FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: In Hungary, the notifications published on the internet contain a summary of the risk assessment available at the Secretariat of Gene Technology Advisory Board.
Slovenian: Na Madžarskem prijave, objavljene na internetu, vsebujejo povzetek ocene tveganja, ki je na voljo pri sekretariatu svetovalnega odbora za gensko tehnologijo.
English: The information contained in this report is based on Member States individual reports and, therefore, does not represent the position of the European Commission.
Slovenian: Informacije v tem poročilu temeljijo na posameznih poročilih držav članic in zato ne predstavljajo stališča Evropske komisije.
English: Belgium reported one accident (fire) in a biological waste storage room without the competent authority having been informed.
Slovenian: Belgija je poročala o eni nesreči (požaru) v skladišču za biološke odpadke, o kateri pristojni organ ni bil obveščen.
English: The present report covers the period from June 2009 to June 2014 following the previous report for the period 2006-2009.
Slovenian: To poročilo zajema obdobje od junija 2009 do junija 2014, predhodno poročilo pa je zajemalo obdobje 2006-2009.
English: Although there are significantly fewer class 3 and 4 activities being carried out, their number is increasing.
Slovenian: Čeprav se izvaja bistveno manj dejavnosti iz razredov 3 in 4, se njihovo število povečuje.
English: Activities were also carried out in hospitals, public institutions, education (universities) or in detection laboratories.
Slovenian: Dejavnosti so se izvajale tudi v bolnišnicah, javnih ustanovah, izobraževalnih ustanovah (na univerzah) ali laboratorijih za odkrivanje.
English: Similarly, Spain, Sweden, and the United Kingdom, would like to simplify the procedures for Class 1 and 2 activities.
Slovenian: Podobno Španija, Švedska in Združeno kraljestvo želijo, da se poenostavijo postopki za dejavnosti iz razredov 1 in 2.
English: Belgium had difficulties interpreting the provisions of the Directive 2009/41/EC concerning commercial activities involving bacterial transformation.
Slovenian: Belgija je imela težave z razlago določb Direktive 2009/41/ES glede komercialnih dejavnosti, ki vključujejo bakterijsko transformacijo.
English: The Netherlands reported a number of specific technical issues including differences in the (strict) GMO-regulations and the less strict regulation of wild type pathogens (Netherlands).
Slovenian: Nizozemska je v poročilu omenila več posebnih tehničnih vprašanj, vključno z razlikami med (strogimi) predpisi za GSO in manj strogimi predpisi za patogene divjega tipa (Nizozemska).
English: The number of inspectors involved in GMM control also varied among Member States.
Slovenian: Tudi število inšpektorjev, vključenih v nadzor GSM, se je razlikovalo med državami članicami.
English: In terms of public consultation and information, almost all reporting Member States have implemented provisions for conducting public consultations, and for informing the public on the outcome of their activities under the Directive.
Slovenian: Kar zadeva javno posvetovanje in obveščanje, so skoraj vse države članice, ki so predložile poročilo, izvajale določbe o opravljanju javnih posvetovanj in obveščanju javnosti o rezultatih svojih dejavnosti v skladu z Direktivo.
English: While the transformation kit is not sold in Belgium, its availability via the internet could potentially make the enforcement of the provisions of 2009/41/EC difficult.
Slovenian: Čeprav se komplet za transformacijo ne prodaja v Belgiji, bi bilo zaradi njegove razpoložljivosti prek interneta morda težko izvrševati določbe Direktive 2009/41/ES.
English: In Slovenia, delays occurred when the external experts (Scientific Committee) or another national body was involved in the processing of a notification.
Slovenian: V Sloveniji so nastale zamude, če so pri obdelavi prijave sodelovali zunanji strokovnjaki (znanstveni odbor) ali drug nacionalni organ.
English: Some Member States also employ advisory scientific bodies in the risk assessment/authorisation process.
Slovenian: V nekaterih državah članicah pri ocenjevanju tveganj/postopku odobritve sodelujejo tudi svetovalni znanstveni organi.
English: Although the internet was primarily used, other means of communication (seminars, meetings, brochures, etc.) were employed.
Slovenian: Čeprav so to večinoma izvajale prek interneta, so uporabile tudi druga komunikacijska sredstva (seminarje, sestanke, brošure itd.).
English: In the two Member States which received responses, the summaries of the comments were made available on the Competent Authorities' website.
Slovenian: V državah članicah, ki sta prejeli odzive, so bili povzetki pripomb objavljeni na spletnem mestu pristojnih organov.
English: Moreover, it is not always possible to distinguish the amendments to earlier notifications from other types of subsequent contained use activities (continuation of activity or new activity).
Slovenian: Poleg tega ni vedno mogoče razlikovati med spremembami prejšnjih prijav in drugimi vrstami dejavnosti nadaljnje uporabe v zaprtem sistemu (nadaljevanje dejavnosti ali nova dejavnost).
English: In Spain, the waste inactivation is optional for class 1 and obligatory for class 2, 3 and 4 but the Competent Authority recommends operators to inactivate the GMOs in all cases.
Slovenian: V Španiji je inaktivacija odpadkov neobvezna za razred 1 in obvezna za razrede 2, 3 in 4, vendar pristojni organ izvajalcem priporoča, naj GSO inaktivirajo v vseh primerih.
English: In the 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).
Slovenian: Regija prestolnice Bruselj je imela nekaj težav pri postopku prijave zaradi bruseljske zakonodaje, ki določa več različnih postopkov za en razred tveganja (skupno osem).
English: In another instance, a commercially available (via the internet) bacterial transformation kit was used to produce a Class 1 GMM.
Slovenian: V drugem primeru se je komercialno razpoložljiv (prek interneta) komplet za bakterijsko transformacijo uporabil za pridobivanje GSM iz razreda 1.
