FAQs Vol. 9 | China NIFDC Answers Questions about Cosmetic Documentation Requirements and New Cosmetic Ingredient Registration and Notification

After May 1, 2022, China’s cosmetics industry has officially entered the 2.0 era of scientific and stringent supervision. Due to the implementation of various new regulations, the documents to be submitted for cosmetic registration and notification become more complicated. If the details of relevant documents are not handled properly, or the correct procedures are not followed, the registration or notification application may fail.

In order to improve the pass rate of cosmetics registration and notification, China National Institutes for Food and Drug Control (NIFDC) opened a "FAQs" column under the "Cosmetics Review" section on its official website on April 19, 2022, to answer the issues uppermost for enterprises. So far, there are 24 questions and answers in total, which are divided into two categories: FAQs on cosmetic acceptance process and FAQs on technical review.

Category 1: Cosmetic Acceptance Process

Category 2: Cosmetic Technical Review

FAQs about cosmetic ingredients’ registration and notification (4)
FAQs about documents’ legality and validity (5)
FAQs about cosmetics registration certificate (1)

FAQs about product formula (5)
FAQs about cosmetic labels (5)
FAQs about information filling on the application system (4)

*See FAQs Vol. 11 for further details.

Table 1: Focus of NIFDC’s FAQs

The following are questions in Category 1 Cosmetic Acceptance Process:

FAQs about Cosmetic Ingredients’ Registration and Notification

1. What should be stated in the letter of authorization (LOA) for domestic responsible person (RP) when applying for the user account of a new cosmetic ingredient (NCI)?

According to Article 11 of the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers (the NCI Dossiers Provisions), the LOA for RP shall at least contain the following contents and information: the name of the NCI’s registrant, notifier and RP; the relationship between the authorizing party and the authorized party; the authorization scope; and the authorization period.

2. What should I do if the LOA for RP for NCI expires?

According to Article 11 of the NCI Dossiers Provisions, when the authorization period specified in the LOA for RP expires, the LOA with the extended authorization period shall be resubmitted within 30 days before the authorization period expires, or the RP shall be changed as required.

3. Can more than one RP be authorized for NCIs?

According to Article 11 of the NCI Dossiers Provisions, the same NCI shall not be authorized to multiple RPs.

4. How to log in to the cosmetic ingredient safety information submission platform (the submission platform)? Do I need to register an account?

Chinese domestic users do not need to register an account but can directly log in through the "Cosmetics Ingredient Safety Information Registration Platform" module on the National Medical Products Administration’s Registration and Notification Platform.

Overseas users need to register on the submission platform, upload the enterprise entity certification documents notarized by the Chinese notary public or certified by the Chinese embassy or consulate, and then log in after passing the review.

FAQs about Documents’ Legality and Validity

1. What are the requirements for the enterprise entity certification documents for overseas users to register an account on the submission platform?

The enterprise entity certification documents should be notarized by the Chinese notary public or certified by the Chinese embassy or consulate. If the text is in a foreign language, it shall be translated into Chinese in a complete and standardized manner, with the original text attached to the corresponding translation.

2. For special cosmetics whose registration is not approved, what are the requirements for the documents for reapplication? Can a copy be used?

According to Article 58 of the Provisions for Management of Cosmetic Registration and Notification Dossiers (the Cosmetic Dossiers Provisions), when re-applying for registration of special products that are not allowed to be registered due to non-safety reasons, copies of the original registration documents can be used. In addition, the applicant shall submit a statement to explain that the registration rejection does not involve safety, including the detailed reasons of the rejection.

3. Can the copy of the original notification documents be used when re-notifying the imported general cosmetics after cancellation?

According to Article 59 of the Cosmetic Dossiers Provisions, a description of the situation should be submitted when re-notifying general products after cancellation. In case of cancellation due to non-safety reasons, copies of the original notification documents can be used when re-applying for notification.

4. Can a copy of the toxicological test report be used for imported multi-color series general cosmetics sampled for toxicological tests per the Working Rules for Cosmetic Registration and Notification Testing (the Working Rules)?

Copies can be used. According to Article 33 of the Cosmetic Dossiers Provisions, multi-color series general cosmetics sampled for toxicological test according to the Working Rules can be notified as a group of products. Each product shall be attached with a list of the series products, a list of basic formulas and colorants, and a list of sampled products.

5. If multiple imported products are listed on the same Production and Sales Certification Documents, is each product's original sales certificate required? If a copy is submitted, does it need to be notarized?

According to Article 27 of the Cosmetic Dossiers Provisions, multiple products can be listed in the same sales certification documents, entrustment relationship documents, and certification documents belonging to the same group company, etc., of imported products. When applying for registration or handling notification of these products, one product can use the original, while others can use the copies. The product name, relevant acceptance number, registration certificate number, or notification number of the product with the original certificate shall be specified.

FAQs about Cosmetics Registration Certificate

1. If the registrant is merged or established as a subsidiary, can the registrant apply for changing the registrant?

According to article 49 of the Administrative Measures on Cosmetics Registration and Notification (the Measures), the cosmetics registration certificate shall not be transferred. Where the subject qualification of the original registrant is canceled due to legal cause such as enterprise merger or separation, and the registrant is changed to a newly established enterprise or other organization, an application for registration change shall be made per the provisions of the Measures.