natgillin/translations-raw huggingface dataset:
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.
Specializirano osebje sistematično in na ad hoc osnovi izvaja inšpekcijske preglede v vseh prostorih ali pri dejavnostih iz posebnega razreda (razredov 3 in 4).
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.
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.
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.
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.
The United Kingdom reported 8 accidents involving contained use of GMMs or GMOs.
Združeno kraljestvo je poročalo o osmih nesrečah, ki so vključevale uporabo GSM ali GSO v zaprtem sistemu.
Problems with interpretation of provisions
Težave pri razlagi določb
Details are available in the accompanying Commission staff working document.
Podrobnejše informacije so na voljo v priloženem delovnem dokumentu služb Komisije.
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.
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.
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.
V Belgiji so v treh regijah različni inšpektorati redno organizirali inšpekcijske preglede, ki so se nanašali na uporabo GSM, tudi patogenov, v zaprtem sistemu.
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.
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.
Accidents in the reporting Member States were few and minor in significance in terms of human health and the environment.
V državah članicah, ki so predložile poročila, je bilo malo nesreč, ki niso zelo vplivale na zdravje ljudi in okolje.
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.
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.
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.
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.
In Finland, Ireland, Lithuania, and the United Kingdom, the inspection intensity was based mainly on the Class of the contained use activity.
Na Finskem in Irskem ter v Litvi in Združenem kraljestvu je bila intenzivnost inšpekcijskih pregledov odvisna zlasti od razreda dejavnosti uporabe v zaprtem sistemu.
Some Member States (Germany, France, Ireland, Lithuania and the United Kingdom), had waste treatment facilities dedicated to GM waste inactivation.
Nekatere države članice (Nemčija, Francija, Irska, Litva in Združeno kraljestvo) imajo objekte za obdelavo odpadkov, namenjene inaktivaciji gensko spremenjenih odpadkov.
When inspections identified areas for improvement, national reports indicated that the competent authorities ensured that notifiers acted to rectify the situation within set deadlines.
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.
However, the definition of microorganism under 2009/41/EC is clear in including animal and plant cell in culture within its scope
Vendar je jasno, da opredelitev pojma mikroorganizem v Direktivi 2009/41/ES v področje uporabe vključuje živalske in rastlinske celice v kulturi.
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.
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.
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.
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.
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.
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.
Bulgaria, Spain and the Czech Republic, would like to see clarity on the legislative framework concerning clinical trials with GMMs.
Bolgarija, Španija in Češka republika želijo, da se pojasni zakonodajni okvir za klinična preskušanja z GSM.
In Austria, Croatia, Cyprus, Germany, Italy, Latvia, Lithuania, Malta, Portugal, Romania and Slovakia, no specific problems with the interpretation of the provisions were reported.
Avstrija, Hrvaška, Ciper, Nemčija, Italija, Latvija, Litva, Malta, Portugalska, Romunija in Slovaška niso poročali o nobenih posebnih težavah z razlago določb.
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).
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).
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.).
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.).
Several activities served commercial purposes such as the manufacture of diagnostics, of veterinary/medicinal products or involving clinical trials.
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.
Notification and approval systems
sistemih prijave in odobritve,
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.
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.
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.
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.
Of the eight accidents reported, six involved class 2 GMMs, and two involved class 3 GMMs.
Od tega je šest nesreč vključevalo GSM iz razreda 2, dve pa GSM iz razreda 3.
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.
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.
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.
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.
Finally, in terms of waste disposal, all reporting Member States have declared having enacted waste management provisions according to the GM class.
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.
Problems with interpretation of the provisions
težavah pri razlagi določb,
The Netherlands reported 13 incidents, without consequences on health or environment, namely a small fire in a biosafety cabinet in a laboratory, a small collision in a corridor while transporting wastes (class 2 micro-organism was present in the waste), a centrifuge failure (GM Neisseria), an ice-machine failure, a needle accident with a low titre of GM Influenza, 2 incidents with an isolator housing animals with GM Influenza, damages to a glass wall of a laboratory, a technical defect, a mistake in the technical construction of a ventilation system, and a cell line infected with GM SARS-virus was fixed with an old fixative which although expired, proved to be effective.
Nizozemska je poročala o 13 nesrečah brez posledic za zdravje ali okolje, in sicer o majhnem požaru v omarici za biološko varnost v laboratoriju, majhnem trku na hodniku pri prevozu odpadkov (v odpadkih je bil prisoten mikroorganizem iz razreda 2), okvari centrifuge (gensko spremenjeni mikroorganizem Neisseria), okvari naprave za pripravo ledu, nesreči z iglo z nizkim titrom gensko spremenjene influence, dveh nesrečah z izolatorjem, v katerem so bile živali z gensko spremenjeno influenco, poškodbah steklene stene laboratorija, tehnični okvari, napaki v tehnični konstrukciji prezračevalnega sistema in nesreči, pri kateri je bila celična linija, okužena z gensko spremenjenim virusom SARS, fiksirana s starim fiksativom, ki se je kljub poteklemu roku uporabe izkazal za učinkovitega.
