In the last issue, we introduced some of the knowledge points of cosmetics registration (relevant report:Cosmetics registration and filing (part one)
), in this issue, FoodPartner.com will take you to understand other contents of cosmetics registration and filing.
8. Clarify the circumstances under which the filing management department changes due to the change of the address of the filing person and the domestic responsible person
Article 36 of the “Measures” stipulates that “If the address of the filing person or the person responsible in the country changes and the filing management department changes, the filing person shall re-file.” Before the address changes, the person in charge only needs to change the address, but according to the new regulations, it needs to be re-filed. This can facilitate the implementation of the main responsibility of the filing person, in case that the company cannot find a person after changing its address. According to relevant personnel, whether it is necessary to re-file is based on whether the address change is cross-provincial.
According to Article 52 of the Measures, “The drug regulatory department responsible for registration and filing management cannot communicate with the registrant and filing information through registration and filing information. If the person or the domestic responsible person gets in touch, the registrant, the filing person, and the domestic responsible person may be listed as key supervision targets on the information service platform, and an announcement will be made through the information service platform.” For companies that cannot be contacted, supervisors will directly include them in the list of business exceptions and freeze relevant accounts.
9. Requirements for the implementation of the annual report system for ordinary cosmetics
Article 37 of the “Measures” stipulates that “The recorder of ordinary cosmetics shall report the production and import status to the drug regulatory department responsible for record management every year. And compliance with laws and regulations, mandatory national standards, and technical specifications. If the products that have been filed are no longer produced or imported, the filer shall promptly report the cancellation of the filed by the drug regulatory authority responsible for the filed management.” That is, ordinary cosmetics no longer have the concept of expiry date, but implement an annual reporting system, requiring the filing party to submit annual production and import status reports. It is understood that if the annual report is not submitted as required, points will be deducted in the quantitative and hierarchical management of the record.
10. Clarify requirements for overseas on-site inspection
According to Article 47 of the Measures, “the technical review agency may notify the review and inspection agency to carry out on-site verification as needed during the process of registered technical review. The domestic on-site verification should be completed within 45 working days, and the overseas on-site verification shall be implemented in accordance with the relevant regulations of overseas verification. The time used for the on-site verification shall not be included in the review time limit. The registration applicant shall cooperate with the on-site verification work, and sampling inspection is required. , Should provide samples as required”.
also clarifies the verification of overseas factories. If it is found that the submission of false information or concealment of actual conditions is involved, the verification department shall conduct overseas inspections based on the actual situation.
11. It is required to disclose the pictures of special cosmetics labels in advance
According to Article 48 of the Measures, “After obtaining the registration certificate for special cosmetics, the registrant shall label the products on the market before putting them on the market. The pictures are uploaded to the information service platform for public inquiry”. This means that the label of the actual sales package needs to be consistent with the registered label, otherwise it may face penalties. Compared with the draft opinions, the”Measures” deletes the requirements for the release of the registered product sales pictures after the provincial bureaus review them after uploading, reflecting the concept of implementing main responsibilities and strengthening post-event supervision.
12. The confidentiality of the product formula is more clear
In the previous draft for comments, it was required that “the registrant should submit the product formula when applying for registration or the filing person should submit the product formula” and “the product formula should include raw materials”Serial number, raw material name, percentage content, purpose of use, etc.” have aroused heated debate in the industry, which means that companies must make their core intellectual property rights-product formulas public, and there is a possibility of exposing trade secrets.
However, in the officially announced”Measures”, the above expressions have been deleted, and Article 55 stipulates that”without the consent of the registrant and the filing person, Drug regulatory authorities, professional technical institutions and their staff, and those participating in the review shall not disclose the trade secrets, undisclosed information or confidential business information submitted by the registrant or filing party. The law provides otherwise or involves national security or major social public Except for benefits”. It can be seen that the state has expressed a clear protection attitude towards the intellectual property rights of enterprises.
13. The definition of Hong Kong, Macao and Taiwan cosmetics and imported cosmetics is more clear
According to Article 62 of the”Measures” in the general cosmetics record numbering rules”China Taiwan, Hong Kong, Macau products:National makeup net preparation word (domestic responsible person Province, Autonomous Region, and Municipality Abbreviation) + four-digit year number + serial number of products registered in the country this year”,”Taiwan, Hong Kong, Macau products in the special cosmetics registration numbering rules:national makeup special words + four-digit year number + products registered this year Sequence number”. It can be seen that the”Measures” defines Hong Kong, Macao and Taiwan cosmetics more clearly, and it will be easier for consumers to distinguish Hong Kong, Macao and Taiwan products from other imported products.
Although cosmetics from Hong Kong, Macao and Taiwan will no longer be imported products, they should refer to import management. Article 61 of the”Measures” states that”the last process of cosmetics that touches the contents is domestically produced products, and those that are completed overseas are imported products. The management of reference imported products is completed in Taiwan, Hong Kong and Macau.”
Generally speaking, the “Measures” not only make clear provisions for the registration and filing management of cosmetics and new cosmetics raw materials, implement the main responsibility of the enterprise, but also strengthen the Supervise management and legal responsibilities, and establish mechanisms for encouraging innovation. For companies, they should study carefully, regulate cosmetics production and operation activities, strengthen cosmetics supervision and management, reduce the risks caused by non-compliance, and promote the high-quality development of the cosmetics industry.
This article is The original article of the Food Safety Compliance Division of FoodPartner.com, please contact us for reprinting. The Food Safety Compliance Division provides domestic and foreign food standards and regulations management and consulting, food safety information monitoring and analysis and early warning, product registration and filing services, label review and compliance consulting, conference training services, etc., for detailed inquiries:, email:[email protected] foodmatenet.com.