4.4.2006   

EN

Official Journal of the European Union

CE 80/43

(1)

An increasing number of foods labelled and advertised in the Community bear nutrition and health claims. In order to ensure a high level of protection for consumers and to facilitate their choice, products put on the market must be safe and adequately labelled.

(2)

Differences between national provisions relating to such claims may impede the free movement of foods and create unequal conditions of competition. They thus have a direct impact on the functioning of the internal market. It is therefore necessary to adopt Community rules on the use of nutrition and health claims on foods.

(3)

General labelling provisions are contained in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (3). Directive 2000/13/EC generally prohibits the use of information that would mislead the purchaser or attribute medicinal properties to food. This Regulation should complement the general principles in Directive 2000/13/EC and lay down specific provisions concerning the use of nutrition and health claims concerning foods to be delivered as such to the consumer.

(4)

This Regulation should apply to all nutrition and health claims made in commercial communications, including, inter alia, generic advertising of food and promotional campaigns, such as those supported in whole or in part by public authorities. It should not apply to claims which are made in non-commercial communications, such as dietary guidelines or advice issued by public health authorities and bodies, or non-commercial communications and information in the press and in scientific publications. This Regulation should also apply to trade marks and other brand names which may be construed as nutrition or health claims.

(5)

Non-beneficial nutrition claims are not covered by the scope of this Regulation; Member States intending to introduce national schemes relating to non-beneficial nutrition claims should notify such schemes to the Commission and to other Member States in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (4).

(6)

At international level the Codex Alimentarius has adopted General Guidelines on claims in 1991 and Guidelines for the use of nutrition claims in 1997. An amendment to the latter has been adopted by the Codex Alimentarius Commission in 2004. That amendment concerns the inclusion of health claims in the 1997 Guidelines. Due consideration is given to the definitions and conditions set in the Codex Guidelines.

(7)

The possibility of using the claim ‘low fat’ for spreadable fats provided for in Council Regulation (EC) No 2991/94 of 5 December 1994 laying down standards for spreadable fats (5) should be adapted to the provisions of this Regulation as soon as possible. In the meantime, Regulation (EC) No 2991/94 applies for the products it covers.

(8)

There is a wide range of nutrients and other substances including, but not limited to, vitamins, minerals including trace elements, amino acids, essential fatty acids, fibre, various plants and herbal extracts with a nutritional or physiological effect that might be present in a food and be the subject of a claim. Therefore, general principles applicable to all claims made on foods should be established in order to ensure a high level of consumer protection, give the consumer the necessary information to make choices in full knowledge of the facts, as well as creating equal conditions of competition for the food industry.

(9)

Foods promoted with claims may be perceived by consumers as having a nutritional, physiological or other health advantage over similar or other products to which such nutrients and other substances are not added. This may encourage consumers to make choices which directly influence their total intake of individual nutrients or other substances in a way which would run counter to scientific advice. To address this potential undesirable effect, it is appropriate to impose certain restrictions as regards the products bearing claims. In this context, factors such as the presence of certain substances, for example the alcohol content of the product or the nutrient profile of the product, are appropriate criteria for determining whether the product can bear claims. The use of such criteria at national level, whilst justified for the purpose of allowing consumers to make informed nutritional choices, is likely to result in barriers to intra-Community trade and should therefore be harmonised at Community level.

(10)

The application of nutrient profiles as a criterion would aim to avoid a situation where nutrition or health claims mask the overall nutritional status of a food product, which could mislead consumers when trying to make healthy choices in the context of a balanced diet. Nutrient profiles as provided for in this Regulation would be intended for the sole purpose of governing the circumstances in which claims may be made. They should be based on generally accepted scientific data relative to the relationship between diet and health. However, profiles should also allow for product innovation and should take into account the variability of dietary habits and traditions, and the fact that individual products may have an important role in the context of an overall diet.

