Detailed interpretation of quality and safety information submission of cosmetic raw materials
The new cosmetic regulation "Administrative Measures for Registration and Filing of Cosmetics" has been implemented, and the cosmetic industry has ushered in a new major change. Cosmetic enterprises are facing a series of new requirements and challenges such as safety evaluation, efficacy basis, and raw material submission. The submission of quality and safety information on the existing raw materials of cosmetics has become the compliance focus of many enterprises.
1. The cosmetic raw material quality and safety information submitted
The cosmetics registration data specification "(draft, 2020/11/4) Article 27 (2) provides that" (raw material safety related information) registrant, filing or domestic responsible person shall fill in the product used in the raw materials of the manufacturer information and upload issued by the raw material manufacturer of raw material quality and safety information file. Raw material producers have according to the cosmetics raw material quality and safety related information submitted to the guide "submitted to the raw material quality and safety related information, the registrant, filing or domestic responsible person can fill in the raw material submitted code associated with raw material quality and safety information file".
Cosmetic raw materials submitted to the code requirements, each production enterprise production of each raw material only corresponds to a submit code, equivalent to the identity card of the raw materials. If the cosmetic product enterprise chooses the enterprise that does not obtain the submitted code, it may not be able to obtain the safety information file of its raw materials, which will directly affect the registration of cosmetic products.
2. Cosmetic raw material quality and safety information submitted to the information process
3. The official cosmetics raw material safety information submitted to the guide
(a) Cosmetics raw material producers refers to the raw material safety responsibility of enterprises, can be the actual production of raw materials enterprises, and the actual production of raw materials enterprises belonging to the same group of companies affiliated enterprises or raw materials commissioned by the production behavior of the entrusted enterprise.
Cosmetic raw material manufacturers should be through the National Medical Products Administration raw material safety information service platform to submit the raw material safety related information for the record enterprise information table and the main body of the enterprise documents, the opening of cosmetic raw material safety related information submitted to the authority.
(b) Overseas or domestic raw material manufacturers can submit their own cosmetics raw material safety information, can also be authorized overseas or domestic legal person enterprises to submit and daily maintenance of raw material safety information. When the authorized enterprise opens the user rights, it shall also submit the authorization issued by the cosmetics raw material manufacturer. The authorization shall specify the authorization relationship and scope of authorization, and the information related to the safety of raw materials in the same quality specification can only be authorized by one enterprise.
(c) The relevant information on the safety of raw materials shall include the trade name of the raw materials, the basic information of the raw materials, the brief description of the production process of the raw materials, the necessary quality control requirements, the evaluation conclusion of the international authoritative organization, and the requirements on the limit of the risk substances.
Cosmetics production water without the need to submit the relevant information on the safety of raw materials, but special sources of water except.
(d) The relevant information of the safety of raw materials is submitted through the information platform, and the material submission code is automatically generated. The raw material submission code consists of five-digit manufacturer's digital code, six-digit raw material digital code and three-digit raw material quality specification digital code, and each group of codes is connected with "-".
(e) National Medical Products Administration active disclosure has been submitted to the raw material safety information of raw material trade name, manufacturer information and raw material submitted to the code.
Cosmetics registration, filing or domestic responsible person in the application for special cosmetics registration or for ordinary cosmetics for the record, you can fill in the material submitted to the code associated with the material safety information file. Raw material manufacturers, safety related information changes, the registrant, the filing person or the domestic responsible person shall timely change the relevant information.
4. Raw material information submitted to the transition period policy
NMPA developed the transition measures and identified the information requirements required for the material submission code. Cosmetic enterprises should be based on the transition period policy, make the corresponding preparation in advance.
Since May 1, 2021, the registrant/filing for registration or filing shall fill in the product formulation of raw materials source and trade name information, which involves the cosmetics safety technical specification "in the quality specification requirements of raw materials, should also be submitted to the raw materials quality specification certificate or safety related information.
Starting from January 1, 2022, when applying for registration or filing, the registrant/filer shall, in accordance with the requirements of the Provisions, provide safety-related information on raw materials with the functions of anti-corrosion, sun protection, coloration, hair dyeing, spot removal and whitening.
