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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102513
Status
Published
Date of creation
2011-10-14 08:50 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)
Date of publication
2011-10-14 08:50 UTC (Guy.VAN-DEN-EEDE@ec.europa.eu)

Origin of report
Country
  • European Union
Contact officer for report
Coordinates
Mr Hugo Maria Schally
Head of Unit
European Commission DG Environment
European Commission Office BU29 04/062
Brussels
Belgium, 1049
Phone:+3222958569
Fax:+3222969558
Email:hugo-maria.schally@ec.europa.eu
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
European Commission
Submission
10. Date of submission
2011-09-27
11. Time period covered by this report
Start date
2007-10-01
Time period covered by this report
End date
2011-09-01
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
EU legislation on genetically modified organisms (GMOs) has been in place since the early 1990s. The EU introduced specific legislation on GMOs to protect its citizens' health and the environment while simultaneously creating a unified market for biotechnology products. Over the last decade, the EU has created a comprehensive legal framework for ensuring safety in the development, use and transfer of GMOs. The main legal measures include:
- Commission Regulation 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired.
- Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms.
- Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, covering the field testing of GMOs (mainly Part B) and the placing on the market of GMOs as well as products containing or consisting of GMOs, e.g. for cultivation, import or processing into industrial products (mainly Part C). The Annex to this report lists further implementing measures relating to Part B and Part C of Directive 2001/18/EC.
- Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms covers exports of GMOs to third countries and unintentional movements of GMOs.
- Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, covering the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs.
- Regulation (EC) No 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.
- Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation.
In the case of Directive 2001/18/EC and of Regulations (EC) No 1829/2003, 1830/2003 and 1946/2003, Member States have introduced domestic provisions to ensure enforcement and/or transposition of this legislation within their respective territories.More information on the content of these legislative acts is available at: http://ec.europa.eu/food/food/biotechnology/gmo_intro_en.htm. A list of all legal measures pertaining to genetically modified organisms has been submitted to the Biosafety Clearing-House. 
For implementing legislation at EU Member States level, please refer to the Member States national reports.
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • Yes
24. Here you may provide further details on the implementation of Article 5 in your country:
EU pharma legislation provides that a medicinal product may only be placed on the market in the EU if it has received a marketing authorisation, granted either by the European Commission or by a member state. As regards medicinal products containing or consisting of GMOs, the assessment for a marketing authorisation must include an environmental risk assessment in line with the requirements of Directive 2001/18/EC. Regulation 1946/2003 mirrors the provisions of the Protocol as regards exports of pharmaceuticals.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
- Contained use:
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms
- Transit:
 Regulation 1946/2003 addresses transboundary movement of GMOs, and specifically requirements for exports of GMOs to third countries as well as for unintentional transboundary movements. According to Article 13 of the Regulation 1946/2003, the exporter shall ensure notification of the transit of GMOs through their territory and have informed the BCH of this decision.
 Transit procedures through the EU are regulated by the EU transport legislation and the Customs Code.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Less than 5
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • Less than 5
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Less than 5
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Less than 5
43. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
  • Yes, always
44. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes, always
45. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Not applicable
46. Has your country informed the notifier(s) and the BCH of its decision(s)?
  • Yes, always
47. Has your country informed the notifier(s) and the BCH of its decision(s) in due time (within 270 days or the period specified in your communication to the notifier)?
  • Not applicable
49. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
  • Yes, always
50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:
The EU applies its domestic legislative framework instead of the Protocol's advanced informed agreement procedure. This framework is compatible with the provisions of the Protocol. The EU domestic legislative framework is built on a range of legislative measures described above.
A company intending to market a GMO in the EU for intentional introduction into the environment must first obtain an authorisation to this end. The authorisation procedure for placing the GMO on the market involves all Member States, as authorised products are granted free movement througout the territory of the EU. The so-called "notification" or "application" submitted by the interested company must include a full evaluation of potential risks to human and animal health and to the environment. It is only after this decision is finally adopted on the basis of a prior risk assessment that the company can proceed with the marketing of the GMO in the EU.
A person or a company who wishes to introduce GMOs into the environment for experimental purposes must first obtain written authorisation from the compentent national authority of the Member State whithin whose territory the experimental release is to take place. Hence, the authorisation procedure is simpler than the one referred above The authorisation is given on the basis of an assessment of the risks presented by the GMO -or GMOs- for the environment and human health. 
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • More than 10
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
60. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • Yes, always
62. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • Yes, always
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
The EU has developed a comprehensive legal framework on GMOs, which also addresses the import of GMOs intended for direct use for food or feed, or for processing. The EU has declared with reference to Article 14.4 of the Cartagena Protocol that it relies on its existing legislative framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU.
With regard to the decisions taken for placing on the market of LMOs-FFP, it has to be noted that those decisions are taken for the whole European territory and not by the Member States individually.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
73. Has your country ever applied the simplified procedure?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
76. Here you may provide further details on the implementation of Article 13 in your country:
The EU has not made use of the simplified procedure for imports of LMOs as specified in Article 13.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
80. Here you may provide further details on the implementation of Article 14 in your country:
The EU has not entered into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1).
The EU has determined as per Article 14(4) and 9 (2) (c) that it relies on its existing legislative framework for intentional movements of GMOs within the European Union and for imports of GMOs into the European Union. This decision has been communicated to other Parties through the Biosafety Clearing- House.                                                                                          
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • Yes
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • Yes, always
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • More than 10
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • Yes, always
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Yes, always
93. Here you may provide further details on the implementation of Article 15 in your country:
The EU domestic legal framework, based on a prior risk assessment before authorisation is given, is applicable. The EU has put in place a comprehensive system of risk assessment and risk management dealing with releases into the environment or placing on the market of GMOs, whether imported into or developed within the EU. The notification provided by the company indending to market a GMO must include a full risk assessment of the risks to human and animal health and to the environment, which is assessed by the European Food Safety Authority (EFSA), with an active involvement of Member States, notably as regards the authorisation of GMOs for cultivation, where they carry out the intial risk assessment. The aim of the environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, both direct and indirect, immediate or delayed, on human health and the environment.