English: For Slovenia, the inclusion of safe organisms in Part C of the Annex II of Directive 2009/41/EC could contribute to the reduction of the number and size of notifications.
Slovenian: Slovenija meni, da bi lahko vključitev varnih organizmov v del C Priloge II k Direktivi 2009/41/ES prispevala k zmanjšanju števila in obsega prijav.
English: Within the framework of Directive 2009/41/EC, the premises for contained use activities must be notified to the national competent authorities when they are to be used for the first time.
Slovenian: V skladu z Direktivo 2009/41/ES je treba prostore za dejavnosti uporabe v zaprtem sistemu prijaviti pri pristojnih nacionalnih organih, ko se prvič uporabijo.
English: Member States applied the Directive in a similar fashion in terms of administration, handling of the notifications, inspections, waste disposal and public consultation and information.
Slovenian: Države članice so Direktivo uporabljale na podoben način v smislu uprave, obravnave prijav, inšpekcijskih pregledov, odstranjevanja odpadkov ter javnih posvetovanj in obveščanja.
English: In Germany, there are two genetic engineering facilities where large animals can be disposed of with the help of a digester (alkaline hydrolysis).
Slovenian: V Nemčiji delujeta dva objekta za gensko inženirstvo, v katerih se lahko z uporabo gnilišča odstranijo velike živali (alkalna hidroliza).
English: In some Member States inspections were conducted by specialised inspectors from the Competent Authority, while in others inspections were carried out at the request of the Competent Authorities by specialised inspectors from other ministries or services.
Slovenian: V nekaterih državah članicah so inšpekcijske preglede izvajali specializirani inšpektorji pristojnega organa, v drugih pa so jih na zahtevo pristojnih organov izvajali specializirani inšpektorji drugih ministrstev ali služb.
English: In some instances, Member States required the most stringent waste management treatment for all classes of GMMs.
Slovenian: V nekaterih primerih so države članice zahtevale najstrožje ravnanje z odpadki za vse razrede GSM.
English: Others (Poland), allowed the Competent Authorities to decide whether a public consultation was needed on the basis of the Class of the activities.
Slovenian: Druge države članice (Poljska) so pristojnim organom dovolile, da se na podlagi razreda dejavnosti odločijo, ali je potrebno javno posvetovanje.
English: Public consultation and information
Slovenian: Javno posvetovanje in obveščanje
English: The following text summarises the information given by Member States under the headings provided and highlights similarities of and differences between the experiences of the Member States.
Slovenian: V nadaljevanju so povzete informacije, ki so jih pod navedenimi naslovi predložile države članice, ter izpostavljene podobnosti in razlike med izkušnjami držav članic.
English: National systems differed slightly in terms of authorities involved.
Slovenian: Nacionalni sistemi so se nekoliko razlikovali v tem, kateri organi so bili vanje vključeni.
English: The national reports showed that Member States addressed clinical trials in considerably different ways.
Slovenian: Iz nacionalnih poročil je razvidno, da so države članice klinična preskušanja obravnavale zelo različno.
English: In Denmark, all activities were inspected upon notification of new premises or of changes in existing ones.
Slovenian: Na Danskem so se ob prijavi novih prostorov ali sprememb obstoječih prostorov pregledale vse dejavnosti.
English: In Austria, there are special legal national provisions for applications concerning gene therapy in clinical trials.
Slovenian: V Avstriji veljajo posebne nacionalne pravne določbe za uporabe pri genskem zdravljenju v kliničnih preskušanjih.
English: Finland also added that, as research groups may move from one institution to another, the need for new notifications of the new premises each time creates additional administrative work.
Slovenian: Finska je dodala tudi, da raziskovalne skupine lahko prehajajo med različnimi ustanovami, zato je zaradi novih prijav novih prostorov vsakič potrebno dodatno upravno delo.
English: Ireland and Denmark considered that there is a need for deregulation of Class 1 GMMs as the requirements under Annex II, Part B of the Directive is considered to be rather heavy given the 'non harmful' status of Class 1 GMMs.
Slovenian: Irska in Danska sta menili, da je treba deregulirati GSM iz razreda 1, saj se zahteve iz dela B Priloge II k Direktivi zdijo razmeroma obsežne glede na „neškodljiv" status GSM iz razreda 1.
English: Directive 2009/41/EC is a recast of Directive 90/219/EEC amended by Directive 98/81/EC.
Slovenian: Direktiva 2009/41/ES je prenovljena različica Direktive 90/219/EGS, spremenjene z Direktivo 98/81/ES.
English: In the Netherlands, only the notifier's name, the title of the project and the issuing date of the licence were published but members of the public could request access to an issued licence.
Slovenian: Nizozemska je javno objavila samo ime prijavitelja, naslov projekta in datum izdaje dovoljenja, vendar je lahko javnost zaprosila za dostop do izdanega dovoljenja.
English: Some Member States had electronic registers (databases) for applications submitted under Directive 2009/41/EC.
Slovenian: Nekatere države članice so imele elektronske registre (zbirke podatkov) za prijave, predložene v skladu z Direktivo 2009/41/ES.
English: In Austria, inspections were organised and conducted on the basis of the characteristics of the activity (e.g. risk class, large scale equipment, inoculation of animals).
Slovenian: V Avstriji so se inšpekcijski pregledi organizirali in izvajali na podlagi značilnosti dejavnosti (npr. razreda tveganja, večjih kosov opreme in inokulacije živali).
English: The Czech Republic is currently amending its legislation which requires a new notification in each case of contained use even for Class 1 activities.
Slovenian: Češka republika trenutno spreminja svojo zakonodajo, v skladu s katero je treba novo prijavo vložiti za vsak primer uporabe v zaprtem sistemu, celo za dejavnosti iz razreda 1.
English: When delays occurred, they were mostly due to requests for additional information, lack of clarity on the notification submission requirements on the part of applicants, the involvement of more than one national body in the approval process, and delays in the delivery of the opinion by the scientific advisory body responsible for the assessment of the notifications.
