LegalizeRegulation (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
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
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.
Article 3
Definitions
For the purpose of this Regulation:
‘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;
‘Produced from GMOs’ means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs;
‘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;
‘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;
‘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;
‘Final consumer’ means the ultimate consumer who will not use the product as part of any business operation or activity;
‘Food’ means food as defined in Article 2 of Regulation (EC) No 178/2002 (2);
‘Ingredient’ means ingredient as referred to in Article 6(4) of Directive 2000/13/EC (3);
‘Feed’ means feed as defined in Article 3(4) of Regulation (EC) No 178/2002;
‘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;
‘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;
‘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
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.
B. LABELLING
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
Article 5
Traceability requirements for products for food and feed produced from GMOs
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.
Article 6
Exemptions
Article 7
Amendment of Directive 2001/18/EC
Directive 2001/18/EC is amended as follows:
Article 4(6) is deleted;
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
The Commission is empowered to adopt delegated acts in accordance with Article 9a in order to supplement this Regulation by establishing and adapting a system for the development and assignment of unique identifiers to GMOs taking account of developments in international fora.
Article 9
Inspection and control measures
Article 9a
Exercise of the delegation
Article 10
Committee
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
This Regulation shall be binding in its entirety and directly applicable in all Member States.
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