China NMPA Lifts the Burden on the Cosmetics Industry in 2023 with a Lenient Policy on Ingredient Safety Information

On 27 March 2023, China National Medical Products Administration (NMPA) released an announcement that lifted the burden on the cosmetics industry. 

I. Transition Period Extension for the Submission of Safety Information 

Considering the impact of the COVID-19 pandemic and other factors, some companies have faced difficulties in collecting and obtaining safety information on cosmetic formulas. To effectively help companies overcome difficulties and deepen the implementation of the "Streamlining Administration and Delegating Power", adjustments have been made to extend the transition period for the submission of safety information on cosmetic formulas. 

1. As of 1 January 2024, when applying for registration of special cosmetics or notification of general cosmetics, cosmetics registration/notification persons shall submit safety information of all ingredients used in product formulas under relevant regulations, technical specifications, and the requirements of this announcement. 

2. For cosmetics registered/notified between 1 May 2021 and 31 December 2023, registration/notification persons shall supplement, before 1 January 2024, quality specification documents or safety information if product formulas involve ingredients of preservative, sunscreen, colorant, hair dye, freckle-removing, and whitening. Safety information on other ingredients used in product formulas shall be archived for future inspection. 

3. For cosmetics registered/notified before 1 May 2021, registration/ notification persons shall supplement, before 1 January 2024, quality specification documents or safety information if product formulas involve ingredients listed on the Technical Specification for Cosmetics Safety. Safety information on other ingredients used in product formulas shall be archived for future inspection. 

 

II. Optimizing Safety Submission Procedure

As of the date of this announcement, cosmetics registration/notification persons can choose the following three methods to submit safety information concerning the ingredients used in the formulas. 

1. Fill in the submission code 

If raw material manufacturers have obtained the submission code for the ingredients, cosmetics registration/notification persons can directly fill in the submission code on the official website. Meanwhile, cosmetics registration/notification persons shall ask raw material manufacturers for safety information and archive it for future inspection. 

2. Fill in the safety information 

If the raw material manufacturers have not obtained the submission code for the ingredients, cosmetics registration/notification persons can fill in the safety information of ingredients on the official website and upload scanned paper documents with the seal of registration/notification persons. The relevant substantiation, such as quality specification, literature review, testing data, etc. shall be archived for future inspection.

3. Mixture of the above two methods 

If cosmetics registration and notification persons have submission codes for some of the ingredients, they can mix the above two methods, that is to say, fill in the submission code for ingredients with the submission code, and fill in safety information for ingredients without the submission code. 

III. In-depth Analysis of this New Announcement and the Regulatory Trend in China by ZMUni

The decision by the Chinese regulatory authorities to extend the transition period to 2024 for the submission of safety information has come as a great relief for the cosmetics industry players. 

According to the previous announcement released by NMPA in 2021, cosmetics registration and notification persons shall supplement the safety information of all ingredients in the product formulas before 1 May 2023. With such a tight deadline around the corner, there is mounting pressure on the cosmetic industry recently. This new announcement will allow companies more time to gather and submit data for their products, which will help them to comply with the stringent regulations set by the Chinese government. 

Additionally, instead of supplementing the safety information of all ingredients, this new announcement only requires applications to supplement the safety information of certain ingredients of the potential risk to consumer health. 

Furthermore, according to the previous announcement released by National Institutes for Food and Drug Control in September 2022, cosmetic registration/notification persons can only be entitled to submit safety information documents after obtaining authorization from raw material manufacturers when the ingredients are not linked to the submission code. However, after this new announcement, cosmetic registration/notification persons can submit safety information without authorization letters from raw materials manufacturers. Although this reduces the time to submit safety information, registration/notification persons are still held accountable for the authenticity and integrity of the safety information as well as the submission cold from raw material manufacturers. 

The Chinese government has taken into consideration the difficulties faced by cosmetic companies and has given a longer transition period for the submission of formula safety information along with optimizing the submission procedure. However, it is worth noting that China's regulation of the cosmetics industry will become increasingly strict and standardized. 

With regulations in place and enforced, cosmetics companies are driven to focus on producing high-quality products. On the one hand, consumers can have greater trust in the safety and quality of the cosmetics they use. On the other hand, it sets a higher standard for the industry as a whole. Overall, while the increasingly strict regulations may be seen as a burden for some companies, it ultimately creates a more trustworthy and healthy environment for the cosmetics industry.