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Procedure : 2001/0180(COD)
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Document selected : A5-0229/2002

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A5-0229/2002

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Texts adopted :

P5_TA(2002)0353

Texts adopted
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Wednesday, 3 July 2002 - Strasbourg
Genetically modified organisms (GMOs) ***I
P5_TA(2002)0353A5-0229/2002
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))

(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.

(1) OJ C 304E, 30.10.2001, p. 327.


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(1),

Having regard to the opinion of the Economic and Social Committee(2),

Having regard to the opinion of the Committee of the Regions(3),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),

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(5), as amended by Regulation (EC) No …/2002 [on genetically modified food and feed](6), 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(7), 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(8).

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(9);
   7) 'food additive' means food additive as defined in Article 1(2) of Council Directive 89/107/EEC(10);
   8) 'flavouring' means flavouring as defined in Article 1(2) of Council Directive 88/388/EEC(11);
   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(12);
   11) 'feed materials' means feed materials as defined in Article 2(a) of Council Directive 96/25/EC(13);
   12) "feed additives' means additives as defined in Article 2(a) of Council Directive 70/524/EEC(14);
   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(15), 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 .... (16)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 304 E, 30.10.2001, p. 327.
(2) OJ C 125, 27.5.2002, p. 69.
(3) OJ C ...
(4) Position of the European Parliament of 3 July 2002.
(5) OJ L 106, 17.4.2001, p. 1.
(6) OJ L ...
(7) OJ L 184, 17.7.1999, p. 23.
(8) 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).
(9) OJ L 31, 1.2.2002, p. 1.
(10) 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).
(11) 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).
(12) 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).
(13) 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).
(14) 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).
(15) 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).
(16)* 180 days following the date of publication of this Regulation in the Official Journal of the European Communities.

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