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 Index 
Texts adopted
Wednesday, 3 July 2002 - Strasbourg
EC-Japan agreement concerning cooperation on anticompetitive activities * (procedure without report)
 Public health (2003-2008) ***III
 Draft supplementary and amending budget No 3/2002
 Genetically modified organisms (GMOs) ***I
 Genetically modified food and feed ***I
 Major-accident hazards involving dangerous substances ***I
 EC framework programme (research 2002-2006) ***I
 EAEC framework programme (research 2002-2006) *
 European Central Bank (annual report 2001)
 Sexual and reproductive health and rights

EC-Japan agreement concerning cooperation on anticompetitive activities * (procedure without report)
PDF 4kWORD 23k
Proposal for a Council and Commission decision concluding the Agreement between the European Communities and the Government of Japan concerning cooperation on anticompetitive activities [COM(2002) 230 - C5-0290/2002 - 2002/0106(CNS)]

(Consultation procedure)

The proposal was approved.


Public health (2003-2008) ***III
PDF 196kWORD 26k
European Parliament legislative resolution on the joint text approved by the Conciliation Committee for a European Parliament and Council decision adopting a programme of Community action in the field of public health (2003-2008) (PE-CONS 3627/2002 – C5&nbhy;0204/2002 – 2000/0119(COD))
P5_TA(2002)0351A5-0234/2002

(Codecision procedure: third reading)

The European Parliament,

–   having regard to the joint text approved by the Conciliation Committee and the relevant Commission statements (PE-CONS 3627/2002 – C5&nbhy;0204/2002),

–   having regard to its position at first reading(1) on the Commission proposal to Parliament and the Council (COM(2000) 285(2)),

–   having regard to the amended proposal (COM(2001) 302(3)),

–   having regard to its position at second reading(4) on the Council common position(5),

–   having regard to the Commission's opinion on Parliament's amendments to the common position (COM(2002) 29 &nbhy; C5&nbhy;0032/2002),

–   having regard to Article 251(5) of the EC Treaty,

–   having regard to Rule 83 of its Rules of Procedure,

–   having regard to the report of its delegation to the Conciliation Committee (A5&nbhy;0234/2002),

1.  Approves the joint text and draws attention to the Commission statements thereon;

2.  Instructs its President to sign the act with the President of the Council pursuant to Article 254(1) of the EC Treaty;

3.  Instructs its Secretary-General duly to sign the act and, in agreement with the Secretary-General of the Council, to have it published, together with the statements by the Commission thereon, in the Official Journal of the European Communities;

4.  Instructs its President to forward this legislative resolution to the Council and Commission.

(1) OJ C 21 E, 24.1.2002, p. 161.
(2) OJ C 337 E, 28.11.2000, p. 122.
(3) OJ C 240 E, 28.8.2001, p. 168.
(4) Texts Adopted, 12.12.2001, Item 13.
(5) OJ C 307, 31.10.2001, p. 27.


Draft supplementary and amending budget No 3/2002
PDF 199kWORD 28k
European Parliament resolution on draft supplementary and amending budget No 3/2002 of the European Union for the 2002 financial year (SEC(2002) 626 – 10426(2002 – C5-0318/2002 – 2002/2128(BUD))
P5_TA(2002)0352A5-0248/2002

The European Parliament,

–   having regard to Article 272 of the EC Treaty, Article 78 of the ECSC Treaty and Article 177 of the Euratom Treaty,

–   having regard to the Financial Regulation of 21 December 1977 applicable to the general budget of the European Communities, as last amended by Regulation (EC, ECSC, Euratom) No 762/2001(1), and in particular Article 15 thereof,

–   having regard to the general budget of the European Union for the 2002 financial year, as finally adopted on 13 December 2001(2),

–   having regard to the Interinstitutional Agreement of 6 May 1999 between the European Parliament, the Council and the Commission on budgetary discipline and improvement of the budgetary procedure(3),

–   having regard to Draft Supplementary and Amending Budget No 2/2002, which was established by the Council on 12 March 2002 (7033/2002– C5-0131/2002),

–   having regard to its resolution of 30 May 2002 on Draft Supplementary and Amending Budget No 2/2002 of the European Union for the 2002 financial year(4),

–   having regard to Preliminary Draft Supplementary and Amending Budget No 3/2002 of the European Union for the 2002 financial year, which was presented by the Commission on 5 June 2002 (SEC(2002) 626),

–   having regard to Draft Supplementary and Amending Budget No 3/2002 which was established by the Council on 27 June 2002 (10426/2002 - C5-0318/2002),

–   having regard to Rule 92 of and Annex IV to its Rules of Procedure,

–   having regard to the report of the Committee on Budgets (A5-0248/2002),

A.   whereas Draft Supplementary and Amending Budget No 3/2002 enters the amounts carried over from 2001 as revenue in the 2002 budget, and whereas the total surplus of EUR 15 billion corresponds almost entirely to the under-implementation of payment appropriations in 2001,

B.   whereas virtually all the EUR 15 billion surplus has already been repaid to the Member States in the form of provisional amounts approved when the 2002 budget was adopted (EUR 1.2 billion) and under Supplementary and Amending Budget No 2/2002 (EUR 10 billion); whereas the remaining amount contained in Draft Supplementary and Amending Budget No 3/2002 is therefore EUR 3.8 billion,

C.   whereas the issue of the problems caused by the under-implementation of the payment appropriations available has already been raised by Parliament in connection with the SAB No 2/2002 procedure,

D.   whereas Draft Supplementary and Amending Budget No 3/2002 also includes a number of adjustments to the 2002 budget which are necessary following the entry into force of Council Decision 2000/597/EC, Euratom of 29 September 2000 on the system of the European Communities' own resources(5) and following the updating of the estimates relating to customs duties and the VAT and GNP bases of assessment,

1.  Notes that the final surplus for the 2002 financial year was EUR 15 billion and calls once again on the Commission to present a detailed analysis of the causes of such a situation and to put forward proposals designed to remedy it;

2.  Recalls its concern (previously expressed in its abovementioned resolution on Draft Supplementary and Amending Budget No 2/2002) regarding the accumulation of outstanding payments and its invitation to the Commission to assess the situation by 30 September 2002 with a view, where necessary, to making appropriate adjustments either under the general transfer procedure or by means of a supplementary budget;

3.  Approves without amendment Draft Supplementary and Amending budget No 3/2002, which was established by the Council on 27 June 2002;

4.  Instructs its President to forward this resolution to the Council, the Commission, the Court of Auditors and the Economic and Social Committee.

(1) OJ L 111, 20.4.2001, p. 1.
(2) OJ L 29, 31.1.2002.
(3) OJ C 172, 18.6.1999, p. 1.
(4) P5_TA(2002)0263.
(5) OJ L 253, 7.10.2000, p. 42.


Genetically modified organisms (GMOs) ***I
PDF 239kWORD 174k
Resolution
Consolidated text
European Parliament legislative resolution on the proposal for a European Parliament and Council regulation concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (COM(2001) 182 – C5&nbhy;0380/2001 – 2001/0180(COD))
P5_TA(2002)0353A5-0229/2002

(Codecision procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2001) 182(1)),

–   having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5&nbhy;0380/2001),

–   having regard to Rule 67 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Consumer Policy and the opinions of the Committee on Industry, External Trade, Research and Eneergy and the Committee on Agriculture and Rural Development (A5&nbhy;0229/2002),

1.  Approves the Commission proposal as amended;

2.  Asks to be consulted again should the Commission intend to amend the proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council and Commission.

Position of the European Parliament adopted at first reading on 3 July 2002 with a view to the adoption of European Parliament and Council Regulation (EC) No .../2002 concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms

P5_TC1-COD(2001)0180


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95(1) thereof,

Having regard to the proposal from the Commission(2),

Having regard to the opinion of the Economic and Social Committee(3),

Having regard to the opinion of the Committee of the Regions(4),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(5),

Whereas:

(1)  Directive 2001/18/EC of the European Parliament and the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EEC of the Council(6), as amended by Regulation (EC) No …/2002 [on genetically modified food and feed](7), requires Member States to take measures to ensure traceability and labelling of authorised genetically modified organisms (GMOs) at all stages of their placing on the market.

(2)  It is necessary to ensure that reliable information is available to consumers on GMOs and the products, food and feed produced therefrom.

(3)  Differences between national laws, regulations and administrative provisions concerning traceability and labelling of GMOs as products or in products as well as traceability of food and feed produced from GMOs may hinder their free movement, creating conditions of unequal and unfair competition.A harmonised Community framework for traceability and labelling of GMOs should contribute to the effective functioning of the internal market.

(4)  Account must be taken of the precautionary principle in implementing this Regulation. In exceptional cases, where there is a risk to health or the environment, but where scientific data is as yet uncertain, the precautionary principle may be used to decide which risk management measures or other steps will be taken to ensure the high level of health protection that the Community desires.

(5)  Traceability requirements for GMOs should facilitate both the withdrawal of products where unforeseen adverse effects to human health, animal health or the environment are established, and the targeting of monitoring to examine potential effects on, in particular, the environment.

(6)  Traceability requirements for food and feed produced from GMOs should be established to facilitate accurate labelling of such products, in accordance with the requirements of Regulation (EC) No …/2002 [on genetically modified food and feed], so as to enable operators and consumers to exercise their freedom of choice in an effective manner as well as control and verification of labelling claims. Requirements for food and feed produced from GMOs should be similar in order to avoid discontinuity of information in cases of change in end use.

(7)  Transmission and retention of information that products contain or consist of GMOs, and the unique codes for those GMOs, at each stage of their placing on the market provides the basis for appropriate traceability and labelling for GMOs. The codes may be used to access specific information on GMOs from a register, and to facilitate their identification, detection and monitoring in accordance with Directive 2001/18/EC.

(8)  Transmission and retention of information that food and feed have been produced from GMOs also provides the basis for appropriate traceability of products produced from GMOs.

(9)  Guidance on sampling and detection should be developed in order to facilitate a coordinated approach for control and inspection, and provide legal certainty for operators.

(10)  Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation.

(11)  Certain traces of materials produced from GMOs in products may be adventitious or technically unavoidable. To cover cases of adventitious or technically unavoidable traces of material produced from GMOs, a threshold should be set, which should be identical to the threshold established in accordance with Regulation (EC) No .../2002 [on genetically modified food and feed]. As and when advances in science and technology allow, appropriately lower thresholds should be established.

(12)  Since the measures necessary for the implementation of this Regulation are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8), they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

(13)  Systems for the development and assignment of unique codes for GMOs should be established before the measures relating to traceability and labelling can be applied.

(14)  This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union,

HAVE ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation provides a framework for the traceability of genetically modified organisms (GMOs), and food and feed produced from GMOs, with the objective of, in accordance with the precautionary principle:

   - protecting human and animal health,
   - protecting the environment and ecosystems,
   - ensuring the smooth operation of the internal market, while recognising the priority which must be accorded to human health and the environment and to the right of the consumer to be given the necessary information to make a free and independent choice, and monitoring the products by means of tracing and labelling,
   - giving consumers the right of free and independent choice,
   - allowing effective measures to be introduced to prevent the unintended presence of GMOs or products thereof in other food or feed, and
   - enabling such products to be withdrawn immediately, rapidly and totally in the event that they should prove harmful or hazardous.

Article 2

Scope

1.  This Regulation shall apply, at all stages of the placing on the market, to:

   a) products consisting of, or containing GMOs, placed on the market in accordance with Community legislation;
   b) foods and food ingredients, including food additives and flavourings, produced from GMOs, placed on the market in accordance with Community legislation;
   c) feed materials, compound feedingstuffs and feed additives, produced from GMOs, placed on the market in accordance with Community legislation.

2.  This Regulation shall not apply to medicinal products for human and veterinary use authorised under the provisions of Council Regulation (EEC) No 2309/93(9).

Article 3

Definitions

For the purpose of this Regulation:

   1) 'genetically modified organism' (GMO) means genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, with the exception of organisms yielded by the techniques of genetic modification listed in Annex IB of that Directive;
   2) 'produced from GMOs' means derived, in whole or in part, from GMOs;
   3) "traceability' means the ability to trace GMOs and products produced from GMOs at all stages of their placing on the market through the production and distribution chains;
   4) 'unique code' means a simple numeric or alphanumeric code which serves to identify a GMO on the basis of the authorised transformation event from which it was developed and providing the means to retrieve specific information pertinent to that GMO;
   5) 'operator' means a person who places a product on the market and also a person who receives a product that has been placed on the market in the Community, either from a Member State of the EU or from a third country, at any stage of the production and distribution chain, but does not include the ultimate consumer;
   6) 'food' means food as defined in Article 2 of European Parliament and Council Regulation (EC) No 178/2002(10);
   7) 'food additive' means food additive as defined in Article 1(2) of Council Directive 89/107/EEC(11);
   8) 'flavouring' means flavouring as defined in Article 1(2) of Council Directive 88/388/EEC(12);
   9) 'feed' or 'feedingstuff' means feed or feedingstuff as defined in Article 3(4) of Regulation (EC) No 178/2002;
   10) 'compound feedingstuffs' means compound feedingstuffs as defined in Article 2(b) of Council Directive 79/373/EEC(13);
   11) 'feed materials' means feed materials as defined in Article 2(a) of Council Directive 96/25/EC(14);
   12) "feed additives' means additives as defined in Article 2(a) of Council Directive 70/524/EEC(15);
   13) "placing on the market' means making available to third parties, whether in return for payment or free of charge;

Making available genetically modified micro-organisms for activities regulated under Council Directive 90/219/EEC(16), including culture collections, shall not be regarded as placing on the market;

   14) 'the first stage of the placing on the market of a product' means the initial transaction in the production and distribution chains, where a product is made available to a third party;
   15) 'pre-packaged' means any single item for sale, consisting of a product and the packaging into which it was put before being offered for sale, whether such packaging encloses the product completely or only partially, but in such a way that the contents cannot be altered without opening or changing the packaging.

Article 4

Traceability and labelling requirements for GMOs

1.  When placing pre-packaged products consisting of, or containing, GMOs on the market, operators shall ensure that the words 'This product contains genetically modified organisms' or 'This product contains genetically modified (or GM) ... (name of crop or GMO)' appear on the label.

2.  At the first stage of the placing on the market of a product consisting of or containing GMOs, including bulk quantities, operators shall ensure that the following information is transmitted to the operator receiving the product:

   a) that it contains or consists of GMOs;
   b) the unique code(s) assigned to those GMOs in accordance with Article 8.

3.  At all subsequent stages of the placing on the market of products referred to in paragraph 2, operators shall ensure that the information received in accordance with paragraph 2 is transmitted to the operators receiving the products.

4.  Without prejudice to Article 6, operators shall have in place systems and standardised procedures to allow the identification, for a period of ten years from each transaction, of the person from whom and to whom the products referred to in paragraph 2 have been made available.

5.  Paragraphs 1 to 4 are without prejudice to other specific requirements in Community legislation.

Article 5

Traceability requirements for products produced from GMOs

1.  When placing products produced from GMOs on the market, operators shall ensure that the following information is transmitted to operators receiving the product:

   a) an indication of each of the food ingredients, including additives and flavouring(s), which is produced from GMOs;
   b) an indication of each of the feed materials or additives which is produced from GMOs;
   c) in the case of products for which no list of ingredients exists, an indication that the product is produced from GMOs.

2.  When placing pre-packaged products produced from GMOs on the market, operators shall ensure that the information referred to in paragraph 1 is transmitted to operators receiving the product and, in addition, that either the words "This product is produced from GMOs" or the words "This product contains [ingredient] produced from GMOs" appear on a label and in connection with the display and the advertising of the product.

3.  With reference to the GMOs from which the product is made, transmission of information in accordance with paragraph 1 shall include the unique code assigned to the GMO in question in accordance with Article 8.

4.  Without prejudice to Article 6, operators shall have in place systems and procedures to allow the identification, for a period of ten years from each transaction, of the person from whom and to whom the products referred to in paragraph 1 have been made available.

5.  Paragraphs 1 and 4 are without prejudice to other specific requirements in Community legislation.

Article 6

Exemptions

1.  In cases where Community legislation provides for specific identification systems, such as lot or batch numbering for pre-packaged products, operators who receive the pre-packaged product shall be obliged to retain the information specified in Articles 4(2) and (3) and 5(1), provided that this information and the lot or batch number is clearly marked on the package and that information about batch or lot numbers is retained for the period of time referred to in Articles 4(4) and 5(4).

2.  By way of derogation from Articles 4(3), 4 (4) and 5(4), operators delivering food to the ultimate consumer shall not be obliged to retain documentation detailing to whom products were sold.

3.  Products intended for direct use as food or feed or for processing which contain traces of materials produced from GMOs shall be exempt from the requirements of Article 5, provided the materials produced from GMOs have been authorised in accordance with Regulation (EC) No .../2002 [on genetically modified food and feed] and their proportion is no higher than established in accordance with that Regulation.

Article 7

Guide to good segregation practice for foodstuffs and food ingredients

The Member States shall encourage and contribute to the drawing up of guides to good segregation practice, which businesses in the food industry shall apply in order to avoid the risks of adventitious or technically unavoidable contamination of foodstuffs with genetically modified material.

Article 8

Unique codes

In accordance with the procedure referred to in Article 10(2), the Commission shall:

   a) prior to the application of Articles 1 to 6 and taking into account international developments, establish the system for development and assignment of unique codes to GMOs;
   b) adapt the system provided for in point (a), as appropriate, taking into account further developments in international fora.

Article 9

Inspection and control measures

1.  Member States shall ensure that inspections, risk assessment on the basis of sample checks and testing (quantitative and qualitative) and other control measures, as appropriate, are carried out to ensure compliance with this Regulation.

2.  Prior to the application of Articles 1 to 6, the Commission shall, in accordance with the procedure laid down in Article 10(2), develop and publish technical guidance on sampling, testing and methods to ensure a coordinated approach for the implementation of paragraph 1.

3.  In developing the above technical guidance, the Commission shall take account of the work of the committee referred to in Article 58(1) of Regulation (EC) No 178/2002 and of the rules of the Community reference laboratory laid down pursuant to Regulation (EC) No .../2002 [on genetically modified food and feed].

4.  In order to support the Member States in meeting the requirements set out in paragraphs 1 and 2, the Commission shall ensure that a central register is put in place at Community level, which shall contain all available sequencing information and reference material for GMOs authorised to be put into circulation in the Community. The competent authorities in the Member States shall have access to the register. The register shall also contain, where available, relevant information concerning GMOs not authorised in the European Union.

Article 10

Committee

1.  The Commission shall be assisted by the committee referred to in Article 58(1) of Regulation (EC) No 178/2002.

2.  Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Articles 7 and 8 thereof.

3.  The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 11

Penalties

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. Member States shall notify those provisions to the Commission, by .... (17)and shall notify it without delay of any subsequent amendment affecting them.

Article 12

Entry into force

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

2.  Articles 1 to 6 and Article 9(1) shall apply with effect from the ninetieth day following the date of publication in the Official Journal of the European Communities of the measure referred to in Article 8(a) and must be consistent with Directive 2001/18/EC. Before the date of application of the measure referred to in Article 8(a), no GMOs, or food or feed products consisting of, containing or produced from GMOs, shall be approved.

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

Done at,

For the European Parliament For the Council

The President The President

(1) OJ C 304E, 30.10.2001, p. 327.
(2) OJ C 304 E, 30.10.2001, p. 327.
(3) OJ C 125, 27.5.2002, p. 69.
(4) OJ C ...
(5) Position of the European Parliament of 3 July 2002.
(6) OJ L 106, 17.4.2001, p. 1.
(7) OJ L ...
(8) OJ L 184, 17.7.1999, p. 23.
(9) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).
(10) OJ L 31, 1.2.2002, p. 1.
(11) OJ L 40, 11.2.1989, p. 27. Directive as last amended by European Parliament and Council Directive 94/34/EC (OJ L 237, 10.9.1994, p. 1).
(12) OJL 184, 15.7.1988, p. 61. Directive as last amended by Commission Directive 91/71/EC (OJ L 42, 15.2.1991, p. 25).
(13) OJ L 86, 6.4.1979, p. 30. Directive as last amended by European Parliament and Council Directive 2002/2/EC (OJ L 63, 6.3.2002, p. 23).
(14) OJ L 125, 23.5.1996, p. 35. Directive as last amended by European Parliament and Council Directive 2001/46/EC (OJ L 234, 1.9.2001, p. 55).
(15) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) n. 2205/2001 (OJ L 297, 15.11.2001, p. 3).
(16) OJ L 117, 8.5.1990, p. 1. Directive as last amended by Decision 2001/204/EC (OJ L 73, 15.3.2001, p. 32).
(17)* 180 days following the date of publication of this Regulation in the Official Journal of the European Communities.


Genetically modified food and feed ***I
PDF 543kWORD 427k
Resolution
Consolidated text
Annex
European Parliament legislative resolution on the proposal for a European Parliament and Council regulation on genetically modified food and feed (COM(2001) 425 – C5&nbhy;0368/2001 – 2001/0173(COD))
P5_TA(2002)0354A5-0225/2002

(Codecision procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2001) 425(1)),

–   having regard to Article 251(2) and Articles 37, 95 and 152(4) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0368/2001),

–   having regard to Rule 67 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Consumer Policy and the opinions of the Committee on Legal Affairs and the Internal Market and the Committee on Agriculture and Rural Development (A5-0225/2002),

1.  Approves the Commission proposal as amended;

2.  Asks to be consulted again should the Commission intend to amend the proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council and Commission.

Position of the European Parliament adopted at first reading on 3 July 2002 with a view to the adoption of European Parliament and Council Regulation (EC) No .../2002 on genetically modified food and feed

P5_TC1-COD(2001)0173


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95 and 152 (4) (b) thereof,

Having regard to the proposal from the Commission(2),

Having regard to the opinion of the Economic and Social Committee(3),

Having regard to the opinion of the Committee of the Regions(4),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(5),

Whereas:

(1)  The free movement of safe and wholesome food and feed is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2)  A high level of protection of human life and health should be ensured in the pursuit of Community policies.

(3)  Account must be taken of the precautionary principle in implementing this Regulation. In exceptional cases, where there is a risk to health or the environment, but where scientific data is as yet uncertain, the precautionary principle may be used to decide which risk management measures or other steps will be taken to ensure the high level of health protection that the Community desires.

(4)  In order to protect human and animal health, food and feed consisting of, containing or produced from genetically modified organisms (hereunder called "genetically modified food and feed") should undergo a safety assessment through a Community procedure before being placed on the market within the Community.

(5)  Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of genetically modified food and feed may hinder their free movement, creating conditions of unequal and unfair competition.

(6)  The requirements arising from the directives, regulations and administrative provisions concerning the evaluation and authorisation of food and feed and of raw materials intended for their production should be identical for all products imported into the European Union, in order to avoid the creation of unequal and unfair conditions of competition.

(7)  An authorisation procedure involving Member States and the Commission has been established for genetically modified foods in European Parliament and Council Regulation (EC) No 258/97 of 27 January 1997 on novel foods and novel food ingredients(6). This procedure should be streamlined and made more transparent.

(8)  Regulation (EC) No 258/97 also provides for a notification procedure for novel foods which are substantially equivalent to existing foods. Whilst substantial equivalence is a key step in the safety assessment process of genetically modified foods, it is not a safety assessment in itself. In order to ensure clarity, transparency and a harmonised framework for authorisation of genetically modified food, this notification procedure should be abandoned in respect of genetically modified foods.

(9)  Feed consisting of or containing genetically modified organisms (GMOs) has so far been authorised in accordance with Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(7); no authorisation procedure exists for feed produced from GMOs; a single, efficient and transparent Community authorisation procedure for feed consisting of, containing or produced from GMOs should be established.

(10)  The new authorisation procedures for genetically modified food and feed should include the new principles introduced in European Parliament and Council Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC(8). They should further make use of the new framework for risk assessment in matters of food safety set up by European Parliament and Council Regulation (EC) No 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety(9). Thus, genetically modified food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food Safety Authority, of any risks which they present for human and animal health and, as the case may be, for the environment. This scientific evaluation should be followed by a risk management decision by the Community, under a regulatory procedure ensuring close co-operation between the Commission and the Member States.

(11)  Experience has shown that authorisation should not be granted for a single use, when a product is likely to be used both for food and feed purposes; therefore such products should only be authorised when fulfilling authorisation criteria for both food and feed.

(12)  Under this Regulation, authorisation may be granted either to a GMO and products for food and/or feed use which consist of, contain or are produced from it, or to foods or feed produced from a GMO. Thus, where a GMO used in the production of food and/or feed has been authorised under this Regulation, foods and/or feed consisting of, containing or produced from that GMO do not need an authorisation under this Regulation, but are subject to the requirements laid down in the authorisation granted in respect of the GMO. Furthermore, foods covered by an authorisation granted under this Regulation are exempted from the requirements of Regulation (EC) No 258/97, except where they fall under one or more of the categories laid down in Article 1 (2) (a) of that Regulation in respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation.

(13)  Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(10) provides for authorisation of additives used in foodstuffs. In addition to this authorisation procedure, food additives consisting of, containing or produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure laid down in Directive 89/107/EEC.

(14)  Flavourings falling under the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(11), which consist of, contain or are produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification.

(15)  Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition(12) provides for an approval procedure for feed materials produced using different technologies that may pose risk to human or animal health and the environment; these feed materials consisting of, containing or produced from GMOs should fall instead under the scope of this Regulation.

(16)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(13) provides for an authorisation procedure for placing on the market additives used in feedingstuffs. In addition to this authorisation procedure, feed additives consisting of, containing or produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure laid down in Directive 70/524/EEC.

(17)  This Regulation covers food and feed produced "from" a GMO but not food and feed "with" a GMO. The determining criterion is whether or not material derived from the genetically modified starting material is present in the food or in the feed. Processing aids as defined in Council Directive 89/107/EEC, which are only used during the food or feed production process, are not covered by the definition of food or feed and, therefore, are not included in the scope of this Regulation. Nor are food and feed which are manufactured with the help of a genetically modified processing aid. Thus, food produced with a genetically modified enzyme that does not remain in the final product and products obtained from animals fed with genetically modified feed or treated with genetically modifed medicinal products will be subject neither to the authorisation requirements, nor to the labelling requirements laid down in this Regulation.

