Legislation connected with GMO Legislation connected with GMO The EU has got itself into a fine mess, and it is the EU who must clean it! Act No. 78/2004 Coll Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EC Council Directive 90/219/EEC of 23 April 1990 Council Directive 98/81/EC of 26 October 1998 Genetically modified organism Genetically modified organism (GMO) means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 Genetic product Genetic product means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market; Manipulation with GMO 1) Contained use of genetically modified organisms; where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment 2) Deliberate release means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment 3) Placing on the market means making available to third parties, whether in return for payment or free of charge Manipulation with GMO 1) The precautionary principle = ensure that all appropriate measures are taken to avoid adverse effects on human and animal health, the environment and biological diversity 2) Conditions stipulated on the delivery list must be observed by user 3) Any person, before undertaking a deliberate release into the environment of a GMO, or the placing on the market of GMOs, as or in products, where the intended use of the product involves its deliberate release into the environment, is to submit a notification to the national competent authority. Risk categories ➢ No risk or insignificant for health or environment (most laboratories) 1st category ➢ Low risk which is easily removed (laboratories producing recombinant proteins) 2nd category ➢ Risk which is removable only by sophisticated corrections 3rd category ➢ High risk 4th category GMO in the world GM APPROVAL DATABASE https://www.isaaa.org/gmapprovaldatabase/default.asp GM crops in the world in 2014 Main growers http://www.isaaa.org/resources/publications/briefs/49/pptslides/pd f/B49-Slides-English.pdf/ The first 30 years of transgenic plants http://www.isaaa.org/resources/publications/pocketk/16/ Growing area of GM crops http://www.isaaa.org/resources/publications/pocketk/16/ Growing area of GM crops http://www.isaaa.org/resources/publications/pocketk/16/ Proportion of main crops http://www.isaaa.org/resources/publications/pocketk/16/ Total area of transgenic crops Year Area (mil. hectare) Year-on-year increase 2008 125 9,4 % 2009 134 7,2 % 2010 148 10,4% 2011 160 8,1% 2012 170 6,3% 2013 175 2,9% 2014 182 4,0% http://www.isaaa.org/resources/publications/pocketk/16/ GM crops areas in 2014 Country Area (mil. ha) Crops USA 73,1 soybean, corn, cotton, canola, pumpkin, papaya, alfalfa Brazílie 42,2 soybean, cotton Argentina 24,3 soybean, corn, cotton Kanada 11,6 rapeseed, maize, soya Indie 11,6 cotton Čína 3,9 cotton plant, tomato, poplar, petunia, papaya, paprika EU (5) 0,1 corn 28 countries total, area 181,5 milions of hectare GM crops areas in 2007-2009 (mil. ha) Country 2007 2008 2009 USA 57.7 62.5 64.0 Brazil 15.0 15.8 21.4 Argentina 19.1 21.0 21.3 India 6.2 7.6 8.4 Canada 7.0 7.6 8.2 China 3.8 3.8 3.7 Paraguay ? 2.7 2.2 EU (8) 0.1 ? ? Harvested areas of the main GM and conventional crops (mil. ha) Crop GM 1996 GM 2004 CON2004 GM/CON Soya 0.5 48.4 91.6 53% Corn 0.3 19.3 145.1 13% Cotton 0.8 9.0 34.9 26% Canola 0.1 4.3 26.2 16% TOTAL 1.7 81.0 297.8 27% Source: FAO 2004 Harvester areas of GM crops (mil. ha) Crop Area in 2004 % Round-up Ready soya 48.4 60 Bt corn 11.2 14 Bt cotton 4.5 6 Herbicide tolerant corn 4.3 5 Herbicide tolerant canola 4.3 5 Bt/Herbicide tolerant corn 3.8 4 Bt/Herbicide tolerant cotton 3.0 4 Herbicide tolerant cotton 1.5 2 TOTAL 81.0 100 Source: James 2004 22 Chinese like GM rice Huang et al. (2005): Science 308, 688-690 Parameter GM rice Conventional rice Number of treatments by pesticides 0.5x 3.7x Expenses for pesticides (Juan/ha) 31 243 Amount of pesticides (kg/ha) 2.0 21.2 Labour for spraying (days/ha) 0.73 9.1 Yield (kg/ha) 6 364 6 151 Number of farmers 123 224 23 Disorders of farmers Huang et al. (2005): Science 308, 688-690 Year Producers of only GM rice Producers of both types of rice Producers of only conventio nal rice on fields with GM on conventio nal fields 2002 0 0 7.7 8.3 2003 0 0 10.9 3.0 Percentage of farmers, who become ill as a consequence of using pesticides (without permanent consequences) What happens in China? 1) Corn with phytase ➢ Enzyme digests phytates ➢ The enzyme is not present in pigs, non-digested phytates from slurry phosphates are produced by micro-organisms; the phosphates contaminate water sources ➢ GM corn is much better feed for pigs 2) Approval of Bt rice Breakthrough event in Asia GMO in EU ? The European GMO database https://euginius.eu/euginius/pages/home.jsf EUginius (EUropean GMO INItiative for a Unified Database System) is an initiative of BVL - the Federal Office of Consumer Protection and Food Safety (Berlin, DE) and WFSR - Wageningen Food Safety Research (formerly RIKILT) of Wageningen UR (Wageningen, NL). EUginius´ intention is to support competent authorities and private users who seek accurate information on genetically modified organisms. GMO and food safety in EU https://food.ec.europa.eu/plants_en