Risico-Analyse van GMO s en de EU Regelgeving. Harry Kuiper. Voormalig RIKILT medewerker en former Chair EFSA GMO Panel

Transcriptie

1 Risico-Analyse van GMO s en de EU Regelgeving Harry Kuiper Voormalig RIKILT medewerker en former Chair EFSA GMO Panel Reűnie 50 e -jaars WUR 18 0ctober 2013

2 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?

3 Activisme tegen GGO gewassen Video: TousCobayes

4 Public Concern

5 Groei van het areaal met GM gewassen Data bron: C. James, ISAAA, 2012

6 Methode om het genetisch materiaal te veranderen in planten: Agrobacterium tumefaciens T-DNA Bron: Universiteit van Manitoba, Canada

7 Celkweek, Selectie en Ontwikkeling Bron: De la Riva et al. (1999) Elec. J. Biotech. 1(3)

8 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

9 GM Gewassen met veranderde agronomische eigenschappen Herbicide tolerante soja Insecten resistente mais (maisboorder) Geen herbicide behandeling Glyphosaat behandeling Resistente maïs Niet-resistente maïs

10 Golden Rice GM crop with enhanced nutritional properties Additional β- caroteen (provitamin A)

11 SAINSBURY SUCCES AND FAILURE February 1996 Tomato with shortened (PG) gene, slowing down the softening process of ripening March 1999 Sainsbury's phase out GM food Customers 'have expressed concern' over genetically-modified food

12 GMO Regelgeving in de EU EU Lidstaten Illustration source:

13 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

14 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 Parma

15 EFSA Guidance for GM Plants and derived Food and Feed Adopted on 24 September 2004, Updated in December 2005 (PMEM) Complemented in Updated December 2006 (Renewals) March 2007 (Stacked events) May 2008, for Public Consultation, May 2011 final version 15

16 Internationaal Kader Veiligheidsbeoordelingen Codex Alimentarius Richtlijnen (FAO, WHO) download/standards/10021/cxg_ 045e.pdf

17 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

18 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

19 Phase 2 Phase 1 Risk Assessment Strategy for GM Food/Feed Traceing of Differences between the GM food and its Conventional Counterpart (Comparative Analysis) Introduced genes (New) proteins (New) metabolites and toxins Toxicological / Nutritional Assessment Gene transfer Degradation Toxicity Allergenicity Toxicity Whole foods

20 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

21 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

22 Authorization under Regulation (EC) 1829/2003 GMO application (via MS) forwarded to EFSA One of the Member States performs initial ERA (cultivation dossier only) Risk Assessment Opinion EFSA GMO Panel Consultation of all EU Member States (all applications) Public consultation European Commission Draft Decision on Authorization Standing Committee on the Food Chain and Animal Health (SCFCAH) QMV: Qualified Majority QMV No QMV Council of Ministers EC/MS: Authorization (yes/no) QMV If no QMV European Commission Draft decision

23 Gentechproducten toegestaan in voedsel & voer in de EU Gewas Koolzaadolie Katoenzaadolie Maïs Aardappel Soja Suikerbiet Cultivatie: Eigenschap Herbicide resistent Herbicide resistent Hybride systeem Herbicide resistent Insect resistent Veranderd zetmeel profiel Herbicide resistent Herbicide resistent IR Maïs en GM Aardappel

24 Genetische modificatie toepassingen in vee Illustratie: G. Laible,

25 Recente ontwikkelingen Snel groeiende zalm Video: ABC News

26 Recente ontwikkelingen Snelgroeiende zalm groeihormoon uit Pacific salmon, continue expressie Bron: AquaBounty

27 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

28 Dank u voor uw aandacht Dank aan dr. ir. Gijs Kleter van het RIKILT