natgillin/translations-raw huggingface dataset:
The product is not intended for therapeutic or prophylactic use, within the meaning of Chapter 30.
Proizvod ni namenjen za terapevtsko ali profilaktično uporabo v smislu poglavja 30.
Commission Regulation (EC) No 350/2009
Uredba Komisije (ES) št. 350/2009
This Regulation shall enter into force on 29 April 2009.
Ta uredba začne veljati 29. aprila 2009.
Commission Regulation (EC) No 351/2009
Uredba Komisije (ES) št. 351/2009
fixing the allocation coefficient to be applied to applications for export licences for certain milk products to be exported to the Dominican Republic under the quota referred to in Article 29 of Regulation (EC) No 1282/2006
o določitvi koeficienta dodeljevanja, ki se bo uporabil za zahtevke za izvozna dovoljenja za izvoz nekaterih mlečnih izdelkov v Dominikansko republiko v okviru kvote iz člena 29 Uredbe (ES) št. 1282/2006
Having regard to Commission Regulation (EC) No 1282/2006 of 17 August 2006 laying down detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards export licences and export refunds in the case of milk and milk products [2], and in particular Article 33(2) thereof,
ob upoštevanju Uredbe Komisije (ES) št. 1282/2006 z dne 17. avgusta 2006 o posebnih podrobnih pravilih za uporabo Uredbe Sveta (ES) št. 1255/1999 glede izvoznih dovoljenj in izvoznih nadomestil za mleko in mlečne izdelke [2] ter zlasti člena 33(2) Uredbe,
Section 3 of Chapter III of Regulation (EC) No 1282/2006 determines the procedure for allocating export licences for certain milk products to be exported to the Dominican Republic under a quota opened for that country.
Oddelek 3 poglavja III Uredbe (ES) št. 1282/2006 določa postopek za dodeljevanje izvoznih dovoljenj za izvoz nekaterih mlečnih izdelkov v Dominikansko republiko v okviru kvote, odprte za to državo.
Applications submitted for the 2009/2010 quota year cover quantities greater than those available.
Količine v zahtevkih, vloženih za kvotno leto 2009/2010, presegajo razpoložljive količine.
As a result, allocation coefficients should be set for the quantities applied for,
Zato je treba za količine v zahtevkih določiti koeficiente dodeljevanja –
The quantities covered by export licence applications for the products referred to in Article 29(2) of Regulation (EC) No 1282/2006 submitted for the period 1 July 2009 to 30 June 2010 shall be multiplied by the following allocation coefficients:
Količine v zahtevkih za izvozna dovoljenja za proizvode iz člena 29(2) Uredbe (ES) št. 1282/2006, vloženih za obdobje med 1. julijem 2009 in 30. junijem 2010, se pomnožijo z naslednjimi koeficienti dodeljevanja:
0,575975 for applications submitted for the part of the quota referred to in Article 30(1)(a) of Regulation (EC) No 1282/2006,
0,575975 za zahtevke, vložene za del kvote iz člena 30(1)(a) Uredbe (ES) št. 1282/2006,
0,336842 for applications submitted for the part of the quota referred to in Article 30(1)(b) of Regulation (EC) No 1282/2006.
0,336842 za zahtevke, vložene za del kvote iz člena 30(1)(b) Uredbe (ES) št. 1282/2006.
Commission Regulation (EC) No 352/2009
Uredba Komisije (ES) št. 352/2009
on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council
o sprejetju skupne varnostne metode za ovrednotenje in oceno tveganja iz člena 6(3)(a) Direktive 2004/49/ES Evropskega parlamenta in Sveta
Having regard to Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) [1], and in particular Article 6(1) thereof,
ob upoštevanju Direktive 2004/49/ES Evropskega parlamenta in Sveta z dne 29. aprila 2004 o varnosti na železnicah Skupnosti ter o spremembi Direktive Sveta 95/18/ES o izdaji licence prevoznikom v železniškem prometu in Direktive 2001/14/ES o dodeljevanju železniških infrastrukturnih zmogljivosti, naložitvi uporabnin za uporabo železniške infrastrukture in podeljevanju varnostnega spričevala (Direktiva o varnosti na železnici) [1], in zlasti člena 6(1) Direktive,
Pursuant to Article 6(1) of Directive 2004/49/EC, the Commission should adopt the first set of common safety methods (hereinafter CSMs) covering at least the risk evaluation and assessment methods mentioned in Article 6(3)(a) of that Directive, on the basis of a recommendation of the European Railway Agency.
