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GB 15193.21-2014: National Food Safety Standard -- Principle for preparing test materials
Status: Valid GB 15193.21: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB 15193.21-2014 | English | 149 |
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National Food Safety Standard -- Principle for preparing test materials
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GB 15193.21-2014
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| GB 15193.21-2003 | English | 199 |
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Principle for preparing test materials
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GB 15193.21-2003
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Basic data | Standard ID | GB 15193.21-2014 (GB15193.21-2014) | | Description (Translated English) | National Food Safety Standard -- Principle for preparing test materials | | Sector / Industry | National Standard | | Classification of Chinese Standard | C53 | | Classification of International Standard | 07.100 | | Word Count Estimation | 5,556 | | Date of Issue | 12/24/2014 | | Date of Implementation | 5/1/2015 | | Older Standard (superseded by this standard) | GB 15193.21-2003 | | Regulation (derived from) | Health Planning Commission Bulletin 2014 No. 21 | | Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China | | Summary | This Standard specifies pre-treatment methods for safety evaluation of test substance when. This Standard is applicable to the subject matter before trials evaluating the safety of the test substance during treatment. | GB 15193.21-2014: National Food Safety Standard -- Principle for preparing test materials---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
National Food Safety Standard.Principle for preparing test materials
National Standards of People's Republic of China
National Food Safety Standard
Before the test, the test substance treatment
Issued on.2014-12-24
2015-05-01 implementation
People's Republic of China
National Health and Family Planning Commission released
Foreword
This standard replaces GB 15193.21-2003 "test substance treatment."
This standard compared with GB 15193.21-2003, the main changes are as follows.
--- Standard name was changed to "national food safety standards of the test before the test substance approach";
--- Increasing the terms and definitions;
--- Increasing the solid test substance treated easily crushed;
--- To increase the body recommended a smaller amount of processing the test substance;
--- Increasing the incorporation of the test substance feed processing;
--- Modify the selection medium;
--- Modify the recommended human handling a large amount of test substance;
--- Modify the teabag handling test substance;
--- Revised higher expansion ratio test disposal;
--- Modify the treatment liquid test substance;
--- Modify the test substance containing toxic treatment of essential nutrients and other substances.
National Food Safety Standard
Before the test, the test substance treatment
1 Scope
This standard specifies the test method for pre-treatment was subjected to safety evaluation when.
This standard applies to the evaluation of the test before the test substance was tested safety when handling.
2 Terms and definitions
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.
3 vehicle selection
Vehicle to help test substance into the test system or an important medium for animals. The test should be based on the physical and chemical characteristics and the nature of the test substance
Choose a suitable solvent (solvent, suspending agent or emulsifier), the test substance is dissolved or suspended in a vehicle, and generally use distilled water, vegetable oil,
Starch, gelatin, carboxymethyl cellulose, sucrose fatty acid esters, such as the use of other solvents shall state the reasons. Chosen vehicle itself should not produce
Toxicity; and between the various components of the test substance is not a chemical reaction, and maintain its stability; no special or irritating odor.
Test 4 test substance pre-treatment methods
Note. According to the requirements of toxicology tests and the need for pre-treatment (such as concentration, removal of known security component, etc.) of the test substance should be provided treatment, consisting of a
Points and proportion, and provide the appropriate information. Processing of test substance shall be consistent with the main steps of the production process of the original product. The test was not carried out
When the same test should be the appropriate treatment for physical and chemical properties of the test characteristics and the test substance.
Processing 4.1 teabag class test substance
Extraction should be products recommended drinking the same way, available water extract of the test article was tested. If the product is no special push
Recommended to drink, the water extract can be used to extract the following conditions. atmospheric pressure, temperature of 80 ℃ ~ 90 ℃, soaking time 30min, by the amount of water
10 times or more the mass was again extracted twice, and the extracts were combined and concentrated to the desired concentration, and marked with the concentrate feed off ratio
system. If the product has a special way of taking the recommendation (such as the recommended consumption after soaking products), it is considered in the test.
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 ℃ ~ 70 ℃
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 ℃ soaking 2H;
b) 4% acetic acid, 60 ℃ 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.
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