Catalogue

One  Introduction to regulatory background

Two  New requirements for user information

Three  New requirements for registration and filing materials

（1） Registration/Filing Application Form

（2） Naming basis of product name

（3） Product Formula

（4） Standards executed by products

（5） Product label

（6） Product inspection report

（7） Product safety assessment data

I、Introduction to regulatory background

In June 2020, the 《Regulations on the Supervision and Administration of Cosmetics》 was released, and the supervision of cosmetics entered a new era.

According to the new definition and classification of cosmetics, cosmetics are divided into special cosmetics and general cosmetics.

The state implements registration management for special cosmetics and record management for ordinary cosmetics.

The cosmetic registrants and registrants are responsible for the quality, safety and efficacy claims of cosmetics.

《Regulations on the Supervision and Administration of Cosmetics》

A 5-year transition period shall be set up for cosmetics registered for hair growth, hair removal, milk beauty, body-building and deodorization before the implementation of these Regulations. During the transition period, the production, import and sales of cosmetics may continue. After the transition period, the cosmetics shall not be produced, imported or sold.

Toothpaste shall be managed with reference to the provisions of these Regulations on ordinary cosmetics. After evaluating the efficacy of the toothpaste according to the national and industrial standards, the registrant can claim that the toothpaste has the effects of preventing caries, suppressing dental plaque, resisting dentine sensitivity, and reducing gum problems. The specific measures for the administration of toothpaste shall be formulated by the drug regulatory department under the State Council and submitted to the market regulatory department under the State Council for review and promulgation. (Not released yet)

These regulations are not applicable to toilet soap, but they are applicable to those that claim to have special cosmetic effects.

After the promulgation of the Cosmetics Supervision and Administration Regulations, the State Administration of Market Supervision and Administration and the State Drug Administration successively promulgated the following supporting regulations in 2021 to ensure the implementation of cosmetics registration and filing under the new regulations.

II、New requirements for user information

Article 18 of the Regulations on the Supervision and Administration of Cosmetics

Article 28 of the Administrative Measures for the Registration and Filing of Cosmetics

The cosmetic registration applicant and the filing person shall meet the following conditions:

（1） Is an enterprise or other organization established according to law;

（2） There is a quality management system suitable for the products applied for registration and filing;

（3） Have the ability to monitor and evaluate adverse reactions of cosmetics.

Where the registration applicant applies for the registration of special cosmetics for the first time or the filing person files ordinary cosmetics for the first time, he/she shall submit the evidentiary materials proving that he/she meets the requirements of the preceding paragraph.

《Provisions on the Administration of Cosmetics Registration and Filing Materials》

Chapter II Requirements for Data Related to User Information

Section I Data Items and Requirements

Article 10 When applying for the registration of special cosmetics or filing ordinary cosmetics for the first time, the domestic registration applicant, the filing person and the domestic responsible person shall submit the following user information related materials:

（1） Information form of the registrant's registrant and resume of the person in charge of quality and safety;

(The resume of the person in charge of quality and safety shall include the education background, work experience and other contents related to his/her requirements)

(Article 32 of 《the Regulations on the Supervision and Administration of Cosmetics》, the cosmetic registrant, the filing person, and the entrusted production enterprise shall set up a person in charge of quality and safety to undertake the corresponding responsibility of product quality and safety management and product release.)

Requirements for the position of the person in charge of quality and safety: The person in charge of quality and safety shall have professional knowledge and legal knowledge related to the quality and safety of cosmetics, such as cosmetics, chemistry, chemicals, biology, medicine, pharmacy, food, public health or law, be familiar with relevant laws, regulations, rules, mandatory national standards and technical specifications, and have more than 5 years of experience in cosmetics production or quality management.

（2） Overview of the registrant's quality management system;

The overview of the quality management system is a summary description of the quality management control capability and process of the registrant and the registrant. It should truthfully and objectively reflect the actual situation, including supplier selection, raw material acceptance, production and quality control, product sample retention and other management systems. The language should be concise and to the point, reflecting the key point setting of quality control and the requirements of daily implementation management.

If the registrant and the registrant have both self production and entrusted production, they shall submit the corresponding version of the quality management system overview.

（3） Overview of adverse reaction monitoring and evaluation system of registrant registrant;

The overview of adverse reaction monitoring and evaluation system is a summary of the adverse reaction monitoring and evaluation capabilities and processes of the registrant, the registrant and the domestic responsible person. It should reflect the actual situation objectively and truthfully. The language should be concise and to the point, reflecting the key points of adverse reaction monitoring, the setting of each link and the requirements of daily implementation management.

