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/ECcross-notes
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 [[F1,F2 assimilatedF2] lawF1] ;
(b)food produced from GMOs, placed on the market in accordance with [[F1,F2 assimilatedF2] lawF1] ;
(c)feed produced from GMOs, placed on the market in accordance with [[F1,F2 assimilatedF2] lawF1] .
2.This Regulation shall not apply to medicinal products [F3authorised under the Human Medicines Regulations 2012 or the Veterinary Medicines Regulations 2013F3] .
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 [F4 Great Britain F4] 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 ( 8 );
‘Ingredient’ means ingredient as referred to in [F5 Article 2(2)(f) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council F5] ;
‘Feed’ means feed as defined in Article 3(4) of Regulation (EC) No 178/2002 ;
[F6 “Placing on the market” means placing on the market as defined in the specific legislation under which the relevant product is authorised; in other cases, it means “marketed” within the meaning given in section 107(11) of the Environmental Protection Act 1990 . F6]
‘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.
[F7 “ Competent authority ” means—
in England, the Secretary of State;
in Wales, the Welsh Ministers;
in Scotland, the Scottish Ministers;F7]
[F8 ‘Appropriate authority’ means—
in relation to England, the Secretary of State;
in relation to Wales, the Welsh Ministers;
in relation to Scotland, the Scottish Ministers;
but the appropriate authority is the Secretary of State if consent is given by—
in relation to Wales, the Welsh Ministers;
in relation to Scotland, the Scottish Ministers;
‘Relevant food standards authority’ means—
in relation to England and Wales, the Food Standards Agency;
in relation to Scotland, Food Standards Scotland.F8]
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)F9the unique identifier(s) assigned to those GMOs ....
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 [[F10,F11 assimilatedF11] lawF10] .
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 [[F12,F13 assimilatedF13] lawF12] .
C. EXEMPTIONS
7.Paragraphs 1 to 6 shall not apply to traces of GMOs in products in a proportion no higher than the thresholds [F14referred to in, or, where relevant, the thresholds established or amended under, Article 4A of this RegulationF14] , 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 [F15or 24F15] of Regulation (EC) No 1829/2003, provided that these traces of GMOs are adventitious or technically unavoidable.
[F16Article 4A Amending thresholds
1.In relation to the thresholds provided for in Article 21 of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC or established by virtue of any other relevant [F17 assimilatedF17] law, an appropriate authority may, by regulations, make provision establishing or amending, where relevant, thresholds mentioned in or established under Article 21(2) or (3) of that Directive.
2.Before making regulations under paragraph 1, the appropriate authority must consult the relevant food standards authority.F16]
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 [[F18,F19 assimilatedF19] lawF18] .
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 [F20or 24F20] of Regulation (EC) No 1829/2003, provided that these traces of GMOs are adventitious or technically unavoidable.
Article 6 Exemptions
1.In cases where [F21otherF21] 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.
F22Article 7 Amendment of Directive 2001/18/EC
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[F23Article 8 Unique identifiers
1.An appropriate authority may, by regulations, make provision for the purposes of adapting the system, as amended from time to time, and as relevant, for assigning unique identifiers to GMOs referred to in Articles 2 and 3 of Commission Regulation (EC) No 65/2004.
2.Before making regulations under paragraph 1, the appropriate authority—
(a)must take account of developments in international fora, and
(b)must consult the relevant food standards authority.F23]
Article 9 Inspection and control measures
1.[F24 The competent authoritiesF24] 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.
[F25 2.An appropriate authority may—
(a)publish technical guidance on sampling and testing for the purposes of facilitating the implementation of this Regulation;
(b)make provision, by regulations, on sampling and testing for the purposes mentioned in point (a), having first consulted the relevant food standards authority.F25]
F263.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F27Article 9a Exercise of the delegation
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[F28Article 10 Regulations
1.Regulations made by the Secretary of State or the Welsh Ministers under this Regulation are to be made by statutory instrument.
2.For regulations made by the Scottish Ministers under this Regulation, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 .
4.A statutory instrument containing regulations made by the Secretary of State under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.
5.A statutory instrument containing regulations made by the Welsh Ministers under this Regulation is subject to annulment in pursuance of a resolution of the National Assembly for Wales.
6.Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).
8.Such regulations may—
(a)contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);
(b)make different provision for different purposes.F28]
F29Article 11 Penalties
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F30Article 12 Review clause
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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.
F312.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F32 ...
OJ C 304 E, 30.10.2001, p. 327 and OJ C 331 E, 31.12.2002, p. 308.
OJ C 125, 27.5.2002, p. 69.
OJ C 278, 14.11.2002, p. 31.
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.
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).
See page 1 of this Official Journal.
OJ L 184, 17.7.1999, p. 23.
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).
OJ C 304 E, 30.10.2001, p. 327 and OJ C 331 E, 31.12.2002, p. 308.
OJ C 125, 27.5.2002, p. 69.
OJ C 278, 14.11.2002, p. 31.
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.
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).
See page 1 of this Official Journal.
OJ L 184, 17.7.1999, p. 23.
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).