The European Union to Amend the Regulation on Labeling of Fragrance Allergens in Cosmetic Products

On September 15, 2022, the European Commission issued G/TBT/N/EU/924 notification to amend Regulation 1223/2009 of the European Parliament and the Council on the labeling of fragrance allergens in cosmetics, for the protection of human health or safety.

According to the original regulation, cosmetic packaging must be marked with the ingredient list, and the fragrances and flavors contained therein and their ingredients can be replaced by “parfum” or “aroma”. However, if the concentration of 25 kinds of fragrance allergens listed in Appendix III of the Regulation exceeds the specified limit, it must be marked individually.

In addition to the 25 fragrance allergens, the Scientific Committee on Consumer Safety (SCCS) determined in its Opinion on Cosmetic Fragrance Allergens (SCCS/1459/11) that another 56 fragrances would also cause allergic reactions. As a result, the Regulation is to be amended – the number of fragrances listed in Appendix III was expanded to 81. According to the requirements of the amendments, fragrance allergens that are newly added to Appendix III shall be individually labeled on the package of a cosmetic product, if their concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products.  

The amendment is proposed to be adopted in the first half 2023. Cosmetic products containing fragrance allergens and not complying with the regulations shall not be placed on the EU market three years after the date of adoption of this Regulation. Five years after the date of adoption, cosmetic products containing those fragrance allergens and not complying with the restrictions shall not be made available on the EU market.

The G/TBT/N/EU/924 notification is under public consultation. The deadline for feedback is November 14, 2022.

Related document:

http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1415977955828&uri=CELEX:32009R1223

More information from CIRS: the requirements of labeling of fragrance allergens in cosmetic products in China

• In 2018, the official website of the National Traditional Chinese Medicine Variety Protection and Evaluation Commission (the Health Food Evaluation Center of the National Medical Products Administration) released the answer to the question “How to label the fragrance allergens in the outer packaging”: Cosmetic products often add fragrance ingredients or vegetable oil for flavors. Some fragrance ingredients and vegetable oil may contain allergens. Some countries (such as the European Union) require manufacturers to label allergens that are in excess of a certain amount to serve as a warning to consumers. Also, the Chinese label of products sold is required to be marked with the warning “This product/* * raw material contains * *” in the precautions. Those allergens shall not be marked in the ingredient label, unless the allergens are added individually in the formula. (http://www.zybh.gov.cn/d?xh=220829. Note: the content of the original text is now deleted)
• Technical Guidelines for Children’s Cosmetics (Draft for Comments): Children’s cosmetics should use as little as or even no fragrance. Meanwhile, it is not recommended to use ingredients that may contain 26 kinds of fragrance allergens. If the product contains 26 kinds of fragrance allergens, safety assessment shall be fully carried out. When the concentration of fragrance allergens exceeds 0.001% in leave-on products or exceeds 0.01% in rinse-off products, it shall be labeled to inform consumers.

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