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.
2.1 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
3.2 Regulatory framework
Based on the nature of files
Based on content
Registration & Filing
Production & Operation Regulations
Import & Export Regulations
4. Compliance Requirements
4.1 Technical standard
Relevant laws & regulations
Allowed raw materials
Allowed auxiliary materials
4.2 Registration & Filing
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
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
Enhancing immune function
Aiding weight loss
Aiding blood lipids reduction
Improving growth and development
Aiding blood sugar reduction
Increasing bone density
Improving nutritional anemia
Aiding protection against chemical liver injury
Relieving body fatigue
Relieving eye fatigue
Facilitating lead excretion
Improving skin moisture
Improving skin oil content
Aiding blood pressure reduction
Regulating enteric bacteria flora
Increasing milk secretion and anti-mutation
Improving endurance during anoxia
Aiding protection against gastric mucosa
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.