（4） Overseas registrants and registrants shall submit the information form of domestic responsible persons;

《Administrative Measures for Registration and Filing of Cosmetics》

Article 8 Where a registrant or a person for record keeping is abroad, an enterprise legal person within the territory of China shall be designated as the responsible person within the territory of China. Domestic responsible persons shall perform the following obligations:

（1） In the name of the registrant and the registrant, handle the registration and filing of cosmetics and new cosmetic ingredients;

（2） Assist the registrant and the registrant in monitoring the adverse reactions of cosmetics, and monitoring and reporting the safety of new cosmetic ingredients;

（3） Assist the registrant and registrant in recalling cosmetics and new cosmetic ingredients;

（4） According to the agreement with the registrant and the registrant, bear the corresponding quality and safety responsibility for the cosmetics and new cosmetic raw materials put on the domestic market;

（5） Cooperate with the supervision and inspection work of the drug regulatory department.

（5） The original of the power of attorney of the domestic responsible person and the original of the notarial certificate;

《Provisions on the Administration of Cosmetics Registration and Filing Materials》

Article 5 The registration and filing materials of cosmetics shall comply with the relevant provisions of the state on the use of seals, with complete signatures and seals, and have legal effect. If an overseas enterprise or other organization does not use the official seal, it shall be signed by the legal representative or the person in charge of the enterprise (other organization). In addition to the user information related materials, if the registration and filing materials of products require the signature of overseas cosmetic registrants and registrants, their legal representatives or responsible persons can authorize the registrants, registrants or the signatories of domestic responsible persons to sign. If the signature is authorized, the original of the power of attorney and the original of the notarial certificate shall be submitted. The power of attorney shall indicate the items and scope of the authorized signature.

（6） Where the registrant or the registrant has produced by himself or entrusted an overseas production enterprise to produce, he shall submit the information form of the production enterprise and the information of the person in charge of quality and safety, and fill in the existing production enterprise and its information at one time. If the production enterprise is overseas, it shall submit the original of overseas production specification certification materials.

(If the original certificate cannot be provided, the photocopy notarized by the Chinese notary office or confirmed by the Chinese embassy (consulate) shall be provided.)

Overseas production specification certificate

Overseas production enterprises shall submit qualification certificates, documents and other supporting materials proving that the production enterprises conform to the quality management system or production quality management specifications. The supporting materials shall be issued or recognized by the competent government departments of the country (region) where they are located, certification institutions or a third party with the certification qualification of the country (region) where they are located, indicating the name and actual production address of the production enterprises.

If there is a valid period for the overseas production quality management specifications, the certificates shall be updated in a timely manner, and the longest period shall not exceed 90 days after the expiration of the valid period; If there is no expiry date, the latest version shall be submitted every five years.

III、New requirements for registration and filing materials

（1） Registration/Filing Application Form

Classification code

The registrant and the registrant shall determine the product category and corresponding product classification code in accordance with the Regulations on the Supervision and Administration of Cosmetics and the classification rules and catalogues of cosmetics. If the efficacy claims of special cosmetics are involved, they shall be declared as special cosmetics.

《Regulations on the Supervision and Administration of Cosmetics》

Article 16 Cosmetics used for hair dyeing, perm, freckle removal and whitening, sun protection, hair loss prevention and cosmetics with new efficacy are special cosmetics. Cosmetics other than special cosmetics are ordinary cosmetics.

The pharmaceutical supervisory and administrative department under the State Council shall formulate and publish the classification rules and catalogues of cosmetics according to the efficacy claims, active parts, product dosage forms, users and other factors of cosmetics.

Article 3 of the Classification Rules and Catalogues of Cosmetics: The cosmetic registrants and registrants shall classify and code the cosmetics according to these Rules and Catalogues according to the efficacy claims, action sites, users, product dosage forms and use methods of the cosmetics.

Delegation document

For cosmetics produced by an overseas enterprise, the registrant, the registrant or the domestic responsible person shall submit the entrustment document. The entrustment document shall at least state the name of the product, the entrusting party, the name and production address of the entrusted production enterprise, the date on which the product is entrusted, and the signature and seal of the entrusted production enterprise legal person or the person authorized by the legal person. If the registrant, the filing person and the entrusted production enterprise belong to the same group company, they can submit the certification materials of the same group company and the product quality assurance documents issued by the enterprise group to confirm the entrustment relationship.

