directory 

1. General  1

1.1 Basic Properties.  1

1.2 Physiological characteristics and special requirements of children.  2

2. Technical requirements for information.  3

2.1 Basic information and related materials.  3

2.2 Product name information.  4

2.2.1 Trademark names.  4

2.2.2 Common names.  5

2.2.3 Attribute names.  5

2.2.4 Other.  5

2.3 Product Formulation.  5

2.3.1 Formulation sheet filling.  5

2.3.2 Feedstock safety information.  6

2.3.3 Requirements for the use of raw materials.  7

2.4 Standards for product implementation.  8

2.4.1 Brief description of the production process.  8

2.4.2 Sensory indicators.  8

2.4.3 Microbiological and physico-chemical indicators and quality control measures.  8

2.4.3.1 Microbiological and physico-chemical indicators.  9

2.4.3.2 Quality control measures.  10

2.4.4 Methods of use.  10

2.4.5 Safety warning phrases.  11

2.4.6 Storage conditions.  12

2.4.7 Duration of use.  12

2.5 Product labelling.  12

2.5.1 General requirements.  12

2.5.2 Content to be labelled.  13

2.5.3 Other claims.  14

2.6 Product inspection report.  15

2.6.1 Microbiological and Physicochemical Inspection Reports.  16

2.6.2 Toxicological test reports.  16

2.6.3 Human safety test reports.  17

2.6.4 Human Efficacy Test Reports.  17

2.7 Product safety assessment information.  18

2.7.1 General requirements.  18

2.7.2 Product safety assessment report (simplified).  18

2.7.2.1 Evidence that can be used in a feedstock security assessment.  18

2.7.2.2 Principles of formulation design for children's cosmetics.  20

2.7.2.3 Evaluation of the use of ingredients such as flavours and fragrances.  21

2.7.2.4 Assessment of risk substances.  22

2.7.2.5 Evaluation of Spray Products Containing Propellants.  22

2.7.2.6 Evaluation of products using stickers and films as carrier materials.  22

2.7.3 Cosmetic safety assessment report (full version).  22

2.7.3.1 Types of evidence available for feedstock security assessments.  23

2.7.3.2 Stability assessment.  23

2.7.3.3 Other assessment content requirements.  23

2.8 Imported children's cosmetics with product formulations designed for the Chinese market   24

Table: Composition of potentially allergenic fragrances released by domestic and overseas authorities at present   25

This guideline is intended for cosmetic registrants, filers for children's cosmetics registration, filing to provide technical guidance, while the technical review of cosmetic technical review department and filing management of children's cosmetics to carry out technical review or technical verification to provide technical reference.

This guideline is the general technical requirements for children's cosmetics. Cosmetics registrants and filers for the registration and filing of children's cosmetics should also be in accordance with the "Regulations for the Supervision and Administration of Cosmetics", "Measures for the Administration of Cosmetics Registration and Filing", "Supervision and Administration of Children's Cosmetics", "Provisions for the Administration of Cosmetics Registration and Filing Data" and other relevant regulations and technical standards, combined with the specific characteristics of the product and the actual situation, to enrich and refine the content.

This guideline is formulated under the current regulations, technical standards and the current level of scientific and technological knowledge, and the relevant contents may be adjusted in due course as the relevant laws and regulations, technical standards and science and technology continue to develop.

1. Overview

1.1 Basic Properties

Children's cosmetics referred to in this guideline refers to children under 12 years of age (including 12 years of age), with cleansing, moisturising, toning, sunscreen and other cosmetics, mainly based on the product label claims and the use of the population to determine. Product labels identify "for the entire population", "the whole family" and other words or the use of trademarks, patterns, harmonies, letters, hanyu pinyin, numbers, symbols, packaging and other implied product use of the population includes children's products, should follow the children's cosmetic products. Relevant regulations and technical standards.

According to the age of the population, children's cosmetics are divided into those for "infants and toddlers" (0 to 3 years old, including 3 years old) and those for "children" (3 to 12 years old, including 12 years old). The use of cosmetics for "infants and young children", the efficacy of claims are limited to cleaning, moisturising, hair care, sun protection, soothing, toning; the use of cosmetics for "children", the efficacy of claims are limited to cleansing, make-up removing, moisturising, cosmetic modification, aroma, hair care, Sunscreen, repair, soothing, toning; children's cosmetics do not meet the above claims of efficacy according to the new efficacy of cosmetics to apply for registration. The requirements for "infant" and "children" cosmetics are different in terms of the selection of raw materials for product formulations, labelling and marking, standards for product implementation, and safety assessment.

1.2 Physiological characteristics and special requirements of children

Children at different stages have different physiological characteristics. Compared with adults, 0 ~ 1 week old "infants" skin is thinner, fewer sebaceous glands, the development is still imperfect, the specific surface area is larger, the skin moisturising and buffering capacity is poor; 1 ~ 3 weeks old "infants" skin structure has tended to be complete, but the stratum corneum, 1 ~ 3 years old "infants" skin structure has tended to be complete, but the stratum corneum, the epidermis is still thin, the skin barrier function is not yet mature, the ability to resist microbial contamination and stimulation of foreign objects is also weaker, it is more likely to occur in contact with dermatitis and other adverse reactions, and need a longer time to recover. Therefore, the design of product formulations for children's cosmetics should be based on the premise of giving priority to safety and necessity of efficacy, using relatively simple product formulations, and reducing the use of raw materials that may contain allergenic components or strong irritants, such as flavourings and fragrances, colouring agents, preservatives, cationic surfactants, chemical sunscreens, and so on.

