natgillin/translations-raw huggingface dataset:
GMMs that do not meet the above criteria may not be included in Part C.
GSM, ki ne izpolnjujejo navedenih meril, ne morejo biti uvrščeni v del C.
Types of GMMs which meet the criteria listed in Part B:
Vrste GSM, ki izpolnjujejo merila, navedena v delu B:
… (to be completed in accordance with the regulatory procedure with scrutiny referred to in Article 20(2))
… (dopolniti v skladu z regulativnim postopkom s pregledom iz člena 20(2))
Principles to be followed for the assessment referred to in Article 4(2)
Načela, ki jih je treba upoštevati pri oceni iz člena 4(2)
This Annex describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Article 4(2).
Ta priloga na splošno opisuje merila, ki jih je potrebno izpolniti, in postopek, po katerem se pripravi oceno iz člena 4(2).
Technical guidance notes [1] may be developed in accordance with the regulatory procedure referred to in Article 20(3) in order to facilitate the implementation and explanation of this Annex, in particular as regards Section B.A.
V skladu z regulativnim postopkom iz člena 20(3) se lahko izdelajo tehnične smernice [1], ki bodo v pomoč pri izvajanju in razlagi te priloge, zlasti glede dela B.A.
Elements of assessment
Elementi ocene
The following should be considered as potentially harmful effects:
Kot možne škodljive učinke je treba upoštevati:
disease to humans, including allergenic or toxic effects,
bolezni ljudi, vključno z alergenimi ali strupenimi učinki,
disease to animals or plants,
bolezni živali ali rastlin,
deleterious effects due to the impossibility of treating a disease or providing an effective prophylaxis,
škodljive učinke nastale zato, ker bolezni ni mogoče zdraviti ali ni mogoče zagotoviti učinkovite zaščite,
deleterious effects due to establishment or dissemination in the environment,
škodljive učinke zaradi uveljavitve ali razširjanja v okolje,
deleterious effects due to the natural transfer of inserted genetic material to other organisms.
škodljive učinke zaradi naravnega prenosa vnesenega genskega materiala v druge organizme.
The assessment referred to in Article 4(2) should be based on the following:
Ocena iz člena 4(2) mora temeljiti na:
the identification of any potentially harmful effects, in particular those associated with:
ugotavljanju vseh možnih škodljivih učinkov, predvsem tistih povezanih:
the recipient micro-organism;
s prejemnim mikroorganizmom;
the genetic material inserted (originating from the donor organism);
z vključenim genskim materialom (izvirajočim iz organizma dajalca);
the vector;
z vektorjem;
the donor micro-organism (as long as the donor micro-organism is used during the operation);
z mikroorganizmom dajalcem (če se mikroorganizem dajalec uporablja med postopkom);
the resulting GMM;
z nastalimi GSM;
the characteristics of the activity;
značilnosti dejavnosti;
the severity of the potentially harmful effects;
teži možnih škodljivih učinkov;
the likelihood of the potentially harmful effects being realised.
verjetnosti sproščanja možnih škodljivih učinkov.
The first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, and any harmful properties associated with the vector or inserted material, including any alteration in the recipient’s existing properties.
Na prvi stopnji ocenjevanja je treba prepoznati škodljive lastnosti prejemnika, in kjer je to potrebno, mikroorganizma dajalca in vse škodljive lastnosti povezane z vektorjem ali vnesenim materialom vključno s katero koli spremembo že obstoječih lastnosti prejemnika.
In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Article 4(3):
Na splošno bi samo tisti GSM, ki kažejo naslednje značilnosti, veljali za primerne za vključitev v razred 1, kot je opredeljeno v členu 4(3):
the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants [2];
ni verjetno, da bi prejemnik ali starševski mikroorganizem povzročil bolezen pri ljudeh, živalih ali rastlinah [2];
the nature of the vector and the insert is such that they do not endow the GMM with a phenotype likely to cause disease to humans, animals or plants [2] This would only apply to animals and plants in the environment likely to be exposed.
narava vektorja in vključka je takšna, da GSM ne daje takega fenotipa, ki bi verjetno povzročil bolezen pri ljudeh, živalih ali rastlinah [2] To bi se uporabljalo samo za živali in rastline v okolju, ki bi bilo verjetno izpostavljeno.
, or likely to have deleterious effects on the environment;
ali škodljive učinke v okolju;
the GMM is unlikely to cause disease to humans, animals or plants [2] This would only apply to animals and plants in the environment likely to be exposed.
ni verjetno, da bi GSM povzročil bolezen pri ljudeh, živalih ali rastlinah [2] To bi se uporabljalo samo za živali in rastline v okolju, ki bi bilo verjetno izpostavljeno.
and is unlikely to have deleterious effects on the environment.
ali imel škodljive učinke na okolje.