Komisija bi morala v skladu s členom 6(1) Direktive 2004/49/ES sprejeti prvo skupino skupnih varnostnih metod (v nadaljnjem besedilu „SVM“), ki obsega vsaj metode za ovrednotenje in oceno tveganja iz člena 6(3)(a) navedene direktive.
The European Railway Agency made a recommendation on the first set of common safety methods (ERA-REC-02-2007-SAF) on 6 December 2007.
Evropska železniška agencija je sprejela priporočilo o prvi skupini skupnih varnostnih metod (ERA-REC-02-2007-SAF) z dne 6. decembra 2007.
In accordance with Directive 2004/49/EC, CSMs should be gradually introduced to ensure that a high level of safety is maintained and, when and where necessary and reasonably practicable, improved.
V skladu z Direktivo 2004/49/ES bi bilo treba SVM uvajati postopno, da se še naprej zagotovi visoka raven varnosti in da se ta izboljša, kadar je to potrebno in izvedljivo.
Article 9(1) of Directive 2004/49/EC requires railway undertakings and infrastructure managers to establish their safety management systems in order to ensure that the railway system can achieve at least the common safety targets (CSTs).
Člen 9(1) Direktive 2004/49/ES določa, da morajo prevozniki v železniškem prometu in upravljavci železniške infrastrukture vzpostaviti sisteme varnega upravljanja, da se zagotovi, da železniški sistem doseže vsaj skupne varnostne cilje („SVC“).
According to point (2)(d) of Annex III to Directive 2004/49/EC, the safety management system must include procedures and methods for carrying out risk evaluation and implementing risk control measures whenever a change of the operating conditions or new material imposes new risks on the infrastructure or on operations.
Sistem varnega upravljanja mora v skladu s točko 2(d) Priloge III k Direktivi 2004/49/ES vključevati postopke in metode za oceno tveganja in izvedbo ukrepov za nadzor nad tveganjem, kadar koli sprememba obratovalnih pogojev ali novi material predstavljata novo tveganje za infrastrukturo ali obratovanje.
That basic element of the safety management system is covered by this Regulation.
Ta uredba določa bistvene elemente sistema varnega upravljanja.
As a consequence of the application of Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways [2] and of Article 9(2) of Directive 2004/49/EC, particular attention should be paid to risk management at the interfaces between the actors which are involved in the application of this Regulation.
Zaradi uporabe Direktive Sveta 91/440/EGS z dne 29. julija 1991 o razvoju železnic Skupnosti [2] in člena 9(2) Direktive 2004/49/ES bi bilo treba nameniti posebno pozornost upravljanju s tveganji pri stikih med udeleženci, za katere se uporablja ta direktiva.
Article 15 of Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community [3] requires Member States to take all appropriate steps to ensure that the structural subsystems constituting the rail system may be placed in service only if they are designed, constructed and installed in such a way as to meet the essential requirements concerning them when integrated into the rail system.
Člen 15 Direktive 2008/57/ES Evropskega parlamenta in Sveta z dne 17. junija 2008 o interoperabilnosti železniškega sistema v Skupnosti [3] zahteva, da države članice izvedejo vse primerne ukrepe, da zagotovijo začetek obratovanja strukturnih podsistemov, ki so del železniškega sistema, in sicer samo, če so zasnovani, zgrajeni in vgrajeni tako, da ob vključitvi v železniški sistem izpolnjujejo ustrezne bistvene zahteve.
In particular, the Member States must check the technical compatibility of these subsystems with the railway system into which they are being integrated and the safe integration of these subsystems in accordance with this Regulation.
Države članice morajo preveriti zlasti tehnično združljivost teh podsistemov z železniškim sistemom, v katerega se vključujejo, ter varno vključitev teh podsistemov v skladu s to uredbo.
The absence of a common approach for specifying and demonstrating compliance with safety levels and requirements of the railway system proved to be one of the obstacles to liberalisation of the railway market.
Nesprejetje skupnega pristopa za določanje in dokazovanje skladnosti s stopnjami varnosti in varnostnimi zahtevami železniškega sistema je ena od ovir pri liberalizaciji trga prevoznih storitev v železniškem prometu.
Therefore, in the past, the Member States performed their own assessments in order to accept a system, or parts of it, which had already been developed and proven safe in other Member States.
Zato so v preteklosti države članice same ocenjevale sisteme ali dele sistemov, ki so jih razvile druge države članice in so se v teh državah članicah že izkazali za varne, da bi jih lahko uporabljale tudi same.
To facilitate mutual recognition between Member States, the methods used for identifying and managing risks should be harmonised among the actors involved in the development and operation of the railway system as well as the methods for demonstrating that the railway system in the territory of the Community conform to safety requirements.
