Highlights of Guidelines for Toxicological Test and Evaluation of Health Food and Its Raw Materials (2020 version)

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On October 31^st, 2020, the State Administration for Market Regulation (SAMR) issued Guidelines for Toxicological Test and Evaluation of Health Food and Its Raw Materials (2020 version) (hereinafter referred to as “the Guidelines”). The Guidelines specifically indicated that health food and its raw materials are required to conduct toxicological tests based on GB 15193.

CIRS made a comparative analysis between "the Guidelines" and Technical Standards for Testing and Assessment of Health Food (Green Book) (2003 version) (hereinafter referred to as “the Green Book”) from multiple aspects, e.g., test items, test methods etc.

Introduction

The Green Book was abolished in July, 2018. After then, the test report using the methods listed in the Green Book cannot be used to apply for health food registration. The contents of the Green Book include: assessment procedures and testing methods of 27 health functions, assessment procedures and testing methods of 18 health food toxicological tests, testing methods of 27 functional components and hygiene test.

The draft of the Guidelines was released for public comments in April, 2019, and now the official version was finally issued by SAMR. In general, the draft and the official one have no significant differences.

Additionally, the testing methods of functional components and hygiene were also released officially on October 31st, 2020, and only the testing methods of 27 health functions haven’t been issued.

Differences between the Guidelines and the Green Book

1. Sample for Toxicological Test of Health Food

The Green Book	The Guidelines
Sample for toxicological test should be health food product.	Sample for toxicological test should be health food product or raw materials.

PS. For the health food raw material which is required to conduct safety assessment, the assessment shall be conducted according to the regulations related to new food raw material, which is consistent with “Health Food Registration Review Rules” (hereinafter referred to as “the Review Rules”).

2. Main Items for Toxicological Test of Health Food

The Green Book	The Guidelines
Generally, it is needed to conduct acute toxicity test, three genetic toxicity tests and 30-day feeding study.	Generally, it is needed to conduct acute toxicity test, three genetic toxicity tests and 28-day oral toxicity test.

3. Testing Methods for Toxicological Test of Health Food

Generally, health food toxicological test includes acute toxicity test, three genetic toxicity tests and 28-day oral toxicity test/30-day feeding study, CIRS made a comparative analysis on them as follows.

S.N.	Items	The Green Book	The Guidelines (according to GB 15193)
1	Acute Toxicity Test	The animals should be observed for 7 or 14 days after given samples. If deaths continue at the 4th day, then observing for 14 days totally. If necessary, it could be extended to 28 days.	The animals should be observed for 14 days, and if necessary, it could be extended to 28 days. In some special emergency situations, it can be shortened to 7 days.
2	Three genetic toxicity tests	There are no recommendations on genetic test combinations.	Two combinations of genetic tests are recommended.
3	28-day oral toxicity test or 30-day feeding study	30-day feeding study: test items are relatively few.	28-day oral toxicity test: test items are more than that of 30-day feeding study.

Differences between 28-day oral toxicity test and 30-day feeding study:

Test items	30-day feeding study	28-day oral toxicity test
Observation	√	√
Eyes examination	×	√
Hematologic examination	3 Items: hemoglobin, red blood cell count, white blood cell count and classification	7 Items: white blood cell count and classification, red blood cell count, hemoglobin concentration, hematocrit, platelet count, prothrombin time (PT), activated partial thromboplastin time (APTT), etc.
Blood biochemistry examination	8 Items: glutamic-pyruvic transaminase (ALT or SGPT), glutamic-oxalacetic transaminease (AST or SGOT), blood urea nitrogen (BUN), creatinine (Cr), blood glucose (Glu), serum albumin (Alb), total protein (TP), total cholesterol (TCH)	14 Items: alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamyltranspeptidase (GGT), alkaline phosphatase (AKP), urea, creatinine (Cr), blood glucose (Glu), total protein (TP), serum albumin (Alb), total cholesterol (TCH), triglyceride (TG), chlorine, potassium, sodium. If necessary, calcium, phosphorus, uric acid (UA), cholinesterase, sorbitol dehydrogenase, total bile acid (TBA), hemoglobin, hormone, etc. can be tested.
Uronoscopy	×	Urine protein, relative density, pH, glucose, occult blood, etc.
Pathological examination	Viscera weighting: absolute and relative weight of liver, kidney, spleen, testis; Histopathological examination (6 items): liver, kidney, gastrointestinal tract, testis, ovary.	Viscera weighting: absolute weight of heart, thymus, paranephros, liver, kidney, spleen, testis; Histopathological examination (16 items): brain, thyroid, thymus, heart, liver, spleen, kidney, paranephros, stomach, duodenum, colon, pancreas, mesenteric lymph nodes, ovary, testis, bladder.

PS: √ refers to “Test items are consistent”; × refers to “Don’t need to be detected”.

4. Additional content listed in the Guidelines

The requirements on samples listed in the Guidelines are consistent with the requirements in the Green Book and the Review Rules, which is that, the same batch of samples should be used for animal function tests and toxicological tests, and the samples should be one of the 3 batches used for the functional components or characteristic ingredients tests, hygiene test, stability test (except for the product whose shelf life is less than the test period, e.g., probiotics, milk, etc. Meanwhile, the Draft supplements some additional information:

When the applicant is required to make a supplementary test, if the original batch samples which is used to apply health registration have exceeded its shelf life, samples with new batches can be used for the supplementary test. However, the applicant should provide all item test report based on technical requirements.

CIRS Comments:

The biggest difference between the Guidelines and the Green Book:

30-day feeding study is required by the Green Book, while the Guidelines requires 28-day oral toxicity test. The test items of 28-day oral toxicity test are more than that of 30-day feeding study.
The Guidelines is in consistent with the Review Rules, but the 30-days feeding study required by the Green Book is contradictory with the Review Rules before it was abolished.

Except for above information, there is no additional changes for the Guidelines.

Guidelines for Toxicological Test and Evaluation of Health Food and Its Raw Materials (2020 version) has been implemented, and the functional evaluation test method of health food is still on the way. CIRS believes that the spring of health food enterprises is coming, please wait patiently.

If you have any needs or questions, please contact us at service@cirs-group.com.

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