The Technical Guidelines for Filling in the Safety Information of Cosmetic Raw Materials (Draft for Comments) have detailed specifications for the brief introduction of production processes, quality control requirements, assessment conclusions of international authorities, requirements for the use of other industries, requirements for the limit of risk substances, and updates of raw material safety information that need to be filled.
1, Production process description
The production process should be by the actual production situation, Fill in the production process description of raw materials, focusing on the steps that may be related to the safety risks of raw materials.
In the brief description of the production process, it should be clear that the type of production process used, such as physical grinding, physical pressing, solvent extraction, chemical synthesis, biological fermentation, etc. A brief overview of the main production steps, such as stirring, heating, distillation, filtration, drying, packaging, etc., may be provided, where specific process parameters are not listed unless they relate to the control of risk substances.
In addition, the Guiding Principles (Draft for Comment) also put forward more detailed requirements for several typical production processes, as shown in the following table.
| Production technology | Demand |
| Solvent extraction | Describe the extraction solvent used and the extraction process, and indicate whether residual solvents are present |
| Raw materials derived directly from animals, plants, algae, or large fungi | Specify the species information used (including Latin names) and extract site information |
| Raw materials derived from fermentation or cell/tissue culture | Clarify the necessary information such as the gene donor organism, original gene information, gene modification information, carrier construction, engineered bacteria information, or cell/tissue origin |
| Other general fermentation or cell/tissue culture raw materials | At least provide information on the source of the engineered bacteria or cells/tissues |
| Hydrolysis process exists | Explain the specific hydrolysis method of raw materials and how to control the degree of hydrolysisWhere hydrolysis is carried out by an enzyme, the specific type of enzyme shall be specified |
2. Quality control requirements
Quality control content; In the process of raw material production, a series of indicators and methods should be set up to effectively control the quality of raw materials. Except for special instructions, cosmetic registrants and record-holders should generally fill in the relevant content of raw material quality control according to the relevant information provided by the raw material manufacturer. However, the “Guiding Principles (Draft for comments)” points out that under the premise of agreeing with raw material manufacturers and accepting raw materials to ensure that the relevant raw materials meet the set quality control standards, cosmetics registrants and record holders can also set control indicators or other requirements on their own.
Raw material identification method; The identification of cosmetic raw materials refers to judging the authenticity of raw materials, which can be identified through the structure and properties of raw materials, chemical reaction, instrumental analysis, or determination of physical constants. Cosmetics registrants and record holders may fill in the identification method of raw materials according to the information provided by raw material manufacturers or their research results.
Control index and detection method; The setting of raw material quality control indicators should be able to reflect the quality standards of raw materials, and the control indicators and testing methods filled in should be consistent with the actual production and quality control of raw materials.
The Guiding Principles (Draft for Comment) put forward detailed requirements for the following types of raw materials:
● A single raw material with a clear chemical structure: its purity requirements should be clear.
● Raw materials with unclear chemical structure (such as various animal and plant extracts): Quantitative requirements for indicative components should be provided, or quantitative requirements for total components, evaporation residue/solid content, drying weight loss/moisture, incandescence residue, typical physical and chemical indicators should be provided. If it is used for special effects such as freckle whitening and hair loss prevention, the specific efficacy ingredients and their control standards should generally be specified.
● Polymer raw materials: Generally, the degree of polymerization and the average molecular weight should be clearly defined.
● Oligopeptide raw materials: The amino acid sequence should be clear, and when filling in the sequence, the 20 natural amino acids should use the standard Chinese name, three-letter or single-letter abbreviation.
● Nano raw materials: should be combined with safety assessment data, at least list the key parameters affecting the safety assessment of raw materials conclusions.
3. Evaluation conclusions of international authoritative institutions
The Guidelines (Draft for Comment) list some common international authorities, such as the European Union Scientific Committee on Consumer Safety (SCCS), the United States Cosmetic Ingredients Evaluation Committee (CIR), the International Fragrance Association (IFRA), the World Health Organization (WHO), and the Food and Agriculture Organization of the United Nations (FAO).
4. Brief description of requirements for use in other industries
Cosmetics registrants and record-holders may fill in relevant information about the requirements for the use of raw materials in food, medicine, and other industries according to the information provided by raw material manufacturers or their research results.
5, risk material limit requirements
According to the nature of raw materials, sources, production and processing processes, and other relevant information, the possible risk substances in cosmetic raw materials are analyzed, and their limit requirements are clarified.
The Guiding Principles (Draft for Comment) lists common risk substance categories in the document and gives examples, as shown in the following table:
| Heavy metal risk | Lead, arsenic, mercury, cadmium, chromium, nickel, selenium, beryllium, antimony, strontium, zirconium, cobalt, etc |
| Pesticide residue risk | Raw materials derived directly from plants and not refined, such as olive oil obtained by direct pressing, need to consider the risk of agricultural residues |
| Biological risk | Total number of colonies, total number of molds and yeasts, thermostable coliform, Staphylococcus aureus, Pseudomonas aeruginosa, etc.The raw materials from biotechnology should also consider the pathogenicity of the host and the control of toxic ingredients |
| Other risk substances | Such as methanol, dioxane, diethylene glycol, asbestos, free formaldehyde, phenol, acrylamide, secondary chain alkylamines, nitrosamines,1, 3-butadiene, hydroquinone, benzene, and so on |
In the last part of the Guiding Principles (Draft for Comments), cosmetics registrants and record-holders shall, by the Provisions on the Management of Cosmetic Registration and Recordkeeping Data, update raw material safety information by the following three different situations.
Where there are changes in product safety assessment data, changes in product safety assessment data shall also be made.
● Raw material quality specification information changes, but does not lead to formula changes: the raw material safety information needs to be updated and maintained by itself
● Small changes in raw material components lead to changes in the formula: product changes
● Material changes: shall not continue to use, cosmetic registrant, recordholder should replace the raw material, and related information update maintenance or change.
Finally, the “Guiding Principles (Draft for comments)” further detailed the requirements for filling in raw material safety information, filling in the gaps that were missing in the guidance during the previous implementation process, and can better guide cosmetics enterprises to carry out relevant information collection and filling in the work. However, it should be pointed out in particular that because the raw material safety information filled in and submitted by themselves needs to be signed and responsible by the cosmetics registrant and the record holder, cosmetics companies must screen the authenticity and reliability of the relevant information and information, and keep the information on file for reference at any time.