ESPEN Congress Geneva 2014 FOOD: THE FACTOR RESHAPING THE SIZE OF THE PLANET. Food labelling and health claims B. Benelam (UK)

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1 ESPEN Congress Geneva 2014 FOOD: THE FACTOR RESHAPING THE SIZE OF THE PLANET Food labelling and health claims B. Benelam (UK)

2 Food labelling and health claims Bridget Benelam Senior Nutrition Scientist British Nutrition Foundation ESPEN congress 7th September 2014

3 Cocoa Theobroma cacoa Drink of Gods (Xocoatl) theo = God broma = drink Mexico (Maya, Incas, Aztecs) Aphrodisiac

4 Making nutrition science accessible to all

5 Outline The EU Food Information to Consumers Regulation Changes to nutrition labelling Nutrition and health claims regulation Nutrition claims Health claims and their scientific substantiation Impact on consumers?

6 FOOD INFORMATION REGULATION

7 Food Information Regulation (FIR) (1169/2011) Previously food labelling covered by a number of different regulations implemented at different times FIR aims to bring these together in one document Applied from 2011 Most aspects apply from 2014, although back of pack labelling is compulsory from 2016

8 Nutrition labelling Flabel research 2010: 85% products had back of pack nutrition labelling 48% products had front of pack nutrition labelling

9 Back of pack (BoP) labelling Will be compulsory on all pre-packed foods in EC Slight changes to format compared to current big 4/8

10 Nutrition information on the backof-pack Current back-of-pack nutrition panel New back-of-pack nutrition panel Per 100g Per 100g Energy 1500kJ/356kcal Protein 9.9g Fat 7.4g Carbohydrates 58.1g of which saturates 1.1g of which sugars 16.8g Carbohydrates 58.1g Fat 7.4g of which sugars 16.8g of which saturates 1.1g Protein 9.9g Fibre 8.9g Salt Sodium Energy 1500kJ/356kcal Below 0.1g Below 0.1g Note that fibre can also be added to the panel but is not compulsory. The newly published food labelling regulations are available at eur-lex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2011:304:0018:0063:en:pdf

11 Front of pack (FoP) labelling Not compulsory, but stipulations on what is included: Just energy (in kcals and KJ), Or energy, fat, saturates, sugars and salt Can be per 100g or ml or per portion If per portion, energy per 100g or ml must also be provided National schemes allowed (provided they don t mislead consumer or conflict with FIR)

12 Front of pack labelling - UK In June 2013, guidance was develop by DH, the FSA and BRC to support FoP nutrition labels that are compliant with the UK Health Ministers Recommendation and the EU FIC regulation The key principles of which are: Provision of energy in kj and kcal per 100g/ml and per specified portion Provision of the amount (g) of fat, saturated fat, total sugars and salt per specified portion Provision of meaningful, recognisable portion information % RI based on the amount of each nutrient and energy value in a portion of the food Colour coding of the nutrient content (may also use the descriptors high, medium or low )

13 Criteria for 100g of food (whether or not it is sold by volume)

14

15 Reference intakes FIR does not refer to GDAs and RDAs now collectively referred to as reference intakes (annex 8) Reference intakes for energy and selected nutrients other than vitamins and minerals are equivalent to GDAs.

16 NUTRITION AND HEALTH CLAIMS REGULATION

17 Health claims regulation background (EC 1924/2006) Previously no regulation of claims made on food although there were some national schemes The regulation aims to Harmonise claims made in EC Provide helpful info for consumers Encourage innovation in the food industry

18 What it covers All food, drinks and dietary supplements All commercial communications Not permitted: Medicinal claims, about preventing, treating or curing a disease. Claims on alcoholic beverages (more than 1.2% alcohol), other than low/reduced alcohol or energy. Claims that suggest health could be affected by not consuming the food. Claims that make reference to a rate or amount of weight loss. Claims that make reference to recommendations of individual doctors and health professionals.

19 Nutrition Claims What a food contains (or does not contain) Approved claims and conditions of use in annex to regulation and online Later additions on omega 3 fatty acids Proposals for x% less claims for reformulation rejected last year

20 Nutrition Claims Nutrition claim can be made on a product provided the specific claim is listed in the Annex to the Regulation Examples 1. High in fibre (at least 6g of fibre per 100g or at least 3g of fibre per 100 kcal) 2. Source of vitamin C (at least 15% of the RDA for vitamin C/100g or 100ml) 3. Sugar-free (contains no more than 0.5 g of sugars per 100 g or 100ml).

21 Health claims Article 13.1 are those based on generally accepted scientific evidence (e.g. calcium contributes to normal muscle function) Article 13.5 are those based on newer evidence (e.g. cocoa flavanols help maintain endothelium-dependent vasodilation which contributes to healthy blood flow) Article 14 are those relating to either: Reduction in disease risk (14a) (e.g. plant sterols have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease) Children's health and development (14b) (e.g. iodine contributes to the normal growth of children).