(18)  In accordance with Article 153 of the Treaty, the Community shall contribute to promoting the right of consumers to information. Additional to other types of information to the public established in this Regulation, labelling of products is a means that enables the consumer to make an informed choice and facilitates fairness of transactions between seller and purchaser.

(19)  Article 2 of Directive 2000/13/EC of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(14) requires that the labelling must not mislead the purchaser as to the characteristics of the foodstuff and, in particular, as to its nature, identity, properties, composition, method of manufacture or production, inter alia.

(20)  Additional requirements for the labelling of genetically modified foods are laid down in Regulation (EC) No 258/97, in Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive 79/112/EEC(15), and in Commission Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings(16).

(21)  Harmonised labelling requirements should be laid down for genetically modified feed to provide final users, in particular livestock farmers, with accurate information on the composition and properties of feed, which enable the user to make an informed choice.

(22)  The labelling should include objective information that a food or feed consists of, contains or is produced from GMOs; clear labelling, irrespective of the detectability of DNA or protein resulting from the genetic modification in the final product, meets the demands expressed in numerous surveys by a large majority of consumers, facilitates informed choice and precludes potential misleading of consumers as regards method of manufacture or production.

(23)  Additionally, the labelling should inform about any characteristic or property which renders a food or feed not equivalent to its conventional counterpart in respect of composition, nutritional value or nutritional effects, intended use of the food or feed and health implications for certain sections of the population, as well as any characteristic or property which gives rise to ethical or religious concerns.

(24)  Regulation (EC) No …/2002 of the European Parliament and of the Council of ... [concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms](17) ensures that the specific information concerning the genetic modification is available at each stage of the placing on the market of GMOs and food and feed produced therefrom and should thereby facilitate accurate labelling.

(25)  Despite the fact that some operators avoid using genetically modified food and feed, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable contamination during cultivation, harvest, transport and processing; in such cases, this food or feed should not be subject to the labelling requirements of this Regulation; in order to achieve this objective, it is necessary to establish thresholds for the adventitious or technically unavoidable presence of genetically modified material in foods or feed.

(26)  In order to establish that the presence of this material is adventitious or technically unavoidable, operators must demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.

(27)  In order to ensure the practicability and feasibility of this Regulation, a threshold of 0,5 %, with the possibility of establishing lower levels, should be established for minute traces in food or feed of genetically modified material authorised under Community legislation, where the presence of such material is adventitious or technically unavoidable; as and when advances in science and technology allow, appropriately lower thresholds should be established.

(28)  Member States should encourage and contribute to the drawing up of guides to good segregation practice to be applied by food operators in order to avoid adventitious or technically unavoidable contamination by genetically modified material.

(29)  It is necessary to establish harmonised procedures for risk assessment and authorisation, that are efficient, time-limited and transparent, and criteria for evaluation of the potential risks arising from genetically modified foods and feed.

(30)  In order to ensure a harmonised scientific assessment of genetically modified foods and feed, such assessments should be carried out by the European Food Safety Authority.

(31)  It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account.

(32)  Risks to the environment may be associated with foods and feed which consist of or contain GMOs. Part C of Directive 2001/18/EC provides that no product consisting of or containing a GMO may be placed on the market without inter alia a risk assessment having been carried out in accordance with that part of the Directive. However, that requirement is waived in respect of any product covered by sectoral Community legislation that provides for a specific environmental risk assessment at least equivalent to the environmental risk assessment carried out in accordance with Annexes II and III to that Directive. This Regulation should satisfy the conditions for the waiver to apply the requirements of that Directive. It is therefore also necessary that its provisions in regard to risk management, labelling, monitoring, information to the public and safeguard clause, must be at least equivalent to those laid down in Directive 2001/18/EC.

(33)  It is necessary to introduce, where appropriate and based on the conclusions of the risk assessment, post-market monitoring requirements for the use of the genetically modified foods for human consumption and for the use of the genetically modified feed for animal consumption. In the case of genetically modified organisms, a monitoring plan concerning environment effects is compulsory in accordance with Directive 2001/18/EC.

(34)  To facilitate controls on genetically modified foods and feed, applicants for authorisation should propose appropriate methods of sampling and detection, and deposit samples of the genetically modified food and feed with the European Food Safety Authority; methods of sampling and detection should be validated, where appropriate, by the Community reference laboratory.

(35)  Technological progress and scientific developments should be taken into account when implementing this Regulation.

(36)  Existing authorisations and notifications for placing on the market genetically modified foods under Regulation (EC) No 258/97 and existing authorisations of genetically modified food and feed, granted under Directives 90/220/EEC and 2001/18/EC, Directive 82/471/EEC or Directive 70/524/EEC, should continue to remain in force, subject to that the European Food Safety Authority is provided with information concerning the risk assessment, methods for sampling and detection as appropriate, including samples of the food and feed and their control samples within six months of the entry into force of this Regulation.

(37)  A register of genetically modified food and feed authorised under this Regulation shall be established, including product specific information, independent, peer-reviewed studies which demonstrate the safety of the product, and sampling and detection methods; non-confidential data should be made available to the public.

(38)  In order to stimulate research and development into genetically modified organisms for food and/or feed use, it is appropriate to protect the investment made by innovators in gathering the information and data supporting an application under this Regulation. This protection should however be limited in time in order to avoid the unnecessary repetition of studies and trials which should be against the public interest.

(39)  The measures necessary for the implementation of this Regulation are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(18). The Commission shall be assisted by the Committee referred to in Article 58(1) of Regulation (EC) No 178/2002.

(40)  Provision should be made for consultation of the European Group on Ethics in Science and New Technologies established by Decision of 16 December 1997 with a view to obtaining advice on ethical issues regarding the placing on the market of genetically modified food or feed. Such consultations should be without prejudice to the competence of Member States as regards ethical issues.

(41)  The content of this Regulation takes account of the international trade commitments of the European Communities and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notification.

(42)  This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the EU,

HAVE ADOPTED THIS REGULATION:

Chapter I

Objective and definitions

Article 1

Objective

The objective of this Regulation, in accordance with the precautionary principle, is:

   a) to provide the basis for the assurance of a high level of protection of human life and health, animal health and welfare, environment and consumers' interest in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market;
   b) to lay down Community procedures for the authorisation and supervision of genetically modified food and feed;
   c) to lay down provisions for the labelling of genetically modified food and feed;
   d) to prevent the unintended presence of material consisting of, containing or produced from GMOs in food and feed.

Article 2

Definitions

For the purposes of this Regulation:

   1) the definitions of "food', "feed', "placing on the market' and "traceability', laid down in Regulation (EC) No 178/2002 shall apply;
   2) the definitions of "organism', "genetically modified organism' ("GMO'), "deliberate release' and "environmental risk assessment' laid down in Directive 2001/18/EC shall apply;
   3) 'genetically modified food' means food consisting of, containing or produced from genetically modified organisms;
   4) 'genetically modified feed' means feed consisting of, containing or produced from genetically modified organisms;
   ( 5) 'genetically modified organisms for food use' means a genetically modified organism which may be used as food or as a source material for the production of food;
   ( 6) 'genetically modified organisms for feed use' means a genetically modified organism which may be used as feed or as a source material for the production of feed;
   ( 7) "produced from genetically modified organisms' means derived, in whole or in part, from genetically modified organisms, but not consisting of or containing genetically modified organisms ;
   ( 8) 'control sample' means the genetically modified organism or its genetic material (positive sample) and the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample);
  9) 'final consumer' means:
   - as regards food, anyone who purchases a foodstuff for their personal or private consumption;
   - as regards feed, a farmer who purchases, for the purpose of feeding animals intended in any way for human consumption, feed consisting of, containing or produced from genetically modified organisms.

Chapter II

Genetically modified food

Section 1

Authorisation and Monitoring

Article 3

Scope

1.  This Section shall apply to:

   a) genetically modified organisms for food use,
   b) food consisting of or containing genetically modified organisms,
   c) food produced from or containing ingredients produced from genetically modified organisms.

2.  Where necessary, it may be determined in accordance with the procedure laid down in Article 36(2) that further types of food fall within the scope of this Section.

Article 4

Requirements

1.  Food falling within the scope of this Section must not:

   - present a danger to human health or the environment,
   - mislead the consumer,
   - differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.

2.  No person shall place on the market a genetically modified organism for food use or food falling within the scope of this Section unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are adhered to.

3.  No genetically modified organism for food use or food falling within the scope of this Section shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1.

4.  The authorisation referred to in paragraph 2 may cover:

   - a genetically modified organism and foods consisting of or containing that genetically modified organism as well as foods produced from or containing ingredients produced from that genetically modified organism, or
   - a food produced from or containing an ingredient produced from a genetically modified organism as well as foods produced from or containing that food.

5.  An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6.  The applicant for an authorisation as referred to in paragraph 2 and, after the authorisation is granted, the authorisation-holder, shall be established in the Community.

7.  Authorisation under this Regulation is without prejudice to Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species(19) and Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed(20).

Article 5

Application for authorisation

1.  To obtain the authorisation referred to in Article 4 (2), an application shall be submitted to the European Food Safety Authority, hereinafter referred to as "the Authority'.

2.  The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15 working days of its receipt. The acknowledgement shall state the date of receipt of the application.

3.  The application shall be accompanied by the following particulars and documents:

   a) the name and the address of the applicant;
   b) the designation of the food, and its specification, including the transformation event(s) used;
   c) where appropriate, the information for the purpose of complying with Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
   d) where appropriate, a detailed description of the method of production and manufacturing;
   e) a copy of the studies, including independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the food complies with the criteria laid down in Article 4(1);
   f) either an analysis, supported by appropriate information and data, demonstrating that the food is not different to a conventional food, having regard to the criteria specified in Article 14(2)(a), or a proposal for labelling the food in accordance with Article 14(2)(a) and (3);
   g) either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 14(2)(b);
   h) a proposal for the labelling of the food and/or foods produced from it in accordance with Article 14(1);
   ( i) where appropriate, the conditions for placing on the market the food or foods produced from it , including specific conditions for use and handling;
   ( j) a method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it;
   ( k) samples of the food and their control samples;
   l) information on the place where the reference material or the samples of the applicant are to be made available to authorities and operators in the EU;
   ( m) where appropriate, a proposal for post-market monitoring for the use of the food for human consumption;
   ( n) a summary of the dossier in a standardised form.

4.  In the case of an application relating to a GMO for food use, references to "food" in paragraph 3 shall be interpreted as referring to food consisting of, containing or produced from the GMO in respect of which an application is made.

5.  The application shall also be accompanied by:

   a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC and a copy of the decision authorising the placing on the market of the genetically modified organism under part C of Directive 2001/18/EC;
   b) a monitoring plan for environmental effects according to Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent.

6.  Where the application concerns a substance the use and placing on the market of which is subject under other provisions of Community law to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7.  The Commission, having first consulted the Authority and the national and local authorities competent within the meaning of Directive 2001/18/EC, shall establish, in accordance with the procedure laid down in Article 36(2), implementing rules for the application of this Article.

8.  Before the entry into force of this Regulation, the Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Article 6

Guides to good segregation practice for food and food ingredients

The Member States shall encourage and contribute to the drawing up of guides to good segregation practice to be applied by food operators in order to avoid adventitious or technically unavoidable contamination of food by genetically modified material.

Article 7

Opinion of the Authority

1.  Save in exceptionally complex cases, the Authority shall give an opinion within six months of the receipt of a valid application.

2.  The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that this information has been provided. Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.

3.  The Authority shall forward the application within 15 days of its receipt to the competent authority or authorities of the Member States. The competent authorities, designated by the Member States, shall forward comments or reasoned objections within four months of the receipt of the application to the Authority which shall immediately circulate them to all competent authorities. Where the Authority's opinion is not in accordance with the opinion of a competent authority of a Member State, the Authority's opinion shall provide an explanation of the reasons for the differences.

4.  In order to prepare its opinion, the Authority:

   a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 5, and examine whether the food complies with the criteria laid down in Article 4 (1);
   b) shall make the application and any supplementary information supplied by the applicant available to the Member States and to the Commission;
   c) shall make the summary of the dossier mentioned in Article 5 (3) (n) available to the public; it shall also be ensured that, on request, the public has reasonable access to the entire application, excluding confidential information. An appropriate reference shall be made in connection with publication of the summary;
   d) may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food;
   e) shall take account of the results of the environmental risk assessment under Directive 2001/18/EC;
   f) shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 5(3)(i) and (j). The reference laboratory shall test and validate the method of detection and identification proposed by the applicant and shall subsequently publish that method;
   g) shall, in verifying the application of Article 14 (2) (a), examine the information and data submitted by the applicant showing that the characteristics of the food are not different in comparison with the conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

5.  In the case of genetically modified organisms or food containing or consisting of genetically modified organisms falling within the scope of this Section, the environmental safety requirements laid down in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human health and the environment which might arise from the deliberate release of genetically modified organisms. During evaluation of requests for the placing on the market of products consisting of or containing genetically modified organisms, the Commission and the national and local authorities competent within the meaning of Directive 2001/18/EC shall be involved by the Authority in accordance with the provisions of that Directive.

6.  In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:

   a) the name and address of the applicant;
   b) the designation of the food, and its specification;
   c) where appropriate, the information required under Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
   d) the proposal for the labelling of the food and/or foods produced from it;
   e) where appropriate, any conditions or restrictions which should be imposed on the supply or use of the food and/or foods produced from it, including post-market monitoring requirements based on the outcome of the risk assessment and effective measures to prevent the unintended presence of the food and/or foods produced from it in other products;
   f) the method, validated by the reference laboratory, for detection, including sampling, access to appropriate reference material, identification of the sequence of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it or with it;
   g) where appropriate, the monitoring plan referred to in Article 5 (5) (b);
   h) information as to where the reference material or the samples of the applicant are to be made available to operators in the EU and for analytical purposes.

7.  The Authority shall forward its opinion to the Commission, the Member States, the appropriate national food safety, environmental risk and human and animal health risk assessment authorities or bodies and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion.

8.  The Authority shall also immediately make public its opinion, the assessment report and the grounds for the opinion. The public may make comments to the Commission within three months from this publication. Reference shall be made to the possibility for the public to have access to the entire application, excluding confidential information.

9.  Before the entry into application of this Regulation, the Commission shall publish a recommendation on the nature of the risk assessment to be undertaken by the Authority for the purpose of preparing its opinion.

Article 8

Authorisation by the Community

1.  Save in exceptionally complex cases, within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account 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 give reasons for taking a decision that differs from the Authority's opinion.

The Commission's draft decision shall immediately be made public.

2.  In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in Article 7 (6), the name of the authorisation-holder and, where appropriate, the unique code attributed to the genetically modified organism as referred to in Regulation (EC) No ../2002 [concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms].

The draft decision shall also include the opinions of the authorities required to be consulted in accordance with Directive 2001/18/EC.

3.  A final decision on the application shall be adopted in accordance with the procedure laid down in Article 36(2). The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.

4.  The Commission shall without delay inform the applicant of the decision taken. It shall also, at the earliest opportunity, notify its decision to the European Parliament, the Member States and the appropriate food safety, environmental risk and human and animal health risk assessment authorities or bodies. The decision shall be published in the Official Journal of the European Communities.

5.  Without prejudice to the procedure provided for in Article 11, the authorisation granted in accordance with the procedure laid down in this Regulation shall, throughout the Community, terminate after ten years and shall be renewable in accordance with Article 12. The authorised food shall be entered in the Register referred to in Article 30. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2. It shall also indicate how and where the public can access the files relating to the application for authorisation, including the evaluation by the Authority, the opinions of the national bodies, the local authorities and public opinion, as well as the issues discussed in connection with the risk management decision and the result of the vote.

6.  The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used subject to their inclusion in a list of substances registered or authorised to the exclusion of others.

7.  The granting of authorisation shall not diminish the general civil and criminal liability of any food operator in respect of the food concerned.

Article 9

Status of existing products

1.  By derogation to Article 4 (2), a product falling within the scope of this Section which has been placed on the market under Directive 90/220/EEC before the entry into force of Regulation (EC) No 258/97 or in accordance with the provisions laid down in Regulation (EC) No 258/97 may continue to be placed on the market, used and processed provided that the following conditions are met:

   a) within six months of the entry into force of this Regulation, the person responsible for placing on the market the concerned product shall notify the Authority of the date at which it was first placed on the market in the Community. This notification shall be accompanied by the particulars mentioned in Article 5 (3) and (5), as appropriate, which the Authority shall forward to the Commission and the Member States. The Authority shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 5 (3) (j) and (k) and shall ask it to test and validate the method of detection and identification proposed by the applicant;
   b) within one year of the entry into force of this Regulation, the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The product concerned shall be entered in the Register. Each entry in the Register shall mention the date at which the concerned product was first placed on the market and shall include the particulars referred to in Article 8(2) as appropriate. It shall also indicate how and where the public can access the files relating to the application and any information submitted subsequently, including the Authority's assessment and, where applicable, opinions of national bodies and of the public, as well as the issues discussed in connection with the risk management decision and the result of the vote.

2.  Within nine years from the date at which the concerned product was first placed on the market, the person responsible for placing it on the market shall submit an application in accordance with Article 12, which shall apply in a like manner.

3.  Products referred to in paragraph 1 and foods containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 10, 11 and 35, which shall apply in a like manner.

4.  Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, the Commission, acting in accordance with the procedure laid down in Article 36(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market.

5.  Detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 36 (2).

Article 10

Supervision

1.  After an authorisation has been issued in accordance with this Regulation, all parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation. Where post-market monitoring as referred to in Article 5(3)(m) and Article 5(5)(b) has been imposed on the authorisation-holder, he shall ensure that it is carried out and shall submit reports to the Authority in accordance with the authorisation. The monitoring reports, excluding confidential information, shall be made accessible to the public.

2.  If the authorisation-holder proposes to modify the terms of the authorisation, he shall submit an application to the Authority.

3.  The authorisation-holder shall forthwith inform the Authority of any new scientific or technical information which might influence the evaluation of the safety in use of the food. In particular, the authorisation-holder shall forthwith inform the Authority of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market. The Authority shall examine the information forwarded and shall notify the Commission, the Member States and the local authorities. The information forwarded shall be made accessible to the public.

Article 11

Modification, suspension and revocation of authorisations

1.  Where, on its own initiative or following a request from a Member State or from the Commission, the Authority is of the opinion that an authorisation granted in accordance with this Regulation should be modified, suspended or revoked, it shall forthwith transmit this opinion to the Commission, the authorisation-holder, the Member States and the local authorities. The opinion shall be made accessible to the public.

2.  The Commission shall examine the opinion of the Authority as soon as possible and prepare a draft of the decision to be taken. The draft shall be made accessible to the public.

3.  In the event of a draft decision which envisages the modification of the authorisation, the draft decision shall include any amendment needed to the particulars mentioned in Article 8 (2).

4.  A final decision on the modification, the suspension or the revocation of the authorisation shall be adopted in accordance with the procedure laid down in Article 36 (2).

5.  The Commission shall without delay inform the authorisation-holder of the decision taken. The decision shall be published in the Official Journal of the European Communities. The Register shall be amended as appropriate. The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.

Article 12

Renewal of authorisations

1.  Without prejudice to the right of a third party to submit an application for authorisation for a food essentially similar to a food for which an authorisation has already been granted, authorisations under this Regulation shall be renewable for ten-year periods, on application to the Authority by the authorisation-holder at the latest one year before the expiry date of the authorisation.

The Authority shall acknowledge receipt of the application, in writing, to the authorisation-holder within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application.

2.  The application shall be accompanied by the following particulars and documents:

   a) a copy of the authorisation for placing the food on the market;
   b) a report on the results of the post&nbhy;market monitoring of the use of food for human consumption, if so specified in the authorisation in accordance with Article 5(3)(m);
   c) without prejudice to the obligations laid down in Article 10(3), any other new information which has become available with regard to the evaluation of the safety in use of the food and the risks of the food to the consumer or the environment;
   d) where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3.  Article 7 and Article 8 shall apply in a like manner.

4.  Where, for reasons beyond the control of the authorisation-holder, no decision is taken on the renewal of an authorisation before its expiry date, the authorisation of the product shall automatically be extended once by one year or until the Commission takes a decision within that year.

5.  The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority, in accordance with the procedure laid down in Article 36 (2).

6.  The Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Section 2

Labelling

Article 13

Scope

1.  This Section shall apply to foods which are to be delivered as such to the final consumer or mass caterers in the Community and which:

   - consist of or contain genetically modified organisms, or
   - are produced from or contain ingredients produced from genetically modified organisms.

2.  This Section shall not apply to processing aids.

3.  This Section shall not apply to foods produced from animals fed with GMOs or products thereof.

4.  This Section shall not apply to foods containing material produced from genetically modified organisms in a proportion no higher than 0,5% or a lower threshold established in accordance with the procedure laid down in Article 36(2), provided that this presence is adventitious or technically unavoidable. As and when advances in science and technology allow, appropriately lower thresholds shall be established.

In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified material. The Commission shall draw up a list of criteria for determining these "appropriate steps". In cooperation with the Authority, the Member States and the local authorities, the Commission shall also lay down appropriate measures to ensure that the utmost care is taken to avoid contamination.

Article 14

Requirements

1.  Without prejudice to the other requirements of Community law concerning the labelling of foodstuffs, foods falling within the scope of this Section shall be subject to the following additional specific labelling requirements:

(a)  Where the food consists of more than one ingredient, the words "genetically modified" or "produced from genetically modified [name of organism]" shall appear in the list of ingredients provided for in Article 6 of Directive 2000/13/EC in parentheses immediately following the ingredient concerned. Alternatively, these words may appear in a footnote to the list of ingredients. It shall be printed in a font of at least the same size as the list of ingredients.

(b)  Where the ingredient is designated by the name of a category, the words "contains [name of ingredient] produced from genetically modified [name of organism]" shall appear in the list of ingredients.

(c)  Where there is no list of ingredients, the words "genetically modified" or "produced from genetically modified (name of organism)" shall appear clearly on the labelling.

(d)  Where the food is offered for sale to the final consumer or to mass caterers without pre-packaging, or in small pre-packaged units, the information required under this paragraph must be permanently and visibly displayed either on the food display or right next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.

2.  In addition to the labelling requirements laid down in paragraph 1, the labelling shall also mention any characteristic or property, as specified in the authorisation, in the following cases:

(a)  Where a food is not equivalent to its conventional counterpart as regards these characteristics or properties:

   - composition,
   - nutritional value or nutritional effects,
   - intended use of the food,
   - implications for the health of certain sections of the population.

(b)  Where a food may give rise to ethical or religious concerns.

3.  In addition to the labelling requirements laid down in paragraph 1 and as specified in the authorisation, the labelling of foods falling within the scope of this Section which do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the foods concerned.

Article 15

Implementing measures

Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2).

Chapter III

Genetically modified feed

Section 1

Authorisation and Monitoring

Article 16

Scope

1.  This Section shall apply to:

   a) genetically modified organisms for feed use;
   b) feed consisting of or containing genetically modified organisms;
   c) feed produced from genetically modified organisms.

2.  Where necessary, it may be determined in accordance with the procedure laid down in Article 36(2) that further types of feed fall within the scope of this Section.

Article 17

Requirements

1.  Feed referred to in Article 16 (1) must not:

   a) present a risk for animal health, human health or the environment;
   b) mislead the user;
   c) harm the consumer by impairing the distinctive features of the animal products;
   d) differ from feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.

2.  No person shall place on the market, use or process a product referred to in Article 16 (1) for feed use or feed falling within the scope of this Section unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are adhered to.

3.  No product referred to in Article 16(1) for feed use or feed falling within the scope of this Section shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1.

4.  The authorisation referred to in paragraph 2 may cover:

   - feed consisting of or containing genetically modified organisms as well as feed produced from such genetically modified organisms, or
   - a feed produced from a genetically modified organism as well as feed produced from or containing that feed.

5.  An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.

6.  The applicant for an authorisation as referred to in paragraph 2 and, after the authorisation is granted, the authorisation-holder, shall be established in the Community.

7.  7 Authorisation under this Regulation is without prejudice to Directive 70/457/EEC and Directive 70/458/EEC.

Article 18

Application for authorisation

1.  To obtain the authorisation referred to in Article 17 (2), an application shall be submitted to the Authority.

2.  The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15 working days of its receipt. The acknowledgement shall state the date of receipt of the application.

3.  The application shall be accompanied by the following:

   a) the name and the address of the applicant;
   b) the designation of the feed referred to in Article 16 (1), and its specification, including the transformation event(s) used;
   c) where appropriate, the information for the purpose of complying with Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
   d) where appropriate, a detailed description of the method of production, manufacturing and intended uses of the feed referred to in Article 16 (1);
   e) a copy of the studies, including independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the feed referred to in Article 16(1) complies with the criteria laid down in Article 17(1), and in particular for feed falling within the scope of Directive 82/471/EEC, the information required under Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition(21);
   f) a proposal for labelling the feed referred to in Article 16(1) consisting of, containing or produced from genetically modified organisms in accordance with Article 26(3)(a) and (c) and (4);
   g) either a reasoned statement that the feed referred to in Article 16 (1) does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 26(3)(d);
   h) where appropriate, the conditions for placing the feed referred to in Article 16 (1) on the market, including specific conditions for use and handling;
   i) a method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed referred to in Article 16 (1);
   j) samples of the feed referred to in Article 16 (1) and their control samples;
   k) information on the place where the reference material or the samples of the applicant are to be made available to authorities and operators in the EU;
   ( l) where appropriate, a proposal for post-market monitoring for the use of the feed referred to in Article 16 (1) for animal consumption;
   ( m) a summary of the dossier in a standardised form.

4.  In the case of an application relating to a GMO for feed use, references to "feed" in paragraph 3 shall be interpreted as referring to feed consisting of, containing or produced from the GMO in respect of which an application is made.

