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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102394
Status
Published
Date of creation
2011-09-30 09:26 UTC (protocolo.cartagena@magrama.es)
Date of publication
2011-09-30 09:27 UTC (protocolo.cartagena@magrama.es)

This document is also available in the following languages:
Origin of report
Country
  • Spain
Contact officer for report
Coordinates
Don Antonio Fernández y Garcia de Vinuesa
Punto focal del Protocolo de Cartagena y Punto Focal del CIISB
Ministerio de Medio Ambiente, y Medio Rural y Marino (MARM)
Pº. Infanta Isabel, 1
Madrid, Madrid
Spain, 28071
Phone:+34 91 347 5334
Fax:+34 91 347 4540
Email:protocolo.cartagena@marm.es
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
ES
Comisión Nacional de Bioseguridad
Consejo Interministerial de Organismos Modificados Genéticamente
Submission
10. Date of submission
2011-09-30
11. Time period covered by this report
Start date
2007-11-01
Time period covered by this report
End date
2011-09-20
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
  • One or more national biosafety regulations
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
ES
España es un Estado Miembro de la Unión Europea y ha traspuesto a su legislación la normativa sobre organismos vivos modificados elaborada por la Unión Europea y el resto de directa aplicación, destacando la directiva 2001/18/CE y los reglamentos 1829/2003 y 1830/2003. Adicionalmente, véase el informe nacional realizado por la Unión Europea.
El marco legislativo actual se regula a través de la Ley 9/2003, de 25 de abril, por la que se establece el régimen jurídico de la utilización confinada, liberación voluntaria y comercialización de organismos modificados genéticamente y del Real Decreto 178/2004, de 30 de enero, por el que se aprueba el Reglamento general para el desarrollo y ejecución de la Ley 9/2003, de 25 de abril, por la que se establece el régimen jurídico de la utilización confinada, liberación voluntaria y comercialización de organismos modificados genéticamente.
Adicionalmente, varios instrumentos, reales decretos, ordenes y reglamentos internos se han aprobado con el objeto de desarrollar la Ley 9/2003 y adaptarse a la realidad cambiante de la biotecnología y dar mayor visibilidad en materia de bioseguridad a la sociedad, destacando entre ellos:
- Instrumento de Ratificación del Protocolo de Cartagena sobre Seguridad de la Biotecnología del Convenio sobre la Diversidad Biológica, hecho en Montreal el 29 de enero de 2000.
- Real Decreto 367/2010, de 26 de marzo, de modificación de diversos reglamentos en el área de medio ambiente para su adaptación a la Ley 17/2009, de 23 de noviembre, sobre libre acceso a las actividades de servicios y su ejercicio, y a la Ley 25/2009, de 22 de diciembre, de modificación de diversas leyes para su adaptación a la Ley de libre acceso a actividades de servicios y su ejercicio. (El Capítulo V modifica parcialmente el Real Decreto 178/2004).
- Orden ARM/2616/2010, por la que se establece la composición y funcionamiento del Comité de Participación en el marco del Consejo Interministerial de Organismos Modificados Genéticamente.
- Reglamentos internos de la Comisión Nacional de Bioseguridad, del Comité de Participación y del Consejo Interministerial de Organismos Modificados Genéticamente.
También se encuentra en preparación el Real Decreto sobre Registro de Parcelas comerciales destinadas a cultivo de organismos modificados genéticamente.
Por otro lado, las Comunidades Autónomas han desarrollado igualmente las competencias que les atribuye la Ley 9/2003 y han elaborado normas que complementan a las mencionadas anteriormente. Esta normativa se puede encontrar en la página Web del Ministerio de Medio Ambiente, Medio Rural y Marino de España:
http://www.marm.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificados-geneticamente-omg-/legislacion-general/Legislacion_espaniola.aspx
Finalmente, existe normativa horizontal que no es específica de la seguridad de la biotecnología pero que hay que tener en cuenta a la hora de la comercialización y liberación de organismos modificados genéticamente, así como la normativa sobre los efectos medioambientales derivados de los daños que pudieran ocasionar los Organismos Vivos Modificados. Dentro de esta normativa se encuentra: 
- Ley 26/2007, de 23 de octubre, de Responsabilidad Medioambiental.
- Ley 27/2006, de 18 de julio, por la que se regulan los derechos de acceso a la información, de participación pública y de acceso a la justicia en materia de medio ambiente.
- Orden ARM/1783/2011, de 22 de junio, por la que se establece el orden de prioridad y el calendario para la aprobación de las órdenes ministeriales a partir de las cuales será exigible la constitución de la garantía financiera obligatoria, previstas en la disposición final cuarta de la Ley 26/2007, de 23 de octubre, de Responsabilidad Medioambiental.
Además, en España como Estado Miembro de la Unión Europea es de aplicación la normativa comunitaria, la cual ha sido recogida en el informe nacional de la Unión Europea.    
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:
ES
Véase el Informe nacional de la Unión Europea
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:
ES
El tránsito de organismos vivos modificados queda regulado por el instrumento de ratificación del Protocolo de Cartagena y las actividades de uso confinado se encuentran reguladas por la Ley 9/2003 y por el Real Decreto 178/2004 por el que se aprueba el Reglamento general para el desarrollo y ejecución de la Ley 9/2003, de 25 de abril, por la que se establece el régimen jurídico de la utilización confinada, liberación voluntaria y comercialización de organismos modificados genéticamente.
Además, en España como Estado Miembro de la Unión Europea es de aplicación la normativa comunitaria, la cual ha sido recogida en el informe nacional de la Unión Europea.
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
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?
  • Yes
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
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?
  • More than 10
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?
  • More than 10
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?
  • More than 10
43. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
  • Yes, always
44. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes, always
45. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Not applicable
46. Has your country informed the notifier(s) and the BCH of its decision(s)?
  • In some cases only
47. Has your country informed the notifier(s) and the BCH of its decision(s) in due time (within 270 days or the period specified in your communication to the notifier)?
  • Not applicable
48. What percentage of your country’s decisions fall into the following categories?
  • No aplicable
%
49. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
  • Yes, always
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:
ES
España aplica la legislación comunitaria y nacional para la autorización de organismos vivos modificados para la liberación al medio ambiente, ya sea con fines experimentales o de comercialización, legislación que se ajusta a las disposiciones del Protocolo.

La Ley 9/2003 especifica que las competencias de la Administración General del Estado y de las Comunidades Autónomas sobre las autorizaciones de los ensayos experimentales y de liberaciones al medio ambiente. El órgano colegiado de la Administración General del Estado que otorga las autorizaciones es el Consejo Interministerial de Organismos Modificados Genéticamente, el cual es asesorado por un órgano colegiado de carácter técnico, la Comisión Nacional de Bioseguridad.
Al respecto de la pregunta 46, España se encuentra en el proceso de actualización de los registros sobre las decisiones y las evaluaciones de riesgo asociadas con la finalidad de facilitarlas al Centro de Intercambio de la Información de la Seguridad de la Biotecnología.
Véase el informe nacional de la Unión Europea
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:
ES
España ha sido ponente de varias solicitudes de autorización de Organismos Modificados Genéticamente para la comercialización como alimento humano, pienso y/o para procesado (algunas de las cuales se encuentran pendientes de resolución) y publicó la resolución de autorización del 18 de octubre de 2004, para la importación y procesado de maíz NK603 después de ser aprobado tras el proceso de autorización comunitario (Decisión de la Comisión, de 19 de julio de 2004 relativa a la comercialización, de conformidad con la Directiva 2001/18/CE del Parlamento Europeo y del Consejo, de un tipo de maíz, Zea mays L., línea NK603. DOCE L 295, 18.9.2004) modificado genéticamente para hacerlo resistente al herbicida glifosato, siendo el país ponente de la solicitud.

Además, son de aplicación directa todos los Reglamentos comunitarios aprobados sobre alimentos y piensos modificados genéticamente (Reglamento (CE) Nº 1829/2003), movimientos transfronterizos (Reglamento (CE) Nº 1946/2003) y trazabilidad y etiquetado de Organismos Modificados Genéticamente y trazabilidad de productos producidos a partir de Organismos Modificados Genéticamente (Reglamento (CE) Nº 1830/2003) y los métodos de muestreos y análisis para el control oficial de los piensos al respecto de la presencia de material modificado genéticamente cuya autorización está pendiente o ha expirado (Reglamento (CE) Nº 619/2011).
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
71. Here you may provide further details on the implementation of Article 12 in your country:
ES
Sin comentarios
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?
  • Yes
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:
ES
Sin comentarios
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:
ES
Véase el informe nacional de la Unión Europea.
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?
  • 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:
ES
España ha implantado en el marco de la legislación europea y nacional, los procedimientos de evaluación del riesgo para la salud y el medio ambiente de todas las actividades que se llevan a cabo con Organsmos Vivos Modificados. Los criterios para dicha evaluación se desarrollan en la Directiva 2001/18/CE y otras Decisiones del Consejo y de la Comisión Europea, así como en las normas nacionales: Ley 9/2003 y el Real Decreto 178/2004.
Al respecto de las pregunta 89, España se encuentra en el proceso de actualización de los registros sobre las evaluaciones de riesgo y su objetivo es facilitarlas al Centro de Intercambio de la Información de la Seguridad de la Biotecnología a corto plazo.
(Véase el informe nacional de la Unión Europea).
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:
ES
Véase informe nacional de la Unión Europea.
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:
ES
Véase el informe nacional de la Unión Europea.
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
115. Here you may provide further details on the implementation of Article 18 in your country:
ES
La Unión Europea ha establecido un marco legal sobre Organismos Modificados Genéticamente en los cuales se recoge las medidas que los notificadotes han de tomar al respecto de la manipulación, transporte, envasado e identificación. (Véase informe nacional de la Unión Europea).
Dentro de la normativa española específica sobre organismos modificados genéticamente, se exige incluir en la solicitud de autorización una propuesta de etiquetado y envasado donde se indique "Este producto contiene organismos modificados genéticamente".
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:
ES
España ha aportado al Centro de Intercambio de la Información sobre la Seguridad de la Biotecnología (CIISB) la información sobre el punto focal nacional para el Protocolo de Cartagena, así como del CIISB, además ha registrado su autoridad nacional competente.
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 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 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 but only partially available 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?
  • Yes
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?
  • Yes
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?
  • No
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Not applicable
130. Is the information submitted by your country to the BCH complete and up-to date?
  • No
131. Here you may provide further details on the implementation of Article 20 in your country:
ES
España ha designado a la Subdirección de Apoyo y Coordinación del Ministerio de Medio Ambiente, y Medio Rural y Marino como punto focal del Centro de Intercambio de Información de la Seguridad de la Biotecnología.
Al respecto de las preguntas 124i, 124q y 130, España se encuentra en el proceso de actualización de los registros sobre las decisiones y las evaluaciones de riesgo asociadas con la finalidad de facilitarlas al Centro de Intercambio de la Información de la Seguridad de la Biotecnología.
Por otro lado, España recoge dentro del Portal Web del Ministerio la información más relevante sobre organismos modificados genéticamente que se puede consultar en el siguiente enlace:
http://www.marm.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificados-geneticamente-omg-/
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:
ES
Los titulares de las actividades reguladas por la Ley 9/2003 que proporcionen información a la Administración podrán invocar el carácter confidencial de determinados datos e informaciones facilitados, aportando la justificación correspondiente. La Administración determinará sobre la confidencialidad solicitada y se abstendrá de facilitar la información a terceros sobre los datos e informaciones a los que reconozca dicho carácter. No se podrá considerar información confidencial las informaciones y datos relativos a la descripción de organismos modificados genéticamente, a la identificación del titular, a la finalidad y al lugar de la actividad, a la clasificación del riesgo de la actividad de utilización confinada y a las medidas de confinamiento, a los sistemas y medidas de emergencia y control y a la evaluación de los efectos para la salud humana y el medio ambiente.
Además, se pondrán a disposición del público la información relativa a las liberaciones voluntarias realizadas, las autorizaciones de comercialización otorgadas, la relación de los organismos modificados genéticamente cuya comercialización haya sido autorizada o rechazada como productos o componentes de productos, los informes de evaluación, los resultados de los controles sobre comercialización y los dictámenes de los comités científicos consultados, especificando para cada producto los organismos modificados genéticamente que contenga y sus usos. 
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?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Regional channels
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
  • Human resources capacity development and training
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Identification of LMOs, including their detection
  • 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?
  • 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:
ES
España ha organizado varios seminarios en materia de bioseguridad a traves de la Agencia Española de Cooperacón Internacional y Desarrollo y ha aportado la información al Centro de Intercambio de Información de la Seguridad de la Biotecnología.
Por otro lado, España ha aportado fondos para la realización de seminarios y talleres en materia de bioseguridad facilitando la información a la Secretaria del Convenio.
Adicionalmente, España ha participado como docente en la realización de varios cursos, seminarios, talleres y programas de intercambio de información destacando la participación en las actividades sobre bioseguridad desarrolladas dentro del Programa de Asistencia Técnica y de Intercambio de Información de la Dirección General de Ampliación de la Comisión Europea.    
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?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • Yes
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:
ES
En materia de participacion, España dispone de la Ley 27/2006, de 18 de julio, por la que se regulan los derechos de acceso a la información, de participación pública y de acceso a la justicia en materia de medio ambiente que incorpora las Directivas 2003/4/CE y 2003/35/CE (Véase informe de la Unión
Europea). La Ley recoge el reconocimiento de los derechos de acceso a la información, de participación y de acceso a la justicia.
Dentro de la regulación específica del derecho de acceso a la información ambiental, la ley establece las obligaciones Administraciones Públicas a informar a los ciudadanos sobre los derechos que les reconoce la Ley y a ayudarles en la búsqueda de la información. Además, para evitar y prevenir daños en caso de amenaza inminente para la salud humana o el medio ambiente, deberá difundirse la información que permita adoptar las medidas necesarias para paliar o prevenir el daño.
Además, la Ley pretende facilitar la obtención de información solicitada que obre en poder de la autoridad a la que se ha dirigido una solicitud. También, establece la regulación de las excepciones a la obligación de facilitar la información ambiental ya que la autoridad pública deberá ponderar en cada caso los intereses públicos y justificar la negativa a suministrar la información solicitada.
Por otro lado, la Ley se ocupa del derecho de participación pública en los asuntos de carácter ambiental en relación con la elaboración, revisión o modificación de determinados planes, programas y disposiciones de carácter general. En este punto, la Ley busca velar por el cumplimiento de una serie de garantías tales como:

• hacer públicamente accesible la información medioambiental relevante
• informar del derecho a participar y de la forma en la que lo pueden hacer
• reconocer el derecho a formular observaciones y comentarios en aquellas fases iniciales del procedimiento
• justificar la decisión finalmente adoptada y la forma en la que se ha desarrollado el trámite de participación
España también ha  ratificado el Convenio de Aarhus (diciembre de 2004), entrando en vigor el 31 de marzo de 2005. El Convenio de Aarhus parte del principio para que los ciudadanos puedan disfrutar del derecho a un medio ambiente saludable y puedan respetarlo y protegerlo, deben tener acceso a la información medioambiental relevante, deben estar legitimados para participar en los procesos de toma de decisiones de carácter ambiental y deben tener acceso a la justicia cuando tales derechos les sean negados. El Convenio ha sido integrado dentro del marco legislativo español.
Al respecto de los Organismos Genéticamente Modificados, España ha aprobado la Orden ARM/2616/2010, por la que se establece la composición y funcionamiento del Comité de Participación en el marco del Consejo Interministerial de Organismos Modificados Genéticamente (CIOMG), a través del cual se pretende asegurar la participación e información pública acerca de la actuación del CIOMG, además de consolidar una vía de comunicación permanente entre la Administración General del Estado y los ciudadanos en las materias que son responsabilidad del mismo. En este sentido, Comité de Participación podrá formular al CIOMG cuantas cuestiones estime oportunas, además de aportar su punto de vista sobre cualquier cuestión relacionada con los organismos modificados genéticamente.
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?
  • Yes, always
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:
ES
España importa soja (harina, cascarilla etc.) y maíz transgénico de países no Partes del Protocolo (Argentina, Estados Unidos, etc.). En general se ha comprobado que en la importación de Organismos Vivos Modificados se transmite información de que el producto contiene Organismos Vivos Modificados.
Se realizan controles en los Puestos de Inspección Fronteriza (PIF), de competencia regional en España, y donde todavía hay dificultades en la interpretación y aplicación de las normas de trazabilidad y etiquetado dependiendo de si la importación es de los Organismos Vivos Modificados o de productos obtenidos o derivados de éstos.
Por otro lado, y bajo los controles llevados a cabo por los laboratorios de control oficiales de los Ministerios de Sanidad y Medio Ambiente, y Medio Rural y Marino se efectúan tomas de muestras de semillas y productos para alimentación animal y humana en fronteras y se hacen análisis cuantitativos y cualitativos para detectar una posible presencia adventicia o accidental de Organismos Vivos Modificados.
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:
ES
Durante el periodo de presentación de informes, en España no se ha registrado ningún movimiento ílicito.
Dentro de la normativa nacional sobre organismos modificados genéticamente, existe un regimén sancionador aplicable a la realización de actividades sin la debida autorización administrativa (Capitulo II del Título IV de la Ley 9/2003).
Por otro lado, la Ley 26/2007, de 23 de octubre, de Responsabilidad Medioambiental recoge en su capitulo III las medidas de prevención, evitación y reparación de daños medioambientales que las Administraciones pueden realizar en caso de un movimiento ílicito.
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?
  • Yes
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:
ES
España dedica aproximadamente 90.000 hectareas a cultivos modificados geneticamente. Principalmente, cultiva maíz MON810 que es el único autorizado para liberación voluntaria en la Unión Europea, y supone un 20 % aproximado del cultivo de maíz de España, por lo que podemos indicar que el impacto del cultivo actual de los organismos modificados genéticamente en los ingresos de los agricultores en general varía por es regiones. Si puede tener importancia en determinadas comarcas donde el taladro es una plaga como Aragón y Cataluña en las que la superficie del cultivo de maíz modificado es elevado.
La producción ecológica de maíz en España también es bastante localizada, por lo que no hay grandes implicaciones por el cultivo de variedades modificadas.
Al respecto de las medidas de coexistencia, la Asociación Nacional de Obtentores Vegetales (ANOVE) adjunta con las semillas de variedades modificadas una Guía Técnica y de Buenas Prácticas para el cultivo, en la cual se recogen las recomendaciones de cultivo, así como las medidas de coexistencia y las obligaciones para la prevención de resistencias.
España participó en la realización de la encuesta preparada por la Comisión Europea sobre las implicaciones socioeconomicas del cultivo de organismos geneticamente modifcados. En la encuesta se recoge que la experiencia es limitada por la pequeña superficie dedicada al cultivo de variedades modificadas.
Finalmente, el Centro de Investigación Conjunta preparó un informe sobre la Adopción y rendimiento del primer cultivo modificado genéticamente introducido en la Unión Europea: Maíz Bt en España, en cual se proporciona datos de costes, producciones y datos sobre la utilización de la tecnología por parte de los agricultores. El informe se puede descagar en la dirección http://ftp.jrc.es/EURdoc/JRC37046.pdf .    
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:
ES
España ha firmado con fecha 21 de julio de 2011 y sigue con el proceso interno de ratificación del instrumento.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • No aplicable
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.
ES
Sería interesante en las preguntas que hacen referencia a la información aportada al Centro de Intercambio de Infomación de la Seguridad de la Biotecnología incluir una casilla que indique no existe informacion para diferenciar los casos en que no se aportado la informacion al Centro de Intercambio de aquellos que la información No existe. En la actualidad, sólo existe una casilla que indica No disponible, no pudiendose diferenciar estos casos
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
ES
Three people from an external consultory company were working to implement Cartagena Protocol between 2010 and 2012
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
ES
At least one in Universidad Complutense de Madrid: "Curso sobre Biotecnología Alimentaria". Updated in BCH. http://bch.cbd.int/database/record.shtml?documentid=104710
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
  • 500,000 USD or more
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
ES
There are 12 guidance documents in European Food Safety Authority. http://www.efsa.europa.eu/en/gmo/gmoguidance.htm?n=20
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
ES
There are 12 guidance documents in European Food Safety Authority. http://www.efsa.europa.eu/en/gmo/gmoguidance.htm?n=20
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
ES
Spain is a Member State of the European Union.
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
ES
The most important one was the RA of maize MON810 and maize NK603
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
ES
Spain implements European legislation.
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
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
  • No
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
  • One or more
Here you may provide further details
ES
European Joint Research Centre - Institute for Prospective Technological Studies, published in 2008: "Adoption and impact of the first GM crop introduced in EU agriculture: Bt maize in Spain"  http://ipts.jrc.ec.europa.eu/publications/pub.cfm?id=1580
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
ES
Our experience is positive and it is summarized in previous report: "Adoption and impact of the first GM crop introduced in EU agriculture: Bt maize in Spain"
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
ES
We have implemented our national biosafety framework which gives us the necessary tools to manage this event.
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
  • Yes
Here you may provide further details
ES
We have three national reference laboratories.
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
ES
We follow EFSA Guidances. Besides we are working on internal guidances to explain how to manage GMO aplications.
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
Here you may provide further details
ES
We are talking about EFSA Guidances
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • 100 or more
Here you may provide further details
ES
In Spain, there are more than 40 Border Inspection Post, and there are inspectors who implement three kind of controls: documental, identity and phisical.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 10 or more
Here you may provide further details
ES
We have 3 governmental laboratories.
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
  • One or more
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
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
ES
Yes, through Ministry of Agriculture Food and  Environment website: http://www.magrama.gob.es/es/
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
  • Post offices
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
Here you may provide further details
ES
Several Universities in Spain developes Biosafety training courses.
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
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
  • None
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • No
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.,
ES
No
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • No
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • One or more