Record details

Origin of report

Country

Italy

Contact officer for report

Coordinates

Dott. Renato Grimaldi

General Director

Ministero dell'Ambiente e della tutela del Territorio e del Mare (MATTM)

Via Cristoforo Colombo, 44

Roma, Italy

Italy, 00147

Phone:	+39 06 5722-3433
Fax:	+39 06 5722-3470
Email:	dg-pnm@minambiente.it

Consulted stakeholders

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

Advisor Evaluation Committee

Submission

10. Date of submission

2011-09-29

11. Time period covered by this report

Start date

2007-10-01

Time period covered by this report

End date

2011-09-29

Party to the Cartagena Protocol on Biosafety

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

Article 2 – General provisions

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

A domestic regulatory framework is fully in place

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

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

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

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

19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?

Less than 5

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:

As an EU Member State, Italy complies with European Community law. The relevant law is EC regulation 1946/2003, which went into effect in november 2003. This regulation states the obligations of the EU with regard to exports of GMO to third countries. EU Regulation 1829 on genetically modified food and feed, and Regulation 183/2003 concerning the traceability and labelling of genetically modified organism and the traceability of food and feed products produced from genetically modified organism and amending directive 2001/18/EC, both went into effect in April 2004.
The italian legal framework to apply the EU Directives and Regulations are as follows:
- The Decree Dlvo 224/2003 to implement Dir 2001/18/CE;
The Decree Dlvo 206/2001 to implement Dir 90/210/CE as amended by Directive 98/81/EC on the contained use of genetically modified micro.organisms;
The Decree Dlvo 70/2005 on sanctions for violations to EC Regulations N. 1829/2003 and n. 1830/2003

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:

Italian legislation complies at 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?

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

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

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

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?

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

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

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

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

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

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

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

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

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

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?

Less than 5

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

None

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

According to EU legislation (EU Directive 2001/18/EC and Regulation 1829/2003), all decisions concerning imports for placing on the market, including release into the environment, are made at the EU level. No decisions regarding the release of GM crops onto the market for cultivation have been made during the period covered by this report.Decisions on releases in the form of field trials are made at the national level. Decisions on field trials are always based on an application corresponding to the provisions of Articles 7-10. Consent must be given by the competent authority before release into the environment and there is no difference if the LMO is nationally produced or imported.

Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)

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

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

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

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

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

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

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

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:

Italy, as part of the European Community, follows the comprehensive legal framework on GMOs developed at European Union level, which also addresses the import of LMOs intended for direct use for food or feed, or for processing. The EC has declared with reference to Article 11.4 Cartagena Protocol that it relies on its existing legislative framework for intentional movements of GMOs within the Community and for imports of GMOs into the EC.

Article 12 – Review of decision

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

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

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

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

None

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

Italy not have significant experience has never proceeded to the application of Article 12

Article 13 – Simplified procedure

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

73. Has your country ever applied the simplified procedure?

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

None

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

Italy has not made use of the implified procedure for imports of LMOs as specified in Article 13.

Article 14 – Bilateral, regional and multilateral agreements and arrangements

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

80. Here you may provide further details on the implementation of Article 14 in your country:

Italy has not entered into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1).

Article 15 – Risk assessment

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

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

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

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

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

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

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

Yes, always

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

Yes, always

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?

None

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

Not applicable

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

Not applicable

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

Italy, as part of the European Community, has put in place a comprehensive system of risk assessment and risk management dealing with releases into the environment or placing on the market of GMOs, whether imported into or developed within the EC. The aim of the environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, both direct and indirect, immediate or delayed, on human healt and the environment. Risk assessments contained in notifications made under EU Regulation 1829/2003 are evaluated by the European Food Safety Authority and the competent authorities of the Member States. The Annex II of the Directive 2001/18/CE and the Commission Decision 2002/623/EC also provides guidance on environment risk assessment of GMOs.
The Italy-NFP in collaboration with the International Centre for Genetic Engineering and Biotechology (ICGEB) ensure the publication of the series (n.3 volumes) "Biosafety Reviews" (2007-2010) instigating a number of scientific studies on areas of major interst for biosafety and risk assessment.Which are also available online.
See http://bch.minambiente.it/EN/Publications/index.asp

Article 16 – Risk management

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

94.1) LMOs for intentional introduction into the environment?

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

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

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

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

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

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

The EU has put in place a comprehensive system of risk assessment and risk management dealing with releases into the environment or placing on the market of GMOs, whether imported into or developed within the EC. The aim of the environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, both direct and indirect, immediate or delayed, on human health and the environment.
See http://www.efsa.europa.eu/en/science/gmo/gmo_guidance.html
The NFP in collaboration with the International Centre for Genetic Engineering and Biotechology (ICGEB) ensure the publication of "New biotechnologies and the national regulatory framework" (2010). Which is also available online.
See http://bch.minambiente.it/EN/Publications/index.asp

Article 17 – Unintentional transboundary movements and emergency measures

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

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

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

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

Less than 5

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

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

No, consultation was never made

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

Not applicable

Article 18 – Handling, transport, packaging and identification

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

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

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

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

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

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

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

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

Italy, as part of the EC, implemented a complete legal framework on GMOs, which also addresses issues of handling, transport, packaging and identification referred to Article 18. The following acts of direct relevance to the implementation of Article 18:
Article 18 (1):
- Council Directive 94/55 of 21 November 1994 on approximation of the laws of members States with regard to the trasport of dangerous goods by road (last emended by Commission Diretive 2006/89/EC implement with Ministerial Decree 3 Jannuary 2007
- Council Directive 96/49 of 23 July 1996 on approximation of the laws of the MS with regard to transport of dangerous good by rail (las emended by Commission Directive 2004/89/EC, implement with Ministeril Decree 7 November 2006)
Article 18 (2) a:
- Article 12 of Regulation (EC) 1946/2003 of 15 July 2003 on transbounderay movments of GMOs;
- Regulation (EC) 1829/2003 of 22 september 2003 on GMO food and feed
- Regulation (EC) 1830/2003 of 22 September 2003 concerning the traceability and labelling of GMO and traceability of products -produced from GM
Italy, as part of the EC, support in the approval process for GMOs requires validation of an event-specific detection method for the relevant GMO (see in particular regulation (EC) No 1829/2003). Italy contributes to the validation of GMO detection methods with n.3 National Reference Centre (ISS, IZS and INRAN) carried out by the European Union Reference Laboratory for GM Food Feed (EU-RL GMFF see http://gmo-crl.jrc.ec.europa.eu/)
- that it contains or consists of GMOs; and
- the unique identification code(s) assigned to those GMOs if such codes exist.
Article 12 of Regulament 1946/2003 further stipulates that for GMOs intended for direct use as food or feed, or for processing, the above information must be supplemented by a declaration by the exporter:
- stating that the GMOs are intended for direct use as food or feed, or for processing and indicating clearly that they are not intended for deliberate release into the environment; and
- giving details of the contact point for further information.
In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing, the above identification requirements may be replaced by a list of unique identifiers used to constitute the mixture.
Regulation 1829/2003 lays down rules on labelling of all GM food and feed. GM food and feed has to be labelled as GM, except if they contain GM material in a proportion no higher than 0.9% and if this presence is adventitious or technically unavoidable.
Under Regulation (EC) 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms, business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market. In particular, the Regulation requires that:
- operators are to have systems and standardised procedures in place to identify to whom and from whom products are made available;
- in the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, written information on the unique identifier(s) assigned to the GMOs of which the product consists or which are contained in it, may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture.
In Regulation (EC) No 65/2004 of 14 January 2004, the EC has established a system for the development and assignment of unique identifiers for genetically modified organisms. The Regulation adopts the format developed by the OECD for Unique Identifiers for Transgenic Plants, which in mid-April 2004 became mandatory for the EC's domestic regulatory framework for GMOs. Moreover, the EC has extended use of this format to unique identifiers for genetically modified micro-organisms and animals pending the development and adoption of any other specific format at an international level. The EC considers the use of the unique identifier as a key to access information available on the Biosafety Clearing-House.
In relation to Article 18(2)(b), the EC wishes to recall that EC legislation contains rules on identification of GMOs that are destined for contained use, in line with the Protocol. Regulation No (EC) 1946/2003 on transboundary movements of genetically modified organisms requires exporters of GMOs destined for contained use to state in accompanying documentation
- that it contains or consists of GMOs;
the unique identification code(s) assigned to those GMOs if such codes exist;
In addition, this information shall be supplemented by a declaration by the exporter which shall specify:
- any requirements for the safe handling, storage, transport and use of the GMOs; and
- the contact point for further information, including the name and address of the individual or institution to whom or which the GMOs are consigned.
In relation to Article 18(2)(c), Regulation No (EC) 1946/2003 requires exporters of GMOs destined for deliberate release into the environment to ensure that documentation accompanying the GMO states:
- that it contains or consists of GMOs; and
- the unique identification code(s) assigned to those GMOs if such codes exist;
In addition, this information shall be supplemented by a declaration by the exporter which shall specify:
- the identity and relevant traits and characteristics of the GMOs;
- any requirements for the safe handling, storage, transport and use of these GMOs;
- the contact points for further information and, as appropriate, the name and address of the importer and exporter; and
- a declaration that the movement is in conformity with the requirements of the Protocol applicable to the exporter.
In this contest legilslative decree 223/2003, implementing Directives n. 2000/77/EC and 2001/46/EC required advance contact operator with transboundari moviment points.
The above requirements regarding identification and documentation of GMOs are in line with Article 18 of the Protocol and without prejudice to further specific requirements imposed by EC legislation.

Article 19 – Competent National Authorities and National Focal Points

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

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

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

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

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

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

Not applicable

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 not available

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

Information available and in the BCH

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

Information not available

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

Information not available

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

Information available and in the BCH

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

Information available and in the BCH

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

Information available and in the BCH

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

Information available and in the BCH

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

Information not available

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 not available

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

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

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

Yes, always

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

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?

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

Italy developed a national BCH (http://bch.minambiente.it) integrated within the website of the Italian Ministry of Environment, Land and Sea Protection (http://www.minambiente.it).
The Italian BCH is designed as an information-sharing platform in support to the decision-making process on national biosafety issues. The Italian BCH was constructed within the international framework set up by the Convention on Biological Diversity, it follows the indications of the Aarhus Convention, reflects the provisions of the European Community, responds to the requirements of the Italian Law on public consultation and access to information, and supports the implementation of legislation by the Italian Regional Authorities.
The Italian BCH consists of five different sections, comprising:
a) A descriptive sections, which provides general information on biosafety issues, including links with relevant Institutions and Organisations;
b) A section on biosafety, with the general outlines of the principles for risk assessment and    risk management, as well as the links to some informatics tools for biosafety;
c) A Legislation section, with a collection of National, European Community and    International legislative relevant documents for biosafety;
d) A section on the use of LMOs,including tools for the information and partecipation of the    public in the area of the section regarding the experimental and commercial releases of LMOs;
e) A BCH section which performs the information task required by the Cartagena Protocol and under the competence of EU Member States as defined by Regulation (EC) 1946/2003.
The BCH platform allows to know feedback of statistical data. In particular quantitative (visits number and countries visitor) and qualitative (frequency of bounce, visited pages, search engines, site of reference, direct traffic, word key of search, loyal visistors and connection time to the site) statistical data collected allow us to analyze periodically the operability of public within the site to ensure proper communication and improve the managment of scientific and techincal contenst.
Italy also cooperates with the information management activities of the European Community through the Joint Research Centre and the GMOREGEX.

Article 21 – Confidential information

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

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

Yes, always

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

Italy, as part EC, applies its domestic legislative framework instead of the Protocol's advance informed agreement procedure. This framework is compatible with the provisions of the Protocol. It contains confidentiality provisions that apply equally to domestic and foreign producers of GMOs.
Article 25 of Directive 2001/18/EC (article 27 of Legislative Decree 224/2003) on the deliberate release into the environment of GMOs stipulates that the European Commission and the Member States shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.
Article 30 of Regulation (EC) No 1829/2003 on genetically modified food and feed allows applicants to indicate which information submitted under the Regulation they wish to be treated as confidential, based on verifiable justification.
Article 16 of Regulation (EC) No 1946/2003 on transboundary movements of GMOs obliges the European Commission and the Member States not to divulge to third parties any confidential information received or exchanged under this Regulation. It allows the exporter to indicate the information in the notification that should be treated as confidential, provided that justification is given in such cases.
However, all the above confidentialy provisions make clear what information shall never be considered as confidential, notably as regards the general description of the GMO, the namae and address of the authorisation holders, the risk assessment information and any methods rand plans for emergency responses.

Article 22 – Capacity-building

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

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

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

Multilateral channels

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

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

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

Human resources capacity development and training
Risk assessment and other scientific and technical expertise
Public awareness, participation and education in biosafety
Training courses (2008, 2009, 2010 and 2011) whose need comes from the recognition of the necessity of creating a network of regional centers that provide comprehensive training in biosafety by the UNIDO e- Biosafety, which includes the University on Concepciòn (Chile), the University of Malaya Kuala Lumpur, University Ghent, Marche Polytechnic University in Ancona and Pontifical Catholic University of Minas Gerais Belo Horizonte Brazil.

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

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

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

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

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:

Not applicable

Article 23 – Public awareness and participation

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

152. Has your country established a biosafety website?

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

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

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

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

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

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

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

More than 5

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

The Italian BCH is an information-sharing platform in support of the decision-making process on national biosafety issues which:
• follows the indications of the Aarhus Convention;
• responds to the requirements of the Italian Law on public consultation and access to information;
• supports the implementation of legislation by the Italian Regional Authorities
Feedback of statistical data are monitored. In particular quantitative (visits number and countries visitor) and qualitative (frequency of bounce, visited pages, search engines, site of reference, direct traffic, word key of search, loyal visistors and connection time to the site) statistical data collected allow us to analyze periodically the operability of public within the site to ensure proper communication and improve the managment of scientific and technical contents

Article 24 – Non-Parties

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

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

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

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?

Not applicable

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:

As regards imports of LMOs, the EU applies its domestic legislative framework to all imports of LMOs, whether these originate from parties or non-parties to the Protocol.
As regards exports of LMOs, notification requirements of the exporter to the competent authority of the Party of import established by Regulation (EC) No 1946/2003 apply regardless of whether the country of import is a Party or a non-Party to the Protocol. Copies of the respective documents are sent to the compentent authority of the member State from which the GMO is exported and to the European Commission (Article 6). Since entry into force of Regulation (EC) No 1946/2003 in November 2003, most notifications for LMOs intended for deliberate release related to the export of LMOs for use in small-scale field trialsl.

Article 25 – Illegal transboundary movements

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

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

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

Less than 5

171. Has your country informed the BCH and the other Party(ies) involved?

Only in some cases

172. Has your country established the origin of the LMO(s)?

173. Has your country established the nature of the LMO(s)?

174. Has your country established the circumstances of the illegal transboundary movement(s)?

Yes, some cases

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

According to Directive 2001/18/EC, it is the Member States that are obliged to take domestic measures to prevent and penalize illegal transboundary movements of GMOs. European legislation contains explicit obligations on Member States to lay down rules on penalties applicable to infringements of the provisions of European regulations. It further states that these penalties shall be effective, proportionate and dissuasive. Specific requirements on Member States to determine penalties applicable to breaches of European and national GMO regulations can be found in:
• Article 33 of the Directive 2001/18/EC on the deliberate release into the environment of GMOs;
• Article 18 of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms; and
• Article 45 of Regulation (EC) No 1829/2003 on genetically modified food and feed.
Article 53 of Regulation (EC) No 178/2002 laying down general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety provides for the possibility to adopt appropriate Community emergency measures for food and feed imported from a third country in order to protect human health, animal health and the environment, where the risk, can not be contained satisfactorily by means of measures taken by the Member States concerned. On this legal basis the Commission adopted on 18 April 2005 emergency measures regarding imports of the non-authorised genetically modified organism Bt10 in maize products and adopted on 5 September 2007 emergency measures regarding the non-authorised genetically modified organism 'LL RICE 601' in rice products. On the basis of satisfactory information regarding the absence of these GMOs in imports to the EU, the measures regarding Bt10 maize were repealed on 7 March 2007 and regarding LLRice601 rice were repealed on 8 June 2010. By contrast, emergency measures regarding the non-authorised genetically modified organism 'Bt63' in rice products originating from China had to be adopted on 3 April 2008. These measures are still in place.
During 2010 was reported illegal presence in the European market of transgenic fish GLOFISH (Danio renio).

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?

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

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

Socio-economic considerations have been relevant at Member State level for the question of co-existence between conventional, organic and GM crops. The European Commission has issued a Recommendation on 13 July 2010 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming. The responsibility to develop national co-existence measures lies with the member States, informed by the guidelines provided by the European Commission.
The Commission has recently issued a report on the socio-economic implications of GMO cultivation, based on the contribution of the Member States and in line with Article 31 of Directive 2001/18/EC. The past or present experience with GMO commercial cultivation in Europe is limited to 7 countries and to herbicide-tolerant (HT) soya, insect-resistant (Bt) maize and starch potato in the European Union. Therefore the amount of statistically relevant information on the ex-post socio-economic impacts of GMO cultivation is rather limited. It focuses mainly on impacts at farm level (seed production, farmers).

Article 27 – Liability and Redress

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

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

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:

Italy have signed Spplementary Protocol in June 2011.

Article 33 – Monitoring and reporting

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

183. If your country did not submit previous reports, indicate the main challenges that hindered the submission

Not applicable

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 further comments

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

The Risk Assessment Searching Mechanism (RASM) (http://www.icgeb.org/ ~ biosafety / rasm.html) is an on line tool for the exchange of information on risk assessment on the deliberate release of LMOs into the environment for commercial purpose, in accordance with Article 10 of the Cartagena Protocol. It is operative since March 2002 and has been developed by ICGEB with the financial support of the Italian Ministry for the Environment, Land and Sea. The RASM collects official documents, related to the official government decisions concerning the commercial release of GMOs worldwide, irrespective of the individual CBD signatory status. Bibliosafety (link to http://www.icgeb.org/biosafety/biobiblio.html) is a database developed by ICGEB with the financial support of the Italian Ministry for the Environment, Land and Sea. It shows almost all of abstracts and bibliographic references to the scientific referenced literature published since 1990 in the field of LMOs risk assessment. The articles received monthly by CABI International (Centre for Agricultural Bioscience International, link to http://www.cabi.org), are screened, classified and made available to the public in the Bibliosafety database. The database is also interoperable with the central portal of the Biosafety Clearing House, hosted by the Convention on Biological Diversity.

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

ICGEB Biosafety Workshops "Problem Formulation: A Strategic Approach in the evaluation of the Science Underpinning GMO Regulatory Decision-making" Trieste 1-5 July 2013 Università Politecnica delle Marche "E-Biosafety Master Summer on campus", Sixth Edition. Ancona, 17-21 June 2013

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

indicator 1.2.4

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

indicator 1.2.5

100,000 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

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

Survey 9.b) Risk management

Here you may provide further details

Annexes II,III, IV and VII of Directive 2001/18/EC provide guidance for carrying out risk assessment and risk management of GMOs. Regulation (EC) n. 18/29/2003 provides a framework for risk assessment and risk management on food and feed from GMOs. The EFSA Guidelines are the basis for the establishment of a common approach to assessment and/or management of risk derived from GMOs among the EU Member States: At national level Legislative Decree n. 224/2003, implementing Directive 2001/18/EC, defines principles for the environmental risk assessment in Annex II and provides guidelines for the assessment reports after the deliberate release of GMOs in the environment and for post-market monitoring in Annexes VI and VII.

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

indicator 1.3.1.2

Here you may provide further details

See answer 9

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

indicator 1.3.2

Here you may provide further details

See answer 9

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

indicator 1.3.3

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

indicator 1.4.2

Survey 13.a) Identify

Survey 13.b) Assess

Survey 13.c) Monitor

Here you may provide further details

See answer 20

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

indicator 1.6.4

Here you may provide further details

The EU has put in place a comprehensive legal framework concerning requirements for ensuring the safe handling, transport, and packaging of living modified organisms. Italy as EU Member State fully complies with the EU legal framework.

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

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

indicator 1.7.1

None

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

indicator 1.7.3

No experience

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

indicator 1.8.3

Here you may provide further details

As a Member State of the EU, Italy participates in the rapid alert system in case of unintentional release of a GMO.

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

50 or more

Survey 19.b) Monitoring

50 or more

Survey 19.c) Management / Control

50 or more

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

indicator 2.2.4

Here you may provide further details

There is a network of official laboratories coordinated by the Italian National Reference Laboratory for GMOs (Centro di Referenza Nazionale per la Ricerca degli OGM - CROGM) involved in the official control conducting analytical detection of GMOs in food and feed.

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

Here you may provide further details

See http://www.izslt.it/izslt/modules/centrireferenzax/docs/centro_ref_OGM/didattica.html

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

indicator 2.2.6

Survey 22.a) Sufficient

Survey 22.b) Effective

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

indicator 2.3.1

50 or more

Here you may provide further details

See http://www.agenziadogane.it/wps/wcm/connect/Internet/ee/

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

indicator 2.3.1

50 or more

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

indicator 2.3.2

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

indicator 2.3.3

10 or more

Here you may provide further details

Actually the Italian network of the laboratories for the official control of GMOs includes ten Experimental Zooprophylactic Institutes, ten Regional Agencies for Environment Protection and six Local Healthy Agency. See http://www.izslt.it/izslt/modules/centrireferenzax/docs/centro_ref_OGM/laboratori.html

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

indicator 2.3.4

10 or more

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

indicator 2.4.1

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

indicator 2.4.2

Here you may provide further details

At Community level: directive 2004/35/CE of the European Parliament and of the Council of 21 april 2004 on environmental liability with regard to the prevention and remedying of environmental damage. At national level: Legislative Decree n. 152/2006 Part VI; Legislative Decree n. 224/2003 art. 36.

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

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

indicator 2.5.2

National website

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

indicator 2.5.2

National website

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

indicator 2.7.1

One or more

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

indicator 2.7.2

One or more

Here you may provide further details

See answer 4

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

indicator 3.1.6

Survey 35.b) Enforcement system

Here you may provide further details

There are two national three-years plans for planning and coordinating national control activities in food and feed to establish uniform criteria for regional planning.

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

One or more

Here you may provide further details

Every year the National Reference Laboratory for GMOs organizes a workshop for the official laboratories to keep the personnel up-to-date about the analytical methods used for the controls. This year the Ministry of Health organized a workshop addressed to the control competent authorities. The aim was to discuss the state of the art and future perspectives of the official controls of GM food and feed, with particular reference to the implementation of National Plans of control.

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

One 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 website

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

indicator 5.2.1

None

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

indicator 5.3.1

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

indicator 5.3.2

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

indicator 5.3.4

10 or more

Here you may provide further details

See http://bch.minambiente.it/EN/Publications/index.asp