Product Compliance
Test/Filing/Registration
Product Compliance
Test/Filing/Registration
1. What are the implementation points of the new rules to be paid attention to from May 1, 2022?
① Product label
According to the Notice of the National Medical Products Administration on (No. 77), starting from May 1, 2022, cosmetics applying for registration or filing must meet the provisions and requirements of the Cosmetics Label Administration Measures.
According to the Announcement of the National Medical Products Administration on the release of<the Provisions on supervision and Administration of Children's cosmetics> (No. 123, 2021), since May 1, 2022, children's cosmetics that apply for registration or filing must be labeled in accordance with the Provisions on supervision and Administration of Children's cosmetics.
② Product added recording
According to the requirements of The Announcement of National Medical Products Administration on (No. 35, 2021) and the Announcement of National Medical Products Administration on (No. 49, 2021), registrants and record holder should adopt a new registration and archival platform, submit the product classification code, product implementation standards and product label sample, fill in the product formula of domestic ordinary cosmetics, and upload the label pictures of special cosmetics sales package before May 1, 2022.
③ Product changes with banned ingredients
According to the state food and drug administration about further clear special-use cosmetics transition management, and other related matters of announcement no. 150 (2021), "about update announcement of cosmetic raw materials disable directory before releasing, has been registered or complete filing products, can be in on May 1, 2022 to apply for formula change, Retain the original registration or filing number. Where the registrant or record holder of cosmetics fails to apply for change within the prescribed time limit, the relevant products shall not continue to be marketed and sold.
④ Product efficacy claims based on the abstract
According to the requirements of the Announcement of the National Medical Products Administration on(No. 50, 2021), cosmetics registered or filed during May 1, 2021 to December 31, 2021 shall be registered or filed before May 1, 2022, According to the requirements of Evaluation Standard for Cosmetic efficacy claims, the efficacy claims of cosmetics are evaluated, and the abstract of product efficacy claims is uploaded.
2. If non-inspection method is used as quality control measure in the product implementation standard, what system filling points should be paid attention to?
In accordance with the Provisions on the Management of Cosmetics Registration and Archival Materials, if non-inspection methods are used as quality control measures, specific implementation plans shall be made clear and the rationality of quality control measures shall be explained to ensure that products meet the requirements of Cosmetics Safety Technical Specifications. Please refer to Table 3 and remarks in Appendix 16 of Regulations on The Management of Cosmetics Registration and Archival Materials when filling in the system.
3. What are the hydrocarbons derived from petroleum coal tar?
Generally, it can include mineral oil, mineral grease, paraffin, microcrystalline wax, paraffin, pure paraffin, liquid paraffin, C13-16 isoalkanes, C13-14 isoalkanes, C10-11 isoalkanes, C10-12 alkane/naphthenes, C10-12 isoalkanes, C10-13 isoalkanes, C11-12 isoalkanes, AND C11-13 Isoalkanes, C12-14 isoalkanes, C12-15 isoalkanes, C12-20 isoalkanes, C13-14 alkanes, C13-15 alkanes, C15-19 alkanes, C15-23 alkanes, C18-21 alkanes, C7-8 isoalkanes, C8-9 isoalkanes, C9-11 Isoalkanes, C9-12 alkanes, C9-13 isoalkanes, etc.
If hydrocarbons derived from petroleum and coal tar are used (except for single component), the chemical Abstract index number (CAS number for short) of relevant raw materials shall be indicated in the remarks column of product formula table of the archival record management system for ordinary cosmetics.
4. Should raw materials containing less than 0.1% be listed in descending order when filling in the registration system?
Yes. According to the "Cosmetics Registration and Archival Data Management Provisions" requirements, product formula should provide the content of all raw materials, the content is calculated in percentage of quality, all raw materials should be in descending order, therefore, the content of less than 0.1% of raw materials should also be in descending order as required.
In addition, according to the "Cosmetics Label Management Measures", on the label of all components not more than 0.1% (W/W) should be "other trace components" as a guide language to lead to separate labeling, can not be listed in descending order according to the content of components.
5. Can the canning step be exempted from the production process description?
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