Slovenian: Zamude so bile večinoma posledica zahtev po dodatnih informacijah, nezadostnega razumevanja zahtev v zvezi z vložitvijo prijave s strani prijaviteljev, vključenosti več kot enega nacionalnega organa v postopek odobritve ter zamud pri predložitvi mnenja svetovalnega znanstvenega organa, odgovornega za oceno prijav.
English: Another reported issue was the potential borderline situation between contained use and deliberate release in clinical trials with GM-viruses in which it cannot be excluded that patients' or experimental animals' excretions may contain the tested viruses.
Slovenian: Druga navedena težava je bil morebitni mejni položaj med uporabo v zaprtem sistemu in namernim sproščanjem v kliničnih preskušanjih z gensko spremenjenimi virusi, pri katerih ni mogoče izključiti, da bodo izločki pacientov ali poskusnih živali vsebovali preskušane viruse.
English: Inspection and enforcement issues
Slovenian: Vprašanja inšpekcijskih pregledov in izvrševanja
English: On the same subject, Finland, the Netherlands, and the United Kingdom would like to see that the definitions in the Directive be reviewed to take into account new techniques or technological advances.
Slovenian: V zvezi s to zadevo Finska, Nizozemska in Združeno kraljestvo želijo, da se pregledajo opredelitve pojmov v Direktivi, pri čemer bi se upoštevale nove tehnike ali tehnološki napredek.
English: Affected personnel were given prophylactic treatment and/or vaccination, and were monitored to ensure full recovery (in the cases of accidental sticking with needles).
Slovenian: Prizadeto osebje se je preventivno zdravilo in/ali cepilo ter spremljalo, da se je zagotovila popolna ozdravitev (v primeru poškodb z injekcijsko iglo).
English: Spain and France also pointed to the burden of the large number of inspections required in order to enforce the provisions of Directive 2009/41/EC.
Slovenian: Tudi Španija in Francija sta izpostavili breme zaradi številnih inšpekcijskih pregledov, ki jih je treba izvajati za izvrševanje določb Direktive 2009/41/ES.
English: Directive 2009/41/EC on the contained use of genetically modified micro-organisms (GMMs) requires the Commission to publish every three year a summary report on Member States experience with that Directive, based on individual reports to be sent by the Member States to the Commission.
Slovenian: V skladu z Direktivo 2009/41/ES o uporabi gensko spremenjenih mikroorganizmov (GSM) v zaprtih sistemih mora Komisija vsaka tri leta objaviti zbirno poročilo o izkušnjah držav članic s to direktivo, ki temelji na posameznih poročilih, ki jih države članice pošljejo Komisiji.
English: Lithuania, Estonia, and Malta would welcome more exchanges on experiences and training among Member States.
Slovenian: Litva, Estonija in Malta bi si želele večje izmenjave izkušenj in usposabljanja med državami članicami.
English: The Danish authorities informed the Commission that this procedure is about to change to allow Class 1 GMM work to start based on the notification alone with inspections following after the start of operations.
Slovenian: Danski organi so Komisijo obvestili, da se bo ta postopek kmalu spremenil, da se bo lahko delo v zvezi z GSM iz razreda 1 začelo že na podlagi prijave, inšpekcijski pregledi pa bodo izvedeni po začetku delovanja.
English: The institutions involved made the necessary adjustments to avoid similar events in the future, such as adapting or changing the standard operating procedures, amending the risk management procedures, improving containment practices, and providing training for staff.
Slovenian: Udeležene institucije so izvedle ustrezne prilagoditve, da bi se v prihodnje izognile podobnim dogodkom; tako so na primer prilagodile ali spremenile standardne operativne postopke, spremenile postopke za obvladovanje tveganja, izboljšale prakse zadrževanja in zagotovile usposabljanje za osebje.
English: Clinical trials using the provisions of the Directive
Slovenian: kliničnih preskušanjih na podlagi določb Direktive,
English: In countries where there are no authorised GM waste treatment facilities, the users inactivate their GMO waste themselves (Denmark, Estonia) or use the general waste treatment facilities available (Belgium, Bulgaria, Hungary, the Czech Republic, Spain and Sweden).
Slovenian: V državah, kjer ni odobrenih objektov za obdelavo gensko spremenjenih odpadkov, uporabniki sami inaktivirajo odpadke GSO (na Danskem in v Estoniji) ali pa uporabijo objekte za obdelavo navadnih odpadkov (v Belgiji, Bolgariji, na Madžarskem, v Češki republiki, Španiji in na Švedskem).
English: In all reported instances, operators promptly complied and implemented the corrective actions requested by the authorities.
Slovenian: V vseh sporočenih primerih so izvajalci hitro upoštevali navodila in izvedli popravne ukrepe, ki so jih zahtevali organi.
English: The notifier does not always know when an activity is considered to be a subsequent contained use of the same containment class, especially in cases when the authorised activity is modified.
Slovenian: Prijavitelj ne ve vedno, kdaj se dejavnost šteje za nadaljnjo uporabo v zaprtem sistemu istega razreda zadrževanja, zlasti v primeru spremembe odobrene dejavnosti.
English: Belgium and Poland, questioned whether activities involving GM plant and animal cells should be considered as GMM activities.
Slovenian: Belgija in Poljska sta dvomili, da bi se morale dejavnosti, ki vključujejo gensko spremenjene rastlinske in živalske celice, šteti za dejavnosti, ki vključujejo GSM.
English: Following this notification subsequent class 1 contained use may proceed without further notification, whereas higher containment class levels require additional specific notification.
Slovenian: Po tej prijavi se lahko dejavnosti nadaljnje uporabe v zaprtem sistemu iz razreda 1 izvajajo brez dodatne prijave, višje razrede stopnje zadrževanja pa je treba dodatno posebej prijaviti.
