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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102630
Status
Published
Date of creation
2011-10-28 20:14 UTC (andrew.bowers@cbd.int)
Date of last update
2011-11-15 15:48 UTC (andrew.bowers@cbd.int)
Date of publication
2011-11-15 15:48 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • Portugal
Contact officer for report
Coordinates
Maria do Carmo Palma
Head of Unit - Environmental Risks and Emergencies Unit
Portuguese Environment Agency - Ministry of Agriculture, Sea, Environment and Spatial Planning
Rua da Murgueira, 9/9A – Zambujal Apartado 7585
Amadora
Portugal, 2611-865
Phone:+ 351 21 4728368
Fax:+ 351 21 4728231
Email:carmo.figueira@apambiente.pt
Submission
10. Date of submission
2011-10-25
11. Time period covered by this report
Start date
2007-10
Time period covered by this report
End date
2011-09
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
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?
  • Less than 5
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:
The EU biosafety framework as reported by the European Commission (EC) is directly or indirectly applicable to Portugal. The EU-Regulations as referenced by the EC are directly applicable, the relevant EU-Directives have been transposed into Portuguese legislation.

The portuguese Decree-law no. 72/2003, of 10th April, transposes the European Directive 2001/18/EC on the deliberate release into the environment of GMO, covering the field trials of GMOs as 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.  

Decree-law no. 2/2001, of 4th January, concerning the contained use of genetically modified micro-organisms transposing into internal jurisprudence the Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC.

Decree-law no. 7/2004, of 17th April, that approves the Protocol on Biosafety of the Convention on Biological Diversity.

Decree-law no. 164/2004, of 3th July, that modifies the Decree-law no. 72/2003, of 10th April in accordance with Regulation no. 1829/2003 of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed and Regulation no. 1830/2003 of the European Parliament and of the Council 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 and amending Directive 2001/18/EC.

Decree-law no. 168/2004, of 7th July, that executes Regulation no. 1830/2003 of the European Parliament and the Council 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 and amending Directive 2001/18/EC

Notice no. 205/2004, of 21st December, where the Ministry of Foreign Affairs makes public that the Government of the Portuguese Republic has deposited, in 30 of September of 2004, its instrument of relative adhesion to the Cartagena Protocol on Biosafety of the Convention on Biological Diversity.

Decree-law no. 36/2006, of 20th February, It assures the execution and it guarantees the fulfilment, in the national jurisprudence, of the decurrent obligations for the Portuguese State of the Regulation No 1946/2003 of the European Parliament and of the Council, of 15 July 2003, on transboundary movements of genetically modified organisms
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:
The EU framework for medical products as outlined by the submission of the European Commission also applies for Portugal. EU pharma 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?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
The EU framework as outlined by the submission of the European Commission also applies for Portugal.

Contained use: 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

Transit: Regulation 1946/2003 addresses transboundary movement of GMOs, and specifically requirements for exports of GMOs to third countries as well as for unintentional transboundary movements. According to Article 13 of the Regulation 1946/2003, the exporter shall ensure notification of the transit of GMOs through their territory and have informed the BCH of this decision.

Transit procedures through the EU are regulated by the EU transport legislation and the Customs Code.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes, to some extent
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Not applicable
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?
  • Not applicable
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:
Further details on the implementation of Articles 7-10 in Portugal and the other EU-Member-States are outlined in the submission of the European Commission with regard to the EU regulatory framework.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • 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:
For a description of the comprehensive regulatory framework of the EU, which is applicable in Portugal, see the respective submission of the European Commission. Decisions for authorisition of LMOs-FFP are taken at the EU-level and authorise the use of these LMOs-FFP in all EU-member states, including Portugal.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
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?
  • No
73. Has your country ever applied the simplified procedure?
  • No
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:
Portugal has not made use of the simplified procedure for imports of LMOs as specified in Article 13.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
80. Here you may provide further details on the implementation of Article 14 in your country:
The Portuguese government did not enter into any bilateral, regional or multilateral agreements.

The EU has determined as per Article 14(4) and 9 (2) (c) that it relies on its existing legislative framework for intentional movements of GMOs within the European Union and for imports of GMOs into the European Union. This decision has been communicated to other Parties through the Biosafety Clearing-House.
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • Yes
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • No
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:
For a description of the comprehensive regulatory framework of the EU regarding thios issue see the respective submission of the European Commission.

Decisions with regard to release and placing on the market of LMOs are taken on an EU level according to its regulatory framework and are binding for all EU Member States, including Portugal. This biosafety framework mandates to conduct a comprehensive risk assessment prior to decision making. For further information see the respective submission of the European Commission.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
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:
For further information on risk management see the submission of the European Commission concerning Article 16.   As a member of the European Union Portugal is obliged to apply the legislative framework of the EU.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • No
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?
  • Never
107. Here you may provide further details on the implementation of Article 17 in your country:
Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.

As a member of the European Union Portugal is obliged to ensure the enforcement of the EU Regulation 1946/2003 in Portugal.
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes, to some extent
115. Here you may provide further details on the implementation of Article 18 in your country:
Further details on the implementation of Articles 18 in Portugal are outlined in the submission of the European Commission with regard to the EU regulatory framework.

