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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109191
Status
Published
Date of creation
2015-11-05 15:21 UTC (andrew.bowers@cbd.int)
Date of publication
2015-11-05 15:21 UTC (andrew.bowers@cbd.int)

Origin of report
1. Country
  • European Union
Contact officer for report
Coordinates
Ella STRICKLAND
Head of Unit of Multilateral International Relations
European Commission / Directorate-General for Health and Food Safety (DG SANTE)
European Commission F101 02/060
Brussels
Belgium, B-1049
Phone:+32 2 299 30 30
Fax:+32 2 299 85 66
Email:SANTE-CARTAGENA-PROTOCOL@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
2015-10-27
11. Time period covered by this report
Start date
2011-10
11. Time period covered by this report
End date
2015-10
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2001 or earlier
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. The EU has created a comprehensive legal framework for ensuring safety in the development, use and transfer of GMOs. The main pieces of legislation are:
- 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 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.
- 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 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 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.
- 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.
- 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.
- Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006.
- Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015  amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory.
More information on the content of these legislative acts is available at:  http://ec.europa.eu/food/plant/gmo/new/legislation/index_en.htm
In the case of Directives 2001/18/EC and (EU) 2015/412, 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 territories. 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?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • Yes
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • 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:
Regulation (EC) No 1946/2003 addresses transboundary movement of GMOs with the aim to ensure coherent implementation of the provisions of the Cartagena Protocol in the EU. It establishes rules for the transit of GMOs and for the transboundary movement of GMOs intended for contained use, in line with the provisions of the Cartagena Protocol.
- 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:
According to Article 13 of Regulation (EC) No 1946/2003, the exporter shall ensure notification of the transit of GMOs to Parties that have taken the decision to regulate 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 OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. 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
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • Yes
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • Yes
36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Less than 5
37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • Less than 5
38. 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
39. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
46. 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)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • More than 10
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
55. 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
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
57. 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
58. 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 MS individually.
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • No
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. Here you may provide further details on the implementation of Article 12 in your country
See Article 20 of Directive 2001/18 and Articles 21 and 22 of Regulation 1829/2003
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
68. Has your country ever applied the simplified procedure?
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
71. 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
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
76. 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.
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • None
b) Management / Control:
  • 100 or more
c) Monitoring:
  • None
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • Yes
84. Does your country have the capacity to detect, 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?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • Yes
88. 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?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • Yes
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Commercial production
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • More than 10
94. 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
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • Yes
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
The EU domestic legal framework on GMOs is based on a prior risk assessment before authorisation can be given. 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 intending 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 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
99. 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
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. 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
105. 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
106. 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
107. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
108. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing types of documentation
110. 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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • None
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 10 or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • One or more
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
This question is relevant to indicator 2.3.4 of the Strategic Plan
  • One or more
122. Here you may provide further details on the implementation of Article 18 in your country:
The EU set up a comprehensive legal framework which addresses the topic of handling, transport, packaging and identification of living modified organisms (art. 18 of Cartagena Protocol):
- Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed; and its implementing Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003;
-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 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms;
- Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms
- Directive 2008/68/EC of 24 September 2008 on the inland transport of dangerous goods.
- 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.
As regards Article 18(1) of Cartagena Protocol, the existing EU legislation, Directive 2008/68/EC contains appropriate rules on the safe transport, handling and packaging.
As regards Article 18(2)(a) of Cartagena Protocol:
- Regulation (EC) No 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.
- Regulation (EC) No 1830/2003 provides that 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 standardized procedures in place to identify to whom and from whom products are made available;
-- At the first stage of the placing on the market of a product consisting of or containing GMOs, including bulk quantities, operators shall ensure that the following information is transmitted in writing to the operator receiving the product:  (a) that it contains or consists of GMOs; (b) the unique identifier(s) assigned to those GMOs; 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.
- Regulation (EC) No 65/2004 established a system for the development and assignment of unique identifiers for genetically modified organisms.
- Regulation (EC) No 1946/2003, under Article 12, provides that 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.
