Regulatory Update: New Rules on Labeling of Allergenic Substances in Cosmetics
More than a decade after the Scientific Committee on Consumer Safety issued its opinion, a new regulation has come into force that introduces substantial changes in the labeling of allergenic substances in cosmetic products.
This regulation, EU No. 2023/1545, enacted on July 26, 2023, and published in the Official Journal of the European Union L 188/1 on July 27, 2023, is an update to Regulation (EC) No. 1223/2009 of the European Parliament and of the Council, with a specific focus on the labeling of allergenic fragrances in cosmetic products. The primary purpose of this revision is to ensure compliance with consumer safety and health protection criteria.
The considerations underlying the new regulation estimate that the percentage of individuals allergic to allergenic fragrances in the European Union hovers between 1 percent and 9 percent. Contact allergies represent specific immune reactivities that persist over a lifetime.
Repeated exposure to enough of an allergen can trigger allergic contact dermatitis, better known as eczema. In the presence of prior sensitization to an allergen, even minute amounts can cause allergic symptoms. A restriction on the use of allergenic fragrances may be an option for primary prevention.
However, sensitized individuals may experience allergic reactions even at lower concentrations than the allowable maximums. Therefore, in order for sensitized individuals to avoid contact with triggers, it is essential to provide information about the potential presence of allergenic fragrances in cosmetic products.
Fragrances are organic compounds widely used in perfumes and other cosmetic items, but also in detergents, fabric softeners, and other household products. It should be noted that regulations governing cosmetic products also extend to household products.
At present, the list of ingredients must accurately specify 26 allergenic fragrances listed in entries 45 and 67 to 92 of Annex III of Regulation (EC) No. 1223/2009.
In response to the Commission’s request to revise the list of allergenic fragrances for individual labeling, the Scientific Committee on Consumer Safety (SCCS) issued an opinion in June 2012 (SCCS/1459/11).
This opinion validated the relevance of the fragrances already listed, and added 56 additional fragrances that caused human allergies, although they had not previously been subject to individual labeling requirements.
Based on this opinion, and to address the potential public health risk, the Commission decided to inform consumers about the presence of these new allergenic fragrances. As a result, Annex III of Regulation (EC) No. 1223/2009 was updated, requiring individual labeling of these allergenic fragrances when their concentration exceeds 0.001% in no-rinse products and 0.01% in rinse-off products.
Similarly, the same standards and regulatory requirements have been applied to fragrances such as preaptenes and proaptenes, which can become contact allergens through oxidation or bioactivation. These substances are now treated in the same way as allergenic fragrances.
In order to improve the clarity and consistency of the rules, changes have been made to existing entries in Annex III, aligning substance names with those in the latest version of CosIng and grouping similar substances under a single entry. In the case of multiple common names for a substance, the label will use the specific name given in the list of ingredients in Article 19(1)(g) in order to simplify labeling and make it more understandable to consumers and economic operators.
The update of Annex III also includes the revision of existing entries for allergenic fragrances, including updating the isomers and changing their CAS and EC numbers. These changes aim to simplify the work of economic operators and national authorities.
Since the new list of allergenic fragrances is likely to overlap with existing restrictions in Annex III, a transition period is needed to allow economic operators to comply with the new provisions. This period is set at three years with regard to placing on the market and five years with regard to making available and final supply to the consumer.
Are you a manufacturer or operator in the cosmetics industry? To ensure compliance and simplify the process, our regulatory service will guide you through the new rules, ensuring that your labels are up-to-date and in line with the regulations
