General principles for all claims
Nutrition and health claims may be used in the labelling, presentation and advertising of foods placed on the market in the Community only if they comply with the provisions of this Regulation.
Without prejudice to Directives 2000/13/EC and 84/450/EEC, the use of nutrition and health claims shall not:
(a)
be false, ambiguous or misleading;
(b)
give rise to doubt about the safety and/or the nutritional adequacy of other foods;
(c)
encourage or condone excess consumption of a food;
(d)
state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general. Derogations in the case of nutrients for which sufficient quantities cannot be provided by a balanced and varied diet, including the conditions for their application, may be adopted in accordance with the procedure referred to in Article 24(2), taking into account the special conditions present in Member States;
(e)
refer to changes in bodily functions which could give rise to or exploit fear in the consumer, either textually or through pictorial, graphic or symbolic representations.
Conditions for the use of nutrition and health claims
1. By 19 January 2009, the Commission shall, in accordance with the procedure referred to in Article 24(2), establish specific nutrient profiles and the conditions, including exemptions, which shall be respected for the use of nutrition and health claims on foods and/or categories of foods.
These nutrient profiles established for food and/or certain categories of food, and the conditions for the use of nutrition or health claims with respect to the nutrient profiles, shall be laid down taking into account in particular:
(a)
the quantities of certain nutrients and other substances contained in the food, such as fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium;
(b)
the role and importance of the food (or of categories of foods) in the diet of the population in general or, as appropriate, of certain risk groups including children;
(c)
the overall nutritional composition of the food and the presence of nutrients that have been scientifically recognised as having an effect on health.
The nutrient profiles shall be based on scientific knowledge about diet and nutrition, and their relation to health.
In setting the nutrient profiles, the Commission shall request the Authority to provide, within 12 months, relevant scientific advice, focusing in particular on:
(i)
whether profiles should be set for food in general and/or categories of food;
(ii)
the choice and balance of nutrients to be taken into account;
(iii)
the choice of reference quantity/basis for profiles;
(iv)
the approach to the calculation of the profiles, and
(v)
testing of a proposed system.
In setting the nutrient profiles, the Commission shall carry out consultations with interested parties, in particular food business operators and consumer groups.
Nutrient profiles and their conditions of use shall be updated to take into account relevant scientific developments in accordance with the procedure referred to in Article 24(2).
2. By way of derogation from paragraph 1, nutrition claims referring to the reduction of fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium shall be allowed without reference to a profile for the specific nutrient/s for which the claim is made, provided they comply with the conditions laid down in this Regulation.
3. Beverages containing more than 1,2 % by volume of alcohol shall not bear:
(a)
health claims;
(b)
nutrition claims, other than those which refer to a reduction in the alcohol or energy content.
4. In the absence of specific Community rules regarding nutrition claims referring to the reduction or absence of alcohol or energy in beverages which normally contain alcohol, relevant national rules may apply in compliance with the provisions of the Treaty.
5. Foods or categories of foods other than those referred to in paragraph 3, for which nutrition or health claims are to be restricted or prohibited, may be determined in accordance with the procedure referred to in Article 24(2) and in the light of scientific evidence.
General conditions
1. The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled:
(a)
the presence, absence or reduced content in a food or category of food of a nutrient or other substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific data;
(b)
the nutrient or other substance for which the claim is made:
(i)
is contained in the final product in a significant quantity as defined in Community legislation or, where such rules do not exist, in a quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific data; or
(ii)
is not present or is present in a reduced quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific data;
(c)
where applicable, the nutrient or other substance for which the claim is made is in a form that is available to be used by the body;
(d)
the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the nutrient or other substance to which the claim relates, as defined in Community legislation or, where such rules do not exist, a significant quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific data;
(e)
compliance with the specific conditions set out in Chapter III or Chapter IV as the case may be.
2. The use of nutrition and health claims shall only be permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim.
3. Nutrition and health claims shall refer to the food ready for consumption in accordance with the manufacturer's instructions.
Scientific substantiation for claims
1. Nutrition and health claims shall be based on and substantiated by generally accepted scientific data.
2. A food business operator making a nutrition or health claim shall justify the use of the claim.
3. The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with this Regulation.
Nutrition information
The obligation and the modalities for providing information pursuant to Directive 90/496/EEC where a nutrition claim is made shall apply, mutatis mutandis , where a health claim is made, with the exception of generic advertising. However, the information to be provided shall consist of information in Group 2 as defined in Article 4(1) of Directive 90/496/EEC.
In addition and as the case may be, the amount(s) of the substance(s) to which a nutrition or health claim relates that does not appear in the nutrition labelling shall also be stated in the same field of vision of the nutrition information and be expressed in accordance with Article 6 of Directive 90/496/EEC.
In the case of food supplements, the nutrition information shall be provided in accordance with Article 8 of Directive 2002/46/EC.
