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Official filing Q&A | Guangdong Safety Assessment Tool, high-frequency question related answers

Q&A on the Filing of Ordinary Cosmetics by Guangzhou Municipal Administration (The 77th issue)

One  How should the auxiliary tool for generating cosmetic safety assessment reports, "Guangdong Safety Assessment", be used?

In order to promote the implementation of the complete cosmetics safety assessment information system, Guangdong Food and Drug Administration has launched the cosmetics safety assessment report auxiliary generation tool "Guangdong Safety Assessment", which is now free of charge for use by cosmetics manufacturers throughout the province. For specific use guidelines, please refer to the guidelines issued on Guangdong Food and Drug Administration's WeChat official account. The website is https://mp.weixin.qq.com/s/T0y_VXgrrEPk86SdXkdXOA


Two  What is the legal positioning of the registration of ordinary cosmetics?

For ordinary cosmetics, the "Regulations on the Supervision and Administration of Cosmetics" clearly stipulate that enterprises complete the filing after submitting the filing materials, eliminating the approval process before the listing of ordinary cosmetics. This means that the filing materials submitted by enterprises are no longer the object of pre-approval, but rather the object of supervision and inspection after the product is listed, and belong to the nature of archiving and future reference. Even if no problems are found during the verification before and after the disclosure of filing information, it does not necessarily mean that the product does not have quality and safety issues. The supervision and verification of product filing materials run through the entire product lifecycle.


Three  How is it required to disclose the registration information of ordinary cosmetics?

According to Article 9 of the Measures for the Administration of Registration and Filing of Cosmetics, the drug regulatory department shall, within 5 working days from the date of completion of the filing of cosmetics, publish relevant information on the management of cosmetics filing to the public for public inquiry. In addition, according to Article 58 (2), for cosmetics that have been filed but the filing information has not yet been made public, if the drug regulatory department responsible for filing management finds that the filing information does not meet the requirements, it may order the filing person to make corrections and publish the filing information to the public after meeting the requirements.


Four   Under what circumstances should a change in production address be supplemented with microbiological and physicochemical testing reports for products produced at the proposed site?

According to Article 41 of the Regulations on the Management of Registration and Filing Materials for Cosmetics, if there is a change or increase in the production site of the registered product, a microbiological and physicochemical inspection report of the product produced at the proposed change site should be supplemented. It is worth noting that although the production address of the production license has changed, there has been no substantial change or increase in the production site of the registered product. For example, if only the place name text is updated or the new site does not involve the production conditions of this product, the registrant shall provide relevant supporting materials or situation explanations, and there is no need to provide additional microbiological and physical and chemical inspection reports.


Five  Can polyethylene be used in cosmetics production according to the Catalogue of Used Cosmetics Raw Materials?

Polyethylene is the main component of plastic microbeads. According to the "Opinions of the Ministry of Ecology and Environment of the National Development and Reform Commission on Further Strengthening the Control of Plastic Pollution" (NDRC Huanzi [2020] No. 80), by the end of 2020, the production of daily chemical products containing plastic microbeads (≤ 5mm) will be prohibited nationwide; By the end of 2022, the sale of daily chemical products containing plastic microbeads (≤ 5mm) will be prohibited nationwide. If polyethylene exists in the form of plastic microbeads in the product, it is prohibited from being used in cosmetics production. If polyethylene is used for other purposes such as emulsifiers or thickeners, it is allowed to be used