COP-MOP-5 annotated agenda

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					Format for the Second National Report
      on the implementation of
 the Cartagena Protocol on Biosafety
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                      GUIDELINES FOR USE OF THE REPORTING FORMAT
The following format for preparation of the second national report on implementation of the Cartagena
Protocol on Biosafety called for under Article 33 of the Protocol is a series of questions based on those
requirements of the Protocol as well as questions that relate to indicators of the Strategic Plan.
Responses to these questions will help Parties to review the extent to which they are successfully
implementing the provisions of the Protocol and will assist the Conference of the Parties serving as the
meeting of the Parties to the Protocol to assess the overall status of implementation of the Protocol.
Questions highlighted in grey may not strictly be based on provisions of the Cartagena Protocol on
Biosafety or the decisions of the Parties to the Protocol. They are included in this reporting format only to
help draw a baseline for the assessment and review of the Protocol in the context of Article 35 and to help
measure progress in the implementation of the Strategic Plan of the Protocol.
The deadline for submission of the second national report is no less than 12 months prior to the sixth
meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol. It is intended
to cover activities undertaken between the presentation of the first national report (or the entry into force of
the Protocol for reporting Parties that ratified or acceded to the Protocol after 11 September 2007) and the
date of reporting for the second national report.
For subsequent national reports, the format is expected to evolve, as questions that are no longer relevant
may be deleted, questions that are relevant to ongoing progress in implementation will be retained, and
additional questions will be formulated pursuant to future decisions of the Conference of the Parties serving
as the meeting of the Parties to the Protocol.
The wording of questions follows the wording of the relevant articles of the Protocol as closely as possible.
The use of terms in the questions follows the meanings accorded to them under Article 3 of the Protocol.
The format tries to minimize the reporting burden on Parties, while eliciting the important information
regarding implementation of the provisions of the Protocol. Most of the questions asked require only a tick
in one or more boxes and for each article, a text field allows the provision of further details on its
implementation. Although there is no set limit on the length of text, in order to assist with the review and
synthesis of the information in the reports, respondents are asked to ensure that answers are as relevant and
as succinct as possible.
The Executive Secretary welcomes any comments on the adequacy of the questions, and difficulties in
completing the questions, and any further recommendations on how these reporting guidelines could be
improved. Space is provided for such comments at the end of the report.
It is recommended that Parties involve all relevant stakeholders in the preparation of the report, in order to
ensure a participatory and transparent approach to its development and the accuracy of the information
requested.
The form is also available on the BCH for completion electronically at the following address:
http://bch.cbd.int/managementcentre/edit/CPBnationalreport2.shtml
IMPORTANT: To facilitate the analysis of the information contained in this report, it is recommended
that Parties submit the report through the Biosafety Clearing-House or as an attachment to an e-mail in
MS Word format, together with a scanned copy of the first signed page, to the Secretariat at:
secretariat@cbd.int
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                 Second National Report
on the Implementation of the Cartagena Protocol on Biosafety
      Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 5
                                                       Origin of report

1.     Country:                                                  Italia

Contact officer for report

2.     Name of contact officer:                                  Renato Grimaldi

3.     Title of contact officer:                                  Director General

                                                                 Ministero dell'Ambiente e della Tutela del
4.     Organization
                                                                 Territorio e del Mare

                                                                 Via Cristoforo Colombo, 44 Roma
5.     Mailing address:

6.     Telephone:                                                +39 06 57223433

7.     Fax:                                                      +390657223470

8.     E-mail:                                                             dg-pnm@minambiente.it

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

Submission

10.    Date of submission:                                                       Type your text here

11.    Time period covered by this report:                       October 2007- Sptember 2011




Signature of the reporting officer1                            _____________________________________




1
  This document is made available as a protected form in MS Word format for further processing of the information contained therein
by the CBD Secretariat. Only text entries and checkboxes are changeable. Once the document is filled in, please save it and print this
first page for signature. The form is also available on the BCH for completion electronically at:
http://bch.cbd.int/managementcentre/edit/CPBnationalreport2.shtml
IMPORTANT: To facilitate the analysis of the information contained in this reports, please send the report to the Secretariat
  via e-mail at secretariat@cbd.int as attachment in MS Word format, together with a scanned copy of the first signed page;
              please do not send this report via fax or postal mail or in electronic formats other than MS Word.
12.   Is your country a Party to the Cartagena                    Yes
      Protocol on Biosafety (CPB)?                                No

                                                                  Yes
13.   If you answered No to question 12, is there
      any national process in place towards                       No
      becoming a Party?                                           Not applicable

