Foods, Nutrients and Food Ingredients with Authorised EU Health Claims: Volume 3

__Foods, Nutrients and Food Ingredients with Authorized EU Health Claims, Volume Three,__ provides an overview of how health claims are regulated in the European Union, along with detailed scientific and regulatory information about permitted health claims for foods and ingredients. The latest volume in this series focuses on regulatory coverage from EC 1924/2006, including the most recently authorized claims. Topics discussed include sections on the Authorized reduction of disease risk claims, including calcium, calcium with Vitamin D, Vitamin D, Folic Acid, Limicol® and MUFA and PUFA., health claims based on emerging science, recent regulatory announcements, and finally, general function claims. The book represents the go-to resource for R&D managers and technical managers in the food and beverage and dietary supplements industry, product development managers, health professionals and academic researchers in the field. * Provides a comprehensive overview of foods and food substances that have achieved approved health claims in Europe under Regulation EC 1924/2006 * Covers properties and applications of each ingredient, as well as evidence for the health claim and how it benefits consumers * Outlines the importance of each claim in product development and marketing, and in regulatory issues, such as conditions of use Foods, Nutrients and Food Ingredients with Authorised EU Health Claims, (2018) 278pp. 978-0-08-100922-2 Cover 1 Title Page 4 Copyright 5 Dedication 6 Contents 8 List of contributors 14 Preface 16 Part One - Regulatory Background 20 1 - European health claims: regulatory developments 22 1.1 - Introduction 22 1.2 - Health claim applications 22 1.2.1 - Article 13.5 claims 23 1.2.1.1 - Authorisations based on newly developed scientific data 23 1.2.1.2 - Authorised proprietary claims 23 1.2.1.3 - Applications still pending 24 1.2.1.4 - Non-authorised applications 25 1.2.2 - Reduction of disease risk claims 25 1.2.3 - Children’s development and health claims 25 1.2.4 - On-hold Article 13.1 claims 26 1.3 - REFIT evaluation of Nutrition and Health Claims Regulation 28 1.3.1 - Nutrient profiles 28 1.3.2 - Botanical claims 29 1.4 - Communications to health professionals 29 1.5 - Guidance 29 1.5.1 - Guidance for SMES 29 1.5.2 - Revisions to EFSA Guidance 29 1.6 - EFSA developments 31 1.6.1 - Changing responsibilities of panels 31 1.7 - Changing political landscape 31 1.7.1 - Potential impact on Brexit of regulatory issues relating to health claims 31 1.7.1.1 - Potential impact on UK food research 34 1.8 - Conclusions 34 1.9 - Sources of further information and advice 35 References 35 Further Reading 37 2 - Consumers and health claims 38 2.1 - Introduction 38 2.2 - Regulation of health claims in Europe and food innovation 39 2.3 - Health claims: what is currently on the market? 40 2.4 - How health claims affect consumers 42 2.4.1 - Perception and attitudes 42 2.4.2 - Understanding 43 2.4.3 - Use in purchase decisions 44 2.4.4 - Effects on consumption 46 2.5 - A realistic perspective on the effect of health claims on consumers 47 References 47 Further Reading 51 Part Two - Authorised Reduction of Disease Risk Claims 52 3 - Authorised EU health claims for calcium and calcium with vitamin D (for low bone mineral density and risk of fractures) 54 3.1 - Introduction 54 3.1.1 - Defining bone health 54 3.1.2 - Health economics of osteoporosis 54 3.2 - Evidence for effect of calcium alone on reduction of post-menopausal bone loss and reduced fracture risk 55 3.2.1 - Dairy intakes as a source of dietary calcium 56 3.3 - Effect of vitamin D alone on fall prevention: prevention of bone loss, fracture reduction, and muscle function and st... 57 3.3.1 - Fall prevention 57 3.3.2 - Prevention of bone loss 57 3.3.3 - Fracture reduction 58 3.3.4 - Muscle function and strength 58 3.3.5 - Vitamin D and bone health 58 3.4 - Calcium and vitamin D combined on osteoporosis prevention 59 