In relation to Article 18(2)(b) of Cartagena Protocol, the EU legislation contains rules on identification of GMOs that are destined for contained use, in line with the Protocol:
- Regulation (EC) No 1946/2003, under Article 12, provides that 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 contained use, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter which shall specify:
-- any requirements for the safe handling, storage, transport and use of these GMOs;
-- the contact point for further information, including the name and address of the individual or institution to whom or which the GMOs are consigned.
Finally, as regards Article 18(2)(c) of Cartagena Protocol, 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 EU legislation.
Article 19 – Competent National Authorities and National Focal Points
124. 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
125. 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)
126. Please provide an overview of the status of the mandatory 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.
This question is relevant to indicator 3.1.5 of the Strategic Plan
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
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
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
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
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
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
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information available but only partially available in the BCH
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
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
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
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
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
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
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
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
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
128. 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
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • No
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • No
131. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
132. 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:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • 5 or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • 10 or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National website
135. 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.
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. 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 name and address of the authorisation holders, the risk assessment information and any methods and plans for emergency responses.
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • No
140. 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
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
143. If you answered Yes to question 142, how were these resources made available?
  • Multilateral channels
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • No
147. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • No
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • No
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • Yes
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • None
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
157. 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 has 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.  There have been no capacity-building activities at the EU level as such.
Article 23 – Public awareness and participation
158. 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
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • Yes
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • Yes
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
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).
- G-TwYST (Genetically modified plants Two Year Safety Testing. http://www.g-twyst.eu).
For details at EU Member States level, please refer to the Member States third national reports.
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. 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?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • None
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • One or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • One or more
173. 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
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • Yes
175. 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
176. 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. 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 European Union approved this amendment on 1 February 2008 but the ratification has not yet taken place. 
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.
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.
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 2009/41/EC on the contained use of GM micro-organisms 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.it/default.asp.
Further information sites include:
- Biotechnology and GMOs Unit website: http://biotech.jrc.it/;
- Community Reference Laboratory for GM Food and Feed: http://gmo-crl.jrc.it/  
- 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
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • No
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • Yes, always
183. 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 competent 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 of exports of LMOs intended for deliberate release related to exports of LMOs for use in small-scale field trials.
EU exports of  LMOs to third countries will be reported in the national reports of individual Member States from which they are exported.
Article 25 – Illegal transboundary movements
184. 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
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
186. 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?
If you replied Never to question 186 please go to question 191
  • More than 10
187. If your country received information concerning cases of illegal transboundary movements of an LMO in the current reporting period, has your country informed the BCH and the other Party(ies) involved?
This question is relevant to indicators 3.1.5 of the Strategic Plan
  • Only the other Party(ies) involved
188. If your country received information concerning cases of illegal transboundary movements of an LMO in the current reporting period, has your country established the origin of the LMO(s)?
  • Yes
189. If your country received information concerning cases of illegal transboundary movements of an LMO in the current reporting period, has your country established the nature of the LMO(s)?
  • Yes
190. If your country received information concerning cases of illegal transboundary movements of an LMO in the current reporting period, has your country established the circumstances of the illegal transboundary movement(s)?
  • Yes
191. 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 obligation 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, when there is a serious risk to human or animal health or to the environment and when this risk cannot be contained satisfactorily by means of measures taken by the Member States concerned. On this legal basis the Commission adopted in 2008 emergency measures regarding the unauthorised genetically modified rice Bt 63 in products originating in or consigned from China (Commission Decision 2008/289/EC). The Commission adopted stricter requirements with a new Decision on emergency measures in 2011 (Commission Decision 2011/884/EU) with further amendments introduced in 2013 (Commission Decision 2013/287/EU). The latter Decision is still in force.
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • Yes
193. 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
194. 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?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • 50 or more
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
None.
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to some extent
197. 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 in 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 and by using Best Practice Documents (BPDs) for the coexistence of GMOs with conventional and organic crops developed by the European Coexistence Bureau, composed of experts from the Member States and the Commission (ECoB - http://ecob.jrc.ec.europa.eu/). To date the ECoB published BPDs for maize, honey and soybean production, and BPDs on cotton and potato production are under preparation.
