Geneticaly modified Food and Feed – current situation in EU

Geneticaly modified Food and Feed – current situation in EU Petr Beneš Food Safety Department Prague, 9 October 2009

Content • Role of the Food Safety Department • Legislation • Authorisation process • Actual information

Definition of GM Food and Feed • Foodcontaining, consistingor produced from GMO´s • Feedcontaining, consistingor produced from GMO´s

Food Safety Department • Administrationofapplications • Participation in SCoFCAHmeetings • Scientific Committee on GM foodandfeed

Legal framework • by April 2004 Directive 2001/18/EC • Regulation (EC) No 1829/2003 of the EP and of the Council • Regulation (EC) No 1830/2003 of the EPand of the Council

Regulation (EC) No 1829/2003 of the EP and of the Council • valid sinceApril 18, 2004 • covers use of GMO´s for food and feed • sets up centralized authorisation procedure • sets up labeling requirements and limits for adventitious or technically unavoidable presence of genetically modified materials in a food or feed

Authorisation procedure Who participates in Authorisation of Applications? - European Food Safety Authority (EFSA) - EU member states (MS) - European Commission (EC)

European Food Safety Authority (EFSA) „GM food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food Safety Authority, of any risks which they present for human and animal health and, as the case may be, for the environment.“ Point (9), Regulation (EC) No 1829/2003

Standing Committee on Food Chain and Animal Welfare • All MS express their positions during voting • Qualified majority must be achieved in favour / against the draft Commission Decision • If no qualified majority is achieved, the draft is submitted to the Council for decision • If no decision is adopted by the Council, the Commission is authorised to make the decision

Application according No 1829/2003 • EU member countries • consultation National Competent Authority • method validation Comunity Reference Laboratory (CRL) 3 months • European Food Safety Authority (EFSA) • risk assessment • final opinion 6 months for validation • Public • comments 30 days 6 months • Standing Committee on Food Chain and Animal Health • member countries • qualified majority (QM) 3 months • European Commision • draft decision • different decision against EFSA´s must be explained European Net of GMO laboratories (ENGL) QM without QM decision without QM Approval / disapproval of Application • Council of Ministers • 90 days for decision (SCoFCAH without QM) decision Register of GM food and feed 3 months Official Journal

Support of GM food and feed – current situation in EU Positions of some MS reflect political situation… X The main criterium for EC decision making is the result of the scientific risk assessment

Support of GM food and feed – current situation in EU Bulgaria Czech Republic EstoniaFinlandNetherlands Slovakia UK Spain Sweden CyprusLuxemburg HungaryPolandAustriaGreece Malta Slovenia

Regulation (EC) No 1829/2003 of the EP and of the Council • valid since 18. April 2004 • covers GMO usage in food and feed • sets up centralized authorisation procedure • sets up labeling requirements and limits for adventitious or technically unavoidable presence of genetically modified materials in a food or feed

Labeling of products with GMO´s a) the content of GM parts is less than 0,9 % - only in case the presence is adventitious or technically unavoidable X b) wilful added GM parts

Labeling of foods of animal origin obtained in animals fed by GM feed? NO! • NO labeling requirements for milk, meat, eggs... etc. • NO traceability requirements applicable

Regulation (EC) No 1830/2003 of the EP and of the Council • harmonizedframeworkforthetraceability • transmissionofwritteninformationbetweenoperators • holding ofinformation(5 yearsfromeachtransaction) • labelingrequirements + Commission Regulation (EC) No 65/2004 • inspectionandcontrolmeasures

Any source of GMO unique identifiers? • development of the unique identifiers according to Commission Regulation (EC) No 65/2004 • BioTrack database (OECD) http://www2.oecd.org/biotech/byIdentifier.aspx

Up to date number of applications • 72 applications presented at 30. 9. 2009 • 60 % applications on maize • applications presented by (only) seven countries: NL, UK, DE, FR, CZ, BE, DK

Community register of GM products Publiclyavailable on EuropeanCommission web pages: http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

Community register of GM products http://ec.europa.eu/food/dyna/gm_register/index_en.cfm Presently 27 products: • 12x GM maize • 6x GM cotton • 3x GM rape • 2x GM yeast, bacteria • 3x GM soya • 1x GM sugar beat

Products withdrawn from the market • GM rape hybrids - Ms1xRf1, Ms1xRf2, Topas 19/2, • GM maize hybrids - Bt176, GA21xMON810 http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

Asynchronous release of GM food and feed • different duration and demandingness of authorisation process in EU and third countries • „zero tolerance“ of presence of non-authorised GMO´s in feed = source of problems

GM maize cultivation – current situation in EU GM maize is cultivated in: Spain, Czech republic, Portugal, Slovakia, Romania National bans on cultivaton: Germany, Austria, France, Greece, Hungary, Lucemburg

Information on GMO • Ministry of Agriculture web pages (in CZ only) • www.mze.cz - section „Zemědělská výroba“ – category „GMO-geneticky modifikované organismy v zemědělství“ • www.mze.cz - section „Potravinářská výroba“ – category „Bezpečnost potravin“ – „Geneticky modifikované potraviny a krmiva“ • Ministry of Environment web pages: • www.mzp.cz/en - section „Environmental Risks“ – category „GMO“

Thank you for your attention!petr.benes@mze.cz

Geneticaly modified Food and Feed – current situation in EU