Fragrance allergens in Cosmetic Products:a review of Directive 2003/15/EC

摘要

On 11 March 2005 Directive 2003/15/EC(1),an amendment to Directive 76/768/EEC on Cosmetic Products(2)(hereinafter CP)entered into its application phase.The Directive introduces,iter alia,restrictions on the use of 24 fragrance ingredients and 2 natural materials in CP(3).The Directive requires,by way of derogation from the 'current exemption from the general labelling requirements,that the presence of these allergens in the final CP above a certain concentration level be indicated in the ingredient label there of.There does not seem to be agreement among safety assessors on the effects and implications of the newly introduced restrictions on the safety assessment of CP,a prerequisite for the placing on the Community market of CP.The view has been expressed that the new restrictions require a reduction in the concentration of the fragrance ingredients concerned to a level considered to be safe for fragrance sensitive consumers(4)and CP with higher concentration levels have been rejected on safety grounds.The use restrictions of Directive 2003/15/EC have to be interpreted in the light of the general principles governing the safety of CP laid down by Directive 76/768/EEC.