Chapter
Part One - Regulatory Background
1 - European health claims: regulatory developments
1.2 - Health claim applications
1.2.1 - Article 13.5 claims
1.2.1.1 - Authorisations based on newly developed scientific data
1.2.1.2 - Authorised proprietary claims
1.2.1.3 - Applications still pending
1.2.1.4 - Non-authorised applications
1.2.2 - Reduction of disease risk claims
1.2.3 - Children’s development and health claims
1.2.4 - On-hold Article 13.1 claims
1.3 - REFIT evaluation of Nutrition and Health Claims Regulation
1.3.1 - Nutrient profiles
1.4 - Communications to health professionals
1.5.1 - Guidance for SMES
1.5.2 - Revisions to EFSA Guidance
1.6.1 - Changing responsibilities of panels
1.7 - Changing political landscape
1.7.1 - Potential impact on Brexit of regulatory issues relating to health claims
1.7.1.1 - Potential impact on UK food research
1.9 - Sources of further information and advice
2 - Consumers and health claims
2.2 - Regulation of health claims in Europe and food innovation
2.3 - Health claims: what is currently on the market?
2.4 - How health claims affect consumers
2.4.1 - Perception and attitudes
2.4.3 - Use in purchase decisions
2.4.4 - Effects on consumption
2.5 - A realistic perspective on the effect of health claims on consumers
Part Two - Authorised Reduction of Disease Risk Claims
3 - Authorised EU health claims for calcium and calcium with vitamin D (for low bone mineral density and risk of fractures)
3.1.1 - Defining bone health
3.1.2 - Health economics of osteoporosis
3.2 - Evidence for effect of calcium alone on reduction of post-menopausal bone loss and reduced fracture risk
3.2.1 - Dairy intakes as a source of dietary calcium
3.3 - Effect of vitamin D alone on fall prevention: prevention of bone loss, fracture reduction, and muscle function and st...
3.3.2 - Prevention of bone loss
3.3.3 - Fracture reduction
3.3.4 - Muscle function and strength
3.3.5 - Vitamin D and bone health
3.4 - Calcium and vitamin D combined on osteoporosis prevention
3.5 - Current EU health claims for calcium, and calcium and vitamin D combined
3.5.1 - Background to the Article 14.1(a) reduction of disease risk claims
3.6 - Areas for future research
4 - Authorised EU health claim for Vitamin D and reduced risk of falls
4.2 - Epidemiology of falls and cost of falls
4.3 - Mechanistic evidence on how vitamin D is related to muscle health
4.4 - Clinical evidence on how vitamin D is related to muscle health
4.5 - Vitamin D and Type II fast twitch muscle fibres and relevance for fall risk
4.6 - Vitamin D and fall prevention
4.7 - Fall reduction by type of vitamin D, by gender, and by dwelling
4.8 - Fall reduction with 800 IU vitamin D by baseline 25-hydroxyvitamin D status
4.9 - Fall prevention and higher bolus doses of vitamin D
4.10 - Current guidelines on vitamin D and fall prevention
4.11 - Authorised EU health claim
4.13 - Sources of further information
5 - Authorised EU health claim for supplementary folic acid
5.2 - What are neural tube defects?
5.3 - Characterisation of folic acid
5.4 - Formulating the health claim
5.5 - Substantiating the health claim
5.5.1 - Direct evidence for folic acid and reduced risk of NTDs
5.5.2 - Observational data
5.5.3 - Evidence relating to the risk factor
5.6 - Authorisation of the claim
5.6.2 - Conditions of use for the claim
5.6.3 - Proposed claim wording
5.6.4 - Authorisation procedures and authorised claim wording
5.6.5 - Claim is a special case
5.8 - Other relevant legislation
5.9 - How the claim is being used in practice
5.10.1 - Incorporating folic acid into a balanced diet at meaningful levels
5.10.2 - Recommendations for supplemental folic acid
5.10.3 - Consumer understanding
5.11 - Future trends: mandatory fortification with folic acid?
