This standard specifies the safety evaluation of gene receptor plants, gene donor organisms, and gene manipulation, as well as the toxicological evaluation, key component analysis and nutritional evaluation, exogenous chemical accumulation evaluation, and drug resistance evaluation of transgenic plants and their products. This standard applies to the edible safety evaluation of transgenic plants and their products. NY/T 1101-2006 Guidelines for the edible safety evaluation of transgenic plants and their products NY/T1101-2006 Standard download decompression password: www.bzxz.net
This standard specifies the safety evaluation of gene receptor plants, gene donor organisms, and gene manipulation, as well as the toxicological evaluation, key component analysis and nutritional evaluation, exogenous chemical accumulation evaluation, and drug resistance evaluation of transgenic plants and their products. This standard applies to the edible safety evaluation of transgenic plants and their products.

ICS65.020.99
Agricultural Industry Standard of the People's Republic of China
NY/T1101-—2006
Guideline for safety assessment of food from genetically modified plant and derived products2006-07-10 Issued
2006-10-01 Implementation
Ministry of Agriculture of the People's Republic of China
S Issued
This standard is proposed by the Ministry of Agriculture of the People's Republic of China. Foreword
This standard is under the jurisdiction of the National Technical Committee for Safety Management of Agricultural Genetically Modified Organisms. NY/T1101-2006
Drafting units of this standard: Science and Technology Development Center of the Ministry of Agriculture, Institute of Nutrition and Food Safety of Chinese Center for Disease Control and Prevention, China Agricultural University, Tianjin Health and Disease Prevention Center.
Main drafters of this standard: Yan Weixing, Li Ning (Science and Technology Development Center of the Ministry of Agriculture), Li Ning (Institute of Nutrition and Food Safety of the Chinese Center for Disease Control and Prevention), Wang Qihuai, Xu Haibin, Huang Kunlun, Wang Jing, Fu Zhongwen 1 Scope
Food Safety Evaluation of Transgenic Plants and Their Products Guide NY/T1101—2006
This standard specifies the safety evaluation of gene recipient plants, gene donor organisms, and gene manipulation, as well as the toxicological evaluation, key component analysis and nutritional evaluation, exogenous chemical accumulation evaluation, and drug resistance evaluation of transgenic plants and their products. This standard applies to food safety evaluation of transgenic plants and their products. 2 Terms and Definitions
The following terms and definitions apply to this standard. 2.1
Transgenic Plant
Genetically Modified Plant
Refers to plants that have their genomes altered by genetic engineering technology and are used for agricultural production or agricultural product processing. 2.2
Products derived from genetically modified plant refer to directly processed products of genetically modified plants and products containing genetically modified plants. 2.3
Recipient plant
recipient plant
refers to the plant into which the recombinant DNA molecule has been introduced.
conventional counterpar
Traditional counterpar
Non-transgenic plants with a traditional food safety history and can be used as reference and comparison objects for the safety evaluation of genetically modified plants and their products, including recipient plants and other related plants.
3 Principles for food safety evaluation of genetically modified plants and their products 3.1 The food safety evaluation of genetically modified plants and their products should be compared with traditional counterpars, and their acceptable safety level should be consistent with that of traditional counterpars.
3.2 The food safety evaluation of genetically modified plants and their products adopts the principles of risk analysis, substantial equivalence and case-by-case handling. 3.3 With the development of science and technology and the continuous improvement of the awareness of food safety of genetically modified plants and their products, the food safety of genetically modified plants and their products should be re-evaluated and reviewed continuously. 4 Safety evaluation of gene recipient plants
4.1 Background information
4.1.1 Scientific name, common name and other names.
4.1.2 Taxonomic status.
4.1.3 Place of origin, planting background.
4.2 Is it toxic to humans and other organisms? If it is toxic, the location of the toxicity and the nature of the toxicity should be stated. 4.3 Is there an allergen? If there is an allergen, the location of the allergen and the characteristics of the allergen should be stated. 4.4 Has there been any other adverse effects on human health? 1
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4.5 Does the production and processing process affect its food safety? 4.6 Does it have a long-term history of safe consumption? 5 Safety evaluation of gene donor organisms
5.1 Background information
5.1.1 Source.
5.1.2 Scientific name, common name and other names.
5.1.3 Taxonomic status.
5.1.4 Life history.
5.2 Safety status
Including toxicity, allergenicity, anti-nutritional effects, pathogenicity. 5.3 Routes and levels of contact with humans
6 Safety evaluation of genetic manipulation
6.1 Description of the traits and characteristics introduced or modified in transgenic plants 6.2 Actual inserted or deleted sequence data
6.2.1 The size and structure of the inserted sequence, and the analytical method to determine its characteristics. 6.2.2 The size and function of the deleted region.
6.2.3 The nucleotide sequence of the target gene and the amino acid sequence of the deduced expressed protein. 6.2.4 The location of the inserted sequence in the plant cell (whether it is integrated into the chromosome, chloroplast, mitochondria, or exists in a non-integrated form) and the method for determining it.
