1. Food and Drink Innovation Network Daventry June 20071 Regulatory Aspects of Foods and Ingredients for Weight Management Neville Craddock Neville Craddock Associates Bletchingley, Surrey, UK

2. Food and Drink Innovation Network Daventry June 20072 Presentation Overview  EU Health and Nutrition Claims Regulation  Requirements  Uncertainties  Specific requirements in relation to weight management  EU Novel Foods Regulation  Recap of current requirements  Possible revisions

3. Food and Drink Innovation Network Daventry June 20073 “THE EU HEALTH CLAIMS REGULATION” Regulation 1924 / 2006 of the European Parliament and of the Council on Nutrition and Health Claims made on Foods Corrected version: OJ L 12, 18.1.2007, pp 3-18

4. Food and Drink Innovation Network Daventry June 20074 Current EU Legislation on Health Claims Legislation already in place:  Labelling Directive 2000 / 13  Medicines Directives 2001 / 83 and 2004 / 27  Misleading Advertising Directive 85 / 450 (as amended)  Directive 89 / 398 (Foods for Particular Nutritional Uses)  General Food Law Regulation 178 / 2002  European Court Judgements Did we really need more? Probably not - but nevertheless it’s coming!

5. Food and Drink Innovation Network Daventry June 20075 DIRECTIVE 2000 / 13 - Article 2.1(b)  The labelling, presentation and advertising of a food “must not attribute … the property of preventing, treating or curing a human disease, or refer to such properties.”  Labelling: “… words, particulars, trade marks, brand name, pictorial matter or symbol placed on any packaging, document, notice, label, ring or collar accompanying or referring to the food.”  Presentation: “…shape, appearance or packaging, packaging materials used, way in which they are arranged and setting in which they are displayed.”  Applies equally to explicit and implied claims  UK forbids any “tonic” claims Arguably does not prevent “health maintenance” claims But “disease risk reduction” has been a very grey area!

6. Food and Drink Innovation Network Daventry June 20076 EU Claims Regulation – General Principles  Only claims that comply with the Regulation will be permitted  Claims must be supported by generally-accepted scientific evidence  capable of justification by operator  Product must contain ‘significant’ quantity of beneficial substance, or reduction of ‘harmful’ substance, and able to deliver claimed effect  in quantity of food “reasonably expected to be consumed”  substance must be biologically available  Refers to food “ready for consumption” (c.f. ‘to be delivered’ earlier?) N.B. Cannot include other foods in claims justification

7. Food and Drink Innovation Network Daventry June 20077 EU CLAIMS REGULATION - Key Definitions “Claim”: any non-mandatory message or representation (including pictorial, graphic or symbolic) that states, suggests or implies a food has particular characteristics. “Health Claim”: any “claim” that states, suggests or implies relationship between a food category, a food or one of its constituents and health. “Reduction of disease risk claim”: any “health claim” that … consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.

8. Food and Drink Innovation Network Daventry June 20078 EU CLAIMS REGULATION - Key Definitions  “Nutrition claim”: … any “claim” that a food has particular beneficial nutrition properties due to  energy it does / does not provide (including reduced / increased)  “nutrients” or “other substances” it contains / contains in reduced or increased proportions / does not contain.  “Nutrient”: protein, carbohydrate, fat, fibre, sodium, vitamins and minerals in Annex to Directive 90/496 and their components.  “Other substance”: substance other than a “nutrient” that has a nutritional or physiological effect.

9. Food and Drink Innovation Network Daventry June 20079 “Health” Claims  All subject to prior authorisation (specific or generic)  Label (presentation or advertising) must include statements / advice  importance of ‘varied and balanced diet and healthy lifestyle’  quantity of food and pattern of consumption to achieve effect  if appropriate, persons who should avoid the food  appropriate warning, for products likely to present a health risk if consumed to excess Guidelines may be adopted “where appropriate”

10. Food and Drink Innovation Network Daventry June 200710 Generally-accepted “Health” Claims Prior authorisation will not be required for claims describing  role of nutrient etc in growth, development or normal functions  psychological and behavioural functions  slimming, weight control  reduction in sense of hunger or increase in satiety  reduction in available energy from the diet Provided they are  based on generally-accepted scientific evidence  well-understood by an “average consumer”  included on ‘Community list’  31 st January 2008 - Member States to provide Commission with list  31 st January 2010 - Community list, after consulting EFSA, permitted claims Complex transitional provisions will apply