English: In Ireland, the Competent Authority received a letter from a member of the public; seeking additional information on the implications/risk associated with class 3 GMM contained use activity (GM strains of Hepatitis).
Slovenian: Na Irskem je pristojni organ prejel dopis člana javnosti, ki je zaprosil za dodatne informacije o posledicah/tveganjih, povezanih z dejavnostjo uporabe GSM iz razreda 3 v zaprtem sistemu (gensko spremenjenih sevov hepatitisa).
English: In their reports, several Member States, stressed that the problems mentioned above and the actual administration of the process (number of notifications, processing of notifications and approval, inspections, etc.) result in a significant administrative burden which merits examination with the view to harmonise and simplify to the extent possible.
Slovenian: Več držav članic je v svojih poročilih izpostavilo, da so zgoraj navedene težave in dejansko upravljanje postopka (število prijav, obdelava prijav in odobritve, inšpekcijski pregledi itd.) povzročili precejšnje upravno breme, ki bi ga bilo treba proučiti, da bi se upravljanje čim bolj uskladilo in poenostavilo.
English: In Finland, the classification of viruses, cell cultures, and especially of pathogens, which have been attenuated, has also been problematic.
Slovenian: Finska je imela težave s klasifikacijo virusov, celičnih kultur in zlasti patogenov, ki so bili oslabljeni.
English: Fewer class 3 and 4 activities were being carried out.
Slovenian: Dejavnosti iz razredov 3 in 4 je bilo manj.
English: According to the information provided by the Member States, when accidents occurred, corrective measures were taken for both the procedural and structural safety aspects, and for the safety of humans and the environment.
Slovenian: Glede na informacije držav članic so se v primeru nesreč sprejeli popravni ukrepi za postopkovne in strukturne varnostne vidike ter za varnost ljudi in okolja.
English: Slovakia reported 3 accidents caused by fire in different facilities including the Institute of Virology (class 1 and 2 GMOs), the Institute of Neuroimmunology (class 1 and 2 GMOs), and the Slovak University of Technology (class 1 GMOs).
Slovenian: Slovaška je poročala o treh nesrečah zaradi požara v različnih objektih, in sicer na inštitutu za virologijo (gensko spremenjeni organizmi (GSO) iz razredov 1 in 2), inštitutu za nevroimunologijo (gensko spremenjeni organizmi iz razredov 1 in 2) in na slovaški tehnološki univerzi (gensko spremenjeni organizmi iz razreda 1).
English: Other approaches to communicate to the public relevant information in the context of Directive 2009/41/EC, included public meetings of advisory bodies and seminars (the Czech Republic), publications of annual reports (Croatia, the Czech Republic, Germany, Spain and the United Kingdom), local or national newspapers (Denmark, Netherlands), brochures (Estonia), competent Ministry publications (Slovakia), and publications of the minutes of meetings (the United Kingdom).
Slovenian: Ostali pristopi k obveščanju javnosti o informacijah, pomembnih v okviru Direktive 2009/41/ES, so vključevali javne sestanke svetovalnih organov in seminarje (v Češki republiki), objavo letnih poročil (na Hrvaškem, v Češki republiki, Nemčiji, Španiji in Združenem kraljestvu), lokalne ali nacionalne časopise (na Danskem in Nizozemskem), brošure (v Estoniji), publikacije pristojnega ministrstva (na Slovaškem) in objavo zapisnikov (v Združenem kraljestvu).
English: In one instance, a GMM falling within the scope of 2009/41/EC was produced using techniques (self-cloning) which do not fall under the scope of Directive 2009/41/EC.
Slovenian: V enem primeru je bil GSM, ki spada na področje uporabe Direktive 2009/41/ES, pridobljen s tehnikami (samokloniranje), ki ne spadajo na področje uporabe Direktive 2009/41/ES.
English: In Hungary, a lot of consultations are necessary between the notifiers and the Competent Authority on the documentation and information requirements before the submission and/or after the submission of the notification.
Slovenian: Na Madžarskem so pred vložitvijo in/ali po vložitvi prijave potrebna številna posvetovanja med prijavitelji in pristojnim organom glede zahtev po dokumentaciji in informacijah.
English: The control procedures included regular annual inspections according to set criteria (periodicity, class of risk, etc.), ad hoc unannounced inspections, audits of facilities approved for the first time, sampling of materials, and audits of documentation and processes.
Slovenian: Nadzorni postopki so vključevali redne letne inšpekcijske preglede glede na določena merila (periodičnost, razred tveganja itd.), ad hoc nenapovedane inšpekcijske preglede, revizije objektov, ki so bili prvič odobreni, vzorčenje materialov ter revizije dokumentacije in postopkov.
English: Most activities were related to research but several served commercial purposes such as the manufacture of diagnostics, veterinary and medicinal products.
Slovenian: Večina dejavnosti je bila povezana z raziskavami, nekatere pa imajo komercialni namen, kot je na primer izdelava diagnostičnih, veterinarskih ali medicinskih izdelkov.
English: In Austria, the Netherlands, and Finland, there is one waste treatment facility dedicated to GM waste inactivation, otherwise the operators inactivate it themselves.
Slovenian: Avstrija, Nizozemska in Finska imajo po en objekt za obdelavo odpadkov, namenjen inaktivaciji gensko spremenjenih odpadkov, sicer pa take odpadke izvajalci sami inaktivirajo.
English: Sweden reported one accident involving a needle accident (student accidentally stuck herself with a syringe containing a GM virus vaccine).
Slovenian: Švedska je poročala o eni nesreči z iglo (študentka se je ponesreči zbodla z brizgo, ki je vsebovala cepivo proti gensko spremenjenemu virusu).
English: In accordance with Article 2(c) of Directive 2009/41/EC, contained use shall mean "any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment".
