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									                                            Competent authority (CA)                                                 GMO Legislation in the Member States (MS)                                       Summary of Part B GMO deliberate release field trials                                  Info
                                                                                                       2.1 Has                                                          2.2 Does the 3.1 Summary of       3.2 If it is not 3.3 Where a field                             4.1 Do you have
                                                                                                      Directive                                                            national   the GMO DR field correct, have you        trial was      If NO, please provide     an authorisation
                                                                                                     2001/18/EC                                                          legislation    trials - do you     made the         authorised but details of field trials that   procedure in
                                                                                                                      If YES, please provide the name(s) of the
    Member State   Contact name     Address            Email:        Telephone:         Fax:            been                                                               include     confirm that the     necessary      did not go ahead, were authorised but did         place for
                                                                                                                                      legislation
                                                                                                    implemented                                                         provision for    information    alterations in the      have you      not go ahead in this text     applicants
                                                                                                     in national                                                        part B GMO        provided is         Excel         indicated this is            box             seeking consent
                                                                                                    legislation in                                                          trials?        correct?        spreadsheet            in the                                   to conduct a
      #NAME?         #NAME?          #NAME?           #NAME?           #NAME?          #NAME?         #NAME?                            #NAME?                            #NAME?           #NAME?            #NAME?             #NAME?                 #NAME?               #NAME?




                                  Federal Ministry                                                                             Austrian Gene Technology Act
                                     of Health,                                                                            (Gentechnikgesetz BGBl. Nr. 510/1994,
                                    Family and                                                                        i.d.g.F)and Ordinance on Deliberate Release of
                    Eva Claudia     Youth, Dep. eva.lang@bmgf                        +43-1-713 44                               GMOs into the Environment                                                 N/A spreadsheet
1    AUSTRIA                                                            -75508                           Yes                                                                Yes              Yes                                  N/A                                         Yes
                       Lang            IV/B/9        j.gv.at                           04-1711                       (Freisetzungsverordnung BGBl. II Nr. 260/2005)                                          is correct
                                  Radetzkystraße                                                                              (Overview available in English at
                                      2 A-1030                                                                       http://www.bmgfj.gv.at/cms/site/standard.html?
                                   Vienna Austria                                                                      channel=CH0808&doc=CMS1113384921462)




                                                                                                                        Royal decree: Arrêté royal du 21 février 2005
                                   Place Victor
                                                                                                                       réglementant la dissémination volontaire dans
                                  Horta, 40, bte   martine.delanoy
                     Martine                                         + 32 2 524 73   +32 2 524 73                    l'environnement ainsi que la mise sur le marché                                                                           No field trials in Belgium
2    BELGIUM                        10, 1060       @health.fgov.b                                        Yes                                                                Yes              Yes                No                No                                          Yes
                     Delanoy                                              57              99                            d'organismes génétiquement modifiés ou de                                                                              since 17 October 2002.
                                    Bruxelles,            e
                                                                                                                           produits en contenant (Moniteur belge,
                                     Belgium
                                                                                                                                        24/02/2005)
                               Ministry of                                                             Genetically modified organisms Act
                             Environment                                                        (http://bch.cbd.int/database/record.aspx?id=840
                                            gtonkovska@m
                  Galya      and Water 22                   +359 2 940     +359 2 940              9) Regulation on the deliberate release and                   N/A spreadsheet
3   BULGARIA                                oew.governmen                                 Yes                                                        Yes   Yes                     N/A   Yes
                Tonkovska    Maria Louisa                      6152           6127                       placing on the market of GMOs                              is correct
                                                 t.bg
                            blvd 1000 Sofia                                                     (http://bch.cbd.int/database/record.aspx?id=402
                                Bulgaria                                                                                63)




                             Environment
                 EIRINI     Officer, LOUKI iconstantinou@                                        Law 160(I)/2003 for the protection of human
                                                                                                                                                                 N/A spreadsheet
4   CYPRUS     KONSTANTIN   AKRITA 1411, environment.m      35722303865    35722774945    Yes   health and the environment from the deliberate       Yes   Yes                     N/A   Yes
                                                                                                                                                                    is correct
                  OU          NICOSIA,        oa.gov.cy                                           release and placing in the market of GMOs
                               CYPRUS




                            Vrsovicka 65,                                                       Act No. 78/2004 Coll., on the use of genetically
     CZECH      Ms Hana     100 10 Prague   hana_jirakova     + 420          + 420                 modified organisms and genetic products,
5                                                                                         Yes                                                        Yes   No         Yes          N/A   Yes
    REPUBLIC    Jirakova      10, Czech       @env.cz       267122066      267310013             including the marked amendments performed
                               Republic                                                                  by the Act No. 346/2005 Coll.




                                Danish
                            Environmental                                                         Statuary Order on deliberate release into the
                              Protection                                                        environment of genetically modified organisms;
                                                            +45 72 54 41   +45 33 32 22
6   DENMARK     Ole Kaae        Agency      OLK@mst.dk                                    Yes     Statuary Order no.1319, November 20. 2006          Yes   No         Yes          Yes   Yes
                                                                 42             28
                            Strandgade 29                                                       (last edition)- copy in english will be send by e-
                                 1401                                                                                  mail.
                            Copenhagen K
                                Ministry of                                                           The main legislative act regulating the use of
                               Environment                                                              GMOs in Estonia is the "Act on Deliberate
                                               tuuli.levandi@e                                                                                                      N/A spreadsheet
7    ESTONIA   Tuuli Levandi   Narva mnt 7A                    +372 62 62 886 +372 62 62 901   Yes    release of GMOs into the Environment" valid       Yes   Yes                     N/A                                  Yes
                                                    nvir.ee                                                                                                            is correct
                               15712 Tallinn                                                           since the first May 2004. Although several
                                 Estonia                                                                   secondary acts under this law exist.
                                  Finnish
                               Environment
                                 Institute,
                               POBox 140,
                  Marja         FIN-00251      marja.ruohonen-
                                                               +358-400-148      +358-20-490                                                                        N/A spreadsheet
8    FINLAND    Ruohonen-        Helsinki,     lehto@ymparist                                  Yes                                                      Yes   Yes                     N/A                                  Yes
                                                                   641              3591                                                                               is correct
                  Lehto         Finland An           o.fi
                                Expert and
                                Inspection
                                 Authority
                               appointed by




                                   Chargée
                               d'étude OGM,
                                 Ministère de
                               l'Agriculture et                                                                                                                                             Anne Grevet has added a
                                 de la Pêche,                                                                                                                                               new worksheet to Annex A
                                                                                                     Decret No. 2007-357 du Mars 2007 modifiant le
                                   Direction    anne.grevet@a                                                                                                                                with details of trials that
                                                               + 33 (0)1 49 55                          decree no. 93-774 du 27 Mars 1993 (see
9    FRANCE    Anne Grevet       générale de griculture.gouv.f                                 Yes                                                      Yes   No         Yes          Yes   did not go ahead and why       Yes
                                                                    58 25                            www.ogm.gouv.fr) (now integrated in the code
                                l'alimentation        rl                                                                                                                                    (emailed to eu-gmo-field-
                                                                                                                    of environment)
                                  251 rue de                                                                                                                                                    trials@csl.gov.uk
                               Vaugirard, 5th                                                                                                                                                        14/01/08)
                                 floor, Room
                                  507, Paris,
                                     France




                                The Federal                                                                                                                                                    The spreadsheet was
                                  Office of                                                                                                                                                     reasonably accurate
                                                                                                      The Genetic Engineering Act implements EU
                                 Consumer                                                                                                                                                         except for the risk
                                                                                                      guidelines in national legislation and seeks to
                               Protection and                                                                                                                                                 management options -
                                                                                                        protect human and animal health and the
                                Food Safety         hans-                                                                                                                                     these do not reflect the
               Dr Hans-Joerg                                 00 49 (0) 3018                           environment from potential adverse effects of
10   GERMANY                      Dept. of    joerg.buhk@bvl                                   Yes                                                      Yes   Yes         No          N/A         risk management          Yes
                   Buhk                                        444 40001                                genetic processes and products. Several
                                  Genetic         .bund.de                                                                                                                                  procedures decided by the
                                                                                                      national ordinances are made under the Act.
                                Engineering                                                                                                                                                 risk assessment authority.
                                                                                                        The Environmental Protection Law is also
                               Mauerstrasse                                                                                                                                                     All of the trials went
                                                                                                               relevant for GMO field trials.
                                39-42, DE-                                                                                                                                                      ahead, not all of the
                               10117, Berlin                                                                                                                                                     SITES went ahead.
                                                                                                      Fully implemented. Hungary has had legislation
                                                                                                         covering the regulation of biotechnological
                                                                                                        activities since March 1998 under the Act on
                                     H-1055                                                            gene technological activities (Act No. XXVII of
                                   Budapest,                                                                  1998) (1998. évi XXVII. törvény a
                                                                                                                                                                                                 Details have been
                                 Kossuth Lajos VertesC@fvm.h                                          géntechnológiai tevékenységr?l). A summary of
11   HUNGARY      Csabáné Vértes                                     -3014582      -3014643     Yes                                                      Yes   No         Yes          Yes    provided in the updated     Yes
                                 tér 11. Postal       u                                                    most of this legislation can be found at:
                                                                                                                                                                                                    spreadsheet
                                 address: 1860                                                        http://biodiv.kvvm.hu/cooperation/research/fol9
                                   Budapest                                                           35505/magyar_jogszabalyok_angol_osszefogla
                                                                                                        loja.doc A detailed description of Hungarian
                                                                                                       GMO legislation is provided in the MS Mission
                                                                                                                            report.




                                  PO Box 3000
                                   Johnstown                                                           Genetically Modified Organisms (Deliberate                                            http://www.epa.ie/whatwed
                    Dr Thomas                       t.mcloughlin                                                                                                     N/A spreadsheet
12    IRELAND                     Castle Estate,                      -915717     -539160346    Yes     release) Regulations-S.I. No 500 of 2003         Yes   Yes                     Yes   o/licensing/gmo/release/pa   Yes
                    McLoughlin                        @epa.ie                                                                                                           is correct
                                  Co Wexford,                                                         implements Directive 2001/18/ECinto Irish law                                                    rtc/trial/.
                                     Ireland




                                    Via Capitan
                                                       dpn-
                                   Bavastro, 174,
13     ITALY      gomes stefano                   biosicurezza@     3.90657E+11   3.90657E+11   Yes       Decreto legislativo 8 luglio 2003, n.224       Yes   Yes        Yes          N/A                                Yes
                                  zip code 00154,
                                                  minambiente.it
                                    Rome, Italy




                                                                                                         2.1.Contained use, deliberate release and
                                                                                                       placing on the market of genetically modified
                                   Republikas                                                             organisms and procedure on monitoring
      LATVIA                                       Sanita.Kalnaca                                                                                                    N/A spreadsheet
14               Sanita Kalnaca    laukums 2,                       37167878715   37167027205   Yes       (accepted by Cabinet of Ministers of the       Yes   Yes                     N/A                                Yes
   (REPUBLIC OF)                                    @zm.gov.lv                                                                                                          is correct
                                   Riga, Latvia                                                        Republic of Latvia on 20 April 2004) 2.2.Law
                                                                                                             "Handling of genetically modified
                                                                                                            organisms"(Law in force from 2008)
                                                                                                         1. The Order on Regulation of Risk Assessment
                                                                                                                on GMOs (adopted by the order No.
                                                                                                                681/689/525/753 of the ministers of
                                                                                                          Environment, Health and Agriculture, and the
                                                                                                         Director of State Food and Veterinary Service);
                                                                                                            2. Law on Genetically Modified Organisms,
                                     Ministry of
                                                                                                         June, 2001 (No. IX-375) legally came into force
                                    Environment.
                                                                                                          since 31 of December 2002; 3. Regulation on
                                       Nature
                                                                                                                 GMOs Deliberate Release into the
                                     Protection                                                                                                                                                  2 field trials listed in the
                                                                                                             Environment, Placing on the Market was
                                    Department,                                                                                                                                                   spreadsheet did not go
                                                                                                         adopted by the order No. D1-225 of the minister
                                     Genetically                                                                                                                                                 ahead because consent
                  Chief Officer                    o.pivoriene@a +37052663562;                            of Environment on April 29, 2004; 4. Order on                 N/A spreadsheet
15   LITHUANIA                        Modified                                     37052663663     Yes                                                      Yes   Yes                     N/A   was not issued by the CA;       Yes
                 Odeta Pivorien?                        m.lt     +37052663564                                  Regulation on Public Information and                        is correct
                                     Organisms                                                                                                                                                   Lithuania has issued any
                                                                                                          Participation in Issuing of Consents for Use of
                                     Division A.                                                                                                                                                consent for GMO field trial
                                                                                                            GMos adopted by the order No. 299 of the
                                     Jakato 4/9,                                                                                                                                                         since now.
                                                                                                          Minister of Environment on June 11, 2003; 5.
                                       Vilnius,
                                                                                                             Establishing of GMOs Steering Committe
                                      LT01105,
                                                                                                         adopted by the order No. 602 of the mInister of
                                      Lithuania
                                                                                                              Environment on December 18, 2001; 6.
                                                                                                             Establishing of GMos Experts Committee
                                                                                                         adopted by the order No. 198 of the Minister of
                                                                                                         Environment on April 25, 2003. We do not have
                                                                                                          our own risk assessment guidance document
                                                                                                                     for 1829/2003 application.


