- Dossiers submitted in the frame of Directive 2001/18/EC
- Dossiers submitted under Regulation (EC) 1829/2003
Since the GMO Directives were implemented in 1990, Belgium has only had three dossiers to process as a Member State rapporteur (lead country).
For two of these dossiers (a GM soybean submitted by Bayer Cropscience in 1998, and a GM sugar beet submitted by Monsanto in 1999), the scientific risk assessment was never completed, these dossiers first being declared incomplete before being withdrawn from the authorisation procedure by the companies in 2004.
The third dossier (ref. C/BE/96/01) related to a genetically modified MS8xRF3 line of oilseed rape developed by Plant Genetic Systems. The management of this dossier is a perfect illustration of the complexity of the GMO authorisation procedure at European level and the length of time it takes. This was also the first dossier which the Biosafety Advisory Council (BAC) had to deal with following its official installation.
=> Follow this link for a detailed history of the assessment and authorisation procedure for dossier C/BE/96/01.
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.
During the first years, the advices were issued by the SBB, under the aegis of the competent authorities. Due to staff shortages and a lack of resources, the SBB's expertise then focussed on aspects relating to the detection and identification of GMOs (molecular characterisation), to the environmental risk assessment and to the monitoring plan.
Between 2003 and 2008, the SBB continued to assess this type of dossier and to issue advices to the competent federal authority under delegation by the Biosafety Advisory Council.
Since 2008, the way in which this type of dossier is assessed is decided by the BAC on a case-by-case basis. Assessment of the few dossiers submitted since 2008 (relating to genetically modified carnations) was again delegated to the SBB by the Biosafety Advisory Council.
Most of the dossiers under Directives 90/220/EEC and after 2001/18/EC were submitted before 2000, the very first dossier, processed in 1993, relating to a GM tobacco.
Since 2005 there has been a significant fall in the number of dossiers submitted under Directive 2001/18/EC. This coincides with entry into force of Regulation (EC) No. 1829/2003 (see below). Since that date, only a few dossiers relating to GMOs not intended for use as food and/or feed (for example, cut flowers, or a GM potato variety developed for the industrial production of amylopectin-enriched starch) have been processed under Directive 2001/18/EC. Almost all the applications for marketing authorisation of GM plants are now submitted under Regulation (EC) No. 1829/2003, despite the fact that the legislation gives notifiers the possibility of splitting applications between the Regulation (for food/feed aspects) and the Directive (for cultivation aspects). Clearly, therefore, the notifiers prefer the single authorisation procedure ("one door – one key"), making it possible to submit a single application for authorisation for food and feed use, cultivation or deliberate release into the environment.
With respect to Directives 90/220/EC and 2001/18/EC, more than half of the dossiers submitted at European level relate to GM maize and oilseed rape which are herbicide-tolerant or insect-resistant or have male sterility. It should be noted that most GMOs that are the subject of an application for marketing authorisation in the EU have already been authorised to this end in other countries, such as the USA, Canada or Japan.
The list of GMOs authorised for placing on the market under Directives 90/220/EEC or 2001/18/EC is available on this website. Within the European Union, only the GM maize MON810 is actually cultivated. However, there has been no commercial cultivation of GM plants on Belgian territory to date.
Belgium is one of the few Member States contributing actively and systematically to the risk assessment process of dossiers submitted under the "GM food/feed" Regulation.
The number of advices and other documents published by the Biosafety Advisory Council relating to these dossiers has greatly increased in the past few years. Between the date on which it was officially installed until the end of 2017, the Council has delivered 82 advices to the competent Minister.
The full list of GMOs authorised for placing on the market within the EU under Regulation (EC) No. 1829/2003 is available on the European Commission website (EU Register of authorised GMOs). The GMOs authorised to date are mainly GM plants (cotton, maize, oilseed rape, soybean, sugar beet) that are herbicide-tolerant or insect-resistant. The fact that these GMOs have been authorised in the EU does not necessarily mean that they are actually present on the European market. Their use continues to be limited in 2015 and the GMOs authorised are essentially used as feed.
For the moment, only a limited number of GMOs and derived products can be sold for human consumption. These are mainly products deriving from genetically modified soybean or maize (such as soya burgers, tofu, corn flour or popcorn), seed oils derived from cotton, maize, soybean or oilseed rape, as well as maize starch, flour and glucose. Although these GMOs and derived products are authorised in Europe, most wholesalers refuse to put them on sale.
The Biosafety Advisory Council also issues advices on environmental risk assessments relating to certain types of dossiers submitted under Regulation (EC) No. 1829/2003 and that include cultivation. To date, the Council has been mandated by EFSA to carry out the safety assessment of three dossiers of this type: EFSA/GMO/UK/2006/30 (maize 59122x1507xNK603), EFSA/GMO/CZ/2008/54 (maize 88017) and EFSA/GMO/BE/2009/71 (maize MON89034 x MON88017).
The participation of the BAC and the SBB in the regulatory risk assessment process has also contributed to enhancing the transparency of the EFSA's work. For example, following remarks by certain Member States, including Belgium, EFSA has been required, for some years, to provide a summary indicating how the comments and observations made by the Member States have been taken into account in each of its scientific opinions on regulatory dossiers.