14.   Here you may provide further details:
         Entry into force 23, September 2003

                                 Article 2 – General provisions

                                                                  A domestic regulatory
                                                                  framework is fully in place
                                                                  A domestic regulatory
                                                                  framework is partially in place
15.   Has your country introduced the necessary
      legal, administrative and other measures for                Only temporary measures have
      the implementation of the Protocol?                         been introduced
                                                                  Only a draft framework exists
                                                                  No measures have yet been
                                                                  taken

                                                                  One or more national biosafety
                                                                  laws
                                                                  One or more national biosafety
                                                                  regulations
16.   Which specific instruments are in place for
                                                                  One or more sets of biosafety
      the implementation of your national biosafety
                                                                  guidelines
      framework?
                                                                  Other laws, regulations or
                                                                  guidelines that indirectly apply
                                                                  to biosafety
                                                                  No instruments are in place

17.   Has your country established a mechanism
      for the budgetary allocations of funds for the              Yes
      operation    of    its   national    biosafety              No
      framework?

18.   Does your country have permanent staff to                   Yes
      administer functions directly related to the
      national biosafety framework?                               No
      Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 7

                                                                    One
19.   If you answered Yes to question 18, how                       Less than 5
      many permanent staff members are in place
                                                                    Less than 10
      whose functions are directly related to the
      national biosafety framework?                                 More than 10
                                                                    Not applicable

                                                                    Yes
20.   Has your country’s biosafety framework /
      laws / regulations / guidelines been submitted                Partially
      to the Biosafety Clearing-House (BCH)?                        No

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                  Yes
      movement, handling and use of living
                                                                    Yes, to some extent
      modified organisms (LMOs) which are
      pharmaceuticals?                                              No

                                                                    Yes
23.   If you answered Yes to question 22, has this                  Partially
      information been submitted to the BCH?                        No
                                                                    Not applicable
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                    Yes
      LMOs?                                                        No

26.   Does your country regulate the contained use                 Yes
      of LMOs?                                                     No

                                                                   Yes
27.   If you answered Yes to questions 25 or 26,                   Partially
      has this information been submitted to the
      BCH?                                                         No
                                                                   Not applicable

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                Yes
      / administrative measures for the operation of
      the AIA procedure of the Protocol?                           No
      Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 9

30.   Has your country adopted a domestic regulatory
      framework consistent with the Protocol regarding           Yes
      the transboundary movement of LMOs for                     No
      intentional introduction into the environment?

31.   Has your country established a mechanism
      for taking decisions regarding first intentional           Yes
      transboundary movements of LMOs for                        No
      intentional introduction into the environment?

32.   If you answered Yes to question 31, does the
                                                                 Yes
      mechanism also apply to cases of intentional
      introduction of LMOs into the environment                  No
      that were not subject to transboundary                     Not applicable
      movement?

33.   Has your country established a mechanism                   Yes
      for monitoring potential effects of LMOs that
      are released into the environment?                         No
                                                         Yes
34.   Does your country have the capacity to detect
                                                         Yes, to some extent
      and identify LMOs?
                                                         No

35.   Has your country established legal
      requirements for exporters under its
      jurisdiction to notify in writing the competent    Yes
      national authority of the Party of import prior
      to the intentional transboundary movement of       No
      an LMO that falls within the scope of the
      AIA procedure?

36.   Has your country established legal                 Yes
      requirements for the accuracy of information
      contained in the notification?                     No

37.   Has your country ever received an
      application / notification regarding intentional   Yes
      transboundary movements of LMOs for                No
      intentional introduction into the environment?

38.   Has your country ever taken a decision on an       Yes
      application / notification regarding intentional
                                                         No
      transboundary movements of LMOs for
      intentional introduction into the environment?     Not applicable

                                                         None
39.   If you answered Yes to question 38, how            Less than 5
      many LMOs has your country approved to
                                                         Less than 10
      date for import for intentional introduction
      into the environment?                              More than 10
                                                         Not applicable

                                                         None
40.   If you answered Yes to question 38, how            Less than 5
      many LMOs, not imported, has your country
                                                         Less than 10
      approved to date for intentional introduction
      into the environment?                              More than 10
                                                         Not applicable

41.   In the current reporting period, how many          None
      applications/notifications has your country        Less than 5
      received regarding intentional transboundary
      movements of LMOs for intentional                  Less than 10
      introduction into the environment?                 More than 10
      Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 11

42.    In the current reporting period, how many                  None
       decisions has your country taken regarding                 Less than 5
       intentional transboundary movements of
       LMOs for intentional introduction into the                 Less than 10
       environment?                                               More than 10

If you replied None to question 42 please go to question 50

43.    With reference to the decisions taken on
       intentional transboundary movements of
                                                                  Yes, always
       LMOs for intentional introduction into the
       environment, has your country received a                   In some cases only
       notification from the Party(ies) of export or
                                                                  No
       from the exporter(s) prior to the
       transboundary movement?

