1. THE IMPACT OF EU REGULATIONS ON NUTRITION AND HEALTH CLAIMS A LEGAL PERSPECTIVE by Hilary Ross Partner Berwin Leighton Paisner tel: 020 7427 1170 email: hilary.ross@blplaw.com

2. If God made a horse, a Committee made a camel …

3. Scope Claims in commercial communications –label –presentations –advertising –websites Brand names/trade names that imply a claim

4. Applications Foods –delivered to final consumer –delivered to mass caterers Includes non pre-packed foods NB. certain exceptions pre-packed foods Issue:- –Commission’s press release misleading

5. Application PARNUTs Mineral water Food supplements

6. Exemptions Spreadable Fats Non-beneficial nutrition claims Soft claims Non commercial communications Allergens

7. Prohibitions False misleading Give rise to doubts about safety/nutritional adequacy Encourage excess consumption of food State/imply balanced or varied diet cannot provide adequate nutrition Refer to bodily functions which could exploit fear in consumer NB. Unfair Commercial Practices Directive

8. Making Nutrition & Health Claims Step 1: Nutrient Profiles To be established for food/categories of foods (January 2009) Profiles –define quantities of certain nutrients/substances –role and importance of food and contribution to diet Profiles to be based on scientific knowledge

9. Derogation –Nutrition claims can be made if 1 nutrient exceeds profile criteria –must be accompanied by statement Update to take into account scientific evidence Special rules for alcohol Issues:- –uncertainty re criteria and no guidance on when it should be updated –derogation for nutrition claims only

10. Step 2: Compliance with General Conditions Presence/absence/reduced content of nutrient / substance shown to have a beneficial effect by generally accepted scientific data Issue:- –unclear legal concepts as no guidance on level or type of evidence or for criteria generally accepted

11. Step 2: Compliance with General Conditions (cont) Nutrient/substance is –present/absent in quantity to achieve effect –form available to be used by body Quantity of product consumed sufficient to produce effect Applies to food ready for consumption Average consumer understands beneficial effects Capable of substantiation Justified Nutritional labelling Issues:- –criteria for determining average consumer’s understanding –level of substantiation required?

12. Step 3: Specific Conditions for Use Nutrition Claims What the product contains Comply with Annex ClaimNHCR Low fatNo more than 3g/100g or 1.5g/100ml Fat freeNo more than 0.5g/100g or 100ml Low sugarsNo more than 5g/100g or 2.5g/100ml Sugars freeNo more than 0.5g/100g or 100ml

13. Issues No super low saturated fat claims No low in cholesterol claims

14. Comparative Claims Permits comparison if between foods of same category Not range of foods No definition of food category Compare similar terms of compositions / nutritional content Reference against range of products within category Significant comparison

15. What about? As much as Super light More than

16. Step 3: Specific Conditions for Use Health Claims Prohibitions:- Health affected by non-consumption Rate or amount of weight loss Recommendation of doctors/health professionals Non-specific claims Endorsement by national association? Issues:- –International association? –Celebrities

17. Step 3: Health Claims Community list developed for –role of nutrient / substance in growth development function –psychological and behavioural functions –slimming/weight control Based on generally accepted scientific evidence and Well understood by average consumer Member States to provide list of claims and conditions (Jan 2008) Community list of permitted claims developed (Jan 2010)

18. Permitted List UK – Calcium, folate and iron (2000+) Omega 3/antioxidants/probiotics? Test is indication of functionality

19. Innovative Claims Can be added to list Based on newly developed scientific evidence 5 yr protection for proprietary data (Article 21) Issues:- –timing of applications eg. cannot apply prior to completion of permitted list –article 14 and 21 not cross referenced to each other –level of protection for proprietary data? –labelling undermine benefit of claim?

20. Step 3: Health Claims Reduction of disease risk claims} and} authorised Children’s development and} health claims NB. special labelling requirements for disease risk claims Issues:- –no definition of children’s development and health claims –no definition of child –distinction between claims only applicable to children and those which apply to whole population

21. Authorisation Process Application → Member States –14 days to acknowledge –Inform EFSA (without delay) –Provide EFSA with application (no time limit) EFSA → inform Member States & Commission (without delay) EFSA → make application available to public EFSA → opinion –5 months from date of VALID application –2 months extension for additional information Public/applicant → 30 days to make comments Commission → draft decision to Standards Committee – 2 months after receiving opinion Guidance to be published Shortest approval time 8 months

22. Authorisation Process (cont) Issues:- –not all stages have time limit –short period to provide supplemental information –what happens if fail to meet deadlines? –Commission does not need to accept EFSA recommendation – science –v- politics

23. National Measures / Safeguard Provisions Member States prohibited from restricting claims in accordance with the Regulation NB. transitional provisions Temporarily suspend claims if –serious grounds for considering non-compliance or –scientific substantiation insufficient Issues:- –enforcement during transitional period? –lack of harmonisation –unclear criteria for temporarily suspending claims –not safety issue

24. Transitional Provisions Nutrition claims in Annex must comply with conditions – 1 July 2007 Other nutrition claims can be used until 19 January 2010 provided used in Member State prior to 1 January 2006 19 January 2010 – only nutrition claims in Annex allowed

25. Bodily function health claims can be made until 31 January 2010 Psychological and slimming claims can be used until 31 January 2010 provided made prior to 19 January 2007 New psychological/slimming claims can be used if application made by 19 January 2008 Products labelled or marketed prior 1 July 2007 can be used until end of shelf life, but not beyond 31 July 2009

26. Summary Legislation badly needed but need for well- drafted legislation Many issues to be clarified Need strong and detailed guidance from Commission Abdication to Member States will undermine harmonisation