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EU revises cosmetics regulations on perfume allergens.

On July 26th, 2023, the European Commission issued Regulation (EU)2023/1545, which revised the individual labeling requirements of perfume allergens in cosmetics in Annex III of Cosmetic Regulation (EC)1223/2009, added new substances and updated the restrictions on some perfume allergens already listed. Perfume substances are used in various products (including cosmetics) to provide products with a unique and pleasant smell, but they may cause contact allergies and allergic reactions. According to point (g) of Article 19(1) of the Regulations on the Administration of Cosmetics, the ingredients used as perfume are marked as "parfum" or "aroma" on the label. However, for substances regarded as perfume allergens, if the concentration of these substances exceeds 0.001% in disposable products and 0.01% in rinsing products, they must be labeled separately. Before the publication of the amendment (EU) No.2023/1545, only 24 kinds of perfume allergens requiring separate labels were listed in Annex III of the Cosmetics Regulations.

The European Commission asked the Scientific Committee on Consumer Safety (SCCS) to study more perfume allergens that are suitable for individual labeling requirements. SCCS adopted the opinion of SCCS/1459/11 (June 26-27, 2012), and identified 56 other substances, which can cause human allergies, but no separate labeling requirements have been formulated. According to SCCS, amendment (EU)No. 2023/1545 expanded the list of perfume allergens requiring separate labels and included it in Annex III of Cosmetics Regulation.In addition, substances such as pre-essence and pre-essence that can be oxidized or biologically activated and converted into known allergens should be regarded as equivalent to perfume allergens and have the same labeling requirements. In order to facilitate the work of economic operators and national authorities, it is necessary to update some existing items of perfume allergens in Annex III of the Cosmetics Regulation, add individual isomers, and keep the common names of substances consistent with the names in the latest version of the Glossary of Common Ingredients (the names of ingredients listed on product labels-Decision (EU)2022/677). If there are multiple common component names, which name should be used is specified in the individual label requirements, thus making the label more convenient for consumers and more concise.Regulation (EU) 2023/1545 came into force on August 16th, 2023 and is directly applicable to all member states. Due to possible major changes, such as adjusting product formulas and containers, canceling products that do not meet the requirements and issuing new labels, the compliance transition period for new products is July 31, 2026, and that for existing products is July 31, 2028.

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