The tear glands of infants and young children are not fully developed, and they blink less frequently, so they cannot secrete enough tears to protect their eyes. Therefore, for "infant" cosmetics claiming to be tear-free, the requirements related to toxicological tests should be more stringent.

In addition, infants and young children have some special behavioural movements (e.g. sucking, scratching, etc.), and the risk of oral exposure should be taken into account when assessing the safety of cosmetics for "infants and young children", if necessary. Some "infant" cosmetics are also used in specific applications, such as in skin folds and specific areas such as the nappy area, which can lead to skin damage due to factors such as tightly closed clothing and nappies, uncontrolled urination and defecation, and so on. Therefore, changes in skin absorption rates due to special conditions should be taken into account in the safety assessment of such products.

For the above reasons, in addition to meeting the general technical requirements for cosmetics for the general population, the registrant and the filer of the children's cosmetics shall develop the children's cosmetics according to the physiological characteristics of children and possible application scenarios, and shall fully carry out the safety evaluation.

Cosmetic registrants and filers are responsible for the quality, safety and efficacy claims of children's cosmetics, and should submit registration and filing information in accordance with the "Regulations on the Administration of Cosmetic Registration and Filing Information", and in accordance with the following technical requirements.

2. Technical requirements for information

2.1 Basic Information and Related Materials

Children's cosmetics registrants, filers should be in accordance with the "Regulations for the Supervision and Administration of Cosmetics," "Cosmetics Classification Rules and Classification Catalogue" and other relevant regulations and technical standards, in the "Cosmetics Registration and Filing Information Sheet" in the classification of the code to choose the efficacy of claims, parts of the body, use of the population, the product dosage form and method of use. Children's cosmetics should include "infants and young children" or "children", belonging to the special cosmetics, the declared category should be consistent with the efficacy claims in the classification code.

In principle, the import of children's cosmetics should be in accordance with the cosmetic registrant, the filer's country (region) or country (region) of production sales package labels (including instructions) in the efficacy of the claim, the role of the part, the use of the population, the product formulations, methods of use, etc. to fill in the classification code and declaration of the category, and shall not be changed arbitrarily.

2.2 Product name information

Children's cosmetics Chinese name is generally composed of three parts: trade name, common name and attribute name. Naming basis for the trademark name, generic name, attribute name of the division should be scientific, accurate, standardised, the specific meaning of each part and the overall explanation of the Chinese name of the product should be reasonable.

Imported children's cosmetics should be submitted at the same time the foreign name and Chinese name of the product, and explain the corresponding relationship between the Chinese name and the foreign name (designed specifically for the Chinese market without the exception of the foreign name); if there is no clear correspondence, it should be a scientific and reasonable description.

Sunscreen children's cosmetics Chinese name contains sunscreen index (SPF value) or PA level and other content, should be in line with China's sunscreen cosmetics sunscreen effect labeling management as well as other relevant regulatory requirements, and with the "cosmetic registration filing application form" filled in the relevant content is consistent.

Children's cosmetics in the Chinese name of the trademark name, common name and attribute name should meet the following requirements.

2.2.1 Trademark names

The use of trade names in addition to compliance with national laws and regulations relating to trademarks, should also be consistent with national laws and regulations relating to the management of cosmetics. To the name of the raw material or to imply the inclusion of a certain raw material as a trademark, the product formula contains the raw material, should be visible on the sales package to explain the purpose of its use; product formulations do not contain the raw material, it should be visible in the sales package visible surface is clearly marked does not contain the raw material, raw material name is used only as a trade mark name. Chinese name of the product in the name of the trademark using letters, hanyu pinyin, numbers, symbols, etc., there should be a corresponding trademark registration certificate, and should be visible on the sales package to explain the meaning of its meaning.

2.2.2 Common names

Common name should be accurate, objective, can be an indication of the product raw materials or describing the use of the product, the use of parts and other words. The use of specific raw material names or raw materials to indicate the category of vocabulary, should be consistent with the composition of the product formula, and the efficacy of the raw materials in the product should be consistent with the efficacy of the product claims; the use of animal, plant or mineral names to describe the product's aroma, colour or shape of the formula can not contain such raw materials, naming the common name can be used in the name of the animal, plant or mineral names plus aroma, colour or shape form can also be indicated after the attribute name. The naming can be in the form of animal, plant or mineral name plus fragrance, colour or shape in the common name, or it can be indicated after the attribute name.

2.2.3 Attribute names

Attribute name should indicate the real physical properties of the product or form, and with the implementation of the product standards in the sensory indicators related to content.

2.2.4 Other

When the trade name, common name and attribute name of different products are the same, other contents that need to be marked should be indicated after the attribute name, including the SPF value, scent, suitable for hair, skin type or specific groups of people, colour or colour number.

Trademark name, generic name or attribute name when used alone to meet the above requirements, when used in combination may cause consumers to product efficacy of ambiguity, should be visible in the sales package to explain the face.

