Genetically modified organisms and the EU
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0167-7799/$ - see front matter Q 2005 Elsevier Ltd. All rights reserved.
Safety Authority (EFSA) the European Commission IP/04/1083&formatZHTML&agedZ0&languageZen
procedures in force. The term refers to procedures
Update TRENDS in Biotechnology Vol.23 No.5 May 2005222approved three new products for use as food and feed:(i) genetically modified insect-resistant maize Bt11 foruse as food ; (ii) herbicide-tolerant maize NK603 for useas feed ; and (iii) maize NK603 derivatives for use as food(http://europa.eu.int/rapid/pressReleasesAction.do?refer-enceZIP/04/1305&formatZHTML&agedZ0&languageZEN&guiLanguageZen).
According to transitional measures authorisations arestill granted for a single use, when a product is likely to beused for both food and feed purposes. After the experiencewith insect-resistant Starlink corn in the US suchproducts should only be authorised when fulfillingauthorisation criteria for both food and feed; this is alsostated in the new regulations, but not yet in operation .The case of Starlink corn was a severe test of USregulatory agencies. The US Environmental ProtectionAgency had restricted its use to feed owing to concernabout the potential for allergenicity. However, Starlinkcorn was later found throughout the food supply, resultingCorresponding author: Jank, B. (email@example.com).Available online 26 March 2005
www.sciencedirect.comthat include a system of committees assisting theCommission when it implements EU legislation incooperation with national authorities. The nature and&guiLanguageZen).
Decision-making on GMOsNotably, like the Union of 15 (before the enlargement togive the new EU), the new Europe of 25 is deeply dividedon the issue of GM food. In the case of the leastcontroversial application, concerning derivatives ofNK603, only 36% of the member states supported theproposal, 36% opposed it and 28% abstained from makinga decision (http://www.greens-efa.org/en/press/detail.php?idZ1993&lgZen). In all three cases, a qualifiedmajority could not be reached, first in the RegulatoryCommittee, or later in the Council. Finally, the Commis-sion was in the position to decide alone according to whatis called in administrative jargon the comitologyincluding provisions for labelling and traceability [1,2].After receiving positive statements by the European Food1Department Evolutionary Biology, University of Vienna, Althanstrasse 14, A-1090 Vienna, Austria2Inter-University Research Centre for Technology, Work and Culture, Schloegelgasse 2, A-8010 Graz, Austria
In 2004, the European Union (EU) abandoned its informalmoratorium on the marketing of new genetically modifiedorganisms (GMOs). Since 18th April 2004 new regulationsfor genetically modified food and feed apply in the EU,
in food recalls by the Food and Drug Administration andsignificant disruption of the food supply .
In addition, for the first time, maize varieties basedon genetically modified insect-resistant maize MON810have been included in the EU seed catalogue (http://europa.eu.int/rapid/pressReleasesAction.do?referenceZgene families in a single step, but the creation of new cropvarieties will ultimately need stable changes in thegenome at individual loci to yield reproducible andconsistent results. TILLING identifies large, diverseallelic series easily and effectively, does it directly inlines close to what is to be made commercially availableand finds useful alleles to pyramid without the need for aphenotype first. As a result, it is already an extremelypowerful way to characterize non-GMO mutants that canbe turned quickly into new crop varieties of enormousvalue.
ConclusionIn conclusion, molecular mapping and marker-assistedselection greatly accelerated the crop improvement pro-cess in the past decade by allowing us to bring useful traitsin from related wild species and follow them throughmultiple backcrosses even when we could not see themexpressed. Now, the strategy of making a very highdensity mutation library directly in commercial varieties
Genetically modified organ
Bernhard Jank1, Johannes Rath1 and Armdoi:10.1016/j.tibtech.2005.03.001
ms and the EU
Spok2of polyploid crops, screening these for particular, desirablealleles by TILLING and then crossing them together,means breeding has become faster again.