                                                                                                          Loi du 13 Janvier 1997 relative au controle de
                                      Ministry of                                                             l'utilisation et de la dissemination des
                                    Health Health                                                        organismes genetiquement modifies, modifiee
                                     Directorate    Marcel.Bruch@ 00 352 247 899   00 352 26 20          par Loi du 13 Janvier 2004 (Law of January 13,                 N/A spreadsheet
16   LUXEMBURG    Marcel Bruch                                                                     Yes                                                      Yes   Yes                     N/A                                   Yes
                                   Allee Marconi L-   ms.etat.lu        51             01 47              1997 relating to the control of the use and the                  is correct
                                         2120                                                               dissemination of the genetically modified
                                    Luxembourg                                                             organisms, modified by Law of January 13,
                                                                                                                                 2004)




                                                                                                                                                                                                 Some permits have been
                                       VROM,
                                                                                                                                                                                                authorised but have had to
                                     Rijnstraat 8,
                                                                                                             Dangerous Substances Act 1990 with a                                               have been later withdrawn
                     Petra         Postbus 30945, petra.hogervors +31 70 339 49    +31 70 339 13                                                                        N/A spreadsheet
17 NETHERLANDS                                                                                     Yes      subsequent amending decree, Decree on           Yes   Yes                     N/A       by the Competent            Yes
                   Hogervorst       2500 GX Den t@minvrom.nl           90               16                                                                                 is correct
                                                                                                             GMOs, which implements the Directive.                                               Authority following legal
                                      Haag, The
                                                                                                                                                                                                  challenges and judicial
                                     Netherlands
                                                                                                                                                                                                         rulings.




                                      Rua da
                                    Murgueira ,
                                      n.9/9A     carmo.figueira
                   Maria do                                         +351 21          +351 21
18   PORTUGAL                        Zambujal,   @apambiente.p                                     Yes        Decree-law n.º 72/2003, of 10th April         Yes   Yes         No          Yes                                   Yes
                 Carmo Palma                                        4728368          4728231
                                   Apartado 7585       t
                                     2611-865
                                     Amadora
                                   12, Blvd.                                                         The Governmental Emergency Ordinance No                                             We have to check the
                                   Libertatii,                                                        43/2007 on the deliberate release into the                                         situation of field trials
                 Ana Maria                       maria.comanoi 0040-21 316 33 0040-21 316 02
19   ROMANIA                       Sector 5                                                    Yes    environment and placing on the market of      Yes   No         Yes          N/A       according to the         Yes
                 Comanoiu                        u@mmediu.ro         82             82
                                  Bucharest,                                                           genetically modified organisms (EGO No                                           Notification B/RO/07/04
                                  ROMANIA                                                                              43/2007)                                                                 (for plum)




                                   Ministry of
                                 Environment
                                   Biosafety
                                                                                                     The Act No. 151/2002 Coll. on use of genetic
      SLOVAK                      Department    ferencik.igor@e   +421 2 5956   +421 2 5956
20              Igor Ferencik                                                                  Yes      technologies and genetically modified       Yes   No         Yes          Yes               -                Yes
     REPUBLIC                   Nam. L. Stura 1 nviro.gov.sk         2646          2575
                                                                                                               organisms as amended
                                    812 35
                                   Bratislava
                                Slovak Republic




                                Dunajska 48, SI-                                                         Management of Genetically Modified
                                                 martin.batic@g    +386(1)       +386(1)                                                                        N/A spreadsheet
21   SLOVENIA   Martin Batic    1000, Ljubljana,                                               Yes   Organisms Act//Zakon o ravnanju z gensko       Yes   Yes                     N/A             N/A                Yes
                                                      ov.si        4787402       4787402                                                                           is correct
                                   Slovenia                                                          spremenjenimi organizmi (Ur.l. RS 23/2005)
                                                                                                                                                                              Annex A is correct with the
                                                                                                    Law 9/2003 on the legal regime of the confined
                                                                                                                                                                               exception for the entries
                                                                                                       use, deliberate release and placing on the
                                                                                                                                                                                 for B/ES/04/19. The
                                                                                                         market. Royal Decree 178/2004 for the
                                                                                                                                                                              purpose of the trial was for
                                                                                                       regulatory development of the Law 9/2003
                                                                                                                                                                               agronomic assessment.
                             Plaza San Juan                                                             Ratification Instrument for the Cartagena
               ANA Fresno                    AFRESNO@m                                                                                                                         Authorisation for release
22    SPAIN                   de la Cruz s/n                   -914535328      -915340548     Yes         Protocol (BOE 181, 30.7.2003) Some           Yes   No   No    No                                   Yes
                  Ruiz                          ma.es                                                                                                                          was requested in various
                              28071 Madrid                                                             Autonomous Regions also have their own
                                                                                                                                                                                autonomous regions.
                                                                                                        implementing legislation for 2001/18 (see
                                                                                                                                                                               These were granted with
                                                                                                    http://www.mma.es/portal/secciones/calidad_co
                                                                                                                                                                                   the exception of
                                                                                                    ntaminacion/omg/legislacion_general/Legislaci
                                                                                                                                                                                   Extremadura and
                                                                                                                    on_espaniola.htm).
                                                                                                                                                                                      Andalusia.
                                                                                                                 Available in English at
                                                                                                    http://www.gmo.nu/gmoenglish.4.778a5d1001f
                                                                                                            29869a7fff935.html. The Swedish
                                                                                                    Environmental Code (SFS 1998:808), Chapter
                                                                                                      13 is the highest level; it defines deliberate
                                                                                                          release as "intentional introduction of
                                                                                                         genetically modified organisms into the
                             Jordbruksverket                                                                                                                                  The updated spreadsheet
                                                                                                         environment without such containment
                             (Swedish Board                                                                                                                                    was sent electronically.
                                                                                                        measures as are mentioned in section 5"
                 Jenny        of Agriculture) Jenny.Andersso +46 (0)36 15 56                                                                                                  However, the column for
23   SWEDEN                                                                                   Yes       (chapter 13, section 6). The Genetically       Yes   No   Yes   No                                   Yes
               Andersson       SE- 551 82        n@sjv.se          87                                                                                                         number of fields was not
                                                                                                        Modified Organisms (Deliberate Release)
                                Jönköping,                                                                                                                                    updated (see note 3.3 in
                                                                                                    Ordinance (SFS 2002:1086) is made under the
                                 Sweden                                                                                                                                          Mission response)
                                                                                                     Environmental code and provides detail about
                                                                                                         administrative procedures, application
                                                                                                    requirements and running GMO field trials etc;
                                                                                                    the Ordinance also covers part C releases (but
                                                                                                       the coexistence regime is described under
                                                                                                    "Precautionary Measures for the Cultivation of
                                                                                                       Genetically Modified Crops (Coexistence)
                                                                                                      Ordinance (SFS 2007:273)". There is also i)



                               Area 8A, 9
                                                                                                                                                                              A consent was issued to
                             Millbank c/o 17
      UNITED                                 Sharon.wort@d     + 44 (0) 207    + 44 (0) 207           Genetically Modified Organisms (Deliberate                              BASF to grow potatoes in
24             Sharon Wort   Smith Square,                                                    Yes                                                      Yes   No   Yes   Yes                                  Yes
     KINGDOM                                 efra.gsi.gov.uk    238 2050        238 2045             Release) Regulations 2002. Introduced 2002.                              Yorkshire but the trial did
                             London, SW1P
                                                                                                                                                                                   not go ahead.
                                 3JR, UK
                                                             Information and application procedures
                                       4.3 Do you provide                                                        4.4 Do you provide                               4.5 Do you have      5.1 Do you have any                                                      5.2 Are there any
 4.2 If YES, how is this information     guidance on the                                                                                                             established                                                                                 crops, traits or
                                                                                                              guidance on the general                                                  specific criteria for                                                                          If YES, please describe which
made available to applicants? Please       information                                                                                                             procedures for                               If YES, please indicate what these are.             crop/trait
                                                                  If YES, please provide a weblink if          principles that need to If YES, please provide a                           acceptance or                                                                             ones and, briefly, why. Please put
provide a weblink if possible. (Please    applicants are                                                                                                             exchanging                                  Please put N/A if you answered NO to          combinations that
                                                                               possible                           be considered for       weblink if possible                               rejection of                                                                                N/A if you answered NO to
   put N/A if you answered NO to       required to provide                                                                                                      information with the                                         question 5.1                        you would not
                                                                                                              management of GMO DR                                                     applications to hold                                                                                     question 5.2
             question 4.1)               in the technical                                                                                                             European                                                                                 authorise for a part
                                                                                                                       trials?                                                         a part B GMO trial?
                                             dossier?                                                                                                             Commission on                                                                                      B trial?
                 #NAME?                        #NAME?                           #NAME?                                #NAME?                    #NAME?                #NAME?                 #NAME?                              #NAME?                             #NAME?                        #NAME?




                                                                                                                                                                                                                  Based on the national regulations the
                                                                                                                                                                                                                 notification is checked by the Ministry in                         So far no DR took place in Austria
 it is in detail available in the under 2.1.
                                                                                                                                                                                                                       assistance of the Austria EPA                                 but generally speaking this could
     mentioned regulations, which are
                                                No                                                                      No                                              Yes                    Yes                (Umweltbundesamt) and the national                  Yes          happen but only AFTER carrying out
          available on our website:
                                                                                                                                                                                                               Scientific Board on Deliberate Release and                           a comprehensive risk-assessment
         http://www.gentechnik.gv.at
                                                                                                                                                                                                               Placing on the Market whether these criteria                        following the case-by-case principle.
                                                                                                                                                                                                                                 are fullfilled.




                                                               Guidance on molecular data that should be
                                                                     provided for Part B field releases
                                                              (http://www.biosecurite.be/gmcropff/EN/TP/p
                                                               artC/GuideMGC_PartB_C.htm) Beside the
                                                               "pure technical dossier", we also provide a
                                                                                                                                                                                                                                                                                     We have no negative list for field
                                                                 guidance note for the compilation of the
                                                                                                                                       http://www.biosecurite.be/                                                                                                                      trials, again a favourable risk
Internet sites and Belgian official journal.                    public dossier within the framework of the                                                                                                     The basic criteria for acceptance is no major
                                                                                                                                       gmcropff/EN/gmcropffMen                                                                                                                      evaluation is the basic criteria, but
         http://www.ogm-ggo.be,                                 deliberate release of transgenic plants for                                                                                                      risks for environment, animal and public
                                                Yes                                                                     Yes            u.html (Protocols for field      No                      No                                                                     No            we can foresee that oilseed rape
http://www.biosecurite.be/gmcropff/EN/g                                    experimental purpose                                                                                                                 health; afterwards, other criteria may exist
                                                                                                                                         releases of transgenic                                                                                                                     would for example be more difficult
             mcropffMenu.html                                 (http://www.biosecurite.be/gmcropff/EN/gmc                                                                                                            depending on the Minister in charge
                                                                                                                                                plants)                                                                                                                              to authorise than other crops like
                                                                 ropffMenu.html) The Royal decree also
                                                                                                                                                                                                                                                                                               potato or maize.
                                                                 provides some guidance in its annexes:
                                                                  guidance on risk evaluation (Directive
                                                               2001/18/EC), guidance on the information
                                                              for the public and model of "survey warning"
                                                                        for the public consultation.
                                                                                                                                                     Prohibitions - GMO Act Article 79. (1) The
                                                                                                                                                    deliberate release into the environment and
                                                                                                                                                      the placing on the market of the following
                                                                                                                                                     GMOs is hereby prohibited: tobacco, vine,
                                                                                                                                                           cotton, damask rose, wheat, and all
                                                                                                                                                          vegetable and orchard crops. (2) The
                                                                                                                                                         Minister of Agriculture and Forestry, in
                                                                                                                                                             consultation with the Minister of
                                                                                                                                                    Environment and Water, shall add GMOs to
                                                                                                                                                       the list under Paragraph (1) by an order
                                                                                                                                                        which shall be promulgated in the State
                                                                                                                                                    Gazette. Article 80. The a deliberate release
Website of the Mnistry of Environment                                                                                                               of any GMOs into the areas included in the              tobacco, vine, cotton, damask rose,
              and Water                                                                                                                                  National Ecological Network within the            wheat, and all vegetable and orchard
                                            No                                                      No                                  No    Yes     meaning given by the Biological Diversity      Yes
http://www2.moew.government.bg/ and                                                                                                                                                                        crops. all GMOs containing antibiotic
     published in the State Gazette                                                                                                                      Act, as well as into the adjoining areas                resistance marker genes
                                                                                                                                                      within a zone of 30 kilometres around any
                                                                                                                                                    such areas, is hereby prohibited. Article 81.
                                                                                                                                                    The deliberate release into the environment
                                                                                                                                                    and the placing on the market of any GMOs
                                                                                                                                                         containing antibiotic resistance marker
                                                                                                                                                     genes is hereby prohibited. Article 82. The
                                                                                                                                                    deliberate release into the environment and
                                                                                                                                                     the placing on the market of any GMOs as
                                                                                                                                                       or in products, which have been refused
                                                                                                                                                          consent in the Member States of the
                                                                                                                                                     European Union, is hereby prohibited. § 4.
                                                                                                                                                       (1) Any genetic modifications of damask
                                                                                                                                                        rose, vine and tobacco within Bulgarian

