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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109465
Status
Published
Date of creation
2015-11-30 14:08 UTC (Melanie.Josefsson@naturvardsverket.se)
Date of publication
2015-11-30 14:08 UTC (Melanie.Josefsson@naturvardsverket.se)

Origin of report
1. Country
  • Sweden
Contact officer for report
Coordinates
Ms Johanna Kirsten
Deputy Director
Ministry of the Environment and Energy
SE-103 33 Stockholm
Stockholm, Stockholm
Sweden, SE-103 33
Phone:+46 8 405 1000
Fax:+46 8 405 1982
Email:johanna.kirsten@gov.se
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Swedish Environmental Protection Agency
Swedish Work Environment Authority
Swedish Agency for Marine and Water Management
Formas
Swedish Gene Technology Advisory Board
Swedish Board of Agriculture
Swedish Chemical Agency
Swedish National Board of Trade
Swedish National Food Agency
Swedish Medical Products Agency
Swedish Civil Contingencies Service
Swedish International Development Cooperation Agency
Swedish Board of Forestry
Swedish Customs Agency
Swedish Ecological Farmers
Greenpeace
Federation of Swedish Farmers
SW Seed
SwedBio
Swedish Society for Nature Conservation
Syngenta Seeds AB
Submission
10. Date of submission
2015-11-30
11. Time period covered by this report
Start date
2012-01-01
11. Time period covered by this report
End date
2015-11-30
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
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country
EU legislation on genetically modified organisms (GMOs) has been in place since the early 1990s. The EU introduced specific legislation on GMOs to protect its citizens' health and the environment while simultaneously creating a unified market for biotechnology products. The EU has created a comprehensive legal framework for ensuring safety in the development, use and transfer of GMOs. The main pieces of legislation are:
- Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, covering the field testing of GMOs and the placing on the market of GMOs as well as products containing or consisting of GMOs, e.g. for cultivation, import or processing into industrial products.
- Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, covering the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs.
- Regulation (EC) No 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.
- Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms covers exports of GMOs to third countries and unintentional movements of GMOs.
- Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation.
- Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms.
- Commission Regulation 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired.
- Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006.
- Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015  amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory.
More information on the content of these legislative acts is available at:  http://ec.europa.eu/food/plant/gmo/new/legislation/index_en.htm
In the case of Directives 2001/18/EC and (EU) 2015/412, and of Regulations (EC) No 1829/2003, 1830/2003 and 1946/2003, Member States have introduced domestic provisions to ensure enforcement and/or transposition of this legislation within their territories. For implementing legislation at EU Member States level, please refer to the Member States national reports.
                                                                                            ]
Article 5 - Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • Yes
24. Here you may provide further details on the implementation of Article 5 in your country:
EU pharmaceuticals legislation provides that a medicinal product may only be placed on the market in the EU if it has received a marketing authorisation, granted either by the European Commission or by a member state. As regards medicinal products containing or consisting of GMOs, the assessment for a marketing authorisation must include an environmental risk assessment in line with the requirements of Directive 2001/18/EC. Regulation 1946/2003 mirrors the provisions of the Protocol as regards exports of pharmaceuticals.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • Yes
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
Transit is not specifically regulated in Swedish or EU law, but the rules for traceability and labelling provide a transparent system if Living Modified Organisms were to be in transit in Sweden.
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
  • No
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?
  • More 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?
  • None
39. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
46. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment
Article  7 - 10 for release on the market is implemented in legislation at the EU level and these answers will be provided by the Member States and the European Commission (Dir. 2001/18, Reg, 1829/2003 and Reg. 1830/2003).
Directive 2001/18/EC is implemented in Swedish Ordinance (2002:1086). Decisions on intentional introduction to the environment as field trials are however made at national level. This procedure is also regulated in Ordinance (2002:1086) and is in compliance with the provisions of the Biosafety protocol. The regulation for authorisation of LMO is based on the use of a LMO, not the transboundary movement in itself even though import might be one of the areas of use.
32. According to EU legislation, the export of GMOs is primarily an issue between the exporter and the Party of import. Swedish authorities are responsible for supervising the exporter's compliance with the rules i.e. Reg. (EU) 1946/2003. 
33.  Regarding exports, the EU legislation (Reg. no 1946/2003) doesn't specifically address the accuracy of the information provided by the exporter. But the penalties laid down in the Swedish Environmental Code Chapter 29 Section 9.7-8 lay down the penalty for violation articles 6, 12 and 13 of Reg. (EU) 1946/2003.
34-39. One of the European authorisation process for release on the market of an LMO (Dir. 2001/18) include that the competent authority that first received a notification shall also write the decision. This was done in by a Swedish authority in 2010. The authorisation is though applicable in all of the European community. Decisions on field trials are taken nationally.
36 - 37 Decisions on field trials are alsways beased on an application that corresponds with the provisions of articles 7-10 and 12. Permission must be given by the proper authority before a release into the environment. There is no difference as to if the LMO is produced within the country or imported.  
We also refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • More than 10
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
57. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • Yes, always
58. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP
Article 11 is implemented in legislation at the EU level. The EU has developed a comprehensive legal framework on GMOs, which also addresses the import of GMOs intended for direct use for food or feed, or for processing. The EU has declared with reference to Article 14.4 of the Cartagena Protocol that it relies on its existing legislative framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU.
With regard to the decisions taken for placing on the market of LMOs-FFP, it has to be noted that those decisions are taken for the whole European territory and not by the MS individually.      
We also refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.
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
Article 12 is implemented in legislation at EU level. See Article 20 of Directive 2001/18 and Articles 21 and 22 of Regulation 1829/2003. Sweden has followed the answers as provided by the European Commission for questions 59-62. We also refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
68. Has your country ever applied the simplified procedure?
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
71. Here you may provide further details on the implementation of Article 13 in your country
Article 13 is implemented in legislation at the EU level. The EU has not made use of the simplified procedure for imports of LMOs as specified in Article 13.  We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.
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
Sweden is a Member State of the European Union. In the European Union, most of the legislation pertaining to the Cartegena Protocol is harmonised.                                                    
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
  • No
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • Yes
84. Does your country have the capacity to detect, identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • Yes
88. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • No
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
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
Articles 15 & 16 are implemented in legislation at the EU level. EU and national legislation require the notifier to perform a risk assessment according to guidance developed by the European Food Safety Agency (EFSA),  when applying for approval of a LMO for cultivation or as food or feed. EU regulation 1829/2003 and 2001:18 apply. Risk assesments are to be evaluated by the competent authorities in all member states. 
Risk assessments for field trials are assessed by competent authorities in Sweden according to national legislation which is in line with EU legislation. 
We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.
Article 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
99. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
Article 18 – Handling, transport, packaging and identification
106. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
107. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
108. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing types of documentation
110. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • None
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • One 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:
Article 18 is implemented through EU legislation. Directive 2008/68/EC has been included instead of Council Directives 94/55/EC and 96/49/EC, which had been repealed. We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety. 
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
125. Here you may provide further details on the implementation of Article 19 in your country
Responsibility for administrating and handling GMOs in Sweden is shared by several central authorities, depending on the type of organisms. The Swedish Board of Agriculture has a major roll because most GMOs are agricultural crops.
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 not available
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 not available
k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available and in the BCH
l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available and in the BCH
m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information available and in the BCH
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information available and in the BCH
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
  • One 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
  • One or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National website
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. Here you may provide further details on the implementation of Article 21 in your country
Regarding question 136. Article 25 in directive 2001/18/EC and article 30 in 1829/2003 implements article 21 of the protocol. This is further implemented in the Swedish Public Access to Information and Secrecy Act 2009:400 and the Public access to information and Secrecy ordinance 2009:641.
Regarding question 136. The notifier is allowed to identify what information it wants to keep confidential. However, the decision on what information to be considered confidential has to be assessed by for the Swedish authority.
We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.                                                                                           
The EU applies its domestic legislative framework instead of the Protocol's advance informed agreement procedure. This framework is compatible with the provisions of the Protocol. It contains confidentiality provisions that apply equally to domestic and foreign producers of GMOs.
Article 25 of Directive 2001/18/EC on the deliberate release into the environment of GMOs stipulates that the European Commission and the Member States shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.
Article 30 of Regulation (EC) No 1829/2003 on genetically modified food and feed allows applicants to indicate which information submitted under the Regulation they wish to be treated as confidential, based on verifiable justification.
Article 16 of Regulation (EC) No 1946/2003 on transboundary movements of GMOs obliges the European Commission and the Member States not to divulge to third parties any confidential information received or exchanged under this Regulation. It allows the exporter to indicate the information in the notification that should be treated as confidential, provided that justification is given in such cases.
However, all the above confidentialy provisions make clear what information shall never be considered as confidential, notably as regards the general description of the GMO, the name and address of the authorisation holders, the risk assessment information and any methods and plans for emergency responses.    

                                                                                                 
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • 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?
  • No
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
143. If you answered Yes to question 142, how were these resources made available?
  • Bilateral 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?
  • Public awareness, participation and education in biosafety
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
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.
  • Scientific biosafety research relating to LMOs
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?
  • No
Article 23 – Public awareness and participation
158. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • Yes
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • Yes
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
The Swedish GMO authorities have a joint organisation, the Swedish Gene Technology Advisory Board and website (http://www.genteknik.se) for dissemination of information on GMO regulations, current research and ongoing applications and remits, including a link to the BCH website. Programs are on a national level.
All authorities have specific information on GMOs in relation to their competence on their website. The designated function of the Swedish Gene Technology Advisory Board is to promote, by means of consultation, uses of gene technology which are ethically defensible from the standpoint of human and animal health. That task includes dissemination of knowledge concerning the development of gene technology. The public should be informed in such a way that its interests in ethical and safety issues are safeguarded, while public debate and participation in such issues is stimulated.
The responsible authorities in Sweden have information on their web sites for all notifications and applications for field trials. The public can read summaries of the notifications and is also given the opportunity to send in any comments to the authorities. Depending on the scope of the application and what legislation it is notified within, the public can also submit comments via the Joint Research Centre website, the EC commission or the competent authorities web-sites.
The website of the Swedish Board of Agriculture (http://www.jordbruksverket.se) contains information about which GM crops have been approved for import and/or cultivation within the EU and decisions on field trials in Sweden.
The Swedish gene technology authorities also have a common website (http://www.gmo.nu) to make it easier for people who use gene technology, or who take interest in the subjekt, to find information about the legislation and the requirements that applies to various types of activities.
In Sweden the principle of public access to official documents is applied. All Swedish citizens are entitled to read the documents held by public authorities. This means that documents received as well as dispatched letters, decisions and reports are in principle official documents and must be made available for anyone to read. Access to official documents may however be restricted if they may be kept secret in order to protect specified interests.
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
  • No
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
  • 5 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
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • 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
  • 5 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
  • 10 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 Swedish GMO authorities have a joint organisation, the Swedish Gene Technology Advisory Board and website (http://www.genteknik.se) for dissemination of information on GMO regulations, current research and ongoing applications and remits, including a link to the BCH website. Programs are on a national level.
All authorities have specific information on GMOs in relation to their competence on their website. The designated function of the Swedish Gene Technology Advisory Board is to promote, by means of consultation, uses of gene technology which are ethically defensible from the standpoint of human and animal health. That task includes dissemination of knowledge concerning the development of gene technology. The public should be informed in such a way that its interests in ethical and safety issues are safeguarded, while public debate and participation in such issues is stimulated.
The responsible authorities in Sweden have information on their web sites for every notifications and applications for field trials. The public can read summaries of the notifications and is also given the opportunity to send in any comments to the authorities. Depending on the scope of the application and what legislation it is notified within, the public can also submit comments via the Joint Research Centre website, the EC commission or the competent authorities web-sites.
The website of the Swedish Board of Agriculture (http://www.jordbruksverket.se) contains information about which GM crops have been approved for import and/or cultivation within the EU and decisions on field trials in Sweden. Information and decisions about field trials are also published in relevant local newspapers.
The Swedish gene technology authorities also have a common website (http://www.gmo.nu) to make it easier for people who use gene technology, or who take interest in the subjekt, to find information about the legislation and the requirements that applies to various types of activities.
In Sweden the principle of public access to official documents is applied. All Swedish citizens are entitled to read the documents held by public authorities. This means that documents received as well as dispatched letters, decisions and reports are in principle official documents and must be made available for anyone to read. Access to official documents may however be restricted if they may be kept secret in order to protect specified interests.
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?
  • No
179. Has your country ever exported LMOs to a non-Party?
  • No
183. Here you may provide further details on the implementation of Article 24 in your country:
We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.
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?
  • No
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
  • Never
191. Here you may provide further details on the implementation of Article 25 in your country
According to Directive 2001/18/EC, it is the Member States that are obliged to take domestic measures to prevent and penalize illegal transboundary movements of GMOs. European legislation contains explicit obligations on Member States to lay down rules on penalties applicable to infringements of the provisions of European regulations. Infringement of EU Reg. no 1946/2003 will in Sweden be regarded as an infringement of the Environmental Code and the penalties laid down in the Code will apply.
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?
  • Not applicable
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
  • None
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
Sweden participates in the European  GMO Socio-Economics Bureau, which aims to facilitate the exchange of technical and socio-implications of the cultivation and use of genetically modified organisms. This group has published a report on the socio-economic implications of the cultivation of Genetically Modified Organisms (GMOs) describing the state of knowledge. https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/framework-socio-economic-analysis-cultivation-genetically-modified-crops
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes
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
  • Less than 5,000 USD
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