Health Food Highlights in the New Food Safety Law Implementation Regulation

On 19 October 2016, Legislative Affairs Office of the State Council P. R. China (SCLAO) released a Notice for public comments on the Food Safety Law Implementation Regulation (Draft) which was set up by CFDA. Previously on 9 December 2015, CFDA had published the first version for public comment. For the revised new one, opinions and advice could be given before 19 November 2016.

As a highly focused special food, there are more detailed requirements on the health food in the revised new Draft. CIRS has sorted out and interpreted the important Articles on health food for your reference.

Highlights on Health Food

Items

Importation information

Article 31

Manufacturers who produce and distribute the health food premix or extract shall apply for the Production License concerning health food.

Article 80

I. Health food can only claim the registered health function.

II. The registration or filing number shall be indicated on the label and specification.

Article 84

I. The product name, dosage, relevant function, production technology, active ingredients, test methods, etc., will all be released when the health food raw material directory is published.

II. If the ingredient, dosage and relevant function of the raw material in the directory are changed due to the changes of production technology, it shall apply for health food registration.

Article 85

The factory shall be on dynamic production state when the inspection agency comes for on-site inspection, and the samples for the test shall be taken on-site.

Article 88

I. The samples that used for health food registration application shall be produced by the factory that met the requirements of health food GMP.

II. The submitted test report shall be issued by qualified inspection agencies.

Article 91

I. There should be counter or area for the selling of health food. The reminder of “health food sales area or counter (保健食品销售专区或者专柜)”  and “This product cannot replace drugs (本品不能代替药物)”shall be set on the conspicuous position.

II. It is forbidden to sell the health food together with common food or drugs.

Article 97

For the same enterprise, it is forbidden to register or file different brands products with the same formula; it is forbidden to register or file different formulas with the same product name.

Article 119

Food that only produced with health food raw materials is not allowed to import in the name of Non-health food.

Article 121

Foods imported by Cross-Border E-commerce (CBEC) shall be compliant with Food Safety Law and the relevant regulations for imported food in this Implementation Regulation.

Article 207

The registration fee and test fee will be required for the health food registration.

CIRS comments

I. For relevant manufacturers, the production application of health food premix and extract in China is clearly stipulated, which shall apply for the Production License concerning Health Food.

II. The on- site inspection shall be on dynamic production state. When the enterprise is notified to be inspected, the factory shall prepare for the production in advance.

III. The registration fee is not free any more. Enterprise shall pay the fee to the government when applying for the health food registration. The charging standard will be developed by the financial department of the State Council, and the price departments under the State Council, together with CFDA. CIRS will keep focus on this matter.

Further information

For the more interpretation on the administrative measure of health food registration and filing in China, please kindly click here.

If you have any other questions, please contact us at service@cirs-reach.com.

Reference:

http://www.chinalaw.gov.cn/article/cazjgg/201610/20161000481908.shtml