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Mucho agradeceremos dar el alcance que merece nuestra propuesta que formalmente solicitamos con este escrito que se basa en la evidencia documentada que de antemano hemos exhibido y la que anexo enviaremos nuevamente. Anke Sentko Vice President Regulatory Affairs & Nutritional Communication Wim Caers Manager Regulatory Affairs 2/2
Subject: MEXICO – Comments on PROY‐NOM‐051‐SCFI/SSA1‐2009 SSS/WCS/IML Regulatory Affairs October 22 nd , 2009, page 1 / 4 On the 26th of August 2009, the proposal for PROY‐NOM‐051‐SCFI/SSA1‐2009 was published in Mexico’s Official Journal. Comments can be submitted during the 60 days of public consultation. Item of PROY‐ NOM‐051 3.3 Definition: “Sugars” Proposal Justification “All mono‐ and disaccharides present in a food or non‐alcoholic beverage, excluding polyols and isomaltulose” ‐ Exclusion of polyols: Because the physiological properties of polyols are different from sugars: polyols are low glycemic, do not promote dental caries and are reduced in calories (for isomalt: Ziesenitz, S.C., 1996, Review ‘Basic Structure and metabolism of isomalt’, Advances in Sweetness: 109‐133 [annex 1.1]). It will bring the Mexican definition in line with Codex Alimentarius (cfr. The joint FAO/WHO Scientific Update on Carbohydrates in Human Nutrition (2007) excludes polyols from the total sugar content [Annex 1.2]. and the European Legislation ( 90/496/EEC; [annex 1.3]). Polyols are mainly used for sugarfree products, no added sugars and/or energy reduced type of products. ‐ Exclusion of isomaltulose: Although this carbohydrate is a disaccharide from a chemistry point of view, its nutritional and physiological properties significantly differ from those of sugars as it is e.g., non‐cariogenic, slow release and low glycaemic so that it would be misleading to the consumer to have them classified as sugars (see e.g. US‐FDA GRAS Notification No. GRN 000184 (isomaltulose)[Annex 1.4]; US Health Claims Regulation on dietary noncariogenic carbohydrate sweeteners and dental caries [Annex 1.5]; ‘Palatinose TM (isomaltulose) – a new innovative carbohydrate’ [Annex 1.6]; ‘Dossier for the scientific substantiation of claims related to Palatinose TM and its nutritional physiological properties’ [Annex 1.7]; Report from Imfeld (University of Zürich): ‘Pilot Study on the Dental Care Properties of Isomaltulose (Palatinose TM )’ [Annex 1.8]; It will also support correct information to the consumer. Isomaltulose will be included under the “carbohydrate” listing, like e.g. starch or maltodextrins, which is where it really belongs, rather than under the “sugar” section.
Page 5: Comision Federal de la mejora regul
Page 9 and 10: Item of PROY‐ NOM‐051 A.3.1 & A
Page 11: Annex 1.1: Ziesenitz, S.C.; 1996;
Page 26 and 27: Volume 61 Supplement 1 December 200
Page 28 and 29: Volume 61, Supplement 1, December 2
Page 30 and 31: S1 S5 S19 S40 S75 S100 S112 S122 S1
Page 32 and 33: FAO/WHO Scientific Update on carboh
Page 34 and 35: cardiovascular diseases and cancer)
Page 36 and 37: REVIEW Carbohydrate terminology and
Page 38 and 39: Table 2 Energy and macronutrient in
Page 40 and 41: are inulin and fructo oligosacchari
Page 42 and 43: Table 3 Principal physiological pro
Page 44 and 45: National Academy of Sciences in 200
Page 46 and 47: product contained X25% whole grain
Page 48 and 49: Henderson L, Gregory J, Swan G (200
Page 50 and 51: REVIEW Nutritional characterization
Page 52 and 53: Table 1 Nutritional characterizatio
Page 54 and 55: Table 2 Principles of carbohydrate
Page 56 and 57:
Table 4 NSP in a selection of foods
Page 58 and 59:
asked to consider both the ‘plant
Page 60 and 61:
Table 5 Continued Plant-rich diet a
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account for any supplemented materi
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eaction vessels, with successive tr
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similar to the situation with sugar
Page 68 and 69:
company working on dietary carbohyd
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van Dam RM, Seidell JC (2007). Carb
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2003). In establishing the energy v
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combustible energy of the fermentab
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glucose, starch, NSP) there is also
