natgillin/translations-raw huggingface dataset:
In order to ensure a high level of protection, the containment and other protective measures applied to a contained use must correspond to the classification of the contained use.
Za zagotovitev visoke stopnje varstva morajo zadrževalni in drugi varstveni ukrepi pri uporabi v zaprtem sistemu ustrezati razvrstitvi uporabe v zaprtem sistemu.
Where there is any uncertainty, the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data.
V primeru negotovosti naj bi se uporabljali zadrževalni in drugi varstveni ukrepi, primerni za višjo razvrstitev, dokler manj strogi ukrepi niso upravičeni na podlagi ustreznih podatkov.
For all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in accordance with relevant Community legislation.
Za vse dejavnosti, ki vključujejo GSM, bi morala veljati načela dobre mikrobiološke prakse ter varnosti in higiene pri delu, skladno z ustrezno zakonodajo Skupnosti.
Appropriate containment measures should be applied at the various stages of an operation to control emissions and the disposal of material from contained uses of GMMs, and to prevent accidents.
Na različnih stopnjah postopka bi morali biti uporabljeni ustrezni zadrževalni ukrepi za nadzor emisij in odstranjevanja materiala, nastalega pri uporabah GSM v zaprtem sistemu, in za preprečevanje nesreč.
Any person, before undertaking for the first time the contained use of a GMM in a particular installation, should forward a notification to the competent authority so that the authority may satisfy itself that the proposed installation is appropriate for the purposes of carrying out the activity in a manner that does not present a hazard to human health and the environment.
Osebe, ki želijo v določenem obratu prvič uporabljati GSM v zaprtem sistemu, bi morali pristojnemu organu predložiti prijavo, tako da se organ lahko prepriča, da je predlagani obrat primeren za izvajanje dejavnosti tako, da ne pomeni tveganja za zdravje ljudi in okolje.
It is also necessary to establish appropriate procedures for the case-by-case notification of specific operations involving the contained use of GMMs, taking account of the degree of risk involved.
Nadalje je treba predvideti ustrezne postopke za prijavo posebnih postopkov, ki vključujejo uporabo GSM v zaprtih sistemih, in to za vsak primer posebej ob upoštevanju stopnje tveganja.
In the case of operations involving high risk, the consent of the competent authority should be given.
Postopke, ki vključujejo velika tveganja, bi moral odobriti pristojni organ.
The containment and other protective measures applied to contained uses should be reviewed periodically.
Zadrževalni ukrepi in drugi varstveni ukrepi pri uporabi v zaprtem sistemu bi se morali redno pregledovati.
It may be considered appropriate to consult the public on the contained use of GMMs.
Utegnilo bi biti primerno, da bi se o uporabi GSM v zaprtih sistemih posvetovali z javnostjo.
People employed in contained uses should be consulted in accordance with the requirements of relevant Community legislation, in particular Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) [6].
Z ljudmi, zaposlenimi pri uporabi v zaprtem sistemu, bi se morali posvetovati skladno z zahtevami ustrezne zakonodaje Skupnosti, zlasti Direktive 2000/54/ES Evropskega parlamenta in Sveta z dne 18. septembra 2000 o varovanju delavcev pred tveganji zaradi izpostavljenosti biološkim dejavnikom pri delu (sedma posebna direktiva v smislu člena 16(1) Direktive 89/391/EGS) [6].
Appropriate measures should be taken to inform any person liable to be affected by an accident on all matters relating to safety.
Treba bi bilo sprejeti ustrezne ukrepe za obveščanje oseb, ki bi jih lahko nesreča prizadela, o vseh zadevah v zvezi z varnostjo.
Emergency plans should be established to deal effectively with accidents.
Treba bi bilo pripraviti učinkovite načrte ukrepov za primere nesreč.
If an accident occurs, the user should immediately inform the competent authority and communicate the information necessary for assessing the impact of that accident and for taking the appropriate action.
Ob nesreči bi moral uporabnik nemudoma obvestiti pristojni organ in sporočiti podatke, s katerimi lahko oceni vplive te nesreče in sprejme ustrezne ukrepe.
It is appropriate for the Commission, in consultation with the Member States, to establish a procedure for the exchange of information on accidents and for the Commission to set up a register of such accidents.
Za Komisijo je primerno, da po posvetovanju z državami članicami določi postopek za izmenjavo informacij o nesrečah in vzpostavi register takih nesreč.
The contained use of GMMs throughout the Community should be monitored, and to this end Member States should supply certain information to the Commission.
Uporaba GSM v zaprtih sistemih v vsej Skupnosti bi morala biti spremljana in nadzorovana in zato bi morale države članice Komisiji zagotoviti določene informacije.
