The Requirements of Toxicology Tests on the Registration of Health Food and “Three New” Food Products in China

1. Introduction

Toxicology experiments refer to experiments in which different ways and durations of exposure to experimental animals are used to detect various toxicity endpoints. The purpose is to determine the level of harmlessness, type of toxicity, target organ, and dose-response relationship, and provide important data for safety evaluation or risk evaluation.

GB 15193.1-2014 specifies the procedures for toxicological evaluation of food safety. According to this standard, the contents of toxicological evaluation tests for food safety include acute oral toxicity test, genetic toxicity test, 28-day acute oral toxicity test, 90-day acute oral toxicity test, teratogenicity test, reproductive toxicity test and reproductive development toxicity test, toxicology test, chronic toxicity test, carcinogenicity test, the combined test of chronic toxicity and carcinogenicity.

2. Food types that need to do toxicology tests in China

Functional health food (that need to be registered), new food raw material (novel food), new food additives, new food contact resin and additive

3. Toxicology tests for functional health food (that need to be registered)

As the "Technical Specifications for Inspection and Evaluation of Health Foods (2003 Edition)" has been abolished, the content of the toxicology experiments of health foods in this article comes from "Health Food Toxicology Evaluation Procedures (Draft).

3.1 Health food

Requirements of test substances

Sample Package	Packaged and finished product Note: When it is not suitable to test with a finished product due to a large recommended amount or other reasons, the samples can be appropriately processed (such as concentration and partial removal of auxiliary materials). Processing instructions and corresponding supporting documents are required in such situation.
Sample Batch	Consistent with the batch number used in the functional test, and should be one of the three batches used in the hygiene test (except for products with a shorter shelf life than the entire test cycle, such as probiotics and dairy products.).

Test Items

Generally, one acute oral toxicity test, three genetic toxicity tests and one 28-day oral toxicity test should be performed, and other test items need to be confirmed based on the test results and the target population.

If health foods are produced by non-traditional techniques and cause a significant change in the material basis, an acute oral toxicity test, three genetic toxicity tests, a 90-day oral toxicity test, and a teratogenic test should be performed, and other toxicity tests should be conducted if necessary.

Raw materials that include in the common food and health food raw material catalogs and are produced only by traditional food production processes, such as physical crushing or water extraction; the eating method is the same as the traditional one; the recommended daily intake is the same as conventional one or comply with national regulations. No toxicity test is required on these products.

Note: For the interpretation of acute oral toxicity test, three genetic toxicity tests and 28-day oral toxicity test, please click here for more understanding.

3.2 New raw materials for health food

When new health food raw materials are used in functional health foods, in addition to the safety evaluation of the product, the safety evaluation of the new raw materials is also required. According to the current regulations, the safety assessment of new raw materials for health foods should be conducted with reference to the regulations for the safety review of new food raw materials (see below for details of the toxicological test of new food raw materials).

4. Toxicology tests for new food raw materials (novel food)

New food raw materials refer to the following items without traditional eating habits in China:

Animals, plants and microorganisms;
Ingredients isolated from animals, plants and microorganisms;
Food ingredients whose original structure has changed;
Other newly developed food ingredients;

Items of toxicology tests

Note:

1) "Y" indicates that the test needs to be carried out; "-" indicates that the test does not require

2) * Reproductive toxicity tests are generally not required.

5. Toxicology tests for new food additives

The tests should be carried out according to the requirements in GB 15193.1-2014. Different types of new food additives have different test requirements.

5.1 Food flavor

S.N.	Certificate	Requirement
1	Permitted by two or more organizations (WHO, FEMA, COE, IOFI).	No toxicology tests are needed.
2	Permitted by only one international organization	Acute oral toxicity test One genetic toxicity test
3	Without permission of international organization	Acute oral toxicity test Three genetic toxicity tests 28-day oral toxicity test
4	The high-purity natural flavor extracted from the edible parts of animals and plants, its chemical structure and related information do not suggest unsafe	No toxicology tests are needed.

5.2 Enzyme

S.N.	Condition	Requirement
1	Produced by edible parts of plants and animals with a long history of safe consumption. WHO has published (or does not require) daily allowable intake or approved by multiple countries or organizations	No toxicology tests are needed.
2	Produced by other sources, complete toxicological information. WHO has published (or does not require) daily allowable intake or approved by multiple countries or organizations	When quality specifications are consistent with international quality standards: acute oral toxicity test, three genetic toxicity tests are required. When quality specifications are inconsistent with international quality standards: additional 28-day oral toxicity test is required.
3	Produced by other sources, incomplete toxicological information. WHO has not published daily allowable intake or approved by only one country.	Acute oral toxicity test Three genetic toxicity tests 28-day oral toxicity test
4	Produced by other sources and without approval by other countries.	Acute oral toxicity test Three genetic toxicity tests 90-day oral toxicity test Teratogenic test

5.3 Other food additives (such as emulsifiers, colorants, antioxidants, etc.)

S.N.	Condition	Requirement
1	Complete toxicology information. WHO has published the allowable intake or approved by multiple countries or organizations.	When quality specifications are consistent with international quality standards: acute oral toxicity test, three genetic toxicity tests are required. When quality specifications are inconsistent with international quality standards: additional 28-day oral toxicity test is required.
2	WHO has not published daily allowable intake and approved by only one country.	Acute oral toxicity test Three genetic toxicity tests 28-day oral toxicity test Teratogenic test
3	Single-component which is high-purity additive made from animals and plants or microorganisms and approved by an international organization or a country.	Acute oral toxicity test Three genetic toxicity tests 28-day oral toxicity test
4	Single-component which is high-purity additive made from animals and plants or microorganisms and without approval by any organization or country.	Acute oral toxicity test Three genetic toxicity tests 90-day oral toxicity test Teratogenic test

6. Toxicology tests for new food contact material (additives and resins)

According to the "Regulations on the Declaration and Acceptance of New Food-Related Products", the toxicological tests of new food contact materials need to be determined based on the results of product migration experiments. The lower the amount of substance migration, the simpler the toxicology test report that needs to be provided.

China,Food,Toxicology,Test,Health Food,New Food Raw Materials,New Food Additive,FCN

Note:

1. "Y" indicates that the project needs to be carried out; "-" indicates that the project is not required;

2. Polymers (average molecular weight greater than 1000 Daltons) should provide toxicological safety assessment data for each monomer;

7. Laboratory requirements for toxicology reports

#	Product Type	Laboratory	Test Method
1	Functional health food (that need to be registered)	Domestic laboratories with food inspection qualifications and records in SAMR	Health Food Toxicology Evaluation Procedures (Draft).
2	New food raw material	Domestic food inspection qualified laboratories (laboratory has obtained CMA qualification for this toxicological test) Overseas GLP laboratory	GB 15193 standards No specific requirement if the tests are done in overseas GLP laboratory
3	New food additives
4	New food contact materials (additives and resins)

Conclusion

Food safety toxicology test is an important method to evaluate the safety of food and food ingredients. Usually, the toxicology test of a new product or a new substance takes months or even more than a year, and the cost ranges from tens of thousands to hundreds of thousands. Therefore, understanding the requirements for toxicological tests when applying for different substances, and choosing a reasonable toxicological test item are important for saving time and costs. Before carrying out the declaration of related new products and substances, the applicant should fully evaluate this.

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