References1 Henikoff, S. and Comai, L. (2003) Single-nucleotide mutations for plantfunctional genomics. Annu. Rev. Plant Biol. 54, 375401
2 McCallum, C.M. et al. (2000) Targeting induced local lesions INgenomes (TILLING) for plant functional genomics. Plant Physiol. 123,439442
3 Perry, J.A. et al. (2003) A TILLING reverse genetics tool and a web-accessible collection of mutants of the legume Lotus japonicus. PlantPhysiol. 131, 866871
4 Till, B.J. et al. (2004) Discovery of induced point mutations in maizegenes by TILLING. BMC Plant Biol. 4, 12
5 Slade, A.J. et al. (2005) A reverse genetic, nontransgenic approach towheat crop improvement by TILLING. Nat. Biotechnol. 23, 7581
6 Ng, P.C. and Henikoff, S. (2001) Predicting deleterious amino acidsubstitutions. Genome Res. 11, 863874functioning of comitology is one of the most commonlyused examples to demonstrate the lack of transparency
novel food or novel food ingredient under regulation (EC) No 258/97 ofthe European Parliament and of the Council, Official Journal of the
Update TRENDS in Biotechnology Vol.23 No.5 May 2005 223and public participation in the current EU decision-making process .
Diverging scientific viewsThe scientific opinions of the EFSA carry significantweight because the Commission puts much emphasis onthe fact that its approvals are based on sound science.Nevertheless, the EFSA, like the scientific committees inplace before the EFSA was established in 2002, has beenrepeatedly confronted with diverging scientific views notonly from stakeholders but also from member states (see). Recently, Friends of the Earth (http://www.foeeurope.org) criticized the failure of the EFSA GMO panel tosupport Austrias, Luxembourgs and Germanys ban ongenetically modified insect-resistant maize Bt176,although its own opinion on antibiotic-resistance genesrecommended that crops containing the ampicillin-resist-ance gene should be banned from commercial growing(http://www.foeeurope.org/GMOs/publications/EFSAre-port.pdf). It is not surprising that some national experts inthe Regulatory Committee arrive at different conclusionson Bt176 than the EFSA. Modern methods exist for theconstruction of transgenic plants using nonantibioticmarkers, or no markers at all, whereas site-specificexcision methods allow the removal of superfluous DNA,including antibiotic-resistance genes. In the absence ofantibiotic-resistance genes in transgenic plants, theproblem of their transfer to bacteria ceases to exist .However, the EFSA stated that it does not believe that thereport calls into question the legitimacy of its opinions(http://www.efsa.eu.int/press_room/press_statements/716_en.html; http://www.efsa.eu.int/mboard/correspon-dence/786/foe-reply1.pdf).
Unlike agencies, which have an advisory function,Regulatory Committees are designed to operate ascontrollers and agents not just of technical requirementsbut also of the completion and administration of theinternal market . Hence, they enjoy political legitimacyalong with legal legitimacy. In cases of scientific uncer-tainty and diverging levels of protection envisaged bymember states  the Regulatory Committees have animportant balancing function. Admittedly, the presentregime might slow down the authorisation of GMOs andGM food in the EU but it makes it more likely thatdifferent views and scientific uncertainty will be takeninto account.
