European Union Comments for the CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES

European Union Comments for the CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES Thirty fifth Session Bad Soden am Taunus, Germany, 4 8 November 2013 AGENDA ITEM 3 Proposed Draft Additional or Revised Nutrient Reference Values for Labelling Purposes in the Codex Guidelines on Nutrition Labelling (CX/NFSDU 13/35/4) European Union competence European Union Vote The European Union (EU) has the following comments on the Proposed Draft Additional or revised Nutrient Reference Values for labelling purposes in the Codex Guidelines on Nutrition Labelling (CX/NFSDU 13/35/8). With regard to Recommendation 1, the EU supports to include the first 3 bodies as RASBs as in Recommendation 1 (EFSA, IOM, NHMRC/MOH) but maintains reservation for the other 3 (NIHN, TWG, IZiNCG). The EU would like to receive additional information about the International Zinc Nutrition Consultative Group, particularly in relation to the RASB criteria 3. While it is noted that its work has been taken on board by a RASB for deciding their national policy, it is not clear whether the definition of a RASB covers organisations that are taken on board by other RASBs to establish policies in this country or region. The EU would like to receive additional information about the National Institute of Health and Nutrition, in particular in relation to the RASB criteria 2. The EU would like to receive additional information about the Technical Working Group on Nutritional Guidelines with regard to the role that non-governmental bodies, particular professional bodies and industry associations play in the development of advice. The EU proposed to include to the definition of an RASB that the DIRVs are derived from a primary evaluation of the scientific evidence. The clarification that the DIRVs are derived from a primary evaluation of the scientific evidence could lead to a re-evaluation of the proposed RSABs. Concerning Recommendation 2, the EU supports this recommendation, but considers that the term 'absorption' could be clarified in order to correctly express the different concepts, such as mentioning 'true absorption' where appropriate (e.g. for zinc) or 'apparent absorption (e.g. for iron). With regard to Recommendation 3, the EU, in principle, is in favour of selecting the most suitable pnrv-r rather than deriving a value by calculating an average as the averaging of values would be calculated with values derived under differing and not comparable circumstances. The EU would like to add the recommendations from EFSA, which have been adopted on 10 October 2013 and are expected to be published on 4 November 2013. The EU had informed the electronic working group about the draft opinion for public consultation found at 1

http://www.efsa.europa.eu/en/consultationsclosed/call/130628.htm, this document is comparable to the final except for the following modifications: a slightly lower reference value for lactating women and justification of this change in the text, few additional changes clarifying the setting of different reference values for men and women,, added reference to an intervention study from 2013, reference to markers of the function of the immune system, which was considered not to be a suitable criterion for deriving the requirement for vitamin C, added reference to effects of genotype, for which data were insufficient to be used for deriving the requirement for vitamin C, incorporation of an additional reference to visionrelated outcomes and cancer from 2013. Therefore, the EU would like to update section 2.3.4 of CX/NFSDU 13/35/4 with the average of the population reference intakes for vitamin C for men and women derived by EFSA: 2.3.4 Vitamin C EFSA IOM (United States & Canada) (NHRMC/MOH) Australia & New Zealand 1 NIHN (Japan) 103 mg 83 mg 45 mg 100 mg WHO/FAO Current NRV-R 45 mg 60 mg The physiological endpoint selected by IOM was near maximal neutrophil concentrations and by NIHN was optimal antioxidant activity in plasma (50 µg/l). The physiological endpoint selected by EFSA was near-saturation of body pools as indicated by a plasma ascorbate concentration of 50 µg/l. In contrast, the physiological endpoint selected by WHO/FAO and NHMRC/MOH was 50 % tissue saturation i.e. halfway between tissue saturation and the point at which clinical signs of scurvy appear. With regard to Recommendations 4 and 5, the EU supports the proposed values. With regard to Recommendation 6, the EU supports the proposed, revised text. With regard to Recommendation 11, the EU expresses doubts about the first proposed modification because we consider that FAO and WHO are organisations recognised to provide authoritative scientific advice while they are not scientific bodies such as IOM or EFSA. Therefore, we prefer to maintain the text as it is. However, we wonder whether having a separate sentence to the effect that FAO and/or WHO are organisations recognised to provide authoritative scientific advice would help clarify the role of FAO and WHO. Furthermore, the EU does not support the deletion of the part in square brackets and notes that the correct spelling is 'competent national and/or regional autorityies'. Also, the EU does not support the insertion of the word 'government' at the end of the definition. Proposed wording: For the purposes of establishing Codex Nutrient Reference Values, a recognized, scientific, authoritative body is an organization supported by a government(s) or competent national and/or regional authorities or FAO and/or WHO that provides independent and transparent* authoritative scientific advice on daily intake reference values upon request, and for which such advice is recognised through its use in the development of 1 National Health and Medical Research Council and New Zealand Ministry of Health (2006) Nutrient Reference Values for Australia and New Zealand. NHMRC, Canberra 2

policies in one or more countries. FAO and/or WHO are organisations recognised to provide authoritative scientific advice. * In providing transparent scientific advice, the Committee would have access to what was considered by a RASB in establishing a daily intake reference value in order to understand the derivation of the value Finally, the EU would prefer a clarification in the definition of the RASB that the DIRVs are derived from a primary evaluation of the scientific evidence. With regard to Recommendation 12, the EU supports the deletions of the footnote. With regard to Recommendation 13, the EU supports the proposed deferral of a decision about vitamin E in order to consider the issues raised by Australia in an ewg in 2014. 3