Da bi olajšali vzajemno priznavanje med državami članicami, bi morali tisti, ki sodelujejo pri razvoju in delovanju železniškega sistema, uskladiti metode za določanje in upravljanje tveganj, kot tudi metode, s katerimi se dokaže, da železniški sistemi na ozemlju Skupnosti ustrezajo varnostnim zahtevam.
As a first step, it is necessary to harmonise the procedures and methods for carrying out risk evaluation and implementing control measures whenever a change of the operating conditions or new material imposes new risks on the infrastructure or on operations, as referred to in point (2)(d) of Annex III to Directive 2004/49/EC.
Najprej je treba uskladiti postopke in metode za ovrednotenje tveganja in izvajanje nadzornih ukrepov, kadar koli sprememba obratovalnih pogojev ali novi material predstavljata novo tveganje za infrastrukturo ali obratovanje, kot je določeno v točki (2)(d) Priloge III k Direktivi 2004/49/ES.
If there is no notified national rule for defining whether or not a change is significant in a Member State, the person in charge of implementing the change (hereinafter referred to as the proposer) should initially consider the potential impact of the change in question on the safety of the railway system.
Če ni priglašenega nacionalnega predpisa, ki bi določal, ali je sprememba v državi članici pomembna ali ne, bi morala oseba, ki je odgovorna za uvedbo spremembe (v nadaljevanju „predlagatelj“), na začetku pretehtati morebitni učinek zadevne spremembe na varnost železniškega sistema.
If the proposed change has an impact on safety, the proposer should assess, by expert judgement, the significance of the change based on a set of criteria that should be set out in this Regulation.
Če predlagana sprememba vpliva na varnost, bi moral predlagatelj strokovno oceniti pomembnost spremembe na podlagi meril, ki naj bi bila določena v tej uredbi.
This assessment should lead to one of three conclusions.
Na podlagi te ocene naj bi bila oblikovana ena od treh ugotovitev.
In the first situation the change is not considered to be significant and the proposer should implement the change by applying its own safety method.
V prvem primeru sprememba ne velja za pomembno; predlagatelj bi moral uvesti spremembo ob uporabi lastne varnostne metode.
In the second situation the change is considered to be significant and the proposer should implement the change by applying this Regulation, without the need for a specific intervention of the safety authority.
V drugem primeru sprememba velja za pomembno; predlagatelj bi moral uvesti spremembo ob uporabi te uredbe, pri čemer posebna intervencija varnostnega organa ni potrebna.
In the third situation the change is considered to be significant but there are Community provisions which require a specific intervention of the relevant safety authority, such as a new authorisation for placing in service of a vehicle or a revision/update of the safety certificate of a railway undertaking or a revision/update of the safety authorisation of an infrastructure manager.
V tretjem primeru sprememba velja za pomembno, vendar obstajajo določbe Skupnosti, v skladu s katerimi je potrebna intervencija ustreznega varnostnega organa, kot na primer novo dovoljenje za začetek obratovanja vozila ali revizija/posodobitev varnostnega pooblastila prevoznika v železniškem prometu ali revizija/posodobitev varnostnega pooblastila upravljavca železniške infrastrukture.
Whenever the railway system already in use is subject to a change, the significance of the change should also be assessed taking into account all safety-related changes affecting the same part of the system since the entry into force of this Regulation or since the last application of the risk management process described in this Regulation, whichever is the latest.
Kadar je predmet spremembe železniški sistem, ki je že v uporabi, bi bilo treba pomembnost spremembe oceniti tudi ob upoštevanju vseh sprememb, povezanih z varnostjo, ki vplivajo na isti del sistema od začetka veljavnosti te uredbe ali od zadnje uporabe postopka upravljanja s tveganji iz te uredbe, pri čemer se upošteva poznejši datum.
The purpose is to assess whether or not the totality of such changes amounts to a significant change requiring the full application of the CSM on risk evaluation and assessment.
Namen tega je oceniti, ali vse spremembe skupaj pomenijo pomembno spremembo, ki zahteva popolno uporabo SVM za ovrednotenje in oceno tveganja.
The risk acceptability of a significant change should be evaluated by using one or more of the following risk acceptance principles: the application of codes of practice, a comparison with similar parts of the railway system, an explicit risk estimation.
Sprejemljivost tveganj pomembne spremembe bi bilo treba ovrednotiti z enim ali več od naslednjih načel sprejemanja tveganja: uporabo kodeksa ravnanja, primerjavo s podobnimi deli železniškega sistema, eksplicitno oceno tveganja.
All principles have been used successfully in a number of railway applications, as well as in other transport modes and other industries.