11. Food and Drink Innovation Network Daventry June 200711 “Disease Risk Reduction” Claims  Will be permitted following formal authorisation  Label must also state  the disease to which claim refers has multiple risk factors  altering one of these may / may not have a beneficial effect  Will appear on the public “Register”

12. Food and Drink Innovation Network Daventry June 200712 “Nutrition” and “Comparative” Claims NUTRITION CLAIMS (e.g. “rich” “low” “free”)  Only permitted if listed in, and comply with, detailed conditions in Annex COMPARATIVE CLAIMS (e.g. “chalk versus cheese”)  Comparison only between foods of same category, taking into account a range of foods in category  Difference in quantity of nutrient and / or energy must be stated  Comparison must relate to same quantity of food  Comparison against range of foods whose composition does not allow a claim, including other brands

13. Food and Drink Innovation Network Daventry June 200713 EU Health and Nutrition Claims Ongoing Issues

14. Food and Drink Innovation Network Daventry June 200714 EFSA Scientific Substantiation of Claims SCIENTIFIC AND TECHNICAL GUIDANCE FOR THE PREPARATION AND PRESENTATION OF THE APPLICATION FOR AUTHORISATION OF A HEALTH CLAIM Draft Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies Published May – closed 17 th June 2007

15. Food and Drink Innovation Network Daventry June 200715 EU CLAIMS REGULATION – Ongoing Issues  "nutrient profiles" (Article 4.1)  how will they be determined?  what will they comprise?  industry wishes to add several nutrient parameters to Annex  complexity of various transitional periods

16. Food and Drink Innovation Network Daventry June 200716 Miscellaneous Issues  Trade Marks, Brand Names or Fancy Names perceived as a claim  may continue without new authorisation but must carry ‘compliant claim’  Generic, traditional descriptors (“digestive”): derogations possible  business application to MS to forward to EC (SCFCAH procedure)  EC to publish rules to enable “transparency and reasonable time”  “Non-beneficial” claims / schemes are not covered (recital 6)  believed aimed at FSA “traffic lights” and similar national schemes  ‘Yellow fat spreads’ Regulation still applies, but will be adapted  National / EU alcohol abuse messages are excluded  Liquid food supplements with >1.2% alcohol are not ‘beverages’

17. Food and Drink Innovation Network Daventry June 200717 EU HEALTH CLAIMS – Outstanding Issues  Traditional generic denominations: need to clarify underlying procedure  Broad scope includes “any commercial communication” incl. websites - enforcement against non-EU operators / TVWF etc?  A lot of work is needed, with the input of all relevant stakeholders (nutrient profiles, Art. 13 list, extension of Annex)  Need for numerous “implementing rules and technical guidelines”  non-prepacked foods  procedure for traditional denominations  derogations for certain nutrients - Art. 3 (d)  specific conditions for labelling and “warnings” - Art. 10  presentation and preparation of applications - Art. 15 (4) and (5)

18. Food and Drink Innovation Network Daventry June 200718 EU HEALTH CLAIMS – Outstanding Issues  No legal definition of “children”  What is “generally-accepted” scientific evidence?  What is “well-understood” by average consumer?  Uncertainty of critical concepts  “normal” body functions  psychological and behavioural functions (intelligence / concentration?)  Is “calorie burning” within “slimming, weight control” scope?  Transitional periods for “child development and health” claims  Clarification of possible overlapping transition periods Interpretation of unclear terms and provisions to obtain legal certainty for operators and enforcement bodies

19. Food and Drink Innovation Network Daventry June 200719 What is an “Average Consumer”? ECJ rulings consistently describe “average consumer” as:  “reasonably well-informed, reasonably observant and circumspect” Claims Regulation: "It is appropriate to protect all consumers from misleading claims. However, the ECJ has found it necessary … since [the Misleading Advertising Directive] to examine the effect on a notional, typical consumer. In line with … proportionality, and to enable the effective application of the protective measures contained in it, this Regulation takes as a benchmark the average consumer as interpreted by the ECJ, taking into account social, cultural and linguistic factors but makes provision to prevent the exploitation of consumers whose characteristics make them particularly vulnerable to misleading claims". Labelling Directive: “… could mislead the purchaser to a material degree” Can Claims Regulation go beyond ECJ?

