1. GENERAL CRITERIA FOR THE SELECTION OF SINGLE-LABORATORY VALIDATED METHODS OF ANALYSIS (TO BE INCLUDED AFTER THE GENERAL CRITERIA)
Inter-laboratory validated methods are not always available or applicable, especially in the case of multi-analyte/multi substrate methods and new analytes. The criteria to be used to select a method are included in the General Criteria for the Selection of Methods of Analysis. In addition the single-laboratory validated methods must fulfill the following criteria:
i. the method is validated according to an internationally recognized protocol (e.g. those referenced in the harmonized IUPAC Guidelines for Single-Laboratory Validation of Methods of Analysis)
ii. the use of the method is embedded in a quality system in compliance with the ISO/IEC 17025: 1999 Standard or Principles of Good Laboratory Practice;
The method should be complemented with information on accuracy demonstrated for instance with:
2. GUIDELINES FOR THE INCLUSION OF SPECIFIC PROVISIONS IN CODEX STANDARDS AND RELATED TEXTS
PRINCIPLES FOR THE ESTABLISHMENT OF CODEX METHODS OF ANALYSIS
Specificity: deleted
Selectivity: Selectivity is the extent to which a method can determine particular analyte(s) in mixtures or matrices without interferences from other components of similar behaviour.
Selectivity is the recommended term in analytical chemistry to express the extent to which a particular method can determine analyte(s) in the presence of interferences from other components. Selectivity can be graded. The use of the term specificity for the same concept is to be discouraged as this often leads to confusion.
Accuracy (as a concept) and Accuracy (as a statistic) to be replaced with the following definition:
Accuracy: The closeness of agreement between a test result and the accepted reference value.
Note:
The term accuracy, when applied to a set of test results, involves a combination of random components and a common systematic error or bias component.
Trueness: The closeness of agreement between the average value obtained from a series of test results and an accepted reference value.
Notes:
1 The measure of trueness is usually expressed in terms of bias.
2 Trueness has been referred to as “accuracy of the mean”. This usage is not recommended.
Selectivity: Selectivity is the extent to which a method can determine particular analyte(s) in mixtures or matrices without interferences from other components of similar behaviour.
Selectivity is the recommended term in analytical chemistry to express the extent to which a particular method can determine analyte(s) in the presence of interferences from other components. Selectivity can be graded. The use of the term specificity for the same concept is to be discouraged as this often leads to confusion.
3. DEFINITIONS OF RISK ANALYSIS TERMS RELATED TO FOOD SAFETY
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).
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.
Performance Criterion (PC): The effect in frequency and/or concentration of a hazard in a food that must be achieved by the application of one or more control measures to provide or contribute to a PO or an FSO.
4. AMENDMENT TO PART 2. CRITICAL REVIEW OF THE PROPOSED AMENDMENTS TO THE PROCEDURES FOR THE ELABORATION OF CODEX STANDARDS AND RELATED TEXTS (ALINORM 04/27/33, Appendix III)
Paragraph 4
“The decision to undertake new work or revision of individual maximum residue limits for pesticides or veterinary drugs, or the maintenance of the General Standard on Food Additives1, the General Standard on contaminants and toxins in foods2, the Food categorization system and the International numbering System, shall follow the procedures established by the Committees concerned and endorsed by the Commission”.
ALINORM 04/27/33A
APPENDIX III
PROPOSED AMENDMENT TO THE RULES OF PROCEDURE
OF THE CODEX ALIMENTARIUS COMMISSION
Rule VIII. Observers
(...)
5. Participation of international intergovernmental organizations in the work of the Commission and the relations between the Commission and such organizations shall be governed by the relevant provisions of the Constitutions of FAO or WHO, as well as by the applicable regulations of FAO or WHO on relations with intergovernmental organizations; such relations shall be handled by the Director-General of FAO or WHO, as appropriate.
6. Participation of international non-governmental organizations in the work of the Commission and the relations between the Commission and such organizations shall be governed by the relevant provisions of the Constitution of FAO or WHO, as well as by applicable regulations of FAO or WHO on relations with international non-governmental organizations. Such relations shall be handled by the Director-General of FAO or WHO, as appropriate, on the advice of the Executive Committee. The Commission shall develop and keep under review principles and criteria concerning the participation of international non-governmental organizations in its work, consistent with the applicable regulations of FAO or WHO.
ALINORM 04/27/33A
APPENDIX IV
DEFINITION OF TRACEABILITY / PRODUCT TRACING
Definition to be included in the Procedural manual
Traceability / product tracing: the ability to follow the movement of a food through specified stage(s) of production, processing and distribution.
