EUROPEAN COMMISSION Brussels, 20.12.2016 SWD(2016) 445 final COMMISSION STAFF WORKING DOCUMENT Details from individual Member States on their experience with Directive 2009/41 of the European Parliament and of the Council of May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014 Accompanying the document COMMISSION WORKING DOCUMENT Experience of Member States with Directive 2009/41 of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014 {COM(2016) 808 final}



COMMISSION STAFF WORKING DOCUMENT Details from individual Member States on their experience with Directive 2009/41/EC of the European parliament and the Council of May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014 Accompanying the document COMMISSION WORKING DOCUMENT Experience of Member States with Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009 – 2014

1.DETAILS FOR INDIVIDUAL MEMBER STATE THREE YEAR REPORTS (raw data translated and compiled) 3 1.An overview of activities and installations 4 2.Notification and approval systems (and relevant changes) 39 3.Inspection and enforcement issues 60 4.Problems with interpretation of the provisions 87 5.Accidents 97

6.Clinical Trials using the provisions of the Directive 102 7.Public consultation and information 109 8.Waste disposal 119 9.Other issues 131 2.TABLE OF COMPETENT AUTHORITIES 135

COMMISSION STAFF WORKING DOCUMENT

Details from individual Member States on their experience with Directive 2009/41/EC of the European parliament and the Council of May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014 1. DETAILS FRO INDIVIDUAL MEMBER STATE THREE YEAR REPORTS (raw data translated and compiled) 1 Overview of activities and installations 1.1 How many notifications were submitted in your Member State under Directive 2009/41/EC on the contained use of GMMs during the reporting period 6 June 2009 and 5 June 2014? Please provide as annex at your report, a table with all the information required by art 18(2) for each of the notifications received, under Directive 2009/41/EC. AUSTRIA GMMs No. of notifications Class 1 74 Class 2 137 Class 3 6 Class 4 0 Amendments to earlier notifications 20 Total 237 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 6 1 GMM + GM animal 14 1 Amendments to earlier notifications - - Total no. of notifications received 20 BELGIUM GMMs No. of notifications Class 1 253 Class 2 273 Class 3 69 Class 4 0 Amendments to earlier notifications (Subsequent use notifications) 418 Total 595

GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 24 risk class 1 GMM: 20 risk class 2 GMM: 4 risk class 3 GMM: 0 GMM + GM animal 113 risk class 1 GMM: 25 risk class 2 GMM: 68 risk class 3 GMM: 20 Amendments to earlier notifications 122 GMM + GM plant: 19 GMM + GM animal: 93 Total no. of notifications received 136 notifications of GMMs/GMOs combined BULGARIA GMMs No. of notifications Class 1 Two Class 2 None Class 3 None Class 4 None Amendments to earlier notifications None Total Two GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant Two Both class 1 GMM + GM animal None Not applicable Amendments to earlier notifications None Not applicable Total no. of notifications received Two CROATIA Nineteen (19) notifications were submitted in Croatia during mentioned period. GMMs No. of notifications Class 1 17 Class 2 2 Class 3 0 Class 4 0 Amendments to earlier notifications Total 19 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 2 1 GMM + GM animal 2 1 and 2 Amendments to earlier notifications Total no. of notifications received 19 CYPRUS GMMs No. of notifications Class 1 1* Class 2 1* Class 3 0 Class 4 0 Amendments to earlier notifications 0 Total 1* GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 0 GMM + GM animal 0 Amendments to earlier notifications 0 Total no. of notifications received 0 * Please note that both Class 1 and Class 2 Activities were included in one notification for the same installation.

CZECH REPUBLIC GMMs No. of notifications Class 1 14 Class 2 2 Class 3 1 Class 4 0 Amendments to earlier notifications 35 Total 52 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 0 GMM + GM animal 0 Amendments to earlier notifications 21 1 and 2 Total no. of notifications received 21 Explanation note: According to the current Czech legislation, a new notification is required in every case a new GMO is to be used (not only new premises). This rule applies even to class 1 of contained use that means the national requirements are stricter than those set by the Directive. An amendment to the Czech Act of GMOs has been drafted with the aim to ease this administrative burden both for notifiers and for the Competent Authorities. The amendment is now in the legislative process. DENMARK GMMs No. of notifications Class 1 244 Class 2 57 Class 3 0 Class 4 0 Amendments to earlier notifications 440 Total 742 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 31 1 and 2 GMM + GM animal 283 1 and 2 Amendments to earlier notifications Total no. of notifications received 314 ESTONIA GMMs No. of notifications Class 1 3 Class 2 3 Class 3 2 Class 4 0 Amendments to earlier notifications 0 Total 8 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 0 GMM + GM animal 0 Amendments to earlier notifications 0 Total no. of notifications received 0 NOTE: Labour inspectorate of Estonia registers notifications only for GMO-s. There are no combined notifications in Estonia FINLAND

GMMs No. of notifications Class 1 136 Class 2 104 Class 3 3 Class 4 0 Amendments to earlier notifications ?? (what does the question specifically mean?) Total 183 (an individual notification may contain activities from several classes) GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 12* 1-2 GMM + GM animal 12* 1-2 Amendments to earlier notifications ?? Total no. of notifications received *) notified together, not necessarily used in combination; please also note that this answer does not cover situations where GMMs are used in combination with non-modified plants or animals or vice versa FRANCE 3500 notifications GMMs No. of notifications Class 1 1850 Class 2 1450 Class 3 180 Class 4 20 Amendments to earlier notifications 500 Total 3500 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 250 1+2+3 GMM + GM animal 2500 1+2+3+4 Amendments to earlier notifications 400 Total no. of notifications received 3150 GERMANY GMMs No. of notifications Class 1 1147 Class 2 2264 Class 3 106 Class 4 5 Amendments to earlier notifications Total 3522 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 12 2 GMM + GM animal 22 2 Amendments to earlier notifications Total no. of notifications received 34 Please provide as annex at your report, a table with all the information required by art 18(2) for each of the notifications received, under Directive 2009/41/EC. Class 3/4: see attached summary report of class 3 and class 4 contained uses.

HUNGARY GMMs No. of notifications Class 1 5 Class 2 20 Class 3 none Class 4 none Amendments to earlier notifications Total 25 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 2 2 GMM + GM animal 3 2 GMM+GM animal + GM plant 2 2 Amendments to earlier notifications Total no. of notifications received 7 IRELAND GMMs No. of notifications Class 1 70 Class 2 75 Class 3 5 Class 4 0 Amendments to earlier notifications 0 Total 150 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 6 Class 1 GMM + GM animal 10 Class 1 and Class 2 GMMs Amendments to earlier notifications 0 Total no. of notifications received 67 ITALY GMMs No. of notifications Installations Activities Total Class 1 33 N.A.* 33 Class 2 50 144 194 Class 3 5 8 13 Class 4 0 0 0 Amendments to earlier notifications 18 13 31 Total 106 165 271 (*) Notification is not due for class1 activity Note: the following table only refers to activities with GMM inoculation. GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 1 2 GMM + GM animal 39 2 GMM + GM animal 3 3 Amendments to earlier notifications 4 2 Total no. of notifications received 47 LATVIA

GMMs No. of notifications Class 1 1 Class 2 Class 3 Class 4 Amendments to earlier notifications Total 1 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 1 1 GMM + GM animal Amendments to earlier notifications Total no. of notifications received 1 LITHUANIA GMMs No. of notifications Class 1 6 Class 2 Class 3 Class 4 Amendments to earlier notifications Total 6 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 1 1 GMM + GM animal 2 1 Amendments to earlier notifications 2 1 Total no. of notifications received 5 MALTA GMMs No. of notifications Class 1 6 Class 2 0 Class 3 0 Class 4 0 Amendments to earlier notifications 0 Total 6 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 0 GMM + GM animal 0 Amendments to earlier notifications 0 Total no. of notifications received 0 NETHERLANDS GMMs No. of notifications Class 1 --- Class 2 --- Class 3 --- Class 4 --- New notifications 519 Amendments to earlier notifications 3281 Total GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant GMM + GM animal Amendments to earlier notifications Total no. of notifications received 3800 In the Netherlands, during the reporting period 210 institutes and companies were actively involved in contained use activities with genetically modified organisms. At these 210 institutes a total of 2315 licensed active contained use activities take place. This contained use involved not only activities with micro-organisms but also with genetically modified plants, animals, viruses, etc. In addition, most companies/institutes carried out activities with combinations of GMO's, i.e. not exclusively with GMM's. 15 new installations were notified compared to the last reporting period. In total 519 new notifications and 3281 amendments on earlier notifications were received during 2009-2014. In general more than one containment level was prescribed per notification.

Overall in the Netherlands we encounter a rise of more than 60% in the amount of new and amended notifications in comparison to the figures of the last reporting period. POLAND GMMs No. of notifications Class 1 250 Class 2 34 Class 3 2 Class 4 0 Amendments to earlier notifications Total 286 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 57 I GMM + GM animal 98 I/II Amendments to earlier notifications Total no. of notifications received 155 PORTUGAL GMMs No. of notifications Class 1 2 Class 2 5 Class 3 - Class 4 - Amendments to earlier notifications - Total 7 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant - GMM + GM animal - Amendments to earlier notifications - Total no. of notifications received - ROMANIA GMMs No. of notifications Class 1 None Class 2 None Class 3 None Class 4 None Amendments to earlier notifications None Total None GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant None GMM + GM animal None Amendments to earlier notifications None Total no. of notifications received None SLOVAKIA GMMs No. of notifications Class 1 55 Class 2 8 Class 3 0 Class 4 0 Amendments to earlier notifications 0 Total 63

GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 12 1 GMM + GM animal 16 (class 1) + 10 (class 2) 1&2 Amendments to earlier notifications Total no. of notifications received 38 Since 1.1.2013 the users of genetic technologies and genetically modified organisms aren´t obliged to notify the start of the new activity classified to the risk class 1 to the Ministry of the Environment of the Slovak Republic (hereinafter referred to as “the ministry”). Once every 6 months, the users of GMOs submit a summary notification on all the GMOs classified in the risk class 1, which they have carried out activities with, including their storage in the reporting period. SLOVENIA GMMs No. of notifications Class 1 7 Class 2 36 Class 3 0 Class 4 0 Amendments to earlier notifications 24 Total 74 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant GMM + GM animal 3 2 in class 1; 1 in class2 Amendments to earlier notifications Total no. of notifications received 3 Information required by art 18(2) under Directive 2009/41/EC is available in the GMO Register at Slovene Biosafety Portal http://www.biotechnology-gmo.gov.si/. SPAIN GMMs + GMP + GMA= All GMOs (**) No. of notifications Class 1 101 Class 2 103 Class 3 22 Class 4 Amendments to earlier notifications Total 226 GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant 35 32 (Class 1) 3 (Class 2) GMM + GM animal 28 27 (Class 1) 1 (Class 2) Amendments to earlier notifications Total no. of notifications received 63 (**) Under the scope of the Spanish Law on GMOs, all kind of genetically modified organisms are included in the requirements for contained use purposes. So we have considered all the notifications received during the reporting period (GMMs + GM Plants + GM Animals) for the four classes of risk. SWEDEN Please note that one “notification” may include more than one GMM activity or new GMM use. Numbers in table are approved activities and the “notifications” are stated above the table.

