Overview on the GMO legislation in Europe EU legislation national legislation

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Overview on the GMO legislation in EuropeEU
legislation national
legislation
Deliberate release Directive 2001/18 approval,
risk assessment, monitoring, withdrawal and
emergency plans, filed tests (Part B) and
commercialisation (Part C), general labelling
provisions
national GM lawsImplementation of 2001/18
plusgood agricultural practiceliabilityco-exist
ence measures
Standing Committee on the food chain / GMO
Food and Feed regulation 1829/2003 Approval and
labelling of GM products Traceability and
Labelling regulation 1830/2003
directly applicable legislation
Seed Directives Approval, control, production of
seeds and repro-ductive material for beet,
 fodder plant, cereals, potato,  oil and fibre
plants,  vegetables
National Seed legislation Approval, control,
production of seeds Registration in national
seed catalogue
Standing Committee on Seeds
GMO-Seed-DirectiveLabelling of GMOs in
conventional seeds
Common Seed catalogue 2002/53/ECAutomatic
inclusion of nationally approved varieties but
exemptions possible for individual member states
automatic inscription, national exemptions
CommonCatalogue
NationalSeed Catalogues
Organic farming regulationCultivation,
Certification, list of ingredientsexcludes the
use GMOs (specific thresholds possible but not
established)
directly applicable legislation
Standing Committee on Organic
Guidelines on Co-existenceRecommendations by the
Commission for the development of national
strategies and best practices
Guidelines not legally binding National and
regional legislation and provisions on
co-existence
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EU and national GMO approval process scheme
GMO approval
Company submits application and data, national
authorities check them and may require additional
information
GMO application to member state
Only required for cultivation, if food and feed
only EFSA recommendation only to which national
authorities can comment
Assessment by national authority
EFSA assessment recommendation
Scientific Committee on GMOs
Commission recommends approval or rejection based
on recommendations
Commission proposal
If qualified majority approves Commission
proposal GMO is approved or rejected. If no
qualified majority decision is taken to Council
of Ministers
Vote in Standing Committee
If qualified majority rejects Commission
proposal, approval is dead. If no qualified
majority decision, then Commission can decide,
even against simple majority of member states.
Vote in Council of Ministers
Commission approval
Once approved, company is notified by initial
member stateOnce a GMO is approved companies can
apply for registration of seed varieties
containing this GM event
Inscription of GM varieties in national seed
catalogue
Seed law
National assessment and approval
Commission automatically inscribes nationally
approved varieties in Common catalogue
Inscription in Common Seed Catalogue of the EU
Individual member states can ban specific
varieties in their country but need approval of
Standing Committee on Seeds
Exemption of specific variety for individual
country
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Votes in the EU Standing Committees and Council
by Country
voting record on GMO approvals SC 29 Nov
04 Proposed Waiving of national bansof
EU-approved GMOs SC 29 Nov 04 Import of GM maize
Mon 863 Council 19 July 04 Import of GM maizeNK
603 Thereafter approved by Commission SC 16 June
04 Import of GM rape seed GT73
Total votes321 Qualified majority 232 ( 13
member states)
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First 17 GM seed varieties will now be inscribed
in the Common European Seed Catalogue

• Mon 810 by Monsanto approved as GMO for
  cultivation in the EU in 1998, Bt-toxin Cry1Ab
  against corn borer (also Bulgaria, 2000)
• 11 varieties inscribed in Spanish, 6 in French
  Seed catalogue
• European Commission decided (8. Sept) to inscribe
  these varieties now in Common Seed Catalogue.
• But not varieties of Syngentas also approved Bt
  176
• Sale and use of these varieties will then be
  unrestricted in all member states, despite the
  fact that most countries have no provisions how
  to handle such cultivation.
• Except, when a national decision is taken, not to
  allow these seeds on the countries territory for
  environmental or agronomic reasons and the EU
  Commission is notified. The Standing Committee
  on Seeds is then to vote on the exemption.

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New GM labelling regulations in food and
feedsince April 2004
gt 95 of all GMOsimported to Europe

• None of these GM products are allowed in organic
  production.
• Labelling thresholds are the same for
  conventional and organic products.

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Co-existence of GM and non-GM food production

• How can GMO and non-GMO farming co-exist in real
  life?
• Which measures are necessary for which type of
  crops?
• Who is responsible?
• GM-seed industry
• GMO users (farmers)
• Non-GMO farmers / organic producers
• bee keepers, farm services, and other
  stakeholders
• Who is liable for which type of damages?
• Health and Environmental damage product
  liability
• Commercial damage from contamination national
  co-existence legislation
• Who covers general costs of prevention, control?
• How are market impacts accounted for and
  compensated?
• Can entire regions be kept GMO free?
• Who should decide about this ?

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Legal basis of co-existence

• EU Directive 2001/18, Article 26a
• Measures to avoid the unintended presence of
  GMOs
• Member States may take appropriate measures to
  avoid the unintended presence of GMOs in other
  products.
• The Commission shall gather and coordinate
  information based on studies at Community and
  national level, observe the developments
  regarding coexistence in the Member States and,
  on the basis of the information and observations,
  develop guidelines on the coexistence of
  genetically modified,conventional and organic
  crops.

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Conflicting co-existence policies

• The EU Commissionso far (old Commission) wants
  to leave to the member states
• to establish code of good agricultural practice,
  
• protection of non-GM and organic farmers and
  food producers
• protection of ecologically sensitive areas,
• liability and redress
• but denies the right to generally ban GM
  cultivation regionally and contests any
  inappropriate restrictions.
• Many member states EU Parliament demand
• EU wide regulations on co-existence
• EU wide civil and environmental liability
  regulations
• Option to establish GMO-free areas where
  co-existence is not reasonably feasible
• Denmark, Austria, Germany, Netherlands
• established co-existence and liability rules in
  their national legislation, which already differ
  significantly. Most other member states are
  preparing such legislation now.

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Costs of co-existence
Estimated additional production costs due to
co-existence 53 - 345 per ha
Source EU Joint Research Centre Scenarios for
co-existence, May 2002