                                                                  Yes, always
44.    Did the notifications contain complete
       information (at a minimum the information                  In some cases only
       specified in Annex I of the Cartagena                      No
       Protocol on Biosafety)?
                                                                  Not applicable

                                                                  Yes, always
45.    Has your country acknowledged receipt of                   In some cases only
       the notifications to the notifier within ninety
       days of receipt?                                           No
                                                                  Not applicable

                                                                  Yes, always
                                                                  In some cases only
46.    Has your country informed the notifier(s) and              In some cases only the notifier
       the BCH of its decision(s)?                                In some cases only the BCH
                                                                  No
                                                                  Not applicable

                                                                  Yes, always
47.    Has your country informed the notifier(s) and
       the BCH of its decision(s) in due time (within             In some cases only
       270 days or the period specified in your                   No
       communication to the notifier)?
                                                                  Not applicable
                                                           [ %] Approving the import without
                                                                conditions
                                                           [ %] Approving the import with
                                                                conditions
                                                           [ %]    Prohibiting the import
48.   What percentage of your country’s decisions
                                                           [ %]    Requesting additional
      fall into the following categories?
                                                                   information
                                                           [ %]    Extending the period for the
                                                                   communication of the decision
                                                                   Not applicable


                                                                   Yes, always
                                                                   In some cases only
49.   In cases where your country approved an
      import with conditions or prohibited an                      In some cases only to the
      import, did it provide reasons on which its                  notifier
      decisions were based to the notifier and the                 In some cases only to the BCH
      BCH?
                                                                   No
                                                                   Not applicable

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                  Yes
      domestic use, including placing on the                       No
      market, of LMOs-FFP?

52.   Has your country established legal                           Yes
      requirements for the accuracy of information
      to be provided by the applicant?                             No
      Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 13

53.    Has your country established a mechanism to
       ensure that decisions regarding LMOs-FFP                   Yes
       that may be subject to transboundary
       movement will be communicated to the                       No
       Parties through the BCH?

54.    Has your country established a mechanism                   Yes
       for taking decisions on the import of LMOs-
       FFP?                                                       No

55.    Has your country declared through the BCH
       that in the absence of a regulatory framework              Yes
       its decisions prior to the first import of an
       LMO-FFP will be taken according to Article                 No
       11.6 of the Cartagena Protocol on Biosafety?

56.    Has your country indicated its needs for                   Yes
       financial and technical assistance and
       capacity-building in respect of LMOs-FFP?                  No

57.    Has your country ever taken a decision on                  Yes
       LMOs-FFP (either on import or domestic
       use)?                                                      No

If you replied No to question 57 please go to question 63

                                                                  None
                                                                  Less than 5
58.    How many LMOs-FFP has your country
                                                                  Less than 10
       approved to date?
                                                                  More than 10
                                                                  Not applicable

                                                                  None
59.    In the current reporting period, how many                  Less than 5
       decisions has your country taken regarding
       the import of LMOs-FFP?                                    Less than 10
                                                                  More than 10

                                                                  None
60.    In the current reporting period, how many
       decisions has your country taken regarding                 Less than 5
       domestic use, including placing on the                     Less than 10
       market, of LMOs-FFP?
                                                                  More than 10

If you replied None to both questions 59 and 60 please go to question 63
                                                                   Yes, always
61.   Has your country informed the Parties
      through the BCH of its decision(s) regarding                 In some cases only
      import, of LMOs-FFP?                                         No

                                                                   Yes, always
62.   Has your country informed the Parties                        In some cases only
      through the BCH of its decision(s) regarding
      domestic use, including placing on the                       Yes, but with delays (i.e.
      market, of LMOs-FFP within 15 days?                          longer than 15 days)
                                                                   No

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                      Yes
      regarding an intentional transboundary                       No
      movement of LMOs?

65.   Has your country ever received a request for                 Yes
      a review of a decision?                                     No

                                                                   Yes, decision reviewed
66.   Has your country ever reviewed / changed a
                                                                   Yes, decision reviewed and
      decision    regarding     an     intentional
                                                                   changed
      transboundary movement of LMOs?
                                                                   No

67.   In the current reporting period, how many                    None
      decisions were reviewed and/or changed
                                                                   Less than 5
      regarding an intentional transboundary
      movement of an LMO?                                          More than 5

If you replied None to the question 67 please go to question 71
      Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 15

                                                                     Yes, always
                                                                     In some cases only
68.    Has your country informed the notifier and
       the BCH of the review and/or changes in the                   In some cases only the notifier
       decision?                                                     In some cases only the BCH
                                                                     No

                                                                     Yes, always
69.    Has your country informed the notifier and                    In some cases only
       the BCH of the review and changes in the                      Yes, but with delays (i.e.
       decision within thirty days?                                  longer than 30 days)
                                                                     No

                                                                     Yes, always
                                                                     In some cases only
70.    Has your country provided reasons to the
       notifier and the BCH for the review and/or                    In some cases only the notifier
       changes in the decision?                                      In some cases only the BCH
                                                                     No

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                       Yes
       regarding an intentional transboundary                        No
       movement of LMOs?

