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GB 15193.18-2015: National food safety standard -- Health guidance values
Status: Valid GB 15193.18: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB 15193.18-2015 | English | 149 |
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3 days [Need to translate]
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National food safety standard -- Health guidance values
| Valid |
GB 15193.18-2015
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| GB 15193.18-2003 | English | 199 |
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2 days [Need to translate]
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Acceptable daily intake estimation
| Obsolete |
GB 15193.18-2003
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| GB 15193.18-1994 | English | 199 |
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2 days [Need to translate]
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Estimation of acceptable daily intake
| Obsolete |
GB 15193.18-1994
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PDF similar to GB 15193.18-2015
Basic data | Standard ID | GB 15193.18-2015 (GB15193.18-2015) | | Description (Translated English) | National food safety standard -- Health guidance values | | Sector / Industry | National Standard | | Classification of Chinese Standard | C53 | | Classification of International Standard | 7.1 | | Word Count Estimation | 7,770 | | Date of Issue | 2015-08-07 | | Date of Implementation | 2015-10-07 | | Older Standard (superseded by this standard) | GB 15193.18-2003 | | Regulation (derived from) | National Food Safety Standard Announcement 2015 No.6 | | Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China | GB 15193.18-2015: National food safety standard -- Health guidance values---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(National Food Safety Standard health guidance values)
National Standards of People's Republic of China
National Food Safety Standard
Health-based guidance values
Issued on.2015-08-07
2015-10-07 implementation
People's Republic of China
National Health and Family Planning Commission released
Foreword
This standard replaces GB 15193.18-2003 "acceptable daily intake (ADI development)."
This standard compared with GB 15193.18-2003, the main changes are as follows.
--- Standard name was changed to "national food safety standard health-based guidance value";
--- Modify the scope of the standard;
--- Modify the terms and definitions;
--- Added "health-based guidance value";
--- Revised ADI developed overview;
--- Delete the words "the development of acceptable daily intake of some exceptions."
National Food Safety Standard
Health-based guidance values
1 Scope
This standard specifies the method for the development of food and food-related chemical health guidance values.
This standard applies to have the threshold can cause toxic effect of the test substance.
2 Terms and definitions
NOTE. health-based guidance values related terms covered in this chapter bilingual and acronyms in Appendix A.
2.1 health-based guidance values
Human a period of time (lifetime or 24h) ingested something (or some) substance without producing detectable adverse health effects of
Safety limits, including the acceptable daily intake, tolerable intake, acute reference dose and the like.
2.2 starting point
Or sensitive data from dose groups observed indicators of experimental animals - response relations for extrapolated dose values of health-based guidance values,
If no observed adverse effect level and the reference dose and the like.
2.3 No observed adverse effect level
Through animal experiments, the existing technical means and detection index was not observed any harmful effects of the test substance-related maximum dose.
2.4 Minimum observed adverse effect level
Under specified conditions, the test substance causing a minimal effect dose animal tissue morphology, function, growth and development, and other harmful effects.
2.5 benchmark dose
Based on the dose - response relationship of research results, obtained using statistical model was caused by a particular test, a lower health risk issue
Students rate (typically 10% quantitative data, qualitative data was 5%) 95% confidence interval dose limits.
2.6 uncertainty factor
Safety factor
For the development of health-based guidance values applied outside push from animals to humans (assuming that the most sensitive), or from some individuals extrapolated to the general
Composite coefficient group used.
3 health-based guidance values
Note. This chapter covered health-based guidance values related terms and acronyms bilingual word Appendix A.
3.1 acceptable daily intake
A human lifetime daily intake of chemicals normally used (such as food additives), no detectable adverse health effects of
the amount. An amount per kilogram of body weight can be ingested, ie mg/kg body weight.
3.1.1 Category ADI
If the toxicity of several similar substances are used or used for food, the group should develop category ADI compound to limit its cumulative intake
Into. Developing category ADI, sometimes based on the average NOAEL/BMD compound of the group, but the group of compounds commonly used in the lowest
NOAEL/BMD, but also consider the relative quality of the individual compounds and test cycle studies.
3.1.2 No provision ADI
According to available information (chemistry, toxicology, etc.) demonstrate that a low toxicity test substance, and its usage and total human dietary intake of people
Does not harm healthy body, you can not have to set specific ADI.
3.1.3 provisional ADI
When a substance is limited safety information or the safety of a substance has been developed ADI questioned according to the latest information, such as to
In order to further provide the required data security in the short term, there is sufficient information that the use of the substance is safe in the short term, but without
Sufficient to determine the long-term food safety, may formulate tentative ADI and the use of larger uncertainty factor, the need to provision tentative ADI Validity
Limit, and in the meantime requested after toxicology test results proved that the test substance is safe, the provisional value to ADI ADI value; as
Toxicology test results prove to be safety problems, revoke provisional ADI value.