Total number of notifications, applications and changes during the time period: 477 Notification (class 1 and class 2, including new class 2 uses): 411 Applications (class 3 and class 4): 18 Changes to already approved GMM-activities: 143 GMMs No. of notifications (numbers are activities notified/approved during the time period) Class 1 123 (7 were later closed during the time period) Class 2 102 (3 were later closed during the time period) Class 3 13 Class 4 2 Amendments to earlier notifications * Total 240 *Amendments to earlier notifications do not include new class 2 uses. Such uses are not included in this list but are a large part of the 411 “notifications” we have registered during the time period. GMMs and GMOs combined No. of notifications Class of GMM GMM + GM plant GMM + GM animal Amendments to earlier notifications Total no. of notifications received The list in the annex includes all active activities and uses within activities regardless of when it was notified. It is not possible to provide a list only covering 5 years. Please also note that one post in the list does not equal one activity or one GMM-use. UNITED KINGDOM GMMs No. of notifications Installation or premises notification 126 (125 from GB; 1 from NI) Class 2 612 (602 from GB; 10 from NI) Class 3 75 (all GB) Class 4 2 (all GB) Amendments to earlier notifications 197 (196 from GB; 1 from NI) Total 1012 (1000 from GB; 12 from NI) a)The figure for ‘amendments to earlier notifications’ includes changes to the contained use that may affect risk (55 significant changes), changes to required containment (6 derogations) and transfer of contained use to a different installation (135 transfers). b)Please note, the Directive is only concerned with genetically modified microorganisms (GMM) and does not require collection of information on work with genetically modified organisms (GMOs i.e. animals and plants). Consequently, such information is not collected in a form that is amenable for reporting purposes. For completeness, figures on combined work with GMMs and either animals or plants (which may or may not be genetically modified) have been compiled by reviewing individual notifications of GMMs. c)The figures in the table below represent a subset of the individual contained use notifications listed in the first table in section 1.1.

GMMs and GMOs combined No. of notifications Class of GMM GMM + plant 18 class 1 (4); class 2 (9); & class 3 (5) GMM + animal 194 class 1 (9); class 2 (161); class 3 (24); Amendments to earlier notifications data not available data not available Total no. of notifications received 212 d)Annex 1 provides details of contained uses notified to the UK competent authorities during the period of this report.

1.2 Of the aforementioned notifications how many were notified for: AUSTRIA Research purposes not applicable (see below). Commercial purposes not applicable. Other (please specify) not applicable. Note ad 1.2 and 1.4 The former distinction of contained uses on the basis of the purpose (i.e. operations of type A and type B in Dir. 90/219/EEC) has been abolished by Dir. 2009/41/EC. In accordance with the current Directive notifiers are not obliged to specify the purpose of the contained use and therefore only the total number is available (total number of installations: 352). BELGIUM Research purposes (Universities, research institutes): 313 Commercial purposes: 150 Other

oHospitals: 88 oEducation – Teaching: 12 oPublic institutions (diagnostic, reference lab, quality control): 32 BULGARIA Research purposes 4 Commercial purposes 0 Other (please specify) 0 CROATIA Research purposes FOURTEEN (14) Commercial purposes FOUR (4) Other (please specify) ONE (1) CYPRUS Research purposes 1 Commercial purposes 0 Other (please specify) 0 CZECH REPUBLIC

Research purposes 57 (incl. amendments to earlier notifications) Commercial purposes 7 (incl. amendments to earlier notifications) Other (please specify) 9 detection laboratories, transport companies (incl. amendments to earlier notifications). DENMARK Research purposes 724 Commercial purposes 60 Other (please specify) 21 (large scale research) ESTONIA Research purposes 8 Commercial purposes 0 Other (please specify) 0 FINLAND Research purposes 146 (estimation) Commercial purposes 27 Other (please specify) 10 (education, core laboratory services) FRANCE

Research purposes 3000 Commercial purposes 500 Other (please specify) GERMANY Research purposes _____ Commercial purposes _____ Other (please specify) _____ No information available (database cannot be evaluated concerning the above criteria) HUNGARY Research purposes 25 Commercial purposes 7 Other (please specify) none IRELAND Research purposes 190 } These figures are inclusive of Commercial purposes 21 } 67 GMO (GM plants and GM Other (please specify) i.e. State 6 animals applications

TOTAL 217 ITALY Research purposes 149 Commercial purposes 16 LATVIA Research purposes 1 Commercial purposes _____ Other (please specify) _____ LITHUANIA Research purposes 11 Commercial purposes _____ Other (please specify) _____ MALTA Research purposes 6 Commercial purposes 0___ Other (please specify) 0___

NETHERLANDS Research purposes --- Commercial purposes --- Other (please specify) --- Remark: due to reporting mechanisms it is not possible for the Netherlands to differentiate the issued licences between commercial or research purposes. POLAND Research purposes 260 Commercial purposes 1 Other (please specify) 25 clinical trials PORTUGAL Research purposes 6 Commercial purposes 1 Other (please specify) _____ ROMANIA Research purposes None Commercial purposes None Other (please specify) None

SLOVAKIA Research purposes 92 Commercial purposes 16 Other (please specify) 0 SLOVENIA Research purposes 63 Commercial purposes 11 Other (please specify) 0 SPAIN Research purposes 200 Commercial purposes 15 (products close to commercial development phases, control quality procedures, manufacture of diagnostics, veterinary or human medicines). Other (please specify) _____ SWEDEN Research purposes 221 (both commercial and academics) Commercial purposes 6* Other (please specify) 12 with education at both high school level and university level; 1 with destruction of GMM in waste, 1 with diagnostics.

*Where the commercial purpose is research or if the purpose is both research and commercialisation, the purpose is included as Research. Several small business companies have research as their main purpose for GMM use. Some also use GMM for production. UK Research purposes 719 in GB and 6 in NI Commercial purposes 229 in GB and 4 in NI Other (please specify) 52 in GB and 1 in NI Other in this case relates to Government Organisations.

1.3 Please comment on the overall trend compared to the previous reporting period (e.g. has the overall number of notifications received increased or decreased, has there been an increase/decrease in respect of certain classes, commercial or research sectors etc.) AUSTRIA - BELGIUM From 6 June 2009 to 5 June 2014, 552 dossiers of installations covering 1150 notifications of contained uses of GMMs, GMOs and/or pathogens have been reviewed by the SBB acting as the advisory body for the competent authorities. - It is not appropriate to compare two different reporting time period (3 years for previous report and 5 years for this one) but in general, the number of dossiers and notifications remained comparable if the average of notifications per year is considered. - Since 1993, Belgium has fully implemented Directive 90/219/EEC in three regional decrees thereby extending the scope to GMOs and non-GM pathogens. This means that, among the 1150 notifications, 426 of them exclusively concerned non-GM pathogens (37%) and 482 notifications concerned GMMs and/or GMOs only (42%). The remaining 242 notifications concerned contained uses of both GMMs/GMOs and non-GM pathogens (21%).

Compared to the previous 3-year reporting period, the percentage of notifications for non-GM pathogens remains exactly the same. In contrast, there was a strong decrease of notifications concerning exclusively MGMs or GMOs in favour of combined operations with GM and non-GM organisms. - Subsequent use notifications: In Belgium, from 2009 to 2014, the subsequent use notifications have steadily increased. They account for up to 82 % which is a high increase compared to the previous reporting period when they represented only 59 % of the total number. - With respect to the type of exploitations, the large majority of GMMs are used by the university research laboratories (60 %) for fundamental research. Sometimes medical researches with GMMs are conducted in hospital labs (9%). GMMs are handled in pharmaceutical companies (23 %) for research purposes or production of enzymes, vaccines and therapeutic molecules. Rarely, GMMs are also used for teaching (2 %). BULGARIA All four notifications received concern initial approval of facilities of academic institutions for contained use of GMM class 1 (Article 6 of the Directive) and in addition two of them included request for work with GM plants class A (see answer to question 2.2). All four notifications were received after July 2012. We expect further notifications for initial approval of facilities from between two and five academic institutions. All will include work with GMM class1 and it is possible that up to two of them will include work with GMM class 2. Additionally we expect that between 2 and 5 of the notifications will include work with GM plants class A and one or two work with GM animals class A. Notification for initial approval of facilities should be updated at least every two years. CROATIA Not applicable. Croatia has been started with the procedure of notification of contained use of GMMs in the middle of 2012. CYPRUS There was an increase in the number of notifications received. The previous reporting period there was no GMMs notification received. CZECH REPUBLIC Most institutions submitted their notifications during the first years after the Czech Act on GMOs came into force in 2004. Since 2006, the number of new subjects starting to use GMMs has increased only moderately. Prevailing notifications concerned new activities with GMMs in previously notified premises - that means mostly amendments to the previous notifications have been submitted (see the explanation note to 1.1. above). The purpose of the notified activities has been almost entirely research and education (Universities). DENMARK There has been an increase in the number of notifications for class 1 and 2. Regarding the classifications of locations there has also been an increase. ESTONIA

