natgillin/translations-raw huggingface dataset:
The hazard identification only needs to be carried out at a level of detail necessary to identify where safety measures are expected to control the risks in accordance with one of the risk acceptance principles referred to in point 2.1.4.
Nevarnosti je treba ugotoviti le tako podrobno, kot je to potrebno za določitev, v katerih primerih lahko varnostni ukrepi nadzorujejo tveganja v skladu z enim od načel sprejemanja tveganja iz točke 2.1.4.
Iteration may be necessary between the risk analysis and the risk evaluation phases until a sufficient level of detail is reached for the identification of hazards.
Iteracija je lahko potrebna med analizo tveganja in fazami ovrednotenja tveganja, dokler se ne doseže ustrezna raven podrobnosti za določanje nevarnosti.
Whenever a code of practice or a reference system is used to control the risk, hazard identification may be limited to:
Če se za nadzor tveganj uporabi kodeks ravnanja ali referenčni sistem, se lahko ugotavljanje nevarnosti omeji na:
verification of the relevance of the code of practice or reference system;
preverjanje pomembnosti kodeksa ravnanj ali referenčnega sistema;
identification of the deviations from the code of practice or from the reference system.
ugotavljanje odstopanj od kodeksa ravnanj ali referenčnega sistema.
Use of codes of practice and risk evaluation
Uporaba kodeksov ravnanja in ovrednotenje tveganja
The proposer, with the support of other involved actors, shall analyse whether one, several or all hazards are appropriately covered by the application of relevant codes of practice.
Predlagatelj ob podpori drugih aktivnih udeležencev analizira, ali so ena ali več nevarnosti ali vse izmed njih ustrezno zajete z uporabo ustreznih kodeksov ravnanja.
They must be widely recognised in the railway domain.
biti morajo širše priznani na železniškem področju.
Upon request, they must be available to assessment bodies for them to either assess or, where relevant, mutually recognise, in accordance with Article 15(5), the suitability of both the application of the risk management process and of its results.
na zahtevo morajo biti na voljo ocenjevalnim organom za oceno ali, če je to potrebno, vzajemno priznanje v skladu s členom 15(5) primernosti tako uporabe postopka upravljanja s tveganji kot tudi njegovih rezultatov.
Where compliance with TSIs is required by Directive 2008/57/EC and the relevant TSI does not impose the risk management process established by this Regulation, the TSIs may be considered as codes of practice for controlling hazards, provided requirement (b) of point 2.3.2 is fulfilled.
Če se na podlagi Direktive 2008/57/ES zahteva skladnost s TSI in ustrezne TSI ne predpisujejo uporabe postopka upravljanja s tveganji, določenega s to uredbo, se lahko TSI štejejo za kodeks ravnanja za nadzor nevarnosti, če je izpolnjena zahteva (b) iz točke 2.3.2.
If one or more hazards are controlled by codes of practice fulfilling the requirements of point 2.3.2, then the risks associated with these hazards shall be considered acceptable.
Če se ena ali več nevarnosti nadzoruje s kodeksom ravnanja, ki izpolnjuje zahteve iz točke 2.3.2, veljajo tveganja, povezana s temi nevarnostmi, za sprejemljiva.
This means that:
To ima dve posledici:
these risks need not be analysed further;
teh tveganj ni treba nadalje analizirati;
the use of the codes of practice shall be registered in the hazard record as safety requirements for the relevant hazards.
uporaba kodeksa ravnanja se navede v evidenci nevarnosti kot varnostna zahteva za ustrezne nevarnosti.
Where an alternative approach is not fully compliant with a code of practice, the proposer shall demonstrate that the alternative approach pursued leads to at least the same level of safety.
Če alternativni pristop ni popolnoma v skladu s kodeksom ravnanja, predlagatelj dokaže, da zagotavlja vsaj enako stopnjo varnosti.