3.5 - Current EU health claims for calcium, and calcium and vitamin D combined 60 3.5.1 - Background to the Article 14.1(a) reduction of disease risk claims 60 3.6 - Areas for future research 63 References 63 Further Reading 66 4 - Authorised EU health claim for Vitamin D and reduced risk of falls 68 4.1 - Introduction 68 4.2 - Epidemiology of falls and cost of falls 68 4.3 - Mechanistic evidence on how vitamin D is related to muscle health 69 4.4 - Clinical evidence on how vitamin D is related to muscle health 69 4.5 - Vitamin D and Type II fast twitch muscle fibres and relevance for fall risk 70 4.6 - Vitamin D and fall prevention 72 4.7 - Fall reduction by type of vitamin D, by gender, and by dwelling 73 4.8 - Fall reduction with 800 IU vitamin D by baseline 25-hydroxyvitamin D status 73 4.9 - Fall prevention and higher bolus doses of vitamin D 74 4.10 - Current guidelines on vitamin D and fall prevention 75 4.11 - Authorised EU health claim 76 4.12 - Conclusions 76 4.13 - Sources of further information 79 References 79 5 - Authorised EU health claim for supplementary folic acid 84 5.1 - Introduction 84 5.2 - What are neural tube defects? 85 5.3 - Characterisation of folic acid 86 5.3.1 - Bioavailability 86 5.4 - Formulating the health claim 87 5.5 - Substantiating the health claim 87 5.5.1 - Direct evidence for folic acid and reduced risk of NTDs 88 5.5.2 - Observational data 91 5.5.3 - Evidence relating to the risk factor 91 5.6 - Authorisation of the claim 93 5.6.1 - EFSA opinion 93 5.6.2 - Conditions of use for the claim 94 5.6.3 - Proposed claim wording 94 5.6.4 - Authorisation procedures and authorised claim wording 94 5.6.5 - Claim is a special case 94 5.7 - Additional data 95 5.8 - Other relevant legislation 96 5.9 - How the claim is being used in practice 96 5.10 - Consumer issues 96 5.10.1 - Incorporating folic acid into a balanced diet at meaningful levels 96 5.10.2 - Recommendations for supplemental folic acid 97 5.10.3 - Consumer understanding 98 5.11 - Future trends: mandatory fortification with folic acid? 99 5.12 - EU DRVs for folate intake 101 5.13 - Conclusions 101 5.14 - Sources of further information and advice 102 References 102 6 - Authorised EU health claim for MUFA and PUFA in replacement of saturated fats 106 6.1 - Introduction 106 6.2 - Characterisation of the substance 106 6.2.1 - Unsaturated fatty acids 106 6.2.2 - Saturated fatty acids 107 6.3 - Authorised EU health claim: UFA and LDL-cholesterol 107 6.3.1 - Claim wording 107 6.3.2 - Conditions of use 107 6.3.3 - Summary of substantiating evidence 108 6.3.3.1 - EFSA opinions 108 6.3.3.2 - Randomised controlled trials 110 6.3.3.3 - Dietary recommendations 111 6.3.3.4 - General discussion 112 6.4 - Other relevant legislation 113 6.5 - Consumer issues 114 6.5.1 - Understanding the health claim 114 6.5.2 - What are the benefits to consumers? 115 6.6 - Potential impact of the claim on product development 115 6.7 - Future trends 116 6.8 - Conclusions 116 6.9 - Sources of further information and advice 117 6.9.1 - Saturated fat in foods 117 6.9.2 - British Heart Foundation 117 6.9.3 - European Food Safety Authority 117 References 117 Part Three - Health Claims Based on Emerging Science and Proprietary Claims 120 7 - Authorised EU health claim for reformulated, non-alcoholic, acidic drinks 122 7.1 - Introduction 122 7.2 - Health claim application 123 7.3 - Characterisation 123 7.3.1 - Characterisation of comparator products 123 7.4 - Target group 123 7.5 - Evidence substantiating the claim 124 7.6 - Authorisation of the claim 126 7.6.1 - Proprietary nature of the claim 127 7.7 - Consumer issues 127 7.8 - Use of the claim 128 7.9 - Related EFSA opinion 128 7.10 - Future trends 128 7.11 - Conclusions 129 References 129 Further Reading 130 8 - Authorised EU health claim for sugar beet fibre 132 8.1 - Introduction 132 8.2 - Characterisation of the ingredient 133 8.3 - Authorised Article 13.5 claim 133 8.3.1 - Increased faecal bulk: some general considerations 134 8.3.2 - Summary