China Cosmetic Ingredient Safety Information via Annex 14 Technical Guidelines have been issued by the National Institute for Drug and Food Control (NIFDC). The guidelines came into effect on September 4, 2023, and aim to standardize and guide the provision of cosmetic raw material safety information.
Cosmetic registrants and notifiers (filers) are strongly encouraged to use this guideline in compliance with relevant regulations and technical standards. It’s essential to recognize that these guidelines are based on current knowledge and provide scientific recommendations. As technology evolves and understanding deepens, these guidelines will be subject to revision and improvement.
Background
The safety and quality of cosmetic products are intricately tied to the raw materials used in their formulation. The Technical Guidelines for Cosmetic Safety Assessment (2021 Edition) emphasize the importance of conducting risk assessments for each raw material and/or risk substance in cosmetics during safety assessment. Additionally, the Data Management Provisions mandate the submission of raw material safety information documents for cosmetics registration and notification (filing) via Annex 14.
Scope of application
These guidelines pertain to the submission of raw material safety information for cosmetics registration and filing by registrants and notifiers (filers), including their domestic responsible persons. They do not apply to situations where raw material manufacturers directly submit such information through raw material platforms. When using these guidelines, compliance with other relevant regulations and technical standards is crucial, and reference to other applicable technical guidelines is recommended.
General principles
The quality and safety of cosmetics hinge on the quality and safety of their raw materials. Registrants and notifiers (filers) are responsible for ensuring the quality, safety, and efficacy claims of cosmetics. This responsibility includes screening, verifying, and managing information related to raw materials throughout the supply chain. Cosmetics registrants and notifiers (filers) must fill in raw material safety information based on thorough research and understanding of the raw materials used.
The safety information for cosmetic raw materials primarily comes from raw material manufacturers, literature, and self-quality control or experimental studies. It is imperative to evaluate and verify the provided information and supplement or improve it as needed. Cosmetic registrants and notifiers (filers) are responsible for the accuracy, completeness, and traceability of the information they submit.
Basic information about raw materials
- Composition of Raw Materials: Detailed and accurate composition information, including components intentionally added and those produced during the production process, should be provided. Residual reactants, by-products, impurities, and additives not present in significant quantities should be considered but may be excluded. In particular the guidelines state:
- Mixtures directly produced by chemical synthesis should be reported in accordance with the Catalogue of Raw Materials. If a mixture is explicitly listed in the catalogue, it can be reported as such, specifying the component range as indicated in relevant quality control indicators. If it’s not listed as a whole but each component is separately listed in the catalogue, each component should be reported separately.
- Signature or characteristic ingredients found in non-single ingredient raw materials like animal and plant extracts should be reported based on their actual presence in the raw material. Depending on the proportion of such ingredients in the final raw material, they can be listed as raw material components. Otherwise, they can be reflected in quality control indicators, with the raw material composition still noted as “XX extract” or “XX filtrate.”
- Plant extracts resulting from the mixing of various plants may have varying extraction rates. To accurately report the proportion of each plant extract, conversion based on the initial feed proportion of plant raw materials can be considered. Encouragement is given to study and report the actual proportion of each component, with research data submitted alongside raw material safety information.
- Raw materials subjected to special surface treatments like coatings or wrapping technology should include coating or carrier materials in the raw material components. The description of the production process should also cover these aspects to fully assess the safety of cosmetic raw materials.Top of Form
Bottom of form
- Component Names: The names of raw material components should adhere to standardized formats, including Chinese names and INCI/English names.
- Component Content: The percentage range of each component in raw materials should be specified.
- Recommended Amount of Addition in Cosmetics: Recommended usage levels provided by raw material manufacturers can be used as technical references but should not replace proper safety assessments.
- Restrictions on Use: Any restrictions on the use of raw materials should be considered based on regulations and technical standards, information from raw material manufacturers, and additional research.
- Raw Material Properties: Objective descriptions of raw material properties, such as color, odor, and physical state, should be provided.
- Description of Physical and Chemical Properties: Relevant physical and chemical properties affecting raw material safety should be described based on scientific research data.
Brief description of the production process
- A summary of the production process should focus on information related to safety risks, including:
- The type of production process used which can be clarified such as physical crushing, physical pressing, solvent extraction, chemical synthesis, biological fermentation, etc.
- A list of the main production steps such as stirring, heating, distillation, filtration, drying, packaging, etc., specific process parameters do not need to be listed, unless related to the control of risk substances.
- Further information is given in the guidelines regarding:
- extraction solvents
- raw materials directly derived from animals, plants, algae or macrofungi (i.e., cosmetic raw materials obtained directly from animals, plants, algae or macrofungi by direct use, physical crushing/pressing/separation, solvent extraction, etc.),
- biotechnology drived raw materials,
Quality control requirements
- Quality Control Content: Raw material quality control information should include identification methods, control indicators, and testing methods.
- Raw Material Identification Methods: Methods to authenticate raw materials should be based on chemical reactions, instrumental analysis, or physical constants.
- Control Indicators and Testing Methods: Quality control indicators should reflect the specific attributes of raw materials, and testing methods should be appropriate and accurate.
International authoritative body assessment conclusions
- Data and risk assessments from internationally recognized organizations such as SCCS, CIR, IFRA, WHO, FAO, etc., should be considered as important technical references in safety assessments.
Brief description of requirements for use in other industries
- Information regarding the use of cosmetic raw materials in other industries can provide additional insights and serve as technical references.
Limit requirements for hazardous substances
- Various risk substances, including heavy metals, pesticide residues, biological risks, and other hazardous substances, should be identified and evaluated based on the specific characteristics of raw materials.
Other Issues that need clarification
- Any additional information relevant to the quality and safety of raw materials should be provided, along with necessary explanations and attachments.
Updates on raw material safety information
- Updates to raw material safety information should be made when there are changes other than the properties of the raw material itself, ensuring compliance with regulations and standards. These updates depend on the nature of the changes and whether they affect the formulation or safety assessment of cosmetics.
Further information
Read the original article on technical guidelines for the filing of safety information for cosmetic ingredient.
Read the original information management requirements for cosmetics registration and filing – Annex 14 .
Discover our services for cosmetics and raw material manufacturers.