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FAQs on Cosmetics Registration and Filing in China-Safety Assessment
On December 15, 2022, the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion on salicylic acid (CAS No. 69-72-7) to assess the safety of salicylic acid in cosmetics for public comments. The deadline for the public consultation is February 17, 2023.
On November 11, 2022, the European Commission issued Regulation (EU) 2022/2195, amending the requirements of European Cosmetics Regulation (EC) No 1223/2009 on the use of Humosalate and Resorcinol, and adding the restrictions on the use of Butylated Hydroxytoluene, Acid Yellow 3 and HAA299 (nano and non nano forms). This revision mainly refers to the scientific opinions issued by the Scientific Committee on Consumer Safety (SCCS) in 2021. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
On November 4, 2022, the European Union Scientific Committee on Consumer Safety (SCCS) issued scientific advice on the safety of triclocarban and triclosan as substances with potential endocrine-disrupting properties, clarifying the safety of their use in cosmetics. The safety assessment was carried out based on all available information, including potential endocrine impacts, with the following conclusions:
CIRS Group has prepared a Brief Guide to Regulatory Requirements of Global Cosmetic Regulations to help enterprises better understand cosmetic regulations around the globe. The Guide is compiled based on CIRS Group’s experience with cosmetic registration/filing. It gives a brief introduction to global cosmetic regulations, which makes it easier for related enterprises to collect regulatory information and know what they need to do during is during export or R&D.
On October 27, 2022, the National Institutes for Food and Drug Control released a FAQ regarding the NMPA codes for cosmetic ingredients. It is worth mentioning that the Platform of Cosmetic Ingredients is only developed to improve the efficiency of cosmetic registration and filing and the competent authorities will not review the submitted safety information. Related enterprises (ingredient manufacturers and enterprises that need to use the ingredient) must bear responsibility for the legality, authenticity, accuracy, and integrity of the ingredient safety information. Enterprises obtaining NMPA codes for one cosmetic ingredient does not mean the ingredient have been approved by the regulatory authority.
The European Union Scientific Committee on Consumer Safety (SCCS) adopted the final revision of the scientific opinion (SCCS/1639/21) on vitamin A (this covers retinol, retinyl acetate, and retinyl palmitate*) during the plenary meeting on October 24-25. Previously, on October 6, 2016, the SCCS issued a scientific opinion (SCCS/1576/16) on vitamin A to assess the safety of its use as a cosmetic ingredient. This SCCS/1639/21 is an updated version of SCCS/1576/16.
Triethanolamine has been getting a lot of attention recently but there is some confusion over mixtures containing it. In general, the concentration of triethanolamine in cosmetics is less than 0.5%, accounting for a low proportion. According to Article 57 of the Detailed Rules on the Implementation of Administration Regulations of the People’s Republic of China on the Administration of Monitored and Controlled Chemicals (MCCs), when the concentration of MCCs is lower than a certain concentration threshold, data declaration and import and export licensing can be exempted. Recently, there was an inquiry on the official website of the General Administration of Customs about the necessity of applying for an Import/Export License for hand sanitizers containing a trace quantity of triethanolamine (0.051).
Since China's overarching cosmetic regulation – Cosmetics Supervision and Administration Regulations (CSAR) – came into force on January 1, 2021, the authorities have been paying close attention to regulatory compliance and punishing enterprises for non-compliance. This article focuses on four of the main categories of non-compliance and provides case studies for each.
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.