30.12.2006   

EN

Official Journal of the European Union

L 404/1

(1)

Regulation (EC) No 999/2001 (3) is intended to provide a single legal framework for transmissible spongiform encephalopathies (TSEs) in the Community.

(2)

Regulation (EC) No 932/2005 of the European Parliament and of the Council of 8 June 2005 amending Regulation (EC) No 999/2001 as regards the extension of the period for transitional measures (4) prolonged the period of application of the transitional measures provided for in Regulation (EC) No 999/2001 until 1 July 2007 at the latest.

(3)

During the General Session of the World Organisation for Animal Health in May 2003, a Resolution was adopted to simplify the current international criteria for the classification of countries according to their Bovine Spongiform Encephalopathy (BSE) risk. A proposal was adopted at the General Session in May 2005. The Articles of Regulation (EC) No 999/2001 should be adapted to reflect the new internationally agreed categorisation system.

(4)

New developments concerning sampling and analysis will require comprehensive amendments to Annex X to Regulation (EC) No 999/2001. It is therefore necessary to make certain technical amendments to the existing definition of ‘rapid tests’ in Regulation (EC) No 999/2001 in order to facilitate amendment of the structure of that Annex at a later stage.

(5)

In the interests of clarity of Community legislation, it is appropriate to clarify that the definition of ‘mechanically separated meat’ provided for in other Community legislation on food safety should be applicable in Regulation (EC) No 999/2001 in the context of TSE eradication measures.

(6)

Regulation (EC) No 999/2001 establishes a monitoring programme for BSE and scrapie. In its opinion of 6-7 March 2003, the Scientific Steering Committee recommended the introduction of a monitoring programme for TSEs in cervids. Therefore the monitoring system provided for in that Regulation should be extended to other TSEs, with the possibility to adopt further measures to implement that system at a later stage.

(7)

A harmonised breeding programme to select for resistance to TSEs in ovine animals has been put in place as a transitional measure by Commission Decision 2003/100/EC of 13 February 2003 laying down minimum requirements for the establishment of breeding programmes for resistance to transmissible spongiform encephalopathies in sheep (5). Regulation (EC) No 999/2001 should be amended to provide a permanent legal basis for that programme, as well as the possibility of amending such programmes to take account of the evaluated scientific results and overall consequences of their implementation.

(8)

Regulation (EC) No 999/2001 prohibits the feeding of certain processed animal proteins to certain animals, with the possibility to provide for derogations. New developments concerning prohibitions on animal feeding may require amendments to be made to Annex IV to that Regulation. It is necessary to make certain technical amendments to the existing wording of the corresponding Article in order to facilitate amendment of the structure of that Annex at a later stage.

(9)

Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (6) establishes rules for the disposal of specified risk materials and animals infected by TSEs. Rules on transit through the Community of products of animal origin have now been adopted. Accordingly, in the interests of consistency of Community legislation, the existing rules in Regulation (EC) No 999/2001 on the disposal of such materials and animals should be replaced by a reference to Regulation (EC) No 1774/2002, and the reference to rules on transit in Regulation (EC) No 999/2001 should be deleted.

(10)

New developments concerning specified risk materials will also require comprehensive amendments to Annex V to Regulation (EC) No 999/2001. It is necessary to make certain technical amendments to the existing wording of the corresponding provisions of that Regulation in order to facilitate amendment of the structure of that Annex at a later stage.

(11)

Although stunning by injection of gas in the cranial cavity is prohibited within the Community, injection of gas may also occur after stunning. It is therefore necessary to amend the relevant provisions on slaughter methods in Regulation (EC) No 999/2001 with a view to prohibiting gas injection into the cranial cavity after stunning.

(12)

Commission Regulation (EC) No 1915/2003 amending Regulation (EC) No 999/2001 (7) sets out new provisions on eradication of scrapie in ovine and caprine animals. Accordingly, it is necessary to prohibit the movement of ovine and caprine animals from holdings where scrapie is officially suspected.

