GB 15193.21-2014National Food Safety Standard -- Principle for preparing test materials (English PDF)

2.1 Test substance

Single ingredient or mixture being tested.

2.2 Vehicle

Make the test substance into the test system, and make it a medium homogeneous mixture.

2.3 of wine group

Production of raw materials containing ethanol alcohol test was used.

2.4 No observed adverse effect level

Through animal experiments, the existing technical means and detection index was not observed any of the test substance-related toxic effects maximum dose.

4.2 Higher expansion ratio test water disposal

Should be considered water-swelling test was administered dose and the impact of the test substance in experimental animals, in order to choose the right side of the test is administered Formula (orally or incorporated into feed). Such as the use of orally administered, should choose water as solvent.

4.3 Processing liquid test substance

Liquid test substances need to be concentrated treatment, which method should be used without destroying the active ingredient. You can use a temperature of 60 °C ~ 70 °C Concentrated by evaporation under reduced pressure or atmospheric freeze-drying methods. After concentrating the liquid test substance meets the test requirements of human recommended amount, but not by Orally administered, in order to allow the incorporation of animal feed administered.

4.4 Pulverized solid test substance is not easy to handle

Easily pulverized solid test substance (such as those containing gum, candied fruit) available lyophilized crushing manner, and described in detail in the test report.

4.5 Test substances containing alcohol treatment

Recommended test substance containing a large amount of ethanol, in the amount of its recommended dosage design test, if more than the maximum oral animal capacity, you can enter Line concentrated. Ethanol concentration of less than 15% volume fraction of the test substance, the concentrated ethanol should be restored to the original styling products test substance concentration degree. Ethanol concentration higher than 15% of the test substance, the ethanol concentration should be adjusted to 15% was concentrated, and adjust a concentration of ethanol each dose group Cause. Do not need to concentrate the test substance, the ethanol concentration > 15% ethanol concentration in each dose group should be adjusted to 15%. When bacterial Reply mutation test should test and flies will remove ethanol. When adjusting the ethanol concentration of the test substance, in principle, should be used for producing the test substance Wine group.

4.6 containing the test substance or treatment of essential nutrients and other substances are known to exist in security issues Essential nutrients and other substances, such as product formulations containing excessive intake is easy to produce a safety problem (such as vitamin A, selenium, etc.) or known security issues substances (such as caffeine, etc.), in an amount designed to test their recommended doses, such as the dose of the toxic substance known to reach Effect dose, based on the original design of the dose should be considered additional to remove the substance or the substance reduced dose (eg dropped unobserved harmful Effect level) of the test substance dose, so that the combined toxic effects of the toxic effects of the test substance and the other ingredients of the substance with other components Evaluated.

4.7 Test substance containing the probiotic microorganisms or other processing

Containing probiotics or other microorganisms when the test substance during the bacterial reverse mutation assay or in vitro cell assay, should inactivate microorganisms, and Explain how.

4.8 Recommended human large amount of test substance treatment

For larger body recommended amount of test substance, when their test dose recommended amount of design, such as more than animals fed the maximum capacity or over-doped the feed limit (10% mass fraction), then it can allow the removal of non-security issues part of the test materials and test report Described in detail.

4.9 Human recommended a smaller amount of test substance treatment

Human recommended a smaller amount of test substance should be tested by oral administration ways.

4.10 Test substance incorporated feed processing

Such as the incorporation of the test substance in feed mass fraction of more than 5%, according to the nutritional needs of the animal feed formulation after the test, such as proteins You can adjust the quality casein, vegetable oil and other fats can be used to adjust, and explain the specific adjustment method. Add the test substance does not exceed the maximum principle the mass fraction of 10% of feed, such as the mass fraction of more than 10%, should be justified.

4.11 Handling food-related products category test substance

4.11.1 Soak vehicle

Depending on the product type and application, can be used distilled water, 4% acetic acid, 65% ethanol and n-hexane.

4.11.2 Soaking temperature and time

Physicochemical properties, performance and use of food containers and packaging materials should be used in a soaking temperature and time of maximum extract.

Under normal circumstances for the test was soaking temperature and time as follows.

a) distilled water, 60 °C soaking 2H;

b) 4% acetic acid, 60 °C soaking 2H;

c) 65% ethanol, 2H soak at room temperature;

d) n-hexane, soak at room temperature 2h.

4.11.3 Soak volume

The test substance should be soaking liquid immersion, soaking the ratio of solvent and the surface area of the test substance, the general area of the contact 2.0mL 1cm2 dip Froth.