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Interpretation on Regulation and Policy for “Three Schemes ”of China Food and Drug Administration

时间:2014-01-27 13:42:06  来源:  点击数:
Key words: Provisions on the Establishment of Major Functions, Internal Organization and Personnel of CFDA; children cosmetics declaration; non-special usage cosmetics classification; existing cosmetics ingredients.
Abstract:China’s State Food and Drug Administration (SFDA) has issued “Three Schemes ” (Main Responsibilities, Internal Structure and Staffing) after it changed name to China Food and Drug Administration (CFDA), which arouses conjectures among industry insiders, especially on the issues that imported non-special use cosmetics must apply for record-keeping to the food and drug administrations at provincial level, however, the detailed laws and regulations on the issue have not been released in China. The article covers policy interpretation, as well as analysis of CFDA’s laws and regulations on children cosmetics declaration, non-special usage cosmetics classification, and existing cosmetics ingredients.
Introduction: After issuing “Three Schemes ”, great expectation has been placed on CFDA, and the new reforms on food regulatory changes in sub-sub-issues, drug regulatory decentralization, strengthen macroeconomic policies and local supervision have been significantly attended by the industry.
One of the options for the current round of institutional reform, Market Supervisory Authority is established with reference to the practice of Guangdong, Shenzhen, Shunde, health products placed under a unified framework for risk analysis of consolidated supervision. But there exist some doubts in plans implement, and the drug administrations at provincial level have not published detailed policies. The policies about cosmetics in the “Three Schemes” are listed below:
1. The procedures of examination and approval required for manufacture of cosmetics and grant of hygiene certificate will be combined into a single examination and approval procedure;
2. The food and drug administrations at provincial level take the responsibilities of the original SFDA for examination and approval of import of non-special function cosmetics; 
3. The CFDA takes the responsibilities of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ) for examination and approval of manufacture and compulsory inspection of cosmetics.
We devote great attention to the devolution of responsibility, or how the state relevant authorities to do after imported non-special purpose cosmetics get approval from provincial food and drug regulatory authorities. If the foreign company should appoint a Chinese responsible agent to deal with registration, how can the other provincial legal units which hope to work as an agency for the other products made by the same applicant get qualifications for declaration? Some import dealers will take advantage of policy loophole to choose remote or small regions based on local development, geography, foreign trade, and difference so as to increase possibility of obtaining qualifications. Some companies worry that the loss of Approval Number will make market more difficult to develop, terefore, they will take a wait-and-see attitude. 
The above is our supposition. The issues on how to realize balance management among food and drug administrations at provincial level, how to make provincial administrative approval system more simple and convenient, and how CFDA to integrate responsibilities will be clear after China unveils detailed policy.
It is learned that, as a principle, the reforms for food and drug administrative bodies at provincial, municipal, and county level will be completed by the end of June, September, and December this year. But will the reform in import non-special purpose cosmetics take two or three years like SFDA began to take up the responsibility of cosmetics registration instead of National Health and Family Planning Commission of China (NHFPC) in 2008? 
Special use cosmetics for sun block, hair perm, hair dye, hair growth, spots removal, fitness, breast shaping, deodorizing, and hair removal are still approved by CFDA which will strengthen supervision system. Beijing Oriental Chemical Information Co., Ltd. (OCI) will keep track of the national latest news and provide solutions for you.
The following is analysis of relevant policies about cosmetics registration in recent years.
1) On May 29, 2012, SFDA issued Letter on Seeking Opinions on Classification Management of Non-special Cosmetics (No.263-2012), inviting public comments on the amended categorized management measures for non-special use cosmetics. Under the draft, SFDA changed definition of freckle removal cosmetic; moved cosmetics intended for whiteing, acne removal into freckle removal cosmetics; strengthened safety risk monitor on nine produces such as hare care products that claim to have effect of secretion control of oil on the skin and head, dandruff removal, andanti-wrinkle, and conducted risk assessment based on information collected from safety risk monitoring and decided whether to regulate them as special use cosmetics; conducted strict supervision for cosmetics for children and required that cosmetic companies not claim that cosmetic products are specifically made for special human groups such as pregnant women or breastfeeding women.
2) On September 17, 2012, SFDA published the third batch of the Inventory of Existing Cosmetic Ingredient in China (IECIC) for public consultations after the first batch and second batch were also released earlier the year, promoting the standard use of cosmetic ingredients.
3) On October 12, 2012, SFDA issued the final version of Guidance on Application and Review of Children's Cosmetics, which will take into effect from February 1, 2013. Under the guidance, applicants should pay close attention to the detailed requirements for the selection and safety evaluation of cosmetic ingredients along with the design principles for the formula from the safety point of view. Producers of children cosmetics shall use minimum varieties of ingredients, choose those that have a certain history of safe use, avoid adopting efficacy components mainly for whitening, spot-removal, acne treatment, deodorant, hair growth, hair dye, hair perm, body-shaping, breast beautifier and so on. Furthermore, it is not encouraged to employ ingredients manufactured with the generic or nano technology. Meanwhile, formula of these products should contain less or no coloring agents, preservatives, and surface-active agents.
Conclusion: CFDA has tightened supervision on classification management of cosmetics according to the newly issued policies and regulations, company declaration and authority supervision will face more challenges once classification management for non-special purpose cosmetics goes into effect, and great changes will take place in cosmetics supervision with the release of policies on devolution of responsibility for approval of import non-special purpose cosmetics. 
References: CFDA's Main Responsibilities, Internal Departments and Staff Organization
                       CFDA's Guidance on Application and Review of Children's Cosmetics
  Letter on Seeking Opinions of Classification Management of Non-special   
  Cosmetics
  CFDA's Letter on Seeking Opinions of the Third Batch of the Inventory of
   Existing  Cosmetic Ingredient  
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