In many Member States (Bulgaria, the Czech Republic, Denmark, Ireland, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, and Slovenia), the Competent Authorities for the notification and approval were the Ministry of Environment or Agencies focusing on environmental issues.
V mnogih državah članicah (v Bolgariji, Češki republiki, na Danskem, Irskem, v Litvi, na Malti, Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem in v Sloveniji) je bilo za prijavo in odobritev pristojno ministrstvo za okolje ali agencija, ki se ukvarja z okoljskimi vprašanji.
Contained use activities are classified into four containment classes: Class 1 represents activities of no or negligible risk; Classes 2, 3 or 4 represent activities of low, moderate and high risk, respectively.
V razredu 1 so dejavnosti brez tveganja ali z zanemarljivim tveganjem, v razredu 2, 3 ali 4 pa so dejavnosti z majhnim, zmernim oziroma velikim tveganjem.
Belgium considered that the procedures regarding the notification of contained uses of GMMs and pathogens should be made more uniform.
Belgija je menila, da bi morali biti postopki v zvezi s prijavo uporab GSM in patogenov v zaprtem sistemu enotnejši.
[11: Article 2(a) of Directive 2009/41/EC]
[11: Člen 2(a) Direktive 2009/41/ES.]
Activities and installations
dejavnostih in obratih,
In terms of enforcement, in all Member States which provided individual reports, when inspections identified situations requiring corrective actions, the competent authorities declare to have used a number of instruments (warnings, infraction notices, etc.) to ensure remedial action and compliance on the part of operators within a set timeframe.
Kar zadeva izvrševanje, so pristojni organi iz vseh držav članic, ki so predložile posamezna poročila, sporočili, da so uporabili številne instrumente (opozorila, obvestila o kršitvah itd.), s katerimi so zagotovili popravne ukrepe in skladnost izvajalcev v določenem roku, če so pri inšpekcijskih pregledih ugotovili, da so potrebni popravni ukrepi.
[7: Article 4(3) of Directive 2009/41/EC]
[7: Člen 4(3) Direktive 2009/41/ES.]
There were no clinical trials using GMMs in Austria, Croatia, Cyprus, the Czech Republic, Estonia, Hungary, Ireland, Latvia, Lithuania, Malta, and Portugal.
V Avstriji, na Hrvaškem, Cipru, v Češki republiki, Estoniji, na Madžarskem, Irskem, v Latviji, Litvi, na Malti in Portugalskem ni bilo kliničnih preskušanj z GSM.
][4: Report on the 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 2006 - 2009, COM(2012) 398 final, 17.7.2012.]
][4: Poročilo o izkušnjah držav članic z Direktivo 2009/41/ES Evropskega parlamenta in Sveta z dne 6. maja 2009 o uporabi gensko spremenjenih mikroorganizmov v zaprtih sistemih (prenovitev) za obdobje 2006-2009 (COM(2012) 398 final, 17. julij 2012).]
In general, with a small number of exceptions, Member States declare processing notifications within the statutory timeframe.
Na splošno so države članice sporočile, da se prijave obdelajo v določenih rokih, izjem pa je bilo malo.
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
Izkušnje držav članic z Direktivo 2009/41/ES Evropskega parlamenta in Sveta z dne 6. maja 2009 o uporabi gensko spremenjenih mikroorganizmov v zaprtih sistemih (prenovitev) za obdobje 2009-2014
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.
Izkušnje držav članic z Direktivo 2009/41/ES Evropskega parlamenta in Sveta z dne 6. maja 2009 o uporabi gensko spremenjenih mikroorganizmov v zaprtih sistemih (prenovitev) za obdobje 2009-2014.
A reinforcement of the European Centre for Disease Prevention and Control (ECDC) was also proposed.
Predlagana je bila tudi okrepitev Evropskega centra za preprečevanje in obvladovanje bolezni (ECDC).
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 312 thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 312 Pogodbe,
This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.
Ta uredba začne veljati na dan objave v Uradnem listu Evropske unije.
The present proposal has no immediate budgetary implications.
Predlog neposredno ne vpliva na proračun.
[8: OJ C , , p.
[8: UL C , , p.
This amendment of Regulation No 1311/2013 should enter into force at the latest on the same day as the adoption of this Draft Amending Budget.
Ta sprememba Uredbe št. 1311/2013 bi morala začeti veljati najpozneje na dan sprejetja tega predloga spremembe proračuna.
The Commission proposes to delete the references to "youth and employment", and "for migration and security measures" from the wording of the relevant Articles.
Komisija predlaga črtanje sklicevanja na „mlade in zaposlovanje" ter „migracije in varnostne ukrepe" iz besedila zadevnih členov.
Member States are also facing increased demands on state resources to finance the public health systems and maintain public services.
Države članice se soočajo tudi z večjimi potrebami po državnih sredstvih za financiranje sistemov javnega zdravstva in ohranjanje javnih storitev.
