FAQs from NMPA on China Cosmetic Supervision and Administration
On March 10, 2022, China NMPA issued an announcement, answering frequently asked questions about cosmetic ingredient safety information, efficacy claim evaluation and sample retention.
With the aim to further standardize the supervision and administration of cosmetics, as well as to protect the legitimate rights and interests of consumers, China National Medical Products Administration (NMPA) has sorted out the questions of great concern to the cosmetics industry, and answered them in an announcement released on March 10, 2022. 1
Q1. How to correctly submit cosmetic ingredient safety information when applying for registration or notification?
A1: According to Cosmetic Supervision and Administration Regulation (CSAR), Administrative Measures on Cosmetics Registration and Notification, as well as Safety and Technical Standards for Cosmetics 2015, cosmetic registrants and notifiers shall carry out safety risk assessment on cosmetic ingredients, and submit the safety information of ingredients used in product formula during the registration and notification. With the launch of the cosmetic ingredients safety information submission platform (the submission platform), the ingredient enterprises can easily submit the ingredient’s safety information uniformly, and obtain the ingredient submission codes. Cosmetic registrants and notifiers just need to fill in the ingredient submission code provided by the ingredient manufacturers, then the platform will help match the ingredients’ safety information documents. Since repeated submission work is avoided in this process, the efficiency of cosmetic registration and notification can be further improved.
Based on the intention to protect trade secrets, the submission platform is only accessible for cosmetic ingredient enterprises. When providing ingredient submission code to cosmetic registrants and notifiers, the ingredient enterprises shall also provide necessary safety information of the ingredients. If any ingredient currently has no submission code, the cosmetic registration and notification will not be affected. Cosmetic registrants and notifiers can submit relevant ingredient safety information on the cosmetics registration and notification information service platform based on the ingredient’s safety information documents provided by its manufacturer.
Q2. How to correctly understand cosmetic efficacy claim evaluation? What should be done for registered and notified products to comply with the regulatory requirements for cosmetic efficacy claim management?
A2: According to Standards for Cosmetic Efficacy Claim Evaluation (Standards), not all cosmetic products require efficacy claim evaluation. For the major efficacy claims of cosmetics on the market, which can be directly recognized by vision, smell or other senses (e.g. cleaning, makeup-removing, beautifying and embellishing, perfuming, body refreshing, hair dyeing, hair perming, hair color maintaining, depilating, deodorizing, auxiliary shaving or barbering, or function achieved through physical covering, adhesion, friction, etc.), they can be exempted from efficacy evaluation. Only for a few claims, which have strong functions and are strictly managed as drugs or quasi-drugs in most countries and regions (e.g. freckle-removing and whitening, sunscreen, anti-hair loss, acne removing, nourishing, repairing, etc.), the human body efficacy evaluation test is required. For other efficacy claims, the evaluation can be based on literature review, research data analysis, or cosmetic efficacy claim evaluation tests as appropriate.
For cosmetics that have been registered and notified before May 1, 2021, cosmetic registrants and notifiers should upload the abstract of the efficacy claim’s basis of relevant products in accordance with the transitional policies. After registrants and notifiers evaluate the efficacy claim of the relevant products as required by Standards, if the content of the efficacy claim involved in the product name or label cannot be supported by the evaluation result, a change application can be filed before the expiry of the transitional period. In the application, the registrants and notifiers shall adjust the classification code of the product based on its actual properties, and amend the relevant content in the product name or label, to make it comply with the regulatory requirements.
Industry Comments
According to NMPA’s answers, for cosmetics registered or notified before May 1, 2021, enterprises are allowed to amend the product names or labels before May 1, 2023, which saves enterprises the trouble of cancelling previous application and re-applying for registration or notification. As the Standards has come into effect on May 1, 2021, the chance for change is not given to the products registered or notified after May 1, 2021.
Q3. How should cosmetic registrants and notifiers keep the samples of products? How to determine the quantity of retained samples?