See http://www.efsa.europa.eu/en/science/gmo/gmo_guidance.html
In accordance with the precautionary principle, environmental risk assessments must be based on the following principles:
 GMO characteristics and GMO use that have the potential to cause adverse effects are to be compared to characteristics and use of the non-modified organism from which the GMO is derived;
 Risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data;
 Risk assessment should be carried out on a case by case basis;
 New information on the GMO and its effects may need to be readdressed in order to determine whether the risk has changed and whether there is a need for amending the risk management accordingly.
Article 4 of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms demands that any person submitting a notification under the authorisation procedures for GMO releases into the environment or placing on the market of GMOs as or in products needs to carry out an environmental risk assessment. Annex III of the Directive specifies the information that may be necessary to carry out the risk assessment. The environmental risk assessment comprises several steps that need to be addressed:
 Identification of characteristics which may cause adverse effects. These characteristics will vary from case to case and may include direct effects on human health or the environment as well as indirect effects occurring through a causal chain of events, through interactions with other organisms, transfer of genetic material or changes in use or management. As observations of indirect effects are likely to be delayed, immediate effects during the period of the release of the GMO as well as delayed effects that become apparent at a later stage or after termination of the release need to be considered.
 Evaluation of the potential consequences of each adverse effect, if it occurs.
 Evaluation of the likelihood of the occurrence of each identified potential adverse effect.
 Estimation of the risk posed by each identified characteristic of the GMO.
 Application of management strategies for risks from the deliberate release or marketing of GMOs.
 Determination of the overall risk of the GMO.Annex VII of the Directive provides guidance on the monitoring plan as part of the risk management strategy. More specific guidance notes are provided in Council Decision 2002/811/EC of 3 October 2002. The objective of the monitoring plan is to confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the risk assessment are correct, and to identify the occurrence of adverse effects of the GMO or its use which were not identified in the risk assessment.

The design of the monitoring plan should, among others:
 Be detailed on a case by case basis;
 Take into account the characteristics of the GMO, its use and scale of use, and the range of relevant environmental conditions;
 Incorporate general surveillance for unanticipated adverse effects;
 Provide for case-specific monitoring for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed and indirect effects which have been identified in risk assessment.;
 Provide for the use of already established routine surveillance practices where appropriate
The EC has cooperated with members of the European Economic Area (Norway, Iceland and Liechtenstein) on the issue of antibiotic resistance markers in risk assessment.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
The legislative framework provides that the environmental risk assessment described under question 93 should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used as well as a risk management strategy to be defined. In cases of limited data availability particular appropriate risk management has to be considered to prevent adverse effects on human health and the environment.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • No
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
107. Here you may provide further details on the implementation of Article 17 in your country:
Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
115. Here you may provide further details on the implementation of Article 18 in your country:
The EU has developed a comprehensive legal framework on GMOs, which also addresses the issues of handling, transport, packaging and identification requirement covered by Article 18. Of the recently adopted legal acts, the following are of direct relevance to the implementation of Article 18:
 Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms;
 Regulation (EC) 1829/2003 of 22 September 2003 on genetically modified food and feed; and
 Regulation (EC) 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.
The three Regulations entered into force in 2003. The latter two have been applicable since mid-April 2004. Two implementing Regulations in this area also took effect in April 2004:
 Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003; and
 Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms.    
            The EU approval process for GMOs requires validation of an event-specific detection method for the relevant GMO (see in particular regulation (EC) No 1829/2003). Validation of GMO detection methods in the EU is carried out by the European Union Reference Laboratory for GM Food Feed (EU-RL GMFF see http://gmo-crl.jrc.ec.europa.eu/)
In relation to Article 18(1), the EC wishes to recall that existing EC legislation contains appropriate rules on the safe transport, handling and packaging of GMOs. These rules are contained in:
 Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (last amended by Commission Directive 2003/28/EC); and
 Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (last amended by Commission Directive 2003/29/EC).
In relation to Article 18(2)(a), the EC wishes to recall that, under Article 12 of Regulation (EC) No 1946/2003 on transboundary movements of GMOs, exporters are required to state in a document accompanying the GMO, which is to be transmitted to the importer receiving the GMO:
 that it contains or consists of GMOs; and
 the unique identification code(s) assigned to those GMOs if such codes exist.
Article 12 further stipulates that for GMOs intended for direct use as food or feed, or for processing, the above information must be supplemented by a declaration by the exporter:
 stating that the GMOs are intended for direct use as food or feed, or for processing and indicating clearly that they are not intended for deliberate release into the environment; and
 giving details of the contact point for further information.
In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing, the above identification requirements may be replaced by a list of unique identifiers used to constitute the mixture.
Regulation 1829/2003 lays down rules on labelling of all GM food and feed. GM food and feed has to be labelled as GM, except if they contain GM material in a proportion no higher than 0.9% and if this presence is adventitious or technically unavoidable.
Under Regulation (EC) 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms, business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market. In particular, the Regulation requires that:
 operators are to have systems and standardised procedures in place to identify to whom and from whom products are made available; and
 in the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, written information on the unique identifier(s) assigned to the GMOs of which the product consists or which are contained in it, may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture.
In Regulation (EC) No 65/2004 of 14 January 2004, the EC has established a system for the development and assignment of unique identifiers for genetically modified organisms. The Regulation adopts the format developed by the OECD for Unique Identifiers for Transgenic Plants, which in mid-April 2004 became mandatory for the EC's domestic regulatory framework for GMOs. Moreover, the EC has extended use of this format to unique identifiers for genetically modified micro-organisms and animals pending the development and adoption of any other specific format at an international level. The EC considers the use of the unique identifier as a key to access information available on the Biosafety Clearing-House.
