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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102651
Status
Published
Date of creation
2011-11-01 14:26 UTC (nina.vik@dirnat.no)
Date of publication
2011-11-01 14:26 UTC (nina.vik@dirnat.no)

Origin of report
Country
  • Norway
Contact officer for report
Coordinates
Dr Casper Linnestad
Senior Adviser
The Norwegian Ministry of the Environment (MD)
P.O.Box 8013 Dep, Oslo
Oslo
Norway, NO-0030
Phone:+4722245985
Email:casper.linnestad@md.dep.no
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Ministry of Agriculture and Food, Ministry of Fisheries and Coastal Affairs, Ministry for Foreign Affairs, Ministry of Health and Care Services and Directorate for Nature Management.
Submission
10. Date of submission
2011-11-01
11. Time period covered by this report
Start date
2007-09-12
Time period covered by this report
End date
2011-09-30
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
With regards to question 20 we will be supplementing our BCH submissions with further details on Norway's regulations on pharmaceuticals.
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?
  • Partially
24. Here you may provide further details on the implementation of Article 5 in your country:
Norway (as an EFTA State) has implemented Regulation (EC) No 726/2004 of the European Parliament and of the Council, EEA agreement annex II, chapter XIII.

The EFTA States shall participate in the work of the European Medicines Agency as set up by Regulation (EC) 726/2004. When decision on approval of medicinal products are taken according to the Commity procedures laid down in  Regulation (EC) No 726/2004, The EFTA States shall simultaneously and within 30 days of the Community Decision, take corresponding decisions on the basis of the relevant acts. The EEA Joint Committee shall be informed and shall periodically publish lists of such decisions in the EEA Supplement to the Official Journal. 

According to the procedures for authorisation of medicinal product for human use or a veterinary medicinal products containing or consisting of genetically modified organisms, the opinion of the Committee shall respect the environmental requirements laid down by Directive 2001/18/EC.                                                    
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Less than 10
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • Less than 10
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • More than 10
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:
The Advance Informed Agreement procedure of the protocol is implemented in the Norwegian legislation through the Gene Technology Act and its regulations.

According to the Act, a company intending to release a GMO into the environment in Norway must first obtain an approval, unless the GMO in question has been approved for placing on the market in the EU. As a consequence of the EEA Agreement, Norway takes part in the approval procedure of GMO in the EU on the same basis as the EU Member States, with the exception of voting procedures. A GMO which has been approved for placing on the market in the EU by Directive 2001/18/EC is also approved for that purpose in Norway, unless the competent authority in Norway considers it to constitute a risk to human health or the environment or otherwise contravene the Gene Technology Act and therefore has decided to restrict or prohibit its placing on the market in Norway.

The application is subject to public consultation and consideration by the Scientific Committee on Food Safety, the Food Safety Authority, the Norwegian Biotechnology Advisory Board, the Directorate for Nature Management and the Ministry of the Environment. Approval may be conditional and granted for a limited time.

In contrast to applications for marketing of LMOs, applications for experimental release into the environment is subject to a national procedure.

Pursuant to Section 35 of the Act of 10 February 1967 relating to procedure in cases concerning the public administration, an authorisation to release a GMO into the environment, including marketing of the GMO to be used as food, feed or for processing, could be revoked if it is found to be based upon incorrect information from the applicant.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • None
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • None
60. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • None
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
The Norwegian lesgislative framework adresses LMOs-FFP, and does not lay down other procedures for LMOs-FFP than for LMOs.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
71. Here you may provide further details on the implementation of Article 12 in your country:
Section 8 of The Norwegian Gene Technology Act establishes that the conditions attached to an approval may be altered, and if necessary the approval may be withdrawn if: a) the risk to health or the environment posed by the use in question proves to be greater than was foreseen when the use was approved, or  b) new technology makes it possible to reduce the risk of adverse effects on health or the environment, or c) this otherwise follows from the rules for reversing decisions that are currently in force.
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • Yes
73. Has your country ever applied the simplified procedure?
  • Yes
74. If you answered Yes to question 73, has your country informed the Parties through the BCH of the cases where the simplified procedure applies?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • More than 5
76. Here you may provide further details on the implementation of Article 13 in your country:
Norway has not applied the simplyfied procedure to LMOs for intentional introduction to the environment.