5.  The application shall also be accompanied by:

   a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC and a copy of the decision authorising the placing on the market of the genetically modified organism under Part C of Directive 2001/18/EC;
   b) a monitoring plan for environmental effects according to Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent.

6.  Where the application concerns a substance the use and placing on the market of which is subject under other provisions of Community law to its inclusion on a list of substances authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7.  The Commission, having first consulted the Authority and the national and local authorities competent within the meaning of Directive 2001/18/EC, shall establish, in accordance with the procedure laid down in Article 36 (2), implementing rules for the application of this Article.

8.  The Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Article 19

Opinion of the Authority

1.  Save in exceptionally complex cases, the Authority shall give an opinion within 6 months of the receipt of a valid application.

2.  The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that this information has been provided. Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.

3.  The Authority shall forward the application within 15 days of its receipt to the competent authority or authorities of the Member States. The competent authorities, designated by the Member States, shall forward comments or reasoned objections within four months of the receipt of the application to the Authority which shall immediately circulate them to all competent authorities. Where the Authority's opinion is not in accordance with the opinion of a competent authority of a Member State, the Authority's opinion shall provide an explanation of the reasons for the differences.

4.  In order to prepare its opinion, the Authority:

   a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 18, and examine whether the feed referred to in Article 16 (1) complies with the criteria laid down in Article 17 (1);
   b) shall make the application and any supplementary information supplied by the applicant available to the Member States and to the Commission;
   c) shall make the summary of the dossier mentioned in Article 18 (3) (m) available to the public; it shall also be ensured that, on request, the public has reasonable access to the entire application, excluding confidential information. An appropriate reference shall be made in connection with publication of the summary;
   d) shall ask the appropriate feed assessment body of the Member State in which the person applying for authorisation is established to carry out a safety assessment of the feed referred to in Article 16(1), and shall take due account of the findings of the assessment;
   e) shall take account of the results of the environmental risk assessment under Directive 2001/18/EC;
   f) shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 18(3)(i) and (j). The reference laboratory shall test and validate the method of detection and identification proposed by the applicant and shall subsequently publish that method;
   g) shall, in verifying the application of Article 26 (3) (c), examine the information and data submitted by the applicant showing that the characteristics of the feed referred to in Article 16 (1) are not different in comparison with the conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

5.  In the case of genetically modified organisms and feed referred to respectively in Article 16(1)(a) and (b), the environmental safety requirements laid down in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of genetically modified organisms. During evaluation of requests for the placing on the market of products consisting of or containing genetically modified organisms, the Commission and the national and local authorities competent within the meaning of Directive 2001/18/EC shall be involved by the Authority in accordance with the provisions of that Directive.

6.  In the event of an opinion in favour of authorising the feed referred to in Article 16 (1), the opinion shall also include the following particulars:

   a) the name and address of the applicant;
   b) the designation of the feed referred to in Article 16 (1), and its specification;
   c) where appropriate, the information required under Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
   d) the proposal for the labelling of the feed referred to in Article 16 (1);
   e) where appropriate, any conditions or restrictions which should be imposed on the placing on the market, including specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and effective measures to prevent the unintended presence of the feed or feed produced from it in other feed products;
   f) the method, validated by the reference laboratory, for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed referred to in Article 16(l);
   g) where appropriate, the monitoring plan as referred to in Article 18 (5) (b);
   h) information on the place where the reference material or the samples of the applicant are to be made available to operators in the EU.

7.  The Authority shall forward its opinion to the Commission, the Member States, the appropriate national food safety, environmental risk and human and animal health risk assessment authorities or bodies and the applicant, including a report describing its assessment of the feed referred to in Article 16(1) and stating the reasons for its opinion.

8.  The Authority shall also immediately make public its opinion, the assessment report and the grounds for the opinion. The public may make comments to the Commission within three months from this publication. Reference shall be made to the possibility for the public to have access to the entire application, excluding confidential information.

Article 20

Authorisation by the Community

1.  Save in exceptionally complex cases, within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account 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 give reasons for taking a decision that differs from the Authority's opinion.

The Commission's draft decision shall immediately be made public.

2.  In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in Article 19 (6), the name of the authorisation holder, and, where appropriate, the unique code attributed to the genetically modified organism as referred to in Regulation (EC) No .../2002 [concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms].

The draft decision shall also include the opinions of the authorities required to be consulted in accordance with Directive 2001/18/EC.

3.  A final decision on the application shall be adopted in accordance with the procedure laid down in Article 36(2). The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.

4.  The Commission shall without delay inform the applicant of the decision taken. It shall also, at the earliest opportunity, notify its decision to the European Parliament, the Member States and the appropriate food safety, environmental risk and human and animal health risk assessment authorities or bodies. The decision shall be published in the Official Journal of the European Communities.

5.  Without prejudice to the procedure provided for in Article 23, the authorisation granted in accordance with the procedure laid down in this Regulation shall, throughout the Community, terminate after ten years and shall be renewable in accordance with Article 24. The authorised feed shall be entered in the Register referred to in Article 30. Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2. It shall also indicate how and where the public can access the files relating to the application for authorisation, including the evaluation by the Authority, the opinions of the national bodies, the local authorities and public opinion, as well as the issues discussed in connection with the risk management decision and the result of the vote.

6.  The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used subject to their inclusion in a list of substances authorised to the exclusion of others.

7.  The granting of authorisation shall not diminish the general civil and criminal liability of any feed operator in respect of the feed concerned.

Article 21

Status of existing products

1.  By derogation to Article 17 (2), products as referred to in Article 16 (1) which have been authorised before the date of application of this Regulation

   - under Directives 90/220/EEC or 2001/18/EC, including use as feed,
   - under Directive 82/471/EEC, which are produced from GMOs, or
   - under Directive 70/524/EEC which consist of, contain or are produced from GMOs,
  

may continue to be placed on the market, used and processed provided that the following conditions are met:

   a) within six months of the entry into force of this Regulation, the person responsible for placing on the market the concerned products shall notify the Authority of the date at which they were first placed on the market in the Community. This notification shall be accompanied by the particulars mentioned in Article 18 (3) and (5), as appropriate, which the Authority shall forward to the Commission and the Member States. The Authority shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in Article 18 (3) (i) and (j) and shall ask it to test and validate the method of detection and identification proposed by the applicant;
   b) within one year of the entry into force of this Regulation, the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The products concerned shall be entered in the Register. Each entry in the Register shall mention the date at which the concerned products were first placed on the market and shall include the particulars referred to in Article 20(2) as appropriate. It shall also indicate how and where the public can access the files relating to the application and any information submitted subsequently, including the Authority's assessment and, where applicable, opinions of national bodies and of the public, as well as the issues discussed in connection with the risk management decision and the result of the vote.

2.  Within nine years from the date at which the concerned products were first placed on the market, the person responsible for placing them on the market shall submit an application in accordance with Article 24, which shall apply in a like manner.

3.  Products referred to in paragraph 1 and feed containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 22, 23 and 35, which shall apply in a like manner.

4.  Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, the Commission, acting in accordance with the procedure laid down in Article 36(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the market.

5.  In the case of authorisations not issued to a specific holder, the person who imports, produces or manufactures the products referred to in this Article shall submit the information or the application to the Authority.

6.  Detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 36 (2).

Article 22

Supervision

1.  After an authorisation has been issued in accordance with this Regulation, all parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation. Where post-market monitoring as referred to in Article 18(3)(l)and Article 18(5)(b) has been imposed on the authorisation-holder, he shall ensure that it is carried out and shall submit reports to the Authority in accordance with the authorisation. The monitoring reports, excluding confidential information, shall be made accessible to the public.

2.  If the authorisation-holder proposes to modify the terms of the authorisation, he shall submit an application to the Authority.

3.  The authorisation-holder shall forthwith inform the Authority of any new scientific or technical information which might influence the evaluation of the safety in use of the feed referred to in Article 16(1). In particular, the authorisation-holder shall forthwith inform the Authority of any prohibition or restriction imposed by the competent authority of any third country in which the feed referred to in Article 16(1) is placed on the market. The Authority shall examine the information forwarded and inform the Commission, the Member States and the local authorities. The information forwarded shall be made accessible to the public.

Article 23

Modification, suspension and revocation of authorisations

1.  Where, on its own initiative or following a request from a Member State or from the Commission, the Authority is of the opinion that an authorisation granted in accordance with this Regulation should be modified, suspended or revoked, it shall forthwith transmit this opinion to the Commission, the authorisation-holder, the Member States and the local authorities. The opinion shall be made accessible to the public.

2.  The Commission shall examine the opinion of the Authority as soon as possible and prepare a draft of the decision to be taken. The draft shall be made accessible to the public.

3.  In the event of a draft decision which envisages the modification of the authorisation, the draft decision shall include any amendment needed to the particulars mentioned in Article 20 (2).

4.  A final decision on the modification, the suspension or the revocation of the authorisation shall be adopted in accordance with Article 36 (2).

5.  The Commission shall without delay inform the authorisation-holder of the decision taken. It shall also, at the earliest opportunity, notify its decision to the European Parliament, the Member States and the appropriate food safety, environmental risk and human and animal health risk assessment authorities or bodies. The decision taken shall be published in the Official Journal of the European Communities. The Register shall be amended as appropriate. The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.

Article 24

Renewal of authorisations

1.  Without prejudice to the right of a third party to submit an application for authorisation for a feed essentially similar to a feed for which an authorisation has already been granted, authorisations under this Regulation shall be renewable for ten-year periods, on application to the Authority by the authorisation-holder at the latest one year before the expiry date of the authorisation.

The Authority shall acknowledge receipt of the application, in writing, to the authorisation-holder within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application.

2.  The application shall be accompanied by the following particulars and documents:

   a) a copy of the authorisation for placing the feed on the market;
   b) a report on the results of the monitoring, if so specified in the authorisation;
   c) any other new information which has become available with regard to the evaluation of the safety in use of the feed and the risks of the feed to animals, humans or the environment;
   d) where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3.  Article 19 and Article 20 shall apply in a like manner.

4.  Where, for reasons beyond the control of the authorisation-holder, no decision is taken on the renewal of an authorisation before its expiry date, the authorisation of the product shall automatically be extended once by one year or until the Commission takes a decision within that year.

5.  The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority, in accordance with the procedure laid down in Article 36 (2).

6.  The Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Section 2

Labelling

Article 25

Scope

1.  This Section shall apply to feed referred to in Article 16 (1).

2.  This Section shall not apply to feed containing material produced from genetically modified organisms in a proportion no higher than 0,5% or a lower threshold established in accordance with the procedure laid down in Article 36(2), provided that this presence is adventitious or technically unavoidable. As and when advances in science and technology allow, appropriately lower thresholds shall be established.

In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified material. The Commission shall draw up a list of criteria for determining these "appropriate steps". In cooperation with the Authority, the Member States and the local authorities, the Commission shall also lay down appropriate measures to ensure that the utmost care is taken to avoid contamination.

Article 26

Requirements

1.  Without prejudice to the other requirements of Community law concerning the labelling of feed, feed referred to in Article 16 (1) shall be subject to the additional specific labelling requirements laid down in this Article.

2.  By way of derogation from paragraph 1 the exemptions from labelling requirements provided for in Article 6 (3) of Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC(22) shall not be applicable for feed referred to in Article 16 (1).

3.  No person shall place a feed referred to in Article 16(1) on the market unless he ensures that the particulars specified below are shown, in a clearly visible, legible and indelible manner, on the packaging, the container, a label or an accompanying document:

  a) the name of the feed:
   - for genetically modified feed the name shall be: "genetically modified [name of the feed]";
   - for feed produced from genetically modified organisms: "produced from genetically modified [name of the feed from which the feed is produced]";
   b) for feed referred to in Article 16(1)(b) the name of the feed on the packaging, the container, a label or an accompanying document shall be accompanied by the relevant unique code as established in Regulation (EC) No…/2002 [concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms];
  c) as specified in the authorisation, any characteristic of the feed referred to in Article 16 (1) such as those indicated hereunder, which is not equivalent to its conventional counterpart:
   - composition,
   - nutritional properties,
   - intended use,
   - implications for the health of certain species or categories of animals.
   d) as specified in the authorisation, any characteristic or property where a feed may give rise to ethical or religious concerns;
   e) where the feed consists of more than one ingredient and is a compound feedingstuff as defined in Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs(23), the words "genetically modified" or "produced from genetically modified [name of organism]" shall appear in the list of ingredients, provided for in Article 5c of that Directive, in parentheses immediately following the ingredient concerned. Alternatively, these words may appear in a footnote to the list of ingredients. It shall be printed in a font of at least the same size as the list of ingredients.

4.  In addition to the requirements laid down in paragraph 3(a) and (b) and as specified in the authorisation, the labelling and accompanying documents of feed falling within the scope of this Section which does not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned.

Article 27

Implementing measures

Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2).

Article 28

Imports

The Commission shall ensure that the requirements arising from the directives, regulations and administrative provisions concerning the evaluation and authorisation of food and feed and of raw materials intended for their production are no less rigorous for products imported into the European Union, in order to avoid the creation of unequal and unfair conditions of competition.

Chapter IV

Common provisions

Article 29

Products likely to be used as food and feed

1.  Where a product is likely to be used both as food and feed, a single application under Articles 6 and 18 shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.

2.  The Authority shall consider whether the application for authorisation should be submitted both as food and feed.

Article 30

Community Register

1.  The Commission shall establish and maintain a Community Register of Genetically Modified Food and Feed, referred to in this Regulation as "the Register'.

The Register shall include information on the method(s) validated by the Community reference laboratory, pursuant to Article 7(4)(f) and Article 19(4)(f), and on the methods used by the national reference laboratories.

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

Article 31

Confidentiality

1.  The applicant may indicate which information submitted under this Regulation he wishes to be treated as confidential because its disclosure may significantly harm his competitive position. Verifiable justification must be given in such cases.

2.  Without prejudice to paragraph 3, the Authority shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision.

3.  Information relating to the following shall not be considered confidential:

   a) name and composition of the genetically modified organism, food or feed referred to in Article 3(1) and Article 16(1) and, where appropriate, indication of the substrate and the micro-organism;
   b) general description of the genetically modified organism and the name and address of the authorisation-holder;
   c) physico-chemical and biological characteristics of the genetically modified organism, food or feed referred to in Article 3(1) and Article 16(1);
   d) effects of the genetically modified organism, food or feed referred to in Article 3(1) and Article 16(1) on human and animal health and on the environment;
   e) effects of the genetically modified organism, food or feed referred to in Article 3(1) and Article 16(1) on the characteristics of animal products and their nutritional properties;
   f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Article 3(1) and Article 16(1) and, where applicable, monitoring requirements and a summary of the results of the monitoring;
   g) information on waste treatment and emergency response.

4.  Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession.

5.  The Commission, the Authority and the Member States shall keep confidential all the information identified as confidential under paragraph 2 except for information which must be made public if circumstances so require, in order to protect human health, animal health or the environment.

6.  If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Authority and the applicant disagree as to its confidentiality.

Article 32

Data protection

The scientific data and other information in the application dossier required under Article 5 (3) and (5) and Article 18 (3) and (5) may not be used for the benefit of another applicant for a period of ten years from the date of authorisation, unless the other applicant has agreed with the authorisation-holder that such data and information may be used. On expiry of this ten-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if he can demonstrate that the food or feed for which he is seeking authorisation is essentially similar to a food or feed already authorised under this Regulation.

Article 33

Community reference laboratory

The Community reference laboratory and its duties and tasks shall be those laid down in the Annex.

National reference laboratories may be established in accordance with the procedure laid down in Article 36 (2).

Detailed rules for implementing this Annex and any changes to it may be adopted in accordance with the procedure laid down in Article 36 (2).

Article 34

Consultation with the European Group on Ethics in Science and New Technologies

1.  The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies established by the Commission Decision of 16 December 1997, with a view to obtaining its opinion on ethical issues.

2.  The Commission shall make available to the public the opinions of the European Group on Ethics in Science and New Technologies.

Article 35

Emergency measures

1.  Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or feed authorised in accordance with this Regulation endangers human health, animal health or the environment, it may provisionally restrict or prohibit the use and/or sale of the food or feed on its territory, as well as suspending or otherwise restricting the import thereto or export therefrom of the food or feed in question until a final decision is taken in accordance with Article 11 or Article 23, as appropriate.

2.  Member States shall ensure that, in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public. The Member State shall immediately inform the Commission, the Authority and the other Member States of actions taken under this Article and give reasons for its decision and the new information or new assessment on which its decision is based, indicating whether and how the conditions of the consent should be amended or the consent should be terminated. A decision on this shall be taken within three months in accordance with the procedure laid down in Article 36(3).

Article 36

Implementing powers of the Commission

1.  The Commission shall be assisted by the Committee referred to in Article 58(1) of Regulation (EC) No 178/2002.

2.  When reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof. The period provided for in Article 5 (6) of Decision 1999/468/EC shall be three months.

3.  When reference is made to this paragraph, the safeguard procedure laid down in Article 6 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof. Any Member State may refer the Commission's decision to the Council within 15 days from the receipt of the notification of this decision, in which case the Council, acting by a qualified majority, may take a different decision within one month from the date of referral to the Council.

Article 37

Repeals

The following Regulations are repealed with effect from the date of application of this Regulation:

   - Regulation (EC) No 1139/98;
   - Regulation (EC) No 49/2000;
   - Regulation (EC) No 50/2000.

Article 38

Amendments to Regulation (EC) No 258/97

"

"By way of derogation from paragraph 2, the procedure laid down in Article 5 shall apply to foods or food ingredients referred to in Article 1 (2) (d) and (e) which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4 (3), are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein."

"

Regulation (EC) No 258/97 is amended with effect from the date of application of this Regulation as follows:

  (1) The following provisions are deleted:
   - Article 1 (2) (a) and (b),
   - Article 3 (2) second paragraph and (3),
   - Article 8 (1) (d),
   - Article 9,
   (2) In Article 3, the first sentence of paragraph 4 is replaced by the following:

Article 39

Amendments to Directive 82/471/EEC

Directive 82/471/EEC is amended with effect from the date of application of this Regulation as follows:

The following paragraph is added to Article 1:

"

3.  "3. This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of European Parliament and Council Regulation (EC) No .../2002 of .... [on genetically modified food and feed]*.

______________________

* OJ L ..."

"

Article 40

Amendments to Directive 70/457/EEC

Directive 70/457/EEC is amended with effect from the date of application of this Regulation as follows:

(1)  Article 4 (5) is replaced by the following:

"

5.  "5. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or feed falling within the scope of Article 16 of European Parliament and Council Regulation (EC) No .../2002 of ...[on genetically modified food and feed]*, the variety shall only be accepted if it has been approved in accordance with that Regulation.

_____________________

* OJ L ..."

"

(2)  Article 7 (4) is replaced by the following:

"

4. a)  "4. (a) In the case of a genetically modified variety as referred to in Article 4(4) an environmental risk assessment equivalent to that laid down in European Parliament and Council Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC* shall be carried out.

(b)  Pending the entry into force of a European Parliament and Council Regulation, referred to in Article 12(3) of Directive 2001/18/EC, laying down the procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in Directive 2001/18/EC, genetically modified varieties shall only be accepted for inclusion in a national catalogue after having being accepted for placing on the market in accordance with Directive 2001/18/EC.

(c)  Articles 13 to 24 of Directive 2001/18/EC shall no longer apply to genetically modified varieties once the Regulation referred to in subparagraph (b) and a sectoral Council Regulation regulating genetically modified plant varieties, introduced on a proposal from the Commission based on the appropriate legal basis in the Treaty, have entered into force.

(d)  The technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedure laid down in Article 40.

_________________

* OJ L 106, 17.4.2001, p. 1."

"

(3)  Article 7 (5) is replaced by the following:

"

5.  "5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of European Parliament and Council Regulation (EC) No 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety*, is accepted only if it has been authorised under the relevant legislation.

____________________

* OJ L 31, 1.2.2002, p. 1."

"

Article 41

Amendments to Directive 70/458/EEC

Directive 70/458/EEC is amended with effect from the date of application of this Regulation as follows:

(1)  Article 4 (3) is replaced by the following:

"

3.  "3. Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or feed falling within the scope of Article 16 of European Parliament and Council Regulation (EC) No .../2002 of ... [on genetically modified food and feed]*, the variety shall only be accepted if it has been approved in accordance with that Regulation.

_________________

* OJ L ..."

"

(2)  Article 7 (5) is replaced by the following:

"

5.  "5. Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of European Parliament and Council Regulation (EC) No 178/2002 of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety*, is accepted only if it has been authorised pursuant to Regulation (EC) No 258/97 for food or Directive 90/220/EEC or Directive 2001/18/EC for feed or Regulation (EC) No .../2002 [on genetically modified food and feed].

________________

* OJ L 31, 1.2.2002, p. 1."

"

Article 42

Information to be provided in accordance with the Cartagena Protocol on Biosafety

1.  Any authorisation or renewal, modification, suspension or revocation of authorisation of a genetically modified organism, food or feed referred to in Article 3 (1) (b) and Article 16 (1) (b) shall be notified by the Commission to the Parties to the Cartagena Protocol on Biosafety through the Biosafety Clearing-House in accordance with Article 11 (1) or Article 12 (1), as the case may be, of the Cartagena Protocol on Biosafety.

The Commission shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the Biosafety Clearing-House.

2.  The Commission shall also process requests for additional information made by any Party in accordance with Article 11 (3) and will provide copies of the laws, regulations and guidelines in accordance with Article 11 (5) of the Cartagena Protocol on Biosafety.

Article 43

Penalties

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. Member States shall notify those provisions to the Commission by [six months after the date of publication of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 44

Transitional measures

1.  Requests submitted under Article 4 of Regulation (EC) No 258/97 before the entry into force of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6 (3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6 (3) or (4) of Regulation (EC) No 258/97.

2.  Applications which have been made concerning the placing on the market of GMOs pursuant to Directive 2001/18/EC or Regulation (EC) No 258/97, in relation to which the assessment procedure has not yet been completed on the date of entry into force of this Regulation, shall be subject to the following procedure:

   - applicants shall supplement their applications within six months of the entry into force of this Regulation in the light of the requirements thereof and shall submit this information to the Authority;
   - the Authority shall deliver an opinion pursuant to Article 7 and/or Article 19;
   - the Community authorisation shall be granted pursuant to Article 8 and/or Article 20.

These products shall be subject to all other provisions of this Regulation.

3.  For a period of not more than 12 months following the date of application of this Regulation, the labelling requirements laid down therein shall not apply to products which have been lawfully manufactured and labelled in the Community, or which have been lawfully imported into the Community and put into circulation, before the aforementioned date.

4.  Notifications concerning products including use as feed submitted under Article 13 of Directive 2001/18/EC before the entry into force of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for under Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.

5.  Requests submitted for products referred to in Article 16 (1) (c) under Article 7 of Directive 82/471/EEC before the entry into force of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.

6.  Requests submitted for products referred to in Article 16 (1) under Article 4 of Directive 70/524/EEC before the entry into force of this Regulation shall be complemented by applications under Chapter III, Section 1 of this Regulation.

Article 45

Review

1.  No later than two years from the date of entry into force of this Regulation and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation accompanied, where appropriate, by any suitable proposal. The report and any proposal shall be made accessible to the public.

2.  Notwithstanding the review provided for in paragraph 1, the Commission shall monitor the application of this Regulation and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.

Article 46

Entry into force

This Regulation shall enter into force on [the twentieth day] following that of its publication in the Official Journal of the European Communities.

It shall apply from [six months after the date of publication of this Regulation].

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

Done at ,

For the European Parliament For the Council

The President The President

ANNEX

Duties and Tasks of the Community reference laboratory

1.  The Community reference laboratory referred to in Article 33 is the Commission's Joint Research Centre.

2.  For the tasks outlined in this Annex, the Commission's Joint Research Centre shall be assisted by a consortium of national reference laboratories, which will be referred to as the "European Network of GMO laboratories".

3.  The Community reference laboratory shall be notably responsible for:

   - reception, preparation, storage and maintenance of the appropriate positive and negative control samples;
   - testing and validation of the method for detection, including sampling and identification of the transformation event and, where applicable, the detection and identification of the transformation event in the food or feed;
   - evaluating the data provided by the applicant for authorisation for placing the food or feed on the market, for the purpose of testing and validation of the method for sampling and detection;
   - submitting full evaluation reports to the Authority.

4.  The Community reference laboratory shall play a role in disputes settlements between Member States concerning the results of the tasks outlined in this Annex.

(1) OJ C 304E, 30.10.2001, p. 221.
(2) OJ C 304 E, 30.10.2001, p. 221.
(3) OJ C
(4) OJ C
(5) Position of the European Parliament of 3 July 2002.
(6) OJ L 43, 14.2.1997, p. 1.
(7) OJ L 117, 8.5.1990, p. 15.
(8) OJ L 106, 17.4.2001, p. 1.
(9) OJ L 31, 1.2.2002, p. 1.
(10) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Directive 94/34/EC (OJ L 237, 10.9.1994, p. 1).
(11) OJ L 184, 15.7.1988, p. 61.
(12) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).
(13) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Directive 1999/20/EC .
(14) OJ L 109, 6.3.2000, p. 29
(15) OJ L 159, 3.6.1998, p. 4. Regulation as last amended by Regulation (EC) No 49/2000 (OJ L 6, 11.1.2000, p. 13).
(16) OJ L 6, 11.1.2000, p. 15.
(17) OJ L
(18) OJ L 184, 17.7.1999, p. 23.
(19) OJ Special Edition, Series III, Chapter 1966-1972, p. 31.
(20) OJ Special Edition, Series I, Chapter 1970(III), p. 674.
(21) OJ L 126, 13.5.1983, p. 23.
(22) OJ L 125, 23.5.1996, p. 35.
(23) OJ L 86, 6.4.1979, p. 30. Directive as last amended by European Parliament and Council Directive 2002/2/EC (OJ L 63, 6.3.2002, p. 23).