73.    Has your country ever applied the simplified                  Yes
       procedure?                                                    No

                                                                     Yes, always
74.    If you answered Yes to question 73, has your
       country informed the Parties through the                      In some cases only
       BCH of the cases where the simplified                         No
       procedure applies?
                                                                     Not applicable

                                                                     None
75.    In the current reporting period, how many
       LMOs has your country applied the                             Less than 5
       simplified procedure to?                                      More than 5
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,                  Yes
      regional or multilateral agreements or
      arrangements?                                                 No

                                                                    Yes, always
78.   If you answered Yes to question 77, has your                  In some cases only
      country informed the Parties through the
      BCH of the agreements or arrangements?                        No
                                                                    Not applicable

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


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).

                                  Articles 15 – Risk assessment

81.   Has your country established a mechanism                      Yes
      for conducting risk assessments prior to
      taking decisions regarding LMOs?                              No

82.   If you answered Yes to question 81, does this                 Yes
      mechanism include procedures for identifying
      experts to conduct the risk assessments?                      No

83.   Has your country established guidelines for                   Yes
      how to conduct risk assessments prior to
      taking decisions regarding LMOs?                              No

84.   Has your country acquired the necessary                       Yes
      domestic    capacity to  conduct   risk
      assessment?                                                   No

85.   Has your country established a mechanism                      Yes
      for training national experts to conduct risk
      assessments?                                                  No
      Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 17

86.    Has your country ever conducted a risk                     Yes
       assessment of an LMO for intentional
       introduction into the environment?                         No

87.    Has your country ever conducted a risk                     Yes
       assessment of an LMO intended for direct use
       as food or feed, or for processing?                        No

88.    If your country has taken decision(s) on                   Yes, always
       LMOs for intentional introduction into the                 In some cases only
       environment or on domestic use of LMOs-
       FFP, were risk assessments conducted for all               No
       decisions taken?                                           Not applicable

                                                                  Yes, always
89.    Has your country submitted summary reports                 In some cases only
       of the risk assessments to the BCH?                        No
                                                                  Not applicable

                                                                  None
90.    In the current reporting period, if your
       country has taken decisions regarding LMOs,                5 or less
       how many risk assessments were conducted                   10 or less
       in the context of these decisions?
                                                                  More than 10

                                                                  Yes, always
91.    Has your country ever required the exporter                In some cases only
       to conduct the risk assessment(s)?                         No
                                                                  Not applicable

                                                                  Yes, always
92.    Has your country ever required the notifier to             In some cases only
       bear the cost of the risk assessment(s) of
       LMOs?                                                      No
                                                                  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:

                                                                   Yes
      (i) LMOs for intentional introduction into the               Yes, to some extent
      environment?                                                 No


                                                                   Yes
      (ii) LMOs intended for direct use as food or
                                                                   Yes, to some extent
      feed, or for processing?
                                                                   No

                                                                   Yes
95.   Has your country established and maintained
      appropriate measures to prevent unintentional                Yes, to some extent
      transboundary movements of LMOs?                             No
      Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 19

96.    Has your country taken measures to ensure
       that any LMO, whether imported or locally
       developed, undergoes an appropriate period                   Yes
       of observation that is commensurate with its                 No
       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                   Yes
       specific traits that may have adverse effects
       on the conservation and sustainable use of                   No
       biological diversity?

98.    Has your country cooperated with other
       Parties with a view to taking measures
       regarding the treatment of LMOs or specific                  Yes
       traits that may have adverse effects on the                  No
       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                  Yes
     contact for the purposes of receiving                          No
     notifications under Article 17?

101. Has your country established a mechanism
     for addressing emergency measures in case of                   Yes
     unintentional transboundary movements of
     LMOs that are likely to have significant                       No
     adverse effect on biological diversity?
102. Has your country implemented emergency
     measures in response to information about                   Yes
     releases that led, or may have led, to
     unintentional transboundary movements of                    No
     LMOs?

