LegalizeRegulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance)
CHAPTER I
OBJECTIVE AND DEFINITIONS
Article 1
Objective
The objective of this Regulation, in accordance with the general principles laid down in Regulation (EC) No 178/2002, is to:
(a) provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market;
(b) lay down Community procedures for the authorisation and supervision of genetically modified food and feed;
(c) lay down provisions for the labelling of genetically modified food and feed.
Article 2
Definitions
For the purposes of this Regulation:
the definitions of ‘food’, ‘feed’, ‘final consumer’, ‘food business’ and ‘feed business’ given in Regulation (EC) No 178/2002 shall apply;
the definition of ‘traceability’, laid down in Regulation (EC) No 1830/2003;
‘operator’ means the natural or legal person responsible for ensuring that the requirements of this Regulation are met within the food businesses or feed businesses under its control;
the definitions of ‘organism’, ‘deliberate release’ and ‘environmental risk assessment’ referred to in Directive 2001/18/EC shall apply;
‘genetically modified organism’ or ‘GMO’ means a 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 I B to Directive 2001/18/EC;
‘genetically modified food’ means food containing, consisting of or produced from GMOs;
‘genetically modified feed’ means feed containing, consisting of or produced from GMOs;
‘genetically modified organism for food use’ means a GMO that may be used as food or as a source material for the production of food;
‘genetically modified organism for feed use’ means a GMO that may be used as feed or as a source material for the production of feed;
‘produced from GMOs’ means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs;
‘control sample’ means the GMO 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);
‘conventional counterpart’ means a similar food or feed produced without the help of genetic modification and for which there is a well-established history of safe use;
‘ingredient’ means ‘ingredient’ as referred to in Article 6(4) of Directive 2000/13/EC;
‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves.
‘pre-packaged food’ means any single item for presentation as such consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, provided that the contents cannot be altered without opening or changing the packaging.
‘mass caterer’ means ‘mass caterer’ as referred to in Article 1 of Directive 2000/13/EC.
CHAPTER II
GENETICALLY MODIFIED FOOD
Section 1
Authorisation and supervision
Article 3
Scope
This Section shall apply to:
(a) GMOs for food use;
(b) food containing or consisting of GMOs;
(c) food produced from or containing ingredients produced from GMOs.
Article 4
Requirements
Food referred to in Article 3(1) must not:
(a) have adverse effects on human health, animal health or the environment;
(b) mislead the consumer;
(c) 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.
The authorisation referred to in paragraph 2 may cover:
(a) a GMO and foods containing or consisting of that GMO as well as foods produced from or containing ingredients produced from that GMO; or
(b) food produced from a GMO as well as foods produced from or containing that food;
(c) an ingredient produced from a GMO as well as food containing that ingredient.
Article 5
Application for authorisation
The application shall be sent to the national competent authority of a Member State.
(a) The national competent authority: (i) shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application; (ii) shall inform without delay the European Food Safety Authority (hereinafter referred to as the Authority); and (iii) shall make the application and any supplementary information supplied by the applicant available to the Authority.
(b) The Authority (i) shall inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them; (ii) shall make the summary of the dossier referred to in paragraph 3(1) available to the public.
The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and shall be accompanied by the following:
(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 applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol);
(d) where applicable, a detailed description of the method of production and manufacturing;
(e) a copy of the studies, including, where available, 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 referred to in Article 4(1);
(f) either an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 13(2)(a), or a proposal for labelling the food in accordance with Article 13(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 13(2)(b);
(h) where appropriate, the conditions for placing on the market the food or foods produced from it, including specific conditions for use and handling;
(i) methods for detection, sampling (including references to existing official or standardised sampling methods) 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;
(j) samples of the food and their control samples, and information as to the place where the reference material can be accessed;
(k) where appropriate, a proposal for post-market monitoring regarding use of the food for human consumption;
(l) an identification of the parts of the application and any other supplementary information that the applicant requests to be treated as confidential, accompanied by verifiable justification, pursuant to Article 30 of this Regulation and Article 39 of Regulation (EC) No 178/2002;
(m) a summary of the dossier in a standardised form.
In the case of GMOs or food containing or consisting of GMOs, 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 or, where the placing on the market of the GMO has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;
(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent.
In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.
