Regulation (EC) No 1924/2006 on Nutrition and Health Claims by Basil Mathioudakis

1. Regulation (EC) No 1924/2006 on Nutrition and Health Claims by Basil Mathioudakis European Commission Head of Unit Food Law, Nutrition and Labelling Workshop on Responsible Consumer Information on Nutrition and Health claims Dubai, 1 March 2011

2. Adoption • Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods • Entered into force on 19 January 2007 • Applicable from 1 July 2007 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1924:20080304:EN:PDF

3. Some examples Miracles in a bottle

4. Some examples Instant muscle amplifier?

5. Objectives of the Regulation • To achieve a high level of consumer protection • To improve the free movement of goods within the internal market • To increase legal security for economic operators and • To ensure fair competition in the area of foods

6. Scope of the Regulation • Claims in labelling, presentation and advertising • Foods to be delivered as such to the final consumer • Certain provisions not applicable to non-prepackaged foods. National rules may apply

7. Scope of the Regulation • Apply to claims made in commercial communications • Generic advertising • Promotional campaigns • Do not apply to claims made in non-commercial communications • Dietary guidelines or advice by public authorities • Information in the press or scientific publications

8. Scope of the Regulation • Voluntary claims about foods, ingredients, nutrients and other substances with a nutritional or physiological effect • Trademarks and brand names

9. Classification of claims • Nutrition claims • Health claims • Growth, development, body function • Psychological, behavioural functions • Slimming/weight control, hunger, satiety, reduction of available energy • Reduction of disease risk claims • Claims referring to children’s growth and development

10. For all claims: • General principles • General conditions

11. General principles and conditions of 1924/2006 • Nutrition and health claims shall (Art. 5): • Refer to a beneficial nutritional/physiological effect • Refer to the food ready for consumption in accordance with the manufacturer’s instructions • Be accompanied by nutrition information (Art. 7) • The nutrient/substance on which the claim is made shall (Art. 5): • Be present in the final product in a quantity to produce the claimed effect • Where applicable, be readily available to be used by the body • Reasonable consumption of the product shall provide a quantity of the nutrient/substance to produce the claimed effect (Art. 5)

12. General principles and conditions of 1924/2006 • Nutrition and health claims shall not (Art. 3): • “be false, ambiguous or misleading” • “give rise to doubt about the safety and/or the nutritional adequacy of other foods” • “encourage or condone excess consumption of a food” • “state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general” • “exploit fear in the consumer”

13. Specific conditions for health claims • Health claims shall not refer to prevention, treatment or cure of a disease • Health claims shall be accompanied by information on(Art. 10): • Importance of balanced diet / healthy lifestyle • Quantity of the food / pattern of consumption required to obtain the claimed effect • Where appropriate, persons who should avoid using the food • Appropriate warning related to excess consumption of the food • Health claims shallnot (Art. 12): • Suggest that health could be affected by not consuming the food • Make reference to rate or amount of weight loss • Make reference to recommendations of individual doctors or health professionals • General well-being claims link to a specific health claim complying with the Regulation (Art. 10.3)

14. General principles and conditions of 1924/2006 • Nutrition and health claims shall: • “be based on and substantiated by generally accepted scientific evidence” (Art. 6.1) Recital 17 “Scientific substantiation should be the main aspect to be taken into account for the use of nutrition and health claims and the food business operators using claims should justify them. A claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence” Recital 23   “Health claims should only be authorized for use in the Community after a scientific assessment of the highest possible standard”  • Be understandable for the average consumer (Art. 5.2)

15. Criteria for substantiation • Regulation – health claims should be substantiated by: • “Generally accepted scientific evidence” • “Taking into account the totality of the available scientific data” • “Weighing the evidence” • Criteria: • Relevance to human health • Causality of the relationship • Food quantity required for claimed effect • Representativeness of data for target population

16. Use of permitted claims For all claims: • If in compliance all operators may use listed/authorised claims • Possibility to protect data for 5 years

17. Restrictions for claims Categories of foods which may not bear nutrition or health claims: • Beverages containing more than 1,2 % by volume of alcohol (except to indicate a reduction in alcohol or energy content or low alcohol content) • Foods not complying with nutrient profiles to be set

18. Implementing the Regulation • Two major implementing measures (Comitology): • The setting of nutrient profiles (Art. 4) • Adoption of permitted health claims