In order to obtain the necessary information to implement this process the user may firstly take into account relevant Community legislation (in particular Directive 2000/54/EC).
Da bi pridobil potrebne podatke za izvajanje tega postopka, lahko uporabnik najprej upošteva ustrezno zakonodajo Skupnosti (zlasti Direktivo 2000/54/ES).
International or national classification schemes (e.g. World Health Organisation, National Institutes of Health) and their revisions due to new scientific knowledge and technical progress may also be considered.
Lahko se upošteva tudi mednarodne ali nacionalne sisteme razvrščanja (npr. Svetovno zdravstveno organizacijo, državne zdravstvene inštitute) ter njihove popravke zaradi novega znanstvenega znanja in tehničnega napredka.
These schemes concern natural micro-organisms and as such are usually based on the ability of micro-organisms to cause disease to humans, animals or plants and on the severity and transmissibility of the disease likely to be caused.
Ti sistemi se nanašajo na naravne mikroorganizme in kot taki navadno temeljijo na sposobnosti mikroorganizmov, da povzročajo bolezni pri ljudeh, živalih ali rastlinah, in na teži in prenosljivosti bolezni, ki bi jo verjetno povzročili.
Directive 2000/54/EC classifies micro-organisms, as biological agents, into four classes of risk on the basis of potential effects on a healthy human adult.
Direktiva 2000/54/ES razvršča mikroorganizme kot biološke dejavnike v štiri razrede tveganja na podlagi možnih učinkov na zdravega odraslega človeka.
These classes of risk can be used as guidance for the purposes of categorisation of the contained use activities in the four classes of risk referred to in Article 4(3).
Te razrede tveganja se lahko uporabi kot smernice pri razvrščanju dejavnosti uporabe v zaprtem sistemu v štiri razrede tveganja iz člena 4(3).
The user may also take into consideration classification schemes referring to plant and animal pathogens (which are usually established on a national basis).
Uporabnik lahko upošteva tudi sisteme razvrščanja, ki se nanašajo na rastlinske in živalske patogene (običajno vzpostavljene v državi).
The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures.
Navedeni sistemi razvrščanja samo okvirno opredelijo razred tveganja dejavnosti in ustrezen sklop zadrževalnih in kontrolnih ukrepov.
The hazard identification process carried out in accordance with points 3 to 5 should lead to the identification of the level of risk associated with the GMM.
Postopek prepoznavanja nevarnosti, izveden v skladu s točkami 3 do 5, naj bi pripeljal do določitve stopnje tveganja povezanega z GSM.
Selection of the containment and other protective measures should then be made on the basis of the level of risk associated with the GMMs together with consideration of:
Izbor zadrževalnih in drugih varstvenih ukrepov naj bi temeljil na stopnji tveganja, povezanega z GSM ob upoštevanju:
the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro-organisms used in the contained use activity);
značilnosti okolja, ki bi bilo verjetno izpostavljeno (npr. ali so v okolju, ki bi lahko bilo izpostavljeno GSM, znani živi organizmi, na katere bi mikroorganizmi, uporabljeni pri dejavnostih uporabe v zaprtem sistemu, lahko škodljivo učinkovali);
the characteristics of the activity (e.g. its scale and/or nature);
značilnosti dejavnosti (npr. njen obseg in/ali vrsta);
any non-standard operations (e.g. the inoculation of animals with GMMs; use of equipment likely to generate aerosols).
vsak nestandardni postopek (npr. inokulacija živali z GSM; uporaba opreme, ki bi lahko povzročila nastanek aerosolov).
Consideration of items (i) to (iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the GMM as identified under point 6.
Upoštevanje postavk (i) do (iii) pri posamezni dejavnosti lahko poveča ali zmanjša stopnjo tveganja, povezanega z GSM, kakor je opredeljena v točki 6, ali jo ohrani nespremenjeno.
The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 4(3).
Analiza, ki je izvedena po zgoraj opisanem postopku, bo pripeljala do razvrstitve dejavnosti v enega od razredov, opisanih v členu 4(3).
The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Article 4(2).
Končna razvrstitev uporabe v zaprtem sistemu mora biti potrjena s pregledom zaključne ocene iz člena 4(2).
See Commission Decision 2000/608/EC of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III to Directive 90/219/EEC on the contained use of genetically modified micro-organisms (OJ L 258, 12.10.2000, p. 43).