A3: As stipulated by Supervision and Administration Measures on Cosmetics Manufacture and Operation (Measures), Provisions for Management of Cosmetic Registration and Notification Dossiers, as well as Good Manufacturing Practices for Cosmetics (Practices), cosmetic registrants and notifiers shall retain the samples of each batch of products that left the factory. The purpose of sample retention system is to ensure the traceability of product quality and safety, and to strengthen the main responsibility of cosmetic registrants and notifiers for product quality and safety. In addition, in the event of quality and safety problems or counterfeiting of products on the market, it is convenient to inspect the legality and safety of each batch of products.
During the actual implementation of the sample retention system, the cosmetics supervision department of NMPA has sorted out the quantity of the retained samples for common products sold on the market (see the table below) in accordance with the regulations mentioned above. Based on the actual supervision work and industry research result, NMPA comprehensively considered factors such as different product categories, packaging specifications, finished product status, etc. to compile this table, which can help enterprises save the operating costs. For product categories not listed in the following table, cosmetic registrants and notifiers can determine the quantity of retained samples according to the regulatory requirements by themselves.
Reference Table for the Quantify of Retained Samples of Cosmetic Registrants and Notifiers:
| No. | Product Category | Reference Quantity of Retained Samples |
| 1 | Hair dyes | ≥ 3 packages; total quantity ≥ 90g/ml |
| 2 | Freckle removing / whitening products | ≥ 3 packages; total quantity ≥ 50g/ml |
| 3 | Makeup products | ≥ 3 packages; total quantity ≥ 60g/ml |
| 4 | Skincare products | ≥ 3 packages; total quantity ≥ 80g/ml |
| 5 | Sunscreens | ≥ 3 packages; total quantity ≥ 50g/ml |
| 6 | Anti-acne products | ≥ 3 packages; total quantity ≥ 200g/ml |
| 7 (1) | Facial masks (sheet masks) | Individually packed product: ≥ 7 patches; total quantity ≥ 140g/ml |
| Boxed product: ≥ 3 boxes ( ≥ 7 patches); total quantity ≥ 140g/ml | ||
| 7 (2) | Facial masks (smear-on masks) | ≥ 3 packages; total quantity ≥ 80g/ml |
| 8 | Shampoo and hair care products | ≥ 3 packages; total quantity ≥ 50g/ml |
| 9 | Nail polish products | ≥ 6 packages; total quantity ≥ 30g/ml |
| 10 | Toothpaste | ≥ 3 packages; total quantity ≥ 80g/ml |
Notes: If the net content of makeup product is less than 1g, when retaining the samples of finished products, samples of semi-finished products can also be retained. The retained samples should meet the needs of product quality testing.
Industry Comments
- There was no specific regulation regarding the quantity of retained samples in cosmetics industry in China. With the latest update on FAQs, NMPA offers enterprises clear guidance on sample retention, and defines a uniform standard for local supervision departments.
- It is reasonable to keep at least three packs of samples for products that are subject to samples retention. When there is a demand for re-testing or arbitration upon samples, the additionally kept samples can be directly used for the second or even third times of sample testing.
Q4. Where should registrants and notifiers of imported cosmetics keep samples of their cosmetics imported into China?
A4: In November 2011, NMPA issued a notice to detail the enforcement rules of Measures. This notice clarified that, since January 1, 2022, overseas cosmetic registrants and notifiers shall keep the samples of each batch of products imported into China, and their responsible persons in China shall keep the samples and records. If the same production batch of products are imported in multiple batches, samples shall be retained at least once at the time of the first import.
With reference to Practices, the entrusted cosmetic registrants and notifiers shall retain samples in their respective domicile or main business premise; they can also retain samples in other business premises where their respective domicile or main business premise is located. Places “where their respective domicile or main business premise is located” are usually deemed to be within the administrative region of the same prefecture-level city or the same municipality directly under the central government. If the responsible person in China keeps the retained samples, the selection of the location for retained samples shall follow the provisions above. The selection of the sample retention site shall meet the requirements of laws and regulations, as well as the product storage requirements indicated on labels.
Industry Comments
According to NMPA, “if the same production batch of products is imported in multiple batches, samples shall be retained at least once at the time of the first import”. With this clarification, the retained samples can represent the overall situation of this production batch of products, and thus it is not required for enterprises to retain samples every time they import the same production batch of products.
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