Fragrance Allergens in Cosmetic Products: new potential challenges for labeling compliance

Fragrance Allergens in Cosmetic Products: new potential challenges for labeling compliance

On 26-27 June 2012 the Scientific Committee on Consumer Safety (SCCS) delivered an opinion SCCS/1459/11 on fragrance allergens in cosmetic products.

Following this Opinion, the services of the European Commission proposed to amend

– Annex II to the Cosmetics Regulation (List of substances prohibited in cosmetic products) to include HICC, atranol and chloroatranol;

– Annex III to the Cosmetics Regulation (List of substances which cosmetic products must not contain except subject to the restrictions laid down) to submit additional contact allergens to the obligation of individual labeling, in addition to the 26 allergens already listed in the Annex III. The additional allergens concerned (62 substances) would be those with the strongest scientific evidence (i.e. contact allergens established in humans as well as pre-haptens/pro haptens which may be activated into them).

The proposed amendments were the subject of a public consultation which was open to all interested stakeholders: individual consumers, industry, citizens organizations, medical associations and National Authorities (including EU Member States and non-EU States authorities).

The public consultation met with a strong reaction from the industry, which raised doubts regarding the feasibility of on-pack labeling in view of the increased number of fragrance allergens proposed for labeling. The expected impact of the on-pack labeling option involves the costs of the re-designing of packages to include additional fragrance allergens and of withdrawing non-compliant packages from the market.

In light of the above potential amendment of Annex III, the industry proposed the E-labeling option, which may cover either the labeling of all allergens (including those already subject to labeling) or only 62 additional fragrance allergens. The e-labeling would promote better readability of the list of ingredients and a faster adaptation to future regulatory changes requiring the labeling of new fragrance allergens.

All interested stakeholders (including consumers, dermatologists, National Authorities and industry) will be consulted from May 2019 on the costs and benefits of the different labeling options for fragrance allergens: e-labeling and on-pack labeling.

Contact us for further information about EU labeling requirements for cosmetic products.