2.3 Product formulation

2.3.1 Formulation sheet completion

Children's cosmetic formulations should be in line with the "cosmetic registration filing information management requirements", the formula should be complete, fill in the form should meet the requirements, the name of the raw material should be in accordance with the "catalogue of cosmetic raw materials have been used" specification to fill in the raw material's Chinese name, the name of the International Cosmetic Ingredients (referred to as the name of the INCI) or the name of the English language, note information is complete; the choice of raw materials and the specific formulas The use of raw materials should be in line with the "Technical Code for Cosmetic Safety" and other relevant regulations and technical standards. Purpose of the use of raw materials should be specific, standardised, should be based on the actual role of raw materials in the product to fill out, and with the physical and chemical properties of raw materials, product properties, production processes, etc. in line.

Product formulations used from petroleum or coal tar hydrocarbons (except for a single component), colouring agents, colour precipitates, propellants in direct contact with the contents, denatured ethanol, categories of raw materials, directly from plants and other raw materials, should be in accordance with the "cosmetic registration filing information management regulations" required to mark the appropriate content.

Formulation of the use of flavours or specific fragrance ingredients, should be in accordance with the "cosmetic registration filing information management regulations" to fill out and submit information.

The use of stickers, film carrier materials, should be indicated in the remarks column of the main carrier material material composition, while providing its source, preparation process, quality control indicators and other information, and should be in line with the relevant laws and regulations, as well as the requirements of technical standards.

Product formulations using animal organs and tissues and blood products extracts as raw materials, should provide its source, composition and preparation process, and provide the raw material production country allows the use of relevant documents, shall not use raw materials have not been approved for use in the country (region) of such raw materials.

2.3.2 Feedstock safety information

Children's cosmetics registrant, filer or responsible person in the territory can fill in their own safety information on raw materials, you can also fill in the raw material reporting code from the cosmetic raw material safety information registration platform associated with raw material safety information. Raw material safety information should reflect the use of specific raw materials, basic information, risk material limit requirements, quality control requirements and other key information. In the "Technical Code for Cosmetic Safety" and other relevant regulations and technical standards, technical standards for raw materials or raw material safety information and other clear requirements, should meet the relevant requirements.

2.3.3 Requirements for the use of raw materials

Children's cosmetics should be selected with a history of safe use of cosmetic raw materials, shall not use new cosmetic raw materials still in the safety monitoring, shall not be used for children's safety is not clear raw materials; not allowed to use gene technology, nanotechnology and other new technologies such as raw materials, such as no alternative raw materials must be used, it should be used in the product safety assessment of the reasons for the information, at least including product formulations must be the use of the raw materials and other raw materials can not be replaced. Other raw materials can not replace the necessity of analysis, to provide the raw material only nanotechnology or gene technology to prepare the source of the description, and the use of children's safety is fully evaluated, if necessary, to provide the results of safety evaluation tests as evidence to support.

Raw materials used in children's cosmetics should comply with the relevant requirements of the "Technical Code for Cosmetic Safety", and shall not use the "Technical Code for Cosmetic Safety" and other technical specifications, mandatory national standards for children's cosmetics explicitly prohibited raw materials; do not recommend the use of raw materials with specific safety risks (such as formaldehyde emitters), as well as raw materials classified as prohibited substances by other countries or regions, such as the use of must be, it should be in the If it must be used, it should be explained in the product safety assessment information, and the safety of children to carry out a full evaluation; in addition, "baby" cosmetics shall not use iodopropynyl butylcarbamate (except for bath products and shampoos), salicylic acid and its salts (except for shampoos), and deposited on titanium dioxide and other raw materials such as silver chloride.

Children's cosmetics are not allowed to use the main purpose of spot whitening, acne, hair removal, deodorant, dandruff, anti-hair loss, hair colouring, perming, etc., such as other purposes of the use of raw materials that may have the above effects, should be the necessity of the use of the use of children's cosmetics should be evaluated for the use of the safety of the use of the necessity of the use of cosmetic products.

Declare the category as "sunscreen" children's cosmetics, in addition to meeting the above requirements, should also meet the requirements of sunscreen cosmetics, product formulations should be filled with a clear sunscreen.

Sunscreen children's cosmetics containing propellants in direct contact with the contents, should be marked in the formulations of the notes column propellant type, additive amount, etc.. Propellants should be in line with the relevant laws and regulations and technical standards for the management of cosmetic raw materials, and their specific use (such as impurities and quality control, etc.) should be in line with the relevant requirements of the "Technical Code for Cosmetic Safety". In accordance with the "Technical Code for Cosmetic Safety" and other relevant requirements for the raw materials used in the maximum permissible concentration requirements, should ensure that the raw material in addition to propellant in the formulation of the amount used in line with the limit requirements.

2.4 Standards for product implementation

2.4.1 Brief description of the production process

A brief description of the production process should be complete and reasonable, and the names of raw materials used or the serial numbers of raw materials used should be consistent with the product formulation; it should be consistent with the basic properties of raw materials and the dosage form of the product, etc.; it should provide the range of the main process parameters, such as temperature, etc., and the risk substances that may be generated during the production process should be adequately assessed in Part 2.7.2.4 of the product safety assessment report.

2.4.2 Sensory indicators

Sensory indicators should be consistent with the product formulation; formulations containing flavours, should be described as having a fragrance or a characteristic smell of raw materials.

