A Compendium of China’s New Regulatory Requirements to be Effective and Transitional Policies to Expire in May 2022

On Jan. 1, 2021, China implemented the Cosmetic Supervision and Administration Regulation (CSAR). Afterwards, a series of subsidiary regulations were successively introduced, providing important guidelines for the industry. To help companies adapt to the new regulations, NMPA also issued various transitional policies. Among them, May 1, 2022 is an important node as it marks the end of some transitional periods, and the implementation of some new regulations. ChemLinked sorted out these regulations to help companies make preparations in advance.

1. Administrative Measures on Cosmetics Labeling

On Jun. 3, 2021, China National Medical Products Administration (NMPA) released the finalized Administrative Measures on Cosmetics Labeling (Measures) and will implement it on May 1, 2022. All cosmetics to be registered and notified shall comply with the Measures starting from the implementation date.

The Measures spells out the requirements for labeling and prohibited cosmetic claims under China's new regulations. Cosmetics that have been registered and notified before May 1, 2022 will be granted a transitional period. The registrants and notifiers shall update the labels that not complied with the Measures by May 1, 2023.

Compared with the previous labeling regulations, the Measures has stricter requirements in terms of labeling definition, consistency with registration and notification documents, Chinese labels, product naming, guiding words, etc. For example,

• The primary packaging of all cosmetics shall bear the product's Chinese name and durability. But for most imported cosmetics, samples, and gifts that have already been on the market, their primary packaging may still bear the original labels without Chinese name and durability;

• For ingredients with concentration less than 0.1% (w/w), their standard Chinese names shall be labeled separately under "other trace ingredients." This means that companies need to check or adjust the formula, and clarify which trace ingredients are by calculating their concentration, and then label them according to new requirements.

Labels of many registered and notified cosmetics need to be redesigned and updated. During the transitional period, companies are recommended to check and update product labels, also to consume the previous packaging materials inventory as soon as possible.

ChemLinked will hold a webinar on China's new labeling regulation on Apr. 26. Welcome to register here.

2. Children Cosmetics Labeling

NMPA requires that from May 1, 2022, children cosmetics applying for registration and notification shall be labeled according to Supervision and Administration Provisions on Children Cosmetics (Provisions) and Administrative Measures on Cosmetics Labeling. For those that have applied for registration and notification before May 1, 2022, the registrant and notifier shall update the label before May 1, 2023.

The Provisions stipulates that children cosmetics

• shall be labeled with the children cosmetics' logo, Little Golden Shield;

• shall be labeled with warning words such as “should be used under adult’s supervision”;

• shall not be labeled with words such as "food grade," "edible," or food-related patterns;

• the packaging shall be avoided confusion with other products such as food and medicine.

Children Cosmetics’ Logo: Little Golden Shield

Regarding the labeling of children cosmetics' logo, it should be labeled in proportion to the logo designated by NMPA on the upper left side of the easily-observed display panel of the sales package. Companies can fine-tune the color and font of the logo according to the actual packaging, but the logo must be clear, durable, and easy to identify.

3. Application for Formula Change of Cosmetics Containing Newly Prohibited Ingredients

On May 28, 2021, NMPA released and implemented the updated Inventory of Prohibited Ingredients for Cosmetics and Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics, adding 24 prohibited ingredients, including Cannabis Sativa Fruit, Cannabis Sativa Seed Oil, and Cannabis Sativa Leaf Extract. From May 28, 2021, cosmetic registrants and notifiers shall not produce or import cosmetics containing prohibited ingredients stipulated in the updated inventories.

For cosmetics registered and notified before May 28, 2021 and containing newly prohibited ingredients, the registrant and notifier can replace or remove the prohibited ingredient, then apply for formula change and submit safety-related documents such as testing reports, safety assessment report before May 1, 2022.

After completing the formula change application, the original registration and notification number can be retained. If the registrant and notifier fail to apply for formula change within the time limit, the relevant product shall not continue to be sold on the market.

4. Document Supplementation of Registered and Notified Cosmetics

The following products shall be supplemented with the corresponding documents before May 1, 2022. Cosmetics registrants, notifiers, and domestic responsible persons (RP) should check the products to ensure that the document supplementation and other relevant work are completed in time.

If the previously notified cosmetics are no longer produced or imported, the notifier or the RP should voluntarily apply for notification cancellation through the new notification platform. If the user account of the new platform has not been obtained, a written application shall be submitted to the municipal medical products administration department for notification cancellation.

5. Electronic Registration Certificate

Starting from Jan. 1, 2022, NMPA began to issue electronic registration certificates as a trial for special cosmetics and high-risk new cosmetic ingredients whose registration has been approved. From May 1, 2022, NMPA will begin to issue electronic registration certificates for special cosmetics whose certificate change or renewal has been approved. The electronic registration certificate has the same legal effect as the paper registration certificate.

6. Regulations Coming Into Effect in 2022

Further Reading

• Noteworthy Regulatory Matters and Key Time Points for Cosmetic Registration and Notification in China in 2022 and Beyond

• NMPA Further Interprets the Requirements for Submitting Annual Report and Supplementary Documents of Notified Cosmetics

• China Consults on Technical Guidelines for Children Cosmetics: Stricter Ingredient Use and Labeling Requirements

• China to Release the Safety and Technical Standard for Cosmetics 2022 (STSC 2022)

• 38 Must-Read FAQs on China’s Cosmetic Ingredient Submission Code: A Clear Application Guide