This number has been increased, especially in class 3. In the previous reporting period there were no any class 3 notifications. FINLAND The overall number of notifications has increased. This is probably due to the current policy that each university research group notifies independently its GMO activities instead of joint notifications covering whole departments or units. FRANCE Generally, in all cases, the notifications are increasing. GERMANY The overall number of notifications has increased with respect to all classes. HUNGARY Compared to the previous reporting period, there has been an increase in the number of Class 2 contained use/installation notifications in Hungary, mainly for research purposes. In our view, the reason for that is that the Government sent detailed information to the universities, laboratories, and other contained use facilities on the obligatory to apply for consent for these activities. In most cases, notifiers propose Class 2 for contained use activities or installations where Class 1 would be also appropriate. The notifiers’ reasoning behind is that by applying stricter contained use measures a higher level human health and environmental safety can be ensured. The competent authority approves the proposed Class level in these cases. There is an increase in the number of GM animal notifications, too. IRELAND Compared to our submission for the 2006 – 2009 report, the number of applications received from research institutions is slightly down (87% compared to 90% during period 2006 - 2009) but the trend is the same in that the majority of applications were submitted by users in research institutions. That said the current reporting period is 5 years as opposed to the 3 year duration of the 2006 – 2009 reporting period which could account for this slight difference Consistent with previous years the majority of the applications submitted during the period belonged to Class 1 (70). These were all applications in respect of first time use of premises. In contrast, 75 applications were received in respect of Class 2 GMM contained use activities, however 45 of these were in respect of first time use of a premises and 30 corresponded to ‘subsequent Class 2 contained use’, i.e. where the premises has been the subject of a previous notification to carry out Class 2 GMM contained use activities.

The number of applications received from commercial users during the reporting period 2009 – 2014 has increased by almost 50%. Again most likely the extended reporting period has had a bearing on this. ITALY The overall number of notifications remains stable (-2%, actually) with respect to the previous period (i.e. 6 June 2004 - 5 June 2009); some more “class 3” activities, fully balanced by the decrease in the “class 1” installations. The actual period is characterised by a significant number of amendments: 11% of the overall submissions have been due to revisions (minor, usually) of previous notifications. No relevant change has to be reported in terms of sector breakdown. LATVIA This is first notification regarding contained use in Latvia. LITHUANIA Compared to the previous reporting period 2006 - 2009, the overall number of notifications increased by 9 notifications for research purposes. MALTA There was an increase from the last reporting period since we received one application to register Class 1 laboratory premises and notification of six Class 1 experiments. NETHERLANDS - POLAND The majority of these activities have taken place in universities or research institutions for fundamental research. The number of installations and contained use activities increased, in comparison with the previous reporting period.

PORTUGAL The number of notifications received during the present report period, increased to more than the double of the number of notifications comparing with the previous report period, regarding the same classes (classes 1 and 2) and in the great majority of notifications for research purposes (only one notification for commercial purposes). ROMANIA Not applicable. SLOVAKIA Compared to the previous reporting period (2006-2009), the overall number of notifications on the contained use of GMOs has slightly increased. The similar trend is seen also when compared number of notifications on the contained use of GMOs classified in the risk class 1 and 2. During this reporting period, we haven´t received notifications on the higher risk classes 3 and 4. The number of notifications for the research and commercial purposes in comparison to the previous reporting period has slightly increased, as well. SLOVENIA The overall number of the notifications has slightly increased. However, number of installations for GMOs in the biosafety class 2 has increased significantly. Some of the installations were newly build and registered, but mainly the installations that were already registered in the biosafety class 1 are upgraded to the biosafety class 2. Consequently there were also more notifications of the activities in the biosafety class 2. Slight increase of the activities with GMMs in the biosafety class 2 for commercial purposes was also recorded. At the moment there are no installations and activities with GMOs/GMMs in containment classified in biosafety class 3 or 4. SPAIN Compared to the previous reporting period the number of notifications of installations has increased significantly (from 50 for the last reporting period to 139 for this reporting period), but taking into account that the current reporting period is broader (5 years). Especially, notifications of installations for class 2 activities are being increased. SWEDEN We have seen a small decline in the number of activities for contained use in the private sector. One reason is that a big company with many GM-activities has closed down most of its research in Sweden.

Each year some activities are closed down and some are new, while some moves to new locations. The number of new or moved activities decreased 2009 and there was a net increase between new and closed down GMM activities of only +1 GMM-activity. In 2010 there was a net increase of +13. For 2011 the increase was +6 with a more normal inflow of new activities. For 2012 the numbers were more normal with a net increase of +35. The trend is kept for 2013 with a net increase of +32 and, so far, 2014 has a net increase of +18. UNITED KINGDOM a)Comparison of the overall notifications between the reporting periods of 2006-2009 and 2009-2014 indicates that the average number of notification per annum is not significantly different (i.e. 170 notifications per annum compared to 177 notification per annum). Similarly, there is no significant difference across the notifications at the different risk classes. b)Within the reporting period, there was a dip in the number of notifications received in 2010/11 (140 notifications), which then increased each year to a peak in 2013/14 (207 notifications). However, when taken as an average over the 5 year period, the average number of notifications is very similar to the previous reporting period.

1.4 Number of installations approved to date: AUSTRIA Research Commercial Other (please specify) Research Commercial Other (please specify) - - - See Note ad 1.2 and 1.4. BELGIUM Research Commercial Other (please specify) 34 261 Hospitals: 138 Education-Teaching: 19 Public institutions: 40 BULGARIA

Research Commercial Other (please specify) 4 None None CROATIA Research Commercial Other (please specify) 12 4 1 CYPRUS Research Commercial Other (please specify) 1 CZECH REPUBLIC Research Commercial Other: detection laboratories, transport companies 82 7 8 DENMARK Research Commercial Large scale 1272 211 29 ESTONIA Research Commercial Other (please specify) 4 FINLAND Research Commercial Other (please specify) information not available information not available information not available 679 in total

FRANCE Research Commercial Other (please specify) Use is associates to the project in an installation but not for research structure GERMANY Research Commercial Other (please specify) No information available (database cannot be evaluated concerning the above criteria) BSL1 installations: 4 594 BSL2 installations: 1 506 BSL3 installations: 107 BSL4 installations: 4 (2x in operation, 2x construction approval) HUNGARY Research Commercial Other (please specify) 14 7 IRELAND Research Commercial Other (please specify) 17 35 3

ITALY Class Commercial Research Other (Education) Total 1 16 248 16 280 2 10 198 4 212 3 1 29 30 Total 27 475 20 522 LATVIA Research Commercial Other (please specify) 1 LITHUANIA Research Commercial Other (please specify) - - - MALTA Research Commercial Other (please specify) 1 0 0 NETHERLANDS See remark under 1.2 Research Commercial Other (please specify) POLAND Research Commercial Other (please specify) 63 15 0

PORTUGAL Research Commercial Other (please specify) 2 1 - ROMANIA Research Commercial Other (please specify) 0 0 0 SLOVAKIA Research Commercial Other (please specify) 74 6 0 SLOVENIA Research Commercial Other (please specify) 56 8 1 education SPAIN 139 Research Commercial Other (please specify) 124 15 SWEDEN An “installation” is always included in an “F-, L- or R-activity”. The “installation” may be identical for more than one “activity”. An “installation” may be a laboratory, an animal department, a large scale facility or any other similar physical place with equipment suitable for the GMM-activity. In a building or at a “site”, there may be one or several “installation”. Sometimes there may be more than one user (employer) in the same building or site.

In Sweden, GMM-activities are notified from 113 users (employers) that are scattered at 32 cities and 157 sites. Today a total number of 624 GMM-activities are active: 23 users (employers) are universities or other research institutes with a total of 472 GMM-activities in class 1-4. There are three hospitals and 14 schools with GMM-activities with GMM-activities in class 1. 73 users are commercial biotech companies, waste management companies or private schools with a total number of 115 GMM-activities in class 1 or class 2. But far from all activities are commercialisation; a large part is research. Research Commercial Other (please specify) 23 users in academia, about 500 GMM activities (class 1-4) 3 hospitals (class 1, notified by country councils) 73 users are commercial, about 100 GMM activities (class 1 and 2) Schools (high school level): 14 GMM-activities (class 1) UNITED KINGDOM a)881 installations (871 in GB and 10 in NI) have been approved to date in the UK. Research Commercial Other (please specify) 509 (507 in GB; 2 in NI) 327 (320 in GB; 7 in NI) 45 (44 in GB; 1 in NI) Other in this case relates to Government organisations.



1.5 Number of activities approved to date: AUSTRIA Class 1 Class 2 Class 3 Class 4 GMO 1584 422 16 0 - BELGIUM Class 1 Class 2 Class 3 Class 4 GMO 983 972 120 0 794 BULGARIA Class 1 Class 2 Class 3 Class 4 GMO Four None None None Two for GM plants, both Class A (see answer to question 2.2) CROATIA Class 1 Class 2 Class 3 Class 4 GMO 15 2 0 0 0 CYPRUS Class 1 Class 2 Class 3 Class 4 GMO 12 12 2 Please note that only one installation was approved by the Department of Labour Inspection for Class 1 and Class 2 Activities. CZECH REPUBLIC

Class 1 Class 2 Class 3 Class 4 GMO 65 31 1 0 included DENMARK Class 1 Class 2 Class 3 Class 4 GMO 741 161 0 0 71 ESTONIA Class 1 Class 2 Class 3 Class 4 GMO Research Research Research FINLAND Class 1 Class 2 Class 3 Class 4 GMO 528 312 7 0 876* *) Notifications on activities + installations 876 in total, of which 197 notifications merely for activities. Please note that the total number includes notifications and applications also on GM-plants and GM-animals and their combinations with GMMs. FRANCE Class 1 Class 2 Class 3 Class 4 GMO Cf 1.1/1.4 Cf 1.1/1.4 Cf 1.1/1.4 Cf 1.1/1.4 Cf 1.1/1.4 GERMANY Class 1 Class 2 Class 3 Class 4 GMO 6959 6986 358 8 HUNGARY Class 1 Class 2 Class 3 Class 4 GMO 5 27

