Fragrance Allergen Requirements in the EU Updated

Annex III of EU Cosmetic Regulation 1223/2009 currently lists 26 allergens, all of which must be listed in the ingredients list on the label or packaging of a product if they are present in concentrations greater than 0.001% in leave-on products and 0.01% in rinse-off products.

In 2011, the Scientific Committee on Consumer Safety (SCCS) published an opinion on fragrance allergens in cosmetic products (SCCS/1459/11). In response to the SCCS opinion, the European Commission published a public consultation on fragrance allergens. The deadline for comments was 14 May 2014.

In the consultation they indicated that three allergens: Hydroxyl- Isohexylcyclohexene Carboxaldehyde (HICC) (annex III, entry 79), Atranol and Chloroatranol should not be used in cosmetics. A transition period of two years for removing from the market products containing Atranol and Chloratranol is proposed. For HICC, the proposed transitional period is two years for placing on the market products containing HICC, and five years for their withdrawal. The transition period would start from the date when the proposed amendment to regulation 1223/2009 comes into force. The European Commission also plans to amend annex III for the following entries, to include the requirement that these substances are included in the ingredient list if they are present in concentrations greater than 0.001% (leave-on products) and 0.01% (rinse-off products).

It is proposed that entries 167 and 168 in annex III, for 1-Limonene; (S)-p-Mentha- 1,8-diene and dl-Limonene (racemic); 1,8(9)-p-Menthadiene; p-Mentha-1,8-diene (Dipentene) respectively, are deleted. Entry 88 in annex III, for d-Limonene(4R)-1-Methyl-4-(1-methylethenyl)cyclohexene, will remain.

In addition to these changes, the European Commission proposes to add the substances in Table 2 to Annex III and require that they are included in the ingredient list when their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.

EU Cosmetic Regulation Compliance

SGS is experienced in enabling organisations to demonstrate their compliance with the EU cosmetics regulation. We conduct tests and safety assessments, as well as monitor regulatory changes, to ensure that cosmetic products are safe to be placed on the market and comply with all relevant national and international regulations. With a network of experts and testing facilities across the EU, America and Asia, SGS is the partner to trust.

For more information, please visit SGS Cosmetics website:

Martin Perry
Cosmetic Safety Assessor
SGS United Kingdom Limited
t: +44 1274 303080