On May 27, 2019, the comprehensive division of NMPA released the draft Management Measures on the Filing of Non-Special Use Cosmetics for public opinion. Enterprises can send the revised opinions to cosmetics supervision and administration division via firstname.lastname@example.org before June 15, 2019.
This draft Management Measures consist of five chapters (30 articles) with one attachment, which include the product filing requirements and management, supervision check of both imported and domestic non-special use cosmetics. The main contents of Management Measures cover domestic responsible person, dossier requirements, waiving conditions of animal testing, management of recorded products, etc. The detailed info can be found below:
Domestic Responsible Person (DRP)
A foreign applicant needs to establish a representative office in China or designate an enterprise legal person as domestic responsible person to handle the filing of imported non-special use cosmetics. Besides the product filing, DRP should be in charge of monitoring of cosmetics adverse reaction, implementing product recall. DRP shall build an audit system for overseas applicant to check if the recorded products are compliant with China cosmetics regulations and mandatory national standards and norms.
2) Change of company name and/or address
Relevant supporting docs issued by competent authority or relevant agency should be submitted.
3) Change of the original DRP into a new one for recorded products
This kind of alteration is based on a consensus of both two sides regarding the attribution of product liability that has been imported and sold in the previous period. Then the original DRP needs to sign an informed consent and fulfill the final confirmation of application via online filing platform.
1) ISO or GMP compliance certificate: Currently, it is only mandatory for imported cosmetics produced under contract manufacture. Nevertheless, it will be required for imported non-special use cosmetics produced under any type of production mode.
2) Certificate of Free Sale (CFS): If the products are specially produced for Chinese market and the Certificate of Free Sale can’t be issued in the country of origin, relevant research and experimental data for Chinese consumers shall be submitted.
3) Toxicological test: it can be waived as long as the manufacturer has obtained the official qualification certification of production quality management system and the safety risk assessment results are sufficient to prove the product safety. It means the animal testing will not be mandatory for imported non-special use cosmetics except the following situations:
- Products claiming for baby or Children care;
- Products containing new approval or recorded cosmetic ingredient. The new cosmetic ingredient has not been included in IECIC list;
- According to the quantitative grading results, the applicant, domestic responsible person or actual manufacturer is listed as a key regulatory object;
- The applicant, domestic responsible person or actual manufacturer has been investigated or punished due to the quality and safety issue of cosmetics in the past three years.
Management of Recorded Products
1) New filing application is required for the change of product name, formula, production process or other info impacting the product quality and safety;
2) Domestic responsible person has to confirm through the online filing platform whether the product continues to be produced or imported every year after the product is recorded;
3) Domestic responsible person should cancel the filing info if the recorded product is no longer produced or imported;
4) In case the recorded product shall be imported through another port outside of the administration region where the domestic responsible person is located, it is necessary to submit the company name, address and contact info of new consignee and a signed receiving agreement of imported cosmetics between the domestic responsible person and new consignee from another province to the online filing platform.
Post-market Surveillance and Inspection
1) Scope of supervision work
Normal official supervision focuses on the filing materials, sampling verification to the authenticity of production and import situation. If necessary, on-site inspection will be performed to check the authenticity of filing materials and whether the overseas manufacturer meets the requirements of quality management system of cosmetic production.
2) New regulatory mode
The sale of recorded products will be suspended when existing the situations hereinafter in the process of technical review:
- Missing required testing item and report;
- The certificate of analysis of raw material is not qualified;
- Product quality and safety risk assessment results can’t determine the product safety;
- Product executive standard including product technical requirements does not meet the safety requirements of cosmetics;
- Other situations where the product safety can’t be determined.
The online filing system users will be restricted for use as result of being regarded as the abnormal status when the government is unable to contact the domestic responsible person, consignee or any other contact info submitted to the online filing system.
The government will adopt the quantitative and hierarchical management system to non-special use cosmetics and implement dynamic quantitative scoring to the applicant or domestic responsible person in accordance with the quality management system, situation of product filing and post-market supervision and inspection. Quantitative grading and scoring results determine the frequency of random inspections, the competent authority will focus on strengthening the supervision and inspection of enterprises and their products with low quantitative scores.
This Management Measures might come into force after the enforcement of Cosmetics Supervision and Administration Regulation which is estimated to be effective in the end of this year. According to the draft Management Measures, the Chinese government prefer to adopt the safety risk assessment rather than alternative methods to replace the animal testing. Nevertheless, it is not like the EU way of animal testing ban but geared to practical situation depending on the type of cosmetics and raw materials and credibility status of enterprise. This is the first time for Chinese government to put forward the exemption of animal testing in imported non-special use cosmetics officially after 5 years since the date of waiving animal testing in domestic non-special use cosmetics. We should know from abovementioned info that the Chinese government will relax control over market access of imported cosmetics but prone to strengthen the post-market surveillance through establishing quantitative and hierarchical management system.
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