The Provisions for Management of Cosmetic Registration and Notification Dossiers, one of the significant subsidiary regulations of the Cosmetic Supervision and Administration Regulation (CSAR), puts forward relevant provisions on the submission of cosmetic ingredients safety information, which requires that:
On December 31, 2021, the Cosmetic Ingredients Safety Information Submission Platform (The Submission Platform) came into service. Cosmetic ingredient manufacturers or their authorized enterprises can log on to the platform to apply for ingredient submission codes. As of August 9, 2022, the Submission Platform has recorded 122,412 pieces of ingredient submission code information.
On July 28, 2022, the Department of Cosmetics Regulation of National Medical Products Administration (NMPA) convened provincial medical products administrations (MPAs), National Institutes for Food and Drug Control (NIFDC), NMPA Information Center, and China Association of Fragrance Flavour and Cosmetic Industries (CAFFCI), holding a video symposium with industry associations.
At the symposium, based on the industry opinions collected before, NMPA systematically analyzed the situation of ingredient safety information submission, and clarified some matters that the industry is concerned about, mainly in the following aspects:
1. The purpose of ingredient safety information submission is to trace and monitor problematic ingredients and products containing them
Ingredient safety is the foundation of product safety. The Submission Platform is for companies to submit ingredient safety information and NMPA to collect that information. Once a quality and safety incident occurs, NMPA can quickly trace and analyze ingredients used in the product, find the source of the incident, as well as track and monitor products using the same problematic ingredient through the Submission Platform, and eventually control the risk.
2. Strengthening the information security management of the Submission Platform
NMPA will strengthen the information security management on the Submission Platform to prevent the leakage of the information uploaded to the platform. Ingredient manufacturers should also enhance their internal control to guard against information leakage during the submission process.
3. Emphasis on the responsibilities of cosmetic registrants and notifiers
Both the ingredient manufacturers and the cosmetic registrants/notifiers can stamp and confirm the ingredient safety information documents submitted together with the registration and notification documents, to ensure the authenticity of the documents.
If the ingredient safety information documents are compiled based on the technical documents provided by the ingredient manufacturers, the registrants/notifiers should also keep the technical documents for future reference.
If the ingredient has quality specification requirements in Safety and Technical Standards for Cosmetics (STSC), the registrants/notifiers should also submit the ingredient quality specification certificate stamped by the ingredient manufacturers.
In addition, NMPA mentioned that it would further carry out special research on ingredient safety information submission, and require MPAs at all levels to actively listen to industry opinions. For common problems, industry associations and enterprises can first reach a consensus on solutions and report them to the MPAs.
After the symposium, when CAFFCI organized enterprises to review the content of the symposium, some enterprises reflected a problem. Due to the different understandings of ingredient separation principles, it may cause inconsistent "ingredient composition" information in the documents submitted by the ingredient manufacturers (when applying for ingredient submission code) and registrants/notifiers (when applying for product registration/notification).
CAFFCI replied that the above inconsistency is due to different understandings of different enterprises, which exist objectively and are difficult to unify. Cosmetics registrants/notifiers should fully perform their main responsibilities, and be responsible for the safety of ingredients used and the authenticity of the registration/notification documents. On the premise of full evaluation, the registrants/notifiers can submit the registration/notification documents scientifically and reasonably according to their own evaluation results.
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