of substantiating evidence 135 8.3.3 - Mechanisms of action 137 8.4 - Article 13.1 claim 138 8.5 - Other legislation 140 8.6 - Conditions of use, warning labels and safety issues 140 8.7 - Consumer issues 141 8.8 - How the claims are being used in practice and future trends 142 8.9 - Conclusions 143 8.10 - Sources of further information and advice 143 References 144 Further Reading 147 9 - Authorised EU health claim for glycaemic carbohydrates and muscular recovery 148 9.1 - Introduction: nutrition optimisation in physical activity at the crossroads of disciplines 148 9.2 - Carbohydrates as key nutrients in physical activity 148 9.2.1 - Bioavailability of carbohydrates 149 9.2.2 - Role of carbohydrates in physical activity 149 9.3 - Measuring recovery after physical activity 149 9.3.1 - Scientific assessment of recovery after physical activity 150 9.3.2 - EFSA health claims guidelines for recovery after physical activity 150 9.4 - Glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise 150 9.4.1 - Assessing glycogen stores in skeletal muscles 151 9.4.2 - Glycogen status influences exercise performance: clinical data 151 9.4.3 - Glycogen status influences exercise performance: mechanisms of action 152 9.4.3.1 - Effects on Na+-K+-ATPase activity 152 9.4.3.2 - Sarcoplasmic reticulum (SR) calcium release 152 9.4.3.3 - Levels of intracellular tetanic free calcium 153 9.4.3.4 - Force production in muscles 153 9.4.4 - Carbohydrate ingestion influences glycogen stores in the context of exercise performance: clinical data 154 9.4.5 - Carbohydrate ingestion influences glycogen stores in the context of exercise performance: mechanisms of action 161 9.4.6 - EFSA and European Commission considerations on the health claim 162 References 163 10 - Authorised EU health claim for chicory inulin 166 10.1 - Introduction 166 10.2 - Authorised EU health claim 167 10.3 - Proprietary data 167 10.4 - Summary of substantiating evidence 169 10.4.1 - Mechanism of action 171 10.5 - Importance of the claim in product development and consumer issues 173 10.6 - Conclusions 174 References 174 Further Reading 177 Part Four - General Function Claims 178 11 - Authorised EU health claim for chitosan 180 11.1 - Introduction 180 11.2 - The role of cholesterol and low-density lipoproteins (LDL) in CVD risk 181 11.3 - Relevance of the claim 182 11.4 - Characterisation of chitosan 182 11.5 - Summary of substantiating evidence 182 11.6 - Proposed mechanism for the effect 184 11.7 - Authorised EU health claim for chitosan 185 11.7.1 - Claim wording 185 11.7.2 - Target population 185 11.7.3 - Conditions of use 185 11.8 - Consumers understanding and perception of authorised claims 191 11.9 - Commercial importance and potential of chitosan in product development 192 11.10 - Conclusions 193 References 194 Further Reading 197 12 - Authorised EU health claim for meal replacements 198 12.1 - Introduction 198 12.2 - Characterisation of meal replacements 198 12.2.1 - Replacement of Directive 2009/39/EC with Regulation (EU) No. 609/2013 199 12.3 - Summary of the authorised claims 200 12.3.1 - Substituting two of the main daily meals of an energy-restricted diet with meal replacements contributes to weight... 200 12.3.1.1 Substantiating evidence 200 12.3.1.2 - Claim wording 203 12.3.1.3 - Conditions and restrictions of use 203 12.3.2 - Substituting one of the main daily meals of an energy-restricted diet with a meal replacement contributes to the m... 204 12.3.2.1 Substantiating evidence 204 12.3.2.2 - Claim wording 204 12.3.2.3 - Conditions and restrictions of use 205 12.4 - Other relevant legislation 205 12.4.1 - On-hold claim for very low-calorie diets (VLCDs) and reduction in body weight 205 12.5 - Consumer issues 205 12.5.1 - The need for meal replacement products 205 12.5.2 - Consumer understanding and flexible use of claim wording 206 12.6 - Potential of the claims in product development 216 12.7 - Future trends 216 12.8 - Conclusions 217 References 217 Further Reading 219 13 - Authorised