Thursday, 29 December 2022 / Published in Cosmetics, News, NMPA Registration in China

China cosmetics filing FAQs – November and December 2022

China cosmetics filing FAQs is a publication first issued by the Beijing Municipal Medical Products Administration (MPA) in November 2021. It informs filers and users about the most common filing application issues for public reference periodically:

On November 22, 2022, the Beijing MPA published the 14th issue of the FAQ for General Cosmetics Filing.
On December 9, 2022, the Beijing MPA published the 15th issue of the FAQ for General Cosmetics Filing.

The frequent questions and Beijing MPA’s answers are set out below.

China cosmetics filing FAQs – 14th Issue

Q1: What is the main purpose of leaving samples?

A1: The purpose of product samples is to ensure product quality and safety can be traced, compacting the main responsibility for product quality and safety of cosmetics filers; at the same time in the sale of products with quality and safety problems and counterfeiting and other circumstances, to facilitate the verification of the legality and safety of each batch of products.

Q2: What are the general requirements for sample retention?

A2: After January 1, 2022, foreign cosmetics filers should be imported into China for each batch of products to leave a sample, in multiple imports of the same production batch of products, should be at least the first import sample.

Q3: Who is the subject of sample retention?

A3: The cosmetic filer.

Q4: How to determine the quantity of sample retention?

A4: According to ” Cosmetics production quality management standards,” the quantity of cosmetic samples should be at least two times the demand for factory inspection, and should meet the requirements of product quality inspection, while the enterprise should be combined with the actual quality management to determine the quantity of samples retention. Some categories of products can refer to the NMPA, “Cosmetics Supervision and Administration FAQ (III)” in the “cosmetics registrant/filer, the number of product samples for the reference table” implementation, the table does not list the type of product, cosmetics filers in accordance with regulatory requirements to determine the quantity of samples. Color cosmetics products with a net content of less than 1 gram, in the finished product samples, can be combined with its semi-finished products for product samples, the quantity of samples should be able to meet the needs of product quality inspection.

Below is the Reference Table for the quantity of product samples retained by cosmetics registrants/filers:

Order Number	Category of the Product	Reference Quantity of Reserved Sample
1	Hair dye products	≥3 packs and total amount ≥ 90g or mL
2	Freckle0reducing / whitening products	≥3 packs and total amount ≥ 50g or mL
3	Makeup products	≥3 packs and total amount ≥ 60g or mL
4	Skin care products	≥3 packs and total amount ≥ 80g or mL
5	Sunscreen products	≥3 packs and total amount ≥ 50g or mL
6	Acne removal products	≥3 packs, and a total amount≥ 200g or mL
7(1)	Mask products (face paste)	Single piece of independent packaging products: ≥7 paste and the total amount ≥140g or mL Box products: ≥3 boxes (7 paste) and a total amount ≥ 140g or mL
7(2)	Mask products (smear)	≥3 packs and total amount ≥ 80g or mL
8	Hair care and hair wash products	≥3 packs and total amount ≥ 50g or mL
9	Nail or toenail polish products	≥6 packs and total amount≥ 30g or mL
10	Toothpaste	≥3 packs and total amount ≥ 80g or mL

Q5: What are the packaging requirements for sample retention?

A5: According to “cosmetic production quality management standards” Article 18 “factory products for finished products, samples should be retention to maintain the original sales packaging.” Sales packaging in the form of sets, the sales package contains more than cosmetics and all the minimum sales units, if the minimum sales unit has been retention on the package, the sales package product samples cannot be left as a whole, but should be retained to meet the quality of traceability needs of the outer packaging. When the set contains multiple cosmetics and all the minimum sales units, the set can choose two ways to leave samples: a way to leave samples of the set as a whole; another way to leave samples of the sales package is to leave samples of the minimum sales packaging unit while retaining the set to meet the needs of quality traceability outside the box.

Q6: What are the requirements of the sample location?

A6: According to “Cosmetics Supervision and Administration Regulations (CSAR)” Article 29, ” cosmetic production quality management standards ” Article 18, the manufacturer should be in its residence or production address for sample retention, where the producer, including independent production of the filer, also includes entrusted production enterprises.

For the entrusted production of cosmetics for the record, according to “cosmetic production quality management standards,” Article 56 “entrusted party should be in its residence or the main place of business samples, but also in its residence or the main place of business in the location of other places to leave samples.” The “residence or main place of business” in the “location” of the understanding, usually identified as not beyond the same prefecture-level city or the same municipality directly under the Central Government within the administrative region. Product sample location is not the residence or the main business premises of the commissioner, the commissioner shall be retention in the sample location address and other information within 20 working days from the date of the first sample to the local department responsible for drug supervision and management report.

The responsible person in the territory to keep the sample, and the choice of the sample location should be implemented with reference to the above provisions. The choice of the sample location should be able to meet the provisions of laws and regulations and labeling requirements for product storage.