IRELAND Class 1 Class 2 Class 3 Class 4 GMO 255 152 5 0 130 ITALY Class 1 Class 2 Class 3 Class 4 GMO Total number of authorisations (since Oct. 2001) N.A.* 454 21 0 N.A. Not-expired authorisations up to date N.A.* 143 8 0 N.A. (*) Notification is not due for class1 activity LATVIA Class 1 Class 2 Class 3 Class 4 GMO 1 LITHUANIA Class 1 Class 2 Class 3 Class 4 GMO 11 - - - - MALTA Class 1 Class 2 Class 3 Class 4 GMO 6 0 0 0 0 NETHERLANDS See remark under 1.1

Class 1 Class 2 Class 3 Class 4 GMO POLAND Class 1 Class 2 Class 3 Class 4 GMO 250 34 2 0 325 PORTUGAL Class 1 Class 2 Class 3 Class 4 GMO 2 5 - - 1 (field trials with maize)* * - Notification submitted accordance with Directive 2001/18/EC ROMANIA Class 1 Class 2 Class 3 Class 4 GMO 0 0 0 0 0 SLOVAKIA Class 1 Class 2 Class 3 Class 4 GMO 7052 5626 0 0 Total number 197 GMM, GM animals, GM plants (See Annex 1) Number of activities was quantified according to the organisms, genes and vectors that were used. Total number of submitted notifications to date: Class 1 Class 2 Class 3 Class 4 GMO 90 18 0 0 Overall 108

SLOVENIA Class 1 Class 2 Class 3 Class 4 GMO 56 27 0 0 SPAIN 234 (The number of activities may not match with the number of notification pointed out above) Class 1 Class 2 Class 3 Class 4 GMO 93 122 19 SWEDEN 5 June 2014 (only still active; closed down are not included) Class 1 Class 2 Class 3 Class 4 GMO 396 208 18 2 UNITED KINGDOM a)In the UK, class 1 activities are not notified as a separate activity. Information on class 1 activities is provided as part of a premises (installations) notification but this does not represent the overall number of class 1 activities being undertaken. Class 2 Class 3 Class 4 GMO 1816 (1795 in GB; 21 in NI) 211 (210 in GB; 1 in NI) 12 (all GB) 3 (all GB)



1.6 Were there any particular difficulties you encountered in the notification process during the reporting period and what in your opinion could be done at EU or national level to alleviate these difficulties? AUSTRIA - BELGIUM Some problems are met in the interpretation of the terms “subsequent activity”: There is no definition of a subsequent “contained use” in the Directive. Although the regional legislation for Brussels-Capital Region defines a subsequent contained use as "any new contained use, modification or continuation of contained use in an installation which has been the subject of a previous notification or authorisation for a contained use of the same or a higher class of risk", the user does not always know when an activity is considered as a subsequent contained use, especially in case of a modification of the authorised activity. Moreover, it is impossible to distinguish the amendments to earlier notifications (see table point 1.1) with other types of subsequent contained uses (continuation of activity or new activity) as defined in the regional decrees. In Brussels-Capital Region some problems were encountered in the notification process due to the Brussels legislation which has set up numerous different procedures regarding the class of risk (8 in total). To solve this difficulty, the Brussels-Capital Region implements first use procedure when the subsequent notification is introduced after expiry of the first use authorisation. That way, the procedure is uniformly applied concerning the reception and the analysis of the notification, the visit on site, the expert advice reception and the authorisation delivery timeframe. This difficulty is not encountered in Walloon Region because there is no separate procedure for a first and a subsequent contained use. BULGARIA Directive 2009/41/EC provides only for the contained use of GM microorganisms but not for GM plants and animals. It will be helpful if the scope of the directive is extended to all GMO and unified requirements for contained use of GM plants and animals are established. In addition it will be useful if a list of Generally Regarded As Safe (GRAS) laboratory strains and cultivars is adopted at EU level, because they account for most of the work done at universities and research institutions. CROATIA

- CYPRUS There was no difficulty in the notification process. CZECH REPUBLIC The current Czech legislation on contained use is stricter than the Directive 2009/41/EC: a new notification is required in every case a new GMO is to be used - even in Class 1 of contained use. The Ministry of the Environment as the Competent Authority has elaborated an amendment to the Czech Act of GMOs with the aim to ease this administrative burden both for notifiers and for the Authorities. The amended Act will comply with the Directive and will not go beyond the EU requirements. The amendment is now in the legislative process and is expected to come into force next year. DENMARK Class 1 notifications make up most of the notifications and there is a lot of administrative work due to this. That is why we are currently working on a change in our procedures in order to make things easier for the companies as well as the authorities ESTONIA Was a question about approved installations. There is an enterprise with allowance in certain address. They want to move to another laboratory in the another building. Does they have to make new notification and get new allowance. FINLAND Problems are similar to the previous reporting period:

A major problem has been the definitions of the directive 2009/41/EC for GMMs, as they are outdated in the present research environment with its new molecular biology techniques. Classification of viruses and cell cultures has also been problematic in some cases. A special problem has been the classification of pathogens that have been attenuated (= can an attenuated pathogen ever be considered non-pathogenic according to the directive, and if so, on what conditions?). Clinical trials with GM-viruses are a borderline case between contained use and deliberate release in cases where it cannot be completely ruled out that the patients’ or animals’ excretions may contain live viruses. Research groups move frequently from one institution to another which means they have to repeatedly send new notifications of their new premises FRANCE Implementation of the computing processing for projects. GERMANY - HUNGARY In most cases notifier’s practice is lacking in the compilation of the notification dossiers, there are lots of consultations necessary between the notifiers and the Competent Authority regarding the required documentation prior to submission or after the notification in the form of asking for further information IRELAND The deregulation of Class 1 GMMs. Class 1 GMM contained use activities are deemed to present negligible or no risk (article 4, Directive 2009/41/EC on the contained use of GMMs). Class 1 GMMs are usually crippled strains with a long history of safe use. Annex II Parts B and C of Directive 2009/41/EC provide for the exclusion of GMMs from the scope of the Directive. However, the requirements under Part B are very onerous given the ‘not harmful’ status of Class 1 GMMs. Under Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work, it is not required that Hazard Group 1 Biological Agents (defined as unlikely to cause human disease) be notified to the Competent Authority rather it is simply required that the principles of Good Occupational Safety and Hygiene be observed.

Class 1 GMMs should be similarly dealt with. ITALY None. LATVIA Latvia has a low activity in this field and therefore we do not have any difficulties at this moment. LITHUANIA There were no particular difficulties during the reporting period. MALTA No. NETHERLANDS No. POLAND -

PORTUGAL No particular difficulties were found. ROMANIA Not applicable. SLOVAKIA During this period we didn’t experience any difficulties in the notification process. SLOVENIA The notification process in Slovenia is well established; however slight delays are caused in the notifications in which the external experts (Scientific Committee) or another CA (Veterinary authority) are involved. SPAIN Difficulties relating to: - Interpretation whether the GMO obtained by new genetic techniques is under the scope of the Directive 2009/41/EC or not. SWEDEN We have not encountered any specific problems with the notification process. The Provisions were changed 2011 and the notification process was enhanced by much more detailed instructions of what information the Competent Authority needs. The notification forms were also updated and tested by some users before launched to public access. See point 2.3.

UNITED KINGDOM a)The notification requirements under the GMO(CU) Regulations (the regulations which implement Directive 2009/41/EC) are well-understood by users and there is believed to be a high level of compliance with these requirements in the UK. The only area that has presented difficulties for users is in deciding when it is appropriate to notify the competent authorities when the contained use changes significantly. b)This has been addressed by working with users (Institute for Safety in Technology and Research) to provide guidance on deciding when changes to the contained use require notification. The guidance is available on-line: ( http://www.istr.org.uk/docs/ISTR%20BSG%20Significant%20Change%20guidance%20v1.pdf ). c)Subject to comments in sections 4.1 and 4.2, the notification of contained use of GMM in the UK is working well.

2 Notification and approval systems (and relevant changes) 2.1 Who is the Competent Authority (CA) for Directive 2009/41/EC on the contained use of GMMs in your Member State? (Please expand where other authorities or ministries are involved or where authorities are established at national/regional level) AUSTRIA The Ministry of Science, Research and Economy is CA for contained uses in Universities and scientific institutions in its purview; the Ministry of Health is CA for all other contained uses. BELGIUM The regulatory framework concerning the contained use of GMMs is implemented and enforced in Belgium at the regional level. Three different regional decrees exist that have first fully implemented the Directive 90/219/EEC (extending the scope to GMOs and pathogens) and then transposed new provisions of Directive 98/81/EC. Directive 2009/41/EC is a recast of the European legislation on contained use and does not suppose the transposition of new provisions in the Belgian regional decrees. A Cooperation agreement concerning biosafety was set up to ensure that the transposition and practical implementation of the Directive 90/219/EEC are done in a harmonised way between the three Regions at the administrative and scientific level. This agreement is still in application for the recast Directive 2009/41/EC.

