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Regulation (EC) No 1924/2006 on Nutrition and Health Claims

by Basil Mathioudakis

European CommissionHead of Unit

Food Law, Nutrition and Labelling

Workshop on Responsible Consumer Information on Nutrition and Health claims

Dubai, 1 March 2011

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Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods

Entered into force on 19 January 2007

Applicable from 1 July 2007

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1924:20080304:EN:PDF

Adoption

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Miracles in a bottle

Some examples

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Instant muscle amplifier?

Some examples

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To achieve a high level of consumer protection

To improve the free movement of goods within the internal market

To increase legal security for economic operators and

To ensure fair competition in the area of foods

Objectives of the Regulation

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Claims in labelling, presentation and advertising

Foods to be delivered as such to the final consumer

Certain provisions not applicable to non-prepackaged foods. National rules may apply

Scope of the Regulation

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Apply to claims made in commercial communications

Generic advertising

Promotional campaigns

Do not apply to claims made in non-commercial communications

Dietary guidelines or advice by public authorities

Information in the press or scientific publications

Scope of the Regulation

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Voluntary claims about foods, ingredients, nutrients and other substances with a nutritional or physiological effect

Trademarks and brand names

Scope of the Regulation

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Nutrition claims

Health claims Growth, development, body function Psychological, behavioural functions Slimming/weight control, hunger, satiety,

reduction of available energy

Reduction of disease risk claims Claims referring to children’s growth and

development

Classification of claims

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For all claims:

General principles

General conditions

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Nutrition and health claims shall (Art. 5): Refer to a beneficial nutritional/physiological effect Refer to the food ready for consumption in accordance

with the manufacturer’s instructions Be accompanied by nutrition information (Art. 7)

The nutrient/substance on which the claim is made shall (Art. 5):

Be present in the final product in a quantity to produce the claimed effect

Where applicable, be readily available to be used by the body

Reasonable consumption of the product shall provide a quantity of the nutrient/substance to produce the claimed effect (Art. 5)

General principles and conditions of 1924/2006

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Nutrition and health claims shall not (Art. 3):

“be false, ambiguous or misleading”

“give rise to doubt about the safety and/or the nutritional adequacy of other foods”

“encourage or condone excess consumption of a food”

“state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general”

“exploit fear in the consumer”

General principles and conditions of 1924/2006

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Health claims shall not refer to prevention, treatment or cure of a disease

Health claims shall be accompanied by information on (Art. 10): Importance of balanced diet / healthy lifestyle Quantity of the food / pattern of consumption required to obtain

the claimed effect Where appropriate, persons who should avoid using the food Appropriate warning related to excess consumption of the food

Health claims shall not (Art. 12): Suggest that health could be affected by not consuming the

food Make reference to rate or amount of weight loss Make reference to recommendations of individual doctors or

health professionals

General well-being claims link to a specific health claim complying with the Regulation (Art. 10.3)

Specific conditions for health claims

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Nutrition and health claims shall:

“be based on and substantiated by generally accepted scientific evidence” (Art. 6.1)

Recital 17 “Scientific substantiation should be the main aspect to be taken into account for the use of nutrition and health claims and the food business operators using claims should justify them. A claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence”

Recital 23   “Health claims should only be authorized for use in the Community after a scientific assessment of the highest possible standard” 

Be understandable for the average consumer (Art. 5.2)

General principles and conditions of 1924/2006

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Regulation – health claims should be substantiated by: “Generally accepted scientific evidence” “Taking into account the totality of the available

scientific data” “Weighing the evidence”

Criteria: Relevance to human health Causality of the relationship Food quantity required for claimed effect Representativeness of data for target population

Criteria for substantiation

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For all claims:

If in compliance all operators may use listed/authorised claims

Possibility to protect data for 5 years

Use of permitted claims

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Categories of foods which may not bear nutrition or health claims:

Beverages containing more than 1,2 % by volume of alcohol (except to indicate a reduction in alcohol or energy content or low alcohol content)

Foods not complying with nutrient profiles to be set

Restrictions for claims

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Two major implementing measures (Comitology):

The setting of nutrient profiles (Art. 4)

Adoption of permitted health claims

Implementing the Regulation

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Procedure for adoption of implementing measures

