A, formula research and demonstration:

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

Second, the pilot production research:

In the GMP workshop of health food, the small-scale production demonstration of the formula was carried out, and the small-scale scientific researchers kept trying and experimenting, and finally determined a set of product formula, production technology and methodology demonstration for product testing.

Third, trial production:

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

Four, the provincial bureau of sampling:

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

Five, physical and chemical, toxicological and functional tests:

General products need safety test (toxicology), functional test (animal function/human food test), stability test, hygiene test and efficacy/iconic component identification test. According to the functions of products 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.

Nutritional supplements do not require functional testing. If the raw materials, processes and quality standards of the articles in the Catalogue of Vitamin and Mineral Complexes (No.202 [2005] of the US Food and Drug Administration) meet the relevant provisions of the state, the safety toxicology test report is generally not required.

Hygienic testing is mainly to detect the physical and chemical indicators and microbial indicators of products, such as heavy metals, pesticide residues, disintegration time, PH value, microorganisms and so on. 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 items.

Generally, the accelerated stability test is carried out. The product is placed at 38℃ and 75% humidity for 65438 0 months, 2 months and 3 months, and all indexes are tested.

Safety inspection is a toxicological inspection of product safety. According to the different product formulations, the items of toxicological testing are also different. General products should be tested in the first and second stages, and some products should be fed for 90 days or further toxicological examination.

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

Re-inspection test: after the sampling is completed, the provincial bureau will designate the test unit to conduct the re-inspection test.

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

Materials to be submitted for health food registration and declaration:

1, application form for registration of domestic health food.

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

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 inconsistent with the name of the drug that has been approved for registration.

4. The applicant guarantees that the patent obtained by others does not constitute infringement.

5. Provide trademark registration documents (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 formula basis; Sources of raw materials and auxiliary materials and the basis for their use.

8. Effective ingredients/iconic ingredients, their contents and test methods.

9, production flow chart and its detailed description and related research data.

10, product quality standards and their compilation instructions (including raw and auxiliary materials quality standards).

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

12, the test report issued by the inspection agency and its related materials,

These include:

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

13, label and description of sample products.

14. Other materials that are helpful for product review.

15, two unopened minimum sales packaging samples.

After receiving the application materials, the State Bureau will conduct on-site verification of the test and sample trial production.

Seven. Technical review and administrative review:

The National Bureau organizes experts to conduct product technical review, and will put forward opinions and report to the manufacturer for supplementary information according to the opinions.

Eight, obtain a 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: national food health word G20 140262.

Extended data:

The declaration function of health products:

The declarable function of health food has undergone many adjustments. According to the Technical Specification for Inspection and Evaluation of Health Foods (People's Republic of China (PRC) and Ministry of Health, 2003 edition), the reporting function of health foods has been adjusted from 22 items to 27 items:

1, enhancing immune function; 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 hypoxia tolerance function;

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 protective effect on chemical liver injury;

7, acne function; The function of removing chloasma; Improve skin moisturizing function; Improve skin oil function;

8. Regulating the function of intestinal flora; Promote digestive function; Laxative function; ; It has auxiliary protective effect on gastric mucosal injury.

References:

Baidu Encyclopedia-Health Food Registration Guide