The competent authorities in charge of the regional decree on contained use of GMMs (and pathogens) application are: For the Brussels-Capital Region: Institut Bruxellois pour la Gestion de l’Environnement (IBGE) / Brussels Instituut voor Milieubeheer (BIM), Authorisation Service For the Walloon Region: Service Public de Wallonie, Direction Générale Opérationnelle 3"Agriculture, Ressources naturelles et de l'Environnement (DGARNE), Department of Permits and Authorisations – External directions. For the Flemish Region: Vlaamse Minister van Leefmilieu, Departement Leefmilieu, Natuur en Energie (LNE), Environmental permit service. At the federal level, the competent authority in charge of emergency planning for the contained use of GMMs is the Federal Public Service Home Affairs. BULGARIA Ministry of Environment and Water is the Competent Authority for Directive 2009/41/EC on the contained use of GMMs and on contained use of other GMOs. Control activities are performed by the regional inspectorates of the ministry and laboratory analysis by Environmental Executive Agency. CROATIA Competent Authorities for the purposes and official control in this Directive 2009/41/EC on the contained use of GMMs are: a)Ministry of science, education and sport. It is responsible for administrative procedure of contained uses. b)Ministry of Health as coordinative body in field of GMOs in Croatia, at same time, it is responsible for conducting official control on the contained use of GMM. Ministry of Health ensures that users of contained use of GMM comply with this Directive. Croatian Committee for contained use of GMO helps to competent authorities in procedure of assessing class of risk on activity in which microorganisms are genetically modified or, in which such as GMMs cultured, stored. Croatian Committee for contained use is independent scientific body made of 11 scientists’ different knowledge and experience of GMO and GMMs. Croatian committee is giving opinion on application on contained use of GMM and reviewing risk assessment. CYPRUS The Competent Authority for Directive 2009/41/EC on the contained use of GMMs in Cyprus is the Minister of Labour, Welfare and Social Insurance through the Department of Labour Inspection. CZECH REPUBLIC

The Ministry of the Environment is the CA for contained use of all GMOs in the Czech Republic. The Ministry of the Environment cooperates closely with the Ministry of Health and Ministry of Agriculture regarding the health and agricultural aspects of the use of GMOs. DENMARK The WEA is CA for the contained use of GMM’s. For notifications with plants and animals the EPA is involved too. This also applies for productions. ESTONIA Competent authority is The Labour Inspectorate of Estonia. Labour Inspectorate has to ask opinion from Committee of Gene Technology of Estonia. This Committee makes their sessions 4 times in the year. This Committee works under Ministry of the Environment of Estonia. FINLAND For notifications and approval the CA is the Board for Gene Technology. The supervisory authority responsible for the inspections is the National Supervisory Authority for Welfare and Health, Finland (Valvira). FRANCE Ministère de l’Education Nationale, de l’Enseignement Supérieur et de la Recherche. Direction Générale de la Recherche et de l’Innovation. GERMANY The CAs for Directive 2009/41/EG in Germany are the Federal state (Bundesländer) authorities. HUNGARY In Hungary, there are two Competent Authorities established at national level, depending on the main goal of the application: one is the Ministry of Agriculture in case of agricultural/commercial notifications, the second is the National Institute for Quality and Organizational Development in HealthCare and Medicine in case of clinical trial notifications. As part of the authorisation procedure, the Genetic Engineering Advisory Board is consulted. The Board is a scientific advisory body composed of 19 representatives delegated by the Hungarian Academy of Sciences, the relevant government ministries and civil society organisations in the field of environmental protection, health, biotechnology and consumer protection.

IRELAND The Environmental Protection Agency has responsibility for the implementation of the legislation. The Department of the Environment, Community and Local Government (DECLG) has responsibility for policy. ITALY According to the Italian Legislative Decree 206/2001, CA is the Ministry of Health, which authorises GMM installations and activities “in accordance with the conclusions of the Inter-ministerial Commission for the GMM Evaluations (further on CIV)”. LATVIA During the reporting period 6 June 2009 and 5 June 2014 the Competent Authority (CA) for Directive 2009/41/EC on the contained use of GMMs in Latvia was the Food and Veterinary Service of Republic of Latvia. In order to achieve the scientific integrity and independence, the Scientific Expert Committee was established. The role of the Scientific Expert Committee is to provide the CA with the scientific advice. Further CA for Directive 2009/41/EC on the contained use of GMMs in Latvia will be State Scientific Institute “Institute of Food Safety, Animal Health and Environment “BIOR”. The State Labour Inspectorate, in conformity with the regulatory enactments regarding labour protection when coming into contact with biological substances, shall ensure the supervision and control of such safety and labour protection measures which are related to the contained use of genetically modified micro-organisms. LITHUANIA There were no relevant changes since the last report in 2009. According to the Law on Genetically Modified Organisms the Ministry of Environment is a Competent Authority for Directive 2009/41/EC on the contained use of GMMs. The GMO Experts Committee was established by the Order on Genetically Modified Organisms Experts Committee and consists of 9 scientists with different scientific background. They analyze the report of risk assessment prepared by the notifier and makes scientific proposals and conclusions to the Competent Authority. The GMO Steering Committee was established by the Order on Genetically Modified Organisms Steering Committee and is a political advisory body for the development and enforcement of national regulatory system with respect to biosafety issues including contained use of GMMs and GMOs. This Committee consists of 21 members appointed by relevant state authorities (e.g. The Ministry of Health, The Ministry of Agriculture, State Food and Veterinary Service), the subordinated organizations, national biotech industry, non-governmental organizations and scientific institutions. The State Environment Protection Service is responsible for inspection of contained use of GMMs and GMOs. Notification and approval systems are determined in the Order on Regulation on Contained Use of Genetically Modified Micro-organisms and the Order on Criteria for Genetically Modified Micro-organisms Classification in conformity to Directive 2009/41/EC. MALTA The Malta Environment and Planning Authority

NETHERLANDS - POLAND The regulatory framework concerning the contained use of GMMs is implemented and enforced in Poland at the national level. The Ministry of the Environment is the competent authority in Poland. After receipt and verification of the notification, the Ministry forwards the notification to the National Commission on GMOs (advisory body) for assessment by reviewers. The consent for contained use of GMOs shall be issued within three months of receipt of the notification. PORTUGAL The Competent Authority for Directive 2009/41/EC is the Portuguese Environment Agency, just as it was for Directive 98/81/EC. We belong to the Ministry of Environment, Spatial Planning and Energy. In the present national legislation - Decree Law n.2/2001, the final approval of a notification is granted by the Portuguese Environment Agency, after receiving a favourable opinion approval from the Directorate General of Health. ROMANIA The Romanian legislation provides for a procedure at the national level for notification and authorization in accordance with the provisions of this Directive, established through the Emergency Government Ordinance No 44/2007 on the contained use of genetically modified microorganisms (GMMs) as amended by Law No 3/2008. Under these legal acts, the institutional framework for the implementation of the GMMs contained use legislation is ensured by the National Environmental Protection Agency, as competent authority, and the following authorities with responsibilities in the field of GMMs: - The central public authority for education and research, which assesses and analyses the notification dossier of contained use activities in research and development domain and issues a notice; - The central public health authority, which assess and analyses the notification dossier of GMMs that may have adverse effects on human health, issues a notice, develops and implements plans for inspection and control; - The central public authority for labour, family, social protection and elderly, which assess and analyses all the notification dossiers with GMMs activities, issues a notice, develops and implements plans for inspection and control; - The central public authority for agriculture, which evaluates and analyses notification dossiers of contained use activities in the agriculture, forestry, live-stock domain and issues a notice;

- The Biosafety Commission - interdisciplinary scientific body, with an advisory role in the decisions making process by NEPA, independent in carrying out its scientific activity, which issues a scientific notice; - The National Sanitary Veterinary and Food Safety Authority, which ensures the inspection and control of the facilities where contained use activities with GMMs are developed; - National Environmental Guard, as the control body, subordinated to the central public authority for the environmental protection, ensures the inspection and the control of the contained use GMMs activities National Environmental Protection Agency, as the competent authority, after the acceptance of the notification and subsequent to the achievement of the public information and public consultation procedure, based on the notices issued by the responsible authorities and by the Biosafety Commission, issues the authorization on the GMMs contained use activities. SLOVAKIA For the contained use of GMOs in our Member State, there are involved only two national authorities. The Ministry of the Environment of the Slovak Republic as the competent authority (policy making, policy implementation, national and international coordination) and the Slovak Environmental Inspection as the inspection organ (enforcement and control). SLOVENIA Ministry of the Environment and Spatial Planning of Slovenia (MESP), Dunajska 47, 1000 Ljubljana Slovenia, is a competent authority to decide upon registration of the premises for contained use of GMOs and upon approvals for the work with GMOs in containment. Registration of the installations for GM animals requires a consensus of the Veterinary authority which operates under the Ministry of agriculture and forestry. SPAIN In Spain, Directive 2009/41/EC has been transposed in the domestic legislation through the Law 9/2003 and Royal Degree 178/2004 and the subsequent modifications. For the implementation in our country of this legislation there are two different CAs: 1) At national level, the Inter-ministerial Council for GMOs (CIOMG) and the National Commission on Biosafety (CNB) at the Ministry of Agriculture, Food and Environment (Madrid, Spain). They are CAs for the activities of contained use carried out by Government Public Research Institutes or for activities with GMOs focused on medical purposes (clinical trials, human and animal medicines/vaccines, etc.). The first one (CIOMG) is the CA for grating permits at national level and the CNB is the scientific body dealing with the risk assessment of activities and installations, which report to the CIOMG and also to the CAs of the Spanish regions. 2) At regional level, the Autonomous Communities (Spanish regions) are the CAs for granting permits for most of the activities carried out with GMOs (except in the cases mentioned above). SWEDEN Swedish Work Environment Authority is the CA for contained use of GMM. Other authorities are responsible for contained use of plants and animals which are not regulated by the Directive 2009/41/EC. Se point 2.2.

UNITED KINGDOM a)In England and Wales, the Health and Safety Executive (HSE) and the Secretary of State for the Department for Environment, Food and Rural Affairs (DEFRA) form the Competent Authority. The functions are delegated to HSE and DEFRA officials. b)In Scotland, the Competent Authority comprises Scottish Ministers and HSE and similarly these functions are delegated to HSE and Scottish Government officials. c)In Northern Ireland, the Competent Authority is the Health and Safety Executive for Northern Ireland (HSENI) and the Department of the Environment, acting jointly. HSENI officials are provided with technical support from HSE, under an Agency Agreement.

2.2 Has the scope of the transposing legislation been extended to the contained use of GM plants and GM animals in your Member State? AUSTRIA Yes GMOs No. of notifications GM animals 797 GM plants 15 Amendments to earlier notifications - Total 812 Note ad 2.2 Austrian legislation requires notification of all (i.e. first and subsequent class 1) uses of GM vertebrate animals. Since Jan. 1, 2013 (transposition date of Directive 2010/63/EC) all uses including breeding of GM animal species protected under that Directive require specific authorizations.

