On September 22, the official website of the State Food and Drug Administration issued a letter on publicly soliciting opinions on the "Cosmetic Label Management Measures (Draft for Comments)" (hereinafter referred to as the "Measures"). The "Measures" are the supporting legislation of the Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the "New Regulations"). It is the sixth part issued after the "Measures for the Administration of Cosmetics Registration (Draft for Comment)", "Measures for the Supervision and Administration of Cosmetics Production and Operation (Draft for comment)", "Standards for Cosmetics Registration and filing information (draft for comment)", "Standards for the registration and filing of Cosmetics New raw materials (Draft for comment)" and "Guiding Principles for the Evaluation of Cosmetic Efficacy Claims (Draft for comment)" New rule. This approach has a significant impact on the cosmetics industry, and the legislative background, key content and lawyers' suggestions are interpreted as follows:

1. Legislative background

Unlike drugs and medical devices, which are mainly selected and used under the guidance of professionals, cosmetics are mainly selected by consumers as daily consumer goods. Product label is the main carrier and form to convey basic product information, ingredient information, efficacy claims and safety information to consumers. Product labeling compliance is a necessary guarantee to ensure the correct, reasonable and safe use of cosmetics by consumers. Strengthening cosmetic label compliance management is a requirement to effectively safeguard the legitimate health rights and interests of consumers, and is also an important part of cosmetic safety supervision. On the other hand, before the functional adjustment of China's cosmetics regulatory agencies, cosmetics supervision and management have been carried out by multi-departments. At present, the regulatory documents and national standards related to cosmetics label management mainly include: Relevant regulatory documents such as the departmental regulations of the Administration of Cosmetics Labeling issued by the former General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ Order No. 100), the Naming Regulations of Cosmetics issued by the former State Food and Drug Administration, and the mandatory national standard of the General Label of Cosmetics issued by the National Standards Commission (GB5296.3-2008), These regulatory documents and standards from different aspects of cosmetics labeling provisions, but the lack of systematic, and even some specific provisions are inconsistent or conflicting, so that the cosmetics industry at a loss. After the promulgation of the new regulations, the State Drug Administration, in order to implement the relevant requirements of the regulations, further strengthen the management of cosmetics labels, and protect the legitimate rights and interests of consumers, organized the drafting of the measures in order to better implement the new regulations, regulate and guide the compliance work of cosmetics labels in the industry.

Second, key content interpretation

The measure consists of 34 articles, which expounds the legislative purpose and scope of application; The cosmetics label is defined. The principles and requirements of cosmetics label management are clarified. The general requirements for labels and the requirements for labels of imported products are clarified. The contents of cosmetics labels should be marked and the specific requirements of each content marking; The innovative terms, writing requirements and efficacy claims are regulated according to management. The contents of prohibited labeling of cosmetics and the management of prohibited terms have been clarified. Cosmetics operators should focus on the following:

1. Label definition
Article 3 The term "cosmetic label" as used in these Measures refers to the general term of the product packaging container, packaging box, the instruction manual attached to the product, and the text, symbol, number, pattern, etc. attached to the packaging container, packaging box and instruction manual to identify and explain the basic information, attribute characteristics and safety warnings of the product.

Lawyer's interpretation: The regulation is a definition of the concept of cosmetic labeling. The concept is adjusted from "cosmetics label" to "cosmetics label", which is not only unified with the regulatory terms of other products such as drugs, but also further clarified that cosmetics labels not only include product packaging containers, packaging boxes and instructions, but also include the text, symbols, numbers, patterns and other information attached to packaging containers, packaging boxes and instructions, and the definition is more accurate and comprehensive. It is more convenient for cosmetics operators to understand and grasp the extension of cosmetics labels, and it is also more conducive to the application and law enforcement of new regulations, which is a great progress in legislative technology.

2. Label principle requirements
Article 4 The minimum sales unit of cosmetics shall be labeled. The label shall comply with relevant laws, administrative regulations, mandatory national standards and technical specifications, and the label content shall be true, complete and accurate, and consistent with the relevant content of product registration or filing.
Cosmetics labels shall be clear, durable, easy to identify and read, shall not have the phenomenon of falling off or pasting, shall not be marked in the form of multi-layer labels, shall not paste, cut, alter and other ways to modify or supplement the relevant content related to product safety.
Cosmetics registrants and record holders are responsible for the legality, integrity and authenticity of cosmetics labels.

