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GB 15193.1-2003 (GB15193.1-2003)

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GB 15193.1-2003: PDF in English
GB 15193.1-2003
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 07.100
C 53
Replacing GB 15193.1-1994
Procedures for toxicological assessment of food
ISSUED ON. SEPTEMBER 24, 2003
IMPLEMENTED ON. MAY 01, 2004
Issued by.
Ministry of Health of the People’s Republic of China;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3 
1.  Scope ... 5 
2.  Normative reference ... 5 
3.  Terms and definitions ... 5 
4.  Requirements for test substances ... 6 
5.  4-stages and contents of toxicological assessment for food safety ... 6 
6.  Principle of selecting toxicity test for different test substances ... 7 
7.  Objective of toxicological assessment of food and result judgment ... 9 
8. Factors that need to be considered during food safety assessment .. 12 
Foreword
Full text of this Standard is compulsory.
This Standard replaces GB15193.1-1994 “Procedures for toxicological assessment of
food”.
Compared with GB15193.1-1994, the main changes in this Standard are as follows.
- Specific contents of test substance have been added in “Scope”. 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 including food additives (including food enrichment), new
resources of food and ingredients, novel foods, irradiated food, food container and
packing materials, food tools, equipment, detergent, disinfectant, pesticide residue,
veterinary drug residue, industrial microorganisms for food, etc.;
- In “Requirements for test substance”. add “For formulated products, the formula 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, test report and relevant data shall be provided;
source of raw materials, production technology, possible intake for human being and
other relevant data shall be provided”;
- In “Four stages and toxicological test”. “TK gene mutation test” has been added in
“Genetic toxicity test” of second-stage. For V79/HGPRT gene mutation test, it has
been changed FROM optional test TO must-test item of gene mutation test in parallel
with Ames test. The previous optional tests have changed to 3 items from 4 items;
- In “Principle of selecting toxicity test for different test substances”. add “Food
container and packing material, pesticide residue”. For the selection principle to
flavoring, “Acute toxicity test” (Article 3.2.4.2.1.1 in 1994 edition, Article 6.4.1.1.1 in
this edition) has been deleted; for additives for other food, the “one-item mutagenicity
test” has been changed to “2-items mutagenicity tests”; “Ames test or mouse bone
marrow micronucleus test (MNT) preferred” has been changed to “Ames test and
mouse bone marrow micronucleus test (MNT) preferred” (Article 3.2.4.2.2.1 in 1994
edition, Article 6.4.1.2.1 in this edition); “selection principle of toxicity test for food
container and packing material” has been added;
- In “Result judgment of all toxicological tests”. result judgments of genetic toxicity have
been re-drafted; and the article-number has been changed from previous 4 to 3.
“Result judgment principle for carcinogenicity test” has been added. The content in
the bracket of novel food has been changed to “if it exceeds 5%, protein shall be
supplemented to the content equivalent to control-group, and the added test
substances shall not exceed 10% of feed at most in principle” (Article 4.2.6 in 1994
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
additives (including food enrichment), new resources of food and ingredients, novel foods,
irradiated food, food container and packing materials, food tools, equipment, detergent,
disinfectant, pesticide residue, veterinary drug residue, industrial microorganisms for food,
etc.
2. Normative reference
The articles contained in the following documents have become part of this Standard
when they are quoted herein. For the dated documents so quoted, all the modifications or
revisions made thereafter shall not be applicable to this Standard. For the undated
documents so quoted, the latest editions shall be applicable to this Standard.
GB15670-1995 The Toxicological Testing Method for Pesticides
Hygiene control measures for irradiated food
Disinfection Management Measures
3. Terms and definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1 Food additive
It refers to the synthetic chemicals or natural materials that are added in food to improve
the food quality and color, aroma and taste, and for the needs of preservation and
processing.
3.2 Novel foods
It refers to food or raw materials of food that are newly discovered, developed (including
new process and new technology) or introduced that have not been eaten yet or merely
eaten in individual-limited regions.
4. Requirements for test substances
4.1 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 formulated product, the formula 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.
4.2 Source of raw materials, production technology, possible intake for human being and
other relevant data shall be provided.
4.3 The test substance must be standardized product that conforms to given formula; its
composition, proportion and purity shall be the same as the practical application; when
testing the toxicity of test substance with high purity, and when testing the toxicity of
possible-existed impurity or conducting special test, pure substance may be selected; or
conduct toxicity test with pure substance or impurity respectively.
5. 4-stages and contents of toxicological assessment for food
safety
5.1 First-stage. acute toxicity test
Acute oral toxicity. LD50, Acute combination toxicity, maximum tolerated dose method.
5.2 Second-stage. genetic toxicity test, traditional teratogenicity test, thirty-day feeding
test.
For the combination of genetic toxicity test, it shall consider the principle of the
combination of prokaryotic cell and eukaryotic cell, in-vivo test and in-vitro test. Select
one-test from Ames test or V79/HGPRT gene mutation test, bone marrow micronucleus
test or mammalian bone marrow chromosome aberration test, 5.2.3 or 5.2.4 respectively.
5.2.1 Salmonella typhimurium/mammal microsomal enzyme test (Ames test) or
V79/HGPRT gene mutation test. Ames test is preferred, and other tests are selected when
necessary.
5.2.2 Micronucleus test of bone marrow cells or test of bone marrow micronucleus test
(PCE).
5.2.3 TK gene mutation test
5.2.4 Analysis of sperm abnormality in mice or chromosome mutagenic analysis.
referring to international organizations and foreign data, and regulations for assessment.
6.4.1.1.1 All the flavorings that have been approved for use or have been formulated for
daily acceptable intake by World Health Organization (WHO), and allowed by two or more
organizations of WHO, FEMA, COE and IOFI, then it may be assessed by referring to
foreign data or regulations.
6.4.1.1.2 If the data is incomplete or is only approved by one of the international
organizations, then acute toxicity test and one of mutagenicity tests specified by this
procedure shall be conducted first; decide whether further test is needed after preliminary
assessment.
6.4.1.1.3 If no data can be referred to and it is not yet allowed to use by international
organization, then conduct the first-stage and second-stage toxicity test first; decide
whether further test is needed after preliminary assessment.
6.4.1.1.4 For single natural flavoring with high purity that is extracted from animal or
plant, if the chemical structure and relevant data do not show unsafety, then toxicity test is
generally not required.
6.4.1.2 Other food additives
6.4.1.2.1 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,
then acute toxicity test and two mutagenicity tests are required; Ames test and
micronucleus test of bone marrow cells shall be preferred. However, the additives with
different production process, purity of finished products and source of impurities, it shall
consider whether the next stage test is needed according to the test results after the
first-stage and second-stage toxicity tests.
6.4.1.2.2 For the additives that have been approved to use by one or more international
organization, but the World Health Organization has not announced the ADI; or the data is
...
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(Above excerpt was released on 2015-07-07, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/GB15193.1-2003