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COMMON POSITION (EC) No 3/2006

adopted by the Council on 8 December 2005

with a view to adopting Regulation (EC) No .../2006 of the European Parliament and of the Council of ...on nutrition and health claims made on foods

(2006/C 80 E/03)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1.   This Regulation harmonises the provisions laid down by law, regulation or administrative action in Member States which relate to nutrition and health claims in order to ensure the effective functioning of the internal market whilst providing a high level of consumer protection.

2.   This Regulation shall apply to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer, including foods which are placed on the market unpacked or supplied in bulk.

It shall also apply in respect of foods intended for supply to restaurants, hospitals, schools, canteens and similar mass caterers.

3.   A trade mark, brand name or fancy name appearing in the labelling, presentation or advertising of a food which may be construed as a nutrition or health claim may be used without undergoing the authorisation procedures provided for in this Regulation, provided that it is accompanied by a related nutrition or health claim in that labelling, presentation or advertising which complies with the provisions of this Regulation.

4.   This Regulation shall apply without prejudice to the following Community provisions:

Article 2

Definitions

1.   For the purposes of this Regulation:

2.   The following definitions shall also apply:

CHAPTER II

GENERAL PRINCIPLES

Article 3

General principles for all claims

Nutrition and health claims may be used in the labelling, presentation and advertising of foods placed on the market in the Community only if they comply with the provisions of this Regulation.

Without prejudice to Directives 2000/13/EC and 84/450/EEC, the use of nutrition and health claims shall not:

Article 4

Conditions for the use of nutrition and health claims

1.   By ... (15), the Commission shall, in accordance with the procedure referred to in Article 24(2), establish specific nutrient profiles and the conditions, including exemptions, which shall be respected for the use of nutrition and health claims on foods and/or categories of foods.

These nutrient profiles established for food and/or certain categories of food, and the conditions for the use of nutrition or health claims with respect to the nutrient profiles, shall be laid down taking into account in particular:

The nutrient profiles shall be based on scientific knowledge about diet and nutrition, and their relation to health.

In setting the nutrient profiles, the Commission shall request the Authority to provide, within 12 months, relevant scientific advice, focusing in particular on:

In setting the nutrient profiles, the Commission shall carry out consultations with interested parties, in particular food business operators and consumer groups.

Nutrient profiles and their conditions of use shall be updated to take into account relevant scientific developments in accordance with the procedure referred to in Article 24(2).

2.   By way of derogation from paragraph 1, nutrition claims referring to the reduction of fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium shall be allowed without reference to a profile for the specific nutrient/s for which the claim is made, provided they comply with the conditions laid down in this Regulation.

3.   Beverages containing more than 1,2 % by volume of alcohol shall not bear:

4.   In the absence of specific Community rules regarding nutrition claims referring to the reduction or absence of alcohol or energy in beverages which normally contain alcohol, relevant national rules may apply in compliance with the provisions of the Treaty.

5.   Foods or categories of foods other than those referred to in paragraph 3, for which nutrition or health claims are to be restricted or prohibited, may be determined in accordance with the procedure referred to in Article 24(2) and in the light of scientific evidence.

Article 5

General conditions

1.   The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled:

2.   The use of nutrition and health claims shall only be permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim.

3.   Nutrition and health claims shall refer to the food ready for consumption in accordance with the manufacturer's instructions.

Article 6

Scientific substantiation for claims

1.   Nutrition and health claims shall be based on and substantiated by generally accepted scientific data.

2.   A food business operator making a nutrition or health claim shall justify the use of the claim.

3.   The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with this Regulation.

Article 7

Nutrition information

The obligation and the modalities for providing information pursuant to Directive 90/496/EEC where a nutrition claim is made shall apply, mutatis mutandis, where a health claim is made, with the exception of generic advertising. However, the information to be provided shall consist of information in Group 2 as defined in Article 4(1) of Directive 90/496/EEC.

In addition and as the case may be, the amount(s) of the substance(s) to which a nutrition or health claim relates that does not appear in the nutrition labelling shall also be stated in the same field of vision of the nutrition information and be expressed in accordance with Article 6 of Directive 90/496/EEC.

In the case of food supplements, the nutrition information shall be provided in accordance with Article 8 of Directive 2002/46/EC.

CHAPTER III

NUTRITION CLAIMS

Article 8

Specific conditions

1.   Nutrition claims shall only be permitted if they are listed in the Annex and are in conformity with the conditions set out in this Regulation.

2.   Amendments to the Annex shall be adopted in accordance with the procedure referred to in Article 24(2) and, where appropriate, after consulting the Authority.

