The Technical General Principles for the Data of Registration and Filing of New Cosmetic Ingredients (hereinafter the “General Principles”), issued by the National Institutes for Food and Drug Control (NIFDC), clarify the technical requirements for the registration/filing data of new cosmetic ingredients.

It was formulated in accordance with the Cosmetics Supervision and Administration Regulation (CSAR), the Measures for the Administration of Cosmetic Registration and Filing, and the Provisions on the Administration of Registration, Filing and Data for New Cosmetic Ingredients.

This article summarizes the core points based on the original text of the General Principles for the reference of registrants, notifiers, and industry colleagues.

I. Scope and Basic Requirements

The General Principles apply to the data submitted by registrants and notifiers of new cosmetic ingredients when applying for registration or filing. Registrants and notifiers must be responsible for the compliance, authenticity, accuracy, completeness, and traceability of the submitted data. Before submission, they should conduct a comprehensive investigation of the new ingredient to be registered/filed, carry out necessary experimental research, and sufficiently study and confirm the ingredient's process, quality, functions, and safety.

II. Case Classification: Determine the "Identity" First, Then Prepare the Data

Based on characteristics such as the source/process and risk level of the new ingredient, the appropriate category is selected and corresponding research data provided.

(1) Classification by Source/Process

New ingredients are generally divided into four categories:

• Chemically synthesized new ingredients: mainly produced by chemical synthesis processes; their quality and safety are closely related to starting materials, synthesis process, reaction conditions, and separation/purification techniques;
• Naturally sourced new ingredients: raw materials are of natural origin (such as plants, animals, and minerals), and the production/processing process should not alter the chemical structure of the original components. Those derived from algae or macrofungi are subject to the same requirements;
• Biotechnology-derived new ingredients: obtained using biotechnologies such as genetic engineering, cell engineering, fermentation engineering, enzyme engineering, or protein engineering during production;
• Others: those not falling under the above categories are managed as "others".

*Note: Raw materials of plant, animal, or mineral origin that undergo further chemical or biotechnological treatment (e.g., chemical modification, microbial fermentation, plant tissue culture) are managed as “chemically synthesized new ingredients” or “biotechnology-derived new ingredients,” while also referencing the requirements for “naturally sourced new ingredients” in data submission.

Depending on the main components and their proportions, new ingredients are further divided into single compounds and mixtures (including “polymers”). A new ingredient registered/filed as a single compound should have a main component that is a single compound with a clearly defined structure, generally at a content of 90% or above (on a dry basis). Where 90% cannot be reached due to technically unavoidable reasons, necessary scientific justification and related research data should be provided, and the ingredient content and the proportion of other main components should be indicated in the "ingredient composition" information.

(2) Classification by Risk Level

Combining existing data such as ingredient characteristics, functions, history of use, and history of safe consumption, new ingredients are divided into the following six cases:

• Case 1: new ingredients with preservative, UV-filter (sunscreen), colorant, hair-dye, or skin-whitening functions;
• Case 2: new ingredients without preservative, UV-filter, colorant, hair-dye, or skin-whitening functions;
• Case 3: new ingredients with preservative, UV-filter, colorant, hair-dye, or skin-whitening functions, with sufficient evidence of three or more years of safe use in cosmetics;
• Case 4: new ingredients without such functions, with sufficient evidence of three or more years of safe use in cosmetics;
• Case 5: new ingredients with sufficient evidence of a history of safe consumption;
• Case 6: polymers composed of one or more structural units linked by covalent bonds, with a number-average molecular weight greater than 1000 Daltons, an oligomer content of less than 10% for components with molecular weight below 1000 Daltons, and stable structure and properties (excluding those with high biological activity).

Those meeting Cases 3–6 can select the corresponding case and have some experimental studies reduced/exempted.

III. Data-Item Requirements: Four Major Parts

Registration/filing data mainly comprises four parts:

• (1) the new-ingredient registration/filing information form and related materials;
• (2) the R&D report (R&D background, ingredient composition and structural identification, physicochemical properties, functional-basis data, etc.);
• (3) research data on the manufacturing process, stability, and quality-control standards; and
• (4) safety-assessment data (existing data, toxicology and human-safety test reports, safety-assessment report, etc.).