In order to be considered safe for human health and the environment, GMMs should meet the list of criteria as defined in Annex II, Part B. To take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of that list, it is appropriate for the Council to revise those criteria, which should, where necessary, be supplemented by guidance notes to facilitate their application.
Da bi GSM veljali za varne za zdravje ljudi in okolje, bi morali izpolnjevati merila iz dela B Priloge II. Ob upoštevanju hitrosti napredka biotehnologije, narave meril, ki jih je treba razviti, in omejenega obsega tega seznama je primerno, da Svet preveri ta merila, katera je treba, kjer je to potrebno, ustrezno dopolniti s podrobnimi smernicami za lažjo uporabo teh meril.
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [7].
Ukrepi, potrebni za izvajanje in prilagoditev te direktive tehničnemu napredku, bi se morali sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [7].
In particular, the Commission should be empowered to adopt the amendments necessary to adapt Annexes II, III, IV and V to technical progress, and to adapt Annex II, Part C. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Komisiji bi bilo treba podeliti pooblastila zlasti za sprejetje sprememb, potrebnih za prilagoditev prilog II, III, IV in V tehničnemu napredku ter za prilagoditev dela C Priloge II. Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te direktive, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
The new elements introduced into this Directive concern only the committee procedures.
Nove določbe te direktive zadevajo samo postopke v odborih.
They therefore do not need to be transposed by the Member States.
Zato ni treba, da jih države članice prenesejo v nacionalni pravni red.
This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex VI, Part B,
Ta direktiva ne bi smela posegati v obveznosti držav članic glede rokov za prenos v nacionalno pravo direktiv, ki so določeni v delu B Priloge VI –
This Directive lays down common measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment.
Ta direktiva določa skupne ukrepe za uporabo gensko spremenjenih mikroorganizmov v zaprtih sistemih z namenom varovanja zdravja ljudi in okolja.
‘micro-organism’ means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture;
„mikroorganizem“ pomeni katero koli mikrobiološko enoto, celično ali necelično, ki je sposobna razmnoževanja ali prenosa genskega materiala, vključno z virusi, viroidi ter živalskimi in rastlinskimi celicami v kulturi;
‘genetically modified micro-organism’ (GMM) means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; within the terms of this definition:
„gensko spremenjen mikroorganizem“ (GSM) pomeni mikroorganizem, v katerem je bil genski material spremenjen na način, ki se ne zgodi naravno s križanjem in/ali naravno rekombinacijo; v okviru te opredelitve:
genetic modification occurs at least through the use of the techniques listed in Annex I, Part A;
se genska sprememba zgodi najmanj z uporabo metod, navedenih v delu A Priloge I;
the techniques listed in Annex I, Part B, are not considered to result in genetic modification;
metode, navedene v delu B Priloge I, se ne štejejo, da imajo za posledico genske spremembe;
‘contained use’ means 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, and to provide a high level of safety for, the general population and the environment;
„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;
‘accident’ means any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment;
„nesreča“ pomeni vsak dogodek, ki ima za posledico pomembno in nenamerno sproščanje GSM med njihovo uporabo v zaprtem sistemu, ki bi lahko pomenilo takojšnjo ali kasnejšo nevarnost za zdravje ljudi ali okolje;
‘user’ means any natural or legal person responsible for the contained use of GMMs;
„uporabnik“ pomeni vsako fizično ali pravno osebo, odgovorno za uporabo GSM v zaprtem sistemu;
‘notification’ means the presentation of the requisite information to the competent authorities of a Member State.
„prijava“ pomeni predložitev zahtevanih podatkov pristojnim organom države članice.
Without prejudice to Article 4(1), this Directive shall not apply:
Brez poseganja v člen 4(1), se ta direktiva ne uporablja:
where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A; or
kadar do genske spremembe pride zaradi uporabe metod/načinov iz dela A Priloge II; ali
for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety for human health and the environment.
za uporabo v zaprtem sistemu le tistih GSM, ki izpolnjujejo merila iz dela B Priloge II in so zato varni za zdravje ljudi in okolje.
These types of GMMs shall be listed in Annex II, Part C.
Te vrste GSM se navedejo v delu C Priloge II.
Article 4(3) and (6) and Articles 5 to 11 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air.
Člen 4(3) in (6) ter členi 5 do 11 se ne uporabljajo za prevoz GSM po cesti, železnici, celinskih plovnih poteh, morju ali zraku.
This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Directive 2001/18/EC or pursuant to other Community legislation which provides for a specific environmental risk assessment similar to that laid down in that Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market.
