance risk based assessment approach; rather a hazard based approach is taking precedence.

cream-1464295__340An opinion on the preservative HEPB*** was also issued by the committee. Levels over 2% were deemed unsafe in rinse off, oral care and leave on products. However, the committee said that with more reliable supporting data on in vitro dermal penetration, it could be considered safe.

The opinions issued by the committee are available for consultation until March 10th. If the conclusion on PHMB is upheld after the consultation period, it is expected the European Commission will draft a new proposal on its regulation.

*HICC: 3 and 4-(4-hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde

**polyaminopropyl biguanide

***hydroxyethoxyphenyl butanone

If you have any questions, please feel free to contact Focal Point Research.  We are industry leading Cosmetic Regulatory Consultants that you can trust to help guide your company in the right direction.