[img_assist|nid=6|title=|desc=|link=none|align=right|width=150|height=65]BASF's GM potato Amflora is now referred to the European Medicines Agency because according to WHO information the antibiotic resistance relates to a group of antibiotics that are much more widely used then assumed by the EFSA.
from Agrarfacts, 21 February 2007:
"GM Potato authorisation referred to European Medicines Agency
A Commission proposal to authorise the first genetically-modified organism for cultivation since 1998 will not be forwarded to the Council for a decision until the European Medicines Agency (EMEA) in London has provided an opinion relating to one of its genes which is resistant to antibiotics, a Commission official confirmed in the margins of yesterday´s Environment Council. The proposal to authorise the GM potato for industrial purposes, and not for food & feed, found no opinion in the 2001/18 Regulatory Committee in December [see AF97-06], with the next step normally being to forward the proposal to Council, which then has 3 months to reach a decision.
If the Council also fails to reach an opinion, the Commission would then have the authority approve the GM potato, made by BASF. However, the need for an opinion from the EMEA could delay the proposal for some months, officials predict. EMEA´s involvement follows a recent report by the World Health Organisation - released after the vote was taken in Committee - which found that some of the antibiotics, which the npt2 gene is resistant to, principally kanamycin & neomycin, are more widely used in veterinary medicine than previously thought. One of the key criteria for authorising antibiotic-resistant marker genes in the EU is that the antibiotic in question is not widely used in medicine. An European Food Safety Authority (EFSA) opinion in 2004 found that npt2 could be used for cultivation & field trials for a number of reasons, including the "low usage" level of the antibiotics in question. If the EMEA finds that the antibiotics are now quite widely used, another opinion from EFSA will be required, but if it finds that usage levels remain low, the approvals process will continue as before. The investigation is relatively straightforward & could be completed very quickly, but a further EFSA opinion, if required, could take months.
In terms of the potato, the fear is that the resistance to antibiotics may be passed on to bacteria in the soil &eventually enter the human food chain, according to one official. The use of antibiotics in feed as growth promoters is banned across the EU in order to avoid humans & animals developing resistance. The move is officially being carried out by DG SANCO, which is examining the approval of the potato for food & feed purposes under Regulation 1829/30, but DG ENVI is blocking its authorisation under Directive 2001/18 until the EMEA reports."