Lawyer's interpretation: This article is a principled provision for cosmetic labeling. The Measures continue the provisions of the Regulations and clarify the main responsibility of cosmetics registrants and record holders for the legitimacy, integrity and authenticity of cosmetics labels. At the same time, it is clear that domestic cosmetics shall not be labeled in the form of multi-layer labels, which means that domestic cosmetics will not be able to produce or sell domestic cosmetics in a similar way to the labeling of imported cosmetics - affiasing English labels and affiasing Chinese labels.

3, import product label requirements
Article 5 Imported cosmetics may use Chinese labels directly or attach Chinese labels; If a Chinese label is affixed, the content of the product safety and efficacy claim on the Chinese label shall be consistent with the relevant content of the original label.

Lawyer's interpretation: The regulation continues the original supervision direction of imported cosmetics labels, and it is clear that imported cosmetics can directly use Chinese labels, and can also be affixed with Chinese labels. At the same time, the content of the Chinese label and the original foreign language label are defined, that is, the content of product safety and efficacy claims, which answers the problem of inconsistent standards in current business practice.

4. Label content requirements

Article 6 Cosmetics labels shall include the following:

(1) Product name, special cosmetics registration certificate number; (2) the name and address of the registrant or recordholder, if the registrant or recordholder is an overseas enterprise, the name and address of the domestic responsible person shall be marked at the same time; (3) The name and address of the production enterprise, and the production license number of the domestic cosmetics enterprise shall be marked at the same time; (4) the standard number of the product execution; (5) all components; (6) net content; (7) term of use; (8) Methods of use; (9) safety warning words; (10) Other contents that should be marked according to laws, administrative regulations and mandatory national standards.
For products with packaging boxes, at least the contents of item (1) (7) shall also be marked on the packaging containers that come into contact with the contents.

Lawyer's interpretation: The regulation is a regulation on the content of the cosmetics label, which summarizes and clarifies the constituent elements that must be marked on the cosmetics label, which is more clear than the original regulation, and is conducive to the understanding and grasp of cosmetics operators. Different from the original provisions, the method stipulates that the product with a packaging box should also be marked on the packaging container of the contact contents at least the product name, the special cosmetic registration certificate number and the use period of three contents, cosmetics operators should pay special attention to, the provision will have a practical impact on the production of product packaging materials. In the case of the abandonment of the product packaging box, based on the consideration of consumer safety, it is reasonable to force the product name, the special cosmetic registration certificate number and the use period to be marked on the packaging container that comes into contact with the contents.

5, product name requirements
Article 8 The name of a cosmetic product generally consists of three parts: trademark name, generic name and attribute name. The trademark name, generic name and attribute name shall meet the following requirements:
(1) In addition to complying with the provisions of the relevant national trademark laws and regulations, the use of the trademark name shall also comply with the provisions of the relevant national cosmetics management laws and regulations;
(2) Shall not claim in the form of a trademark the medical effect or the effect that the product does not have. If the name of the raw material or the term implying the inclusion of a certain raw material is used as the trademark name, and the product formula contains the raw material, the purpose of use shall be explained in front of the sales package; If the product formula does not contain the raw material, it shall be clearly marked on the visible surface of the sales package that the product does not contain the raw material, and the name of the raw material is only used as a trademark name;
(3) The general name shall be accurate and objective, and may be a text indicating the raw materials of the product or describing the use and use of the product. The use of specific raw material names or words indicating the category of raw materials should be consistent with the composition of the product formula, and the efficacy of the raw material in the product should be consistent with the product efficacy claims. Where animal, plant and mineral names are used to describe the flavor, color or shape of the product, the formula does not contain such raw materials, and the form of flavor, color or shape can be used in the common name when naming the animal, plant and mineral names, or indicated after the attribute name;
(4) The attribute name shall indicate the true physical character or form of the product;
(5) When the trademark name, common name and attribute name of different products are the same, other contents that need to be marked shall be indicated after the attribute name, including color or color number, sun protection index, odor, applicable hair type, skin type or specific groups of people. Conventional, customary use of cosmetics names can omit the common name or attribute name;
(6) If the trademark name, generic name or attribute name meets the above requirements of this article when used separately, and the combination may cause consumers to have ambiguity about the efficacy of the product, it shall be explained in the visible surface of the sales package.