20. Food and Drink Innovation Network Daventry June 200720 Energy - Restricted Diets for Weight Reduction Directive 1996 / 8 and Regulation 1924 / 2006

21. Food and Drink Innovation Network Daventry June 200721 Foods for Particular Nutrition Uses  “Foodstuffs which, owing to their special composition or manufacturing process:  are clearly distinguishable from foodstuffs for normal consumption,  which are suitable for their claimed nutritional purposes  and which are marketed in such a way as to indicate such suitability.”  Medicinal claims prohibition applies to all foods including PARNUTS foods  PARNUTS foods must be notified to FSA Council Directive 89/398/EEC

22. Food and Drink Innovation Network Daventry June 200722 Foods for Weight - Reduction Diets  Foods for use in energy-restricted diets for weight reduction are specially formulated foods which, when used as instructed by the manufacturer, replace the whole or part of the total daily diet  Two categories: products presented as  replacement for the whole of the daily diet All individual components must be in the same package 'Total diet replacement for weight control`  replacement for one or more meals of the daily diet 'Meal replacement for weight control`  All must meet compositional criteria specified in Annex 1

23. Food and Drink Innovation Network Daventry June 200723 Labelling of “Slimming” Foods (1) In addition to requirements of Directive 2000/13 must declare  available energy (kJ and kcal), proteins, carbohydrates and fat  per specified quantity of product ready for use as recommended  average quantity of each mineral and vitamin specified in annex 5.1  per specified quantity of product ready for use as recommended  in addition, meal replacements must declare %RDAs  appropriate preparation instructions and statement as to importance of following those instructions

24. Food and Drink Innovation Network Daventry June 200724 Labelling of “Slimming” Foods (2) In addition to requirements of Directive 2000/13 must declare  laxative effect statement if product provides > 20g per day polyols  importance of maintaining an adequate daily fluid intake  whole daily diet replacements must state that product  provides adequate amounts of all essential nutrients for the day  should not be used for more than three weeks without medical advice  meal replacements must state that product  is useful for the intended use only as part of an energy restricted diet other foods should be a necessary part of such diet

25. Food and Drink Innovation Network Daventry June 200725 Foods for Weight - Reduction Diets Directive 96/8:  labelling, advertising and presentation must not refer  to the rate or amount of weight loss which may result  to a reduction in sense of hunger or increase in sense of satiety Regulation 1924/2006, Article 13(1)(c)  now allows health claims describing or referring in particular to a reduction in the sense of hunger or an increase in the sense of satiety under specified conditions

26. Food and Drink Innovation Network Daventry June 200726 Foods for Weight - Reduction Diets  Directive 96/8, Article 5, paragraph 3 is replaced by the following:  ‘3. The labelling, advertising and presentation of the products concerned shall not make any reference to the rate or amount of weight loss which may result from their use.’ Reference may in future be made to reduction in sense of hunger or increase in sense of satiety Member States must apply these provisions from 1 July 2007

27. Food and Drink Innovation Network Daventry June 200727 NOVEL FOODS EU Regulation 258 / 97

28. Food and Drink Innovation Network Daventry June 200728  Came into force 15 May 1997  EU-wide mandatory pre-market approval system for “novel” foods  Safety-based assessment  Applies in all (27) Member States Recommendation 97 / 618 describes scientific aspects for assessments Since April 2004 GM foods have a separate legislative route EC Novel Foods Regulation 258/97

29. Food and Drink Innovation Network Daventry June 200729 EU Regulation 258/97 - Scope … not used for human consumption to a significant degree within EC (before 15 th May 1997) and which …  … has new or intentionally modified primary molecular structure  … consists of or isolated from micro-organisms, fungi or algae  … consists of, or isolated from, plants and ingredients isolated from animals, except for foods obtained by traditional propagating or breeding practices and having a history of safe food use  [… to which has been applied a (novel) production process … (which) gives rise to significant changes in composition or structure which affect nutritional value, metabolism or level of undesirable substances]

30. Food and Drink Innovation Network Daventry June 200730 Categories – some examples  foods with a new / modified primary molecular structure  (e.g. SALATRIM, Tagatose, Isomaltulose)  foods from micro-organisms / fungi / algae  (e.g. fungal lycopene, DHA, Glucosamine)  foods from plants / animals obtained by traditional practices  (e.g. Phytosterols, Nangai nuts, Noni, Chia, Baobab)  new food processing methods that change composition  (e.g. HPP of fruit preparations, new enzymic process)

31. Food and Drink Innovation Network Daventry June 200731 Exemptions  ANY food on sale in the EU prior to May 1997  (General Food Safety Law Regulation 178/2002 applies)  Products with clearly defined, separate safety assessment route  Additives  Flavourings  Extraction solvents Providing the level of safety is equivalent to that delivered by 258/07  Processing aids  Medicines (e.g. UK MHRA)  n.b. they routinely check!!