3.1.4 can not propose ADI
In the following cases, the test substance does not propose ADI.
a) can take advantage of the safety information is not sufficient;
b) lack of information on substances used in foods;
c) lack of material properties and purity quality specifications.
3.2 tolerable intake
Humans over a period of time or lifetime exposure to certain chemicals, does not produce the amount of adverse health effects can be detected. Per kg
The amount of weight that can be ingested, ie mg/kg body weight, including tolerable daily intake provisional maximum tolerable daily intake, Provisional Tolerable Weekly Intake
And the amount of the provisional tolerable monthly intake.
3.2.1 tolerable daily intake
Similar to ADI, for those who are not intentionally added substances, such as contaminants in food.
3.2.2 Type TI
If a similar toxicity of several substances used as or in food, in this group of compounds should be developed to limit its category TI cumulative intake
Into. Developing Type TI, sometimes based on an average of the group of compounds NOAEL/BMD, but the group of compounds commonly used in the lowest NOA-
EL/BMD, but also consider the relative quality of the individual compounds and test cycle studies.
3.2.3 provisional maximum tolerable daily intake
Applies to no accumulation of contaminants in food, contaminants in food and drinking water due to the naturally occurring, and therefore represents the humanity allowed
Exposure levels. For both essential nutrients and trace elements food ingredients, places a range to represent the lower limit of the representative body shall
Required level, the upper limit is PMTDI. Because usually the lack of results of human exposure to low doses, therefore, generally known as the tolerable intake
"Tentative", the new data may change the provisional tolerable intake.
3.2.4 Provisional Tolerable Weekly Intake
Applicable to the accumulated effect of food contaminants (such as heavy metals), which represents the inevitable human exposure to these contaminants, the weekly
Permissible exposure.
3.2.5 provisional tolerable monthly intake
Applicable to the accumulation effect in the human body and has a long half-life of food contaminants, which represents human exposure to these inevitable
When contaminants monthly allowable exposure.
3.3 Acute Reference Dose
Human intake of certain chemicals (such as pesticides) within 24h or less, without producing detectable adverse health effects
Amount.
4 developing methodologies
4.1 collect relevant data
For the development of health-based guidance values, we should first collect relevant toxicological research data, from the need for the appropriate database, peer experts
Review of the literature and unpublished studies such as business reports of scientific information adequately reviewed. Evaluation of toxicity data for general use
Weights of evidence, the right to differ materially small studies in the following order. epidemiological studies, animal toxicological studies, in vitro tests and quantitative knot
Frame - response relationship.
4.2 determine the starting point
To determine the starting point and end of the test depends on the test system selection, design dose, mode of action and toxicity dose - response model. often
There NOAEL and starting with BMD.
Select the uncertainty factor of 4.3
Given when extrapolated from experimental animal studies to humans, there are inherent uncertainties, including extrapolation uncertainty, people within species between species
Extrapolation uncertainty, high-dose extrapolation to low doses of uncertainty, a small amount of experimental animals results extrapolated to large crowds of uncertainty,
Experimental animals low genetic heterogeneity extrapolated to high population heterogeneity and uncertainty.
The extrapolation of animal data to humans is usually 100-fold uncertainty factor as a starting point, that is 10 times the difference between species, and within population susceptibility
10-fold difference. When the data is insufficient should further increase the uncertainty factor, such as the subchronic study results pushed to the outer chronic studies to
LOAEL instead of NOAEL, the database is not complete, but need to make up part of the judgment, the general acquiescence of each uncertain factor
Value set to 10.
4.4 Calculation health-based guidance values
Health-based guidance values according to formula (1).
HBGV = POD/UFs (1)
Where.
HBGV --- health-based guidance values;
POD --- starting point;
UFs --- uncertainty factor.
Appendix A
Health-based guidance values related terms
Bilingual health-based guidance values related terms and acronyms in Table A.1.
Table A.1 health guidance values bilingual terminology and acronyms
Chinese name English name abbreviations
Health-based guidance values Health-BasedGuidanceValues HBGV
Starting PointofDeparture POD
No observed adverse effect level no-observed-adverse-effect-level NOAEL
The minimum observed adverse effect level lowest-observed-adverse-effect-level LOAEL
BenchmarkDose BMD benchmark dose
Uncertainty factor UncertaintyFactors UFs
AcceptableDailyIntake ADI acceptable daily intake
Category ADI groupADIs -
No ADI provisions ADInotspecified -
Provisional ADI TemporaryADI -
Not proposed ADI noADIalocated -
Tolerable Intake TolerableIntake TI
TolerableDailyIntake TDI tolerable daily intake
Category TI groupTI -
Provisional maximum tolerable daily intake ProvisionalMaximumTolerableDailyIntake PMTDI
Provisional Tolerable Weekly Intake ProvisionalTolerableWeeklyIntake PTWI
Provisional tolerable monthly intake ProvisionalTolerableMonthlyIntake PTMI
AcuteReferenceDose ARfD acute reference dose
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