NMPA Internal Training: Noteworthy Points on Cosmetic Notification, Labeling, Efficacy Evaluation and Safety Assessment

Since May 1, 2021, China has implemented a new cosmetic registration and notification system. However, after the implementation, cosmetic companies encountered various problems during the actual registration or notification process due to the brand-new regulation framework. During a recent training course hosted by NMPA, officials and review experts addressed the concerned questions relating to cosmetic notification, labeling, efficacy evaluation, safety assessment, etc., from cosmetic companies. Following are the noteworthy points:

1. Notification of General Cosmetics

Pre-market review for the notification of general cosmetics is no longer needed. The notification of general cosmetics is deemed completed after the submission of notification dossiers, then the cosmetics can be placed on the market. The basic notification information will be made public within five working days after the submission. However, the five working days is not for dossier review, but just for the authority to compile the information for publicity. After the notification, notified cosmetics will be subject to random post-market inspections.

From January 1, 2022, the annual reporting system will be implemented for general cosmetics. The notifiers shall submit the annual report for cosmetics notified more than one year ago through the new registration and notification online system from January 1 to March 31 each year. 

2. Cosmetic Labeling

• Companies are encouraged to design the labels and packaging of the cosmetics including cosmetic samples in accordance with the Administrative Measures on Cosmetics Labeling. Cosmetics manufactured before May 1, 2023 with labels complying with the old regulations can be sold until the expiry date.

• For imported cosmetics with wordings/logos like “quasi drug”, “drug fact”, “+”, etc. on the labels which do not comply with the new Measures, the companies shall re-design the labels or packaging for the Chinese market, otherwise, severe punishments will be imposed. It is prohibited to attach a Chinese sticker to cover the non-compliant wordings/logos.

• For label samples with medical, false, or exaggerated claims, related enterprises will directly become the key supervision targets. All their products will be reviewed and inspected, which means the products cannot be exempted from animal testing. For enterprises who expect to avoid animal testing, please be noted with this provision seriously.

• For protecting consumer's interests, the primary packaging of cosmetics shall simply bear the product name and durability without attaching other captions due to the limited space. For imported cosmetics, the product name in English and Chinese shall be consistent.

• Sales packaging shall be submitted for the notification of general cosmetics but not necessary for the registration of special cosmetics.

• Multi-layer labels, trademarks indicating medical effects, and logos of organic certifications are not accepted in China.

• For products with several actual manufacturers, the names and addresses of all manufacturers shall be listed.

• The national standards of cosmetic labeling and the inventories of prohibited claims are under formulation. The regulations on electronic labels are still at the stage of investigation and assessment.

3. Efficacy Evaluation

• If a product is exempted from the disclosure of efficacy evaluation abstracts, the company can decide whether to conduct the efficacy evaluation.

• The research data used for efficacy evaluation can be private data, e.g., the research data from companies, testing institutions, patents, etc.

• The requirements for efficacy claims are applicable to not only cosmetic labels but also advertisements. The claims in advertisements shall correspond to those on the labels.

• For products claiming the efficacy of a certain ingredient, the effective concentration shall be taken into consideration for efficacy evaluation and related proof shall be included in the evaluation reports for future post-market inspections. But there is no need for companies to indicate the effective concentration in the evaluation abstract because of the confidentiality of the formula.

• There are no officially designated efficacy evaluation institutions and no requirements for the validity period of evaluation reports.

4. Safety Assessment

• From May 1, 2021, to December 31, 2021, companies can either provide a safety assessment report or a toxicological testing report for cosmetics' registration / notification.

• The priority of safety assessment supporting evidence should be as follows: requirements of Safety and Technical Standards for Cosmetics > safety assessment conclusions from authoritative organizations > the historical usage of ingredients in the enterprise > the highest historical usage amount in the Inventory of Existing Cosmetic Ingredients 2021.

• The safety assessment of nano ingredients can use the assessment conclusions from international authoritative organizations. The guidelines for the safety assessment of nano ingredients and the review of such assessment reports are under formulation.

5. Special Categories

• For hair growth products, depilating products, breast beauty products, slimming products, and deodorants, even if their registration certificates obtained under the old regulations are expired, these products can be still sold until Dec. 31, 2025. with no need to renew the certificates.

• There is no need for notified soaps to renew the certificates as well. They can be sold until Dec. 31, 2025.

• For products specially designed for Chinese consumers, enterprises shall submit the supporting documents to prove the formula is designed based on the skin type, consumer demand, etc. of Chinese consumers. Besides, only local Chinese consumers can be selected for related consumer studies or human trials, while ethnic Chinese can’t be the participant.

• Deodorants for foot and eyelash growth products are not defined as cosmetics. Sunscreens for hair belong to products with new efficacy, which shall comply with the requirements for products with new efficacy.