If the risk for a particular hazard cannot be made acceptable by the application of codes of practice, additional safety measures shall be identified by applying one of the two other risk acceptance principles.
Če tveganja za določeno nevarnost z uporabo kodeksa ravnanja ni mogoče zmanjšati na sprejemljivo raven, se z uporabo enega od ostalih dveh načel sprejemanja tveganja določijo dodatni varnostni ukrepi.
hazard identification in accordance with point 2.2.6;
ugotavljanje nevarnosti v skladu s točko 2.2.6;
registration of the use of the codes of practice in the hazard record in accordance with point 2.3.5;
navedbo uporabe kodeksov ravnanja v evidenco nevarnosti v skladu s točko 2.3.5;
documentation of the application of the risk management process in accordance with point 5;
dokumentiranje uporabe postopka upravljanja s tveganji v skladu s točko 5;
The proposer, with the support of other involved actors, shall analyse whether one, several or all hazards are appropriately covered by a similar system that could be taken as a reference system.
Predlagatelj ob podpori drugih aktivnih udeležencev analizira, ali so ena ali več nevarnosti ali vse izmed njih ustrezno zajete v podobnem sistemu, ki bi se lahko uporabljal kot referenčni sistem.
it has already been proven in-use to have an acceptable safety level and would therefore still qualify for approval in the Member State where the change is to be introduced;
v praksi se je že izkazalo, da je njegova raven varnosti zadovoljiva, in bi torej bil v državi članici, kjer se sprememba uvaja, odobren;
If the system under assessment deviates from the reference system, the risk evaluation shall demonstrate that the system under assessment reaches at least the same safety level as the reference system, applying another reference system or one of the two other risk acceptance principles.
Če sistem, ki se ocenjuje, odstopa od referenčnega sistema, se z ovrednotenjem tveganja dokaže, da sistem, ki se ocenjuje, dosega vsaj enako raven varnosti kot referenčni sistem z uporabo drugega referenčnega sistema ali enega od ostalih dveh načel sprejemanja tveganja.
If at least the same safety level as the reference system cannot be demonstrated, additional safety measures shall be identified for the deviations, applying one of the two other risk acceptance principles.
Če ni mogoče dokazati vsaj enake ravni varnosti, kot jo ima referenčni sistem, se za odstopanja določijo dodatni varnostni ukrepi z uporabo enega od ostalih dveh načel sprejemanja tveganja.
If the hazards are not covered by one of the two risk acceptance principles laid down in points 2.3 and 2.4, the demonstration of risk acceptability shall be performed by explicit risk estimation and evaluation.
Če nevarnosti niso zajete v enem od dveh načel sprejemanja tveganja iz točk 2.3 in 2.4, se sprejemljivost tveganja dokaže z eksplicitno oceno in ovrednotenjem tveganja.
The acceptability of the estimated risks shall be evaluated using risk acceptance criteria either derived from or based on requirements contained in Union legislation or in notified national rules.
Sprejemljivost ovrednotenih tveganj se ovrednoti z uporabo meril sprejemanja tveganja, ki izhajajo iz zahtev, določenih v zakonodaji Unije, ali iz priglašenih nacionalnih pravil oziroma na njih temeljijo.
Depending on the risk acceptance criteria, the acceptability of the risk may be evaluated either individually for each associated hazard or the combination of all hazards as a whole considered in the explicit risk estimation.
Glede na merila sprejemanja tveganja se lahko sprejemljivost tveganja oceni posamično za vsako povezano nevarnost ali skupaj za v celoti gledane vse nevarnosti, upoštevane pri eksplicitni oceni tveganja.
If the risk associated with one hazard or a combination of several hazards is considered acceptable, the identified safety measures shall be registered in the hazard record.
Če velja tveganje, povezano z eno ali več nevarnostmi, za sprejemljivo, se določeni varnostni ukrepi navedejo v evidenci nevarnosti.