Article 9

Comparative claims

1.   Without prejudice to Directive 84/450/EEC, a comparison may only be made between foods of the same category, taking into consideration a range of foods of that category. The difference in the quantity of a nutrient and/or the energy value shall be stated and the comparison shall relate to the same quantity of food.

2.   Comparative nutrition claims shall compare the composition of the food in question with a range of foods of the same category, which do not have a composition which allows them to bear a claim, including foods of other brands.

CHAPTER IV

HEALTH CLAIMS

Article 10

Specific conditions

1.   Health claims shall be prohibited unless they comply with the general requirements in Chapter II and the specific requirements in this Chapter and are authorised in accordance with this Regulation and included in the lists of authorised claims provided for in Articles 13 and 14.

2.   Health claims shall only be permitted if the following information is included in the labelling, or if no such labelling exists, in the presentation and advertising:

3.   Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim included in the lists provided for in Article 13 or 14.

4.   Where appropriate, guidelines on the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2) and, if necessary, in consultation with interested parties, in particular food business operators and consumer groups.

Article 11

National medical associations and health-related charities

In the absence of specific Community rules concerning recommendations of or endorsements by national medical associations and health-related charities, relevant national rules may apply in compliance with the provisions of the Treaty.

Article 12

Restrictions on the use of certain health claims

The following health claims shall not be allowed:

Article 13

Health claims other than those referring to the reduction of disease risk

1.   Health claims describing or referring to:

which are included in the list provided for in paragraph 3 may be made without undergoing the authorisation procedure laid down in Articles 15 to 18, if they are:

2.   Member States shall provide the Commission with lists of claims as referred to in paragraph 1 by ... (16) at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification.

3.   After consulting the Authority, the Commission shall adopt, in accordance with the procedure referred to in Article 24(2), a Community list of permitted claims as referred to in paragraph 1, and all necessary conditions for the use of these claims by ... (17) at the latest.

4.   Any changes to the list referred to in paragraph 3, based on generally accepted scientific data, shall be adopted in accordance with the procedure referred to in Article 24(2), after consulting the Authority, on the Commission's own initiative or following a request by a Member State.

5.   Any additions of claims to the list referred to in paragraph 3 based on newly developed scientific data and/or which include a request for the protection of proprietary data shall be adopted following the procedure laid down in Articles 15 to 18.

Article 14

Reduction of disease risk claims

1.   Notwithstanding Article 2(1)(b) of Directive 2000/13/EC, reduction of disease risk claims may be made where they have been authorised in accordance with the procedure laid down in Articles 15 to 18 of this Regulation for inclusion in a Community list of such permitted claims together with all the necessary conditions for the use of these claims.

2.   In addition to the general requirements laid down in this Regulation and the specific requirements of paragraph 1, for reduction of disease risk claims the labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.

Article 15

Application for authorisation

1.   When reference is made to this Article, an application for authorisation shall be submitted in accordance with the following paragraphs.

2.   The application shall be sent to the national competent authority of a Member State.

3.   The application shall include the following:

4.   The Commission, having first consulted the Authority, shall establish in accordance with the procedure referred to in Article 24(2) implementing rules for the application of this Article, including rules concerning the preparation and presentation of the application.

5.   Before ... (18), the Authority shall publish detailed guidance to assist applicants in the preparation and the presentation of the application.

Article 16

Opinion of the Authority

1.   In giving its opinion, the Authority shall endeavour to respect a time limit of six months from the date of receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.

2.   The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit.

3.   In order to prepare its opinion, the Authority shall:

4.   In the event of an opinion in favour of authorising the health claim, the opinion shall include the following particulars:

5.   The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the health claim and stating the reasons for its opinion and the information on which its opinion was based.

6.   The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.

The applicant or members of the public may make comments to the Commission within 30 days from such publication.

Article 17

Community authorisation

1.   Within three months after receiving the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 22(2) a draft decision on the lists of permitted health claims, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. Where the draft Decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.

2.   Any draft decision to amend the lists of permitted health claims shall include the particulars referred to in Article 16(4).

3.   A final decision on the application shall be adopted in accordance with the procedure referred to in Article 24(2).

4.   The Commission shall, without delay, inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.

5.   Health claims included in the lists provided for in Articles 13 and 14 may be used, in conformity with the conditions applying to them, by any food business operator, if they are not restricted for use in accordance with the provisions of Article 20.

6.   The granting of authorisation shall not lessen the general civil and criminal liability of any food business operator in respect of the food concerned.