Lawyer's interpretation: This article is a principled provision on the name of cosmetic products. In addition to the continuation of the original standards, the processing for the first time clearly stipulates that the use of trademark names in addition to complying with the provisions of the relevant laws and regulations of the national trademark, but also should comply with the provisions of the relevant laws and regulations of the national cosmetics management, establishing the compliance standards of cosmetic product names. The regulation is a response to the phenomenon that many operators in the cosmetics business practice register certain words (such as no-add, organic, a touch of white, white doctor, etc.) as trademarks and use them in the names of cosmetics to mislead consumers. According to the regulation, the use of cosmetics trademarks must not only comply with the requirements of the Trademark Law, but also comply with the requirements of cosmetics regulatory regulations. At the same time, the law also further clarifies: cosmetics may not claim medical effects or effects that products do not have in the form of trademark names, and some brands respond to the phenomenon of skirting through product names in business practice.

6. Ingredient labeling requirements
Article 12 Cosmetics labels shall be marked on the visual surface of the sales package with the name of all ingredients of cosmetics, and "ingredients" as a guide, and listed in descending order according to the formula content.
Where there are ingredients in a cosmetic formula containing less than 0.1% (w/w), all ingredients not exceeding 0.1% (w/w) shall be labeled separately with "other trace ingredients" as a guide and may not be listed in descending order of the formula content.
Cosmetic ingredients shall be marked with the standard Chinese names of cosmetic raw materials. If the formula is filled in the form of compound or mixed raw materials, the content of each component in the formula should be used as the basis for determining whether it is a trace component.

Lawyer's interpretation: The regulation continues the whole ingredient labeling of cosmetics and the descending order of cosmetic ingredients, but at the same time, for the first time, it requires that if there is an ingredient with a content of no more than 0.1% (w/w) in the cosmetic formula, all ingredients with a content of no more than 0.1% (w/w) should be separately labeled with "other trace ingredients" as the guide language. The regulation means that trace ingredients in cosmetic ingredients will be more prominently displayed to consumers, and consumers will be able to see what trace ingredients are more prominently. This regulation is a response to the phenomenon of conceptual addition of trace ingredients in cosmetics business practice, and avoids misleading consumers by adding conceptual trace ingredients in cosmetics.

7, small size packaging label requirements
Article 17 If the net content of cosmetics is not more than 15g or 15mL, only the product name, the name of the registrant or the record holder, the net content, the use period and other information need to be marked on the visual surface of the sales package. In direct contact with the contents of the packaging container should also be marked on the product name and use period, other should be marked on the label information can be marked in the internal manual or electronic label.
If it is marked in the form of an electronic label, the words "electronic label" shall be marked below the image code, and the code can be scanned and identified by conventional devices such as smart phones.

Lawyer's interpretation: The regulation is a requirement for small cosmetic packaging labels. The regulation continues the regulatory direction of simplifying the labeling of small cosmetic packaging labels, and at the same time introduces the innovative concept of "electronic labeling". The introduction of electronic labels has solved the difficult problem of small cosmetic labeling, increased the flexibility of cosmetic label forms, and reflected the progress of cosmetic supervision with The Times.

8. Efficacy claims are based on requirements
Article 19 The efficacy claim in the cosmetic label should have sufficient scientific basis, and the scientific basis for the cosmetic efficacy claim includes relevant research data, efficacy evaluation data or literature. Sources of research data include human trials, in vitro trials, consumer use tests, and other scientific research trials.
The claims of the efficacy of the raw material in the cosmetic label should be consistent with the purpose of the use of the raw material in the product formula, and the amount of the raw material added to the product formula should not be less than the effective amount to achieve the claimed efficacy of the product. The evaluation of product efficacy claims shall be carried out in accordance with the guiding principles for the evaluation of cosmetic efficacy claims published by the drug regulatory department under The State Council. The efficacy of the product claims that the human efficacy evaluation test is carried out by the inspection agency with the corresponding qualification for the safety and efficacy of cosmetics, and the test results are considered objective and effective, and the efficacy can be marked on the product label "has been evaluated and verified".

