Examples: GMOs released outdoors for industrial purposes (e.g. GM trees for paper or starch industry), for energy production (biofuels), for bioremediation (e.g. GM micro-organisms to break down contaminants), for landscape improvement, for ornamental use (e.g. GM cut carnation), for pest control (e.g. GM sterile insects).

 

A notification should be made through a platform of the European Commission. Please see EFSA’s website for all information on the application procedure.

 

An application for the placing on the market shall include information specified in Article 13 of Directive 2001/18/EC, in particular: An environmental risk assessment (ERA) in accordance with the principles set out in Annex II (and the guidance notes supplementing Annex II) and on the basis of information specified in Annex III of the Directive; Information on precise instructions and conditions for use and labelling of the product (according to Annex IV of the Directive). Traceability and labelling requirements are also specified in Regulation (EC) No 1830/2003; A post-market monitoring plan (in accordance with Annex VII) in order to confirm the assumptions of the ERA and to trace and identify any adverse effects of the GMO or its use on human health or the environment which were not anticipated in the ERA; A summary of the notification (SNIF), aimed at informing the public through its publication on the internet; A protocol for the detection of the GMO.

 

Risk assessment

The Member State which receives the notification, hereafter termed the lead country, conducts the risk assessment and submits its report to the European Commission which forwards it to the other Member States for consultation. During this process, Member States are offered two opportunities to submit comments, objections or requests for information on the notification: a 60-day commenting period and, if objections are raised, a subsequent 45-day commenting period. If objections are maintained after the second round, the European Commission requests an opinion of the European Food Safety Authority (EFSA).

Inputs of the Biosafety Advisory Council (BAC) and of the SBB

If Belgium is chosen as lead country for an application, the BAC, with the scientific support of external experts and the SBB, is responsible for carrying out the risk assessment (see chapter “some figures”).

Most of the dossiers processed by Belgium under Directive 2001/18/EC (and previously under Directive 90/220/EEC) relate to dossiers submitted through other Member States (see also chapter “some figures”). The assessment of these dossiers is in most of the cases performed by the SBB on mandate of the BAC. The SBB contributes to the risk assessment process at two points in the procedure:

1. During the initial 60-day commenting period, after the assessment report has been forwarded by the lead country;
2. If comments were submitted, the SBB assesses the additional information requested from the notifier during the subsequent 45-day period to determine whether its initial comments have been addressed.

Decision-making

The authorisation involves the national authorities and the European Commission. Based on the assessment report of the lead country and, where applicable, EFSA opinion, the European Commission proposes to Member States to grant or refuse the authorisation. A qualified majority is required to approve the Commission’s proposal. If a qualified majority cannot be reached between the Member States (first in the Regulatory Committee under Directive 2001/18/EC, and second in the Appeal Committee), the final decision is taken by the Commission.
Authorisations are valid for a maximum of 10 years and are renewable.

Under the new Directive (EU) 2015/412 Member States have the possibility to restrict or prohibit GMO cultivation on their territory either during the authorisation procedure, or after a GMO has been authorised for cultivation in the EU.

 

Procedure 2: Placing on the market under Regulation (EC) 1829/2003

(mandatory when the scope of the notification covers food and feed use)

Examples: GM crops used as food and/or feed; food or feed enzymes, additives, vitamins and flavourings containing, consisting of, or produced from GMOs (including from GM micro-organisms); biomasses used as feed materials.

How to apply ?

The placing on the market of GMOs for use as food or feed is governed by Regulation (EC) No. 1829/2003. Applications may concern either new GMOs or renewals of authorisations of GMOs previously authorised. If the application also covers cultivation, the applicant can submit the application (i) either under Regulation (EC) No 1829/2003 only or (ii) both under Directive 2001/18/EC (for the cultivation aspects) and Regulation (EC) No 1829/2003 (for the food/feed aspects). The risk assessment procedure of the applications for food/feed purposes or cultivation, is centralised. An application should be made through a platform of the European Commission. Please see EFSA’s website for all information on the application procedure.

An application for authorising a GMO for food or feed uses must comply with the requirements set out in Regulation (EC) 1829/2003 and also with those set out in Commission Implementing Regulation (EU) 503/2013. EFSA has published a guidance to help the applicants submitting an application for authorisation of GM plants for food and feed uses, import and processing, and/or cultivation in the European Union under Regulation (EC) No 1829/2003.

Risk assessment

EFSA carries out the risk assessment of the application and issues an opinion, which is published in the EFSA Journal and submitted to the European Commission and the Member States. The EFSA assessments are undertaken by the GMO Panel, a group of independent scientific experts assisted by specialised working groups. If the scope of an application submitted under Regulation (EC) No. 1829/2003 also covers cultivation, EFSA delegates the environmental risk assessment to a Member State. The results of this assessment are integrated in EFSA’s overall evaluation.

The "GM food/feed" Regulation allows for a contribution by the Member States to the risk assessment process (Article 6.4). During a 90-day consultation period (in accordance with the procedure established under Directive 2001/18/EC), Member States may submit their comments on an application to EFSA. When EFSA publishes its opinion, it must include an annex detailing how the comments made by the Member States were taken into account in formulating its opinion.

The opinion is also made available by EFSA to the public for a 30-days consultation.

Inputs of the Biosafety Advisory Council and of the SBB

The Biosafety Advisory Council, with the scientific support of external experts and the SBB, takes part in the 90-day consultation procedure of all GMO applications for food and feed. On request of the competent Minister, the Biosafety Advisory Council delivers an advice on all dossiers submitted under the "GM food/feed" Regulation, complementing the final opinion published by EFSA). The Belgian authorities determine their position on the European Commission draft decisions primarily on the basis of this advice and the EFSA's opinion.

Decision-making

Based on EFSA’s opinion, the European Commission proposes to Member States to grant or refuse the authorisation. A qualified majority is required to approve the Commission’s proposal. If a qualified majority cannot be achieved between the Member States (first in the Standing Committee on Plants, Animals, Food and Feed, second at an Appeal Committee), the final decision is taken by the Commission.
Authorisations are valid for a maximum of 10 years (renewable).