EU health claim for arabinoxylan 220 13.1 - Introduction 220 13.2 - Characterisation of arabinoxylan 221 13.2.1 - Chemical structure and prevalence in major cereal grains 221 13.2.2 - Functional properties of arabinoxylans 222 13.3 - Proposed health benefits from the consumption of arabinoxylans 222 13.3.1 - Digestion of arabinoxylan in the large intestine 222 13.3.2 - Beneficial effects from SCFAs generated by arabinoxylan fermentation 222 13.3.3 - Effects on appetite regulation 223 13.3.4 - Effects on glucose metabolism 223 13.3.5 - Effects on lipid metabolism 223 13.3.6 - Enhanced mineral absorption 224 13.3.7 - Antioxidant and anti-cancer activity 224 13.4 - Authorised EU health claim 224 13.4.1 - Legislation in Europe 224 13.4.2 - Conditions of use and target population 225 13.4.3 - Substantiating evidence from human studies 225 13.5 - Conditions of use for arabinoxylan and safety issues 232 13.5.1 - Recommended dose 232 13.5.2 - Safety issues 232 13.5.3 - Upper level of intake 232 13.6 - Consumer issues 233 13.6.1 - Arabinoxylan content of common foods 233 13.7 - Conclusions 233 13.8 - Sources of further information and advice 234 References 234 14 - Authorised EU health claim for alpha-cyclodextrin 238 14.1 - Introduction 238 14.2 - Process for authorisation of the claim 238 14.3 - Characterisation 239 14.4 - Target population 239 14.5 - Authorised claim wording 239 14.6 - Substantiating evidence 240 14.6.1 - Initial claim submission 240 14.6.2 - Further assessment 240 14.6.2.1 - Proposed mechanism 242 14.6.3 - Summary of evidence 243 14.7 - Conditions of use 244 14.8 - Consumer issues and product development 244 14.9 - Conclusions 245 References 246 15 - Authorised EU health claim for carbohydrates and maintenance of normal brain function 248 15.1 - Introduction 248 15.2 - Article 13.1 claim on carbohydrates and maintenance of normal brain function 249 15.2.1 - Characterisation of glycaemic carbohydrates 249 15.2.2 - Claimed health effects for carbohydrates 249 15.3 - Commission Regulation (EU) No. 1018/2013 of 23 October 2013 250 15.4 - Other claimed health effects for glucose 251 15.5 - Article 13.5 claim on carbohydrates and contribution to normal cognitive function 251 15.5.1 - Characterisation of the food/constituent 251 15.5.2 - Claimed health effects and proposed conditions of use 252 15.5.3 - Outcome of authorisation processes 252 15.6 - Further application for maintenance of normal brain function claim 252 15.7 - Consumer issues 252 15.8 - Conclusions 254 References 255 16 - Authorised EU health claims for activated charcoal, lactulose and melatonin 256 16.1 - Introduction 256 16.2 - Activated charcoal 258 16.2.1 - Characterisation of the substance 258 16.2.2 - EFSA scientific opinion 258 16.2.2.1 - Summary of substantiating evidence 258 16.2.3 - Authorisation of the claim 260 16.2.4 - How the claim is being used 260 16.3 - Lactulose 260 16.3.1 - Characterisation of the substance 260 16.3.2 - Substantiation of the claim 261 16.3.2.1 - Summary of substantiating evidence 261 16.3.3 - Claim authorisation 262 16.3.4 - Use of the claim 262 16.4 - Melatonin 262 16.4.1 - Characterisation of the substance 262 16.4.2 - Role of melatonin in the body 262 16.4.3 - Substantiation of the claim 262 16.4.3.1 - Summary of substantiating evidence 263 16.4.3.2 - Mechanisms of action 264 16.4.4 - Authorisation of the claim 264 16.4.4.1 - Conditions of use 265 16.4.5 - Use of the claim 265 16.5 - Conclusions 265 16.6 - Sources of further information and advice 266 Acknowledgements 266 References 266 Further Reading 267 Index 268 Back Cover 278 Cover......Page 1 Title Page......Page 4 Copyright......Page 5 Dedication......Page 6 Contents......Page 8 List of contributors......Page 14 Preface......Page 16 Part One - Regulatory Background......Page 20 1.2 - Health claim applications......Page 22 1.2.1.2 - Authorised proprietary claims......Page 23 1.2.1.3 - Applications still pending......Page 24 1.2.3 - Children’s development and health claims......Page 