EU Register of authorised GMOs https://webgate.ec.europa.eu/dyna2/gm-register/ Innovative biotechnology for people and planet https://europabio.org The European Association for Bioindustries, is Europe's largest and most influential biotech industry group. Initiated in 1996 to represent the interests of the biotechnology industry at European level, and constantly engaged in a dialogue with the European Parliament, the European Commission and the Council of Ministers EuropaBio aims to influence legislation on biotechnology, representing Healthcare and Industrial biotechnology sectors. Biosafety Clearing-House https://bch.cbd.int/en/ The BCH Knowledge Base is an online tool designed to help users become familiar with the Clearing-House, learn how to submit records, search for information and complete other important tasks. EUSAGE https://www.eu-sage.eu/ EU-SAGE is a network representing plant scientists at 134 European plant science institutes and societies that have joined forces to provide information about genome editing and promote the development of European and EU member state policies that enable the use of genome editing for sustainable agriculture and food production. More other .... https://euroseeds.eu/ https://fefac.eu/ "Directive of the EP and of the Council amending Directive 2001/18/EC as regards the possibility for Member States to prohibit or restrict the cultivation of GMOs in their territory" Adopted by the European Parliament on January 13th, 2015 ➢ Member States may prohibit or restrict the cultivation of GMOs in part or all of their countries ➢ Not restrict the free circulation of EU-authorised GM seed, planting and propagating material, or affect the authorisation and risk assessment process carried out by EFSA on GM food and feed, status in 2015 Czech Republic Estonia Finland Netherlands Spain Portugal Romania Sweden Belgium Ireland United Kingdom Cyprus Luxembourg Hungary Poland Austria Greece Slovenia Latvia Malta Lithuania Bulgaria France Slovakia Croatia Germany Italy Denmark As of 31st January 2024 5 plant species 94 varieties Cottonwood 5 varieties Maize 47 varieties Rapeseed 8 varieties Soya 26 varieties Sugar beet 1 variety http://ec.europa.eu/food/dyna/ gm_register/index_en.cfm As of 31st January 2024 1 plant species Area of MON810 in Czech Republic 2005-2016 GM corn MON810 Food of plant origin NO Feed of plant origin YES Food of animal origin in EU NO Food of animal origin outside of EU YES As of 31st January 2024 32 plant species 577 varieties https://www.isaaa.org/gmapprovaldatabase/ ➢ Conventional feed accounts for only 15% in the EU ➢ The EU is mainly dependent on protein-rich feeds imports up to 75% One of the most important commodities in the feed industry is soybeans ➢ 82% of soya produced worldwide is GM soya ➢ The EU produces less than 2% of its soy annually!!! ➢ 13 million tonnes of soya ➢ 18 million tonnes of soybean meal Imports of soya beans and soya bean meal Source: www.fefac.org Requests regarding handling GM corn Variety Feature Import and processing Growing NK 603 Glyphosate YES YES 59122 Western corn rootworm + Gluphosinate YES YES GA21 Glyphosate YES YES T25 Gluphosinate YES YES 1507 European highflyer + Gluphosinate YES NO MIR604 Western corn rootworm + Gluphosinate YES NO Requests for treatment with hybrids Varieties Feature Import and processing Growing NK 603 x MON 810 European high-flyer + Glyphosate YES YES 1507 x 59122 European high-flyer + Gluphosinate YES YES NK 603 x 1507 Western corn rootworm + glufosinát YES YES MON89034 x MON88017 Western corn rootworm + Glyphosate YES YES 59122 x 1507 x NK 603 Western corn rootworm + Gluphosinate + Glyphosate YES YES Bt11 x MIR162 x GA21 Western corn rootworm + Gluphosinate + Glyphosate YES YES Other GM crops in EU – 03/2010 Crop Feature Mode Using Soya Glyphosate growing Sugar beet Glyphosate growing Potatoe Starch composition growing industry Rape Glyphosate transport feed, industry Rice Gluphosinate transport feed, industry Cotton Lepitoptera + gluphosinate transport - Gillyflower Colour of flower + resistance to herbicide transport flowers GM crops in CZ in 2009 maize potatoes flax plum trees tobacco Ivanovice na Hané maize Popůvky maize Pohořelice maize Humpolec potatoes Vikýřovice flax Areas for individual crops (CZ) Crop Company Area potatoes BASF, UEB 11.33 ha maize Monsanto, Pioneer, Syngenta 11.91 ha plum trees VÚRV 0.09 ha flax Agritec 0.03 ha tobacco UK Praha 0.002 ha Labelling of GM food and feed Products consisting of or containing GMOs, food produced from GMOs or feed produced from GMOs must be labelled (1829/2003): „This product contains genetically modified organisms” This does not apply to foods containing GMOs, the proportion of which in individual ingredients or in a single-ingredient food does not exceed 0.9%, provided that the presence of this material is adventitious or technically unavoidable. Labelling of GM food and feed Are medicines containing products of GM organisms correctly labelled in the Czech Republic and the EU? Marking in other countries ➢ Producers in the EU, Japan, Malaysia and Australia are obliged to label products containing GMOs Approach according to the characteristics of the final product not according to the technique by which it is obtained! ➢ They do not need to be labelled in the USA and Canada because they do not pose a threat to human or animal health or cause environmental damage. They are considered to be normal foodstuffs. Livestock fed GM feed Meat, milk, eggs and other products from animals fed GM feed do not need to be labelled because the products are indistinguishable from conventional food After all, when an animal (or human) ingests GM feed (food), it breaks down the DNA into basic bases and uses these for its own use GM crops available in CZ The same situation as in the EU ➢ Import of GM soya for oil production ➢ Import and growing of GM maize (different varieties) for food and feed What about in the world? ➢ GM rapeseed for the production of margarine and edible oils ➢ GM corn - corn flour, starch, popcorn, vegetable oils, sweeteners ➢ GM soy - bakery and meat products, tofu, tempeh, soybean oil, chocolate emulsifier ➢ In the USA, GM alfalfa, sugar beet, canola, papaya, pumpkin ➢ GM tomatoes and GM peppers in China ➢ In 2014, Cuba was the only country in the world where products from GM animals - Nile tilapia - are distributed Brazil Releases Genetically Modified Mosquitoes to Combat Dengue Cases ➢ The British biotechnology company Oxitec developed genetically modified male mosquitoes, which carry a gene that kills female offspring before reaching their maturity ➢ Only female Aedes aegypti mosquitoes carry dengue fever and spread the virus to people ➢ Hence, releasing modified mosquitoes could help reduce the population of mosquitoes in the country 52https://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID=20714 ➢ Brazil placed the eggs of modified male mosquitoes in boxes with water to prompt hatching ➢ They complete the cycle inside these boxes in about ten days, and the adult insects come out to do their work.” ➢ This method could reduce the population by up to 90%. Rules of coexistence Farmed fields constitute an area totalling about 4 264 000 ha in the Czech Republic 92% 8% 0% Standard Ecological GMO 0,2% Distances between crops 200 m GM maize Standard maize “Eco“ maize 70 m Depends on “heritability” of individual crops Sowing decreases the requested distance 55 Declaration of Farmers Biotech Network – 4 December 2009 Declaration appealing to European leaders to invest in green biotechnology agriculture. The declaration states: "We demand the freedom of choice between traditional, organic and green biotechnology agriculture. We call upon the EU Commission and the European Parliament to allow us to become more competitive and more sustainable. National governments must also provide significant political and public support to strengthen our ability to meet current and future expectations of farm productivity." http://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID =5119 56 The Pope and GMO ? In May 2009 on its meeting, the Academy surprisingly blessed GMO as a possible solution to the problems with starvation, safety and permanent sustainability of life in developing countries The Pontifical Academy of Sciences 57 Independent risk assessment of GMOs European Food Safety Authority (EFSA) EFSA GMO Panel Independent advisory body to the European Commission on technical matters related to GMOs ➢ Risk assessment of GMOs ➢ Development of guidelines for the processing of applications for GMO authorisation ➢ Assessing applications for the authorisation of GM food and feed on the market ➢ Provide objective, science-based advice ➢ Provide clear information based on the most up-to-date scientific knowledge and data 58 advisory body to the Ministry of the Environment Number of members: 17 Selected professional professions + group of external collaborators ➢ Preparation of expert opinions on Notices of Disposal (dozens per year) and Applications for Environmental Release (units per year) as well as other technical matters ➢ Cooperation in the development of legislation, methodological guidelines and recommendations of the Ministry of the Environment ➢ Preparation of opinions on applications for placing GMOs on the EU market and other EU documents ➢ Advisory and consultative activities in communication with notifiers and applicants ➢ Active participation in cooperation with other Czech authorities - ČIŽP, MZd, MZe, SÚJB, SÚKL and international organisations - ENGL, EFSA, OECD, contacts with similar commissions in other countries ➢ Direct cooperation with the GMO Department of the Ministry of Environment: ad hoc consultations, expert opinions on issues, participation in monitoring, etc. ➢ Ensures the highest level of expertise - organizes expert lectures, members and collaborators inform about participation in seminars and conferences, monitor the latest scientific knowledge in the field of genetic modifications - www pages ➢ Informs the public: organising public meetings, publishing minutes of meetings and opinions on current materials on the public website of the Ministry of Environment - GMO Find a similar commission on your country's website https://www.mzp.cz/cz/ceska_komise_pro_nakladani_gmo