Foods, Nutrients and Food Ingredients with Authorised EU Health Claims, Volume 1

434 Pages·2014·2.904 MB·English

by  Michele Jeanne Sadler

Foods, Nutrients and Food Ingredients with
Authorised EU Health Claims
Related titles:
Functional foods: concept to product (Second edition)
(ISBN 78-1-84569-690-0)
Innovations in food labeling
(ISBN 978-1-84569-676-4)
Performance functional foods
(ISBN 978-1-85573-671-9)
Woodhead Publishing Series in Food Science, Technology and Nutrition:
Number 263
Foods, Nutrients and
Food Ingredients with
Authorised EU
Health Claims
Volume 1
Edited by
M. J. Sadler
AMSTERDAM(cid:141)BOSTON(cid:129)CAMBRIDGE(cid:129)HEIDELBERG(cid:129)LONDON
NEW YORK(cid:129)OXFORD(cid:129)PARIS(cid:129)SAN DIEGO
SAN FRANCISCO(cid:129)SINGAPORE(cid:129)SYDNEY(cid:129)TOKYO
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Contents
Contributor contact details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Woodhead Publishing Series in Food Science, Technology and Nutrition. . xvii
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxvii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxxi
Part I Regulatory background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1 The regulation of health claims in Europe . . . . . . . . . . . . . . . . . . . . . . . 3
N. Binns, Independent consultant in nutrition and food regulation, UK
1.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3 Development of the list of claims under Article 13.3. . . . . . . . . . . 7
1.4 Regulatory approval procedure for Article 13.5 and 14
health claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.5 Transition periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.6 Scientific substantiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1.7 Community Register of claims . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.8 Wording of health claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.9 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.10 Nutrient profiling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
1.11 Conclusion and future trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
1.12 Sources of further information and advice . . . . . . . . . . . . . . . . . . 20
1.13 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Part II Authorised disease risk reduction claims, children’s
development and health claims, and proprietary claims . . . . . . 23
2 Authorised EU health claims for barley and oat beta-glucans . . . . . 25
J. Harland, Harland Hall Associates, UK
2.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.2 Authorised Article 13.1/14.1(a) cholesterol claims . . . . . . . . . . . 28
2.3 Summary of substantiating evidence related to
cholesterol claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2.4 Other relevant legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
2.5 Conditions of use, warning labels and safety issues. . . . . . . . . . . 39
2.6 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
vi Contents
2.7 How the claims are being used in practice . . . . . . . . . . . . . . . . . . 40
2.8 Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
2.9 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
2.10 Sources of further information and advice . . . . . . . . . . . . . . . . . . 42
2.11 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
3 Authorised EU health claims for xylitol and sugar-free chewing
gum (SFCG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
K. K. Mäkinen, University of Turku, Finland
3.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.2 The chemical profile of xylitol . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
3.3 Authorised health claims. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
3.4 Substantiating evidence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
3.5 Other relevant legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
3.6 Warning labels and safety issues. . . . . . . . . . . . . . . . . . . . . . . . . . 60
3.7 Incorporation of sugar-free chewing gum (SFCG) as part of
a balanced dietary regimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
3.8 Consumer understanding of the wording used in
recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
3.9 Use of dental health claims in practice . . . . . . . . . . . . . . . . . . . . . 64
3.10 Medical and other uses of xylitol chewing gum . . . . . . . . . . . . . . 65
3.11 Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
3.12 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
3.13 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4 Authorised children’s development and health claims in the EU . . . 73
J. Harland, Harland Hall Associates, UK
4.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
4.2 Authorised health claims. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.3 Summary of substantiating evidence. . . . . . . . . . . . . . . . . . . . . . . 80
4.4 Other relevant legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4.5 Conditions of use, warning labels and safety issues. . . . . . . . . . . 86
4.6 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
4.7 How the claims are being used in practice . . . . . . . . . . . . . . . . . . 88
4.8 Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
4.9 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
4.10 Sources of further information and advice . . . . . . . . . . . . . . . . . . 90
4.11 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
5 Authorised EU health claims for water-soluble tomato
concentrate (WSTC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
A. K. Duttaroy, University of Oslo, Norway
5.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
5.2 Epidemiology of tomato consumption and cardiovascular
