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How to fill out the inspection application form for health production-related products of the Ministry of Health

Application for health food inspection

1. Technical information that needs to be provided

1. One copy of product formula and formula basis: please stamp the company (applicant unit) Official seal, the name and dosage of raw materials should be indicated in the formula. If food additives (including nutritional enhancers) are used, please indicate the name and dosage of the additive.

2. A flow chart and process description of the product production process: the detailed production process should be provided. If enzyme preparations or other additives and processing aids are used during the processing, please provide the name. If necessary, please Provide usage.

3. Two copies of product standards (enterprise standards).

4. Two copies of product labels and instructions (samples): should comply with relevant requirements.

5. A copy of the trademark acceptance letter (copy).

6. Other supporting materials: relevant information on functional ingredients, domestic and foreign relevant information on toxicology and functional science, etc.

7. Fill in the Ministry of Health health-related product inspection application form as required (in triplicate) with a pen or signature pen, and no alterations are allowed.

8. A health food technical review form filled out as required.

2. Sample volume, inspection time limit and requirements to be provided

(1) Requirements

1. The samples submitted for inspection must be finalized packaging products and must be consistent with The packaging will be the same or similar when it is put on the market in the future.

2. Hygiene inspection samples: Send 3 batches of samples (produced on different dates), the quantity depends on the inspection items and packaging conditions.

3. Packaging requirements: Each smallest independent package should be labeled. The label should at least contain the sample name (full name), specifications, batch number (or production date), and manufacturer.

4. Stability test samples: Send 3 batches of samples (the batch number is consistent with the hygiene sample batch number), the quantity is determined according to the inspection items and packaging conditions.

5. Toxicology test samples: any of the three batches of hygiene test samples, the quantity is 800 times the maximum daily recommended amount (including ames test and 30-day feeding) The sample size required for the first and second stage tests), if the sample is less than 2kg, the sample will be sent as 2kg. The batch numbers of toxicological, functional and human test samples must be consistent. Additional items or special/valuable samples will be discussed separately. Concentrates, samples without excipients, samples with high expansion, non-water-soluble samples, tea bags, samples with recommended amounts greater than 6g/kg or 10ml/kg, samples with sugar content greater than 30%, and samples containing alcohol are discussed separately.

6. When liquid products undergo toxicological testing, concentrated liquids can be sent, and the concentration multiple, sample batch, density, and certificate stamped with an official seal should be indicated; for solid products, samples for toxicological testing should be sent. It should be crushed first and passed through a 100-mesh sieve; if any auxiliary materials are removed, it should be noted which auxiliary materials were removed and a certificate stamped with an official seal should be provided.

7. For products that require human testing, calculate the sample size required for testing based on the recommended product volume.

8. Functional test samples: any batch of samples from the three batches of hygiene test samples, the quantity is the maximum recommended daily amount × m times (mouse test: m=200, rat Test: m=400).

(2) Inspection charges

Charges will be made according to the relevant charging standards of the Guangdong Provincial Price Bureau, and a collection notice will be issued. The enterprise (applicant) shall submit the collection notice within three days after holding the collection notice. Pay the payment to China Construction Bank or make a bank transfer; after receiving the receipt of the payment notice from the company or the fax of the bank acceptance form, the samples will be sent to the laboratory for testing after financial verification by our center.

(3) Inspection time limit

Laboratory project name

Inspection time limit (days)

Inspection fee (yuan)

Function

Energy

Learn

Test

Test

Enhance immune function

3~4 months

43470

Relieving physical fatigue

3~4 months

20797

Has auxiliary protective function against chemical liver injury

3~4 months

33597

Improves hypoxia tolerance function

< p> March

33664

Assist in lowering blood lipids (animal function)

April to May

33580

< p> Assist in lowering blood sugar (animal function)

4~5 months

21053

Antioxidant function (animal function)

4 ~May

22775

Laxative function (animal function)

February to March

22186

Improve memory function (animal function)

5~6 months

26034

Improve nutritional anemia function (animal function)

4~5 months

32207

Weight loss function (animal function)

4~5 months

34379

Throat clearing function (animal function)

March

20000

Gastric mucosal protection function (animal function)

