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BackgroundUnder the existing Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers, new cosmetic ingredients (NCIs) are classified into six distinct situations based on their functions, traits, history of use or consumption in cosmetics at home and abroad, etc., each with different testing requirements.
However, due to the lack of specific rules, registrants and notifiers of NCIs are sometimes confused when submitting relevant dossiers. Issues such as unclear determination of ingredient attributes, insufficient submission of materials, the unqualified certification or publishing agencies of the source of the safe consumption /use history data, and uneven quality of safety assessments have been observed during the technical review process. |
NCI Determining Criteria
In response to this, the China National Institutes for Food and Drug Control (NIFDC) unveiled the Guidelines for Research and Determination of Safe Use History of New Cosmetic Ingredients (Trial) (Draft for Comments) (the Safe Use History Guidelines) and the Guidelines for Research and Determination of Safe Consumption History of New Cosmetic Ingredients (Trial) (Draft for Comments) (the Safe Consumption History Guidelines) for public consultation on May 31, 2024. The two technical documents further clarify and refine the documentation requirements for NCIs falling under Situations 3, 4, and 5, so as to ensure that NCI registrants and notifiers can provide sufficient information to support the claims of safe use and/or consumption history.
The public consultation period for the draft guidelines will run until June 18, 2024. Stakeholders are encouraged to provide feedback via email to [email protected].
Safe Use History Guidelines (Draft)
The Safe Use History Guidelines is appliable to the research and determination of the safe use history of NCIs in Situation 3 and Situation 4. It mainly outlines the overview, application scope, general principles, basic requirements for safe use history proof materials, proof material format requirements, and safety assessment requirements. Key points include:
Basic Proof Material Requirements: Materials should be able to fully describe the use situation of the NCIs to be registered or notified in the marketed cosmetics, as well as include the listing time, the amount of use, safety, and other related information. The information collection work can be carried out from the aspects of ingredient consistency, the type and time of the listing of the marketed cosmetics, the use amount of the marketed cosmetics, the adverse reaction monitoring, etc.
Ingredient Consistency: Emphasis is placed on verifying that ingredients used in the marketed cosmetics recorded in the proof materials match those of the NCIs to be registered or notified, ensuring all-aspect consistency in composition, quality, and production processes.
Product Type Requirements: Products not classified as cosmetics abroad yet aligning with China's definition (such as hair dye cosmetics managed as quasi-drugs in Japan) must be attached with the management attribution, regulatory documents, efficacy, mechanism of action, etc. of the relevant products abroad. However, if products containing NCIs fail to meet China's cosmetic definition, the safe use history of the NCIs will not be recognized.
Listing Time: Cosmetics containing corresponding NCIs should have been on the market for at least three years, and at least one product should have been sold continuously for three years or more.
Use Amount of the Marketed Cosmetics: The three-year cumulative sales volume/factory volume of relevant cosmetics shall not be less than 100,000 pieces, and shall not be less than 30,000 pieces per year. For NCIs with functions of preservation, sun protection, coloring, hair dyeing, freckle removal and whitening, anti-hair loss, anti-acne, anti-wrinkle (except physical anti-wrinkle), anti-dandruff, and deodorization, in addition to the amount requirements, it is also necessary to accurately grasp the situation of no less than 100 consumers using the same product for a long time (1 year or more) continuously.
Safe Consumption History Guidelines (Draft)
The draft of Safe Consumption History Guidelines applies to the research and determination of the safe consumption history for NCIs in Situation 5. Its main text consists of 6 parts, including the overview, application scope, general principles, basic requirements for safe consumption history proof materials, common certification sources and key points, as well as safety assessment requirements. Key highlights include:
Basic Proof Material Requirements: The ingredients listed in the safe consumption history proof materials in this guideline should be food raw materials that have obtained food safety certification or other corresponding qualifications from relevant supervision and management departments in China, or ingredients that are safe for eating published by relevant supervision and management departments and authoritative technical institutions at home and abroad, and have a certain corresponding relationship with the NCIs to be registered or notified. The information can be collected from the aspects of the sources of the consumption history proof materials, the consistency/relevance of the ingredients, the consumption conditions, and the restriction requirements.
Proof Material Sources: Materials should be derived from reputable sources such as the supervision and management departments in related fields such as food, agriculture, and health, or technical institutions with relevant functions or technical capabilities of food safety risk assessment. They shall be publicly released data and information with certain authority. If proof materials are from China's supervision and management departments, these departments should be at the provincial level or above. If from foreign supervision and management departments, they should be at least national level. If from technical institutions, they should be internationally recognized authoritative institutions or organizations.
Ingredient Consistency/Relevance: The NCIs to be registered or notified must align with the food raw materials listed in the safe consumption history proof materials, with evidence demonstrating consistency in source, composition, and usage specifications. Special attention is given to fermentation products' safety. The collected safe edible historical data of biological fermentation raw materials should focus on the safety of the fermentation products themselves.
ChemLinked Comments
Industry insiders note that currently, NCIs with safe use history exceeding three years and NCIs with safe consumption history account for the largest proportion of all notified NCIs. The introduction of these two guidelines provides a clearer direction for companies to apply for NCIs, allowing companies to more clearly and accurately identify the situations to which their NCIs apply, thereby avoiding detours and wasting application costs.
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