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Health

Management measures for sampling inspection of cosmetics (soliciting opinions, children's cosmetics, etc.)

2022-06-27   

In order to implement the regulations on the supervision and administration of cosmetics and the measures for the supervision and administration of the production and operation of cosmetics, the State Food and Drug Administration recently solicited public opinions on the administrative measures for sampling inspection of cosmetics (Draft for comments) (hereinafter referred to as the administrative measures). The deadline for soliciting opinions is July 14, 2022. The reporter learned that on September 28, 2020, the State Food and Drug Administration (SFDA) publicly solicited opinions on the regulations on sampling inspection and management of cosmetics (Draft for comments). Compared with the previous version of the draft for comments, the draft for comments has adjusted and refined the relevant contents, and the name of the document has changed from "management specifications" to "management measures". There are 8 chapters and 63 articles in the management measures, mainly including plan formulation, sampling, inspection and result submission, re inspection and objection, verification and disposal, information disclosure, etc. The Administrative Measures specify that the sampling inspection of cosmetics should focus on the following products: Children's cosmetics and special cosmetics; Cosmetics using new raw materials; There are many problems found in supervision and inspection, adverse reaction monitoring, safety risk monitoring, complaint reporting, public opinion monitoring and other regulatory work; The unqualified rate of previous sampling inspection is high; Wide circulation range and high frequency of use; Other products with high safety risk. According to the management measures, sampling is divided into on-site sampling and network sampling. The sampling personnel shall not inform the cosmetics manufacturer or operator in advance before sampling. Sampling personnel shall not be less than 2. The management measures have explained the situation of "abnormal sampling". In the sampling, the sampling unit shall file a case for investigation according to law or report the problem clues to the competent department in charge of drug supervision and administration according to law if it is found that the following circumstances are suspected to exist: unregistered special cosmetics or ordinary cosmetics that have not been put on the market for sale or imported; Cosmetics that exceed the service life; Imported cosmetics without Chinese label; Cosmetics with prohibited labels; Other suspected illegal circumstances. In terms of "investigation and risk control on registrants and recorders", the administrative measures stipulates that when the verification and disposal department conducts investigation on overseas cosmetics registrants and recorders, the overseas cosmetics registrants and recorders may entrust their domestic responsible persons to assist in the investigation and sign and receive relevant law enforcement documents on behalf of them. If overseas cosmetic registrants and recorders refuse to implement the relevant administrative punishment decisions, the import of cosmetics shall be prohibited within 10 years according to law. In addition, the administrative measures also provide for "investigation of denial of production / import". If the cosmetics registrant, the recorder, the entrusted production enterprise and the domestic responsible person raise objection to the authenticity of the samples and deny that the products that are not in conformity with the provisions or have problems are produced or imported by them, the inspection and disposal department shall focus on the investigation of the production records, product samples and sales records of the products involved, and conduct sampling inspection on other batches or similar products and raw materials stored or reserved by the above-mentioned enterprises. The verification and disposal department shall comprehensively judge whether the products are produced or imported by the enterprise in combination with the on-site investigation, sampling inspection, product traceability in the business link, objection application materials submitted by the enterprise, etc. After investigation and verification, cosmetic note:

Edit:Yuanqi Tang Responsible editor:Xiao Yu

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