Free Sale Certificate

Imported products shall be provided with the certificate of marketing issued by the competent government department or industry association of the country (region) where the cosmetic registrant and the registrant are located or the country (region) where the cosmetics are produced, except for those products manufactured by overseas manufacturers entrusted by the domestic registrant and the registrant and the registrant and the registrant are specially designed for the Chinese market. The listed sales certificate shall at least specify the name of the registrant, the registrant or the manufacturer, the name of the product, the name of the institution issuing the document and the date of issuance of the document, and shall be signed and sealed by the institution for confirmation.

1. If the combined packaging product has both imported and domestic parts, only the marketing certification documents of the imported part shall be submitted.

2. If the sales package is specially designed for the Chinese market, it shall submit the documents proving that the product has been marketed in the country where the cosmetic registrant and the registrant are located or the country (region) where the product is produced, and submit the explanatory materials that the product formula and production process are consistent with the products in the country where the cosmetic registrant and the registrant are located or the country (region) where the product is produced.

The documents such as the certificates of the listed sales of the imported products, the documents of the entrustment relationship or the certificates belonging to one group company can list multiple products at the same time. When applying for registration or filing of these products, one of the products can use the original, and the other products can use the copies, and specify the product name where the original is located and the relevant acceptance number, registration certificate number or filing number and other information.

（2） Naming basis of product name

The basis for naming the product name shall specify the trademark name, common name and attribute name, and explain their specific meanings respectively.

For imported products, the foreign name and the Chinese name shall be explained respectively, and the corresponding relationship between the Chinese name and the foreign name shall be explained (except for those designed for the Chinese market without foreign name).

Documentary evidence is required for registered trademarks. Where the Chinese name of a product uses letters, Chinese pinyin, numbers, symbols, etc., a trademark registration certificate shall be provided.

（3） Product Formula

Requirements for formula table: the product formula table shall include the serial number, name, percentage content and purpose of use of raw materials.

Raw material name

The product formula shall provide the names of all raw materials, including the standard Chinese name, international cosmetic raw material name (INCI name for short) or English name. The name of the ingredients in the formula shall use the standard Chinese name, INCI name or English name specified in the list of used cosmetic ingredients;

If the formula contains new cosmetic raw materials that are still under safety monitoring, the name of the raw materials that have been registered or filed shall be used; If the name of INCI marked on the original package of the imported product is inconsistent with the name of the ingredient in the formula, it shall be explained.

If the color additive is used, the color additive index number (CI number for short) specified in the Technical Specifications for the Safety of Cosmetics shall be indicated in the name column of the raw materials of the product formula, except for those without CI number; If the color additive is lake, "(lake)" shall be marked after the color additive, and the type of lake used shall be stated in the formula remark column;

If nano materials are used, "(nanometer level)" shall be marked after the name of such components.

Percent content

The product formula shall provide the content of all raw materials, which shall be calculated by mass percentage, and all raw materials shall be arranged in descending order of content; For raw materials containing two or more ingredients (except for essence), the composition and corresponding content shall be listed.

Purpose

The main use purpose shall be marked according to the actual role of raw materials in the product; For products applying for spot removing and whitening, sun protection, hair dyeing, perm and hair loss prevention, the corresponding effective ingredients should be marked in the column of the use purpose of the formula. If the effective raw materials are not single ingredients, the specific effective ingredients should be specified in the column of the use purpose of the formula.

Remarks column

The following situations shall be explained in the remarks column:

Where denatured ethanol is used, the name and dosage of the denaturant shall be stated;

Where category raw materials are used, specific names of raw materials shall be stated;

If it is directly derived from plants, the specific use parts of the original plants shall be specified;

If hydrocarbons (except single component) from petroleum and coal tar are used, the chemical abstract index number (CAS number for short) of relevant raw materials shall be indicated in the remark column of the product formula table;

If there are propellants in direct contact with the contents of the product, the type and addition of propellants shall be indicated in the remark column of the formula.

Raw material information, raw material safety information

From May 1, 2021, when applying for registration or filing, the registrant filing person shall fill in the trade name and manufacturer information of the product formula raw materials,

From January 1, 2022, when applying for registration or filing, the registrant filing person shall provide the safety related information of the raw materials with anti-corrosion, sunscreen, coloring, hair dyeing, spot removal and whitening functions in accordance with the requirements of the Provisions.