Ta direktiva se ne uporablja za shranjevanje, gojenje, prenos in prevoz, uničevanje, odstranjevanje ali uporabo GSM, ki so bili dani v promet v skladu z Direktivo 2001/18/ES ali na podlagi druge zakonodaje Skupnosti, ki predvideva posebno oceno tveganja za okolje, podobno tisti, ki je določena z navedeno direktivo, če je uporaba v zaprtem sistemu v skladu s pogoji, če obstajajo, za odobritev za dajanje v promet.
Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs.
Države članice zagotovijo sprejetje vseh ustreznih ukrepov za izognitev škodljivim učinkom na zdravje ljudi in okolje, ki bi lahko nastali zaradi uporabe GSM v zaprtem sistemu.
To that end, the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that those contained uses may pose, using as a minimum the elements of assessment and the procedure set out in Annex III, Sections A and B.
V ta namen uporabnik izvede oceno uporab v zaprtem sistemu glede na tveganje za zdravje ljudi in okolje, ki ga take uporabe v zaprtem sistemu lahko predstavljajo, in pri tem uporabi vsaj tiste elemente ocene in postopka, ki so določeni v oddelkih A in B Priloge III.
The assessment referred to in paragraph 2 shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with Article 5:
Glede na oceno iz odstavka 2 se uporabe v zaprtem sistemu dokončno razvrstijo v enega od štirih razredov po postopku, določenem v Prilogi III, na podlagi česar se v skladu s členom 5 določi stopnja zadrževanja:
Class 1 activities of no or negligible risk, that is to say activities for which level 1 containment is appropriate to protect human health and the environment.
Razred 1 Dejavnosti brez tveganja ali z zanemarljivim tveganjem, to so dejavnosti, za katere je primerna 1. stopnja zadrževanja za varovanje zdravja ljudi in okolja.
Class 2 activities of low risk, that is to say activities for which level 2 containment is appropriate to protect human health and the environment.
Razred 2 Dejavnosti z majhnim tveganjem, to so dejavnosti, za katere je primerna 2. stopnja zadrževanja za varovanje zdravja ljudi kot tudi okolja.
Class 3 activities of moderate risk, that is to say activities for which level 3 containment is appropriate to protect human health and the environment.
Razred 3 Dejavnosti z zmernim tveganjem, to so dejavnosti, za katere je primerna 3. stopnja zadrževanja za varovanje zdravja ljudi in okolja.
Class 4 activities of high risk, that is to say activities for which level 4 containment is appropriate to protect human health and the environment.
Razred 4 Dejavnosti z velikim tveganjem, to so dejavnosti, za katere je primerna 4. stopnja zadrževanja za varovanje zdravja ljudi in okolja.
Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless, by agreement with the competent authority, there is sufficient evidence to justify the application of less stringent measures.
Če obstaja dvom o tem, kateri razred je primeren za predlagano uporabo v zaprtem sistemu, je treba uporabiti strožje varstvene ukrepe, razen če zadostni dokazi sporazumno s pristojnim organom upravičujejo uporabo manj strogih ukrepov.
The assessment referred to in paragraph 2 shall especially take into account the question of disposal of waste and effluents.
Ocena iz odstavka 2 upošteva zlasti odstranjevanje odpadkov in odpadnih vod.
Where appropriate, the safety measures needed in order to protect human health and the environment shall be implemented.
Kadar je to potrebno, se izvedejo potrebni varnostni ukrepi z namenom varovanja zdravja ljudi in okolja.
A record of the assessment referred to in paragraph 2 shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 6, 8 and 9 or on request.
Uporabnik hrani evidenco o oceni iz odstavka 2 in jo v primerni obliki predloži pristojnemu organu kot del prijave v skladu s členi 6, 8 in 9 ali na zahtevo.
Save to the extent that point 2 of Annex IV allows other measures to be applied, the user shall apply the general principles and the appropriate containment and other protective measures set out in Annex IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured.
Uporabnik uporablja, razen če točka 2 Priloge IV dopušča uporabo drugih ukrepov, splošna načela in primerne zadrževalne in druge varstvene ukrepe, določene v Prilogi IV, ki ustrezajo razredu uporabe v zaprtem sistemu, tako da ohrani izpostavljenost delovnega mesta in okolja kakršnim koli GSM na najnižji razumno izvedljivi ravni, in da je zagotovljena visoka stopnja varnosti.
