Nutrition and Health Claims Proposal - Latest Developments

On 16 July 2003, the European Commission published a proposal for a Regulation on nutrition and health claims (the "proposed Regulation"). The aim of the proposed Regulation is to ensure that consumers are better informed and to replace the different national provisions relating to such claims with common provisions at Community level. Under the proposed Regulation certain nutrition claims and health claims would be banned including health claims on beverages containing more than 1.2% by volume of alcohol. The proposed Regulation also contains provisions to allow in the future the banning or restricting of the use of nutrition or health claims on additional foods or categories of foods. In addition, set out in the proposed Regulation is the criteria with which permitted claims would have to comply.

The proposed Regulation is following the co-decision procedure and is therefore being considered by both the European Parliament (the "EP") and the Council of Ministers (which consists of representatives from Member States). On 26 May the EP completed its first reading in the co-decision procedure when it adopted its resolution on the proposed Regulation. At the time of writing, only a provisional version of the EP's resolution had been published. On 3 June 2005 the Council reached a political agreement on the content of the Regulation.

The Council and the EP have failed to reach an agreement on some of the key elements of the proposed Regulation. In particular in relation to the authorisation of health claims and whether foodstuffs should meet certain nutrient profiles (such as the amounts of fat, sugar and salt they contain) before they would be permitted to carry a claim.

The proposed Regulation would regulate the use of nutrition and health claims on foods. A nutrition claim is defined in the proposal 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". The Council has suggested amending the text so that it would only apply to claims that state, suggest or imply a food has "beneficial" nutrition properties. A health claim is defined as "any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health". Under the Food Labelling Directive (2000/13) attributing to foods any properties of prevention, treatment or cure of a human disease, or any reference to such properties is prohibited. The Commission is proposing to allow claims in relation to the "reduction of a disease risk factor". A reduction of disease risk claim is defined in the proposal as "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".

The Commission proposes that under the Regulation nutrition and health claims on beverages containing more than 1.2% volume of alcohol would be banned except nutrition claims referring to a reduction in the alcohol or energy content which would, however, still be permitted. The Commission's proposal also contains provisions which would allow additional foods or categories of foods to be selected in the future for which claims would either be prohibited or restricted. The Council supports these provisions but the EP has proposed that they are deleted.

The proposed Regulation contains a number of health claims which would be banned including: general well being claims; claims which make reference to the rate or amount of weight loss; and claims which make reference to psychological and behavioural functions. The EP opposes the banning of these claims. The Commission has confirmed that it is prepared to compromise on these provisions and that it can accept the EP's amendments subject to re-drafting. However, the Council has indicated that it supports a number of the bans set out in the Commission's original proposal, such as, health claims in relation to the rate or amount of weight loss. Furthermore, the Council has put forward additional health claims which it believes should also be banned, including claims which suggest that health could be affected by not consuming the food.

The Commission has proposed that under the Regulation a procedure would be introduced for establishing nutrient profiles which foods or certain categories of foods would need to respect in order to bear a nutrition or health claim. Nutrition claims which refer to the reduction in the amounts of fats, sugars and salt would be exempt from this requirement. It is intended that the nutrient profiles would be established, in particular, by reference to the amounts of fats, sugars and salt contained in a food. It is proposed that the nutrient profiles would be produced by the Commission assisted by Member States' representatives. The Commission would also be obliged to seek the advice of the European Food Safety Authority (the "EFSA") and consult with interested parties, in particular food business operators and consumer groups. The Council has debated at length the issue of nutrient profiles and some Member States have raised concerns about the lack of detail contained in the proposed Regulation on this point. However, in its political agreement reached on 3 June, the Council confirmed it supports for the establishment of nutrient profiles and the requirement that foods or certain categories of foods should respect these profiles in order to be permitted to bear a nutrition or health claim.

The EP rejected these provisions and voted to delete all references to nutrient profiles. The Commission has, in response to the EP's vote, confirmed that it considers nutrient profiles to be a central element of the proposed Regulation without which, it believes, the fundamental objectives of the proposed Regulation would be weakened.

Set out in the proposed Regulation are the general conditions and principles with which nutrition and health claims would be required to comply. In particular, claims could not be false, ambiguous or misleading and not give rise to doubt about the safety and/or the nutritional adequacy of other foods. In addition, the substance about which the claim is made would have to be present (or not present) in sufficient quantities in order to produce the effect claimed. Claims would also have to be scientifically substantiated.