(13)

Based on evolving scientific knowledge, Regulation (EC) No 999/2001 should allow the extension to other species of the scope of the rules concerning the placing on the market and export of bovine, ovine and caprine animals, their semen, embryos and ova.

(14)

The opinion of the Scientific Steering Committee of 26 June 1998 indicates that certain restrictions regarding sourcing of raw material for the manufacture of di-calcium phosphate should be observed. Accordingly, di-calcium phosphate should be removed from the list of products which are not subject to restrictions on placing on the market under Regulation (EC) No 999/2001. The absence of restrictions applicable to milk and dairy products should be clarified.

(15)

Based on evolving scientific knowledge and risk classification, and notwithstanding the possibility to adopt safeguard measures, Regulation (EC) No 999/2001 should permit the adoption in accordance with the comitology procedure of more specific requirements for the placing on the market and export of products of animal origin originating from Member States or third countries with a controlled or undetermined risk of TSE.

(16)

The measures necessary for the implementation of Regulation (EC) No 999/2001 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 (8).

(17)

In particular, the Commission should be empowered to adopt decisions approving the rapid tests, adapting the age of the animals, introducing the tolerance level, allowing feeding of young animals of ruminant species with proteins derived from fish and extending certain provisions to other animal species; to establish rules providing for exemptions from the requirement to remove and destroy specific risk material; to establish criteria to demonstrate improvement of the epidemiological situation and criteria for granting exemptions from certain restrictions as well as production processes. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 999/2001 and/or to supplement that Regulation by the addition of new non-essential elements, those measures should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(18)

Regulation (EC) No 999/2001 should therefore be amended accordingly,

1)

the following recital shall be inserted:

2)

the following recitals shall be inserted:

3)

in Article 3, paragraph 1 shall be amended as follows:

4)

Article 5 is hereby amended as follows:

5)

Article 6 is hereby amended as follows:

6)

the following Article shall be inserted:

‘Article 6a

Breeding Programmes

1.   Member States may introduce breeding programmes to select for resistance to TSEs in their ovine populations. Those programmes shall include a framework to recognise the TSE-resistant status of certain flocks and may be extended to include other animal species based on scientific evidence corroborating the resistance to TSE of particular genotypes of those species.

2.   Specific rules for the programmes provided for in paragraph 1 of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

3.   Member States which introduce breeding programmes shall submit regular reports to the Commission in order to enable the programmes to be scientifically evaluated, in particular with regard to their impact on the incidence of TSEs but also on genetic diversity and variability and on the maintenance of old or rare ovine breeds or of those that are well-adapted to a particular region. The scientific results and overall consequences of the breeding programmes shall be evaluated regularly, and where necessary, those programmes shall be amended accordingly.’;

7)

Article 7 is hereby amended as follows:

8)

in Article 8, paragraphs 1 to 5 shall be replaced by the following:

‘1.   The specified risk material shall be removed and disposed of in accordance with Annex V to this Regulation and with Regulation (EC) No 1774/2002. It shall not be imported into the Community. The list of specified risk material referred to in Annex V shall include at least the brain, spinal cord, eyes and tonsils of bovine animals aged over 12 months and the vertebral column of bovine animals above an age to be determined in accordance with the procedure referred to in Article 24(3). Taking into account the different risk categories laid down in the first subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) (b), the list of specified risk material in Annex V shall be amended accordingly.

2.   Paragraph 1 of this Article shall not apply to tissues from animals which have undergone an alternative test approved for that distinct purpose in accordance with the procedure referred to in Article 24(3) provided that this test is listed in Annex X, is applied under the conditions provided for in Annex V and the test results are negative.

The Member States which authorise the use of an alternative test pursuant to this paragraph shall inform the other Member States and the Commission.

3.   In Member States, or regions thereof, with a controlled or undetermined BSE risk, the laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injection into the cranial cavity in connection with stunning, shall not be used on bovine, ovine or caprine animals whose meat is intended for human or animal consumption.

4.   The data relating to age set out in Annex V may be adjusted. Such adjustments shall be based on the latest proven scientific findings concerning the statistical probability of the occurrence of a TSE in the relevant age groups of the Community's bovine, ovine and caprine population.

