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Nutrition and Health Claims

Policy Position

FDF supports in principle the European Commission (EC) Regulation 1924/2006 which will harmonise the use of scientifically substantiated nutrition and health claims and enable consumers to make informed and meaningful choices. However the strict nature of the conditions for making claims could restrict product innovation as companies might not invest in R&D if they can not communicate the benefits of a new product to consumers.

The legislation is complex with several transitional measures and much uncertainty remains. In particular:

• the European Commission was due to adopt a list of permitted Article 13.1 health claims by 31 January 2010 but this deadline was not met. The European Commission is now intending adopt this list in tranches - the partial list covering the first batch of 94 EFSA opinions is not due to be published in the Official Journal until December 2010 at the earliest.
• the European Commission was due to establish nutrient profiles for foods bearing claims by 19 January 2009 but this work has been delayed due to the difficulty in reaching agreement on the levels of fat, salt and sugar, the product categories and the exemptions

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Background

EC Regulation 1924/2006 on nutrition and health claims made on foods was adopted on 20 December 2006 and came into effect on 1 July 2007, although a number of the provisions are subject to transitional measures up to 2022 for trademarks. The Regulation:

• sets out general principles and conditions for all claims including the provision for the EC to establish nutrient profiles for foods bearing claims (Article 4);
• lists authorised nutrition claims in the Annex;
• provides for a EC list of generally accepted health claims (Article 13);
• provides for a pre-market approval system for:
• claims based on ‘new’ science and/or proprietary data (Article 13.5); and
• disease risk reduction and children’s health (Article 14).

Nutrient profiles will restrict the use of claims on products which contain high levels of fats, sugars and salt – if a product fails one of the nutrient profiles then the product will not be allowed to bear any health claim. A nutrition claim will be permitted provided that a claim about the failing nutrient is displayed with equal prominence on the label. The DG Sanco proposal went through interservice consultation in mid-February 2009 but it was heavily criticised and the Commission President intervened. We are waiting for a new draft

Nutrition claimswill only be permitted if they are listed in the Annex to the Regulation. The Annex has recently been amended to include the five fatty acid claims (source of omega-3 fatty acids, high omega 3 fatty-acids, high monounsaturated fat, high polyunsaturated fat and high unsaturated fat) and a proposal for additional claims to be added to the Annex is being discussed by the European Commission.

For Article 13 health claims a positive list will be drawn up by the EC based on advice from the European Food Safety Authority (EFSA). EFSA is currently assessing the 4,000+ health claims submitted by the EC and has decided to publish its opinions in several batches. The first batch of 94 opinions was published on 1 October 2009 and the second batch of 31 opinions was published on 25 February 2010. Subsequent batches will be published as follows:

• Third batch: September 2010
• Fourth batch: February 2011
• Fifth batch: September 2011
• Sixth batch: December 2011

The European Commission is working on draft legislative proposals for the inclusion of claims on a partial positive list of permitted claims with reference to the first batch of EFSA opinions. The proposal is being discussed with Member States and will be put to the vote in the EC Standing Committee on the Food Chain and Animal Health when discussions are complete – possibly 5 July. The Commission intends to include a provision which in general terms would refer to the following: any claim/s which is not included in the list or being under EFSA evaluation may not be marketed longer than 6 months following the entry into force of this Regulation. Negative claims will be included on the Community Registrar.

Any additions of claims to the Article 13 list based on newly developed scientific evidence and/or which include a request for the protection of proprietary data (Article 13.5) and claims referring to disease risk reduction and children’s health (Article 14) will be approved on a case by case basis following the submission of a scientific dossier to EFSA.

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