Acceptable Daily Intake (ADI) – An estimate of the amount of a substance in food or drinking water, expressed on a body-weight basis, that can be ingested daily over a lifetime without appreciable risk (standard human = 60 kg). The ADI is listed in units of mg per kg of body weight.
- Temporary ADI: Used by JECFA when data are sufficient to conclude that use of the substance is safe over the relatively short period of time required to generate and evaluate further safety data but are insufficient to conclude that use of the substance is safe over a lifetime. A higher-than-normal safety factor is used when establishing a temporary ADI and an expiration date is established by which time appropriate data to resolve the safety issue should be submitted to JECFA. The temporary ADI is listed in units of mg per kg of body weight.
- ADI “not specified” – food additives: A term applicable to a food substance of very low toxicity which, on the basis of the available data (chemical, biochemical, toxicological, and other), the total dietary intake of the substance arising from its use at the levels necessary to achieve the desired effect and from its acceptable background in food does not, in the opinion of JECFA, represent a hazard to health. For that reason, and for reasons stated in individual evaluations, the establishment of an acceptable daily intake expressed in numerical form is not deemed necessary. An additive meeting this criterion must be used within the bounds of good manufacturing practice, i.e., it should be technologically efficacious and should be used at the lowest level necessary to achieve this effect, it should not conceal inferior food quality or adulteration, and it should not create a nutritional imbalance.
- ADI “not specified” – veterinary drugs: Available data on the toxicity and intake of the veterinary drug indicate a large margin of safety for consumption of residues in food when the drug is used according to good practice in the use of veterinary drugs. For that reason, and for the reasons stated in the individual evaluation, the Committee has concluded that use of the veterinary drug does not represent a dietary hazard to human health and that there is no need to specify a numerical ADI.
- ADI “not limited”: A term no longer used by JECFA that has the same meaning as ADI “not specified”.
- Conditional ADI: A term no longer used by JECFA to signify a range above the “unconditional ADI” which may signify an acceptable intake when special problems, different patterns of dietary intake, and special groups of the population that may require consideration are taken into account.
- No ADI allocated: There are various reasons for not allocating an ADI, ranging from a lack of information to data on adverse effects that call for advice that a food additive or veterinary drug should not be used at all. The report should be consulted to learn the reasons that an ADI was not allocated.
Acceptable Flavoring agents – Used to describe flavouring agents that are of no safety concern at current levels of intake. If an ADI has been allocated to the agent, it is maintained unless otherwise indicated.
Acceptable Food additives – Used on some occasions when present uses are not of toxicological concern or when intake is self-limiting for technological or organoleptic reasons.
Acceptable level of treatment – ADIs are expressed in terms of mg per kg of body weight per day. In certain cases, however, food additives are more appropriately limited by their levels of treatment. This situation occurs most frequently with flour treatment agents. It should be noted that the acceptable level of treatment is expressed as mg/kg of the commodity. This should not be confused with an ADI.
Adverse health effect – A change in the morphology, physiology, growth, development, reproduction or life span of an organism, system, or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other influences.
- The additive is acceptable for use in the raw materials or other ingredients (including food additives) according to this Standard;
- The amount of the additive in the raw materials or other ingredients (including food additives) does not exceed the maximum use level specified in this Standard;
- The food into which the additive is carried over does not contain the additive in greater quantity than would be introduced by the use of raw materials, or ingredients under proper technological conditions or manufacturing practice, consistent with the provisions of this standard.
Codex Committees – The Codex system is supported by eight horizontal committees covering all foods and twelve vertical committees which focus on only one specific food category or sector. Six of the vertical Codex Committees are active, and six are currently inactive.
