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China NMPA Provides Relief for Cosmetic Industry with Eased Ingredient Safety Information Submission Policies

For ingredients without an ingredient submission code, cosmetics registrants and notifiers are now allowed to fill in and submit the ingredient safety information documents by themselves. The transition period of the cosmetic ingredient safety information submission policies has been extended to January 1, 2024. For all cosmetics registered and notified before 2024, only registrants and notifiers of specific categories of ingredients are required to supplement the safety information.

On March 27, 2023, China’s National Medical Products Administration (NMPA) announced adjustments to its management policies on the submission of cosmetic ingredient safety information, relaxing some regulatory requirements. This move is in response to some enterprises experiencing difficulties in obtaining the necessary documents due to factors such as COVID-19 pandemic related restrictions. 1

It is worth noting that upon the issuance of this announcement, in case of any inconsistency between this announcement and relevant documents on this topic previously released by NMPA, this announcement shall prevail. The English translation of the announcement is available for free now and can be downloaded via the button at the end of this article.

The key highlights of the announcement are as follows:

1. Specifying the responsibilities of cosmetics registrants and notifiers.

When using the ingredients included in the Inventory of Existing Cosmetic Ingredients in China (the IECIC), cosmetic registrants and notifiers should collect detailed ingredient safety-related information by requesting it from the ingredient manufacturers, reviewing literature, conducting research and testing, etc., and compile the information documents. The cosmetic ingredient safety information mainly includes ingredient quality specifications, safety risk substance control, ingredient safety risk assessment conclusions and other information related to ingredient safety.

Additionally, cosmetic registrants and notifiers should review and evaluate the authenticity and completeness of the submission code and the corresponding ingredient safety information provided by ingredient manufacturers.

  • If there is any problem with the authenticity, the ingredient concerned should not be used;

  • If there are completeness issues, the registrants or notifiers can supplement corresponding ingredient safety information documents, then fill in and submit the documents by themselves. The problems in the ingredient submission code shall also be explained.

2. Clarifying two ways of submitting cosmetic ingredient safety information and simplifying some procedures.

  • For ingredients with submission code, cosmetic registrants or notifiers can fill in the submission code directly and request the corresponding ingredient safety information documents from the ingredient manufacturer for archiving for future reference;

  • For ingredients without the submission code, cosmetic registrants or notifiers can fill in the ingredient safety-related information of the ingredients through the Cosmetics Registration and Notification Information Service Platform, and upload a scanned copy of the paper documents stamped with the seal of the registrant or notifier. Relevant supporting materials of ingredient safety information documents, such as ingredient quality specification certification documents provided by ingredient manufacturers, literatures, relevant research and test data, etc., shall be archived for future reference;

  • If a product contains the above two types of ingredients, the enterprise should adopt both submission methods simultaneously.

3. Granting an additional one-year buffer period for the cosmetic ingredient safety information submission policies.

As early as March 5, 2021, NMPA introduced several transitional measures on ingredient safety information submission, stipulating that starting from January 1, 2023, the registrants and notifiers of the newly registered and notified cosmetics shall provide safety information on all ingredients used in their product formulas. Before May 1, 2023, the registrants and notifiers should complete the supplementation of safety information of all ingredients in the product formula for cosmetics previously registered or notified.

This announcement postpones the policy's commencement date for the registrants and notifiers to submit safety information of all ingredients in newly registered and notified cosmetics to January 1, 2024. For cosmetics registered or notified before then, the deadline for supplementing ingredient safety information has been extended from May 1, 2023 to December 31, 2023. Their submission requirements have also been relaxed from mandatory for all ingredients to only covering specific ingredients (such as those with quality specification requirements, preservatives, sunscreens, and other functional ingredients), for which both safety information documents and quality specification certification documents are acceptable. The safety information documents of other ingredients in the product formula shall be archived by the enterprise for future reference and do not need to be submitted.


ChemLinked Comments

Due to the tight deadline and heavy workload of supplementing ingredient safety information, enterprises are facing enormous pressure. NMPA's decision to relax the policies on cosmetic ingredient safety information submission aims to provide some respite to the industry. For example, the extension of the transitional period and the permission for cosmetics registrants and notifiers to fill in the ingredient safety information independently without obtaining authorization from ingredient manufacturers will effectively simplify the ingredient submission process and gives enterprises more time to prepare. The measures to alleviate the requirements for supplementing safety information for most ingredients and focus only on specific ingredients’ safety information will not only greatly save time of the companies concerned, but also resolve the problem of some ingredients not submitting codes.

However, it is important to note that the changes do not signal a loosening of policies but rather reflect the authorities' understanding of the difficulties of enterprises. As such, enterprises must still devote effort to completing the submission work before the final deadline.

* Chemlinked will hold a webinar on April 19, 2023 to interpret the latest regulations on the submission of ingredient safety information, which supports English and Japanese. Please stay tuned.


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