CFDA Released the First Batch of Health Food Raw Materials for Record (filing) Nutrition Supplements

In China there are two categories of health food:

I. Nutrition supplement (vitamin and (or) mineral supplement)

II. Functional health food

What Is the Nutriti on Supplement in China?

In accordance with “Provisions on the Application & Approval for Nutrition Supplement (Trial)(Notice No.[2005]202)”, the definition of nutrition supplement is:

Nutrition supplement is the product that replenishes the vitamins and (or) minerals but without providing energy.

Current Legislations of Nutrition Supplement in China

Under the current regulatory framework, companies who plan to place nutrition supplement in Chinese market must apply for and obtain a health food approval certificate from China Food and Drug Administration (CFDA). Foreign companies shall appoint a Chinese agent to deal with registration and obtain such certificate.

The current main regulations regarding nutrition supplement are listed as follows.

NO.

Regulations

Publish Authority

Release Date

Registration Regulations

1

Administrative Measure on Health Food Registration (Trial) (Order No.19)

CFDA

2005-4-30

2

Provisions on the Application & Approval for Nutrition Supplement (Trial) (Notice No. [2005]202)

CFDA

2005-5-20

Test Regulations

1

Guideline on Stability Test of Health Food

CFDA

2013-12-02

Label Regulations

1

Notice on Provisions and Guidance for the Naming of Health Food (Notice No.[2012]78)

CFDA

2012-3-15

2

Rules on the Labeling of Health Food (NO.(1996)38)

MOH

1996-7-18

Other Relevant Laws and Regulations

1

Examination method and evaluation criterion on GMP of health food (NO.[2003]77)

MOH

2003-4-2

2

GB 16740-2014 National Standard Health Food

NHFPC

2014-12-24

3

GB2760-2014 Food Safety National Standards for the Usage of Food Additives

NHFPC

2014-12-24

4

 Advertisement Law (Order No.22)

President of the People’s Public of China

2015-4-24

5

Food Safety Law (Order No.21)

President of the People’s Public of China

2015-4-24

6

Administrative Measure of Food Production License

CFDA

2015-8-31

7

Administrative Measures of Food Operation License

CFDA

2015-8-31

8

Administrative Measures of Food Recall

CFDA

2015-3-11

Future Legislations of Nutrition Supplement in China

The regulatory framework pertaining to the nutrition supplement is changing significantly recently. Some general updated laws and regulations were released and implemented in 2015. According to the new Food Safety Law, if the nutrition supplements meet the requirements, companies who plan to place them in Chinese market only need to filing (record) the product instead of applying for the registration certificate.

The drafted main regulations regarding nutrition supplement are listed as follows.

NO.

Regulations

Publish Authority

Release Date

Registration Regulations

1

Administrative Measures of Health Food Registration and Filing(Draft)

CFDA

2015-7-28

2

Administrative Measures on Health Food Function Directory and Health Food Raw Materials Directory (Draft)

CFDA

2015-7-28

3

Nutrition Supplement Raw Materials Directory (Draft)

CFDA

2016-02-17

Label regulations

1

Administrative Measures on the Labeling of Health Food (Draft) 

CFDA

2015-7-28

Other Relevant Laws and Regulations

1

Supervision and Administrative Measures of Food Commerce in Network(Draft) 

CFDA

2015-8-18

2

Supervision and Management on Cross-Border Electronic Commerce of Imported Food through Bonded Online Shopping (Draft)

AQSIQ

2015-10-13

What Kind of Health Food Could Apply for the Filing Certificate?

I. The domestic functional health food of which the raw materials meet the requirements in the Health Food Raw Materials Directory.
II. The domestic and imported nutrition supplement of which the vitamins and (or) minerals meet the requirements in the Health Food Raw Materials Directory.

Therefore, “Health Food Raw Materials Directory” is the most important condition to judge if the health food is in the filing (record) scope.

With the focus of the directory, China Food and Drug Administration (CFDA) released the first batch of approved Health Food Raw Materials Directory (Draft) (EN version free download) on February 17, 2016. However, the first batch of the drafted directory is only applicable to the nutrition supplement. Compared with the requirements of “Provisions on the Application & Approval for Nutrition Supplement (Trial)”, the approved vitamin & mineral category, approved compounds, daily intake and other requirements of the first batch drafted directory are changed.