Through national legislation that can be
                                            No                         N/A                          No               N/A                No    No                         N/A                         No                     N/A
found on the internet (www.moa.gov.cy)


                                                                                                                                                         Criteria for acceptance or rejection of
                                                                                                                                                      applications are based on the Decree No.
                                                                                                                                                    209. These are: information on an applicant,
                                                                                                                                                      information on a professional consultant,
                                                                                                                                                     characteristic of the use of GMO, period of
All the necessary information is included                                                                                                                the introduction into the environment,
 in Decree No. 209 of 15 April 2004, on           Applicants can discuss their notification prior                                                     information if the applicant is planning to
                                                                                                          See answer 4.3. Moreover,                  ask for the deliberate release of GMOs into
     detailed conditions for the use of                to its submission with the staff at the                                                                                                             Herbicide tolerant oil seed rape. This
                                                                                                            staff at the Ministry can                  the environment in any member state of
   genetically modified organisms and       Yes    Ministry of the Environment and also with        Yes                                 Yes   Yes                                                    Yes   species can cross with wild relatives
                                                                                                          send a guidance in English                   European Communities or outside of its
       genetic products (Annex II).                the experts of the Czech Commisssion for                                                                                                                 and spread into the environment.
                                                                                                          by request of an applicant.                     territory, the risk assessment of the
       http://www.env.cz/AIS/web-                    the use of GMOs and genetic products.
      pub.nsf/$pid/MZPMVF3V1K0U                                                                                                                            deliberate release of GMO into the
                                                                                                                                                    environment, information on the recipient or
                                                                                                                                                     parental organism, information on genetic
                                                                                                                                                    modification and genetically modified higher
                                                                                                                                                          plant, information on the amount of
                                                                                                                                                      genetically modified higher plats that is to
                                                                                                                                                        used and on the total area of premises,




                                                                                                                                                    Experimental release of GMO's that transfer
                                                                                                                                                      genes conferring resistance to antibiotics
http://www.mst.dk/Genteknologi/Forsoeg            http://www.mst.dk/Genteknologi/Forsoegsud
                                            Yes                                                     Yes                                 Yes   Yes    used in human or veterinary medicine shall      No                     N/A
             sudsaetning/                                          saetning/
                                                                                                                                                    not be granted approval (Statuary Order, art.
                                                                                                                                                                         3)
                                                                                                                                                                                                               In case of GM rapeseed which will
  It is documented in law, available in
                                                                                                                                                                                                             intend to cultivate next to the organic
State Gazette. www.riigiteataja.ee (only   Yes                                                      No               N/A                 Yes   No                         N/A                          Yes
                                                                                                                                                                                                               agriculture, it is quite likely that we
              in Estonian)
                                                                                                                                                                                                                            will refuse.




                                                                                                                                                      This question must be asked from our CA
   www.geenitekniikanlautakunta.fi         Yes                      as above                        Yes            as above              Yes   No                                                      No                      N/A
                                                                                                                                                                 i.e. gtlk.stm@stm.fi




                                                                                                          This is not available on the
                                                                                                             web but is available on
                                                                                                           request from the Ministry
                                                                                                                of agriculture. The
                                                                                                           document is produced by
                                                                                                          the Commission du Genie
                                                                                                                  Biomoleculaire
                                                                                                           "Recommandations pour
                                                                                                             la redaction du dossier
                                                                                                            scientifique et technique
                                                                                                          de demande d'autorisation
  cf the document "La procedure de                                                                            d'experimentation de                     No specific criteria - all applications are
                                                 - the guidance is not available on the web,                                                                                                                 No specific criteria - all applications
        demande d'autorisation                                                                                 plantes superieures                   considered on a case-by-case basis. If any
                                           Yes      but it is available on request from the         Yes                                  No    No                                                      No     are considered on a case-by-case
     d'experimentation de plantes                                                                         genetiquement modifiees"                    information is missing it is returned to the
                                                             Ministry of Agriculture                                                                                                                                         basis
 superieures genetiquement modifies                                                                             (copy provided). It                                    applicant.
                                                                                                          provides guidelines on the
                                                                                                          general issues that should
                                                                                                              be taken into account
                                                                                                          when planning a field trial,
                                                                                                           and in annexes provides
                                                                                                            indicative guidelines for
                                                                                                            management of trials of
                                                                                                           sugar beet, oilseed rape,
                                                                                                          maize, based on biological
                                                                                                            characteristics of these
                                                                                                           crops. There is a section


                                                                                                                                                                                                                  The CA would only refuse an
                                                                                                                                                                                                                   application if the crop-gene
                                                                                                                                                         The notifier must prove that he/she is
                                                                                                           The new, more detailed                                                                                combination was assessed to
                                                                                                                                                         entitled to carry out the trial at the site
                                                                                                           guidance document will                                                                                   present some risks to the
On the BVL website - a small amount of                                                                                                                 specified - i.e. that the consent could go
                                                                                                          provide this information -                                                                         environment and it was not possible
  information plus contact details, and           A guidance document is available, however                                                           ahead if approved. If the notifier is not the
                                                                                                           as a recommendation.                                                                                to identify adequate management
http://www.bvl.bund.de/cln_027/nn_491      Yes   it is out of date. It is currently being updated   No                                   Yes   Yes   owner of the site evidence must be provided       No
                                                                                                             Each application is                                                                                 measures to manage the risks.
826/DE/06__Gentechnik/gentechnik__n                            but is not yet ready.                                                                    that the owner agrees the trial can take
                                                                                                          decided case-by-case so                                                                              Generally, applications that fall in
          ode.html__nnn=true                                                                                                                          place on his/her land (e.g. a letter must be
                                                                                                          this is only 'guidance' for                                                                        this category would not get as far as
                                                                                                                                                     provided by the owner). The applicant must
                                                                                                            certain types of crops.                                                                              actually lodging an application
                                                                                                                                                        specify exactly where the trial must be.
                                                                                                                                                                                                             because of prior discussions with the
                                                                                                                                                                                                                               CA.
                                                                                                                                                                                                         Authorization decisions are made on
                                                                                                                                                                                                         a case-by-case basis where potential
                                                                                                                                                                                                               risks of the release and the
  All elements of the regulatory system                                                                                                                                                                  management of those risks are taken
  regarding GMOs are published in the                                                                      http://biodiv.kvvm.hu/coop                                                                          into account, so no specific
                                                   Information on the legal framework including
 Official Gazette as well on the Internet                                                                  eration/funding/doc684655                                                                      examples. It depends on the quality
                                                    which kind of information is required in the
   (http://biodiv.kvvm.hu). If applicants                                                                  The consent also contains                                                                         of information contained in the
                                                        notification (including formats for the
have further questions, the CA (Ministry                                                                    requirements the consent                                                                        notification (for example on the
                                                     notification as well as the principles of the
 of Agriculture and Rural Development)                                                                     holder has to comply with,                                                                      thoroughness of the ERA), on the
                                                     era according to Directive 2001/18/EC) is
  and the Ministry of Environment and        Yes                                                     Yes        including isolation      Yes   No                       N/A                        Yes    planned release site (for example if
                                                    available on the Internet. If applicants have
Water can answer them by telephone or                                                                         distances, handling of                                                                         there is a GM maize producing
                                                     further questions, we answer them on the
 through arranged meetings. Applicants                                                                       waste, etc. If applicants                                                                    pharmaceuticals, a larger isolation
                                                        phone or during arranged meetings.
can also participate in the meeting of the                                                                 have further questions, we                                                                        distance will be required. If the
                                                            Websites: www.biosafety.hu;
       Advisory Committee for Gene                                                                          answer them on phone or                                                                       planned release site is not suitable,
                                                                 http://biodiv.kvvm.hu
    Technological Applications which                                                                       during arranged meetings.                                                                      the release is rejected), etc. Where
        evaluates their application.                                                                                                                                                                     wild species are genetically modified
                                                                                                                                                                                                          and thereby contravene Article 9 of
                                                                                                                                                                                                             the Act of Nature Conservation
                                                                                                                                                                                                         (1999) the application would also be



  Guidance is provided on web page -                   Guidance is provided on web page -
http://www.epa.ie/whatwedo/licensing/g       Yes   http://www.epa.ie/whatwedo/licensing/gmo/r        No               N/A                Yes   No                       N/A                        No             Case by case basis
             mo/release/                                             elease/




http://bch.minambiente.it/English/Legisla
                                                   http://bch.minambiente.it/Documenti/PDFFIL
          tion/sezlegislativa.html                                                                           The guidance is being
                                             Yes      ES/DecretoLegislativo-8-luglio-2003-n.-        Yes                                 Yes   Yes   The criteria are included into the guidance   No                     N/A
 http://bch.minambiente.it/English/Docu                                                                           elaborated
                                                              224.pdf (see Annex III)
            ments/TitoloIIEN.pdf




  The information relating authorization
   procedure is available through: - the
                                                                                                           https://bch.cbd.int/databas                                                                    There are many plants which are
    data base of the Biosafety clearing
                                                                                                            e/record.shtml?id=5635                                                                       able to pollinate with rape in Latvia.
                   house
                                                                                                             The national legislation                                                                    The national scientists think that in
https://bch.cbd.int/database/record.shtm     No                                                      Yes                                 Yes   No                       n/a                        Yes
                                                                                                           envisage to apply general                                                                       relation to GM rape there is no
  l?id=5635; - the national data base of
                                                                                                              principles for the risk                                                                     possibility to ensure traceability of
 laws and regulations system (NAIS) in
                                                                                                                   assessment.                                                                             GM elements into environment.
                  Latvian.
   http://pro.nais.lv/naiser/request.cfm
    A National Regulation on GMOs
      Deliberate Release into the
Environment, Placing on the Market was
adopted by the order No. D1-225 of the
  minister of Environment on April 29,      Yes                  http://gmo.am.lt                   Yes        http://gmo.am.lt           Yes   No                         N/A                          No                     N/A
    2004 and is published in Official
 Lithuanian Journal "Valstybes zinios".
 The weblink is http://gmo.am.lt - it is
           only in Lithuanian.