2.4.3 Microbiological and physicochemical indicators and quality control measures

2.4.3.1 Microbiological and physico-chemical indicators

Children's cosmetics microbiological and physical and chemical indicators should be based on the "Technical Code for Cosmetic Safety", "Cosmetics Registration and Record Inspection Code of Practice" and mandatory national standards, and combined with the actual situation of product production and quality control settings. Microbiological indicators and physical and chemical indicators of harmful substances in the limit value must be in line with the "Technical Code for Cosmetic Safety" requirements; microbiological indicators in the total number of colonies ≤ 500CFU / mL (CFU / g); physical and chemical indicators of restricted ingredients (such as sunscreen agent, etc.) should be in line with the "Technical Code for Cosmetic Safety," "Cosmetics use of the maximum permissible concentration of "On the basis of formula filling and product quality control (such as test results, product stability in the shelf life, etc.) set in the formula filling within a reasonable range, such as more than a reasonable range, it should provide a sufficient basis to explain the stability of the product process and product quality controllability.

Microbiological and physical and chemical indicators should also take into account the physiological characteristics of children's skin of different age ranges and the way of use, to set a scientific and reasonable range of indicators, and to encourage the development of children's cosmetics for the implementation of standards that are stricter than the mandatory national standards and technical specifications for products. In principle, children's cosmetics should set the pH range (except for the dosage form that cannot determine the pH value), the pH range of resident cosmetics should be in the range of 4.5~7.5 (including 4.5 and 7.5); the pH range of shower cosmetics should be in the range of 4.5~8.5 (including 4.5 and 8.5); if you consider the physiological characteristics of specific parts of the use of the (such as baby nappy area), product attributes and the stability of raw materials. If, taking into account the physiological characteristics of specific use areas (such as the diaper area of infants and young children, product properties and stability of raw materials and other factors, the set pH range belongs to any of the following cases, a scientific and reasonable explanation should be provided, and a full safety assessment should be carried out: (1) set the lower limit of the pH range of ≥ 3.5 but < 4.5; (2) set the upper limit of the pH range of resident cosmetics > 7.5 but ≤ 10.5; (3) set the upper limit of the pH range of shower cosmetics > 8.5 but ≤ 10.5 8.5 but ≤10.5.

2.4.3.2 Quality control measures

Quality control measures should be based on the needs of the actual quality control of the product, each microbiological indicators and physical and chemical indicators to provide at least 1 quality control measures, and further elaborated in the brief description of the specific implementation programme to ensure that the final product in line with the "Technical Specification for the Safety of Cosmetics" as well as the implementation of the product standard requirements. The quality control measures and brief description of the same item should be scientific, reasonable, and should have a corresponding relationship.

Quality control measures can be used to test the way, can also be used in a non-test way, acceptable quality control measures include, but are not limited to: batch-by-batch inspection of products, full inspection, raw materials and related indicators of control, production process control. Adoption of test methods as quality control measures, should be correctly filled out the specific name of the test method, and indicate the reasonable frequency of testing; the use of "Cosmetic Safety Technical Specification" other than the test method, it should also be stated that the method of "Cosmetic Safety Technical Specification" contained in the specific test method to carry out the verification, verification of the results are in line with the requirements of a complete test method and method of validation information to be retained in the archives for further inspection. Raw materials to take the control of relevant indicators as quality control measures, the relevant content should be consistent with the raw material safety information of the raw material. Take the production process control as quality control measures, the relevant content should be scientific and reasonable.

Children's cosmetics should be produced in accordance with the requirements of the quality management standard for cosmetic production, children's skin care cosmetics production workshop environmental requirements should be in line with the relevant provisions.

2.4.4 Methods of use

Children's cosmetics should have a clear method of use, to ensure that consumers can be used correctly. The use of the population has special requirements, should be clear use of the age range, and with the product classification code in the use of the population; the use of special requirements of the site, should be clear product specific use of the site, and with the product classification code in the use of the site is consistent.

The use of sunscreen children's cosmetics should ensure that consumers are able to use them correctly to achieve the desired sunscreen effect, for example, by specifying the amount to be used, the amount of time that needs to be used in advance, reapplication, and other relevant recommendations in the methods of use, and the content should be scientific and reasonable.

2.4.5 Safety warning phrases

Children's cosmetics should be labelled with safety warnings in accordance with the "Measures for the Administration of Cosmetic Labelling", "Technical Code for Cosmetic Safety", "Supervision and Administration of Children's Cosmetics" and other relevant regulations, and should be labelled with "Attention" or "Warning" as a guide, and "Should be used under adult supervision", etc.. "Should be used under adult supervision" and so on.

The use of cosmetics containing "infants and young children" or "children" should be labelled in accordance with the requirements of the "Technical Code for Cosmetic Safety", and when children's products use restricted components, the corresponding conditions of use and precautions should be printed on the label, such as the use of Strontium chloride, should be marked with "children should not be commonly used"; "infants and young children" use powder cosmetics containing "talc: hydrated magnesium silicate", should be marked with "The powder should be kept away from children's nose and mouth" and other warning terms.

For pressure filling sol and other flammable products, should be in accordance with China's relevant regulations and technical standards require labelling attention to fire and explosion prevention and other content, or in the form of a graphic warning.

For children's cosmetics whose classified code efficacy is declared to be make-up removing and beauty modification, the use of the scene should be clearly defined and labelled with "Please wash in time", "If you feel unwell, please stop using immediately" and other similar warning terms.

It is not recommended that children use spray-type sunscreen cosmetics, and if they must use them, the risk of inhalation should be fully considered, and the instructions for use should be labelled with "Do not spray directly on the face", "Spray on the palm of the hand before applying to the face", "Avoid inhalation" and other similar warnings. Avoid inhalation" and other similar warnings.

2.4.6 Storage conditions

Children's cosmetics should set scientific and reasonable storage conditions.

