Record details

Origin of report

Country

Sweden

Contact officer for report

Coordinates

Deputy Director Johanna Kirsten

Deputy Director

Ministry of the Environment

Ministry of the Environment SE-103 33 STOCKHOLM Sweden

STOCKHOLM

Sweden, SE-103 33

Phone:	+46 8 405 22 30
Email:	johanna.kirsten@environment.ministry.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 Board of Fisheries
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
Plant Science Sweden AB
SW Seed
SwedBio
Swedish Society for Nature Conservation
Syngenta Seeds AB

Submission

10. Date of submission

2011-10-07

11. Time period covered by this report

Start date

2006-07-01

Time period covered by this report

End date

2011-10-07

Party to the Cartagena Protocol on Biosafety

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

Article 2 – General provisions

15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?

A domestic regulatory framework is fully in place

16. Which specific instruments are in place for the implementation of your national biosafety framework?

One or more national biosafety laws
One or more national biosafety regulations

17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?

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

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)?

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

We refer to the EU's Second National Report on the Implementation of the Cartegena Protocol on Biosafety

Article 5 – Pharmaceuticals

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

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

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

Pharmaceuticals are regulated under EU-law as other LMOs

Article 6 – Transit and Contained use

25. Does your country regulate the transit of LMOs?

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

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

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

Regarding 25: Transit is not specifically regulated in Swedish or EU-law, but the rules for traceability and labelling provides for a transparent system if LMOs were to be in transit via Sweden. Regarding 26: Decisions on LMO that are micro-organisms in risk class 3 or 4 (high risk human pathogens) are routinely sent to the Swedish Focal Point for submission to the BCH mechanism, as we cannot exclude export of such LMOs (all are used in research). We also refer to the EU's Second National Report on the Implementation of the Cartegena Protocol on Biosafety.

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?

30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?

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

32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?

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

34. Does your country have the capacity to detect and identify LMOs?

35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?

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

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

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

39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?

None

40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?

More than 10

41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

None

42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

None

50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:

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.
30-32. Decisions on field trials are always based on an application that corresponds with the provisions of articles 7-10 and 12. Permission must be given by proper authority before a release into the environment. There is no difference if the LMO is produced within the country or imported.
33. Monitoring is required by EU Dir. 2001/18 and the Swedish Ordinance (2002:1086) on the Deliberate Release of Genetically Modified Organisms in the Environment.
35. 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.
36. 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.
38-42. 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. Since 2006, 23 applications have been submitted and all have received permission (5 year permits).
We also refer to the EU's Second 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)

51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?

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

53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?

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

55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?

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

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

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

More than 10

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

More than 10

60. 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

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

Yes, always

62. 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

63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:

Article 11 is implemented in legislation at EU level and Sweden has answered questions 51-63 according to the European Commission's Second National Report on the Implementation of the Cartegena Protocol on Biosafety .

Article 12 – Review of decision

64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?

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

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

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

None

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

Article 12 is implemented in legislation at EU level. Sweden has followed the answers as provided by the European Commission for questions 64-70. We also refer to the EU's Second National Report on the Implementation of the Cartegena Protocol on Biosafety

Article 13 – Simplified procedure

72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?

73. Has your country ever applied the simplified procedure?

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

None

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

Article 13 is implemented in legislation at EU level. Sweden has followed the answers as provided by the European Commission for questions 72-75.

Article 14 – Bilateral, regional and multilateral agreements and arrangements

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

78. If you answered Yes to question 77, has your country informed the Parties through the BCH of the agreements or arrangements?

Yes, always

79. If you answered Yes to question 77, please provide a brief description of the scope and objective of the agreements or arrangements entered into:

Sweden is a Member State of the European Union. In the European Union the main part of issues covered by the Cartagena Protocol is totally harmonised legislation

Article 15 – Risk assessment

81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?

82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?

83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?

84. Has your country acquired the necessary domestic capacity to conduct risk assessment?

85. Has your country established a mechanism for training national experts to conduct risk assessments?

86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?

87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?

88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?

