the impact of eu regulations on nutrition and health claims a legal perspective by hilary ross...

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