2.4.7 Duration of use

Children's cosmetics should have a clear expiry date.

2.5 Product labelling

Children's cosmetic labels, including registered products to be listed on the sales package and the record of product sales packaging (including packaging containers, boxes, instructions, etc.) to identify the description of the product's basic information, attribute features and safety warnings, such as text, symbols, numbers, patterns and other content should be consistent with the "Cosmetics Supervision and Administration Regulations," "Cosmetic Labeling Regulations," and other relevant laws and regulations and technical standards, the label content Should be legal, true, complete, accurate, and consistent with the product registration or filing of the relevant content.

2.5.1 General requirements

Cosmetics registrant, the filer should be based on the submitted product label sample made of sales packaging labels. Product labels (including instructions) involving claims of efficacy, the role of parts, the use of people, product dosage forms, methods of use and other content, should be submitted with the product classification code, the declaration of the category in line with the content of the "Cosmetic Labelling Regulations" must be marked, shall not exceed the contents of the product label samples.

Children's cosmetics should avoid confusion with food, drugs and other products in terms of traits, odour and appearance to prevent children from accidentally eating or misusing them; they should not contain any prohibited contents, and should not be labelled with words such as "food-grade", "edible", etc., or food-related patterns. Food-grade", "edible" and other words or patterns related to food should not be labelled.

Children's cosmetics should be easily observed in the sales package display surface (hereinafter referred to as the main display layout) of the upper left in accordance with the relevant requirements of the State Drug Administration marked children's cosmetics logo.

Imported children's cosmetics can be used directly in Chinese labels, can also be made of Chinese labels affixed to the original product sales package, Chinese labels in the efficacy of the claim, the role of the part, the use of the crowd, the product dosage form, the use of the contents of the cosmetic registrant, the filing of the person's country (region) or the country (region) of the production of sales packages in the relevant contents of labels (including instructions) corresponds to the same, the safety warning terms (including) Caution) is not less than the original sales package label (including instructions) in the relevant content. Imported sunscreen class children's cosmetics sales packaging SPF value, PA level and other content, should be consistent with the Chinese name of the product or the Chinese label content, if not consistent, to provide sales packaging designed specifically for the Chinese market.

2.5.2 Content to be labelled

Children's cosmetic labels marked in the Chinese name of the product, corporate information, product implementation of the standard number, the full composition, net content, duration of use, methods of use, safety warning terms, innovative terms, etc., should be in line with the "Cosmetic Label Management Measures" and other relevant laws and regulations; methods of use, safety warning terms, the duration of use, etc., should be in line with the implementation of the product standards in the relevant content.

Label full ingredient labelling should be consistent with the product formulation. Production process to be used but in subsequent production steps to remove the water, volatile solvents and other additives, as well as in order to ensure the quality of cosmetic raw materials added to the raw material trace stabilizers, preservatives, antioxidants and other ingredients can not be labelled in the full composition.

Children's cosmetics used in the fragrance and aromatic plant oil raw materials containing domestic and foreign authorities may be allergenic fragrance components (see attached table), according to the requirements of Part 2.7.2.3 should be labelled in the product label, can be labelled in the label in the full composition of the name of the specific fragrance components, but also in the label of the other position at the label.

Sunscreen children's cosmetics should be marked sunscreen effect such as SPF value, PA level and other relevant content, the identification of the value should be consistent with the human efficacy of the test report of the determination of the results, and in line with China's sunscreen cosmetic sunscreen effect of labelling management, as well as other relevant regulatory requirements.

Claims of waterproof performance, should be consistent with the choice of waterproof performance measurement methods and results. In general, only "waterproof", "sweat" and other objective terms, can be regarded as claiming general waterproof performance; the use of "highly waterproof sweat" and other subjective terms, If subjective terms such as "highly waterproof and sweatproof", or specific usage scenarios such as "suitable for outdoor activities such as swimming", or other similar terms are used, they can be regarded as claiming strong water resistance.

(b) When there are several independently formulated products or components in the sales package of a product, and when each product or component may be used separately, the sun protection effect marking may be labelled uniformly if the same value can be selected; if the same value cannot be selected, it shall be labelled separately.

Other in accordance with the "Cosmetic Labelling Regulations" on the label content of special provisions, such as the need to explain the name of the product, to explain the innovative terminology to explain, etc., should be marked on the visible surface of the sales package.

2.5.3 Other claims

Children's cosmetic labels with claims of efficacy, characteristics of use and other content, there should be sufficient scientific evidence, of which the claim of efficacy refers to the "Rules and Classification Catalogue of Cosmetic Classification" Schedule 1 claims of efficacy in the classification catalogue of the "category of efficacy", or based on the classification catalogue of the "explanation and claim guidelines" can clearly determine the efficacy of the content of claims and claim guidelines" in the classification catalogue can clearly determine the efficacy category of the claim content.

Registrant, the filer should be in accordance with the "Cosmetics Efficacy Claims Evaluation Specification" and other relevant regulatory requirements, to carry out the evaluation of children's cosmetics efficacy claims, and uploaded in the State Drug Administration of the special website designated by the efficacy of the product claims based on the summary. Registrant, the filer of the efficacy claims submitted on the basis of the summary of the scientific nature, authenticity, reliability and traceability is responsible for.

Efficacy claims for repair, soothing and specific claims such as sensitive skin, tear-free formula, raw material efficacy, mild (non-irritating), quantitative indicators (efficacy claims to maintain time, efficacy claims related statistics, etc.) and other content, the label content should be consistent with the product efficacy claims based on the summary, shall not be marked false or misleading content.