In relation to Article 18(2)(b), the EU wishes to recall that EU legislation contains rules on identification of GMOs that are destined for contained use, in line with the Protocol. Regulation No (EC) 1946/2003 on transboundary movements of genetically modified organisms requires exporters of GMOs destined for contained use to state in accompanying documentation 
 that it contains or consists of GMOs;
 the unique identification code(s) assigned to those GMOs if such codes exist;
In addition, this information shall be supplemented by a declaration by the exporter which shall specify:
 any requirements for the safe handling, storage, transport and use of the GMOs; and
 the contact point for further information, including the name and address of the individual or institution to whom or which the GMOs are consigned.
In relation to Article 18(2)(c), Regulation No (EC) 1946/2003 requires exporters of GMOs destined for deliberate release into the environment to ensure that documentation accompanying the GMO states:
 that it contains or consists of GMOs; and
 the unique identification code(s) assigned to those GMOs if such codes exist;
In addition, this information shall be supplemented by a declaration by the exporter which shall specify:
 the identity and relevant traits and characteristics of the GMOs;
 any requirements for the safe handling, storage, transport and use of these GMOs;
 the contact points for further information and, as appropriate, the name and address of the importer and exporter; and
 a declaration that the movement is in conformity with the requirements of the Protocol applicable to the exporter.
The above requirements regarding identification and documentation of GMOs are in line with Article 18 of the Protocol and without prejudice to further specific requirements imposed by EC legislation.
The EU has also put in place requirements concerning the handling, transport, packaging and identification of GMOs, for any use foreseen in Article 18 of the Protocol.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, one
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
123. Here you may provide further details on the implementation of Article 19 in your country:
The European Union has designated its own competent authority and focal point, while EU Member States have also designated their own national focal points and competent authorities. There is close collaboration and information sharing between EU and national administrations. 
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information available and in the BCH
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available and in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available and in the BCH
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available and in the BCH
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information available and in the BCH
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available and in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
128. Has your country experienced difficulties accessing or using the BCH?
  • No
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
131. Here you may provide further details on the implementation of Article 20 in your country:
The EU appointed the Joint Research Centre (JRC) of the European Commission as the European Community BCH Focal Point in January 2004. According to BS-I/3, BCH National (and/or regional, institutional) Focal Points liaise with the Secretariat regarding issues of relevance to the development and implementation of the Biosafety Clearing-House, including information clearance before publication to the BCH central portal, liaison with the Secretariat regarding the technical aspects (layout, system, database) of national participation to the Biosafety Clearing-House. In this respect, the JRC has contributed to the work of the Informal Advisory Committee (IAC) of technical experts on the BCH, collaborating with the review of the first year activity of the BCH central portal which was undertaken with a view to defining the medium-to-long term programme of work. Regular contacts and good cooperation with the Secretariat regarding implementation of Article 20 (BCH) are established. For instance, the Commission database on "GMO detection methods" was interlinked with the BCH (as decided in the IAC-BCH meeting in March 2011).
Individual EU Member States may complete the above answer by providing their own specific replies with regards to the questions above.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
134. Here you may provide further details on the implementation of Article 21 in your country:
The EU applies its domestic legislative framework instead of the Protocol's advance informed agreement procedure. This framework is compatible with the provisions of the Protocol. It contains confidentiality provisions that apply equally to domestic and foreign producers of GMOs.
Article 25 of Directive 2001/18/EC on the deliberate release into the environment of GMOs stipulates that the European Commission and the Member States shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.
Article 30 of Regulation (EC) No 1829/2003 on genetically modified food and feed allows applicants to indicate which information submitted under the Regulation they wish to be treated as confidential, based on verifiable justification.
Article 16 of Regulation (EC) No 1946/2003 on transboundary movements of GMOs obliges the European Commission and the Member States not to divulge to third parties any confidential information received or exchanged under this Regulation. It allows the exporter to indicate the information in the notification that should be treated as confidential, provided that justification is given in such cases.
However, all the above confidentialy provisions make clear what information shall never be considered as confidential, notably as regards the general description of the GMO, the namae and address of the authorisation holders, the risk assessment information and any methods and plans for emergency responses.
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Bilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • No
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Scientific biosafety research relating to LMOs
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • No
146. Does your country still have capacity-building needs?
  • No
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
The EU and its Member States have contributed to capacity building initiatives in the field of biosafety for the effective implementation of the Protocol in developing country Parties as well as in Parties with economies in transition.
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • Yes
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • More than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
EU legislation on GMOs promotes public awareness and participation as an integral part of its regulatory framework. EU legislation on traceability and labelling of GMOs authorised in the EU is specifically aimed at ensuring that accurate information is available to the public. Moreover, the EU is Party to the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (signed in 1998 and ratified in 2005). The main legal instrument to align EU Member States legislation with the provisions of the Aarhus Convention on access to information is Directive 2003/4/EC of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC. To further support citizens' rights of access to information, the EU has also adopted Directive 2003/35/EC on public participation, Regulation 1049/2001 of 30 May 2001 regarding public access to European Parliament, Council and Commission documents and Regulation 1642/2003 of 22 July 2003, amending Regulation 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. [                                                      
An amendment to the Aarhus Convention was adopted in May 2005. This amendment makes more specific the obligations placed on Parties with regard to public participation in genetically modified organism (GMO) decision-making processes. Relevant Community law governing GMOs, and in particular Directive 2001/18/EC and Regulation (EC) No 1829/2003, incorporates provisions for public participation in decision-making on GMOs, consistent with the amendment to the Aarhus Convention. The Community has decided on 18 December 2006 to ratify this amendment; the ratification has not yet taken place since the Community would like it to happen as far as possible simultaneously with the ratification by its Member States. 
Article 9 of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms stipulates that Member States shall consult the public and, where appropriate, groups on the proposed deliberate release of GMOs into the environment for any other purpose than for placing on the market. In doing so, Member States shall lay down arrangements for this consultation, including a reasonable time-period, in order to give the public or groups the opportunity to express an opinion. Member States are to make available to the public information on all intentional releases of GMOs into the environment in their territory, and the Commission shall make available to the public the information contained in the system of exchange of information established within the EU.
