Report of the 33rd Session of the Codex Committee on Nutrition and ...

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REP 12/NFSDU Appendix V 55APPENDIX VPROPOSED DRAFT ANNEX TO THE CODEX GUIDELINES ON NUTRITIONLABELLING:GENERAL PRINCIPLES FOR ESTABLISHING NUTRIENT REFERENCE VALUES FORNUTRIENTS ASSOCIATED WITH RISK OF DIET-RELATED NONCOMMUNICABLEDISEASES FOR THE GENERAL POPULATION(At Step 3 <strong>of</strong> <strong>the</strong> Procedure)1. PREAMBLEThese principles apply to <strong>the</strong> establishment <strong>of</strong> <strong>Codex</strong> Nutrient Reference Values for labelling purposesfor nutrients associated with risk <strong>of</strong> diet-related noncommunicable diseases (NRVs-NCD) for <strong>the</strong>general population identified as individuals older than 36 months. These values may be used forhelping consumers 1) estimate <strong>the</strong> relative contribution <strong>of</strong> individual products to overall healthfuldietary intake, and 2) as one way to compare <strong>the</strong> nutrient content between products. Governments areencouraged to use <strong>the</strong> NRVs-NCD, or alternatively, consider <strong>the</strong> suitability <strong>of</strong> <strong>the</strong> general principlesbelow and additional factors specific to a country or region in establishing <strong>the</strong>ir own reference valuesfor labelling purposes, for nutrients associated with diet-related noncommunicable diseases.For example, at <strong>the</strong> national level, population-weighted values for <strong>the</strong> general population may beestablished by weighting science-based reference values for daily intakes for age-sex groups usingcensus data for a country and proportions <strong>of</strong> each age-sex group. Governments may also considerwhe<strong>the</strong>r to establish separate food label reference values for specific segments <strong>of</strong> <strong>the</strong> generalpopulation.2. DEFINITION(S)2.1 Nutrient Reference Values - Noncommunicable Disease (NRVs-NCD) refer to <strong>Codex</strong>nutrient reference values for food labelling purposes for nutrients that are associated with risk <strong>of</strong> dietrelatednoncommunicable diseases not including nutrient deficiency diseases or disorders.2.2 Daily Intake Reference Values as used in <strong>the</strong>se principles refer to reference nutrient intakevalues provided by FAO/WHO or o<strong>the</strong>r recognized authoritative scientific bodies that may beconsidered in establishing an NRV-NCD based on <strong>the</strong> principles and criteria in Section 3. Thesevalues may be expressed in different ways (e.g., as a single value or a range), and are applicable to <strong>the</strong>total population or to a segment <strong>of</strong> <strong>the</strong> population (e.g., recommendations for a specified age range).2.3 Upper Level <strong>of</strong> Intake (UL) 22 is <strong>the</strong> maximum level <strong>of</strong> habitual intake from all sources <strong>of</strong> anutrient or related substance judged to be unlikely to lead to adverse health effects in humans.2.4 Acceptable Macronutrient Distribution Range (AMDR) is a range <strong>of</strong> intakes for a particularenergy source that is associated with reduced risk <strong>of</strong> diet-related noncommunicable diseases whileproviding adequate intakes <strong>of</strong> essential nutrients. For macronutrients, <strong>the</strong>y are generally expressed as apercentage <strong>of</strong> energy intake.3. GENERAL PRINCIPLES FOR ESTABLISHING NRVs-NCD3.1 Criteria for Selection <strong>of</strong> NutrientsThe following criteria should be considered in <strong>the</strong> selection <strong>of</strong> nutrients for <strong>the</strong> establishment <strong>of</strong>NRVs-NCD: Relevant convincing 23 / generally accepted 24 scientific evidence for <strong>the</strong> relationship between anutrient and noncommunicable disease risk, including validated biomarkers for relevant disease risk.22Different countries may use o<strong>the</strong>r terms for this concept, for example, Tolerable Upper Nutrient Intake Level (UL) orupper end <strong>of</strong> safe intake range.