Annexed to the proposed Regulation is a list of nutrition claims including "light/lite", "fat-free" and "high fibre". The conditions which the nutrition claims must comply with are also set out in Annex. For example, it is proposed that a product claiming "high fibre" would have to contain at least 6g fibre per 100g; or at least 3g per 100 kcal. The Council has suggested amending the text to clarify that only those nutrition claims set out in the Annex would be permitted.

The Commission has proposed that a health claim should only be permitted if it is first authorised under the Regulation. An evaluation of the claim would be undertaken by the EFSA with the public being given time to comment on the EFSA's opinion. However, certain long established health claims would be permitted without undergoing the authorisation process. Member States would be required to submit lists of these claims which would, following an evaluation by the EFSA, be entered into a Community list of permitted health claims. The Council supports the proposal for a Community authorisation process. However, the EP voted to delete all references to the authorisation process and, instead, for it to be replaced with a notification process. The Commission has responded to the EP's proposal by defending the authorisation approach arguing that it would make "life easier" for small and medium sized enterprises, whilst the notification approach would undermine fair competition and not provide sufficient protection to the consumer.

The Commission has proposed that under the Regulation, nutrition labelling, as set out in Directive 90/496, would be mandatory where a nutrition or health claim is made. Where a nutrition claim is made Group 1 information (energy value, protein, carbohydrates and fat) would be required. Where a health claim is made Group 1 and Group 2 information (sugars, saturates, fibre and sodium) would be required. In addition, where a claim is made in relation to a substance which does not appear in the nutrition labelling, the amount of this substance would also need to be indicated. The Council and the EP have accepted the nutrition labelling provisions put forward by the Commission. However, the EP has proposed that the nutrition information should also be given per package or portion together with an indication of the amount of the substance present, in the foodstuff bearing the claim, in relation to its daily reference intake values. The Commission has confirmed that it can accept part of the EP's proposed amendment subject to it being re-drafted.

Additional specific labelling requirements for health claim are set out in the Commission's proposal. In particular, it would be obligatory to include on the label the following information:

• a statement indicating the importance of a balanced diet and a healthy lifestyle
• the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect
• where appropriate, a statement addressed to persons who should avoid using the food
• where appropriate, a warning not to exceed quantities of the product that may represent a risk to health.

The EP is proposing that the statement indicating the importance of a balanced diet and a healthy lifestyle should only be required "where necessary". However, the Commission opposes this amendment. In addition, the Council provided alternative wording to replace "a warning not to exceed quantities of the product that may represent a risk to health" with "an appropriate warning for products that are likely to present a health risk if consumed to excess".

For reduction of disease risk claims a statement would be required that diseases have multiple risk factors and that altering just one of these risk factors may or may not have a beneficial effect.

The EP and the Council have put forward amendments to the Commission's proposed Regulation in respect of trademarks:

• the Council has proposed that a trademark, brand name or fancy name appearing in the labelling, presentation or advertising of a food may be construed as a nutrition or health claim without undergoing the authorisation procedures provided that it is accompanied by a related nutrition or health claim which complies with the proposed Regulation
• the EP has proposed that trademarks that comply with Council Directive 89/104 and Council Regulation 40/94 (the Community trademark) should fall outside the scope of the Regulation. Other types of commercial brand names, such as trade names, should also fall outside the scope of the Regulation provided that where they constitute a nutrition or health claim, they are accompanied by an additional permitted nutrition or health claim, whenever they are used in the labelling, advertising or presentation of food.

The Commission has confirmed that it cannot accept the amendment put forward by the EP.

The Council is expected to adopt its common position, based on its political agreement, in the Autumn. Once the Council has formally adopted its common position the dossier will be returned to the EP for further consideration. Upon receipt of the common position the EP, generally, has three months within which to consider the dossier and propose further amendments. At this stage of the co-decision procedure there are restrictions on the type of amendments that the EP can propose. However, the EP is permitted to put forward amendments which were included in its resolution adopted in May 2005, amendments to the new text proposed by the Council in its common position (unless they were already rejected by the EP in May) and amendments which are designed to reach a compromise between the Council and EP. It is important to note that a number of the EP's key amendments were only narrowly adopted in May 2005, particularly, in light of the fact that at the first stage of the co-decision procedure amendments are adopted within the EP by simple majority of votes cast but at the second stage of the co-decision procedure an absolute majority of the EP membership is required.

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