5.   Rules providing for exemptions from paragraphs 1 to 4 of this Article may be adopted in accordance with the procedure referred to in Article 24(3), with regard to the date of the effective enforcement of the feeding prohibition provided for in Article 7(1) or, as appropriate for third countries or regions thereof with a controlled BSE risk, with regard to the date of the effective enforcement of the ban of mammalian protein in feed for ruminants with a view to limiting the requirements to remove and destroy specified risk material to animals born before that date in the countries or regions concerned.’;

9)

in Article 9, paragraphs 1 and 2 shall be replaced by the following:

‘1.   The products of animal origin listed in Annex VI shall be produced using production processes approved in accordance with the procedure referred to in Article 24(3).

2.   Bones of bovine, ovine and caprine animals from countries or regions with a controlled or undetermined BSE risk shall not be used for the production of mechanically separated meat (MSM). Before 1 July 2008, the Member States shall submit a report to the Commission on the use and the production method of MSM in their territory. This report shall include a statement as to whether the Member State intends to continue with the production of MSM.

The Commission shall thereupon present a communication to the European Parliament and the Council on the future necessity and use of MSM in the Community, including the information policy towards consumers.’;

10)

Article 12 is hereby amended as follows:

11)

in Article 13, paragraph 1 is hereby amended as follows:

12)

in Article 15, paragraph 3 shall be replaced by the following:

‘3.   In accordance with the procedure referred to in Article 24(3), the provisions of paragraphs 1 and 2 may be extended to other animal species.

4.   Rules for implementing this Article may be adopted in accordance with the procedure referred to in Article 24(2).’;

13)

Article 16 is hereby amended as follows:

14)

the following Article shall be inserted:

‘Article 23a

The following measures which are designed to amend non-essential elements of this Regulation, including by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3):

15)

Article 24 shall be replaced by the following:

‘Article 24

Committees

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health. However, the Standing Committee on Zootechnics shall also be consulted by the Commission with regard to Article 6a.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The time-limits referred to in Article 5(6) of that Decision shall be three months and, in the case of safeguard measures referred to in Article 4(2) of this Regulation, 15 days.

3.   Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

16)

the following Article shall be inserted:

‘Article 24a

Decisions to be adopted in accordance with one of the procedures referred to in Article 24 shall be based on an appropriate assessment of the possible risks for human and animal health and shall, taking into account existing scientific evidence, maintain, or if scientifically justified increase, the level of protection of human and animal health ensured in the Community.’.

30.12.2006   

EN

Official Journal of the European Union

L 404/9

(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 31 January 2008 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 19 January 2008, 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).

30.12.2006   

EN

Official Journal of the European Union

L 404/26

(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 of vitamins and minerals to or their use in 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 health effects and it is therefore necessary to set maximum amounts for them when they are added to foods, as the case may be. These amounts 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 amounts 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 amounts 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 (e.g. the addition of iodine to salt), 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 those 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 amounts and any conditions of use based on the application of the principles and criteria stipulated in this Regulation and the adoption of minimum amounts 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 1924/2006 of the European Parliament and of the Council of 20 December 2006 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 business 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.

(1)

‘Authority’ means the European Food Safety Authority established by 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 (8);

(2)

‘other substance’ means a substance other than a vitamin or a mineral that has a nutritional or physiological effect.

(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; and

(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 sub-groups of the population;

(b)

the nutrient profile of the product established as provided for by Regulation (EC) No 1924/2006.

(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;

(h)

information about the substances listed in Annex III, Part C, whose use is generally allowed as referred to in Article 8(5).

(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 19 January 2007; 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 19 January 2010.

30.12.2006   

EN

Official Journal of the European Union

L 404/39

(1)

The Community can contribute to protecting the health, safety and economic and legal interests of citizens through actions in the field of consumer protection.

(2)

It is therefore appropriate to establish a programme of Community action in the field of consumer policy, replacing Decision No 20/2004/EC of the European Parliament and of the Council of 8 December 2003 establishing a general framework for financing Community actions in support of consumer policy for the years 2004 to 2007 (4). That Decision should therefore be repealed.