In cases of GMO notifications for placing on the market of GMOs as or in products, Article 24 of Directive 2001/18/EC stipulates that the Commission makes available to the public the summary dossier that is to accompany notifications for placing on the market of GMOs or a combination of GMOs as or in products. It also provides for the Commission to make available the assessment report issued by the national authority of the Member State which received the notification.
Regulation (EC) No 1829/2003 on genetically modified food and feed establishes a register of genetically modified food and feed authorised under this Regulation, including product specific information. It makes non-confidential data available to the public. Article 5 of the Regulation stipulates that the European Food Safety Authority receiving from national authorities an application for authorisation for placing on the market of GM food shall make a summary of the application available to the public. The public can make comments to the Commission on the authority's opinion. Monitoring plans are to be made available to the public after deletion of any information identified as confidential. Similar provisions exist with regard to the authorisation of GM feed (Article 17). Access to information held by the European Food Safety Authority in relation to procedure under Regulation 1829/2003 should be provided according to Regulation 1049/2001.
Directive 90/219/EEC on the contained use of GM micro-organisms in conjunction with Directive 98/81/EC amending Directive 90/219/EEC states that EU Member States may provide, where appropriate, that the public shall be consulted on any aspect of proposed contained use. It includes a requirement that information on emergency plans and safety measures to be taken in the event of an accident is made publicly available.
With regard to transboundary movements of GMOs, Article 6 of Regulation (EC) No 1946/2003 requires the Commission to make available to the public all non-confidential documents related to notifications of exports of GMOs to third countries. In cases of unintentional transboundary movements of GMOs, Article 14 requires Member States to take the appropriate measures to inform, among others, the public about the movement.
The EU maintains online information systems that provide the public with up-to-date information on the legislative framework for GMOs, applications for GMO authorisations and imports, decisions taken by relevant authorities, the results of environmental risk assessment and measures provided as part of risk management. The EU's main information portals for these purposes are: http://ec.europa.eu/food/food/biotechnology/index_en.htm and http://gmoinfo.jrc.ec.europa.eu/
Further information sites include:
 JRC Unit Molecular Biology and Genomics website: http://mbg.jrc.ec.europa.eu/;
 Community Reference Laboratory for GM Food and Feed: http://gmo-crl.jrc.ec.europa.eu/
 European Food Safety Authority: http://www.efsa.eu.int/index_en.html
 European Community Biodiversity Clearing-House Mechanism: http://biodiversity-chm.eea.eu.int/
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • No
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • Yes, always
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
167. Here you may provide further details on the implementation of Article 24 in your country:
As regards imports of LMOs, the EU applies its domestic legislative framework to all imports of LMOs, whether these originate from parties or non-parties to the Protocol.
As regards exports of LMOs, notification requirements of the exporter to the competent authority of the Party of import established by Regulation (EC) No 1946/2003 apply regardless of whether the country of import is a Party or a non-Party to the Protocol. Copies of the respective documents are sent to the compentent authority of the member State from which the GMO is exported and to the  European Commission (Article 6). Since entry into force of Regulation (EC) No 1946/2003 in November 2003, most notifications for LMOs intended for deliberate release related to the export of LMOs for use in small-scale field trials.
Exports of LMOs to third countries (e.g. for field trials or laboratory research) will be reported in the national reports of individual Member States from which they are exported.                                                
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Less than 5
171. Has your country informed the BCH and the other Party(ies) involved?
  • Only the other Party(ies) involved
173. Has your country established the nature of the LMO(s)?
  • Yes
174. Has your country established the circumstances of the illegal transboundary movement(s)?
  • Yes, some cases
175. Here you may provide further details on the implementation of Article 25 in your country:
According to Directive 2001/18/EC, it is the Member States that are obliged to take domestic measures to prevent and penalize illegal transboundary movements of GMOs. European legislation contains explicit obligations on Member States to lay down rules on penalties applicable to infringements of the provisions of European regulations. It further states that these penalties shall be effective, proportionate and dissuasive. Specific requirements on Member States to determine penalties applicable to breaches of European and national GMO regulations can be found in:
• Article 33 of the Directive 2001/18/EC on the deliberate release into the environment of GMOs;
• Article 18 of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms; and
• Article 45 of Regulation (EC) No 1829/2003 on genetically modified food and feed.
Article 53 of Regulation (EC) No 178/2002 laying down general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety provides for the possibility to adopt appropriate Community emergency measures for food and feed imported from a third country in order to protect human health, animal health and the environment, where the risk, can not be contained satisfactorily by means of measures taken by the Member States concerned. On this legal basis the Commission adopted on 18 April 2005 emergency measures regarding imports of the non-authorised genetically modified organism Bt10 in maize products and adopted on 5 September 2007 emergency measures regarding the non-authorised genetically modified organism 'LL RICE 601' in rice products. On the basis of satisfactory information regarding the absence of these GMOs in imports to the EU, the measures regarding Bt10 maize were repealed on 7 March 2007 and regarding LLRice601 rice were repealed on 8 June 2010. Emergency measures regarding  the non-authorised genetically modified organism 'Bt63' in rice products originating from China had to be adopted on 3 April 2008. These measures are still in place. It must be underlined that these are control measures to stop the import of food/feed because the products are illegal, not because of identification of adverse effects.
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • No
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to a limited extent
178. Here you may provide further details on the implementation of Article 26 in your country:
Socio-economic considerations have been relevant at Member State level for the question of co-existence between conventional, organic and GM crops. The European Commission has issued a Recommendation on 13 July 2010 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming. The responsibility to develop national co-existence measures lies with the member States, informed by the guidelines provided by the European Commission.
The Commission has recently issued a report on the socio-economic implications of GMO cultivation, based on the contribution of the Member States and in line with Article 31 of Directive 2001/18/EC. The past or present experience with GMO commercial cultivation in Europe is limited to 7 countries and to herbicide-tolerant (HT) soya, insect-resistant (Bt) maize and starch potato in the European Union. Therefore the amount of statistically relevant information on the ex-post socio-economic impacts of GMO cultivation is rather limited. It focuses mainly on impacts at farm level (seed production, farmers).
