DEFINITIONS OF RISK ANALYSIS TERMS RELATED TO FOOD SAFETY
For the purposes of the Codex Alimentarius:
Food means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of "food" but does not include cosmetics or tobacco or substances used only as drugs.
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 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.
Contaminant means any substance not intentionally added to food, which is present in such food 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 as a result of environmental contamination. The term does not include insect fragments, rodent hairs and other extraneous matter.
Pesticide means 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 means 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.
Good Agricultural Practice in the Use of Pesticides (GAP) includes the nationally authorized safe uses of pesticides under actual conditions necessary for effective and reliable pest control. It encompasses a range of levels of pesticide applications up to the highest authorised use, applied in a manner which leaves a residue which is the smallest amount practicable.
Authorized safe uses are determined at the national level and include nationally registered or recommended uses, which take into account public and occupational health and environmental safety considerations.
Actual conditions include any stage in the production, storage, transport, distribution and processing of food commodities and animal feed.
Codex maximum limit for pesticide residues (MRLP) is the 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
b) 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.
Consideration of the various dietary residue intake estimates and determinations both at the national and international level in comparison with the ADI, should indicate that foods complying with Codex MRLs are safe for human consumption.
Veterinary drug means any substance applied or administered to any food producing animal, such as meat or milk producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behaviour.
Residues of veterinary drugs include 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.
Codex maximum limit for residues of veterinary drugs (MRLVD) is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or m g/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.
Good Practice in the Use of Veterinary Drugs (GPVD) is the official recommended or authorized usage including withdrawal periods, approved by national authorities, of veterinary drugs under practical conditions.
Processing aid means 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.
1 These Definitions were adopted by the 22nd Session of the Commission (1997) on an interim basis: they are subject to modification in the light of developments in the science of risk analysis and as a result of efforts to harmonize similar definitions across various disciplines
Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.
Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.
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.
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.
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. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable.
Dose-response assessment: The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).
Exposure assessment: The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant.
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 management: The process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures.
Risk communication: The interactive exchange of information and opinions concerning risk among risk assessors, risk managers, consumers and other interested parties.
Contents of this Section
This Section of the Procedural Manual sets out the working procedures of the subsidiary bodies of the Codex Alimentarius Commission. It is primarily addressed to the Chairpersons and the Host Government Secretariats of individual Codex Committees.
The Guidelines for Codex Committees describe the organization and conduct of meetings and the preparation and distribution of working papers and reports. The Codex Reference System for Documents is explained in this Section.
Special technical sections are included on principles for the establishment or selection of Codex methods of analysis. Codex sampling procedures and on analytical terminology for use by Codex Committees.
The Format of Codex Standards and an explanatory note on how Committees should draft Codex Standards are described here. A section describes the Criteria for the Establishment of Work Priorities.
To ensure that the appropriate sections of Codex Commodity Standards have been reviewed for food safety, nutrition, consumer protection and food analysis, a section on the Relations between Commodity Committees and General Committees is included for guidance to Codex Commodity Committees.