Proposed changes to food labelling requirements - Article 1B

The discussion paper on Nutrition Claims and Functional Claims (SANCO/1341/2001) and responses to it.

The European Community has already adopted detailed rules on labelling (Directive 2000/13/EC on the Labelling, Presentation and Advertising of Foodstuffs) and Nutrition Labelling (Council Directive 90/496/EEC on Nutritional Labelling of Foodstuffs).

The White Paper on Food Safety (January 2000) announced its intention of proposing an amendment to the Labelling Directive 2000/13/EC with the aim of increasing transparency and consumer choice. Particular reference was made in the White Paper to the abolition of the “25% Rule which provides that, where a compound ingredient (i.e. an ingredient that is itself derived from several ingredients) is less than 25% of the weight of the ingredients used, then a label can simply identify the compound ingredient and it is not necessary to list the component ingredient (although additives used in the compound ingredient have to be declared). The issues of the labelling of allergens and whether specific provisions should be brought in to govern functional and nutritional claims were also highlighted as areas for review.

Discussion Paper on Functional and Nutritional Claims

A major complication for many years has been the issue of claims used on the labels of certain foods to promote the product (e.g. x percent fat-free, or “diet). Certain countries have adopted national provisions to cover these claims. The Discussion Paper on Nutritional Nutrition Claims and Functional Claims aims to present the main issues that have emerged in discussions on the harmonisation of bills on nutrition and functional claims and invited comments from all interested parties on:

• definitions of the various terms used, i.e. “claim itself and “nutritional claims and “functional claims;
• the relevant conditions under which such claims may be made;
• types of evaluation and authorisation systems for such claims

A broad range of proposals have been brought together for discussion within the Paper. The various heads of debate touched upon were as follows:

“Claims:

One of the heads of discussion concerns whether to roll all nutritional and functional claims together as per the Codex Alimentarius into one general definition of “claim - the Codex Alimentarius defines this as “any representation which states, suggests or implies that a food has particular characteristics relating to its origin, nutritional properties, nature, production, processing, composition or any other quality.

Nutritional Claims:
Definition:
Nutritional claims have now extended beyond the remit of Council Directive 90/496/EEC to include other substances, such as fibre, anti-oxidants (lutein, lycopene) and lactic bacteria, which do not have a nutritional effect but rather a physiological one and the directive should be expanded to take this into account.

Conditions/Criteria:

Consideration of Characteristics: Whether, in nutritional claims, there should be some criteria or guideline by which the most commonly used nutrition claims (such as “low, “rich, “light, etc) may be used, i.e. to include an indication of the characteristics which make the food what is, in fact, claimed. As this type of claim often refers to very different components of the food - it could refer to less fat, less sugar, or less caffeine, in the context of the “light claim. Whether, rather than stating “x percent fat-free, there should actually be stated how much fat remains in the product. Codex Alimentarius states that a minimum difference of 25% should be used in connection with the terms “increased or “reduced and the end product should be clarified.

Reference: Whether comparative nutritional claims should have a reference product with which it might be compared. For example, For comparative claims there should be conditions set, which could include the following:

• the foods being compared should be different versions of the same food or similar foods,
• a statement of the amount of difference in the energy value or nutrient content should be given,
• the following information should appear in close proximity to the comparative claim (i) the amount of difference, expressed as a percentage, (ii) the identity of the food(s) to which the food is being compared.

Diet:Whether it is impossible to consider any food separately from the overall diet of the consumer. Whether there should be a distinct category of foods called “functional foods. Against this it has been argued that every food has a function and there is no good justification for creating a specific category of “functional foods.

Set Level:It is suggested that claims on vitamins and minerals should only be allowed if they are present in significant amounts, i.e. a criteria of, for example, 15% of the recommended daily allowance (RDA).

Functional claims: Definition: Functional claims relating to beneficial effects of a nutrient on certain normal bodily functions (White Paper). The Codex Alimentarius states in the guidelines that a nutrient claim should describe the physiological role of the nutrient in growth, development and normal functions of the body i.e. “calcium aids in the development of strong bones and teeth. The Commission states that it is not aware of other serious alternatives to the Codex definition.

Conditions/Criteria:

Diet: The claim must be stated in the context of the total diet and should not encourage over consumption of a given food product. The claim must be communicated in such a way as to assist consumer understanding of the basis of the claim.

Set Level: The food for which a claim is made must be at least a significant source of the nutrient in question in the case where increased consumption is recommended. Likewise, the food for which a claim is made must be low in, reduced in, or free of the nutrient in question where reduced consumption is recommended.

Consideration of Characteristics: Where a particular substance has been eliminated in order to reduce the risk of a negative effect, the degree of elimination must be controlled and it must be demonstrated that such elimination has not modified the normal nutritional value or other related properties of the food (i.e. “lactose-free).

Review: There must be substantiated control of the chemical identity and the quality of the nutrient for which the claim is made. The claim must be based on generally accepted scientific evidence that is kept under regular review.

Questions of Authorisation of Functional and Nutritional Claims:

• Whether there should be a pre-marketing approval necessary, or a list compiled of approved claims for each nutrient or substance, and possibly their specific wording.
• If a notification procedure to the competent authorities of Member States should be brought about to facilitate monitoring and allow a prompt reaction, where necessary. Attached to the Discussion Paper is a list of tables stating the claims and conditions warranting the claims for different nutrients (and other substances) by both the Codex Alimentarius and conditions in use in some Member States. The objectives of the Commission in issuing both the proposal for a directive amending the labelling requirements for food ingredients (please see associated article on Law-Now) and this Discussion Paper are laudable, in that they hope to promote harmonisation and the free movement of goods as well as increasing consumer choice and confidence. The industry response to the Discussion Paper on Nutrition Claims and Functional Claims applauded the intentions of harmonisation and increased information, but generally regarded the Paper as a missed opportunity for addressing and developing a comprehensive European strategy for health related claims with a harmonised framework. Industry on the whole welcomed the prospect of a set criteria by which claims might be clearly stated and that any rules on the use of such terms as may be proposed must be applied equally to all foods, regardless of their composition, the type of outlet from which they are sold, or whether or not they are pre-packed, and should be efficient, transparent, proportionate and predictable. There are reservations within industry about the use of a regulatory prior-approval process for any claim. However, it was commented that a process for obtaining pre-marketing advice addressing the legality and substantiation of certain claims, such as that offered by the UK Joint Health Claims Initiative (JHCI) may be helpful to consumers, industry and enforcement authorities alike. There is no wish by industry to get bogged down by the minutiae; however, a clear regulated framework would be welcome. On the basis of the comments received from consumers and industry regarding this Discussion Paper, the Commission will prepare a legislative proposal on nutritional and functional claims towards the end of 2001 or early 2002. For further information, please contact Jessica Burt by e-mail at [email protected] or by telephone on +44 (0)20 7367 3000.