Yu Qionghua, YangYang

SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd., China

EU Cosmetics Regulation (EC) No 1223/2009[1]stipulates that “cosmetics” refer to any substance or mixture applied on any part of the human body surface including epidermis, hair, nails, lips and genitalia, or exposed to teeth and oral mucosa for the purpose of cleanness, change in smell and appearance, protection and conditioning, or preventing body smell, etc. Also, Chinese Cosmetics Hygiene Supervision Regulations[2]specifies that “cosmetics” refer to chemical products applied on any part of human body like skin, hair, nails and lips by means of inunction, spraying for the purpose of cleanness,removal of undesirable smell, skin care, beauty and grooming, etc.

There are differences in the definition of cosmetics between the EU and Chinese regulations, but both of them require that the cosmetic products must have their appropriate efficacy, such as cleanness, change in appearance, skin care and beauty; otherwise, they can not be called “cosmetics”.

Faced with fierce competition in today’s cosmetics industry, enterprises have put full emphasis on efficacy claims even with multiple features simultaneously contained in one product. For example, “brightening, tightening,nourishing and moisturizing the skin, minimizing the appearance of pores, significantly reducing fine lines and wrinkles, and skin smoothing” claimed for a skin care product; “24 hours of styling and moisturizing” claimed for a hair spray, etc. Therefore, the product claims shall be the first consideration[3]for consumers to select and buy the cosmetic products.

As a result, “The claims shall not mislead the consumers”[4]has become particularly important, which is also a common requirement for claims in the cosmetic regulations of each country. The claims must describe the features or functions of products explicitly or implicitly,which, as an important marketing tool, can not only help the consumers to choose the proper products, but also can enhance the competitiveness of product itself, and promote the continuous innovation of enterprises. The author focuses on the analysis of the EU and Chinese regulations on cosmetics product claims, hoping to help enterprises better understand the regulatory requirements,and improving their market competitiveness.

Regulations on cosmetics daims of EU

EU regulations on claims generally follow two principles,namely, “protect the consumers from being misled” and“ensure fair competition among enterprises”.[5]

EC No 1223/2009[1]has the following provisions on claims: for the cosmetic products launched in the market,the words, name, trademark, pictures and figures or other identifications used on their labels and advertisements should not imply that some unrealistic features and efficacy are included for the products. In order to define the responsibility,EC No 1223/2009 stipulates that a responsible person shall be designated for each type of cosmetic products within the specified standards. Based on whether the cosmetic products are produced within the EU, or exported and then re-imported back into the EU, whether the cosmetic manufacturer's company is within the EU, whether the cosmetic products are imported, and whether a cosmetic product is launched in the market with the name or trademark of a distributor, the manufacturer, the person designated by the manufacturer or importer, and the distributor, etc., may be considered as the responsible person. The responsible person is responsible for ensuring the implementation of common criteria; but if the distributor has changed the claims, he will become a responsible person.[1,5]

In order to standardize the claim of cosmetic products,the EU specially released the Common Criteria for the Justification of Claims Used in Relation to Cosmetic Products in 2013 (European Union Commission Regulation EU No 655/2013).[5]This regulation applies to any claims within the scope of cosmetic products,regardless of types and media of used market tools, types of claims, as well as target consumer groups.

EU No 655/2013 stipulates 6 principles that cosmetic product claims must adhere to, i.e. legality, authenticity,evidence support, honesty, fairness, and informed decision-making.

“Legality compliance” means that the claims must meet all regulatory requirements. “Truthfulness” means that the claims and introduction of products shall not be based on any wrong information. If the product claims contain a specific ingredient, it must be included in its formula. If the claims mention the efficacy of a certain ingredient, the product itself must have the same efficacy.The following claims are not allowed: “alcohol free” if the product contains alcohol; “48-hour moisturizing” if the product can only prove a short-term moisturizing efficacy;“containing honey” if the product contains only some honey flavor but no honey; and “containing moisturizing aloe” if the product itself has no moisturizing effect.

“Evidential support” means that the product claims must be supported by sufficient evidence. Types of evidence may be different, depending on the nature of claims and general knowledge. The responsible person has the right to decide that which type of evidence will be used to support the claims, but he must obey the management of regulatory authorities. The research for supporting product claims shall be related to the product and its claims. All the research data and available information shall be taken into account when evaluating the validation methods. The following claims are forbidden; “l(fā)et you fly” alike; and“cleanness claimed for a soap”, because “cleaning” is the essential nature of soaps and needs not be proven.

“Honesty” means that the claims shall not mislead the consumers, the properties that the product does not have cannot be claimed, nor can the product’s relevant information be hidden. When the supporting evidence cannot prove a certain product claim, its speculation also shall not be regarded as the evidence for claims. If the product claims that it has some “improved properties”, the claims shall reflect the actual features. The common properties of similar products shall not be claimed as the being a peculiar features of a certain product.If the product has the properties only under the specific conditions, these conditions shall also be explained clear.

“Fairness” means that the claims can be compared,which must be objective, without defaming the competitors.Moreover, the claims shall not denigrate the rightful and safe ingredients in cosmetic products, and shall not cause confusion to the competitors’ products.

“Informed decision-making” means that the claims must include the information which can facilitate the users to make a choice, meanwhile, for most consumers,the marketing illustration of products must be clear,accurate, relevant, and easy to understand.

In addition, the regulation also particularly emphasizes that the purpose of legislation is not to limit the phraseology list applicable for claims, but so that the above 6 principles shall be followed. In the light of the above principles,enterprises can choose the phraseology of claims, as long as the claims are supported by some corresponding evidences.The regulation does not specify any methods for evaluating the claims, but these evaluation methods must be based on scientific practice.