The Commission issued a report on the socio-economic implications of GMO cultivation ( http://ec.europa.eu/food/food/biotechnology/reports_studies/index_en.htm), based on the contribution of the Member States. In view of the limited past and present experience with GMO commercial cultivation in Europe, the amount of statistically relevant information on the ex-post socio-economic impacts of GMO cultivation in the EU is rather limited.  Therefore the report called for an advanced reflexion at European level, with sound scientific basis, to "define 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 EU. 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."
As a follow up, 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 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 has started since January 2013 to develop Reference Documents that will enable a science-based assessment of these impacts in the Member States and across the EU. The first Reference Document "Framework for the socio-economic analysis of the cultivation of genetically modified crops", setting a general framework for the socio-economic analysis of GMO cultivation, has been finalised and published in 2005 (https://ec.europa.eu/jrc/en/eseb/documents.). ESEB is in the process of drafting a reference document for measurement of socio-economic impacts in the EU Member States of the cultivation of insect resistant maize. Next reference documents will concern Herbicide Tolerant (HT) Maize, HT soya and HT sugarbeet.
Finally, the recent Directive (EU) 2015/412 gives the possibility to the Member States to restrict or prohibit the cultivation of GMOs in their territory. Under this new Directive, Member States may adopt opt-out decisions on GMO cultivation based on compelling grounds distinct from the environmental risk assessment undertaken in the context of the authorisation procedure at EU level, such as environmental policy objectives, town and country planning, land use, socio-economic impacts, coexistence, agricultural policy objectives, public policy, etc. . In this context, the methodologies and indicators for measuring socio-economic impacts drawn in the abovementioned ESEB's Reference Documents could be useful for the Member States when adopting opt-out decisions on GMO cultivation.
States may take opt-out decisions on GMO cultivation based on legitimate considerations different from the risk assessment undertaken in the context of the authorisation procedure at EU level, such as socio-economic concerns, town and country planning, land use and general environmental policy objective different to risks. In this context, the methodologies and indicators for measuring socio-economic impacts drawn in the abovementioned ESEB's Reference Documents will be useful for the Member States when adopting opt-out decisions on GMO cultivation based on socio-economic concerns.
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
200. 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?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • No
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • Yes
202. 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 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, the Environmental Liability Directive (ELD), 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.
The European Commission has undertaken several measures to improve the implementation of the ELD: awareness raising and information factsheets and brochures; training manual, slides and program; stakeholder workshops/conferences and expert meetings; studies etc.
Furthermore, the Commission is currently preparing the ELD evaluation and report. Out of more than 1200 cases reported by the Member States, no incidents of environmental damage caused by GMOs in the EU were reported within the reporting period 2007-2013.     
More information is available on: http://ec.europa.eu/environment/legal/liability/index.htm
Article 28 – Financial Mechanism and Resources
203. 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?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • 50,000 USD or more
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due 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 MS 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.
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 special situation of the European Union and its Member States as regards the Cartagena Protocol and its implementation, which is done in two layers as referred above (Q207), makes it challenging to always find a correspondence in the reporting format.
It has been appreciated the possibility to refer to the previous report in some questions, as agreed in decision BS-VII/14. However, the way this has been implemented is not as useful as it could be in order to allow Parties that are in full compliance with their reporting obligations fill in the format without providing the same information repeatedly.
As recommended in the EU response to CBD Notification 2015-002 concerning UTM, any reference to Article 17 (e.g. questions 99 to 101 of this report) should be focused on the release of an LMO, rather than on the UTM which results or may result from that release. This would avoid any misinterpretation or doubt in the interpretation of UTM versus ITM and would clarify in which cases Article 17 or Article 25 apply. Therefore:
- Question 99 should be "Has your country established a mechanism for addressing emergency measures in case of releases which lead or may lead to unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?"
- Question 100 should be "Does your country have the capacity to take appropriate measures in the event that a release which leads or may lead to an unintentional transboundary movement of an LMO occurs?"
- Question 101 should be "In the current reporting period, how many times has your country received information concerning occurrences resulting in a release that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?"