From January 1, 2023, when applying for registration or filing, the registrant filing person shall provide safety related information of all raw materials in accordance with the requirements of the Provisions. For cosmetics that have been registered or filed before, the registrant and the registrant shall supplement the safety related information of all ingredients in the product formula before May 1, 2023.

New cosmetic raw materials

Where new cosmetic raw materials are used under safety monitoring, the registrant, the registrant or the domestic responsible person shall submit the registration application or handle the filing only after confirmation by the registrant and the registrant of new raw materials.

Carrier material

If adhesive or membrane carrier materials are used, the material composition of the main carrier materials shall be indicated in the remark column, and the source, preparation process, quality control indicators and other data shall be provided.

Essence filling method

The product formula essence can be filled in two ways, and the following data shall be submitted respectively:

1. If only "essence" raw materials are filled in the product formula table, there is no need to submit the type and content of specific flavor components in essence; If the product label identifies the specific flavor component in the essence, and if the original package label of the imported product identifies the specific flavor component, it shall be stated in the remarks column of the formula table.

2. If "essence" and the specific flavor components in essence are filled in the product formula table at the same time, the information on the types and contents of all flavor components contained in the essence issued by the essence raw material manufacturer shall be submitted.

Animal organs, tissues and blood products

If the extracts of animal organs and blood products are used as raw materials in the product formula, the source, composition and preparation process of the extracts shall be provided, and the relevant documents allowed by the country where the raw materials are produced shall be provided.

（4） Standards executed by products

The standards to be implemented for products include all ingredients, brief description of production process, sensory indicators, microbial and physical and chemical indicators and their quality control measures, methods of use, storage conditions, service life and other contents, which shall meet the requirements of relevant national laws and regulations, mandatory national standards and technical specifications.

Product name

Including Chinese name and foreign name of imported products.

Total components

Including the serial number, name and purpose of all raw materials used in the production of the product. All raw materials shall be arranged in descending order of content.

Process description

1. The main steps of the actual production process should be briefly described, including feeding, mixing, filling, etc. If two or more production steps of raw materials in the formula table, such as premixing and filling, are completed in cooperation with different production enterprises, they should be noted.

2. It shall reflect the range of main production process parameters, all raw materials shall be clearly listed in the production steps, and the name or serial number of raw materials used shall be consistent with those listed in the product formula; If the same raw material is used in different steps, it shall be distinguished; If water, volatile solvent and other additives need to be used in the production process but removed in the subsequent production steps, they should be noted.

Sensory index

1. Color refers to the objective color of product contents.

The same product has many distinguishable colors, which should be described one by one; If it is difficult to distinguish the color, it can describe the main color of the product when it is presented visually or used, and can also describe the color range.

2. Character refers to the form of product contents.

3. Odor refers to whether the content of the product has smell. (Fragrant, characteristic odor of raw materials, tasteless)

The sensory indicators of each part of the packaged product shall be stated separately.

For products using stickers and membrane carrier materials, the color and properties of stickers, membrane materials and immersion solution shall be described respectively.

Microbial, physical and chemical indicators and quality control measures

1. The microbial and physical and chemical indicators actually controlled by the product shall be submitted. The microbial and physical and chemical indicators shall meet the requirements of the Technical Specifications for Safety of Cosmetics and the Work Specifications for Registration and Filing Inspection of Cosmetics.

2. The corresponding quality control measures shall be submitted according to the microbial and physical and chemical indicators actually controlled by the product.

3. If the inspection method is used as a quality control measure, the inspection frequency shall be indicated, Name of the inspection method (If the method used is completely consistent with the method in the Technical Safety Standard for Cosmetics, the name of the method in the standard shall be filled in; if the method is inconsistent, the name of the verified method shall be filled in, indicating whether the method has been verified with the method in the Technical Safety Standard for Cosmetics, and the complete inspection method and method verification data shall be kept on file for future reference.)

4. If the non inspection method is used as the quality control measure, the specific implementation plan shall be clarified and the rationality of the quality control measure shall be explained to ensure that the product meets the requirements of the Technical Specifications for Safety of Cosmetics.

Usage method

The use methods of cosmetics shall be described, and if there are special requirements for the users and the use parts, they shall be explained; The safety warning words shall comply with the requirements of the cosmetic label management regulations, the Technical Specifications for Safety of Cosmetics and other relevant regulations.