3~4 Month

17915

Poison

Theory

Test

Test

ames test

70 days

4200

Acute oral toxicity test

35 days

1950

ld50 micronucleus

50 days

4950

ld50 micronucleus sperm aberration

80 days

7950

Mouse bone marrow micronucleus test

40 days

3000

Mouse sperm abnormality test

60 days

3000

Mouse testis chromosomal aberration test

70 days

5151

Bone marrow cells Chromosome aberration test

60 days

3300

Rat 30-day feeding test

80 days

23241

90-day feeding test

130 days

36000

Traditional teratogenicity test in rats

130 days

18000

Others

Negotiable

Stable

Performance test

Test

Physical and chemical inspection

(Items are determined according to standards)

120 days

According to items

Microbiology Inspection

(Items are determined according to standards

120 days

According to items

Health

Academic inspection< /p>

Inspection

Physical and chemical inspection

(Items are determined according to standards)

33 days

According to items

p>

Microbiological inspection

(items are determined according to standards)

33 days

According to items

Note: Table The content is for reference only, and the details will be determined at the time of acceptance.

Commissioned inspection of approved health foods, fortified foods, special nutritional foods and general foods

1. Technical information that needs to be provided

1. Products One recipe: please stamp the official seal of the enterprise (applicant). The name and dosage of the raw materials should be indicated in the formula. If food additives (including nutritional enhancers) are used, please indicate the name and dosage of the additive.

2. A flow chart and process description of the product production process: the detailed production process should be provided. If enzyme preparations or other additives and processing aids are used during the processing, please provide the name. If necessary, please Provide usage.

3. Two copies of product standards (enterprise standards): there should be enterprise standard number, release date, and implementation date.

4. Two copies of product labels and instructions (samples): should comply with relevant requirements.

5. A copy of the trademark acceptance letter (copy).

6. If it is an approved health food, a copy of the approval document (copy) should be provided.

7. Fill in the entrusted inspection form (in triplicate) as required, fill it in with a pen or signature pen, and no alteration is allowed.

2. Sample volume, inspection time limit and requirements to be provided

(1) Requirements

1. Samples submitted for inspection must be finalized packaging products for sale on the market , New trial production products can be temporarily packaged, but they should be finalized packaging products and be consistent or similar to the packaging when they are put on the market in the future.

2. Hygiene inspection samples: Send 3 batches of samples (produced on different dates). The quantity is determined according to the inspection items and packaging conditions. The amount of retained samples is calculated as 1 times the amount of the inspection samples.

3. Packaging requirements: Each smallest independent package should be labeled. The label should at least contain the sample name (full name), specifications, batch number (or production date), and manufacturer.

4. If you need to do toxicological testing and send any batch of products from the three hygiene batches, the sample size will be determined according to the project.

5. Special circumstances shall be determined through negotiation between the two parties according to the specific circumstances.

(2) Inspection time limit

Laboratory project name

Inspection time limit (days)

Inspection fee (yuan)

Poison

Theory

Test

Test

ames test

70

4200

Acute oral toxicity test

35

1950

ld50 micronucleus

50

4950

ld50 micronucleus sperm aberration

80

7950

Mouse bone marrow micronucleus test< /p>

40

3000

Mouse sperm abnormality test

60

3000

Chromosome aberration test in mouse testis

70

5151

Chromosome aberration test in bone marrow cells

60

3300

Rat 30-day feeding test

80

23241

90-day feeding test

130

p>

36000

Traditional teratogenicity test in rats

130

18000

Others

Negotiable

4200

Stable

Sexual test

Test

Physical and chemical test

(Items are determined according to standards)

120

According to items

Microbiological inspection

(Items are determined according to standards)

p>

120

Determined according to the project

Health

Academic inspection

Physical and chemical inspection

Physical and chemical inspection

(Items are determined according to standards)

33

According to items

Microbiological examination

(Items Determined according to standards)

33

Determined according to projects

(3) Inspection charges

According to the charging standards of Guangdong Provincial Price Bureau It is stipulated that charges will be charged and a collection notice will be issued. The enterprise (applicant unit) will take the collection notice to the China Construction Bank to pay the payment, or remit money through the bank; after receiving the receipt of the collection notice from the enterprise or the fax of the bank acceptance slip, it will be verified. Our center's finance department will send the samples to the laboratory for testing within 2 days (excluding rest days) after receiving the payment.