Yes, always

89. Has your country submitted summary reports of the risk assessments to the BCH?

In some cases only

90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?

More than 10

91. Has your country ever required the exporter to conduct the risk assessment(s)?

Yes, always

92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?

Yes, always

93. Here you may provide further details on the implementation of Article 15 in your country:

Regarding question 82-85 Sweden does not have a special mechanism for training experts, but the staff involved in assessing risk assessment is well educated.
88, 91. The legislation requires the notifier to perform a risk assessment. Risk assessments are to be evaluated by all member-states. Risk assessments contained in notifications made under EU Reg. 1829/2003 are evaluated by the European Food Safety Authority and the competent authorities of the member-states. Field trials are assessed nationally.
92.There is a fee for submitting a notification to Swedish authorities.
Laws states that all risk assessment shall be done by the notifier and for contained use of LMOs that are micro-organisms, the risk assessment must be done according to the EU-directive 2009/41/EC on the contained use of genetically modified micro-organisms and the workers protection EU-directive 2000/54/EC on biological agents.
We also refer to the EU's Second National Report on the Implementation of the Cartegena Protocol on Biosafety.

Article 16 – Risk management

94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:

94.1) LMOs for intentional introduction into the environment?

94.2) LMOs intended for direct use as food or feed, or for processing?

95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?

96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?

97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?

98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?

99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:

Regarding question 96, the EU legislation stipulates that a step-wise introduction into the environment. A thorough risk assessment must be done prior to commercialisation but this does not necessarily include field trials in all Member States where the GMO will be released.
Concerning 94: Respective Swedish authorities are responsible for supervising, through inspections, all activity with LMOs.
Concerning 98: A case-by-case risk assessment must be done prior to commercialisation.
We also refer to the EU's Second National Report on the Implementation of the Cartegena Protocol on Biosafety.

Article 17 – Unintentional transboundary movements and emergency measures

100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?

101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?

102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?

103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?

Less than 5

104. Has your country notified affected or potentially affected States, the BCH and, where appropriate, relevant international organizations, of the above release?

Yes, for every occurence

105. If you answered Yes to question 104, who did your country notify?

The affected or potentially affected State

106. Has your country immediately consulted the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures?

Yes, always

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

Concerning 101. The Swedish Board of Agriculture has an organisation for handling of crisis that would deal with such measures.
Concerning 102. In 2010 there was an incident in Sweden where a GM-potato authorised only for field trials was discovered in plantings with a GM-potato that was authorised for commercial cultivation. This co-mingling was not considered as an environmental risk. The Member States that also cultivated this potato were immediately notified. Since there was no risk for transboundary movement, the BCH or others outside of the European Community were not informed.

Article 18 – Handling, transport, packaging and identification

108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?

109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?

110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?

111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?

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?

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

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

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

Article 18 is implemented in legislation at EU level and Sweden has followed the answers provided by the European Commission for questions 108-114. Regarding 109, the EU legislation does not accept a "may contain" labelling, but it is mandatory to label if a product contains GMOs.
Regarding 11: Sweden is furthermore a Contracting Party to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR). EU Council Directive 94/55/EC on the Approximation of the Laws of the Member-States with regard to the Transport of Dangerous Goods stipulates that the ADR rules shall be extended to cover national traffic, as well. Even Dir 96/49/EC on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail applies. Accordingly, GMO:s classified as dangerous goods are transported according to the ADR rules. This involves requirements for packaging, labelling and accompanying documentation.
We also refer to the EU's Second National Report on the Implementation of the Cartegena Protocol on Biosafety.

Article 19 – Competent National Authorities and National Focal Points

116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?

117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?

118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?

Yes, more than one

119. In case your country designated more than one competent national authority, has your country conveyed to the Secretariat the respective responsibilities of those authorities?

120. Has your country made available the required information referred in questions 116-119 to the BCH?

Yes, all information

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

122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?

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

The responsibility for administrating and handling GMOs in Sweden is shared by several central authorities depending on type of organisms. The Swedish Board of Agriculture takes a large part because most GMOs so far have been agricultural crops.

