Cosmetics labels are facing major changes under the new regulations -- Interpretation of the "Measures for the Administration of Cosmetics Labels" | Legal Observations on cosmetics
In order to protect the legitimate rights and interests of consumers and ensure the safety of cosmetics use, the State Food and Drug Administration issued the "Measures for the Administration of Cosmetics Labels (Draft for Comments)" in September 2020. On June 3, 2021, the State Food and Drug Administration passed and officially announced the "Measures for the Management of Cosmetic Labels" (hereinafter referred to as the "Measures"), which will come into effect on May 1, 2022. As the supporting legislation of the Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the "New Regulations"), the "Method" has clarified the detailed requirements for the management of cosmetics labels, and unified the relevant regulations on the supervision and administration of cosmetics labels issued by the relevant regulatory authorities, which has a significant impact on the cosmetics industry. Now, the specific interpretation of the legislative background, key contents and transitional arrangements of this provision is as follows:
1. Legislative background
Cosmetics are different from drugs; Drugs are mainly selected and used under the guidance of professionals, while cosmetics are mainly selected by consumers as daily consumer goods. Cosmetics labels are the main carriers to convey basic product information, attribute characteristics, efficacy claims and safety warnings to consumers. True, complete and accurate labeling is a necessary guarantee to ensure consumers' correct, reasonable and safe use of products. Strengthening cosmetic label compliance management is a requirement to effectively safeguard the legitimate health rights and interests of consumers, and has always been an important part of cosmetic safety supervision. In the early days, China's cosmetics industry was supervised and managed by multiple departments, and the legal documents related to cosmetics label management mainly included: The former AQSIQ issued the departmental regulations "Cosmetics labeling Management Regulations" (AQSIQ Order No. 100), the former State Food and Drug Administration issued the "Cosmetics naming Regulations" and other relevant normative documents, and the mandatory national standard issued by the National Standards Commission "Cosmetics General Label" (GB5296.3-2008). The above documents have clarified the requirements for cosmetics labeling from different aspects, but the lack of systematic, and even some specific provisions are inconsistent, so that cosmetics companies are at a loss. At this stage, with the adjustment of the cosmetics regulatory authorities and the promulgation and implementation of the new regulations, in order to implement the relevant requirements of the "new Regulations", unify and strengthen the management of cosmetics labels, and protect the legitimate rights and interests of consumers, the State Food and Drug Administration formulated and issued the "Method" according to the legislative ideas determined by the "new Regulations". Based on laws and regulations such as the Product Quality Law of the People's Republic of China, the Advertising Law of the People's Republic of China and the new Regulations, the "Measures" unify and standardize the contents of previous rules, standards and normative documents related to the management of cosmetics labels in view of the current situation of cosmetics supervision. Clear business standards for cosmetic registrants or registrants.
Second, key content interpretation
The "Method" consists of 23 articles, the main contents of which are: the definition of cosmetics labels, the main responsibility of cosmetics registrants and record holders, and the principle requirements for the content and form of cosmetics labels; The content and refinement requirements of cosmetics labels should be specified, and the content of cosmetics labels prohibited were specified. The specific situation of label defects is specified, and the application of relevant laws and regulations is clarified. Cosmetics registrants or registrants should focus on the following:
1, cosmetics label definition
Article 3 The term "cosmetics label" as mentioned in these Measures refers to the characters, symbols, numbers, patterns and other marks used to identify and explain the basic information, attribute characteristics and safety warnings of the product on the sales package of the product, as well as the packaging containers, packaging boxes and instructions with identifying information.