Horizontal Codex Committees:
- Food Labeling (known as Codex Committee on Food Labeling or CCFL)
- Food Additives (CCFA)
- Contaminants in Foods (CCCF)
- Pesticides Residues (CCPR)
- Residues of Veterinary Drugs in Foods (CCRVDF)
- Food Hygiene (CCFH)
- Food Import and Export Inspection and Certification Systems Food Labeling (CCFICS)
- Codex Committee on General Principles (CCGP)
Vertical Codex Committees:
- Cereals, Pulses and Legumes (CCCPL)
- Fresh Fruits and Vegetables (CCFFV)
- Fats and Oils (CCFO)
- Processed Fruits and Vegetables (CCPFV)
- Sugars (CCS)
- Spices and Culinary Herbs (CCSCH)
- Cocoa Products and Chocolate (CCCPC)
- Fish and Fishery Products (CCFFP)
- Milk and Milk Products (CCMMP)
- Meat Hygiene (CCMH)
- Natural Mineral Waters (CCNMW)
- Vegetable Proteins (CCVP)
Contaminant – means any substance not intentionally added to food or feed for food producing animals, which is present in such food or feed as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or feed, or as a result of environmental contamination. The term does not include insect fragments, rodent hairs and other extraneous matter.
- Maximum Level for a Contaminant in a Food or Feed Commodity is the maximum concentration of that substance recommended by the Codex Alimentarius Commission to be legally permitted in that commodity.
Food Additive – means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonably expected to result (directly or indirectly), in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods. The term does not include contaminants or substances added to food for maintaining or improving nutritional qualities.
Food Hygiene – comprises conditions and measures necessary for the production, processing, storage and distribution of food designed to ensure a safe, sound, wholesome product fit for human consumption.
Food Safety Objective (FSO) – The maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the appropriate level of protection (ALOP).
Good Manufacturing Practice (GMP) in the Use of Food Additives – means that:
- the quantity of the additive added to food does not exceed the amount reasonably required to accomplish its intended physical nutritional or other technical effect in food;
- the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technological effect in the food itself, is reduced to the extent reasonably possible;
- the additive is of appropriate food grade quality and is prepared and handled in the same way as a food ingredient. Food grade quality is achieved by compliance with the specifications as a whole and not merely with individual criteria in terms of safety.
Good Practice in the Use of Veterinary Drugs – is the official recommended or authorized usage including withdrawal periods, approved by national authorities, of veterinary drugs under practical conditions.
Hazard Characterization – The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food.
Hazard Identification – The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods.
Highest observed intake – the highest level of intake observed or administered as reported within a study(ies) of acceptable quality. It is derived only when no adverse health effects have been identified.
Homeostatic mechanism – A mechanism effected through a system of controls activated by negative feedback that allow the maintenance of normal body functions in the presence of a variable nutrition environment.
International Numbering System for food additives (INS) – The INS (INS) is intended as a harmonized naming system for food additives as an alternative to the use of the specific name, which may be lengthy.
- Temporary MRL: Used by JECFA when a temporary ADI has been established and/or when it has been found necessary to provide time to generate and evaluate further data on the nature and quantitation of residues. In this summary temporary MRLs are expressed in terms of mg/kg tissue or mg/l milk.
- MRL “not specified”: Available data on the identity and concentration of residues of the veterinary drug in animal tissues indicate a large margin of safety for consumption of residues in food when the drug is used according to good practice in the use of veterinary drugs. For that reason, and for the reasons stated in the individual evaluation, the Committee has concluded that the presence of drug residues in the named animal product does not present a health concern and that there is no need to specify a numerical MRL.
Maximum Use Level of an additive – The highest concentration of the additive determined to be functionally effective in a food or food category and agreed to be safe by the Codex Alimentarius Commission. It is generally expressed as mg additive/kg of food.
Nutrient-related hazard identification – The identification of a nutrient- related hazard in a particular food or group of foods.
Nutrient-related hazard characterization – The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with a nutrient-related hazard.
Nutrient-related risk characterization – The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on nutrient-related hazard identification, nutrient-related hazard characterization and intake assessment.
Nutritional risk – A function of the probability of an adverse health effect associated with inadequate or excessive intake of a nutrient or related substance and the severity of that effect, consequential to a nutrient- related hazard(s) in food.
Performance Objective (PO) – The maximum frequency and/or concentration of a hazard in a food at a specified step in the food chain before the time of consumption that provides or contributes to an FSO or ALOP, as applicable.