22 Making a claim on food Nutrition Claim Health Claim Is the claim about: - Disease risk reduction? - Child development and health? Must be listed in EC nutrition claims annex NO Article 13 claim YES Article 14 claim Is the claim based on...? Generally accepted scientific evidence New evidence EC Health Claims Authorisation process Member state list of article 13 health claims EC list of permitted health claims

23 Approval process EFSA NDA panel provides scientific opinion on the proposed claim dossier EC considers EFSA opinion and consumer understanding and gives final decision on approval/rejection

24 Key questions EFSA s NDA Panel considers in the scientific evaluation of health claims Is the food/constituent sufficiently defined and characterised? No Yes Is the claimed effect sufficiently defined, and is it a beneficial physiological effect? No Yes Have pertinent human studies been presented to substantiate the claim? Yes No No The application is not considered further The NDA Panel weighs the evidence from all pertinent studies

25 Issues with implementation Initially there was a lack of guidance on which article was most appropriate for different products and on the information required in a dossier Many claims submitted under wrong article (13.1 not 13.5) There were a huge number of applications Many issues with quality of dossiers Many claims rejected and a large number on hold

26 Key issues with dossiers Claimed health effect too vague or not relevant Food/component not sufficiently characterised e.g. probiotics where strain was not specified or dairy products Studies provided were insufficient to show cause and effect

27 Issues with studies used include Lack of human studies Inappropriate biomarkers used Doses used too high Studies on populations that cannot be extrapolated to general population (specific population groups can be used e.g. older adults, pregnant women but not sick people)

28 Case study 1 Lycopene and normal cardiac function (article 13.1) Panel considered lycopene sufficiently characterised Normal cardiac function considered a beneficial physiological effect Scientific substantiation: Narrative reviews or consensus opinions which did not provide original data and also covered other compounds 3 animal studies health outcomes unrelated to claimed effect 3 human observational studies on blood concentrations of lycopene and combined risk of CHD/stroke none reported on dietary intakes of lycopene 3 human observational studies on blood concentrations of lycopene and risk of CHD only one reported on dietary intakes and did not show a beneficial effect. No cause and effect relationship established negative opinion claim not authorised by EC

29 Case study 2 Water soluble tomato concentrate and platelet aggregation (article 13.5) Detailed info provided on characterisation Provided well-described literature searches to show health benefit of reducing platelet aggregation Scientific substantiation (some proprietary studies): Well defined literature search with relevant studies 3 published RCTs in humans 5 unpublished human trials (3 RCTs and 2 uncontrolled trials) 5 published and 2 unpublished non-human studies (all considered supportive) Studies used appropriate measures of platelet aggregation, were appropriately powered and used doses relevant to proposed conditions of use Concluded that cause and effect relationship established positive opinion and approval by EC.

30

31 Overall aim of Bacchus To develop tools and resources that will facilitate the generation of robust and exploitable scientific evidence that can be used to support claims of a cause and effect relationship between consumption of bioactive peptides and polyphenols and beneficial effects related to cardiovascular health in humans

32 Guidance on applying for health claim authorisations EFSA scientific and technical guidance published (2011) following a public consultation and stakeholder meeting Public consultation and specific guidance also published on claims related to: Gut and immune function (2011) Antioxidants, oxidative damage and cardiovascular health (2011) Appetite ratings, weight control and blood glucose concentrations (2012) Bone, joints, skin and oral health (2012) Physical performance (2012) Functions of the nervous system including psychological functions (2012)

33 Current issues include There are still a lot of claims on hold Issues with the flexibility of wording Treatment of article 13.1 vs 13.5 claims Consumer understanding and effect on behaviour change

34 Wording of health claims Dossiers submitted to EFSA should contain suggested wording for the health claim for EFSA s consideration The NDA Panel may suggest alternative wording Once the EC has authorised the claim, food companies should stick to the authorised wording but there is some flexibility (so long as any changes made are to help consumer understanding) A claim can never suggest or state that a product prevents, cures or treats a disease

35 CONSUMERS

36 Do consumers read food labels?

37 Impact of food labels? Most people are able to use nutrition information when prompted few actually look for it spontaneously when shopping less than one-third of consumers said they had looked for nutrition information on the packaging (from 9% in France to 27% in the UK). (Flabel 2009)

38 Health claims Not always distinguished from nutrition claims Aids to consumer understanding/acceptance of health claims Familiarity with the nutrient or ingredient Concise wording Positive references to good health rather than reference to poor health Perceived healthiness of the product on which the claim is made.

39 Conclusions Regulation on food labelling, nutrition and health claims harmonises practices in EU Does it stimulate innovation in the food industry? Can we get more consumers to look at use food labels? Can food labels encourage healthier eating?

40 Thank you!

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