        Information on demand               No                                                      No                                    No    No                         N/A                          No                     N/A




                                                                                                            In the Netherlands, GM
                                                                                                            field trials are classified
                                                                                                                into three levels of
                                                                                                           containment according to
                                                                                                           a GMO s properties and
                                                                                                           stage of breeding/market
                                                                                                            development. Mitigation                                                                           We would not reject any crops, traits
                                                                                                               measures are set in                                                                             or combinations out of hand before
                                                                                                           proportion to the level of                 Provided applications are complete, they are             an application was considered. To
                                                  http://www.vrom.nl/ggo-vergunningverlening
                                                                                                            perceived risk that their                      assessed on a case-by-case basis                     be authorised they would have to
  An application form and covering                Additional documents are provided covering
                                                                                                              release could result in                  according to the potential risk they pose for          satisfy the criteria for a case-by-case
 guidance is available on the VROM                for example trial location, confidentiality and
                                            Yes                                                     Yes   adverse effects on human        Yes   No      harming either human or animal health or        No        evaluation set out in 2001/18.
 website, i.e. http://www.vrom.nl/ggo-             category (area and number of locations) of
                                                                                                                  health and the                      the environment, irrespective of the species,           However in some cases (for instance
         vergunningverlening                          GM field trials. In the application form
                                                                                                               environment. Case-                         traits or crop/trait combination being                 with genetically modified forage
                                                    guidance is given on numerous questions
                                                                                                                specific mitigation                                     considered.                             grass), it would be very difficult, if
                                                                                                                measures are also                                                                                    not impossible to get an
                                                                                                              included in the permit                                                                                       authorisation.
                                                                                                          conditions. The categories
                                                                                                             in short are as follows:
                                                                                                            Category 1. Small scale
                                                                                                           field trials with mitigation
                                                                                                            measures.which ensure
                                                                                                          that the possible effects of
    Besides Decree-law 72/2003 that
                                                     Upon request of the applicant additional
establishes the required procedures and                                                                                                                                                                       Depending on the location of the trail
                                                   guidance is provided on the information to
content of the notification, some general                                                                                                              - definition of a isolation distance - type of          sugarbeet crop/trait would not be
                                                  include in the technical dossiers. In the near
  infomration is made available at the      Yes                                                     No                                    Yes   Yes      GMO modification - environmental risk          Yes   authorised, as in Portugal there are
                                                   future this guidance will be put available in
    Portuguese Environment Agency                                                                                                                                       assessment                               wild species that are sexualy
                                                      the Portuguese Environment Agency
  website (www.apambiente.pt). When                                                                                                                                                                                       compatible.
                                                                     website.
required preparatory meetings are held.
                                                                                                       The guidance is provided
                                                                                                            by the National
The authorization procedure is included                                                                                                                                                          Any GMO having adverse effects on
                                                                                                       Environmental Protection
          in EGO No 43/2007                                                                                                                                                                      human health and the environment,
                                                                                                       Agency (NEPA), working
http://www.mmediu.ro/dep_mediu/legisl                                                                                                                                                           including GMOs which contain genes
                                           No                                                   Yes      under the Ministry of     Yes   Yes       According to EGO No 43/2007.           Yes
   atie_OMG/OUG_43-2007.pdf and                                                                                                                                                                  expressing resistance to antibiotics,
                                                                                                           Environment and
http://www.anpm.ro/afisareact.aspx?id_                                                                                                                                                              which may have such adverse
                                                                                                       Sustainable Development
                act=336                                                                                                                                                                                        effects.
                                                                                                      (MESD), when the notifiers
                                                                                                          are requesting this.




http://www.enviro.gov.sk/servlets/page/8
                                           No                         -                         No                -                Yes   No                       -                       No                     N/A
             68?c_id=2213




The applicant could find the information
     on GMO DR trial authorisation
   procedure in the Official Journal of
 Republic Slovenia and on the webpage
                                                   There is an Regulation on the content of
   of Ministry of the Environment and
                                                   application information for the deliberate
  Spatial planinng(MESP) or Slovenian                                                                                                             before the application is accepted or
                                                  release of the GMOs into the environment
      Biosafety Portal(SBP). MESP:         No                                                   No               N/A               Yes   Yes   rejected the administrative completeness   No                     N/A
                                                 (OJ RS 42/2005) where the applicant could
http://www.mop.gov.si/si/zakonodaja_in                                                                                                                should be always examine.
                                                find all information which should be provided
_dokumenti/okolje/zakon_o_ravnanju_z
                                                             in the technical dossier.
 _gensko_spremenjenimi_organizmi/ or
    SBP: http://www.biotechnology-
gmo.gov.si/eng/slovenija/zakonodaja/ind
                  ex.html
                                                                                                                                                     Completeness check; application form
                                                                                                                                                     written in Spanish; step-by-step criteria
                                                                                                        Management is case by
 There is a procedure published on the                                                                                                               (information supporting the application
                                                                                                        case in the ERA report.
  Ministry of the Environment website,                                                                                                            increases with the stage of development of
                                                                                                      http://www.mma.es/portal/                                                                          Sugar beet in the South of Spain/
       documents are available at:                                                                                                                 the GMO); appropriate isolation distances
                                             No           Guidance is being developed           Yes   secciones/calidad_contam       Yes   Yes                                                    Yes     presence of wild relatives (Beta
http://www.mma.es/portal/secciones/cali                                                                                                          (physical, biological, temporal); presence of
                                                                                                      inacion/omg/notificaciones                                                                                    maritima)
dad_contaminacion/omg/notificaciones_                                                                                                                non GM border rows; absence of local
                                                                                                      _autorizaciones/liberac_vo
        autorizaciones/index.htm                                                                                                                      varieties in the proposed region of the
                                                                                                              luntaria.htm
                                                                                                                                                    release (in some cases); no field trials in
                                                                                                                                                                  protected areas.




                                                                                                      No guidance is provided to
 Via the Swedish Board of Agriculture                                                                                                                  The GMO must be safe from an
                                                                                                      applicants on general risk
website at www.sjv.se/genteknik and the                                                                                                          environmental, health and safety perspective
                                             Yes             www.sjv.se/genteknik               No    management principles - it     Yes   No                                                     No                    N/A
   website shared between several                                                                                                                   but apart from this all applications are
                                                                                                       is left to the applicant to
       authorities, www.gmo.nu.                                                                                                                       assessed on a case-by-case basis.
                                                                                                                 propose.




                                                                                                          ACRE will advise on
http://www.defra.gov.uk/environment/gm
                                                                                                      conditions for the consent
/regulation/index.htm There is usually an
                                                                                                      which are attached to the
informal initial meeting held between the                                                                                                                                                                    There aren t any specific
                                                                                                      consent when issued. The
        notifier and the CA before the                                                                                                                                                                  combinations that would result in an
                                                                                                       GMI will also advise on
application is submitted. At this time the         http://www.defra.gov.uk/environment/gm/reg                                                    Acceptance or rejection of a trial is done on           immediate refusal. Refusal will only
                                             Yes                                                Yes   principles that need to be     Yes   No                                                     No
CA can offer guidance about the level of                        ulation/guide.htm                                                                         a case-by-case basis.                         occur after examination on a case-by-
                                                                                                             considered for
  information required for an application.                                                                                                                                                              case basis and following advice from
                                                                                                      management of GMO DR
 It is not compulsory but is useful. There                                                                                                                                                                             ACRE.
                                                                                                        trials to ensure that an
 is also a website with guidance which is
                                                                                                        applicant is complying
           currently being updated.
                                                                                                             with consents.
                                                                               Assessment of applications
5.3 Is a dedicated                                                                                                          5.5 How important do
scientific advisory                                                                                                            you consider the
                                                                                                                                                                                                        d) Risk management
    committee                                            Does the Committee                                                following information to b) Information about the                                                       e) Proposals for
                      If YES, what is the name of                                      If OTHER, please provide                                                              c) The environmental risk measures & rationale,                             f) Management of wastes   g) Emergency response
 established for                                         comprise any of the                                                  be when assessing     genetic modification and                                                     monitoring during and
                        the advisory committee?                                            details if possible                                                                      assessment          including day-to-day                                   from the trial              plan
  assessment of                                              following?                                                    application dossiers? (1         the GMO                                                                    post-trial
                                                                                                                                                                                                       management of the trial
       part B                                                                                                                 = low, 7 = high). a)
  applications?                                                                                                           Information on personnel
     #NAME?                     #NAME?                          #NAME?                           #NAME?                           #NAME?                   #NAME?                    #NAME?                   #NAME?                   #NAME?                   #NAME?                    #NAME?




                      Scientific Board on Deliberate
                       Release and Placing on the
                                                       Government scientists,Non-
       Yes             Market (Wissenschaftlicher                                                   xxx                              1                         7                        6                         4                       5                        2                         3
                                                         government scientists
                      Ausschuss für Freisetzungen
                          und Inverkehrbringen)




                                                                                      9 non-government scientists
                                                                                     and 15 officials (non-scientific).
                                                                                          See Arrêté royal du 2
                                                                                         septembre 2005 portant
                                                                                      nomination des membres du
                                                            Non-government                Conseil consultatif de
                       Belgian Biosafety Advisory
       Yes                                              scientists,Officials (non-     biosécurité (Moniteur belge,                  6                         7                        7                         7                       7                        7                         7
                                Council
                                                                scientific)             06/10/2005); the council is
                                                                                     made of 12 effective members
                                                                                       and 12 substitute members;
                                                                                     the "officials" are persons from
                                                                                        the public services, with a
                                                                                          scientific background
                        Consultative Commission on            Non-government                 non-governmental
        Yes              GMOs with the Minister of        scientists,Officials (non-   organisations representatives    1   7   6   4   3   2   5
                          Environment and Water               scientific),Other          in a non-voting capacity.




                                                                                        [Government scientists = 6;
                                                        Government scientists,Non-
        Yes                     Not provided                                           non-government scientists = 1;   7   5   1   2   3   6   4
                                                          government scientists
                                                                                             Lay persons = 3]




                        Czech Commission for the use
                                                      Government scientists,Non-
                           of Genetically Modified
        Yes                                          government scientists,Officials             No other.              2   6   7   5   3   4   1
                           Organisms and Genetic
                                                            (non-scientific)
                                  Products




 No (Danish Forest
 and Nature Agency
receive applications;
     Minister for
                                    N/A                            Other                            N/A                 3   4   7   6   5   2   1
 Environment takes
    the decision
 regarding approval
       or not)
                                                                           lay persons from NGOs (3),
                                           Government scientists,Non-     consumer protection (1) [Note:
          Advisory Committee for
Yes                                       government scientists,Officials   Government scientists = 2;           2   7   6   5   4   3   1
           Genetic Modification
                                              (non-scientific),Other      Non-government scientists = 8;
                                                                           Officials (non-scientific) = 2]



                                               Part B applications are
                                          assessed by expert authorities,
       The answer is no, see under        and if needed by other experts
No                                                                                There is no committee!         2   3   7   6   5   4   1
             additional info.             that give their expert opinion to
                                            the CA (The Board for Gene
                                                    Technology)




            There is currently no
                                                                                     7 other persons are
          Committee appointed to
                                                                                representatives of: industries
         assess part B applications
                                                                               using GMOs,workers of these
         because of the 'Grenelle de
                                           Government scientists,Non-         industries, the farm production,
Yes   l'environnement' (July-October                                                                             4   7   7   7   7   7   4
                                           government scientists,Other             consumers association,
           2007). The Ministry of
                                                                                   environment protection
      Agriculture is currently awaiting
                                                                                  association, a member of
          the new law, then a new
                                                                                    parliament, a lawyer
       Committee can be appointed.




                                                                              Scientists cover the disciplines
                                                                                of genetics, plant breeding,
                                                                                   bacteriology, virology,
                                                                                 environmental protection
                                                                                   organisations, ecology
       The Central Commission for                                              committee, representative of
Yes                                         Non-government scientists                                            5   7   7   5   5   5   3
        Biological Safety (CCBS)                                                union (scientist), consumer
                                                                                protection. All discussions
                                                                               focus on safety. None of the
                                                                                    authorities assessing
                                                                              applications are represented on
                                                                                       the Committee.
                                                                      6 Government scientists; 5 non-
                                                                        government scientists; 1 lay
                                                                       person Other representatives
                                        Government scientists,Non-
      Advisory Committee for Gene                                       are from non-governmental
Yes                                      government scientists,Lay                                      6   7   7   7   7   7   6
       Technological Applications                                        organisations dealing with
                                                persons
                                                                         environmental, health and
                                                                       consumer protection issues.
                                                                       Number of representatives: 6




         Advisory Committee on                                        Government scientists = 6; non-
                                        Government scientists,Non-
Yes       Genetically Modiifed                                          government scientists = 6;      7   7   7   7   7   7   7
                                        government scientists,Other
               Organisms                                                   Other = 2 (NGOs).




