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EN

27.7.2023

Official Journal of the European Union
L 188/1

II
Non-legislative acts
REGULATIONS
COMMISSION REGULATION EU 2023/1545
of 26 July 2023
amending Regulation EC No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products Text with EEA relevance
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation EC No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products 1, and in particular Article 311 thereof, Whereas:
1

Fragrance substances are organic compounds with characteristic, usually pleasant, odours. They are widely used in perfumes and other perfumed cosmetic products, but also in many other products such as detergents, fabric softeners and other household products.

2

Contact allergy is a life-long, altered specific reactivity in the human immune system. Upon re-exposure to a sufficient amount of an allergen, eczema allergic contact dermatitis may develop. When a person has already been sensitised to an allergen, a much lower concentration of it is sufficient to trigger symptoms of an allergy. The percentage of the population allergic to fragrance allergens in the Union can be estimated to 19 % 2.

3

Different measures aim to protect the whole population from acquiring fragrance allergies primary prevention and to protect sensitised individuals from developing allergy symptoms secondary prevention.

4

For the purposes of primary prevention, a restriction of fragrance allergens may be sufficient. However, sensitised persons may develop symptoms when they are exposed to lower concentrations of an allergen than the maximum permitted levels. Therefore, as a measure of secondary prevention, it is important to provide information on the presence of individual fragrance allergens in cosmetic products so that sensitised persons can avoid contact with the substance to which they are allergic.

5

In accordance with Article 191, point g, of Regulation EC No 1223/2009, a cosmetic product is to be made available on the Union market only where a list of ingredients is indicated on its packaging. Furthermore, that Article specifies that perfume and aromatic compositions and their raw material are to be referred to by the terms parfum or aroma in the list of ingredients and complemented by substances the mention of which is required under the column Other in Annex III to that Regulation. Currently, 24 fragrance allergens listed in entries 45
and 67 to 92 of Annex III to Regulation EC No 1223/2009 are to be mentioned in the list of ingredients individually labelled.

1 OJ L 342, 22.12.2009, p. 59.
2 Impact assessment study on fragrance labelling on cosmetic products - Publications Office of the EU europa.eu, p. 64.