EU Cosmetic Ingredient Glossary

Ban of 2-Chloro-p-Phenylenediamine and restriction of Phenylene Bis-Diphenyltriazine and Climbazole

On 30 April 2019, the European Commission has published new regulations amending Annexes II (prohibited substances), III (restricted substances), IV (colorants) and V (UV filters) to Regulation (EC) No 1223/2009 on cosmetic products.

2-Chloro-p-Phenylenediamine ban

The European Commission has banned the use of 2-Chloro-p-Phenylenediamine, its sulphate and dihydrochloride salts in eyebrow, eyelash and hair dye cosmetic products. This decision was based on the opinion of the Scientific Committee on Consumer Safety (SCCS), which have concluded that the substance and its salts may pose a risk to human health. The substance has been added to list of prohibited substance in Annex II of the Regulation.

The prohibition applies from 22 November 2019 for new products and from 22 February 2020 for products already available on the EU market.

Phenylene Bis-Diphenyltriazine restriction

Considering the SCCS opinion on Phenylene Bis-Diphenyltriazine, which was published in 2018, the European Commission has decided to amend Annex VI to the cosmetics Regulation and add the following restrictions on use of this substance:

  • Phenylene Bis-Diphenyltriazine is safe for use as a UV filter in cosmetics at a maximum concentration of 5 %, except in applications, which may lead to inhalation exposure

Climbazole restriction

Climbazole is currently listed in Annex V of the Regulation and it is allowed for use as a preservative at a maximum concentration of 0,5 %.  In addition, it may also be used as a non-preservative, but the same restriction applies.

Last year, the SCCS has published an addendum to its earlier opinions on Climbazole, rising concerns over the safety of use of Climbazole both as a preservative and non-preservative at the current allowed concentrations of 0,5 %. In light of the SCCS conclusion of the safety of climbazole, the European commission has adopted amendments to Annexes II and V with the following restrictions on use of this substance:

  • Climbazole is safe for use as a preservative in face cream, hair lotion and foot care products at a maximum concentration of 0,2 % and as a preservative in rinse-off shampoo at the maximum concentration of 0,5 %
  • The use of climbazole as a non-preservative is restricted to use in a rinse-off shampoo as an anti-dandruff agent, at the maximum concentration of 2 %

The restriction applies from 27 November 2019 for new products containing Climbazole and from 27 February 2020 for products already available on the EU market containing Climbazole.