BACKGROUND

New rules will shortly be adopted regulating the use and substantiation of health and nutrition claims in the EU. The European Parliament agreed a compromise text on 16 May 2006 opening the way for formal adoption of the new Regulation by the Council of Ministers (in other words Member States’ Ministers). The rules are designed to protect consumers from misleading, unsubstantiated or exaggerated claims of the health and nutritional benefits of food and drink products, whether such claims appear on the label or in advertising.1

NUTRIENT PROFILES

One of the most controversial aspects of the proposed Regulation is the concept of nutrient profiles. Nutrient profiles will be established for foods or certain categories of food, based on factors such as the level of fat, sugar and salt, within two years of the Regulation coming into force.

In general, only foods matching these agreed profiles will be permitted to carry health or nutrition claims. However, an important exception was agreed as part of the compromise between the Parliament and Council. This will allow a nutrition claim (but not a health claim) to be made for a food where one nutrient exceeds the relevant nutrient profile, subject to certain conditions. For example, where a food is high in sugar but low in salt and fat it may carry a nutrition claim, provided that such a claim is accompanied by a prominent statement that the food is high in sugar.

NUTRITION CLAIMS2

A list of permitted nutrition claims is set out in the Annex to the Regulation, together with the conditions that will have to be met for the claim to be made. These include claims such as "energy reduced", "low fat", "source of fibre" and "with no added sugars".

Only nutrition claims appearing on the list will be permitted. Provision is included for this list to be amended in the future.

HEALTH CLAIMS3

Health claims will be regulated according to the type of claim being made. The European Commission will compile a list of well-established (or "generic") health claims, such as "calcium is good for your bones". Food producers will be able to use such claims without specific approval provided that the claim is based on generally accepted scientific evidence and is well understood by the average consumer.

In order to encourage innovation in the food industry, innovative health claims that are based on new science may be approved for use on a case-by-case basis. It is anticipated that they will generally be approved using a relatively simple authorisation procedure.

Individual health claims relating to disease reduction or to children's development and health will be subject to a strict authorisation procedure. Such claims will need to be approved jointly by the EU Member States and the European Commission, following an evaluation of the scientific evidence by the European Food Safety Authority.

GENERAL CONDITIONS

The Regulation includes a number of general conditions that must be met before any nutrition or health claim may be made. These include, among others, requirements that:

  • the nutrient or substance for which a claim is made is contained in the final product in a "significant quantity" as defined in EU legislation or (if no such definition exists) in a quantity that will result in the nutritional or physiological effect claimed
  • average consumers should be able to understand the beneficial effects as expressed in the claim
  • claims should be based on, and substantiated by generally accepted scientific evidence.

PROHIBITED CLAIMS

The Regulation will prohibit, among others, nutritional or health claims that:

  • are false, ambiguous or misleading
  • give rise to doubt about the safety and/or nutritional adequacy of other food
  • encourage or condone excess consumption of a food.

In addition, health claims may not refer to rates or amounts of weight loss or to recommendations of individual doctors or health professionals. They may also not suggest that health could be affected by not consuming the food.

Drinks containing more than 1.2% by volume of alcohol will not be able to make any health claims. However, nutrition claims relating to the reduction of alcohol content or the reduction of energy content only will normally be allowed.

BRAND NAMES

A trade mark or brand name appearing in labelling, presentation or advertising of a food which may be construed as a nutrition or health claim may be used without requiring authorisation. However, it will only be permitted if it is accompanied by a related nutrition or health claim that does comply with the Regulation.

A 15-year transitional period will, however, apply in the case of products bearing trade marks or brand names that do not comply with the Regulation, where the brand name or trade mark existed before 1 January 2006.

NEXT STEPS

The Regulation is currently expected to be adopted formally by the Council in the autumn. It will come into force 20 days after it has been published in the EU's Official Journal. However, businesses will not have to comply with its requirements until six months after the Regulation's entry into force. There is also a number of transitional measures designed to allow businesses sufficient time to adapt to the new requirements. These vary depending, for example, on the type of claim made.

Footnotes

1 The proposal for a Regulation in this area was first made in July 2003. A Common Position was reached by Member States in the Council of Ministers in December 2005 see Food, feed and drink quarterly update March 2006 p.6.

2 A nutrition claim is defined in the draft Regulation as "any claim which states, suggests or implies that a food has particular nutrition properties due to the energy it provides, provides at a reduced or increased rate or does not provide and/or the nutrient or other substances it contains, contains in a reduced or increased proportion, or does not contain".

3 A health claim is defined in the draft Regulation as "any claim which states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health".

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.