EU Authorisation
In this section you can read about the EU regulations governing the field trials, commercial growing and food safety of GMOs. This is governed at the European level and by international agreements.
In this section, you can also find information about GeneWatch's work to ensure that decisions about whether to allow markeing or testing of GMOs is governed by the Precautionary Principle. In particular, GeneWatch is following the decision making process of the European Food Safety Authority (EFSA) which plays a key role in the European assessment system. More information about this work can be found under the EFSA topic heading.
Background
In 1990 the European Union passed the first Directive (90/220/EEC) explicitly covering the deliberate release of GMOs. This Directive made it necessary to carry out a environmental risk assessment of the GMO and gain official authorisation prior to any field trial, commercial planting or importation into the EU.
In 1997 the first food safety regulations were passed (Regulation EU 258/97) in the EU and in 1998 the first food labelling regulations came into effect.
Also 1998, the EU Council of Ministers bought about a de-facto moratorium on all applications for import and commercial growing of GM crops and food in Europe. Member States had a number of concerns and wanted;
- the risk assessment process to be stronger and able to take into account the wider effects of altered agricultural practices on the environment;
- their to be a fuller traceability and labelling system;
- a liability regime should something go wrong.
In 2001 the EU agreed new regulations covering the Environmental risk assessment of field trials and commercial growing and in 2003 agreed rules covering the authorisation, traceability and labelling of GM foods and animal feeds. This process has resulted in a more centralised process of authorisation that is mainly handled by the European Food Safety Authority.
By 2004 the EU member states were still failing to authorise the commercial planting or importation of GM crops. There was growing realisation that some kind of co-existence legislation was needed to prevent the contamination of non-GM seed by GM seed. This problem has not yet been resolved.
In May 2003 the USA, Argentina and Canada made a formal complaint to the WTO about the de-facto moratorium on GM crops and food in the EU. By May 2004 the EU Commission giving into pressure from the US, started to override the EU Council of Ministers and authorised the first GMO (Bt11 maize) in Europe since 1998.
Resources
- GeneWatch Comments on Marketing Applications
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GeneWatch comments on carnation line 123.2.38
12th April 2005
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GeneWatch Comments on cotton line 281-24-236/3006-210-23
11th November 2004
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GeneWatch comments on GM potato line EH92-527-1
15th June 2004
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GeneWatch comments on maize hybrid MON810xNK603
20th April 2004
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GeneWatch comments on oilseed rape MS8/RF3
24th March 2004
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GeneWatch Comments on LLRICE62
25th February 2004
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GeneWatch comments on carnation line 123.2.38
- Press Releases
- GeneWatch PR: EU Commission Gives into US Pressure on GM maize 19th May 2004
- GeneWatch PR: Belgian decision will prevent GM oilseed rape being grown in Britain 2nd February 2004
- GeneWatch PR: GM Herbicide-Tolerant Oilseed rape: Belgian Adivce Means European Ban Likely. 29th January 2004
- GeneWatch PR: Biotech Companies Should Withdraw GM Crop Applications 13th January 2004
- GeneWatch PR: Genetically Modified Foods: Put the Consumer First. 3rd December 2003
- GeneWatch PR: GM crops harmful to wildlife: another reason to halt commercialisation. 16th October 2003
- GeneWatch PR: Time for Government to act on public concerns and halt the commercialisation 24th September 2003
- GeneWatch PR: Brussels bureaucrats increase GM conflict by sacrificing organic non-GM standards: 23rd July 2003
- GeneWatch PR: No good reason to pursue GM crop commercialisation in the UK now: GeneWatch UK response to Prime Minister's Strategy Unit Report on GM crops 11th July 2003
- GeneWatch PR: GeneWatch UK welcomes MEPs' vote to give consumers choice about GM food 3rd July 2002
- GeneWatch PR: GeneWatch UK Challenges the Commercialisation of UK's First GM Crop at Hearing in Manchester 29th April 2002
- GeneWatch PR: Royal Society Endorses GeneWatch UK Concerns on Regulation of GM Foods 6th February 2002
- GeneWatch PR: House of Lords Lets Down Consumers and the Environment 21st January 1999
- GeneWatch PR: Industry and Government admit not enough is known about genetically modified crops – But consumers will still be eating them. 21st October 1998
- GeneWatch PR: 77% of the public believe there should be a ban on growing genetically engineered crops and food in Britain. 14th June 1998
- GeneWatch PR: GeneWatch UK Calls For A Halt On Growing Genetically Engineered Oilseed Rape 12th June 1998
- Briefings
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Briefing 33: Can Biological Containment Work for Crops and Society?
1st December 2005
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Response to questionnaire for Member States on the implementation of Regulation (EC) 1829/2003 on genetically modified food and feed
23rd February 2005
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Briefing 30: Genetic Technologies: A Review of Developments in 2004
1st February 2005
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Briefing 29: Growing GM crops: The Need for Contamination and Liability Rules
1st October 2004
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Briefing 26: Genetic Technologies: A Review of Developments in 2003
1st February 2004
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Briefing 22: Genetic Technologies: A Review of Developments in 2002
1st February 2003
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Briefing 21: Genetic Modification: The Need for Special Regulation
1st January 2003
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EU Parliamentary Briefing No 2.
1st June 2002
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EU Parliamentary Briefing No 1.
1st February 2002
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Briefing 17: Genetic Technologies: A Review of Developments in 2001
1st February 2002
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Briefing 9: GM Crops and Food: A Review of Developments in 1999
1st January 2000
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Briefing 4: Genetically Engineered Crops and Food: The Case for a Moratorium
1st November 1998
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Briefing 1: Genetically Modified Foods: Will Labelling Provide Choice?
1st March 1998
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Briefing 33: Can Biological Containment Work for Crops and Society?
- Links
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South African Department of Agriculture.
Follow the links through to plant genetic resources for details of all GM plant releases in South Africa.
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Agbios
A Canadian company, specialising in regulatory issues of GM crops and which aides companies to submit release applications. They have an online database of GM crops commercially grown around the world.
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BINAS
The Biosafety Information Network and Advisory Service of the United Nations Industrial Development Organization. BINAS monitors global developments in regulatory issues in biotechnology.
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Biosafety Clearing House
An information exchange mechanism established by the Cartagena Protocol on Biosafety to assist Parties to implement its provisions and to facilitate sharing of information on, and experience with, living modified organisms (LMOs).
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EU Community Register of GM Food and Feed
Lists all the GM food and crops that can be imported and/or grown in the EU and used for food or animal feed.
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EC Joint Research Centre - Biotechnology and GMOs
This site lists all applications made under both part B (experimental releases) and part C (commercial releases) of the Directive 2001/18/EC.
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The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service's (APHIS) Biotechnology Regulatory Services (BRS)
This program regulates the field testing, movement, and importation of GMOs in the USA that are known to be, or could be plant pests.
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Information Systems for Biotechnology (ISB)
Provides a very useful searchable database of US commercialised and experimental crops.
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Austrialian Office of the Gene Technology Regulator
Provides online information on the regulation and commercial status of GM crops and food in Australia.
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Canadian Plant Biosafety Office
Provides online information on the regulation and commercial status of GM crops and food in Canada.
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South African Department of Agriculture.
