GB 15193.1-2014 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 15193.1-2014 | English | 115 |
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National Food Safety Standard -- Procedures for toxicological assessment of food
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| GB 15193.1-2003 | English | 150 |
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Procedures for toxicological assessment of food
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| GB 15193.1-1994 | English | RFQ |
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Procedures for toxicological assessment on food safety
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GB 15193.1-2014: National Food Safety Standard -- Procedures for toxicological assessment of food---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB15193.1-2014
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National food safety standard –
Procedures for toxicological assessment of food
Issued on. DECEMBER 24, 2014
Implemented on. MAY 01, 2015
Issued by. National Health and Family Planning Commission of the PRC
Table of Contents
Foreword... 3
1.Scope... 4
2.Requirements for test substances... 4
3.Contents of toxicological assessment for food safety... 4
4.Principle of selecting toxicity test for different test substances... 5
5.Objective of toxicological assessment of food and result judgment... 8
6.Factors that need to be considered during food safety assessment.. 11
Foreword
This Standard replaces GB15193.1-2003 “Procedures for toxicological assessment of
food”.
Compared with GB15193.1-2003, the main changes in this Standard are as follows.
- The standard name is changed to be “Food safety national standard – Procedures for
toxicological assessment of food”;
- Modify “Scope”;
- Delete “Terms and definitions”;
- Modify “Requirements for test substances”;
- Modify “contents of toxicological assessment for food safety”;
- Modify “Principle of selecting toxicity test for different test substances”;
- Modify “Objective of toxicity test”;
- Modify “toxicological assessment result judgment”;
- Modify “Factors that need to be considered during food safety assessment”.
Procedures for toxicological assessment of food
1.Scope
This Standard specifies the procedure for toxicological assessment of food.
This Standard is applicable to the assessment of the safety of chemical, biological and
physical factors that may cause harm to health concerned during food production,
processing, storing, transport and selling process. Assessment objects include food and
its raw material, food additives, new food raw materials, irradiated food, food related
products (used for food packaging materials, containers, detergent, disinfectant; and the
tools and equipment used for food production and marketing), and food pollutants.
2.Requirements for test substances
2.1 It shall provide the test substance’s name, batch number, content, storage
conditions, sources of raw materials, production processes, quality specifications,
character, human recommended (possible) intake, and other relevant information.
2.2 For single-ingredient chemical substance, the physical, chemical property (including
chemical structure, purity, stability, etc.) of test substance (including impurities when
necessary) shall be provided. For mixed substances (including formulated products), the
composition of test substance shall be provided; when necessary, physical property,
chemical property (including chemical name, structure, purity, stability, solubility, etc.) of all
compositions of test substances and relevant data shall be provided.
3.Contents of toxicological assessment for food safety
3.1 Acute oral toxicity test.
3.2 Genetic toxicity test.
3.2.1 Genetic toxicity test contents. Bacterial reverse mutation test, mammalian
erythrocyte micronucleus test, mammalian bone marrow chromosome aberration test,
mouse spermatogonia or spermatocytes chromosome aberration test, in-vitro mammalian
cell HGPRT gene mutation test, in-vitro mammalian cell TK gene mutation test, in-vitro
mammalian chromosome aberration test, rodent dominant lethal test, in-vitro mammalian
cell DNA damage repair (unscheduled DNA synthesis) test, Drosophila sex-linked
recessive lethal test.
3.3 28-day oral toxicity test.
3.4 90-day oral toxicity test.
3.5 Teratogenicity test.
3.6 Reproductive toxicity and reproductive-developmental toxicity test.
3.10 Chronic toxicity and carcinogenicity merge test.
4.Principle of selecting toxicity test for different test substances
4.1 For all substances that are firstly-innovated by our country, especially that the
chemical structure suggests that there are potential chronic toxicity, genetic toxicity or
carcinogenic properties;
4.2 For derivatives or analogs of which the chemical structure is basically same as that
of known substances (refer to those that have passed safety evaluation and are allowed
for use), or the substances that have safe-use history in some countries and regions, then
it may firstly conduct the acute oral toxicity studies, genetic toxicity test, 90-day oral
toxicity test, and teratogenicity test.
4.4 Selection of the safety toxicology assessment test for food additives, new
resources of food and ingredients, food related products, pesticide residue,
veterinary drug residue
4.4.1 Food additives
4.4.1.1 Flavoring
4.4.1.2 Enzyme preparations
4.4.1.2.1 For enzyme preparations that have long history of safe consumption and that
are produced from edible parts of animals or plants, if the World Health Organization has
announced the acceptable daily intake (ADI) or ADI is not required to be specified or
several countries have approved the use, on the basis of providing relevant proving
materials, generally it does not require to conduct toxicological test.
4.4.1.3 Other food additives
4.4.1.3.1 For the additives with comparatively complete toxicological data and the World
Health Organization has announced the ADI or that the ADI is not required to be specified,
or several countries have approved the use, if the quality specifications are consistent with
international quality specifications, then acute oral toxicity test and genetic toxicity tests
are required; if the quality specifications are not consistent with international quality
specifications, then it requires additional 28-day oral toxicity test; According to the test
results, determine whether it needs to further conduct other related toxicity test.