103. In the current reporting period, how many                   Never
     times has your country received information
     concerning occurrences that led, or may have                Less than 5
     led,    to     unintentional      transboundary             Less than 10
     movement(s) of one or more LMOs to or
     from territories under its jurisdiction?                    More than 10

If you replied Never to question 103 please go to question 107

104. Has your country notified affected or                       Yes, for every occurrence
     potentially affected States, the BCH and,
                                                                 Yes, for some occurrences
     where appropriate, relevant international
     organizations, of the above release?                        No

                                                                 The affected or potentially
                                                                 affected State
105. If you answered Yes to question 104, who did
                                                                 The BCH
     your country notify?
                                                                 Relevant international
                                                                 organizations
                                                                 Not applicable

                                                                 Yes, always
106. Has your country immediately consulted the                  Yes, in some cases
     affected or potentially affected States to
     enable them to determine appropriate                        No, consultation was made but
     responses and initiate necessary action,                    not immediately
     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                 Yes
     movement are handled, packaged and
                                                                 Yes, to some extent
     transported under conditions of safety, taking
     into account relevant international rules and               No
     standards?
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 21

109. Has your country taken measures to require
     that documentation accompanying LMOs-
     FFP clearly identifies that, in cases where the
                                                               Yes
     identity of the LMOs is not known through
     means such as identity preservation systems,              Yes, to some extent
     they may contain living modified organisms                No
     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
                                                               Yes
     identity of the LMOs is known through means
     such as identity preservation systems, they               Yes, to some extent
     contain living modified organisms and are not
                                                               No
     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              Yes
     and specifies any requirements for the safe
                                                               Yes, to some extent
     handling, storage, transport and use, the
     contact point for further information,                    No
     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            Yes
     traits and/or characteristics, any requirements
                                                               Yes, to some extent
     for the safe handling, storage, transport and
     use, the contact point for further information            No
     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    Yes, to some extent
     documentation of LMOs?                            No

                                                       Yes
114. Has your country established procedures for
                                                       Yes, to some extent
     the sampling and detection of LMOs?
                                                      No
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 23

115. Here you may provide further details on the implementation of Article 18 in your
     country:
     INFO FOLLOWS BUT NON VIVIBLE IN THE PAGE
     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
           Article 19 – Competent National Authorities and National Focal Points

116. Has your country designated one national                Yes
     focal point for the Cartagena Protocol to be
     responsible for liaison with the Secretariat?           No

117. Has your country designated one national
     focal point for the Biosafety Clearing-House            Yes
     to liaise with the Secretariat regarding issues
     of relevance to the development and                     No
     implementation of the BCH?

118. Has your country designated one or more
     competent national authorities, which are
                                                             Yes, one
     responsible for performing the administrative
     functions required by the Cartagena Protocol            Yes, more than one
     on Biosafety and are authorized to act on your          No
     country’s behalf with respect to those
     functions?

119. In case your country designated more than
                                                             Yes
     one competent national authority, has your
     country conveyed to the Secretariat the                 No
     respective   responsibilities  of    those              Not applicable
     authorities?

                                                             Yes, all information
120. Has your country made available the required
     information referred in questions 116-119 to            Yes, some information
     the BCH?                                                No

121. In case your country has designated more
                                                             Yes
     than one competent national authority, has
     your country established a mechanism for the            No
     coordination of their actions prior to taking           Not applicable
     decisions regarding LMOs?

122. Has your country established adequate
                                                             Yes
     institutional capacity to enable the competent
     national authority(ies) to perform the                  Yes, to some extent
     administrative functions required by the                No
     Cartagena Protocol on Biosafety?

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


         Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
     Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 25

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.

                                                                 Information available and in
                                                                 the BCH
a.    Existing national legislation, regulations and
      guidelines for implementing the Protocol, as               Information available but not
      well as information required by Parties for the            in the BCH
      advance informed agreement procedure                       Information available but only
      (Article 20, paragraph 3 (a))                              partially available in the BCH
                                                                 Information not available

                                                                 Information available and in
                                                                 the BCH
b.    National laws, regulations and guidelines                  Information available but not
      applicable to the import of LMOs intended                  in the BCH
      for direct use as food or feed, or for
      processing (Article 11, paragraph 5)                       Information available but only
                                                                 partially available in the BCH
                                                                 Information not available

                                                                 Information available and in
                                                                 the BCH
c.    Bilateral,   multilateral    and     regional              Information available but not
      agreements and arrangements (Articles 14,                  in the BCH
      paragraph 2 and 20, paragraph 3 (b))                       Information available but only
                                                                 partially available in the BCH
                                                                 Information not available

                                                                 Information available and in
                                                                 the BCH
d.    Contact details for competent national
      authorities (Article 19, paragraphs 2 and 3),              Information available but not
      national focal points (Article 19, paragraphs 1            in the BCH
      and 3), and emergency contacts (Article 17,                Information available but only
      paragraph 3 (e))                                           partially available in the BCH
                                                                 Information not available
                                                      Information available and in
                                                      the BCH
e.   Reports submitted by the Parties on the          Information available but not
     operation of the Protocol (Article 20,           in the BCH
     paragraph 3 (e))                                 Information available but only
                                                      partially available in the BCH
                                                      Information not available

