L 188/2
EN
Official Journal of the European Union
27.7.2023
(6)
In response to the request of the Commission for an update of the list of individually labelled fragrance allergens, the Scientific Committee on Consumer Safety (SCCS) adopted an opinion at its plenary meeting of 26-27 June 2012 (3).
It confirmed that the fragrance allergens listed in entries 45 and 67–92 of Annex III to Regulation (EC) No 1223/2009 are still relevant.
Furthermore, it identified 56 additional fragrance allergens, which have clearly caused allergies in humans and which have currently no requirement of individual labelling.
(7)
In light of the SCCS opinion, it can be concluded that there is a potential risk to human health arising from the use of the additional fragrance allergens identified by the SCCS and that it is necessary to inform consumers about the presence of those fragrance allergens.
Therefore, an obligation to individually label those fragrance allergens should be introduced in Annex III to Regulation (EC) No 1223/2009 when their concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products.
Furthermore, fragrance substances, such as prehaptens and prohaptens, that can be transformed to known contact allergens via air oxidation or bioactivation should be treated as equivalent to fragrance allergens and be subject to the same restrictions and other regulatory requirements.
(8)
For reasons of consistency and clarity, it is also necessary to update certain existing entries for fragrance allergens in Annex III to Regulation (EC) No 1223/2009 by aligning common names of the substances to those of the latest version of the Common Ingredients Glossary referred to in Article 33 of that Regulation, and by grouping similar substances in one entry.
Furthermore, when there are multiple common ingredient names for a substance, it should be set out in the individual labelling requirement which name is to be used in the list of ingredients referred to in Article 19(1), point (g), in order for the labelling to be streamlined and more consumer-friendly, as well as to facilitate the work of economic operators and national authorities.
(9)
For reasons of completeness and clarity, it is also necessary to update certain existing entries for fragrance allergens in Annex III to Regulation (EC) No 1223/2009 by adding isomers and by complementing and amending the respective CAS and EC numbers, thus facilitating the work of economic operators and national authorities.
(10)
As the updated list of fragrance allergens is likely to result in entries in Annex III to Regulation (EC) No 1223/2009 combining existing and new restrictions, it is necessary to provide that the economic operators should, on the one hand, continue to apply existing restrictions, and, on the other hand, be allowed a reasonable period of time to comply with new restrictions.
(11)
With regard to the new restrictions, economic operators should be allowed a reasonable period of time to adapt to them by making the adjustments to product formulations and containers that are necessary to ensure that only cosmetic products complying with the new requirements are placed on the market.
Economic operators should also be allowed a reasonable period of time to withdraw from the market cosmetic products which do not comply with the new requirements and which were placed on the market before the new labelling provisions become applicable.
Considering the relatively low and stable percentage of consumers developing allergic contact dermatitis, the large number of new fragrance allergens to be individually labelled and the significant number of cosmetic products concerned, the transition period should be 3 and 5 years, respectively.
(12)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS REGULATION:
Article 1 Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
(3) SCCS (Scientific Committee on Consumer Safety), opinion on fragrance allergens in cosmetic products (SCCS/1459/11), 26-27 June 2012.