New Trends of Comsmetic Regulations in China

Hua Zhao, Zhaoqing Zhou, Ying Tang

Department of Cosmetics, School of Sciences, Beijing Technology and Business University, China

Beijing Key Laboratory of Plant Resources Research and Development, Beijing Technology and Business University, China

With the social progress and economic development,more and more people begin to emphasize on their healthy skin care, which promotes the continuous prosperity of the cosmetic market. The China Food and Drug Administration (shortened as CFDA) also has promulgated a series of policies and regulations one aたer another to strengthen the scientific supervision of cosmetics and guarantee the healthy and orderly development of the cosmetic industry.[1]

Requirements for Filing of Domestc Non-special use Cosmetcs

China’ s current laws and regulations divide the cosmetics into two major types: the special use cosmetics, the non-special use cosmetics. The former is under license administration while the later is under filing administration. In April 2011, CFDA issued the Administrative Measures for Filing of Domestic Non-special-use Cosmetics[CFDA-Licensing [2011], No. 181][2]for strengthening the administration of domestic non-special use cosmetics. However, due to the high cost of safety inspection by enterprises and lack of eあective supervision measures,the implementation of the aforesaid notice was not satisfactory. To promote and deepen the filing of domestic non-special-use cosmetics, CFDA issued the Notice on the Adjustment of Cosmetics Registration and Filing Administration[3](hereinafter referred to as the Notice)on 16 December 2013 by starting with “catering to the voice of the industry, streamlining administration and delegating power to lower levels, reflecting the main body responsibility of enterprises, implementing supervision measures, guiding enterprises standardized development and promoting the self-discipline of the industry”. The Notice requires that since 30 June 2014, the manufacturer of domestic non-special use cosmetics shall conduct online record-keeping of the products online before placing products in the market. The filing information shall be confirmed by the provincial food and drug authority and then released on the CFDA oきcial website for public inquiry. On the other hand, the provincial food and drug authority will no longer issue the Domestic Non-special use Cosmetics Filing Certificate.

The Notice firstly made an adjustment to the filing process, the filing requirement, reduced while post-market,strengthened. The previous post-market filing requirements for non-special use cosmetics manufactured in China has been changed into pre-market online notification from 6 Jun 2014, which is similar to EU cosmetics management mode. Next, the provincial food and drug authority is only responsible for checking the integrity of filing materials during the filing stage, and the safety supervision will be done in a form of post-supervision.Secondly, the Notice simplified the filing materials of domestic non-special use cosmetics. The enterprise only needs to submit the basic information such as product formula (excluding their contents with the exception of restricted substances), sales packaging online. Other R&D related information shall be filed by the enterprise for future reference. This practice allows the enterprise to file its products more conveniently, thus alleviating its pressure of materials declaration and strengthening its subject responsibility for product safety in the meanwhile. Thirdly, filing information is published to push forward social supervision. The filing certificate is no longer issued for filed products and instead, filing related information is publicized in a unified way on the CFDA website for public supervision and inquiry. Fourthly, the dual-filing is implemented for commissioned production.Both entrusting party and manufacturer shall report and submit filing information to the provincial food and drug authority so that regulatory authority can work better in supervision and the requirement of shared responsibility of production safety for both parties is reflected. Meanwhile, through an intelligent recognition function of the networked database, the information reported by both parties is integrated and merged to avoid the redundancy of data.[4]

The Notice also provides for the contents including ingredient information, changes in filing materials and verification of filing information in the filing materials.Others such as the products declared for children or infants, preparation of technical requirements for products,product test and materials of risk assessment for products should be done in accordance with the requirements of related laws and regulations.[5]

Skin-whitening cosmetcs are newlyclassified as special-use cosmetcs

Market survey data shows that more than 80% of the consumers aged 20-50 use whitening products, the demand for spot removing product and lighten skin product as well as whitening and sunscreen product is also growing. As one of the major categories of cosmetics consumption in China, whitening product needs special attention.[6]There are many cosmetics in the market today declare to be helpful to whiten skin. A consensus on its possible safety risks has been reached by countries. Special administration has been implemented to these cosmetics. For example, the sking whitening cosmetics are classified as OTC drugs and quasi-drugs in Japan.

