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Page 1: 06 - Innovating Food, Innovating the Law - Dario Dongo

Nutrition & Health ClaimsNutrition & Health Claims

Reg. (EC) n. 1924/06

Avv. Dario Dongo © 2011

EU & Regulative Policies, HeadFederalimentare

[email protected] - GSM +39 335 7313 726

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Health claimsHealth claims

« A troubled implementation and mixed stakeholders views on Reg.

(EC) n. 1924/2006 »

Piacenza, October 13, 20112

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Scope Scope (1)(1)

This Regulation shall apply to nutrition and health claims made in commercial commercial communicationscommunications, whether in the labelling, presentation or advertising of foodsfoods to be delivered delivered as such to the final consumeras such to the final consumer (Art. 1.2)

All B2C information referring to food (and not, for example to a meal composition, or a complete diet)

Internet information is included

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Scope Scope (2)(2)

1) Trademarks (registered brand )2) Brand names (unregistered brand but well

known on the market and protected at national level)

3) Fancy names (remaining category)-> moratorium until 19.1.2022 for 1 and 2 previous 1.1.05

-> after 15 years, a nutrition or health claim may be used without undergoing the authorisation procedures provided for in this Regulation, provided that it is accompanied by a related nutrition or health claim in that labelling, presentation or advertising which complies with the provisions of this Regulation. (Art. 1.3)

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Scope Scope (3)(3)

For generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health

-> eg. “digestives”, “cough sweets”, “healthy biscuits”

-> a possible derogation, via an appropriate procedure (Art. 1.4, 25. 2)

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Definition: Definition: ClaimClaim

‘Claim’ means any message or representation, in any form, including pictorial, graphic or symbolic representation,

which is not mandatory under Community or national legislation,

which states, suggests or implies that a food has

particular characteristics (Art. 2.2.1)

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General Principles for all Claims (1)

The use of nutrition and health claims shall not:

• be falsefalse, • ambiguousambiguous or • misleadingmisleading, • give rise to doubt about doubt about the safety safety and/or

the nutritional, adequacy of other foods7

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General Principles for all Claims (2)

The use of nutrition and health claims shall not:

• encourage or condone excess consumption of a food, the role and

importance of the food (or of categories of food) and the contribution to the diet of the population in general or, as appropriate, of

certain risk groups including children

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Definition: Definition: HealthHealth ClaimsClaims

‘Health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health (Art. 2.2.5, 13)

‘Reduction of disease risk claim’ means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease (Art. 2.2.6)

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Art. 13.1 health claimsArt. 13.1 health claimsEFSA Opinions: Total 2.758 claims

1st batch: October 1st 2009 : 521 claims 2nd batch: February 25 2010: 416 claims 3rd batch: October 19 2010: 808 claims 4th batch: April 08 2011: 442 claims 5th batch : June 30 2011: 536 claims 6th batch : July 28 2011: 35 claims

A decision is still pending with regard to the scientific assessment of the botanical claims that were submitted

under this process. Furthermore, claims for which additional data has been submitted under the ‘further assessment’ process will be assessed by EFSA at a later stage (expected: autumn this year)

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Obstacles Obstacles (1)(1)Building of art. 13 claims list:

Lack of common metodology Lack of common metodology for the presentation and justification of claims

Too strict tnterpretation of “scientifical substantation” “scientifical substantation” by EC and EFSA = double blind clinical tests on healthy people

Confused processConfused process, , without uniformity

Process delayed

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ObstaclesObstacles (2)(2)

Scientific evaluation of claims:

Evaluation criteria. unclear unclear and inappropriate in the nutritional/fisiological area

Same evaluation criteria and same standard for art. 13 and art. 14 claims

Botanical claims. lack of consistency with the approval procedure provided for traditional herbal medicines

Clinical data Clinical data on patients are not considered

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Troubles Troubles (1)(1)

Pharmaceutical approach Pharmaceutical approach ((Food products are different of pharmaceutical ones)

EC mandate to EFSA is disproportionatedisproportionate and not adapted to the food research

LackLack of informationinformation for consumers : lack of informed and awared choices (Distorsion of consumers information)

Misunderstanding of the Regulation principles -> 80%

rejection of pre-selected health claims

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TroublesTroubles (2)(2)Scientific research Scientific research shows diferent levels of evidence

(intermediate, advanced)

Golden standards requirements Golden standards requirements hamper R&D and innovation

Food pyramidFood pyramid and dietary guidelines lack of evidence

Food SupplementsFood Supplements. lack of security = uncontrolled information sources

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EHPM viewEHPM view

Industry’s main concerns: • Piecemeal adoption of the lists• Lack of Impact Assessment• Lack of guidance/clarity on EFSA’s evaluation• lack of dialogue

• Article 13 should benefit from a different assessment and authorisation process than Article 14 claims (recital 26)

http://www.ehpm.org/

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European Parliament question European Parliament question (1)(1)

Elisabetta Gardini (PPE), Mario Mauro (PPE) and other MEP’s question the EC about:

remarkable complexity remarkable complexity of the implementation process = lack of claritylack of clarity

95 % authorisation requests for substances other than vitamins and minerals are expected to be rejectedrejected

Distortion of information to consumers Distortion of information to consumers = a large amount of information on the effects of vitamins and minerals but very little information on other other substancessubstances

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European Parliament question European Parliament question (2)(2)

Given the impact of this regulation on health claims, will the Commission rectify these distortions of the market

and of consumer information that are taking place?

http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+WQ+E-2011-005587+0+DOC+XML+V0//EN&language=EN

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Definition: Definition: NutritionNutrition ClaimsClaims ‘Nutrition claim’ means any claim which

states, suggests or implies that a food has particular beneficial nutritional properties due to:the energy (kcal) it provides; provides at a reduced or increased rate; or does not provide; and/orthe nutrients or other substances it contains; contains in reduced or increased proportions; or does not contain (Art. 2.2.4)

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Nutrition claimsNutrition claims The nutrition claims’ list is too limited

(i.e. GI claims are not provided)

Why to exclude other true indications which are noteworthy

for consumers? 19

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Industry positionIndustry position

Recognition of traditional valuestraditional values Research, Research, promotion and incentives InnovationInnovation as a competition tool (in the

global market) Consumers’ confidenceconfidence to be gained on

scientific based claims

Scientific criteria Scientific criteria to be proportional to the true nature of food

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Food supplement, the Food supplement, the Italian approachItalian approach

Directive 2002/46/EC: Directive 2002/46/EC: harmonization of FS sector Operators must: guarantee product safety + inform about

its plausible effects Legislative Decree 21 of May 2004Legislative Decree 21 of May 2004: the nutritional or

physiological effect must be stated in the FS labelling With Regulation 1924/2006/ECRegulation 1924/2006/EC, the physiological effect

became an health declaration with the only obligation for producer to commercialize a safe product = FS can be FS can be inactiveinactive

Real need to harmonize the plausible effect with Regulation Claims

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EMEAEMEA/EFSA /EFSA

FoodDrinkEurope and Federalimentare ask for the same the same

procedures procedures to be applied from EFSA and EMEA

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Thank you for your Thank you for your attentionattention

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