If hazards arise from failures of technical systems not covered by codes of practice or the use of a reference system, the following risk acceptance criterion shall apply for the design of the technical system:
Če nevarnosti nastanejo zaradi odpovedi tehničnih sistemov, ki niso vključene v kodeks ravnanja ali uporabo referenčnega sistema, se pri zasnovi tehničnega sistema upošteva naslednje merilo sprejemanja tveganja:
For technical systems where a functional failure has a credible direct potential for a catastrophic consequence, the associated risk does not have to be reduced further if the rate of that failure is less than or equal to 10–9 per operating hour.
pri tehničnih sistemih, pri katerih je verjetno, da ima lahko odpoved katastrofalne posledice, povezanega tveganja ni treba še bolj zmanjšati, če je stopnja pojavnosti odpovedi manjša ali enaka 10–9 na delovno uro.
Without prejudice to the procedure specified in Article 8 of Directive 2004/49/EC, a more demanding criterion then the one laid down in point 2.5.4 may be requested, through a notified national safety rule, in order to maintain a national safety level.
Brez poseganja v postopek iz člena 8 Direktive 2004/49/ES se lahko prek priglašenega nacionalnega varnostnega predpisa zahteva strožje merilo od tistega iz točke 2.5.4, da se ohrani stopnja nacionalne varnosti.
In the case of additional authorisations for placing in service of vehicles, the procedures of Articles 23 and 25 of Directive 2008/57/EC shall apply.
V primeru dodatnih dovoljenj za začetek obratovanja vozil se uporabijo postopki iz členov 23 in 25 Direktive 2008/57/ES.
If a technical system is developed by applying the 10–9 criterion laid down in point 2.5.4, the principle of mutual recognition is applicable in accordance with Article 15(5).
Če je tehnični sistem razvit z uporabo merila 10–9 iz točke 2.5.4, se načelo vzajemnega priznavanja uporablja v skladu s členom 15(5).
Nevertheless, if the proposer can demonstrate that the national safety level in the Member State of application can be maintained with a rate of failure higher than 10–9 per operating hour, this criterion may be used by the proposer in that Member State.
Če pa lahko predlagatelj dokaže, da se lahko stopnja nacionalne varnosti v državi članici uporabe ohrani na stopnji pojavnosti odpovedi nad 10–9 na delovno uro, lahko predlagatelj to merilo uporabi v zadevni državi članici.
the results shall be sufficiently accurate to serve as robust decision support.
rezultati morajo biti dovolj zanesljivi, da se lahko na njihovi podlagi sprejemajo odločitve.
Minor changes in input assumptions or prerequisites shall not result in significantly different requirements.
Manjše spremembe začetnih predpostavk ali predpogojev ne smejo privesti do znatnih sprememb v zahtevah.
Any inadequacy of safety measures expected to fulfil the safety requirements or any hazards discovered during the demonstration of compliance with the safety requirements shall lead to reassessment and evaluation of the associated risks by the proposer in accordance with point 2.
Če se izkaže, da varnostni ukrepi, katerih namen je izpolniti varnostne zahteve, niso ustrezni ali se med dokazovanjem skladnosti z varnostnimi zahtevami odkrije kakršna koli nevarnost, mora predlagatelj v skladu s točko 2 povezana tveganja ponovno oceniti in ovrednotiti.
The new hazards shall be registered in the hazard record in accordance with point 4.
Nove nevarnosti se navedejo v evidenci nevarnosti v skladu s točko 4.
Hazard record(s) shall be created or updated (where they already exist) by the proposer during design and implementation until acceptance of the change or delivery of the safety assessment report.
Evidenco nevarnosti predlagatelj uvede ali posodablja (če ta že obstaja) med zasnovo in izvajanjem do sprejetja spremembe ali izdaje poročila o varnostni oceni.
A hazard record shall track the progress in monitoring risks associated with the identified hazards.
V evidenci nevarnosti se beleži napredek, dosežen pri spremljanju tveganj, povezanih z ugotovljenimi nevarnostmi.