REP 12/NFSDU Appendix V 56[In addition,Option 1governments may consider <strong>the</strong> suitability <strong>of</strong> probable evidence 25 in conjunction with o<strong>the</strong>rrelevant bases in establishing <strong>the</strong>ir own food label reference value(s) .OROption 2<strong>the</strong> suitability <strong>of</strong> probable evidence 4 may need to be considered.] Public health importance <strong>of</strong> <strong>the</strong> nutrient-noncommunicable disease risk relationship(s) among<strong>Codex</strong> member countries.3.2 Selection <strong>of</strong> Suitable Data Sources to Establish NRVs-NCD3.2.1 Relevant daily intake reference values provided by FAO/WHO that are based on a recentreview <strong>of</strong> <strong>the</strong> science should be taken into consideration as primary sources in establishing NRVs-NCD.3.2.2 Relevant daily intake reference values that reflect recent independent review <strong>of</strong> <strong>the</strong> science,from recognized authoritative scientific bodies o<strong>the</strong>r than FAO/WHO could also be taken intoconsideration. Higher priority should be given to values in which <strong>the</strong> evidence has been evaluatedthrough a systematic review.3.2.3 The daily intake reference values should reflect intake recommendations for <strong>the</strong> generalpopulation.3.3. Selection <strong>of</strong> Appropriate Basis for Determining and Expressing NRVs-NCD3.3.1 Relevant and peer-reviewed scientific evidence for quantitative reference values for dailyintake should be available in order to determine an NRV-NCD that is applicable to <strong>the</strong> generalpopulation.3.3.2 Daily intake reference values from FAO/WHO or o<strong>the</strong>r recognized authoritative scientificbodies that may be considered for NRVs-NCD include values expressed in absolute amounts or as apercentage <strong>of</strong> energy intake.3.3.3 For practical application in nutrition labelling, a single NRV-NCD for <strong>the</strong> general populationshould be established for each nutrient that meets <strong>the</strong> principles and criteria in this Annex.232425[Convincing Evidence is evidence based on epidemiological studies showing consistent associations between exposureand disease, with little or no evidence to <strong>the</strong> contrary. The available evidence is based on a substantial number <strong>of</strong> studiesincluding prospective observational studies and where relevant, randomized controlled trials <strong>of</strong> sufficient size, durationand quality showing consistent effects. The association should be biologically plausible. The definition <strong>of</strong> ‘convincingevidence’ was taken from <strong>the</strong> following FAO/WHO reports: 1) Fats and Fatty Acids in Human Nutrition: <strong>Report</strong> <strong>of</strong> anExpert Consultation. FAO Food and Nutrition Paper 91. Rome. FAO, 2010. and 2) Diet, Nutrition and <strong>the</strong> Prevention <strong>of</strong>Chronic Diseases. WHO Technical <strong>Report</strong> Series 916. WHO, 2003.]For <strong>the</strong>se General Principles <strong>the</strong> terms convincing/generally accepted evidence are considered synonymous.[Probable Evidence is evidence strong enough to support a judgement <strong>of</strong> a probable causal relationship,which wouldgenerally justify goals and recommendations designed to reduce <strong>the</strong> incidence <strong>of</strong> cancer. All <strong>of</strong> <strong>the</strong> following aregenerally required: Evidence from at least two independent cohort studies, or at least five case control studies. No substantial unexplained heterogeneity between or within study types in <strong>the</strong> presence or absence <strong>of</strong> anassociation or direction <strong>of</strong> effect. Good quality studies to exclude with confidence <strong>the</strong> possibility that <strong>the</strong> observed association results from random orsystematic error, including confounding, measurement error and selection bias. Evidence for biological plausibility.The definition <strong>of</strong> ‘probable evidence’ is adapted from <strong>the</strong> World Cancer Research Fund/American Institute for CancerResearch (AICR) report: Food, Nutrition, Physical Activity and <strong>the</strong> Prevention <strong>of</strong> Cancer: a Global Perspective.Washington, DC: AICR, 2007, p. 60. The definition and application <strong>of</strong> “probable evidence” [is specific to consideration<strong>of</strong> an appropriate basis for food label reference values by governments], and is not applicable to <strong>Codex</strong> recommendationson scientific substantiation for health claims. The latter is provided in <strong>the</strong> Annex on Recommendations on <strong>the</strong> ScientificSubstantiation <strong>of</strong> Health Claims in <strong>the</strong> Guidelines for Use <strong>of</strong> Nutrition and Health Claims (CAC-GL 23-1997).]
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EREP12/NFSDUJOINT FAO/WHO FOOD STAN
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REP12/NFSDUiiiTABLE OF CONTENTSSumm
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REP12/NFSDUvLIST OF ABBREVIATIONS(U
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REP 12/NFSDU 27. The Delegation <st
Page 9 and 10: REP 12/NFSDU 421. WHO continues to
Page 11 and 12: REP 12/NFSDU 6PRINCIPLES FOR THE DE
Page 13 and 14: REP 12/NFSDU 82. Definitions2.1 Nut
Page 15 and 16: REP 12/NFSDU 10Status of</s
Page 17 and 18: REP 12/NFSDU 1291. With reference t
Page 19 and 20: REP 12/NFSDU 149.Packaging120. An a
Page 21 and 22: REP 12/NFSDU 16SUMMARY STATUS OF WO
Page 23 and 24: REP 12/NFSDU Appendix I 18Mrs Maria
Page 25 and 26: REP 12/NFSDU Appendix I 20Mr Hongmi
Page 27 and 28: REP 12/NFSDU Appendix I 22Ariane Va
Page 29 and 30: REP 12/NFSDU Appendix I 24Ms Yvonne
Page 31 and 32: REP 12/NFSDU Appendix I 26Pr<strong
Page 33 and 34: REP 12/NFSDU Appendix I 28NEPAL / N
Page 35 and 36: REP 12/NFSDU Appendix I 30Dr Chang
Page 37 and 38: REP 12/NFSDU Appendix I 32Mrs Krist
Page 39 and 40: REP 12/NFSDU Appendix I 34Ms Nancy
Page 41 and 42: REP 12/NFSDU Appendix I 36Pr<strong
Page 43 and 44: REP 12/NFSDU Appendix I 38Mrs Isabe
Page 45 and 46: REP 12/NFSDU Appendix I 40Mrs Nynke
Page 47 and 48: REP 12/NFSDU Appendix I 42CODEX SEC
Page 49 and 50: REP 12/NFSDU Appendix III 44APPENDI
Page 51 and 52: REP 12/NFSDU Appendix IV 464. SUITA
Page 53 and 54: REP 12/NFSDU Appendix IV 48manufact
Page 55 and 56: REP 12/NFSDU Appendix IV 506.2 Ener
Page 57 and 58: REP 12/NFSDU Appendix IV 527.2. O<s
Page 59: REP 12/NFSDU Appendix IV 54ANNEXTAB
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