PROPOSED DRAFT REVISED CODE OF ETHICS FOR INTERNATIONAL TRADE IN FOOD CAC/RCP 20-1979, Rev. 1 (1985)
(At Step 3 of the Procedure)
PREAMBLE
THE CODEX ALIMENTARIUS COMMISSION,
RECOGNIZING THAT:
(a) Adequate, safe, and wholesome food is a vital element for the achievement of acceptable standards of living and that the right to a standard of living adequate for the health and wellbeing of individuals and their family is proclaimed in the Universal Declaration of Human Rights of the United Nations, the Rome Declaration of the World Food Summit;
(b) Food is a vital and critical item of international trade and its quality and safety is influenced primarily by prevailing commercial practices and such food legislation and food control practices as are in operation in particular countries;
(c) Food purchases utilize a significant portion of the income of consumers, particularly low-income consumers, who often also represent the most vulnerable group and for whom ensuring of safe, sound and wholesome food and protection from unfair trade practices is critical;
(d) There is ever present concern about food safety, unfair trade practices in quality, quantity and presentation of food, misleading claims, food losses and wastage and, generally about food quality and nutritional status everywhere; the establishment of effective food control systems can lead to improvements in this situation;
(e) Food legislation and food control infrastructures may not be sufficiently developed in many countries to enable adequate protection of their food exports and imports and to prevent the dumping of sub-standard and unsafe foods;
(f) The World Trade Organization Agreements on trade, particularly the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT) establish certain rights and obligations of Members for measures that affect international trade directly and indirectly;
(g) The International Code of Marketing of Breast-milk Substitutes and relevant resolutions of the World Health Assembly set forth principles for the protection and promotion of breastfeeding which is an important aspect of primary health care;
(h) The Rome Declaration and the Plan of Action of the World Food Summit encourage the assurance of adequate supplies of safe and nutritious food for all people, which is dependent upon the facilitation of trade and the use of appropriate food production and process controls exercised by both the food industry and governments;
(i) Member countries may encounter difficulties in complying with the food regulations of importing Member countries, and as a consequence in access to markets;
AND CONSIDERING THAT:
(a) The major objectives of the work of the Codex Alimentarius Commission are to protect the health of the consumers and ensure fair practices in international trade in food through the elaboration and harmonization of standards and related texts addressing food safety and quality, methods of analysis and sampling, inspection and certification systems;
(b) The publication of the Codex Alimentarius is intended to assist in the harmonisation of the definitions and requirements for food and in doing so to facilitate international trade;
(c) The above stated objectives can best be achieved by each country establishing or strengthening its food legislation and food control infrastructures, taking into account the standards and related texts of the Codex Alimentarius Commission and, where necessary, taking advantage of the work of international organizations competent to advise and provide assistance in these areas;
(d) A code of ethical conduct for international trade in food embodying the principles of consumer protection can be complementary to national food legislation and food control infrastructures and, at the same time facilitate effective international cooperation;
(e) Due consideration should be given to the particular needs of developing countries, enabling them to produce and maintain a safe and wholesome food supply;
hereby decides to recommend that member countries commit themselves to the ethical framework set forth in this code and undertake to support its implementation in the larger interest of the world community.
1.1 The objective of this code is to provide [advice/guidance] to governments and thereby to protect the health of the consumers and ensure fair practices in the food trade.
1.2 The code is designed for use by member governments, by those engaged in international trade and by producers and consumers in order to judge whether trade practices are acceptable.
This code applies to all food introduced into international trade and applies mutatis mutandi to concessional and food aid transactions.
"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.
4.1 International trade in food and food aid transactions should be conducted in a manner that is consistent with the objectives of ensuring the protection of consumers’ health and fair practices in food trade, especially taking into account the Codex Principles for Food Import and Export Inspection and Certification.
[4.2 International trade in food should be consistent with the obligations of member countries under the SPS and TBT Agreements.]
4.3 Countries should ensure that their national regulations do not create unjustified barriers to trade.
4.4 Appropriate national food standards, based on risk analysis where applicable, should be established and enforced [] [taking into account] [based on] the relevant standards and related texts established by the Codex Alimentarius Commission.
4.5. In the preparation and application of food regulations, countries should take into account the special needs and situation of developing countries, in conformity with the provisions of the SPS and TBT Agreements where applicable.
4.6. While not lowering the level of consumer health protection, when the difficulties of member countries are identified in ensuring that the food they produce, import and export meets international standards, assistance programs should be facilitated, including those of FAO and WHO, to enhance the capability of these countries to produce, import and export safe and wholesome food.
5.1 Food that is traded internationally should conform:
(a) to the requirements of Codex Alimentarius Commission’s relevant standards and related texts; or
(b) to such food legislation as may be in force in the exporting and/or importing country; food standards and safety requirements of importing countries should be transparent and available to exporting countries ; or
(c) to the provisions contained, regarding food, in bilateral or multilateral agreements signed by the exporting country and the importing country; or
(d) in the absence of such provisions, to such standards and requirements as may be agreed upon, taking into account the provisions of Codex Standards and related texts wherever possible.
