Germany | BCH-NR3-DE-109559 | Third National Report on the Implementation of the Cartagena Protocol on Biosafety

General Information

Country

Germany

Contact person submitting the report

9. Organizations/stakeholders who were consulted or participated in the preparation of this report

Federal Ministries concerned, Federal Office of Consumer Protection and Food Safety (BVL)

EN

10. Time period covered by this report

From

01 Jan 2011

To

31 Dec 2015

Party to the Cartagena Protocol on Biosafety

11. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?

Yes

EN

Article 2 – General provisions

14. 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

EN

15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?

2001 or earlier

EN

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

EN

18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?

Yes

EN

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

EN

20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?

Yes

EN

21. Here you may provide further details on the implementation of Article 2 in your country

As a member of the EU the European legislation on genetically modified organisms (GMOs), which has been in place since the early 1990s, is either directly applicable in Germany or has been implemented into German law. The EC has created a comprehensive legal framework and introduced specific legislation on GMOs. Therefore the comprehensive information given in the report of the EU also partly covers the situation in Germany. Germany has fully implemented existing EC-legislation into national law through the German Gentechnikgesetz [Gene Technology Act] and the EG-Gentechnikdurchführungs-gesetz [German law regulating the implementation of the European provisions in the field of GMO]. These legal measures are publicly available on the homepage of the German CompetentNational Authority (BVL) which also hosts the German BCH-homepage (currently under development): <a href="http://www.bvl.bund.de/cln_027/nn_491818/DE/06_Gentechnik/09_BiosafetyClearingHouse/05__RechtlicheGrundlagen/rechtGrundlagen__node.html__nnn=true">http://www.bvl.bund.de/cln_027/nn_491818/DE/06_Gentechnik/09_BiosafetyClearingHouse/05__RechtlicheGrundlagen/rechtGrundlagen__node.html__nnn=true</a> and <a href="http://www.biosafety-bch.de/">http://www.biosafety-bch.de/</a> In addition to European legislation German law foresees administrative fines and penalties to ensure compliance with relevant provisions. The Articles 38 and 39 of the German Gentechnikgesetz [Gene Technology Act] as well as the §§ 6 and 7 of the German EG-Gentechnik-Durchführungsgesetz [German Law regulating the implementation of the European provisions in the field of GMOs] include penal provisions that serve to enforce the aims and provisions of the Cartagena Protocol. These provisions penalize behaviours that can contravene the goals of the Cartagena Protocol, for example the deliberate release of a GMO into the environment or the placing on the market of a GMO without the necessary authorization by the competent authority. Moreover, § 6, 2nd paragraph of the German EG-Gentechnik-Durchführungsgesetz [German Law regulating the implementation of the European provisions in the field of GMOs] penalizes the transboundary movement of living modified organisms carried out in contravention of the relevant German and European laws. Further details see report of the EC

EN

Article 5 - Pharmaceuticals

22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?

Yes

EN

23. If you answered Yes to question 22, has this information been submitted to the BCH?

Yes

EN

24. Here you may provide further details on the implementation of Article 5 in your country:

see report of the EC

EN

Article 6 – Transit and Contained use

25. Does your country regulate the transit of LMOs?

Yes

EN

26. Does your country regulate the contained use of LMOs?

Yes

EN

27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?

Yes

EN

28. Here you may provide further details on the implementation of Article 6 in your country:

see report of the EC

EN

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?

Yes

EN

30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?

Yes

EN

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

EN

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

EN

33. Has your country established legal requirements for the accuracy of information contained in the notification?

Yes

EN

34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

No

EN

35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

No

EN

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?

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?

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?

None

EN

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

EN

40. 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?

41. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?

42. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?

43. Has your country informed the notifier(s) and the BCH of its decision(s)?

44. What percentage of your country’s decisions fall into the following categories?

45. 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?

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

see report of the EC Applications/notifications regarding the transboundary movement of LMOs for intentional introduction into the enviroment refer, to the German experience to applications regarding the (commercial) use of LMOs. In the EU, decisions on applications with this objective are taken at the EU level among the EU member states, but not by a single EU member state. Information to questions 37-49 regarding the EU level will be delivered from the EU NFP.

EN

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?

Yes

EN

48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?

Yes

EN

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?

Yes

EN

50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?

Yes

EN

51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?

No

EN

52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?

No

EN

53. How many LMOs-FFP has your country approved to date?

54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?

55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?

56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?

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?

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

see report of the EC In the EU, decisions on LMOs-FFP are taken at the EU level among the EU member states, but not in a single EU member state. Information to questions 58-62 regarding the EU level will be delivered from the EU NFP. 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.

EN

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

EN

60. Has your country ever received a request for a review of a decision?

Yes

EN

61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?

Yes, decision reviewed and changed

EN

62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?