      Commissione Interministeriale
                                    Government scientists,Officials
          di valutazione (CIV) -
Yes                                      (non-scientific),Lay            No details are available       7   7   7   7   7   7   7
       Interministerial Evaluation
                                           persons,Other
               Committee




           The Expert Committee
          supervised by Food and
Yes   veterinary service assesses the   Non-government scientists                  n/a                  1   5   7   6   4   2   3
              risk assessment
              documentation.
                                                                              (11 non-government
                                                                        scientists). The GMO Experts
                                                                         Committee is a consultative
                                                                       advisory body with a clear task
                                                                            to act as advisor to the
                                                                        Competent Authority giving an
                                                                            advice in handling and
                                                                         scrutinizing notifications and
                                                                              requests for the risk
                                                                        assessment of contained use,
                                                                       experimental releases of GMOs
                                                                          at national level, deliberate
                                                                           release into environment
Yes   The GMO Experts Committee         Non-government scientists                                         7   7   7   7   7   7   7
                                                                       and/or placing to the market of
                                                                            GMOs. This committee
                                                                        consists of 11 scientists from
                                                                           different scientific areas:
                                                                             genetic, microbiology,
                                                                             biochemistry, health,
                                                                        agriculture, zoology, forestry,
                                                                         geology, veterinary science.
                                                                        GMO steering committee - 24
                                                                        members from governmental,
                                                                        non-governmental institutions,
                                                                        NGOs, consumers protection
                                                                                    agency.



          Comité interministérial -
        Interministerial committee,                                     Non-government scientists or
Yes                                     Government scientists,Other                                       4   6   7   5   4   4   3
      established for part B and part                                  other, depending on the subject
           C and contained use




                                                                          Comment for 5.5, below: In
                                                                           reality all these points are
      The Netherlands Commission              Non-government            important and necessary in an
Yes     on Genetic Modification           scientists,Officials (non-        application dossier. The      5   7   7   6   6   4   4
               (COGEM)                            scientific)          ranking of each component will
                                                                         also change according to the
                                                                             phase of the release.




No                                                 Other                             ----                 1   5   7   2   4   6   3
       A new Biosafety Commission
            is in course of being
         established (based on the
      provisions of EGO No 43/2007                                         The componence of the new
Yes   and of the Order No 98/2008 of      Non-government scientists        Biosafety Commission is in        2   6   7   3   5   4   1
        the Minister of Environment                                        course of being established.
       and Sustainable Development
      on organizing and functionning
      of the Biosafety Commission).




                                        Government scientists,Officials
        Commission for biological
Yes                                          (non-scientific),Lay                     NGOs                   3   7   6   5   2   1   4
      safety and its board of experts
                                               persons,Other




                                                                           14 non-government scientists.
                                                                              The seven members of the
                                                                          SCDR and their seven deputies
                                                                                were appointed by the
        Scientific committee for the                                        Government on the proposal
        deliberate release of GMOs                                         from the ministry responsible
         into the environment and                                         for science, taking into account
      placing products on the market                                             their expert system of
         (SCDR) is established to                                            assessment in science. The
       providing expert opinions on                                         independent members of the
      ERA for GMOs management in                                             committee have expertise in
Yes                                       Non-government scientists                                          5   7   7   7   7   7   7
       administrative procedures for                                            various fields including
             the GMO DR trials                                             genetics, biology, agriculture,
        (http://www.biotechnology-                                                 veterinary science,
      gmo.gov.si/eng/slovenija/strok                                         biochemistry and molecular
      ovna_podpora/znanstveni_odb                                             biology, microbiology, and
      or_za_sproscanje_gso/index.ht                                            medicine. In addition, the
                     ml)                                                       SCDR may invite to the
                                                                           discussion other experts from
                                                                                  fields relevant to the
                                                                           notification and preparation of
                                                                                    an expert opinion.
                                                                         7 government scientists; 49
                                                                        officials (Central and Regional
         National Commission on       Government scientists,Officials
Yes                                                                        Government); attendance        6   7           7            5              7                7   5
             Biosafety (CNB)           (non-scientific),Lay persons
                                                                             varies according to the
                                                                           notification; 1 lay person.




          A committee is established
           called the Swedish Gene
         Technology Advisory Board
      (SGTAB). It was established on
            1 July 1994. The Board
             monitors national and
        international developments in   Government scientists,Non-
                                                                        Politicians x 7, one from each            4 (but see Mission
Yes      genetic engineering, reviews government scientists,Officials                                     4   7                        7   Depends on the crop/trait   5   4
                                                                            of the Political parties                  response)
         ethical issues arising in this   (non-scientific),Other
       field, and gives advice aiming
       to promote ethically justifiable
            and safe use of genetic
       engineering, in order to protect
             human health and the
                 environment.




         Advisory Committee for
                                                                        12 non-government scientists
Yes    Releases to the Environment      Non-government scientists                                         4   7           7            7              7                7   5
                                                                            and 2 farming experts
                 (ACRE).
                                           The consent                                                                                         Information provided to the public
6.1 Is there a standard                                                                                                                                                                                                 8.1 Has standard or
format for the consent    Is the consent document                                                           7.1 What information must be         7.2 Where is this                                                      best practice been
                                                                                                                                                                                                  7.3 Are the public                                                                                        8.2 What are the reasons
document? If possible          published? If no                                                            published about GM field trials          information          Please provide                                    developed for                                          If NO, how are
                                                     6.2 If YES, where is it     Please provide a                                                                                                given opportunity to                             If yes, please provide                                         for the specific
  please provide an          consents have been                                                               that have been authorised,        published? (please       weblink here, or                                 management of                                       management procedures
                                                           published?           weblink if possible                                                                                                  comment on                                      details if possible                                    management procedures
example by emailing to      issued, please say if it                                                           particularly with regard to       provide a weblink      details of 'OTHER'                                certain crops or                                         determined?
                                                                                                                                                                                                    applications?                                                                                                  proposed?
      eu-gmo-field-           would be published                                                                        location?                 where possible)                                                        traits or crop/trait
   trials@csl.gov.uk                                                                                                                                                                                                       combinations
       #NAME?                     #NAME?                    #NAME?                     #NAME?                         #NAME?                         #NAME?                  #NAME?                    #NAME?                 #NAME?                     #NAME?                        #NAME?                       #NAME?


                                                                                                       With regard to location information
                                                                                                         is available in the governmental
                                                                                                        homepage in part III of the GMO-
                                                                                                      Register acc. to § 101c Abs. 1und 2
                                                                                                       GTG (Gentechnikregister gemäß §
                                                                                                              101c Abs. 1und 2 GTG):
                                                                                                      http://www.bmgfj.gv.at/cms/site/sta
                                                                                                                                                                                                                                                                                so far no DR has been
                                                                                                      ndard.html?channel=CH0817&doc=
                                                                                                                                                                     http://www.bmgfj.gv.at/c                                                                                   carried out, but a lot of
                                                                                                       CMS1140603787871. Information
                                                      Competent Authority      http://www.gentechnik.                                                                ms/site/detail.htm?them                                                                                  international experience is
          No                         Yes                                                              is published in the GMO register: 1)           Websites                                            Yes                     No
                                                          website                       gv.at                                                                        a=CH0264&doc=CMS11                                                                                           already available -
                                                                                                          community/municipality where
                                                                                                                                                                           40603787871                                                                                        especially from the EEP on
                                                                                                       cultivation is intended; 2) hectares
                                                                                                                                                                                                                                                                                 CU and DR of GMOs.
                                                                                                        of cultivation; 3) type of plant and
                                                                                                      variety of the GMO; 4) type of GMO
                                                                                                       inkl. Unique Identifier; 5) Authority
                                                                                                      of the Land where more information
                                                                                                           is provided. Details may vary
                                                                                                       between the Federal Länder (there
                                                                                                                  are 9 in Austria)




                                                                                                                                                                          The name of the
                                                                                                                                                                                                                                                             See
                                                                                                                                                                     municipality is included
                                                                                                                                                                                                                                                http://www.biosecurite.be/g
                                                                                                                                                                      in the notification, and
                                                                               http://www.biosecurite.                                                                                                                                          mcropff/EN/gmcropffMenu.
                                                                                                                                                                      the notification can be                                                                                                                Crop biology,Previous
                                                                               be/gmcropff/EN/DREN.                                                                                                                                               html (Protocols for field
                                                                                                                                                                          consulted at the                                                                                                                    experience,Published
                                                      Competent Authority        html (database of all     The name of the municipality is                                                                                                         releases of transgenic
          No                         Yes                                                                                                          Websites,Other        municipality offices             Yes                    Yes                                                                          research,Other official
                                                          website               field trials since 1999,   public, not the precise location                                                                                                        plants). Protocols are
                                                                                                                                                                          during the public                                                                                                                 guidance (please provide
                                                                               with related documents                                                                                                                                            available for sugar beet,
                                                                                                                                                                      consultation, or at the                                                                                                               details below if possible)
                                                                                        available)                                                                                                                                                  chicory and brassica
                                                                                                                                                                        offices of the public
                                                                                                                                                                                                                                                    (oilseed rape, indian
                                                                                                                                                                     services in charge of the
                                                                                                                                                                                                                                                          mustard).
                                                                                                                                                                            authorisation
                                                         1.all information, contained in the
                                                              notification except for the
                                                       confidential information, but no less
                                                                                                                                                                     Annex II to the GMO Act
                                                        than: (a) description of the GMOs;
                                                                                                                                                                    providing for technological
                                                            (b) name and address of the
                                                                                                                                                                       isolation distances for
                                                        applicant; (c) purpose and location
                                                                                                                                                                      certain types of crops,
                                                       of the release site; (d) methods and
                                                                                                                            The said website should                 namely:cereals, legumes,
                                                       plans for monitoring of the GMO or
                                                                                                                            be established under the                  oilseed and fibre crops,
                                                             GMOs and for emergency
            Competent Authority   http://www2.moew.gov                                                                      Ministry of Environment                forage crops and potatoes.
No    Yes                                                  response; (e) storage site; (f)                 Websites                                    Yes   Yes                                                                     Crop biology
                website                 ernment.bg/                                                                         and Water. However, no                  Please refer to Genetically
                                                         methods for transport; (g) use of
                                                                                                                             such website exists at                  modified organisms Act,
                                                        the GMOs; (h) risk assessment; 2.
                                                                                                                                    present.                                    Annex
                                                       the consent Particularly with regard
                                                                                                                                                                   II(http://bch.cbd.int/databas
                                                          to location: the map of the site
                                                                                                                                                                   e/record.aspx?id=8409) for
                                                        wherein transgenic crops are to be
                                                                                                                                                                   more precise information on
                                                             grown,including cadastrial
                                                                                                                                                                              that issue.
                                                           numbers, the list of owners of
                                                       adjoining fields and the agricultural
                                                                       practices.




                                                                  application, approval,
No    Yes                                                       complementary information,                   Other            Government archive       Yes   No                                     No deliberate release yet
                                                                   location of release.



                                                              The summary of the notification
                                                               which is provided to the public
                                                              corresponds with the information                                Pending notifications
                                  http://www.env.cz/AIS/
                                                              required in summary notification                                  are available at:
                                           web-
                                                            information format according to the                             http://www.env.cz/AIS/w
                                  pub.nsf/$pid/MZPMVF
                                                               Council Decision 2002/813/EC.                                           eb-
                                    AJ8DZE - in Czech                                                                                                                                              Authorised GMO field trials
                                                              Only very technical information,                              pub.nsf/$pid/MZPMVFD                                                                                 Crop biology,Previous
            Competent Authority   language. The English                                                                                                                                            are managed case by case
Yes   Yes                                                    confidential information, annexes             Websites          1A63R Authorisations      Yes   No                                                                  experience,Published
                website               versions will be                                                                                                                                               depending on crop/trait
                                                             and the personal data included in                                  are available at:                                                                                      research
                                  published by the end of                                                                                                                                                combinations.
                                                              the dossier are not made public.                              http://www.env.cz/AIS/w
                                      January 2008 in
                                                            The exact location of field trials (the                                    eb-
                                    Biosafety Clearing
                                                             municipality and the land register                             pub.nsf/$pid/MZPMVFA
                                          House.
                                                             number, cadastral number) is                                            J8DZE
                                                             provided to the public, except the
                                                             maps that are part of the dossier.


                                                        When the trial has been authorised:
                                                                     On the website
                                                        (http://www.mst.dk/Genteknologi/Fo
                                                          rsoegsudsaetning/) a brief articel
                                                            with information of the type of
                                                          GMO, the purpose of the fieldtrial
                                                          and the location (eg name of city
                                                           nearby) - interested public have
                                                                                                                                                                                                    Management procedures
                                  http://www.mst.dk/Gent access to precise information on
            Competent Authority                                                                                                                                                                       are deternined by the
Yes   Yes                         eknologi/Forsoegsudsa     the location of the field trial on        Newspapers,Websites             N/A              Yes   No                N/A
                website                                                                                                                                                                             conditions layed down in
                                           etning/        demand to Danish Environmental
                                                                                                                                                                                                          the consent.
                                                             Protection Agency. When the
                                                          application is under consideration
                                                         the same informations are given by
                                                        local and national press - interested
                                                             public have access to precise
                                                          information on the location of the
                                                           field trial on demand to Danish
                                                          Environmental Protection Agency.
                                                              Name of the applicant; resume of
                                                              the application; name of the GM
            Inspectors of GMO          In State Gazette,      product with intended location by                           www.ametlikudteadaand                                                     Impossible to say - not
Yes   Yes                                                                                                Websites                                       Yes   No
             field trials website     www.riigiteataja.ee        township or city; CA contact                                    ed.ee                                                                  needed yet.
                                                               information; deadline for public
                                                                           opinion.