① New ingredients derived from algae or macrofungi are subject to these requirements;

② Naturally sourced new ingredients and new ingredients using microorganisms (fungi, bacteria) or plant/animal cells during production must submit this item;

③ Where the ingredient must exist in a multi-component form, this item must be submitted;

④ For new ingredients with a defined chemical or statistical structure (e.g., single compounds, polymers), this item must be submitted;

⑤ Functional-basis data for functions other than preservative, UV-filter, colorant, hair-dye, skin-whitening, and anti-hair-loss are retained on file for inspection;

⑥ For indicators closely related to ingredient quality/safety (content/purity, marker components, risk substances), where methods not specified in the Safety and Technical Standards for Cosmetics (STSC) or the Pharmacopoeia of the People's Republic of China (ChP) are used, the specific method text and data on method applicability and reliability shall be provided;

⑦ Where basic stability studies show good stability, or where relevant safety risks can be effectively controlled through specific storage conditions and precautions, accelerated and/or long-term stability tests may be retained on file for inspection.

IV. Key Points of the Basic Requirements for Each Data Item

(1) Basic Information

Includes the new-ingredient registration/filing information form and the ingredient naming basis. The Chinese name should be developed based on source, process, composition, and structure information, with a naming basis attached; the English name/INCI name and chemical name (for those with a defined chemical structure, key information such as substitution positions should be reflected) should also be properly provided.

(2) R&D Report

R&D background: summarize the project background, research status (literature, patents), application status (including use in cosmetics and other industries), regulatory status (including relevant laws/standards, new chemical substance registration, whether derived from protected animals/plants), the analysis justifying the ingredient as a new ingredient, and list the main references.

Ingredient source and safety-background data: Naturally sourced new ingredients must provide a species-identification report issued by a professional institution (for plants/animals, species information and Latin names shall be specified); for mineral-derived ingredients, an identification report from a qualified professional institution shall be provided. A literature review of the safety background of the plant, animal, or mineral raw materials used shall be conducted. New ingredients derived from algae or macrofungi are subject to the same requirements.

Use of microorganisms: Where microorganisms are used, the strain source and identification information must be provided; where the strain has been genetically modified, this must be specifically explained.

Basis for mandatory multi-component form: New ingredients should generally be of single origin and should not be compounded ingredients obtained by physical mixing. Where, for technically unavoidable reasons, the ingredient must exist in a multi-component form, necessary scientific justification and related research data shall be provided, as listed in the table below:

Chemical composition and structural identification: list the main chemical composition and the proportions of each part; for those with a defined structure, systematic characterization such as elemental analysis, mass spectrometry, infrared spectroscopy (IR), and nuclear magnetic resonance spectroscopy (NMR) shall be conducted, with specific interpretation of the spectra. Polymers shall also provide the test methods and results for the degree of polymerization, average molecular weight and its distribution; Case 6 ingredients shall also provide the test results for the content of oligomers below 1000 Daltons.

Physicochemical properties: accurately fill in the ingredient appearance and important physicochemical information (melting point, boiling point, solubility, pH, partition coefficient (LogPow), specific rotation, etc.); nano-ingredients shall undergo necessary physicochemical characterization based on their characteristics and safety-assessment needs.

Functional basis: clarify the intended use in cosmetics; for new ingredients with preservative, UV-filter, colorant, hair-dye, skin-whitening, anti-hair-loss, anti-wrinkle functions, and other functions exerting effects on the human body, the mechanism of action shall also be studied, and possible safety risks analyzed and assessed in light of the mechanism.

(3) Manufacturing Process and Quality-Control Standards

Process summary: generally includes at least the production materials, main steps (including pre-treatment, separation/purification, etc.) and process parameters closely related to quality/safety assessment; for ingredients obtained by chemical synthesis or enzymatic reactions, the reaction equations for each step shall be attached and the reaction principles explained in conjunction with the equations.

Impurities and risk substances: risks of concern include, but are not limited to, microorganisms, heavy metals and other harmful substances, and cosmetic-prohibited substances. Chemically synthesized: list and analyze specific starting materials, auxiliaries used, intermediates, and by-products, and analyze the residue of various impurities in the final product. Naturally sourced: in light of the source and safety background, focus on possible endogenous risk substances, and analyze possible exogenous risk substances in light of the actual production process. Biotechnology-derived: in addition to risk analysis based on source and production process, conduct targeted safety-risk analysis based on the biotechnology used. Risk substances shall be controlled by appropriate measures (e.g., setting corresponding indicators and test methods in the quality standard where necessary), and analyzed and assessed in the safety-assessment report.