Slovenian: V skladu s členom 2(c) Direktive 2009/41/ES uporaba v zaprtem sistemu „pomeni vsako dejavnost, pri kateri se mikroorganizmi gensko spremenijo ali pri kateri se taki GSM gojijo, shranjujejo, prenašajo in prevažajo, uničujejo, odstranjujejo ali uporabljajo na kateri koli drug način in za katero se uporabljajo posebni zadrževalni ukrepi za omejevanje njihovega stika s prebivalstvom in okoljem in za zagotavljanje visoke ravni varstva prebivalstva in okolja".
English: Finland received few notices of mild accidents (i.e. needle pricks) in class 2 activities with no consequences.
Slovenian: Finska je prejela nekaj obvestil o lažjih nesrečah (tj. o zbodljajih z iglo) pri dejavnostih iz razreda 2 brez posledic.
English: Other Member States (Spain, United Kingdom) decide on a case by case basis whether a clinical trial is regarded as contained use or as a deliberate release.
Slovenian: Druge države članice (Španija in Združeno kraljestvo) se pri vsakem kliničnem preskušanju posebej odločijo, ali gre za uporabo v zaprtem sistemu ali namerno sproščanje.
English: The information contained in this document has been compiled by the Commission from individual reports submitted by Member States in accordance with Article 17 of Directive 2009/41/EC on the contained use of genetically modified micro-organisms.
Slovenian: Informacije iz tega dokumenta je Komisija zbrala iz posameznih poročil, ki so jih predložile države članice v skladu s členom 17 Direktive 2009/41/ES o uporabi gensko spremenjenih mikroorganizmov v zaprtih sistemih.
English: With the exception of Slovenia and the United Kingdom, Member States received no responses to public consultations and information made publicly available under Directive 2009/41/EC during the reporting period.
Slovenian: Razen Slovenije in Združenega kraljestva države članice v obdobju poročanja niso prejele odzivov na javna posvetovanja in javno dostopne informacije v skladu z Direktivo 2009/41/ES.
English: The Netherlands also believed there is a need for simplification and harmonisation of disinfectants used as biocides in laboratories.
Slovenian: Po njenem mnenju je treba tudi poenostaviti in uskladiti zahteve za razkužila, ki se uporabljajo kot biocidni proizvodi v laboratorijih.
English: The national reports showed both similarities and differences in the implementation and enforcement processes required by articles 10 and 16 of Directive 2009/41/EC in the Member States.
Slovenian: Iz nacionalnih poročil so razvidne podobnosti in razlike med postopki izvajanja in izvrševanja, ki se zahtevajo v državah članicah v skladu s členoma 10 in 16 Direktive 2009/41/ES.
English: Overview of activities and installations (reporting period 06.06.2009 - 05.06.2014)
Slovenian: Pregled dejavnosti in obratov (obdobje poročanja: 6. junij 2009-5. junij 2014)
English: [8: Together with the Danish Working Authority][9: Together with the Ministry of Science, Research and Economy][10: Together with the Ministry of Science, Education and Sports ]
Slovenian: ][10: Skupaj z ministrstvom za znanost, izobraževanje in šport. ]
English: Differences arose in those areas covered by the Directive on which Member States have either enacted additional legislation as for example, in extending the provisions of Directive 2009/41/EC to cover GM plants and animals, maintaining the requirements for notification for each Class 1 activity, or when they apply the provisions of 2009/41/EC as in requiring for all Classes, inactivation of waste before disposal or employing independent advisory scientific bodies for the assessment of notifications.
Slovenian: Razlike so nastale na področjih uporabe Direktive, na katerih so države članice bodisi uvedle dodatno zakonodajo, na primer z razširitvijo določb Direktive 2009/41/ES na gensko spremenjene rastline in živali ter ohranitvijo zahtev za prijavo vsake dejavnosti iz razreda 1, bodisi uporabljajo določbe Direktive 2009/41/ES tako, da je pri vseh razredih potrebna inaktivacija odpadkov pred odstranitvijo ali sodelovanje neodvisnih svetovalnih znanstvenih organov pri ocenjevanju prijav.
English: Member States generally conducted public consultations as part of the authorisation process, as foreseen under Article 12 of Directive 2009/41/EC.
Slovenian: Države članice so javna posvetovanja na splošno izvajale kot del postopka odobritve, kot je določeno v členu 12 Direktive 2009/41/ES.
English: Belgium, Finland, Slovenia, the United Kingdom and Sweden pointed out that the large number of notifications, the high information requirements for each notification, the detailed reporting system, and the complexity of the different procedures can result in a heavy administrative burden for both authorities and notifiers.
Slovenian: Belgija, Finska, Slovenija, Združeno kraljestvo in Švedska so izpostavili, da zaradi številnih prijav, obsežnih zahtev po informacijah pri vsaki prijavi, sistema podrobnega poročanja in zapletenosti raznih postopkov lahko nastane veliko upravno breme za organe in prijavitelje.
English: Some Member States regarded clinical trials as falling exclusively under Directive 2001/18/EC (Sweden or Netherlands), while other Member States, ( Denmark and Finland) regarded them as falling exclusively within the scope of Directive 2009/41/EC.
Slovenian: Nekatere države članice so menile, da klinična preskušanja zajema izključno Direktiva 2001/18/ES (Švedska ali Nizozemska), druge države članice (Danska in Finska), pa so menile, da spadajo izključno na področje uporabe Direktive 2009/41/ES.
English: The approaches of public consultations varied among the Member States.
Slovenian: Pristopi držav članic k javnim posvetovanjem so se razlikovali.
English: Three Member States (Estonia, Lithuania, and Malta) considered that specific training programmes for inspectors and joint inspections with other Member States would improve the inspection process.
Slovenian: Tri države članice (Estonija, Litva in Malta) so menile, da bi se postopek izvajanja inšpekcijskih pregledov izboljšal s posebnimi programi usposabljanja za inšpektorje in skupnimi inšpekcijskimi pregledi z drugimi državami članicami.