(3)

Integrating consumer interests in all Community policies, in accordance with Article 153 of the Treaty, should be given high priority, together with the consumer policy objectives set out in this programme. Coordination with other Community policies and programmes is a key part of ensuring that consumer interests are taken fully into account in other policies. In order to promote synergies and avoid duplication, other Community funds and programmes should provide for financial support for the integration of consumer interests in their respective fields.

(4)

This Decision lays down, for the entire duration of the programme, a financial envelope constituting the prime reference, within the meaning of point 37 of the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management (5), for the budgetary authority during the annual budgetary procedure.

(5)

It is of general European interest that the health and safety aspects of services and non-food products and the economic and legal interests of citizens, as well as consumers' interests in the development of standards for products and services, be represented at Community level. Given the particular nature of the organisations concerned, the renewal of Community support for the functioning of such organisations should not be subject to the principle of gradual decrease of the extent of Community support.

(6)

It is appropriate to ensure a transition between this programme and the programme it replaces, in particular regarding the continuation of multi-annual measures and the evaluation of the previous programme's successes and areas that need more attention. As of 1 January 2014, the technical and administrative assistance appropriations should cover, if necessary, the expenditure related to the management of actions not completed by the end of 2013.

(7)

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 (6).

(8)

Implementation of the programme should take into account the fact that the internal market will not function properly if consumers are less well protected in some Member States than in others. The programme should therefore focus especially on consumer protection and consumer awareness in the Member States which have acceded on or after 1 May 2004, in order to ensure a level playing field for all Member States.

(9)

The Agreement on the European Economic Area (hereinafter referred to as ‘the EEA Agreement’) provides for cooperation in the field of consumer protection between the European Community and its Member States, on the one hand, and the countries of the European Free Trade Association participating in the European Economic Area (hereinafter referred to as ‘the EFTA/EEA countries’), on the other. Provision should also be made to open the programme to participation by other countries, in particular the neighbouring countries of the European Union and countries which are applying for, are candidates for, or are acceding to, membership of the European Union.

(10)

In the context of the implementation of the programme, cooperation with third countries not participating in the programme should be encouraged, taking into account any relevant agreements between those countries and the Community.

(11)

The value and impact of the measures taken under the programme should be regularly monitored and evaluated, including by independent external evaluators. For the purposes of evaluating consumer policy, measurable objectives should be formulated and indicators developed.

(12)

Since the objectives of this Decision cannot be sufficiently achieved by the Member States due to the cross-border nature of the issues involved, and can therefore by reason of the greater potential of Community action efficiently and effectively to protect the health, safety and economic and legal interests of citizens 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 Decision does not go beyond what is necessary in order to achieve those objectives,

(a)

to ensure a high level of consumer protection, notably through improved evidence, better consultation and better representation of consumers' interests;

(b)

to ensure the effective application of consumer protection rules, in particular through enforcement cooperation, information, education and redress.

(a)

50 % of the costs of actions jointly financed by the Community and one or more Member States, or by the Community and the competent authorities of the third countries participating pursuant to Article 8; except in the case of actions of exceptional utility, the Community contribution to the costs of which shall not exceed 70 %;

(b)

85 % of the costs of actions intended to develop integrated European Master Degree courses in consumer issues;

(c)

50 % of expenditure for the functioning of European consumer organisations;

(d)

95 % of expenditure for the functioning of European consumer organisations representing consumer interests in the development of standards for products and services at Community level.

(a)

scholarship grants for individual mobility of teachers and students in the framework of integrated European Master Degree courses in consumer issues. The management of these grants may be entrusted to the Erasmus National Agencies of the Life Long Learning programme;

(b)

travel and subsistence allowances for the exchange of enforcement officials.

(a)

the annual work plan for the implementation of the Programme, setting out;

(b)

the arrangements, including selection and award criteria, for the implementation of the actions referred to in Article 4(1)(a).