Quality standards: establish quality standards (ingredient appearance, physicochemical indicators, qualitative identification methods, quantitative control indicators and test methods); test methods should in principle refer to the STSC or the ChP, and the applicability and reliability of other methods should be analyzed and, where necessary, validated.

Stability studies: including basic stability research, accelerated stability testing, and long-term stability testing. Basic research is generally conducted on at least 1 batch, and the conditions generally include at least high temperature (e.g., 60°C), high humidity (e.g., 90%RH ± 5%RH), and strong-light irradiation. Where stability is good or risks can be effectively controlled through specific storage conditions, accelerated and/or long-term tests may be retained on file for inspection.

V. Safety Assessment: Conducting Tests by Case

Safety assessment should, on the basis of fully utilizing existing data, conduct necessary toxicology and human-safety tests according to the case classification and actual safety risks. Existing safety-background information is used to assist in toxicity prediction, risk identification, and risk grading; unless otherwise specified, it is not a direct basis for exempting relevant toxicology studies.

In general, the toxicology and human-safety test items required for each case are as follows:

• Case 1: generally submit toxicology test data for items 1–9 of Table 2; those with skin-whitening function shall also submit item 11;
• Case 2: generally submit toxicology test data for items 1–7 of Table 2;
• Case 3: generally submit toxicology test data for items 1–7 of Table 2; for those with skin-whitening function, if information on safe use by no fewer than 100 consumers for long-term (1 year or more) continuous use of cosmetics containing the new ingredient cannot be provided, item 11 shall also be submitted;
• Case 4: generally submit toxicology test data for items 1–6 of Table 2;
• Case 5: generally submit toxicology test data for items 2–5 of Table 2; for those with skin-whitening function, if the above consumer-use information cannot be provided, item 11 shall also be submitted;
• Case 6: generally submit toxicology test data for items 2 and 4 of Table 2.

① New ingredients registered/filed under Cases 1 and 2, and those registered/filed under Case 6 where the molecular weight of the polymer's monomer unit is less than 1000 Daltons and the monomer unit has not previously been used as a cosmetic ingredient in China, shall submit this item; those intending to use existing safety-background information to exempt acute oral or dermal toxicity tests shall submit this item;

② Where existing safety-background information shows that the new ingredient is practically non-toxic by acute oral route or of micro-toxicity or below by acute dermal route, the relevant toxicology test may be exempted;

③ Where the new ingredient does not have UV-absorption characteristics, or based on its intended use and scope does not actually pose relevant safety risks, relevant test/analysis reports and/or explanatory materials may be provided to exempt the corresponding toxicology tests;

④ Generally, at least one gene-level test and one chromosome-level test shall be included;

⑤ Where the new ingredient is likely to be ingested orally when used in cosmetics, subchronic oral toxicity test data shall be provided;

⑥ With sufficient scientific justification, where relevant safety risks can be fully assessed through other data, relevant scientific justification and research data may be provided to exempt the corresponding toxicology tests;

⑦ Where inhalation exposure is possible, complete inhalation-toxicity test data shall be provided;

⑧ New ingredients registered under Case 1 with skin-whitening function shall submit this item; those registered under Cases 3 and 5 with skin-whitening function, if the above consumer-use information cannot be provided, shall supplement this item;

⑨ Where percutaneous-absorption test data are used in the safety assessment, this item shall be provided.

Test-method requirements: toxicology and human-safety tests for new ingredients should generally be conducted in accordance with the STSC; where not specified, national standards or internationally accepted methods apply. For animal-alternative methods, appropriate test methods should be selected in accordance with the principle of Integrated Approaches to Testing and Assessment (IATA), and the testing strategy explained. Animal-alternative methods not yet included in the STSC may use methods validated and included by internationally recognized alternative-method validation bodies, together with the methodological background and the basis for inclusion by the relevant bodies.

Test-institution requirements: institutions conducting toxicology and human-safety tests shall obtain CMA or CNAS accreditation, or meet GCP, GLP or similar accreditation/recognition requirements. Registrants and notifiers should generally conduct safety assessments in accordance with the principles and procedures of the Technical Guidelines for Cosmetic Safety Assessment, and clarify the use scope, safe usage level, and other information of the new ingredient.

VI. Comparison Table: Main Differences Between the Final Version and the Draft for Comments

About CIRS

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