Once the system has been accepted and is in operation, the hazard record shall be further maintained by the infrastructure manager or the railway undertaking in charge of the operation of the system under assessment as an integrated part of its safety management system.
Ko je sistem že sprejet in obratuje, evidenco nevarnosti nadalje vzdržuje upravljavec železniške infrastrukture ali prevoznik v železniškem prometu, ki je odgovoren za delovanje sistema, ki se ocenjuje, kot sestavnega dela sistema varnega upravljanja.
It shall contains a clear reference to the origin of the hazards and to the selected risk acceptance principles and clearly identify the actor(s) in charge of controlling each hazard.
Vsebuje jasno sklicevanje na izvor nevarnosti in izbrana načela sprejemanja tveganja ter jasno opredeljuje udeležence, ki so odgovorni za nadzor vsake nevarnosti.
All hazards and related safety requirements that cannot be controlled by one actor alone shall be communicated to another relevant actor in order to find jointly an adequate solution.
O vseh nevarnostih in z njimi povezanih varnostnih zahtevah, ki jih ne more nadzorovati samo en udeleženec, je treba obvestiti drugega ustreznega udeleženca, da skupaj poiščeta primerno rešitev.
The hazards registered in the hazard record of the actor who transfers them shall only be regarded as controlled when the evaluation of the risks associated with these hazards is made by the other actor and the solution is agreed by all concerned.
Nevarnosti, navedene v evidenci nevarnosti udeleženca, ki jih ta prenese, se štejejo za „nadzorovane“ le, če drugi udeleženec ovrednoti tveganja, povezana s temi nevarnostmi, in se vse udeležene strani strinjajo z rešitvijo.
The risk management process used to assess the safety levels and compliance with safety requirements shall be documented by the proposer in such a way that all the necessary evidence showing the suitability of both the application of the risk management process and of its results are accessible to an assessment body.
Predlagatelj postopek upravljanja s tveganji, ki je bil uporabljen za oceno ravni varnosti in skladnosti z varnostnimi zahtevami, dokumentira tako, da so ocenjevalnemu organu dostopna vsa potrebna dokazila o ustreznosti uporabe postopka upravljanja s tveganji in njegovih rezultatov.
The documentation produced by the proposer under point 5.1 shall at least include:
Dokumentacija, ki jo pripravi predlagatelj v skladu s točko 5.1, vključuje vsaj:
a description of the organisation and the experts appointed to carry out the risk assessment process;
opis organizacije in strokovnjake, imenovane za izvedbo postopka ocene tveganj;
results of the different phases of the risk assessment and a list of all the necessary safety requirements to be fulfilled in order to control the risk to an acceptable level;
rezultate različnih faz ocene tveganja in seznam vseh potrebnih varnostnih zahtev, ki jih je treba izpolniti, da se tveganje zmanjša na sprejemljivo raven;
evidence of compliance with all the necessary safety requirements;
dokazila o skladnosti z vsemi potrebnimi varnostnimi zahtevami;
all assumptions relevant for system integration, operation or maintenance, which were made during system definition, design and risk assessment.
vse predpostavke, ki so pomembne za povezovanje, delovanje ali vzdrževanje sistema in so bile sklenjene med opredelitvijo sistema, oblikovanjem in oceno tveganja.
The assessment body shall establish its conclusion in a safety assessment report as defined in Annex III.
Ocenjevalni organ svoje zaključke navede v poročilu o varnostni oceni, kot je opredeljeno v Prilogi III.
CRITERIA FOR ACCREDITATION OR RECOGNITION OF THE ASSESSMENT BODY
MERILA ZA AKREDITACIJO ALI PRIZNANJE OCENJEVALNEGA ORGANA
The assessment body shall fulfil all requirements of the ISO/IEC 17020:2012 standard and of its subsequent amendments.
Ocenjevalni organ izpolnjuje vse zahteve standarda ISO/IEC 17020:2012 in njegovih poznejših sprememb.