Glej Odločbo Komisije 2000/608/ES z dne 27. septembra 2000 o smernicah za ocenjevanje tveganja v skladu s Prilogo III k Direktivi 90/219/EGS o uporabi gensko spremenjenih mikroorganizmov v zaprtih sistemih (UL L 258, 12.10.2000, str. 43).
This would only apply to animals and plants in the environment likely to be exposed.
To bi se uporabljalo samo za živali in rastline v okolju, ki bi bilo verjetno izpostavljeno.
CONTAINMENT AND OTHER PROTECTIVE MEASURES
ZADRŽEVALNI IN DRUGI VARSTVENI UKREPI
These tables present the normal minimum requirements and measures necessary for each level of containment.
Te tabele predstavljajo običajne najmanjše zahteve in ukrepe potrebne za vsako stopnjo zadrževanja.
Containment is also achieved through the use of good work practices, training, containment equipment and special installation design.
Zadrževanje je doseženo tudi z uporabo dobre delovne prakse, usposabljanjem, opremo za zadrževanje in s posebno zasnovo obrata.
For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene shall apply:
Pri vseh aktivnostih, ki vključujejo GSM, se uporabljajo načela dobre mikrobiološke prakse in naslednja načela dobre varnosti in higiene pri delu:
to keep workplace and environmental exposure to any GMM to the lowest practicable level;
obdržati izpostavljenost delovnega mesta in okolja kateremu koli GSM na najnižji izvedljivi ravni;
to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary;
izvajati tehnično-tehnološke ukrepe pri viru in jih, če je to potrebno, dopolniti z ustrezno osebno varovalno obleko in opremo;
to test adequately and maintain control measures and equipment;
ustrezno preverjati in vzdrževati kontrolne ukrepe in opremo;
to test, when necessary, for the presence of viable process organisms outside the primary physical containment;
preverjati navzočnost za življenje sposobnih procesnih organizmov zunaj prvotnega fizičnega zaprtega sistema, če je potrebno;
to provide appropriate training of personnel;
zagotoviti ustrezno usposabljanje osebja;
to establish biological safety committees or subcommittees, if required;
ustanoviti odbore ali pododbore za biološko varnost, če je to potrebno;
to formulate and implement local codes of practice for the safety of personnel, as required;
izoblikovati in izvajati lokalne kodekse ravnanja za varnost osebja, kot je zahtevano;
where appropriate, to display biohazard signs;
namestiti znake za biološko nevarnost, kjer je to primerno;
to provide washing and decontamination facilities for personnel;
zagotoviti prostore za umivanje in dekontaminacijo za osebje;
to keep adequate records;
voditi ustrezne evidence;
to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area;
prepovedati prehranjevanje, pitje, kajenje, nanašanje kozmetičnih sredstev ali shranjevanje živil za prehrano ljudi v delovnem območju;
to prohibit mouth pipetting;
prepovedati pipetiranje z usti;
to provide written standard operating procedures where appropriate to ensure safety;
zagotoviti pisne standardne operativne delovne postopke, kjer je to potrebno za zagotovitev varnosti;
to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs;
imeti na voljo učinkovita razkužila in natančno določene postopke razkuževanja za primere razlitja GSM;
to provide safe storage for contaminated laboratory equipment and materials, when appropriate.
zagotoviti varno shranjevanje kontaminirane laboratorijske opreme in materiala, kjer je to primerno.
The titles of the tables are indicative:
Naslovi preglednic so okvirni:
Table I A presents minimum requirements for laboratory activities.
Tabela I A navaja najmanjše zahteve za laboratorijske aktivnosti.
Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs.
Tabela I B navaja dodatke in spremembe tabele I A za aktivnosti v rastlinjakih / rastnih komorah, ki vključujejo GSM.
Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs.
Tabela I C navaja dodatke in spremembe tabele I A za aktivnosti na živalih, ki vključujejo GSM.
Table II presents minimum requirements for activities other than laboratory activities.
Tabela II navaja najmanjše zahteve za vse aktivnosti, razen laboratorijskih.
In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level.
Morda bi bilo v posameznih primerih treba uporabiti kombinacijo ukrepov iste stopnje iz tabele I A in tabele II.
In some cases users may, with the agreement of the competent authority, not apply a specification under a particular containment level or combine specifications from two different levels.
V nekaterih primerih uporabnikom v dogovoru s pristojnim organom ni treba uporabiti posameznih tehničnih zahtev za določeno zadrževalno stopnjo ali pa lahko združuje tehnične zahteve dveh različnih stopenj.