Storage conditions

The product storage conditions shall be set according to the characteristics of product packaging and product stability.

Service life

The service life of the product shall be set according to the product packaging, product stability or relevant experimental results.

（5） Product label

《Regulations on the Supervision and Administration of Cosmetics》

Article 35 The minimum sales unit of cosmetics shall have labels. The label shall comply with relevant laws, administrative regulations and mandatory national standards, and the content shall be true, complete and accurate.

Imported cosmetics can either use Chinese labels directly or attach Chinese labels; If a Chinese label is added, the content of the Chinese label shall be consistent with that of the original label.

《Measures for the Administration of Cosmetic Labels》

Article 5 The minimum sales unit of cosmetics shall be labeled. The label shall meet the requirements of relevant laws, administrative regulations, departmental rules, mandatory national standards and technical specifications. The content of the label shall be legal, authentic, complete and accurate, and consistent with the relevant content of product registration or filing.

The cosmetic label shall be clear, durable, easy to identify and read, and shall not have the phenomenon of falling off of the printed words, insecure adhesion, etc.

《Regulations on the Supervision and Administration of Cosmetics》

Article 36 The following contents shall be indicated on the label of cosmetics:

（1） Product name, registration certificate number of special cosmetics;

（2） Name and address of the registrant, the registrant and the entrusted production enterprise;

（3） Cosmetic production license number;

（4） The number of the standard implemented by the product;

（5） All components;

（6） Net content;

（7） Term of use, method of use and necessary safety warnings;

（8） Other contents required to be indicated by laws, administrative regulations and mandatory national standards.

Article 7 of 《The Measures for the Administration of Cosmetic Labels》, the Chinese label of cosmetics shall at least include the following contents:

（1） Chinese name of the product, registration certificate number of special cosmetics;

（2） The name and address of the registrant and the registrant for record keeping. If the registrant or the registrant for record keeping is an overseas enterprise, the name and address of the domestic responsible person shall be indicated at the same time;

（3） The name and address of the manufacturer and the number of the production license of the manufacturer shall also be indicated for domestic cosmetics;

（4） The number of the standard implemented by the product;

（5） All components;

（6） Net content;

（7） Service life;

（8） Method of use;

（9） Necessary safety warning words;

（10） Other contents required to be indicated by laws, administrative regulations and mandatory national standards.

For products with packaging boxes, the Chinese name and service life of the product shall also be marked on the packaging containers that directly contact the contents.

Encouragement: Cosmetics registrants and registrants shall label and mark cosmetics in accordance with the Measures from the date of this announcement.

Implementation: From May 1, 2022, cosmetics applying for registration or filing must comply with the provisions and requirements of the Measures.

Transition period: For cosmetics that have previously applied for registration or filed, but have not been labeled in accordance with the provisions of the Measures, the cosmetic registrant and the filing person must complete the update of the product label before May 1, 2023, so that they meet the provisions and requirements of the Measures.

Product name in Chinese

The Chinese name of the product shall be marked at a prominent position on the visible side of the sales package, and at least one guiding phrase shall be used to lead to it.

Trade name

The use of trademark names shall comply with the provisions of national laws and regulations on trademarks, as well as the provisions of national laws and regulations on cosmetics management. It is not allowed to declare the medical effect or the effect that the product does not have in the form of commercial brand name. The use of a term that implies a certain type of raw materials as a trademark name. If the product formula contains such raw materials, the purpose of use shall be described visually in the sales package; If the product formula does not contain such raw materials, it shall be clearly marked on the visible side of the sales package that the product does not contain such raw materials, and the relevant terms are only used for trademark names.

Common Name

A common name shall be accurate and objective, and may be words indicating the raw materials of the product or describing the use and location of the product. Where specific names of raw materials or words indicating the categories of raw materials are used, they shall be consistent with the ingredients of the product formula, and the efficacy of the raw materials in the product shall be consistent with the efficacy claims of the product.

For example: trade name+nicotinamide whitening face cream, the formula should contain nicotinamide, and nicotinamide should have whitening effect. The product claims whitening effect.

