Declaration process of health products:

1. Formulation research and demonstration:

According to the requirements of raw materials consumption of health food in China, a formula with strong compatibility, reasonable dosage form and certain efficacy was made, which was studied and demonstrated by health food experts and nutritionists.

Second, the research on small-scale production:

The small-scale production demonstration of the formula was carried out in the GMP small-scale workshop of health food, and the small-scale researchers kept trying and testing, and finally determined the product formula, production technology and methodological demonstration of a set of product testing.

3. Pilot production:

Requirements: In the GMP workshop of health food, three batches of qualified raw materials, auxiliary materials and packaging materials (which are tested in the laboratory) are produced according to the formula and process of the pilot test, and the functional components, components, physical and chemical indexes of the finished products are tested in the laboratory.

IV. Sampling by the provincial bureau:

The provincial bureau conducts sampling from the trial-production unit, mainly checking: product formula; Product quality standards and instructions; Raw materials and packaging materials in and out of the warehouse and inspection records, manufacturer qualifications; Production records of finished products; Finished product inspection records; Instrument use records, equipment use records, production unit qualifications, pilot production tables, etc.

5. Physicochemical, toxicological and functional tests:

General products need to undergo safety tests (toxicology), functional tests (animal function/human food test), stability tests, hygiene tests and efficacy/symbolic component identification tests. According to the function of the product and the characteristics of raw materials, it is also possible to require the declared products to be tested for hormones and stimulants, strain identification tests, raw material variety identification, etc.

for nutrient supplements, functional tests are not required. If the raw materials, processes and quality standards of articles within the List of Vitamins and Mineral Compounds (No.22 [25] of the State Food and Drug Administration) meet the relevant provisions of the state, it is generally not required to provide a safety toxicology test report.

Hygienic inspection mainly refers to the physical and chemical indicators and microbial indicators of products, such as heavy metals, pesticide residues, disintegration time limit, PH value, microorganisms, etc. Stability testing is to test whether the indicators of the product are stable within the claimed shelf life, and its testing items are the same as those of hygiene testing.

generally, the accelerated stability test is carried out, and the indicators are tested when the product is placed at 38℃ and 75% humidity for 1 month, 2 months and 3 months.

Safety inspection is a toxicological inspection of product safety. According to different product formulations, the items of toxicological testing are different. General products should be tested in the first and second stages, and some products should be fed for 9 days or further toxicological examination.

Functional inspection is to test the claimed functions of products according to national standards or test methods approved by the jury.

recheck test: the provincial bureau will designate a test unit to conduct recheck test after sampling is completed.

VI. Product acceptance: Product acceptance refers to the acceptance by the National Bureau, and the application materials need to be prepared in the early stage.

materials to be submitted for the registration and declaration of health food:

1. Application form for registration of domestic health food.

2. A copy of the applicant's ID card, business license or other legal registration documents.

3. Provide retrieval materials (retrieved from the database of the government website of the State Food and Drug Administration) that the common name of the health food applied for registration is not the same as the name of the drug that has been approved for registration.

4. The applicant's guarantee that the patent obtained by others does not constitute infringement.

5. Provide trademark registration certificate (unregistered trademarks are not required).

6. product research and development report (including research and development ideas, function screening process, expected effect, etc.).

7. Product formula (raw materials and auxiliary materials) and formula basis; Sources of raw materials and auxiliary materials and basis for their use.

8. Effective components/iconic components, contents and inspection methods of effective components/iconic components.

9. Sketch of production process and its detailed description and relevant research data.

1. Product quality standards and their compilation instructions (including quality standards for raw materials and auxiliary materials).

11. Types, names, quality standards and selection basis of packaging materials in direct contact with products.

12. Test report and related materials issued by the inspection organization,

including:

Test application form; Notice of acceptance of inspection by the inspection unit; Safety toxicology test report; Functional test report; Test reports on stimulants, illegal drugs, etc. (application for registration to relieve physical fatigue, lose weight and improve growth and development function); Test report of functional components; Stability test report; Hygienic test report; Other inspection reports (such as raw material identification, strain toxicity test report, etc.).

13. Sample product labels and instructions.

14. Other materials that are helpful for product review.

15. Two unopened samples of the minimum sales package.

after receiving the application materials, the national bureau will conduct on-site verification of the test and sample trial production.

VII. Technical review and administrative review:

The National Bureau organizes experts to conduct technical review of products, and will put forward opinions, and the reporting manufacturer will supplement the information according to the opinions.

VIII. Obtaining certificate:

The format of the approval number of domestic health food is: national food health word G+4-digit year number +4-digit serial number; The format of the approval number of imported health food is: national food health word J+4-digit year number +4-digit serial number.

such as: certificate of domestic health food: Guo Shi Jian Zi G214262.

Extended information:

Declarable function of health products:

Declarable function of health food has been adjusted many times. According to the technical specification for inspection and evaluation of health food (People's Republic of China and Ministry of Health, 23 edition), the notifiable functions of health food have been adjusted from the previous 22 to 27:

1. Enhancing immunity; Auxiliary hypolipidemic function; Auxiliary hypoglycemic function;

2, antioxidant function; Assist to improve memory function; Relieve visual fatigue;

3. Promote the function of discharging lead; Clear throat function; Auxiliary blood pressure lowering function;

4, improve sleep function; Promote lactation function; Relieve physical fatigue; Improve the function of hypoxia tolerance;

5. It has auxiliary protection function for radiation hazards; Weight loss function; Improve the growth and development function;

6, increase bone density function; Improve nutritional anemia; It has auxiliary protection function for chemical liver injury;

7. Acne removing function; Function of removing chloasma; Improve skin moisture function; Improve skin oil function;

8, regulating the function of intestinal flora; Promote digestive function; Laxative function; ; It has auxiliary protective function for gastric mucosal injury.

Reference: Baidu Encyclopedia-Health Food Registration Guide.