RA/QA The European Commission updates the restrictions in Cosmetic Products for: Phenylene Bis-Diphenyltriazine; 2-Chloro-p-Phenylenediamine; Climbazole

On April 30th this year, the European Commission published three amendments to the Cosmetics Regulation (EC) No 1223/2009:

·       Update of Annex VI by indicating that Phenylene Bis-Diphenyltriazine can be used as UV Filter at maximum concentration of 5% (as previously agreed by SCCS in 2018) except in applications that may lead to exposure of the end user's lungs by  inhalation - in which it cannot be used. (COMMISSION REGULATION (EU) 2019/680)

·         Update of Annex II by banning 2-Chloro-p-Phenylenediamine, its sulfate and dihydrochloride salts in hair dye products, as well as in eyebrow and eyelash dye products. These types of products containing the prohibited substance shall not be placed on the Union market as from 22 November 2019 and shall not be made available on the Union market as from 22 February 2020. (COMMISSIONREGULATION (EU) 2019/681)

·         1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one, under the INCI name Climbazole, allowed concentrations have been modified as follows:

-   Update of Annex III by indicating that Climbazole used in rinse-off anti dandruff shampoo shall be used at maximum concentration of 2,0%.

-   Update of entry 32 in Annex V by stating that Climbazole used as preservative shall be used at maximum concentration of 0,2% in hair lotions, face creams and foot care products while the maximum concentration must be of 0,5% in rinse-off shampoos.

Cosmetic products containing climbazole and not complying with those conditions shall not be placed on the Union market as from 27 November 2019 and shall not be made available on the Union market as from 27 February 2020. (COMMISSION REGULATION (EU) 2019/698)

Finally, the EU draft Commission regulation on the authorisation of HEPB (Hydroxyethoxyphenyl Butanone) in rinse off, oral care and leave-on cosmetic products at a maximum concentration of 0,7% has been published.

Clàudia Miralles

Regulatory Department


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