25 1.2.4 - On-hold Article 13.1 claims......Page 26 1.3.1 - Nutrient profiles......Page 28 1.5.2 - Revisions to EFSA Guidance......Page 29 1.7.1 - Potential impact on Brexit of regulatory issues relating to health claims......Page 31 1.8 - Conclusions......Page 34 References......Page 35 Further Reading......Page 37 2.1 - Introduction......Page 38 2.2 - Regulation of health claims in Europe and food innovation......Page 39 2.3 - Health claims: what is currently on the market?......Page 40 2.4.1 - Perception and attitudes......Page 42 2.4.2 - Understanding......Page 43 2.4.3 - Use in purchase decisions......Page 44 2.4.4 - Effects on consumption......Page 46 References......Page 47 Further Reading......Page 51 Part Two - Authorised Reduction of Disease Risk Claims......Page 52 3.1.2 - Health economics of osteoporosis......Page 54 3.2 - Evidence for effect of calcium alone on reduction of post-menopausal bone loss and reduced fracture risk......Page 55 3.2.1 - Dairy intakes as a source of dietary calcium......Page 56 3.3.2 - Prevention of bone loss......Page 57 3.3.5 - Vitamin D and bone health......Page 58 3.4 - Calcium and vitamin D combined on osteoporosis prevention......Page 59 3.5.1 - Background to the Article 14.1(a) reduction of disease risk claims......Page 60 References......Page 63 Further Reading......Page 66 4.2 - Epidemiology of falls and cost of falls......Page 68 4.4 - Clinical evidence on how vitamin D is related to muscle health......Page 69 4.5 - Vitamin D and Type II fast twitch muscle fibres and relevance for fall risk......Page 70 4.6 - Vitamin D and fall prevention......Page 72 4.8 - Fall reduction with 800 IU vitamin D by baseline 25-hydroxyvitamin D status......Page 73 4.9 - Fall prevention and higher bolus doses of vitamin D......Page 74 4.10 - Current guidelines on vitamin D and fall prevention......Page 75 4.12 - Conclusions......Page 76 References......Page 79 5.1 - Introduction......Page 84 5.2 - What are neural tube defects?......Page 85 5.3.1 - Bioavailability......Page 86 5.5 - Substantiating the health claim......Page 87 5.5.1 - Direct evidence for folic acid and reduced risk of NTDs......Page 88 5.5.3 - Evidence relating to the risk factor......Page 91 5.6.1 - EFSA opinion......Page 93 5.6.5 - Claim is a special case......Page 94 5.7 - Additional data......Page 95 5.10.1 - Incorporating folic acid into a balanced diet at meaningful levels......Page 96 5.10.2 - Recommendations for supplemental folic acid......Page 97 5.10.3 - Consumer understanding......Page 98 5.11 - Future trends: mandatory fortification with folic acid?......Page 99 5.13 - Conclusions......Page 101 References......Page 102 6.2.1 - Unsaturated fatty acids......Page 106 6.3.2 - Conditions of use......Page 107 6.3.3.1 - EFSA opinions......Page 108 6.3.3.2 - Randomised controlled trials......Page 110 6.3.3.3 - Dietary recommendations......Page 111 6.3.3.4 - General discussion......Page 112 6.4 - Other relevant legislation......Page 113 6.5.1 - Understanding the health claim......Page 114 6.6 - Potential impact of the claim on product development......Page 115 6.8 - Conclusions......Page 116 References......Page 117 Part Three - Health Claims Based on Emerging Science and Proprietary Claims......Page 120 7.1 - Introduction......Page 122 7.4 - Target group......Page 123 7.5 - Evidence substantiating the claim......Page 124 7.6 - Authorisation of the claim......Page 126 7.7 - Consumer issues......Page 127 7.10 - Future trends......Page 128 References......Page 129 Further Reading......Page 130 8.1 - Introduction......Page 132 8.3 - Authorised Article 13.5 claim......Page 133 8.3.1 - Increased faecal bulk: some general considerations......Page 134 8.3.2 - Summary of substantiating evidence......Page 135 8.3.3 - Mechanisms of action......Page 137 8.4 - Article 13.1 claim......Page 138 8.6 - Conditions of use, warning labels and safety issues......Page 140 8.7 - Consumer issues......Page 141 8.8 - How the claims are being used in practice and future