Lawyer's analysis:
This regulation is the definition of the label of cosmetics. In terms of the regulation, cosmetics registrants or registrants should pay attention to the following: (1) The title of the regulation will adjust the "cosmetics label" to "cosmetics label", which is unified with other product regulatory terms such as drugs. (2) The regulation specifies that the extension of the cosmetics label not only includes the text, symbol, number, pattern and other marks used to identify the basic information, attribute characteristics and safety warnings of the product on the product sales package, but also includes the packaging containers, packaging boxes and instructions with identifying information. Compared with the original system, the definition expands the extension of cosmetics labels, especially the cosmetics packaging containers and packaging boxes into the category of cosmetics labels, which means that cosmetics packaging containers and packaging boxes must also comply with the compliance requirements of cosmetics labels, such as not express or implied medical effects.
2, cosmetics label responsibility body
Article 4 The registrant and recordholder of cosmetics shall be responsible for the legality, authenticity, completeness, accuracy and consistency of cosmetic labels.
Lawyer's analysis:
This regulation is a regulation on the responsibility of the cosmetics label. The new regulation stipulates that cosmetics registrants and record holders are responsible for the quality and safety claims of cosmetics. The "Measures" continue the provisions of the "New Regulations", further specify the provisions of cosmetics registrants and record holders for the legitimacy, authenticity, integrity, accuracy and consistency of cosmetics labels, and clarify the main body of responsibility for cosmetics labels. This means that in business models such as commissioned processing, entrusted cosmetics manufacturers are not the subject of statutory responsibility for product label compliance, and cosmetics registrants or recordholders should pay attention to cosmetic label compliance.
3, cosmetics Chinese label form
Article 6 Cosmetics shall have labels in Chinese. Chinese labels shall use standard Chinese characters, the use of other words or symbols, should be used in the visual surface of the product sales package to explain the corresponding standard Chinese characters, except for the website, the name and address of overseas enterprises and conventional professional terms must use other words.
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.
Except for registered trademarks, the font size of other characters on the same visual surface of the Chinese label shall be less than or equal to the corresponding standard Chinese font size.
Lawyer's analysis:
This regulation is a requirement for the form of Chinese labels for cosmetics. Cosmetics registrants or record holders should pay attention to the following issues: (1) Cosmetics Chinese labels should use standardized Chinese characters, the use of other words or symbols, should use standardized Chinese characters in the visual surface of the product sales package corresponding explanation, except the website, the name and address of overseas enterprises and conventional professional terms must use other words. However, it is not explicitly required whether the corresponding interpretation of other words or symbols needs to be on the same visual surface. (2) In addition to registered trademarks, the size of other text fonts on the same visual surface of the Chinese label shall be less than or equal to the size of the corresponding standard Chinese font. According to the legal interpretation, the size of other text fonts of Chinese labels is not subject to the size of the corresponding standard Chinese font on the same visual surface. (3) The new regulations stipulate that imported cosmetics can directly use Chinese labels, and can also attach Chinese labels; If a Chinese label is affixed, the content of the Chinese label shall be consistent with that of the original label. On the basis of the new regulations, the scope of consistency between the content of the Chinese label of imported products and the original foreign label is specified in detail, and it is clear that the scope of consistency of the label is only the product safety content and the efficacy claim content, narrowing the scope of consistency.
4, cosmetics Chinese label content
Article 7 The Chinese label of cosmetics shall include at least the following contents:
(1) the Chinese name of the product and the number of the special cosmetic registration certificate;
(2) the name and address of the registrant or recordholder, and 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) necessary safety warning words;
(10) Other contents that should be marked according to laws, administrative regulations and mandatory national standards.
For products with packaging boxes, the Chinese name of the product and the term of use of the product shall also be marked on the packaging containers that come into direct contact with the contents.
Lawyer's analysis:
This regulation is a requirement for the content of cosmetics labels in Chinese. The method Outlines the content that must be marked on the cosmetics label and is more clear. Compared with the new regulations, the method also further stipulates that products with packaging boxes should also be marked on the packaging container that comes into contact with the contents of at least two contents: product name and use term. In the case of the abandonment of cosmetic packaging boxes, based on consumer safety considerations, it is reasonable to force the product name and use period to be marked on the packaging containers that come into contact with the contents. However, this regulation will have a technical impact on the production of product packaging materials, especially the use period, which should be of concern to cosmetics registrants or record holders.