6.2.5 The copy number of the inserted sequence.
6.3 Map of target gene and vector construction
Name, source, structure, characteristics and safety of the vector, including whether the vector is pathogenic and whether it may evolve into pathogenicity. 6.4 Data of each fragment of the inserted region in the vector 6.4.1 Size, function and name of donor organism of promoter and terminator. 6.4.2 Size, function and name of donor organism of marker gene and reporter gene. 6.4.3 Name and source of other expression regulatory sequences (such as artificial synthesis or name of donor organism). 6.5 Transgenic method
6.6 Data of expression of inserted sequence
6.6.1 Organs and tissues where inserted sequence is expressed, such as roots, stems, leaves, flowers, fruits, seeds, etc. 6.6.2 Expression level of inserted sequence and analysis method. 6.6.3 Stability of expression of inserted sequence.
7 Toxicological evaluation of genetically modified plants and their products 7.1 Toxicological evaluation of newly generated substances in genetically modified plants and their products 7.1.1 The newly generated substances in genetically modified plants and their products include proteins, fats, carbohydrates, vitamins, metabolites and other components. When conducting safety evaluation, substances separated from genetically modified plants and their products can be used, or substances that are identical in structure and function to the substances in genetically modified plants and their products can be produced through other means. 7.1.2 The toxicological evaluation of newly generated substances in genetically modified plants and their products should consider the content of newly generated substances in the edible parts of plants and the exposure levels of different populations.
7.1.3 Toxicological evaluation of proteins expressed by exogenous genes. NY/T1101-2006
7.1.3.1 Comparison of the characteristics of amino acid sequence similarity between proteins expressed by exogenous genes and known toxic proteins and anti-nutritional ingredients (such as protease inhibitors and lectins). When the protein expressed by the exogenous gene is not similar to the protein with a known history of safe consumption, an oral toxicology test should be conducted and its biological function in the transgenic plant should be evaluated. 7.1.3.2 Stability of exogenous gene expressed protein during processing and gastrointestinal digestive system 7.1.4 The potential toxicity evaluation of other components other than protein that have no history of safe consumption should refer to traditional toxicology methods, including toxicokinetics, genotoxicity, subchronic toxicity, chronic toxicity/carcinogenicity, and reproductive developmental toxicity evaluation. 7.1.5 The evaluation of the potential toxic effects of transgenic plants and their products caused by the change of characteristics due to gene modification should be conducted by feeding tests and other necessary toxicology tests.
7.2 Evaluation of the allergenicity of transgenic plants and their products 7.2.1 For proteins expressed due to gene modification in transgenic plants and their products, their potential allergenicity should be comprehensively evaluated in accordance with the principles of overall, step-by-step and case analysis. 7.2.2 The evaluation of the allergenicity of exogenous gene expressed proteins usually includes four contents: 1. Source: Determine the methods and data used to evaluate the allergenicity based on the information on the allergenicity of the gene donor organism. The information on the allergenicity of the gene donor organism includes the available screening serum allergy type, the degree and frequency of allergic reactions, the structural characteristics and amino acid sequence of the protein expressed by the exogenous gene, the physicochemical properties and immunological characteristics of the protein expressed by the exogenous gene. The homology of the amino acid sequence: the comparison of the homology of the amino acid sequence of the protein expressed by the exogenous gene with that of the known allergen. For proteins derived from known allergens or with sequence homology to known allergens, if allergic serum is available, immunological methods can be used for evaluation; for proteins derived from non-known allergens or with no sequence homology to known allergens, target serum screening should be performed if necessary.
--Stability: The stability of the protein expressed by the exogenous gene during processing and in the gastrointestinal digestive system. 8 Analysis of key components and nutritional evaluation of transgenic plants and their products 8.1 The analysis and evaluation of key components of transgenic plants and their products shall take into account the influence of factors such as the natural variation range of relevant components of the recipient organism.
The analysis of key components of transgenic plants and their products mainly includes: nutrients, including proteins and amino acids, fats and fatty acids, carbohydrates (including dietary fiber), minerals, vitamins, etc. www.bzxz.net
-Anti-nutritional components and natural toxins, including anti-nutritional factors and enzyme inhibitors, etc. - Other beneficial components other than nutrients, including phytochemicals, etc. - New components generated by genetic modification and other possible unexpected components. 8.2 Transgenic plants and their products that have changed nutritional quality and function shall be subject to nutritional evaluation, including changes in the nutrient intake of the population and the possible nutritional effects on the population, etc., especially the effects of the maximum intake on health and the nutritional effects on special sensitive populations.
8.3 The impact of processing conditions on the content, structure, function and bioavailability of the main nutrients, anti-nutritional components and other beneficial components of transgenic plants and their products shall be evaluated.
9 Evaluation of the accumulation of exogenous chemicals in transgenic plants and their products To evaluate whether transgenic plants and their products will lead to an increase in pesticide residues, accumulation of fungal toxins and other major pollutants that are harmful to the human body.
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Evaluation of drug resistance in transgenic plants and their products 0
If transgenic plants and their products contain drug resistance marker genes, their drug resistance should be evaluated. 4
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