5.12 - EU DRVs for folate intake
5.14 - Sources of further information and advice
6 - Authorised EU health claim for MUFA and PUFA in replacement of saturated fats
6.2 - Characterisation of the substance
6.2.1 - Unsaturated fatty acids
6.2.2 - Saturated fatty acids
6.3 - Authorised EU health claim: UFA and LDL-cholesterol
6.3.2 - Conditions of use
6.3.3 - Summary of substantiating evidence
6.3.3.2 - Randomised controlled trials
6.3.3.3 - Dietary recommendations
6.3.3.4 - General discussion
6.4 - Other relevant legislation
6.5.1 - Understanding the health claim
6.5.2 - What are the benefits to consumers?
6.6 - Potential impact of the claim on product development
6.9 - Sources of further information and advice
6.9.1 - Saturated fat in foods
6.9.2 - British Heart Foundation
6.9.3 - European Food Safety Authority
Part Three - Health Claims Based on Emerging Science and Proprietary Claims
7 - Authorised EU health claim for reformulated, non-alcoholic, acidic drinks
7.2 - Health claim application
7.3.1 - Characterisation of comparator products
7.5 - Evidence substantiating the claim
7.6 - Authorisation of the claim
7.6.1 - Proprietary nature of the claim
7.9 - Related EFSA opinion
8 - Authorised EU health claim for sugar beet fibre
8.2 - Characterisation of the ingredient
8.3 - Authorised Article 13.5 claim
8.3.1 - Increased faecal bulk: some general considerations
8.3.2 - Summary of substantiating evidence
8.3.3 - Mechanisms of action
8.6 - Conditions of use, warning labels and safety issues
8.8 - How the claims are being used in practice and future trends
8.10 - Sources of further information and advice
9 - Authorised EU health claim for glycaemic carbohydrates and muscular recovery
9.1 - Introduction: nutrition optimisation in physical activity at the crossroads of disciplines
9.2 - Carbohydrates as key nutrients in physical activity
9.2.1 - Bioavailability of carbohydrates
9.2.2 - Role of carbohydrates in physical activity
9.3 - Measuring recovery after physical activity
9.3.1 - Scientific assessment of recovery after physical activity
9.3.2 - EFSA health claims guidelines for recovery after physical activity
9.4 - Glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise
9.4.1 - Assessing glycogen stores in skeletal muscles
9.4.2 - Glycogen status influences exercise performance: clinical data
9.4.3 - Glycogen status influences exercise performance: mechanisms of action
9.4.3.1 - Effects on Na+-K+-ATPase activity
9.4.3.2 - Sarcoplasmic reticulum (SR) calcium release
9.4.3.3 - Levels of intracellular tetanic free calcium
9.4.3.4 - Force production in muscles
9.4.4 - Carbohydrate ingestion influences glycogen stores in the context of exercise performance: clinical data
9.4.5 - Carbohydrate ingestion influences glycogen stores in the context of exercise performance: mechanisms of action
9.4.6 - EFSA and European Commission considerations on the health claim
10 - Authorised EU health claim for chicory inulin
10.2 - Authorised EU health claim
10.4 - Summary of substantiating evidence
10.4.1 - Mechanism of action
10.5 - Importance of the claim in product development and consumer issues
Part Four - General Function Claims
11 - Authorised EU health claim for chitosan
11.2 - The role of cholesterol and low-density lipoproteins (LDL) in CVD risk
11.3 - Relevance of the claim
11.4 - Characterisation of chitosan
11.5 - Summary of substantiating evidence
11.6 - Proposed mechanism for the effect
11.7 - Authorised EU health claim for chitosan
11.7.2 - Target population
11.7.3 - Conditions of use
11.8 - Consumers understanding and perception of authorised claims
11.9 - Commercial importance and potential of chitosan in product development
12 - Authorised EU health claim for meal replacements
12.2 - Characterisation of meal replacements
12.2.1 - Replacement of Directive 2009/39/EC with Regulation (EU) No. 609/2013
12.3 - Summary of the authorised claims
12.3.1 - Substituting two of the main daily meals of an energy-restricted diet with meal replacements contributes to weight...