Since January 1, 2023, the registrant/filer shall, when applying for registration or filing, provide safety related information on all raw materials in accordance with the requirements of the regulations. Had been registered or completed for the record of cosmetics, the registrant, the filing person shall be in 2023 may 1 recently added to provide all the raw materials in the product formula safety related information.
5. Raw material enterprises and cosmetics enterprises to deal with measures
(1) Cosmetics raw material enterprises
Complete the raw material quality and safety information submitted as soon as possible, for the downstream cosmetics enterprise product registration convenience. Raw material quality and safety information/submission code under the new system shall be provided synchronously during cosmetic filing/registration.
(2) Cosmetics product enterprises
Collate the existing stock of raw materials, and if there are the same raw materials produced by different raw material manufacturers, conduct the in-house raw material system or raw material code collation as required to meet the requirements of the subsequent new regulations. Under the new regulations, registration of cosmetics for the record needs to be directly related to the raw material manufacturer. If the raw material manufacturer needs to be changed after the record, the raw material information should be maintained through the record registration platform, and safety evaluation should be conducted if necessary.
Q1: If the information on the quality and safety of cosmetic raw materials is not submitted within the stipulated time, what penalties will be imposed?
Answer: The submission of quality and safety information on cosmetic raw materials can be provided by the raw material manufacturer or the cosmetic enterprise using this raw material at the time of product registration. If the manufacturer did not submit the information at the early stage, there would be no submission code. The registration of finished products cannot be associated with the relevant information through the submission code. The registration of finished products must be filled in.
If it is not filled, the entire finished product registration is unable to proceed.
Q2: What are the specific requirements for notarization of power of attorney? The system is not yet open, what is the current implementation?
Answer: According to the information communicated at the training meeting of Higher Education Institute of FDA from April 22 to 23, the power of attorney for submitting the information on the quality and safety of cosmetic raw materials does not need to be notarized.
The system is not open, the current quality and safety information of raw materials can only be filled in by the cosmetic product registration.
Q3: If the ingredient list of cosmetic raw materials contains residues that are not functional ingredients, such as 1% glucose and 2% solvent residues, the label will be very long if the whole ingredient is labeled as containing impurities, can it not be labeled on the cosmetic label?
Answer: According to the standard requirements of cosmetic labeling ingredient list, these are required to be labeled; However, it can be compared with the "Full Composition List-Label Exemption".
Total composition table-labeling exemption is divided into the following five points:
1, in order to protect the raw materials and add the right amount of preservatives, antioxidants and other components. Because that addition amount of the raw material is limited or small, the content of the preservative, antioxidant and other components brought in by the raw materials in the final cosmetic is much smaller than the limit requirement of the cosmetic health specification, and the labeling can be exempted;
2, mixed in the raw material of trace impurities, under the current technical conditions, these trace impurities inevitably exist in the raw material, the presence of these trace impurities does not affect the safety evaluation and use of the raw material:
3. trace unreacted substances or reaction byproducts existing in the reaction products:
4. Processing aids intentionally added to the manufacturing process but not present in the final product:
5. Non-woven fabrics used as carriers for facial masks and other products are not considered as cosmetic ingredients.
Q4: Regarding forbidden plants, if I am not sure whether a plant can be used, is there any organization that can inquire?
A: substances on the list of banned plants must not be used; The plant raw materials in the catalog of used cosmetic raw materials can be used, if not sure whether it belongs to, you can find a consulting agency or industry experts to judge, but there should be no special agency issued a report format conclusion; If it is finally confirmed that the used cosmetic raw materials are not included, a new raw material registration is required.
Q5: Cosmetic raw materials do not have a production license. Perhaps the distributor will fill in the information according to the manufacturer. If the raw material information reporting system is enabled, how can you distinguish between the manufacturer and the distributor?
Answer: Cosmetic raw materials should be submitted by the manufacturer or the submitter authorized by the manufacturer. The submission code cannot be obtained until the raw materials are submitted.
Q6: Notarization is not required for the guarantee of raw materials and for the registration and filing of new raw materials. Is this right?
Answer: The authorization for submission of raw material quality and safety information does not need to be notarized. New raw materials registration, registration and filing of people outside the country, it is necessary to authorize the responsible person in the country, the authorization needs to be notarized.