(11)

The establishment of nutrient profiles should take into account the content of different nutrients and substances with a nutritional or physiological effect, in particular those such as fat, saturated fat, trans-fatty acids, salt/sodium and sugars, excessive intakes of which in the overall diet are not recommended, as well as poly- and mono-unsaturated fats, available carbohydrates other than sugars, vitamins, minerals, protein and fibre. When setting the nutrient profiles, the different categories of foods and the place and role of these foods in the overall diet should be taken into account. Exemptions from the requirement to respect established nutrient profiles may be necessary for certain foods or categories of foods depending on their role and importance in the diet of the population. These would be complex technical tasks and the adoption of the relevant measures should be entrusted to the Commission, taking into account the advice of the European Food Safety Authority.

(12)

Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (6) presented in a liquid form and containing more than 1,2 % by volume of alcohol are not considered as beverages under this Regulation.

(13)

There is a wide variety of claims currently used in the labelling and advertising of foods in some Member States relating to substances that have not been shown to be beneficial or for which at present there is not sufficient scientific agreement. It is necessary to ensure that the substances for which a claim is made have been shown to have a beneficial nutritional or physiological effect.

(14)

In order to ensure that the claims made are truthful, it is necessary that the substance that is the subject of the claim is present in the final product in quantities that are sufficient, or that the substance is absent or present in suitably reduced quantities, to produce the nutritional or physiological effect claimed. The substance should also be available to be used by the body. In addition, and where appropriate, a significant amount of the substance producing the claimed nutritional or physiological effect should be provided by a quantity of the food that can reasonably be expected to be consumed.

(15)

It is important that claims on foods can be understood by the consumer and it is appropriate to protect all consumers from misleading claims. However, since the enactment of Council Directive 84/450/EEC of 10 September 1984 concerning misleading and comparative advertising (7), the Court of Justice of the European Communities has found it necessary in adjudicating on advertising cases to examine the effect on a notional, typical consumer. In line with the principle of proportionality, and to enable the effective application of the protective measures contained in it, this Regulation takes as a benchmark the average consumer, who is reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors, as interpreted by the Court of Justice, but makes provision to prevent the exploitation of consumers whose characteristics make them particularly vulnerable to misleading claims. Where a claim is specifically aimed at a particular group of consumers, such as children, it is desirable that the impact of the claim be assessed from the perspective of the average member of that group. The average consumer test is not a statistical test. National courts and authorities will have to exercise their own faculty of judgment, having regard to the case-law of the Court of Justice, to determine the typical reaction of the average consumer in a given case.

(16)

Scientific substantiation should be the main aspect to be taken into account for the use of nutrition and health claims and the food business operators using claims should justify them.

(17)

A nutrition or health claim should not be made if it is inconsistent with generally accepted nutrition and health principles or if it encourages or condones excessive consumption of any food or disparages good dietary practice.

(18)

Given the positive image conferred on foods bearing nutrition and health claims and the potential impact these foods may have on dietary habits and overall nutrient intakes, the consumer should be able to evaluate their global nutritional quality. Therefore, nutrition labelling should be compulsory and should be extensive on all foods bearing health claims.

(19)

General nutritional labelling provisions are contained in Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs (8). According to that Directive, where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labelling should be compulsory. Where a nutrition claim is made for sugars, saturates, fibre or sodium, the information to be given should be that of Group 2 as defined in Article 4(1) of Directive 90/496/EEC. In order to achieve a high level of consumer protection, this obligation to provide the information of Group 2 should apply, mutatis mutandis, where any health claim is made, with the exception of generic advertising.

(20)

A list of permitted nutrition claims and their specific conditions of use should also be created based on the conditions for the use of such claims that have been agreed at national or international level and laid down in Community legislation. Any claim considered to have the same meaning for consumers as a nutrition claim included in the aforementioned list should be subject to the same conditions of use indicated therein. For example, claims related to the addition of vitamins and minerals such as ‘with …’, ‘restored …’, ‘added …’, or ‘enriched …’ should be subject to the conditions set for the claim ‘source of …’. The list should be regularly updated in order to take into account scientific and technological developments. Furthermore, for comparative claims it is necessary that the products being compared be clearly identified to the final consumer.

(21)

Conditions for claims such as ‘lactose-free’ or ‘gluten-free’, addressed to a group of consumers with specific disorders, should be dealt with in Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (9). In addition, that Directive provides the possibility that foodstuffs for normal consumption can indicate their suitability for use by these groups of consumers if they fulfil the conditions for such statement. Until the conditions for such statements are set at Community level, Member States may maintain or adopt relevant national measures.

(22)

Health claims should only be authorised for use in the Community after a scientific assessment of the highest possible standard. In order to ensure harmonised scientific assessment of these claims, the European Food Safety Authority should carry out such assessments.

(23)

There are many factors, other than dietary ones, that can influence psychological and behavioural functions. Communication on these functions is thus very complex and it is difficult to convey a comprehensive, truthful and meaningful message in a short claim to be used in the labelling and advertising of foods. Therefore, it is appropriate, when using psychological and behavioural claims, to require scientific substantiation.

(24)

In the light of Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (10) which prohibits, in the labelling, presentation and advertising of products covered by that Directive, any reference to the rate or amount of weight loss which may result from their use, it is considered appropriate to extend this restriction to all foods.

(25)

Health claims other than those referring to the reduction of disease risk, based on generally accepted scientific data, should undergo a different type of assessment and authorisation. It is therefore necessary to adopt a Community list of such permitted claims after consulting the European Food Safety Authority.

(26)

In order to keep up with scientific and technological developments, the list referred to above should be revised promptly whenever necessary. Such revisions are implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.

(27)

A varied and balanced diet is a prerequisite for good health and single products have a relative importance in the context of the total diet. Furthermore, diet is one of the many factors influencing the onset of certain human diseases. Other factors such as age, genetic predisposition, the level of physical activity, the consumption of tobacco and other drugs, environmental exposure and stress may all influence the onset of human diseases. Specific labelling requirements should therefore apply in respect of claims relating to the reduction of a disease risk.

(28)

In order to ensure that health claims are truthful, clear, reliable and useful to the consumer in choosing a healthy diet, the wording and the presentation of health claims should be taken into account in the opinion of the European Food Safety Authority and in the subsequent authorisation procedure.

(29)

In some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based. Other legitimate factors relevant to the matter under consideration should therefore be taken into account.

(30)

For the sake of transparency and in order to avoid multiple applications in respect of claims which have already been assessed, a public register containing the lists of such claims should be established and updated by the Commission.

(31)

In order to stimulate research and development within the agri-food industry, it is appropriate to protect the investment made by innovators in gathering the information and data supporting an application pursuant to this Regulation. This protection should however be limited in time in order to avoid the unnecessary repetition of studies and trials.

(32)

Given the particular nature of foods bearing claims, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products.

(33)

Adequate transitional measures are necessary to enable food business operators to adapt to the requirements of this Regulation.

(34)

Since the objective of this Regulation, namely to ensure the effective functioning of the internal market as regards nutrition and health claims whilst providing a high level of consumer protection, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(35)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (11),

(a)

Directive 89/398/EEC and Directives adopted on the basis thereof;

(b)

Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (12);

(c)

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (13).

(a)

the definitions of ‘food’, ‘food business operator’, ‘placing on the market’ and ‘final consumer’, set out in Articles 2, 3(3), 3(8) and 3(18) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (14), shall apply;

(b)

the definition of ‘food supplement’ set out in Directive 2002/46/EC shall apply;

(c)

the definitions of ‘nutrition labelling’, ‘protein’, ‘carbohydrate’, ‘sugars’, ‘fat’, ‘saturates’, ‘mono-unsaturates’, ‘poly-unsaturates’ and ‘fibre’ set out in Directive 90/496/EEC shall apply;

(d)

the definition of ‘labelling’ set out in Article 1(3)(a) of Directive 2000/13/EC shall apply.