Therefore, under the Notice, skin-whitening products are newly incorporated into the scope spot-removing products and are managed as special-use cosmetics. All cosmetics declared to be helpful to beautify and whiten skin intended to be placed on the Chinese market should get approval certificate from CFDA. It is highlighted that skin whitening products providing only physical cover should mark clearly on product labels. On 11 April 2014, CFDA issued the Letter on Further Clarifying Implementation of Cosmetics Registration and Filing[7]to further define the scope of whitening cosmetics clearly. The product defined as a whitening product, should subject to management in accordance with the regulations for special-use cosmetics. Cosmetic companies should not use any confusing statements or words to imply a whitening eあect. Whitening skin through a superfical physical covering and the label marks the expression of whitening, the product will be defined as a whitening product and subject to management in accordance with special-use cosmetics regulations. Products which explicity indicate or imply that the products achieve whitening effect through physical coverage but without an accompanying efficacy claim only having the function of cleaning or exfoliating should be listed as non-special use cosmetic.

Inventory of Existng Cosmetc Ingredient in China

The selection of ingredients plays an important role in the safety of cosmetics. In order to further strengthen the administration of cosmetic ingredients, CFDA updated the Inventory of Existing Cosmetic Ingredient[8]in China (IECIC 2015 Final Version) on 23 December 2015 (hereinafter referred to as the IECIC). IECIC is an objective collection of cosmetic ingredients in use and serves as the main reference for determining the regulatory status of cosmetic ingredients. But it is not the list of approved cosmetic ingredients in China. It needs to be noted that CFDA has not conducted any risk assessments of the ingredients listed in the IECIC 2015, therefore, manufacturers have to undertake the responsibility of product safety by selecting ingredients that comply with relevant regulations and standards and also by conducting their own risk assessments.

IECIC includes 8,783 ingredients in Chinese names,INCI names/English names. There are 153 revisions in total. IECIC will be adjusted and improved to ensure its legitimacy, feasibility and scientific nature as the reference for determining the new cosmetic ingredients.

Safety and Technical Standards for Cosmetcs

As an important technical specification in the cosmetic industry, the Hygienic Standard for Cosmetics (HSC 2007)plays a critical role in promoting the scientific and technological progress of the industry and ensuring the safety of cosmetics. Nonetheless, with the development of the cosmetic industry and the improvement of scientific understanding, the HSC 2007 fails to meet the development needs of the current cosmetic industry in some aspects. For example, some of the concepts, terms and expressions need to be further improved. Some test and evaluation methods,and technical safety requirements for products and ingredients are relatively lagging behind or missing. Hence HSC 2007 is urgently to be revised and perfected.

On 23 December 2015, CFDA issued the Safety and Technical Standards for Cosmetics (2015 Version) (No.268, 2015)[9], which will be taken into implementation since 1 December 2016. The Safety and Technical Standards for Cosmetics has revised and improved related terms and definitions, detailed the general requirements for cosmetic safety technologies and adjusted the limited level of some hazardous substances. It has also revised list of cosmetic prohibited, restricted and permitted ingredients based on HSC 2007, the EU’s new regulations and latest global cosmetics safety and supervision standards,revised physiochemical test and evaluation methods,removed the sections out of the scope of the Safety and Technical Standards for Cosmetics from the Hygienic Standard for Cosmetics, added 60 test methods for prohibited and restricted substances, standardized the microbiological test method, toxicological method, human safety and eきcacy evaluation test method.

Issuing the Safety and Technical Standards for Cosmetics indicated that the target and requirements of China’s cosmetic supervision would focus more on the assurance of product safety and highlighted the orientation of the Safety and Technical Standards for Cosmetics as a technical standard. Comparing with the Hygienic Standard for Cosmetics, the Safety and Technical Standards for Cosmetics clarified the definition and the scope is more strict in safety requirements for the products, ingredients and production processes of cosmetics, and better meets the current needs of safety supervision throughout the R&D, production and use of cosmetics. Oral care products are not included in the definition of cosmetics in Safety and Technical Standards for Cosmetics. But this kinds of products will be managed as cosmetics when the technical requirements and evaluation methods are mature. Components related to oral care products in the Hygienic Standard for Cosmetics are also removed from the list of restricted components. In summary, the revision of the Safety and Technical Standards for Cosmetics raised the barrier to entry the industry, strengthened the requirements on R&D technology in enterprises, improved the quality of products in the market and better protected the interests of consumers.

Guidance for Safety Risk Assessment of Cosmetcs

In order to regulate and guide safety risk assessment, and guarantee the safety of cosmetics consumption, CFDA organized the draた Guidance for Safety Risk Assessment of cosmetics (shortened as the Guidance) (Request for Comments(RFC))[10]for consultation public on 10 November 2015. The Guidance clarified respectively the scope of application, basic principles and requirements, qualifications for safety risk assessors, risk assessment procedure, toxicology studies,risk assessment of cosmetics ingredients, safety evaluation of cosmetics product and safety risk assessment report, and related terms and definations. Additionally, the appendixes of the Guidance provided the templates of the risk assessment report on cosmetics ingredients and the safety assessment report on cosmetics product.