Major-accident hazards involving dangerous substances ***I
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Resolution
Consolidated text
Annex
European Parliament legislative resolution on the proposal for a European Parliament and Council directive amending Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances (COM(2001) 624 – C5&nbhy;0668/2001 – 2001/0257(COD))
P5_TA(2002)0355A5-0243/2002

(Codecision procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2001) 624(1)),

–   having regard to Article 251(2) of the EC Treaty and Article 175(1) of the EC Treaty, pursuant to which the Commission submitted the proposal (C5&nbhy;0668/2001),

–   having regard to Rule 67 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Consumer Policy and the opinion of the Committee on Industry, External Trade, Research and Energy (A5&nbhy;0243/2002),

1.  Approves the Commission proposal as amended;

2.  Asks to be consulted again should the Commission intend to amend the proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council and Commission.

Position of the European Parliament adopted at first reading on 3 July 2002 with a view to the adoption of European Parliament and Council Directive 2002/…./EC amending Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances

P5_TC1-COD(2001)0257


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 175 (1) thereof,

Having regard to the proposal from the Commission(2),

Having regard to the opinion of the Economic and Social Committee(3),

Having regard to the opinion of the Committee of the Regions(4),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(5),

Whereas:

(1)  Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances(6) aims at the prevention of major accidents which involve dangerous substances and the limitation of their consequences for man and the environment, with a view to ensuring high levels of protection throughout the Community in a consistent and effective manner.

(2)  In the light of recent industrial accidents and studies on carcinogens and substances dangerous for the environment carried out by the Commission at the Council's request, the scope of Directive 96/82/EC needs to be broadened.

(3)  The cyanide spill that polluted the Danube following the accident at Baia Mare in Romania in January 2000 has demonstrated that certain storage and processing activities in mining have a potential to produce very serious consequences.The Communications of the Commission on the safe operation of mining activities(7) and on the sixth environment action programme of the European Community(8) have therefore highlighted the need for an extension of the scope of Directive 96/82/EC. In its Resolution of 5 July 2001 on the Commission Communication on the safe operation of mining activities the European Parliament also welcomed the extension of the scope of that Directive to cover risks arising from storage and processing activities in mining.

(4)  The firework accident at Enschede in the Netherlands in May 2000 has demonstrated the major hazard potential arising from storage and manufacture of pyrotechnic substances. Therefore, the definition of such substances in Directive 96/82/EC should be clarified and simplified.

(5)  The explosion at the Grande Paroisse fertiliser plant in Toulouse on 21 September 2001 has emphasised the accident potential arising from the storage of ammonium nitrate and ammonium nitrate-based fertilisers, in particular, material rejected during the manufacturing process or returned to the manufacturer (so&nbhy;called "off-specs"). Therefore, the existing categories of ammonium nitrate and ammonium nitrate-based fertilisers in Directive 96/82/EC should be reviewed with a view to include "off-specs" material in particular.

(6)  The provisions of this Directive should not be applied to sites where ammonium nitrate and ammonium nitrate-based fertilisers which on delivery conformed to the specification in this Directive but subsequently have become degraded or contaminated, are temporarily present prior to removal for reprocessing or destruction.

(7)  The accident at Toulouse revealed numerous breaches of the provisions laid down in Directive 96/82/EC, in particular the fact that the building where the explosion took place had not been the subject of a safety report and that the hazard study of the ammonium nitrates produced and stored on this industrial site had not been reviewed since 1995.

(8)  In the light of the accident in Toulouse, it is vital to make the provisions applying to operators more stringent with regard to their general obligations, the relevance of safety reports which are central to the safety of industrial plants, internal and external emergency plans and the information provided to the public, in order to reduce the risks of accidents at source and consequently limit, as far as possible, strategic errors in risk perception and trivialisation of risks.

(9)  The hazardousness of a substance depends on a number of parameters: intrinsic properties, temperature, pressure, particle size or possible mixture with other substances. Consequently, a product considered stable in certain conditions or applications may be explosive in others and create a risk of a major accident.

(10)  Studies carried out by the Commission in close cooperation with the Member States support extending the list of carcinogens with appropriate qualifying quantities and significantly lowering the qualifying quantities assigned to substances dangerous for the environment in Directive 96/82/EC.

(11)  It is appropriate at the same time to clarify and correct certain passages in Directive 96/82/EC.

(12)  Directive 96/82/EC should therefore be amended accordingly.

(13)  The measures provided for in this Directive have been the subject of a public consultation process involving interested parties,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 96/82/EC is amended as follows:

1.  In Article 4, points (e) and (f) are replaced by the following:

"
   e) the exploitation (exploration, extraction and processing) of minerals in mines and quarries, with the exception of processing operations and related storage involving dangerous substances as defined in Annex I of this Directive;
   f) waste land-fill sites with the exception of operational tailings disposal facilities containing dangerous substances as defined in Annex I of this Directive and used in connection with the processing of minerals.
"

2.  In Article 4 the following point is added after point (f):

"

(fa) offshore exploration and exploitation of minerals.

"

3.  In Article 6(1), the following indent is added after the second indent:

"
   - for establishments not previously falling within the scope of application of this Directive, within three months of the date on which the Directive applies to the establishment concerned as provided in the first sentence of Article 2(1).
"

4.  In Article 6(2), the following point is added after point (g):

"

(ga) training measures for the staff of the establishment or operating firm and external enterprises on prevention and emergency measures in the event of a major accident.

"

5.  In Article 6(4) the following indent is added after the first indent:

"
   - substantial modification of an installation, an establishment or a storage area, or
"

6.  Article 7(1) is replaced by the following:

"

1.  Member States shall require the operator to draw up a document setting out his major-accident prevention policy evidencing his compliance with his obligations and to ensure that it is properly implemented. The major-accident prevention policy established by the operator shall be designed to guarantee a high level of protection for man and the environment by appropriate means, structures and management systems.

1a. For establishments not previously falling within the scope of application of this Directive, the document shall be drawn up without delay and in any case no later than within three months of the date on which the Directive applies to the establishment concerned as provided in the first sentence of Article 2(1).

"

7.  In Article 8(2), the following points are added after point (a):

"

(aa) in accordance with this Directive and in particular Article 12 thereof, operators are required to take the necessary measures to prevent domino effects occurring in the event of major accidents;

(ab) the public shall be informed of the possible dangers and risks of domino effects occurring through the local press, by post and on the official website of the regional authority concerned;

"

8.  Article 8(2)(b) is replaced by the following:

"
   b) provision is made for cooperation in supplying information to the authority responsible for the preparation of external emergency plans.
"

9.  Article 9(2) is replaced by the following:

"

2.  The safety report shall contain at least the data and information listed in Annex II. It shall also contain an updated inventory of the dangerous substances present in the establishment. It shall also list the persons involved in drawing up the report and describe the methods used. Several safety reports, sections of reports, or other equivalent reports drawn up in accordance with other legislation may be merged into a single safety report for the purposes of this Article, when such an arrangement makes it possible to avoid the unnecessary repetition of information and duplication of work carried out by the operator or by the competent authority, provided that all the requirements of this Article are satisfied.

"

10.  In Article 9(3) the following indent is added after the third indent:

"
   - for establishments not previously falling within the scope of application of this Directive, without delay and in any case no later than one year from the date on which the Directive applies to the establishment concerned as provided in the first sentence of Article 2(1).
"

11.  In Article 9(5), the second indent is replaced by the following:

"
   - at any other time, and compulsorily in the event of changes in work organisation with an impact on the safety of an installation, at the initiative of the operator or the request of the competent authority, where justified by new facts or to take account of new technical knowledge about safety matters arising, for example, from analysis of accidents or, as far as possible, 'near misses', and of developments in knowledge concerning the assessment of hazards.
"

12.  In Article 9(6), the following point is added after point (c):

"

Member States shall ensure that the different methods used for drawing up safety reports are ultimately drawn together in a single European method.

"

13.  In Article 10, the second indent is replaced by the following:

"
   - reviews, and where necessary revises, the safety report.
"

14.  In Article 10, a new paragraph is added after the first paragraph:

"

The operator shall provide the competent authority referred to in Article 16 with full particulars of the review and revision, if any, of its major-accident prevention policy, the management systems and procedures referred to in Articles 7 and 9 and the safety report, before making any change.

"

15.  In Article 11(1)(a) the following indent is added after the third indent:

"
   - for establishments not previously falling within the scope of application of this Directive, without delay and in any case no later than one year from the date on which the Directive applies to the establishment concerned as provided in the first sentence of Article 2(1).
"

16.  In Article 11(1)(b) the following indent is added after the third indent:

"
   - for establishments not previously falling within the scope of application of this Directive, without delay and in any case no later than one year from the date on which the Directive applies to the establishment concerned as provided in the first sentence of Article 2(1).
"

17.  Article 11(3) is replaced by the following:

"

3.  Without prejudice to the obligations of the competent authorities, Member States shall ensure that the internal emergency plans provided for in this Directive are drawn up in consultation with personnel employed inside the establishment and that the public is consulted when external emergency plans are drawn up and reviewed in accordance with paragraph 4.

3a. In accordance with the relevant national legislation, the operator of the establishment or enterprise shall consult the internal body responsible for safety and risk prevention matters. The latter shall also involve the staff of external enterprises employed on the site of the establishment in its work.

"

18.  In Article 11, the following paragraph is added:

"

4a. Member States shall ensure that external emergency plans take into account Council Decision 2001/792/EC, Euratom of 23 October 2001 establishing a Community mechanism to facilitate reinforced cooperation in civil protection assistance interventions*.

________________

* OJ L 297, 15.11.2001, p. 7.

"

19.  In Article 11, the following paragraph is added after paragraph 5:

"

5a. If an event listed in paragraph 5 occurs, Member States shall inform the monitoring and information centre established according to Decision 2001/792/EC, Euratom) and cooperate with this centre.

"

20.  In Article 12(1), first subparagraph, the following point is added after point (c):

"

(ca) technical measures put in place to reduce hazard areas, such as effective passive safety measures (tank dikes, concrete skirts, burial) to prevent the risk of explosion, moving high-risk installations within the perimeter of the establishment, the reduction of volumes stored on site and changes in production processes to eliminate the use of dangerous intermediate products.

"

21.  In Article 12(1), the second subparagraph is replaced by the following:

"

Member States shall ensure that their land-use and/or other relevant policies and the procedures for implementing those policies take account of the need, in the long term, to maintain appropriate distances between establishments covered by this Directive and residential areas, buildings and areas of public use, transport routes, industrial establishments, recreational areas, and areas of particular natural sensitivity or interest, and, in the case of existing establishments, of the need for additional technical measures in accordance with Article 5 so as not to increase the risks to people.

"

22.  In Article 12, the following paragraph is added after paragraph 1:

"

1a. By ...*, the Commission, in close cooperation with the Member States, shall draw up guidelines defining a harmonised technical database of risk data and risk scenarios to be used for assessing the compatibility between existing establishments covered by this Directive and the sensitive areas listed in paragraph 1. This method of assessment shall in any case take account of the evaluations made by the competent authorities, the information obtained from operators and all other relevant information such as the socio-economic benefits of development and the mitigating effects of emergency plans.

By ...(9), the Commission, in close cooperation with the Member States, shall develop guidelines setting out a methodology for establishing appropriate minimum safety distances between establishments covered by this Directive and the sensitive areas listed in paragraph 1.

1b. The Commission shall in the same context develop a scheme of incentives and/or funding for the relocation of establishments covered by this Directive which do not provide for the appropriate safety distance. This could be done in the framework of regional policy.

23.  In Article 13(1) the first subparagraph is replaced with the following:

"1. Member States shall ensure that information on safety measures and on the requisite behaviour in the event of an accident is supplied regularly and in the most appropriate form, without their having to request it, to all persons and all establishments serving the public (schools, hospitals, etc.) liable to be affected by a major accident originating in an establishment covered by Article 9.

"

24.  Article 13(4) is replaced by the following:

"

4.  Member States shall ensure that the safety report is made available to the public, in particular, people living in municipalities in which establishments covered by this Directive are located. Information concerning the availability of the safety report and emergency plans shall appear in the local press and on the website of the competent national authority. The operator may ask the competent authority not to disclose to the public certain parts of the report, for reasons of industrial, commercial or personal confidentiality, public security or national defence. In such cases, with the approval of the competent authority, the operator shall supply to the authority, and make available to the public, an amended report excluding those matters.

The inventory of the categories of dangerous substances present in the establishment with the respective amounts shall not be exempt from disclosure. The safety report shall also be forwarded to the local advisory bodies, in accordance with the provisions of the first subparagraph, as shall the emergency plans.

4a. Member States shall ensure that this information is clearly posted in establishments subject to the jurisdiction of the public authorities and in any establishment open to large numbers of people (schools, hospitals, etc.) in areas in which an establishment covered by the scope of application of this Directive is located.

The council offices of municipalities in which an establishment covered by this Directive is located shall make available to anyone who so requests, the safety report, in accordance with the provisions of paragraph 4, and the external emergency plans.

"

25.  After Article 13, the following new article is added:

"

Article 13a

Training of the staff of establishments or enterprises and of external enterprises

Member States shall ensure that the establishment or operator and external enterprises provide their staff with regular training so that they are able to take the initial emergency measures required in the event of a major accident, and master any new manufacturing process involving dangerous substances.

The establishment or operator and external enterprises working on the site of the establishment or enterprise shall provide the competent authorities at regular intervals, and least once every two years, with a report on the training measures for their respective staff on dealing with major accidents.

The report must provide details of:

   - the training body or officers,
   - its registration number with the public authorities,
   - the length of training,
   - the type of training provided,
   - the staff concerned.

"

26.  In Article 17(1) a new subparagraph is added after the second subparagraph:

"

Member States shall suspend the activities of an establishment or enterprise if the operator has failed to:

   - inform the competent authority in accordance with Article 6 (4) indents 1 and 2, and Article 10,
   - forward to the competent authorities the report on staff training in his establishment and external enterprises.

Member States shall notify the enterprise without delay of its non-compliance and the suspension of activities. They shall also inform it of the deadlines for complying with the provisions of this Directive.

If the enterprise has not replied by the deadlines set, Member States may prohibit the enterprise from operating, after giving the enterprise further notice of its non-compliance.

"

27.  In Article 19, the following paragraph is added after paragraph 1:

"

1a. For establishments covered by this Directive, Member States shall supply to the Commission at least the following information:

   a) the name or trade name of the operator and the full address of the establishment concerned;
   b) the activity or activities of the establishment.

The Commission shall set up and keep up to date a database containing the information provided by the Member States.

"

28.  Article 20(1) is replaced by the following:

"

1.  Member States shall ensure, in the interests of transparency, that the competent authorities are required to make information received pursuant to this Directive available to any natural or legal person who so requests.

Information obtained by the competent authorities or the Commission may, where national provisions so require, be kept confidential if it calls into question:

   - the confidentiality of the deliberations of the competent authorities and the Commission;
   - the confidentiality of international relations and national defence;
   - public security;
   - the confidentiality of preliminary investigation proceedings or of current legal proceedings;
   - commercial and industrial secrets, including intellectual property - but exclusively relating to processes. Access to information concerning the storage of substances covered by Annex I may not be withheld;
   - personal data and/or files;
   - data supplied by a third party if that party asks for them to be kept confidential.

"

29.  Annex I is amended as set out in the Annex to this Directive.

Article 2

1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by (10)... at the latest. They shall forthwith inform the Commission thereof.

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

2.  Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at ,

For the European Parliament For the Council

The President The President

A N N E X

Annex I to Directive 96/82/EC is amended as follows:

1.  In the Introduction the following point 6 is added:

"

6.  For the purposes of this Directive, a gas is a substance that is completely gaseous at 20ºC at a standard pressure of 101.3 kPa.

"

2.  In Part 1 the figures for ammonium nitrate are replaced by the following:

"Ammonium nitrate

Ammonium nitrate

Ammonium nitrate

Ammonium nitrate

5000

1250

350

10

10000

5000

2500

50"

3.  In Part 1, the following lines are added:

"Potassium nitrate

1250

5000

Potassium nitrate

5000

10000"

4.  In Part 1 the entry which starts with the words: "The following CARCINOGENS" is replaced by the following:

"The following CARCINOGENS at concentrations above 5%:

4-Aminobiphenyl and/or its salts, Benzotrichloride, Benzidine and/or salts, Bis (chloromethyl) ether, Chloromethyl methyl ether, 1,2-Dibromoethane, Diethyl sulphate, Dimethyl sulphate, Dimethylcarbamoyl chloride, 1,2-Dibromo-3-chloropropane, 1,2-Dimethylhydrazine, Dimethylnitrosomine, Hexamethylphosphoric triamide, Hydrazine, 2-Naphtylamine and/or salts, 4-Nitrodiphenyl, and 1,3 Propanesultone

0,5

2"

5.  In Part 1 the entry "Automotive petrol and other petroleum spirits" is replaced by the following:

"Petroleum products:

(a) gasolines and naphthas,

(b) kerosenes (including jet fuels),

(c) gas oils (including diesel fuels, home heating oils and gas oil blending streams)"

2500

25000

6.  In Part 1, Notes 1 and 2 are replaced by the following:

"

1.  Ammonium nitrate (5000/10000)

This applies to ammonium nitrate-based compound/composite fertilisers (compound/composite fertilisers contain ammonium nitrate with phosphate and/or potash) in which the nitrogen content as a result of ammonium nitrate is 24.5%* by weight or less, and which are capable of self-sustaining decomposition according to the UN Trough Test (see United Nations Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria, Part III, sub-section 38.2).

2.  Ammonium nitrate (1250 / 5000):

fertiliser grade

This applies to straight ammonium nitrate-based fertilisers and to ammonium nitrate-based compound/composite fertilisers in which the nitrogen content as a result of ammonium nitrate is

   - more than 24.5 %* by weight, except for mixtures of ammonium nitrate with dolomite, limestone and/or calcium carbonate with a purity of at least 90 %,
   - more than 15.75 %** by weight for mixtures of ammonium nitrate and ammonium sulphate,
   - more than 28 %*** by weight for mixtures of ammonium nitrate with dolomite, limestone and/ or calcium carbonate with a purity of at least 90 %,
  

and which fulfil the requirements of Annex II of Council Directive 80/876/EEC****.

  

2a. Ammonium nitrate (350/2500)

This applies to ammonium nitrate and ammonium-nitrate based preparations in which the nitrogen content resulting from the ammonium nitrate is:

   - more than 24.5% by weight
   - more than 15.75% by weight for mixtures of ammonium nitrate and ammonium sulphate,
   - more than 28% by weight for mixtures of ammonium nitrate with dolomite, limestone and/or calcium carbonate with a purity of at least 90%, and which contain a percentage equal to or less than 0.2% of combustible substances and aqueous ammonium nitrate solutions in which the concentration of ammonium nitrate is more than 90% by weight.
  

2b. Ammonium nitrate (10/50):

"off-specs" material and fertilisers not fulfilling the detonation test 

This applies to

   - material rejected during the manufacturing process and to ammonium nitrate and preparations of ammonium nitrate, straight ammonium nitrate-based fertilisers and ammonium nitrate-based compound/composite fertilisers referred to in Notes 2 and 2a, that are being or have been returned from the final user to a manufacturer, temporary storage or reprocessing plant for reworking, recycling or treatment for safe use, because they no longer comply with the specifications of Notes 2 and 2a;
   - fertilisers referred to in Notes 1 and 2 which do not fulfil the requirements of Annex II of Directive 80/876/EEC.
  

2c. Potassium nitrate (1250/5000)

Composite potassium-nitrate based fertilisers composed of potassium nitrate in crystalline form

Potassium nitrate (5000/10000)

Composite potassium-nitrate based fertilisers composed of potassium nitrate in prilled/granular form.

____________________

* A nitrogen content of 24.5% by weight corresponds to a 70% ammonium nitrate solution.

** A nitrogen content of 15.75% by weight corresponds to a 45% ammonium nitrate solution.

*** A nitrogen content of 28% by weigh corresponds to an 80% ammonium nitrate solution.

**** OJ L 250, 23.9.1980, p. 7. Directive as amended by European Parliament and Council Directive 97/63/EC (OJ L 335, 6.12.1997, p. 15).

"

7.  In Part 2 the entries 4 and 5 "EXPLOSIVE" are replaced by the following:

"4.

EXPLOSIVE (see Note 2)

where the substance or preparation falls under HD 1.4

50

200

5.

EXPLOSIVE (see Note 2).

where the substance or preparation falls under any of: HD 1.1, HD 1.2, HD 1.3, HD 1.5, HD 1.6, R2, R3

10

50"

8.  In Part 2 entry 9 "DANGEROUS FOR THE ENVIRONMENT" is replaced by the following:

"9.

DANGEROUS FOR THE ENVIRONMENT risk phrases:

R50: "Very toxic to aquatic organisms" (including R50/53)

R51/53: "Toxic to aquatic organisms"; and "May cause long term adverse effects in the aquatic environment"

100

200

200

500"

9.  In the Notes to Part 2, Note 1 is replaced by the following:

"

1.  Substances and preparations are classified according to the following Directives and their current adaptation to technical progress:

   Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (11),
   Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(12),
   Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (UN/ADR classification scheme)(13),
   Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(14),
   Council Directive 91/689/EEC of 12 December 1991 on hazardous waste(15).

In the case of substances and preparations which are not classified as dangerous according to any of the above Directives but which nevertheless are present, or are likely to be present, in an establishment and which possess or are likely to possess, under the conditions found at the establishment, equivalent properties in terms of major&nbhy;accident potential, the procedures for provisional classification shall be followed according to the relevant Article of the appropriate Directive.

In the case of substances and preparations with properties giving rise to more than one classification, for the purposes of this Directive the lowest thresholds shall apply. However, for the application of the summation rule in Note 4 of these Notes, the threshold used shall always be the one corresponding to the classification concerned.

For the purposes of this Directive, the Commission shall establish and keep up to date a list of substances which have been classified into the above categories by harmonised decision in accordance with Directive 67/548/EEC.

"

10.  In the Notes to Part 2, Note 2 is replaced by the following:

"

2.   "Explosive" means a substance or preparation which is classified with risk phrase R2 or R3, or which is classified in any of the hazard divisions HD1.1 to HD1.6 according to the UN/ADR classification scheme. Included in this definition are pyrotechnics, which for the purposes of this Directive are defined as substances (or mixtures of substances) designated to produce heat, light, sound, gas or smoke or a combination of such effects through self-sustained exothermic chemical reactions.

The hazard divisions and risk phrases concerned are:

   1.1 HD 1.1: "Substances and articles which have a mass explosion hazard. (A mass explosion is an explosion which affects almost the entire load virtually instantaneously).
"
   1.2 HD 1.2: "Substances and articles which have a projection hazard but not a mass explosion hazard."
   1.3 HD 1.3: "Substances and articles which have a fire hazard and either a minor blast hazard or a minor projection hazard or both, but not a mass explosion hazard: (a) combustion of which gives rise to considerable radiant heat; or (b) which burn one after another, producing minor blast or projection effects or both."
   1.4 HD 1.4: "Substances and articles which present only a slight risk in the event of ignition or initiation during carriage The effects are largely confined to the package and no projection of fragments of appreciable size or range is to be expected. An external fire shall not cause virtually instantaneous explosion of virtually the entire contents of the package."
   1.5 HD 1.5: "Very insensitive substances having a mass explosion hazard which are so insensitive that there is very little probability of initiation or of transition from burning to detonation under normal conditions of carriage. As a minimum requirement they shall not explode in the external fire test."
   1.6 HD 1.6: "Extremely insensitive articles which do not have a mass explosion hazard. The articles contain only extremely insensitive detonating substances and demonstrate a negligible probability of accidental initiation or propagation. The risk is limited to the explosion of a single article."

R2: "Substances or preparations which create the risk of an explosion by shock, friction, fire or other sources of ignition"

R3: "Substances or preparations which create extreme risks of explosion by shock, friction, fire or other sources of ignition"

In the case of objects containing explosive or pyrotechnic substances or preparations, if the quantity of the substance or preparation contained in the object is known, that quantity shall be considered for the purposes of this Directive. If the quantity is not known, then for the purposes of this Directive the whole object shall be treated as explosive."

11.  In the Notes to Part 2, Note 3 (b) (1), second indent, is replaced by the following:

"
   - substances and preparations which have a flash point lower than 55°C and which remain liquid under pressure, where particular processing conditions, such as high pressure or high temperature, may create major-accident hazards;
"

12.  In the Notes to Part 2, Note 3 (c) (2) is replaced by the following:

"
   2. gases which are flammable in contact with air at ambient temperature and pressure (risk phrase R12, second indent), which are in a gaseous or supercritical state, and
"

13.  In the Notes to Part 2, Note 3 (c) (3) is replaced by the following:

"
   3. flammable liquid substances and preparations maintained at a temperature above their boiling point.
"

14.  In the Notes to Part 2, Note 4 is replaced by the following :

"

4.  In the case of an establishment where no individual substance or preparation is present in a quantity above or equal to the relevant qualifying quantities, the following summation rule shall be applied to determine whether the establishment is covered by the relevant requirements of this Directive.

This Directive shall apply if the sum

q1/QU + q2/ QU + q3/ QU + q4/ QU + q5/ QU + ... is greater than or equal to 1,

where qx = the quantity of dangerous substances x (or category of dangerous substances) falling within Parts 1 or 2 of this Annex,

and QU = the relevant threshold quantity from column 3 of Parts 1 or 2.

This Directive shall apply, with the exception of Articles 9, 11 and 13, if the sum

q1/QL + q2/ QL + q3/ QL + q4/ QL + q5/ QL + ... is greater than or equal to 1,

where qx = the quantity of dangerous substances x (or category of dangerous substances) falling within Parts 1 or 2 of this Annex,

and QL = the relevant threshold quantity from column 2 of Parts 1 or 2.

This summation rule shall be used to assess the overall hazards associated with: toxicity, flammability, and eco-toxicity. It must therefore be applied three times:

   a) for the summation of substances and preparations named in Part 1 and classified as toxic or very toxic, together with substances and preparations falling into categories 1 or 2;
   b) for the summation of substances and preparations named in Part 1 and classified as oxidising, explosive, flammable, highly flammable, or extremely flammable, together with substances and preparations falling into categories 3, 4, 5, 6, 7a, 7b or 8;
   c) for the summation of substances and preparations falling into categories 9 (i) or 9 (ii).