If animal, plant or mineral names are used to describe the flavor type, color or shape of the product, the formula may not contain this raw material. When naming, animal, plant or mineral names can be used in the common name, and the flavor type, color or shape can also be indicated after the attribute name;

For example: trademark+isolation cream (menthol green), trademark+moisturizing body milk (rose fragrance)

The common name and attribute name shall indicate the real physical state or form of the product

When the trade names, common names and attribute names of different products are the same, other contents that need to be marked shall be indicated after the attribute names, including color or color number, sun protection index, smell, applicable hair, skin or specific people;

If the trademark name, common name or attribute list meets the above requirements of this article when used alone, and may cause consumers to have ambiguity about the efficacy of the product when used in combination, it shall be explained on the visible side of the sales package.

For example, ordinary cosmetics: "Xmei" is the trademark name, the general name is: essence of white orchid (including white orchid oil), and the attribute name is: liquid

Product name: X whitening orchid essence liquid

Since the combination word "whitening" appears in the product name, in order not to let consumers have ambiguity about the product efficacy, the product name should be explained visually on the sales package

Component

The label of cosmetics shall be marked with the standard Chinese names of all ingredients of cosmetics on the visible side of the sales package, which shall be introduced with "ingredients" as the guiding words, and listed in descending order according to the content of each ingredient in the product formula.

Other trace components (including 0.1%)

If there are ingredients in the cosmetic formula with the content of no more than 0.1% (w/w), all ingredients with the content of no more than 0.1% (w/w) shall be introduced with "other trace ingredients" as the guide words and otherwise marked, and may not be listed in descending order of the content of ingredients.

Composite or mixed raw materials

If the formula is filled in in the form of compound or mixed raw materials, the content of each component in the formula shall be used as the basis for ranking the component content and determining whether it is a trace component.

Service life

The service life of the product shall be marked on the visible side of the sales package in one of the following ways, and shall be introduced with the corresponding guiding words:

Production date and shelf life: The production date shall be identified in Chinese characters or Arabic numerals in the order of four digit year, two digit month and two digit date;

Production batch number and limited use date.

For products with packaging boxes, when the service life is marked on the packaging containers that directly contact the contents, in addition to the above methods, the production batch number and the service life after opening can also be marked.

When the sales package contains multiple independently packaged products, each independently packaged product shall be marked with a service life, and the service life on the visible side of the sales package shall be marked according to the service life of the independently packaged product that expires earliest among them; The service life of a single independently packaged product can also be marked separately.

Other new requirements

Number of standards implemented by the product

The cosmetic label shall be marked with the standard number of the product on the visible side of the sales package, which shall be introduced with the corresponding guide words.

Registration Certificate No. of Special Cosmetics

Special cosmetics: mark the registration certificate number of special cosmetics on the visible side of the sales package, and lead it out with the corresponding guide words. (The registration certificate number of special cosmetics is the registration certificate number issued by the State Drug Administration)

Innovative terms

If the cosmetic labels use innovative terms that are not yet widely used in the industry and are not easy for consumers to understand, but are not prohibited from labeling, their meanings shall be explained in adjacent positions.

These Measures shall apply to the label of cosmetics provided to consumers in the form of free trial, gift, exchange, etc.

Example of Chinese label guide words for cosmetics:

Product name in Chinese:

Net content:

Composition:

Other trace components:

usage method:

Caution (or warning):

Domestic responsible person:

Address:

Filed by (for special cosmetics, the registrant):

Address:

Manufacturer:

Address:

Executive standard No.:

Production date and shelf life (or production batch number and limited use date):

Registration certificate number of special cosmetics (no need to mark this item for ordinary cosmetics):

Those produced independently by the registrant or registrant may be simplified as follows:

"Registered person/manufacturer:" or "Filing person/manufacturer:"

Small size cosmetics with a net content of no more than 15g or 15mL

For small size packaged products with the net content of cosmetics no more than 15g or 15mL, only the Chinese name of the product, the number of the registration certificate of special cosmetics, the name of the registrant or the registrant, the net content, the service life and other information should be marked on the visible side of the sales package. Other information that should be marked can be marked in the instructions attached to the product.

For small size packaging products with packaging boxes, the Chinese name and service life of the product shall also be marked on the packaging containers that directly contact the contents.