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generated through bioenergetic inef
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Table 4 cE, ME and NME, and content
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ME (Atwater general system) (Merill
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(o0.8 kg in the adult), increase af
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B1.4 MJ from protein in men, did no
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food and body weight, height or BMI
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esults may relate not only to the d
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ecologist, who is pre-occupied with
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Table 5 Effect of NSP (dietary fibr
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As already described, almost any ca
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in adolescents. Possible mechanisms
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unit, such as a grant or fellowship
Page 102 and 103:
Conference on Medical Research. Ros
Page 104 and 105:
Prentice AM, Poppitt SD (1996). Imp
Page 106 and 107:
REVIEW Carbohydrate intake and obes
Page 108 and 109:
Total carbohydrate intake Introduct
Page 110 and 111:
composition of the diet did not sub
Page 112 and 113:
European Journal of Clinical Nutrit
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postmenopausal US women (Howard et
Page 116 and 117:
weight loss was greater after 6 mon
Page 118 and 119:
European Journal of Clinical Nutrit
Page 120 and 121:
its carbohydrate content, whereas a
Page 122 and 123:
Table 4 Continued Duration Interven
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Despite a substantially lower GL fo
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increased physical activity has bee
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with normal glucose tolerance: the
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Westerterp KR, Verboeket-van de Ven
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especially the NSP, complicates com
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1.21, 1.35, 1.40 and 1.64. The patt
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esidual confounding provide the jus
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carbohydrate have generated broadly
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There is no good evidence of benefi
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Meyer KA, Kushi LH, Jacobs Jr DR, S
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from prospective studies which have
Page 146 and 147:
Table 3 Prospective studies of diet
Page 148 and 149:
of sucrose-containing foods, such a
Page 150 and 151:
Acrylamide Acrylamide is a chemical
Page 152 and 153:
Nicodemus KK, Jacobs Jr DR, Folsom
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carbohydrate and fat may have a low
Page 156 and 157:
Foods having very different nutrien
Page 158 and 159:
esearch activities and food selecti
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highest satiety score was boiled po
Page 162 and 163:
patients: a new basis for carbohydr
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and lipid levels, to a greater exte
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insufficient for the use of glycaem
Page 168 and 169:
Dr Hans Englyst: Director and share
Page 175 and 176:
Annex 1.4: US‐FDA GRAS Notificati
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FDA/CFSAN/OFAS: Agency Response Let
Page 179 and 180:
Annex 1.5: US Health Claims Regulat
Page 181 and 182:
jlentini on PROD1PC65 with RULES 30
Page 183 and 184:
Annex 1.6: “PalatinoseTM (isomalt
Page 185 and 186:
Isomaltulose is tooth friendly, unl
Page 187 and 188:
CONFIDENTIAL Regulatory Affairs & N
Page 189 and 190:
CONFIDENTIAL General or usual name:
Page 191 and 192:
Page 193 and 194:
CONFIDENTIAL Plasma glucose change
Page 195 and 196:
Page 197 and 198:
CONFIDENTIAL Rise in blood glucose
Page 199 and 200:
Page 201 and 202:
CONFIDENTIAL References Regulatory
Page 203:
Annex 1.8: Report from Imfeld (Univ
Page 240:
Annex 2.2: Roberfroid, M.B., 1999;
Page 244:
Annex 3.2: “Letter of no objectio
Page 247 and 248:
1 Nutrition and Health Claims (CAC/
Page 249 and 250:
Page 251 and 252:
Page 361:
Annex 3.2: “Letter of no objectio
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