The assessment body shall exercise professional judgement in performing the inspection work defined in that standard.
Ocenjevalni organ pri izvajanju pregledov iz tega standarda poda strokovne sodbe.
The assessment body shall fulfil both the general criteria concerning competence and independence in that standard and the following specific competence criteria:
Ocenjevalni organ izpolnjuje splošna merila o usposobljenosti in neodvisnosti v tem standardu ter naslednja specifična merila usposobljenosti:
competence in risk management: knowledge and experience of the standard safety analysis techniques and of the relevant standards;
usposobljenost na področju upravljanja tveganja: znanje in izkušnje s standardnimi varnostnimi analizami tehnologij in ustreznimi standardi;
all relevant competences for assessing the parts of the railway system affected by the change;
vse ustrezne usposobljenosti za ocenjevanje delov železniškega sistema, na katere vpliva sprememba;
competence in the correct application of safety and quality management systems or in auditing management systems.
usposobljenost za pravilno uporabo varnostnih sistemov in sistemov za upravljanje kakovosti ali sistemov za upravljanje revizij.
By analogy to Article 28 of Directive 2008/57/EC concerning the notification of notified bodies, the assessment body shall be accredited or recognised for the different areas of competence within the railway system, or parts of it for which an essential safety requirement exists, including the area of competence involving the operation and maintenance of the railway system.
Po analogiji s členom 28 Direktive 2008/57/ES glede obveščanja o priglašenih organih se ocenjevalni organ akreditira ali prizna za različna področja pristojnosti v železniškem sistemu ali na njegovih delih, za katere obstaja bistvena varnostna zahteva, vključno s področjem pristojnosti, ki vključuje delovanje in vzdrževanje železniškega sistema.
The assessment body shall be accredited or recognised for assessing the overall consistency of the risk management and the safe integration of the system under assessment into the railway system as a whole.
Ocenjevalni organ se akreditira ali prizna za oceno splošne skladnosti upravljanja s tveganji in varne vključitve sistema, ki se ocenjuje, v železniški sistem kot celoto.
This shall include competence of the assessment body in checking the following:
To vključuje pristojnost ocenjevalnega organa pri preverjanju naslednjega:
organisation, that is the arrangements necessary to ensure a coordinated approach to achieving system safety through a uniform understanding and application of risk control measures for subsystems;
organizacije, tj. ukrepov, potrebnih za zagotovitev usklajenega pristopa pri doseganju varnosti sistema na podlagi enotnega razumevanja in uporabe ukrepov nadzorovanja tveganja za podsisteme;
methodology, that is evaluation of the methods and resources deployed by various stakeholders to support safety at subsystem and system level; and
metodologije, tj. vrednotenje metod in sredstev, ki so jih uporabile različne zainteresirane strani, da bi podprle varnost na ravni podsistemov in na ravni sistema, ter
the technical aspects necessary for assessing the relevance and completeness of risk assessments and the level of safety for the system as a whole.
tehničnih vidikov, ki so potrebni za ocenjevanje ustreznosti in popolnosti ocen tveganja, in ravni varnosti za sistem kot celoto.
The assessment body may be accredited or recognised for one, several or all of the areas of competence listed in points 2 and 3.
Ocenjevalni organ je lahko akreditiran ali priznan za eno, več ali vsa območja pristojnosti, ki so našteta v točkah 2 in 3.