Democratic deficitsIn our opinion, the present approach of Commissiondecisions in the absence of clear majorities in Council doesnot seem appropriate to approve GMOs on a routine basis.One way to overcome this democratic deficit would be toestablish a positive list for approved products similar to theDirective onFoodAdditives . In this case, authorisationsalso require a favourable decision of the European Parlia-ment. Currently, despite the fact that Council and Parlia-ment together adopted the new regulations on GMOs, therole of the Parliament in the implementation phase islimited to formal control. Furthermore, under a reformed
comitology regime, the European Parliament should beentitled toact onan equal footingwith theCouncil  as this
www.sciencedirect.comEuropean Union OJ L300/48; http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_300/l_30020040925en00480051.pdf
4 Commission Decision of 19 July 2004 concerning the placing on themarket, in accordance with Directive 2001/18/EC of the EuropeanParliament and of the Council, of a maize product (Zea mays L. lineNK603) genetically modified for glyphosate tolerance,Official Journalof the European UnionOJ L295/35; http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_295/l_29520040918en00350037.pdf
5 Bucchini, L. and Goldman, L.R. (2002) Starlink corn: a risk analysis.Environ Health Perspect. 110, 513
6 Allio, L. (2003) The Case for Comitology Reform: Efficiency, Transpar-ency, Accountability. The European Policy Centre, Brussels, Belgium,http://www.euractiv.com/Article?tcmuriZtcm:29-117024-16&typeZAnalysis
7 Spok, A. et al. (2004): Risk Assessment of GMO Products in theEuropean Union. Toxicity assessment, allergenicity assessment andsubstantial equivalence in practice and proposals for improvementand standardisation, Federal Ministry of Health and Women, Vienna,Austria, http://www.bmgf.gv.at/cms/site/attachments/6/8/7/CH0255/CMS1090828056047/risk_assessment_of_gmo_products-bmgf-layout.pdf
8 Davison, J. (2004) Monitoring horizontal gene transfer. Nat. Biotech-nol. 22, 1349
9 Levidow, L. et al. (2000) Genetically modified crops in the EuropeanUnion: regulatory conflicts as precautionary opportunities. J. RiskRes. 3, 189208would encompass the spirit of the future EuropeanConstitution (Title III, Art. 35) . Intervention by theCouncil and Parliament in the implementation phaseshould be limited to exceptional cases.
Given that the majority of Europeans is opposed to GMfood , the approval procedure would benefit fromincreased transparency to the general public. Whenapproving GMO products for use as food and feed theCommission also referred to new provisions on labellingand traceability. For the first time farmers see labels onGM feed. However, products obtained from animals fedwith GM feed are not subject to labelling. These exemp-tions require open communication with the public becausethe criteria are less stringent compared with GM-freelabels, including organic farming  and the inter-national fair-trade movement (http://www.fairtrade.net/pdf/sp/english/FLO-Generic%20Environmental%20Stan-dards.SF.pdf; http://www.fairtrade.net/pdf/hl/english/FLO-generic-environmental-standards.HL.pdf). GM-related labelling should enable the final consumer notonly the farmer to influence agricultural production.
References1 Regulation (EC) No. 1829/2003 of the European Parliament and of theCouncil of 22 September 2003 on genetically modified food and feed,Official Journal of the European Union OJ L268/1; http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf
2 Regulation (EC) No. 1830/2003 of the European Parliament and of theCouncil of 22 September 2003 concerning the traceability andlabelling of genetically modified organisms and the traceability offood and feed products produced from genetically modified organismsand amending Directive 2001/18/EC, Official Journal of the EuropeanUnion OJ L268/24; http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00240028.pdf
3 Commission Decision of 19 May 2004 authorising the placing on themarket of sweet corn from genetically modified maize line Bt11 as a10 Directive 2003/114/EC of the European Parliament and of the Councilof 22 December 2003 amending Directive 95/2/EC on food additives
other than colours and sweeteners, Official Journal of the EuropeanUnion OJ L24/58; http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_024/l_02420040129en00580064.pdf
11 Treaty Establishing a Constitution for Europe, Official Journal of theEuropean Union OJ C310/1; http://europa.eu.int/eur-lex/lex/JOHtml.do?uriZOJ:C:2004:310:SOM:EN:HTML
12 Rowe, G. (2004) How can genetically modified foods be made publiclyacceptable? Trends Biotechnol. 22, 107109
13 Council Regulation (EC) No 1804/1999 of 19 July 1999 supplementing
Regulation (EEC) No 2092/91 on organic production of agriculturalproducts and indications referring thereto on agricultural productsand foodstuffs to include livestock production, Official Journal of theEuropean Union OJ L221/1; http://europa.eu.int/eur-lex/pri/en/oj/dat/1999/l_222/l_22219990824en00010028.pdf
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Genetically modified organisms and the EUDecision-making on GMOsDiverging scientific viewsDemocratic deficitsReferences