As a member of the European Union Portugal is obliged to apply the legislative framework of the EU. Portugal has implemented the EU directives and ensures the enforcement of the EU regulations.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, one
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
123. Here you may provide further details on the implementation of Article 19 in your country:
Portugal has designated one competent authority and focal point.
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 not available
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 available and in the BCH
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 and in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available 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 not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available 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?
  • No
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • No
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • No
128. Has your country experienced difficulties accessing or using the BCH?
  • No
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
131. Here you may provide further details on the implementation of Article 20 in your country:
The Portugal BCH focal point is regularly coordinating its activities with the national focal points from the other EU member states, with the BCH focal point of the European Community and with the SCBD secretariat.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
134. Here you may provide further details on the implementation of Article 21 in your country:
For further information regarding confidential information see the respective submission of the European Commission.
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?
  • No
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • No
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • No
146. Does your country still have capacity-building needs?
  • No
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
No additional information.
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
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?
  • No
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • Less than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
For further information regarding EU-wide implementation of Article 23 see the respective submission of the European Commission.
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • No
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • No
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
167. Here you may provide further details on the implementation of Article 24 in your country:
For further information regarding Article 24 implementation see the respective submission of the European Commission, since all imports were authorised according to the EU biosafety framework.
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
175. Here you may provide further details on the implementation of Article 25 in your country:
For further information regarding measures concerning illegal transboundary movement of LMOs see the respective submission of the European Commission.
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?
  • No
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes
178. Here you may provide further details on the implementation of Article 26 in your country:
Discussions on the consideration of socio-economic aspects of LMO use are ongoing both at the national level and in coordination with the respective activities of other EU member states and the European Commission. For further information regarding EU level activities see the submission of the European Commission.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
For further information see the respective submission of the European Commission.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
Re: Q. 14 - Entry into force on 29 December 2004

No further comments.
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
No difficulties have been encoutered in filling this report.
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
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • Less than 1 per year
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • No
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
  • No funds mobilized
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • No
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • None
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • Yes
Survey 9.b) Risk management
  • Yes
Here you may provide further details
In addition of the legislative guidance documents at EU level, the European Food Safety Authority also published several documents regarding this issue.  The Joint Research Centre also published several guidance documents on detection of GMOs.
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • Yes
Here you may provide further details
The guidance documents refered to in question 9 are used by EU-Member States.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • Yes
Here you may provide further details
As a member of the European Union, Portugal adopted a common approache regarding this issue.  For further information on risk assessment see submission of the European Commission.
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
Portugal conducts risk assessment of LMO, for the placing on the market of LMO, under the EU regulatory framework.  Decisons with regard to release and placing on the market of LMOs are taken on an EU level according to its regulatory framework and are binding for all Member States, incluinding Portugal. This biosafety framework mandates to conduct a comprehensive risk assessment prior to decision making. For further information see the respective submission of the European Union.
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
Here you may provide further details
Further details on this issue in Portugal are outlined in the submission of the European Commission with regard to the EU regulatory framework.  As a member of the EU, Portugal is obliged to apply the legislative framework of the EU.  Therefore, Portugal has implemented the EU Directives and ensures the enforcement of the EU Regulations.
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • Yes
Here you may provide further details
Further details on this topic in Portugal and the other EU-Member States are outlined in the submission of the European Commission with regard to the EU regulatory framework.  Should be noted that Portugal as transpose and apply at a national level all the EU legislation regaridn this topic.
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • Yes
Here you may provide further details
Discussions on the consideration of socio-economic aspects of LMO use are ongoing both at the national level and in coordintation with the respective activities of the other Member States and the European Commission.  For further information regarding EU level activities see the submission of the European Commission.
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
No experience.
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • Yes
Here you may provide further details
Article 14 of Regulation 1946/2003 provides for measures to prevent unitentional transboundary movement of GMOs and appropriate responses, including emergency measures.  As a member of the European Union, Portugal is obliged to ensure the enforcement of the EU Regulation 1946/2003 in Portugal.  For further information see submission of the European Commission.
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • One or more
Survey 19.b) Monitoring
  • One or more
Survey 19.c) Management / Control
  • One or more
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Here you may provide further details
In Portugal there are one EU Reference Laboratory for GM Food Feed.  For further information see submission of the European Commission.
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Here you may provide further details
For further information see submission of the European Commission.
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • Yes
Survey 22.b) Effective
  • Yes
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • None
Here you may provide further details
Although it has not been given specific training to customs officers in relation to the identification of GMOs, they were trained in labelling and documental identifying of the presence of GMOs as well as carry out sampling for subsequent laboratory analysis in order to confirm or not the presence of GMOs.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • One or more
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • 10 or more
Here you may provide further details
See answer in question 20.
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • No
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • Yes
Here you may provide further details
Further details on the response measures for damage to biodiversty in Portugal and the other EU-Member States are outlined in the submission of the European Commission with regard to the EU regulatory framework.
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • Yes
Here you may provide further details
For further information see submission of the European Commission.  Decisons for authorisation of LMOs-FFP are taken at the Eu-level and authorise the use of these LMOs-FFP in all EU-Member States, incluiding Portugal.
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
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
  • One or more
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • None
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Here you may provide further details
The EU framework, as outlined by the submission of the European Commission, also applies for Portugal.  Portugal develops actions of monitoring and enforcement under the EU legislation and under applicable Portuguese legislation that were transpose into national law.
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
  • None
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
  • None
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • National website
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
  • None
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • No
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • Yes
Here you may provide further details
As a member of the European Union, Portugal adopts the EU communication strategy on Biosafety and all the legislative framework.   For further information see submission of the European Commission.
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
At EU level there are several educational materials on biosafety that are available and accessible to the public.  For further information see submission of the European Commission.