SAFETY ASSESSMENT REPORT OF THE ASSESSMENT BODY
POROČILO O VARNOSTNI OCENI OCENJEVALNEGA ORGANA
The safety assessment report of the assessment body shall contain at least the following information:
Poročilo o varnostni oceni ocenjevalnega organa vsebuje vsaj naslednje informacije:
identification of the assessment body;
identifikacijo ocenjevalnega organa;
the independent assessment plan;
načrt neodvisne ocene;
the definition of the scope of the independent assessment as well as its limitations;
opredelitev obsega neodvisne ocene in njegovih omejitev;
the results of the independent assessment including in particular:
rezultate neodvisne ocene, zlasti:
detailed information on the independent assessment activities for checking the compliance with the provisions of this Regulation;
podrobne informacije o dejavnostih neodvisne ocene za preverjanje skladnosti z določbami te uredbe;
any identified cases of non-compliances with the provisions of this Regulation and the assessment body’s recommendations;
vse ugotovljene primere neskladnosti z določbami te uredbe in priporočili ocenjevalnega organa;
the conclusions of the independent assessment.
zaključke neodvisne ocene.
They must be relevant for the control of the considered hazards in the system under assessment.
biti morajo primerni za nadzor obravnavanih nevarnosti v ocenjevanem sistemu.
Successful application of a code of practice for similar cases to manage changes and control effectively the identified hazards of a system in the sense of this Regulation is sufficient for it to be considered as relevant;
Uspešna uporaba kodeksa ravnanja pri podobnih primerih za upravljanje sprememb in učinkovit nadzor ugotovljenih nevarnosti sistema v smislu te uredbe je dovolj, da se ga lahko šteje za pomembnega;
Commission Implementing Regulation (EU) No 403/2013
Izvedbena uredba Komisije (EU) št. 403/2013
concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) as a feed additive for poultry for fattening and for laying and for weaned piglets and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005 and (EC) No 1876/2006 (holder of authorisation DSM Nutritional Products)
o izdaji dovoljenja za pripravek iz endo-1,4-beta-ksilanaze, endo-1,3(4)-beta-glukanaze in endo-1,4-beta-glukanaze, ki jih proizvaja Trichoderma reesei (ATCC 74444), kot krmni dodatek za perutnino za pitanje in nesnice ter za odstavljene pujske in o spremembi uredb (ES) št. 1259/2004, (ES) št. 1206/2005 in (ES) št. 1876/2006 (imetnik dovoljenja DSM Nutritional Products)
A preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 74252) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on chickens for fattening by Commission Regulation (EC) No 1259/2004 [3], on turkeys for fattening by Commission Regulation (EC) No 1206/2005 [4], and on laying hens and weaned piglets by Commission Regulation (EC) No 1876/2006 [5].
Pripravek iz endo-1,4-beta-ksilanaze, endo-1,3(4)-beta-glukanaze in endo-1,4-beta-glukanaze, ki jih proizvaja Trichoderma longibrachiatum (ATCC 74252), je bil v skladu z Direktivo 70/524/EGS brez časovne omejitve odobren kot krmni dodatek za piščance za pitanje z Uredbo Komisije (ES) št. 1259/2004 [3], za purane za pitanje z Uredbo Komisije (ES) št. 1206/2005 [4] ter za kokoši nesnice in odstavljene pujske z Uredbo Komisije (ES) št. 1876/2006 [5].
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of that preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) (formerly ATCC 74252), as a feed additive for chickens for fattening, turkeys for fattening, laying hens and piglets and, in accordance with Article 7 of that Regulation, for a new use for all poultry species for fattening and laying, requesting that additive to be classified in the additive category ‘zootechnical additives’.
V skladu s členom 10(2) Uredbe (ES) št. 1831/2003 in v povezavi s členom 7 navedene uredbe je bil vložen zahtevek za ponovno oceno pripravka iz endo-1,4-beta-ksilanaze, endo-1,3(4)-beta-glukanaze in endo-1,4-beta-glukanaze, ki jih proizvaja Trichoderma reesei (ATCC 74444) (prej ATCC 74252), kot krmnega dodatka za piščance in purane za pitanje, kokoši nesnice in pujske ter v skladu s členom 7 navedene uredbe za novo uporabo za vse vrste perutnine za pitanje in nesnice ter za uvrstitev navedenega dodatka v kategorijo dodatkov „zootehnični dodatki“.