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THE IMPACT OF EU REGULATIONS ON NUTRITION AND HEALTH CLAIMS A LEGAL PERSPECTIVE

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. If God made a horse, a Committee made a camel …. Scope. Claims in commercial communications label

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THE IMPACT OF EU REGULATIONS ON NUTRITION AND HEALTH CLAIMS A LEGAL PERSPECTIVE

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  1. THE IMPACT OF EU REGULATIONS ON NUTRITION AND HEALTH CLAIMSA 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 ClaimsStep 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 UseNutrition Claims • What the product contains • Comply with Annex

  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 UseHealth 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

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