1. What is the main purpose of retaining samples?
The purpose of retaining product samples is to ensure the traceability of product quality and safety, and to compact the main responsibility of the cosmetic notification applicant for product quality and safety; At the same time, it is convenient to check the legality and safety of each batch of products when the sold products have quality and safety problems, counterfeiting and other circumstances.
2. What are the general requirements for retaining samples?
After January 1, 2022, the overseas cosmetics registrant shall retain samples for each batch of products imported into China. If the same batch of products is imported multiple times, the samples shall be retained at least once at the time of first import.
3. Who is the subject of sample retention?
The cosmetic notification applicant shall retain samples for each batch of products leaving the factory, and the entrusted production enterprise shall also retain samples.
4. How to determine the quantity of sample retention?
According to the Good Manufacturing Practice for Cosmetics, the quantity of retained cosmetics samples should be at least two times the quantity required for factory inspection, and should meet the requirements of product quality inspection. Meanwhile, the enterprise should determine the quantity of retained samples based on the actual quality management.
The table below is for reference in the production and operation practice of enterprises sorted out by NMPA. For the types of products not listed in the table below, the registrants and filers of cosmetics should determine the quantities of retained samples in accordance with the relevant regulations. 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.
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 |
5. What are the packaging requirements for sample retention?
According to Article 18 of the Good Manufacturing Practice for Cosmetics, "for factory products are finished products, the samples should be kept in the original sales package. For sales package in the form of sets, the sales package contains multiple cosmetics and all of them are the minimum sales units, if the samples for the minimum sales unit in the package have been retained, the sales package product samples cannot be retained as a whole, but the outer package of the sets that can meet the quality traceability should be retained. For factory products that are semi-finished products, the retained samples should be sealed and ensure that the product quality is stable with label information that meets the traceability requirements."
That is to say, the sample of finished products should be kept in the original sales package. When the set products contain multiple cosmetics and all are the minimum sales units, the set products can choose two ways to retain samples: one is to retain samples for the set products as a whole; Another way is to retain samples for the minimum sales package unit, while retaining the outer package of the set that can meet the quality traceability requirements. The retained samples of semi-finished products shall be sealed and ensure the stability of product quality, and shall have label information including product name, enterprise name, specification, storage conditions, shelf life, etc.
6. What are the requirements for the sample location?
According to Article 29 of the Cosmetics Supervision and Administration Regulations (CSAR), and Article 18 of the Good Manufacturing Practice for Cosmetics, the production enterprises shall retain samples at their residence or production address. The production enterprises here include the filer of independent production as well as the entrusted production enterprises.
For the cosmetic notification applicant of entrusted production, according to Article 56 of Good Manufacturing Practice for Cosmetics, "entrusted party shall retain samples at its residence, or main business address, or other business address where their residence or main business address are 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 place where the sample is retained is not the residence or main business address, the entrusted party shall report the address and other information of the sample location to the local drug regulatory department within 20 working days from the date of the first sample retention.
If the responsible person within the territory of China retains the sample, the selection of the sample location shall be carried out with reference to the above provisions. The selection of sample location shall meet the requirements of laws and regulations and the product storage requirements indicated on the label.
7. How to manage the retained samples?
The cosmetics notification applicant and the entrusted production enterprise should establish relevant systems, effectively store the sample products, and keep the sample records in accordance with the relevant laws and regulations and the requirements of labeling. Cosmetic notification applicants and entrusted production enterprises that are only engaged in semi-finished products should also retain samples according to regulations. The retention period of samples shall not be less than 6 months after the expiration of the product service life. If it is found that the retained samples have deteriorated within the service life, the enterprise shall timely analyze the reasons, and recall the batch of cosmetics that have been put on the market according to law, and actively eliminate the safety risks.
OUR SERVICE
Comments