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Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance)
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The application shall contain the following information:
Genetically modified food
Food containing or consisting of genetically modified plants
Food produced from genetically modified plants or containing ingredients produced from genetically modified plants
Genetically modified feed
Feed containing or consisting of genetically modified plants
Feed produced from genetically modified plants
Genetically modified plants for food or feed uses
Products other than food and feed containing or consisting of genetically modified plants with the exception of cultivation
Seeds and other plant propagating material for cultivation in the Union.
A proposal for a unique identifier for the genetically modified plant developed in accordance with Regulation (EC) No 65/2004.
This description would include, for example, a detailed description of specific methods of production of food or feed which would be due to the nature of the genetic modification or which would lead to food or feed with specific characteristics.
Additional authorisation requirements provided for in Union law, related to the placing on the market of the food or feed or applicable ‘maximum residue level’ (MRL) where the food or feed is likely to contain residues of plant protection products.
All the requirements of Part II shall be provided in the application except where such requirements are not justified by the scope of the application (for example, where the application is limited to food or feed produced from GMOs).
family name;
genus;
species;
subspecies;
cultivar, breeding line;
common name;
information concerning reproduction:
mode(s) of reproduction;
specific factors affecting reproduction (if any);
generation time;
sexual compatibility with other cultivated or wild plant species;
survivability:
ability to form structures for survival or dormancy;
specific factors, if any, affecting survivability;
dissemination:
ways and extent of dissemination (to include, for example, an estimation of how viable pollen and/or seed declines with distance);
special factors affecting dissemination, if any;
geographical distribution within the Union of the sexually compatible species;
where a plant species is not grown in the Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts;
other potential interactions of the genetically modified plant with organisms in the ecosystem where it is usually grown, or used elsewhere, including information on toxic effects on humans, animals and other organisms.
Plant to bacteria gene transfer;
Plant to plant gene transfer.
A systematic review of studies published in the scientific literature and studies performed by the applicant within the period of 10 years prior to the date of submission of the dossier on the potential effects on human and animal health of the genetically modified food and feed covered by the application shall be included in the application. This systematic review shall be carried out by taking into account the guidance of EFSA on application of systematic review methodology to food and feed safety assessments to support decision making(1).
Where the information obtained from those studies is not coherent with the information obtained from the studies performed in accordance with the requirements set out in Annex II, the applicant shall provide a thorough analysis of the respective studies and provide plausible explanations for the observed discrepancies.
Additional information which might influence the evaluation of the safety of the genetically modified food or feed generated following the submission of the application, as well as any information regarding any prohibition or restriction imposed by a competent authority of any third country on the basis of a safety assessment shall be provided by the applicant.
The application shall provide the information required under Articles 5(3)(c) and 17(3)(c) of Regulation (EC) No 1829/2003 for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
The provided information shall contain as a minimum the information specified in Annex II to Regulation (EC) No 1946/2003 of the European Parliament and of the Council(2):
The name and contact details of the applicant for a decision for domestic use;
The name and contact details of the authority responsible for the decision;
Name and identity of the GMO;
Description of the gene modification, the technique used, and the resulting characteristics of the GMO;
Any unique identification of the GMO;
Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety;
Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate;
Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety;
Approved uses of the GMO;
A risk assessment report consistent with Annex II to Directive 2001/18/EC;
Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.
The application shall include:
a proposal for labelling in all official languages of the Union, where a proposal for specific labelling is required in accordance with Articles 5(3)(f) and 17(3)(f) of Regulation (EC) No 1829/2003;
either a reasoned statement that the food or feed does not give rise to ethical or religious concerns or a proposal for labelling in all official languages of the Union as required by Articles 5(3)(g) and 17(3)(g) of Regulation (EC) No 1829/2003;
when appropriate a proposal for labelling complying with the requirements of point A(8) of Annex IV to Directive 2001/18/EC.
The applicant shall provide methods for detection, sampling and identification, as well as samples of the food or feed and their controls samples to the European Union Reference Laboratory (EURL) as referred to in Article 32 of Regulation (EC) No 1829/2003.
The application shall include a copy of the completed form for the submission of those samples to the EURL and proof of sending to the EURL.
The application shall include information as to the place where the reference material can be accessed.
The applicant shall follow the instructions for the preparation and the sending of the samples provided by the EU Reference laboratory (EURL) as referred to in Article 32 of Regulation (EC) No 1829/2003. These instructions are published on the following webpage: http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm
The information required in the notification as set out in Annex III to Directive 2001/18/EC shall be provided where it is not covered by the requirements of other parts of the application.
This Part specifies the standardised form, which the summary of the application dossier must follow.
Depending on the scope of the application, some of the requested information may not be applicable.
The summary shall not contain parts considered to be confidential in accordance with Article 30 of Regulation (EC) No 1829/2003.
Food containing or consisting of genetically modified plants
Food produced from genetically modified plants or containing ingredients produced from genetically modified plants
Feed containing or consisting of genetically modified plants
Feed produced from genetically modified plants
Products other than food and feed containing or consisting of genetically modified plants with the exception of cultivation
Seeds and plant propagating material for cultivation in the Union
No | | |
Yes | | (in that case, specify) |
Yes | | |
No | | (in that case, provide risk analysis data on the basis of the elements of Part B of Directive 2001/18/EC) |
No | | |
Yes | | (in that case, specify) |
No | | |
Yes | | In that case, specify the third country, the date of application and, where available, a copy of the risk assessment conclusions, the date of the authorisation and the scope of the application |
In the case of products other than food and feed containing or consisting of genetically modified plants, a proposal for labelling which complies with the requirements of point A(8) of Annex IV to Directive 2001/18/EC must be included.
In the EU
In EU export markets
Description of the experimental design (number of locations, growing seasons, geographical spread, replicates and number of commercial varieties in each location) and of the statistical analysis.
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