The assessment referred to in Article 4(2) and the containment and other protective measures applied shall be reviewed periodically, and forthwith if:
Ocena iz člena 4(2) ter zadrževalni in drugi uporabljeni varstveni ukrepi se pregledujejo v rednih časovnih presledkih in takoj, če:
the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct; or
uporabljeni zadrževalni ukrepi niso več primerni ali če razred, v katerega so bile razvrščene uporabe v zaprtem sistemu, ni več ustrezen; ali
there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge.
če obstaja sum, da ocena z vidika novega znanstvenega in strokovnega znanja ni več ustrezna.
When premises are to be used for the first time for contained uses, the user shall be required, before commencing such use, to submit to the competent authorities a notification containing at least the information listed in Annex V, Part A.
Ko se prostori prvič uporabijo za uporabe v zaprtem sistemu, mora uporabnik pri pristojnih organih pred začetkom take uporabe vložiti prijavo, ki vsebuje vsaj podatke iz dela A Priloge V.
Following the notification referred to in Article 6, subsequent class 1 contained use may proceed without further notification.
Po prijavi iz člena 6 se nadaljnja uporaba v zaprtem sistemu iz razreda 1 lahko izvaja brez dodatne prijave.
Users of GMMs in class 1 contained uses shall be required to keep the record of each assessment referred to in Article 4(6), which shall be made available to the competent authority on request.
Uporabniki GSM pri uporabah v zaprtem sistemu iz razreda 1 hranijo evidenco o vsaki oceni iz člena 4(6), ki mora biti na voljo pristojnemu organu na zahtevo.
For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part B shall be submitted.
Za prvo in vse naslednje uporabe v zaprtem sistemu iz razreda 2, ki se izvaja v prostorih, ki so bili prijavljeni v skladu s členom 6, je treba predložiti prijavo, ki vsebuje podatke iz dela B Priloge V.
If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification.
Če je bila za prostore že predložena prijava za uporabe v zaprtem sistemu iz razreda 2 ali višjega razreda in so bile izpolnjene vse s tem povezane zahteve za odobritev, se lahko uporaba v zaprtem sistemu iz razreda 2 izvaja takoj po vloženi novi prijavi.
However, the applicant may himself request from the competent authority a decision on the grant of a formal authorisation.
Vlagatelj pa lahko sam zahteva odločitev o dovoljenju od pristojnega organa.
The decision must be made within a maximum of 45 days from the notification.
Odločitev mora biti sprejeta najpozneje v 45 dneh od prijave.
If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to in paragraph 1, or earlier with the agreement of the competent authority.
Če za prostore še ni bila predložena nobena prijava za uporabe v zaprtem sistemu iz razreda 2 ali višjega razreda, se lahko uporaba v zaprtem sistemu iz razreda 2, če pristojni organ ne nasprotuje, začne izvajati 45 dni po predložitvi prijave iz odstavka 1 ali prej s privolitvijo pristojnega organa.
For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 6, a notification containing the information listed in Annex V, Part C shall be submitted.
Za prvo in vse naslednje uporabe v zaprtem sistemu iz razreda 3 ali razreda 4, ki naj bi se izvajale v prostorih, za katere je bila predložena prijava v skladu s členom 6, se predloži prijava, ki vsebuje podatke iz dela C Priloge V.
A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority, which shall communicate its decision in writing:
Uporaba v zaprtem sistemu iz razreda 3 ali višjega razreda se ne sme izvajati brez predhodne odobritve pristojnega organa, ki svojo odločitev pisno sporoči:
at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed;
najkasneje v 45 dneh po predložitvi nove prijave, če gre za prostore, za katere je že bila predložena prijava za uporabe v zaprtem sistemu iz razreda 3 ali višjega razreda in so bile izpolnjene vse s tem povezane zahteve za odobritev uporabe v zaprtem sistemu enakega ali višjega razreda, ki naj bi se izvajala;
at the latest 90 days after submission of the notification, in other cases.
v drugih primerih najkasneje v 90 dneh po predložitvi prijave.
Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Articles 6, 8 and 9.
Države članice določijo organ ali organe, pristojne za izvajanje ukrepov, ki jih sprejmejo v skladu s to direktivo, ter za sprejemanje in potrjevanje prijav iz členov 6, 8 in 9.
The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the information given, the correctness of the assessment referred to in Article 4(2) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures.
Pristojni organi preučijo skladnost prijav z zahtevami te direktive, točnost in popolnost danih podatkov, pravilnost ocene iz člena 4(2) in razred uporabe v zaprtem sistemu in, kadar je primerno, ustreznost zadrževalnih in drugih varstvenih ukrepov, ravnanja z odpadki in ukrepov za primer nesreče.
If necessary, the competent authority may:
Če je treba, lahko pristojni organ: