Regulation (EC) No 1830/2003 of the European Parliament and of the Council

of 22 September 2003

concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC

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 European 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 of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(5) 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) 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. Directive 2001/18/EC should therefore be amended accordingly.

(3) Traceability requirements for GMOs should facilitate both the withdrawal of products where unforeseen adverse effects on human health, animal health or the environment, including ecosystems, are established, and the targeting of monitoring to examine potential effects on, in particular, the environment. Traceability should also facilitate the implementation of risk management measures in accordance with the precautionary principle.

(4) 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 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(6), so as to ensure that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner as well as to enable 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.

(5) The transmission and holding 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 provide 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.

(6) The transmission and holding of information that food and feed have been produced from GMOs also provide the basis for the appropriate traceability of products produced from GMOs.

(7) The Community legislation concerning GMOs as or in feed should also apply to feed intended for animals which are not destined for food production.

(8) 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. Account should be taken of registers containing information on genetic modifications in GMOs established by the Commission in accordance with Article 31(2) of Directive 2001/18/EC and Article 29 of Regulation (EC) No 1829/2003.

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

(10) Certain traces of GMOs in products may be adventitious or technically unavoidable. Such presence of GMOs should therefore not trigger labelling and traceability requirements. It is therefore necessary to fix thresholds for the adventitious or technically unavoidable presence of material consisting, containing or produced from GMOs both when the marketing of such GMOs is authorised in the Community and when their adventitious or technically unavoidable presence is tolerated by virtue of Article 47 of Regulation (EC) No 1829/2003. It is also appropriate to provide that, when the combined level of adventitious or technically unavoidable presence of the above material in a food or feed or in one of its components is higher than the aforesaid labelling thresholds, such presence should be indicated in accordance with the provisions of this Regulation and detailed provisions to be adopted for its implementation.

(11) It is necessary to ensure that consumers are fully and reliably informed about GMOs and the products, foods and feed produced therefrom, so as to allow them to make an informed choice of product.

(12) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7).

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

(14) The Commission should submit a report to the European Parliament and the Council on the implementation of this Regulation and, more specifically, on the effectiveness of the rules on traceability and labelling.

(15) 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

Objectives

This Regulation provides a framework for the traceability of products consisting of or containing genetically modified organisms (GMOs), and food and feed produced from GMOs, with the objectives of facilitating accurate labelling, monitoring the effects on the environment and, where appropriate, on health, and the implementation of the appropriate risk management measures including, if necessary, withdrawal of products.

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) food produced from GMOs, placed on the market in accordance with Community legislation;

(c) feed 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 Regulation (EEC) No 2309/93(8).

Article 3

Definitions

For the purpose of this Regulation:

1. "Genetically modified organism" or "GMO" means genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex IB to Directive 2001/18/EC;

2. "Produced from GMOs" means derived, in whole or in part, from GMOs, but not containing or consisting of 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 identifier" 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 natural or legal person who places a product on the market or who receives a product that has been placed on the market in the Community, either from a Member State or from a third country, at any stage of the production and distribution chain, but does not include the final consumer;

6. "Final consumer" means the ultimate consumer who will not use the product as part of any business operation or activity;

7. "Food" means food as defined in Article 2 of Regulation (EC) No 178/2002(9);

8. "Ingredient" means ingredient as referred to in Article 6(4) of Directive 2000/13/EC(10);

9. "Feed" means feed as defined in Article 3(4) of Regulation (EC) No 178/2002;

10. "Placing on the market" means placing on the market as defined in the specific Community legislation under which the relevant product has been authorised; in other cases, it is defined as in Article 2(4) of Directive 2001/18/EC;

11. "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;

12. "Pre-packaged product" means any single item offered 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, provided that the contents cannot be altered without opening or changing the packaging.

Article 4

Traceability and labelling requirements for products consisting of or containing GMOs

A. TRACEABILITY

1. 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 in writing to the operator receiving the product:

(a) that it contains or consists of GMOs;

(b) the unique identifier(s) assigned to those GMOs in accordance with Article 8.

2. At all subsequent stages of the placing on the market of products referred to in paragraph 1, operators shall ensure that the information received in accordance with paragraph 1 is transmitted in writing to the operators receiving the products.

3. In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, the information referred to in paragraph 1(b) may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture.

4. Without prejudice to Article 6, operators shall have in place systems and standardised procedures to allow the holding of information specified in paragraphs (1), (2) and (3) and the identification, for a period of five years from each transaction, of the operator by whom and the operator to whom the products referred to in paragraph 1 have been made available.

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

B. LABELLING

6. For products consisting of or containing GMOs, operators shall ensure that:

(a) for pre-packaged products consisting of, or containing GMOs, the words "This product contains genetically modified organisms" or "This product contains genetically modified [name of organism(s)]" appear on a label;

(b) for non-pre-packaged products offered to the final consumer the words "This product contains genetically modified organisms" or "This product contains genetically modified [name of organism(s)]" shall appear on, or in connection with, the display of the product.

This paragraph shall be without prejudice to other specific requirements in Community legislation.

C. EXEMPTIONS

7. Paragraphs 1 to 6 shall not apply to traces of GMOs in products in a proportion no higher than the thresholds established in accordance with Article 21(2) or (3) of Directive 2001/18/EC and in other specific Community legislation, provided that these traces of GMOs are adventitious or technically unavoidable.

8. Paragraphs 1 to 6 shall not apply to traces of GMOs in products intended for direct use as food, feed or for processing in a proportion no higher than the thresholds established for those GMOs in accordance with Articles 12, 24 or 47 of Regulation (EC) No 1829/2003, provided that these traces of GMOs are adventitious or technically unavoidable.

Article 5

Traceability requirements for products for food and feed produced from GMOs

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

(a) an indication of each of the food ingredients 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. Without prejudice to Article 6, operators shall have in place systems and standardised procedures to allow the holding of the information specified in paragraph 1 and the identification, for a period of five years from each transaction, of the operator by whom and to whom the products referred to in paragraph 1 have been made available.

3. Paragraphs 1 and 2 shall be without prejudice to other specific requirements in Community legislation.

4. Paragraphs 1, 2 and 3 shall not apply to traces of GMOs in products for food and feed produced from GMOs in a proportion no higher than the thresholds established for those GMOs in accordance with Articles 12, 24 or 47 of Regulation (EC) No 1829/2003, provided that these traces of GMOs are adventitious or technically unavoidable.

Article 6

Exemptions

1. In cases where Community legislation provides for specific identification systems, such as lot numbering for pre-packaged products, operators shall not be obliged to hold the information specified in Articles 4(1), 4(2), 4(3) and 5(1), provided that this information and the lot number is clearly marked on the package and that information about lot numbers is held for the periods of time referred to in Articles 4(4) and 5(2).

2. Paragraph 1 shall not apply to the first stage of placing on the market of a product or to primary manufacture or re-packaging of a product.

Article 7

Amendment of Directive 2001/18/EC

Directive 2001/18/EC is amended as follows:

1. Article 4(6) is deleted;

2. the following paragraph is added to Article 21:

"3. For products intended for direct processing, paragraph 1 shall not apply to traces of authorised GMOs in a proportion no higher than 0,9 % or lower thresholds established under the provisions of Article 30(2), provided that these traces are adventitious or technically unavoidable."

Article 8

Unique identifiers

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

(a) prior to the application of Articles 1 to 7 establish a system for development and assignment of unique identifiers to GMOs;

(b) adapt the system provided for in point (a), as appropriate.

In so doing, account shall be taken of developments in international fora.

Article 9

Inspection and control measures

1. Member States shall ensure that inspections and other control measures including sample checks and testing (qualitative and quantitative), as appropriate, are carried out to ensure compliance with this Regulation. Inspection and control measures may also include inspection and control regarding the holding of a product.

2. Prior to the application of Articles 1 to 7, the Commission, in accordance with the procedure referred to in Article 10(3), shall develop and publish technical guidance on sampling and testing to facilitate a coordinated approach for the implementation of paragraph 1 of this Article. In developing the above technical guidance, the Commission shall take account of the work of national competent authorities, the committee referred to in Article 58(1) of Regulation (EC) No 178/2002 and the Community Reference Laboratory established under Regulation (EC) No 1829/2003.

3. In order to help the Member States meet 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 which are not authorised in the European Union.

Article 10

Committee

1. The Commission shall be assisted by the committee set up by Article 30 of Directive 2001/18/EC.

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

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

3. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4. The Committee shall adopt its rules of procedure.

Article 11

Penalties

Member States shall lay down the rules on penalties applicable to infringements 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, not later than 18 April 2004 and shall notify it without delay of any subsequent amendment affecting them.

Article 12

Review clause

No later than 18 October 2005, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation, in particular with regard to Article 4(3) and, where appropriate, bring forward a proposal.

Article 13

Entry into force

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

2. Articles 1 to 7 and Article 9(1) shall apply with effect from the 90th day following the date of publication in the Official Journal of the European Union of the measure referred to in Article 8(a).

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

Done at Brussels, 22 September 2003.

For the European Parliament

The President

P. Cox

For the Council

The President

R. Buttiglione

(1) OJ C 304 E, 30.10.2001, p. 327 and OJ C 331 E, 31.12.2002, p. 308.

(2) OJ C 125, 27.5.2002, p. 69.

(3) OJ C 278, 14.11.2002, p. 31.

(4) Opinion of the European Parliament of 3 July 2002 (not yet published in the Official Journal), Council Common Position of 17 March 2003 (OJ C 113 E, 13.5.2003, p. 21), Decision of the European Parliament of 2 July 2003 (not yet published in the Official Journal) and Council Decision of 22 July 2003.

(5) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Council Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27).

(6) See page 1 of this Official Journal.

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

(8) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal products (OJ L 214, 24.8.1993, p. 1). Regulation as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

(9) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

(10) Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29). Directive as amended by Commission Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).