Economic activities are disrupted causing liquidity constraints and a severe deterioration in the financial situation of economic actors (enterprises, and in particular SMEs).
Gospodarske dejavnosti so motene, kar povzroča likvidnostne omejitve in resno načenja finančni položaj gospodarskih akterjev (podjetij in zlasti MSP).
The availability of special instruments for 2020 is presented in the technical adjustment of the MFF for 2020.
Razpoložljivost posebnih instrumentov za leto 2020 je predstavljena v tehnični prilagoditvi večletnega finančnega okvira za leto 2020.
HAS ADOPTED THIS REGULATION:
SPREJELA NASLEDNJO UREDBO:
The outbreak represents a severe public health emergency for citizens, societies and economies.
Izbruh pomeni izjemne izredne razmere na področju javnega zdravja za državljane, družbe in gospodarstva.
Acting in accordance with a special legislative procedure,
v skladu s posebnim zakonodajnim postopkom,
(3) It is proposed to mobilise the Global Margin for Commitments as soon as possible, in order allow for its rapid use in 2020, as proposed in Draft Amending Budget No 2/2020.
(3) Predlaga se čimprejšnja sprostitev skupne razlike v okviru obveznosti, da se omogoči njena hitra uporaba v letu 2020, kot je predlagano v predlogu spremembe proračuna št. 2/2020.
Amendments provided in this Regulation are limited to the change of the purpose of the use of the Global margin for commitments and do not increase financial obligations.
Spremembe, predvidene v tej uredbi, so omejene na spremembo namena uporabe skupne razlike v okviru obveznosti in ne povečujejo finančnih obveznosti.
(1) The COVID-19 outbreak and the associated public health crisis, which require extraordinary measures to be taken, has put great pressure on the available financial resources within and outside the MFF ceilings.
(1) Izbruh COVID-19 in z njim povezana javnozdravstvena kriza, ki zahtevata izredne ukrepe, sta povzročila velik pritisk na razpoložljiva finančna sredstva znotraj in zunaj zgornjih meja večletnega finančnega okvira.
The COVID-19 outbreak has affected the society and economy in the European Union in a dramatic way requiring the Member States to adopt exceptional measures.
Izbruh COVID-19 je močno vplival na družbo in gospodarstvo v Evropski uniji, zaradi česar so morale države članice sprejeti izredne ukrepe.
A reinforcement of the European Union Civil Protection Mechanism/rescEU was proposed, to coordinate joint procurement and increase the stock of medicines, personal protective equipment and medical products, to repatriate European citizens stranded outside the EU.
Predlagana je bila okrepitev mehanizma Unije na področju civilne zaščite/rescEU za usklajevanje skupnega javnega naročanja in povečanje zalog zdravil, osebne zaščitne opreme in medicinskega materiala ter repatriacijo evropskih državljanov, ki so obtičali zunaj EU.
Margins left available below the MFF ceilings for commitment appropriations shall constitute a Global Margin for Commitments, to be made available over and above the ceilings established in the MFF for the years 2016 to 2020.'
Razpoložljive razlike v okviru zgornjih mej večletnega finančnega okvira za odobritve za prevzem obveznosti tvorijo skupno razliko v okviru obveznosti, ki je na razpolago nad zgornjimi mejami, določenimi v večletnem finančnem okviru za leta 2016 do 2020."
‘The commitment appropriations may be entered in the budget over and above the ceilings of the relevant headings laid down in the MFF where it is necessary to use the resources from the Emergency Aid Reserve, the European Union Solidarity Fund, the Flexibility Instrument, the European Globalisation Adjustment Fund, the Contingency Margin, the specific flexibility to tackle youth unemployment and strengthen research and the global margin for commitments in accordance with Council Regulation (EC) No 2012/2002 (*), Regulation (EU) No 1309/2013 of the European Parliament and of the Council (**), and the Interinstitutional Agreement on budgetary discipline, on cooperation in budgetary matters and on sound financial management (***).
„V proračun se lahko vključijo odobritve za prevzem obveznosti nad zgornjimi mejami ustreznih razdelkov iz večletnega finančnega okvira, kadar je treba uporabiti sredstva iz rezerve za nujno pomoč, Solidarnostnega sklada Evropske unije, instrumenta prilagodljivosti, Evropskega sklada za prilagoditev globalizaciji, varnostne rezerve, posebne prožnosti za reševanje brezposelnosti mladih in krepitev raziskav ter skupne razlike v okviru obveznosti v skladu z Uredbo Sveta (ES) št. 2012/2002 (*), Uredbo (EU) št. 1309/2013 Evropskega parlamenta in Sveta (**) ter Medinstitucionalnim sporazumom o proračunski disciplini, sodelovanju v proračunskih zadevah in dobrem finančnem poslovodenju (***).
Having regard to the consent of the European Parliament,
ob upoštevanju odobritve Evropskega parlamenta,