                                                                                                                                                                     Best practices have been                                   Crop biology,Previous
            Competent Authority     www.geenitekniikanlaut Municipality, but the public decision                           The Official Journal of
Yes   Yes                                                                                             Websites,Other                                    Yes   Yes   provided at least for potato                                experience,Published
                website                   akunta.fi        contains the address of the notifier                              the Government
                                                                                                                                                                             and birch                                                research




                                                                                                                                                                       Indicative guidance has
                                                                                                                                                                             been produced
                                                                                                                                                                    ("Recommandations pour la
                                                                                                                                                                          redaction du dossier
                                                                                                                                                                     scientifique et technique de
                                                                                                                                                                        demande d'autorisation
                                                                                                                                                                          d'experimentation de
                                                                                                                                                                           plantes superieures
                                                                                                                                                                      genetiquement modifiees"
                                                                                                                                                                         dated December 2005
                                                                                                                             www.ogm.gouv.fr It                       (copy provided) based on                                   Crop biology,Previous
                                                                                                                          must also be advertised                      report by the Committee
                                    http://www.ogm.gouv.fr                                                                                                                                                                       experience,Published
            Competent Authority                               The town must be given, the grid                            in the town hall in which                 (January 2002) "Rapport de
Yes   Yes                           /experimentations/doss                                            Websites,Other                                    Yes   Yes                                                               research,Other (please
                website                                           reference is not required                                 the field trial will take                 la Commission du Genie
                                         iers/2007.htm                                                                                                                                                                          provide details below if
                                                                                                                            place, also put in the                        Biomoleculaire et du                                         possible)
                                                                                                                               official journal.                         Comite Provisoire de
                                                                                                                                                                             Biovigilance sur
                                                                                                                                                                    l'experimentation au champ
                                                                                                                                                                    des plantes transgeniques",
                                                                                                                                                                        published jointly by the
                                                                                                                                                                     Ministry of Agriculture and
                                                                                                                                                                    the Ministry of Environment
                                                                                                                                                                    (will try to get key headings
                                                                                                                                                                      translated). Management
                                                                                                                                                                        procedures are applied
                                                                                                                                                                     generally along these lines,
                                                            The whole application is published
                                                           including location, the crop and the
                                                                                                                                                                     There is not any standard
                                                            trait, but not commercial business
                                                                                                                                                                     practice officially because
                                                           information and personal data. The
                                                                                                                                                                     each is decided on a case-
                                                            application is publicly available for
                                                                                                                                                                    by-case basis, but isolation
                                                              4 weeks when the application is
                                                                                                                                                                    and post-trial management
                                                              complete and the CA will accept
                                                                                                                          Information is published                      procedures are crop-
                                                              comments for a 4 further weeks                                                                                                      Each application is decided   Crop biology,Previous
            Competent Authority                                                                                             in the communities in                     specific rather than trait-
Yes   Yes                           http://www.bvl.bund.de after that. Regarding location - the     Newspapers,Websites                                 Yes   Yes                                  on a case-by-case basis      experience,Published
              website,Other                                                                                                which the trial will take                     specific. In practice,
                                                               BVL must publish down to the                                                                                                       (and see previous answer).          research
                                                                                                                                     place                          although each application is
                                                              smallest official category of land
                                                                                                                                                                      considered on a case-by-
                                                             classification (the parcel of land),
                                                                                                                                                                      case basis, management
                                                             the trial normally occupies only a
                                                                                                                                                                        procedures tend to be
                                                            small part of this. The notifier may
                                                                                                                                                                     comparable on a crop-by-
                                                               not know exactly where on this
                                                                                                                                                                             crop basis.
                                                              parcel the trial will be over a 4-5
                                                                       year programme.
                                                                                                                               The draft consent is
                                                                                                                             published in the Official
                                     A summary of the                                                                         Journal of the CA and
                                   consent document is                                                                          on the CA website
                                                                                                                                                                                                   Management procedures       Crop biology,Previous
            Competent Authority   published in the Official    Current practice is to publish site      Newspapers,Websites, www.biosafety.hu and
Yes   Yes                                                                                                                                                  Yes   No                               applied on a case-by-case    experience,Published
              website,Other        Journal as well as on                  locations.                           Other             the JRC website
                                                                                                                                                                                                            basis                    research
                                        the webpage                                                                          http://gmoinfo.jrc.it. The
                                    (www.biosafety.hu)                                                                        Registrar shall provide
                                                                                                                             printed data from if it is
                                                                                                                                     asked for.




                                                                                                                                                                                                                               Crop biology,Previous
                                  http://www.epa.ie/down                                                                        Register of GMO users                                                                           experience,Published
            Competent Authority                                                                                                                                        refer to above web page-
Yes   Yes                         loads/pubs/other/gmo/f            Townland or townlands                       Other            in Ireland-available in   Yes   Yes                                                           research,Other official
                website                                                                                                                                                   consent conditions
                                           ield/                                                                                 Headquarters of EPA                                                                          guidance (please provide
                                                                                                                                                                                                                              details below if possible)



                                                                       See the following link
                                                              (http://bch.minambiente.it/EN/index.
                                                                                                                               http://bch.minambiente.i
                                                                 asp). [NOTE: exact details not
                                                                                                                               t/English/GMO%20docu
No    No                                                      provided, but appears to be regional            Websites                                     Yes   No                                         N/A
                                                                                                                               ments%20and%20decis
                                                              notification and farmers/neighbours
                                                                                                                                   ions/pubreg.html
                                                               adjacent to the proposed GMO site
                                                                        must be notified].
                                                                 According to national legislation
                                                                 The Food and Veterinary Service
                                                              shall ensure: the establishment of a
                                                                   database, which includes the
                                                                following information: 1. locations
                                                                    of the deliberate release of
                                                               genetically modified organisms; 2.
                                                              the sites of cultivation of genetically
                                                                    modified organisms; 3. the
                                                              publication of information regarding                               no any informtion has
No    No                                                                                                     Newspapers                                    No    No              n/a                     No opinion
                                                               the permits issued in Latvia for the                               been published yet.
                                                                     deliberate release into the
                                                              environment of genetically modified
                                                                 organisms, as well as the list of
                                                                genetically modified organisms in
                                                                the newspaper Latvijas V?stnesis
                                                                     [the official Gazette of the
                                                                    government of Latvia]. The
                                                                   information shall indicate the
                                                                  person who has submitted the
                                                                                                                                                                                                                                 Crop biology,Previous
                                                                                                                                                                                                                                  experience,Published
            Competent Authority                                                                     Newspapers,Websites,
Yes   Yes                            http://gmo.am.lt/       The region and municipality                                          TV or radio.           Yes   No                                                                research,Other official
                website                                                                                    Other
                                                                                                                                                                                                                                guidance (please provide
                                                                                                                                                                                                                                details below if possible)




                                                                                                                             - on the release site -                                                 No experience with GMO
                                                           Main objective of the application.                                very visible - town hall                                                   field releases, but
                                                           The application dossier without                                 of the municipality (local                                                management procedures
No    No    N/A - not published                                                                             Other                                        Yes   No                N/A                                               Published research
                                                           confidential information may be                                  regulatory body) where                                                   may be considered on the
                                                                 consulted by public                                           the GM field trial is                                                  grounds of published
                                                                                                                             planned (very visible)                                                          research




                                                          Published information includes the                                                                            Taking account of the                                    Crop biology,Published
                                  http://www.vrom.nl/ggo-      application, permit, risk                                                                               appropriate containment                                   research,Other official
                                   vergunningverlening -     assessment, advertisements.                                 Library of the Ministry of                   measures, GM crops are                                    guidance (please provide
            Competent Authority                                                                     Newspapers,Websites,
Yes   Yes                         Vergunningendatabase However, the exact location of GM                                 the Environment (Public         Yes   Yes   managed according to good                                       details below if
                website                                                                                    Other
                                    - De database Zelf -    research trials is not provided,                                     Register)                            agricultural practice in the                               possible),Other (please
                                       Zoekresultaten     instead a plot 100 times the exact                                                                         same way as their non-GM                                    provide details below if
                                                                 size is made public.                                                                                        equivalents.                                               possible)




                                                          During public consultation (before
                                                               an authorisation is given)
                                                           Portuguese Environment Agency
                                                                                                                              Municipal Councils
                                                         publishes all the information (except                                                                                                                                   Crop biology,Previous
No    No                                                                                               Websites,Other       where the field trials are   Yes   No                 ---                 In a case by case basis
                                                             the confidential information)                                                                                                                                            experience
                                                                                                                                    located
                                                         submited by the applicant, including
                                                         the detailed identification of the field
                                                                     trial location.
                                                                                                                                                        The National Institute for
                                                                                                                                                         Varieties Testing and
                                                                                                                On the site of MMDD:
                                                              The locality and the county (or                                                         Registering (NIVTR), under                                   Crop biology,Previous
            Competent Authority    www.mmediu.ro and                                                           www.mmediu.ro and the
No    Yes                                                    region). Distances to the natural      Websites                              Yes   Yes    the Ministry of Agriculture                                 experience,Published
                website              www.anpm.ro                                                                    site of NEPA:
                                                                     protected areas.                                                                   and Rural Development                                            research
                                                                                                                   www.anpm.ro
                                                                                                                                                       established protocols and
                                                                                                                                                         good practice guides.




                                                            According to The Act No. 151/2002
                                                           Coll. on use of genetic technologies
                                                            and genetically modified organisms
                                                             as amended the Ministry shall be
                                                             obliged to make publicly available
                                                               via the Internet the substantial
                                                                     content of submitted
                                                           notifiers´applications, reports on the
                                                                   result of introduction into
                                                           environment of genetically modified
                                                                  organisms. The subject to
                                                            intellectual property or trade secret
                                                                                                               http://www.enviro.gov.sk                                                                            Crop biology,Previous
                                                               shall not be following data and                                                                                         generally valid principle
Yes   No                                     -                                                      Websites   /servlets/page/868?c_id    Yes   No                  -                                              experience,Published
                                                           information: -general characteristics                                                                                         widely used in EU
                                                                                                                         =2215                                                                                           research
                                                            -commercial name and address of
                                                             the notifier -commercial name of
                                                                  user and in case of import,
                                                                 commercial name of foreign
                                                            producer and importer -assignment
                                                              to the risk class of the contained
                                                                use and its respective level of
                                                               containment -result of the risk
                                                                 assessment and its review -
                                                            evaluation of foreseeable effects, in
                                                                 particular harmful effects on
                                                                    humans or environment

                                  The consent document
                                      is published in the
                                     registers of GMOs       In general, information published
                                    where the GMO DR        about GM field trials are similar to
                                   field trials form a part     the information requested by                                                          As we have no field trials so
                                    of the registers. The     Council Decision 2002/813/EC.                                                            far, it is envisaged that the
                                  register is managed as Information regarding location is a                                                            applicant should propose
                                    public register by the   part of the register which shall be                                                         the best practice for the
                                  competent ministries in     kept as a public document, and                                                             management of certain
                                    accordance with the therefore should be available to the                                                           crops or traits. The SCDR
                                                                                                                In the paper version
                                       legislation. At the   public primarily on the request in                                                       who provide expert opinion
No    Yes         Other                                                                              Other     which could be obtained    Yes   No                                               N/A
                                  moment, they are only          paper dossier. Further, this                                                          on the risk assessment for
                                                                                                                   on the request
                                        available in the    information should be available to                                                          GMO management in the
                                    Slovenian language,        the public in the level of exact                                                        administrative procedures
                                  and on the request but       geographical location and grid                                                         therefore, rutinely examine
                                         it is already in   reference of the site in the region.                                                        also the adequacy of the
                                     preparation also an    Because, this information is a part                                                          management proposed
                                    electronic version of     of the register and anyone shall                                                              from the applicant.
                                   the registers of GMO.     have the right to peruse the data
                                   So far, there have not          from the GMO register.
                                    been field trials with
                                     GMOs in Slovenia.
                                                           Summarised Tables and SNIFs are
                                                            published in the Web. Regarding
                                  http://www.mma.es/por        location only information of
                                  tal/secciones/calidad_c province (municipalities) where field                             http://www.mma.es/port                Management procedures         Management procedures
                                  ontaminacion/omg/noti trials are carried out is published.                                al/secciones/calidad_co               are specified by the Plant   are specified by the OEVV,      Crop biology,Previous
            Competent Authority
Yes   Yes                         ficaciones_autorizacion      We do not provide the exact                Websites          ntaminacion/omg/notific   Yes   Yes    Varieties Office (Oficina   also applied on a case-by-      experience,Published
                website
                                   es/index.htm (only for location of the site to prevent them                              aciones_autorizaciones/               Española de Variedades        case basis as included in            research
                                     central government,     from being destroyed, unless a                                         index.htm                        Vegetales, OEVV)               the ERA Report.
                                        not regional)         specific public request for this
                                                          information is made to the offices of
                                                           the relevant Competent Authorities.



