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For the purpose of regulating the supervision and administration of cosmetics, and protecting the legitimate rights and interests of consumers, China National Medical Products Administration (NMPA) has released an announcement to answer the questions of great concern to the cosmetics industry.
Q1. How to correctly submit cosmetic ingredient safety information in the process of registration or notification?
A1. According to Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations) , Administrative Measures for the Registration and Notification of Cosmetics, and the Technical Specification for the Safety of Cosmetics , cosmetic registration or notification persons shall conduct safety risk assessment of cosmetic ingredients, and submit the safety information of ingredients used in product formula during the registration and notification. In order to optimize the administrative efficiency of the ingredients in cosmetic industry, NMPA has established the Cosmetic Ingredient Safety Information Registration Platform (the Registration Platform). On the platform, the ingredient manufactures can effectively submit safety information of the ingredients, and obtain the ingredients submission codes. Cosmetic registration or notification persons just need to fill in the ingredients submission code provided by the ingredient manufacturers, then the platform will automatically associate the code with safety information documents of ingredients. This avoids the repeated submission of safety information documents, so the efficiency of cosmetic registration and notification can be further improved.
In consideration of protecting trade secrets, the Registration Platform is only accessible to cosmetic ingredient manufactures. When providing submission code to registration or notification persons, the ingredient manufactures shall also provide necessary safety information of the ingredients. If the submission code is not provided, cosmetic registration or notification persons can submit relevant safety information of ingredients on the Information Service Platform for Registration and Filing of Cosmetics based on the safety information documents of ingredients issued by the manufacturers.
Q2. How to correctly understand cosmetic efficacy claim evaluation? What should be done for registered and notified products to comply with the regulatory requirements of cosmetic efficacy claim?
A2. According to the Standards for Cosmetic Efficacy Claim Evaluation (the Standards) issued by NMPA, not all cosmetic products are required to provide efficacy claim evaluation. For the major efficacy claims of cosmetics on the market, which can be directly evaluated by sight, smell or other senses (e.g. cleaning, makeup-removing, beautifying and embellishing, perfuming, body refreshing, hair dyeing, hair perming, hair color maintaining, hair-removing, 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 external drug products 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. Other efficacy claims can be evaluated by means of literature review, research data analysis or cosmetic efficacy claim evaluation test, etc.
For cosmetics that have been registered and notified before May 1, 2021, cosmetic registration or notification persons shall upload the justification abstract of the efficacy claim of relevant products under the transitional policies. As required by the Regulations, registration or notification persons shall evaluate their efficacy claim. If the evaluation result cannot support the efficacy claim presented in the product name or label, an application for amendment shall be filed before the expiry of the transitional period. In the application, the registration or notification persons shall adjust the classification code of the product based on its actual properties, and modify the relevant content in the product name or label, to make it comply with the regulatory requirements.
Q3. How should cosmetic registration or notification persons retain the samples of products? What’s the requirement for the quantity of retained examples?
A3. As stipulated by the Measures for the Supervision and Administration of Production and Distribution of Cosmetics (the Measures), the Rules for Registration and Notification Dossiers of Cosmetics (the Rules) , and Good Manufacturing Practices for Cosmetics (the Practices), cosmetic registration or notification persons shall retain the samples of each batch of products leaving the factory. The purpose of sample retention system is to ensure the traceability of product quality and safety, and to specify the accountability of registration or notification persons. Meanwhile, if there is any quality issues or counterfeiting, the legality and safety of each batch of products can be inspected effectively.
In the actually practice of the sample retention, the Cosmetic Supervision Department of NMPA has sorted out the quantity of the retained samples for common products sold on the market (Table 1). Drawn under the regulations mentioned above, from actual supervision work, and industry research results, this table takes the factors such as different product categories, packaging specifications, finished products status,etc., into consideration. It, therefore, reduces the operation cost for enterprises. For product categories not listed in Table 1, cosmetic registration or notification persons are allowed to determine the quantity of retained samples according to the regulatory requirements.
Table 1: Recommended Quantify for Retained Samples
No. | Product Category | Recommended Quantity for 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 from semi-finished products can also be used. The retained samples shall meet the requirement of product quality testing.
Q4. Where should the samples of imported cosmetics be retained by registration or notification persons?
A4. In November 2011, NMPA issued a notice of the enforcement rules of the Measures. It clarified that, since January 1, 2022, overseas cosmetic registration or notification persons shall retain samples from each batch of products imported into China, and their responsible persons in charge within the territory of 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 the Practices, the entrusted cosmetic registration or notification persons shall retain samples in their domicile or main business premise; they may also retain samples in other business premises where their domicile or main business premise is located. The understanding of "location" of the domicile or main business premise is generally deemed as not exceeding 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 place for keeping the samples shall refer to the above provisions. Meanwhile, It shall meet the requirements of laws and regulations, and the requirements of product storage indicated on labels.
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