Syngenta "bt10"

Dossier: BASF's starch-potatoe EH92-527-1 - "Amflora"
Last updated July 2007
Go to: legal documents background information

The pending approval for commercial release of a genetically modified potatoe, which has been developed by Amylogene, Sweden, now taken over by BASF, Germany, would be the first EU approval for cultivation of a GMO since 1998. A proposal of the EU Commission to approve the cultivation of " EH92-527-1" was submitted to the Standing Committee on GMOs under Directive 2001/18 in December 2006, but did not get the necessary qualified majority. On July 16th 2007 the Council Agricultural Ministers had to vote on the proposal and, again, could not agree with qualified majority. According to the EU rules it is now up to the Commission to make a decision. The Commissioner in charge, Stavros Dimas, has announced that he would now approve the planting of the potato.

At this point approval is sought under Directive 2001/18 (deliberate release of GMOs into the environment) for cultivation only. An additional application has been filed by BASF under Regulation 1829/2003 (genetically modified food and feed) for approval as food and feed. Such an approval would ease the need to prevent any of the GM potatoes accidentially entering the food chain and also allow to use the waste from GM starch production in animal feed.

The advantage of the potatoe, derived from the variety "Prevalent", would be to ease the extraction of starch from the potatoes, as ordinary potatoes produce two types of starch, of which only amylopectin (70-80%) is used for food and non-food purposes while amylose (20-30%) must be separated by means of chemical, physical und enzymatic processes, including the use of substantial quantities of processing water. By supressing the genes for the production of amylose the EH92-527-1 potatoe produces over 98% of amylopectin. Amylose is used to produce paste, adhesives, lubricants, films, building materials, synthetics and other industrial products. Roughly one quarter of all potatoes grown in Europe is already used for non-food industrial purposes, another half for animal feed and only one quarter for human consumption, which is constantly declining since the 1980ies.

The BASF potato supresses by means of antisense inhibition of a single gene, coding for a granule-bound starch synthase (gbss). The only known additional protein produced by the GM potato is from the neomycin phosphotransferase gene (nptII), coding for a protein giving the plant resistance to the antibiotic kanamycin. According to Directive 2001/18 antibiotic resistance markers should be phased out from commercially released GMOs by 2004. However, the European Food Safety Authorities GMO panel deemed that kanamycin-resistance could be neglected with respect to human health threats, as it was already widely spread in the environment and in humans. However, the World Health Organisation, WHO, classifies nptII as a "critically important" antibiotic. When asked by the EU Commission in 2006 the European Medicines Agency EMEA also contradicted EFSAs assessment and confirmed the critical importance of nptII in human medicine.
The construct has been first submitted for approval to the Swedish authorities by the company Amylogene in 1996. Newer varieties of starch-potatoes without an antibiotic resistance gene are tested as well.

At this moment no GMO potatoes are grown world-wide. GM varieties developed by Monsanto to kill the Colorado beetle had been grown but were withdrawn from the market in the USA. BASF and others are presently testing potato varieties with resistance to phytophtera.

Cordis report on Council decision
Friends of the Earth Europe Press release on Council of Ministers vote 16th July 2007
Greenpeace EU Unit Background note on potato vote

Legal documents:

Documents under Directive 2001/18 (approval for cultivation)

European Commission 9 November 2006, submitted to the Standing Committee on GMOs
Draft Commission Decision concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a potato product (Solanum tuberosum L. line EH92-527-1) genetically modified for enhanced content of the amylopectin component of starch

C/SE/96/3501 Sweden Amylogene HB Potato variety EH92-527-1 with modified starch content
February 2003 Full text of the original application
February 2003 Summary notification file Public comments file
May 2004 Assessment report file Public comments to the risk assessment file
June 2005 BASF amended report on sequence and molecular structure
June 2005 BASF report on possible open reading frames
June 2005 BASF response to EFSA
July 2004 Response of United Kingdom Competent Authority
June 2000 Test of different types of potato pulp in a feeding experiment with heifers

European Medicines Agency, EMEA (February 2007)
Presence of the antibiotic resistance marker gene nptII in GM plants for food and feed uses
Upon request of the Commission EMEA suggests that the antibiotic marker contained in the starch-potatoe does have significant therapeutic relevance and questions the assumptions of EFSA.

EFSA, 9 November 2006
Summary of the dossier for approval as food and feed

European Commission, 14 November 2006
Comments in consultation on the approval for food and feed

EFSA, GMO Panel, Adopted on 7 December 2005
Opinion of the GMO Panel on an application (Reference EFSA-GMO-UK-2005-14) for the placing on the market of genetically modified potato EH92-527-1 with altered starch composition, for production of starch and food/feed uses, under Regulation (EC) No 1829/2003 from BASF Plant Science [1]

EFSA, GMO Panel, 2004
Opinion of the Scientific Panel on Genetically Modified Organisms on the use of antibiotic resistance genes as marker genes in genetically modified plants, EFSA Journal 48, 1-18.

BASF
Application for Amylopectin Potato Event EH92-527-1 according to Regulation (EC) No 1829/2003 PART II SUMMARY

Joint Research Centre, 14 September 2006
Event-specific method to detect and quantify the EH92-527-1 potato transformation using real time PCR

Institute for Reference Materials and Measurements, 2006,
Certification of EH92-527-1 Fraction and Identity of Non-Modified and Genetically Modified Potato Powder Certified Reference Materials ERM®-BF421a and ERM®-BF421b

Background information:

Royal Society of Chemistry, UK, Nov 2006 BASF touts GM spuds for starch

ISB (Information Systems for Biotechnology), Nov 2006 Searching for Unintended Compositional Changes in GE Potatoes

Food-Navigator, Feb 2006, GM potato no threat to health, says EFSA

Consiglio delli diritti genetici, Struttura del costrutto (in Italian, shows the GM inserts and lists their use in other GMOs)