None

EN

63. Has your country informed both the notifier and the BCH of the review and/or changes in the decision?

64. Has your country informed both the notifier and the BCH of the review and changes in the decision within thirty days?

65. Has your country provided reasons to both the notifier and the BCH for the review and/or changes in the decision?

66. Here you may provide further details on the implementation of Article 12 in your country

Germany decided to suspend an existing EU-authorisation for the intentional introduction of a LMO into the environment for cultivation at the national level.

EN

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

EN

68. Has your country ever applied the simplified procedure?

No

EN

69. If you answered Yes to question 68, has your country informed the Parties through the BCH of the cases where the simplified procedure applies?

70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?

None

EN

71. Here you may provide further details on the implementation of Article 13 in your country

Article 14 – Bilateral, regional and multilateral agreements and arrangements

72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?

No

EN

73. If you answered Yes to question 72, how many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?

74. If you answered Yes to question 72, has your country informed the Parties through the BCH of the agreements or arrangements?

75. If you answered Yes to question 72, please provide a brief description of the scope and objective of the agreements or arrangements entered into

76. Here you may provide further details on the implementation of Article 14 in your country

see report of the EC

EN

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

EN

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

EN

79 a. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs? Risk assessment:

100 or more

EN

79 b. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs? Management / Control:

100 or more

EN

79 c. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs? Monitoring:

50 or more

EN

80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?

Yes

EN

81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?

No

EN

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?

No

EN

83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?

Yes

EN

84 a. 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? Detect:

Yes

EN

84 b. 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? Identify:

Yes

EN

84 c. 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? Assess:

Yes

EN

84 d. 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? Monitor:

Yes

EN

85 a. 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? Risk assessment:

Yes

EN

85 b. 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? Risk management:

Yes

EN

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?

No

EN

87. Has your country adopted any common approaches to risk assessment with other countries?

Yes

EN

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?

Yes

EN

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?

Yes

EN

90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):

Commercial production
Field trial
LMOs for Contained use
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?

In some cases only

EN

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

EN

93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?

More than 10

EN

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

EN

95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?

Yes

EN

96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?

Yes

EN

97. Here you may provide further details on the implementation of Articles 15 and 16 in your country

see Report of the EC

EN

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

EN

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

EN

100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?

Yes

EN

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?

More than 10

EN

102. If you answered Yes to question 101, has your country notified affected or potentially affected States, the BCH and, where appropriate, relevant international organizations, of the above release?

Yes, for some occurrences

EN

103. If you answered Yes to question 101, who did your country notify?

The affected or potentially affected State

EN

104. If you answered Yes to question 101, has your country immediately consulted the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures?

Yes, always

EN

105. Here you may provide further details on the implementation of Article 17 in your country

see report of the EC comment to question 103: information generally generated i.e.by inspection or control activities of competent national institutions. Since no adverse effect to the biological diversity of the receiving environments could be verified neither in the exporting nor the importing country, occurances were not notified to the BCH.

EN

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

EN

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?

No

EN

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?

Yes

EN

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

EN

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?

Yes

EN

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 or a stand-alone document

EN

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

EN

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 or a stand-alone document

EN

114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?

Yes

EN

115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?

Yes

EN

116. How many customs officers in your country have received training in the identification of LMOs?

None

EN

117. Has your country established procedures for the sampling and detection of LMOs?

Yes

EN

118. How many laboratory personnel in your country have received training in detection of LMOs?

100 or more

EN

119. Does your country have reliable access to laboratory facilities for the detection of LMOs?

Yes

EN

120. How many laboratories in your country are certified for LMO detection?

10 or more

EN

121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?

10 or more

EN

122. Here you may provide further details on the implementation of Article 18 in your country:

see Report of the EC Regulation (EC) No. 1946/2003 and other relevant EU regulations are implemented into national laws where appropriate, e. g. EG-Gentechnikdurchführungsgesetz.

EN

Article 19 – Competent National Authorities and National Focal Points

123. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?

n/a

EN

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

EN

125. Here you may provide further details on the implementation of Article 19 in your country

see report of the EC

EN

Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)

126 a. 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. 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

EN

126 b. 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. 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

EN

126 c. 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. Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))

Information available and in the BCH

EN

126 d. 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. 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

EN

126 e. 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. Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))

Information available and in the BCH

EN

126 f. 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. Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)

Information available and in the BCH

EN

126 g. 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. Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)

Information not available

EN

126 h. 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. Illegal transboundary movements of LMOs (Article 25, paragraph 3)

Information available but only partially available in the BCH

EN

126 i. 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. 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 but only partially available in the BCH

EN

126 j. 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. Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)

Information available and in the BCH

EN

126 k. 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. 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

EN

126 l. 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. 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

EN

126 m. 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. 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

EN

126 n. 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. Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)

Information available and in the BCH

EN

126 o. 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. LMOs granted exemption status by each Party (Article 13, paragraph 1)

Information not available

EN

126 p. 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. 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

EN

126 q. 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. 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 but only partially available in the BCH

EN

127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?