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
The European Union has undertaken steps and procedures towards a prompt ratification of this Protocol.
The EU legislation on liability for environmental damage is already fully consistent with the adopted Supplementary Protocol. Therefore, no legal amendments seem necessary at the EU level to formally conclude the agreement . However, conclusion of the Protocol requires the consent of the European Council and the European Parliament. The necessary administrative procedures thereto have recently been initiated.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
It has to be noted that as far as the EU and its Member States are concerned, there are two layers of implementation of the Protocol, one at EU level and one at national level.
The present EU report contains information on implementation of the Cartagena Protocol at EU level. EU Member States will provide in their national reports information on their national implementation of the Cartagena Protocol as well as the implementing EU legislation.
EU Member States separate reporting will offer information on the particular situation of individual Member States at least with regard to the following questions: 21, 28, 50, 93, 99, 130, 131,160, 163 and 167.
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
The way in which EU legislation in relation to biosafety is structured makes it challenging to always find a correspondence in the reporting format.  In addition, the fact that the BCH provided a locked document caused additional difficulties in the preparation of this report.
Survey on indicators of the Strategic Plan (2014)
In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.
When did your national biosafety framework become operational?
indicator 1.1.1
  • 2001 or earlier
Here you may provide further details
100,000 USD or more  The European Commission mobilizes around 100,000 USD/year to support the implementation of the Cartagena Protocol (including financial support to specific activities, to the CBD Secretariat and to the participation of developing countries in the COP-MOP meetings). The specific amounts are agreed upon in ENRTP ("Thematic Programme for Environment and sustainable management of Natural Resources, including energy") contracts.      For details at EU Member States level, please refer to the Member States national survey reports.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
At the EU level, "Better Training for Safer Food" is a training programme on food and feed safety, animal health and animal welfare, and plant health, including analysis of GMOs. The courses are delivered in EU and non-EU countries, targeting the staff of competent authorities dealing with official controls from EU and select non-EU countries.  The Joint Research Centre of the European Commission (JRC) manages the GMO programme and organized training activities on detection methods. Details please see at   http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/default.htm    For details at EU Member States level, please refer to the Member States national survey reports.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • Yes
Here you may provide further details
Capacity-building initiatives are coordinated among the European Commission's units responsible for biotechnology policy, financial issues and GMO detection methods.  In addition, analysis of GMOs is part of the Better Training for Safer Food (BTSF) training initiative of the European Commission, managed by the JRC ( http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/default.htm).       For details at EU Member States level, please refer to the Member States national survey reports.
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • 100,000 USD or more
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • No
Here you may provide further details
The programming process for the EU budget 2014-2020 is still on-going. No preliminary earmarking is yet agreed but the European Commission is looking positively at further voluntary support to the activities of the Cartagena Protocol.  In addition, budget allocations are decided on an annual basis and no reliable funding promise can be made before decisions are formally taken.    For details at EU Member States level, please refer to the Member States national survey reports.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • 10 or more
Here you may provide further details
The European Union has established a bilateral Dialogue on Biotech Market Access Issues established as part of the Mutually Agreed Solution reached between Argentina, Canada and the European Union following the WTO dispute "Measures in the European Communities Affecting the Approval and Marketing of Biotech Products (WT/DS292)".    The Joint Research Centre of the European Union has established several collaborative projects (e.g. Framework Programme projects) with European laboratories related to detection optimisation and validation of LMO detection and quantification methods.     For details at EU Member States level, please refer to the Member States national survey reports.
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • Yes
Survey 9.b) Risk management
  • Yes
Here you may provide further details
Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms provides a framework for the environmental risk assessment of genetically modified organisms and contains several annexes related to the risk assessment and risk management:  - Annex II of this Directive provides for the principles for the environmental risk assessment,  - Annex III specifies the information that is required to carry out the risk assessment,  - Annex IV specifies additional information that is required for organisms to be placed on the market,  - Annex VII describes the general principles to be followed in the design of the monitoring plan.  Furthermore, Decision 2002/623 of 24 July 2002 establishes guidance notes supplementing Annex II of Directive 2001/18/EC and Decision 2002/811/EC establishes guidance notes supplementing Annex VII of Directive 2001/18/EC.     Regulation 1829/2003 on genetically modified food and feed organisms provides a framework for the risk assessment of food and feed consisting of, containing or produced from genetically modified organismsgenetically modified organisms. Implementing Regulation 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 provides for specific rules on the information needed for their assessment.    Besides these legislative guidance documents, the European Food Safety Authority also published several scientific guidance documents on risk assessment that are available on their website:  http://www.efsa.europa.eu/en/gmo/gmoguidance.htm.    The Joint Research Centre also published several guidance documents on detection of GMOs that are available on their website:  http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm.     For details at EU Member States level, please refer to the Member States national survey reports.
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • Yes
Here you may provide further details
The guidance documents referred to in question 9 are used by the European Food Safety Authority and/or by Member States to assess the applications provided by applicants in view to get a market approval in the European Union.     For details at EU Member States level, please refer to the Member States national survey reports.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • Yes
Here you may provide further details
The EU is a partner in the discussions under the Codex Alimentarius and the Organisation for Economic Co-operation and Development (OECD).     As examples, the Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology developped several documents regarding the safety assessment of genetically modified foods including the following:   • Principles for the Risk Analysis of Foods Derived from Modern Biotechnology (2003)   • Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (2003)   • Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (2003)  • Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals (2008)    The OECD's Working Group on the Harmonization of Regulatory Oversight in Biotechnology has since its inception in 1995 developed technical documents that facilitate environmental risk/safety assessment of transgenic organisms, especially plants. These tools for risk assessors and regulators include science-focused documents on the biology of the organism and introduced traits, documents that supplement and expand upon the information in the biology and trait documents (e.g. module on herbicide tolerance), and guidance documents (e.g. how to use information from detection technologies for bacteria) and recently, a document on molecular characterization of transgenic plants.
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
The opinions of the European Food Safety Authorities on the risk assessment of genetically modified organisms (GMO) are available on the EFSA website: http://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoader?panel=GMO&questiontype=2    For details at EU Member States level, please refer to the Member States national survey reports.