BELGIUM Yes GMOs No. of notifications GM animals 170 GM plants 51 Amendments to earlier notifications 183 Total 221 BULGARIA Yes, Bulgarian legislation classifies GM plants and animals either as class A – no or negligible risk for the human or animal health and for the environment and class B – all other cases. GMOs No. of notifications GM animals 0 GM plants 2, both Class A Amendments to earlier notifications 2 Total 2 CROATIA Yes GMOs No. of notifications GM animals 2 GM plants 2 Amendments to earlier notifications Total 4 CYPRUS No There was no need because there were no activities and/or installations involving GMOs. GMOs No. of notifications GM animals 0 GM plants 0 Amendments to earlier notifications 0 Total 0

CZECH REPUBLIC Yes GMOs No. of notifications GM animals 4 GM plants 3 Amendments to earlier notifications 38 (mostly lab. mice) Total 45 DENMARK Yes GMOs No. of notifications GM animals 26 GM plants 4 Amendments to earlier notifications Total 30 ESTONIA Yes: For GM animals No: For GM plant GMOs No. of notifications GM animals GM plants Amendments to earlier notifications Total Labour Inspectorate doesn’t gather these data. FINLAND Yes GMOs No. of notifications GM animals 17 GM plants 14 Amendments to earlier notifications what does this question specifically mean? Total 31 FRANCE

Yes GMOs No. of notifications GM animals GM plants Amendments to earlier notifications Total GERMANY Yes GMOs No. of notifications GM animals 54 GM plants 30 Amendments to earlier notifications Total 84 HUNGARY Yes GMOs No. of notifications GM animals 2 GM plants none Amendments to earlier notifications Total 2 IRELAND Yes GMOs No. of notifications GM animals 61 GM plants 6 Amendments to earlier notifications Total 67 ITALY Yes According to 2001/18/EC directive, the contained use of GMOs (e.g. for testing/research purposes) should be carried out by implementing containment measures based on the same principles as laid down in 90/219/EEC: it is not expected any notification to CAs. Contained uses of GMOs are non-regulated activities, both to at EC and national levels.

GMOs No. of notifications GM animals N.A. GM plants N.A. Amendments to earlier notifications N.A. Total N.A. LATVIA Yes GMOs No. of notifications GM animals GM plants Amendments to earlier notifications Total LITHUANIA Yes GMOs No. of notifications GM animals GM plants Amendments to earlier notifications Total MALTA Yes GMOs No. of notifications GM animals 0 GM plants 0 Amendments to earlier notifications 0 Total 0 NETHERLANDS Yes See remark under 1.1 GMOs No. of notifications GM animals GM plants Amendments to earlier notifications Total

POLAND - GMOs No. of notifications GM animals GM plants Amendments to earlier notifications Total PORTUGAL Yes GMOs No. of notifications GM animals - GM plants - Amendments to earlier notifications - Total - ROMANIA No Not for the time being. Romania limited the scope of the transposition legal act to the scope of the Directive on the contained use of GMMs. GMOs No. of notifications GM animals 0 GM plants 0 Amendments to earlier notifications 0 Total 0 SLOVAKIA Yes GMOs No. of notifications GM animals 3 GM plants 4 Amendments to earlier notifications 0 Total 7

SLOVENIA Yes. The biosafety framework in Slovenia is covered by horizontal legislation based on Management of Genetically Modified Organisms (MGMO) Act (OJ RS 23/2005 and amended OJ RS 21/2010). The Act implements the provisions of the Directive 2009/41/EC and beside GMMs regulates also GM plants and animals. GMOs No. of notifications GM animals 3 GM plants Amendments to earlier notifications Total 3 SPAIN Yes. GMOs No. of notifications GM animals 35 GM plants 28 Amendments to earlier notifications Total 63 SWEDEN Yes. GMOs No. of notifications GM animals Swedish Board of Agriculture: all other GM animals except water living organisms Swedish Agency for Marine and Water Management: GM water living organisms Swedish Board of Agriculture: 59 permits (for premises) during the period June 2009-June 2014 of which 43 were valid in June 2014. Swedish Agency for Marine and Water Management: 5 permits (for premises) and 3 notifications (for GMO) during the period June 2009-June 2014 GM plants Swedish Board of Agriculture Swedish Board of Agriculture: About 30 premises have a permit for contained use of GM plants. The permits are valid for five years and the number of premises has been steady for the last ten years. New activities and plant species are to be notified to the CA. An estimate of notified operations with plants since 2009 is about 10 per year. Amendments to earlier notifications Total 78 permits and 3 notifications UNITED KINGDOM a) Yes. The legislation has been extended to require notification, risk assessment and application of control measures for contained use of GM plants or GM animals (referred to as larger GMOs in the UK legislation) that present a risk to human health greater than the unmodified parental organism. Such work is rare, and there has only been one such contained use notified in the reporting period.

GMOs No. of notifications GM animals 0 GM plants 1 Amendments to earlier notifications 0 Total 1 b) There is also complementary domestic legislation (Environmental Protection Act 1990, associated regulations and the Genetically Modified Organisms (Northern Ireland) Order 1991) that requires risk assessment and application of containment for the contained use of larger GMOs to ensure protection of the environment. HSE inspects premises working with larger GMOs on behalf of DEFRA, Scottish and Welsh Governments under separate Agency Agreements.

2.3 What % of notifications was not processed within the statutory timeframe? AUSTRIA 0 BELGIUM In Belgium, the procedure for the notification of contained use of GMOs and/or pathogens is a part of the general procedure for application of an environmental permit. Furthermore, the Brussels-Capital Region and the Flemish Region define two timeframes, one for the technical expert (the SBB) to write an advice, and one for the competent authority to deliver the authorisation. The timeframe for the Brussels and Flemish competent authorities to deliver the authorisation is linked to the timeframe for delivering the environmental permit, which is longer than the contained use authorisation timeframe. The competent authorities can only respect the timeframe to deliver the authorisation if the user has already obtained an environmental permit. An authorisation can only be delivered when the environmental permit has been obtained. For a small percentage of the dossiers, the delivery of the advice by the SBB to the competent authority was postponed, often due to a ‘stop the clock’ (awaiting further information from the user, visit of the facility…). In the Walloon region, the user submits a biosafety dossier to the technical expert (the SBB) before any application for an environmental permit. Hence the timeframe starts only when the user submits his application for an environmental permit to the competent authority, to which the advice of the technical expert is joined. During this 5-year reporting period, all applications for contained use of GMOs and/or pathogens were processed within the statutory timeframe of the environmental permit. BULGARIA All notifications were processed within the statutory timeframe.

CROATIA None. CYPRUS 0 CZECH REPUBLIC None. For notifications of Classes 1 and 2 contained use there are no authorisation procedures with set time limits for the CA. DENMARK 0 % ESTONIA 0 % FINLAND 0 FRANCE

About 10% GERMANY No information available. HUNGARY In case of 3 notifications, approximately in 10% of all cases. IRELAND 0 % ITALY It’s hard to estimate such a percentage for the whole reporting period. In fact, a time-monitoring system has been implemented only in April 2013; since then, we have calculated an average percentage of about 15%. However, in the first half of 2014, the figure has been significantly lower (less than 5%). LATVIA 0 LITHUANIA -

MALTA N/A NETHERLANDS 38% POLAND For 10% of the notification was postponed, often due to a “stop the clock” procedure (awaiting further information from the notifier, etc.). PORTUGAL 0 ROMANIA - SLOVAKIA - SLOVENIA 30% of the notifications were not processed in the given timeframe. However, most of the delays were short and in all cases notifiers were approached with the ample explanation. We did not receive any complaint about it.

SPAIN Generally statutory timeframe is fulfilled, although in the most of the cases the clock is stopped when additional information is required. SWEDEN We have not recorded this but it is not a significantly large percentage. UNITED KINGDOM 3.7%.

2.4 What gave rise to such delays in the notification process and what efforts are being made to lessen or prevent such delays in the future? AUSTRIA - BELGIUM The reason for delay in delivering the advice, if any, was often the lack of pertinent information needed to perform a correct analysis of the contained use activity, requiring further information from the user. Hence the timeframe is generally longer that the legal one because of a “stop the clock” while the competent authority is waiting for some information. To extend the timeframe, the Brussels competent authority implements most of the time a first use procedure when the subsequent notification is introduced after expiry of the first use authorisation. BULGARIA

Not applicable, see answer to question 2.3. CROATIA Not applicable. CYPRUS Not applicable. CZECH REPUBLIC see 2.3 However, the CA often asks the notifiers for clarification of some data in the submitted notifications and/or for additional information. To prevent these delays, the Czech CA provides guidelines and there is a possibility of consultations with the notifiers in advance. DENMARK Not applicable. ESTONIA No answer. FINLAND Not applicable.

FRANCE No modification in the future. GERMANY - HUNGARY The following efforts have been made to prevent the delays: consultation between notifiers and the Competent Authority prior to submission or asking for further information after the submission. Furthermore, there have been some changes in the internal structure of the Ministry of Agriculture. This was the reason that in one case, the notification has been released after the authority’s deadline. Since this case, there has not been any delay in the authority’s work. IRELAND Not applicable. ITALY Dead time between CIV’s meetings. Meeting frequency has been increased (now every three weeks); however, in urgent cases, CIV may be convened at any time. Moreover, we are studying an ICT solution which should allow to speed up the authorization process. LATVIA Latvia has a low activity in this field.