The relevant provisions of the Directive apply if any of the sums obtained by (a), (b) or (c) is greater than or equal to 1.

"

15.  In Annex II, Part IV, a new point is inserted after point A:

"

Aa. Hazard studies :

   - of each substance present or potentially present on the site of the establishment,
   - of the interaction, including the domino effect, of substances present on the site.

The hazard studies must take account of the accidents that have already occurred and accidents of which there is a high risk of occurrence due to the substance or substances present together in the establishment, the consequences that these accidents have caused or may cause, and the lethal effect thresholds linked to the hazards and risks identified.

"

16.  In Annex III, point (c), subparagraph (i) is replaced by the following:

"

i)   organisation and personnel - the roles and responsibilities of personnel involved in the management of major hazards at all levels in the organisation. The identification of training needs of such personnel and the provision of the training so identified. The involvement of employees and of subcontractors working in the establishment.

"

17.  In Annex V, the following point is added after point 10:

"

10a. A map, on an easily-readable scale, showing risk areas.

For these areas, the map must show the population, the type of settlement and the natural resources and environments concerned.

"

(1) OJ C 75 E, 26.3.2002, p. 357.
(2) OJ C 75 E, 26.3.2002, p. 357.
(3) OJ C …
(4) OJ C …
(5) Position of the European Parliament of 3 July 2002.
(6) OJ L 10, 14. 1.1997, p.13.
(7) COM (2000) 664 final.
(8) COM (2001) 31 final.
(9)* Three years after the adoption of this Directive."
(10)* 12 months after its entry into force.
(11) OJ 196, 16. 8. 1967, p. l. Directive as last amended by Commission Directive 2000/33/EC (OJ L 136, 8. 6. 2000, p. 90).
(12) OJ L 200, 30.7.1999, p. 1.
(13) OJ L 319, 12.12.1994, p.7. Directive as last amended by Commission Directive 2001/7/EC (OJ L 30,1.2.2000, p.43).
(14) OJ L 327, 22.12.2000, p. 1.
(15) OJ L 377, 31.12.1991, p. 20. Directive as last amended by Directive 94/31/EC (OJ L 168, 2.7.1994, p. 28).


EC framework programme (research 2002-2006) ***I
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Resolution
Consolidated text
European Parliament legislative resolution on the amended proposal for a decision of the European Parliament and of the Council concerning the rules for the participation of undertakings, research centres and universities and for the dissemination of research results for the implementation of the European Community framework programme 2002-2006 (COM(2001) 822 – C5-0017/2002 – 2001/0202(COD))
P5_TA(2002)0356A5-0203/2002

(Codecision procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal and amended proposal to the European Parliament and the Council (COM(2001) 500(1) and COM(2001) 822(2)),

–   having regard to Articles 167 and 172(2) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0017/2002),

–   having regard to Rule 67 of its Rules of Procedure,

–   having regard to the report of the Committee on Industry, External Trade, Research and Energy and the opinion of the Committee on Culture, Youth, Education, the Media and Sport (A5-0203/2002),

1.  Approves the Commission proposal as amended;

2.  Asks to be consulted again should the Commission intend to amend the proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council and Commission.

Position of the European Parliament adopted at first reading on 3 July 2002 with a view to the adoption of European Parliament and Council Regulation (EC) No..../2002 concerning the rules for the participation of undertakings, research centres and universities and for the dissemination of research results for the implementation of the European Community sixth framework programme 2002-2006

P5_TC1-COD(2001)0202


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 167 and the second paragraph of Article 172 thereof,

Having regard to the proposal from the Commission(3),

Having regard to the opinion of the Economic and Social Committee(4),

Acting in accordance with the procedure referred to in Article 251 of the Treaty(5),

Whereas:

(1)  The sixth framework programme of the European Community for research, technological development and demonstration activities, aimed at contributing towards the creation of the European Research Area (2002-2006) (hereinafter referred to as "the sixth framework programme"), was adopted by Decision No …/2002/EC of the European Parliament and Council(6). The rules for financial participation by the Community, as set out in Annex III to that Decision, need to be supplemented by other provisions.

(2)  Those provisions should fit into a coherent and transparent framework which takes full account of the objectives and characteristics of the instruments defined in Annex III to the sixth framework programme in order to guarantee the most efficient implementation possible, taking into account the need for easy access of participants through simplified procedures. This will be especially the case for SMEs, owing to the participation of enterprise groupings.

(3)  The rules for the participation of undertakings, research centres and universities should take account of the nature of the research and technological development activities, including demonstration activities. They may, moreover, vary depending on whether the participant is based in a Member State, in an Associated State – whether a candidate country or not – or in a third country, and on its legal structure, namely whether it is a national organisation, an international organisation – of European interest or not – a small or medium-sized enterprise, a European Economic Interest Grouping, or an association formed by participants.

(4)  In conformity with the sixth framework programme, the participation of legal entities from third countries should be envisaged, in line with the objectives of international cooperation, particularly as enshrined in Articles 164 and 170 of the Treaty.

(5)  International organisations which are dedicated to developing cooperation in the field of research in Europe and which are largely made up of Member States or Associated States contribute to the creation of the European Research Area. They should therefore be encouraged to participate in the sixth framework programme.

(6)  The Joint Research Centre (hereinafter referred to as the "JRC") takes part in indirect research and technological development actions on the same basis as legal entities established in a Member State.

(7)  Activities under the sixth framework programme should comply with the financial interests of the Community and should safeguard those interests. The Commission's responsibility for implementation of the framework programme and its specific programmes also includes the financial aspects arising therefrom.

(8)  The rules governing the dissemination of research results should promote the protection of the intellectual property and the use and dissemination of those results. They should ensure that participants have mutual access to pre-existing know-how and to knowledge arising from research work to the extent necessary to conduct the research work or to use the resulting knowledge. At the same time, they should guarantee the protection of the participants' intellectual assets. They should also take account of the features of the integrated projects and networks of excellence, in particular by offering a high degree of flexibility to the participants, and allowing them to agree among themselves on the most suitable arrangements for their collaboration and for the exploitation of the resulting knowledge. These agreements may form part of a consortium agreement.

(9)  Activities under the sixth framework programme should be conducted in compliance with ethical principles, including those reflected in the Charter of Fundamental Rights of the European Union, and should strive both to increase the role of women in research and to improve information for, and dialogue with, society, as well as promoting participation from the outermost regions of the Community,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

INTRODUCTORY PROVISIONS

Article 1

Subject

This Regulation establishes rules for the participation of enterprises, research centres and universities and rules for the dissemination of results from research carried out under the sixth framework programme, with the exception of RTD activities executed by a joint undertaking or any other structure set up pursuant to Article 171 of the Treaty.

Article 2

Definitions

For the purposes of this Regulation:

1)   "RTD activity" means one of the research and technological development activities, including demonstration activities, described in Annexes I and III to the sixth framework programme;

2)   "direct action" means an RTD activity undertaken by the JRC in the execution of the tasks assigned to it under the sixth framework programme;

3)   "indirect action" means an RTD activity undertaken by one or more participants by means of an instrument of the sixth framework programme;

4)   "instruments" means the mechanisms for indirect Community intervention as laid down in Annex III to the sixth framework programme, with the exception of Community financial participation pursuant to Article 169 of the Treaty;

5)   "contract" means a grant agreement between the Community and the participants concerning the performance of an indirect action establishing rights and obligations between the Community and the participants on the one hand, and between the participants in that indirect action on the other;

6)   "consortium agreement" means an agreement that participants in an indirect action conclude amongst themselves for its implementation. Such an agreement shall not affect participants' obligations to the Community and to one another arising out of this Regulation and the contract;

7)   "participant" means a legal entity contributing to an indirect action and having rights and obligations with regard to the Community under the terms of this Regulation or according to the contract;

8)   "legal entity" means any natural person, or any legal person created under the national law of its place of establishment, under Community law, or international law, having legal personality and being entitled to have rights and obligations of any kind in its own name;

9)   "consortium" means all the participants in the same indirect action;

10)   "coordinator" means the participant appointed by participants in the same indirect action and accepted by the Commission, having specific additional obligations arising out of this Regulation and the contract;

11)   "international organisation" means any legal entity arising from an association of States, other than the Community, established on the basis of a treaty or similar act, having common institutions and an international legal personality distinct from that of its Member States;

12)   "international European interest organisation" means an international organisation, the majority of whose members are European Community Member States or Associated States, and whose principal objective is to promote scientific and technological cooperation in Europe;

13)   "associated candidate country" means an associated State acknowledged by the Community as a candidate for accession to the European Union;

14)   "Associated State" means a State which is party to an international agreement with the Community, under the terms or on the basis of which it makes a financial contribution to all or part of the sixth framework programme;

15)   "third country" means a State that is neither a Member State nor an Associated State;

16)   "European Economic Interest Grouping" (EEIG) means any legal entity established in accordance with Council Regulation (EEC) No 2137/85(7);

17)   "small and medium-sized enterprises" (hereinafter referred to as "SMEs") means enterprises which meet the criteria set out in Commission Recommendation 96/280/EC(8);

18)   "enterprise grouping" means any legal entity made up for the most part of SMEs and representing their interests;

19)   "budget" means a financial plan estimating all the resources and expenditure needed to carry out an indirect action;

20)   "irregularity" means any infringement of a provision of Community law or any breach of a contractual obligation resulting from an act or omission by a legal entity which has, or would have, the effect of prejudicing the general budget of the Communities or budgets managed by them through unjustified expenditure;

21)   "pre-existing know-how" means the information which is held by participants prior to the conclusion of the contract or acquired in parallel with it, as well as copyrights or rights pertaining to such information following applications for, or the issue of, patents, designs, plant varieties, supplementary protection certificates or similar forms of protection;

22)   "knowledge" means the results, including information, whether or not they can be protected, which are yielded by direct actions and indirect actions, as well as copyrights or rights pertaining to such information following applications for, or the issue of, patents, designs, plant varieties, supplementary protection certificates or similar forms of protection;

23)   "dissemination" means the disclosure of knowledge by any appropriate means other than publication resulting from the formalities for protecting knowledge;

24)   "use" means the direct or indirect utilisation of knowledge in research activities or for developing, creating and marketing a product or process or for creating and providing a service;

25)   "work programme" means a plan drawn up by the Commission for the implementation of a specific programme;

26)   "joint programme of activities" covers the actions undertaken by participants which are required for implementing a network of excellence;

27)   "access rights" means licences and rights to use knowledge or pre-existing know-how;

28)   "legitimate interest" means a participant's interest of any kind, particularly a commercial interest, that may be claimed in the cases specified in this Regulation; to this end the participant must prove that failure, in any given instance, to take account of his interest would result in his suffering disproportionately great harm;

29)   "implementation plan" covers all actions by participants in an integrated project;

30)   "industrial States" are those third countries that are members of G7;

31)   "public body" means a public sector body or a legal entity governed by private law with a public service mission providing adequate financial guarantees.

Article 3

Independence

1.  Two legal entities shall be independent of one another for the purposes of this Regulation where there is no controlling relationship between them. A controlling relationship shall exist where one legal entity directly or indirectly controls the other or one legal entity is under the same direct or indirect control as the other. Control may result in particular from:

   a) direct or indirect holding of more than 50% of the nominal value of the issued share capital in a legal entity, or of a majority of voting rights of the shareholders or associates of that entity;
   b) direct or indirect holding in fact or in law of decision-making powers in a legal entity.

2.  Direct or indirect holding of more than 50% of the nominal value of the issued share capital in a legal entity or a majority of voting rights of the shareholders or associates of the said entity by public investment corporations, institutional investors or venture-capital companies and funds shall not in itself constitute a controlling relationship.

3.  Ownership or supervision of legal entities by the same public body shall not in itself give rise to a controlling relationship between them.

CHAPTER II

PARTICIPATION IN INDIRECT ACTIONS AND FINANCING

Article

General principles

1.  Any legal entity taking part in an indirect action may receive a Community financial contribution subject to the provisions of Articles 6 and 7.

2.  Any legal entity established in an Associated State may take part in indirect actions on the same footing and shall have the same rights and obligations as a legal entity established in a Member State, subject to the provisions of Article 5.

3.  The JRC may participate in indirect actions on the same footing and shall have the same rights and obligations as a legal entity established in a Member State.

4.  Any international European interest organisation may take part in indirect actions on the same footing and shall be entitled to the same rights and bound by the same obligations as a legal entity established in a Member State in accordance with its Statute of Establishment.

5.  The work programmes may specify and restrict the participation of legal entities in an indirect action according to their activity and type and according to the instrument deployed and to take into account specific objectives of the sixth framework programme.

Article 5

Minimum numbers of participants and their place of establishment

1.  The work programmes shall specify the minimum number of participants required for each indirect action and also their place of establishment, according to the nature of the instrument and the objectives of the RTD activity.

2.  Subject to paragraph 3, the minimum number of participants established by the work programmes shall not be fewer than three independent legal entities established in three different Member States or Associated States, of which at least two shall be established in a Member State or associated candidate country.

3.  Specific support actions and actions in favour of human resources and mobility, except for research training networks, may be executed by a single legal entity.

4.  An EEIG or any legal entity established in a Member State or Associated State according to its national law and which is made up of independent legal entities meeting the criteria of this Regulation may be the sole participant in an indirect action, provided that its composition is in accordance with the conditions fixed pursuant to the provisions of paragraphs 1 and 2.

Article 6

Participation by legal entities from third countries

1.  Over and above the minimum number of participants fixed in accordance with the terms of Article 5, any legal entity established in a third country may participate in RTD activities referred to under the heading "Focusing and Integrating Community Research" of the sixth framework programme. Detailed provisions for this participation may be set out in the relevant work programme. The involvement of participants from industrial States may be subject to arrangements of a reciprocal nature, which could take the form of a scientific and technological agreement.

Any legal entity established in a third country targeted by the specific international cooperation activities referred to under the heading "Focusing and Integrating Community Research" of the sixth framework programme may receive a Community financial contribution within the limits of the budget allocated in Annex II to the sixth framework programme for the action referred to in point (b) of Article 164 of the Treaty.

Any legal entity established in a third country other than a country covered by the second subparagraph, and taking part in the RTD activities referred to in the first subparagraph, may receive a Community financial contribution if provision is made for this purpose under an RTD activity or if it is essential for carrying out the indirect action.

2.  Any legal entity established in a third country which has concluded a scientific and technological cooperation agreement with the Community may take part in RTD activities other than those covered by paragraph 1, over and above the minimum number of participants fixed in accordance with the terms of Article 5, in accordance with the conditions stipulated in that agreement.

It may receive a Community financial contribution if provision is made for this under an RTD activity or if it is essential for carrying out the indirect action.

3.  Any legal entity established in a third country other than those covered by paragraph 2 may take part in RTD activities other than those covered by paragraph 1, over and above the minimum number of participants fixed in accordance with the terms of Article 5, if such participation is provided for under an RTD activity or if it is essential for carrying out the indirect action.

It may receive a Community financial contribution if provision is made for this under an RTD activity or if it is essential for carrying out the indirect action.

Article 7

Participation by international organisations

Any international organisation other than international European interest organisations may take part in RTD activities referred to in Article 6(1), subject to the conditions set out in the first and third subparagraphs thereof, and in other RTD activities subject to the conditions set out in Article 6(2) and (3).

Article 8

Conditions relating to technical competence and resources

1.  Participants shall have the knowledge and technical competence needed to carry out the indirect action.

2.  At the time when they present their proposal, participants shall have at least the potential resources needed to carry out the indirect action, and shall be able to specify the relevant source of those funds made available by third parties, including public authorities.

As work progresses, participants shall have the resources as and when needed to carry out the indirect action.

The resources needed to carry out the indirect action are understood to be human resources, infrastructure, financial resources and, if necessary, intangible property and other resources made available by a third party on the basis of a prior commitment.

Article 9

Submission of proposals for indirect actions

1.  Proposals for indirect actions shall be submitted under the terms of calls for proposals. These terms shall be set out in the work programmes.

Calls for proposals may involve a two-stage evaluation procedure. In this case, following a positive evaluation of an outline proposal in the first stage, the proposers concerned shall be requested to submit a complete proposal in the second stage.

2.  Paragraph 1 shall not apply to:

   a) specific support actions for the activities of legal entities identified in the work programmes;
   b) specific support actions consisting of a purchase or service governed by the terms applicable to public procurement procedures;
   c) specific support actions with particular characteristics and value to the objectives and the scientific and technological content of specific programmes, for which grant applications may be submitted to the Commission if so provided for in the work programme of the relevant specific programme and where such a request does not fall within the scope of an open call for proposals;
   d) specific support actions covered by Annex III, point 1.7, first paragraph, of Decision No .../2002/EC [on the sixth framework programme].

3.  The Commission may issue calls for expressions of interest in order to assist it in identifying precise objectives and requirements that may be included in the work programmes and in the calls for proposals. This shall be without prejudice to any subsequent decision adopted by the Commission regarding the evaluation and selection of proposals for indirect actions.

4.  Calls for expressions of interest and calls for proposals shall be published in the Official Journal of the European Communities and shall also be given the widest possible publicity, in particular using the Internet pages of the sixth framework programme and through specific information channels such as the national contact points set up by the Member States and the Associated States.

Article 10

Evaluation and selection of proposals for indirect actions

1.  The proposals for indirect actions covered in Article 9(1) and Article 9(2)(c) shall be evaluated according to the following criteria, where applicable:

   a) scientific and technological excellence and degree of innovation;
   b) ability to carry out the indirect action successfully and to ensure its efficient management, assessed in terms of resources and competencies and including the organisational arrangements laid down by the participants;
   c) relevance to the objectives of the specific programme;
   (d) European added value, critical mass of resources mobilised and contribution to Community policies;
   e) quality of the plan for using and disseminating the knowledge, potential for promoting innovation, and clear plans for the management of intellectual property.

2.  In applying paragraph 1(d), the following criteria shall also be taken into account:

a)   for networks of excellence, the scope and degree of the effort to achieve integration and the network's capacity to promote excellence beyond its membership, as well as the prospects of the durable integration of their research capabilities and resources after the end of the period covered by the Community's financial contribution;

b)   for integrated projects, the scale of ambition of the objectives and the capacity of the resources to make a significant contribution to reinforcing competitiveness or solving societal problems;

c)   for integrated initiatives relating to infrastructure, the prospects of the initiative's continuing long term after the end of the period covered by the Community's financial contribution.

3.  In applying paragraphs 1 and 2, the following additional criteria may be taken into account:

   a) synergies with education at all levels;
   b) readiness and capacity to engage with actors beyond the research community and the public as a whole, to help spread awareness and knowledge and to explore the wider societal implications of the proposed work;
   c) activities to increase the role of women in research.

4.  Calls for proposals shall determine, in accordance with the type of instruments deployed or the objectives of the RTD activity, how the criteria set out in paragraph 1 shall be applied by the Commission. These criteria, and those of paragraphs 2 and 3, may be specified or complemented in the work programme, in particular to take account of the contribution of the proposals for indirect actions to improve information for and dialogue with society and to promote competitiveness of SMEs.

5.  A proposal for an indirect action which contravenes fundamental ethical principles or which does not fulfil the conditions set out in the work programme or in the call for proposals shall not be selected. Such a proposal may be excluded from the evaluation and selection procedures at any time.

Any participant having committed an irregularity in the implementation of an indirect action may be excluded from the evaluation and selection procedure at any time, due regard being had to the principle of proportionality.

6.  The Commission shall evaluate the proposals with the help of independent experts appointed in accordance with the provisions of Article 11. For some specific support actions, particularly those covered by Article 9(2), independent experts shall be appointed only if the Commission deems it appropriate. The Commission shall publish the list of the experts selected.

All proposals submitted for indirect actions shall be treated confidentially by the Commission, which shall ensure that the principle of confidentiality is upheld in all procedures and that the independent experts are bound by this.

Unless otherwise specified in the call for proposals, proposals shall not be evaluated anonymously.

7.  Proposals for indirect actions shall be selected on the basis of the evaluation results and having regard to the Community funds available. The Commission shall adopt and publish guidelines setting out detailed provisions for evaluation and selection procedures.

Article 11

Appointment of independent experts

1.  The Commission will designate independent experts to assist with the evaluation required under the sixth framework programme and the specific programmes, and also for the assistance referred to in Article 10(6) and the second subparagraph of Article 18(1).

It may in addition set up groups of independent experts to advise on the implementation of Community research policy.

2.  The Commission will appoint the independent experts in accordance with one of the following procedures:

(a)  The independent experts appointed by the Commission for the evaluations provided for in Article 6 of Decision No .../2002/EC [on the sixth framework programme] and in specific programmes under the sixth framework programme shall be very high-ranking individuals from the fields of science, industry or politics with significant experience in research, research policy or research programme management at national or international level.

(b)  The independent experts appointed by the Commission to assist in the evaluation of proposals for networks of excellence and integrated projects and in monitoring the projects selected and carried out shall be individuals from the fields of science or industry and/or with experience in the field of innovation and also with the highest level of knowledge and who are internationally recognised authorities in the relevant specialist area.

(c)  The independent experts appointed by the Commission to form the groups referred to in the second subparagraph of paragraph 1 shall be professionals renowned for their knowledge, skills and top-level experience in the field or regarding the issues to be dealt with by the group.

(d)  For cases other than those covered by points (a), (b) and (c), and in order to take the various operators in the research sector into consideration in a balanced manner, the Commission shall appoint independent experts with skills and knowledge appropriate to the tasks assigned to them. To this end, it shall rely on calls for applications from individuals or calls addressed to research institutions with a view to establishing lists of suitable candidates, or may, if it deems appropriate, select any individual with the appropriate skills from outside the lists.

3.  When appointing an independent expert, the Commission will ensure that the expert is not faced with a conflict of interests in relation to the matter on which he is required to give an opinion. To this end, the Commission shall require experts to sign a declaration to the effect that there is no such conflict of interest at the time of their appointment and undertaking to inform the Commission if one should arise in the course of their duties.

Article 12

Contracts and Consortium Agreements

1.  The Commission shall conclude a contract for each proposal selected for an indirect action. This contract shall be drawn up in accordance with the provisions of the sixth framework programme, and in accordance with this Regulation, taking into account the characteristics of the various instruments concerned.

The Commission, after conferring with interested parties from the Member States and the Associated States, will elaborate a model contract to facilitate the drawing up of contracts.

2.  The contract shall establish the rights and obligations of all participants in accordance with this Regulation, and in particular the provisions for the scientific, technological and financial monitoring of the indirect action, for the updating of its objectives, for changes in consortium membership and for the payment of the Community financial contribution, as well as, if applicable, conditions for the eligibility of any necessary expenditure and rules for dissemination and use.

The contract, which shall be concluded between the Commission and all participants in an indirect action, shall enter into force on signature by the Commission and the coordinator. The other participants identified in the contract shall accede to it in accordance with its terms and shall enjoy the rights and assume the obligations of participants.

Any participant joining an ongoing indirect action shall accede to the contract and enjoy the rights and assume the obligations of participants with regard to the Community.

3.  In order to ensure the protection of the financial interests of the Community, appropriate penalties shall be included in the contracts, as defined inter alia in Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995(9).

4.  The conclusion of a contract shall not affect the right of the Commission to adopt a recovery decision, enforceable in accordance with Article 256 of the Treaty, to obtain reimbursement of an amount due from a participant. Before adopting a decision of this kind, the Commission shall ask for the participant's comments to be submitted before a specified date.

5.  Participants in an indirect action shall conclude a consortium agreement, unless otherwise specified in the call for proposals. The Commission shall publish non-binding guidelines on points that may be addressed by the consortium agreement, such as:

   - the internal organisation of the consortium;
   - intellectual property rights arrangements;
   - settlement of internal disputes, pertaining to the consortium agreement.

To this end the Commission shall confer with interested parties from the Member States and the Associated States.

Article 13

Execution of indirect actions

1.  The consortium shall implement the indirect action and shall take all necessary and reasonable measures to that end.

The Community financial contribution shall be paid to the coordinator. The coordinator shall administer the Community financial contribution regarding its allocation between participants and activities in accordance with the contract and with decisions taken by the consortium according to the internal procedures established in the consortium agreement.

Participants shall inform the Commission of any event, including the modification of the consortium agreement, which might affect the implementation of the indirect action and the rights of the Community.

2.   Technical implementation of the indirect action shall be the collective responsibility of the participants. Each participant shall also be liable for the use of the Community financial contribution in proportion to his share of the project up to a maximum of the total payments he has received.

Should a participant breach the contract and should the consortium not make good this breach, the Commission may, as a last resort and if all other approaches have been explored, hold the participants liable under the following conditions:

   (a) Independently of the appropriate action it shall take against the defaulting participant, the Commission shall require the remaining participants to implement the indirect action.
   (b) Should the implementation be impossible or should the remaining participants refuse to comply with subparagraph (a), the Commission may terminate the contract and recover the Community financial contribution. When investigating the financial disadvantage, the Commission shall take into account the work already undertaken and results obtained, thereby establishing the debt.

(c)  For the part of the debt established according to subparagraph (b) that is owed by the defaulting participant, the Commission shall distribute it among the remaining participants, on the basis of each participant's share of the expenses accepted and up to the amount of the Community financial contribution each participant is entitled to receive.

Where a participant is an international organisation, a public body or a legal entity whose participation in the indirect action is guaranteed by a Member State or an Associated State, that participant shall be responsible solely for its own debt and shall not bear the debt of any other participant.

3.   Paragraph 2 shall not apply to indirect actions implemented by means of instruments such as specific research projects for SMEs, actions to promote and develop human resources and mobility and, when duly justified, specific support actions.

4.  The coordinator shall keep accounts making it possible to determine at any time what portion of the Community funds has been allocated to each participant for the purposes of the project. He shall communicate that information to the Commission every year.

5.  When several legal entities are grouped in a common legal entity acting as a single participant in accordance with Article 5(4), that legal entity shall take on the duties set out in paragraphs 1, 2(a) and 2(b). The liability of its members shall be defined according to the law under which this common legal entity was established.

Article 14

Community financial contribution

1.  In accordance with Annex III to the sixth framework programme, and within the limits of the Community framework for State aid for research and development(10), the Community financial contribution may take the following forms:

   (a) For networks of excellence, it shall take the form of a fixed grant for integration, on the basis of the joint programme of activities. The amount of that grant shall be calculated taking into account the degree of integration, the number of researchers that all participants intend to integrate and the characteristics of the field of research concerned and of the joint programme of activities. It shall be used to complement the resources deployed by the participants in order to carry out the joint programme of activities.
  

This grant shall be paid out on the basis of results, following the ongoing execution of the joint programme of activities, and on condition that its expenses, which are to be certified by an external auditor, or in the case of public entities, a competent public officer, are greater that the grant itself.

   (b) For some actions to promote human resources and mobility and some specific support actions, except for the indirect actions covered by Article 9(2)(b), it may take the form of a lump sum payment.
   (c) For integrated projects and the other instruments, except for those covered by points (a) and (b) and indirect actions covered by Article 9(2)(b), it shall take the form of a grant to the budget, calculated as a percentage of the budget established by the participants to carry out the indirect action, adapted according to the type of activity and taking into account the cost model used by the participant concerned.

The expenses needed to implement the indirect action shall be certified by an external auditor or, in the case of public legal entities, a competent public officer.

2.  Eligible expenses shall be defined in accordance with the first subparagraph of Article 12(2) and will meet the following conditions:

   a) they must be actual, economically sound and necessary for the implementation of the indirect action;
   b) they must be determined in accordance with the usual accounting principles of the individual participant;
   c) they must be recorded in the accounts of the participants or, in the case of the resources of third parties referred to in the last subparagraph of Article 8(2), in the corresponding financial documents of those third parties;
   d) they shall be exclusive of indirect taxes, duties and interest and may not give rise to profit.

By derogation from the actual-cost principle and with the agreement of the participants, the contract may lay down average rates of Community financial participation by type of expenditure or pre-set lump sums, as well as a value by activity which shall be approximate to the expenses envisaged.

3.  Costs for management of the consortium shall be reimbursed up to 100% of the costs incurred and shall include the cost of audit certificates. In this case legal entities which participate in the indirect action on an additional-cost basis may claim the full costs they have incurred for management, insofar as they can produce detailed evidence of them. The contracts shall lay down a maximum percentage of management costs in relation to the Community contribution. A share of no more than 7% shall be reserved for management costs by the consortium.

Article 15

Changes in consortium membership

1.  A consortium may modify its membership on its own initiative, and may in particular extend it to include any legal entity contributing to the implementation of the indirect action.

A participant's withdrawal shall not affect access rights under Articles 26(2) and 27(2).

The consortium must notify any change of its membership to the Commission, which may object within six weeks of the notification. New participants shall accede to the contract according to the terms of Article 12(2).

2.  The joint programme of activities for a network of excellence or the implementation plan for an integrated project shall specify which changes in the membership of the consortium shall require the prior publication of a call for applications.

The consortium shall publish the call for applications and advertise it widely using specific information support, particularly Internet sites on the sixth framework programme, the specialist press and brochures, and the national contact points set up by the Member States and Associated States for information and support.

The consortium shall evaluate applications in the light of the criteria which governed the evaluation and selection of the indirect action, defined according to the terms of Article 10(4) and (5), and with the assistance of independent experts appointed by the consortium on the basis of the criteria described in Article 11(2)(b).

The subsequent modification of the consortium shall follow the procedure established in the third subparagraph of paragraph 1.

Article 16

Additional financial contribution

The Commission may increase the Community financial contribution to an indirect action already under way in order to expand its scope to cover new activities which may involve new participants.

It shall do so in the case of the indirect actions referred to in Article 9(1) and (2)(c) by way of a call for supplementary proposals, which the Commission shall publish and advertise in accordance with Article 9(4) and which may be restricted, if necessary, to indirect actions already under way. The Commission shall evaluate and select such proposals in accordance with Article 10.

Article 17

Consortium activities in favour of third parties

If the contract provides for the consortium to undertake all or part of its activities in favour of third parties, the consortium shall ensure that this is properly made public, in accordance where applicable with the contract.

The consortium shall evaluate and select any application received from third parties in accordance with the principles of transparency, fairness and impartiality and also with the terms stipulated in the contract.

Article 18

Scientific, technological and financial monitoring and audits

1.  The indirect actions to which the Community contributes shall be periodically evaluated by the Commission on the basis of progress reports which shall also cover the implementation of the plan for the use or dissemination of knowledge submitted by the participants in accordance with the terms of the contract.

In monitoring the networks of excellence, the integrated projects and, where necessary, other indirect actions, the Commission shall be assisted by independent experts appointed in accordance with Article 11(2).

The Commission shall ensure that all the information which it receives on pre-existing know-how and on knowledge expected or acquired during the course of an indirect action is treated confidentially.

2.  In accordance with the contract, the Commission shall take any useful steps to ensure that the objectives of the indirect action are achieved with proper regard for the financial interests of the Community. The Commission may, where necessary for the sake of these interests, adjust the Community financial contribution or suspend the indirect action if the terms of this Regulation or of the contract have been infringed.

3.  The Commission, or any representative authorised by it, shall have the right to carry out scientific, technological and financial audits on the participants, in order to ensure that the indirect action is being or has been performed under the conditions claimed and in accordance with the terms of the contract.

The contract shall specify the conditions under which participants may object to a technological audit of the use and dissemination of the knowledge being carried out by certain authorised representatives of the Commission.

4.  Pursuant to Article 248(2) of the Treaty, the Court of Auditors may verify the use of the Community's financial contribution.

Article 19

Information made available to Member States and Associated States

The Commission shall make available to any Member State or Associated State, upon request, its useful information on knowledge arising from work carried out in an indirect action, provided that such information is relevant to public policy, unless the participants provide a reasoned case against doing so.

Under no circumstances shall such availability confer any rights or impose any obligations of the Commission and participants, as set out in Articles 21 to 28, on Member States or Associated States receiving such information.

Unless such general information becomes public or is made available by the participants or has been communicated without any confidentiality restrictions, Member States and Associated States shall comply with the Commission's obligations on confidentiality as established by this Regulation.

Article 20

Protection of the financial interests of the Community

The Commission shall ensure that, when indirect actions are implemented, the financial interests of the Community are protected by effective checks and by deterrent measures and, if irregularities are detected, by penalties which are effective, proportionate and dissuasive, in accordance with Council Regulations (EC, Euratom) Nos 2988/95 and 2185/96(11), and with European Parliament and Council Regulation (EC) No 1073/1999(12).

CHAPTER III

RULES FOR DISSEMINATION AND USE

Article 21

Ownership of knowledge

1.  Knowledge arising from work carried out under direct actions shall be the property of the Community.

2.  Knowledge arising from work carried out under indirect actions provided for in Article 9(2)(b) and (d) shall be the property of the Community. Knowledge arising from work carried out under other indirect actions shall be the property of the participants carrying out the work leading to that knowledge.

3.  Where several participants have jointly carried out work generating the knowledge referred to in paragraph 2, and where their respective share of the work cannot be ascertained, they shall have joint ownership of such knowledge. They shall agree among themselves on the allocation and the terms of exercising the ownership of the knowledge in accordance with the provisions of this Regulation and of the contract.

4.  Knowledge arising from work carried out under cooperative or collective research projects shall be the joint property of the SMEs or the enterprise groupings, which shall agree on the allocation and the terms of exercising the ownership of the knowledge in particular in the consortium agreement in accordance with the provisions of this Regulation and of the contract.

5.  If personnel employed by a participant are entitled to claim rights to knowledge, the participant shall take steps or reach appropriate agreements to ensure that these rights can be exercised in a manner compatible with its obligations under this Regulation and the contract.

6.  Where a participant transfers ownership of knowledge to a third party, it shall take steps or conclude agreements to pass on its obligations, in particular concerning the granting of access rights and the dissemination and use of the knowledge, under this Regulation and the contract to the assignee. As long as the participant is required to grant access rights, it shall give prior notice to the Commission and the other participants in the same indirect action of the envisaged assignment and the assignee.

The Commission or other participants in the indirect action may object within 30 days of notification to such a transfer of ownership. The Commission may object to any transfer of ownership to third parties, in particular to those not established in a Member State or an Associated State, if such a transfer is not in accordance with the interests of developing the competitiveness of the dynamic, knowledge-based European economy, or is inconsistent with ethical principles. The other participants may object to any transfer of ownership if this would adversely affect their access rights.

Article 22

Protection of knowledge

1.  Where knowledge is capable of industrial or commercial application, its owner shall provide for its adequate and effective protection in conformity with relevant legal provisions, the contract and the consortium agreement, and having due regard to the legitimate interests of the participants concerned.

2.  Where the Commission considers it necessary to protect knowledge in a particular country, and where such protection has not been applied for or has been waived, the Commission may, with the agreement of the participant concerned, adopt protective measures. In this event, and as far as that particular country is concerned, the Community shall take on the obligations regarding the granting of access rights in the place of the participant. The participant may only refuse if it can demonstrate that its legitimate interests will be significantly impaired.

3.  A participant may publish or allow the publication, on whatever medium, of data concerning knowledge it owns or knowledge obtained during work in connection with cooperative or collective research projects, provided that this does not affect the protection of that knowledge. The Commission and the other participants in the same indirect action shall be given prior written notice of any planned publication. A copy of such data shall on request be made available to them within 30 days of the request. The Commission and the other participants may object to publication within a period of 30 days from receipt of the data, if they consider that the protection of their knowledge could thereby be adversely affected.

Article 23

Use and dissemination of knowledge

1.  The participants and the Community shall use or cause to be used the knowledge which they own arising from the direct actions or indirect actions, in accordance with the interests of the participants concerned. The participants shall set out the terms of use in a detailed and verifiable manner in accordance with this Regulation and the contract.

2.  If dissemination of the knowledge does not adversely affect its protection or use, the participants shall ensure that it is disseminated within a period laid down by the Community. Should the participants fail to do so, the Commission may disseminate the knowledge. Particular account shall be taken of the following factors:

   - the need to safeguard intellectual property rights;
   - the benefits of swift dissemination, for example in order to avoid duplication of research efforts and to create synergies between indirect actions;
   - confidentiality;
   - the legitimate interests of the participants.

Article 24

Making available knowledge arising from direct actions

Knowledge arising from work carried out under direct actions may be made available to one or more interested legal entities, in particular to those established in a Member State or an Associated State, provided that the said legal entities undertake to use the knowledge or to ensure that it is used. Such availability of knowledge shall be subject to appropriate conditions to be laid down and published by the Commission, in particular concerning the payment of fees.

Article 25

Principles for access rights in indirect actions

1.  Access rights in accordance with Articles 26 and 27 shall be granted on written request. The granting of access rights may be made conditional on the conclusion of specific agreements, aimed at ensuring that they are used only for the intended purpose, and of appropriate undertakings as to confidentiality. Participants may also conclude agreements with the purpose, in particular, of granting additional or more favourable access rights, including access rights to third parties, in particular to enterprises associated with participants, or specifying the requirements applicable to access rights, but not restricting the latter. Such agreements shall comply with the applicable competition rules.

The Commission may object to any grant of access rights to third parties, in particular to those not established in a Member State or an Associated State, if such a grant is not in accordance with the interests of developing the competitiveness of the dynamic, knowledge-based European economy, or is inconsistent with ethical principles.

2.  Access rights to pre-existing know-how shall be granted provided that the participant concerned is free to grant them.

3.  A participant may explicitly exclude specific pre-existing know-how from the obligation to grant access rights, by means of a written agreement between the participants, before the participant concerned signs the contract or before a new participant joins the indirect action. The other participants may only withhold their agreement if they demonstrate that implementation of the indirect action or their legitimate interests will be significantly impaired thereby.

4.  Except where the participant granting access rights so agrees, such rights shall confer no entitlement to grant sub-licences.

Article 26

Access rights for the execution of indirect actions

1.  Participants in the same indirect action shall enjoy access rights to the knowledge arising from work carried out under the indirect action and to the pre-existing know-how, if that knowledge or pre-existing know-how is needed to carry out their own work under that indirect action. Access rights to knowledge shall be granted on a royalty-free basis. Access rights to pre-existing know-how shall also be granted on a royalty-free basis, unless otherwise agreed before signature of the contract.

2.  Subject to its legitimate interests, the termination of the participation of a participant shall in no way affect the obligation to grant access rights pursuant to paragraph 1 to the other participants in the same indirect action until its end.

Article 27

Access rights for use

1.  Participants in the same indirect action shall enjoy access rights to the knowledge arising from work carried out under the indirect action and to the pre-existing know-how, if that knowledge or pre-existing know-how is needed to use their own knowledge. Access rights to knowledge shall be granted on a royalty-free basis, unless otherwise agreed before signature of the contract. Access rights to pre-existing know-how shall be granted under fair and non-discriminatory conditions.

2.  Subject to the participants' legitimate interests, access rights may be requested under the conditions laid down in paragraph 1 until two years after the end of the indirect action or after the termination of the participation of a participant, whichever falls earlier, unless there is provision for a longer period.

Article 28

Incompatible or restrictive commitments

1.  Participants shall make no commitments incompatible with the obligations provided for in this Regulation.

2.  Participants in the same indirect action shall be informed as soon as possible by the participant required to grant access rights of any limitations to the granting of access rights to pre-existing know-how, of any obligations to grant rights to knowledge, or of any restriction which might substantially affect the granting of access rights, as the case may be.

CHAPTER IV

FINAL PROVISIONS

Article 29

Entry into force

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

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

Done at ,

For the European Parliament For the European Council

The President The President

(1) OJ C 332 E, 27.11.2001, p. 275.
(2) OJ C 103 E, 30.4.2002, p. 266.
(3) OJ C 332E, 27.11.2001, p. 275 and OJ C 103E, 30.4.2002, p. 266.
(4) OJ C 94, 18.3.2002, p. 1.
(5) Position of the European Parliament of 3 July 2002.
(6) OJ L
(7) OJ L 199, 31.7.1985, p. 1.
(8) OJ L 107, 30.4.1996, p. 4.
(9) OJ L 312, 23.12.1995, p. 1.
(10) OJ C 45, 17.2.1996, p. 5.
(11) OJ L 292, 15.11.1996, p. 2.
(12) OJ L 136, 31.5.1999, p. 1.


EAEC framework programme (research 2002-2006) *
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European Parliament legislative resolution on the amended proposal for a Council decision concerning the rules for the participation of undertakings, research centres and universities in the implementation of the framework programme 2002-2006 of the European Atomic Energy Community (Euratom) (COM(2001) 823 – C5&nbhy;0236/2002 – 2001/0327(CNS))
P5_TA(2002)0357A5-0205/2002

(Consultation procedure)

The European Parliament,

–   having regard to the Commission proposal and amended proposal to the Council (COM(2001) 725(1) and COM(2001) 823(2)),

–   having been consulted by the Council pursuant to Article 7 of the Euratom Treaty (C5&nbhy;0236/2002),

–   having regard to Rule 67 of its Rules of Procedure,

–   having regard to the report of the Committee on Industry, External Trade, Research and Energy (A5&nbhy;0205/2002),

1.  Approves the Commission proposal as amended;

2.  Calls on the Commission to alter its proposal accordingly, pursuant to Article 119, second paragraph, of the Euratom Treaty;

3.  Calls on the Council to notify Parliament should it intend to depart from the text approved by Parliament;

4.  Calls for initiation of the conciliation procedure under the Joint Declaration of 4 March 1975 if the Council intends to depart from the text approved by Parliament;