Article 18

Modification, suspension and revocation of authorisations

1.   The applicant/user of a claim included in one of the lists provided for in Articles 13 and 14 may apply for a modification of the relevant list. The procedure laid down in Articles 15 to 17 shall apply, mutatis mutandis.

2.   On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether a health claim included in the lists provided for in Articles 13 and 14 still meets the conditions laid down in this Regulation.

It shall forthwith transmit its opinion to the Commission, the Member States and, where relevant, to the original applicant of the claim in question. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.

The applicant/user or a member of the public may make comments to the Commission within 30 days of such publication.

The Commission shall examine the opinion of the Authority and any comments received as soon as possible. If appropriate, the authorisation shall be modified, suspended or revoked in accordance with the procedure laid down in Article 17.

CHAPTER V

GENERAL AND FINAL PROVISIONS

Article 19

Community Register

1.   The Commission shall establish and maintain a Community Register of nutrition and health claims made on food, hereinafter referred to as ‘the Register’.

2.   The Register shall include the following:

Health claims authorised on the basis of proprietary data shall be recorded in a separate Annex to the Register together with the following information:

3.   The Register shall be made available to the public.

Article 20

Data protection

1.   The scientific data and other information in the application required under Article 15(2) may not be used for the benefit of a subsequent applicant for a period of seven years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:

2.   Until the end of the seven-year period specified in paragraph 1, no subsequent applicant shall have the right to refer to data designated as proprietary by a prior applicant unless and until the Commission takes a decision on whether a claim could be or could have been included in the list provided for in Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.

Article 21

National provisions

Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may not restrict or forbid trade in or advertising of foods which comply with this Regulation by the application of non-harmonised national provisions governing claims made on certain foods or on foods in general.

Article 22

Notification procedure

1.   If a Member State considers it necessary to adopt new legislation, it shall notify the Commission and the other Member States of the envisaged measures and give the reasons justifying them.

2.   The Commission shall consult the Standing Committee on the Food Chain and Animal Health instituted by Article 58(1) of Regulation (EC) No 178/2002 (hereinafter referred to as the Committee) if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.

3.   The Member State concerned may take the envisaged measures six months after the notification referred to in paragraph 1, provided that the Commission's opinion is not negative.

If the Commission's opinion is negative, it shall determine, in accordance with the procedure referred to in Article 24(2) and before the expiry of the period referred to in the first subparagraph of this paragraph, whether the envisaged measures may be implemented. The Commission may require certain amendments to be made to the envisaged measure.

Article 23

Safeguard measures

1.   Where a Member State has serious grounds for considering that a claim does not comply with this Regulation, or that the scientific substantiation provided for in Article 6 is insufficient, that Member State may temporarily suspend the use of that claim within its territory.

It shall inform the other Member States and the Commission and give reasons for the suspension.

2.   In accordance with the procedure referred to in Article 24(2), a decision shall be taken, where appropriate after obtaining an opinion from the Authority.

The Commission may initiate this procedure on its own initiative.

3.   The Member State referred to in paragraph 1 may maintain the suspension until the decision referred to in paragraph 2 has been notified to it.

Article 24

Committee procedure

1.   The Commission shall be assisted by the Committee.

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.

3.   The Committee shall adopt its rules of procedure.

Article 25

Monitoring

To facilitate efficient monitoring of foods bearing nutrition or health claims, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by forwarding to it a model of the label used for the product.

Article 26

Evaluation

By ... (19) at the latest, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market in foods in respect of which nutrition or health claims are made and on the consumers' understanding of claims, together with a proposal for amendments if necessary.

Article 27

Transitional measures

1.   Foods placed on the market or labelled prior to the date of application of this Regulation which do not comply with this Regulation may be marketed until their expiry date, but not later than ... (20). With regard to the provisions in Article 4(1), foods may be marketed until12 months following adoption of the relevant nutrient profiles and their conditions of use.

2.   Products bearing trade marks or brand names existing before 1 January 2005 which do not comply with this Regulation may continue to be marketed until ... (21) after which time the provisions of this Regulation shall apply.

3.   Nutrition claims which have been used in a Member State before 1 January 2005 in compliance with national provisions applicable to them and which are not included in the Annex, may continue to be used until ... (22) under the responsibility of food business operators and without prejudice to the adoption of safeguard measures as referred to in Article 23.

4.   Nutrition claims in the form of pictorial, graphic or symbolic representation, complying with the general principles of this Regulation, which are not included in the Annex and are used according to specific conditions and criteria elaborated by national provisions or rules, shall be subject to the following:

Nutrition claims not authorised under this procedure may continue to be used for twelve months following the adoption of the Decision.