LITHUANIA - MALTA N/A NETHERLANDS In the Netherlands all activities with GMO's and GMM's need a license, resulting in lots of work for the competent authority. In combination with related work, like development of new licensing software, discussions about new legislation and a shortage of personnel it was not possible to process al the licenses within the applicable timeframe of 45 days. The mentioned new legislation will, among others, change the license for class I and mostly class II into a notification scheme, thus lessening the effort needed. It is planned to put this new legislation into force before the end of 2014. POLAND The duration of the procedure depends on the Commission on GMOs and the reviewers, whose opinion is necessary to grant consents for contained use of GMOs in Poland. PORTUGAL - ROMANIA - SLOVAKIA -

SLOVENIA Most of the delays are short and are mainly caused due to a very short period (30 days only) for The Scientific Committee to evaluate and give an opinion on the risk assessment of the notifications. Slightly longer delays are caused by the Veterinary authority which operates under the Ministry of agriculture and forestry. MESP put a lot of effort to explain the situation to the Veterinary authority in order to acquire their consent sooner. SPAIN There are delays in the statutory timeframe by several reasons: 1)The administrative process is quite long taking into account the previous assessment by the National Commission on Biosafety, visits and control at the facilities and the different procedures, opinions or permits granted by the CIOMG and the different CAs (CIOMG or regions). 2)Request for additional information to the notifiers. 3)Timeframes between meetings of the National Commission on Biosafety (usually it held one a month) 4)Previous inspections to the facilities before granting permits. SWEDEN In the beginning of the time period the notification procedure was somewhat more time consuming. We got more incomplete notifications than now. With our new provisions which came into force from New Year 2012, the notification procedure has been simplified. We have developed new forms for notification of class 1 and class 2 which can be downloaded and sent electronically to us. The notifications have become significantly better with the new forms, which simplifies our work. UNITED KINGDOM a)Requirement for further information from the user in order to assess the adequacy of the risk assessment (this involved 3 rounds of exchange of information); 2) Timescales for assessment of notifications were not met; and 3) Delay in issuing of the clearance letters to be sent to the notifiers. The performance of the notification process is monitored and improvements in procedures identified and remedied. The performance (which was of a high standard) has improved with all deadlines being met.

3. Inspection and enforcement issues

3.1 Outline the procedure undertaken for the inspection of contained use installations/activities during the reporting period providing details of the number and the overall percentage of installations/activities inspected. Please mention the number of specialised inspectors available for inspections under Directive 2009/41/EC. AUSTRIA Inspections were based on the characteristics of the activity, e.g. risk class, large scale equipment, inoculation of animals, etc.. In the reporting period 147 inspections were undertaken in 61 installations, i.e. about 18 % of installations. The total number of inspectors available is 10. BELGIUM Procedure Inspections were organised in the three regions by different inspectorates on a regular basis and concerned contained uses with GMOs as well as pathogens. In the Flemish Region inspections were done by 2 inspection bodies, the Flemish Agency for Care and Health of the Flemish Community and the Environmental Inspection Department of the Flemish Competent Authority, respectively concerning Public Health and Environment. Failures or non-respect by the user of the applicable conditions delivered in the environmental permit may give rise to a criminal penalty or an administrative fine. In case that the offense is likely to cause a substantial and immediate harm to public health and the environment, the license may be suspended or revoked by the competent authority. Number and the overall percentage of inspected installations During the period from 6 June 2009 until 5 June 2014, the Flemish Environmental Inspectorate Division carried out 161 inspections controlling contained use at 131 different installations. From these 131 installations, 67 were required to have an authorisation and 64 were not. This means that less than 30% of the installations having an authorisation were controlled. Over the last 5 years an average of 0,42 full time equivalents a year was spent on Directive 2009/41/EC inspections including preparation of the inspection, the inspection itself and the administrative consequences of the inspection (writing exhortations and official reports of infringement). In the Brussels-Capital Region, 25% of the installations were controlled. For the Walloon Region, we do not have detailed information but it is estimated that 3% of the installations were controlled. In summary, 177 inspections were carried out by the Environmental Inspection Departments in the three regions (161 inspections in the Flemish Region, 14 inspections in the Brussels-Capital Region and 2 inspections in the Walloon Region).

Number of inspectors In the Flemish Region, the Environmental Inspectorate has 6 specialised inspectors involved in controlling contained use activities. In the Brussels-Capital Region, 5 inspectors received training in biosafety and are performing controls on the contained use activities. In the Walloon region, no specialized inspectors are appointed for biosafety. These inspectors are not spending their full time on controlling contained use of GMO’s and pathogens. As inspectors fulfil several tasks covering multiple matters concerning the environment or public health, only a certain percentage of their time can be dedicated to inspection of contained use activities. BULGARIA Inspections are performed by the regional inspectorates of Ministry of Environment and Water. Representatives of Environmental Executive Agency and the Ministry are also present. Facilities to be inspected and the schedule of inspections are approved yearly by the Minister of the Environment and Water based on the list of actual or potential operators that might work with GMOs. Additionally, unscheduled inspections may take place when unauthorised use of GMO is suspected. After receiving notification for initial approval of facilities for contained use of GMO, inspections are performed to verify conformity with the requirements for safe work at given containment class. Approved facilities are inspected at least once every two years. Samples can be taken during the inspection if necessary and analysed for presence of GMOs. The number of inspections during five year period is as follows: 2011 - 23 inspections; 2012 – 14 inspections; 2013 – 18 inspections; 2014 –14 scheduled inspections, ongoing. Currently in each of the sixteen regional inspectorates there is at least one person appointed to undertake inspections for contained use and release into the environment of GMOs. In addition, there is an analytical laboratory (two people) in the Environmental Executive Agency that performs the necessary analytical work and whose staff participates in inspections and collection of samples. CROATIA Periodically sites visiting. In Croatia there are two specialised inspectors of Ministry of Health available for inspection under Directive 2009/41/EC. CYPRUS The Department of Labour Inspection during the reporting period has carried out inspections in the premises of the installation approved for the use of GMMs and in various premises in order to verify whether GMMs are used. About 20 Labour Inspectors were partially involved under the instructions of a specialised Labour Inspection Officer. CZECH REPUBLIC The Authority responsible for the state supervision of the use of GMOs is the Czech Environmental Inspectorate (hereinafter “CEI”). It co-operates with other state supervision bodies in fulfilling this task. CEI undertakes inspections of subjects authorised for contained use of GMOs, in accordance with the yearly schedule based on: -information from the Ministry of Environment on notifications and authorisations;

-results and findings of the previous inspections; -information from other sources and ad hoc initiatives; The inspections are targeted on compliance with requirements for the contained space, documentation, waste treatment, transport of GMOs, equipment of the premises, training of the personnel etc. Totally 141 inspections were carried out in contained use premises within the reported period. All authorised facilities were checked, some of them repeatedly. CEI consists of the Headquarters and 10 Regional Inspectorates. At each of them, one inspector has been trained for GMOs supervision, although it represents only part of their agenda, depending on the number of GMO facilities in the region (there are no GMO premises in 3 regions, nevertheless the inspectors have been trained there as well). That means 10 regional inspectors and 1 person at the Headquarters deal part-time with inspections under the Directive. An inspection is always carried out by 2 inspectors (either 2 regional inspectors or 1 regional plus 1 from the Headquarters). DENMARK When a location is notified the first time it is always visited to be approved. This also applies when changes are made to an already classified location. There are 5 inspectors in Denmark who spend part of their working hours with inspection. This procedure is about to change. In the future we are planning to allow class 1 GMO work to start based on the notification. There does not have to be a visit to the locations before they can start. Instead there will be inspections afterwards at selected locations. ESTONIA There is one inspector for such inspections, but during reporting period there is no inspections made. FINLAND An inspector from the National Supervisory Authority for Welfare and Health, Finland (Valvira) contacts the operator before the inspection and prepares an inspection report after the visit. From 2007 it has also been possible to use a written inspection procedure for the inspection of earlier inspected activities and premises, if certain conditions are met. The operators which commence the class 2 or 3 use of GMOs for the first time or start use of higher class are inspected within a year after the CA has handled the notification or the application. The inspection interval is risk based, so that class 3 use is inspected more often (at least every second year) than class 1 or 2 use. During the reporting period 135 inspections were performed (33 % of all valid notifications). With the exception of a ten month period when only one inspector was available, two full-time inspectors worked in control of GMO use.

FRANCE 25 visits/controls, 0, 7 %. 2 inspectors. GERMANY In Germany, the Federal state authorities are responsible for monitoring installations and work involving genetic engineering and for implementing the resultant enforcement measures. Inspections are conducted when there is a need for them and also on a routine basis when there is no specific need for them. Inspections conducted when there is a need for them to take place, for example, in the following cases: - New installations (mainly before they are put into service), - Significant alterations to installations, - Requests or incidents. The routine inspections are conducted at fixed intervals which are shorter the higher the safety level involved and also, in some cases, the more intensively the installation is used. The intervals may also be adjusted to take into account unusual circumstances and the lessons learned from previous inspections. Routine inspections are conducted at approximately the following intervals: - S1 installations: every three to six years, - S2 installations: every two to three years, - S3 and S4 installations: annually.

During the reporting period almost all installations used for genetic engineering underwent at least one on-site inspection. The number of inspectors varies depending on the size of the Federal state, their respective responsibilities and the number of installations located in the Federal states which are used for genetic engineering. See also the extended scope of German legislation on genetic engineering: it covers not only installations where work involving GM micro-organisms is carried out but also installations in which work is carried out involving (exclusively) GM plants or GM animals. HUNGARY Laboratories complying with Class 1 and Class 2 containment level specifications also conform to the requirements of the quality assurance systems of Good Laboratory Practices (GLP). The GLP requirements themselves are stricter than what is needed to execute for Class 1 and Class 2 containment measures for GMOs. The audits are conducted once a year and the compliance with GLP is checked every two years. Every contained use has been verified in these schemes. Each contained use has been verified by 4 inspectors (on average). IRELAND As per our suggestion in our submission on report 2006 – 2009, we continue to believe that the wording in the Directive could be more explicit requiring the establishment of biological safety committees as well as the appointment of a biological safety officer particularly where large multi user centres are involved. Each year a draft site inspection plan for GMO/GMM contained use activities is drawn up. During the site inspection we consult with a competent person on site (usually the biological safety officer). We use a checklist originally adopted by the European Enforcement Project (EEP). We do not charge for site inspections. The level of compliance within GMO/GMM contained use facilities is high. Class 2 GMM, Class 3 GMM, GM Animal / Plant activities are inspected once every 3 years. Class 1 GMM contained use activities are inspected once every 6 years (given their history of safe use and negligible risk). The inspection of Class 1 GMM contained use activities on a less regular basis was deemed necessary give the small team of 2 persons with responsibility for both licensing and enforcement and both contained use and deliberate release. Enforcement activities carried out during reporting period: Year From 6th June 2009 2010 2011 2012 2013 Until 5th June 2014 Number of installations inspected 9 17 16 8 16 4 % of installations inspected 17 33 31 14.5 29 73.