《Provisions on the Administration of Cosmetics Registration and Filing Materials》

Article 32

If there are multiple sales packages, the label pictures of all sales packages shall be submitted. If one or more of the following situations are met, the label image of one sales package shall be submitted, and the label image of other sales packages may not be uploaded repeatedly:

1. Only the specifications of net content are different;

2. Only the information such as sales channels, promotions, special funds for festivals and gifts are attached to the uploaded sales package;

3. Only the color of the sales package is different;

4. The registered or recorded products are sold in combination in the form of boxes, gift boxes, etc., and the combination process does not touch the contents of the products. In addition to adding the name of the combined packaging products, other contents marked do not exceed the contents of each product label;

5. The difference from the uploaded sales package can be clearly reflected through the text description and has been noted.

（6） Product inspection report

The product inspection report of the registered or filed product shall be issued by the cosmetic registration and filing inspection agency, and shall comply with the provisions of the Technical Specifications for Cosmetics Safety, the Work Specifications for Cosmetics Registration and Filing Inspection and other relevant regulations.

If the manufacturer of ordinary cosmetics has obtained the relevant qualification certification of the production quality management system issued by the competent government department of the country (region) where it is located, and the product safety risk assessment results can fully confirm the product safety, it may be exempted from submitting the toxicological test report of the product, except for the following circumstances:

1. The product is claimed to be used by infants and children;

2. The product uses new cosmetic raw materials that are still under safety monitoring;

3. According to the quantitative grading and scoring results, the filing person, the domestic responsible person and the production enterprise are listed as the key regulatory objects.

If there are more than one manufacturer, and all the manufacturers have obtained the relevant qualification certification of production quality management system issued by the competent government department of the country (region) where they are located, they can be exempted from submitting toxicological test reports.

（7） Product safety assessment data

《Provisions on the Administration of Cosmetics Registration and Filing Materials》

Article 34 The registrant and the registrant shall carry out the product safety assessment in accordance with the requirements of the technical guidelines related to the safety assessment of cosmetics, and form a product safety assessment report.

For cosmetics that must be used with instruments or tools (except for brushes, air cushions, hair curling tools, etc. that are only used for auxiliary brushing), the safety under the conditions of using the instruments or tools should be evaluated; It shall also provide information on whether the instrument or tool has cosmetic function, whether it participates in the reproduction process of cosmetics, and whether it changes the mechanism of action between the product and the skin.

From January 1, 2022, before applying for registration of special cosmetics or filing of ordinary cosmetics, cosmetic registrants and registrants must carry out cosmetic safety assessment according to the requirements of Technical Guidelines for Cosmetic Safety Assessment and submit product safety assessment materials.

Before May 1, 2024, cosmetic registrants and registrants may submit simplified product safety assessment reports in accordance with the relevant requirements of the Technical Guidelines for Cosmetics Safety Assessment.

Before May 1, 2024, cosmetic registrants and registrants shall submit a complete version of the product safety assessment report in accordance with the relevant requirements of the Technical Guidelines for Cosmetics Safety Assessment.

《Technical Guidelines for Cosmetics Safety Assessment》

Basic Requirements

The cosmetic registrant and registrant shall carry out safety assessment by themselves or entrust a professional organization to form a safety assessment report and be responsible for its authenticity and scientificity

The safety assessment data of cosmetics shall be updated timely as needed, and the shelf life shall not be less than 10 years after the expiration of the shelf life of the last batch of marketed products.

The resume of the appraiser shall be attached to the evaluation report, and the resume shall include the educational experience, cosmetics related experience, professional training experience, etc. of the appraiser.

Safety Assessment Report of Cosmetic Products

The safety assessment report of cosmetic products usually includes the summary, product introduction, product formula, formula design principles (only for children's cosmetics), safety assessment of each ingredient in the formula, assessment of potential risk substances, risk control measures or suggestions, safety assessment conclusion, signature and resume of safety assessment personnel, references and appendixes.

Requirements for cosmetic safety assessment personnel

1. Have professional knowledge related to the quality and safety of cosmetics such as medicine, pharmacy, biology, chemistry or toxicology, understand the production process and quality and safety control requirements of finished cosmetics or raw materials, and have more than 5 years of professional experience in related fields.

2. Be able to consult and analyze relevant literature information such as chemistry and toxicology, and analyze, evaluate and interpret relevant data.

3. Be able to fairly and objectively analyze the safety of cosmetics, conduct safety assessment based on a comprehensive analysis of all available data and exposure conditions, and be responsible for the scientificity, accuracy, authenticity and reliability of the assessment report.

4. Be able to learn relevant knowledge of safety assessment, understand and master new safety assessment theories, technologies and methods, and apply them to practice through regular professional training.