Record details

Origin of report

1. Country

Portugal

Contact officer for report

Coordinates

Luis Gramacho

National Focal Point for the Cartagena Protocol

Portuguese Environment Agency - Ministry of Environment, Spatial Planning and Energy (APA)

Rua da Murgueira, 9/9A - Zambujal Apartado 7585 2611-865 Amadora

Amadora, Lisboa

Portugal, 2611-865

Phone:	+ 351 21 4721410
Email:	luis.gramacho@apambiente.pt

Consulted stakeholders

9. Organizations/stakeholders who were consulted or participated in the preparation of this report

Directorate-General of Food and Veterinary Medicine and the Institute for Agrarian and Veterinarian Research - Ministry of Agriculture and Sea; Tax and Customs Authority - Ministry of Finance; National Authority of Medicines and Health Products - Ministry of Health

Submission

10. Date of submission

2015-10-30

11. Time period covered by this report

Start date

2011-10-01

11. Time period covered by this report

End date

2015-10-31

Party to the Cartagena Protocol on Biosafety

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

Article 2 – General provisions

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

This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan

A domestic regulatory framework is fully in place

15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?

This question is relevant to the indicator 1.1.1 of the Strategic Plan

2001 or earlier

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

One or more national biosafety laws

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?

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

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. 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
Decree-law no. 55/2015, of 17th April, concerning the contained use of genetically modified microorganisms and genetically modified organisms, with a view to protecting human health and the environment, transposing Directive No. 2009/41/EC of the European Parliament and of the Council, of 6 May 2009

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:

The EU framework for medical products as outlined by the report submitted by 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?

This question is relevant to indicator 1.8.1 of the Strategic Plan

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

This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan

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:

The EU legal framework specified in the report submited by the European Commission also applies for Portugal, namely:
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 OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?

This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan

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

31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?

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

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

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

This question is relevant to indicator 1.1.4 of the Strategic Plan

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

This question is relevant to indicator 1.1.5 of the Strategic Plan

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

None

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

None

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

The EU biosafety framework as reported by the European Commission (EC) is directly or indirectly applicable to Portugal.
Decisions for authorisition of LMOs are taken at the EU-level and the authorisations are applied in all EU-member states, including Portugal.
Please see European Commission responses to questions 34 to 39.
Further details on the implementation of Articles 7-10 in Portugal and the other EU-Member-States are outlined in the report submitted by 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)

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

This question is relevant to indicator 1.1.2 of the Strategic Plan

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

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

This question is relevant to indicator 3.1.5 of the Strategic Plan

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

This question is relevant to indicator 1.1.2 of the Strategic Plan

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

This question is relevant to indicator 1.2.1 of the Strategic Plan

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

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

Decisions for authorisition of LMOs-FFP are taken at the EU-level and applyied to all Member-States, including Portugal. In this sense Portugal has no individual decisions.
Please see European Commission responses to questions 52 to 55.
For a description of the comprehensive regulatory framework of the EU, which is applicable in Portugal, see the respective submission of the European Commission.

Article 12 – Review of decision

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

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

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

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

None

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

For further details see Article 20 of Directive 2001/18/EC and Articles 21 and 22 of Regulation 1829/2003.

Article 13 – Simplified procedure

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

68. Has your country ever applied the simplified procedure?

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

None

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

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

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

76. 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.

Articles 15 & 16 – Risk Assessment and Risk Management

77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?

78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?

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

This question is relevant to indicator 2.2.3 of the Strategic Plan

a) Risk assessment:

One or more

b) Management / Control:

One or more

c) Monitoring:

One or more

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

This question is relevant to indicator 2.2.5 of the Strategic Plan

81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?

This question is relevant to indicator 2.2.5 of the Strategic Plan

82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?

This question is relevant to indicator 2.2.5 of the Strategic Plan

83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?

This question is relevant to indicator 2.2.6 of the Strategic Plan

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

This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan

a) Detect:

b) Identify:

c) Assess:

d) Monitor:

85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?

This question is relevant to indicators 1.3.1 of the Strategic Plan

a) Risk assessment:

b) Risk management:

86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?

This question is relevant to indicator 2.2.5 of the Strategic Plan

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

This question is relevant to indicator 1.3.2 of the Strategic Plan

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

This question is relevant to indicator 1.4.1 of the Strategic Plan

89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?

This question is relevant to indicator 1.3.3 of the Strategic Plan

90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):

Commercial production
Field trial
LMOs for Contained use
LMOs for direct use as food
LMOs for direct use as feed
LMOs for processing

91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?

This question is relevant to indicator 3.1.5 of the Strategic Plan

In some cases only

92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?

Yes, always

93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?

More than 10

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

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

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

This question is relevant to indicator 2.2.4 of the Strategic Plan

97. Here you may provide further details on the implementation of Articles 15 and 16 in your country

For a description of the comprehensive regulatory framework of the EU regarding this 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 17 – Unintentional transboundary movements and emergency measures

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

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

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

This question is relevant to indicator 1.8.3 of the Strategic Plan

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

Never

105. 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

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

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

This question is relevant to indicator 1.6.1 of the Strategic Plan

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

This question is relevant to indicator 1.6.1 of the Strategic Plan

109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?

Existing types of documentation

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

This question is relevant to indicator 1.6.2 of the Strategic Plan

111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?

Existing types of documentation

112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?

This question is relevant to indicator 1.6.2 of the Strategic Plan

113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?

Existing types of documentation

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

This question is relevant to indicator 1.6.4 of the Strategic Plan

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

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

This question is relevant to indicator 2.3.1 of the Strategic Plan

None

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

Yes, to some extent

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

This question is relevant to indicator 2.3.1 of the Strategic Plan

One or more

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

This question is relevant to indicator 2.3.2 of the Strategic Plan

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

This question is relevant to indicator 2.3.3 of the Strategic Plan

None

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

The National Institute for Agricutural and Veterinarian Research (INIAV) has one GMO laboratory which is on the accreditation process. By the end of 2015, the accreditation dossier will be submitted to the Portuguese Accreditation Body. The GMO laboratory is operating under the ISO 17025 rules and since may 2014, it covers seed, food and feed analysis.
Further details on the implementation of Articles 18 in Portugal are outlined in the report submitted by 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

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

Not applicable

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

125. 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)

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

This question is relevant to indicator 3.1.5 of the Strategic Plan

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

Information available and in the BCH

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

Information available and in the BCH

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

Information not available

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

Information available and in the BCH

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

Information available and in the BCH

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

Information available and in the BCH

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

Information not available

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

Information not available

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

Information available and in the BCH

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

Information available and in the BCH

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

Information available and in the BCH

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

Information available and in the BCH

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

Information available and in the BCH

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

Information not available

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

Information not available

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

Information not available

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

Information available and in the BCH

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

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

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

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

This question is relevant to indicator 4.1.8 of the Strategic Plan

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

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

This question is relevant to indicator 4.3.1 of the Strategic Plan

None

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

This question is relevant to indicator 4.3.2 of the Strategic Plan

None

135. 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

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

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

Yes, always

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

For further information regarding confidential information see the respective submission report of the European Commission.

Article 22 – Capacity-building

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

This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan

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

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

144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?

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

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

This question is relevant to indicator 1.2.1 of the Strategic Plan

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

This question is relevant to indicator 1.2.7 of the Strategic Plan

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

This question is relevant to indicator 1.2.2 of the Strategic Plan

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

This question is relevant to indicator 1.2.4 of the Strategic Plan

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

This question is relevant to indicator 1.2.3 of the Strategic Plan

None

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

157. 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

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

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

This question is relevant to indicator 5.3.2 of the Strategic Plan

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

This question is relevant to indicator 5.3.1 of the Strategic Plan

162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?

This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan

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

This question is relevant to indicator 5.2.1 of the Strategic Plan

None

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

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

This question is relevant to indicator 2.5.1 of the Strategic Plan

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

This question is relevant to indicator 2.5.1 of the Strategic Plan

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

This question is relevant to indicator 2.5.2 of the Strategic Plan

Yes, to some extent

Here you may provide further details

Public consultation regarding field trials.

168. If you answered Yes to question 167, please indicate the modalities used to inform the public:

This question is relevant to indicator 2.5.2 of the Strategic Plan

National website

169. If you indicated more than one modality for public participation in question 168, which one was most used?

This question is relevant to indicator 2.5.2 of the Strategic Plan

National website

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

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

This question is relevant to indicator 2.7.1 of the Strategic Plan

One or more

172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:

This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan

5 or more

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

Yes, to some extent

Here you may provide further details

Information available in the website of Portuguese Environment Agency

174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?

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

Not applicable

176. 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 report of the European Commission.

Article 24 – Non-Parties

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

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

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

180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?

181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?

183. 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 report of the European Commission, since all imports were authorised according to the EU biosafety framework.

Article 25 – Illegal transboundary movements

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

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

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

If you replied Never to question 186 please go to question 191

Never

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

All goods entering or leaving the European Union, via air, maritime, postal or road, are submitted to a risk analysis process in order to identify, as soon as possible, high risk shipments in several risk areas such as the area under the present questionnaire.
This risk analysis is made under a EU Risk Management framework, with the help of automatic risk tools and special technics, that leads to the identification mentioned bellow and to the performance of specific controls on EU external Border.
For further information regarding measures concerning illegal transboundary movement of LMOs see the respective submission report of the European Commission.

Article 26 – Socio-economic considerations

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

This question is relevant to indicator 1.7.2 of the Strategic Plan

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

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

This question is relevant to indicator 1.7.1 of the Strategic Plan

None

195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:

This question is relevant to indicator 1.7.3 of the Strategic Plan

None

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

197. 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 report of the European Commission.

Article 27 – Liability and Redress

198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?

199. If you answered No to question 198, is there any national process in place towards becoming a Party?

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

This question is relevant to indicator 2.4.1 of the Strategic Plan

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

This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan

202. 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

Portugal signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on 20 September 2011.
For further information see the respective submission of the European Commission.

Article 28 – Financial Mechanism and Resources

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

This question is relevant to indicator 1.2.5 of the Strategic Plan

Not applicable

Article 33 – Monitoring and reporting

204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?

This question is relevant to indicator 3.1.6 of the Strategic Plan

a) Monitoring system:

b) Enforcement system:

205. Has your country submitted all the previous due National Reports?

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.

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.