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I Information

Council

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COMMON POSITION (EC) No 1/2005

adopted by the Council on 19 July 2004

with a view to the adoption of Regulation (EC) No.../2005 of the European Parliament and of the Council of... on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

(Text with EEA relevance)

(2005/C 25E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37 and 152(4)(b) thereof,

Having regard to the proposal from the Commission,

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

Having consulted the Committee of the Regions,

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

This Regulation establishes, in accordance with the general principles laid down in Regulation (EC) No 178/2002, harmonised Community provisions relating to maximum levels of pesticide residues in or on food and feed of plant and animal origin.

Article 2

Scope

1.   This Regulation shall apply to products of plant and animal origin or parts thereof covered by Annex I to be used as fresh, processed and/or composite food or feed in or on which pesticide residues may be present.

2.   This Regulation shall not apply to the products covered by Annex I where it may be established by appropriate evidence that they are intended for:

3.   Maximum residue levels for pesticides set in accordance with this Regulation shall not apply to products covered by Annex I intended for export to third countries and treated before export, where it has been established by appropriate evidence that the third country of destination requires or agrees with that particular treatment in order to prevent the introduction of harmful organisms into its territory.

4.   This Regulation shall apply without prejudice to Directives 98/8/EC (12) and 2002/32/EC and Regulation (EEC) No 2377/90 (13).

Article 3

Definitions

1.   For the purpose of this Regulation, the definitions in Regulation (EC) No 178/2002 and in Article 2(1) and (4) of Directive 91/414/EEC shall apply.

2.   The following definitions shall also apply:

Article 4

List of groups of products for which harmonised MRLs shall apply

1.   The products, product groups and/or parts of products referred to in Article 2(1) to which harmonised MRLs shall apply shall be defined in and covered by Annex I in accordance with the procedure referred to in Article 45(2). Annex I shall include all products for which MRLs are set, as well as the other products for which it is appropriate to apply harmonised MRLs in particular in view of their relevance in the diet of consumers or in trade. Products shall be grouped in such a way that MRLs may as far as possible be set for a group of similar or related products.

2.   Annex I shall be first established within three months from the entry into force of this Regulation and shall be revised when appropriate, in particular at the request of a Member State.

Article 5

Establishment of a list of active substances for which no MRLs are required

1.   Active substances of plant protection products evaluated under Directive 91/414/EEC for which no MRLs are required shall be defined in accordance with the procedure referred to in Article 45(2) of this Regulation and listed in Annex IV hereto, taking into account the uses of those active substances and the matters referred to in Article 14(2), (a), (c) and (d) of this Regulation.

2.   Annex IV shall be first established within 12 months from the entry into force of this Regulation.

CHAPTER II

PROCEDURE FOR APPLICATIONS FOR MRLS

SECTION 1

SUBMISSION OF APPLICATIONS FOR MRLS

Article 6

Applications

1.   Where a Member State envisages granting an authorisation or a provisional authorisation for the use of a plant protection product in accordance with Directive 91/414/EEC, that Member State shall consider whether, as a result of such use, an existing MRL set out in Annex II or III to this Regulation needs to be modified, whether it is necessary to set a new MRL, or whether the active substance should be included in Annex IV. If necessary it shall require the party requesting the authorisation to submit an application in accordance with Article 7.

2.   Parties demonstrating, through adequate evidence, a legitimate interest, including manufacturers, growers and producers of products covered by Annex I may also submit an application to a Member State in accordance with Article 7.

3.   Where a Member State considers that the setting, modification or deletion of an MRL is necessary, that Member State may also compile and evaluate an application for setting, modifying or deleting the MRL in accordance with Article 7.

4.   Applications for import tolerances shall be submitted to rapporteur Member States designated pursuant to Directive 91/414/EEC or, if no such rapporteur has been designated, applications shall be made to Member States designated by the Commission in accordance with procedure referred to in Article 45(2) of this Regulation at the request of the applicant. Such applications shall be made in accordance with Article 7 of this Regulation.

Article 7

Requirements relating to applications for MRLs

1.   The applicant shall include in an application for an MRL the following particulars and documents:

2.   The evaluating Member State may, where appropriate, request the applicant to provide supplementary information in addition to information required under paragraph 1 within a time limit specified by the Member State.

Article 8

Evaluation of applications

1.   A Member State to which an application complying with Article 7 is submitted pursuant to Article 6 shall immediately forward a copy to the European Food Safety Authority established by Regulation (EC) No 178/2002 (hereinafter referred to as 'the Authority') and the Commission and draw up an evaluation report without undue delay.

2.   Applications shall be evaluated in accordance with the relevant provisions of the Uniform Principles for the Evaluation and Authorisation of Plant Protection Products set out in Annex VI to Directive 91/414/EEC or specific evaluation principles to be laid down in a Commission Regulation in accordance with the procedure referred to in Article 45(2) of this Regulation.

3.   By way of derogation from paragraph 1 and by agreement between the Member States concerned, evaluation of the application may be carried out by the rapporteur Member State designated pursuant to Directive 91/414/EEC for that active substance.

4.   Where a Member State encounters difficulties in evaluating an application or in order to avoid duplication of work, it may be decided in accordance with the procedure referred to in Article 45(2) which Member State shall evaluate particular applications.

Article 9

Submission of evaluated applications to the Commission and the Authority

1.   After completion of the evaluation report, the Member State shall forward it to the Commission. The Commission shall without delay inform the Member States and forward the application, the evaluation report and the supporting dossier to the Authority.

2.   The Authority shall acknowledge in writing receipt of the application to the applicant, the evaluating Member State and the Commission without delay. The acknowledgement shall state the date of receipt of the application and the accompanying documents.

SECTION 2

CONSIDERATION OF APPLICATIONS CONCERNING MRLS BY THE AUTHORITY

Article 10

The Authority's opinion on applications concerning MRLs

1.   The Authority shall assess the applications and the evaluation reports and give a reasoned opinion on, in particular, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL. That opinion shall include:

2.   The Authority shall forward its reasoned opinion to the applicant, the Commission and the Member States. The reasoned opinion shall clearly define the basis for each conclusion reached.

3.   Without prejudice to Article 39 of Regulation (EC) No 178/2002, the Authority shall make its reasoned opinion public.

Article 11

Time limits for the Authority's opinion on applications concerning MRLs

1.   The Authority shall give its reasoned opinion as provided for in Article 10 as soon as possible and at the latest within three months from the date of receipt of the application.

2.   Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until that information has been provided. Such suspensions are subject to Article 13.

Article 12

Assessment of existing MRLs by the Authority

1.   The Authority shall, within a period of 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC after the entry into force of this Regulation, submit a reasoned opinion based in particular on the relevant assessment report prepared under Directive 91/414/EEC to the Commission and the Member States on:

2.   For substances included in Annex I to Directive 91/414/EEC before the entry into force of this Regulation, the reasoned opinion referred to in paragraph 1 of this Article shall be delivered within 12 months of the entry into force of this Regulation.

Article 13

Administrative review

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

For that purpose, a request shall be submitted to the Commission within two months after the day on which the party concerned became aware of the act or omission in question.

The Commission shall take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act within a set time-limit.

SECTION 3

SETTING, MODIFYING OR DELETION OF MRLS

Article 14

Decisions on applications concerning MRLs

1.   Upon receipt of the opinion of the Authority and taking into account that opinion, a Regulation on the setting, modification or deletion of an MRL or a Decision rejecting the application shall be prepared by the Commission without delay and at the latest within three months, and submitted for adoption in accordance with the procedure referred to in Article 45(2).

2.   With regard to the acts referred to in paragraph 1, account shall be taken of:

3.   The Commission may request at any time that supplementary information be provided by the applicant or by the Authority. The Commission shall make available any supplementary information received to the Member States and the Authority.

Article 15

Inclusion of new or modified MRLs in Annexes II and III

1.   The Regulation referred in Article 14(1) shall:

2.   Where a temporary MRL is set as provided for in paragraph 1(b), it shall be deleted from Annex III by a Regulation one year after the date of the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substance concerned, in accordance with the procedure referred to in Article 45(2) of this Regulation. However, where one or more Member States so requests, it may be maintained for an additional year pending confirmation that any scientific studies necessary for supporting an application for setting a MRL have been undertaken. In cases where such confirmation is provided, the temporary MRL shall be maintained for a further two years, provided that no unacceptable safety concerns for the consumer have been identified.

Article 16

Procedure for setting temporary MRLs in certain circumstances

1.   The Regulation referred to in Article 14(1) may also set a temporary MRL to be included in Annex III in the following circumstances:

2.   The inclusion of temporary MRLs as referred to in paragraph 1 shall be based on the opinion of the Authority, monitoring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals.

The continued validity of the temporary MRLs referred to in paragraph 1(a), (b) and (c) shall be reassessed at least once every 10 years and any such MRLs shall be modified or deleted as appropriate.

The MRLs referred to in paragraph 1(d) shall be reassessed at the expiry of the period for which the essential use was authorised.

Article 17

Modifications of MRL following revocation of authorisations of plant protection products

Amendments to Annexes II or III needed to delete an MRL following the revocation of an existing authorisation for a plant protection product may be adopted without seeking the opinion of the Authority.

CHAPTER III

MRLS APPLICABLE TO PRODUCTS OF PLANT AND ANIMAL ORIGIN

Article 18

Compliance with MRLs

1.   The products covered by Annex I shall not contain, from the time they are placed on the market as food or feed, or fed to animals, any pesticide residue exceeding:

2.   Member States may not prohibit or impede the placing on the market or the feeding to food-producing animals within their territories of the products covered by Annex I on the grounds that they contain pesticide residues provided that:

3.   By way of derogation from paragraph 1, Member States may authorise, further to a post-harvest treatment with a fumigant on their own territory, residue levels for an active substance which exceed the limits specified in Annexes II and III for a product covered by Annex I where the active substance/product combinations are listed in Annex VII provided that:

The active substance/product combinations listed in Annex VII shall be defined in accordance with the procedure referred to in Article 45(2).

4.   In exceptional circumstances, and in particular further to the use of plant protection products in accordance with Article 8(4) of Directive 91/414/EEC or in pursuance of obligations in Directive 2000/29/EC (14), a Member State may authorise the placing on the market and/or the feeding to animals within its territory of treated food or feed not complying with paragraph 1, provided that such food or feed does not constitute an unacceptable risk. Such authorisations shall immediately be notified to the other Member States, the Commission and the Authority, together with an appropriate risk assessment for consideration without undue delay in accordance with the procedure referred to in Article 45(2), with a view to setting a temporary MRL for a specified period or taking any other necessary measure in relation to such products.

Article 19

Prohibition concerning processed and/or composite products

The processing, and/or mixing for dilution purposes with the same or other products, of the products covered by Annex I not complying with Articles 18(1) or 20 with a view to placing them on the market as food or feed or feeding them to animals shall be prohibited.

Article 20

MRLs applicable to processed and/or composite products

1.   Where MRLs are not set out in Annexes II or III for processed and/or composite food or feed, the MRLs applicable shall be those provided in Article 18(1) for the relevant product covered by Annex I, taking into account changes in the levels of pesticide residues caused by processing and/or mixing.

2.   Specific concentration or dilution factors for certain processing and/or mixing operations or for certain processed and/or composite products may be included in the list in Annex VI in accordance with the procedure referred to in Article 45(2).

CHAPTER IV

SPECIAL PROVISIONS RELATING TO THE INCORPORATION OF EXISTING MRLS INTO THIS REGULATION

Article 21

First establishment of MRLs

1.   MRLs for products covered by Annex I shall be first established and listed in Annex II in accordance with the procedure referred to in Article 45(2), incorporating the MRLs provided for under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, taking into account the criteria mentioned in Article 14(2) of this Regulation.

2.   Annex II shall be established within 12 months from the entry into force of this Regulation.

Article 22

First establishment of temporary MRLs

1.   Temporary MRLs for active substances for which a decision on inclusion or non-inclusion in Annex I to Directive 91/414/EEC has not yet been taken shall be first established and listed in Annex III to this Regulation, unless already listed in Annex II hereto, in accordance with the procedure referred to in Article 45(2), taking into account the information provided by the Member States, where relevant the reasoned opinion mentioned in Article 24, the factors referred to in Article 14(2) and the following MRLs:

2.   Annex III shall be established within 12 months from the entry into force of this Regulation in accordance with Articles 23, 24 and 25.

Article 23

Information to be provided by the Member States on national MRLs

Where an active substance is not yet included in Annex I to Directive 91/414/EEC and where a Member State has set, by the date of entry into force of Annex I to this Regulation at the latest, a national MRL for that active substance for a product covered by Annex I to this Regulation, or has decided that no MRL is required for that active substance, the Member State concerned shall notify the Commission, in a format and by a date to be established in accordance with the procedure referred to in Article 45(2) of the national MRL, or the fact that no MRL is required for an active substance, and where relevant and at the request of the Commission:

Article 24

Opinion of the Authority on data underlying national MRLs

1.   At the request of the Commission, the Authority shall provide a reasoned opinion to the Commission on potential risks to consumer health arising from:

2.   In preparing the reasoned opinion referred to in paragraph 1, the Authority shall take into account the scientific and technical knowledge available, and in particular, information provided by the Member States as required by Article 23.

Article 25

Setting of temporary MRLs

Taking into account the opinion of the Authority, if such opinion is requested, temporary MRLs for active substances referred to in Article 23 may be set and listed in Annex III pursuant to Article 22(1) or, as appropriate, the active substance may be included in Annex IV pursuant to Article 5(1).

CHAPTER V

OFFICIAL CONTROLS, REPORTS AND SANCTIONS

SECTION 1

OFFICIAL CONTROLS OF MRLS

Article 26

Official controls

1.   Without prejudice to Directive 96/23/EC (15), Member States shall carry out official controls on pesticide residues in order to enforce compliance with this Regulation, in accordance with the relevant provisions of Community law relating to official controls for food and feed.

2.   Such controls on pesticide residues shall, in particular, consist of sampling and subsequent analysis of the samples and identification of the pesticides present and their respective residue levels.

Article 27

Sampling

1.   Each Member State shall take a sufficient number and range of samples to ensure that the results are representative of the market, taking into account the results of previous control programmes. Such sampling shall be carried out as close to the point of supply as is reasonable, to allow for any subsequent enforcement action to be taken.

2.   The sampling methods necessary for carrying out such controls of pesticide residues in products other than those provided for in Directive 2002/63/EC (16) shall be determined in accordance with the procedure referred to in Article 45(2) of this Regulation.

Article 28

Methods of Analysis

1.   The methods of analysis of pesticide residues shall comply with the criteria set out in the relevant provisions of Community law relating to official controls for food and feed.

2.   Technical guidelines dealing with the specific validation criteria and quality control procedures in relation to methods of analysis for the determination of pesticide residues may be adopted in accordance with the procedure referred to in Article 45(2).

3.   All laboratories analysing samples for the official controls on pesticide residues shall participate in the Community Proficiency Tests for pesticide residues organised by the Commission.

SECTION 2

COMMUNITY CONTROL PROGRAMME

Article 29

Community Control Programme

1.   The Commission shall prepare a coordinated multiannual Community control programme, identifying specific samples to be included in the national control programmes and taking into account problems that have been identified regarding compliance with the MRLs set out in this Regulation, with a view to assessing consumer exposure and the application of current legislation.

2.   The Community control programme shall be adopted and updated every year in accordance with the procedure referred to in Article 45(2). The draft Community control programme shall be presented to the Committee referred to in Article 45(1) at least six months before the end of each calendar year.

SECTION 3

NATIONAL CONTROL PROGRAMMES

Article 30

National control programmes for pesticide residues

1.   Member States shall establish multiannual national control programmes for pesticide residues. They shall update their multiannual programme every year.

Those programmes shall be risk-based and aimed in particular at assessing consumer exposure and compliance with current legislation. They shall specify at least the following:

2.   Member States shall submit their updated national control programmes for pesticide residues, as mentioned in paragraph 1, to the Commission and to the Authority at least three months before the end of each calendar year.

3.   Member States shall participate in the Community Control Programme as provided for in Article 29.

SECTION 4

INFORMATION BY THE MEMBER STATES AND ANNUAL REPORT

Article 31

Information by the Member States

1.   Member States shall submit the following information concerning the previous calendar year to the Commission, the Authority and the other Member States by 31 August each year:

2.   Implementing measures relating to the submission of information by the Member States may be established in accordance with the procedure referred to in Article 45(2) after consultation with the Authority.

Article 32

The Annual Report on pesticide residues

1.   On the basis of the information provided by the Member States under Article 31(1) the Authority shall draw up an Annual Report on pesticide residues.

2.   The Authority shall include information on at least the following in the Annual Report:

3.   Where a Member State has not provided information in accordance with Article 31, the Authority may disregard the information relating to that Member State when compiling the Annual Report.

4.   The format of the Annual Report may be decided in accordance with the procedure referred to in Article 45(2).

5.   The Authority shall submit the Annual Report to the Commission by the last day of February each year.

6.   The Annual Report may include an opinion on the pesticides to be covered in future programmes.

7.   The Authority shall make public the Annual Report, as well as any comments by the Commission or Member States.

Article 33

Submission of the Annual Report on pesticide residues to the Committee

The Commission shall submit the Annual Report on pesticide residues to the Committee referred to in Article 45(1) without delay, for review and recommendations on any necessary measures to be taken regarding reported infringements of the MRLs set out in Annexes II and III.

SECTION 5

SANCTIONS

Article 34

Sanctions

The Member States shall lay down rules on the sanctions applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The sanctions provided for must be effective, proportionate and dissuasive.

The Member States shall notify those rules and any subsequent amendment to the Commission without delay.

CHAPTER VI

EMERGENCY MEASURES

Article 35

Emergency measures

Articles 53 and 54 of Regulation (EC) 178/2002 shall apply where, as a result of new information or of a reassessment of existing information, pesticide residues or MRLs covered by this Regulation may endanger human or animal health requiring immediate action.

CHAPTER VII

SUPPORT MEASURES RELATING TO HARMONISED PESTICIDE MRLS

Article 36

Support measures relating to harmonised pesticide MRLs

1.   Support measures relating to harmonised pesticide MRLs shall be established at Community level, including:

2.   Any necessary implementing provisions concerning the measures referred to in paragraph 1 may be adopted in accordance with the procedure referred to in Article 45(2).

Article 37

Community contribution to the support measures for harmonised pesticide MRLs

1.   The Community may make a financial contribution of up to 100 % of the cost of the measures provided for in Article 36.

2.   The appropriations shall be authorised each financial year as part of the budgetary procedure.

CHAPTER VIII

COORDINATION OF APPLICATIONS FOR MRLS

Article 38

Designation of national authorities

Each Member State shall designate one or more national authorities to coordinate cooperation with the Commission, the Authority, other Member States, manufacturers, producers and growers for the purposes of this Regulation. Where more than one authority is designated by a Member State, it shall indicate which of the designated authorities shall act as a contact point.

The national authorities may delegate tasks to other bodies.

Each Member State shall inform the Commission and the Authority of the names and addresses of the designated national authorities.

Article 39

Coordination by the Authority of information on MRLs

The Authority shall:

Article 40

Information to be submitted by the Member States

Member States shall submit to the Authority, at its request, any available information necessary for the assessment of the safety of MRLs.

Article 41

Database of the Authority on MRLs

Without prejudice to the applicable provisions of Community and national law on access to documents, the Authority shall develop and maintain a database, accessible to the Commission and to the competent authorities of the Member States, containing the relevant scientific information and GAPs relating to the MRLs, the active substances and the processing factors set out in Annexes II, III, IV and VII. In particular it shall contain dietary intake assessments, processing factors and toxicological endpoints.

Article 42

Member States and Fees

1.   Member States may recover the costs of work associated with setting, modifying or deleting MRLs, or with any other work arising from obligations under this Regulation, by means of a fee or charge.

2.   Member States shall ensure that the fee or charge referred to in paragraph 1:

It may include a scale of fixed charges based on average costs for the work referred to in paragraph 1.

CHAPTER IX

IMPLEMENTATION

Article 43

Scientific opinion of the Authority

The Commission or the Member States may request the Authority for a scientific opinion on any measure related to the assessment of risks under this Regulation. The Commission may specify the time limit within which such an opinion shall be provided.

Article 44

Procedure for the adoption of the Authority's opinions

1.   When the Authority's opinions pursuant to this Regulation require only scientific or technical work involving the application of well-established scientific or technical principles they may, unless the Commission or a Member State objects, be issued by the Authority without consulting the scientific committee or the scientific panels mentioned in Article 28 of Regulation (EC) No 178/2002.

2.   The implementing rules pursuant to Article 29(6)(a) of Regulation (EC) No 178/2002 shall specify the cases in which paragraph 1 above shall apply.

Article 45

Committee Procedure

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Article 58 of Regulation (EC) No 178/2002 (hereinafter referred to as ‘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 set at three months.

3.   The Committee shall adopt its rules of procedure.

Article 46

Implementing measures

In accordance with the procedure referred to in Article 45(2) and, where appropriate, taking into account the opinion of the Authority, the following shall be established or may be amended:

Article 47

Report on implementation of this Regulation

Not later than 10 years after the entry into force of this Regulation, the Commission shall forward to the European Parliament and to the Council a report on its implementation and any appropriate proposals.

CHAPTER X

FINAL PROVISIONS

Article 48

Repeal and adaptation of legislation

1.   Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC are hereby repealed with effect from the date referred to in the second paragraph of Article 50.

2.   Article 4(1)(f) of Directive 91/414/EEC shall be replaced by the following:

Article 49

Transitional Measures

1.   The requirements of Chapter III shall not apply to products lawfully produced or imported into the Community before the date referred to in the second paragraph of Article 50.

However, in order to ensure a high level of consumer protection, appropriate measures concerning those products may be taken in accordance with the procedure referred to in Article 45(2).

2.   Where it is necessary in order to allow for the normal marketing, processing and consumption of products, further transitional measures may be laid down for the implementation of certain MRLs provided for in Articles 15, 16, 21, 22, and 25.

Those measures, which shall be without prejudice to the obligation to ensure a high level of consumer protection, shall be adopted in accordance with the procedure referred to in Article 45(2).

Article 50

Entry into force

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

Chapters II, III and V shall apply as from six months from the publication of the last of the Regulations establishing Annexes I, II, III and IV.

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

Done at Brussels,

For the European Parliament

The President

For the Council

The President

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(1)OJ C 234, 30.9.2003, p. 33.

(2)  Opinion of the European Parliament of 20 April 2004 (OJ C 104 E, 30.4.2004), Council Common Position of 19 July 2004 and position of the European Parliament of .......... (not yet published in the Official Journal).

(3)OJ L 340, 9.12.1976, p. 26. Directive as last amended by Regulation (EC) No 807/2003, (OJ L 122, 16.5.2003, p. 36).

(4)OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2004/61/EC, (OJ L 127, 29.4.2004, p. 81).

(5)OJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive 2004/61/EC.

(6)OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2004/61/EC.

(7)OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/71/EC (OJ L 127, 29.4.2004, p. 14).

(8)OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (EC) No 807/2003.

(9)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).

(10)OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commission Directive 2003/100/EC (OJ L 285, 1.11.2003, p. 33).

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

(12)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1). Directive as last amended by Regulation (EC) No 1882/2003, (OJ L 284, 31.10.2003, p. 1).

(13)  Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 546/2004 (OJ L 87, 25.3.2004, p. 13).

(14)  Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1). Directive as last amended by Commission Directive 2004/70/EC (OJ L 127, 29.4.2004, p. 97).

(15)  Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10). Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(16)  Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p. 30).

(17)  OJ L .... .’

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

On 14 March 2003 the Council received from the Commission a proposal for a Regulation of the European Parliament and of the Council on maximum residue levels of pesticides in products of plant and animal origin.

The European Parliament adopted its opinion at a first reading on 20 April 2004. The European Economic and Social Committee adopted its opinion on 16 July 2003.

The Council adopted its common position on 19 July 2004, in accordance with the procedure laid down in Article 251 of the Treaty.