32. Food and Drink Innovation Network Daventry June 200732 Supplements and Additives - Prior Use  Dietary supplement use prior to 15th May is NOT indicative of significant use as a food ingredient  This view was ‘formalised’ by MS at SCFCAH* in February 2005  Similar view applies if history of prior use only as a food additive  Number of examples  Phosphated distarch phosphate - glucosamine * Standing Committee on the Food Chain and Animal Health

33. Food and Drink Innovation Network Daventry June 200733 EU Novel Food Regulation 258/97 Safety-Driven  Novel Foods / Ingredients must not  present a danger to the consumer  mislead the consumer  differ from those they are intended to replace such that their normal consumption would be nutritionally disadvantageous Safety Assessment or Notification  Via one of two procedures, depending on degree of "novelty"  Full Assessment, or  “Notification” - if “substantially equivalent” to existing product

34. Food and Drink Innovation Network Daventry June 200734 So … where are the problems … and what needs to be done?

35. Food and Drink Innovation Network Daventry June 200735 Regulation 258/97 – Issues and Problem Areas  Imprecise definitions – clarity needed for practical application:  “Significant consumption” - numerical and / or nutritional?  “Substantially Equivalent” – ambiguity: neither term defined “reasonably similar” or “virtually identical”?  ‘Traditional’ foods  History of Safe Food Use  Balance between “customary knowledge” and “modern science”  WTO compatibility  Novel Processes  Generic versus Company authorisations  Cost and Timescale of applications  “Arbitrary” cut-off date of 15 th May 1997

36. Food and Drink Innovation Network Daventry June 200736 NFR Review - The Biggest Hurdle?  “History of safe food use” for ‘exotic foods’ can be subjective:  assumes lengthy history of food use in a particular country or culture sufficient to show that any risks are probably acceptable  but … impossible to establish certainty of “safety” without extensive scientific and toxicological studies  Goal should be “acceptable (or proportionate) level of risk”  “History of use, with reasonable certainty of no harm" better reflects that “no risk” is unachievable, but minimized risk is possible Long history of use by indigenous populations is evidence of safety  dependent on the management of known risks  discontinued if found to be disproportionately unsafe

37. Food and Drink Innovation Network Daventry June 200737 Imprecise Definitions – Adverse Consequences Precise definitions and consistent application of concepts are needed  “Significant”: is qualitative and subjective  “Consumption to significant degree”:  pre-1997 imports - proof difficult …  excluding pharmacies?!  historic, local production and/or traditional domestic consumption  use and sales in all EU-27 Does refusal to accept full range of availability of the products, and then using “lack of consumption” as argument to block 3rd country imports constitute non-tariff barrier?

38. Food and Drink Innovation Network Daventry June 200738 Revision of Regulation 258/97 – current thinking  Retain 15 May 1997 cut-off, but  public comment before assessment to ensure products are novel?  Centralised assessment and authorisation procedure  “Substantial equivalence” & Notification procedure may be dropped  possibility of alternative approach for 'me too' applications?  Different categories could be dropped (food defined under 178/2002)  novel processes and non-traditional breeding methods may stay  More emphasis on history of (safe) food use for traditional (non-EU) foods rather than usual suite of safety studies

39. Food and Drink Innovation Network Daventry June 200739 Revision of Regulation 258/97 – current thinking  Greater clarity of terms and concepts, e.g. guidelines to accompany legislation  “traditional foods” … “consumption to a significant degree”  Flexibility for simultaneous applications under 'Claims' and 'Supplements‘ rules  Usual consultations etc for comment Aspects that would need to be addressed:  Proportionate balance of “customary knowledge” and “modern science” to produce “scientific evidence” in safety dossiers for ‘traditional foods’  How, where and by whom, can valid “scientific evidence” be produced:  e.g. by applicant industry / national authority; university / research institutes; third country / EU?  More cost-effective administrative and scientific assessment process  economically and technically feasible; learn from others  Feasibility of generic applications / authorisations?

40. Food and Drink Innovation Network Daventry June 200740 Thank you for your attention, ladies and gentlemen. Any comments or questions?

41. Food and Drink Innovation Network Daventry June 200741 Neville Craddock Associates Tun House 28 High Street Bletchingley Surrey UK nevillecraddock@tunhouse28.fsnet.co.uk Tel: +44 (0) 1883 740 553 Mob: +44 (0) 7802 641 081 nevillecraddock@tunhouse28.fsnet.co.uk