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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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the impact of eu regulations on nutrition and health claims a legal perspective

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

slide2
If God made a horse,

a Committee made a camel …

scope
Scope
  • Claims in commercial communications
    • label
    • presentations
    • advertising
    • websites
  • Brand names/trade names that imply a claim
applications
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
application
Application
  • PARNUTs
  • Mineral water
  • Food supplements
exemptions
Exemptions
  • Spreadable Fats
  • Non-beneficial nutrition claims
  • Soft claims
  • Non commercial communications
  • Allergens
prohibitions
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
making nutrition health claims step 1 nutrient profiles
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
slide9
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
step 2 compliance with general conditions
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
step 2 compliance with general conditions cont
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?
step 3 specific conditions for use nutrition claims
Step 3: Specific Conditions for UseNutrition Claims
  • What the product contains
  • Comply with Annex
issues
Issues
  • No super low saturated fat claims
  • No low in cholesterol claims
comparative claims
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
what about
What about?
  • As much as
  • Super light
  • More than
step 3 specific conditions for use health claims
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
step 3 health claims
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)
permitted list
Permitted List
  • UK – Calcium, folate and iron (2000+)
  • Omega 3/antioxidants/probiotics?
  • Test is indication of functionality
innovative claims
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?
step 3 health claims1
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
authorisation process
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
authorisation process cont
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
national measures safeguard provisions
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
transitional provisions
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
slide25
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
summary
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