We’ve translated a selection of some of the latest FAQs on cosmetics registration and filing in China with a focus on cosmetic ingredient quality and safety information submission (NMPA code) to help you understand the current requirements.
1. How do you fill in the safety information for cosmetic ingredients during the cosmetics registration and filing process in China?
On January 1, 2022, China National Medical Products Administration (NMPA) launched the cosmetic ingredients safety information platform. Since then, cosmetic ingredient suppliers have been able to create an account on the platform and submit the safety information of their cosmetic ingredients to generate a code. This code can then be shared with downstream cosmetic registrants, filers, or the domestic responsible person to distribute the safety information of cosmetic ingredients and report to the NMPA.
2. What are the requirements for submitting cosmetic ingredient safety information?
- From January 1, 2024, cosmetic registrants and filers should provide the quality and safety information for all cosmetic ingredients in cosmetic product formulas for submission, if they need to apply for cosmetic registration or filing;
- Cosmetics that have been registered or filed before May 1, 2021 – If the Safety and Technical Standards for Cosmetics have specific requirements on the quality specifications of one of the cosmetic ingredients contained in the cosmetic product formulas, registrants or filers of the cosmetic products should supplement the certifying documents on the quality specifications of the cosmetic products or the safety information of the cosmetic ingredient for submission before January 1, 2024. Safety information on other ingredients in the product formulas should be kept by the registrants or filers for future review.
- Cosmetics that are registered or filed between May 1, 2021, and December 31, 2023 – If the ingredients with functions such as preservative, sunscreen, colorant, hair dye, anti-freckle, and whitening are contained in the product formulas, registrants or filers of the cosmetic products must supplement the documents certifying the quality specification of the ingredient or the safety information of the ingredient for submission before January 1, 2024. Safety information on other ingredients in the product formulas must be kept by the registrants or filers for future review.
3. Should one or multiple manufacturers of the same ingredient be reported?
Manufacturers of the same ingredient need to report based on the quality specifications of that ingredient. If the quality specifications of multiple manufacturers are consistent, multiple manufacturers can be filled in as one. If not, they need to report separately.
4. What content is included in the cosmetic ingredient safety information?
The cosmetic ingredients safety information includes:
- Trade name of the ingredient;
- Basic information about the ingredient;
- Brief description of the ingredient production process;
- Necessary quality control requirements;
- Evaluation conclusions of international authoritative institutions; and
- Requirements to limit risk substances.
5. What are the precautions when filling the NMPA code?
At present, if the NMPA codes filled in for the cosmetics filing are inconsistent with the data of the ingredients safety information registration platform, the registrant should verify the following information with the ingredient manufacturer (supplier):
(1) whether the NMPA code corresponds to the target ingredient; and
(2) whether specific ingredients in the cosmetics formula, such as the composition and proportion of the composite ingredients, are consistent with the information reported on the ingredients safety information registration platform.
6. What are the requirements for the enterprise entity certification documents required for overseas users that register on the cosmetic ingredients safety information registration platform?
The proof documents of the enterprise entity should be notarized by a Chinese notary office or confirmed by the Chinese embassy (consulate). All texts in foreign languages should be translated into Chinese in a complete and standardized manner, and the original text should be attached to the corresponding translation.
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