5.   Health claims as referred to in Article 13(1)(a) may be made from the date of entry into force of this Regulation until the adoption of the list referred to in Article 13(3), under the responsibility of food business operators provided that they comply with this Regulation and with existing national provisions applicable to them, and without prejudice to the adoption of safeguard measures as referred to in Article 23.

6.   Health claims other than those referred to in Article 13(1)(a) and 14, which have been used in compliance with national provisions before the date of entry into force of this Regulation, shall be subject to the following:

Article 28

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from ... (24).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at..., ....

For the European Parliament

The President

For the Council

The President

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(1)OJ C 110, 30.4.2004, p. 18.

(2)  Opinion of the European Parliament of 26 May 2005, Council common position of 8 December 2005 and position of the European Parliament of ... (not yet published in the Official Journal).

(3)OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

(4)OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession.

(5)OJ L 316, 9.12.1994, p. 2.

(6)OJ L 183, 12.7.2002, p. 51.

(7)OJ L 250, 19.9.1984, p. 17. Directive as last amended by Directive 2005/29/EC of the European Parliament and of the Council (OJ L 149, 11.6.2005, p. 22).

(8)OJ L 276, 6.10.1990, p. 40. Directive as last amended by Commission Directive 2003/120/EC (OJ L 333, 20.12.2003, p. 51).

(9)OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(10)OJ L 55, 6.3.1996, p. 22.

(11)OJ L 184, 17.7.1999, p. 23.

(12)OJ L 229, 30.8.1980, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.

(13)OJ L 330, 5.12.1998, p. 32. Directive as amended by Regulation (EC) No 1882/2003.

(14)OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(15)  Twenty four months after the date of entry into force of this Regulation.

(16)  Last day of the month of entry into force of this Regulation, plus one year.

(17)  Last day of the month of entry into force of this Regulation, plus three years.

(18)  First day of the sixth month following the date of entry into force of this Regulation.

(19)  Last day of the fifth month following the date of entry into force of this Regulation, plus six years.

(20)  Last day of the 18th month following the date of entry into force of this Regulation.

(21)  Date of entry into force of this Regulation, plus 10 years.

(22)  Two years after the date of entry into force of this Regulation.

(23)  Twelve months after the date of entry into force of this Regulation.

(24)  First day of the sixth months following the date of entry into force of this Regulation.

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ANNEX

Nutrition claims and conditions applying to them

LOW ENERGY

A claim that a food is low in energy, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain more than 40 kcal (170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 ml for liquids. For table-top sweeteners the limit of 4 kcal (17 kJ)/portion, with equivalent sweetening properties to 6 g of sucrose (approximately one teaspoon of sucrose), applies.

ENERGY-REDUCED

A claim that a food is energy-reduced, and any claim likely to have the same meaning for the consumer, may only be made where the energy value is reduced by at least 30 %, with an indication of the characteristic(s) which make(s) the food reduced in its total energy value.

ENERGY-FREE

A claim that a food is energy-free, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain more than 4 kcal (17 kJ)/100 ml. For table-top sweeteners the limit of 0,4 kcal (1,7 kJ)/portion, with equivalent sweetening properties to 6 g of sucrose (approximately one teaspoon of sucrose), applies.

LOW-FAT

A claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 3 g of fat per 100 g for solids or 1,5 g of fat per 100ml for liquids (1,8 g of fat per 100 ml for semi-skimmed milk).

FAT-FREE

A claim that a food is fat-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,5 g of fat per 100 g or 100 ml. However, claims expressed as ‘X % fat-free’ shall be prohibited.

LOW-SATURATED FAT

A claim that a food is low in saturated fat, and any claim likely to have the same meaning for the consumer, may only be made if the sum of saturated fatty acids and trans-fatty acids in the product does not exceed 1,5 g per100 g for solids or 0,75 g/100 ml for liquids and in either case the sum of saturated fatty acids and trans-fatty acids must not provide more than 10 % of energy.

SATURATED FAT-FREE

A claim that a food does not contain saturated fat, and any claim likely to have the same meaning for the consumer, may only be made where the sum of saturated fat and trans-fatty acids does not exceed 0,1 g of saturated fat per 100 g or 100 ml.

LOW SUGAR

A claim that a food is low in sugar, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 5g of sugar per 100 g for solids or 2,5 g of sugar per 100 ml for liquids.

SUGAR-FREE

A claim that a food is sugar-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,5 g of sugar per 100 g or 100 ml.

WITH NO ADDED SUGAR

A claim stating that sugars have not been added to a food, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties. If sugars are naturally present in the food, the following indication should also appear on the label: ‘CONTAINS NATURALLY OCCURRING SUGARS’.

LOW SODIUM/SALT

A claim that a food is low in sodium/salt, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,12 g of sodium, or the equivalent value for salt, per 100 g or per 100 ml. For waters, other than natural mineral waters falling within the scope of Directive 80/777/EEC, this value should not exceed 2 mg of sodium per 100 ml.

VERY LOW SODIUM/SALT

A claim that a food is very low in sodium/salt, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,04 g of sodium, or the equivalent value for salt, per 100 g or per 100 ml. This claim shall not be used for natural mineral waters and other waters.

SODIUM-FREE or SALT-FREE

A claim that a food is sodium-free or salt-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,005 g of sodium, or the equivalent value for salt, per 100 g.

SOURCE OF FIBRE

A claim that a food is a source of fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 3 g of fibre per 100 g or at least 1,5 g of fibre per 100 kcal.

HIGH FIBRE

A claim that a food is high in fibre, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 6 g of fibre per 100 g or at least 3 g of fibre per 100 kcal.

SOURCE OF PROTEIN

A claim that a food is a source of protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 12 % of the energy value of the food is provided by protein.

HIGH PROTEIN

A claim that a food is high in protein, and any claim likely to have the same meaning for the consumer, may only be made where at least 20 % of the energy value of the food is provided by protein.

SOURCE OF (NAME OF VITAMIN/S) AND/OR (NAME OF MINERAL/S)

A claim that a food is a source of vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least a significant amount as defined in the Annex to Directive 90/496/EEC or an amount provided for by derogations granted according to Article 7 of Regulation (EC) No .../2006 of the European Parliament and of the Council of ... on the addition of vitamins and minerals and of certain other substances to foods (1).

HIGH (NAME OF VITAMIN/S) AND/OR (NAME OF MINERAL/S)

A claim that a food is high in vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least twice the value of ‘source of (NAME OF VITAMIN/S) and/or (NAME OF MINERAL/S)’.

CONTAINS (NAME OF THE NUTRIENT OR OTHER SUBSTANCE)

A claim that a food contains a nutrient or another substance, for which specific conditions are not laid down in this Regulation, or any claim likely to have the same meaning for the consumer, may only be made where the product complies with all the applicable provisions of this Regulation, and in particular Article 5. For vitamins and minerals the conditions of the claim ‘source of’ shall apply.

INCREASED (NAME OF THE NUTRIENT)

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

REDUCED (NAME OF THE NUTRIENT)

A claim stating that the content in one or more nutrients has been reduced, and any claim likely to have the same meaning for the consumer, may only be made where the reduction in content is at least 30 % compared to a similar product, except for micronutrients where a 10 % difference in the reference values as set in Council Directive 90/496/EEC shall be acceptable and for sodium, or the equivalent value for salt, where a 25 % difference shall be acceptable.

LIGHT/LITE

A claim stating that a product is ‘light’ or ‘lite’, and any claim likely to have the same meaning for the consumer, shall follow the same conditions as those set for the term ‘reduced’; the claim shall also be accompanied by an indication of the characteristic(s) which make(s) the food ‘light’ or ‘lite’.

NATURALLY/NATURAL

Where a food naturally meets the condition(s) laid down in this Annex for the use of a nutritional claim, the term ‘naturally/ natural’ may be used as a prefix to the claim.

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(1)  OJ L ...

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

II.   OBJECTIVES

The proposed Regulation covers nutrition and health claims used in the labelling, presentation and advertising of foods and aims at setting conditions for the use of such claims.

The main objectives of this proposal are:

III.   ANALYSIS OF THE COMMON POSITION

1.   General remarks

The Council's common position conforms to the objectives of the Commission proposal while introducing a certain number of modifications among which:

The Commission has accepted the common position agreed by the Council.

2.   European Parliament amendments

In its Plenary vote on 26 May 2005, the European Parliament adopted 75 amendments to the proposal (Amendments 22 and 23 are linguistic and do not affect the English version).

The Council:

3.   Other innovations introduced by the Council

Other innovations introduced in the common position include:

Annex

The conditions for the use of the nutrition claims contained in the Annex to the Regulation have been modified to take into account, in particular, recent technical and scientific developments in this field.

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(1)  Doc. COM/2003/ 0424 final – COD 2003/0165.

(2)  Doc. 9200/05.

(3)OJ C 112, 30.4.2004, p. 44.

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