In these tables ‘optional’ means that the user may apply these measures on a case-by-case basis, subject to the assessment referred to in Article 4(2).
V teh tabelah izraz „po izbiri“ pomeni, da se uporabnik lahko odloči za uporabo teh ukrepov za vsak primer posebej, ob upoštevanju ocene iz člena 4(2).
In implementing this Annex, Member States may in addition incorporate in the following tables the general principles set out in points 1 and 2, with a view to clarifying the requirements.
Države članice lahko pri izvajanju te priloge zaradi jasnosti zahtev v tabele dodatno vključijo še splošna načela iz točk 1 in 2.
Table I A
Tabela I A
Containment and other protective measures for laboratory activities
Zadrževalni in drugi varnostni ukrepi za laboratorijske aktivnosti
Specifications
Tehnične zahteve
Containment levels
Stopnje zadrževanja
Laboratory suite: isolation [1]
Laboratorijski oddelek: izolacija [1]
Not required
ni obvezno
Laboratory: sealable for fumigation
Laboratorij: možnost zatesnitve ob zaplinjenju
Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean
Površine, ki so odporne na vodo, kisline, baze, topila, razkužila, sredstva za dekontaminacijo in se jih lahko čisti
Required (bench)
obvezno (delovne površine)
Required (bench, floor)
obvezno (delovne površine, tla)
Required (bench, floor, ceiling, walls)
obvezno (delovne površine, tla, strop, stene)
Entry to lab via airlock [2]
Vstop v laboratorij skozi zračno zaporo [2]
Optional
po izbiri
Negative pressure relative to the pressure of the immediate environment
Podtlak glede na tlak v neposrednem okolju
Required except for [3]
obvezno razen za [3]
Extract and input air from the laboratory should be HEPA [4]-filtered
Izpust in dovod zraka v laboratorij naj bosta skozi filter HEPA [4]
Required (HEPA — extract air except for [3])
obvezno (HEPA – odvod zraka razen za [3])
Required (HEPA— input and extract air [5])
obvezno (HEPA – izpust in dovod zraka [5])
Microbiological safety post
Delovno mesto osebe odgovorne za mikrobiološko varnost
On site
na licu mesta
In the building
v stavbi
En suite [6]
na oddelku [6]
In lab = double-ended
v laboratoriju = z dvojno steno
System of work
Sistem dela
Biohazard sign on the door
Znak za biološko nevarnost na vratih
Specific measures to control aerosol dissemination
Posebni ukrepi za nadzor nad razširjanjem aerosolov
Required minimise
obvezno čim bolj zmanjšati
Required prevent
obvezno preprečiti
Suitable protective clothing and (optional) footwear
primerna varovalna obleka in (po izbiri) obutev
Complete change of clothing and footwear before entry and exit
pred vstopom in izstopom zamenjati vso obleko in obutev
Efficient vector control (e.g. for rodents and insects)
Učinkovit nadzor nad vektorji (npr. za glodavce in žuželke)
Inactivation of GMMs in effluent from hand-washing sinks or drains and showers and similar effluents
Inaktivacija GSM v odpadni vodi iz umivalnikov in prh ter podobnih odpadnih vod
Inactivation of GMMs in contaminated material and waste
Inaktivacija GSM v kontaminiranem materialu in odpadkih
Laboratory to contain its own equipment
Laboratorij mora imeti svojo opremo
An observation window or alternative is to be present so that occupants can be seen
Opazovalno okno ali druga rešitev, ki omogoča opazovanje ljudi v laboratoriju
Table I B
Tabela I B
Containment and other protective measures for glasshouses and growth-rooms
Zadrževalni in drugi varnostni ukrepi za rastlinjake in rastne komore
The terms ‘glasshouse’ and ‘growth-room’ refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment.
Pojma „rastlinjak“ in „rastna komora“ se nanašata na objekte s stenami, streho in tlemi, ki so zasnovani in uporabljani predvsem za gojenje rastlin v nadzorovanem in zavarovanem okolju.
