1. How to correctly fill out and submit the safety information related to cosmetic ingredients in the process of cosmetic registration and filing?
According to the Regulations for the Supervision and Administration of Cosmetics, Administrative Measures for Cosmetics Regulation and Notification, Technical Specification for the Safety of Cosmetics, relevant regulations and technical specifications, cosmetic registration and filing persons should conduct a safety risk assessment of cosmetic product ingredients, and fill out and submit safety information of cosmetic ingredients in the registration and filing process. In order to promote the safety management of cosmetic ingredients in China’s cosmetic industry, NMPA has made full use of information technology to organize and establish the Cosmetic Ingredient Safety Information Registration Platform, which can facilitate cosmetic ingredient enterprises to fill out and submit ingredient safety information, and generate a cosmetic ingredient submission code. Cosmetic registrants and filing persons can only fill in the cosmetic ingredient safety information code provided by cosmetic ingredient enterprises, associated with the Platform, and do not need to fill in cosmetic ingredient information in detail, which can improve the efficiency of cosmetic registration and filing.
Based on the consideration of protecting trade secrets, the Platform is only for cosmetic ingredient enterprises to fill in and use. Cosmetic ingredient enterprises should provide necessary ingredient safety information while providing a cosmetic ingredient submission code. It will not affect the cosmetic registration and filing work without the code, cosmetic registrants and filing persons can report safety information related to cosmetic ingredients through the Platform according to the safety information documents of cosmetic ingredients issued by the raw material manufacturers.
2. For the registrants and filing persons of cosmetics, how to keep samples of products? How to determine the quantities of retained samples?
According to the Provisions for the Supervision and Administration of Cosmetics Manufacture and Distribution, the Provisions for the Registration or Filing Dossier of Cosmetics, and the Good Manufacturing Practice for Cosmetics, the registrants and filing persons of cosmetics shall retain samples of each batch of products that leave the factory. The purpose of this sample retention system is to ensure the traceability of product quality and safety, put the main responsibility of the registrants and filing persons for product quality and safety into effect; meanwhile, it is convenient to check the legality and safety of each batch of products when sold products have quality and safety problems, counterfeit products, etc.
In the actual implementation of this sample retention system, the Cosmetics Supervision Department of NMPA refers to the actual supervision work and combines industry research results, then sorts out the quantities of retained samples of common products sold in the market in accordance with the above-mentioned regulations, the aim of saving the operating costs of enterprises, overall consideration of factors such as different product categories, packaging specifications, finished product status, etc. The table below is for reference in the production and operation practice of enterprises. For the types of products not listed in the table below, the registrants and filing persons of cosmetics should determine the quantities of samples to be retained in accordance with the relevant regulations.
Reference table for the quantities of retained samples
No. | Product Categories | Reference Quantities of Retained Samples |
1 | Hair dye products | Package quantities≥3 and total volume≥90g or mL |
2 | Anti-spot and whitening products | Package quantities≥3 and total volume≥50g or mL |
3 | Make-up products | Package quantities≥3 and total volume≥60g or mL |
4 | Skincare products | Package quantities≥3 and total volume≥80g or mL |
5 | Sunscreen products | Package quantities≥3 and total volume≥50g or mL |
6 | Anti-acne products | Package quantities≥3 and total volume≥200g or mL |
7 (1) | Face mask products (sheet mask) | A single piece of independent packaging products: patch quantities≥7 and total volume≥140g or mL; Boxed products: box quantities≥3 (patch quantities≥7) and total volume≥140g or mL |
7 (2) | Face mask products (liquid mask) | Package quantities≥3 and total volume≥80g or mL |
8 | Shampoo and hair care products | Package quantities≥3 and total volume≥50g or mL |
9 | Nail polish products | Package quantities≥6 and total volume≥30g or mL |
10 | Toothpaste | Package quantities≥3 and total volume≥80g or mL |
Note: If the net content of make-up products is less than 1g, the samples can be retained in combination with the semi-finished products when retaining samples of finished products. The retained samples shall meet the requirements of product quality inspection.
3. Where should the registrants and filing persons of imported cosmetics retain samples of cosmetics imported into China?
As of January 1, 2022, the registrants and filing persons of overseas cosmetics shall retain samples for each batch of products imported into China, and the samples and records shall be kept by the domestic responsible person. For the products of the same production batch that are imported several times, the samples shall be kept at least once when the products are imported for the first time.
According to the Good Manufacturing Practice for Cosmetics, the cosmetic registrants and filing persons of entrusted production shall retain samples at their residence or main business address or other business address where their residence or main business address is located. For the understanding of "location" in "the location of their residence or main business address", it is generally recognized as not exceeding the administrative area of the same prefecture-level city or the same municipality. If the samples are retained by the domestic responsible person, the selection of sample retention location shall be implemented with reference to the above provisions. Meanwhile, the selection of sample retention location shall be able to meet relevant rules and regulations and the storage requirements marked on the product label.
4. What is the difference between the filing cancellation voluntarily conducted by the filing person and that conducted by the filing management department? Is it necessary to conduct the filing cancellation if the products are no longer produced or imported?
According to the Cosmetics Supervision and Administration Regulations and the Administrative Measures for Cosmetics Regulation and Notification, for products that are no longer produced or imported, the filing person can voluntarily apply for cancellation on the filing platform. For products that voluntarily apply for cancellation without violation of rules and regulations, the related products that have been listed before the voluntary filing cancellation can be sold until the expiration of the shelf life. While the filing cancellation conducted by the regulatory department is a kind of punishment for illegal acts. According to Article 65 of the Regulations, the products whose filing certificates are cancelled by the filing department shall not sold or imported from the date of the filing cancellation. If the products are still sold or imported, the regulatory department will punish them in accordance with the relevant regulations.
It is suggested that filing persons and domestic responsible persons of general products should sort out the products that have completed the filing as soon as possible. If the products continue to be produced and imported, the annual report shall be submitted, and the related materials shall be supplemented in accordance with the relevant regulations. And it shall take the initiative to apply for the filing cancellation for the products that are no longer produced and imported. Considering that some filing persons and domestic responsible persons have not registered the new platform account during the process of connecting the new and old platform, these filing persons and domestic responsible persons can submit a written application to the local MPA for the voluntary filing cancellation, and the filing management department will assist in completing the filing cancellation and public information update of the filing products on the new platform, so as not to affect the continued marketing and import of related products.
5. Are toothpaste and soap cosmetics?
According to the Cosmetics Supervision and Administration Regulations (CSAR), toothpaste is managed with reference to the regulations on general cosmetics. Soaps that claim to have special cosmetic efficacy, such as anti-spot and whitening, are regulated as cosmetics, but general soaps are not regulated as cosmetics.
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