(a)

the EFTA/EEA countries, in accordance with the conditions established in the EEA Agreement;

(b)

third countries, in particular countries to which the European Neighbourhood Policy applies, countries that are applying for, are candidates for, or are acceding to, membership of the European Union, and the western Balkan countries included in the stabilisation and association process, in accordance with the conditions laid down in the respective bilateral or multilateral agreements with those countries establishing the general principles for their participation in Community programmes.

1.1.

Monitoring and assessment of market developments with an impact on the economic and other interests of consumers, including studies, price surveys, surveys of changes in the structure of markets, surveys of consumers and business, collection and analysis of consumer complaints, collection and analysis of data on cross-border business-to-consumer trade and markets.

1.2.

Development and maintenance of databases.

1.3.

Collection and analysis of statistical and other relevant evidence, the statistical element of which will be developed using as appropriate the Community Statistical Programme.

4.1.

Legal and technical expertise, including studies, in relation to regulation and its impact.

4.2.

Legal and technical expertise, including studies, in relation to policy development on the safety of products and services and the economic and legal interests of consumers.

4.3.

Legal and technical expertise, including studies, in relation to assessment of the need for product safety standards and the drafting of standardisation mandates for products and services.

4.4.

Seminars, conferences, workshops and meetings of stakeholders and experts.

8.1.

Actions to improve the coordination of monitoring and enforcement and to improve cooperation between competent authorities, including the development and maintenance of IT tools (e.g. databases, information and communication systems) and the organisation of seminars, conferences, workshops and meetings of stakeholders and experts on enforcement, exchanges of enforcement officials and training, also for members of the judiciary.

8.2.

Monitoring and assessment of the safety of non-food products and services, including the reinforcement and extension of the scope and operation of the RAPEX alert system, taking developments in market surveillance information exchange into account, and the further development of the consumer product safety network as provided for in Directive 2001/95/EC.

8.3.

Joint monitoring and enforcement actions and other actions in the context of administrative and enforcement cooperation.

8.4.

Actions for administrative and enforcement cooperation with third countries which are not participating in the programme.

10.1.

Monitoring the functioning of alternative dispute resolution schemes and assessing their impact.

10.2.

Financial contributions for joint actions with public or non-profit bodies constituting Community networks which provide information and assistance to consumers to help them exercise their rights and obtain access to appropriate dispute resolution (the European Consumer Centres Network).

10.3.

Actions improving communication with EU citizens on consumer issues, especially in Member States which acceded to the European Union on or after 1 May 2004, including publications on issues of interest for consumer policy, provision of information on-line, and actions providing information about consumer protection measures and consumer rights.

11.1.

Specific actions targeted at young consumers, old consumers and vulnerable groups of consumers who are clearly less able to defend their interests, and the development of interactive tools for consumer education.

11.2.

Financial contributions to the development of integrated European Master Degree courses in consumer issues, including a scheme of scholarships enabling students to spend up to six months in a different country.

1.

The financial contributions for actions referred to in Article 4(1)(a) may be awarded to a public body or a non-profit-making body designated through a transparent procedure by the Member State or the competent authority concerned and agreed by the Commission.

2.

The financial contributions for actions referred to in Article 4(1)(b) may be awarded to higher education institutions of the Member States or third countries participating pursuant to Article 8, as defined in Article 2 of Decision No 2317/2003/EC of the European Parliament and of the Council of 5 December 2003 establishing a programme for the enhancement of quality in higher education and the promotion of intercultural understanding through cooperation with third countries (Erasmus Mundus) (2004-2008) (1).

3.

The financial contributions for actions referred to in Article 4(2)(a) may be awarded to students and teachers participating in the integrated European Master Degree courses in consumer issues benefiting from co-financing under Article 4(1)(b).

4.

The financial contributions for actions referred to in Article 4(2)(b) may be awarded to the consumer protection enforcement officials referred to in Regulation (EC) No 2006/2004 and Directive 2001/95/EC.

5.

The financial contributions for actions referred to in Article 4(1)(c) may be awarded to European consumer organisations which:

6.

The financial contributions for actions referred to in Article 4(1)(d) may be awarded to European consumer organisations which: