China Health Food Regulation
Aug 19, 2020
Lennie Tao
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CONTENTS

1. Definition


According to GB 16740-2014, health food in China refers to food products which claim to have specific health functions or supplement certain vitamins or minerals. That is, health food is suitable for certain groups of people with the function of maintaining homeostasis, not aiming at the purpose of therapy, and will bring no acute, sub-acute or chronic harm to human body.

2. Classification


2.1 Functional health food

Such food, which shares common properties with general food and can regulate human body functions, help maintain homeostasis and modify physiological parameters which are generally considered risk factors in the development of diseases but is not used or does not make claims purporting to offer efficacy in the treatment of disease.

2.2 Nutrition supplement

These products, with vitamins and minerals as major ingredients, are used for the purpose of supplementing nutrients for the human body. There are single-ingredient and multi-ingredient nutritional supplements.

3. Supervision System


3.1 Competent authorities & Responsibilities

competent authorities and responsibilities.png

3.2 Regulatory framework

Based on the nature of files

regulatory framework.png

Based on content

Content

Authority

Name 

General

NPC

Food Safety Law of The PRC (2015)

State Council

Regulations   for the Implementation of Food Safety Law of the PRC

NOH

GB 16740-2014 National Standard for Health Food (2014)

Registration & Filing

SAMR

Administrative Measures for Registration and Filing of Health   Food (2016)

SAMR

Guidance   for Health Food Registration (2016)

SAMR

Detailed   Guidance for Health Food Registration Approval (2016)

SAMR

Health Food Raw Materials Directory (1st Batch) (2017)

SAMR

List of Auxiliary Materials for Health Food Filing and Terms   of Use (Trial) (2017)

SAMR

Directory   of Health Function Available to Claim for Health Food (The 1st Batch) (2017)

SAMR

Guideline for Health Food Filing Application (Trial) (2017)

SAMR

Main   Production Process of Health Food Filing Products (Trial) (2017)

Production & Operation Regulations

SAMR

Food   production license management measures (Revised 2017)

SAMR

Detailed Rules for Examination of Health Food Production   Licensing (2016)

SAMR

Food   Business License Review General Rules (Trial) (2015)

SAMR

Management   Measures for Daily Supervision And Inspection of Food Production And   Operation (2016)

SAMR

Food   Safety Sampling Inspection Management Measures (2014)

SAMR

Internet   Food Safety Violations Investigation Measure (2016)

SAMR

Food Recall Management Measures (2015)

SAMR

Measures   for the Supervision and Administration of the Quality and Safety of the Marketing   of Edible Agricultural Products (2016)

Labelling

MOH

SAMR

SAMR

Provisions for Healthy Food Labeling (1996)

Administrative Measures on Health Food Labeling (Draft)   (2015)

Inspection Points of Health Food Labeling (2017)

Import & Export Regulations

SAMR

Import   and Export Food Safety Management Measures (2011)

SAMR

Import   and Export Pre-Packaged Food Label Inspection Supervision and Management Regulations   (2012)

SAMR

Regulations   on the Registration of Foreign Producers of imported Foods (2012)

SAMR

Imported Food importers and Exporters Filing Management   Regulations (2012)

SAMR

Import and Export Commodities Random Inspection Management   Measures (2002)

SAMR

Import and Export Goods Exemption Inspection Measures (2002)

4. Compliance Requirements


4.1 Technical standard

Item

Relevant laws & regulations

Allowed raw materials

Health Food Raw Materials Directory (1st Batch)

Allowed auxiliary materials

List of Auxiliary Materials for Health Food Filing and Terms   of Use (Trial)

4.2 Registration & Filing

Registration Scope

1. Health foods containing raw materials beyond the scope of permitted health foods raw material catalog

2. Health foods imported for the first time

Registration Procedure for Imported Health Food

Ref: Administrative Measures for Registration and Filing of Health Foods

registration process.png

Filing process

filing process.png

4.3 Labelling requirements

1. It should not claim that the function of the product (listed below) is to prevent or treat any disease.

2. It should indicate clearly who is the appropriate and/or inappropriate consumer for the product, accurate labeling of active/marker ingredients and their contents.

3. The functions and ingredients must be consistent with those on the label and in the instructions.

Health food functions approved in China

No.

Approved Function

No.

Approved Function

1

Enhancing immune function

15

Aiding weight loss

2

Aiding blood lipids reduction

16

Improving growth and development

3

Aiding blood sugar reduction

17

Increasing bone density

4

Increasing antioxidants

18

Improving nutritional anemia

5

Improving memory

19

Aiding protection against chemical liver   injury

6

Relieving body fatigue

20

Removing acne

7

Relieving eye fatigue

21

Removing chloasma

8

Facilitating lead excretion

22

Improving skin moisture

9

Clearing throat

23

Improving skin oil content

10

Aiding blood pressure reduction

24

Regulating enteric bacteria flora

11

Improving sleep

25

Facilitating digestion

12

Increasing milk secretion and   anti-mutation

26

Improving constipation

13

Improving endurance during anoxia

27

Aiding protection against gastric mucosa

14

Aiding protection   against radioactivity



4.4 Important notes

♦ SAMR is responsible for the registration of domestic health food, as well as the registration and filing of imported health foods; while the filing of domestic health foods should be approved by provincial administrations for market regulation.

♦ There are 27 function claims that have been predefined by CFDA (now special food registration department of SAMR) for health foods. The time required for application and approval of health food and the associated financial expense are different for different function claims.

♦ Imported health food products must have been sold in a foreign market for more than one year before being registered and filed in China.

♦ Health food products with different formulas shall apply for individual registration or filing.

♦ Health food registration application should be made after passing toxicology experiment about product safety, function experiment, test for functional components or marked ingredients, hygiene testing and stability testing.

♦ The validity period of health food approval is five years, which should be extended before the expiration.

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