II.   OBJECTIVES

The proposal overhauls and streamlines European pesticides legislation by replacing four existing Council Directives with a single Regulation. The aim of the new, harmonised provisions is twofold: to facilitate trade within the Single Market and with third countries, import tolerances being granted to exporters to the EU in certain cases, and to ensure a consistent level of consumer protection across the Community. The proposal also provides for the role of the European Food Safety Authority (EFSA) in this field. Under the new provisions, as amended by the Council, following a transitional period, MRLs would only be set at Community level through a procedure where Member States assess the need for an MRL and submit an evaluation report to the Commission. EFSA would be responsible for risk assessment based on the Member State evaluation report and data received from applicants, while the Commission would handle risk management by setting MRLs.

III.   ANALYSIS OF THE COMMON POSITION

A.   GENERAL OBSERVATIONS

The Council's common position broadly accords with the positions taken by the Commission and the Parliament, inasmuch as it:

In particular, the Council agreed with a series of parliamentary amendments aiming to ensure the smooth functioning of the new procedures and to increase consistency between the new Regulation and other Community legislation. In addition, the Council felt that it was appropriate to introduce further amendments, for example, to allow Member States the flexibility to deal with MRL exceedences that arise in certain exceptional cases. The Council also reordered and reformatted parts of the text of the Regulation so as to clarify the roles of the Member States, EFSA and the Commission and to separate transitional provisions from the standard procedures under the new regime. A number of technical and editorial amendments were also introduced.

B.   SPECIFIC COMMENTS

(a)   Application procedure: the respective roles of the EFSA and the Member States

In its proposal, the Commission had foreseen an exclusive role for EFSA in scientific evaluation work and the setting of MRLs. However, the Council agreed with the Parliament that Member States should perform a preliminary analysis of MRL applications in line with established procedures under Directive 91/414/EEC. In addition, the Council agreed that a copy of MRL applications received by Member States should immediately be sent to the Commission and to EFSA (Article 8).

(b)   Procedure for routine work performed by EFSA

In the light of the substantial workload foreseen for EFSA, the Council introduced a new article designed to avoid unnecessary consultation of scientific bodies on matters of routine, i.e. in cases where EFSA issues opinions purely based on well-established scientific principles (Article 44). This provision is analogous to Article 31 of Regulation 178/2002/EC.

(c)   Administrative review

A new article was added with a view to providing a form of legal redress regarding decisions taken by EFSA and also in the event of non-action by EFSA (Article 13).

(d)   Time scale and transition to the new procedures

To ensure a smooth transition to the new provisions, the Council followed the Parliament in setting down specific deadlines for the completion of the principal technical annexes, which will set out a list of harmonised MRLs (Annex II), a list of harmonised temporary MRLs (Annex III) and a list of active substances for which no MRLs are required (Annex IV). In the same spirit, the Council also introduced a deadline for drawing up the annex listing the products to which harmonised MRLs will apply (Annex I). Like Parliament, the Council considered that the Regulation should not apply in full until after the crucial annexes have been drawn up (Articles 4, 5, 21, 22 and 50).

(e)   Possibility to extend the validity of temporary MRLs

In order to facilitate a smooth transition to a fully harmonised regime (e.g. where Member States indicate that extra time is required to complete scientific studies on substances that have been authorised nationally), the Council decided that it should be possible for temporary MRLs, which will normally be valid for one year, to be maintained in Annex III for up to three additional years in certain cases (Article 15).

(f)   The use of pesticides for post-harvest treatment

A derogation was introduced in order to provide for the practice of post-harvest fumigation of products (e.g. with a view to protecting them against pests during storage and transport, which can entail the temporary exceedence of MRLs while the product remains in storage or transit) (Article 18(3)).

(g)   The use of pesticides in exceptional circumstances

In order to provide for exceptional circumstances (e.g. when an emergency use of a plant protection product is required to control pest(s) in accordance with Article 8(4) of Directive 91/414/EEC), emergency provisions were introduced allowing a Member State to authorise the placing on the market and/or the feeding to animals within its territory of food or feed that is not in compliance with the MRLs laid down in the Regulation. Such authorisations are to be notified to the other Member States, the Commission and EFSA, with a view to setting temporary MRLs and taking any other necessary actions. Such authorisations can only be granted provided that the treated food or feed does not constitute an unacceptable risk to consumers (Article 18(4)).

(h)   Definitions

In redrafting the text to improve legal clarity, the Council added two new definitions, namely ‘critical GAP’ (i.e. the Good Agricultural Practice that forms the basis for a harmonised MRL under the Regulation) and ‘CXL’ (i.e. an MRL set by the Codex Alimentarius Commission), and deleted the definition of ‘composite foodstuffs’. In addition, the Council followed the European Parliament in clarifying the definition of ‘pesticide residues’ (Article 3).

(i)   Technical and editorial amendments

A large number of other changes, including technical adjustments and clarifications, were also made.

(j)   Amendments not accepted by Council

Further discussion is needed, in particular, on issues associated with risk assessment, and on provisions concerning the use of plant protection products, where Council was unable to agree to a number of Parliament's amendments at this stage. Such items concern, in particular, approaches to exposure assessment in the context of MRL-setting, considerations surrounding the most appropriate way of providing information to the public, and the drafting of provisions concerning good agricultural practice and pest management.

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COMMON POSITION (EC) No 2/2005

adopted by the Council on 24 September 2004

with a view to the adoption of Decision No.../2005/EC of the European Parliament and of the Council of... establishing a multiannual Community programme to make digital content in Europe more accessible, usable and exploitable

(Text with EEA relevance)

(2005/C 25E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 157(3) thereof,

Having regard to the proposal from the Commission,

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

After consulting the Committee of the Regions,

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

Whereas:

HAVE DECIDED AS FOLLOWS:

Article 1

Objective of the Programme

1.   This Decision establishes a Community programme for the period 2005 to 2008 to make digital content in Europe more accessible, usable and exploitable, facilitating the creation and diffusion of information — in areas of public interest — at Community level.

The programme shall be known as the ‘eContentplus’ programme (hereinafter ‘the Programme’).

2.   In order to attain the overall aim of the Programme, the following lines of action shall be addressed:

The activities to be carried out under those lines of action target areas of public sector information, spatial data and educational, cultural and scientific content as set out in Annex I. The Programme shall be implemented in accordance with Annex II.

Article 2

Participation

1.   Participation in the Programme shall be open to legal entities established in the Member States. It shall also be open to participation of legal entities established in the candidate countries in accordance with bilateral agreements in existence or to be concluded with those countries.

2.   Participation in the Programme may be opened to legal entities established in EFTA States which are contracting parties to the EEA Agreement, in accordance with the provisions of that Agreement.

3.   Participation in the Programme may be opened, without financial support by the Community, to legal entities established in third countries and to international organisations, where such participation contributes effectively to the implementation of the Programme. The decision to allow such participation shall be adopted in accordance with the procedure referred to in Article 4(2).

Article 3

Competences of the Commission

1.   The Commission shall be responsible for the implementation of the Programme.

2.   The Commission shall draw up a work programme on the basis of this Decision.

3.   In the implementation of the Programme, the Commission shall, in close cooperation with the Member States, ensure general consistency and complementarity with other relevant Community policies, programmes and actions that impinge upon the development and use of European digital content and the promotion of linguistic diversity in the information society, in particular the Community research and technological development programmes, IDA, eTEN, eInclusion, eLearning, MODINIS and Safer Internet.

4.   The Commission shall act in accordance with the procedure referred to in Article 4(2) for the purposes of the following:

5.   The Commission shall inform the committee referred to in Article 4 of progress with the implementation of the Programme.

Article 4

Committee

1.   The Commission shall be assisted by a committee.

2.   Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three months.

3.   The Committee shall adopt its rules of procedure.

Article 5

Monitoring and Evaluation

1.   In order to ensure that Community aid is used efficiently, the Commission shall ensure that actions under this Decision are subject to prior appraisal, follow-up and subsequent evaluation.

2.   The Commission shall monitor the implementation of projects under the Programme. The Commission shall evaluate the manner in which the projects have been carried out and the impact of their implementation in order to assess whether the original objectives have been achieved.

3.   The Commission shall report on the implementation of the lines of action referred to in Article 1(2) to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions by mid-2006 at the latest. In this context, the Commission shall report on the consistency of the amount for 2007 and 2008 with the financial perspective. If applicable, the Commission shall take the necessary steps within the budgetary procedures for 2007 and 2008 to ensure the consistency of the annual appropriations with the financial perspective. The Commission shall submit a final evaluation report at the end of the Programme.

4.   The Commission shall forward the results of its quantitative and qualitative evaluations to the European Parliament and the Council together with any appropriate proposals for the amendment of this Decision. The results shall be forwarded before presentation of the draft general budget of the European Union for the years 2007 and 2009 respectively.

Article 6

Financial framework

1.   The financial framework for the implementation of the Community actions under this Decision for the period from 1 January 2005 to 31 December 2008 is hereby set at EUR 135 million, of which EUR 55,6 million is for the period until 31 December 2006.

2.   For the period following 31 December 2006, the amount shall be deemed to be confirmed if it is consistent for this phase with the financial perspective in force for the period commencing in 2007.

3.   The annual appropriations for the period from 2005 to 2008 shall be authorised by the budgetary authority within the limits of the financial perspective. An indicative breakdown of expenditure is given in Annex III.

Done at Brussels,

For the European Parliament

The President

For the Council

The President

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(1)OJ C 117, 30.4.2004, p. 49.

(2)  Opinion of the European Parliament of 22 April 2004 (OJ C 104 E, 30.4.2004), Council Common Position of 24 September 2004 and Position of the European Parliament of .......... (not yet published in the Official Journal).

(3)OJ L 14, 18.1.2001, p. 32.

(4)  Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the reuse of public sector information (OJ L 345, 31.12.2003, p. 90).

(5)  Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society, (OJ L 167, 22.6.2001, p. 10).

(6)  Directive 96/9 EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases (OJ L 77, 27.3.1996, p. 20).

(7)  Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(8)  Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).

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

(10)OJ C 172, 18.6.1999, p. 1. Agreement as amended by Decision 2003/429/EC of the European Parliament and of the Council (OJ L 147, 14.6.2003, p. 25).

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ANNEX I

ACTIONS

I.   INTRODUCTION

eContentplus has the overall aim of making digital content in Europe more accessible, usable and exploitable, facilitating the creation and diffusion of information – in areas of public interest – at Community level.

It will create better conditions for accessing and managing digital content and services in multilingual and multicultural environments. It will broaden users' choice and support new ways of interacting with knowledge-enhanced digital content, a feature which is becoming essential to make content more dynamic and tailored to specific contexts (learning, cultural, people with special needs, etc.).

The Programme will pave the way for a structured framework for quality digital content in Europe — The European Digital Content Area — by facilitating transfer of experiences, best practice and cross-fertilisation between content sectors, content providers and users.

Three lines of action are foreseen:

II.   LINES OF ACTION

A.   Facilitating at Community level access to digital content, its use and exploitation

The activities to be carried out under this line of action encompass the establishment of networks and alliances between stakeholders, encouraging the creation of new services.

Target areas are public sector information, spatial data, learning and cultural content.

The focus will be on:

B.   Facilitating improvement of quality and enhancing best practice related to digital content between content providers and users, and across sectors

The activities to be carried out under this line of action are intended to facilitate the identification and wide diffusion of best practice in methods, processes and operations to achieve higher quality, greater efficiency and effectiveness in the creation, use and distribution of digital content.

These activities encompass experiments that demonstrate searchability, usability, reusability, composability and interoperability of digital content within the context of the existing legal framework while meeting from the early stage of the process the requirements of different target groups and markets in an increasingly multilingual and multicultural environment, and extending beyond mere localisation technologies.

These activities will exploit the benefits of enhancing digital content with machine-understandable data (semantically well-defined metadata based on relevant descriptive terminology, vocabularies and ontologies).

The experiments will be conducted in thematic clusters. The gathering, dissemination and cross-sector fertilisation of gained knowledge will be an integral part of the experiments.

Target application areas are public sector information, spatial data, digital learning and cultural content, as well as scientific and scholarly digital content.

C.   Reinforcing cooperation between digital content stakeholders and awareness

The activities to be carried out under this line of action include measures accompanying relevant legislation relating to digital content, and fostering increased collaboration between digital content stakeholders, as well as awareness building. These activities will support the development of benchmarking, monitoring and analysis tools, the impact assessment of the Programme and the dissemination of results. They will identify and analyse emerging opportunities and problems (e.g. trust, quality marking, intellectual property rights in education) and propose, as appropriate, solutions.

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ANNEX II

THE MEANS FOR IMPLEMENTING THE PROGRAMME

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ANNEX III

INDICATIVE BREAKDOWN OF EXPENDITURE

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

II.   OBJECTIVE

The purpose of this proposal is to create conditions for broader access to and use of digital content and where necessary for greater economic return from services based on access and (re)use of digital content through making a significant contribution to the eEurope strategy in sectors such as e-learning, e-government etc (a succession programme to the current eContent programme expiring end-2004).

III.   ANALYSIS OF THE COMMON POSITION

The common position shares the overall objective of the proposal submitted by the Commission, and also, in general terms, the proposed means of attaining that objective. However, in the course of discussion within the Council, the text of the proposal has partly been reworded. The main points of the common position which differ from the Commission proposal and the European Parliaments amendments (see below point IV) are as follows:

IV.   EUROPEAN PARLIAMENT AMENDMENTS

1.   European Parliament amendments accepted by the Commission and adopted by the Council

2.   European Parliament amendments accepted by the Commission but not adopted by the Council

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(1)OJ C 98, 23.4.2004, p. 39.

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COMMON POSITION (EC) No 3/2005

adopted by the Council on 7 October 2004

with a view to the adoption of Directive 2005/..../EC of the European Parliament and of the Council of... on ship-source pollution and on the introduction of sanctions for infringements

(Text with EEA relevance)

(2005/C 25E/03)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,

Having regard to the proposal from the Commission,

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

Having regard to the opinion of the Committee of the Regions,

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

WHEREAS:

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Purpose

1.   The purpose of this Directive is to ensure that persons responsible for ship-source pollution are subject to appropriate sanctions, in order to improve maritime safety and to enhance protection of the marine environment from pollution by ships.

2.   This Directive does not prevent Member States from taking more stringent measures against ship-source pollution in conformity with international law.

Article 2

Definitions

For the purpose of this Directive:

Article 3

Scope

1.   This Directive shall apply, in accordance with international law, to discharges of polluting substances in:

2.   This Directive shall apply to discharges of polluting substances from any ship, irrespective of its flag, with the exception of any warship, naval auxiliary or other ship owned or operated by a State and used, for the time being, only on government non-commercial service.

Article 4

Infringements

Member States shall ensure that ship-source discharges of polluting substances into any of the areas referred to in Article 3(1) are regarded as infringements if committed with intent, recklessly or by serious negligence.

Article 5

Exceptions

1.   A discharge of polluting substances into any of the areas referred to in Article 3(1) shall not be regarded as an infringement if it satisfies the conditions set out in Annex I, Regulations 11(a) or 11(c) or in Annex II, Regulations 6(a) or 6(c) of Marpol 73/78.

2.   A discharge of polluting substances into the areas referred to in Article 3(1)(c), (d) and (e) shall not be regarded as an infringement for the owner, the master or the crew when acting under the master's responsibility if it satisfies the conditions set out in Annex I, Regulation 11(b) or in Annex II, Regulation 6(b) of Marpol 73/78.

3.   A discharge of polluting substances into any of the areas referred to in Article 3(1) shall not be regarded as an infringement if it satisfies the conditions set out in Annex I, Regulations 9 or 10 or in Annex II, Regulation 5 of Marpol 73/78.

Article 6

Enforcement measures with respect to ships within a port of a Member State

1.   If irregularities or information give rise to a suspicion that a ship which is voluntarily within a port or at an off-shore terminal of a Member State has been engaged in or is engaging in a discharge of polluting substances into any of the areas referred to in Article 3(1), that Member State shall ensure that an appropriate inspection, taking into account the relevant guidelines adopted by the International Maritime Organisation (IMO) is undertaken in accordance with its national law.

2.   Insofar as the inspection referred to in paragraph 1 reveals facts that could indicate an infringement within the meaning of Article 4, the competent authorities of that Member State and of the flag State shall be informed.

Article 7

Enforcement measures by coastal States with respect to ships in transit

1.   If the suspected discharge of polluting substances takes place in the areas referred to in Article 3(1)(b), (c), (d) or (e) and the ship which is suspected of the discharge does not call at a port of the Member State holding the information relating to the suspected discharge, the following shall apply:

2.   Where there is clear objective evidence that a ship navigating in the areas referred to in Article 3(1)(b) or (d) has, in the area referred to in Article 3(1)(d), committed an infringement resulting in a discharge causing major damage or a threat of major damage to the coastline or related interests of the Member State concerned, or to any resources of the areas referred to in Article 3(1)(b) or (d), that State shall, subject to Part XII, Section 7 of the 1982 United Nations Convention on the Law of the Sea, provided that the evidence so warrants, submit the matter to its competent authorities with a view to instituting proceedings, including detention of the ship, in accordance with its national law.

3.   In any case, the authorities of the flag State shall be informed.

Article 8

Sanctions

1.   Member States shall take the necessary measures to ensure that the infringements referred to in Article 4 are subject to effective, proportionate and dissuasive sanctions, which may include criminal or administrative sanctions.

2.   Each Member State shall take the measures necessary to ensure that the sanctions referred to in paragraph 1 apply to any person who is found responsible for an infringement as referred to in Article 4.

Article 9

Compliance with international law

Member States shall apply the provisions of this Directive without any discrimination in form or in fact among foreign ships and in accordance with applicable international law, including Section 7 of Part XII of the 1982 United Nations Convention on the Law of the Sea, and they shall promptly notify the flag State of the vessel and any other State concerned of measures taken in accordance with this Directive.

Article 10

Accompanying measures

For the purposes of this Directive, Member States and the Commission shall cooperate, where appropriate, in close collaboration with the European Maritime Safety Agency and, where appropriate, in the framework of the action programme to respond to accidental or deliberate marine pollution as set up by Decision No 2850/2000/EC (3) in order to:

Article 11

Reporting

Every three years, Member States shall transmit a report to the Commission on the application of this Directive by the competent authorities. On the basis of these reports, the Commission shall submit a Community report to the European Parliament and the Council.

Article 12

Committee

1.   The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS), created by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS). (4)

2.   The Commission shall regularly inform the Committee set up by Decision No 2850/2000/EC of any proposed measures or other relevant activities concerning the response to marine pollution.

Article 13

Amendment procedure

Amendments to Marpol 73/78 as referred to in Article 2, point 1 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002.

Article 14

Implementation

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than.............. (5) and forthwith inform the Commission thereof.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 15

Entry into force

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

Article 16

Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament

The President

For the Council

The President

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(1)OJ C 220, 16.9.2003, p. 72.

(2)  Opinion of the European Parliament of 13 January 2004 (OJ C 92E, 21.4.2004, p. 77).

(3)  Decision No 2850/2000/EC of the European Parliament and of the Council of 20 December 2000 setting up a Community framework for cooperation in the field of accidental or deliberate marine pollution (OJ L 332, 28.12.2000, p. 1). Decision amended by Decision No 787/2004/EC (OJ L 138, 30.4.2004, p. 12).

(4)OJ L 324, 29.11.2002, p. 1. Regulation as amended by Commission Regulation (EC) No 415/2004 (OJ L 68, 6.3.2004, p. 10).

(5)  18 months following the date of its entry into force.

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ANNEX

Summary, for reference purposes, of the Marpol 73/78 discharge regulations relating to discharges of oil and noxious liquid substances, as referred to in Article 2.2

PART I:   OIL (MARPOL 73/78, ANNEX I)

For the purposes of Marpol 73/78 Annex I, ‘oil’ means petroleum in any form including crude oil, fuel oil, sludge, oil refuse and refined products (other than petrochemicals which are subject to the provisions of Marpol 73/78 Annex II) and ‘oily mixture’ means a mixture with any oil content.

Excerpts of the relevant provisions of Marpol 73/78 Annex I:

Regulation 9:   Control of discharge of oil

Regulation 10:   Methods for the prevention of oil pollution from ships while operating in special areas

Regulation 11:   Exceptions

Regulations 9 and 10 of this Annex shall not apply to:

PART II:   NOXIOUS LIQUID SUBSTANCES (MARPOL 73/78 ANNEX II)

Excerpts of the relevant provisions of Marpol 73/78 Annex II:

Regulation 3:   Categorisation and listing of noxious liquid substances

Regulation 5:   Discharge of noxious liquid substances

Category A, B and C substances outside special areas and Category D substances in all areas

Subject to the provisions of [...] regulation 6 of this Annex,

Category A, B and C substances within special areas [as defined in Marpol 73/78 Annex II, Regulation 1, including the Baltic Sea]

Subject to the provisions of paragraph 14 of this regulation and regulation 6 of this Annex,

Regulation 6:   Exceptions

Regulation 5 of this Annex shall not apply to:

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

In the framework of the codecision procedure (Article 251/TEC), the Council reached, on 11 June 2004, a political agreement on the draft Directive of the European Parliament and of the Council on ship-source pollution and on the introduction of sanctions for infringements (1). Following legal/linguistic revision, the Council adopted its common position on 7 October 2004.

In taking its position, the Council took account of the opinion of the European Parliament in its first reading on 13 January 2004 (2) and of the opinion of the Economic and Social Committee (3) (4).

The Directive aims at transposing into Community law the international rules on ship-source pollution of the Marpol Convention, by providing that violations of the discharge rules are infringements, and establishing harmonised rules for their enforcement. It also aims at extending the rules, on the one hand, to cover discharges of oil resulting from damages when committed intentionally, recklessly or by serious negligence and, on the other hand, to ensure the widest possible enforcement under the United Nations Convention on the Law of the Sea (Unclos).

II.   ANALYSIS OF THE COMMON POSITION

In the aftermath of the accident of the oil tanker Prestige, the Council emphasised not only the importance of the maritime safety policy but the necessity to ensure that any person who has caused or contributed to a pollution incident through grossly negligent behaviour should be subject to appropriate sanctions. The approach adopted by the Council to this Commission proposal, submitted in March 2003 and backed by a European Council conclusion that same month highlighting the choice of the appropriate legal basis, is founded on the principle of making full use of the Community's rights under Unclos, whilst complying with Member States' obligations under the International Convention for the Prevention of Pollution from Ships (Marpol).

The Council considers that the transposition of the Marpol regime regarding ship-source pollution into Community law will ensure a stricter and more harmonised application and enforcement in the Member States. It shares the view that it is necessary to establish that all discharges of polluting substances are considered infringements if they are committed with intent, recklessly or by serious negligence.

Following the principle of respecting the Marpol provisions, exceptions are provided in the case when a discharge is made in order to save lives or the ship itself. The exception under the Marpol Convention concerning the owner and the master in cases of discharges resulting from accidents applies in international sea areas and the exclusive economic or equivalent zone of Member States. In these cases, as a logical consequence of the Marpol provisions, the crew is protected when acting under the master's responsibility. In Member States' internal waters and territorial sea, on the other hand, the Council deems it appropriate to exercise the Community's rights under Article 211(4) of Unclos, in order to enhance the protection of the coastline, and to lift the exception provided for discharges resulting from accidents.

The Council considers that sanctions against infringements of ship-source pollution have to be effective, proportionate and dissuasive and may include criminal or administrative sanctions. It also agrees that these sanctions have to apply to any person found responsible for marine pollution, i.e. shall cover the whole chain of responsibility. Whilst the infringements are defined in the Directive, the Council is of the view that the minimum binding rules for criminal penalties, liability and jurisdiction should be established in the parallel Framework Decision proposed by the Commission and examined by the Council in its ‘Justice and Home Affairs’ formation.

The Council welcomes the streamlining of strict enforcement measures against ships calling at any port of a Member State in line with the relevant international guidelines. It endorses the enhanced information sharing on suspected discharges between Member States and third countries, either as port or as flag States, in order to facilitate the enforcement of the appropriate measures.

Finally, the Council is of the view that all possibilities under the Unclos Convention to protect the coastline and the resources of this area shall be used, including enforcement measures by coastal States with respect to ships in transit navigating in the territorial sea or exclusive economic or equivalent zone in accordance with Article 220(6) of Unclos, when there is clear objective evidence of a discharge causing major damage or threat of major damage to the coastline or any resources of the territorial sea or the exclusive economic or equivalent zone. In this case, the Member State concerned shall submit the matter to its competent authorities with a view to instituting proceedings, including detention of the ship, in accordance with its national law.

III.   AMENDMENTS

Considering the fact that the Council follows a considerably different approach to this draft Directive compared to the originally proposed text, as pointed out above, it was not possible to reflect the major part of the amendments proposed by the European Parliament in first reading in the common position.

The common position includes some other smaller modifications and clarifications to the Commission proposal. On a few points, amendments proposed by the European Parliament were partially or totally integrated with a view to ensuring a consistent legislative text.

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(1)  The Commission presented its proposal on 7 March 2003 (OJ C 76, 25.3.2004, p. 5) under the title ‘Proposal for a Directive of the European Parliament and of the Council on ship-source pollution and on the introduction of sanctions, including criminal sanctions, for pollution offences’.

(2)  Doc. 5181/04 CODEC 24 MAR 2 ENV 8 DROIPEN 1 (not yet published in the Official Journal).

(3)OJ C 220, 16. 9.2003, p. 72.

(4)  The Committee of the Regions decided not to deliver an opinion.

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COMMON POSITION (EC) No 4/2005

adopted by the Council on 21 October 2004

with a view to the adoption of Decision No.../2005/EC of the European Parliament and of the Council of... amending Decision No 1419/1999/EC establishing a Community action for the European Capital of Culture event for the years 2005 to 2019

(2005/C 25E/04)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 151 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Committee of the Regions (1),

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

Whereas:

HAVE DECIDED AS FOLLOWS:

Article 1

Decision 1419/1999/EC is hereby amended as follows:

Article 2

This Decision shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

It shall apply from 1 May 2004.

Done at Luxembourg,

For the European Parliament

The President

For the Council

The President

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(1)OJ C 121, 30.4.2004, p. 15.

(2)  Opinion of the European Parliament of 22 April 2004 (OJ C 104 E, 30.4.2004), Council Common Position of 21 October 2004 and Position of the European Parliament of ... (not yet published in the Official Journal).

(3)OJ L 166, 1.7.1999, p. 1.

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ANNEX

ORDER OF ENTITLEMENT TO NOMINATE A ‘EUROPEAN CAPITAL OF CULTURE’

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(1)  The Culture/Audiovisual Council, at its meeting of 28 May 1998, noted the exchange of positions between Greece and the Netherlands in accordance with Article 2(1) of Decision 1419/1999/EC.

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

II.   AIM OF THE PROPOSAL

The proposal aims to allow the new Member States to participate in the European Capital of Culture event before the current decision expires in 2019. It does not change the existing order of entitlement for nominations from Member States, but establishes a new system appointing two Member States eligible to submit nominations each year from 2009 onwards, so that two capitals may be selected in the Member States.

III.   ANALYSIS OF THE COMMON POSITION

1.   General comments

The Council did not make any amendment to the Commission's proposal. The Commission accepted in full one of the five amendments proposed by the Parliament (amendment 1).

2.   Amendments made by the European Parliament

2.1.   Amendments accepted by the Council

The Council endorsed in full the amendment proposed by the Parliament and accepted by the Commission (amendment 1).

2.2.   Amendments not integrated by the Council

The Council, like the Commission, considered that amendments 2, 3, 4 and 5 went beyond the scope of the proposal and did not regard it as appropriate to incorporate them.

III.   CONCLUSIONS

The Council considers that its common position is balanced and fully in line with the main objective of the Commission's proposal, thereby facilitating the participation of the new Member States in the European Capital of Culture event as soon as possible.

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(1)OJ C 121, 30.4.2004, p. 15.

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COMMON POSITION (EC) No 5/2005

adopted by the Council on 12 November 2004

with a view to the adoption of Regulation (EC) No.../2005 of the European Parliament and of the Council of... on conditions for access to the natural gas transmission networks

(Text with EEA relevance)

(2005/C 25E/05)

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,

Following consultation of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (1),

Whereas:

HAVE ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1.   This Regulation aims at setting non-discriminatory rules for access conditions to natural gas transmission systems taking into account the specificities of national and regional markets with a view to ensuring the proper functioning of the internal gas market.

This objective shall include the setting of harmonised principles for tariffs, or the methodologies underlying their calculation, for access to the network, the establishment of third party access services and harmonised principles for capacity allocation and congestion management, the determination of transparency requirements, balancing rules and imbalance charges and facilitating capacity trading.

2.   Member States may establish an entity or body set up in compliance with Directive 2003/55/EC for the purpose of carrying out one or more functions typically attributed to the transmission system operator, which shall be subject to the requirements of this Regulation.

Article 2

Definitions

1.   For the purpose of this Regulation, the following definitions shall apply:

2.   The definitions contained in Article 2 of Directive 2003/55/EC, which are relevant for the application of this Regulation, shall also apply with the exception of the definition of transmission in point 3 of that Article.

Article 3

Tariffs for access to networks

1.   Tariffs, or the methodologies used to calculate them, applied by transmission system operators and approved by the regulatory authorities pursuant to Article 25(2) of Directive 2003/55/EC, as well as tariffs published pursuant to Article 18(1) of that Directive, shall be transparent, take into account the need for system integrity and its improvement and reflect actual costs incurred whilst ensuring appropriate incentives with respect to efficiency, including appropriate return on investments, and where appropriate taking account of the benchmarking of tariffs by the regulatory authorities. Tariffs, or the methodologies used to calculate them, shall be applied in a non-discriminatory manner.

Member States may decide that tariffs may also be determined through market-based arrangements, such as auctions, provided that such arrangements and the revenues arising therefrom are approved by the regulatory authority.

Tariffs, or the methodologies used to calculate them, shall facilitate efficient gas trade and competition, while at the same time avoiding cross-subsidies between network users and providing incentives for investment and maintaining or creating interoperability for transmission networks.

2.   Tariffs for network access shall not restrict market liquidity nor distort trade across borders of different transmission systems. Where differences in tariff structures or balancing mechanisms would hamper trade across transmission systems, and notwithstanding Article 25(2) of Directive 2003/55/EC, transmission system operators shall, in close cooperation with the relevant national authorities, actively pursue convergence of tariff structures and charging principles including in relation to balancing.

Article 4

Third party access services

1.   Transmission system operators shall:

2.   Transportation contracts signed with non-standard start dates or with a shorter duration than a standard annual transportation contract shall not result in arbitrarily higher or lower tariffs not reflecting the market value of the service, in accordance with the principles laid down in Article 3(1).

3.   Where appropriate, third party access services may be granted subject to appropriate guarantees from network users with respect to the creditworthiness of such users. Such guarantees must not constitute any undue market entry barriers and must be non-discriminatory, transparent and proportionate.

Article 5

Principles of capacity allocation mechanisms and congestion management procedures

1.   The maximum capacity at all relevant points referred to in Article 6(3) shall be made available to market participants, taking into account system integrity and efficient network operation.

2.   Transmission system operators shall implement and publish non-discriminatory and transparent capacity allocation mechanisms, which shall:

3.   When transmission system operators conclude new transportation contracts or renegotiate existing transportation contracts, these contracts shall take into account the following principles:

4.   When capacity contracted under existing transportation contracts remains unused and contractual congestion occurs, transmission system operators shall apply paragraph 3 unless this would infringe the requirements of the existing transportation contracts. Where this would infringe the existing transportation contracts, transmission system operators shall, following consultation with the competent authorities, submit a request to the network user for the use on the secondary market of unused capacity in accordance with paragraph 3.

5.   In the event that physical congestion exists, non-discriminatory, transparent capacity allocation mechanisms shall be applied by the transmission system operator or, as appropriate, the regulatory authorities.

Article 6

Transparency requirements

1.   Transmission system operators shall make public detailed information regarding the services they offer and the relevant conditions applied, together with the technical information necessary for network users to gain effective network access.

2.   In order to ensure transparent, objective and non-discriminatory tariffs and facilitate efficient utilisation of the gas network, transmission system operators or relevant national authorities shall publish reasonably and sufficiently detailed information on tariff derivation, methodology and structure.

3.   For the services provided, each transmission system operator shall make public information on technical, contracted and available capacities on a numerical basis for all relevant points including entry and exit points on a regular and rolling basis and in a user-friendly standardised manner.

4.   The relevant points of a transmission system on which the information must be made public shall be approved by the competent authorities after consultation with network users.

5.   Where a transmission system operator considers that it is not entitled for confidentiality reasons to make public all the data required, it shall seek the authorisation of the competent authorities to limit publication with respect to the point or points in question.

The competent authorities shall grant or refuse the authorisation on a case-by-case basis, taking into account in particular the need to respect legitimate commercial confidentiality and the objective of creating a competitive internal gas market. If the authorisation is granted, available capacity shall be published without indicating the numerical data that would contravene confidentiality.

No such authorisation as referred to in this paragraph shall be granted where three or more network users have contracted capacity at the same point.

6.   Transmission system operators shall always disclose the information required by this Regulation in a meaningful, quantifiably clear and easily accessible way and on a non-discriminatory basis.

Article 7

Balancing rules and imbalance charges

1.   Balancing rules shall be designed in a fair, non-discriminatory and transparent manner and shall be based on objective criteria. Balancing rules shall reflect genuine system needs taking into account the resources available to the transmission system operator.

2.   In the case of non-market based balancing systems, tolerance levels shall be designed in a way that either reflects seasonality or results in a tolerance level higher than that resulting from seasonality, and that reflects the actual technical capabilities of the transmission system. Tolerance levels shall reflect genuine system needs taking into account the resources available to the transmission system operator.

3.   Imbalance charges shall be broadly cost-reflective, whilst providing appropriate incentives on network users to balance their input and off-take of gas. They shall avoid cross-subsidisation between network users and shall not hamper the entry of new market entrants.

Any calculation methodology for imbalance charges as well as the final tariffs shall be made public by the competent authorities or the transmission system operator as appropriate.

4.   Transmission system operators may impose penalty charges on network users whose input into and off-take from the transmission system is not in balance according to the balancing rules referred to in paragraph 1.

5.   Penalty charges which exceed the actual balancing costs incurred shall be taken into account when calculating tariffs in a way that does not reduce the interest in balancing and shall be approved by the competent authorities.

6.   In order to enable network users to take timely corrective action, transmission system operators shall provide sufficient, well-timed and reliable on-line based information on the balancing status of network users. The level of information provided shall reflect the level of information available to the transmission system operator. Where they exist, charges for the provision of such information shall be approved by the competent authorities and shall be made public by the transmission system operator.

7.   Member States shall ensure that transmission system operators endeavour to harmonise balancing regimes and streamline structures and levels of balancing charges in order to facilitate gas trade.

Article 8

Trading of capacity rights

Each transmission system operator shall take reasonable steps to allow capacity rights to be freely tradable and to facilitate such trade. Each such operator shall develop harmonised transportation contracts and procedures on the primary market to facilitate secondary trade of capacity and recognise the transfer of primary capacity rights where notified by network users. The harmonised transportation contracts and procedures shall be notified to the regulatory authorities.

Article 9

Guidelines

1.   Where appropriate, Guidelines providing the minimum degree of harmonisation required to achieve the aim of this Regulation shall specify:

2.   Guidelines on the issues listed in paragraph 1 are laid down in the Annex. They may be amended by the Commission; this shall be done in accordance with the procedure referred to in Article 14(2).

3.   The application and amendment of Guidelines adopted pursuant to this Regulation shall reflect differences between national gas systems, and shall therefore not require uniform detailed terms and conditions of third party access at Community level. They may, however, set minimum requirements to be met to achieve non-discriminatory and transparent network access conditions necessary for an internal gas market, which may then be applied in the light of differences between national gas systems.

Article 10

Regulatory authorities

When carrying out their responsibilities under this Regulation, the regulatory authorities of the Member States established under Article 25 of Directive 2003/55/EC shall ensure compliance with this Regulation and the Guidelines adopted pursuant to Article 9 of this Regulation.

Where appropriate they shall cooperate with each other and with the Commission.

Article 11

Provision of information

Member States and the regulatory authorities shall, on request, provide to the Commission all information necessary for the purposes of Article 9.

The Commission shall fix a reasonable time limit within which the information is to be provided, taking into account the complexity of the information required and the urgency with which the information is needed.

Article 12

Right of Member States to provide for more detailed measures

This Regulation shall be without prejudice to the rights of Member States to maintain or introduce measures that contain more detailed provisions than those set out in this Regulation and the Guidelines referred to in Article 9.

Article 13

Penalties

1.   The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 1 July 2006 at the latest and shall notify it without delay of any subsequent amendment affecting them.

2.   Penalties provided for pursuant to paragraph 1 shall not be of a criminal law nature.

Article 14

Committee procedure

1.   The Commission shall be assisted by the Committee set up by Article 30 of Directive 2003/55/EC.

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 set at three months.

3.   The Committee shall adopt its Rules of Procedure.

Article 15

Commission Report

The Commission shall monitor the implementation of this Regulation. In its report under Article 31(3) of Directive 2003/55/EC, the Commission shall also report on the experience gained in the application of this Regulation. In particular the report shall examine to what extent the Regulation has been successful in ensuring non-discriminatory and cost-reflective network access conditions for gas transmission networks in order to contribute to customer choice in a well functioning internal market and to long-term security of supply. If necessary, the report shall be accompanied by appropriate proposals and/or recommendations.

Article 16

Derogations and exemptions

This Regulation shall not apply to:

Article 17

Entry into force

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

It shall apply from 1 July 2006 with the exception of the second sentence of Article 9(2), which shall apply from 1 January 2007.

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

Done at Brussels,

For the European Parliament

The President

For the Council

The President

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(1)  Opinion of the European Parliament of 20 April 2004 (OJ C 104 E, 30.4.2004) and Council Decision of ....

(2)OJ L 176, 15.7.2003, p. 57.

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

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ANNEX

GUIDELINES ON

1.   THIRD PARTY ACCESS SERVICES

2.   PRINCIPLES UNDERLYING CAPACITY ALLOCATION MECHANISMS, CONGESTION MANAGEMENT PROCEDURES AND THEIR APPLICATION IN THE EVENT OF CONTRACTUAL CONGESTION

2.1.   Principles underlying capacity allocation mechanisms and congestion management procedures

2.2.   Congestion management procedures in the event of contractual congestion

3.   DEFINITION OF THE TECHNICAL INFORMATION NECESSARY FOR NETWORK USERS TO GAIN EFFECTIVE ACCESS TO THE SYSTEM, THE DEFINITION OF ALL RELEVANT POINTS FOR TRANSPARENCY REQUIREMENTS AND THE INFORMATION TO BE PUBLISHED AT ALL RELEVANT POINTS AND THE TIME SCHEDULE ACCORDING TO WHICH THIS INFORMATION SHALL BE PUBLISHED

3.1.   Definition of the technical information necessary for network users to gain effective access to the system

Transmission system operators shall publish at least the following information about their systems and services:

3.2.   Definition of all relevant points for transparency requirements

Relevant points shall include at least:

3.3.   Information to be published at all relevant points and the time schedule according to which this information should be published

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

II.   OBJECTIVE OF THE PROPOSAL

The proposal aims at completing the Internal Gas Market Directive (2003/55/EC) adopted last year by setting fair and detailed rules for third party access to the gas transmission networks of Member States, taking into account the specificities of national and regional markets. It can be seen as a parallel to Regulation (EC) 1228/2003 on conditions for access to the network for cross-border exchanges in electricity, adopted as part of the internal market package. The proposal builds on a set of guidelines agreed on a voluntary basis by the European Gas Regulatory Forum (Madrid Forum) which will receive a binding character through the proposed Regulation.

III.   ANALYSIS OF THE COMMON POSITION

1.   GENERAL REMARKS

All the changes which the Council has introduced to the Commission proposal have been accepted by the Commission.

2.   SPECIFIC REMARKS

IV.   CONCLUSIONS

The Council believes that to a large extent the common position meets the substance of most of the wishes expressed by the European Parliament, and that it will contribute to the achievement and the proper functioning of the internal gas market.

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