transgenic plants and GM Food/Feed on the EU Market
The placing on the EU market of genetically modified organisms (GMOs) is regulated since the early 1990s. Directive 90/220/EEC was the first main legislation regulating the release of all GMOs (plants, animals, micro-organisms) into the environment. Part C of this regulation stipulated provisions for import, processing of GMOs for feed purposes and cultivation. Since this regulation lacked provisions for the use of GMOs for food purposes, the novel food Regulation (EC) No. 258/97 was put in place in 1997 in order to regulate the placing on the market of GMOs intended for food purposes.
On 17 October 2002, Directive 90/220/EC has been repealed by Directive 2001/18/EC and on 22 March 2003, Regulation (EC) No. 258/97 has been replaced by Regulation (EC) No. 1829/2003 on genetically modified (GM) food and feed. With the entering into force of the GM food and feed regulation, consents to be given under Directive 2001/18/EC could no longer include the use of GMOs for feed purposes; they were restricted to import and cultivation. In contrast to the novel food regulation, Regulation (EC) No. 1829/2003 covers both food and feed uses of the GMOs. As Directive 2001/18/EC has been taken up in the regulation on GM food and feed, Regulation (EC) No. 1829/2003 stipulates the conditions for import, cultivation and the use of GMOs as or in food and feed products.
In order to get a consent for import and/or cultivation, a notification should be submitted under Directive 2001/18/EC. In case one envisages authorisation for a food or feed product containing or consisting of GMOs, the applicant can either submit the application under Regulation (EC) No 1829/2003 in order to obtain authorisation for the deliberate release of a GMO into the environment - in accordance with the criteria laid down by Directive 2001/18/EC - and for the use of this GMO in food or feed products - in accordance with the criteria laid down by Regulation (EC) No 1829/2003; or the application can be submitted both under Directive 2001/18/EC and Regulation (EC) No 1829/2003.
Market authorisations for GMOs, as or in products, can only be granted if certain conditions are fulfilled. The applicant should carry out a case-by-case 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 Directive 2001/18/EC. In addition to the ERA, the applicant should provide information on precise instructions and conditions for use and labelling of the product (according to Annex IV of the Directive). A new Regulation concerning the traceability and labelling of GMOs has been adopted in 2003 (Regulation (EC) No 1830/2003) stating that labelling is mandatory at all stages of the placing on the market and that a label of a GMO product should contain the words "this product contains genetically modified organisms". Directive 2001/18/EC also contains an obligation to provide 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. In addition, a summary of the notification, termed SNIF (summary notification information format), should be made available in order to inform the public through its publication on the internet (http://gmoinfo.jrc.it) and a protocol for detection of the GMO. In summary an application for marketing must contain a SNIF, an ERA, proposal for labelling, a post-market monitoring plan and a detection protocol.
Once an application for marketing has been submitted, it will be evaluated for its completeness (is all the requested information given?) and its scientific relevance. Since under Directive 2001/18/EC, the notifier must submit the notification to the competent national authority of the Member State where the product is to be first placed on the market, the evaluation of the notification occurs at national level.
In case an application is submitted under Regulation (EC) No 1829/2003, the application handed in to a competent authority of a Member State choice, will be send directly to EFSA (European Food Safety Authority) for evaluation. After completeness check, EFSA will invite the Member States to provide scientific comments on the application. In addition, EFSA may ask an assessment body of a Member State to carry out the safety assessment of the food/feed or the environmental risk assessment. However, if the application concerns GMOs to be used as seeds or other plant-propagating material, EFSA is obliged to ask a national competent authority to carry out the environmental risk assessment. EFSA will conclude on the final assessment.
If under Directive 2001/18/EC the national authority gives a favourable opinion on the placing on the market of the GMO concerned, this Member State informs the other Member States via the Commission on its opinion. If there are no objections raised by the other Member States, the competent authority that carried out the original evaluation grants the consent for the placing on the market of the product. The product may then be placed on the market throughout the European Union in conformity with any conditions required in that consent. Consent is given for a maximum period of 10 years for the initial consent. After 10 years a renewed application has to be submitted, which, in principle, is subject to the same time-limitation, i.e. 10 years.
If any objections are raised, a decision has to be taken at Community level. The Commission first asks for the opinion of the European Food Safety Authority (EFSA). If the scientific opinion is favourable, the Commission then proposes a draft Decision to the Regulatory Committee composed of representatives of Member States for opinion. If the Regulatory Committee gives a favourable opinion, the Commission adopts the Decision. If not, the draft Decision is submitted to the Council of Ministers for adoption by qualified majority or rejection. If the Council does not act within 3 months, the Commission can adopt the decision.
For applications submitted under Regulation (EC) No 1829/2003, decisions are taken directly at Community level. As for notifications submitted under Directive 2001/18/EC, if the opinion of EFSA is favourable, the Commission will initiated the decision procedure by proposing a draft Decision to the Regulatory Commitee.