Rules on nutrition and health claims for food soon to be tightened

United Kingdom

The European Commission has published a proposed Regulation on nutrition and health claims made on foods, including food supplements. Under the proposal, no food product would be prohibited but claims on food products will have to be in compliance with the Regulation, with conditions for the use of nutrition and health claims, prohibition of certain claims and scientific evaluation of the use of claims in relation to the nutritional profile of foods. Current projections are that the Regulation will come gradually into force by 2005. The main proposals are as follows:

  • nutrition claims, such as "low fat" or "high fibre" will be subject to conditions set out in an Annex to the Regulation, e.g. "low energy" claims may only be made where the product contains less than 40 kcal/100g and less than 20 kcal/100ml
  • the Commission will make a positive list of well established health claims regarding the role of a nutrient in the body that will be permitted
  • novel claims which are not well established will require individual scientific evaluation by the European Food Safety Authority and pre-marketing approval
  • vague claims referring to general well-being, e.g. "helps your body to resist stress", or claims making reference to psychological and behavioural functions, e.g. "improves your memory", will not be permitted
  • slimming or weight control claims will not be allowed, e.g. "halves/reduces your calorie intake"
  • reference to and endorsement by doctors or health professionals will not be permitted
  • health claims on alcoholic beverages above 1.2% will not be allowed except claims referring to a reduction in alcohol or energy content
  • the Commission will evaluate nutritional profiles of foods with a view to restricting the use of claims on some foods based on their nutritional profile, subject to exemptions for certain claims on foods depending on their role and importance in the diet of the population.

The proposed Regulation must now pass through the European legislative process. The proposal notes that consultations with Member States and stakeholders on a discussion paper and later on a preliminary draft proposal have already been held and, therefore, further consultation is not planned. There may be, nevertheless, further opportunities to have an influence in relation to the detail of the proposals.

Nutrition Claims and Conditions applying to them

The Annex to the proposed Regulation sets out the various categories of nutrition claims and specifies the conditions that will apply to them as follows:

Low energy – food must contain less than 40 kcal (170 kJ)/100g and less than 20kcal (80 kJ)/100ml.

Energy–Reduced – energy value reduced by at least 30% with an indication of the characteristic(s) which make(s) the food reduced in its total energy value.

Energy free – contains less than 4kcal (17 kJ)/100ml.

Low fat – no more than three 3g of fat per 100g or 1.5g of fat per 100ml.

Fat free – contains no more than 0.5g of fat per 100g or 100ml. "X% fat-free" prohibited.

Low saturated fat – contains no more than 1.5g of saturates per 100g for solids or 0.75g of saturates per 100ml for liquids and saturated fat must not provide more than 10% of energy.

Saturated fat free- contains no more than 0.1g of saturated fat per 100g or 100ml.

Low sugars - contains no more than 5g of sugars per 100g or 100ml.

Sugars free- contains no more than 0.5g of sugars per 100g or 100ml.

With no added sugars – does not contain any added mono– or disaccharides or any other food used for its sweetening properties.

Low sodium/salt- contains no more than 0.12g of sodium or the equivalent value for salt per 100g or per 100ml.

Very low sodium/salt – contains no more than 0.04g of sodium or the equivalent value for salt per 100g or per 100ml.

Sodium-free or salt-free- contains no more than 0.005g of sodium or the equivalent value for salt per 100g.

Source of fibre - contains at least 3g of fibre per 100g or at least 1.5g of fibre per 100kcal.

High fibre - contains at least 6g of fibre per 100g or at least 3g of fibre per 100kcal.

Source of protein - at least 12% of the energy value of the food is provided by protein.

High protein - at least 20% of the energy value of the food is provided by protein.

Natural source of vitamins and/or minerals – contains at least 15% of the recommended daily allowance specified in the Annex of Council Directive 90/496/EEC per 100g or 100ml.

Enriched or fortified vitamins and/or minerals – contains vitamins and/or minerals in at least a significant amount as defined in the Annex of Directive 90/496/EEC.

High Vitamins and/or minerals – contains at least twice the value of that specified for "source of vitamins and minerals".

Contains (name of the nutrient or other substance) – product compliance with all the applicable provisions of the Regulation.

Increased (name of the macronutrient) – meets the conditions for the claim "source of" and the increase in content is at least 30% compared to a similar product.

Reduced (name of the nutrient) – reduction in content is at least 30% compared to a similar product, except for micronutrients where a 10% difference in the reference values as set in Council Directive 90/496/EEC shall be acceptable.

Light/lite- meets conditions as set for "reduced" and the claim is accompanied by an indication of the characteristic(s) which make the food "light" or "lite".

In most of the above categories it is also permitted to use the term "naturally" as a prefix to the claim where the foods have the specific characteristic naturally, for example, naturally low in energy. The conditions apply to claims of the above specific categories and any claim likely to have the same meaning for a consumer.

Health claims relating to human diseases

This proposal for a Regulation maintains the prohibition on claims referring to the prevention, treatment or cure of a human disease. However a difference between "prevention" and "reduction of a disease risk factor" is made and a derogation is provided in Article 13 of the proposed Regulation. It is proposed that reduction of disease risk claims may be made where they have been authorised in accordance with the Regulation but the label would be required to also bear a statement indicating that diseases have multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.

It is acknowledged that diet and certain foods can make important contributions to the support and maintenance of health, and that diet and certain foods can play a role in the management of certain disease risk factors. It seems that claims referring to the reduction of the risk of disease will be allowed by authorisation "if they are based on sufficient and recognised scientific findings and if they are tested and confirmed by an independent body within the European Union". Health claims will be assessed by the European Food Safety Authority according to an authorisation procedure laid down in the proposed Regulation and the final decision will be included in a "register".

Whilst the commission does not envisage any problems with this authorisation regime being implemented under their existing budget and human resources, it can only be presumed, at least in the period just after the directive comes fully into force, that food products will experience some delays in getting to market if it is necessary to go through this process.

Summary

There are currently no legally enforceable conditions required for nutritional claims such as "light" or "X% fat free" other than a general duty not to mislead the consumer. The proposed directive aims to harmonise the use of these claims with required conditions for their use. This will have the benefit of providing a level playing field across Europe so assisting the marketing of products across borders and providing clear guidelines for when a nutritional claim may be made. The directive also held back from cross referencing the claims, eg the making of a low fat claim is not reliant on the salt content of a product. This would have been too restrictive on the market and difficult to enforce. As the commission has pointed out there is no such thing as a "bad food" only "bad diets".

The directive follows increased pressure from consumer groups on claims which are factually correct but which are perceived to be misleading by implication. The example of the claim "90% fat free" used to promote a product as a healthy option is often referred to. This has been a grey area for the market with tight regulations for certain claims and guidance only for the rest.

Nevertheless the drawbacks of the directive are clear, it is possible that consumer choice will be reduced in certain areas, for example where one product is lower in fat than another in that product range it will be increasingly difficult for producers to advertise this fact where the strict boundaries for the use of certain claims are not met. The fact that the directive has been extended even to the vague well used marketing adage of "light or lite" will significantly restrict producers in the more borderline cases of advertising the differences between their products.

The directive illustrates a marked trend in increased regulation in the food arena and in particular in relation to the labelling of food.

For a copy of the proposed Regulation please click here: http://www.europa.eu.int/eur-lex/en/com/pdf/2003/com2003_0424en01.pdf - This will open a PDF in a new window.

For further information on the content and implications of the proposed Regulation, please contact:

Jessica Burt on +44 (0)20 7367 3589, email [email protected]; or Natalie Wood on + 44 (0)20 7367 2523, email [email protected]