Vsa načela so bila uspešno uporabljena pri številnih železniških napravah ter v drugih načinih prevoza in drugih sektorjih.
The ‘explicit risk estimation’ principle is frequently used for complex or innovative changes.
Načelo „eksplicitne ocene tveganja“ se pogosto uporabi za kompleksne ali inovativne spremembe.
The proposer should be responsible for the choice of the principle to apply.
Za izbiro uporabljenega načela bi moral biti odgovoren predlagatelj.
In accordance with the principle of proportionality as set out in Article 5 of the Treaty, this Regulation should not go beyond what is necessary to achieve its objective which is to establish a CSM on risk evaluation and assessment.
V skladu z načelom sorazmernosti iz člena 5 Pogodbe ta uredba ne bi smela prekoračiti okvirov, ki so potrebni za doseganje navedenega cilja, ki je vzpostaviti SVM za ovrednotenje in oceno tveganja.
When a widely recognised code of practice is applied, it should therefore be possible to reduce the impact of applying the CSM.
Ob uporabi splošno priznanega kodeksa ravnanja bi moralo biti torej možno zmanjšati vpliv uporabe SVM.
In the same way, where there are Community provisions which require the specific intervention of the safety authority, the latter should be allowed to act as the independent assessment body in order to reduce double checking, undue costs to the industry and time to market.
Kadar obstajajo določbe Skupnosti z zahtevo po posebni intervenciji varnostnega organa, pa bi moralo biti slednjemu dovoljeno delovati kot neodvisni ocenjevalni organ, da se preprečijo dvojno preverjanje, neupravičeni stroški za sektor in čas do začetka trženja.
Article 6(5) of Directive 2004/49/EC requires the Member States to make any necessary amendments to their national safety rules to comply with the CSMs.
V skladu s členom 6(5) Direktive 2004/49/ES morajo države članice sprejeti vse potrebne spremembe svojih nacionalnih varnostnih predpisov, da jih uskladijo s SVM.
In view of the different approaches currently in use for assessing safety, a transitional period is necessary, in order to give sufficient time to the actors concerned, where needed, to learn and apply the new common approach as well as to gain experience from it.
Ker se sedaj uporablja več različnih pristopov za ocenjevanje varnosti, je potrebno prehodno obdobje, da bodo imeli zadevni udeleženci na razpolago dovolj časa, da po potrebi spoznajo in vzpostavijo novi skupni pristop ter o njem pridobijo izkušnje.
The measures provided for in this Regulation are in accordance with the opinion of the Committee established in accordance with Article 27(1) of Directive 2004/49/EC,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem odbora, ustanovljenega v skladu s členom 27(1) Direktive 2004/49/ES –
This Regulation establishes a common safety method on risk evaluation and assessment (CSM) as referred to in Article 6(3)(a) of Directive 2004/49/EC.
V tej uredbi so določene skupne varnostne metode za ovrednotenje in oceno tveganja (SVM) iz člena 6(3)(a) Direktive 2004/49/ES.
The purpose of the CSM on risk evaluation and assessment is to maintain or to improve the level of safety on the Community’s railways, when and where necessary and reasonably practicable.
Namen SVM za ovrednotenje in oceno tveganja je ohraniti ali, kadar je to potrebno in izvedljivo, izboljšati stopnjo varnosti železnic Skupnosti.
The CSM shall facilitate the access to the market for rail transport services through harmonisation of:
SVM olajšujejo dostop do trga storitev v železniškem prometu z uskladitvijo:
the risk management processes used to assess the safety levels and the compliance with safety requirements;
postopkov upravljanja s tveganji, ki se uporabljajo za ocenjevanje stopenj varnosti in skladnosti z varnostnimi zahtevami;
the exchange of safety-relevant information between different actors within the rail sector in order to manage safety across the different interfaces which may exist within this sector;
izmenjave informacij, ki se nanašajo na varnost, med različnimi udeleženci v železniškem sektorju, da bi varnost upravljali na različnih vmesnikih, ki obstajajo v tem sektorju;
the evidence resulting from the application of a risk management process.
rezultatov, zbranih med postopki upravljanja s tveganji.
The CSM on risk evaluation and assessment shall apply to any change of the railway system in a Member State, as referred to in point (2)(d) of Annex III to Directive 2004/49/EC, which is considered to be significant within the meaning of Article 4 of this Regulation.
SVM za ovrednotenje in oceno tveganja se uporabljajo pri vsaki spremembi železniškega sistema v državi članici, kot je določeno v točki (2)(d) Priloge III k Direktivi 2004/49/ES, ki velja v skladu s členom 4 te uredbe za pomembno spremembo.
