Cosmetics regulation in China - Part two

The Inspection Points and Evaluation Guidelines entered into force from 1st December 2022. It shows the control of quality management in China is getting stricter. An inspection on-site happens not only in China but also aboard. There were only few inspections aboard in the last three years because of pandemic. We estimate the inspection on-site out of China will be more frequent in the future.

In accordance with the CSAR and the “Measures for Supervision and Administration of Cosmetic’s Production and Operation”, NMPA has formulated the Inspection Points and Evaluation Guidelines for Cosmetics Production Quality Management Standards.

There are two types of inspections according to the type of production: 

1. The notifier or registrant is the manufacturer at the same time. The inspection points have 81 items totally, of which 29 are key items and 52 are general items.

2. The notifier or registrant has an entrusted manufacturer. A total of 24 items are inspected, including 9 key items and 15 general items.

We take several important inspection points from the production of entrusted manufacturer and have a look.

Article 55 of Cosmetic Production Quality Management Standards

The commissioning party (the notifier or registrant) shall establish and implement a product release management system, on the basis of the completion of the factory release of the entrusted production enterprise, to ensure that the product has passed the inspection, the relevant production and quality activity records have been audited and approved before releasing and placing on the market.

Checking Point 13

1. Whether the notifier or registrant has established and implemented a product release management system.

2. Before a product is released to the market, does the notifier or registrant ensure that the product is inspected and passed the inspection items, including at least the manufacturer inspection items; does the notifier or registrant ensure that the relevant production and quality activity records are reviewed and approved by the respective head of QS.

Article 56 of Cosmetic Production Quality Management Standards

The commissioning party should establish and implement a sample retention management system.

Checking Point 16

1. Whether the notifier or registrant has set up a special area for retention of samples; whether the storage conditions conform to the relevant regulations and the requirements stated on the labels.

2. Whether the notifier or registrant has retained samples of finished products which are placed on the market batch by batch in accordance with the regulations; whether the quantity of samples retained and the packaging conform to the regulations; whether the retention period is not less than 6 months after the expiry of the product use period.

3. Whether the notifier or registrant keeps records of the retained samples as required and whether the quality of the retained samples is recorded within the expiry date.

4. Whether the notifier or registrant regularly observes the retained samples in accordance with the sample retention management system; whether the notifier or registrant promptly analyses the causes when the retained products are found to have deteriorated within the expiry date and recalls the cosmetics with the same batch no. that have been put on sale, so as to eliminate safety risks on its own initiative.

Article 58 of Cosmetic Production Quality Management Standards

The notifier, registrant, and entrusted manufacturer of cosmetics shall establish and implement a product sales record system, and ensure that the sales records and shipping documents of the products sold are consistent with the actual goods.

The product sales record shall include at least the product name, number of special cosmetic registration certificate or general cosmetic notification, expiry date, net content, quantity, sales date, price, as well as the purchaser’s name, address, and contact information.

Checking Point 19

1. Whether the notifier or registrant has established and implemented a product sales record system

2. Whether the product sales records include the product name, registration certificate number of special cosmetic or notification number of general cosmetic, expiry date, net content, quantity, date of sale, sales price, and the name, address and contact details of the purchaser

3. Whether the delivery documents and sales records of the products sold are consistent with the actual produc

National Cosmetic Adverse Reaction Monitoring platform

National cosmetic adverse reaction monitoring platform is online from 1st October 2022. The official website is  https://caers.adrs.org.cn/adrcos/.

Cosmetics notifier or registrant, entrusted manufacturer, cosmetics operator, medical institution in the discovery or knowledge of adverse reactions of cosmetics, should report the reverse reaction through the national cosmetic adverse reaction monitoring system. Cosmetic operators and medical institutions who are not available to report online should report to the local competent authority via paper statements, which will submit the reports online on their behalf. 

Other companies and individuals can report cosmetic adverse reactions to the cosmetic notifier or registrant, the responsible person, or to the local competent authorities as well.

The Electronic Registration Certificate for Cosmetics

From 1st October 2022, electronic registration certificate was issued in accordance with the “Administrative Measures for Registration and Notification of Cosmetics” for special cosmetics, new cosmetic ingredients and special cosmetics that have been approved for change or renewal of registration certificates. Previously issued paper registration certificate will continue to be valid until expiry date.

Notification number has also replaced paper certificate for notification of general cosmetics. 

The optimisation of testing management for general cosmetics notification

Cosmetics applying for notification or registration in China should be tested for chemistry, physics and microbiology in designated labs. 

China NMPA issued a notice, further optimising the management measures for the notification testing of general cosmetics in January 2023. 

If the cosmetics are low risk general cosmetics, the Chinese notifiers or entrusted manufacturers have production license for cosmetics and qualified personnel as well, own the related and appropriate equipment and devices for testing, then they are allowed to conduct the above-mentioned tests in accordance with the “Code of Practice for Registration and Notification Inspection of Cosmetics” and submit the test reports as part of notification dossiers. However, this notice applies to Chinese notifiers or entrusted manufacturers only.

China’s First Clean Beauty Standard Released

In July of 2022, the Guangdong Cosmetic Association released the first clean beauty standard – “Clean Beauty Code”. It defines 6 criteria of clean beauty including raw material, formulation, production, packaging and recycle.

“Technical definition and calculation guide for natural ingredients in cosmetic products” was published by Shanghai Household Chemicals Association in May 2022.

From 2021 the most popular cross-border e-commerce platform Tmall has set up a special section for clean beauty cosmetics. At the beginning, among over 70 brands, all were from abroad. However, more Chinese brands have now claimed their cosmetics as clean beauty. For the Chinese consumers, few of them know the difference between certified natural cosmetics, natural inspired cosmetics, vegan cosmetics and clean beauty cosmetics, etc. It might be a big chance for natural cosmetic brands in Europe which want to enter the Chinese cosmetic market.