Legal framework for food and feed surveillance for GMO in the European Union

1
Legal framework for food and feed surveillance
for GMO in the European Union

• European legislation including
• EC Directives EC No 90/219 and No 2001/18
• EC Regulation 1829/2003 (GMO food and feed)
• EC Regulation 1830/2003 (GMO traceability)
• EC Regulation 65/2004 (GMO unique identifier)
• Commission Recommendation 2004/787 (GMO Sampling)
• Decision 2006/754 (not approved GMO rice LL601)

2
Genetic engineering
Genetic engineering this technique allows
selected individual genes to be transferred from
one organism into another, also between
non-related species

• Unlike other breeding methods, the application
  of this technology is strictly regulated (e.g.
  Directive 90/219).
• A genetically modified organism used as food or
  feed or a food/feed product derived from a GMO
  can only be put on the market in the EU after it
  had been authorized (Regulation 1829/2003).

3
Horizontal legislation concerning GMO
Council Directive (EC) No 90/219/EEC Directive
for the contained use of genetically modified
micro organisms
Has to be considered if GMO are used for the
production of e.g. food ingredients or food and
feed compounds in contained use (production
plant / fermentation plant).
Applicable only for the organisms and only in the
production plant.
4
First GMO authorisations for food use in the
European Union
Decision No 96/281/EC of 3rd April 1996
Genetically modified soybeans (Glycine max. L.)
with increased tolerance to the herbicide
glyphosate
Decision 97/98/EG of 23rd January 1997
Genetically modified maize (Zea mays L.) with the
combined modification for insecticidal properties
conferred by the Bt-endotoxin-gene and increased
tolerance to the herbicide glufosinate ammonium
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Horizontal legislation concerning GMO Definition
GMO according to Directive 2001/18/EC
First GMO authorisations for food use in the
European Union have been based on
Directive (EC) No 90/220/EEC, replaced by
Directive 2001/18/EG Directive for the
deliberate release of GMOs into the environment
Genetically modifiedorganism (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
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Regulation (EC) No 1829/2003

• Regulation (EC) No 1829/2003 of the European
  Parliament and the Council of 22 September 2003
  on genetically modified food and feed
• Also applicable for food additives, food
  flavourings and additives in feeding stuffs.
• Risk assessment under the responsibility of the
  European Food Safety Authority (EFSA).
• A single community authorisation procedure for
  both food and feed,
• authorization should not be granted for a single
  use, when a product is likely to be used both for
  food and feed.
• Authorisation is valid throughout the community
  for 10 years.

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ScopeRegulation (EC) No 1829/2003

• Genetically modified food
• article 3 Scope
• GMO for food use,
• food containing or consisting of GMO,
• food produced from or containing ingredients
  produced from GMO
• Genetically modified feed
• article 15 Scope
• GMO for feed use,
• Feed containing or consisting of GMO,
• Feed produced from GMO.

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Regulation 1829/2003, recital (16)

• Processing aids which are only used during the
  food or feed production process are not covered
  by the definition of food and feed and therefore,
  are not included in the scope of this Regulation.
  
• Products obtained from animals fed with
  genetically modified feed or treated with
  genetically modified medicinal products will be
  subject neither to the authorisation requirements
  nor to the labelling requirements referred to in
  this Regulation.

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Labelling requirements of food according to
Regulation (EC) No 1829/2003
Food products containing or consisting of
GMOs or produced from GMOs or containing
ingredients produced from GMO delivered as such
to the final consumer or to mass caterers
(restaurants, hospitals, canteens and similar
establishments) must be labelled in accordance
with Regulation 1829/2003, regardless of whether
or not the final product contains DNA or protein
from genetic modification. The labelling
obligation also applies to highly refined
products, such as oil obtained from genetically
modified rape.
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threshold

• Labelling according article 12 (food) resp.
  article 24 (feed)
• Labelling is not needed for foods containing
  material which contains, consists of or is
  produced from GMOs
• in a portion no higher than 0,9 per cent
• provided
• Presence is adventitious or technically
  unavoidable
• GMO is authorized within the EU
• Or limited for a defined time for GMO which have
  been authorized within the EU (e.g. Decision
  2007/304/EC concerning Bt176 products for 5 years)

11
Regulation (EC) No 1829/2003, recital (27)

• In order to establish that the presence of this
  material
• is adventitious or technically unavoidable,
  operators
• must be in the position to demonstrate to the
  competent
• authorities that they have taken appropriate
  steps to
• avoid the presence of the genetically modified
  food or
• feed.

12
GMO

• Calculation about the content of GMO or material
  derived from GMO is based on percentage of the
• food ingredients considered individually or
• food consisting of a single ingredient.

13
Tracebility according to Regulation (EC) No
1830/2003

• Operators shall have in place systems and
  standardised procedures to allow the holding of
  information and the identification for a period
  of five years from each transaction, of the
  operator by whom and the operator to whom the
  products have been made available.

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Regulation (EC) No 65/2004

• Unique identifier (ID) for GMO
• The format comprises nine alphanumeric digits in
  total.
• Collected in Community Register of GM food and
  feed, e.g. Transformation event 0001 has the
  unique ID SYN-BT011-1 and
• Transformation event 0002 has the unique ID
• MON-00603-3
• Only for GMOrganisms and products consisting of
  containing GMOrganisms.

15
Community Register of GM Food and Feed according
to Regulation (EC) 1829/2003

• Community Register of GM Food and Feed
• http//europa.eu.int/comm/food/dyna/gm_register/
• index_en.cfm

16
Existing products, entered in the Community
Register of GM Food and Feed under Article 8 and
20 of the Regulation (EC) 1829/2003

• Transformation event MON 40-3-2
• Notifier Monsanto Services International
  S.A./N.V.
• Date of notification 13-07-2004
• Designation Glyphosate-tolerant soyabean
  40-3-2
• Unique ID MON-Ø4Ø32-6
• Transformation event NK 603
• Notifier Monsanto Services International
  S.A./N.V.
• Date of notification 14-07-2004
• Designation Glyphosate tolerant NK 603 maize
• Unique ID MON-ØØ6Ø3-6
• http//europa.eu.int/comm/food/dyna/gm_register/in
  dex_en.cfm

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Recommendation 2004/787/EC (2004, October 14)

• Technical guidance on sampling and testing
  according to Regulation (EC) No 1830/2003,
  article 9 (2)
• Laboratory Accreditation according EN ISO/IEC
  17025, organisation according EN ISO/IEC 24276
• Analyses according EN ISO/IEC 21571, 21569, 21570
• Sampling recommendation
• For products that have received authorisations
  for their placing on the EU-market.

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Non-approved GMO Food/Feed products on the EU
market

• 2004 genetically modified papaya
• 2005 information about genetically modified corn
  Bt 10
• 2006 genetically modified rice LL 601
• 2006 genetically modified rice Bt 63
• Next ?

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Non-authorized LL 601 rice

• Commission Decision 2006/578/EC of 23 August 2006
  on emergency measures
• Confirmed by Commission Decision 2006/601/EC
  which repealed and replaced 2006/578
• Certain rice products from the United States must
  be accompanied by an original analytical report
  issued by an accredited laboratory attesting that
  the product does not contain genetically modified
  rice LL 601
• Commission Decision 2006/754 amended Decision
  2006/601/EC
• Defining a common protocol for sampling and
• For the analysis for the control of the absence
  of the genetically modified rice LL 601