English: During the period 2009-2014 most contained use activities declared by Member States fell within class 1 or class 2.
Slovenian: V obdobju 2009-2014 je večina dejavnosti uporabe v zaprtem sistemu, ki so jih navedle države članice, spadala v razred 1 ali 2.
English: According to the information provided, most contained use activities in the Member States fell into class 1 or class 2.
Slovenian: Glede na predložene informacije je v državah članicah večina dejavnosti uporabe v zaprtem sistemu spadala v razred 1 ali 2.
English: According to its national report, there were no GMMs contained use activities in Romania during the reporting period.
Slovenian: Romunija je v nacionalnem poročilu navedla, da v obdobju poročanja ni izvajala dejavnosti uporabe GSM v zaprtem sistemu.
English: Further details from the individual Member States' three year reports are provided in the accompanying Commission staff working document.
Slovenian: Podrobnejše informacije iz posameznih triletnih poročil držav članic so na voljo v priloženem delovnem dokumentu služb Komisije.
English: Few Member States (Belgium, Lithuania, Poland and Portugal), prescribed that all types of residues had to be inactivated prior to disposal.
Slovenian: Nekaj držav članic (Belgija, Litva, Poljska in Portugalska) je določilo, da je treba pred odstranjevanjem inaktivirati vse vrste ostankov.
English: In Germany, although the way inspections were conducted varied among the federal states in terms of periodicity, common approaches based on risk classification and the use patterns of the facility were followed.
Slovenian: Čeprav se je periodičnost izvajanja inšpekcijskih pregledov v Nemčiji razlikovala med zveznimi deželami, so se upoštevali skupni pristopi na podlagi razvrstitve tveganj in vzorcev uporabe objekta.
English: In other Member States (Austria, Croatia, Cyprus, Estonia, France, Hungary, Italy, Latvia, the United Kingdom), the tasks of the Competent Authorities were carried out by other Ministries alone or in collaboration with others like the Ministry of Health (Austria, Croatia, Italy, United Kingdom), the Ministry of Labour (Cyprus, Estonia), the Ministry of Agriculture and Rural Development (Hungary, Latvia), the Ministry of National/Higher Education, Science and Research (France), specific authorities for Biotechnology/Biosafety (Belgium, Finland, Spain), Work Environment (Sweden) or Food and Consumer Protection (Germany).
Slovenian: V drugih državah članicah (v Avstriji, na Hrvaškem, Cipru, v Estoniji, Franciji, na Madžarskem, v Italiji, Latviji in Združenem kraljestvu) so naloge pristojnih organov samostojno opravljala druga ministrstva ali pa so jih opravljala v sodelovanju z drugimi organi, kot so ministrstvo za zdravje (v Avstriji, na Hrvaškem, v Italiji in Združenem kraljestvu), ministrstvo za delo (na Cipru in v Estoniji), ministrstvo za kmetijstvo in razvoj podeželja (na Madžarskem in v Latviji), ministrstvo za nacionalno/višje izobraževanje, znanost in raziskave (v Franciji), posebni organi za biotehnologijo/biološko varnost (v Belgiji, na Finskem in v Španiji), delovno okolje (na Švedskem) ali prehrano in varstvo potrošnikov (v Nemčiji).
English: Most Member States use autoclave or chemical treatment to dispose of GMM waste, and/or incinerate GM plants and animals.
Slovenian: Večina držav članic za odstranjevanje odpadkov GSM uporablja avtoklav ali kemično obdelavo in/ali sežiga gensko spremenjene rastline in živali.
English: The national reports show that problems of interpretation of the provisions of the Directive arise in some reporting Member States, particularly in the cases of the definition of genetic modification in the Directive, in the case of notifications involving modifications using novel techniques, in the assessment of the various classes of GMMs, in the subsequent 'contained use' activity, and as regards to clinical trials in the context of the Directive.
Slovenian: Nacionalna poročila kažejo, da se v nekaterih državah članicah, ki so predložile poročila, pojavljajo težave z razlago določb Direktive, zlasti v primeru opredelitve genske spremembe v Direktivi, pri prijavah, ki vključujejo spremembe z uporabo novih tehnik, pri ocenjevanju različnih razredov GSM, pri dejavnosti naslednje uporabe v zaprtem sistemu in pri kliničnih preskušanjih v okviru Direktive.
English: Some Member States (Austria, Czech Republic, France, Ireland, Romania and Spain) focussed the public consultation only on class 3 and 4.
Slovenian: V nekaterih državah članicah (v Avstriji, Češki republiki, Franciji, na Irskem, v Romuniji in Španiji) so bila javna posvetovanja osredotočena le na razreda 3 in 4.
English: Inspections are conducted systematically and on an ad hoc basis in all premises or in specific class (classes 3 and 4) activities using specialised staff.
Slovenian: Specializirano osebje sistematično in na ad hoc osnovi izvaja inšpekcijske preglede v vseh prostorih ali pri dejavnostih iz posebnega razreda (razredov 3 in 4).
English: Bulgaria, the Czech Republic and Hungary considered that there is a need to discuss whether clinical trials fall under the scope of Directive 2009/41/EC or under the scope of Directive 2001/18/EC.
Slovenian: Bolgarija, Češka republika in Madžarska so menile, da so potrebne razprave o tem, ali klinična preskušanja spadajo na področje uporabe Direktive 2009/41/ES ali Direktive 2001/18/ES.
English: In Belgium, some problems were encountered with the interpretation of the terms "subsequent contained use activity" following the first time notification of premises for a particular containment class activity.
Slovenian: Belgija je imela nekaj težav z razlago pojma „dejavnost nadaljnje uporabe v zaprtem sistemu" po prvi prijavi prostorov za posamezno dejavnost iz določenega razreda zadrževanja.
English: The United Kingdom reported 8 accidents involving contained use of GMMs or GMOs.