                                                      Information available and in
                                                      the BCH
f.   Decisions by a Party on regulating the transit   Information available but not
     of specific living modified organisms            in the BCH
     (LMOs) (Article 6, paragraph 1)                  Information available but only
                                                      partially available in the BCH
                                                      Information not available

                                                      Information available and in
                                                      the BCH
g.   Occurrence of unintentional transboundary        Information available but not
     movements that are likely to have significant    in the BCH
     adverse effects on biological diversity
     (Article 17, paragraph 1)                        Information available but only
                                                      partially available in the BCH
                                                      Information not available

                                                      Information available and in
                                                      the BCH
                                                      Information available but not
h.   Illegal transboundary movements of LMOs          in the BCH
     (Article 25, paragraph 3)
                                                      Information available but only
                                                      partially available in the BCH
                                                      Information not available

                                                      Information available and in
i.   Final decisions regarding the importation or     the BCH
     release of LMOs (i.e. approval or prohibition,   Information available but not
     any conditions, requests for further             in the BCH
     information, extensions granted, reasons for
     decision) (Articles 10, paragraph 3 and 20,      Information available but only
     paragraph 3(d))                                  partially available in the BCH
                                                      Information not available
     Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 27

                                                                 Information available and in
                                                                 the BCH
j.    Information on the application of domestic                 Information available but not
      regulations to specific imports of LMOs                    in the BCH
      (Article 14, paragraph 4)                                  Information available but only
                                                                 partially available in the BCH
                                                                 Information not available

                                                                 Information available and in
                                                                 the BCH
k.    Final decisions regarding the domestic use of              Information available but not
      LMOs that may be subject to transboundary                  in the BCH
      movement for direct use as food or feed, or
      for processing (Article 11, paragraph 1)                   Information available but only
                                                                 partially available in the BCH
                                                                 Information not available

                                                                 Information available and in
l.    Final decisions regarding the import of                    the BCH
      LMOs intended for direct use as food or feed,
      or for processing that are taken under                     Information available but not
      domestic regulatory frameworks (Article 11,                in the BCH
      paragraph 4) or in accordance with annex III               Information available but only
      (Article 11, paragraph 6) (requirement of                  partially available in the BCH
      Article 20, paragraph 3(d))
                                                                 Information not available

                                                                 Information available and in
                                                                 the BCH
m.    Declarations regarding the framework to be                 Information available but not
      used for LMOs intended for direct use as food              in the BCH
      or feed, or for processing (Article 11,
      paragraph 6)                                               Information available but only
                                                                 partially available in the BCH
                                                                 Information not available

                                                                 Information available and in
                                                                 the BCH
n.    Review and change of decisions regarding                   Information available but not
      intentional transboundary movements of                     in the BCH
      LMOs (Article 12, paragraph 1)                             Information available but only
                                                                 partially available in the BCH
                                                                 Information not available
                                                     Information available and in
                                                     the BCH
                                                     Information available but not
o.   LMOs granted exemption status by each           in the BCH
     Party (Article 13, paragraph 1)
                                                     Information available but only
                                                     partially available in the BCH
                                                     Information not available

                                                     Information available and in
                                                     the BCH
p.   Cases where intentional transboundary           Information available but not
     movement may take place at the same time as     in the BCH
     the movement is notified to the Party of
     import (Article 13, paragraph 1)                Information available but only
                                                     partially available in the BCH
                                                     Information not available

                                                     Information available and in
                                                     the BCH
q.   Summaries of risk assessments or
     environmental reviews of LMOs generated by      Information available but not
     regulatory processes and relevant information   in the BCH
     regarding products thereof (Article 20,         Information available but only
     paragraph 3 (c))                                partially available in the BCH
                                                     Information not available

125. Has your country established a mechanism
     for strengthening the capacity of the BCH       Yes
     National Focal Point to perform its             No
     administrative functions?

126. Has your country established a mechanism
     for the coordination among the BCH National
     Focal Point, the Cartagena Protocol focal       Yes
     point,    and     the  competent   national     No
     authority(ies) for making information
     available to the BCH?

                                                     Yes, always
127. Does your country use the information
     available in the BCH in its decision making     Yes, in some cases
     processes on LMOs?                              No

128. Has your country experienced difficulties       Yes
     accessing or using the BCH?                     No
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 29

                                                                    Yes
129. If you answered Yes to question 128, has
     your country reported these problems to the                    No
     BCH or the Secretariat?                                        Not applicable

130. Is the information submitted by your country                   Yes
     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:
     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                     Yes
     protect confidential information received
     under the Protocol?                                            No

                                                                    Yes, always
133. Does your country allow the notifier to
     identify information that is to be treated as                  In some cases only
     confidential?                                                  No

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                   Yes
     other Parties in the development and/or
     strengthening of human resources and                           No
     institutional capacities in biosafety?
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 31

                                                               Bilateral channels
136. If you answered Yes to question 135, how                  Regional channels
     were these resources made available?                      Multilateral channels
                                                               Not applicable

137. Has your country provided support to other
     Parties    in    the     development   and/or             Yes
     strengthening of human resources and                      No
     institutional capacities in biosafety?