                                                              The CA must make available the
                                                                                                                                                                                                   Case-by-case: Basic
                                                             Decision, any new information that
                                                                                                                                                                                                guidelines for crops are in
                                                             comes to light about the crop/trait,
                                                                                                                                                                                                 place, but all applications
                                                             and the reports from the trial. The
                                                                                                                                                                                               are assessed on a case-by-
                                                              CA must have public register of
                                                                                                                                                                                                 case basis. The applicant
                                  http://www.sjv.se/amne       sites available, and declare the                          http://www.sjv.se/amnes
                                                                                                                                                                                                proposes the management
                                  somraden/vaxtmiljovatt        detection of any unauthorised                            omraden/vaxtmiljovatten
                                                                                                                                                                                                measures and the CA will       Crop biology,Previous
            Competent Authority   en/genmodifieradevaxt     release. Maps showing the detailed                           /genmodifieradevaxter/f
Yes   Yes                                                                                            Newspapers,Websites                              Yes   No                                 only change the measures if     experience,Published
                website           er/faltforsok/genomford   location are mailed on request. The                          altforsok/genomfordafor
                                                                                                                                                                                                 they consider them to be            research
                                  aforsok.4.1f85a8610db         consent holder is required to                            sok.4.1f85a8610dbb8e0
                                                                                                                                                                                                inadequate, in which case
                                  b8e0d718000723.html         publish locally that a trial will be                           d718000723.html.
                                                                                                                                                                                                    they will decide on
                                                               held and inform the head of the
                                                                                                                                                                                                 additional measures. No
                                                              administrative region. Decisions
                                                                                                                                                                                                  guidance is provided on
                                                            reached on applications considered
                                                                                                                                                                                                  management of wastes
                                                              by an authority are always to be
                                                                                                                                                                                                         from trials.
                                                                        made public.




                                                              The information that must be
                                                             published is laid down in the GM
                                  http://www.defra.gov.u
                                                            Deliberate Release Regulations in                                                                                                   Management procedures          Crop biology,Previous
            Competent Authority   k/environment/gm/regu                                              Newspapers,Websites,
Yes   Yes                                                       paragraph 34; specifically                                      Public register       Yes   No                                  are applied on a case-by-      experience,Published
                website           lation/consents/index.h                                                   Other
                                                              applicants must advertise in a                                                                                                           case basis                    research
                                            tm
                                                            national newspaper with a 4 figure
                                                                      grid reference.
                                                                                       Management of authorised GMO deliberate release field trials
                                   8.3 Is there a
                                requirement for the                                                                            8.4 Does the CA require the consent                                                                                                8.5 Is there an established procedure
If 'Other official guidance' or consent holder to                                                                            holder to provide monitoring reports? (If    If yes, does the CA assess these? (or                                                        for following up observed or
                                                       If yes, what evidence is                                                                                                                                    If reports are assessed by another body,
     'Other' please provide    demonstrate 'duty of                                     If OTHER, please provide details       not trials held yet, would the consent    would the CA assess these if trials had                                                  unexpected effects? (If no trials have
                                                               required:                                                                                                                                              please provide the name of the body
          details here            care' to ensure                                                                            holder be required to provide monitoring                   been held?)                                                                   been held, will procedures be
                                adventitious GMOs                                                                                             reports?)                                                                                                                         established?)
                                 are not present in
           #NAME?                   #NAME?                      #NAME?                              #NAME?                                   #NAME?                                     #NAME?                                      #NAME?                                       #NAME?




                                                                                                                                                                                                                   Generally it is the CAs duty but acc. to the
                                                       Provision of sample(s) for                                                                                                                                     Gene Technology Act(§ 101 (5) it is
                                      Yes               official testing,CA takes                                                              Yes                              Assessed by another body           possible to delegate thid duty to the EPA of                    Yes
                                                      official sample(s) for testing                                                                                                                                  Austria (Umweltbundesamt) or other
                                                                                                                                                                                                                                 external experts.




  Other official guidance is at                        Provision of sample(s) for
http://www.biosecurite.be/gmc          No               official testing,CA takes                                                              Yes                                        Yes                                                                                      No
 ropff/EN/gmcropffMenu.html                           official sample(s) for testing
      No   Not applicable         Yes   Assessed by another body   Consultative Commission on GMOs   Yes




      No   Not applicable         Yes             Yes                                                No




      No   Not applicable         Yes             Yes                                                Yes




N/A   No   Not applicable   N/A   Yes             Yes                           N/A                  Yes
            N/A                 No           Not applicable                                                           Yes   Yes                                                   Yes




                                                                                                                                   Also by the Finnish Environment Institute
                                No           Not applicable                                                           Yes   Yes                                                   No
                                                                                                                                          and other Expert Institutes




                                                                       There is no formal requirement as such.
                                                                     There is a 'gentleman's agreement in place
                                                                      under which the companies do not release
    Inspectors may make                                                  anything other than the GMO that is
     decisions about risk            CA takes official sample(s) for authorised under the consent. It is not in the
 management, based on long      No    testing,Other please provide notifier's interests to do this deliberately and   Yes   No          the CGB assesses all of them.             No
term experience of GMO field                details if possible          risk their reputation. Documents are
            trials                                                     required to declare that the GMO is the
                                                                      authorised GMO. Sampling may be done,
                                                                      depending on resources available, but it is
                                                                                not done systematically.




                                                                                                                                  A report is required from each site, for each
   Monitoring reports from
                                                                                                                                    year until the trial is declared complete.
  notifiers could be used to                                           The inspection authorities are entitled to
                                                                                                                                  BVL uses the EC format. Monitoring reports
    change management           No           Not applicable           take samples and check this. The Landers        Yes   Yes                                                   No
                                                                                                                                       are also sent to the other Federal
 practices - but this has not                                           have their own GM testing laboratories.
                                                                                                                                     authorities involved in the assessment
actually happened in reality.
                                                                                                                                   procedure, and the inspection authorities.
                                                                                                  Consent holder reports are assessed by the
                                                                                                    CA, by the Ministry of Environment and
                              Production assurance
                                                                                                         Water as well as by the Advisory
                           documents from the consent
                    Yes                                          Yes             Yes                   Committee for Gene Technological         Yes
                          holder,GM testing results from
                                                                                                      Applications. The submission of the
                                the consent holder
                                                                                                   notifier s annual report on the monitoring
                                                                                                       is a prerequisite for further release.




                               Production assurance
                           documents from the consent
                          holder,GM testing results from
                            the consent holder,Quality
OECD publications   Yes     assurance documents from             Yes             Yes                                                            Yes
                           the consent holder,Provision
                              of sample(s) for official
                              testing,CA takes official
                                sample(s) for testing



                                                                                                      Istituto Superiore di Sanità, Istituto
      N/A           No            Not applicable                 Yes   Assessed by another body     Zooprofilattico, Ente nazionale sementi     No
                                                                                                          elette, Agenzia delle Dogane.




                    No            Not applicable           n/a   Yes   Assessed by another body          Food and veterinary service            Yes
                                     GM testing results from the
                                     consent holder,Provision of
Recommendations for GMO                                            Monitoring zones, investigations and reports               The GMO Expert Committee assesses the
                               Yes       sample(s) for official                                                   Yes   Yes                                                  Yes
  Field trials in Lithuania                                                       are required                                               report
                                       testing,CA takes official
                                         sample(s) for testing




                               No          Not applicable                              N/A                        Yes   Yes                       N/A                        Yes




                                                                                                                              Reports are assessed by the CA (Bureau
                                                                                                                              GGO, or Gmo-office). The notifier has to
   Official guidance: NAK
                                                                                                                              submit a post-harvest report annually as a
   isolation distances for
                                                                                                                              precondition for continuing a permit. At the
 agricultural seed and seed    No          Not applicable                                                         Yes   Yes                                                  No
                                                                                                                               end of the trial programme, the notifier s
potatoes; Other: Advice from
                                                                                                                               final annual website is placed on the JRC
           COGEM
                                                                                                                                   Biotechnology and GMOs website
                                                                                                                                          (deliberate release).




                               No          Not applicable                              ----                       Yes   Yes                                                  Yes
                                                           The monitoring reports are, also, assessed
          GM testing results from the
                                                             by the Ministry of Agriculture and Rural
    Yes   consent holder,Provision of          Yes   Yes                                                 No
                                                           Development. In the future will be assessed
          sample(s) for official testing
                                                                  by the Biosafety Commission.




-   No           Not applicable            -   Yes   Yes                        -                        Yes




    No           Not applicable                Yes   Yes                                                 Yes
          Production assurance
       documents from the consent                                                                Central Government assesses the reports:
      holder,GM testing results from For Plant Variety Registration Trials (OEVV)                Interministerial Council for GMO (CIOMG)
Yes     the consent holder,Quality      only, except in specific cases where there   Yes   Yes     and National Commission on Biosafety        Yes
        assurance documents from              has been seed contamination.                           (CNB), and the regional competent
       the consent holder,Provision                                                                               authorities.
      of sample(s) for official testing




                                        In one location some sampling was done
                                                                                                 Note: The report should be in the format as
                                       because the applicant asked for permit to
                                                                                                       described Annex VII to 2001/18
                                       release 9 events, but only 7 of these were
                                                                                                   (Commission Decision 2003/701/EC of
                                      finally authorised. Samples were taken and
      CA takes official sample(s) for                                                             8/10/2003). The consent holders should
No                                     tested to make sure only the 7 authorised     Yes   Yes                                                 No
                 testing                                                                          also send in reports of volunteers found
                                         GMOs had been released. The consent
                                                                                                     during post trial monitoring. The CA
                                      holder was asked to provide a PCR test for
                                                                                                 contacts the consent holder to inform them
                                           the events and an external lab was
                                                                                                         that the report is acceptable.
                                             commissioned to do the testing.




          Production assurance
       documents from the consent
      holder,GM testing results from                                                             The reports are also assessed by the GM
Yes                                                                                  Yes   Yes                                                 No
        the consent holder,Quality                                                                          Inspectorate (GMI)
       assurance documents from
            the consent holder
                                                                                        Inspection and enforcement                                                                                                                              Non-compliance (breach of consent conditions)
                                                                                                                                                                             10.1 Are procedures in    10.2 How many breaches      b) Number of cases
                                                                                                                                    9.3 If there is NOT a nominated          place for dealing with         of consent have        where material has      c) Number of fines or         d) Number of
                                        9.1 Does the CA have an Inspectorate        9.2 If YES, what is the name of the             inspectorate, how is regulatory             non-compliances,             occurred in the     accidentally entered the written warnings issued.   prosecutions pursued.
If YES, please describe this briefly
                                       nominated specifically for GMO DR trial                 Inspectorate?                   compliance achieved? (Please put N/A if        including criteria for    following categories: a)   marketplace. Please      Please provide brief      Please provide brief
                                                                                                                               you have answered 'YES' to question 9.1)         initiating a formal    Number of technical non- provide brief details if     details if possible.      details if possible.
                                                                                                                                                                                  investigation?              compliances.              possible.

             #NAME?                                   #NAME?                                      #NAME?                                        #NAME?                              #NAME?                     #NAME?                   #NAME?                    #NAME?                    #NAME?




                                                                                                                               it is the duty of the CAs see also response
                                                         No                                                                                                                           Yes                  no DR took place         no DR took place          no DR took place          no DR took place
                                                                                                                                                  under 8.4.




