AMENDMENTS TO THE PROCEDURAL MANUAL OF THE CODEX ALIMENTARIUS COMMISSION
DEFINITIONS FOR THE PURPOSES OF THE CODEX ALIMENTARIUS DEFINITIONS OF RISK ANALYSIS TERMS RELATED TO FOOD SAFETY
APPENDIX TO THE PROCEDURAL MANUAL: GENERAL DECISIONS OF THE COMMISSION
GUIDELINES FOR THE INCLUSION OF SPECIFIC PROVISIONS IN CODEX STANDARDS AND RELATED TEXTS (SECTION H)
PRINCIPLES FOR THE ESTABLISHMENT AND APPLICATION OF MICROBIOLOGICAL CRITERIA TO FOODS
GUIDELINES FOR THE USE OF CODEX COMMITTEES ON THE INCLUSION OF PROVISIONS ON NUTRITIONAL QUALITY IN FOOD STANDARDS AND OTHER CODEX TEXTS
GUIDELINES ON THE ELABORATION AND/OR REVISION OF CODES OF HYGIENIC PRACTICE FOR SPECIFIC COMMODITIES
(a) The establishment of additional food hygiene requirements for specific food items or food groups should be limited to the extent necessary to meet the defined objectives of individual codes.
(b) Codex Codes of Hygienic Practice should serve the primary purpose of providing advice to governments on the application of food hygiene provisions within the framework of national and international requirements.
(c) The Revised Recommended International Code of Practice - General Principles of Food Hygiene (including the Guidelines for the Application of the Hazard Analysis Critical Control Point (HACCP) System) and the Revised Principles for the Establishment and Application of Microbiological Criteria for Foods are the base documents in the field of food hygiene.
(d) All Codex Codes of Hygienic Practice applicable to specific food items or food groups shall refer to the General Principles of Food Hygiene and shall only contain material additional to the General Principles which is necessary to take into account the particular requirements of the specific food item or food group.
(e) Provisions in Codex Codes of Hygienic Practice should be drafted in a sufficiently clear and transparent manner such that extended explanatory material is not required for their interpretation.
(f) The above considerations should also apply to Codex Codes of Practice which contain provisions relating to food hygiene.
CRITERIA FOR THE ESTABLISHMENT OF WORK PRIORITIES AND FOR THE ESTABLISHMENT OF SUBSIDIARY BODIES OF THE CODEX ALIMENTARIUS COMMISSION (SECTION J)
NEW WORK TO BE UNDERTAKEN BY EXISTING SUBSIDIARY BODIES
1. When a Codex Committee proposes to elaborate a standard, code of practice or related text within its terms of reference, it should first consider the priorities established by the Commission in the Medium-Term Plan of Work, any specific relevant strategic project currently being undertaken by the Commission and the prospect of completing the work within a reasonable period of time. It should also assess the proposal against the criteria set out in paragraph 4, below.
2. If the proposal falls in an area outside the Committee's terms of reference the proposal should be reported to the Commission in writing together with proposals for such amendments to the Committee's terms of reference as may be required.
NEW WORK WHICH MAY REQUIRE THE ESTABLISHMENT OF A NEW SUBSIDIARY BODY
3. When a Member wishes to propose the elaboration of a standard, code of practice or related text in an area not covered by the terms of reference of any existing subsidiary body, it should accompany its proposal with a written statement to the Commission referring to the Commission's Medium-Term Objectives and containing, as far as practicable, the information required by the appropriate section of paragraph 4, below.
RELATIONS BETWEEN COMMODITY COMMITTEES AND GENERAL SUBJECT COMMITTEES (SECTION K)89
89 New texts appears in bold in this section
FOOD ADDITIVES AND CONTAMINANTS
1) Third paragraph (p. 114)
· In preparing working papers for the Codex Committee on Food Additives and Contaminants, the Secretariat should make a report to the Committee concerning the endorsement of provisions for food additives (including processing aids), on the basis of the General Principles for the Use of Food Additives. Provisions for food additives should indicate the INS number, the ADI, technological justification, proposed level, and whether the additive was previously endorsed (or temporarily endorsed)
· Sections (i), (ii) and (iii) (pages 114-115): deleted and integrated into the General Principles for the Use of Food Additives.
2) First paragraph p. 115 "When commodity standards are sent to governments for comments at Step 3, they should contain a statement that the provisions "in respect of food additives and contaminants are subject to endorsement by the Codex Committee on Food Additives and Contaminants and to incorporation into the General Standard for Food Additives or the General Standard for Contaminants and Toxins in Food
3) Second paragraph and Sections (i) to (v) on page 115-116: delete and replace with
(i) When establishing provisions for food additives, Codex committees should follow the General Principles for the Use of Food Additives and the Preamble of the General Standard for Food Additives. Full explanation should be provided for any departure from the above recommendations.
(ii) When an active commodity committee exists, proposals for the use of additives in any commodity standard under consideration should be prepared by the committee concerned, and forwarded to the Codex Committee on Food Additives and Contaminants for endorsement. When the Codex Committee on Food Additives and Contaminants decides not to endorse specific additives provisions (use of the additive, or level in the end-product), the reason should be clearly stated. The section under consideration should be referred back to the Committee concerned if further information is needed, or for information if the Codex Committee on Food Additives and Contaminants decides to amend the provision.
(iii) When no active commodity committee exists, proposals for new additive provisions or amendment of existing provisions, should be forwarded directly by member countries to the Codex Committee on Food Additives and Contaminants.
90 These Definitions are proposed 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.
A. STATEMENTS OF PRINCIPLE CONCERNING THE ROLE OF SCIENCE IN THE CODEX DECISION-MAKING PROCESS AND THE EXTENT TO WHICH OTHER FACTORS ARE TAKEN INTO ACCOUNT RELATING TO THE ROLE OF FOOD SAFETY RISK ASSESSMENT
1. The food standards, guidelines and other recommendations of Codex Alimentarius shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information, in order that the standards assure the quality and safety of the food supply.
2. When elaborating and deciding upon food standards Codex Alimentarius will have regard, where appropriate, to other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade.
3. In this regard it is noted that food labelling plays an important role in furthering both of these objectives.
4. When the situation arises that members of Codex agree on the necessary level of protection of public health but hold differing views about other considerations, members may abstain from acceptance of the relevant standard without necessarily preventing the decision by Codex.
B. STATEMENTS OF PRINCIPLE RELATING TO THE ROLE OF FOOD SAFETY RISK ASSESSMENT
1. Health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances.
2. Food safety risk assessment should be soundly based on science, should incorporate the four steps of the risk assessment process, and should be documented in a transparent manner.
3. There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are essential for a pragmatic approach.
4. Risk assessments should use available quantitative information to the greatest extent possible and risk characterizations should be presented in a readily understandable and useful form.