                                                               Bilateral channels
138. If you answered Yes to question 137, how were             Regional channels
     these resources made available?                           Multilateral channels
                                                               Not applicable

139. Is your country eligible to receive funding               Yes
     from the Global Environment Facility (GEF)?               No

If you replied No to question 139 please go to question 143

140. Has your country ever initiated a process to              Yes
     access GEF funds for building capacity in
     biosafety?                                                No

                                                               Very easy
141. If you answered Yes to question 140, how                  Easy
     would you characterize the process?
                                                               Average
Please add further details about your experience in
accessing GEF funds under question 150.                        Difficult
                                                               Very difficult

                                                               Pilot Biosafety Enabling Activity
                                                               Development of National
                                                               Biosafety Frameworks
                                                               Implementation of National
                                                               Biosafety Frameworks
142. Has your country ever received funding from               Building Capacity for Effective
     the GEF for building capacity in biosafety?               Participation in the BCH
                                                               (Phase I)
                                                               Building Capacity for Effective
                                                               Participation in the BCH
                                                               (Phase II)
                                                               None of the above
143. During the current reporting period, has your
     country undertaken activities for the           Yes
     development and/or strengthening of human
     resources and institutional capacities in       No
     biosafety?
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 33

                                                              Institutional capacity
                                                              Human    resources     capacity
                                                              development and training
                                                              Risk assessment and other
                                                              scientific and technical expertise
                                                              Risk management
                                                              Public awareness, participation
                                                              and education in biosafety
                                                              Information exchange and data
                                                              management           including
                                                              participation in the Biosafety
                                                              Clearing-House
                                                              Scientific,     technical  and
                                                              institutional collaboration at
                                                              subregional,      regional and
                                                              international levels
                                                              Technology transfer
                                                              Identification     of     LMOs,
                                                              including their detection
                                                              Socio-economic considerations
                                                              Implementation    of     the
                                                              documentation   requirements
                                                              under Article 18.2 of the
                                                              Protocol
                                                              Handling    of        confidential
                                                              information
                                                              Measures      to     address
                                                              unintentional and/or illegal
                                                              transboundary movements of
                                                              LMOs
                                                              Scientific biosafety     research
                                                              relating to LMOs
                                                              Taking into account risks to
                                                              human health
                                                              Other: Training courses (2008,
                                                              2009, 2010 and 2011) whose
                                                              need comes from the recognition
                                                              of the necessity of creating a
144. If you answered Yes to question 143, in                  network of regional centers that
     which of the following areas were these                  provide comprehensive training
     activities undertaken?                                   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
145. During the current reporting period, has your   Yes
     country carried out a capacity-building needs
     assessment?                                     No

                                                     Yes
146. Does your country still have capacity-
                                                     Yes, a few
     building needs?
                                                     No
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 35

                                                              Institutional capacity
                                                              Human    resources     capacity
                                                              development and training
                                                              Risk assessment and other
                                                              scientific and technical expertise
                                                              Risk management
                                                              Public awareness, participation
                                                              and education in biosafety
                                                              Information exchange and data
                                                              management           including
                                                              participation in the Biosafety
                                                              Clearing-House
                                                              Scientific,     technical  and
                                                              institutional collaboration at
                                                              subregional,      regional and
                                                              international levels
                                                              Technology transfer
147. If you answered Yes to question 146, indicate
                                                              Identification     of     LMOs,
     which of the following areas still need
                                                              including their detection
     capacity-building.
                                                              Socio-economic considerations
                                                              Implementation    of     the
                                                              documentation   requirements
                                                              under Article 18.2 of the
                                                              Protocol
                                                              Handling    of        confidential
                                                              information
                                                              Measures      to     address
                                                              unintentional and/or illegal
                                                              transboundary movements of
                                                              LMOs
                                                              Scientific biosafety     research
                                                              relating to LMOs
                                                              Taking into account risks to
                                                              human health
                                                              Other: <Text entry>
                                                              Not applicable
148. Has your country developed a capacity-                  Yes
     building strategy or action plan?                       No

149. Has your country submitted the details of               Yes
     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:


                       Article 23 – Public awareness and participation

151. Has your country established a strategy or put
                                                               Yes
     in place legislation for promoting and
     facilitating public awareness, education and              Yes, to some extent
     participation concerning the safe transfer,               No
     handling and use of LMOs?