5.  Asks to be consulted again if the Council intends to amend the Commission proposal substantially;

6.  Instructs its President to forward its position to the Council and Commission.

Text proposed by the Commission   Amendments by Parliament
Amendments 1 and 2
Title
COUNCIL DECISION concerning the rules for the participation of undertakings, research centres and universities in the implementation of the framework programme 2002-2006 of the European Atomic Energy Community (Euratom)
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the rules for the participation of undertakings, research centres and universities in the implementation of the sixth framework programme (2002-2006) of the European Atomic Energy Community (Euratom)
(This amendment applies throughout).
Compromise amendment 30
Recital 2
(2)  These provisions must be in line with a coherent and transparent framework which takes full account of the objectives and characteristics of the instruments defined in Annex III to the specific programme "Nuclear Energy", adopted by Council Decision No …/200./Euratom , in order to guarantee the most efficient implementation possible.
(2)  These provisions must be in line with a coherent and transparent framework which takes full account of the objectives and characteristics of the instruments defined in Annex III to the specific programme "Nuclear Energy", adopted by Council Decision No …/200./Euratom , in order to guarantee the most efficient implementation possible, taking into account the need for easy access of participants through simplified procedures. This will be especially the case for SMEs, due to the participation of enterprise groupings.
Compromise amendment 31
Recital 8
(8)  Activities under the framework programme must comply with the financial interests of the Community and must safeguard those interests.
(8)  Activities under the sixth framework programme must comply with the financial interests of the Community and must safeguard those interests. The Commission"s responsibility for the implementation of the framework programme and its specific programmes also includes the financial aspects arising therefrom.
Compromise amendment 32
Article 2, points (a) to (o)
(a) "indirect action" means an RTDT activity undertaken by one or more participants by means of an instrument of the 2002-2006 framework programme;
(a) "indirect action" means an RTD activity undertaken by one or more participants by means of an instrument of the sixth framework programme;
(b) "RTDT activity" means one of the research and technological development activities, including demonstration activities, and training activities, described in Annex to the 2002-2006 framework programme;
(b) "RTD activity" means one of the research and technological development activities, including demonstration activities, and training activities, described in Annex to the sixth framework programme;
(c) "budget" means a financial plan estimating all the resources and expenditure needed to carry out an indirect action;
(c) "budget" means a financial plan estimating all the resources and expenditure needed to carry out an indirect action;
(d) "consortium" means all the participants in the same indirect action;
(d) "consortium" means all the participants in the same indirect action;
(da) "coordinator" means the participant appointed by participants in the same indirect action and accepted by the Commission, having specific additional obligations arising out of this Regulation and the contract;
(e) "contract" means a grant agreement concerning the performance of an indirect action establishing rights and obligations between the Community and the participants in that indirect action;
(e) "contract" means a grant agreement between the Community and the participants concerning the performance of an indirect action establishing rights and obligations between the Community and the participants on the one hand, and between the participants in that indirect action, on the other;
(ea) "consortium agreement" means an agreement that participants in an indirect action conclude amongst themselves for its implementation. Such an agreement shall not affect participants" obligations to the Community and to one another arising out of the Regulation and the contract;
(f) "legal entity" means any natural person, or any legal person created under the national law of its place of establishment, under Community law, or international law, having legal personality and being entitled to have rights and obligations of any kinds in its own name;
(f) "legal entity" means any natural person, or any legal person created under the national law of its place of establishment, under Community law, or international law, having legal personality and being entitled to have rights and obligations of any kinds in its own name;
(g) "Associated State" means a State which is party to an international agreement with the Community, under the terms or on the basis of which it makes a financial contribution to all or part of the budget of the 2002-2006 framework programme;
(g) "Associated State" means a State which is party to an international agreement with the Community, under the terms or on the basis of which it makes a financial contribution to all or part of the budget of the sixth framework programme;
(h) "Associated candidate country" means an Associated State acknowledged by the Community as a candidate for accession to the European Union;
(h) "Associated candidate country" means an Associated State acknowledged by the Community as a candidate for accession to the European Union;
(i) "European Economic Interest Grouping" (EEIG) means any legal entity established in accordance with Council Regulation (EEC) No 2137/85;
(i) "European Economic Interest Grouping" (EEIG) means any legal entity established in accordance with Council Regulation (EEC) No 2137/85;
(j) "instruments" means the mechanisms for indirect Community intervention as laid down in Annex III to the specific programme "Nuclear Energy";
(j) "instruments" means the mechanisms for indirect Community intervention as laid down in Annex III to the specific programme "Nuclear Energy";
(k) "irregularity" means any infringement of a provision of Community law or any breach of a contractual obligation resulting from an act or omission by a legal entity which has, or would have, the effect of prejudicing the general budget of the Communities or budgets managed by them through unjustified expenditure;
(k) "irregularity" means any infringement of a provision of Community law or any breach of a contractual obligation resulting from an act or omission by a legal entity which has, or would have, the effect of prejudicing the general budget of the Communities or budgets managed by them through unjustified expenditure;
(l) "international organisation" means any legal entity resulting from an association of States, other than the Community, established on the basis of a treaty or similar act, having common institutions and an international legal personality distinct from that of its Member States;
(l) "international organisation" means any legal entity resulting from an association of States, other than the Community, established on the basis of a treaty or similar act, having common institutions and an international legal personality distinct from that of its Member States;
(m) "international European interest organisation" means an international organisation, the majority of whose members are European Community Member States or Associated States, and whose principal objective is to promote scientific and technological cooperation in Europe;
(m) "international European interest organisation" means an international organisation, the majority of whose members are European Community Member States or Associated States, and whose principal objective is to promote scientific and technological cooperation in Europe;
(n) "participant" means a legal entity contributing to an indirect action and having rights and obligations with regard to the Community under the terms of this Decision or according to the contract;
(n) "participant" means a legal entity contributing to an indirect action and having rights and obligations with regard to the Community under the terms of this Regulation or according to the contract;
(o) "third country" means a State that is neither a Member State nor an Associated State;
(o) "third country" means a State that is neither a Member State nor an Associated State;
(oa) "work programme" means a plan drawn up by the Commission for the implementation of a specific programme;
(ob) "joint programme of activities" covers the actions undertaken by participants which are required for implementing a network of excellence;
(oc) "implementation plan" covers all actions by participants in an integrated project;
(od) "Industrial States" are those third countries that are members of G7;
(oe) "public body" means a public sector body or a legal entity governed by private law with a public service mission providing adequate financial guarantees.
Compromise amendment 33
Article 5, paragraph 5
5.   Depending on the type of instrument deployed or the objectives of the RTDT activity, the work programme for the specific programme may, if necessary, restrict participation in an indirect action to legal entities according to their activities or types.
5.  Work programmes may specify and restrict participation in an indirect action according to their type, according to the instrument deployed and to take into account specific objectives of the framework programme.
Compromise amendment 34
Article 6, paragraphs 2 to 5
2.  For networks of excellence and integrated projects, the minimum number of participants shall not be less than three independent legal entities established in three different Member States or Associated States, of which at least two shall be Member States or Associated candidate countries.
2.  Subject to paragraph 3, the minimum number of participants established by the work programmes shall not be fewer than three independent legal entities established in three different Member States or Associated States, of which at least two shall be established in a Member State or associated candidate country.
3.  Specific support actions and actions in favour of human resources and mobility, except for research training networks, may be executed by a single legal entity.
3.  Specific support actions and actions in favour of human resources and mobility, except for research training networks, may be executed by a single legal entity.
When the work programme establishes a minimum number that is greater than or equal to two legal entities established in as many Member States or Associated States, this number shall be fixed according to the conditions provided for in paragraph 4.
4.  For instruments other than those covered in paragraphs 2 and 3, the minimum number of participants shall not be less than two independent legal entities established in two different Member States or Associated States, of which at least one shall be a Member State or an Associated candidate country.
5.  An EEIG or any legal entity established in a Member State or Associated State which is made up of independent legal entities meeting the criteria of this Decision may be the sole participant in an indirect action, provided that its composition is in accordance with the conditions fixed pursuant to the provisions of paragraph 1 to 4.
5.  An EEIG or any legal entity established in a Member State or Associated State according to its national law and which is made up of independent legal entities meeting the criteria of this Regulation may be the sole participant in an indirect action, provided that its composition is in accordance with the conditions fixed pursuant to the provisions of paragraphs 1 and 2.
Compromise amendment 35
Article 7
1.  Subject to other restrictions that may be specified in the work programme of the specific programme, any legal entity established in a third country may participate in RTDT activities, over and above the minimum number of participants fixed in accordance with the terms of Article 6, if such participation is provided for under an RTDT activity or if it is necessary for carrying out the indirect action.
1.  Subject to other restrictions that may be specified in the work programme of the specific programme, over and above the minimum number of participants fixed in accordance with the terms of Article 6, any legal entity established in a third country may participate in RTD activities foreseen under the heading "Focusing and Integrating Community Research" of the sixth framework programme. Detailed provisions for this participation may be set out in the relevant work programme. The involvement of participants from Industrial States may be subject to arrangements of a reciprocal nature, which could take the form of a scientific and technological agreement.
2.  Any legal entity established in a third country may receive a Community financial contribution, if provision is made for this under an RTDT activity or if it is essential for carrying out the indirect action.
2.  Any legal entity established in a third country may receive a Community financial contribution, if provision is made for this purpose under an RTD activity or if it is essential for carrying out the indirect action.
Amendment 36
Article 9, paragraph 2, subparagraph 1
2.  At the time when they present their proposal, participants shall have at least the potential resources needed to carry out the indirect action, and shall specify the relevant source.
2.  At the time when they present their proposal, participants shall have at least the potential resources needed to carry out the indirect action, and shall be able to specify the relevant source of those funds made available by third parties, including public authorities.
Compromise amendment 37
Article 10
1.  Proposals for indirect actions shall be submitted under the terms of calls for proposals published in the Official Journal of the European Communities and, as far as possible, widely advertised by other means.
1.  Proposals for indirect actions shall be submitted under the terms of calls for proposals. These terms are set out in the work programmes.
Calls for proposals may involve a two-stage evaluation procedure. In this case, following a positive evaluation of an outline proposal in the first stage, the proposers concerned shall be requested to submit a complete proposal in the second stage.
2.  Paragraph 1 shall not apply to:
2.  Paragraph 1 shall not apply to:
(a)  Specific support actions for the activities of legal entities identified in the work programme;
(a)  Specific support actions for the activities of legal entities identified in the work programme;
(b)  Specific support actions consisting of a purchase or service governed by the terms applicable to public procurement procedures;
(b)  Specific support actions consisting of a purchase or service governed by the terms applicable to public procurement procedures;
(c)  Specific support actions with particular characteristics and value to the objectives and the scientific and technological content of the specific programme, for which grant applications may be submitted to the Commission if so provided for in the work programme of the specific programme and where such a request does not fall within the scope of an open call for proposals.
(c)  Specific support actions with particular characteristics and value to the objectives and the scientific and technological content of the specific programme, for which grant applications may be submitted to the Commission if so provided for in the work programme of the specific programme and where such a request does not fall within the scope of an open call for proposals.
(d)  Specific support actions covered by Article 12.
(d)  Specific support actions covered by Article 12.
3.  Calls for expressions of interest may be issued prior to calls for proposals in order to enable the Commission to identify and evaluate precise objectives and requirements, without prejudice to any decisions it may subsequently take.
3.  The Commission may issue calls for expressions of interest in order to assist it in identifying precise objectives and requirements that may be included in the work programmes and in the calls for proposals. This shall be without prejudice to any subsequent decision adopted by the Commission regarding the evaluation and selection of proposals for indirect actions.
3a. Calls for expressions of interest and calls for proposals shall be published in the Official Journal of the European Communities and shall also be given the widest possible publicity, in particular using the Internet pages of the sixth framework programme and through specific information channels such as the national contact points set up by the Member States and the Associated States.
Compromise amendment 38
Article 11
1.  The proposals for indirect actions covered in Article 10(1) and Article 10(2)(c) shall be evaluated according to the following criteria:
1.  The proposals for indirect actions covered in Article 10(1) and Article 10(2)(c) shall be evaluated according to the following criteria, where applicable:
(a)  Relevance to the objectives of the specific programme;
(a) scientific and technological excellence and the degree of innovation;
(b)  Scientific and technological excellence;
(b) ability to carry out the indirect action successfully and to ensure its efficient management, assessed in terms of resources and competencies and including the organisational modalities foreseen by the participants;
(c)  Added value to the Community, including the critical mass of resources mobilised, the expected impact or contribution to Community policies;
(c) relevance to the objectives of the specific programme;
(d)  Quality of the plan for the use or dissemination of the knowledge, potential for promoting innovation, and ability to manage intellectual property;
(d)  European added value, critical mass of resources mobilised and contribution to Community policies;
(e)  The ability to successfully carry out the indirect action, assessed in terms of resources, competencies and organisation.
(e) quality of the plan for using and disseminating the knowledge, potential for promoting innovation, and clear plans for the management of intellectual property.
2.  In applying paragraph 1(c), the following criteria will also be taken into account:
2.  In applying paragraph 1(d), the following criteria will also be taken into account:
(a)  For networks of excellence, the scope and degree of the effort to achieve integration and the network's capacity to promote excellence beyond its membership, as well as the prospects of the long-term integration of their research capabilities and resources after the end of the period covered by the Community financial contribution;
(a)  For networks of excellence, the scope and degree of the effort to achieve integration and the network's capacity to promote excellence beyond its membership, as well as the prospects of the durable integration of their research capabilities and resources after the end of the period covered by the Community financial contribution;
(b)  For integrated projects, the scale of ambition of the objectives and the capacity of the resources to make a significant contribution to reinforcing competitiveness or solving societal problems;
(b)  For integrated projects, the scale of ambition of the objectives and the capacity of the resources to make a significant contribution to reinforcing competitiveness or solving societal problems;
(c)  For integrated initiatives relating to infrastructure, the prospects of the initiative's continuing long term after the end of the period covered by the Community financial contribution.
(c)  For integrated initiatives relating to infrastructure, the prospects of the initiative's continuing long term after the end of the period covered by the Community financial contribution.
2a. In applying paragraphs 1 and 2, the following additional criteria can be taken into account:
(a) synergies with education at all levels;
(b) readiness and capacity to engage with actors beyond the research community and the public as a whole, to help spread awareness and knowledge and to explore the wider societal implications of the proposed work;
(c) activities to increase the role of women in research.
3.  The work programme of the specific programme shall determine, in accordance with the type of instruments deployed or the objectives of the RTDT activity, which of the criteria set out in paragraph 1 shall be applied by the Commission. These criteria, and those of paragraph 2, will be clarified or complemented, particularly to take account of the contribution of the proposals for indirect actions to improve information for and dialogue with society as well as to increase the role of women in research.
3.  Calls for proposals shall determine, in accordance with the type of instruments deployed or the objectives of the RTD activity, how the criteria set out in paragraph 1 shall be applied by the Commission. These criteria, and those of paragraphs 2 and 2a, may be specified or complemented in the work programme, in particular to take account of the contribution of the proposals for indirect actions to improve information for and dialogue with society and to promote competitiveness of SMEs.
4.  Any proposal for an indirect action which contravenes fundamental ethical principles, particularly those set out in the Charter of Fundamental Rights of the European Union, or which does not fulfil the conditions set out in the work programme or in the call for proposals may be excluded from the evaluation and selection procedure at any time.
Any participant having committed an irregularity in the implementation of an indirect action may be excluded from the evaluation and selection procedure at any time.
4.  A proposal for an indirect action which contravenes fundamental ethical principles or which does not fulfil the conditions set out in the work programme or in the call for proposals shall not be selected.Such a proposal may be excluded from the evaluation and selection procedures at any time.
Any participant having committed an irregularity in the implementation of an indirect action may be excluded from the evaluation and selection procedure at any time.
5.  The Commission shall evaluate and select the proposals for indirect actions in accordance with transparent, fair and impartial procedures laid down in an evaluation manual, which it will make public.
6.  The Commission shall evaluate the proposals with the help of independent experts appointed in accordance with the provisions of Article 12. For some specific support actions, particularly those covered by Article 10(2), independent experts shall be appointed only if the Commission deems it appropriate.
6.  The Commission shall evaluate the proposals with the help of independent experts appointed in accordance with the provisions of Article 12. For some specific support actions, particularly those covered by Article 10(2), independent experts shall be appointed only if the Commission deems it appropriate. The Commission shall publish the list of the experts selected.
All proposals submitted for indirect actions shall be treated confidentially by the Commission, which shall ensure that the principle of confidentiality is upheld in all procedures and that the independent experts are bound by this.
Unless otherwise specified in the call for proposals, proposals shall not be evaluated anonymously.
6a. Proposals for indirect actions shall be selected on the basis of the evaluation results and having regard to the Community funds available. The Commission shall adopt and publish guidelines setting out detailed provisions for evaluation and selection procedures.
Compromise amendment 39
Article 12
1.  The Commission shall designate independent experts to assist with the evaluation required under the 2002-2006 framework programme and the specific programme, and also for the assistance referred to in Article 18(6) and the second subparagraph of Article 26(1).
1.  The Commission will designate independent experts to assist with the evaluation required under the sixth framework programme and the specific programmes, and also for the assistance referred to in Article 11(6) and the second subparagraph of Article 19(1).
It may in addition set up groups of independent experts to advise on the implementation of its research policy.
It may in addition set up groups of independent experts to advise on the implementation of Community research policy.
2.  The Commission shall appoint the independent experts in accordance with one of the following procedures:
2.  The Commission will appoint the independent experts in accordance with one of the following procedures:
(a)  The independent experts appointed by the Commission for the evaluations provided for in Articles 5 and 6 of the 2002-2006 framework programme and Article 7(2) of the specific programme shall be very high-ranking individuals from the fields of science, industry or politics with significant experience in research, research policy or research programme management at national or international level.
(a)  The independent experts appointed by the Commission for the evaluations provided for in Article 7 of the sixth framework programme and its specific programmes shall be very high-ranking individuals from the fields of science, industry or politics with significant experience in research, research policy or research programme management at national or international level.
(b)  The independent experts appointed by the Commission to assist in the evaluation of proposals for networks of excellence and integrated projects and in monitoring the projects selected and carried out shall be individuals from the fields of science or industry with the highest level of knowledge and who are internationally recognised authorities in the relevant specialist area.
(b)  The independent experts appointed by the Commission to assist in the evaluation of proposals for networks of excellence and integrated projects and in monitoring the projects selected and carried out shall be individuals from the fields of science or industry and/or with experience in the field of innovation and also with the highest level of knowledge and who are internationally recognised authorities in the relevant specialist area.
(c)  The independent experts appointed by the Commission to form the groups referred to in the second subparagraph of paragraph 1 shall be professionals renowned for their knowledge, skills and top-level experience in the field or regarding the issues to be dealt with by the group.
(c)  The independent experts appointed by the Commission to form the groups referred to in the second subparagraph of paragraph 1 shall be professionals renowned for their knowledge, skills and top-level experience in the field or regarding the issues to be dealt with by the group.
(d)  For cases other than those covered by subparagraphs (a), (b) and (c), and in order to take the various operators in the research sector into consideration in a balanced manner, the Commission shall appoint independent experts with skills and knowledge appropriate to the tasks assigned to them. To this end, it shall rely on calls for applications from individuals or calls addressed to research institutions with a view to establishing lists of suitable candidates, or may, if it deems appropriate, select any individual with the appropriate skills from outside the lists.
(d)  For cases other than those covered by subparagraphs (a), (b) and (c), and in order to take the various operators in the research sector into consideration in a balanced manner, the Commission shall appoint independent experts with skills and knowledge appropriate to the tasks assigned to them. To this end, it shall rely on calls for applications from individuals or calls addressed to research institutions with a view to establishing lists of suitable candidates, or may, if it deems appropriate, select any individual with the appropriate skills from outside the lists.
3.  When appointing an independent expert, the Commission shall ensure that the expert will not be faced with a conflict of interests in relation to the matter on which he is required to give an opinion. To this end, the Commission shall require experts to sign a declaration to the effect that there is no such conflict of interest at the time of their appointment and promising to inform the Commission if one should arise in the course of their duties.
3.  When appointing an independent expert, the Commission will ensure that the expert is not faced with a conflict of interests in relation to the matter on which he is required to give an opinion. To this end, the Commission shall require experts to sign a declaration to the effect that there is no such conflict of interest at the time of their appointment and undertaking to inform the Commission if one should arise in the course of their duties.
Compromise amendment 40
Article 13
Contracts
Contracts and Consortium Agreements
1.  Contracts for the indirect action proposals selected shall be drawn up on the basis of the appropriate model contract established by the Commission in accordance with the provisions of the 2002-2006 framework programme and this Decision, account being taken, as far as is required, of the characteristics of the various instruments concerned.
1.  The Commission shall conclude a contract for each proposal selected for an indirect action. This contract shall be drawn up in accordance with the provisions of the sixth framework programme, and in accordance with this Regulation, taking into account the characteristics of the various instruments concerned.
The Commission, after conferring with interested parties from the Member States and the Associated States, will elaborate a model contract to facilitate the drawing up of contracts.
2.  The contract shall establish the rights and obligations of participants in accordance with this Decision, and in particular the arrangements for the technical, technological and financial monitoring of the indirect action, for the updating of its objectives, for changes in consortium membership, for the payment of the Community financial contribution and, if applicable, conditions for the eligibility of any necessary expenditure.
2.  The contract shall establish the rights and obligations of all participants in accordance with this Regulation, and in particular the provisions for the scientific, technological and financial monitoring of the indirect action, for the updating of its objectives, changes in consortium membership, the payment of the Community financial contribution and, if applicable, conditions for the eligibility of any necessary expenditure.
The contract shall establish rules for dissemination and use of knowledge and results in accordance with Title II, Chapter 2 of the Treaty.
The contract shall establish rules for dissemination and use of knowledge and results in accordance with Title II, Chapter 2 of the Treaty.
The contract, which shall be concluded between the Commission and all participants in an indirect action, shall enter into force on signature by the Commission and the coordinator. The other participants identified in the contract shall accede to it in accordance with its modalities and shall enjoy the rights and assume the obligations of participants.
Any participant joining an ongoing indirect action shall accede to the contract and enjoy the rights and assume the obligations of participants towards the Community.
3.  In order to ensure the protection of the financial interests of the Community, appropriate penalties shall be included in the contracts.
3.  In order to ensure the protection of the financial interests of the Community, appropriate penalties shall be included in the contracts, as defined inter alia in Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities" financial interests(1).
3a. Participants in an indirect action shall conclude a consortium agreement, unless otherwise specified in the call for proposals.
The Commission shall publish non-binding guidelines on points that may be addressed by the consortium agreement, such as:
- the internal organisation of the consortium;
.
- settlement of internal disputes, pertaining to the consortium agreement.
To this end the Commission shall confer with interested parties from the Member States and the Associated States.
____________________________
(1). OJ L 312, 23.12.1995, p. 1.
Compromise amendment 41
Article 14
1.  In accordance with the terms of the contract, and with its own organisation arrangements, the consortium shall ensure the technical implementation of the indirect action, with the participants being jointly and severally liable.
1.   The consortium shall implement the indirect action and shall take all necessary and reasonable measures to that end.
2.  The Community financial contribution to an indirect action shall be paid, in accordance with the arrangements stipulated in the contract, to the participant designated by the consortium and approved by the Commission.
The Community financial contribution shall be paid to the coordinator. The coordinator shall administer the Community financial contribution regarding its allocation between participants and activities in accordance with the contract and with decisions taken by the consortium according to the internal procedures established in the consortium agreement.
That participant shall administer the Community financial contribution according to decisions taken by the consortium regarding its allocation to participants and activities.
Participants shall inform the Commission of any event, including the modification of the consortium agreement, which might affect the implementation of the indirect action and the rights of the Community.
3.  Subject to the arrangements provided for in the contract based on the type of the instrument and the extent of the contribution made by participants:
2.  Technical implementation of the indirect action shall be the collective responsibility of the participants. Each participant shall also be liable for the use of the Community financial contribution in proportion to his share of the project up to a maximum of the total payments he has received.
Should a participant breach the contract and should the consortium not make good this breach, the Commission may, as a last resort and if all other approaches have been explored, hold the participants liable under the following conditions:
(a) each participant shall bear unlimited joint and several liability for the use made of the Community financial contribution allocated in accordance with the second subparagraph of paragraph 2, except for the part allocated to the participants referred to in subparagraph (b);
(a)  Independently of the appropriate action it shall take against the defaulting participant, the Commission shall require the remaining participants to implement the indirect action.
(b) a participant who cannot for legal reasons be held jointly and severally liable shall be liable only for that part of the Community financial contribution allocated specifically to it in accordance with paragraph 2.
(b)  Should the implementation be impossible or should the remaining participants refuse to comply with subparagraph (a), the Commission may terminate the contract and recover the Community financial contribution. When investigating the financial disadvantage, the Commission shall take into account the work already undertaken and results obtained, thereby establishing the debt.
(c)  For the part of the debt established according to subparagraph (b) that is owed by the defaulting participant, the Commission shall distribute it among the remaining participants, on the basis of each participant's share of the expenses accepted and up to the amount of the Community financial contribution each participant is entitled to receive.
Where a participant is an international organisation, a public body or a legal entity whose participation in the indirect action is guaranteed by a Member State or an Associated State, this participant is solely responsible for its own debt and shall not bear the debt of any other participant.
4.  The Commission shall have recourse to the liability referred to in paragraph 3(a) only if the damage incurred by the Community has not been rectified by either the participant at fault or the consortium, on its own initiative, within a reasonable period of time.
3.  Paragraph 2 shall not apply to indirect actions implemented by means of instruments such as specific research projects for SMEs, actions to promote and develop human resources and mobility and, when duly justified, specific support actions.
3a. The coordinator shall keep accounts making it possible to determine at any time what portion of the Community funds has been allocated to each participant for the purposes of the project. It shall communicate that information to the Commission every year.
5.  When several legal entities are grouped in a common legal entity acting as a single participant in accordance with Article 6(5), that legal entity shall take on the duties outlined in paragraphs 1 and 2 of this Article and shall be liable to the Community, notwithstanding the arrangements signed between the legal entities forming the common legal entity.
4.  When several legal entities are grouped in a common legal entity acting as a single participant in accordance with Article 6(5), that legal entity shall take on the duties set out in paragraphs 1, 2(a) and 2(b). The liability of its members shall be defined according to the law under which this common legal entity was established.
Compromise amendment 42
Article 15
In accordance with Annex III to the framework programme, the Community financial contribution may take three distinct forms, as follows:
1.  In accordance with Annex III to the sixth framework programme, the Community financial contribution may take the following forms:
(a)  For networks of excellence, it shall take the form of a grant for integration, the amount of which is determined in relation to the value of the capacities and resources which all the participants propose to integrate. It shall complement the resources deployed by the participants in order to carry out the joint programme of activities.
(a)  For networks of excellence, it shall take the form of a fixed grant for integration, on the basis of the joint programme of activities. The amount of that grant shall be calculated taking into account the degree of integration, the number of researchers that all participants intend to integrate, the characteristics of the field of research concerned and the joint programme of activities. It shall be used to complement the resources deployed by the participants in order to carry out the joint programme of activities.
The contribution shall be paid with regard to the execution of the joint programme of activities and on the basis of those expenses relating to it which are in addition to those borne by the participants themselves and which are certified by an external auditor or, in the case of public legal entities, a competent public officer.
This grant shall be paid out on the basis of results, following the ongoing execution of the joint programme of activities, and on condition that its expenses, which are to be certified by an external auditor, or in the case of public entities, a competent public officer, are greater that the grant itself.
(b)  For some actions to promote human resources and mobility and some specific support actions, except for the indirect actions covered by Article 10(2)(b), it may take the form of a lump sum payment.
(b)  For some actions to promote human resources and mobility and some specific support actions, except for the indirect actions covered by Article 10(2)(b), it may take the form of a lump sum payment.
(c)  For integrated projects and the other instruments, except for those covered by (a) and (b) and indirect actions covered by Article 10(2)(b), it shall take the form of a grant to the budget, calculated as a percentage of the budget allocated by the participants to carry out the indirect action, adapted according to the type of activity.
(c)  For integrated projects and the other instruments, except for those covered by points (a) and (b) and indirect actions covered by Article 10(2)(b), it shall take the form of a grant to the budget, calculated as a percentage of the budget established by the participants to carry out the indirect action, adapted according to the type of activity and taking into account the cost model used by the participant concerned.
The contract shall specify the expenses needed to implement the indirect action, which have to be certified by an external auditor or, in the case of public legal entities, a competent public officer.
The expenses needed to implement the indirect action have to be certified by an external auditor or, in the case of public legal entities, a competent public officer.
1a. Eligible expenses shall be defined in accordance with the first subparagraph of Article 13(2) and will meet the following conditions:
- they must be actual, economic and necessary for the implementation of the indirect action;
- they must be determined in accordance with the usual accounting principles of the individual participant;
- they must be recorded in the accounts of the participants or, in the case of the resources of third parties referred to in the last subparagraph of Article 9(2), in the corresponding financial documents of those third parties;
- they shall be exclusive of indirect taxes, duties and interest and may not give rise to profit.
.The contract may lay down average rates by type of expenditure or pre-set lump sums as well as, with the agreement of the participants, a value by activity which shall be closely approximate to the expenses incurred.
By derogation from the actual cost principle and with the agreement of the participants, the contract may lay down average rates of Community financial participation by type of expenditure or pre-set lump sums, as well as a value by activity which shall be approximate to the expenses envisaged.
1b. Costs for management of the consortium shall be reimbursed up to 100% of the costs incurred and shall include the cost of audit certificates. In this case legal entities which participate in the indirect action on an additional cost basis may claim the full costs they have incurred for management, in so far as they can produce detailed evidence of them. The contracts shall lay down a maximum percentage of management costs in relation to the Community contribution. A share of no more than 7% shall be reserved for management costs by the consortium.
Compromise mendment 43
Article 16
1.  Within the limits of the Community financial contribution and regardless of the instrument, the membership of a consortium may, on its own initiative or in execution of the contract, be modified with the agreement of the Commission, and in particular be extended to include any legal entity contributing to the implementation of the indirect action.
1.  A consortium may modify its membership on its own initiative, and may in particular extend it to include any legal entity contributing to the implementation of the indirect action.
With the exception of the changes described in paragraph 2, the consortium shall identify new legal entities on such terms as it deems appropriate, or in accordance with the contract.
With the exception of the changes described in paragraph 2, the consortium shall identify new legal entities on such terms as it deems appropriate, or in accordance with the contract.
The consortium must notify any change of its membership to the Commission, which may object within 6 weeks of the notification. New participants shall accede to the contract according to the terms of Article 13(2).
2.  The joint programme of activities for a network of excellence or the implementation plan for an integrated project shall specify which changes in the membership of the consortium shall require the prior publication of a competitive call.
2.  The joint programme of activities for a network of excellence or the implementation plan for an integrated project shall specify which changes in the membership of the consortium shall require the prior publication of a competitive call.
The consortium shall publish the competitive call and advertise it widely using specific information support, particularly Internet sites on the 2002-2006 framework programme, the specialist press and brochures.
The consortium shall publish the competitive call and advertise it widely using specific information support, particularly Internet sites on the sixth framework programme, the specialist press and brochures, and the national contact points set up by the Member States and Associated States for information and support.
The consortium shall evaluate offers:
The consortium shall evaluate offers:
(a) in the light of the criteria which governed the evaluation and selection of the indirect action, defined according to the terms of Article 11(3) and (4);
(a) in the light of the criteria which governed the evaluation and selection of the indirect action, defined according to the terms of Article 11(3) and (4) ;
(b) with the assistance of independent experts appointed by the consortium on the basis of the criteria described in Article 12(2)(b).
(b) with the assistance of independent experts appointed by the consortium on the basis of the criteria described in Article 12(2)(b).
In accordance with paragraph 1, the Commission may object if and when the consortium proposes, following this evaluation, to extend its membership to new participants.
The subsequent modification of the consortium shall follow the procedure established in the third subparagraph of paragraph 1.
Compromise amendment 44
Article 17, paragraph 2
It shall do so by way of a call for proposals, restricted, if necessary, to indirect actions under way, after the termination of an evaluation conducted in accordance with Article 11.
It shall do so in the case of the indirect actions referred to in Article 10(1) and (2)(c) by way of a call for supplementary proposals, which the Commission shall publish and advertise in accordance with Article 10(3a) and which may be restricted, if necessary, to indirect actions already under way. The Commission shall evaluate and select such proposals in accordance with Article 11.
Compromise amendment 45
Article 18, paragraph 2
The consortium shall evaluate and select the applications received in accordance with the principles of transparency, fairness and impartiality and also with the terms stipulated in the contract.
The consortium shall evaluate and select any application received from third parties in accordance with the principles of transparency, fairness and impartiality and also with the terms stipulated in the contract.
Compromise amendment 46
Article 19
Technical, technological and financial monitoring and audits
Scientific, technological and financial monitoring and audits
1.  The indirect actions to which the Community contributes shall be periodically evaluated by the Commission on the basis of progress reports which shall also cover the implementation of the plan for the use or dissemination of knowledge submitted by the participants in accordance with the terms of the contract.
1.  The indirect actions to which the Community contributes shall be periodically evaluated by the Commission on the basis of progress reports which shall also cover the implementation of the plan for the use or dissemination of knowledge submitted by the participants in accordance with the terms of the contract.
In monitoring the networks of excellence, the integrated projects and, where necessary, other indirect actions, the Commission shall be assisted by independent experts appointed in accordance with Article 12(2).
In monitoring the networks of excellence, the integrated projects and, where necessary, other indirect actions, the Commission shall be assisted by independent experts appointed in accordance with Article 12(2).
The Commission shall ensure that all the information which it receives on pre-existing know-how and on knowledge expected or acquired during the course of an indirect action is treated confidentially.
2.  In accordance with the contract, the Commission shall take any useful steps to ensure that the objectives of the indirect action are achieved with proper regard for the financial interests of the Community. The Commission may, where necessary for the sake of these interests, adjust the Community financial contribution or suspend the indirect action if the terms of this Decision or of the contract have been infringed.
2.  In accordance with the contract, the Commission shall take any useful steps to ensure that the objectives of the indirect action are achieved with proper regard for the financial interests of the Community. The Commission may, where necessary for the sake of these interests, adjust the Community financial contribution or suspend the indirect action if the terms of this Regulation or of the contract have been infringed.
3.  The Commission, or any representative authorised by it, shall have the right to carry out technical, technological and financial audits on the participants, in order to ensure that the indirect action is being or has been performed under the conditions claimed and in accordance with the terms of the contract.
3.  The Commission, or any representative authorised by it, shall have the right to carry out scientific, technological and financial audits on the participants, in order to ensure that the indirect action is being or has been performed under the conditions claimed and in accordance with the terms of the contract.
The contract shall specify the conditions under which participants may object to a technological audit of the use and dissemination of the knowledge being carried out by certain authorised representatives of the Commission.
4.  Pursuant to Article 160C of the Treaty, the Court of Auditors may check on the use of the Community"s financial contribution, on the basis of its own rules.
4.  Pursuant to Article 160C of the Treaty, the Court of Auditors may verify the use of the Community"s financial contribution.
Compromise amendment 47
Article 19 a (new)
Article 19a
Information made available to Member States and Associated States
The Commission shall make available to any Member State or Associated State its useful information on knowledge arising from work carried out in an indirect action upon request, provided that such information is relevant to public policy, unless the participants provide a reasoned case against doing so.
Under no circumstances shall such availability confer any rights or obligations of the Commission and participants, as set out in Articles 20 to 27, on Member States or Associated States receiving such information.
Unless such general information becomes public or is made available by the participants or has been communicated without any confidentiality restrictions, Member States and Associated States shall comply with the Commission"s obligations on confidentiality as established by this Regulation.
Amendment 28
Article 23, paragraph 1, subparagraph 2
The base rate for the Community financial contribution shall not exceed 17.5% over the duration of the 2002-2006 Framework programme.
The base rate for the Community financial contribution shall not exceed 24% over the duration of the sixth framework programme.
Amendment 29
Article 23, paragraph 2, indent (a)
(a) the capital related expenditures of specifically defined projects to which priority status has been awarded by that committee, at a uniform rate equal to 37.5%;
(a) the capital related expenditures of specifically defined projects of direct relevance to ITER, at a rate higher than 23%;

(1) OJ C 75 E, 26.3.2002, p. 333.
(2) OJ C 103 E, 30.4.2002, p. 331.


