1. “Genetic Engeneering and Biotechnology, dead or sustainable development ?” Legal and Economicic Aspects Biotechnology Food and Agriculture Biotechnology and Genetic Engineering Medicine and Health Introduction

2. Genetic Engeneering and Biotechnology, Dead or Sustainable Development ?” Legal and Economic Apects INTRODUCTION Biotechnological research took on the characteristics of a genuine technological revolution, Economic and Social Committee, without previous as regards the speed of development. The economic analysis and the legal regulation of genetic engineering and biotechnology had therefore to chasing a situation of the use of the various products and the various techniques.

3. Biotechnology Food and Agriculture Legal and Economic Apects The EU has a comprehensive food safety strategy. This covers not just safe food, but also animal health and animal welfare, and plant health. The strategy ensures that food is traceable as it moves from the farm through to table. The high standards apply to food produced inside the EU and to food imports. The EU food strategy has three core elements legislation on the safety of food and animal feed; sound scientific advice on which to base decisions; enforcement and control

4. Biotechnology Food and Agriculture Legal and Economic Apects Accommodating diversity and transition The EU takes great care to ensure that traditional foods are not forced off the market by its food standards, that innovation is not stifled, and that quality does not suffer.The EU takes great care to ensure that traditional foods are not forced off the market by its food standards, that innovation is not stifled, and that quality does not suffer. When new members join the EU and therefore enter the EU single market, transitional measures may be needed to allow them time to catch up with the EU's high food safety standards. However, foodstuffs which do not meet EU standards cannot be sold outside those countries in the meantime.When new members join the EU and therefore enter the EU single market, transitional measures may be needed to allow them time to catch up with the EU's high food safety standards. However, foodstuffs which do not meet EU standards cannot be sold outside those countries in the meantime.

5. Biotechnology Food and Agriculture Legal and Economic Aspects Basing decisions on sound science Science is the essential foundation on which the EU bases decisions on food. An independent agency based in Parma in Italy, the European Food Safety Agency (EFSA), Under European legislation, all GMOs and derived products must be evaluated by EFSA before they can be authorised in the EU. For any GMO and derived food or feed to be authorised in the EU, a company must submit an authorisation application in line with European legislation. The European Commission forwards the application to EFSA and requests a scientific risk assessmentScience is the essential foundation on which the EU bases decisions on food. An independent agency based in Parma in Italy, the European Food Safety Agency (EFSA), Under European legislation, all GMOs and derived products must be evaluated by EFSA before they can be authorised in the EU. For any GMO and derived food or feed to be authorised in the EU, a company must submit an authorisation application in line with European legislation. The European Commission forwards the application to EFSA and requests a scientific risk assessment provides advice when legislation is being draftedprovides advice when legislation is being drafted In deciding what to do, the Commission applies the precautionary principle. In other words, it will act without waiting for scientific certainty if the scientists say there is at least a potential danger.In deciding what to do, the Commission applies the precautionary principle. In other words, it will act without waiting for scientific certainty if the scientists say there is at least a potential danger.

6. Biotecnology Food and Agriculture Legal and Economic Apects Enforcement and Control The Commission enforces EU feed and food law by checking that EU legislation has been properly incorporated into national law and implemented by all EU countries, and through on-the-spot inspections in the EU and outside. A specialist agency to help – the Commission’s Food & Veterinary Office (FVO) is based at Grange in Ireland. The FVO can check individual food production plants, but its main task is to check that both EU governments and those of other countries have the necessary machinery in place for checking that their own food producers are sticking to the EU’s high food safety standards.

7. Biotechnology Food and Agriculture Legal and Economic Apects The Most Important European Legislation  Directive 2001/18/EC Directive 2001/18/EC  Regulation No 1829/2003 on genetically modified food and feed Regulation No 1829/2003 on genetically modified food and feed  Regulation No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms Regulation No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms  Questions and answers on the regulation of GMOs in the European Union (October 2005) Questions and answers on the regulation of GMOs in the European Union (October 2005

8. Biotechnology Food and Agriculture Legal and Economic Apects Traceability and Labelling The European Union guarantees the traceability and labelling of genetically to inform consumers through the compulsory labelling of this type of products; modified organisms and products produced from GMOsThe European Union guarantees the traceability and labelling of genetically to inform consumers through the compulsory labelling of this type of products; modified organisms and products produced from GMOs to create a "safety net" based on the traceability of these products at all stages of production and placing on the market.to create a "safety net" based on the traceability of these products at all stages of production and placing on the market. to surveillare the potential effects on human health or the environment and the withdrawal of products if an unforeseen risk to human health or the environment is identified.to surveillare the potential effects on human health or the environment and the withdrawal of products if an unforeseen risk to human health or the environment is identified.