5, cosmetics Chinese name content
Article 8 The Chinese name of a cosmetic product generally consists of three parts: trademark name, generic name and attribute name. Conventional and customary cosmetics names may omit the generic name or attribute name, and 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. It is not allowed to claim in the form of a trademark a medical effect or an effect that the product does not have. Where a trademark name is used to imply the use of a certain type of raw material, and the product formula contains such raw materials, the purpose of use shall be explained in front of the sales package; If the product formula does not contain such raw materials, it shall be clearly marked on the visible surface of the sales package that the product does not contain such raw materials, and the relevant terms are only used as trademark names;
(2) The common 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 type of raw material 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 the name of animal, plant or mineral is used to describe the flavor, color or shape of the product, the formula may not contain the raw material, and the name may be used in the general name of animal, plant or mineral in the form of flavor, color or shape, or may be indicated after the attribute name;
(3) The attribute name shall indicate the true physical character or form of the product;
(4) 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;
(5) 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 analysis:
This regulation is a detailed requirement for the composition of the Chinese name of cosmetics. Cosmetics registrants or registrants should pay attention to the following: (1) This transaction establishes three compliance standards for cosmetics trademarks for the first time. First of all, the use of cosmetics trademarks should comply with the provisions of the national Trademark Law and other relevant laws and regulations, such as the use of the same or similar name and logo of the Red Cross and Red Crescent; Secondly, the cosmetics trademark should also comply with the provisions of the relevant laws and regulations of the national cosmetics management, such as not to claim the medical effect or the effect that the product does not have in the form of a trademark name, not to imply the use of a certain type of raw material as a trademark name false publicity, such as no addition, organic, a white, a doctor and so on. This regulation is a response to the phenomenon that some cosmetics registrants or registrants register certain words as trademarks and use them in the names of cosmetics to evade the compliance supervision of cosmetics and mislead consumers, which has certain practical significance. Third, to imply the inclusion of a certain type of raw materials as a trademark name, the product formula contains such raw materials, should be in the sales package in front of its purpose of use; If the product formula does not contain such raw materials, it shall be clearly marked on the visible surface of the sales package that the product does not contain such raw materials, and the relevant terms are only used as trademark names. (2) For the general name of cosmetics, the method stipulates the principle requirements of the general name of cosmetics: accurate and objective; It is also stipulated that the generic name of cosmetics using the name of specific raw materials or the words indicating the class of raw materials should be consistent with the composition of the product formula, and the effect of the raw material in the product should be consistent with the product effect claim. (3) In addition to the compliance of cosmetics trademarks and cosmetics generic names separately, the new regulations also stipulate that the combination of trademark names, generic names or attribute names may cause consumers to have ambiguity about the efficacy of the product, and should also be explained in the visual surface of the sales package, such as "immediate whitening cream". This method puts forward higher requirements for the compliance of the Chinese name content of cosmetics, and cosmetics registrants or recordholders should pay attention to it.
6, cosmetics Chinese name form
Article 9 The Chinese name of the product shall be marked in a prominent position on the visual surface of the sales package, and at least one of them shall be led out by the guiding language.
The Chinese name of cosmetics shall not use letters, Chinese pinyin, numbers, symbols, etc., except for registered trademarks, representing sun protection index, color numbers, series numbers, or other letters, Chinese pinyin, numbers, symbols, etc. Where the registered trademark in the Chinese name of the product uses letters, Chinese pinyin, numbers, symbols, etc., its meaning shall be explained in the visual face of the product sales package.
The registration certificate number of special cosmetics shall be the registration certificate number issued by the State Drug Administration and marked on the visible surface of the sales package.