Other related to product efficacy, safety claims, should be consistent with the corresponding supporting information.

Children's cosmetic labelling claims shall not have the "Regulations on the Supervision and Administration of Cosmetics", "Cosmetic Labelling Regulations" and other relevant laws and regulations prohibit the labelling or claiming content. Sunscreen children's cosmetics shall not encourage consumers to exposure to the sun or guarantee the effect of sunscreen absolute claims.

2.6 Product inspection report

Product inspection reports should be issued by the cosmetic registration and filing inspection agency, should be in line with the "Technical Code for Cosmetic Safety" "Cosmetics Registration and Filing Inspection Code of Practice" and other relevant laws and regulations and technical standards.

Product inspection reports contained in the product information should be "cosmetic registration record information sheet" to maintain consistency with the relevant information. Due to changes in product name and other reasons, resulting in the inspection report in the Chinese name of the product, the name of the company does not affect the test results of information and "cosmetic registration filing information form" is inconsistent, it should be explained, and submitted to change the inspection report application form and inspection and testing agencies issued by the supplemental inspection report or letter of correction.

Declare new efficacy of children's cosmetics, the first new efficacy should be confirmed, confirmed in accordance with the "cosmetic registration and filing test specification" "cosmetic efficacy claims evaluation specification" and other normative documents to carry out product testing and efficacy claims evaluation, the results should be in line with the relevant requirements.

2.6.1 Microbiological and physico-chemical test reports

Children's cosmetics microbiological and physical and chemical test items should be consistent with the "Technical Code for Cosmetic Safety" "Cosmetics Registration and Record Inspection Code of Practice" and other relevant regulations and technical standards, the test results should be consistent with the "Technical Code for Cosmetic Safety" as well as the implementation of the standard requirements of the product.

2.6.2 Toxicological test reports

Toxicological test test items should be consistent with the "cosmetic registration and record test specification" requirements. Toxicological test method should be "Cosmetic Safety Technical Specification" method. Toxicological test results should be determined in accordance with the "Cosmetic Safety Technical Specification" for the correct evaluation of the relevant content.

Acute eye irritation/corrosivity test results for children's cosmetics should be non-irritating or slightly irritating, and tear-free formulations can be claimed only when the test results are non-irritating; skin irritation/corrosivity test results should be non-irritating, skin allergy test conclusions should be non-sensitising, and skin phototoxicity test results should be non-photototoxic.

2.6.3 Human safety test reports

Sunscreen children's cosmetics should be carried out in accordance with the requirements of the "Technical Code for Cosmetic Safety" human skin closed patch test, 30 cases of subjects in the number of adverse skin reactions should be less than or equal to the number of cases of 1, and shall not appear 2 and more than 2 levels of adverse skin reactions.

2.6.4 Reports of human efficacy tests

Children's cosmetics claiming sun protection need to be tested for SPF value. Non-sunscreen cosmetics containing a sum of chemical sunscreens ≥ 0.5% (w/w) (except for lotions, perfumes, and nail polish) need to be tested for SPF.

Products labelled with long-wave UV protection index (PFA value) or PA+ ~ PA ++++ need to test the PFA value; products claiming UVA protection effect or claiming broad-spectrum sunscreen need to test the parameters of cosmetic anti-UVA ability - critical wavelength or PFA value.

Sunscreen children's cosmetics claiming "waterproof", "sweatproof" or "suitable for swimming and other outdoor activities" and other content, according to its claimed degree of resistance to water or time according to the prescribed method of testing waterproof. Performance. If the result of the measurement of the waterproof performance of the product shows that the SPF value decreases by more than 50% after bathing, the waterproof effect shall not be claimed.

Imported children's cosmetics sales package labels marked SPF value, PFA value, PA, UVA protection or claim that "waterproof" "sweat" "suitable for swimming and other outdoor activities" and other related content should provide SPF, UVA protection test report or test report of waterproof performance. And other related content, should provide SPF, UVA protection test report or waterproof performance test report, shall not modify the sales package label (including instructions) to reduce the label to test test items.

2.7 Product safety assessment information

2.7.1 General requirements

The safety assessment of children's cosmetics should be in line with the principles and requirements of the Technical Guidelines for the Safety Assessment of Cosmetics, and should be exposure-oriented, combining children's physiological characteristics as well as the product's method of use, site of action, amount of use, residue and other exposure levels. The product safety assessment report should be standardised and complete, and should be based on the assessment of all raw materials and risk substances, and obtain correct assessment conclusions.

Since the ratio of children's body surface area to body weight is usually greater than that of adults, the daily use of cosmetic products will result in higher systemic exposure for children than for adults, therefore, the actual safe use concentration of the same raw material in children's cosmetics is in principle lower than that in adult cosmetics. When assessing the exposure of cosmetics, priority is given to citing the exposure data of children's cosmetics in the assessment documents of domestic and foreign cosmetic research institutes or in the publicly published exposure research literature.

The safety assessment of cosmetic products for "infants and young children" should also take full account of the behavioural development of infants and young children, such as the possibility of higher exposures than those of adults due to certain mannerisms (e.g. sucking, scratching, etc.) and the differences in metabolism between infants and adults, and therefore use more rigorous assessment data, wherever possible, when necessary.