Cosmetics safety risk assessment refers to the scientific evaluation of known or potential adverse eあects to human health for cosmetics via the application of the existing scientific materials. Cosmetics can be generally consid-ered as a combination of various ingredients. The safety of the ingredients is the premise of cosmetics safety. The safety evaluation of cosmetic products shall be based on the risk assessments of all ingredients and risk substance.The safety risk assessment for cosmetics may reflect the potential risks of cosmetics effectively and replace the toxicology test for final products to some extent. At present, the United States, the EU, Japan and other developed countries and regions are using risk assessment widely to evaluate the safety of cosmetics. However, currently,there is no guidance document of safety risk assessment for cosmetics in China. The Guidance for Risk Evaluation of Substances with Potential Risks in Cosmetics issured by the former State Food and Drug Administration just described the risk evaluation procedure for substances with possible safety risk in cosmetics, which is diきcult to guide the safety risk assessment of cosmetics scientifically and systematically. Though the Guidance does not serve as a law-enforcement basis for cosmetics supervision, it will be adopted as a technical document for carrying out the safety risk assessment for cosmetics. Hence it has important directive significance to the standardized and safe production of cosmetics manufacturers.

Cosmetc Producton License

In the past, the cosmetics manufacturers must have the National Industrial Production License and the Hygiene License for Production Enterprises of Cosmetics.The lack of unified administration has always been criticized by the industry. On December 15, 2015, CFDA issued the Notice on Related Items of Cosmetics Production License (No. 265, 2015)[11]and the Notice about How to Better Implement the Relevant Work of Cosmetics Production License to implement the production license system for cosmetics manufacturers. It means that all cosmetic manufacturers in China have to obtain the Cosmetics Production License approved and issued by the provincial FDA. In the meanwhile, CFDA also issued the Work Specification of Cosmetics Production License and the Key Inspection Points of Production License of Cosmetics, which marked the formal implementation of certificates’ combination. The new certificate puts forword strict requirements on quality management system of manufacturers. And the new certificate has also more detailed requirements on workshop and production equipment. It will play a positive role in standardizing cosmetics production.

Conclusion

In recent years, in order to adapt to rapid development of the cosmetics industry, the administration departments advocate scientific supervision, make on-going eあorts to standardize and improve the legal and regulation system of cosmetics, build a cosmetics supervision network platform, strengthen mutual communication and coordination among government departments, enterprises and the public, and emphasize on the subject responsibilities of enterprises, industry self-discipline and social supervision principles. These approaches will further stimulate the sense of responsibility and innovation potential of enterprises and lead to the more prosperous and harmonious development of the cosmetics market.

Reference

[1] Hao Xu; Zitao Wang; Weijing He; et al. Discussion on Drug Supervision Responsibility and Present Situation, Strategies of Cosmetic Administration. Pharmacy and Clinics of Chinese Materia Medica 2015, 6(2), 92-97.

[2] China Food and Drug Administration.CFDA[2011]181 Notice of Administration of Domestic Non-special Use Cosmetic 2011.

[3] China Food and Drug Administration. Notice of the Adjustment Of Cosmetic Registration(No.10) 2013.

[4] Ziyu Song. Existing Problems and Solutions of Cosmetic Industry Manage.Capital Medicine 2014, 11, 53-54.

[5] Yu. Chinese Cosmetic Regulations Developments Inventory.Fujian Textile 2015, 8, 10-11.

[6] Bo Song. New Cosmetic Regulations Come to Implement and Whitening Market Consolidation Coming Soon. China United Business News 2014, 3, 1-2.

[7] China Food and Drug Administration. CFDA(2014)70 the Implementation Letter about Further Clarify the Cosmetic Registration and Filling 2014.

[8] China Food and Drug Administration. Notice of Issued Inventory of Existing Cosmetic Ingredients in China(2005)CFDA[2015]105. 2015.

[9] China Food and Drug Administration. Notice of Issued Safety and Technical Standards for Cosmetics(2015),CFDA[2015]268. 2015.

[10] China Food and Drug Administration. Cosmetic Safety Risk Assessment (Request for Comments) 2015.

[11] China Food and Drug Administration. Notice of the Relevant Items of the License System for Production of Cosmetics,CFDA[2015]265. 2015.