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

124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.

124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))

Information available and in the BCH

124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)

Information available and in the BCH

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

Information available and in the BCH

124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))

Information available and in the BCH

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

Information available and in the BCH

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

Information not available

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

Information not available

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

Information not available

124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))

Information available but only partially available in the BCH

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

Information not available

124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)

Information available and in the BCH

124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))

Information available and in the BCH

124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)

Information available and in the BCH

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

Information not available

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

Information available and in the BCH

124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)

Information not available

124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))

Information available and in the BCH

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

126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?

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

Yes, in some cases

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

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

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

We also refer to the EU's Second National Report on the Implementation of the Cartegena Protocol on Biosafety

Article 21 – Confidential information

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

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

Yes, always

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

Regarding question 132. 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 133. 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 also refer to the EU's Second National Report on the Implementation of the Cartegena Protocol on Biosafety

Article 22 – Capacity-building

135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?

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

138. If you answered Yes to question 137, how were these resources made available?

Bilateral channels

139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?

143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?

144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?

Institutional capacity
Implementation of the documentation requirements under Article 18.2 of the Protocol
Scientific biosafety research relating to LMOs

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

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

Yes, a few

147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.

Scientific biosafety research relating to LMOs

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

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

Article 23 – Public awareness and participation

151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?

152. Has your country established a biosafety website?

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

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

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

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

157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?

158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?

159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?

More than 5

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

151. Swedish GMO authorities have a joint website (http://www.gmo.nu) for information on GMO regulations, including a link to the BCH website. 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 on such issues is stimulated.
153. 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, namely:
• the security of the Realm or its relations with another state or international organization;
• the central fiscal, monetary or currency policies of the Realm;
• the inspection, control or other supervisory activities of a public authority;
• the interest of preventing or prosecuting crime;
• the public economic interest;
• the protection of the personal or economic circumstances of private subjects; or
• the preservation of animal or plant species.
154. The responsible authorities have information on their web sites on every notification. 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.
155. 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.

Article 24 – Non-Parties

161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?

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

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

166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?

Not applicable

Article 25 – Illegal transboundary movements

168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?

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

170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?

Never

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

Regarding question 168. 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

176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?

Not applicable

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

Yes, to a limited extent

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

Sweden has submitted a report (2010 Feb) to the EU Commission on expected socio-economic consequences of the use of GMOs in Sweden. The EU has published "Report from the Commission to the European Parliament and the Council on socio-economic implications of the GMO cultivation on the basis of Member States contributions SEC (2011) 481 final.

Article 27 – Liability and Redress

179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?

180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?

Article 33 – Monitoring and reporting

182. Has your country submitted the previous national reports (Interim and First National Reports)?

Survey on indicators of the Strategic Plan (2014)

In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.

When did your national biosafety framework become operational?

indicator 1.1.1

2001 or earlier

Here you may provide further details

Sweden provides funding for implementation of the Biosafety Protocol through regular national budgetary allocation for among other things an information portal on LMOs at http://www.genteknik.nu and the Swedish Board of Agriculture.

Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?

indicator 1.2.3

10 per year or more

Here you may provide further details

Several universities offer academic courses in gene technology and biosafety. Biosafety is also included in academic courses in Molecular Biology.

Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?

indicator 1.2.4

Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?

indicator 1.2.5

Less than 5,000 USD

Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?

indicator 1.2.6

Here you may provide further details

Government funding is provided for university education in biosafety.

Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?

indicator 1.2.8

One or more

Here you may provide further details

Sweden is a member state of the European Union. Within the EU, the majority of the issues covered by the Biosafety Protocol.

Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?

indicator 1.3.1.1

Survey 9.a) Risk assessment

Survey 9.b) Risk management

Here you may provide further details

Sweden uses the risk assessment guidance published by the European Food Safety Agency and approved by the European Union.

Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?

indicator 1.3.1.2

Here you may provide further details

Sweden uses the risk assessment guidance published by the European Food Safety Agency and approved by the European Union.

Survey 11. Has your country adopted any common approaches to risk assessment with other countries?

indicator 1.3.2

Here you may provide further details

Sweden uses the risk assessment guidance published by the European Food Safety Agency and approved by the European Union.

Survey 12. Has your country ever conducted a risk assessment of an LMO?

indicator 1.3.3

Here you may provide further details

Sweden conducts risk assessments within the framework of applications for field trials of LMO.

Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?

indicator 1.4.2

Survey 13.a) Identify

Survey 13.b) Assess

Survey 13.c) Monitor

Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?

indicator 1.6.4

Here you may provide further details

Sweden follows the guidance and regulations approved by the European Union, particularly the Directive 2001/18/EG.

Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?

indicator 1.7.2

Here you may provide further details

The Swedish Environmental Code 13 Chapter §13 specifies the a permits for intentional release of genetically modified organisms is to be granted only if is is ethical. Sweden also participates in the EU Working Group European GMO Socio-Economic Bureau.

Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?

indicator 1.7.1

None

Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?

indicator 1.7.3

The general public is invited to submit comments on applications for field trials, which are included in the decision making process.

Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?

indicator 1.8.3

Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?

indicator 2.2.3

Survey 19.a) Risk assessment

10 or more

Survey 19.b) Monitoring

10 or more

Survey 19.c) Management / Control

10 or more

Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?

indicator 2.2.4

Here you may provide further details

The Swedish Food Agency's laboratories are active in monitoring and managing LMOs.

Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?

indicator 2.2.5

Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?

indicator 2.2.6

Survey 22.a) Sufficient

Survey 22.b) Effective

Survey 23. How many customs officers in your country have received training in the identification of LMOs?

indicator 2.3.1

None

Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?

indicator 2.3.1

10 or more

Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?

indicator 2.3.2

Here you may provide further details

The Swedish Food Agency's laboratories

Survey 26. How many laboratories in your country are certified for LMO detection?

indicator 2.3.3

One or more

Here you may provide further details

The Swedish Food Agency's laboratories

Survey 27. How many of the certified laboratories in the previous question are operational?

indicator 2.3.4

One or more

Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?

indicator 2.4.1

Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?

indicator 2.4.2

Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?

indicator 2.5.2

Here you may provide further details

The public is informed of pending applications for field trials and is provided the opportunity to comment on the website of the Swedish Board of Agriculture.

Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?

indicator 2.5.2

National website
Public hearings

Survey 32. If you indicated multiple modalities for public participation in the question above, which one was most used?

indicator 2.5.2

National website

Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?

indicator 2.7.1

5 or more

Survey 34. How many biosafety training materials and/or online modules are available in your country?

indicator 2.7.2

10 or more

Survey 35. Does your country have in place a monitoring and/or an enforcement system?

indicator 3.1.6

Survey 35.a) Monitoring system

Survey 35.b) Enforcement system

Here you may provide further details

The monitoring and enforcement systems are mainly organized by the Swedish Board of Agriculture and the Swedish Food Agency. The Swedish Environmental Protection Agency has an advisory role in monitoring and enforcement.

Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.

indicator 4.3.1

5 or more

Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.

indicator 4.3.2

10 or more

Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.

indicator 4.3.2

National Libraries

Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?

indicator 5.2.1

5 or more

Here you may provide further details

Sweden has collaborative initiatives through the European Union.

Survey 40. Does your country have any awareness and outreach programmes on biosafety?

indicator 5.3.1

Here you may provide further details

The Swedish Gene Technology Board and the Swedish Board of Agriculture have initiatives on outreach about biosafety.

Survey 41. If you answered yes to the question above, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place.

indicator 5.3.1
E.g. local, national, etc.,

The Swedish Gene Technology Board and the Swedish Board of Agriculture have initiatives on outreach about biosafety.

Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?

indicator 5.3.2

Here you may provide further details

The Swedish Gene Technology Board and the Swedish Board of Agriculture have initiatives on outreach about biosafety.

Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.

indicator 5.3.4

10 or more

Here you may provide further details

See http://www.genteknik.se/sv/skolmaterial-etc