“Genetic Engeneering and Biotechnology,

dead or sustainable development ?” Legal and Economicic Aspects

BiotechnologyFood and Agriculture

Biotechnology and Genetic Engineering

Medicine and Health

IntroductionIntroduction

Genetic Engeneering and Biotechnology, Dead or Sustainable Development ?”

Legal and Economic Apects

INTRODUCTION

Biotechnological research took on the characteristics of a Biotechnological research took on the characteristics of a

genuine technological revolution, Economic and Social genuine technological revolution, Economic and Social

Committee, without previous as regards the speed of Committee, without previous as regards the speed of

development.development.

The economic analysis and the legal regulation of genetic The economic analysis and the legal regulation of genetic

engineering and biotechnology had therefore to chasing a engineering and biotechnology had therefore to chasing a

situation of the use of the various products and the various situation of the use of the various products and the various

techniquestechniques..

BiotechnologyBiotechnologyFood and AgricultureFood and Agriculture

Legal and Economic ApectsLegal and Economic Apects

The EU has a comprehensive food safety strategy. This The EU has a comprehensive food safety strategy. This covers not just safe food, but also animal health and covers not just safe food, but also animal health and animal welfare, and plant health. The strategy ensures animal welfare, and plant health. The strategy ensures that food is traceable as it moves from the farm through that food is traceable as it moves from the farm through to table. The high standards apply to food produced to table. The high standards apply to food produced inside the EU and to food imports.inside the EU and to food imports.

The EU food strategy has three core elements The EU food strategy has three core elements legislation on the safety of food and animal feed; legislation on the safety of food and animal feed; sound scientific advice on which to base sound scientific advice on which to base decisions; decisions; enforcement and controlenforcement and control

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Accommodating diversity and transitionAccommodating diversity and transition

• The EU takes great care to ensure that The EU takes great care to ensure that traditional foods are not forced off the market traditional foods are not forced off the market by its food standards, that innovation is not by its food standards, that innovation is not stifled, and that quality does not suffer.stifled, and that quality does not suffer.

• When new members join the EU and therefore When new members join the EU and therefore enter the EU single market, transitional enter the EU single market, transitional measures may be needed to allow them time measures may be needed to allow them time to catch up with the EU's high food safety to catch up with the EU's high food safety standards. However, foodstuffs which do not standards. However, foodstuffs which do not meet EU standards cannot be sold outside meet EU standards cannot be sold outside those countries in the meantime.those countries in the meantime.

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Basing decisions on sound science

• Science is the essential foundation on which the EU bases decisions on Science is the essential foundation on which the EU bases decisions on food. An independent agency based in Parma in Italy, the European Food food. An independent agency based in Parma in Italy, the European Food Safety Agency (EFSA), Safety Agency (EFSA), Under European legislation, all GMOs and derived Under European legislation, all GMOs and derived products must be evaluated by EFSA before they can be authorised in the 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 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 company must submit an authorisation application in line with European legislation. The European Commission forwards the application to EFSA legislation. The European Commission forwards the application to EFSA and requests a scientific risk assessment and requests a scientific risk assessment

• provides advice when legislation is being drafted provides advice when legislation is being drafted

• In deciding what to do, the Commission applies the precautionary principle. In deciding what to do, the Commission applies the precautionary principle. In other words, it will act without waiting for scientific certainty if the In other words, it will act without waiting for scientific certainty if the scientists say there is at least a potential danger.scientists say there is at least a potential danger.

BiotecnologyFood and Agriculture

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Enforcement and Control

The Commission enforces EU feed and food law by checking that EU The Commission enforces EU feed and food law by checking that EU legislation has been properly incorporated into national law and legislation has been properly incorporated into national law and implemented by all EU countries, and through on-the-spot inspections in the implemented by all EU countries, and through on-the-spot inspections in the EU and outside.EU and outside.

A specialist agency to help – the Commission’s Food & Veterinary Office A specialist agency to help – the Commission’s Food & Veterinary Office (FVO) is based at Grange in Ireland. (FVO) is based at Grange in Ireland. The FVO can check individual food production plants, but its main task is to 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 check that both EU governments and those of other countries have the necessary machinery in place for checking that their own food producers necessary machinery in place for checking that their own food producers are sticking to the EU’s high food safety standards.are sticking to the EU’s high food safety standards.

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The Most Important European Legislation

Directive 2001/18/EC 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

Questions and answers on the regulation of GMOs in the European Union (October 2005)

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Traceability and Labelling

• The European Union guarantees the traceability and labelling The European Union guarantees the traceability and labelling of genetically to inform consumers through the compulsory of genetically to inform consumers through the compulsory labelling of this type of products; modified organisms and labelling of this type of products; modified organisms and products produced from GMOs products produced from GMOs

• to create a "safety net" based on the traceability of these to create a "safety net" based on the traceability of these

products at all stages of production and placing on the products at all stages of production and placing on the market. market.

• to surveillare the potential effects on human health or the to surveillare the potential effects on human health or the environment and the withdrawal of products if an unforeseen environment and the withdrawal of products if an unforeseen risk to human health or the environment is identified.risk to human health or the environment is identified.

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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

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POLANDPoland 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

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BulgariaBulgaria 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 CommercialisationIt is possible to produce and sell GMO tomatoes.

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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.

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