Lawyer's interpretation: The regulation is a specific requirement for the basis for claiming the efficacy of cosmetics. On the basis of strengthening product safety supervision, strengthening product efficacy supervision is a new requirement put forward by the new regulation. The regulation once again clarifies that the efficacy claims in cosmetic labels should have sufficient scientific basis, and the scientific basis for cosmetic efficacy claims includes relevant research data, efficacy evaluation data or literature. At the same time, the regulation clearly states for the first time that the efficacy of the raw material declared in the cosmetic label should be consistent with the purpose of the use of the raw material in the product formula, and the amount of the raw material added to the product formula should not be less than the effective amount to achieve the claimed efficacy of the product. The regulation is a response to the phenomenon of excessive marketing of product raw materials in cosmetic business practices. Cosmetics are composed of cosmetic raw materials, but the efficacy of cosmetic raw materials is not equal to the efficacy of cosmetics. In the operation of cosmetics, the efficacy of cosmetic raw materials and products should be systematically declared, and the efficacy of cosmetic raw materials should not be isolated and over-declared on the premise of separation from the efficacy of cosmetics, so as not to mislead consumers. At the same time, the regulation also stipulates that if the product has been objectively and effectively tested by a third-party qualified organization, the content of the efficacy "has been evaluated and verified" can be marked in the product label. The regulation relaxes the labeling space of product efficacy, quantifies the efficacy of products, and cosmetics operators can consider using, especially effective products such as sunscreen products.

Third, business suggestions

In terms of industrial characteristics, cosmetics are not only the results of scientific research and development, but also have the characteristics of fashion products. As a fashion product, cosmetics labels have a great impact on product sales, cosmetics companies invest more in packaging labels, the introduction of the new regulations and the approach will have a systemic impact on the cosmetics industry, cosmetics operators should pay great attention to. Based on the development status of the industry and the new regulations, the recommendations are as follows:

1. Pay attention to the digestion of existing inventory packaging labels.

The method has set up new registrants, record holders, trace ingredients and other labeling content, and adjusted the definition of production enterprises, which means that all cosmetics labels have to be adjusted after the introduction of the new regulations and the method, so the digestion of existing inventory packaging labels is a big challenge. At this stage, cosmetics operators should reasonably plan the inventory of packaging materials and minimize the pressure on inventory digestion, so as not to lead to the scrapping of packaging materials. At the same time, more attention should be paid to the implementation of the method and the setting of the transition period.

2. Pay timely attention to legislative developments and accurately grasp the label compliance boundary.

The method is a systematic and major adjustment of the original "Regulations on the Management of cosmetics labeling" : for example, the registrant, recordholder, producer labeling requirements, the method stipulates that "the name and address of the registrant, recordholder, domestic responsible person and production enterprise should be marked with the name and address of the enterprise specified in the product registration certificate or recordholder certificate, respectively, with the corresponding guidance language." There are systematic changes in the content of the logo and the requirements for full ingredient labeling, so in the face of these adjustments, cosmetics operators and relevant practitioners need to pay timely attention to the legislative dynamics and accurately grasp the label compliance boundary.

3, increase research and development investment, pay attention to product efficacy claims.

In the first 30 years of the development of China's cosmetics industry, consumers have low requirements for products, the industry research and development ability is limited, the policy supervision is strict, and the industry management is heavy on marketing; The development of the cosmetics industry in the next 30 years, consumer requirements to increase, enterprises have a certain research and development capabilities, policies to release innovation space, industry management to research and development. Specifically, the new regulations and the measures put forward requirements for the efficacy of cosmetics, it is clear that the efficacy of cosmetics must be supported by scientific evidence, and the summary of the relevant efficacy evaluation basis should be actively open to social supervision on the website designated by the national drug supervision and administration department. Therefore, cosmetics operators should take the initiative to increase investment in research and development, research and development reserves, on the one hand is the needs of industry development, on the other hand is also a measure to meet regulatory needs.

4. Attach great importance to the compliance of imported cosmetics labels.

In 2014, when the original "Label Management Measures" solicited opinions from the outside world, it stipulated that imported cosmetics must be specially designed for Chinese packaging. This time, the method can be adjusted to design Chinese packaging specifically for China, and can also be affixed in Chinese, and the form has been relaxed. However, the method also stipulates that the content of the Chinese label related to product safety and efficacy claims should be consistent with the relevant content of the original label, which means that the corresponding content of the foreign original packaging must meet the requirements of China's regulations. At the same time, the method also stipulates that the packaging container of products in direct contact with the content must have the Chinese name and the relevant provisions of the warranty period, and also puts forward new requirements for imported products in the original packaging. Imported cosmetics operators should pay close attention to.