2.7.2 Product safety assessment report (simplified version)

2.7.2.1 Evidence available for feedstock security assessment

At least one piece of evidence should be selected in the following order for safety assessment to determine the safety of the ingredient.

2.7.2.1.1 Ingredients in the list of restricted components, permitted preservatives, permitted sunscreens and permitted colourants in the "Technical Code for Cosmetic Safety" shall comply with the requirements for their use.

2.7.2.1.2 Domestic and foreign authorities have established the relevant limit values or relevant assessment of raw materials, in line with the requirements of China's cosmetic-related regulations, can be used in their risk assessment of the conclusion of the assessment should be listed in the assessment of the name of the relevant organisations, assessment of the concentration of the assessment of the conclusion of the information; such as the limit values of the different authoritative bodies or the assessment results are inconsistent, should be based on the reliability of data and the relevance of the relevant conclusions. If the limit values or assessment results of different authorities are inconsistent, the relevant assessment conclusions should be adopted scientifically and reasonably based on the reliability and relevance of the data.

2.7.2.1.3 If the historical use concentration in the listed (at least 3 years) products of the cosmetic registrant or filer is adopted for assessment, the historical use concentration in the listed products shall be indicated, and (1) Domestic special cosmetic products and imported cosmetic products: registered or filed formulas (which must be consistent with the registered or filed submitted formulas); product registration certificates or filing vouchers; product listing supporting documents; (2) Domestic general cosmetics: production feeding records, process sheets and ingredient lists with raw material content or calculable raw material content; filing vouchers; product listing documents; (3) Adverse Reaction Monitoring Situation Statement and other supporting documents, and assess whether it is within the range of historical use concentration.

2.7.2.1.4 Correctly use the highest historical use level of ingredients in the Catalogue of Used Cosmetic Ingredients in relation to the type of product.

For raw materials that only have the highest historical usage information of the resident product, the drenched product can be used with reference to the information of the resident product. However, for raw materials with only the highest historical usage information for rinsed products, the information for rinsed products may not be used with reference to the information for rinsed products.

In the case of a specific ingredient within a category of ingredients, the highest historical use of the category of ingredients cannot be used, but the highest historical use of the specific ingredient should be used.

2.7.2.1.5 For feedstocks for which it is not possible to use any of the above types of evidence, a complete safety assessment should be carried out in accordance with the risk assessment procedure to ensure that the feedstock is safe for use.

2.7.2.2 Principles of formulation design for children's cosmetics

Children's cosmetic formulations should follow the principles of safety first, efficacy necessary, minimal formulation, should be combined with children's physiological characteristics, from the safety of raw materials, stability, function, compatibility and other aspects of the assessment of the scientific nature and necessity of raw materials used, in particular, flavours and fragrances, coloring agents, preservatives, and surfactants and other raw materials.

2.7.2.2.1 Flavours, fragrances and aromatic plant oils should be used in a rational manner with safety as a priority, and the scientific validity and necessity of the types and amounts of raw materials used should be explained and a safety assessment carried out in accordance with Part 2.7.2.3.

2.7.2.2.2 Colouring agents should be used reasonably under the premise of safety priority. When using more than 4 (including 4) colouring agents, should explain the types of raw materials used, the dosage of the scientific nature and necessity, to carry out relevant research to ensure that the product is safe to use, and, if necessary, to submit human safety test data as evidence to support.

2.7.2.2.3 Preservatives should be used reasonably under the premise of safety priority and efficacy necessity. When the amount of preservatives used in resident products is close to the limit of the "Technical Code for Cosmetic Safety" (more than 90%), or when more than five (including five) preservatives stipulated in the "Technical Code for Cosmetic Safety" are used, relevant scientific evidence should be provided to explain the scientific nature and necessity of the types of raw materials used, and the amount of raw materials used. If necessary, research data on formulation optimisation shall be provided as evidence support, and human safety test data of the final formulation may also be provided as evidence support.

2.7.2.2.4 Surfactants should be used reasonably on the premise that safety is given priority and efficacy is necessary, and the use of raw materials such as quaternary ammonium cationic surfactants is not recommended. If quaternary ammonium cationic surfactants are used, the science and necessity of their use should be analysed and, if necessary, human safety test data should be submitted as evidence support.

2.7.2.2.5 The formulation of sunscreen children's cosmetics should take into account the safety and sunscreen effect. In principle, the formula shall not contain more than 5 types of chemical sunscreen agents (including 5 types) and the amount used shall be lower than the limit of the "Technical Code for Cosmetic Safety"; when titanium dioxide and zinc oxide are used at the same time, the total amount used shall be ≤ 25%.

When one or more of the following circumstances are met, the scientific nature and necessity of the amount of raw materials used should be fully substantiated: (1) the use of more than six (including six) chemical sunscreen agents in the formula; (2) the use of individual chemical sunscreen agents close to the "Cosmetic Safety Technical Code" limit (more than 90%); (3) titanium dioxide, zinc oxide, the total amount of titanium dioxide and zinc oxide used in excess of the formula amount of 25%. If necessary, provide research data on formulation optimisation as evidence support.

When the SPF value of sunscreen children's cosmetics is high, the safety of use for children should also be fully evaluated. If necessary, submit human trial test safety evaluation data as evidence support.

