Submission of safety information for cosmetics raw materials will soon be standardized according to the Cosmetic Supervision and Administration Regulation (CSAR) and the Measures for the Administration of Cosmetics Registration and Filing in China. To this end, the China National Institutes for Food and Drug Control (NIFDC) has recently launched a public consultation on the draft guidelines for submitting cosmetics raw materials’ safety information, which will be open till May 20, 2023.
The current draft guidelines include 11 parts and outline vital points and technical principles for the submission of safety information for cosmetics raw materials. The document cover aspects such as basic information, brief description of ingredient production techniques, necessary quality control requirements, risk limits for substances, and more.
The guidelines are applicable to cosmetic registrants and filers for self-declaration and submission of the raw materials’ safety information, however, the guidelines are not applicable for raw material manufacturers for reporting the respective information through the raw materials platform.
The technical guidelines discuss the importance of safety and effectiveness in cosmetic products and emphasize the significance of raw materials in ensuring product quality. It references the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition) and the Data Management Provisions for Cosmetic Registration and Filing Materials to highlight the need for risk assessment and safety information documentation for raw materials used in cosmetics.
These guidelines provide detailed instructions on filling in the raw material safety information of cosmetic products. By addressing aspects such as the production process, quality control requirements, international assessment conclusions, and risk substances, with the aim of ensuring accurate and comprehensive documentation of cosmetics raw material safety information.
The scope of application of these guidelines is defined as the filing and submission of raw material safety information by cosmetics registrants and filers during the product filing or registration process. It does not apply to situations where raw material manufacturers submit safety information through the raw material platform.
The general principles outlined emphasize that the responsibility for the quality, safety, and efficacy claims of cosmetics lies with the cosmetics registrants and filers. They are required to enquire, verify, and manage information related to the quality and safety of raw materials throughout the supply chain. Research work should be conducted when necessary to ensure a comprehensive understanding of the raw materials’ quality and safety, which forms the basis for filling in the raw material safety information.
The safety information of cosmetic raw materials can be obtained from various sources, including:
- quality specification documents
- related materials
- data and information provided by raw material manufacturers
- self-quality control or experimental studies.
Raw material manufacturers are responsible for providing relevant information, and cosmetics registrants and filers should screen and evaluate the materials and information provided. They can also conduct their own research and supplement the safety information accordingly.
The guidelines provide recommendations on filling in the basic information about raw materials, including:
- the composition of raw materials
- component names
- component content
- restrictions on the use of raw materials
- raw material properties.
The composition should be detailed and truthful, and specific principles are suggested for splitting the composition in certain circumstances. Component names should be filled in accordance with the “Raw Material Catalog,” and component content should reflect the composition and quality control. The recommended amount of addition in cosmetics can be provided by raw material manufacturers or determined based on research. Restrictions on the use of raw materials should be filled in accordance with regulations and technical standards. The physical and chemical properties of raw materials should be accurately described based on scientific data and research.
The guidelines highlight the need to provide a brief description of the production process of raw materials. This description should focus on steps that may be related to raw material safety risks. It should include information on the type of production process used, such as:
- physical crushing
- solvent extraction
- chemical synthesis
- biological fermentation.
Additionally, the main production steps should be outlined, including:
Specific process parameters may not be necessary unless they are related to the control of risk substances.
For raw materials derived from animals, plants, algae, or macrofungi, the specific information about the species used and extraction sites should be provided. Similarly, for raw materials obtained through biotechnology processes, such as fermentation or cell/tissue culture, details regarding gene modification, vector construction, engineered bacteria, or cell/tissue sources should be included in the description of the production process.
The guidelines also emphasize the importance of quality control requirements for raw materials. This includes filling in information about raw material identification methods, control indicators, testing methods, and other key details relevant to the quality of raw materials. Raw material identification methods should be based on chemical reactions, instrumental analysis, or physical constants. Control indicators and testing methods should be set based on the attributes, sources, and processing of the raw materials. Purity requirements, quantitative requirements for index components, and specifications for nano-raw materials should also be addressed. The guidelines provide specific recommendations for oligopeptide raw materials and highlight the need to control microbial contamination for biotechnology-derived raw materials.
Safety assessment by other international organizations
Furthermore, the guidelines suggest referring to international authoritative bodies for safety assessment conclusions. Data or risk assessment information released by institutions such as the European Union Scientific Committee on Consumer Safety (SCCS), the US Committee for the Evaluation of Cosmetic Raw Materials (CIR), and others should be collected and utilized as technical references.
The guidelines also encourage providing a brief description of the requirements for using cosmetic ingredients in other industries. This helps in gaining a comprehensive understanding of the properties of raw materials. Additionally, the guidelines emphasize the importance of setting limit requirements for risk substances, such as heavy metals, pesticide residues, biological risks, and other common risk substances.
Finally, the guidelines allow for clarifications on other issues related to the quality and safety of raw materials and provide guidance on updating raw material safety information when necessary. Changes to the quality specification information of raw materials, composition changes in the formula, and substantial changes to raw materials are addressed, with instructions on how to handle each situation.
How to submit comments
Comments from the industry can be submitted using the feedback form to the following email addresses: email@example.com before 20 May 2023.
To access the full draft guidelines on the submission of safety information for cosmetics raw materials and the feedback form, visit the provided link.
Read our article on China’s cosmetic ingredient safety information requirements that have recently been updated by the National Medical Products Administration (NMPA) on March 27, 2023.
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