Q7: How to manage retention samples?

A7: The cosmetic filer, entrusted with the production of enterprises should be in accordance with the relevant laws and regulations and labeling requirements, the establishment of systems and effective storage of retained products, save the sample records. The retention period shall not be less than 6 months after the expiration of the product use period. Found that the retention of samples of products deteriorated within the use period, companies should promptly analyze the causes and recall the batch of cosmetics that have been listed for sale in accordance with the law, and take the initiative to eliminate safety risks.

China cosmetics filing FAQs – 15th Issue

Q1: How should the Chinese label of imported cosmetics standardize the content of efficacy claims?

A1: According to Article 6 of the Administrative Measures on Cosmetic Labeling, if a Chinese label is affixed, the content of the product safety and efficacy claim on the Chinese label shall correspond to the relevant content of the original label.

There are two situations in which the content related to the efficacy claim of the label of imported cosmetics Chinese labeled:

(1) Where the original label does not have the relevant content of the efficacy claim, the content related to the efficacy claim shall not be marked on the Chinese label affixed.

(2) Where the original label has content related to efficacy claims, the content related to the efficacy claim shall be marked on the Chinese label affixed.

Q2: For products with multiple sales packaging, can I provide a label image of only one of the sales packaging?

A2: According to Article 32 (4) of the Regulations on the Administration of Cosmetics Registration and Filing Documents, if there are multiple sales packaging, the label pictures of all sales packaging shall be submitted. If one or more of the following situations are met, submit the label image of one of the sales packaging, and the label image of the other sales packaging cannot be uploaded repeatedly:

(1) Only the net content specifications are different;

(2) Only attach information such as sales channels, promotions, holiday

special funds, gifts and other information on the uploaded sales packaging;

(3) Only the color of the sales packaging is different;

(4) Registered or filed products are sold in combination in the form of sets of boxes, gift boxes, etc., and the combination process does not touch the product content, except for the addition of the combined packaging product name, other marked content does not exceed the content of each product label;

(5) The text description can clearly reflect the difference with the uploaded sales packaging, and has been remarked and explained.

Q3: If the registered trademark in the product name uses letters, Hanyu Pinyin, numbers, symbols, etc., is it necessary to explain the specific meaning?

A3: According to Article 9 of the Administrative Measures on Cosmetic Labeling, the names of cosmetics Chinese shall not be named with letters, Chinese Pinyin, numbers, symbols, etc., except for registered trademarks, sunscreen index, color numbers, serial numbers, or other letters that must be used, Chinese Pinyin, numbers, symbols, etc. If the registered trademark in the product Chinese name uses letters, Chinese pinyin, numbers, symbols, etc., the meaning shall be explained in the visible face of the product sales packaging.

Q4: Is it possible to use words indicating raw materials in product names?

A4: According to Article 8 of the Administrative Measures on Cosmetic Labeling:

If a term implying a certain type of raw material is used as a trademark name, and the product formula contains such raw materials, the purpose of use shall be explained in the sales packaging visually; If the product formula does not contain such raw materials, it shall be clearly marked on the visible surface of the sales packaging that the product does not contain such raw materials, and the relevant terms shall only be used as trademark names.

The generic name should be accurate and objective, and may be text indicating the raw materials of the product or describing the purpose of the product, the part of use, etc. The use of specific raw material names or terms indicating the category of raw materials shall be consistent with the ingredients of the product formula, and the efficacy of the raw materials in the product shall be consistent with the product efficacy claims. If the name of animal, plant or mineral is used to describe the fragrance, color or shape of the product, the raw material may not be included in the formula, and the name of animal, plant or mineral may be used in the generic name in the form of fragrance, color or shape, or it may be indicated after the attribute name.

Q5: How is the transition period stipulated in the Administrative Measures on Cosmetic Labeling?

A5: From May 1, 2022, the product labels of cosmetics applying for registration or filing must comply with the provisions and requirements of the Administrative Measures on Cosmetic Labeling. If cosmetics that apply for registration or filing before May 1, 2022 fail to carry out label identification in accordance with the provisions of the Administrative Measures on Cosmetic Labeling, the cosmetics registrant and recorder must complete the update of the product label before May 1, 2023, so that it complies with the provisions and requirements of the Administrative Measures on Cosmetic Labeling.

Q6: How should the label content of products with small packaging be standardized?

A6: According to Article 17 of the Administrative Measures on Cosmetic Labeling, small-sized packaged products with a net content of not more than 15g or 15mL of cosmetics only need to indicate the name of the product Chinese, the number of the special cosmetics registration certificate, the name, net content, period of use and other information of the registrant or recordation person on the visible surface of the sales package, and other information that should be marked can be marked in the manual attached to the product. For small-sized packaged products with packaging boxes, the name of the product Chinese and the expiration date of the product shall also be marked on the packaging container in direct contact with the contents.