ITALY According to the Italian Legislative Decree 206/2001, the inspection functions are exercised by officers identified by CIV (art. 17); moreover, if needed, CIV can request the inspection of a GMM installation/activity (art. 18). No inspections have been requested by CIV during the reporting period. LATVIA As there is only class 1 the State Labour Inspectorate is not involved. LITHUANIA There were no relevant changes with regard to control procedure requirements since the last report in 2009. In the period 2009 – 2014 about 15 inspections were conducted by one specialised inspector. MALTA One inspection of the class one facility was conducted by the permitting officer prior to the permit being issued to check for compliance with the legislation for class 1 installations. There are no specialised inspectors on GMMs; one should note that Malta only had one application to date. NETHERLANDS Annually 50-60 contained use facilities have been inspected by ILT, which is about 20-25% per year. The task is carried out by 4 different inspectors, total about 2 FTE. ILT has the aim to contact each user at least every four year. Based on risk and compliance and complexity of work this frequency may increase. Prime concern is that the mandatory Biological Safety Officer (BSO) performs the annual audits. So the inspection for a great part focuses on the administrative obligations. The inspection always includes a random reality check of compliance including among others. The GMOs handled, the way of working and containment integrity. This latter aspect is also inspected by the inspectors of local authorities. POLAND Three authorities carry out inspections of contained use installations: The State Labour Inspection is in charge of the safety and hygiene of work; they inspect the labelling of facilities, the safety measures and the equipment used. The State Sanitary Inspection controls biological factors, whereas the Environmental Protection Inspection is in charge of the control of wastes from contained use activities. These three authorities can carry out inspections on their own initiative or upon request by the Ministry of Environment. The State Labour Inspection has conducted 13 inspections.

PORTUGAL Until the present date, the Inspectorate-General for Agriculture, Fisheries, Environment and Spatial Planning (IGAMAOT) hasn’t carried out inspections of contained use installations/activities. ROMANIA National Environmental Guard (NEG) is the control and inspection body under the Ministry of Environment and Climate Change. Within the Biodiversity, Biosecurity and Protected Areas of NEG Control Directorate, there are inspectors with responsibility regarding control and inspection activities for the entire domain of activities in the directorate, not strictly specialized in accordance with Directive 2009/41/EC. They also have other inspection and control duties in accordance with Directive 2001/18/EC, as well as on biodiversity and natural protected areas. SLOVAKIA The authority responsible for the state supervision of the use of GMOs is the Slovak Inspectorate of Environment ( SIE). In total 9 inspectors have been trained on the supervision of GMOs, although inspections under Directive 2009/41/EC represent only a part of their agenda, depending on the number of GMO facilities in the region. SIE cooperates with other state supervision bodies in fulfilling this task. SIE regularly carries out inspections in accordance with a yearly schedule, based on the information provided by the own findings mainly previous inspection reports and scientific publications, information of the Ministry of the Environment and other authorities. Inspections are based by that date known information on the inspected facility involving maps of the facility, information about the used donor and recipient organisms, genes used for the genetic manipulation, plasmids as well as used techniques and risk assessment. Inspections are targeted on compliance with the requirements for the premises, waste treatment, transport of GMOs, record keeping, training of personnel, etc. The requirements for safe work with GMOs are also inspected although laboratory safety is not the main task of the inspections. The last day of the inspection there is a final meeting with the responsible persons, where the outcome and findings of the inspection is discussed in detail. It is common SIE practise that the responsible persons are informed about the outcome immediately and according to the Slovak law, a detailed protocol or report is written and sent to the head of the inspected facility. Detailed procedure of the inspection, based on the Slovak law, was issued by the publishing house of the Slovak Academy of Sciences in 2008, ISBN 978-80-224-1048-9. During the reporting period through 141 inspections all the 467 registered installations were inspected, i.e. all the permitted activities were inspected (100%). In general, each permit holder is visited at least once every 3 years; but larger institutes are visited once or twice a year. Inspection visits were carried out also in the institutions for which permits for contained use of GMO were not issued SLOVENIA Installations and activities are inspected according to annual plan of inspections ensuring that each installation is inspected at least every four years, or more often depending on the outcome of the previous inspection. Newly registered installations are inspected as soon as possible. The inspections are undertaken according to the adopted procedure using checklists what ensures uniform proceeding at all installations. In the reporting period 47 inspections were performed. Slovenia has two specialised environmental inspectors for GMOs. Each inspector has been available for 5% of full working time for inspections of GMMs, GM plants and GM animals under Slovenian MGMO Act what ensures regular and thorough supervision.

SPAIN There is not an Official Body for inspection under Directive 2009/41/EC in Spain. Generally, the Spanish regions are the competent for the inspection actions. Nevertheless, after the application of the notification by the users and before giving the consent, specialised member(s) of the National Commission on Biosafety (CNB) accompanied by a representative of the competent region where the installation is placed, regularly carry out visits and controls on the premises. They check the records of activities and the major objective of control is to confirm the effectiveness of the respective containment level and to evaluate compliance with relevant approval conditions. 100% of installations are visited and controlled. There are 4 members from the Biotechnology Unit at the Ministry of the Agriculture, Food and Environment, as part of the National Commission on Biosafety (CNB), who participate at the visits and controls. SWEDEN In most cases we inspected activities as part of the process of accepting notifications for class 2 or give permits for class 3 work. The focus was on activities with the potential greatest risk. 17 installations/activities was inspected. The number of specialised inspectors is two who also have many other duties according to contained use of GMM as well as other, non-GMM related duties. UNITED KINGDOM a)In the UK, inspections are undertaken by HSE and HSENI. HSE carries out such inspections across Great Britain and applies the same inspection regime to all contained use work with high-hazard biological agents (including GMMs). Inspection is undertaken by HSE specialist microbiology inspectors. In Northern Ireland HSENI’s inspections (mostly class 1 and 2 GMM contained uses) are carried out by a non-specialist inspector, who calls on HSE for specialist support, when required. b)The inspection programme in Great Britain covers contained uses involving GMMs, larger GMOs, non-genetically-modified human pathogens (under domestic legislation implementing Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work) and non-genetically-modified specified animal pathogens (derived from domestic legislation and implementing Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease). c)The inspection programme is prioritised according to a hazard and risk system that focuses on activities in CL3 and CL4 laboratories. Contained uses involving GMMs are not targeted per se but captured as part of this programme.

d)Higher hazard laboratories receive more frequent inspections. CL4 laboratories are inspected at least once per year, most being visited multiple times per year. e)CL3 laboratories are inspected based on a prioritisation scheme that considers the inherent hazard of the work, the safety performance of the user and time elapsed since last inspection. Those laboratories undertaking class 3 contained uses are generally inspected every 2-5 years. f)Premises only working with class 1 and 2 GMMs are not inspected as part of a proactive inspection programme. However, many of the premises will be visited as part of other inspection or engagement visits. For example, HSE’s Regulatory Compliance Officer (RCO) may provide advice on compliance with the legislation either through site visits or presentations at industry led events. Similarly, the lower containment laboratories may be scrutinised as part of a CL3 inspection or a larger GMO inspection at that specific premises. Furthermore, an inspection may be instigated should issues be identified from a contained use or premises notification, where in the view of the inspector further enquiries are merited. g)Inspections are generally topic-based and cover containment and control, training and competence, audit and inspection and risk assessment. Preparation for an inspection will include a review of the notified GM contained uses at the site. The topic of risk assessment evaluates the correctness of final classification and considers compliance with the GMO (CU) Regulations. h)As mentioned in para 2.2(b), HSE undertakes a programme of ~15 inspections of laboratories handling larger GMOs (e.g. animals, plants, insects) each year on behalf of DEFRA and the Devolved Administrations. This includes a review of the risk assessments and inspection of the premises used for the contained use work, to check the adequacy of the containment and control measures. i)HSE has a specific team (Biological Agents Unit – CEMHD8), which implements the inspection regime and reviews the adequacy of notifications of biological agents (including GMMs). Currently the Biological Agents Unit comprises of 7 Specialist Inspectors, 4 Principal Specialist Inspectors and 1 Regulatory Compliance Officer. In Northern Ireland there is one part time inspector. A joint inspection with a Specialist Inspector from HSE of all the notified centres is carried out. Inspections are also carried out by the local inspector to deal with specific topics during this period. j)Over the period of the report, there have been 645 inspections undertaken by HSE’s Biological Agents Unit, of which 342 were at sites where work with GMMs and larger GMOs (e.g. animals, plants, and insects) is undertaken. This represents in the region of ~40% of all the GM premises notified and includes 100% of the CL3 and CL4 notified premises.

3.2 What were the problems most frequently encountered during the course of inspections carried out during the reporting period? AUSTRIA -

BELGIUM The most frequent or severe problems encountered were related to: - Waste management : the inactivation method is non-adequately validated; - Authorisation : absence or non-compliance for the use of non GM-pathogens; - Risk signalisation: absence of biohazard signs; - Storage of contaminated laboratory equipment: lack of measures; - Accident prevention and emergency response plans; - Biosafety cabinets: certification of the HEPA filtered closed system; - Restricted access to the controlled area. The inspectors of the Brussels-Capital region pay particular attention on the waste management. The principal control matters are: sufficient evacuation frequency, on-site inactivation, availability of disinfectants, and waste disposal by a certified waste collector. BULGARIA Most academic institutions were not aware that facilities for contained use of GMO should be approved and registered even when they work only with model organisms routinely used in scientific research (e.g. laboratory strains of E.coli, Arabidopsis thaliana, etc.). CROATIA One technical issue (floor surface).

CYPRUS No problems have been encountered during the course of inspections. CZECH REPUBLIC Apart from one case of unauthorised GMM, most frequent deficiencies found by the Inspection were of an administrative character: missing updates or parts of the documentation etc. These imperfections did not mean any risk to the environment. DENMARK When examining the notifications for research projects the risk assessment is often not sufficient. During inspections some times the written material on working procedures does not always correspond to the way things are carried out in practise. Sometimes it also turns out that the company has forgotten to notify the research project and has just notified the location where the project is going to take place. Companies don’t always remember to give the information that a location is no longer being used for work with GMM’s. Examples of things th