In order to unify the related parties to understand and implement the regulation, Guidelines to Commission Regulation EU No 655/2013[6]was also released by EU in 2013, which describes the detailed requirements of various criteria.

Regulations on cosmetics daims of China

The current Administrative Provisions on Cosmetics Labeling[4]clearly puts forward that the following contents shall not be labeled on the cosmetic identification: the exaggerated function, false propaganda, belittling to similar products; the explicit or implied medical functions;a product name easy to mislead or confuse the consumers.In 2010, China Food and Drug Administration (CFDA)issued Naming Rules of Cosmetics[7]and Naming Guidelines of Cosmetics,[8]both of which are for the expansion for “the contents not allowed to be labeled”,mentioned in Administrative Provisions on Cosmetics Labeling.

At the end of 2014, CFDA issued Regulations on the Supervision and Administration of Cosmetics (2014)[9]and Administrative Measures for Cosmetics Labeling(2014),[10]which put forward more strict and specific requirements on cosmetic product claims. Although these two regulations have not been implemented yet, but from a global view, the standardized administration of cosmetic claims is an irresistible trend.

In June 2016, CFDA issued Notice on the Labeling Requirements for the Efficacy of Sunblock (No. 107, 2016),[11]which provides that the highest SPF value marked for sunscreen cosmetics was adjusted from “30+” to “50+”,and the maximum allowable PA value marked for sunscreen cosmetics was adjusted from “+++” to “++++”. The detection methods shall be in accordance with Safety and Technical Standards for Cosmetics (2015), and when necessary, refer to the relevant methods released by ISO. In August 2016,CFDA also issued Reply of the Request on Clearing Labeling Requirements of Cosmetics (No. 568, 2016),[12]providing more detailed requirements on SPF labeling of cosmetic products.

1) When the SPF value is 2～5 (including 2 and 5), the measured SPF value is labeled.

2) When the SPF value is 6～50 (including 6 and 50),the labeling upper limit is the actual measured SPF value;and the lower labeling limit is the smaller between lower limit on 95% confidence interval and the maximum integer multiple of 5 which is lower than actual value.

3) When the SPF value is higher than 50, and the lower limit on 95% confidence interval of actual testing value is higher than 50, the SPF of sunscreen cosmetics shall be labeled as “50+”; when the SPF value is higher than 50, and the lower limit on 95% confidence interval of actual testing value is lower than 50, the labeling upper limit is “50+”,and the lower labeling limit is the lower limit of measured value within a 95% confidence interval.

The change of the above regulations shows that the gap between Chinese and EU regulations is narrowing, with the trend of development in line with international norms.

Summary

Viewed from EU and China’s cosmetics regulations,for the efficacy claims of cosmetic products, the regulatory efforts have been enhanced gradually, with laws and regulations increasingly perfect, which will put forward higher requirements for enterprises. As for enterprises,firstly, they must understand the requirements of the relevant laws and regulations; secondly, they should ensure the efficacy of cosmetic product claims to comply with the regulatory requirements; finally, they need to actively innovate and improve the product’s market competitiveness premitted by laws and regulations.

[1] European Union. Regulation (EC) No 1223/2009 of the European parliament and of the council of 30 November 2009 on cosmetic products. Office Journal of the European Union 2009, L342, 59-209.

[2] National Health and Family Planning Commission of the People's Republic of China. Regulations on the Hygiene Supervision over Cosmetics 1989. http://www.nhfpc.gov.cn/zwgkzt/pgz/200804/29220.shtml.

[3] Characteristics of Chinese Women’s Demand for Cosmetics 2016. http://mt.sohu.com/20160404/n443292246.shtml.

[4] CFDA. Provisions on the Administration of Cosmetics Labeling (Decree No.100 of AQSIQ). http://www.aqsiq.gov.cn/xxgk_13386/ywxx/spjhzp/201102/t20110228_178328.htm.

[5] European Union. Commission regulation (EU) No 655/2013 of 10 J u l y 2013 laying down common criteria for the justification of claims used in relation to cosmetic products. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0655.

[6] Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. http://europa.eu/geninfo/query/resultaction.jsp?query_source=GROWTH&Query Text=+%2 8EU%29+No+655%2F2013&op=Search&swlang=en&form_build_id=form- 61qhpl DWCFU9ss ZRhf9Gkeb_Jd IN4MGIi Qw IRz RBg O8&form_id=nexteuropa_europa_search_search_form. ec.europa.eu/Docs Room/documents/13173/attachments/1/.../pdf.

[7] CFDA. Naming Rules of Cosmetics (CFDA MC No. 72[2010]),2010.

[8] CFDA. Naming Guidelines of Cosmetics (CFDA MC No.72[2010]), 2010.

[9] CFDA. Regulations on the Supervision and Administration of Cosmetics (Draft for comment). http://www.sda.gov.cn/WS01/CL0781/108920.html.

[10] CFDA. Administrative Measures for Cosmetics Labeling (Draft for comment). http://www.sda.gov.cn/WS01/CL0781/109234.html.

[11] CFDA. Administrative Requirements for SPF Identifications of Sunscreen Cosmetics. http://www.sda.gov.cn/WS01/CL0087/154562.html.

[12] CFDA. Replies to Relevant Problems on Further Defining the Requirements of Cosmetic Labeling (CFDA MC No.568 [2016]).http://www.sda.gov.cn/WS01/CL0846/162960.html.