19. Procedure for adoption of implementing measures • Scientific assessment by European Food Safety Authority (EFSA) • Preparation of legal act by European Commission • Vote in Committee (Member States representatives) • Scrutiny of European Parliament and Council • Adoption by European Commission

20. Nutrient profiles • Foods can bear claims if they comply with nutrient profiles • Derogations foreseen for nutrition claims • Strong opposition from many food sectors / Some support from certain sectors • Strong support for the concept, from consumer and health NGOs

21. Nutrition Claims • Provisions on nutrition claims are fully applicable since January 2010 • List of nutrition claims in the Annex may be updated as appropriate via the Regulatory Committee procedure • First revision finalised in February 2010 to include • Claims about unsaturated fat (poly and mono) • Claims about omega-3-FA • New revision in the pipeline

22. Function claims – Chronology • 31 January 2008 - Member States submitted national lists – (44.000 entries) • End 2008 - Consolidated list submitted to EFSA for evaluation • (4185 main entry claims / around 10.000 similar health relationships) • 2009 - Clarification process • March 2010 - Submission of an addendum to EFSA (452 main entry claims) • May 2010 – EFSA publishes consolidated database (4637 main entry claims) • Approx 300 claims withdrawn so far

23. Adoption of the list • EFSA to finalise its assessment of claims on substances other than “botanicals” (June 2011) • Commission to adopt list of permitted claims (end 2011 / early 2012) • Possibility to present additional data for some claims • Claims on “botanicals” to be considered subsequently • List of rejected claims in Register • Claims under evaluation by EFSA and/or regulator remain on the market

24. Individual Authorisation procedures Approval of claims for reduction of disease risk and children’s growth and development • Application to National Authorities • EFSA opinion within 5 months • Community authorisation: • Commission prepares decision • Commission adopts decision through Regulatory Committee

25. Individual Authorisation procedures • EFSA has received approximately 312 applications (83 withdrawn) • 268 children’s claims • 44 newly developed science/proprietary data • Commission has received 102 EFSA opinions • For the majority, the applicant/public made comments to the Commission – Article 16(6) of Regulation • Scientific comments are transmitted to EFSA and a response is provided • Comments and EFSA response to comments on SANCO’s website: http://ec.europa.eu/food/food/labellingnutrition/claims/comments_efsa_en.htm

26. Individual Authorisation procedures • Until now the Standing Committee (SCFCAH) voted in favour of draft Commission Regulations that: • Permit 15 claims • Reject 56 claims • Information on authorised and rejected claims is available in the Register:http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/index_en.htm • 35 applications under consideration

27. Implementing the Regulation • Implementing measures (Commission Regulations 353/2008 and 1169/2009) setting rules on: • Individual applications • Conditions of use • Validity check of applications from national authorities • Withdrawal of individual applications http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2008R0353:20091221:EN:PDF • Guidance document (2007) on: • Interaction with other EU legislation • Comparative nutrition claims • Classification of claims http://ec.europa.eu/food/food/labellingnutrition/claims/guidance_claim_14-12-07.pdf • New guidance documents in the pipeline on: • Validity check of applications from national authorities • Correct use of authorised claims

28. Wording of the claims Importance of consumer understanding A certain flexibility provided Linguistic differences may impact perception of claim Final judgment on consumer understanding is made by enforcement authorities Intention to follow EFSA’s wording but difficulties exist Some examples on Art. 13 claims… “Folate contributes to normal homocysteine metabolism” “Vitamin C increases non-haem iron absorption” “Zinc contributes to normal acid-base metabolism” Implementation challenges – wording

29. Conditions of use Guiding principles GeneralNon Product-specific Comprehensivetaking different elements into account (e.g. All related claims: nutrition claims, Art. 13 and Art. 14 claims) Implementation challenges – conditions of use

30. Other implementation issues Traditional use for botanicals Borderline issues Food vs. medicinal claims Extrapolation of data from sick people Implementation challenges – Other issues

31. Enforcement • Enforcement – National Competent authorities • May request FBOs to produce all relevant data proving compliance with Regulation (Art. 6.3) • Enforcement – Self-Regulatory bodies • Important part to play • Synergies with competent authorities should be developed • Compliance with general and specific principles and conditions is important

32. Thank you for your attention