2.7.2.3 Evaluation of the use of raw materials such as flavours and fragrances

Used Cosmetic Raw Materials Catalogue" included "flavour" refers to a class of raw materials, so can not use the "used cosmetic raw materials catalogue" in the "flavour" of the highest historical use as the basis for assessment, should provide products with flavours in line with the International Fragrance Association (IFRA) practice regulations or in line with China's relevant national standards. Daily Fragrance Association (IFRA) practice regulatory requirements or in line with China's relevant national standards to prove documents.

Product formulation formulas fill in the same time "flavour" and flavour in the specific spice components, should be submitted to the manufacturer of raw materials on the flavour of all the spices contained in the flavour component types and content of information, and the safety assessment of each spice component.

Children's cosmetics used in flavours and aromatic plant oils raw materials if they contain domestic and foreign authorities issued by the potentially allergenic fragrance components (see attached table), in principle, the product should be the potentially allergenic fragrance component content should be calculated, if it is > 0.001% in the resident products, in the shower products > 0.01%, it should be used to children's safety should be fully assessed If it is >0.01% in showering products, the safety for children should be fully evaluated and marked in the product label.

2.7.2.4 Assessment of risk substances

Based on the source of raw materials, physical and chemical properties, preparation process and the production process of the product to produce or bring in the analysis of risky substances, combined with the existing toxicological test data, clinical studies, population epidemiological surveys and other information, identify the risky substances that may be contained in the cosmetic products, based on the relevant provisions of the "Technical Code for Cosmetic Safety", the conclusions of the domestic and foreign authoritative institutions for risk assessment or in accordance with the procedures for risk assessment of the safety assessment of risky substances. The safety assessment of the substances is carried out.

2.7.2.5 Assessment of aerosol products containing propellants

For the actual use of propellant-containing aerosol products, the exposure of the formulation ingredients in the human body is the concentration of the ingredients after the propellant has been removed, and the propellant should be assessed separately from the other ingredients, which should be assessed as the concentration of the components of the formulation (in 100 per cent) after the propellant has been removed.

2.7.2.6 Evaluation of products using carrier materials such as stickers and films

The stability (degradation, generation of risk substances, migration of risk substances to the content, etc.) of the carrier materials such as stickers and films should be adequately assessed for safety.

2.7.3 Cosmetic safety assessment report (full version)

Cosmetics safety assessment report (full version) compared to the simplified version of the report, raw material safety assessment can be used in the type of evidence requirements are different, should also be added to the product stability assessment, other assessment content requirements are the same.

2.7.3.1 Types of evidence available for feedstock security assessments

At least one piece of evidence should be selected in the following order for safety assessment to determine the safety of the ingredient.

2.7.3.1.1 Raw materials in the list of restricted components, permitted preservatives, permitted sunscreens and permitted colourants in the "Technical Code for Cosmetic Safety" shall comply with the requirements for their use.

2.7.3.1.2 Domestic and foreign authorities have established the relevant limit values or relevant assessment of raw materials, in line with the requirements of China's cosmetic-related regulations, can be used in their risk assessment of the conclusions of the assessment should be listed in the assessment of the name of the relevant organisations, assessment of the concentration of the assessment of the conclusions, etc.; such as different authoritative bodies of the limit values or assessment results are inconsistent, according to the reliability and relevance of the data, the relevant conclusions of the risk assessment. The relevant assessment conclusions should be adopted in a scientific and reasonable manner.

2.7.3.1.3 For feedstocks for which it is not possible to use any of the above types of evidence, a complete safety assessment should be carried out in accordance with the risk assessment procedure to ensure that the feedstock is safe for use.

2.7.3.2 Stability assessment

Relevant physico-chemical indicators should be evaluated in the context of the product to determine the stability of the product. Confirmation of the presence of chemical and/or biological interactions between raw materials, which should be assessed if they pose a potential safety risk, as well as an assessment of the physico-chemical stability of containers or carriers in direct contact with the contents and their compatibility with the product should be carried out.

2.7.3.3 Other assessment content requirements

The technical requirements for the other assessment elements in the full version of the report are the same as in sections 2.7.2.2 to 2.7.2.6 of the simplified version of the report.

2.8 Imported children's cosmetics with product formulations designed for the Chinese market

For imported children's cosmetic products whose formulations are specially designed for the Chinese market (except for those whose production is entrusted by the domestic authorities to foreign countries), in addition to meeting the requirements of Part 2.1 to Part 2.7 above, they shall also submit a description of the formulation design for the skin type and consumer demand of Chinese children, which shall reflect the necessity of designing for the Chinese market as well as the relevant research and development work carried out. For example, sunscreen children's cosmetics can be from the perspective of reducing UV damage in Chinese children, analysis of Chinese children's Fitzpatrick skin typing, UV response characteristics and health risks, UV intensity and distribution characteristics, based on consumers' health needs and aesthetic needs of market research or demand analysis, etc., to explain the product development and formulation design ideas; product efficacy claims evaluation information Chinese adult consumers should be selected in China to carry out consumer testing research or human efficacy tests; product safety assessment information should be based on Chinese children's skin exposure data, give full consideration to the use of Chinese children's cosmetics characteristics, and encourage the citation of similar formulations in the international and domestic markets for many years listed in the safety evaluation data as evidence to support. In addition, when applying for renewal of the validity of the certificate of registration of special cosmetics, it should also submit the adverse reaction monitoring data of children's consumers in China, including at least the number of years on the market, the number of sales, and the summary of information on cases of adverse reactions, etc., and the content should be legal, true, accurate, complete and traceable.

Table: Composition of potentially allergenic fragrances released by domestic and overseas authorities at present