trends......Page 142 8.10 - Sources of further information and advice......Page 143 References......Page 144 Further Reading......Page 147 9.2 - Carbohydrates as key nutrients in physical activity......Page 148 9.3 - Measuring recovery after physical activity......Page 149 9.4 - Glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise......Page 150 9.4.2 - Glycogen status influences exercise performance: clinical data......Page 151 9.4.3.2 - Sarcoplasmic reticulum (SR) calcium release......Page 152 9.4.3.4 - Force production in muscles......Page 153 9.4.4 - Carbohydrate ingestion influences glycogen stores in the context of exercise performance: clinical data......Page 154 9.4.5 - Carbohydrate ingestion influences glycogen stores in the context of exercise performance: mechanisms of action......Page 161 9.4.6 - EFSA and European Commission considerations on the health claim......Page 162 References......Page 163 10.1 - Introduction......Page 166 10.3 - Proprietary data......Page 167 10.4 - Summary of substantiating evidence......Page 169 10.4.1 - Mechanism of action......Page 171 10.5 - Importance of the claim in product development and consumer issues......Page 173 References......Page 174 Further Reading......Page 177 Part Four - General Function Claims......Page 178 11.1 - Introduction......Page 180 11.2 - The role of cholesterol and low-density lipoproteins (LDL) in CVD risk......Page 181 11.5 - Summary of substantiating evidence......Page 182 11.6 - Proposed mechanism for the effect......Page 184 11.7.3 - Conditions of use......Page 185 11.8 - Consumers understanding and perception of authorised claims......Page 191 11.9 - Commercial importance and potential of chitosan in product development......Page 192 11.10 - Conclusions......Page 193 References......Page 194 Further Reading......Page 197 12.2 - Characterisation of meal replacements......Page 198 12.2.1 - Replacement of Directive 2009/39/EC with Regulation (EU) No. 609/2013......Page 199 12.3.1.1 Substantiating evidence......Page 200 12.3.1.3 - Conditions and restrictions of use......Page 203 12.3.2.2 - Claim wording......Page 204 12.5.1 - The need for meal replacement products......Page 205 12.5.2 - Consumer understanding and flexible use of claim wording......Page 206 12.7 - Future trends......Page 216 References......Page 217 Further Reading......Page 219 13.1 - Introduction......Page 220 13.2.1 - Chemical structure and prevalence in major cereal grains......Page 221 13.3.2 - Beneficial effects from SCFAs generated by arabinoxylan fermentation......Page 222 13.3.5 - Effects on lipid metabolism......Page 223 13.4.1 - Legislation in Europe......Page 224 13.4.3 - Substantiating evidence from human studies......Page 225 13.5.3 - Upper level of intake......Page 232 13.7 - Conclusions......Page 233 References......Page 234 14.2 - Process for authorisation of the claim......Page 238 14.5 - Authorised claim wording......Page 239 14.6.2 - Further assessment......Page 240 14.6.2.1 - Proposed mechanism......Page 242 14.6.3 - Summary of evidence......Page 243 14.8 - Consumer issues and product development......Page 244 14.9 - Conclusions......Page 245 References......Page 246 15.1 - Introduction......Page 248 15.2.2 - Claimed health effects for carbohydrates......Page 249 15.3 - Commission Regulation (EU) No. 1018/2013 of 23 October 2013......Page 250 15.5.1 - Characterisation of the food/constituent......Page 251 15.7 - Consumer issues......Page 252 15.8 - Conclusions......Page 254 References......Page 255 16.1 - Introduction......Page 256 16.2.2.1 - Summary of substantiating evidence......Page 258 16.3.1 - Characterisation of the substance......Page 260 16.3.2.1 - Summary of substantiating evidence......Page 261 16.4.3 - Substantiation of the claim......Page 262 16.4.3.1 - Summary of substantiating evidence......Page 263 16.4.4 - Authorisation of the claim......Page 264 16.5 - Conclusions......Page 265 References......Page 266 Further Reading......Page 267 Index......Page 268 Back Cover......Page 278