European Central Bank (annual report 2001)
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European Parliament resolution on the 2001 Annual Report of the European Central Bank (C5&nbhy;0196/2002 – 2002/2092(COS))
P5_TA(2002)0358A5-0220/2002

The European Parliament,

–   having regard to the 2001 Annual Report of the European Central Bank (C5&nbhy;0196/2002),

–   having regard to Article 113 of the EC Treaty,

–   having regard to Article 15 of the Statute of the European System of Central Banks and of the European Central Bank,

–   having regard to Rule 40 of its Rules of Procedure,

–   having regard to its resolution of 2 April 1998 on democratic accountability in the third stage of EMU(1),

–   having regard to its resolution of 4 July 2001 on the 2000 Annual Report of the European Central Bank(2),

–   having regard to the report of the Committee on Economic and Monetary Affairs (A5&nbhy;0220/2002),

A.   whereas the euro cash changeover has been a complete success in every euro area country,

B.   whereas the public showed its willingness to cooperate and is, in an overwhelming majority, satisfied with the new currency, even though consumer prices for some everyday articles have risen unjustifiably and exorbitantly in 2002, thereby bringing the euro into disrepute because such price increases are associated in the public mind with the introduction of the single currency,

C.   whereas retailers, the banking sector, cash-in-transit companies and security forces devoted themselves to ensuring a successful changeover,

D.   whereas both the economic and political environments were exceptionally volatile during 2001,

E.   whereas when the high-tech bubble in the United States burst, the world's largest economy stalled, thereby constituting a major shock for the rest of the world, including the euro area,

F.   whereas the spectre of global recession loomed on the horizon just after the terrorist attacks on September 11,

G.   whereas the ECB lowered its main refinancing rate on four occasions in 2001 for a total of 150 basis points, driving it down to 3.25 % at the end of the year,

H.   whereas the inflationary outlook changed rapidly during 2001, beginning with the carryover effects of the 2000 oil price tightening and ending with lower inflationary pressures caused by the deceleration of activity,

I.   whereas several sector-based shocks affecting subcomponents of the harmonised index of consumer prices (HICP), (for instance, the effects of foot-and-mouth disease on unprocessed food prices) disturbed the aggregate pattern of inflation and made the analysis of its underlying trends more difficult,

J.   whereas in 2001 the increase in the HICP exceeded the upper limit of the range set by the ECB to guarantee price stability, and whereas underlying inflation continued to accelerate,

K.   whereas the acceleration of prices from January 2002 onwards was linked to a number of factors, but some abusive 'rounding up' practices were spotted, particularly in the service sector, taking advantage of the introduction of euro notes and coins and fuelling the partially unjustified sentiment among the population that price increases had been widespread during the changeover; whereas the ECB itself admitted that such effects were more widespread than expected,

L.   whereas the Commission's latest spring forecasts showed that inflation could remain close to 2% both in 2002 and 2003,

M.   whereas the central banks of Canada and Sweden put an end to a long series of rate cuts by increasing their main refinancing rate in April 2002, and whereas the chairman of the Federal Reserve declared in his testimony to the US Congress on 17 April 2002 that "over time, the current accommodative stance of (Fed) monetary policy is not likely to be consistent with maintaining price stability",

N.   whereas the euro has stabilised against all major currencies in 2001 after the sharp falls experienced in 1999 and in 2000,

O.   whereas the European Central Bank should continue to follow its current path towards increased transparency and democratic accountability,

P.   whereas the enlargement process should trigger a reform of the leading bodies of the ECB within the framework drawn up in the Nice Treaty,

Q.   whereas Article 10 of the Protocol on the Statute of the European System of Central Banks and the European Central Bank calls on the Governing Council to vote and to act by a simple majority,

1.  Congratulates the ECB and the eurosystem for their brilliant implementation of the euro cash changeover;

2.  Praises the swift reaction of the ECB in the days after September 11 by providing the financial system with ample flexibility and cutting its main interest rates on September 17 by a significant amount;

3.  Welcomes the close cooperation of the European Central Bank and the US Federal Reserve in responding to the financial turbulence in a timely fashion by making interest rate cuts on the same day, notes this example of the partnership on which global economic stability must continue to be founded;

4.  Regards the reduction of 150 basis points in interest rates over the course of 2001 as appropriate and considers that the behaviour of the ECB should effectively defuse unfair criticisms arguing that the ECB is obsessed with short-term inflation monitoring;

5.  Welcomes the pragmatism shown by the ECB in its monetary policy by increasingly taking into account a wide array of business and economic indicators and by having not reacted mechanically to one-off events, such as the acceleration of food and energy prices; notes in this regard that financial indicators demonstrate that market participants remain confident as to the ECB's capability to keep inflation under the 2% limit in the medium term;

6.  Calls, nevertheless, on the ECB to be vigilant and to reassess carefully the inflationary outlook if euro-area growth were to re-accelerate, which is the most likely scenario in the coming months; reaffirms the overriding importance of the primary objective (maintenance of price stability) over other considerations, recalls that maintenance of price stability is a necessary prerequisite for sustainable growth;

7.  Notes that Article 10 of the Protocol on the statute of the European System of Central Banks and of the European Central Bank states that the Governing Council shall act by a simple majority; welcomes the President of the ECB's recent declaration that he did not dismiss the possibility of voting becoming a more normal procedure in the Governing Council in future;

8.  States that ECB monetary policy will be facilitated if wage negotiators do not misinterpret short-term price deviations as long-term ones; calls for continuous wage moderation especially in times when recovery is fragile; interprets the relatively small increase in unemployment across Europe in 2001 as a sign that labour market reforms in the euro area have begun to bear fruit;

9.  Recalls that the Stability and Growth Pact is an essential element of the euro area's credibility and that attainment of a balanced fiscal position is a prerequisite for the full functioning of automatic stabilisers; recalls also that the correct policy mix between monetary and fiscal policy presupposes sound public finances, and that allowing national budgets to "breathe" in connection with the pace of economic activity is fully understandable as long as the budget is balanced over an entire economic cycle; calls on Member States which have not yet reached a balanced fiscal position to avoid any dramatic drift in their current budgetary position;

10.  Calls on Member States to step up structural reforms which would introduce higher flexibility in goods and labour markets, thereby preventing the emergence of bottlenecks and raising the "speed limit" at which an economy can grow without generating inflationary pressures; calls on the ECB to stimulate reforms in Europe by laying emphasis in its publications on the euro area's remaining weak points in this regard;

11.  Advises the ECB to study links between asset prices and inflation pressures without reacting slavishly to the boom-and-bust cycles of stock prices by accommodating the excessive expectations of financial markets;

12.  Takes the view that the aforementioned considerations should also extend to the trend in property prices, and calls on the ECB to clarify the weightings to be assigned to the different factors;

13.  Considers that the difference between the mandates of the ECB and the Federal Reserve should not be over-emphasised, as evidence has shown that the ECB reacted with pragmatism and flexibility whereas the steeper decrease in US interest rates in 2001 merely reflected the fact that the slowdown was much more pronounced on the other side of the Atlantic;

14.  Supports the two-pillar strategy by highlighting the many convergences which exist in practice between the ECB and other major central banks; recalls that the long-term link between money and inflation is recognised by most academics; stresses, however, that first-pillar management is complex and may be ill-suited for day-to-day decision-making; takes due note of the fact that the objective for M3 is only expressed in terms of reference value and that the ECB does not react mechanically to deviations in reference value; concedes that statistical improvements are difficult to make; remarks, however, that statistical improvements which are unveiled and immediately used to justify a policy move, as in May, were criticised on transparency grounds; calls on the ECB to pursue a detailed explanation policy over the content and the role of the first pillar;

15.  Welcomes the ECB's open attitude in its monetary dialogue with the Parliament, which has led to a number of improvements in the ECB's communication strategy; accepts the Governing Council decision that interest rate decisions will be taken only at its first meeting of each month in order to defuse excessive tensions on financial markets; welcomes the statement from the President of the ECB to limit repeated statements from some ECB Governing Council members which create confusion and raise false expectations in financial markets;

16.  Suggests, nevertheless, that the ECB Governing Council explicitly endorse the forecasts designed by its own economic department and corresponding units of NCBs, and that the ECB forecasts be reshaped in order to detail an explicit central scenario with precise figures and not just ranges, including a detailed assessment of headline and core inflation trends; underlines the fact that this forecast should not only be a staff paper but an official ECB council document; notes, however, that where governing council members disagree with the central view of their colleagues they should be able to note such dissent anonymously as a footnote to the publication of the forecast;

17.  Regrets that steps have not been taken to publish the arguments which are discussed at the ECB Governing Council and calls again for the minutes to be published; in this context, proposes that a summary of the stances of both the approving and dissenting parties, including the balance of votes and the dissenting opinion, should be published in an anonymous way to avoid inappropriate pressure being brought to bear on the Governing Council members; reiterates its long standing view of the need for the ECB to publish summary minutes of each Governing Council meeting shortly after the following Governing Council meeting; repeats its call for an annual publication of a country-by-country review of trends, similar to the US Federal Reserve's beige book, which would give the ECB the chance to influence the discussion of productivity trends and price and wage expectations;

18.  Asks the ECB to intensify its analysis of the impact of the euro changeover on consumer prices; entirely agrees that in the long term the euro will have a positive impact on consumer prices by stimulating competition in the euro area; urges, however, the ECB, consumer organisations and national governments to maintain their vigilance for the time being; calls for dual price displays to continue at least until September 30 2002 in order to deter abuse in holiday resorts during summer and concealed price increases in September for back-to-school purchases;

19.  Notes that the euro has been broadly stable over the course of 2001; believes that net inflows of portfolio investments since the second quarter of 2001 bode well for the euro's external value; also believes that net inflows of direct investments in the last quarter of 2001, if sustained, may provide the boost that the euro needs in the future;

20.  Welcomes the impressive rise in the issuing of euro bonds and money market papers by non-residents, calls for the Financial Services Action Plan to be speeded up in order to reap the full benefits arising from an integrated single financial market;

21.  Approves of the ECB's close monitoring of the different forms of electronic money which are emerging;

22.  Calls on the ECB to support the timely implementation of the directive on cross-border border payments in euro, in particular by producing follow-up reports to identify the remaining obstacles and design concrete solutions to overcome them;

23.  Recalls that there is neither an opt-out nor an automatic link between EU membership and participation in monetary union for candidate countries, and that the introduction of the single currency requires successful participation in the exchange rate mechanism (ERM) as well as strict compliance with the convergence criteria laid down in the Treaty;

24.  Shares the view expressed by the ECB that ERM II is sufficiently flexible to be adopted by candidate countries in the transition period leading to full participation in monetary union;

25.  Stresses, in connection with the enlargement of monetary union, the desirability of a high level of convergence in the real economy in order to limit the strain involved, both for the Community and for the candidate countries;

26.  Underlines that, for candidate countries, some forms of "hard peg" to the euro, such as currency board arrangements, absolutely presuppose a domestic political consensus on this type of measure and a very strong and lasting discipline in every other respect of economic policy including fiscal policy, as well as a total commitment to take the necessary structural measures to bring the country up to euro area standards; cites Argentina as an example of a currency board, apparently working well, leading to a relaxation of economic policies and leading in turn to an economic and social disaster;

27.  Asks the ECB to report without delay any threat to central bank independence in the candidate countries;

28.  Notes the enabling clause introduced in the Nice Treaty with a view to enlargement, allowing the ECB to launch an initiative regarding voting procedures in the Governing Council; strongly recommends that this issue be discussed at the European Convention;

29.  Stresses the need for an efficient voting system representing an accurate depiction of Europe's economic landscape; rejects, however, any system that would exclude smaller member States from ECB decision-making; also rejects any system that would prevent NCB governors from attending Governing Council meetings;

30.  Recalls its preference for greater involvement of the European Parliament in nominating ECB executive board members, including the capability to confirm their appointments; also calls for this confirmation procedure to be adopted at the next IGC;

31.  Deems it necessary to nominate not only central bankers for the ECB executive board but also people with economic and monetary expertise recruited from outside the inner circle of central banking; considers it important, moreover, to ensure diversity when Member States nominate national central bank governors; urges Member States to ensure full transparency and Parliament involvement when NCB governors are nominated; considers it fruitful for a national debate on economic policy to be held when such nominations take place; encourages the nomination of competent women in the decision-making bodies and management functions of the ECB;

32.  Advises the ECB to evaluate the amount of legacy notes and coins that would not return at all to their respective national central banks and outline accounting guidance in order to avoid early and biased evaluations by national treasuries;

33.  Advises the ECB to study the depth of interaction between the major trade blocs in the context of globalisation, assessing not only the volume of trade flows but also possible channels of financial contagion between both sides of the Atlantic;

34.  Calls on the ECB to make a thorough review of the status of gold included in central bank balance sheets; finds the idea of trading gold for securities for profitability purposes interesting; is nevertheless worried by the consequences of increased central bank exposure to financial risks and the emergence of conflicts of interest originating from central bank holdings in the economy and calls on the ECB to establish a balanced assessment of such a reallocation; calls on the ECB to formulate binding and harmonised accounting rules for the national central banks when valuing their gold and currency reserves; observes that it would be more transparent and more effective to have an open debate on the level of external ESCB reserves;

35.  Calls on the ECB to campaign within the different international organisations, in particular the Financial Stability Forum, G8, etc. for more transparency and better regulation of international finance;

36.  Instructs its President to forward this resolution to the Council, the Commission and the European Central Bank.

(1) OJ C 138, 4.5.1998, p. 177.
(2) OJ C 65 E, 14.3.2002, p. 159.


Sexual and reproductive health and rights
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European Parliament resolution on sexual and reproductive health and rights (2001/2128 (INI))
P5_TA(2002)0359A5-0223/2002

The European Parliament,

–   having regard to the Universal Declaration of Human Rights, adopted in 1948,

–   having regard to the United Nations International Covenant on Civil and Political Rights, adopted in 1966,

–   having regard to Article 12 of the United Nations International Covenant on Economic, Social and Cultural Rights, adopted in 1966,

–   having regard to Articles 5 and 152 of the EC Treaty,

–   having regard to the Charter of Fundamental Rights of the European Union,

–   having regard to the European Convention on Human Rights,

–   having regard to Articles 12(1) and 16(1) of the Convention on the Elimination of All Forms of Discrimination Against Women, and to General Recommendations 21 and 24 of the Committee on the Elimination of Discrimination Against Women,

–   having regard to Article 24 of the Convention on the Rights of the Child, adopted in 1989,

–   having regard to the Declaration and Action Programme of the United Nations Conference on Population and Development (Cairo, 13 September 1994), and to the Key Actions Document of the ICPD +5 Conference (1999),

–   having regard to the Declaration and Action Programme of the Fourth World Conference on Women (Beijing, 15 September 1995), and to the Outcome Document of the FWCW +5 Conference (New York, 10 June 2000),

–   having regard to its resolutions of 29 September 1994 on the outcome of the Cairo International Conference on Population and Development(1), and 4 July 1996(2) on the follow-up to that Conference,

–   having regard to its resolutions of 15 June 1995(3) and 21 September 1995(4) on the Fourth World Conference on Women in Beijing: "Equality, Development and Peace", and 18 May 2000 on the follow-up to the Beijing Action Platform(5),

–   having regard to its resolution of 9 March 1999(6) on the state of women's health in the European Community,

–   having regard to the White Paper of the European Commission "A new impetus for European youth" of 21 November 2001 (COM(2001)681),

–   having regard to the document of the World Health Organization "Definitions and Indicators in Family Planning, Maternal & Child Health and Reproductive Health Used in the WHO Regional Office for Europe", March 1999,

–   having regard to the STOA final report "Fertility awareness and contraception" (Workplan 1995),

–   having regard to Rule 163 of its Rules of Procedure,

–   having regard to the report of the Committee on Women's Rights and Equal Opportunities (A5-0223/2002),

A.   whereas women and men should have the freedom to make their own informed and responsible choice in regard to their sexual and reproductive health and rights, while not losing sight of the importance of the health of others, and have all the means and possibilities to do so,

B.   whereas the EU competence in this field consists in providing guidelines and useful initiatives to encourage cooperation,

C.   whereas government policies that disregard men's and women's informed consent on contraceptive use in order to meet demographic goals may give rise to coercive practices,

D.   considering disparities in sexual and reproductive health and rights within the EU and within the Member States, in particular the huge inequalities experienced by European women in terms of access to reproductive health services, contraception and abortion, according to their income and/or their country of residence,

E.   whereas studies show that there are fewer abortions in some Member States which combine liberal legislation on the termination of pregnancy with effective sexuality education, high quality family planning services and availability of a wide range of contraceptives; whereas, however, some Member States with similar policies still have high rates of both abortion and teenage pregnancies,

F.   whereas attention should be devoted not only to terminating unwanted pregnancies but also, and particularly, to preventing unwanted pregnancies,

G.   whereas not only women but men too bear responsibility for preventing unwanted pregnancies,

H.   whereas in preventing unwanted pregnancies good information is extremely important regarding sexuality, responsibility towards others in relationships, health, the various ways of preventing pregnancy, etc, and parents and educational establishments can play an important part in this,

I.   whereas ease of access to all forms of contraception would reduce unwanted pregnancies and sexually transmitted diseases,

J.   whereas unsafe abortions seriously endanger women's physical and mental health,

K.   whereas higher abortion rates and lower contraceptive use in the candidate countries in comparison with the Member States, and the lack of information for women in terms of systematic and adequate sexuality education in the candidate countries,

L.   whereas health systems in many applicant countries possess inadequate medical and hygiene facilities and are insufficiently geared to the needs of the population,

M.   considering the increased rate of adolescent pregnancies and the lack of high quality sexuality education and specific sexual and reproductive health counselling and services for adolescents in some Member States,

N.   considering the alarming spread of sexually transmitted diseases, the risks of unsafe sexual contact and the persistence of stereotypes which erroneously associate the risk of HIV/AIDS infection with certain means of transmission despite the information provided on preventive measures and means of transmission in the EU, and the importance of promoting a high level of sexual health as a means of preventing sexually transmitted diseases,

O.   whereas sexual violence has a devastating impact on the sexuality and the reproductive health of women and teenage girls, and whereas female genital mutilation has a damaging effect on sexual relations, pregnancies and childbirth,

P.   considering the incompleteness of readily available statistics on sexual and reproductive health indicators on a European level at present,

Q.   whereas too many women, including growing numbers of young girls, are still becoming pregnant unintentionally,

R.   whereas the subject of sexual and reproductive health and rights cannot be approached solely from the point of view of access to contraceptives and abortion,

S.   whereas contraceptives are mainly used by women,

T.   considering the difficulties in comparing sexual and reproductive health policies, both within the EU and between the EU and the candidate countries,

As regards contraception

1.  Notes that the legal or regulatory policy concerning reproductive health falls within the Member States' sphere of competence and that subsidiarity applies to these areas; notes however that the EU can play a supportive role through the exchange of best practices;

2.  Recommends the governments of the Member States and the candidate countries to develop a high quality national policy on sexual and reproductive health, in cooperation with plural civil society organizations, providing comprehensive information concerning effective and responsible methods of family planning, and ensuring equal access to all forms of high quality contraceptive methods as well as fertility awareness methods;

3.  Recommends the governments of the Member States and the candidate countries to ensure that women and men can give their fully informed consent on contraceptive use, as well as on fertility awareness methods;

4.  Urges the governments of the Member States and the candidate countries to strive to provide contraceptives and sexual and reproductive health services free of charge, or at low cost, for underserved groups, such as young people, ethnic minorities and the socially excluded;

5.  Urges the Member States to ensure that people living in poverty have better access to reproductive and sexual health services and, in particular, to offer them the choice of contraception and the prevention/diagnosis of sexually transmitted diseases;

6.  Recommends the governments of the Member States and the candidate countries to facilitate access to affordable emergency contraception (e.g. the morning-after pill);

7.  Urges the governments of the Member States and the candidate countries to promote scientific research in the field of male contraception, so as to ensure equality between men and women as regards the effects of using contraceptive methods;

As regards unwanted pregnancies and abortion

8.  Underlines that abortion should not be promoted as a family planning method;

9.  Recommends the governments of the Member States and the candidate countries to strive to implement a health and social policy which will lead to a lower incidence of abortion, in particular through the provision of family planning counselling and services and the offering of material and financial support for pregnant women in difficulties, and to regard unsafe abortion as an issue of major public health concern;

10.  Recommends the governments of the Member States and the candidate countries to ensure the provision of unbiased, scientific and readily understandable information and counselling on sexual and reproductive health, including the prevention of unwanted pregnancies and the risks involved in unsafe abortions carried out under unsuitable conditions;

11.  Calls upon the governments of the Member States and the candidate countries to provide specialised sexual and reproductive health services which include high quality and professional advice and counselling adapted to the needs of specific groups (e.g. immigrants), provided by a trained, multidisciplinary staff; underlines that advice and counselling must be confidential and non-judgmental and that in the event of legitimate conscientious objection of the provider, referral to other service providers must take place; where advice on abortion is provided, attention must be drawn to the physical and psychological health risks associated with abortion, and alternative solutions (adoption, availability of support in the event of a decision to keep the child) must be discussed;

12.  Recommends that, in order to safeguard women's reproductive health and rights, abortion should be made legal, safe and accessible to all;

13.  Calls upon the governments of the Member States and the candidate countries to refrain in any case from prosecuting women who have undergone illegal abortions;

As regards adolescent sexual and reproductive health / sexuality education

14.  Underlines that the sexual and reproductive health of adolescents and their needs with regard to sexuality and reproduction differ from those of adults;

15.  Points out that active participation of young people (their rights, views and competence) is important in the development, implementation and evaluation of sexuality education programmes in cooperation with other parties, particularly parents; enhancing parenting skills and capacities also has an important part to play in this;

16.  Stresses that sexuality education should be provided in a gender-sensitive way, i.e. that account must be taken of the particular sensitivities of boys and girls, starting early in life, continuing to adulthood, with a focused approach at different stages of development, and taking into account different lifestyles, whereby due attention should be paid to sexually transmitted diseases (notably HIV/AIDS);

17.  Stresses that sexuality education must be considered in a holistic and positive way that pays attention to psycho-social as well as bio-medical aspects and is based on mutual respect and responsibility;

18.  Calls upon the governments of the Member States and the candidate countries to make use of various methods in reaching young people, including formal and informal education, publicity campaigns, social marketing for condom use and projects such as confidential telephone help-lines, and to consider the needs of special groups, and encourage the use of peer educators in sexuality education;

19.  Calls upon the governments of the Member States and the candidate countries to improve and extend young people's access to health services (family planning youth centres, in schools, etc.) and to tailor those services to their preferences and requirements;

20.  Calls upon the governments of the Member States and the candidate countries to provide support for pregnant adolescents (whether they wish to terminate their pregnancy or to carry it to full term), and to ensure their further education;

21.  Calls on the Member States' governments to maintain and increase the level of information made available to the general public (especially to the most peripheral sections of society which have greatest difficulty in securing access to information) on HIV/AIDS infection, the ways in which the disease is transmitted and the sexual practices which facilitate transmission;

As regards EU sexual and reproductive health policy in general

22.  Welcomes the research currently supported by the Commission on relevant sexual and reproductive health indicators and harmonized definitions and urges the Commission to ensure the continuity of these initiatives under the new Community Health Action Programme;

23.  Calls upon the governments of the Member States and the candidate countries to provide relevant data and information on policies to the Commission in order to compile a Europe- wide database on sexual and reproductive health statistics and to compose a vademecum on best practices and positive experiences in the field of sexual and reproductive health;

24.  Calls upon the governments of the Member States and the candidate countries to provide access to sexual and reproductive health services without any discrimination on the grounds of sexual orientation, gender identity or marital status;

25.  Recommends that a process of mutual learning should be started, based on comparisons of sexual and reproductive health data and on sharing positive experiences and best practices in Member States' and candidate countries' sexual and reproductive health programmes and policies;

26.  Calls upon the Commission to take up the opinions of young people on sexual and reproductive health and rights as an important theme in the follow-up to the White Paper on a new impetus for European youth;

27.  Urges the Council and the Commission in their pre-accession strategy to provide more technical and financial support to the candidate countries in order to develop and implement health promotion programmes and quality standards in sexual and reproductive health services, and to ensure that existing EU aid to Eastern Europe and Central Asia includes these types of programmes;

28.  Calls upon the Commission to take into account the devastating impact of the Mexico City Policy of the Bush Administration, which denies funding to non-governmental organisations which occasionally refer women to abortion clinics as a last resort, especially with regard to programmes for Central and Eastern Europe; calls upon the Commission to fill in the budgetary gap provoked by the Mexico City Policy ;

29.  Regrets in this respect the outcome of the UN Special Session On Children of May 2002 which, as a result of a coalition of the Holy See, the United States and several other UN member states, could not agree on a positive reference to expanding the access to reproductive health services, including information and education on reproductive and sexual health, and calls upon the Council and the Commission to coordinate the efforts of the Member States so as to guarantee at future events a better representation of the EU positions on the UN level;

30.  Calls upon the Commission to ensure that permanent monitoring and evaluation of the ICPD and FWCW programmes of action are taking place, and to send regularly summary reports to the European Parliament;

31.  Welcomes the target set in the Outcome Document of FWCW +5 of achieving universal access to high quality primary health care by 2015, including sexual and reproductive health care; asks the Council, in the framework of the follow-up procedure, within the limits of its competence, to develop indicators and benchmarks on the critical areas of concern, and to send regularly summary reports to the European Parliament;

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32.  Instructs its President to forward this resolution to the Council and Commission, and to the Governments of the Member States and the candidate countries.

(1) OJ C 305, 31.10.1994, p. 80.
(2) OJ C 211, 22.7.1996, p. 31.
(3) OJ C 166, 3.7.1995, p. 92.
(4) OJ C 269, 16.10.1995, p. 146.
(5) OJ C 59, 23.2.2001, p. 258.
(6) OJ C 175, 21.6.1999, p. 68.

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