                                                                                      Service Inspection des Produits de
                                                                                 consommation, Bien-être animal et CITES &
                                                        Yes                           Service de l'Inspection fédérale de                         N/A                                  No                         0                         0                        0                          0
                                                                                  l'environnement (see Arrêté Ministériel du
                                                                                   18/10/2006, Moniteur belge, 07/11/2006)
In the event of occurrence, after the grant of
   an authorization for deliberate release, of
any changes upon the deliberate release of a
GMO or a combination of GMOs which may
    increase the risk to human health or the
environment, the applicant shall be obligated
      immediately: 1. to take the necessary
   measures for protection of human health              15 Regional Inspectorates for Environment
      and the environment; 2. to inform the                   and Water under the Ministry of
   Minister of Environment and Water of the                Environment and Water. Also, several
 changes or of the new circumstances; 3. to               structures of Ministry of Agriculture and
review the protective measures applied and,             Food Supply have control powers in specific
  if necessary, to modify the said measures.            cases i.e. Executive Agency of Plant Variety
 (2) Where the data referred to in Paragraph               Testing, Crops Approbation and Seed
        (1) are received at the Ministry of       Yes                                                   N/A   Yes     no consents issued        N/A               N/A               N/A
                                                           Control, the National Plant Protection
 Environment and Water or members of the                Service, the National Veterinary Service, the
    Commission become aware of any such                 National Grain and Forage Service, the Vine
data, the said information shall be subject to           and Wine Executive Agency, the National
       evaluation by the Commission. The                 Agency for Fisheries and Aquaculture, the
information referred to in Paragraph (1) and            National Forestry Board, and the Executive
  the evaluation of the Commission shall be                     Agency for Animal Breeding.
       made available to the public. (3) The
     requirement under Paragraph (1) shall
furthermore apply should new scientific data
concerning an increase in the risk to human
health or the environment become available
both while consideration of an application is
         in progress and after grant of an
   authorization for deliberate release. (4) In

                                                        Inspectors authorized according to national
                                                  Yes                                                   N/A   No              N/A               N/A               N/A               N/A
                                                                        legislation.




 The monitoring plan contains requirements
    for observation of any effects. If new                                                                          No breaches of consents
unexpected effects occur, article 8 of the Act                                                                        have occurred in the
                                                  Yes     The Czech Environmental Inspectorate          N/A   Yes                               None             None               None
78/2004 describes provisions concerning the                                                                          Czech Republic since
  new information on the risks of GMOs to                                                                                    2002.
     human health or the environment.




                                                          Danish Environmental Protection Agency
                                                                                                                                                         2 writen warnings (the
                                                          (note that the Statuary order in english is
         See Statuary Order, art. 11              Yes                                                   N/A   Yes   2 (failure in monitoring)    0     above mentioned failure in    0
                                                         outdated on this item - it is now the agency
                                                                                                                                                               monitoring)
                                                        that carries out inspection and enforcement).
                                                   Environmental Inspectorate under Ministry of
                                                    Environment is responsible for the general
                                             Yes    monitoring of GMOs. The Plant Production                            N/A                         Yes               N/A                 N/A               N/A                          N/A
                                                   Inspectorate under Ministry of Agriculture is
                                                    responsible for the controls of GM seeds.




                                                     The Finnish Environment Institute The
                                                   Finnish Food Safety Authority The National
                                             Yes                                                                        N/A                         Yes              None                 None             None                         None
                                                    Product Control Agency for Welfare and
                                                                    Health




                                                                                                                                                             5 There was a problem
                                                                                                                                                             with pollen barriers not
                                                                                                                                                           being implented when the
                                                                                                                                                               isolation distance for
                                                                                                                                                          maize was set at 200m (it
                                                                                                                                                           was extended to 400m in
                                                                                                                                                          2006). If the pollen barrier
                                                                                                                                                             was not in place it was
                                                                                                                                                              treated as a legal non
                                                                                                                                                            compliance and the trial
                                                                                                                                                             had to be destroyed by
This has not happended to date, but the CA                                                                                                                  administrative measure -
    would refer to the scientific advisory   Yes    National Inspectorate for Plant Protection                          N/A                         Yes            this was a risk         0                 0                            0
           committee for advice.                                                                                                                            management issue. Now
                                                                                                                                                           the 400m pollen barrier is
                                                                                                                                                           in place, this action is not
                                                                                                                                                            necessary. Advice is not
                                                                                                                                                           sought from the scientific
                                                                                                                                                          committee where there are
                                                                                                                                                              issues with the pollen
                                                                                                                                                           barrier as 400m isolation
                                                                                                                                                             is adequate to prevent
                                                                                                                                                           gene flow. This is the risk
                                                                                                                                                           manager's (= Inspector's)
                                                                                                                                                             decision. In 2005, there
                                                                                                                                                                  were 5 cases of




                                                                                                        Enforcement is part of the Federal                 Zero but detail is held by            Zero but detail is held by   Zero but detail is held by
Any cases would be addressed on a case-by-
                                             No                                                    legislation, but the Landers administer it, so   No           the Landers /            Zero         the Landers /                the Landers /
               case basis.
                                                                                                    each Lander nominates its own inspectors.                   Inspectorates.                        Inspectorates.               Inspectorates.
    Consent holders have to monitor the
   expected or unexpected effects of the
release and submit a report within 30 days           Central Agricultural Office, Directorate of
 after the harvest every year. Unexpected      Yes   Plant Production and Horticulture, Seed                         N/A                       Yes       0            0            0            0
effects or accidents have to be reported to                        Inspectorate
 the CA according to the emergency plan
               without delay.




regular site inspection would be carried out
                                               Yes     EPA-Competent authority in Ireland                            N/A                       Yes      N/A          N/A          N/A          N/A
        by a competent agronomist




                                                                                                     After the approvation of the Guidance,
                                               No                                                    Ispection of the GMO trials will be co-   No       N/A          N/A          N/A          N/A
                                                                                                   managed by National CA and Regional CA.




 The National Phytosanitary Laboratory
                                               Yes      The State Nature Protection Board                             n/a                      Yes   No opinion   No opinion   No opinion   No opinion
annually performs analytical seed control.
   To inform the MoE, public about the
unexpected effects and take the appropriate                                                                                                       0 (No consents issued so   0 (No consents issued so   0 (No consents issued so   0 (No consents issued so
                                                     Yes        MoE , GMO Division                              N/A                         Yes
  measures, if e.g. unavoidable accident -                                                                                                                  far)                       far)                       far)                       far)
          suspend the field trial.




  May be established on the advice of the                                                  Inspectorate functions are established for all         No experience with GMO     No experience with GMO     No experience with GMO     No experience with GMO
                                                     No                                                                                     No
       'interministerial committee'                                                              activities in relation with GMOs.                      field release              field release              field release              field release




   Such effects are treated individually. If
adverse effects were found emergency plans           Yes        VROM Inspectorate                               N/A                         Yes            None                       None                       None                       None
   would automatically be implemented.




After the field trails finishes the notifier as to
                                                           Inspecção Geral do Ambiente e
      check and report periodically any              Yes                                                        N/A                         Yes             Two                   None reported          None of our knowledge              None
                                                             Ordenamento do Território
    unexpected effects (ex: volunteers).
      No special procedure, but the
                                                                                                                                                                                          Shall be submitted lately,   Shall be submitted lately,
representatives of NIVTR and the consent                 National Environmental Guard
                                                Yes                                                             N/A                         Yes   No breaches in 2007 year.   No cases.    after asking for updated     after asking for updated
 holders have this obligation, established                (NEG)working under MESD.
                                                                                                                                                                                           information from NEG.        information from NEG.
   through the consent (authorization)




  The procedure is in detail described in
Article 19 of the Act No. 151/2002 Coll. on
use of genetic technologies and genetically
                                                Yes   The Slovak Environmental Inspection                         -                         Yes              0                   0                    0                            0
     modified organisms as amended-
´Responsibilities of user at introducton into
              the environment´




                                                                                                  There is not nominated inspectorate
                                                                                             specifically for GMO DR tials. According to
                                                                                                 MGMOAct inspection supervision and
 In the application, consent holder should
                                                                                                enforcement shall be performed by the
     describe the provisions in case of
                                                                                             Inspectorate of the Republic of Slovenia for
unintended release as well as the methods
                                                                                              the Environment and Spatial Planning, the
used to insure the place of release. Further,
                                                No                   N/A                         Health Inspectorate of the Republic of     Yes             N/A                 N/A                  N/A                          N/A
  in Article 37 of the MGMOAct there is a
                                                                                            Slovenia, the Inspectorate of the Republic of
   procedure of measures which shal be
                                                                                            Slovenia for Agriculture, Forestry, and Food,
  implemented by the applicant in case of
                                                                                             the Office for Inspection Supervision within
         unintended release of GMO
                                                                                            the Veterinary Administration of the Republic
                                                                                                of Slovenia, each in accordance with its
                                                                                                             competencies.
It is mandatory for notifiers to submit a final                                                                            1 (Cases where either the
  report after the completion of a trial which                                                                                isolation distance was
                                                        Inspectors are based in the Regional CAs
    covers these two effects. Any reported        Yes                                                  N/A   Yes   1   0     infringed or crop waste     0
                                                                          only
      effects would be followed up by the                                                                                     material had not been
      Competent Authority s Inspectors.                                                                                    incorporated into the soil)




                                                        Inspection Division of the Swedish Board of
None to date, but would be assessed case-               Agriculture, established 2007. Prior to 2007
                                                  Yes                                                  N/A   Yes   0   0               0                 0
                  by-case                                   inspections were carried out by the
                                                                   Competent Authorities.




The agreement between the GM team and
the GMI states that the GMI will undertake
 inspection visits and produce reports for               The GM Inspectorate (England). There is
                                                  Yes                                                  N/A   Yes   0   0               0                 0
Defra to consider. It is expected that reports                 also a GMI for Scotland.
would highlight any unusual or unexpected
     circumstances and action taken.
conditions)
              10.3 Are details of non-
                   compliances             If YES, where are they
              published? (If no trials   published. Please provide
                                                                       Any other information
              have been held, would      further information and a
               non-compliances be            weblink if possible.
                    published?)

                      #NAME?                      #NAME?                     #NAME?




                                         Attention, no discussion so
                        No
                                              far on this aspect




                        No
No




No




No




No   N/A
Yes



                                         Dear addressee, 1) The B applications are
                                            assessed by expert authorities, and if
                                           needed by other experts that give their
                                          expert opinion to the CA (The Board for
        I do not know and I do not         Gene Technology) 2) I am not the best
No                                        person to answer these questions. If you
       know if they were published
                                           still have the possibility, please contact
                                         gtlk.stm@stm.fi (anna kaisa vaatanen or
                                          irma salovuori) - they represent the CA.
                                          Especially about questions 5.1, 5.5, 8.5
                                                           and 10.3




       Non-compliances would not
       be published if there was a
No    prosecution - this is the job of
       the Justice system, not the
         Ministry of Agriculture.




No
                                             Hungary has a duty to ensure that
                                         systematic and independent research is
                                       carried out to determine the potential risks
       No non-compliances have
                                           of deliberately releasing GMOs in its
           been found. However,
                                         territory (2001/18/EC, preamble (21). By
      according to the Act on gene
                                        adopting a step-by-step approach , we
        technological activity, the
                                            encourage notifiers to progressively
            competent authority
                                      increase the scale of environmental impact
       publishes information (e.g.
                                        studies on their products as they develop
            compliances or non-
Yes                                     towards the market. Our aim is to gather
      compliances) on the results
                                      biosafety evidence that demonstrates there
       of the official inspections in
                                           are no risks to human health and the
          its official journal on an
                                          environment from releasing GMOs and
             annual basis. Such
                                       their products. We wish to ensure that this
        information would also be
                                        evidence relates specifically to Hungarian
       published on the website of
                                      environments and does not rely on studies
         the controlling authority.
                                         undertaken in environments that are not
                                             relevant to our agri-environments
                                                        /ecosystems.




No




No




                                        If competent authority has recognized
                                        violation in the field of GMO deliberate
No                                       release, amount of fine: " for physical
                                      person 20 500 LVL; " for legal person as
                                                  from 100 -1000 LVL
No   N/A




No   N/A




No




No
                                             The consent holders and the
                                      reprezentatives of the competent authority
                                      and of the inspection body to be obliged to
                                         participate together (according to a
                                         programm)for eliminating the waste
                                         materials and destroying the GMOs
No
                                      resulting from the field trial, which are not
                                       used in a future experiment; to be kept a
                                          clear situation of the quantities of
                                      imported,cultivated and harvested GMOs.
                                       To be established guideliness at the EU
                                                  level, on this issue.




No                  -                                       -




       In case of non-compliance
      the results are not published
Yes
      on the websites but they are
      publicly available on request
No




No




        They are published in the
        public register and also in
       GMI annual report which is
Yes   published on the GMI website
            at http://www.gm-
      inspectorate.gov.uk/reportsP
                ublications/

								
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