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China to Issue New Regulations for Health Food Supervision

  •   1 Aug 2012
  •    Nadine He
  •   Post a comment


    The Regulations on the Supervision and Administration of Health Food is expected to be issued in the near future, which indicates that the State would regulate foods with healthcare functions strictly.

    The State is making every effort to hasten the promulgation of the Regulations on the Supervision and Administration of Health Food, which will supplement the Food Safety Law involving the products approval, production, distribution and supervision of health food industry. The issue will further raise the access threshold to ensure a safety environment considering the prevailing problems resulting from the legislative loss in health food supervision. Since 1996, nearly 12,000 health foods have been approved by the government, while as the Regulations comes out, there would be at least 2000 kinds of which substandard to be banned for sale in China accordingly. So any manufacturers and exporters of health food into China’s market shall pay more attention to comply with the forthcoming Regulations.

    Article 51 of Food Safety Law issued in July 2009 specified that, the State should execute strict control on the food claimed of specific healthcare functions. The food shall not cause acute, sub-acute or chronic hazard to human health, and its label and instruction shall not involve disease prevention or treatment functions. The content should be true and clearly indicate the applicable and inapplicable population, effective ingredients or representative ingredients and the content, and the functions and ingredients shall be consistent with those on the labels and instructions. According to it, the corresponding regulations for detailed measures on the control of health food, namely the Regulations on the Supervision and Administration of Health Food should be made accordingly, while it is under enactment since 2009 without a legal version coming out. Thus, under such an inadequate safety control and supervision system, many substandard products prevail in the health food market. Some enterprises abuse additives in their products, some exaggerate functions beyond the approved information of SFDA. For example, though the State Food and Drug Administration released bulletins of illegal advertising of health food and punished the manufactures strictly, more and more illegal ads still exist. Under such circumstances, the release of the Regulations is a must. Fortunately, four drafts in three years have been released till now, and the legal version is expected to come out.

    Naming guidance for health food

    Actually, some regulations have been released to regulate the health food market. On 15 March 2012, SFDA issued the Naming Rules and Guidelines for Health Food to create a scientific and standard nomenclature system. According to the guidelines, praising words, over-exaggerated words and absolute words such as ancestral, miraculous, top are prohibited for use in generic names of health food. This guidelines also regulates that words misleading people, vulgar or with feudal superstition tone, and manifesting or implying curing effects (As the health food definition specified in GB16740-97 that the health food are referred to which used for certain groups of people with the aim to adjust organic functions instead of curing diseases) should not be used when naming, so will the words such as human name, organ, cell, place, Pinyin, local dialect, etc.

    Functional scope adjustment for health food

    Last August, SFDA issued the Opinion Draft for the Functional Scope Adjustment of Health Food, in which the existing 27 items of functions officially approved to describe health food shall be adjusted, with 4 items cancelled, 4 items for gastrointestinal functions combined into 1 item, and another 3 items for facial metabolism into 1 item, thus there would finally be 18 items left with authorization, such as be helpful to enhance immunity, to reduce blood fat, to reduce blood sugar, to improve sleep, etc. Then on 4 June this year, the same draft version was open for public re-consultation again until 20 June. Though the legal version hasn’t come out, without doubt will the state gradually narrow down the functional scope of the health food. This adjustment will fail thousands of products and strictly keep them out of the market.

    Possible highlights in the forthcoming regulations

    No matter the naming rules and guidelines or the functional scope adjustment, both are in accordance  with the forthcoming Regulations. In near future, the China’s health food market will face a large-scale rectification. It is possible that the Record-keeping System would be authorized in the Regulations. Currently, the health food registration in China should comply with the Provisions for Health Food Registration, which applies to the registration of both domestic and imported health food in China. According to it, Approval System is nationally used requiring a certification for product registration, which needs complete procedure for every product approval no matter the main content is of the same or not. But in the opinion draft of the Regulations, for the nutritional supplement, it only needs to apply to the record-keeping under security approval of SFDA.

    Confronting the coming strict supervision, every relevant enterprise should be ready to meet the regulations, especially the manufacturers of small and medium size which risk high to be kept outside the market. Products applying for registration must strictly comply with the new standards and requirements no matter the state takes approval or record-keeping system. And according to China National Accreditation (CNAS), the future accreditation for health food manufactures and laboratories shall comply with the forthcoming Regulations, and even the prior ones already licensed to produce health food should be re-accredited by CNAS accordingly.


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