EU: Proposed Legislation on Health Claims

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EU: Proposed legislation on health claims

On 16 July, the European Commission adopted a proposed regulation on nutrition and health claims intended to better inform consumers and harmonise the market.

On 16 July 2003, the European Commission today adopted a proposed Regulation on nutrition and health claims made on foods, including food supplements. As consumers have become increasingly concerned about what they eat and how this affects their health, the food industry has responded by providing more detailed nutrition labelling and often making claims about the beneficial effects of certain foods. The existing EU rules on labelling(1) and nutrition labelling(2), which do not define conditions for the use of nutrition claims and do not allow health claims to be made, are often not properly enforced. Consumers can therefore be misled by claims that have not been properly substantiated. The proposed Regulation will give legal security and address these issues by specifying the conditions for the use of nutrition and health claims, prohibiting certain claims and scientifically evaluating the use of claims in relation to the nutritional profile of foods. No food product will as a consequence be prohibited but claims on food products will have a true meaning for the consumer.

David Byrne, Commissioner for Health and Consumer Protection, underlined the importance of the proposed Regulation. “The implementation of this proposal will allow both industry and consumers to benefit from the correct use of claims. Consumers will receive accurate and meaningful information while food producers will be able to use serious and scientifically substantiated claims as a marketing tool without being drowned out by the many unsubstantiated and inaccurate claims that currently exist on the market. Furthermore, the creation of a Regulation at EU-level will enable operators to compete on a fair and equal basis in all EU Member States.”

Nutrition claims: What am I eating?

Nutrition claims, such as “low fat” or “high fibre”, refer to what is or is not contained in the product. There are currently no legally binding conditions regulating the use of these claims. The proposed Regulation aims to harmonise the use of such claims so that products claiming to be for example “high fibre” have a defined minimum amount of fibre per a defined unit (eg 6 g per 100g). Furthermore, some claims may be misleading. For example a product claiming to be “90% fat free” may be stating correct facts but it is still misleading since it implies that it has a low fat content while in reality 10% fat represents a fairly high fat content.

The list below gives the nutrition claims foreseen by the legislation:

Low energy

Energy-reduced

Energy-free

Low fat

Fat-free

Low saturated fat

Saturated fat free

Low sugars

Sugars-free

With no added sugars

Low sodium / salt

Very low sodium / salt

Sodium-free or salt-free

Source of fibre

High fibre

Source of protein

High protein

Natural source of vitamins and/or minerals

Enriched or fortified in vitamins and/or minerals

High vitamins and/or minerals

Contains (name of the nutrient or other substance)

Increased (name of the macronutrient)

Reduced (name of the nutrient)

Light/lite

Health claims: What does this food do to me?

Health claims refer to what a food or a food component does to the consumer. It is currently prohibited to make any claims that are misleading to consumers. Many health claims regarding the role of a nutrient in the body are uncontroversial and well established, such as the claim that calcium plays an important role in strengthening the teeth and bones.

Within three years of the Regulation entering into force, the Commission will make a positive list of such well established claims that will be permitted. A distinction is made between these well established claims and more novel claims, such as “whole grain may keep your heart healthy/may reduce the risk of heart disease”. For the latter type, individual scientific evaluation and pre-marketing approval will be required. Only claims that can be substantiated will be permitted on the EU level after being evaluated by the European Food Safety Authority. Food operators will thus benefit from the possibility to make a meaningful claim, including promoting a product's possible impact to reduce the risk of diseases. Consumers will be able to rely on clear and verifiable claims.

It clearly follows from this new approach to health claims, that any information about foods and their nutritional value used in labelling, marketing and advertising which is not clear, accurate and meaningful and cannot be substantiated will not be permitted. This concerns vague claims referring to general wellbeing (eg "helps your body to resist stress", "preserves youth") or claims making reference to psychological and behavioural functions (eg “improves your memory” or “reduces stress and adds optimism”). Slimming or weight control claims will not be allowed (e.g. "halves/reduces your calories intake")(3). Reference to and endorsement by doctors or health professionals will not be permitted as they might e.g. suggest that not eating the specified food might lead to health problems. Health claims on alcoholic beverages above 1.2 % will also not be allowed since alcohol is known to entail other health and social problems. Only claims referring to a reduction in alcohol or energy content, will be allowed.

Nutritional profiles: “good diets” and “bad diets”

The basic principle in nutrition is that there are no “good foods” and “bad foods” but rather “good diets” and “bad diets”. In a long-term varied diet all foods can be included. However, foods bearing a claim will automatically be perceived as "good" foods by consumers. Furthermore, claims about the benefit of consuming a certain product may lead consumers to eat too much of something that should only make up a small part of a good diet. It is therefore necessary to restrict the use of claims on some foods based on their nutritional profile. The amount of total fat, saturates, sugar or salt are criteria for the nutritional profile of products, since scientific evidence shows a link between over-consumption of such nutrients and some chronic diseases (in particular WHO report of March 2003).

Within 18 months of adoption of the Regulation, the Commission will evaluate nutritional profiles in close consultation with stakeholders and based on the opinion of the European Food Safety Authority (EFSA) and in conjunction with the Member States in the Standing Committee for the Foodchain and Animal Health. Exemptions may be necessary for certain claims on foods depending on their role and importance in the diet of the population.

The draft Regulation will need the approval of the European Parliament and the Council of Ministers. It is foreseen to come gradually into force by 2005.

Although this planned legislation has been well received by European consumer associations, it was criticised by the CIAA (Confederation of the food and drinks industries of the EU) whose chairman Jean Martin declared: "While we support the principle of establishing a harmonised regulatory framework encompassing all types of claims, including disease risk reduction claims, we strongly oppose any a priori prohibition of claims or exclusion of categories of foods from the possibility of communicating a nutrition or health benefit to the consumer. All claims that are science based and well understood by the consumer should be allowed".

The complete text of the proposed legislation is available at:

Box: Nutrition claims which could possibly be applied to tomato products and conditions applying to them

Natural source of vitamins and/or minerals

A claim that a food is a natural source of vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 15% of the recommended daily allowance specified in the Annex of Council Directive 90/496/EEC per 100 g or 100 ml.

Enriched or fortified in vitamins and/or minerals

A claim that a food is enriched or fortified vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains the 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

A claim that a food is high in vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least twice the value of “source of vitamins and minerals”. In case of foods naturally high in vitamins and/or minerals, the term “naturally” may be used as a prefix to this claim.

Contains (name of the nutrient or other substance)

A claim that a food contains a nutrient or another substance, or any claim likely to have the same meaning for the consumer, may only be made where the product complies with all the applicable provisions of this Regulation. In the case of foods that naturally contain the named nutrient or other substance, the term “naturally” may be used as a prefix to this claim.

Increased (name of the macronutrient)

A claim stating that the content in one or more nutrients has been increased, and any claim likely to have the same meaning for the consumer, may only be made where the product meets the conditions for the claim “source of” and the increase in content is at least 30% compared to a similar product.

(1)Directive 2000/13/EC on the labelling, presentation and advertising of foods

(2)Directive 90/496/EEC on nutrition labelling on foodstuffs

(3)Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction