4.4.2006   

EN

Official Journal of the European Union

CE 80/1

(1)

Subsequent to the adoption of Decision No 1229/2003/EC of the European Parliament and of the Council of 26 June 2003 laying down a series of guidelines for trans-European energy networks (3), the need has arisen to integrate fully the new Member States accession and candidate countries in those guidelines and to adapt further, as appropriate, those guidelines to the new proximity policy of the European Union.

(2)

The priorities for trans-European energy networks stem from the creation of a more open and competitive internal energy market as a result of the implementation of Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity (4) and of Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas (5). Those priorities follow the conclusions of the Stockholm European Council of 23 and 24 March 2001 concerning the development of the infrastructure needed for the operation of the energy market. A special effort should be undertaken to achieve the objective of making greater use of renewable energy sources as a contribution to further a sustainable development policy. However, this should be achieved without creating disproportionate disturbances to the normal market equilibrium. Full account should also be taken of the objectives of the Community's transport policy and specifically the opportunity to reduce road traffic by using pipelines.

(3)

This Decision serves to move closer towards the target for the level of electricity interconnection between Member States which was agreed by the Barcelona European Council of 15 and 16 March 2002, and thus improve network reliability and integrity, ensure that there is security of supply and that the internal market functions properly.

(4)

As a rule, the construction and maintenance of energy infrastructure should be subject to market principles. This is also in line with the common rules for the completion of the internal market in energy and the common rules on competition law which aim at the creation of a more open and competitive internal energy market. Community financial aid for construction and maintenance should therefore remain highly exceptional. Those exceptions should be duly justified.

(5)

Energy infrastructure should be constructed and maintained so as to enable the internal energy market to operate efficiently, with due regard to existing procedures for consulting the people affected, without detracting from strategic and, where appropriate, universal service criteria and public service obligations.

(6)

In the light of potential synergies between natural gas networks and olefin networks, due importance should be given to the development and integration of olefin networks in order to meet the olefin gas consumption needs of the industries in the Community.

(7)

The priorities for trans-European energy networks also stem from the growing importance of the trans-European energy networks for securing and diversifying the Community's energy supplies, incorporating the energy networks of the new Member States, accession and candidate countries, and ensuring the coordinated operation of the energy networks in the Community and in neighbouring countries after consulting the Member States concerned. Indeed neighbouring countries to the Community play a vital role in the Community's energy policy. They supply a major part of the Community's requirements of natural gas, are key partners for the transit of primary energy to the Community and will progressively become more important players in the Community,s internal gas and electricity markets.

(8)

Among the projects relating to trans-European energy networks, it is necessary to highlight the priority projects, which are very important for the operation of the internal energy market or the security of energy supply.

(9)

The procedure for identifying projects of common interest in the context of trans-European energy networks should ensure the smooth application of Council Regulation (EC) No 2236/95 of 18 September 1995 laying down general rules for the granting of Community financial aid in the field of trans-European networks (6). That procedure should distinguish two levels: a first level establishing a restricted number of criteria for the identification of such projects, and a second level describing the projects in detail, referred to as ’specifications’.

(10)

Priority for funding pursuant to Regulation (EC) No 2236/95 should be given to projects of European interest, i.e. projects of common interest referred to in this Decision and included in the axes for priority projects set out in this Decision.

(11)

Member States, when submitting projects under the relevant Community financial instruments, should give appropriate priority to projects covered by Annex I that meet the criteria of this Decision.

(12)

Since the project specifications are liable to change, they can only be given by way of indication. The Commission should therefore be empowered to update them. Since the projects may have considerable political, environmental and economic implications, it is important to find the appropriate balance between legislative oversight and flexibility in determining projects that deserve potential Community support.

(13)

Where appropriate for certain priority projects, or sections of priority projects, or groups of priority projects in order to improve their preparation and implementation for the duration of the priority projects concerned, the Commission, in consultation with the Member States involved, should ensure and coordinate cooperation with users and operators, with a view to ensuring that the necessary monitoring is carried out in order to keep the Community informed of progress. In so doing, the Commission should consult, together with the Member States concerned, operators, users, regional and local authorities and representatives of civil society with a view to gaining fuller knowledge of demand for transmission services, of the constraints and of the service parameters required to optimise the use of the infrastructure concerned.

(14)

Member States should be invited to coordinate implementation of certain projects, in particular cross-border projects or sections of cross-border projects.

(15)

A more favourable context for the development and construction of trans-European energy networks should be created, mainly by providing stimulus for technical cooperation between the entities responsible for networks, by facilitating the implementation of authorisation procedures applicable for network projects in the Member States in order to reduce delays and by mobilising as appropriate the Funds, instruments and financial programmes of the Community available for network projects. The Community should support Member States' measures taken in pursuit of that objective.

(16)

Since the budget allocated to the trans-European energy networks is mainly intended to finance feasibility studies, it is the Community Structural Funds, financial programmes and instruments that could enable, if necessary, funding to be provided for such, in particular interregional, interconnection networks.

(17)

The identification of projects of common interest, their specifications and priority projects should be without prejudice to the results of the environmental impact assessment of the projects and of the plans or programmes.

(18)

The measures necessary for the implementation of this Decision 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 (7).

(19)

The Commission should periodically draw up a report on the implementation of this Decision.

(20)

Since this Decision covers the same subject matter and scope as Council Decision 96/391/EC of 28 March 1996 laying down a series of measures aimed at creating a more favourable context for the development of trans-European networks in the energy sector (8) and Decision No 1229/2003/EC, those two Decisions should be repealed,

1.

in electricity networks, to:

2.

in gas networks (transporting natural gas or olefin gases), to:

(a)

encouraging the effective operation and development of the internal market in general and of the internal energy market in particular, while encouraging the rational production, transportation, distribution and use of energy resources and the development and connection of renewable energy resources, so as to reduce the cost of energy to the consumer and contribute to the diversification of energy sources;

(b)

facilitating the development and reducing the isolation of the less-favoured and island regions of the Community, thereby helping to strengthen economic and social cohesion;

(c)

reinforcing the security of energy supplies, for example by strengthening relations with third countries in the energy sector in the mutual interest of all parties concerned, in particular in the framework of the Energy Charter Treaty and cooperation agreements concluded by the Community;

(d)

contributing to sustainable development and protection of the environment, inter alia, by involving renewable energies and by reducing the environmental risks associated with the transportation and transmission of energy.

1.

for both electricity and gas networks:

2.

for electricity networks:

3.

for gas networks:

(a)

the identification of projects of common interest referred to in Article 6;

(b)

the creation of a more favourable context for development of those networks.

(a)

the projects fall within the scope of Article 2;

(b)

the projects meet the objectives and priorities for action set out in Articles 3 and 4 respectively;

(c)

the projects display potential economic viability.

2.

(a)

they shall have a significant impact on the competitive operation of the internal market; and/or

(b)

they shall strengthen security of supply in the Community; and/or

(c)

they shall result in an increase in the use of renewable energies.

(a)

technical cooperation between the entities responsible for the trans-European energy networks, in particular for the proper functioning of the connections mentioned in Annex II, points 1, 2 and 7;

(b)

facilitating implementation of the authorisation procedures for projects on trans-European energy networks in order to reduce delays;

(c)

the provision of assistance to the projects of common interest from Community Funds, instruments and financial programmes applicable to those networks.

4.4.2006   

EN

Official Journal of the European Union

CE 80/27

(1)

There is a wide range of nutrients and other ingredients that might be used in food manufacturing, including, but not limited to, vitamins, minerals including trace elements, amino acids, essential fatty acids, fibre, various plants and herbal extracts. Their addition to foods is regulated in Member States by differing national rules that impede the free movement of these products, create unequal conditions of competition and thus have a direct impact on the functioning of the internal market. It is therefore necessary to adopt Community rules harmonising national provisions relating to the addition of vitamins and minerals and of certain other substances to foods.

(2)

This Regulation aims to regulate the addition of vitamins and minerals to foods and the use of certain other substances or ingredients containing substances other than vitamins or minerals that are added to foods or used in the manufacture of foods under conditions that result in the ingestion of amounts greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers. In the absence of specific Community rules regarding prohibition or restriction of use of substances or ingredients containing substances other than vitamins or minerals under this Regulation or under other specific Community provisions, relevant national rules may apply without prejudice to the provisions of the Treaty.

(3)

Some Member States require the mandatory addition of some vitamins and minerals to certain ordinary foods, for reasons dictated by public health considerations. These reasons may be pertinent at national or even regional level, but would not currently justify harmonisation of the mandatory addition of nutrients across the Community. However, if and when this became appropriate, such provisions could be adopted at Community level. Meanwhile, it would be useful for information on such national measures to be compiled.

(4)

Vitamins and minerals may be added to foods voluntarily by food manufacturers or must be added as nutritional substances as provided for by specific Community legislation. They may also be added for technological purposes as additives, colourings, flavourings or other such uses including authorised oenological practices and processes provided for by relevant Community legislation. This Regulation should apply without prejudice to the specific Community rules concerning the addition to or use of vitamins and minerals to specific products or groups of products or their addition for purposes other than those covered by this Regulation.

(5)

Given that detailed rules on food supplements containing vitamins and minerals have been adopted by 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 (3), provisions of this Regulation regarding vitamins and minerals should not apply to food supplements.

(6)

Vitamins and minerals are added to foods by manufacturers for a number of purposes including to restore their content where this has been reduced during manufacturing, storage or handling procedures or to provide a similar nutritional value to foods for which they are intended as alternatives.

(7)

An adequate and varied diet can, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities such as those established and recommended by generally acceptable scientific data. However, surveys show that this ideal situation is being achieved neither for all vitamins and minerals nor by all groups of the population across the Community. Foods to which vitamins and minerals have been added appear to make an appreciable contribution to the intake of these nutrients and as such may be considered to make a positive contribution to overall intakes.

(8)

Some nutrient deficiencies, although not very frequent, can be demonstrated to exist at present in the Community. Changes in the socio-economic situation prevailing in the Community and the life styles of different groups of the population have led to different nutritional requirements and to changing dietary habits. This in turn has led to changes in the energy and nutrient requirements of various groups of the population and to intakes of certain vitamins and minerals for these groups that would be below those recommended in different Member States. In addition, progress in scientific knowledge indicates that intakes of some nutrients for maintaining optimal health and well-being could be higher than those currently recommended.

(9)

Only vitamins and minerals normally found in and consumed as part of the diet and considered essential nutrients should be allowed to be added to foods although this does not mean that their addition thereto is necessary. Controversy as to the identity of these essential nutrients that could potentially arise should be avoided. It is therefore appropriate to establish a positive list of these vitamins and minerals.

(10)

The chemical substances used as sources of vitamins and minerals which may be added to foods should be safe and also be bio-available i.e. available to be used by the body. For this reason a positive list of these substances should also be established. Such substances that have been approved by the Scientific Committee on Food in an opinion expressed on 12 May 1999, on the basis of the above criteria of safety and bio-availability, and can be used in the manufacture of foods intended for infants and young children, other foods for particular nutritional uses or food supplements should appear in this positive list. Although sodium chloride (common salt) does not appear among the substances in this list, it may continue to be used as an ingredient in the preparation of food.

(11)

In order to keep up with scientific and technological developments, it is important to revise the above lists promptly, when necessary. Such revisions would be implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.

(12)

Foods to which vitamins and minerals are added are, in most cases, promoted by manufacturers and may be perceived by consumers as products having a nutritional, physiological or other health advantage over similar or other products without such nutrients added. This may induce consumer choices that may be otherwise undesirable. To counter this potential undesirable effect, it is considered appropriate to impose some restrictions on the products to which vitamins and minerals can be added, in addition to those that would result naturally from technological considerations or become necessary for safety reasons when maximum limits of vitamins and minerals in such products are set. The content in the product of certain substances, such as alcohol, would, in this context, be an appropriate criterion for not allowing vitamins and minerals to be added to it. Any derogation from banning the addition of vitamins and minerals to alcoholic beverages should be limited to protecting traditional wine recipes, with the relevant products being notified to the Commission. No claims about any nutritional or health benefits of the additions should be made. Moreover, in order to avoid any confusion for the consumer as to the natural nutritional value of fresh foods, the addition of vitamins and minerals thereto should not be allowed.

(13)

This Regulation is not intended to cover the use of vitamins and minerals in trace quantities as authenticity markers used with the objective of combating fraud.

(14)

Excessive intakes of vitamins and minerals may result in adverse effects and it is therefore necessary to set maximum safe levels for them when they are added to foods, as the case may be. These levels must ensure that the normal use of the products, under the instructions for use provided by the manufacturer and in the context of a diversified diet, will be safe for the consumer. Therefore those levels should be total maximum safe levels for the vitamins and minerals present in the food naturally and/or added to the food for whatever purpose, including for technological uses.

(15)

For that reason, those maximum levels and any other conditions restricting their addition to foods, where necessary, should be adopted taking into account their upper safe levels established by scientific risk assessment based on generally acceptable scientific data and their potential intake from other foods. Due account should also be taken of the population reference intakes of vitamins and minerals. Where it is necessary, for certain vitamins and minerals, to establish restrictions regarding the foods to which they can be added, priority should be given to the purposes of restoring their content where this has been reduced during manufacturing, storage or handling procedures and of providing a similar nutritional value to foods for which those foods are intended as alternatives.

(16)

Vitamins and minerals added to foods should result in a minimum amount being present in the food. Otherwise the presence of too small and insignificant amounts in these fortified foods would not offer any benefit to consumers and would be misleading. The same principle underlies the requirement that these nutrients should be present in a significant amount in the food in order to be allowed to be declared in nutrition labelling. Therefore it would be appropriate that the minimum amounts of vitamins and minerals in foods to which vitamins and minerals have been added should be the same as those significant amounts that should be present for those nutrients to be declared in nutrition labelling unless otherwise provided for by appropriate derogations.

(17)

The adoption of maximum levels and any conditions of use based on the application of the principles and criteria stipulated in this Regulation and the adoption of minimum levels would be implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.

(18)

General labelling provisions and definitions 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 (4). This Regulation should therefore be confined to the necessary additional provisions. Those additional provisions should also apply without prejudice to Regulation (EC) No ../2006 of the European Parliament and of the Council of …. on nutrition and health claims made on foods (5).

(19)

Given the nutritional importance of products to which vitamins and minerals have been added and their potential impact on dietary habits and overall nutrient intakes, the consumer should be able to evaluate the global nutritional quality of those products. Therefore, by derogation from Article 2 of Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs (6), nutrition labelling should be compulsory.

(20)

A normal and varied diet contains many ingredients, which in turn contain many substances. The intake of these substances or ingredients resulting from their normal and traditional use in current diets would not cause concern and does not need to be regulated. Some substances other than vitamins and minerals or ingredients containing them are added to foods as extracts or concentrates and may result in intakes that are significantly higher than those that could be ingested through eating an adequate and varied diet. The safety of such practices is in some cases seriously contested and the benefits are unclear; therefore they should be regulated. It is appropriate, in such cases, that food operators, responsible for the safety of the foods they place on the market, assume the burden of proof in relation to their safety.

(21)

Given the particular nature of foods to which vitamins and minerals are added, means additional to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products.

(22)

Since the objective of this Regulation, namely to ensure the effective functioning of the internal market as regards the addition of vitamins and minerals and certain other substances to foods 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.

(23)

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 (7),

(a)

foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such products rendered necessary by the particular nutritional requirements of the persons for whom they are intended;

(b)

novel foods and novel food ingredients;

(c)

genetically modified food;

(d)

food additives and flavourings;

(e)

authorised oenological practices and processes.

(a)

a deficiency of one or more vitamins and/or minerals in the population or specific population groups that can be demonstrated by clinical or sub-clinical evidence of deficiency or indicated by estimated low levels of intake of nutrients; or

(b)

the potential to improve the nutritional status of the population or specific population groups and/or correct possible deficiencies in dietary intakes of vitamins or minerals due to changes in dietary habits; or

(c)

evolving generally acceptable scientific knowledge on the role of vitamins and minerals in nutrition and consequent effects on health.

(a)

unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish;

(b)

beverages containing more than 1,2 % by volume of alcohol, except and by way of derogation from Article 3(2), to products:

and provided that no nutrition or health claim is made.

(a)

upper safe levels of vitamins and minerals established by scientific risk assessment based on generally acceptable scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different groups of consumers;

(b)

intakes of vitamins and minerals from other dietary sources.

(a)

the contribution of individual products to the overall diet of the population in general or of subgroups of the population;

(b)

the nutrient profile of the product established as provided for by Regulation (EC) No .../2006 (10).

(a)

if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:

(b)

if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, part C.

(a)

the vitamins and minerals which may be added to foods as listed in Annex I;

(b)

the vitamin formulations and mineral substances which may be added to foods as listed in Annex II;

(c)

the maximum and minimum amounts of vitamins and minerals which may be added to foods and any associated conditions set in accordance with Article 6;

(d)

the information regarding national provisions on the mandatory addition of vitamins and minerals referred to in Article 11;

(e)

any restrictions on the addition of vitamins and minerals as set out in Article 4;

(f)

the substances for which dossiers have been submitted as provided for in Article 17(1)(b);

(g)

information about the substances referred to in Annex III and the reasons for their inclusion therein.

(a)

on the mandatory addition of vitamins and minerals to specified foods or categories of foods; or

(b)

on the prohibition or restriction on the use of certain other substances in the manufacture of specified foods,

(a)

the substance in question is used for addition to foods marketed in the Community on … (15); and

(b)

the Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than … (16).

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.