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 CLAIMSA LEGAL PERSPECTIVE
by Hilary RossPartner
Berwin Leighton Paisnertel: 020 7427 1170
email: hilary.ross@blplaw.com
If God made a horse,
a Committee made a camel …
ScopeClaims in commercial communications– label– presentations– advertising– websites
Brand names/trade names that imply a claim
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
PARNUTs
Mineral water
Food supplements
Exemptions
Spreadable Fats
Non-beneficial nutrition claims
Soft claims
Non commercial communications
Allergens
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 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
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
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)
Nutrient/substance is– present/absent in quantity to achieve effect– form available to be used by body
Quantity of product consumed sufficient to produce effectApplies to food ready for consumptionAverage consumer understands beneficial effectsCapable of substantiationJustifiedNutritional labellingIssues:-– criteria for determining average consumer’s understanding– level of substantiation required?
Step 3: Specific Conditions for UseNutrition Claims
What the product contains Comply with Annex
Claim NHCR
Low fat No more than 3g/100g or 1.5g/100ml
Fat free No more than 0.5g/100g or 100ml
Low sugars No more than 5g/100g or 2.5g/100ml
Sugars free No more than 0.5g/100g or 100ml
Issues
No super low saturated fat claims
No low in cholesterol claims
Comparative Claims
Permits comparison if between foods of same categoryNot range of foodsNo definition of food categoryCompare similar terms of compositions / nutritional contentReference against range of products within categorySignificant comparison
What about?
As much as
Super light
More than
Step 3: Specific Conditions for UseHealth Claims
Prohibitions:-Health affected by non-consumptionRate or amount of weight lossRecommendation of doctors/health professionalsNon-specific claimsEndorsement by national association?Issues:-– International association?– Celebrities
Step 3: Health ClaimsCommunity 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
UK – Calcium, folate and iron (2000+)
Omega 3/antioxidants/probiotics?
Test is indication of functionality
Innovative Claims
Can be added to listBased on newly developed scientific evidence5 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 ClaimsReduction 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 ProcessApplication → 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 publicEFSA → opinion– 5 months from date of VALID application– 2 months extension for additional information
Public/applicant → 30 days to make commentsCommission → draft decision to Standards Committee – 2 months after receiving opinionGuidance to be publishedShortest approval time 8 months
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
Member States prohibited from restricting claims in accordance with the RegulationNB. transitional provisionsTemporarily 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
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
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
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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