Some examples of the main changes are collected as following:

Changes

Example

The category of vitamins and minerals is reduced from 25 to 22.

I. Chromium and molybdenum are deleted.

II. Beta-carotene is merged into the vitamin A category.

The compounds are reduced from 112 to 61.

I. The calcium caseinate, calcium citrate malate and calcium malate as the compound for calcium supplement are deleted.

II. The heme iron (ferrous porphyrin) and hemin (ferriheme) as the compound for iron supplement are deleted.

The daily intake range is changed.

I. The daily intake of calcium for adult is reduced from 250-1000 mg to 200-800 mg.

II. The daily intake of vitamin D for adult is increased from 1.5-10 ug to2.0- 15 ug.

III. The daily intake range of vitamin B1 for nursing mothers is expanded from 0.5-1.0 mg to 0.3- 1.5 mg.

The application scope of some compounds is narrowed.

Calcium acetate, calcium lactate, vitamin A, selenium yeast, ferrous lactate, ferrous succinate and potassium carbonate are restricted to be used in nutrition supplement for people aged more than 4 years old.

Matters Needing Attention for Filing Nutrition Supplements

If manufacturers would like to record (filing) the nutrition supplements, the raw materials, product dosage form, daily intake, quality standards, product labeling shall conform to the requirements of the first batch raw material directory.

Attention Matters

Example

Compound raw materials

I. Compounds used in the filing nutrition supplement must conform to the requirements of nutrition supplement raw material directory. Any compounds used that are out of the scope of the directory shall be applied for approval in accordance with “Administrative Measures on Health Food Raw Material Directory and Health Function Directory”.
II. Nutrition supplement that is also suitable for 1-4 year-old children could only use the compounds that are marked for all people in the directory.
III. Premix feed is prohibited to be used.

Product dosage form

I. The major dosage form of filing nutrition supplements should be in tablets, capsules, granular, powder or oral liquid rather than sustained-release preparations, controlled release preparations, sublingual absorption preparations, gastro-resistant preparations or sprays.

II. Dosage form shall match physical and chemical properties of the raw materials (e.g., soft capsule dosage form cannot be used for water-soluble nutrients).

Daily intake

The total daily intake of filing nutrition supplements made in granular and powder form shall not be more than 20g. Filing nutrition supplements in oral liquid shall not be more than 30ml per day.

Nutrition supplement quality standards

Filing nutrition supplements should be in accordance with the GB 16740-2014 National Standard Health Food , the relevant standards and technical requirements.

Product labeling

The labeling of filing nutrition supplements should conform to the regulation named Administrative Measures on the Labeling of Health Food.

The Advantages and Disadvantages of Record (Filing) Policy

Advantages

The cost (about 20,000 RMB) of the re-test could be saved.

The duration (about 80 workdays) of technical evaluation with CFDA could be saved.

Disadvantages

The homogeneity phenomenon of the filing heath food will be comparatively serious.

The logo for the filing health food and the logo "blue hat" for the registration health food may be different.

The implementation date is not sure.

Only the domestic functional health food and domestic & imported nutrition supplement of which the raw materials meet the requirements in the Health Food Raw Materials Directory could apply for the filing certificate. However, the raw materials in the directory are very limited.

Oversea enterprise who would like to save the money and time for putting nutrition supplement in Chinese market is suggested to wait for the filing policy to come into force. However, in order to sell original and more competitive products in China, enterprise is advised to register the nutrition supplement that is demanded in the Chinese market. In addition, two-pronged strategy for nutrition supplement is also recommended.
With the regard to the procedures of the health food record (filing), please kindly click below link for further information.

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CIRS Initially set up by China Inspection and Quarantine (CIQ) Bureau in 2007 and now has grown to be a leading provider of comprehensive compliance services for companies doing businesses in/with China. We provide one-stop solutions to your regulatory issues in China. We also deliver the most up-to-date regulatory information about food safety control laws in China. For health food, we offer the following service: 

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