IOM (United States & Canada) Vitamin E M: 15 mg α- tocopherol F: 15 mg α- tocopherol Vitamin C M: 90 mg F: 75 mg Magnesium M: 413 mg F: 316 mg Selenium M: 55 µg F: 55 µg Iron M: 8 mg F: 18 mg EFSA (EU) NHMRC/MOH (Australia & New Zealand) - M: 10 mg α-toc equiv F: 7 mg α-toc equiv M: 110 mg M: 45 mg F: 95 mg F: 45 mg - M: 413 mg F: 316 mg - M: 70 µg F: 60 µg - M: 8 mg F: 18 mg NIHN (Japan) TWG (Malaysia) IZiNCG WHO/FAO (2004) M: 8 mg F: 8 mg M: 100 mg F: 100 mg M: 359 mg F: 283 mg M: 30 µg F: 25 µg M: 7 mg F: 11 mg M: 10 mg F: 7.5 mg - M: 10 mg α-te F: 7.5 mg α-te (best estimate, not INL 98 ) - M: 45 mg F: 45 mg M: 70 mg F: 70 mg -- - M: 260 mg F: 220 mg M: 33 µg - M: 34 µg F: 25 µg F: 26 µg M: 9-14 mg F: 20-29 mg - M: 9.1; 11.4; 13.7; 27.4 mg F: 19.6; 24.5; 29.4; 58.8 mg (15%; 12%; 10%; 5% absorption respectively) Zinc Protein (g/kg/day) Protein (g/day) (reference body weight) M: 11 mg F: 8 mg M: 0.8 F: 0.8 M: 56 (70 kg) F: 46 (57 kg) - M: 14 mg F: 8 mg M: 0.83 F: 0.83 M: 62 (74.6 kg) F: 52 (62.1 kg) M: 0.84 F: 0.75 M: 64 (76 kg) F: 46 (61 kg) M: 12 mg F: 9 mg M: 0.9 F: 0.9 M: 60 (66 kg) F: 50 (52 kg) M: 6.7 mg F: 4.9 mg M: 1.00 F: 1.00 M: 62 (62 kg) F: 55 (55 kg) M: 13; 19 mg F: 8; 9 mg (30%; 22% absorption respectively) M:.4.2; 7.0; 14.0 mg F: 3.0; 4.9; 9.8 mg (50%; 30%; 15% absorption respectively) - WHO/FAO (2007) M: 0.83 F: 0.83 - M: 54 (65 kg) F: 46 (55 kg) 2

Table 2C: Supplementary Information: Vitamin C, Se, Fe and Zn Physiological endpoint Reason for choice of endpoint(s) % Dietary absorption and basis 5 Vitamin C United States & Canada European Union Australia & New Zealand Japan Near-maximal neutrophil concentrations Near-saturation body pools Body pool to prevent deficiency (scurvy), vitamin C turnover studies and biochemical indices in man Optimal antioxidant activity in plasma (50µmol/L), and prevention of cardiovascular diseases Coefficient variation Primary evaluation Year(s) of evaluation Estimated to provide antioxidant protection - 10% CV YES 1998 2000 1996 Several health outcomes possibly associated with vitamin C intake were also considered but data were found to be insufficient to establish DRVs. For healthy adults, the AR is determined from the quantity of vitamin C that balances metabolic vitamin C losses and allows the maintenance of an adequate body pool characterised by fasting plasma ascorbate concentrations at around 50 µmol/l. EAR based on prevention of deficiency and half-way point to tissue saturation with a safety margin in recognition of limited data available across the various age bands 80% absorption (for an intake of about 100 mg/day) 85% absorption efficient, catabolic rate of 2.9% (21% CV) and rounding Year latest literature 10% CV YES 2012-2013 2013 20% CV YES 2005 2003 Estimated to provide antioxidant protection - 10% CV YES 2008 2000 Malaysia - - 70-90% of usual dietary intake of ascorbic acid (30-180 mg/day is absorbed (MOH 2005) WHO/FAO (2004) Body pool of vitamin C Amount required to half saturate body tissues with vitamin C 85% absorption efficienc 10% CV NO, based on FAO/WHO (2002) and IOM (2000) - - 25% CV YES 1998 2004 1998 3