Slovenian: Združeno kraljestvo je poročalo o osmih nesrečah, ki so vključevale uporabo GSM ali GSO v zaprtem sistemu.
English: Problems with interpretation of provisions
Slovenian: Težave pri razlagi določb
English: Details are available in the accompanying Commission staff working document.
Slovenian: Podrobnejše informacije so na voljo v priloženem delovnem dokumentu služb Komisije.
English: Few Member States (Finland, the Netherlands, Slovakia, Sweden and United Kingdom) reported accidents according to the definition laid down in Article 2(d) of Directive 2009/41/EC and the procedures laid down in Articles 14 and 15 of that Directive.
Slovenian: Malo držav članic (Finska, Nizozemska, Slovaška, Švedska in Združeno kraljestvo) je poročalo o nesrečah v smislu člena 2(d) Direktive 2009/41/ES in v skladu s postopki iz členov 14 in 15 navedene direktive.
English: In Belgium, the inspections were organised in the three regions by different inspectorates on a regular basis, and concerned contained uses of GMMs including pathogens.
Slovenian: V Belgiji so v treh regijah različni inšpektorati redno organizirali inšpekcijske preglede, ki so se nanašali na uporabo GSM, tudi patogenov, v zaprtem sistemu.
English: The national reports showed that, in the Member States, several and at times different authorities, ministries and/or agencies are involved in the notification and approval process and in inspection and enforcement.
Slovenian: Nacionalna poročila so razkrila, da v državah članicah pri postopku prijave in odobritve ter inšpekcijskih pregledih in izvrševanju sodeluje več organov, ministrstev in/ali agencij, ki so včasih tudi različni.
English: Accidents in the reporting Member States were few and minor in significance in terms of human health and the environment.
Slovenian: V državah članicah, ki so predložile poročila, je bilo malo nesreč, ki niso zelo vplivale na zdravje ljudi in okolje.
English: In some Member States (Austria, Bulgaria, Cyprus, Finland, Portugal and Sweden), no public consultations were carried out, because no application was received during the reporting period for the classes under Directive 2009/41/EC which the national provisions call for a public consultation.
Slovenian: V nekaterih državah članicah (v Avstriji, Bolgariji, na Cipru, Finskem, Portugalskem in Švedskem) javna posvetovanja niso potekala, ker te države v obdobju poročanja niso prejele prijav za razrede iz Direktive 2009/41/ES, za katere je treba v skladu z nacionalnimi določbami opraviti javno posvetovanje.
English: Belgium, Hungary, Lithuania, the Netherlands and the Czech Republic would welcome better explanation, early guidance and harmonised views across the EU on gene therapy, on synthetic biology, and on other new techniques or technological advances.
Slovenian: Belgija, Madžarska, Litva, Nizozemska in Češka republika bi si želele boljših pojasnil, pravočasnih smernic in usklajenih stališč po vsej EU o genskem zdravljenju, sintezni biologiji ter drugih novih tehnikah ali tehnološkem napredku.
English: In Finland, Ireland, Lithuania, and the United Kingdom, the inspection intensity was based mainly on the Class of the contained use activity.
Slovenian: Na Finskem in Irskem ter v Litvi in Združenem kraljestvu je bila intenzivnost inšpekcijskih pregledov odvisna zlasti od razreda dejavnosti uporabe v zaprtem sistemu.
English: Some Member States (Germany, France, Ireland, Lithuania and the United Kingdom), had waste treatment facilities dedicated to GM waste inactivation.
Slovenian: Nekatere države članice (Nemčija, Francija, Irska, Litva in Združeno kraljestvo) imajo objekte za obdelavo odpadkov, namenjene inaktivaciji gensko spremenjenih odpadkov.
English: When inspections identified areas for improvement, national reports indicated that the competent authorities ensured that notifiers acted to rectify the situation within set deadlines.
Slovenian: Ko je bilo pri inšpekcijskih pregledih ugotovljeno, da je treba nekatera področja izboljšati, so po podatkih iz nacionalnih poročil pristojni organi zagotovili, da so prijavitelji ukrepali in položaj popravili v določenih rokih.
English: However, the definition of microorganism under 2009/41/EC is clear in including animal and plant cell in culture within its scope
Slovenian: Vendar je jasno, da opredelitev pojma mikroorganizem v Direktivi 2009/41/ES v področje uporabe vključuje živalske in rastlinske celice v kulturi.
English: Belgium, the Czech Republic, Finland, Hungary, the Netherlands, Spain and the United Kingdom encountered problems in assessing whether the application of certain new techniques resulting in a GMM fell within the scope of Directive 2009/41/EC.
Slovenian: Belgija, Češka republika, Finska, Madžarska, Nizozemska, Španija in Združeno kraljestvo so se srečali s težavami pri ocenjevanju, ali uporaba nekaterih novih tehnik za pridobivanje GSM spada na področje uporabe Direktive 2009/41/ES.
English: In general, Member States declare addressing waste management by class or category of waste in accordance with the requirements of Article 5 and of Annex IV of Directive 2009/41/EC.
Slovenian: Na splošno so države članice v poročilih navedle, da z odpadki ravnajo glede na razred ali kategorijo odpadkov v skladu z zahtevami iz člena 5 Direktive 2009/41/ES in iz Priloge IV k Direktivi.
English: In Belgium, the Czech Republic, Latvia, Poland, Romania, Slovakia, Slovenia, Spain and the United Kingdom, the public had access to the information or summary of the applications available in the data bases.
Slovenian: V Belgiji, Češki republiki, Latviji, na Poljskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji in Združenem kraljestvu je imela javnost dostop do informacij ali povzetka prijav, ki so na voljo v zbirkah podatkov.
English: Bulgaria, Spain and the Czech Republic, would like to see clarity on the legislative framework concerning clinical trials with GMMs.