5.2 [Except when the food represents a risk to health, a country may export food that does not comply with its national regulations if that food complies with the regulations of the importing country and is exported in accordance with the requirements of the importing country.]
[5.3 No food should be in international trade which:
(a) has in or upon it any substance in an amount which renders it poisonous, harmful or otherwise injurious to health; or
(b) consists in whole or in part of any substance which is unfit for human consumption or contains foreign matter to an extent which makes it unfit for human consumption; or
(c) is adulterated; or
(d) is labelled or presented in a manner that is false, misleading or deceptive or that may adversely affect the safety of the food; or
(e) is prepared, packaged, stored, transported or marketed under unsanitary conditions; or
(f) has a remaining shelf-life that will not allow its distribution in the importing country before the expiry date.]
5.4 The provisions of Article 5.3 a) and b) do not prevent the export of raw or semi-processed foods which are not edible as such in order to be further processed, reprocessed or reconditioned in the importing country for the purpose of human consumption. Where special processing or culinary practices or storage conditions or any specific conditions are required to render the food harmless, the exporter should provide adequate information on such processing or conditions to the importer.
Specific Requirements: Foods for Infants, Young Children and other Vulnerable Groups
5.5 Food for infants, young children and other vulnerable groups should be in accordance with standards elaborated by the Codex Alimentarius Commission. The marketing and labelling of foods for infants and young children should be in accordance with relevant provisions of the International Code of Marketing for Breast-milk Substitutes (Article 9), World Health Assembly resolutions and Codex standards and related texts.
6.1 When rejection of a food product arises from:
- evidence of a serious food safety or public health problem in the exporting country; or
- evidence of serious misrepresentation or consumer fraud; or
- evidence of a serious failure in the inspection or control system in the exporting country,
- The exchange of information between authorities of the importing and exporting countries regarding the rejections of imported food should be in accordance with the Codex Guidelines for the Exchange of Information between Countries on Rejections of Imported Food; and
- the competent authorities of the importing and exporting country should take appropriate actions in accordance with their legal and administrative procedures, taking into account the Codex Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems, in particular paragraphs 30 to 37, and the Codex Guidelines for the Exchange of Information between Countries on Rejections of Imported Food, in particular, paragraphs 4 to 10. .
6.2 Except when the food represents a risk to health, food that has been exported and subsequently rejected at the time of import due to non conformity with the standards and other requirements of the importing country, may be
- allowed to be re-exported to the exporting country; or
- allowed to be re-exported to another country only if the precise reasons for the rejection are disclosed to the potential importer before re-export.
6.3 Information should be supplied regarding the action taken following the rejection or retention of a consignment of food, taking into account the Codex Guidelines for the Exchange of Information between Countries on Rejections of Imported Food
7.1 The implementation of this code rests with:
(importing and exporting member countries who should,
(i) provide adequate food legislation and food control infrastructures to comply or verify compliance with Articles 4 and 6 of this Code, including certification and inspection systems and other legal or administrative procedures that also apply to re-exports of food as appropriate and necessary, and
(ii) work with the regulated industry, including all food manufacturers, distributors, transporters consumers and all others concerned with the international trade in food - particularly in respect of Article 5 – to ensure that the General Principles in Article 4 are taken into account; and
(iii) use the Codex Principles for Food Import and Export Inspection and Certification and the Codex Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems to the fullest extent possible.
and further, will depend on
- such cooperation and consultative procedures as may be established between governments of importing and exporting countries, and, generally, between all those concerned with international food trade, and
- the extent to which international food standards and related texts, elaborated by the Codex Alimentarius Commission are considered and applied where relevant and appropriate.
7.2 deleted
7.2 (previous 7.3) This code should be promoted by member countries in their respective territorial jurisdictions in accordance with their legal and administrative procedures regulating the conduct of exporters, importers and all those engaged in international food trade.
8. Where special circumstances exist under which it is neither possible nor desirable to apply certain provisions of this code, as in the case of famines and other emergency situations (where the appropriate competent authorities in recipient and donor countries responsible for food control may decide to establish mutually agreed criteria), due regard should always be given to the basic principles of the safety of the food and other provisions of this code as may be applicable under those circumstances.
9. Countries denying entry to food for reasons involving serious considerations of public health or fraud and having reason to believe that the food may be exported to or distributed in countries should inform the competent authorities in the other countries in accordance with the Codex Guidelines for the Exchange of Information between Countries on Rejections of Imported Food. For emergency situations countries should follow the current version of the Codex Guidelines for the Exchange of Information between Countries in Food Control Emergency Situations. In addition, should an exporting country become aware of a problem related to an exported food product, the exporting country should immediately inform the competent authority in the importing country about the problem.
[Transferred to Article 4- General Principles]
1 including related methods of analysis and sampling plans
2 including related methods of analysis and sampling plans