disease (CVD) risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Contents vii
5.3 Human platelets and vascular homeostasis. . . . . . . . . . . . . . . . . . 94
5.4 Isolation and characterisation of water-soluble tomato extract:
effects on human platelet aggregation. . . . . . . . . . . . . . . . . . . . . . 96
5.5 Further characterisation of water-soluble tomato extract . . . . . . . 99
5.6 Human trials using the water-soluble tomato extract . . . . . . . . . 101
5.7 EU approval of the health claim of the platelet inhibitory
property of the water-soluble tomato extract . . . . . . . . . . . . . . . 103
5.8 Commercially available Fruitflow® products. . . . . . . . . . . . . . . 105
5.9 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
5.10 Acknowledgement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
5.11 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Part III Ingredients with permitted ‘general function’ claims . . . . . . 111
6 Authorised EU health claims for choline . . . . . . . . . . . . . . . . . . . . . . 113
K. V. Lukasik, Balchem Corporation, USA
6.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
6.2 Characterization of the substance . . . . . . . . . . . . . . . . . . . . . . . . 114
6.3 Allowable health claims according to Commission Regulation
423/2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
6.4 Other relevant EU legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
6.5 Conditions of use and safety considerations. . . . . . . . . . . . . . . . 122
6.6 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
6.7 Potential of health claims in product development. . . . . . . . . . . 125
6.8 Claims being used in practice . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
6.9 Conclusion and future trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
6.10 Sources of further information and advice . . . . . . . . . . . . . . . . . 129
6.11 Acknowledgements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
6.12 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
7 Authorised EU health claims for creatine . . . . . . . . . . . . . . . . . . . . . 139
R. B. Child, Alimentarius Ltd, UK
7.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
7.2 Creatine characterisation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
7.3 Authorised health claim. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
7.4 Legislation relevant to the use of the creatine health claim . . . . 145
7.5 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
7.6 Importance of the claim in product development . . . . . . . . . . . . 147
7.7 Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
7.8 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
7.9 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
viii Contents
8 Authorised EU health claims for intense sweeteners and sugar
replacers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
C. Shortt, Johnson & Johnson EAME, UK
8.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
8.2 Overview of intense sweeteners and sugar replacers . . . . . . . . . 152
8.3 Applications of intense sweeteners and sugar replacers,
related authorised nutrition and health claims. . . . . . . . . . . . . . . 154
8.4 Safety of intense sweeteners and sugar replacers . . . . . . . . . . . . 166
8.5 Conclusion and future trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
8.6 Sources of further information and advice . . . . . . . . . . . . . . . . . 170
8.7 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
9 Authorised EU health claims related to the management of
lactose intolerance: reduced lactose content, dietary lactase
supplements and live yoghurt cultures . . . . . . . . . . . . . . . . . . . . . . . . 177
A. K. Kies, DSM Biotechnology Center, The Netherlands
9.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
9.2 Lactose maldigestion and intolerance. . . . . . . . . . . . . . . . . . . . . 180
9.3 Foods with reduced lactose content . . . . . . . . . . . . . . . . . . . . . . 185
9.4 Lactase enzyme, as a dietary supplement . . . . . . . . . . . . . . . . . . 189
9.5 Live yoghurt cultures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
9.6 Conclusion and future trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
9.7 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204
10 Authorised EU health claims for polyphenols in olive oil . . . . . . . . . 212
S. Lockyer and I. Rowland, University of Reading, UK
10.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
10.2 Characterisation of polyphenols in olive products . . . . . . . . . . . 213
10.3 Authorised health claim. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
10.4 Role of low density lipoprotein (LDL) oxidation in
cardiovascular disease (CVD) risk . . . . . . . . . . . . . . . . . . . . . . . 215
10.5 Studies that supported the claim . . . . . . . . . . . . . . . . . . . . . . . . . 216
10.6 Mechanism of oxLDL reduction by intake of olive oil
phenolics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
10.7 Unsuccessful health claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
10.8 Safety issues and conditions of use. . . . . . . . . . . . . . . . . . . . . . . 220
10.9 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
10.10 How the claim is being used in practice . . . . . . . . . . . . . . . . . . . 223
10.11 Conclusion and future trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
10.12 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
11 Authorised EU health claims for resistant starch and
post-prandial glycaemic responses . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
A. de la Hunty, Ashwell Associates, UK and J. Scott, Ingredion UK
Ltd, UK
11.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