Pesticide – Any substance intended for preventing, destroying, attracting, repelling, or controlling any pest including unwanted species of plants or animals during the production, storage, transport, distribution and processing of food, agricultural commodities, or animal feeds or which may be administered to animals for the control of ectoparasites. The term includes substances intended for use as a plant growth regulator, defoliant, desiccant, fruit thinning agent, or sprouting inhibitor and substances applied to crops either before or after harvest to protect the commodity from deterioration during storage and transport. The term normally excludes fertilizers, plant and animal nutrients, food additives, and animal drugs.
- Pesticide Residue: Any specified substance in food, agricultural commodities, or animal feed resulting from the use of a pesticide. The term includes any derivatives of a pesticide, such as conversion products, metabolites, reaction products, and impurities considered to be of toxicological significance.
- Maximum Limit for Pesticide Residues (MRL): Maximum concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legally permitted in or on food commodities and animal feeds. MRLs are based on GAP data and foods derived from commodities that comply with the respective MRLs are intended to be toxicologically acceptable. Codex MRLs, which are primarily intended to apply in international trade, are derived from estimations made by the JMPR following a toxicological assessment of the pesticide and its residue; and review of residue data from supervised trials and supervised uses including those reflecting national good agricultural practices. Data from supervised trials conducted at the highest nationally recommended, authorized or registered uses are included in the review. In order to accommodate variations in national pest control requirements, Codex MRLs take into account the higher levels shown to arise in such supervised trials, which are considered to represent effective pest control practices.
Processing Aid – Any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product.
Provisional Maximum Tolerable Daily Intake (PMTDI) – The endpoint used for contaminants with no cumulative properties. Its value represents permissible human exposure as a result of the natural occurrence of the substance in food and in drinking-water. In the case of trace elements that are both essential nutrients and unavoidable constituents of food, a range is expressed, the lower value representing the level of essentiality and the upper value the PMTDI.
- PTMI (Provisional Tolerable Monthly Intake): An endpoint used for a food contaminant with cumulative properties that has a very long half-life in the human body. Its value represents permissible human monthly exposure to a contaminant unavoidably associated with otherwise wholesome and nutritious foods.
- PTWI (Provisional Tolerable Weekly Intake): An endpoint used for food contaminants such as heavy metals with cumulative properties. Its value represents permissible human weekly exposure to those contaminants unavoidably associated with the consumption of otherwise wholesome and nutritious foods.
- Risk Analysis: A process consisting of three components: risk assessment, risk management and risk communication.
- Risk Assessment: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.
- Risk Assessment Policy: Documented guidelines on the choice of options and associated judgements for their application at appropriate decision points in the risk assessment such that the scientific integrity of the process is maintained.
- Risk Characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.
- Risk Communication: The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.
- Risk Estimate: The qualitative and/or quantitative estimation of risk resulting from risk characterization.
- Risk Management: The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.
- Risk Profile: The description of the food safety problem and its context.
A = % ash,
W = % water, and
D = % diluent and carrier.
The ADI is expressed in terms of mg T.O.S. per kg of body weight.
Traceability/Product Tracing – the ability to follow the movement of a food through specified stage(s) of production, processing and distribution.
- Residues of Veterinary Drugsinclude the parent compounds and/or their metabolites in any edible portion of the animal product and include residues of associated impurities of the veterinary drug concerned.
- Maximum Limit for Residues of Veterinary Drugs (MRL)is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or μg/kg on a fresh weight basis) that is recommended by the Codex Alimentarius Commission to be legally permitted or recognized as acceptable in or on a food. It is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake (ADI), or on the basis of a temporary ADI that utilizes an additional safety factor. It also takes into account other relevant public health risks as well as food technological aspects. When establishing an MRL, consideration is also given to residues that occur in food of plant origin and/or the environment. Furthermore, the MRL may be reduced to be consistent with good practices in the use of veterinary drugs and to the extent that practical analytical methods are available.