Article 6
Opinion of the Authority
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 referred to in Article 4(1);
(b) may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food in accordance with Article 36 of Regulation (EC) No 178/2002;
(c) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment;
(d) shall forward to the Community reference laboratory referred to in Article 32 the particulars referred to in Article 5(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant;
(e) shall, in verifying the application of Article 13(2)(a), examine the information and data submitted by the applicant to show that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.
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 applicable, the information required under Annex II to the Cartagena Protocol;
(d) the proposal for the labelling of the food and/or foods produced from it;
(e) where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or food containing or consisting of GMOs, conditions for the protection of particular ecosystems/environment and/or geographical areas;
(f) the method, validated by the Community reference laboratory, for detection, including sampling, 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; an indication of where appropriate reference material can be accessed;
(g) where appropriate, the monitoring plan referred to in Article 5(5)(b).
Article 7
Authorisation
Article 8
Status of existing products
By way of derogation from Article 4(2), products falling within the scope of this Section which have been lawfully placed on the market in the Community before the date of application of this Regulation may continue to be placed on the market, used and processed provided that the following conditions are met:
(a) in the case of products 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 referred to in Regulation (EC) No 258/97, operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission of the date on which they were first placed on the market in the Community;
(b) in the case of products which have been lawfully placed on the market in the Community but are not covered by point (a), operators responsible for placing on the market the products concerned shall, within six months after the date of application of this Regulation, notify the Commission that the products were placed on the market in the Community before the date of application of this Regulation.
Within three years from the date of application of this Regulation, operators responsible for placing on the market products referred to in paragraph 1(b) shall submit an application in accordance with Article 11, which shall apply mutatis mutandis.
Article 9
Supervision
Article 10
Modification, suspension and revocation of authorisations
Article 11
Renewal of authorisations
The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and accompanied by the following:
(a) a copy of the authorisation for placing the food 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 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.
Section 2
Labelling
Article 12
Scope
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:
(a) contain or consist of GMOs; or
(b) are produced from or contain ingredients produced from GMOs.
Article 13
Requirements
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 specific labelling requirements:
(a) where the food consists of more than one ingredient, the words ‘genetically modified’ or ‘produced from genetically modified (name of the ingredient)’ shall appear in the list of ingredients provided for in Article 6 of Directive 2000/13/EC in parentheses immediately following the ingredient concerned;
(b) where the ingredient is designated by the name of a category, the words ‘contains genetically modified (name of organism)’ or ‘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) the indications referred to in (a) and (b) may appear in a footnote to the list of ingredients. In this case they shall be printed in a font of at least the same size as the list of ingredients. Where there is no list of ingredients, they shall appear clearly on the labelling;
(e) where the food is offered for sale to the final consumer as non-pre-packaged food, or as pre-packaged food in small containers of which the largest surface has an area of less than 10 cm2, the information required under this paragraph must be permanently and visibly displayed either on the food display or immediately next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.
In addition to the labelling requirements referred to 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 different from its conventional counterpart as regards the following characteristics or properties: (i) composition; (ii) nutritional value or nutritional effects; (iii) intended use of the food; (iv) implications for the health of certain sections of the population;
(b) where a food may give rise to ethical or religious concerns.
Article 14
Implementing measures
The following measures may be adopted by the Commission:
— measures necessary for operators to satisfy the competent authorities as referred to in Article 12(3),
— measures necessary for operators to comply with the labelling requirements set out in Article 13,
— specific rules concerning the information to be given by mass caterers providing food to the final consumer. In order to take account of the specific situation of mass caterers, such rules may provide for adaptation of the requirements set out in Article 13(1)(e).
Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).
CHAPTER III
GENETICALLY MODIFIED FEED
Section 1
Authorisation and supervision
Article 15
Scope
This Section shall apply to:
(a) GMOs for feed use;
(b) feed containing or consisting of GMOs;
(c) feed produced from GMOs.
Article 16
Requirements
Feed referred to in Article 15(1) must not:
(a) have adverse effects on human health, animal health or the environment;
(b) mislead the user;
(c) harm or mislead 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.
The authorisation referred to in paragraph 2 may cover:
(a) a GMO and feed containing or consisting of that GMO as well as feed produced from that GMO; or
(b) feed produced from a GMO as well as feeds produced from or containing that feed.
Article 17
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