Updates on the chinese cosmetics guidelines
The year 2021 witnesses the great revolution of China’s cosmetic regulation system. The Cosmetic Supervision and Administration Regulation (CSAR 2021) replaces the old Cosmetics Hygiene Supervision Regulations (CHSR 1989). The core concept of the new CSAR is safety supervision of cosmetic raw materials and cosmetics, from registration to post-market entry. In addition, manufactures of existing cosmetic raw materials are subject to further new requirements. Below you find the key facts at a glance:
- Registration or notification of new cosmetic ingredients
- Registration or notification of cosmetic products
- Risk assessment for cosmetic ingredients and cosmetics
- Reporting of safety information for existing cosmetic ingredients
Registration or Notification of New Cosmetic Ingredients
The regulation outlines a clear and executable requirement for new cosmetic ingredients that ends the situation where raw materials have rarely been approved since 2014.
Under the new regulation, cosmetic ingredients are now classified as new and existing ones.
New cosmetic ingredients (NCI) are classified as high-risk NCI and low-risk NCI according to their functions:
- High-risk NCI are NCI with functions of preservatives, sunscreens, colorants, hair dyes and freckles fading and whitening. High-risk NCI are subject to registration, meaning that they require review and approval.
- Ingredients other than high-risk NCI are defined as low-risk NCI. Low-risk NCI are subject to notification. The notification process is completed immediately after submission.
Some toxicity tests could be waivered depending on their functions or use history. In addition, alternative methods to animal tests are conditionality accepted by the National Medical Products Administration (NMPA).
New requirements such as function claim, risk assessment and post-market supervision are outline under the new regulation.
Not sure how to deal with these changes? Want to find out which tests are exempted for your ingredients? Please contact our colleagues at knoell Shanghai. We can also assist you as a local agent.
Registration or Notification of Cosmetic Products
Cosmetic products are now officially classified as special functional or general cosmetics.
Special functional cosmetic products include hair dyes, perm products, skin whitening products, UV protection products, hair removal products.
The claimed function must be supported by sufficient scientific evidence including literature, research data or efficacy evaluation test reports. All the information will be made publicly available on the NMPA website. Quality control certificates on manufacture, like GMP, are required for imported cosmetics.
The good news is that toxicological tests are no longer required for the notification of imported general cosmetic products.
Registration or notification takes place through the new NMPA online platform. Please note that all submitted documents must be in Chinese language, and knoell Shanghai is ready to provide this translation service.
Risk assessment for cosmetic ingredients and cosmetics
Another newly introduced measure on safety control is risk assessments for cosmetic ingredients and cosmetic products. They form an important part of the submission dossiers for their registration or notification.
Toxicological profiles of new and existing ingredients are usually required from manufactures of cosmetic raw materials, while risk assessment reports are prepared for cosmetic products.
For high-risk NCI requirements of the conventional risk assessment, the Chinese risk assessment report, apply in addition. This means, safety evaluation conclusion on e.g. physical-chemical parameters, microorganisms, and packaging are required in addition to the toxicological profile.
Reporting of safety information for existing cosmetic ingredients
To strengthen the supervision of cosmetic raw materials, the manufacturers of existing cosmetic ingredients, no matter if located in China or not, must provide an “ingredient record number” to the downstream users (i.e. cosmetic product manufacturers) supporting the notification or registration of their respective cosmetics in China. The record number is obtained by submitting ingredient safety information via NMPA's online platform.
The safety information includes raw material confidential information such as the composition, production process, quality control requirements and its supporting methods, limits of risk substances.
In addition to safety assurance and data protection, reporting safety information can also create marketing opportunities, because ingredient names, record numbers and the corresponding names of ingredient manufacturers will be disseminated publicly. This means, any manufacturer of cosmetic products can use this information to select and buy these ingredients for their own products from the listed manufacturers.
Please note that this NMPA platform is not available yet. Therefore, no action is required just yet. We will inform you as soon as the platform has been launched. So watch this space!
With us as your reliable partner, you no longer need to worry about:
- Regulatory compliance analysis prior to entering the market;
- Analysis of available information and preparation for data gap analysis;
- Preparation of safety information;
- Study concept management and monitoring;
- Risk assessments;
- Dossier submission and post-submission support;
We are here to assist you in all these aspects, moving your business forward.
Please visit our cosmetics page to learn more or contact us directly via email to clarify your questions or discuss your concerns.