关键词: RAPEX系统, 化妆品, 原料, 安全

Abstract:

The aim was to analyze the cosmetic information bulletin of EU RAPEX, focusing on the analysis of products with chemical risks, and to provide reference for cosmetic ingredient management. The data from EU RAPEX system in 2005-2021 were summarized. The violations of the products were analyzed. According to the illegal substance, product type, country of origin and reason of violation, the notified results were analyzed statistically. Comparative analysis was made on the management of the notified substances according to the relevant information in European Union and China cosmetics ingredient management. At the same time, according to the whitening agent, preservative, flavor and fragrance, hair colorant, colorant, heavy metal, drug composition and other different categories of in-depth interpretation, its enlightenment was explored to the management of cosmetics raw materials in China. From February 2005 to May 2017, the REPEX system notifies 364 cosmetic products with chemical risk, involving 92 substances with violations. The most frequently reported violation is the addition of hydroquinone for skin-lightening products. Perfume is the most frequently reported product type. The main reason for violation is not as requiring to mark allergenic flavor fragrance. The most frequently reported country of origin is China, mainly because China does not have formulated management requirements for allergenic flavor fragrances, which leads to the labeling of flavor fragrances in China’s exported cosmetics does not meet the relevant requirements of the EU. The most frequently reported reasons for product violations are the detection or illegal addition of banned ingredients. Substances that need attention include whitening agents, preservatives, allergenic fragrances, hair colorants, colorants, heavy metal and pharmaceutical ingredients. Stronger post-marketing regulation of the related products is recommended for hydroquinone, Kathon and mercury. Strengthening or clarifying the requirements for raw material management such as kojic acid, allergenic flavor fragrances, and bimatoprost are needed. Increased training in the regulated use of preservatives and hair dyes should be implemented to establish technical standards for ingredients used in industries such as carbamazone and methylisothiazolinone that are more expensive and prone to violations. Risk monitoring is carried out for heavy metal starting materials （e.g., nickel, zirconium, antimony, chromium, cobalt, etc.）, and management measures are in place if necessary. Special attention should be paid to colorants CI 45161, CI 45174 and solvent yellow 172 in the new cosmetic ingredient registration filing work. With reference to the EU flexible notification and disposal mechanism, timely control measures should be taken on cosmetic ingredients with safety risks.

Key words: RAPEX system, cosmetic, ingredient, safety