Those changes may be of a technical, operational or organisational nature.
Take spremembe so lahko tehničnega, operativnega ali organizacijskega značaja.
As regards organisational changes, only those changes which could impact the operating conditions shall be considered.
Za organizacijske spremembe veljajo samo spremembe, ki bi lahko vplivale na obratovalne pogoje.
Where the significant changes concern structural subsystems to which Directive 2008/57/EC applies, the CSM on risk evaluation and assessment shall apply:
Če se pomembne spremembe nanašajo na strukturne podsisteme, za katere se uporablja Direktiva 2008/57/ES, se uporabljajo SVM za ovrednotenje in oceno tveganja:
if a risk assessment is required by the relevant technical specification for interoperability (TSI).
če se v ustreznih tehničnih specifikacijah za interoperabilnost (TSI) zahteva ocena tveganja.
In this case the TSI shall, where appropriate, specify which parts of the CSM apply;
V tem primeru se v TSI po potrebi določi, kateri del SVM se uporabi;
to ensure safe integration of the structural subsystems to which the TSIs apply into an existing system, by virtue of Article 15(1) of Directive 2008/57/EC.
da se zagotovi varna vključitev strukturnih podsistemov, za katere se uporabljajo TSI, v obstoječi sistem v skladu s členom 15(1) Direktive 2008/57/ES.
However, application of the CSM in the case referred to in point (b) of the first subparagraph must not lead to requirements contradictory to those laid down in the relevant TSIs which are mandatory.
Vendar zaradi uporabe SVM v primeru iz točke (b) prvega pododstavka ne smejo biti določene zahteve, ki nasprotujejo obveznim zahtevam iz ustreznih TSI.
Nevertheless if the application of the CSM leads to a requirement that is contradictory to that laid down in the relevant TSI, the proposer shall inform the Member State concerned which may decide to ask for a revision of the TSI in accordance with Article 6(2) or Article 7 of Directive 2008/57/EC or a derogation in accordance with Article 9 of that Directive.
Če zaradi uporabe SVM nastane zahteva, ki ni v skladu s TSI, predlagatelj obvesti zadevne države članice, ki se lahko odločijo, da zahtevajo revizijo TSI v skladu s členom 6(2) ali členom 7 Direktive 2008/57/ES ali odstopanje v skladu s členom 9 navedene direktive.
networks that are functionally separate from the rest of the railway system and intended only for the operation of local, urban or suburban passenger services, as well as railway undertakings operating solely on these networks;
omrežja, ki so funkcionalno ločena od ostalega železniškega sistema in so predvidena samo za lokalni, mestni in primestni potniški promet, kakor tudi prevoznike v železniškem prometu, ki opravljajo dejavnost samo na teh omrežjih;
privately owned railway infrastructure that exists solely for use by the infrastructure owner for its own freight operations;
zasebno železniško infrastrukturo, ki jo uporablja izključno njen lastnik za lastne prevoze blaga;
heritage vehicles that run on national networks providing that they comply with national safety rules and regulations with a view to ensuring safe circulation of such vehicles;
vozila, ki so del kulturne dediščine in obratujejo v nacionalnih omrežjih, če izpolnjujejo nacionalna varnostna pravila in predpise, kar zagotavlja varno obratovanje teh vozil;
This Regulation shall not apply to systems and changes, which, on the date of entry into force of this Regulation, are projects at an advanced stage of development within the meaning of Article 2(t) of Directive 2008/57/EC.
Določbe te uredbe se ne uporabljajo za sisteme in spremembe, ki so na dan začetka veljavnosti te uredbe v poznejši fazi razvoja, kot je opredeljeno v členu 2(t) Direktive 2008/57/ES.
For the purpose of this Regulation the definitions in Article 3 of Directive 2004/49/EC shall apply.
Za namene te uredbe se uporabljajo opredelitve pojmov iz člena 3 Direktive 2004/49/ES.
The following definitions shall also apply:
Poleg teh opredelitev se uporabljajo tudi naslednje opredelitve pojmov:
‘risk’ means the rate of occurrence of accidents and incidents resulting in harm (caused by a hazard) and the degree of severity of that harm;
„tveganje“ pomeni stopnjo pojavnosti nesreč in motenj, pri katerih nastane škoda (zaradi nevarnosti), ter stopnjo resnosti te škode;
‘risk analysis’ means systematic use of all available information to identify hazards and to estimate the risk;
„analiza tveganja“ pomeni sistematično uporabo vseh razpoložljivih informacij za prepoznavanje nevarnosti in oceno tveganja;