152. Has your country established a biosafety                  Yes
     website?                                                  No

                                                               Yes
153. Has your country established a mechanism to
     ensure public access to information on living             Yes, to a limited extent
     modified organisms that may be imported?                  No

                                                               Yes
154. Has your country established a mechanism to
     consult the public in the decision-making                 Yes, to a limited extent
     process regarding LMOs?                                   No

                                                               Yes
155. Has your country established a mechanism to
     make available to the public the results of               Yes, to a limited extent
     decisions taken on LMOs?                                  No

156. Has your country taken any initiative to                  Yes
     inform its public about the means of public
     access to the Biosafety Clearing-House?                   No
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 37

157. In the current reporting period, has your
                                                                    Yes
     country promoted and facilitated public
     awareness, education and participation                         Yes, to a limited extent
     concerning the safe transfer, handling and use                 No
     of LMOs?

                                                                    Yes
158. If you answered Yes to question 157, has
     your country cooperated with other States and                  No
     international bodies?                                          Not applicable

159. In the current reporting period, how many
                                                                    Never
     times has your country consulted the public in
     the decision-making process regarding LMOs                     Less than 5
     and made the results of such decisions                         More than 5
     available to the public?

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-                  Yes
     Parties regarding transboundary movements                      No
     of LMOs?

162. Has your country ever imported LMOs from                       Yes
     a non-Party?                                                   No

163. Has your country ever exported LMOs to a                       Yes
     non-Party?                                                     No
                                                                  Yes, always
164. If you answered Yes to questions 162 or 163,
     were the transboundary movements of LMOs                     In some cases only
     consistent with the objective of the Cartagena               No
     Protocol on Biosafety?
                                                                  Not applicable

                                                                  Yes, always
165. If you answered Yes to questions 162 or 163,                 In some cases only
     was information about these transboundary
     movements submitted to the BCH?                              No
                                                                  Not applicable

                                                                  Yes, always
166. If your country is not a Party to the Cartagena
     Protocol, has it contributed information to the              In some cases only
     BCH on LMOs released in, or moved into, or                   No
     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                        Yes
     transboundary movements of LMOs carried
     out in contravention of its domestic measures                No
     to implement this Protocol?

169. Has your country established a strategy for                  Yes
     detecting illegal transboundary movements of
     LMOs?                                                        No
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 39

170. In the current reporting period, how many                   Never
     times has your country received information                 Less than 5
     concerning cases of illegal transboundary
     movements of an LMO to or from territories                  Less than 10
     under its jurisdiction?                                     More than 10

If you replied Never to question 170 please go to question 175

                                                                 Yes
                                                                 Only in some cases
                                                                 Only the other Party(ies)
171. Has your country informed the BCH and the                   involved
     other Party(ies) involved?
                                                                 Only the BCH
                                                                 No
                                                                 Not applicable

                                                                 Yes
172. Has your country established the origin of the
                                                                 Yes, some cases
     LMO(s)?
                                                                 No

                                                                 Yes
173. Has your country established the nature of
                                                                 Yes, some cases
     the LMO(s)?
                                                                 No

                                                                 Yes
174. Has    your    country    established  the
     circumstances of the illegal transboundary                  Yes, some cases
     movement(s)?                                                No
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                      Yes
     import, has it ever taken into account socio-                Only in some cases
     economic considerations arising from the
     impact of the LMO on the conservation and                    No
     sustainable use of biological diversity?                     Not applicable

                                                                  Yes
177. Has your country cooperated with other
     Parties on research and information exchange                 Yes, to a limited extent
     on any socio-economic impacts of LMOs?
                                                                  No
   Second National Report on the Implementation of the Cartagena Protocol on Biosafety- Page 41

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                    Yes
     Lumpur Supplementary Protocol on Liability and
     Redress?                                                    No

180. Has your country initiated steps towards                    Yes
     ratification, acceptance or approval of the Nagoya-
     Kuala Lumpur Supplementary Protocol?                        No

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

                                                                 Yes
                                                                 Yes, Interim report only
182. Has your country submitted the previous
     national reports (Interim and First National                Yes, First report only
     Reports)?                                                   No
                                                                 Not applicable
                                                              Lack of financial resources to
                                                              gather the necessary
                                                              information
                                                              Lack of relevant information at
                                                              the national level
                                                              Difficulty in compiling the
183. If your country did not submit previous                  information from various
     reports, indicate the main challenges that               sectors
     hindered the submission
                                                              No obligation to submit (e.g.
                                                              country was not a Party at the
                                                              time)
                                                              Other, please specify
                                                              [Type your text here]
                                                              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

				
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