Yes

EN

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

EN

129. Does your country use the information available in the BCH in its decision making processes on LMOs?

Yes, in some cases

EN

130. Has your country experienced difficulties accessing or using the BCH?

No

EN

131. Is the information submitted by your country to the BCH complete and up-to date?

Yes

EN

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:

One or more

EN

133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:

10 or more

EN

134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:

National website

135. Here you may provide further details on the implementation of Article 20 in your country

see report of the EC Submission of information is an ongoing process which requires considerable time. Allocation of necessary recources is a function of availablity of recources and current priority of current duties.

EN

Article 21 – Confidential information

136. Has your country established procedures to protect confidential information received under the Protocol?

Yes

EN

137. Does your country allow the notifier to identify information that is to be treated as confidential?

Yes, always

EN

138. Here you may provide further details on the implementation of Article 21 in your country

see Report of the EC

EN

Article 22 – Capacity-building

139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?

Yes

EN

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

EN

141. If you answered Yes to question 140, how were these resources made available?

142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?

Yes

EN

143. If you answered Yes to question 142, how were these resources made available?

Bilateral channels

EN

144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?

No

EN

145. If you answered Yes to question 144, how would you characterize the process?

146. Has your country ever received funding from the GEF for building capacity in biosafety?

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?

Yes

EN

148. If you answered Yes to question 147, in which of the following areas were these activities undertaken?

Human resources capacity development and training
Risk assessment and other scientific and technical expertise
Risk management
Public awareness, participation and education in biosafety
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
Socio-economic considerations
Implementation of the documentation requirements under Article 18.2 of the Protocol
Measures to address unintentional and/or illegal transboundary movements of LMOs
Scientific biosafety research relating to LMOs
Taking into account risks to human health

149. During the current reporting period, has your country carried out a capacity-building needs assessment?

No

EN

150. If you answered Yes to question 149, has this information been submitted to the BCH?

151. Does your country still have capacity-building needs?

No

EN

152. If you answered Yes to question 151, indicate which of the following areas still need capacity-building.

153. Has your country developed a capacity-building strategy or action plan?

No

EN

154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?

Yes

EN

155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?

10 per year or more

EN

156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?

No

EN

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

see report of the EC.

EN

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

EN

159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?

No

EN

160. Does your country have any awareness and outreach programmes on biosafety?

No

EN

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.):

see Report of the EC

EN

162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?

Yes

EN

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?

None

EN

164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?

Yes

EN

165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?

Yes

EN

166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?

Yes

EN

167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?

Yes

EN

168. If you answered Yes to question 167, please indicate the modalities used to inform the public:

National website
Newspaper

169. If you indicated more than one modality for public participation in question 168, which one was most used?

Newspaper

EN

170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?

Yes

EN

171. How many academic institutions in your country are offering biosafety education and training courses and programmes?

10 or more

EN

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:

25 or more

EN

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

EN

174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?

Yes

EN

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?

Less than 5

EN

176. Here you may provide further details on the implementation of Article 23 in your country

see Report of the EC

EN

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

EN

178. Has your country ever imported LMOs from a non-Party?

Yes

EN

179. Has your country ever exported LMOs to a non-Party?

Yes

EN

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

EN

181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?

No

EN

182. 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?

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.

EN

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

EN

185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?

Yes

EN

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?

More than 10

EN

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?

Only the other Party(ies) involved

EN

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

EN

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

EN

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, some cases

EN

191. Here you may provide further details on the implementation of Article 25 in your country

see Report of the EC

EN

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?

No

EN

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

EN

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?

10 or more

EN

195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:

196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?

Yes, to some extent

EN

197. Here you may provide further details on the implementation of Article 26 in your country

see Report of the EC

EN

Article 27 – Liability and Redress

198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?

Yes

EN

199. If you answered No to question 198, is there any national process in place towards becoming a Party?

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?

No

EN

201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?

Yes

EN

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

see Report of the EC The Supplementary Protocol has been ratified on 27th August 2013.

EN

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?

50,000 USD or more

EN

Article 33 – Monitoring and reporting

204 a. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol? Monitoring system:

Yes

EN

204 b. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol? Enforcement system:

Yes

EN

205. Has your country submitted all the previous due National Reports?

Yes

EN

206. If you answered No to question 205, indicate the main challenges that hindered the submission:

Other information

207. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.

see Report of the EC

EN

Comments on reporting format

208. Please use this field to provide any other information on difficulties that you have encountered in filling in this report

see Report of the EC

EN

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