12.3.1.1 Substantiating evidence
12.3.1.3 - Conditions and restrictions of use
12.3.2 - Substituting one of the main daily meals of an energy-restricted diet with a meal replacement contributes to the m...
12.3.2.1 Substantiating evidence
12.3.2.3 - Conditions and restrictions of use
12.4 - Other relevant legislation
12.4.1 - On-hold claim for very low-calorie diets (VLCDs) and reduction in body weight
12.5.1 - The need for meal replacement products
12.5.2 - Consumer understanding and flexible use of claim wording
12.6 - Potential of the claims in product development
13 - Authorised EU health claim for arabinoxylan
13.2 - Characterisation of arabinoxylan
13.2.1 - Chemical structure and prevalence in major cereal grains
13.2.2 - Functional properties of arabinoxylans
13.3 - Proposed health benefits from the consumption of arabinoxylans
13.3.1 - Digestion of arabinoxylan in the large intestine
13.3.2 - Beneficial effects from SCFAs generated by arabinoxylan fermentation
13.3.3 - Effects on appetite regulation
13.3.4 - Effects on glucose metabolism
13.3.5 - Effects on lipid metabolism
13.3.6 - Enhanced mineral absorption
13.3.7 - Antioxidant and anti-cancer activity
13.4 - Authorised EU health claim
13.4.1 - Legislation in Europe
13.4.2 - Conditions of use and target population
13.4.3 - Substantiating evidence from human studies
13.5 - Conditions of use for arabinoxylan and safety issues
13.5.1 - Recommended dose
13.5.3 - Upper level of intake
13.6.1 - Arabinoxylan content of common foods
13.8 - Sources of further information and advice
14 - Authorised EU health claim for alpha-cyclodextrin
14.2 - Process for authorisation of the claim
14.5 - Authorised claim wording
14.6 - Substantiating evidence
14.6.1 - Initial claim submission
14.6.2 - Further assessment
14.6.2.1 - Proposed mechanism
14.6.3 - Summary of evidence
14.8 - Consumer issues and product development
15 - Authorised EU health claim for carbohydrates and maintenance of normal brain function
15.2 - Article 13.1 claim on carbohydrates and maintenance of normal brain function
15.2.1 - Characterisation of glycaemic carbohydrates
15.2.2 - Claimed health effects for carbohydrates
15.3 - Commission Regulation (EU) No. 1018/2013 of 23 October 2013
15.4 - Other claimed health effects for glucose
15.5 - Article 13.5 claim on carbohydrates and contribution to normal cognitive function
15.5.1 - Characterisation of the food/constituent
15.5.2 - Claimed health effects and proposed conditions of use
15.5.3 - Outcome of authorisation processes
15.6 - Further application for maintenance of normal brain function claim
16 - Authorised EU health claims for activated charcoal, lactulose and melatonin
16.2 - Activated charcoal
16.2.1 - Characterisation of the substance
16.2.2 - EFSA scientific opinion
16.2.2.1 - Summary of substantiating evidence
16.2.3 - Authorisation of the claim
16.2.4 - How the claim is being used
16.3.1 - Characterisation of the substance
16.3.2 - Substantiation of the claim
16.3.2.1 - Summary of substantiating evidence
16.3.3 - Claim authorisation
16.3.4 - Use of the claim
16.4.1 - Characterisation of the substance
16.4.2 - Role of melatonin in the body
16.4.3 - Substantiation of the claim
16.4.3.1 - Summary of substantiating evidence
16.4.3.2 - Mechanisms of action
16.4.4 - Authorisation of the claim
16.4.4.1 - Conditions of use
16.4.5 - Use of the claim
16.6 - Sources of further information and advice