Contents ix
11.2 Characterisation of the ingredient. . . . . . . . . . . . . . . . . . . . . . . . 230
11.3 Authorised health claim. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
11.4 Summary of substantiating evidence. . . . . . . . . . . . . . . . . . . . . . 232
11.5 Nutrition labelling and nutrition claims regulations . . . . . . . . . . 238
11.6 Conditions of use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
11.7 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
11.8 Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
11.9 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
11.10 Sources of further information and advice . . . . . . . . . . . . . . . . . 244
11.11 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Part IV Foods and nutrients with permitted health claims 249
12 Authorised EU health claims for betaine . . . . . . . . . . . . . . . . . . . . . . 251
K. K. Tiihonen, DuPont Nutrition and Health, Finland, K. Riihinen,
M. Lyyra and E. Sarkkinen, Oy Foodfiles Ltd, Finland,
S. A. S. Craig, DuPont Nutrition and Health, USA and P. Tenning,
DuPont Nutrition and Health, Denmark
12.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
12.2 Characterisation of betaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
12.3 Authorised health claim on normal homocysteine metabolism . 254
12.4 Interaction with other EU legislation concerning betaine. . . . . . 259
12.5 Conditions of use of betaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261
12.6 Consumer understanding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
12.7 Importance of the claim in food product development
and supplement marketing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
12.8 Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
12.9 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
12.10 Sources of further information . . . . . . . . . . . . . . . . . . . . . . . . . . 268
12.11 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
13 Authorised EU health claims for vitamins and minerals . . . . . . . . . 274
M. J. Sadler, Rank Nutrition Ltd, UK
13.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274
13.2 Characterisation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
13.3 Authorised claims for vitamins and minerals . . . . . . . . . . . . . . . 275
13.4 Conditions of use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
13.5 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291
13.6 Other relevant legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
13.7 Importance of the claim in product development and potential
future trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
13.8 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296
13.9 Sources of further information and advice . . . . . . . . . . . . . . . . . 296
13.10 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296
x Contents
14 Authorised EU health claims for the replacement of saturated fats 298
K. M. Livingstone, The University of Reading, UK
14.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298
14.2 Characterisation of the constituents . . . . . . . . . . . . . . . . . . . . . . 299
14.3 Scientific substantiation for the authorised claim: fatty
acids (FA) and cholesterol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300
14.4 Dietary recommendations and further considerations. . . . . . . . . 303
14.5 Impact on product development . . . . . . . . . . . . . . . . . . . . . . . . . 308
14.6 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311
14.7 Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313
14.8 Sources of further information and advice . . . . . . . . . . . . . . . . . 314
14.9 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 314
15 Authorised EU health claims for proteins, meat and fish . . . . . . . . 318
U. Arens, Freelance nutrition writer, UK
15.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 318
15.2 Nutrition labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320
15.3 Nutrient claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321
15.4 Health claims. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323
15.5 Consumer aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326
15.6 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327
15.7 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327
16 Authorised EU health claim for walnuts . . . . . . . . . . . . . . . . . . . . . . 329
T. Poon, Intertek Cantox, Canada and N. Baldwin, Intertek Cantox,
UK
16.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329
16.2 Characterisation of walnuts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 330
16.3 Health claims related to walnuts in the EU. . . . . . . . . . . . . . . . . 333
16.4 Health claims related to walnuts in other jurisdictions. . . . . . . . 342
16.5 Health claims related to other nuts in the EU and various
jurisdictions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 342
16.6 Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 345
16.7 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346
17 Authorised EU health claims for carbohydrate-electrolyte
solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349
R. Murray, Sports Science Insights, LLC, USA
17.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349
17.2 Characteristics of carbohydrate-electrolyte solutions. . . . . . . . . 351
17.3 Health claim evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 352
17.4 Benefits to consumers and use of sports drinks . . . . . . . . . . . . . 355
17.5 Scientific substantiation of efficacy . . . . . . . . . . . . . . . . . . . . . . 357
17.6 Product development issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
17.7 Claim usage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364