9. Biotechnology Food and Agriculture Legal and Economic Apects OGM Compass a web site for information on genetically modified organisms Filmato Normativa paesi www.gmo-compass.org/eng/regulation/regulatory_process/ www.gmo-compass.org/eng/news/country_reports/ http://www.gmo-compass.org/flash/popup.php?lang=eng

10. Biotechnology Food and Agriculture Legal and Economic Apects POLAND Poland inside the U.E. is one of those countries that in theory isn’t agreed with introduction of GMOs in agriculture and supports a policy of development of organic products According to Polish law, anyone wishing to sell products containing GMOs must seek government and report the presence of genetically modified label But in the country there is no laboratory responsible for testing the foods placed on the market in order to verify the presence of GMOs. Moreover, no police authority or health care is explicitly responsable for enforcing the law The European Commission has approved a ban on the cultivation of Poland throughout the country of 16 different varieties of GM maize and about 700 non-transgenic corn. It 'the first time ever, since they were first authorized the transgenic plants in the EU (January 1997), which the Commission gives its green light to a national ban on the cultivation of GMOs already approved at EU level. Currently, the law does not allow GMO tomatoes. In Poland, at the 16, nine are already those who have rejected GMOs. In Poland the situation is very contradictory not always the legislation on GMOs is applied, there no transparency for consumers and not always supporters of 'organic farming can find the right media at the institutional level

11. Biotechnology Food and Agriculture Legal and Economic Apects Bulgaria Bulgaria thus had a Biosecurity Act from 1996. The new Act was published in the State Gazette on 29 March 2005. The Bulgarian Act has established stricter authorisation procedures, with differentiation among contained use, experimental field trials, putting products entirely or partially containing GMPs on the market, and GMP transportation and cross-border movements. The first three categories are under the authority of the Ministry of the Environment and Water (MEW), whereas the latter is under the authority of the Ministry of Agriculture and Forests (MAF). The broad outline of the current Bulgarian Act dealing with the scientific evaluation of authorisation request applications, cultivation conditions as well as labelling and traceability rules are based on Directive 2001/18 An Advisory Commission on GMP is in charge of giving opinions on all the procedures for granting, modifying or withdrawing authorisations administered by the Ministries of the Environment (MEW) and of Agriculture (MAF). The petitioner must provide an assessment of the risks on the environment and on human health. After reception of the Commission’s opinion, public consultation and consultation of the MAF, the MEW accepts or rejects the authorisation request, within a period of 90 days after reception. As regard Commercialisation of products entirely or partially containing GMPs needs an authorisation by MAF. Each finished product must show a label indicating the presence of GMPs Mais OGM has not yet been approved for production and Commercialisation It is possible to produce and sell GMO tomatoes.

12. Biotechnology Food and Agriculture Legal and Economic Apects Olanda The Dutch Ministry of Agriculture, Nature and Food Quality places much importance on biotechnology. The first is that the agriculture and food industries are vital to the Dutch economy. The second is that the government believes that biotechnology can make a huge contribution to solving a number of intractable societal and social problems, such as environmental problems and food shortages in developing countries. The advent of genetically modified crops (gm crops) is a hot topic in the Netherlands and the rest of Europe. The question is whether conventional and organic agriculture can co-exist with the cultivation of genetically modified organisms (GMOs). Dutch legislation guarantees the traceability and labelling of OGM to inform consumers Currently no gm crops are grown commercially in the Netherlands and there are only a limited number of small-scale field trials.

13. Biotechnology Food and Agriculture Legal and Economic Apects Turchia Inserire collegamento con documento PDF TURCHIA