Norway has implemented article 13a through national regulations relating to the labelling, transport, import and export of genetically modified organisms of 2 September 2005. The transport and import of genetically modified organisms may take place without special approval when the requirements in these regulations regarding labelling and packaging are fulfilled. Transport of genetically modified organisms which is covered by and fulfils the requirements in or is approved pursuant to rules applying to the transport of dangerous goods may take place without special approval. However, approval is required for the transport and import of the following genetically modified organisms:

- Genetically modified microorganisms where the activity is classified in risk classes 3 and 4.
- Volume of culture exceeding 10 litres of genetically modified microorganisms where the activity is classified in risk class 2.
- Live animals and plants used as host organisms for genetically modified microorganisms.
- Transport where it is not possible to satisfy the requirements in these regulations regarding packaging and labelling.
- All genetically modified animals, with the exception of
1) traditional livestock that have no wild relatives in Norwegian fauna with which they can cross, 2)laboratory animals, e.g. mice, rats, hamsters intended for use in laboratories approved for contained use of genetically modified organisms and 3)embryos, eggs, semen, cell and tissue cultures of animal cells

These imports are not subject to reporting, and the number of LMOs the simplified procedure has been applied to is not known, but is asssumed to be higher than five.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • Yes
78. If you answered Yes to question 77, has your country informed the Parties through the BCH of the agreements or arrangements?
  • No
79. If you answered Yes to question 77, please provide a brief description of the scope and objective of the agreements or arrangements entered into:
The Agreement on the European Economic Area, which entered into force on 1 January 1994, brings together the 27 EU Member States and the three EEA EFTA States - Iceland, Liechtenstein and Norway - in a single market, referred to as the "Internal Market". The EEA Agreement provides for the inclusion of EU legislation covering the four freedoms - the free movement of goods, services, persons and capital - throughout the 30 EEA States. In addition, the Agreement covers cooperation in other important areas such as research and development, education, social policy, the environment, consumer protection, tourism and culture, collectively known as "flanking and horizontal" policies.

As a consequence of the EEA Agreement, Norway takes part in the approval procedure for LMOs in the EC on the same basis as the EU Member States, with the exception of voting procedures. A LMO which has been approved for placing on the market for direct use for food, feed or for processing in the EU by Directive 2001/18/EC is also approved for those purposes in Norway, unless the competent authority in Norway considers it to constitute a risk to human health or the environment or otherwise contravene the Gene Technology Act and therefore has decided to restrict or prohibit its placing on the market in Norway.
80. Here you may provide further details on the implementation of Article 14 in your country:
Please se question 79
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • Yes
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • In some cases only
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • None
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • Yes, always
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Yes, always
93. Here you may provide further details on the implementation of Article 15 in your country:
Before a LMO may enter the Norwegian market, an extensive risk assessment is conducted. The competent authorities ask the Norwegian Scientific Comitee for food safety (VKM) to conduct a risk assessment. This means that the scientific assessment of environmental risk is separated form risk management, and that the whole process shall be carried out in an open and transparent way. Through competent authorities and advisory bodies, such as VKM, Norway takes an active part not only in the risk assessments conducted in the EU, but also in the development of guidelines for the risk assessment of LMOs. 

Regulations relating to impact assessment pursuant to the Gene Technology Act provide a basic guideline on how to conduct risk assessments prior to taking decisions regarding LMOs. In addition, as stated as response to question 79, Norway participates in the EU approval process for LMOs, and The European Food Safety Authority (EFSA) provides more detailed guidelines in how to perform risk assessments of LMOs.

No decisions regarding LMOs have been taken in Norway in the current reporting period.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
The environmental risk assessment should be conducted with a view to identify whether there is a need for risk management and if so, the most appropriate methods to be used. If new information on the genetically modified organism and its effects on human health or the environment becomes available, the environmental risk assessment may need to be readdressed in order to:
- determine whether the risk has changed;
- determine whether there is a need for amending the risk management accordingly.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • Yes
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Less than 5
104. Has your country notified affected or potentially affected States, the BCH and, where appropriate, relevant international organizations, of the above release?
  • No
106. 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?
  • No, consultation was never made
107. Here you may provide further details on the implementation of Article 17 in your country:
Questions 104 and 106 are not applicable, as there are no incidents that have led, og may have led, to unintentional transboundry movements of LMOs from Norway in the current reporting period.                                                
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • No
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
115. Here you may provide further details on the implementation of Article 18 in your country:
The Norwegian legislative framework adresses Article 18 of the protocol through inter alia regulations relating to the labelling, transport, import and export of genetically modified organisms.The object of these regulations is to simplify the transport and import of genetically modified organisms, fulfill Norway's obligations under the Cartagena Protocol relating to genetically modified organisms, ensure consumer choice and prevent adverse effects of genetically modified organisms.

Section 19. of the regulations regarding labelling of products consisting of or containing genetically modified organisms establishes that such products shall be labelled in Norwegian and/or English with the words "Inneholder genmodifiserte organismer" alternatively "Inneholder (name of organism(s))" and/or "Contains genetically modified organisms" alternatively "Contains genetically modified (name of organism(s))". On packaged products, the information shall be given on a label on each packaged unit. For other products, the information shall be given on an accompanying document or notice.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, more than one
119. In case your country designated more than one competent national authority, has your country conveyed to the Secretariat the respective responsibilities of those authorities?
  • Yes
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
121. 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?
  • Yes
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information available and in the BCH
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information available but not in the BCH
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available but only partially available in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available but only partially available in the BCH
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available but only partially available in the BCH
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information not available
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available but only partially available in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • No
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
128. Has your country experienced difficulties accessing or using the BCH?
  • No
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Not applicable
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
131. Here you may provide further details on the implementation of Article 20 in your country:
Comment questions 124 i), k) and l): Without exception, all national decisions made by Norway so far regarding release of LMOs and use of FFPs, are from before the Cartagena Protocol entered into force. It is our aim to publish information also on these LMOs in the BCH.

Comment question 125: We have, strictly speaking, not established any mechanism as such for strengthening the capacity of our BCH NFP. We have, however, sought to participate in BCH relevant workshops organized by, or with assistance of, the CBD/CPB secretariate.

Comment question 126: We are hesitant to say that we have established a mechanism as such, but the links between the two national focal points and competent national authorities are well defined, and constitutes a "mechanism". Both for question 125 and 126 one may ask what the term "mechanism" implies/should imply.

Comment question 130: We believe that with regards to the central information required by the CPB after the entry into force of the Protocol, we are complete and up to date. But our review of the status of Norway's BCH submissions does show that there are some areas where we both could (and should) submit more information. We will continue to keep focus on this.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Bilateral channels
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Bilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • No
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • 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
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • No
146. Does your country still have capacity-building needs?
  • Yes, a few
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Socio-economic considerations
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
Norway has not received external support related to capacity builing. However, cooperation with South-Africa in establishing systems for environmental risk assessment capacities in South-Africa (2008-2010) has contributed to capacity building in Norway as well.

The Norwegian Gene Technology Act requires information on effect on socioeconomic factors in the Party of Export. There are capacity building needs in terms of which effects to be considered, how these effects should be weighed and of how data should be collected.
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • No
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • No
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • More than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
Question 152. The competent Norwegian authorities and relevant agencies have established biosafety websites. However, there is no central biosafety website

Question 159. Following the Norwegian Gene Technology Act, public consultations are mandatory for all applications for marketing of LMOs in Norway. Public awareness and participation is facilitated.
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • Yes
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • No
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
167. Here you may provide further details on the implementation of Article 24 in your country:
Regulations relating to the labelling, transport, import and export of genetically modified organisms does not require approval for transport and import of certain LMOs, such as laboratory animals intended for use in laboratories approved for contained use of genetically modified organisms and genetically modified microorganisms where the activity is classified in risk classes below 3 (cultures up to 1 litre). Imports and exports of such LMOs for research purposes to and from Non-Parties have taken place in the reporting period.
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Less than 5
171. Has your country informed the BCH and the other Party(ies) involved?
  • Only the other Party(ies) involved
172. Has your country established the origin of the LMO(s)?
  • Yes
173. Has your country established the nature of the LMO(s)?
  • Yes
174. Has your country established the circumstances of the illegal transboundary movement(s)?
  • Yes, some cases
175. Here you may provide further details on the implementation of Article 25 in your country:
[Pursuant to Sections 17, 18, 20, 21, 23, 24 and 25 of the Gene Technology Act, several measures can be used to prevent and penalize transboundary movements of GMO carried out in contravention ccc of  the Norwegian legal framework on GMO, including supervision (Section 17), right of inspection (Section 18), order to cease activity (Section 20), duty to prevent and limit damage (Section 21), compensation (Section 23), coercive fine (Section 24) and penalties (Section 25).

The Norwegian Food Safety Authority and the Norwegian Directorate for Nature Management exercise supervision over the implementation of the Gene Technology Act. Each year, the Norwegian Food Safety Authority takes several samples of food, feed and seed products consisting of, containing or produced from soy beans, maize and rape seed from shipments, production sites and shops.
                                                
So far the sampling and testing have in most cases revealed low levels (between 0,1 and 1 %, mostly below 0,1 %) of unintentional or technically unavoidable GMO presence in conventional soy beans, maize and rape seeds. Due to the low levels of presence, documentation provided by the responsible persons/companies on the measures taken to avoid such GMO presence, the fact that the GMO present have been authorized in the European Union and an assessments of environmental and health risks related to the presence, it has been concluded that the presence did not contravene the Gene Technology Act.

For emergency measures regarding spesific non-authorised LMOs, please refer to the EU report.
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Yes
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to a limited extent
178. Here you may provide further details on the implementation of Article 26 in your country:
The purpose of the Gene Technology Act is inter alia to ensure that the production and use of genetically modified organisms take place in an ethically justifiable and socially acceptable manner, in accordance with the principle of sustainable development and without adverse effects on health and the environment. Hence, socioeconomic considerations is a central part of the Norwegian impact assessment prior to the marketing of LMOs and LMOs-FFP.

The assessment of sustanability issues (ecological, economical and social) is to be performed on a global scale. This implies that considerations should  also focus on the country producing the LMO in question.

When assessing the LMOs benefit to society, the focus is primarely on effects in Norway, such as whether the LMO helps solving a social problem, create employment opportunities or tends to create problems for existing production that otherwise should be maintained.

Under the provisions of the Gene Technology Act, The Norwegian Biotechnology Advisory Board has a role in the assessments of LMOs. The main task of the Norwegian Biotechnology Advisory Board is to evaluate the social and ethical consequences of modern biotechnology and to discuss usage which promotes sustainable development.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
Survey on indicators of the Strategic Plan (2014)
In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.
When did your national biosafety framework become operational?
indicator 1.1.1
  • 2001 or earlier
Here you may provide further details
Norway has supported the implementation of the Biosafety Protocol through a workshop on socio-economics in New Dehli, India in 2011 and a Meeting of the Ad Hoc Technical Expert Group (AHTEG) on socio-economics in Bolivia later this year.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
GenØk - Centre for Biosafety provides an annual International biosafety course in Tromsø. Holistic Foundations for Assessment and Regulation of Genetic Engineering and Genetically Modified Organisms is a theoretical and hands-on course for NGO/Civil Society Leaders, Senior Scientists, Policy Makers and Regulators from Developing Countries. This 2-week course is a mix of lectures, group discussions, casework and practical laboratory sessions. 40 participants from ODA-countries are given full sponsorship. In addition there are 20 places available for participants with sponsorships from other sources. - See more at: http://genok.com/capacity-building/courses/#sthash.mVCZ7mXt.dpuf
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • Yes
Here you may provide further details
GenØk - Centre for Biosafety is coordinating biosafety capacity-building initiatives.
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • 100,000 USD or more
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • Yes
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • 3 or more
Here you may provide further details
By establishing »research hubs», GenØk aims to contribute to the development of hubs with regional capacity on biosafety issues.  These hubs will coordinate research and courses in the region, as well as build networks with scientists who do biosafety relevant research. The hubs will be established within existing research environments.    GenØk's objective is to establish one hub for South-America, one for Africa and one for Asia.  GenØk cooperates with National Institute of Scientific and Industrial Research (NISIR) in Zambia, the Federal University of Santa Catarina in Brazil and North West University in South-Africa. Additionally, GenØk has a long-term cooperation on capacity building with  Third World Network in Malaysia.  - See more at: http://genok.com/capacity-building/research-hubs/#sthash.ksVaEa7l.dpuf
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • Yes
Survey 9.b) Risk management
  • Yes
Here you may provide further details
Regulations relating to impact assessment pursuant to the Gene Technology Act provides guidance on the risk assessment and risk management. In addition the Norwegian Scientific Committe for Food Safety (VKM) use the guidance documents on risk assessment by the European Food Safety Authority (EFSA)
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • Yes
Here you may provide further details
See question 9
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • Yes
Here you may provide further details
Norway takes part in discussions under the OECD and Codex Alimentarius. In addition Norway takes part in the risk assessment in the EU.
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
On average, ten risk assessments of LMOs are conducted  by the Norwegian Scientific Committee for Food Safety each year
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • Yes
Here you may provide further details
These aspects are regulated by Regulations relating to the labelling, transport, import and export of genetically modified organisms. See http://www.regjeringen.no/en/dep/md/documents-and-publications/acts-and-regulations/regulations/2005/regulations-relating-to-the-labelling-tr.html?id=440383
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • Yes
Here you may provide further details
The Norwegian Gene Technology Act lays down sustainability, benefit to society and ethics as  criteria when applications for the release of LMOs are assessed. Appendix IV of Regulations relating to impact assessment pursuant to the Gene Technology Act describes the evaluation of ethical considerations, sustainability and benefit to society, cf section 17 of the regulations.    Article 26 of the Gene Technology Act states that The Norwegian Biotechnology Advisory Board (NBAB) shall give opinions on matters that come within the scope of this Act and other questions relating to biotechnology. NBAB is an independent body consisting of 21 members appointed by the Norwegian government. Each member has a background and/or education which makes him/her competent to discuss questions regarding modern biotechnology. Eight members of the board represent different public organisations. The main tasks of the Norwegian Biotechnology Advisory Board is to evaluate the social and ethical consequences of modern biotechnology and to discuss usage which promotes sustainable development.
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • 50 or more
Here you may provide further details
Peer-reviewed articles are used both by the NBAB (see question 15) and by the Norwegian Environment Agency in questions regarding socio-economic considerations of LMOs.
Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?
indicator 1.7.3
There is an ongoing  process of  developing further national guidance on the assessment of sustainability, benefit to society and ethics.
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • Yes
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • One or more
Survey 19.b) Monitoring
  • 10 or more
Survey 19.c) Management / Control
  • 10 or more
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Here you may provide further details
The Norwegian Veterinary Institute serves as the national LMO Laboratory in Norway, and is member of European Network of GMO laboratories (ENGL).
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • Yes
Survey 22.b) Effective
  • Yes
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • None
Here you may provide further details
There is no specific training of custom officers related to identification of LMOs in Norway. However, it is the Norwegian Food Safety Authority that collects samples directly from imported goods. The personel performing the collection of samples receices theoretical training on how to collect samples from shipments of grains or from products in shops. The identification per se is done by laboratory personel at the Norwegian Veterinary institute.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • One or more
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Here you may provide further details
See Q20.
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • No
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • Yes
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • Yes
Here you may provide further details
The Gene Technology Act states that the processing of applications for the deliberate release of LMOs shall always include public consultation. The public consultation shall be held well before a decision is made. It must be carried out in a way that ensures that the general public, and particularly interest groups who will be affected, are given access to relevant information and a real opportunity to make their opinions known. A decision to hold a public consultation shall be published.
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • National website
  • Public hearings
Survey 32. If you indicated multiple modalities for public participation in the question above, which one was most used?
indicator 2.5.2
  • Public hearings
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • One or more
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • One or more
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • 5 or more
Here you may provide further details
Every year the NBAB organizes seminars, workshops and educational events related to socioeconomics and biosafety. The Norwegian Committe for Food Safety occasionally organizes events related to risk assessment.
Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.
indicator 4.3.2
  • 10 or more
Here you may provide further details
The Norwegian Biotechnology Advisory Board and The Norwegian Committee for Food Safety publish their opinions and risk assessments for each application regarding the release of LMOs
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • www.bion.no and www.vkm.no
Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
indicator 5.2.1
  • One or more
Here you may provide further details
Norway  co-hosted with the Governments of India a workshop on socioeconomics in 2011. The workshop was held in New Delhi, India.
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Survey 41. If you answered yes to the question above, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place.
indicator 5.3.1
E.g. local, national, etc.,
The Public consultations and the work by the Norwegian Biotechnology Advisory Board are central elements of the communication strategy on biosafety.
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • Yes
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • One or more