| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109130
Status
Published
Date of creation
2015-11-02 12:29 UTC (janne.ovrebo.bohnhorst@miljodir.no)
Date of publication
2015-11-02 12:29 UTC (janne.ovrebo.bohnhorst@miljodir.no)

Origin of report
1. Country
  • Norway
Contact officer for report
Coordinates
Dr Casper Linnestad
Senior Adviser
The Norwegian Ministry of Climate and Environment (KLD)
P.O.Box 8013 Dep,
Oslo
Norway, NO-0030
Phone:+47 92833602
Fax:+47 22 24 95 60
Email:casper.linnestad@kld.dep.no
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Norwegian Envioronment Agency and The Norwegian Food Safety Authority
Submission
10. Date of submission
2015-11-02
11. Time period covered by this report
Start date
2011-10-01
11. Time period covered by this report
End date
2015-10-31
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2001 or earlier
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
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 Medicine Agency as set up by Regulation (EC) 726/2004. When a decision on approval of medicinal products are taken according to the Committee procedures laid down in  Regulation (EC) No 726/2004, The EFTA States shall simultaneously and within 30 days of the Committee 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 products for human use or a veterinary medicinal product containing or consisting of genetically modified organisms, the opinion of the Committee shall respect the environmental requirement laid down by Directive 2001/18/EC.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • Yes
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • Yes
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • Yes
36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • None
37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • Less than 10
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?
  • More than 10
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?
  • Less than 5
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?
  • Yes
41. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes
42. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • No
43. Has your country informed the notifier(s) and the BCH of its decision(s)?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only the BCH
44. What percentage of your country’s decisions fall into the following categories?
  • Approval of the import/use of the LMO(s) with conditions
55%
  • Prohibition of the import/use of the LMO(s)
45%
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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only 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
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 by the Directive in the EU. As a consequence of the EEA Agreement (also described under question 75), 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 by the Directive for placing on the market in the EU 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's assessment criteria sustainability, ethics and social utility and therefore has decided to restrict or prohibit its placing on the market in Norway. This only applies to directive 2001/18/EC and not to the regulation 1829/2003/EC as the latter regulation has not been implemented in Norway. This only applies to directive 2001/18/EC and not to the regulation 1829/2003/EC as the latter regulation has not been implemented 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 Norwegian Environment Agency and the Ministry of Climate and Environment. Approval may be conditional and granted for a limited time. The conditions of the approval may be altered and the approval may be revoked if certain conditions are met.
In contrast to applications for marketing of LMOs, applications for experimental release into the environment is subject to a national procedure
In regard to question 44, reporting on approving the import with conditions, we recognize the requirement of GMO-labelling as a condition. With regard to requesting additional information Norway has, from 2008, on a routine basis requested additional information according to the purpose of Norwegian gene technology Act, as set out in its section 1, is 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.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • None
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • Less than 5
55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • Less than 5
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
57. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • Yes, but with delays (i.e. longer than 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
The Norwegian legislative framework addresses LMOs-FFP, and does not lay down other procedures for LMOs-FFP than for LMOs.
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • No
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. Here you may provide further details on the implementation of Article 12 in your country
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) contravene the Gene Technology Act's assessment criteria sustainability, ethics and social utility, or d) this otherwise follows from the rules for reversing decisions that are currently in force.
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?
  • Yes
68. Has your country ever applied the simplified procedure?
  • Yes
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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
71. Here you may provide further details on the implementation of Article 13 in your country
Norway has not applied the simplified 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 interbreed,
2. laboratory animals, e.g. mice, rats, hamsters intended for use in laboratories approved for contained use of genetically modified organisms,
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 assumed to be higher than five.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • Yes
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?
This question is relevant to indicator 1.2.8 of the Strategic Plan
  • One or more
74. If you answered Yes to question 72, has your country informed the Parties through the BCH of the agreements or arrangements?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
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
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.
76. Here you may provide further details on the implementation of Article 14 in your country
Please see Q75
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • 10 or more
b) Management / Control:
  • 10 or more
c) Monitoring:
  • 10 or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • Yes
84. Does your country have the capacity to detect, identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • Yes
88. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • Yes
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Commercial production
  • 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • More than 10
94. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes, to some extent
Here you may provide further details
In our regulation this is required, however, as only genetically modified carnation as cut flowers has been approved it has not been relevant.
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • Yes
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
Before an LMO may enter the Norwegian market, an extensive risk assessment is conducted. The competent authorities ask the Norwegian Scientific Committee for food safety (VKM) to conduct a risk assessment. This means that the scientific assessment of environmental risks is separated from the risk handling, 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 active part not only in the risk assessments conducted by 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 75, Norway participates in the EU approval process for LMOs, and The European Food Safety Authority (EFSA) provides more detailed guidelines on how to perform risk assessments 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 must be used. If new information on LMO 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
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
99. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Less than 5
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?
This question is relevant to indicators 3.1.5 of the Strategic Plan
  • No
103. If you answered Yes to question 101, who did your country notify?
This question is relevant to indicators 3.1.5 of the Strategic Plan
  • Relevant international organizations
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?
  • No, consultation was never made
105. Here you may provide further details on the implementation of Article 17 in your country
For more information, please see Q191.
With regard to Q102-104; we have had no incidents of unintentional movements from Norway and thus we recognise these questions as not applicable
Article 18 – Handling, transport, packaging and identification
106. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
107. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
108. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing or a stand-alone document
110. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing or a stand-alone document
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • No
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • One or more
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 50 or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • One or more
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
This question is relevant to indicator 2.3.4 of the Strategic Plan
  • One or more
122. Here you may provide further details on the implementation of Article 18 in your country:
The Norwegian legislative framework addresses 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, fulfil 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 "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 in an accompanying document or notice.
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?
  • Yes
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
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
126. Please provide an overview of the status of the mandatory information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
This question is relevant to indicator 3.1.5 of the Strategic Plan
a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information available and in the BCH
d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information available but only partially available in the BCH
i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available but only partially available in the BCH
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available and in the BCH
l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available and in the BCH
m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information not available
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available and in the BCH
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • No
128. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • No
131. Is the information submitted by your country to the BCH complete and up-to date?
  • No
132. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • 10 or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • 10 or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • national and international publications
135. Here you may provide further details on the implementation of Article 20 in your country
With regard to question 126n; as a consequence of the EEA agreement and implementation of Directive 2001/18/EC in Norway (also described in Q46 and Q75), GMOs approved by this Directive in EU are also legal to place on the marked in Norway, unless Norway decides to restrict or prohibit its placing on the marked according to the Norwegian gene technology act. However, we do not recognize a ban after an approval in EU as a change of a decisions.
With regard to Q126f, g, m, o and p: the correct answer would be not applicable.
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • Yes
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?
  • Yes, to some extent
141. If you answered Yes to question 140, how were these resources made available?
  • Regional channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
143. If you answered Yes to question 142, how were these resources made available?
  • Multilateral channels
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • No
147. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
148. If you answered Yes to question 147, 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
  • 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
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes, a few
152. If you answered Yes to question 151, indicate which of the following areas still need capacity-building.
  • Socio-economic considerations
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • No
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • Yes
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 10 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
Article 23 – Public awareness and participation
158. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • Yes
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • Yes
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • One or more
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
  • Newspaper
  • Mailing lists
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Public hearings
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • No
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • 10 or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • 25 or more
173. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • Yes
175. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • More than 5
176. Here you may provide further details on the implementation of Article 23 in your country
The competent Norwegian authorities and relevant agencies have established biosafety websites. However, there is no central biosafety website.
According to the Norwegian Gene Technology Act, public consultations are mandatory for all applications for marketing of LMOs in Norway. Public awareness and participation is facilitated.
The Norwegian Biotechnology Advisory Board provides relevant information to the public through publications, seminars and workshops.
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • Yes
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • No
183. 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 do 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 during the reporting period  
Article 25 – Illegal transboundary movements
184. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
186. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
If you replied Never to question 186 please go to question 191
  • Less than 5
187. If your country received information concerning cases of illegal transboundary movements of an LMO in the current reporting period, has your country informed the BCH and the other Party(ies) involved?
This question is relevant to indicators 3.1.5 of the Strategic Plan
  • Only the other Party(ies) involved
188. If your country received information concerning cases of illegal transboundary movements of an LMO in the current reporting period, has your country established the origin of the LMO(s)?
  • Yes
189. If your country received information concerning cases of illegal transboundary movements of an LMO in the current reporting period, has your country established the nature of the LMO(s)?
  • Yes
190. If your country received information concerning cases of illegal transboundary movements of an LMO in the current reporting period, has your country established the circumstances of the illegal transboundary movement(s)?
  • Yes, some cases
191. 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 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).
Norwegian Environment Agency and the Norwegian Food Safety Authority perform supervision over the implementation of the Gene Technology Act. Each Year the Norwegian Food Safety Authority takes 100-150 samples of products consisting of, containing or produced from soy beans, maize, rape seeds, rice and papaya in their annually based monitoring and surveillance program 'Monitoring of genetically modified material'. The samples are taken from shipments, production sites and shops and are analysed for GMO, and documentation controls are performed.
So far the sampling and testing have in most cases revealed low levels (mostly below 0.9 %) of unintentional or technically unavoidable GMO presence in conventional soybeans, maize, rape seeds and rice. The papaya products were processed and, hence not considered LMO. However, one sample of maize from Argentina contained the illegal event Bt 176.
Due to the low level presence of GMO, 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.
However, during the current reporting period we have had one incidence of illegal genetically modified Zebra fish, as notified at BCH.
For emergency measures regarding specific non-authorised LMOs, please refer to the EU report.
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • Yes
193. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Yes
194. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • 10 or more
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes
197. 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 sustainability 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.
The assessment of the LMOs benefit to society is primarily focused on effects in Norway, such as whether the LMO helps solving a social problem, create employment opportunities or tend to create problems for existing production that in 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 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.  
Norway is a member of the AHTEG on Socio-economic considerations and participates actively in the current activities under the Protocol aiming at exchanging information on socio-economic impacts of LMOs and working towards developing guidance.
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
200. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • No
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • Yes
Article 28 – Financial Mechanism and Resources
203. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • 1,000,000 USD or more
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due National Reports?
  • Yes