1.

‘claim’ means any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics;

2.

‘nutrient’ means protein, carbohydrate, fat, fibre, sodium, vitamins and minerals listed in the Annex to Directive 90/496/EEC, and substances which belong to or are components of one of those categories;

3.

‘other substance’ means a substance other than a nutrient that has a nutritional or physiological effect;

4.

‘nutrition claim’ means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to:

5.

‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health;

6.

‘reduction of disease risk claim’ means 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;

7.

‘Authority’ means the European Food Safety Authority established by Regulation (EC) No 178/2002.

(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.

(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.

(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.

(a)

health claims;

(b)

nutrition claims, other than those which refer to a reduction in the alcohol or energy content.

(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:

(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.

(a)

a statement indicating the importance of a varied and balanced diet and a healthy lifestyle;

(b)

the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;

(c)

where appropriate, a statement addressed to persons who should avoid using the food; and

(d)

an appropriate warning for products that are likely to present a health risk if consumed to excess.

(a)

claims which suggest that health could be affected by not consuming the food;

(b)

claims which make reference to the rate or amount of weight loss;

(c)

claims which make reference to recommendations of individual doctors or health professionals and other associations not referred to in Article 11.

(a)

the role of a nutrient or other substance in growth, development and the functions of the body, or

(b)

psychological and behavioural functions; or

(c)

without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet,

(i)

based on generally accepted scientific data; and

(ii)

well understood by the average consumer.

(a)

The national competent authority shall:

(b)

the Authority shall:

(a)

the name and address of the applicant;

(b)

the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;

(c)

a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in this Regulation;

(d)

where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;

(e)

a copy of other scientific studies which are relevant to that health claim;

(f)

a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;

(g)

a summary of the application.

(a)

verify that the proposed wording of the health claim is substantiated by scientific data;

(b)

consider whether the wording of the health claim complies with the criteria laid down in this Regulation;

(c)

give advice on whether the proposed wording of the health claim is understandable and meaningful to the average consumer.

(a)

the name and address of the applicant;

(b)

the nutrient or other substance, or the food or the category of food, in respect of which a claim is to be made and its particular characteristics;

(c)

the recommended wording of the proposed health claim, including, as the case may be, the specific conditions of use;

(d)

where applicable, conditions or restrictions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and in advertising.

(a)

the nutrition claims and the conditions applying to them as set out in the Annex;

(b)

restrictions adopted in accordance with Article 4(5);

(c)

the authorised health claims and the conditions applying to them provided for in Articles 13(3), 14(1), 18(2), 20, 23(2) and 27(6) and the national measures referred to in Article 22(3);

(d)

a list of rejected health claims and the reasons for their rejection.

1.

the date the Commission authorised the health claim and the name of the original applicant that was granted authorisation;

2.

the fact that the Commission authorised the health claim on the basis of proprietary data;

3.

the fact that the health claim is restricted for use unless a subsequent applicant obtains authorisation for the claim without reference to the proprietary data of the original applicant.

(a)

the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and

(b)

the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and

(c)

the health claim could not have been authorised without the submission of the proprietary data by the prior applicant.

(a)

Member States shall communicate to the Commission, by … (16) at the latest, such nutrition claims and the national provisions or rules applicable, accompanied by scientific data in support of such provisions or rules;

(b)

the Commission shall, in accordance with the procedure referred to in Article 24(2), adopt a Decision concerning the use of such claims.

(a)

health claims which have been the subject of evaluation and authorisation in a Member State shall be authorised as follows:

Health claims not authorised under this procedure may continue to be used for six months following the adoption of the Decision;

(b)

health claims which have not been the subject of evaluation and authorisation in a Member State: such claims may continue to be used provided an application is made pursuant to this Regulation before … (23), health claims not authorised under this procedure may continue to be used for six months after a decision is taken pursuant to Article 17(3).