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
Here you may provide further details
The EU domestic legal framework provides for   - detection and identification tools for GMOs to be placed on the market: these methods are provided by the applicants, are validated by the European Union Reference Laboratory for GM Food Feed (website: http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx), and controls are implemented by Member State's authorities.  - risk assessments prior to the authorization of GMOs (see question 3), aiming to assess potential risks to the environment (including the biodiversity), human and animal health, that are evaluated by the European Food Safety Authority and/ or the Member States;  - monitoring of experimental releases of GMOs and of GMOs placed on the market: the monitoring strategy is proposed by the applicant in the application, assessed by the European Food Safety Authority and/ or the Member States, specified in the authorization decision, implemented by the applicant, controlled by the Member States, and the results and methods of the monitoring are assessed by the Member States and the European Food Safety Authority for cultivation applications. The JRC maintains a public database on "Deliberate Release and Placing on the EU Market of GMOs - GMO Register" at: http://gmoinfo.jrc.ec.europa.eu/
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • Yes
Here you may provide further details
The EU has developed a comprehensive legal framework on GMOs, which also addresses the issues of handling, transport and packaging.   Existing EU legislation contains appropriate rules on the safe transport, handling and packaging of GMOs. These rules are contained in:  - Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (last amended by Commission Directive 2003/28/EC); and   - Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (last amended by Commission Directive 2003/29/EC).
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • Yes
Here you may provide further details
Socio-economic considerations have been relevant at Member State level for the question of co-existence between conventional, organic and GM crops. The European Commission has issued a Recommendation on 13 July 2010 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming. The responsibility to develop national co-existence measures lies with the member States, informed by the guidelines provided by the European Commission.  The Commission issued on 15 April 2011 a report ( http://ec.europa.eu/food/food/biotechnology/reports_studies/index_en.htm) on the socio-economic implications of GMO cultivation, based on the contribution of the Member States and in line with Article 31 of Directive 2001/18/EC and the conclusions of the Environment Council of December 2008.   The report stresses that past or present experience with GMO commercial cultivation in Europe is limited to 7 countries and to herbicide-tolerant (HT) soya, insect-resistant (Bt) maize and starch potato in the European Union. Therefore the amount of statistically relevant information on the ex-post socio-economic impacts of GMO cultivation is rather limited. It focuses mainly on impacts at farm level (seed production, farmers). The report called for " an advanced reflection at European level, with sound scientific basis, with the objective of:   - Defining a robust set of factors to properly capture the actual ex ante and ex post socio-economic consequences of the cultivation of GMOs, from seed production to consumers across the European Union. A methodological framework should be built-up to define precise socio-economic indicators to be monitored in the long run, and the appropriate rules for data collection. The pool of consulted parties should embrace all the regulatory and economic actors of the "seed-to-shelves" chain, as well as the wider society.   - Exploring different approaches to possibly make use of the increased understanding of these multi-dimensional socio-economic factors in the management of GMO cultivation in the European Union. The expertise of the Member States having already started reflecting on these aspects should be taken into consideration.  This reflection should be set up and implemented jointly by the Member States and the Commission. Stakeholders should also be actively associated to ensure the success of this process."   To follow up on this conclusion, the Commission has set up a technical working group (the "European GMO Socio-Economics Bureau" - ESEB) composed of experts from the Member States and the Commission to achieve the first objective. The ESEB started its work in January 2013.  The mission of the ESEB is to organise and facilitate the exchange of technical and scientific information regarding the socio-economic implications of the cultivation and use of GMOs between Member States and the Commission. On the basis of this process, the ESEB will develop Reference Documents that will enable a science-based assessment of these impacts in the Member States and across the EU.  The scope of the ESEB will cover the impacts of GM crop cultivation in the EU, and the impacts of the use of these GM crops for food, feed or industrial purposes (along the whole food/industrial chain, and marketing to consumers). It should focus on particular crops/traits or products of direct relevance to the European Internal Market that are currently approved or awaiting approval for cultivation and use at EU level.  The ESEB will aim to achieve these goals:   • To define methodological tools to investigate the crop/trait or product-specific ex-ante and ex-post socio-economic implications, on users and non-users of GMOs, of the cultivation and processing of GMOs along the seed-to-shelves chain in Europe.   • To undertake analysis of the data collected at Member State level according to the agreed methodologies as necessary.  To this end the ESEB will:   1. Define sets of crop/trait or product-specific indicators related to the socio-economic impacts of the cultivation and processing of GMOs, to be measured at Member State or other appropriate levels,   2. Define the methodologies and tools needed to collect existing and/or new data in a consistent way at Member State or other appropriate levels, and the methodologies necessary to perform a robust socio-economic analysis of the collated data to enable cross-comparison between Member States.  3. As necessary, analyse the socio-economic data generated by Member States and by any other relevant information sources (published) and make the analysis available via reports to the Member States, the Commission and the public.  The outputs 1 and 2 will be consolidated in "Reference Documents" that will assist Member States should they wish to carry out socio-economic impact assessments of GMOs at national level.   For a particular GM crop/trait or product, the impacts on different sectors of the economy and the society, and the indicators to be measured can vary between Member States. The Reference Documents will be developed so that they are, as far as possible, applicable across the EU, whilst at the same time taking into consideration the diversity of European socio-economic contexts.   Socioeconomic impact assessments in this context are understood to cover, as far as possible, the whole chain, namely farmers (households), consumers, upstream and downstream sectors (seed, feed, food industry) as well as the trade sector.   The ESEB may provide technical guidance for primary data collection activities in the Member States and gathering at EU level, according to the parameters and methodology agreed in the Reference Documents. The ESEB could also provide a central repository for data collected by the Member States for further analysis as necessary.   The ESEB defined an initial 3-year work programme, which was validated by the Competent authorities under Directive 2001/18/EC. The work programme is the following:   • Reference document on General framework for socio-economic impact assessment of GM crops close to commercialisation in the EU by Q2 2014;  • Reference document for socio-economic impact assessment of Insect Resistant maize by Q3 2015;  • Reference document for socio-economic impact assessment of Herbicide Tolerant maize by Q1 2016;  • Reference document for socio-economic impact assessment of Herbicide Tolerant Soya by Q3 2016;  • Reference document for socio-economic impact assessment of Herbicide Tolerant sugar beet by Q4 2016.
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • 50 or more
Here you may provide further details
In order to prepare the report on socio-economic impacts of GMO cultivation of 2011, the Commission sent an indicative questionnaire to the EU Member States, Norway and stakeholders, including reference to peer-reviewed publications. 25 out of 27 Member States sent contributions, as well as Norway and several stakeholders. All contributions referred to peer-reviewed published material. The report also referred to several EU funded projects which findings were published in peer-reviewed journals.     In November 2011, the Joint Research Centre of the Commission (JRC) and the Food and Agriculture Organisation of the United Nations (FAO) organised an international workshop on socio-economic impacts of GM crops (http://ipts.jrc.ec.europa.eu/publications/pub.cfm?id=5019. This workshop aimed to review the main findings of scientists who are active worldwide in the field of socio-economic assessment and publish in peer reviewed journals.
Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?
indicator 1.7.3
No experience
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • Yes
Here you may provide further details
Specific capacities include information channels among Member States of the European Union allowing for rapid dissemination of the information in case of unintentional release of a GMO, expertise of the European Union Reference Laboratory for GM Food Feed and detection capacities in the Member States.     Article 50 of Regulation 178/2002 on the general principles of food law set up a Rapid Alert System for Food  and Feed which is a means of allowing rapid dissemination of the information in case of unintentional release of a GMOs.    Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.    Regulation (CE) N° 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules was adopted by the European Parliament and the Council on 29 April 2004. The key elements of the Regulation N° 882/2004  are:     • To ensure that official controls on feed and food are carried out regularly, on a risk basis and with appropriate frequency;   • To establish a clear EU framework for a control system systematically setting out the rules to be respected with the aim of greater harmonisation and the integration of controls across the entire food and feed chain under the "farm to fork" principle;   • To establish appropriate control methods and techniques such as monitoring, surveillance, verification, audit, inspection, sampling and analysis (in compliance with relevant Community rules, or with internationally recognised rules or protocols;   • To establish a community and national reference laboratories network; (European Union Reference Laboratory for GM Food Feed and detection)  • The requirement that the competent authorities prepare of a single integrated multi-annual national control plan to ensure the effective implementation of the Regulation;     For details at EU Member States level, please refer to the Member States national survey reports.
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • None
Survey 19.b) Monitoring
  • None
Survey 19.c) Management / Control
  • 100 or more
Here you may provide further details
The Joint Research Centre of the European Union organized general training courses on detection of GMOs in food and feed samples as well as ad-hoc training courses for National Reference Laboratories under Regulation (EC) 882/2004.
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Here you may provide further details
At the EU level, the EU Reference Laboratory for GM Food Feed (EU-RL GMFF) is responsible for the scientific assessment and validation of detection methods for GM Food and Feed as part of the EU authorisation procedure and the coordination of the National Reference Laboratories for GMO in the 27 Member States. The EU-RL GMFF is supported by ENGL, the European Network of GMO Laboratories, and hosted by the Joint Research Centre of the European Commission (http://gmo-crl.jrc.ec.europa.eu/default.htm)    For details at EU Member States level, please refer to the Member States national survey reports.
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Here you may provide further details
The Joint Research Centre of the European Union uses both training materials and guidances when organizing training courses on detection of GMOs. These documents are publicly available on the following webpages: http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm and http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/documentation.htm.
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • Yes
Survey 22.b) Effective
  • Yes
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • None
Here you may provide further details
No specific training to custom officers was organized at EU level.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 10 or more
Here you may provide further details
The staff of the European Reference Laboratory (EURL) working on detection methods for GMOs is composed of less than 10 persons.     Furthermore, the JRC is distributing information on LMO detection methods to personnel of more than 100 laboratories in the Member States. We refer to the Member States national survey reports for this information at EU Member States level.
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Here you may provide further details
The JRC runs the EURL-GMFF that has sophisticated laboratory facilities. However, it is not normally involved in detection and control of LMOS, which is responsibility of the Member States, but is occupied with method validation.    For details at EU Member States level, please refer to the Member States national survey reports.
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Here you may provide further details
At the European Union level, only the Joint Research Center is certified for LMO detection.   For details at EU Member States level, please refer to the Member States national survey reports.
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Here you may provide further details
At the European Union level, only the Joint Research Center is certified for LMO detection. This laboratory is operational.      For details at EU Member States level, please refer to the Member States national survey reports.
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • No
Here you may provide further details
Not applicable for the European Union.   For details at EU Member States level, please refer to the Member States national survey reports.
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • Yes
Here you may provide further details
In the European Union, the provisions of the Cartagena Protocol on Biosafety are covered by the European legislation on Biosafety which is maintaining as a central cornerstone the precautionary principle. The liability provisions of the Nagoya-Kuala Lumpur Supplementary Protocol are covered by the Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004, on environmental liability with regard to the prevention and remedying of environmental damage, which establishes a framework based on the "polluter pays" principle, according to which the polluter pays and repairs when environmental damage occurs.  Member States and their relevant competent authorities which are responsible for the design and implementation of national legislation on environmental liability will also be responsible for the detailed measures laid down in article 12 of the Protocol, which allow Parties either to apply existing domestic law or to develop new civil liability rules and procedures or to apply a combination of both.
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • Yes
Here you may provide further details
Before a GMO can be approved, the Commission consults the public on the risk assessment done by the European Food Safety Agency (EFSA).   After the consultation, the Commission analyses the comments and checks with EFSA whether the scientific ones have an impact on its opinion.  The documents available for the public consultation as well as all comments received are published on the following websites: http://ec.europa.eu/food/plant/gmo/authorisation/authorisation_applications_1829-2003_en.htm and http://gmoinfo.jrc.ec.europa.eu/gmc_browse.aspx.
