This standard specifies the method for establishing the acceptable daily intake (ADI) of food and food-related chemical substances. This standard applies to chemical substances that may cause harm to health during the production, processing, storage, transportation and sales of food, including food additives (including nutritional fortifiers), food containers and packaging materials, food tools, equipment, detergents, disinfectants, pesticide residues, veterinary drug residues, etc. GB 15193.18-2003 Establishment of the Acceptable Daily Intake (ADI) GB15193.18-2003 standard download decompression password: www.bzxz.net

ICS 07. 100
National Standard of the People's Republic of China
GB15193.18—2003
Replaces GB15193.18—1994
Establishment of acceptable daily intake (ADI)
Acceptable daily intake estimation2003-09-24Promulgated
Ministry of Health of the People's Republic of China
Standardization Administration of the People's Republic of China
Implementation on 2004-05-01
GB15193.18-2003
This standard is mandatory in its entirety.
This standard replaces GB15193.18—1994 "Establishment of acceptable daily intake (ADI)". The main technical differences between this standard and GB15193.18-1994 are: 1. Addition of "Fan Gui" to the "Fan Gui": Chemical substances that may cause harm to health during the production, processing, preservation, transportation and sale of food, including food additives (including nutritional fortifiers), food containers and packaging materials, food tools, equipment, detergents, disinfectants, pesticide residues, veterinary drug residues, etc.
3-1994 shall be abolished at the same time.
From the date of implementation of this standard, GB15193.18-This standard is proposed and managed by the Ministry of Health of the People's Republic of China. Drafting unit of this standard: Institute of Nutrition and Food Safety, Chinese Center for Disease Control and Prevention. Main drafters of this standard: Li Youhui, Cao Laifu. This standard was first issued in 1994, and this is the first revision. 116
1 Scope
Establishment of daily acceptable intake (ADI)
This standard specifies the method for establishing the daily acceptable intake (ADI) of food and chemical substances related to food. GB15193.18--2003
This standard applies to chemical substances that may cause harm to health during the production, processing, storage, transportation and sales of food, including food additives (including nutritional fortifiers), food containers and packaging materials, food tools, equipment, detergents, disinfectants, pesticide residues, veterinary drug residues, etc.
2 Terms and Definitions
The following terms and definitions apply to this standard. 2.1
Acceptable daily intake, ADI The acceptable daily intake refers to the amount of a substance that humans can ingest daily for a lifetime without causing detectable harm to health. It is expressed in terms of the amount that can be ingested per kilogram of body weight, i.e. mg/(kg body weight·d). 2.2Www.bzxZ.net
No-observed-adverse-effect-level, NOAEL The maximum dose at which no toxic effects related to the test substance are observed through animal experiments using existing technical means and detection indicators. 2.3
Safety factorsafety factor
The safety factor is the coefficient used to calculate the acceptable daily intake (ADI) based on the maximum no observed adverse effect level (NOAEL), that is, the NOAEL is divided by a certain coefficient to obtain the ADI. The value of the coefficient used depends on factors such as the nature of the toxic effects of the test substance, the scope and dosage of the test substance, the applicable population, and the quality of toxicological data. 3 Overview of ADI formulation
3.1ADI is calculated by dividing the NOAEL by a reasonable safety factor. 3.2 Determination of NOAEL: The determination of NOAEL depends on the selection of the test system, dosage design, representativeness of the test indicators and sensitivity of the method.
3.3 Application of safety factor: In view of the inherent uncertainty in extrapolating from limited animal tests to the human population, it is necessary to determine a certain safety margin based on the differences in sensitivity between and within species, the difference in the number of experimental animals and the exposed population, the diversity of complex disease processes in the human population, the difficulty in estimating human intake, and the possible synergistic effects between multiple components in food. The commonly used method is to use a safety factor.
The safety factor is generally set at 100, that is, it is assumed that humans are 10 times more sensitive to the test substance than experimental animals, and the sensitivity difference within the human population is 10 times. The safety factor is mainly determined based on experience, rather than being fixed. The use of the safety factor to formulate the ADI is not a simple mathematical calculation. The determination of the safety factor should be increased or decreased accordingly based on the nature of the test substance, the quantity and quality of the existing toxicological data, the nature of the toxic effects of the test substance, and the scope, quantity, and applicable population of the test substance in actual application. Only on the basis of a comprehensive analysis of all the data can an appropriate safety factor be determined. 4 Some special cases for establishing acceptable daily intake
4.1 Group ADI
If several compounds with similar toxic effects are used or applied to food, a group ADI should be established for this group of compounds to limit their cumulative intake. When establishing a group ADI, sometimes the average NOAEL of the group of compounds can be used, but the lowest NOAEL in the group of compounds is often used, and the relative quality of the research on individual compounds and the test period are also considered. 4.2 No ADI is specified (ADI not specified) According to the existing data (chemistry, biochemistry, toxicology, etc.), it is shown that the toxicity of a certain test substance is very low, and its usage and total intake in human diet do not cause harm to human health, then there is no need to specify a specific ADI, but the substances that meet this requirement must be subject to good production standards and must not be used for adulteration, covering up food quality defects or causing nutritional imbalance. 4.3 Temporary ADI
When the safety data of a substance is limited, or the latest data raises questions about the safety of a substance for which an ADI has been established, if there is sufficient information to believe that the substance is safe to use in the short term, but it is not sufficient to determine long-term food safety, a temporary ADI can be established and a larger safety factor (usually 100×2) can be used. The validity period of the temporary ADI must also be specified, and the results of toxicological tests must fully prove that the test substance is safe during this period. The temporary ADI value will be changed to the ADI value; if the results of toxicological tests prove that there are safety issues, the temporary ADI value will be revoked. 4.4 No ADI allocated: In the following cases, no ADI will be allocated for the test substance: a) Insufficient safety data; b) It is considered unsafe to use in food; c) No methods and specifications for property identification and purity testing have been established. 118
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