Risico-Analyse van GMO’s en de EU Regelgeving Harry Kuiper Voormalig RIKILT medewerker en former Chair EFSA GMO Panel
Reűnie 50e-jaars WUR 18 0ctober 2013
Genetische Modificatie van Voedsel: Veel Vragen Transfer of genetic material and crossing of species barriers, playing God?
Impact on the environment, human/animal health? Risks and Benefits? Adequate safety test systems? Contribution to a sustainable agriculture? Traceability, labelling and GM-free foods?
Who are the stakeholders and which interests?
Activisme tegen GGO gewassen
Video: TousCobayes
Public Concern
Groei van het areaal met GM gewassen
Data bron: C. James, ISAAA , 2012
Methode om het genetisch materiaal te veranderen in planten: Agrobacterium tumefaciens T-DNA
Bron: Universiteit van Manitoba, Canada
Celkweek, Selectie en Ontwikkeling
Bron: De la Riva et al. (1999) Elec. J. Biotech. 1(3)
First Generation of GM Plants with Agronomical Traits
Improved disease resistance (viruses, fungi)
Improved pest resistance (lepidoptera, beetles)
Tolerance for herbicides (glyphosate, glufosinate)
Combined herbicide tolerance/ pest resistance (stacks)
8
GM Gewassen met veranderde agronomische eigenschappen Herbicide tolerante soja
Insecten resistente mais (maisboorder)
Geen herbicide behandeling
Glyphosaat behandeling
Resistente maïs
Niet-resistente maïs
“Golden Rice” GM crop with enhanced nutritional properties Additional β- caroteen (provitamin A)
SAINSBURY SUCCES AND FAILURE
February 1996 Tomato with shortened
March 1999 Sainsbury's phase out GM
(PG) gene, slowing down the softening process of ripening
Customers 'have
food
expressed concern' over genetically-modified food
GMO Regelgeving in de EU
EU Lidstaten
Illustration source: http://europa.eu/abc/maps/index_en.htm
EU legislation on GMOs To introduce a GM product on the EU market: Impact Assessment for humans, animals and the environment
• Regulation (EC) 1829/2003 (Food and Feed) • Directive 2001/18/EC (Release into the Environment)
• 8 June 2013: Commission Implementing Regulation (EC) 503/2013 on GM applications
European Food Safety Authority Responsible for Risk Assessment in the EU EFSA
Structure: ● Executive director ● Scientific committee and panels ● 11 Scientific Panels ● GMO Panel
Independent, e.g. from European Commission (EC)
Advice to EC and Member States Risk Assessment, not Risk Management http://www.efsa.europa.eu
Parma
EFSA Guidance for GM Plants and derived Food and Feed Adopted on 24 September 2004, Updated in December 2005 (PMEM) Complemented in ● December 2006 (Renewals) ● March 2007 (Stacked events)
Updated ● May 2008, for Public Consultation,
● May 2011 final version 15
Internationaal Kader Veiligheidsbeoordelingen
Codex Alimentarius Richtlijnen (FAO, WHO) http://www.codexalimentarius.net/ download/standards/10021/CXG_ 045e.pdf
EFSA Guidance Environmental Risk Assessment GM Plants SCIENTIFIC OPINION
Guidance on the environmental risk assessment of genetically modified plants EFSA Panel on Genetically Modified Organisms (GMO)
European Food Safety Authority (EFSA), Parma, Italy
EFSA Journal 2010;8(11):1879
The Comparative Safety Assessment Approach Compare the properties of the GMO and derived products with their non-GM (conventional) counterparts
FIND THE DIFFERENCE(S): INTENDED AND UNINTENDED (UNEXPECTED) AND EVALUATE THEM
Risk Assessment Strategy for GM Food/Feed
Phase 1
Traceing of Differences between the GM food and its Conventional Counterpart (Comparative Analysis)
Introduced genes
(New) proteins (New) metabolites and toxins
Phase 2
Toxicological / Nutritional Assessment
Gene transfer
Degradation Toxicity Allergenicity
Toxicity
Whole foods
Analysis of the Composition of GM and non-GM Products is Key Fat, fatty acid profile Protein, amino acid profile Micronutrients Anti-nutrients Crude fibre Ash Moisture content Crop specific toxicants
–OECD Consensus Documents
Toxicological Assessment: Safe Level of Consumption ● Newly or differently expressed proteins
● Possible new constituents ● Possible alterations in content of natural food and feed constituents
● Animal feeding trials with whole GM food/feed only if there are Indications for adverse effects 21
Authorization under Regulation (EC) 1829/2003 GMO application (via MS) forwarded to EFSA One of the Member States performs initial ERA (cultivation dossier only)
Public consultation
Risk Assessment Opinion EFSA GMO Panel
Consultation of all EU Member States (all applications)
European Commission Draft Decision on Authorization Standing Committee on the Food Chain and Animal Health (SCFCAH)
QMV: Qualified Majority
QMV
No QMV
EC/MS: Authorization (yes/no)
Council of Ministers QMV
If no QMV
European Commission Draft decision
Gentechproducten toegestaan in voedsel & voer in de EU Gewas
Eigenschap
Koolzaadolie
Herbicide resistent
Katoenzaadolie
Herbicide resistent Hybride systeem
Maïs
Herbicide resistent Insect resistent
Aardappel
Veranderd zetmeel profiel
Soja
Herbicide resistent
Suikerbiet
Herbicide resistent
Cultivatie:
IR Maïs en GM Aardappel
Genetische modificatie toepassingen in vee
Illustratie: G. Laible, http://dx.doi.org/10.1016/j.cimid.2007.11.012
Recente ontwikkelingen Snel groeiende zalm
Video: ABC News
Recente ontwikkelingen Snelgroeiende zalm groeihormoon uit Pacific salmon, continue expressie
Bron: AquaBounty
Conclusies Robuste risk assessment strategie for GM foods/feed,
geaccordeerd op internationaal niveau (OECD,FAO/WHO, EFSA)
Na een positieve beoordeling geen veiligheidsrisico’s voor mens dier en/of milieu
GMO’s behoren tot de best onderzochte voedingsgewassen
Geen onnodige dierproeven Milieu effecten GM dieren behoeven verder onderzoek
Dank u voor uw aandacht
Dank aan dr. ir. Gijs Kleter van het RIKILT