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • National website
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • One or more
Here you may provide further details
At the EU level, the JRC (EU Reference Laboratory for GM Food Feed (EU-RL GMFF), responsible for the scientific assessment and validation of detection methods for GMOs and the coordination of the National Reference Laboratories for GMO in the 27 Member States, organizes workshops and trainings courses on GMO detection and analysis (see  http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/default.htm).    For details at EU Member States level, please refer to the Member States national survey reports.
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • One or more
Here you may provide further details
The Joint Research Centre published an interactive course on 'The Analysis of food and feed samples for the presence of genetically modified organisms (GMOs)' (interactive DVD) as well as an User Manual "The Analysis of Food Samples for the Presence of Genetically Modified Organisms". Both materials are publicly available on the website http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/documentation.htm.    For details at EU Member States level, please refer to the Member States national survey reports.
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Here you may provide further details
In the EU, regulations including Regulation (EC) 1946/2003 are directly applicable in Member States and Directives including Directive 2001/18/EC have to be transposed by Member States. The European Commission monitors the transposition of Directives.   The European Food Veterinary Office of the European Commission further verifies the implementation by the Member States of the legal obligations under the Community legislation on food safety, animal health, plant health and animal welfare, including the GMO legislation. The reports of the FVO are publicly available: http://ec.europa.eu/food/fvo/index_en.cfm.
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • 10 or more
Here you may provide further details
At the EU level, the European Commission organized at least 10 events since 2011, the largest ones being:  - 3 public hearings on "GMO risk assessment and management" (March 2011), "Socio-economic dimensions of GMO cultivation" (October 2011) and "Environmental monitoring of GM crops" (March 2012). Detailed information available on the website http://ec.europa.eu/food/food/biotechnology/index_en.htm.  -  7 workshops organized by the the EU Reference Laboratory for GM Food Feed (EU-RL GMFF). Detailed information available on the website http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/workshops.htm.
Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.
indicator 4.3.2
  • 10 or more
Here you may provide further details
On 13 June 2013, the European Food Safety Authority (EFSA) had published 44 opinions since 2012 related to the biosafety of GMOs. All the GMO-related publications of EFSA are published on the website http://www.efsa.europa.eu/en/gmo/gmoscdocs.htm?p=0.  The European Commission recently published a report on EU-funded research related to the Biosafety of GMOs called "A decade of EU-funded GMO research (2001 - 2010)" (publicly available on the website http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf)  The JRC (EURL-GMFF) has published more than 20 LMO related documents at:  http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • National website
Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
indicator 5.2.1
  • None
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Here you may provide further details
At the EU level, several programmes are relevant:  1) "Better Training for Safer Food" is a training programme on food and feed safety, animal health and animal welfare, and plant health, including analysis of GMOs. The courses are delivered in EU and non-EU countries, targeting the staff of competent authorities dealing with official controls from EU and select non-EU countries.  2) EU research programmes on the biosafety of GMOs, which include a module on communication, e.g.   • AMIGA (Assessing and Monitoring the Impacts of Genetically modified plants (GMPs) on Agro-ecosystems, http://www.amigaproject.eu/project/overview/),   • DEMETRA (DEvelopment of a quick Monitoring index as a tool to assess Environmental impacts of TRAnsgeniccrops, http://www.life- demetra.eu/aesito/demetra),   • PRICE (PRactical Implementation of Coexistence in Europe,  http://price-coexistence.com/),  • GRACE (Verification of GMO risk assessment elements and review and communication of evidence collected on the biosafety of GMO, http://www.grace-fp7.eu/content/project),  • MARLON (Monitoring of Animals for Feed-related Risks in the Long Term),   • VERDI (Valuating environmental impacts of GM crops - ecological and ethical criteria for regulatory decision-making, http://www.verdi-fp7.eu).     For details at EU Member States level, please refer to the Member States national survey reports.
Survey 41. If you answered yes to the question above, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place.
indicator 5.3.1
E.g. local, national, etc.,
See details in answer to question 40.
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • Yes
Here you may provide further details
The European Commission promotes transparency and stakeholders consultation.  Information on GMO related-issues including future and existing rules, register of authorized GMOs, monitoring reports of cultivated GMOs are all available on the website http://ec.europa.eu/food/plant/gmo/legislation/index_en.htm.  Stakeholders are consulted on GMO-related policies through e.g. the Advisory Group on the Food Chain and Animal and Plant Health of DG SANCO.   The European Commission also organized public hearings on "GMO risk assessment and management" (March 2011), "Socio-economic dimensions of GMO cultivation" (October 2011) and "Environmental monitoring of GM crops" (March 2012) to communicate with the public and the stakeholders.  Consumer information is further assured through the labeling of products containing, consisting or produced from GMOs, allowing consumer choice.    Openness and transparency are also fundamental aspects of the European Food Safety Authority (EFSA) and are enshrined as concepts in EFSA's founding regulation. Among other activities:   - website http://www.efsa.europa.eu/en/panels/gmo.htm providing a lot of information;  - regular meetings with stakeholders to discuss scientific issues and exchange views on various aspects of GMO risk assessment;  (http://www.efsa.europa.eu/en/gmo/gmoshmeetings.htm, http://www.efsa.europa.eu/en/gmo/gmomsmeetings.htm  http://www.efsa.europa.eu/en/gmo/gmonetworks.htm);  - public consultations on draft guidance documents and technical reports on these public consultations  that are published.  - open plenary meeting of the GMO panel on 17-18 April 2013 where observers could participate.
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • 10 or more
Here you may provide further details
To date, the European Food Safety Authority (EFSA) had published 10 guidance documents related to the risk assessment of GMOs, available on the website http://www.efsa.europa.eu/en/gmo/gmoguidance.htm  The Joint Research Centre has published an interactive course on 'The Analysis of food and feed samples for the presence of genetically modified organisms (GMOs)' (interactive DVD) as well as an User Manual "The Analysis of Food Samples for the Presence of Genetically Modified Organisms". Both materials are publicly available on the website http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/documentation.htm.