Lobby Letter to NMPA on Material Safety Information Submission, Efficacy Evaluation, Transition Period and Labelling

2021-12-17 | Beijing

Some core commands and questions are as follows: 

1. There are a large number of raw material suppliers, most of which are small and medium-sized raw material enterprises. Most member enterprises purchase global products. Many imported products involve small and medium-sized foreign suppliers with no molecular organization in China. Therefore, there are many difficulties in understanding and technical requirements of raw material safety information retention.

2. The span of reporting high-risk raw materials is large, especially for preservatives and pigments, which makes it difficult for raw material suppliers and cosmetics enterprises to execute.

3. The specific technical requirements for filling in the raw material information safety form need to be refined. Raw material suppliers and manufacturers do not have a clear and unified understanding of the definition of cosmetics raw material components, impurities and safety risk substances required by laws and regulations. If the submission is inconsistent, it is difficult to submit it in the original way for product registration and sample preparation, and the preparation period of imported products will be long.

4. Can the submission of product raw material safety information be postponed and related to product registration and filing? At the same time, it is not mandatory for enterprises to add other raw material specifications when registering and filing products, and it is necessary to issue the raw material safety information form guideline as soon as possible and organize relevant training.

5. It is hoped that enterprises will be given more flexibility in the implementation of efficacy evaluation data, such as expanding the scope of application and basic principles of equivalent evaluation, and allowing enterprises to upload and publish efficacy claims before their products are put on the market, rather than when they are registered for filing.

6. It is a new requirement for enterprises to retain samples of imported products. A one-year transition period for retained samples of imported products is expected.

7. Release the definition of the label as soon as possible.