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Parliamentary questions
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21 September 2007
Answer given by Mr Dimas on behalf of the Commission
Question reference: P-4070/2007

1. At the beginning of 2007, the attention of the Commission was drawn to a recent report of the World Health Organisation on the use of kanamycin and other related antibiotics as reserve medicine for the treatment of tuberculosis. As the Honourable Member rightly points out, the genetically modified (GM) potato contains a gene that encodes resistance to these antibiotics. The Commission therefore decided to consult the European Agency for the Evaluation of Medicinal Products (EMEA) with a view to confirming the opinion of European Food Safety Authority (EFSA) on the safety of the gene. In its reply, EMEA concluded that: (i) the use of the antibiotics in question is limited but not minor, and (ii) EMEA is not competent for evaluating the potential for horizontal gene transfer. The Commission subsequently transmitted the letter to EFSA. In this context it is particularly important to highlight the respective competence and expertise of the two agencies. EMEA has been requested to assess the usefulness of the antibiotics concerned, EFSA has been requested to assess the safety of the gene encoding for antibiotic resistance in genetically modified organisms (GMOs). The EFSA, in the light of the information provided by EMEA, published a statement indicating that its initial assessment of the use of the antibiotic resistance marker gene was maintained on the basis of both (i) the low probability of horizontal gene transfer and (ii) the fact that the gene cannot be expressed in bacteria due to the genetic construct. In view of this position the Commission prepared its proposal for the draft decision which was presented to the Council.

2. The draft decision, in Article 3(h), lays down the obligation for the consent holder to ensure that the potato tubers will be physically separated from potatoes for food and feed uses during planting, cultivation, harvest, transport, storage and handling in the environment. Moreover, the consent holder shall ensure that the potato tubers shall be delivered exclusively to designated starch processing plants for processing into industrial starch within a closed system. Finally, the potato will be only processed into industrial starch on the basis that, pending Community approval for the product for use as or in feed, the by-product material from this process is used exclusively for industrial purposes or destroyed. Given these legal obligations, the Commission has established all possible requirements to prevent under the current decision the presence of potato in other products and in the feed and food chain.

A complementary application was made under Regulation (EC) No 1829/2003(1) on GM food and feed. It covers the by-products of the starch extraction when they are used as feed. It also covers the unintended presence of the GM potato in food and feed. Following a risk assessment by EFSA's GMO panel and a positive scientific opinion, this application is currently in the process of elaborating the modalities of risk management, before a possible submission for the opinion of the experts of Member States under the comitology procedure.

3. Article 4(2) of Directive 2001/18/EC(2) foresees only the phasing out of antibiotic resistance marker genes (ARMGs) in GMOs which may have adverse effects on human health and the environment. As a means to phase out ARMGs in new GMOs to be placed on the market, the safety of individual ARMGs has to be assessed. EFSA, in its very detailed opinion on ARMGs in food products (published in April 2004(3)) categorised individual ARMGs into different groups taking into account ‘their current usage in clinical and veterinary medicine, the likely occurrence of horizontal gene transfer from genetically modified plants to microbes and the potential impact of horizontal gene transfer where naturally occurring resistance to the relevant antibiotics exists in the microbial gene pool’.

In that same context, the Commission has convened several working group meetings with the relevant national competent authorities, and the majority of Member States concurred with the opinion of EFSA. Member States and the Commission agreed to take into account the results of the working group without prejudice to the case-by-case environmental risk assessment. Moreover, in the light of the information provided by EMEA concerning the use of kanamycin and neomycin in human and veterinary medicine, the EFSA GMO panel published a statement in March 2007, reiterating its earlier conclusions that the use of the nptII gene as selectable marker in GM plants (and derived food or feed) does not pose a risk to human or animal health or to the environment. The GMO Panel also confirms earlier safety assessments of GM plants and derived food/feed comprising the nptII gene. Therefore the authorisation of the particular product is not contradictory to the provisions of the directive on the phasing out of ARMG.

4. The authorisation of this potato did not consider any economic aspects of the marketing of the product. Being based on Directive 2001/18/EC the draft decision examined only the aspects related to the safety of environmental and human health as indicated in the respective environmental risk assessment which was carried out in accordance with the principles of Annex II to the directive.

(1)Regulation (EC) No 1829/2003 of the Parliament and of the Council of 22 September 2003 on genetically modified food and feed; OJ L 268, 18.10.2003.
(2)Directive 2001/18/EC of the Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC — Commission Declaration, OJ L 106, 17.4.2001.
(3)The EFSA Journal (2004) 48.

OJ C 189, 13/07/2010
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