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05/03/2010

Subject: Authorisation for the cultivation of the genetically modified Amflora potato variety


10 March 2010

P-1617/10

WRITTEN QUESTION by Kriton Arsenis (S&D) to the Commission

SUBJECT: Authorisation for the cultivation of the genetically modified Amflora potato variety

On 2 March 2010, the Commission authorised for the first time since 1998 the cultivation of a genetically modified organism (GMO) in the European Union. Specifically, it is now allowing Member States to cultivate the Amflora transgenic potato variety, which, according to experts, contains a gene making it resistant to antibiotics in general use. Furthermore, since it has authorised the use of Amflora derivatives in animal fodder, it is practically certain that the gene will make its way into the human food chain.

The Commission indicates that its decision is based on consistently favourable body of expert opinion. However, presumably in the light of inconsistencies between opinions issued by the EFSA, the Commission had already asked it to cooperate closely with the EMEA in order to come up with an agreed expert assessment opinion regarding the safety of the gene, which merely serves to cast doubt on the validity of this opinion.

Furthermore, the Commission’s decision, taken a few days previously on 17 February 2010, to transfer the unit responsible for matters relating to biotechnology and GMOs from the Directorate‑General for the Environment to the Directorate‑General for Health only served to obscure matters still further.

In view of this, can the Commission provide the following information:
1. What were the reasons for the above administrative reshuffle involving the transfer of the unit responsible for matters relating to GMOs from the Directorate‑General for the Environment to the Directorate‑General for Health?
2. What prompted the Commission to ask the EFSEA and EMEA for a joint exert opinion on the safety of the gene in question?
3. Do the opinions received by the Commission rule out the existence in the Amflora potato variety of a gene increasing resistance to antibiotics?
4. According to the above opinions, what impact is the crop in question likely to have on human health and biodiversity?


P-1617/2010 Answer given by Mr Dalli on behalf of the Commission

The Commission has decided to re-organise several services to better reflect its political priorities but also to streamline the use of its limited resources and improve its internal coordination. Most of the GMO applications are now submitted under Regulation 1829/2003 on GM food and feed(1) for which the Directorate-General for Health and Consumers has been responsible since 2003. In addition, the Directorate-General for Health and Consumers is the Commission's service responsible for the European Food Safety Authority (EFSA) which plays a key role in the authorisation of GMOs. Therefore, the transfer of the management of the GMO legislation from the Directorate-General for Environment to the Directorate-General for Health and Consumers was the most rational approach. Other Directorate-Generals will continue to be involved in the framing of GMO policy in the context of existing Commission inter-service coordination.

The opinion adopted in June 2009 on Antibiotic Resistance Marker Genes (ARMs) in genetically modified plants is an opinion from EFSA which was prepared in collaboration with experts from the European Medicines Agency and from the European Centre for Disease Prevention and Control. This consolidated opinion was requested by the Commission in 2008. The consolidated opinion of 2009 recognised the therapeutic relevance of kanamycin and neomycin and concluded by reiterating its previous favourable opinions on Amflora potato.

The EFSA opinions do not rule out the existence in Amflora potato of nptII gene. On the contrary, these opinions assess the presence of nptII gene in Amflora potato and its implication on human and animal health and the environment. They conclude on the safety of nptII gene in Amflora potato based on the low probability of gene transfer from plant to bacteria and the fact that this antibiotic resistance marker gene in bacteria is already widespread in the environment.

In its opinions concerning the placing on the market of Amflora potato for cultivation published in February 2006 and of June 2009, EFSA concludes that the product is unlikely to have adverse effect on human and animal health and the environment including biodiversity in the context of its proposed uses.

(1) Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, OJ L 268, 18.10.2003.

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