Scientific assessment by European Food Safety Authority (EFSA)

Preparation of legal act by European Commission

Vote in Committee (Member States representatives)

Scrutiny of European Parliament and Council

Adoption by European Commission

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Foods can bear claims if they comply with nutrient profiles

Derogations foreseen for nutrition claims

Strong opposition from many food sectors / Some support from certain sectors

Strong support for the concept, from consumer and health NGOs

Nutrient profiles

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Provisions on nutrition claims are fully applicable since January 2010

List of nutrition claims in the Annex may be updated as appropriate via the Regulatory Committee procedure

First revision finalised in February 2010 to include

Claims about unsaturated fat (poly and mono)Claims about omega-3-FA

New revision in the pipeline

Nutrition Claims

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Function claims – Chronology

31 January 2008 - Member States submitted national lists – (44.000 entries)

End 2008 - Consolidated list submitted to EFSA for evaluation (4185 main entry claims / around 10.000 similar

health relationships)

2009 - Clarification process

March 2010 - Submission of an addendum to EFSA (452 main entry claims)

May 2010 – EFSA publishes consolidated database (4637 main entry claims)

Approx 300 claims withdrawn so far

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Adoption of the list

EFSA to finalise its assessment of claims on substances other than “botanicals” (June 2011)

Commission to adopt list of permitted claims (end 2011 / early 2012)

Possibility to present additional data for some claims

Claims on “botanicals” to be considered subsequently

List of rejected claims in Register

Claims under evaluation by EFSA and/or regulator remain on the market

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Approval of claims for reduction of disease risk and children’s growth and

development

Application to National Authorities EFSA opinion within 5 months Community authorisation:

Commission prepares decision Commission adopts decision through

Regulatory Committee

Individual Authorisation procedures

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EFSA has received approximately 312 applications (83 withdrawn)268 children’s claims 44 newly developed science/proprietary data

Commission has received 102 EFSA opinions

For the majority, the applicant/public made comments to the Commission – Article 16(6) of Regulation

Scientific comments are transmitted to EFSA and a response is provided

Comments and EFSA response to comments on SANCO’s website: http://ec.europa.eu/food/food/labellingnutrition/claims/comments_efsa_en.htm

Individual Authorisation procedures

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Until now the Standing Committee (SCFCAH) voted in favour of draft Commission Regulations that: Permit 15 claims Reject 56 claims

Information on authorised and rejected claims is available in the Register: http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/index_en.htm

35 applications under consideration

Individual Authorisation procedures

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Implementing measures (Commission Regulations 353/2008 and 1169/2009) setting rules on: Individual applications Conditions of use Validity check of applications from national authorities Withdrawal of individual applications

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2008R0353:20091221:EN:PDF

Guidance document (2007) on: Interaction with other EU legislation Comparative nutrition claims Classification of claims

http://ec.europa.eu/food/food/labellingnutrition/claims/guidance_claim_14-12-07.pdf

New guidance documents in the pipeline on: Validity check of applications from national authorities Correct use of authorised claims

Implementing the Regulation

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Wording of the claims Importance of consumer understanding

A certain flexibility provided Linguistic differences may impact perception of claim Final judgment on consumer understanding is made by

enforcement authorities

Intention to follow EFSA’s wording but difficulties exist

Some examples on Art. 13 claims… “Folate contributes to normal homocysteine metabolism” “Vitamin C increases non-haem iron absorption” “Zinc contributes to normal acid-base metabolism”

Implementation challenges – wording

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Conditions of use

Guiding principlesGeneral Non Product-specificComprehensive taking different elements into

account (e.g. All related claims: nutrition claims, Art. 13 and Art. 14 claims)

Implementation challenges – conditions of use

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Other implementation issues

Traditional use for botanicals

Borderline issuesFood vs. medicinal claimsExtrapolation of data from sick people

Implementation challenges – Other issues

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Enforcement – National Competent authorities May request FBOs to produce all relevant data proving

compliance with Regulation (Art. 6.3)

Enforcement – Self-Regulatory bodies

Important part to play

Synergies with competent authorities should be developed

Compliance with general and specific principles and conditions is important

Enforcement

Thank you for your attention