Standard No.:	GB 15193.1-2014
English Name:	National Food Safety Standard Procedures for toxicological assessment of food
Chinese Name:	食品安全国家标准 食品安全性毒理学评价程序
Professional Classification:	GB    National Standard
Source Content Issued by:	National Health and Family Planning Commission
Issued on:	2014-12-24
Implemented on:	2015-5-1
Status:	valid
Superseding:	GB 15193.1-2003 Procedures for toxicological assessment of food
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	110.0
Delivery:	via email in 1 business day

National food safety standard - Procedures for toxicological assessment on food safety 1 Scope This standard specifies the procedures for toxicological assessment on food safety. It is applicable to evaluating the safety of chemical, biological and physical factors involved in the process of food production, processing, preservation, transportation and sales, and the inspection objects include food and its raw materials, food additives, new food raw materials, irradiated food, food-related products (packaging materials, containers, detergents, disinfectants of food as well as tools and equipment for food production and management) and food pollutants. 2 Requirements for test substances 2.1 The name, batch number, content, preservation conditions, raw material sources, production process, quality specifications, characteristics, recommended (possible) intake by human body and other relevant information shall be provided. 2.2 For single-component substances, the physical and chemical properties (including chemical structure, purity, stability, etc.) of the test substance (including its impurities if necessary) shall be provided. For the mixture (including formula products), the composition of the test substance shall be provided, if necessary, the relevant information about the physical and chemical properties (including chemical name, chemical structure, purity, stability, solubility, etc.) of each component of the test substance shall be provided. 2.3 If the test substance is a formula product, it shall be a standardized product, and its composition, proportion and purity shall be the same as that for practical application. If the test substance is an enzyme preparation, it shall be the product before adding other compound ingredients. 3 Contents of the tests for toxicological assessment on food safety 3.1 Acute oral toxicity test. 3.2 Genetic toxicity test.   3.2.1 Contents of genetic toxicity test. Bacterial reverse mutation test, mammalian erythrocyte micronucleus test, mammalian bone marrow cell chromosome aberration test, mouse spermatogonial/spermatocyte chromosome aberration test, in vitro mammalian cell HGPRT gene mutation test, in vitro mammalian cell TK gene mutation test, in vitro mammalian cell chromosome aberration test, rodent dominant lethal test, in vitro mammalian cell DNA damage repair (unscheduled DNA synthesis) test, and sex-linked recessive lethal test. 3.2.2 Combination of genetic toxicity tests. Generally, the principle of combining prokaryotic cells with eukaryotic cells, and in vivo test with in vitro test shall be followed. According to the characteristics of the test substances and the test purpose, the following combinations of genetic toxicity test are recommended: Combination 1: bacterial reverse mutation test; mammalian erythrocyte micronucleus test or mammalian bone marrow cell chromosome aberration test; mouse spermatogonial/spermatocyte chromosome aberration test or rodent dominant lethal test.

Foreword i 1 Scope 2 Requirements for test substances 3 Contents of the tests for toxicological assessment on food safety 4 Principles for selecting toxicity test for different test substances 5 Purpose and result judgment of test for toxicological assessment on food safety 6 Factors to be considered when assessing food safety