4.4.1.3.3 For the additives with single component and high-purity extracted from animal,
plant or microorganism, if it is a new variety, then it needs to conduct oral toxicity test,
genetic toxicity test, 28-day oral toxicity test, and teratogenicity test. After preliminary
assessment, determine whether it needs to conduct further test. If it has been approved
for use by a foreign country or an international organization, then it shall conduct oral
toxicity test, genetic toxicity test, and 28-day oral toxicity test. After preliminary
assessment, determine whether it needs to conduct further test.
4.4.2 New food raw materials
It shall be evaluated in accordance with "New food raw material declaration and
acceptance provisions" (State-Health-Food-Announcement [2013] 23).
4.4.3 Food related products
It shall be evaluated in accordance with "Food related product new varieties declaration
and acceptance provisions" (Health-Supervision-Announcement [2011] 49).
5.Objective of toxicological assessment of food and result judgment
5.1 Objectives of toxicological test
5.1.1 Acute toxicity test
Understand the degree of toxicity, property and possible target organ of test substance;
provide basis for selection of dose and toxicity observation index for further toxicity test;
classify the acute toxicity dosage according to LD50.
5.1.5 Teratogenicity test
Understand whether the test substance has teratogenic effects and developmental toxicity;
and obtain the not-observed adverse effect doses of teratogenic effects and
developmental toxicity.
5.1.6 Reproductive toxicity test and reproductive-developmental toxicity test
Understand the test substance’s reproductive-developmental toxicity to experimental
animals’ reproduction and their offspring, such as gonadal function, estrous cycle, mating
behavior, gestation, childbirth, breast-feeding and weaning, and progeny growth and
development. Obtain the not-observed adverse effect dose-level; provide a scientific basis
for preliminarily formulating human-group safe contact limits.
5.2 Determination of various toxicology test results
5.2.1 Acute Toxicity Test
If LD50 is less than 100 times of recommended (possible) human-intake, then generally it
shall give up that the test substance can be used in food; no further additional toxicology
test shall be conducted.
5.2.2 Genetic Toxicity Test
5.2.2.1 If 2 or more items in genetic toxicity test combination are positive, then it
indicates that the test substance is likely to be genetic toxicity and carcinogenic effects;
generally it shall give up that the test substance can be used in food.
5.2.3 28-day oral toxicity test
For test substances that only require to conduct acute toxicity, genetic toxicity and 28-day
oral toxicity test, if the test is found without significant toxic effects, the preliminary
assessment may be made on considering other various test results. If the test is found to
have significant toxicity, especially when there is dose-response relationship, then it shall
consider to conduct further toxicity test.
5.2.4 90-day oral toxicity test
According to the not-observed adverse effect dose obtained by the test to conduct
assessment, the principle is.
5.2.5 Teratogenicity test
According to the test results, evaluate if the test substance is the teratogenic substance to
laboratory animals. If teratogenic test result is positive, then reproductive toxicity and
reproductive-developmental toxicity test shall not be continued. For other developmental
toxicities that are observed in teratogenicity test, it shall combine with 28-day and (or)
90-day oral toxicity test results to conduct the assessment.
5.2.7 Chronic toxicity and carcinogenicity test
5.2.7.1 According to the not-observed adverse effect dose obtained by the chronic
toxicity test to conduct assessment, the principle is.
5.2.7.2 According to the tumor incidence, latency and multiple that are obtained by
carcinogenicity test to conduct the judgment of carcinogenicity test results, the principle is
(for those that comply with one of the following conditions, it may be considered that the
carcinogenicity test result is positive. If dose-response relationship exists, then the
judgment is more reliable).
6.Factors that need to be considered during food safety assessment
6.1 Test indicators’ statistical significance, biological significance and
toxicological significance
6.2 Test substance of larger recommended (possible) human-intake
It shall consider that, when the given test substance is too high, it may affect nutrient
intake and bioavailability, so as to cause some toxicology performance, rather than that
the toxicity is caused by the test substance.
6.3 Time-toxic effect relationship
When conducting analysis and assessment to toxic effects of experimental animals that
are caused by the test substance, it shall consider that, at the same dose level, the toxic
effects change along the time.
6.6 Animal toxicity test and in-vitro test data
The various animal toxicity tests and in-vitro test systems listed in this Standard are the
most important data that can be obtained under the current management (regulations)
toxicological assessment level; it is also the main basis for safety assessment. When test
result is positive, and the result judgment is involved in whether the test substance could
be applied in food, the repeatability of result and dose-response relationship shall be
considered.
6.8 Data of toxicokinetics test
Toxicokinetic test is an important aspect for toxicological assessment to chemical
substances, because different chemical substances or dose amount often have significant
impact to the differences of toxicokinetic or metabolism. In toxicity test, the animal species
with the same metabolism method and mode as human being shall be, in principle,
applied as much as possible for test. Studying the difference of test substance’s
absorption, distribution, excretion and biotransformation on animal and human being has
important significance on deducting the animal test results to human being and reducing
the uncertainty.
6.9 Comprehensive assessment
While conducting final assessment, the physiochemical property, structure, degree of
toxicity, metabolism characteristic, accumulation, contacted human being scope, usage
amount and usage scope in food, recommended (possible) intake for human being, and
other factors of test substance shall be comprehensively considered; For the substances
that have been applied in food for a relative long-time, they are of great significance to the
epidemiology investigation for contact people; however, it is usually difficult to obtain the
reliable data on dose-response relationship.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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