Lawyer's analysis:
This regulation is mainly a regulation on the form of the Chinese name of cosmetics. Cosmetics registrants or record persons should pay attention to the following: (1) The Chinese name of cosmetics shall not use letters, Chinese pinyin, numbers, symbols, etc., except for registered trademarks, representing sun protection index, color numbers, series numbers, or other letters, Chinese pinyin, numbers, symbols, etc. Where the registered trademark in the Chinese name of the product uses letters, Chinese pinyin, numbers, symbols, etc., its meaning shall be explained in the visual face of the product sales package. However, the regulation does not require interpretation in the same visual surface. (2) The Chinese name of cosmetics should be marked in a prominent position on the visual surface of the sales package, and at least one of the guiding words, such as "product name". Visible surface refers to any surface, including the underside, that can be seen by consumers without damaging the sales package.
7. Cosmetic ingredients
Article 12 Cosmetics labels shall be marked on the visual surface of the sales package with the standard Chinese name of all ingredients of cosmetics, with "ingredients" as the guide language, and listed in descending order according to the content of each ingredient in the product formula. 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 ingredient content.
Where the formula is filled in the form of compound or mixed raw materials, the content of each component in the formula shall be used as the basis for ordering the content of the component and determining whether it is a trace component.
Lawyer's analysis:
The regulation is a specific regulation on the labeling of cosmetic ingredients, which continues the supervision idea of the whole ingredient labeling of cosmetics and the descending order of cosmetic ingredients. Cosmetic registrants or recordholders should pay attention to the following issues: (1) In principle, the labeling form of cosmetic ingredients should be marked on the visual surface of the sales package. However, according to the provisions of Article 17 of the Measures, the net content of cosmetics is not greater than 15g or 15mL of small size packaging products, only need to mark the Chinese name of the product, the number of the special cosmetic registration certificate, the name of the registrant or the record person, the net content, the use period and other information on the visual surface of the sales package. Other information that should be labeled, such as ingredients, may be labeled in the accompanying product description. (2) Cosmetic labels are listed in descending order of the amount of each ingredient in the product formula. However, the "General Label for Cosmetics" (GB5296.3-2008) stipulates that if the amount of ingredients added is less than or equal to 1%, the name of the ingredients can be arranged in any order after the amount of ingredients added is greater than 1%. After the implementation of this method, whether the "General label for Cosmetics" (GB5296.3-2008) is implemented or adjusted needs to be further clarified by the official. If it is no longer performed, it means that ingredients containing more than 0.1% (w/w) must be arranged in descending order of content. (3) The method proposed the concept of trace ingredients for the first time, stipulating that if there is an ingredient with a content not exceeding 0.1% (w/w) in a cosmetic formula, all ingredients not exceeding 0.1% (w/w) should be labeled separately with "other trace ingredients" as the guide language, and may not be listed in descending order of the ingredient content. This regulation is a response to the phenomenon of conceptual addition of trace ingredients in cosmetics business practice, and avoids the behavior of misleading consumers by adding conceptual trace ingredients in cosmetics, which has certain practical significance. (4) The method for the first time clarifies the labeling requirements of compound ingredients or mixed raw materials, and stipulates that if the formula is filled in the form of compound or mixed raw materials, the content of each ingredient in the formula should be used as the basis for ordering the content of the ingredient and determining whether it is a trace ingredient. This regulation is aimed at the cosmetic business practice of compounding ingredients or mixed raw materials labeling form and sorting standards are not uniform, has a strong practical significance.
三、Transitional arrangements
Considering the actual needs of the industry to implement the new regulations and digest the inventory of packaging consumables, the method provides a transition period for cosmetics registrants or recordholders. Specifically: (1) Encourage cosmetics registrants and record holders to label cosmetics in accordance with the provisions of the Measures from the date of this announcement. (2) From May 1, 2022, cosmetics "new products" applying for registration or filing, product labels must comply with the provisions and requirements of the measures. (3) For cosmetics "old products" that have been registered or filed, the cosmetics registrant and filing person must complete the update of the product label before May 1, 2023, so that it meets the provisions and requirements of the Measures.