Slovenian: Bolgarija, Španija in Češka republika želijo, da se pojasni zakonodajni okvir za klinična preskušanja z GSM.
English: In Austria, Croatia, Cyprus, Germany, Italy, Latvia, Lithuania, Malta, Portugal, Romania and Slovakia, no specific problems with the interpretation of the provisions were reported.
Slovenian: Avstrija, Hrvaška, Ciper, Nemčija, Italija, Latvija, Litva, Malta, Portugalska, Romunija in Slovaška niso poročali o nobenih posebnih težavah z razlago določb.
English: The reported accidents included two needle stick injuries (Toxoplasma gondii and Mycobacterium marinum), a, instrument measurement failure, an accidental splashing, (a droplet of culture of Pseudomonas aeruginosa splashed into the eye), a drop of a box of plates containing 36 plates of Yersinia pestis, a centrifuge failure which could potentially led to an aerosol of GM Legionella pneumophila exposure, a drainage system failure (Fusarium graminearum), and two filtration failures with GM viruses (Lentivirus vector with inserted sequence encoding for shRNA against KIAA0020 and Hepatitis C virus).
Slovenian: Med navedenimi nesrečami sta bili dve poškodbi z injekcijsko iglo (Toxoplasma gondii in Mycobacterium marinum), okvara merilnega instrumenta, nehoten pljusk (kapljica kulture Pseudomonas aeruginosa je prišla v oko), padec škatle s 36 petrijevkami Yersinia pestis, okvara centrifuge, ki bi lahko povzročila aerosolno izpostavljenost gensko spremenjeni bakteriji Legionella pneumophila, okvara drenažnega sistema (Fusarium graminearum) in dve okvari pri filtraciji z gensko spremenjenimi virusi (lentivirusni vektor z vstavljenim kodirnim zaporedjem za shRNA proti KIAA0020 in virusu hepatitisa C).
English: During inspections, some issues were identified with regard to: waste management; inaccurate or outdated documentation; lack of knowledge regarding the newest GM technologies; insufficient recording of the training of the staff; contained use of GMOs/GMMs without having obtained the proper authorisation; poor or missing identification and signalisation of genetic engineering facilities or laboratories; adequacy of standard control measures; and in some instances, insufficient biosafety measures (decontamination, protective clothing, restricted access, etc.).
Slovenian: Med inšpekcijskimi pregledi so bile ugotovljene nekatere težave v zvezi z ravnanjem z odpadki, netočno ali zastarelo dokumentacijo, premajhno seznanjenostjo z najnovejšimi tehnologijami na področju genskega spreminjanja, nezadostnim evidentiranjem usposabljanja osebja, uporabo GSO/GSM v zaprtem sistemu brez ustreznega dovoljenja, slabo ali manjkajočo identifikacijo in označevanjem objektov ali laboratorijev za genski inženiring, ustreznostjo standardnih nadzornih ukrepov in v nekaterih primerih nezadostnimi ukrepi za zagotavljanje biološke varnosti (dekontaminacija, zaščitna obleka, omejen dostop itd.).
English: Several activities served commercial purposes such as the manufacture of diagnostics, of veterinary/medicinal products or involving clinical trials.
Slovenian: Več dejavnosti je imelo komercialne namene, kot je na primer izdelava diagnostičnih izdelkov ali zdravil za ljudi oziroma živali, ali pa je vključevalo klinična preskušanja.
English: Notification and approval systems
Slovenian: sistemih prijave in odobritve,
English: Bulgaria, Finland, Hungary, Spain and the Czech Republic showed support for harmonisation of the guidance and the procedures for the evaluation and notification of clinical trials with GMMs at Union level.
Slovenian: Bolgarija, Finska, Madžarska, Španija in Češka republika so izrazile podporo usklajevanju smernic in postopkov za ocenjevanje in prijavo kliničnih preskušanj z GSM na ravni Unije.
English: Some Member States (Belgium, Denmark, France, Finland, Italy, Poland, Slovenia and Spain) reported increase in the notifications for gene therapy clinical trials, while in Germany the number has decreased.
Slovenian: Nekatere države članice (Belgija, Danska, Francija, Finska, Italija, Poljska, Slovenija in Španija) so v poročilih navedle, da se je povečalo število prijav kliničnih preskušanj z genskim zdravljenjem, v Nemčiji pa se je njihovo število zmanjšalo.
English: Of the eight accidents reported, six involved class 2 GMMs, and two involved class 3 GMMs.
Slovenian: Od tega je šest nesreč vključevalo GSM iz razreda 2, dve pa GSM iz razreda 3.
English: In all reported cases, Member States reported that the appropriate corrective measures were undertaken in all accidents involving humans/personnel, on the processes and operating procedures, and the contained used premises and/or installations.
Slovenian: V vseh sporočenih primerih so države članice v poročilih navedle, da so bili v vseh nesrečah, ki so vključevale ljudi/osebje, sprejeti ustrezni popravni ukrepi v zvezi s postopki in operativnimi postopki ter prostori in/ali obrati za uporabo v zaprtem sistemu.
English: With the exception of Cyprus and Romania, Member States have extended the transposed provisions of Directive 2009/41/EC on GMM to the contained uses of GM plants and GM animals.
Slovenian: Vse države članice razen Cipra in Romunije so določbe Direktive 2009/41/ES o GSM, prenesene v nacionalno pravo, razširile na uporabe gensko spremenjenih rastlin in živali v zaprtem sistemu.
English: Finally, in terms of waste disposal, all reporting Member States have declared having enacted waste management provisions according to the GM class.
Slovenian: Kar zadeva odstranjevanje odpadkov, so vse države članice, ki so predložile poročilo, navedle, da izvajajo določbe za ravnanje z odpadki glede na razred gensko spremenjenih mikroorganizmov.
English: Problems with interpretation of the provisions
Slovenian: težavah pri razlagi določb,