All provisions of Table I A shall apply with the following additions/modifications:
Uporabljajo se vsa določila tabele I A, z naslednjimi dodatki/spremembami:
Building
Stavba
Glasshouse: permanent structure [7]
Rastlinjak: trajen objekt [7]
Entry via a separate room with two interlocking doors
Vstop preko ločenega prostora z avtomatskim sledilnim zapiranjem dvojnih vrat
Control of contaminated run-off water
Nadzor nad kontaminirano odtekajočo vodo
Minimise [8] run-off
čim bolj zmanjšati [8] odtok
Prevent run-off
preprečiti odtok
Measures to control undesired species such as insects, rodents, arthropods
Ukrepi za nadzor nad nezaželenimi vrstami, kot so žuželke, glodalci, členonožci
Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of GMMs
Pri prenašanju živega materiala med rastlinjakom / rastno komoro, zavarovanim objektom in laboratorijem je potrebno nadzorovati razširjanje GSM
Minimise dissemination
čim bolj zmanjšati razširjanje
Prevent dissemination
preprečiti razširjanje
Table I C
Tabela I C
Containment and other protective measures for activities in animal units
Zadrževalni in drugi varnostni ukrepi za dejavnosti v enotah za živali
Isolation of animal unit [9]
Izoliranost enot za živali [9]
Animal facilities [10] separated by lockable doors
Objekti za živali [10] ločeni z vrati, ki jih je mogoče zakleniti
Animal facilities designed to facilitate decontamination (waterproof and easily washable material (cages, etc.))
Objekti za živali zasnovani tako, da olajšujejo dekontaminacijo (material, ki je vodotesen in se lahko pere (kletke itd.))
Floor and/or walls easily washable
Tla in/ali stene, ki se lahko perejo
Required (floor)
obvezno (tla)
Required (floor and walls)
obvezno (tla in stene)
Animals kept in appropriate containment facilities such as cages, pens or tanks
Živali zaprte v ustreznih zaprtih objektih, kot so kletke, ograde ali bazeni
Filters on isolators or isolated room [11]
Filtri na izolatorjih ali izoliranih sobah [11]
Containment and other protective measures for other activities
Zadrževalni in drugi varnostni ukrepi za druge dejavnosti
Viable micro-organisms should be contained in a system which separates the process from the environment (closed system)
Za življenje sposobni mikroorganizmi naj se zadržujejo v sistemu, ki ločuje proces od okolja (zaprti sistem)
Control of exhaust gases from the closed system
Nadzor nad izpušnimi plini iz zaprtega sistema
Required, minimise dissemination
obvezno, čim bolj zmanjšati razširjanje
Required, prevent dissemination
obvezno, preprečiti razširjanje
Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system
Nadzor nad aerosoli med vzorčenjem, dodajanjem materiala v zaprti sistem ali prenos materiala v drug zaprt sistem
Inactivation of bulk culture fluids before removal from the closed system
Inaktivacija večje količine tekoče kulture pred odstranitvijo iz zaprtega sistema
Required, by validated means
obvezno, z validiranimi sredstvi
Seals should be designed so as to minimise or prevent release
Zatesnitev naj bi bila zasnovana tako, da čim bolj zmanjša ali prepreči sproščanje
No specific requirement
ni posebnih zahtev
The controlled area should be designed to contain spillage of the entire contents of the closed system
Nadzorovano območje naj bo zasnovano tako, da zadrži razlitje celotne vsebine zaprtega sistema
The controlled area should be sealable to permit fumigation
Nadzorovano območje naj bo mogoče zatesniti, da se omogoči zaplinjenje
Entry via airlock
Vstop skozi zračno zaporo
Required (bench if any)
obvezno (delovne površine, če so)
Required (bench if any, floor)
obvezno (delovne površine, če so, tla)
Specific measures to adequately ventilate the controlled area in order to minimise air contamination
Posebni ukrepi za ustrezno prezračevanje nadzorovanega območja, da se čim bolj zmanjša kontaminacija zraka
The controlled area should be maintained at an air pressure negative to the immediate surroundings
V nadzorovanem območju naj se vzdržuje podtlak glede na neposredno okolico
Extract and input air from the controlled area should be HEPA filtered
Izpust in dovod zraka iz nadzorovanega območja naj bosta skozi filter HEPA
Required (extract air, optional for input air)
obvezno (izpust zraka, po izbiri za dovod zraka)
Required (input and extract air)
obvezno (dovod in izpust zraka)
Closed systems should be located within a controlled area
Zaprti sistemi naj bodo na nadzorovanem območju
Access should be restricted to nominated personnel only
Dostop naj bo omejen samo na določeno osebje
Biohazard signs should be posted
Postavljeni naj bodo znaki za bio nevarnost
Personnel should shower before leaving the controlled area
Osebje naj se oprha, preden zapusti nadzorovano območje
Personnel should wear protective clothing
Osebje naj nosi varovalno obleko
Required (work clothing)
obvezno (delovna obleka)
Complete change before exit and entry
preobleka v celoti pred izstopom in vstopom