natgillin/translations-raw huggingface dataset:
appropriate arrangements are in place under which the competent authorities are enabled to perform the audits and inspections referred to in Article 39(1) or delegate the performance of such audits and inspections to the competent authorities of the Member State or third country that is a Contracting Party to the Agreement on the European Economic Area where the laboratory is located; and
Določitev uradnega laboratorija je pisna in vključuje podroben opis:
that laboratory is already designated as an official laboratory by the competent authorities of the Member State on whose territory it is located.
nalog, ki jih laboratorij izvaja kot uradni laboratorij;
The designation of an official laboratory shall be in writing and shall include a detailed description of:
pogojev, v skladu s katerimi izvaja navedene naloge iz točke (a); in
the tasks that the laboratory carries out as an official laboratory;
ureditev, ki so potrebne za zagotavljanje učinkovitega usklajevanja in sodelovanja med laboratorijem in pristojnimi organi.
the conditions under which it carries out the tasks referred to in point (a); and
Pristojni organi lahko kot uradni laboratorij določijo samo laboratorij, ki:
the arrangements necessary to ensure efficient and effective coordination and collaboration between the laboratory and the competent authorities.
ima strokovno znanje in izkušnje, opremo in infrastrukturo, ki so potrebni za opravljanje analiz, preskusov ali diagnosticiranja vzorcev;
The competent authorities may only designate as an official laboratory a laboratory which:
ima zadostno število ustrezno usposobljenih, izurjenih in izkušenih članov osebja;
has the expertise, equipment and infrastructure required to carry out analyses or tests or diagnoses on samples;
zagotavlja, da se naloge, ki se nanj prenesejo v skladu z odstavkom 1, izvajajo nepristransko in so brez nasprotja interesov, kar zadeva naloge, ki jih izvaja kot uradni laboratorij;
has a sufficient number of suitably qualified, trained and experienced staff;
lahko pravočasno zagotovi rezultate analize, preskusa ali diagnosticiranja vzorcev, odvzetih med uradnim nadzorom in drugimi uradnimi dejavnostmi; in
ensures that the tasks conferred upon it as set out in paragraph 1 are performed impartially and which is free from any conflict of interest as regards the exercise of its tasks as an official laboratory;
deluje v skladu s standardom EN ISO/IEC 17025 in s katerim ga nacionalni akreditacijski organ, ki deluje v skladu z Uredbo (ES) št. 765/2008, tudi akreditira.
can deliver in a timely manner the results of the analysis, test or diagnosis carried out on the samples taken during official controls and other official activities; and
Obseg akreditacije uradnega laboratorija iz točke (e) odstavka 4:
operates in accordance with the standard EN ISO/IEC 17025 and is accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008.
vključuje tiste laboratorijske analitske, preskusne ali diagnostične metode, ki jih mora laboratorij uporabljati za analize, preskuse ali diagnosticiranje, kadar deluje kot uradni laboratorij;
The scope of the accreditation of an official laboratory as referred to in point (e) of paragraph 4:
lahko zajema eno ali več laboratorijskih analitskih, preskusnih ali diagnostičnih metod ali skupin metod;
shall include those methods of laboratory analysis, test or diagnosis required to be used by the laboratory for analyses, tests or diagnoses, when it operates as an official laboratory;
se lahko določi prožno, da se lahko v obseg akreditacije poleg metod, ki jih je uradni laboratorij uporabljal, ko je dobil akreditacijo, vključijo prilagojene različice teh metod ali nove metode na podlagi validacije, ki jo opravi laboratorij sam, brez posebne ocene, ki jo nacionalni akreditacijski organ opravi pred uporabo navedenih prilagojenih ali novih metod.
may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods;
Kadar noben uradni laboratorij, določen v Uniji ali tretji državi, ki je pogodbenica Sporazuma o Evropskem gospodarskem prostoru, v skladu z odstavkom 1, nima potrebnega strokovnega znanja in izkušenj, opreme, infrastrukture in osebja za opravljanje novih ali posebno neobičajnih laboratorijskih analiz, preskusov ali diagnosticiranja, lahko pristojni organi zaprosijo laboratorij ali diagnostični center, ki ne izpolnjuje ene ali več zahtev iz odstavkov 3 in 4, naj opravi te analize, preskuse in diagnosticiranje.
may be defined in a flexible manner, so as to allow the scope of accreditation to include modified versions of the methods used by the official laboratory when the accreditation was granted or new methods in addition to those methods, on the basis of the laboratory’s own validations without a specific assessment by the national accreditation body prior to the use of those modified or new methods.
člen 38
Where no official laboratory designated in the Union or in a third country that is a Contracting Party to the Agreement on the European Economic Area in accordance with paragraph 1 has the expertise, equipment, infrastructure and staff necessary to perform new or particularly uncommon laboratory analyses, tests or diagnoses, the competent authorities may request a laboratory or diagnostic centre which does not comply with one or more of the requirements set out in paragraphs 3 and 4 to carry out those analyses, tests and diagnoses.
Obveznosti uradnih laboratorijev
Article 38
Kadar rezultati analize, preskusa ali diagnosticiranja vzorcev, odvzetih med uradnim nadzorom ali drugimi uradnimi dejavnostmi, pokažejo tveganje za zdravje ljudi, živali ali rastlin oziroma v primeru GSO in fitofarmacevtskih sredstev tudi za okolje ali pokažejo verjetno neskladnost, uradni laboratoriji o tem nemudoma obvestijo pristojne organe, ki so jih določili za to analizo, preskus ali diagnosticiranje, ter, če je ustrezno, pooblaščena telesa ali fizične osebe, na katere so bile naloge prenesene.
Obligations of official laboratories
Vendar pa se lahko s posebnimi dogovori med pristojnimi organi, pooblaščenimi telesi ali fizičnimi osebami, na katere so bile naloge prenesene, in uradnimi laboratoriji določi, da se ne zahteva, da se te informacije zagotovijo nemudoma.
Where the results of an analysis, test or diagnosis carried out on samples taken during official controls or other official activities indicate a risk to human, animal or plant health, or, as regards GMOs and plant protection products, also to the environment, or point to the likelihood of non-compliance, official laboratories shall inform immediately the competent authorities which designated them for that analysis, test or diagnosis and, where relevant, delegated bodies or natural persons to which tasks have been delegated.
Uradni laboratoriji na zahtevo referenčnega laboratorija Evropske unije ali nacionalnega referenčnega laboratorija sodelujejo v medlaboratorijskih primerjalnih preskusih ali preizkusih strokovne usposobljenosti, organiziranih za analize, preskuse ali diagnosticiranje, ki jih opravljajo kot uradni laboratoriji.
However, specific arrangements between the competent authorities, delegated bodies or natural persons to which tasks have been delegated and the official laboratories may specify that this information is not required to be provided immediately.
Uradni laboratoriji na zahtevo pristojnih organov dajo javnosti na voljo imena metod, ki se uporabljajo za analize, preskuse ali diagnosticiranje v okviru uradnega nadzora in drugih uradnih dejavnosti.
Upon request by the European Union reference laboratory or national reference laboratory, official laboratories shall take part in inter-laboratory comparative tests or proficiency tests that are organised for the analyses, tests or diagnoses they perform as official laboratories.
Uradni laboratoriji na zahtevo pristojnih organov skupaj z rezultati navedejo metodo, uporabljeno za posamezno analizo, preskus ali diagnosticiranje v okviru uradnega nadzora in drugih uradnih dejavnosti.
Official laboratories shall, upon request of the competent authorities, make available to the public the names of the methods used for analyses, tests or diagnoses performed in the context of official controls and other official activities.
člen 39
Official laboratories shall indicate, at the request of the competent authorities, together with the results, the method used for each analysis, testing or diagnosis, performed in the context of official controls and other official activities.
Presoje uradnih laboratorijev
Article 39
Pristojni organi organizirajo presoje uradnih laboratorijev, ki so jih določili v skladu s členom 37(1), redno in kadar menijo, da je presoja potrebna, razen če menijo, da so take presoje zaradi ocene v zvezi z akreditacijo iz točke (e) člena 37(4) nepotrebne.
Audits of official laboratories
Pristojni organi takoj prekličejo določitev uradnega laboratorija v celoti ali samo v zvezi z nekaterimi nalogami, kadar uradni laboratorij ne sprejme ustreznih in pravočasnih ukrepov, da bi izboljšal stanje, ko rezultati presoje iz odstavka 1 pokažejo kar koli od naslednjega:
The competent authorities shall organise audits of the official laboratories they have designated in accordance with Article 37(1) on a regular basis and any time they consider that an audit is necessary, unless they find such audits to be redundant considering the accreditation assessment referred to in point (e) of Article 37(4).
uradni laboratorij ne izpolnjuje več pogojev iz člena 37(4) in (5);
The competent authorities shall immediately withdraw the designation of an official laboratory, either completely or for certain tasks, where it fails to take appropriate and timely remedial action following the results of an audit provided for in paragraph 1 which disclose any of the following:
ne izpolnjuje obveznosti iz člena 38;
it no longer complies with the conditions provided for in Article 37(4) and (5);
ni dovolj uspešen pri medlaboratorijskih primerjalnih preskusih iz člena 38(2).
it does not comply with the obligations provided for in Article 38;
Člen 40
it is underperforming at inter-laboratory comparative tests referred to in Article 38(2).
Odstopanja od pogoja obvezne akreditacije za nekatere uradne laboratorije
Article 40
Z odstopanjem od točke (e) člena 37(4) lahko pristojni organi ne glede na to, ali izpolnjujejo pogoj iz navedene točke, kot uradne laboratorije določijo:
Derogations from the condition for the mandatory accreditation for certain official laboratories
laboratorije:
By way of derogation from point (e) of Article 37(4), competent authorities may designate the following as official laboratories irrespective of whether they fulfil the condition provided for in that point:
katerih edina dejavnost je odkrivanje trihinele v mesu;
laboratories:
ki za odkrivanje trihinele uporabljajo samo metode iz člena 6 Izvedbene uredbe Komisije (EU) 2015/1375 [58];
whose sole activity is the detection of Trichinella in meat;
ki odkrivanje trihinele opravljajo pod nadzorom pristojnih organov ali uradnega laboratorija, določenega v skladu s členom 37(1) ter akreditiranega v skladu s standardom EN ISO/IEC 17025 za uporabo metod iz točke (ii) te točke, in
that only use the methods of detection of Trichinella referred to in Article 6 of Commission Implementing Regulation (EU) 2015/1375 [58];
ki redno sodelujejo v medlaboratorijskih primerjalnih preskusih ali preizkusih strokovne usposobljenosti, ki jih organizirajo nacionalni referenčni laboratoriji v zvezi z metodami, ki jih uporabljajo za odkrivanje trihinele, ter pri navedenih preskusih dosegajo zadovoljive rezultate;
that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 37(1) and accredited in accordance with the standard EN ISO/IEC 17025 for the use of the methods referred to in point (ii) of this point; and
laboratorije, ki izvajajo samo analize, preskuse ali diagnosticiranje v okviru drugih uradnih dejavnosti, pod pogojem, da:
that participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories for the methods they use for the detection of Trichinella;
uporabljajo samo laboratorijske analitske, preskusne in diagnostične metode iz člena 34(1) ter točk (a) ali (b) člena 34(2);
laboratories which only carry out analyses, tests or diagnoses in the context of other official activities, provided that they:
opravljajo analize, preskuse ali diagnosticiranje pod nadzorom pristojnih organov ali nacionalnih referenčnih laboratorijev v zvezi z metodami, ki jih uporabljajo;
only use the methods of laboratory analysis, test and diagnosis referred to in Article 34(1) and point (a) or (b) of Article 34(2);
redno sodelujejo v medlaboratorijskih primerjalnih preskusih ali preizkusih strokovne usposobljenosti, ki jih organizirajo nacionalni referenčni laboratoriji v zvezi z metodami, ki jih uporabljajo, ter pri navedenih preskusih dosegajo zadovoljive rezultate, in
carry out the analyses, tests or diagnoses under the supervision of the competent authorities or of the national reference laboratories in relation to the methods they use;
imajo vzpostavljen sistem zagotavljanja kakovosti, da zagotovijo točne in zanesljive rezultate uporabljenih laboratorijskih analitskih, preskusnih in diagnostičnih metod.
participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories in relation to the methods they use; and
Kadar se v zvezi z metodami, ki jih uporabljajo laboratoriji iz točke (b) odstavka (1) tega člena, zahteva potrditev rezultata laboratorijske analize, preskusa ali diagnosticiranja, potrditveno laboratorijsko analizo, preskus ali diagnosticiranje opravi uradni laboratorij, ki izpolnjuje zahteve iz točke (e) člena 37(4).
have a quality assurance system in place to ensure sound and reliable results from the methods for laboratory analysis, test and diagnosis used.
Uradni laboratoriji, določeni v skladu z odstavkom 1, se nahajajo v državah članicah, na ozemlju katerih se nahajajo pristojni organi, ki jih določijo.
Where the methods used by the laboratories referred to in point (b) of paragraph 1 of this Article require confirmation of the result of the laboratory analysis, test or diagnosis, the confirmatory laboratory analysis, test or diagnosis shall be carried out by an official laboratory which complies with the requirements set out in point (e) of Article 37(4).
člen 41
The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.
Pooblastilo za sprejetje odstopanj od pogoja obvezne akreditacije vseh laboratorijskih analitskih, preskusnih in diagnostičnih metod, ki jih uporabljajo uradni laboratoriji
Article 41
Komisija sprejme delegirane akte v skladu s členom 144 za dopolnitev te uredbe v zvezi s tem, v katerih primerih in pod katerimi pogoji lahko pristojni organi v skladu s členom 37(1) kot uradne laboratorije določijo laboratorije, ki ne izpolnjujejo pogojev iz točke (e) člena 37(4) v zvezi z vsemi metodami, ki jih uporabljajo za uradni nadzor ali druge uradne dejavnosti, če taki laboratoriji izpolnjujejo naslednje pogoje:
Powers to adopt derogations from the condition for the mandatory accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories
delujejo in so akreditirani v skladu s standardom EN ISO/IEC 17025 za uporabo ene ali več metod, podobnih drugim metodam, ki jih uporabljajo, in reprezentativnih zanje, ter
The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where, and the conditions under which, competent authorities may designate as official laboratories, in accordance with Article 37(1), laboratories which do not fulfil the conditions referred to in point (e) of Article 37(4) in relation to all the methods they use for official controls or other official activities, provided that such laboratories comply with the following conditions:
redno in znatno uporabljajo metode, za katere so pridobili akreditacijo iz točke (a) tega člena, razen kar zadeva področje iz točke (g) člena 1(2), če ni validirane metode za odkrivanje določenega škodljivega organizma na rastlinah iz člena 34(1) in (2).
they operate and are accredited in accordance with the standard EN ISO/IEC 17025 for the use of one or more methods which are similar to and representative of the other methods they use; and
Člen 42
they make regular and significant use of the methods for which they have obtained the accreditation referred to in point (a) of this Article; except, as regards the area governed by the rules referred to in point (g) of Article 1(2), where a validated method for the detection of the particular pests of plants referred to in Article 34(1) and (2) does not exist.
Začasna odstopanja od pogoja obvezne akreditacije uradnih laboratorijev
Article 42
Z odstopanjem od točke (a) člena 37(5) lahko pristojni organi obstoječi uradni laboratorij začasno določijo kot uradni laboratorij v skladu s členom 37(1) za uporabo laboratorijske analitske, preskusne ali diagnostične metode, za katero ni pridobil akreditacije iz točke (e) člena 37(4):
Temporary derogations from the conditions of the mandatory accreditation for official laboratories
kadar se uporaba te metode na novo zahteva s pravili Unije;
By way of derogation from point (a) of Article 37(5), the competent authorities may temporarily designate an existing official laboratory as an official laboratory in accordance with Article 37(1) for the use of a method of laboratory analysis, test or diagnosis for which it has not obtained the accreditation referred to in point (e) of Article 37(4):
kadar je zaradi spremembe metode, ki se uporablja, potrebna nova akreditacija ali razširitev obsega akreditacije, ki jo je uradni laboratorij že pridobil, ali
when the use of that method is newly required by Union rules;
kadar je uporaba metode potrebna zaradi izjemnih razmer ali nastajajočega tveganja za zdravje ljudi, živali ali rastlin ali dobrobit živali oziroma v primeru GSO in fitofarmacevtskih sredstev tudi za okolje.
when changes to a method in use require a new accreditation or an extension of the scope of the accreditation obtained by the official laboratory; or
Za začasno določitev iz odstavka 1 veljajo naslednji pogoji:
in cases where the need for the use of the method results from an emergency situation or an emerging risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.
uradni laboratorij je že akreditiran v skladu s standardom EN ISO/IEC 17025 za uporabo metode, ki je podobna metodi, ki ni vključena v obseg akreditacije;
The temporary designation referred to in paragraph 1 shall be subject to the following conditions:
uradni laboratorij ima vzpostavljen sistem zagotavljanja kakovosti, da zagotavlja točne in zanesljive rezultate pri uporabi metode, ki ni vključena v obseg veljavne akreditacije;
the official laboratory is already accredited in accordance with the standard EN ISO/IEC 17025 for the use of a method which is similar to the one not included within the scope of its accreditation;
analize, preskusi ali diagnosticiranje po navedeni metodi se opravljajo pod nadzorom pristojnih organov ali nacionalnega referenčnega laboratorija.
the analyses, tests or diagnoses are carried out under the supervision of the competent authorities or the national reference laboratory for that method.
Uradni nadzor živali in blaga, ki vstopajo v Unijo
The temporary designation provided for in paragraph 1 shall not exceed a period of one year.
Člen 43
It may be renewed once for a further period of one year.
Uradni nadzor živali in blaga, ki vstopajo v Unijo, se organizira glede na tveganje.
CHAPTER V
V zvezi z živalmi in blagom iz členov 47 in 48 se takšen uradni nadzor izvaja v skladu s členi 47 do 64.
Official controls on animals and goods entering the Union
Živali in blago, razen tistih, za katere velja uradni nadzor na mejnih kontrolnih točkah iz oddelka II
Article 43
Člen 44
Official controls on animals and goods entering the Union shall be organised on a risk basis.
Uradni nadzor živali in blaga, razen tistih, za katere velja uradni nadzor na mejnih kontrolnih točkah iz oddelka II
In relation to animals and goods referred to in Articles 47 and 48, such official controls shall be performed in accordance with Articles 47 to 64.
Pristojni organi za ugotavljanje skladnosti s pravili iz člena 1(2) izvajajo redno, glede na tveganje in ustrezno pogosto, uradni nadzor nad živalmi in blagom, ki vstopajo v Unijo, za katere se člena 47 in 48 ne uporabljata.
Animals and goods other than those subject to official controls at border control posts under section II
Ustrezna pogostost uradnega nadzora nad živalmi in blagom iz odstavka 1 se določi ob upoštevanju:
Article 44
tveganj za zdravje ljudi, živali ali rastlin ali dobrobit živali oziroma v primeru GSO in fitofarmacevtskih sredstev tudi za okolje, ki so povezana z različnimi vrstami živali in blaga;
Official controls on animals and goods other than those subject to official controls at border control posts under Section II
kakršnih koli informacij, ki kažejo na verjetnost, da bi potrošniki lahko bili zavedeni, zlasti glede vrste, istovetnosti, značilnosti, sestave, količine, trajnosti, države izvora, kraja porekla oziroma postopka proizvodnje ali izdelave blaga;
To ascertain compliance with the rules referred to in Article 1(2), the competent authorities shall perform official controls regularly, on a risk basis and with appropriate frequency, on animals and goods entering the Union and to which Articles 47 and 48 do not apply.
pretekle skladnosti z zahtevami pravil iz člena 1(2), ki se uporabljajo za zadevne živali ali blago:
On animals and goods referred to in paragraph 1 the appropriate frequency of the official controls shall be determined, taking into account:
tretje države in obrata porekla ali mesta pridelave, kakor je ustrezno;
the risks to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, associated with different types of animals and goods;
izvoznika;
any information indicating the likelihood that consumers might be misled, in particular as to the nature, identity, properties, composition, quantity, durability, country of origin or place of provenance, method of manufacture or production of goods;
izvajalca dejavnosti, ki je odgovoren za pošiljko;
the history of compliance with the requirements established by the rules referred to in Article 1(2) applicable to the animals or goods concerned:
že izvedenega nadzora nad zadevnimi živalmi in blagom in
of the third country and establishment of origin or place of production, as appropriate;
jamstev, ki jih dajo pristojni organi tretje države porekla glede skladnosti živali in blaga z zahtevami pravil iz člena 1(2) ali zahtevami, ki so priznane kot vsaj enakovredne tem zahtevam.
of the exporter;
Uradni nadzor iz odstavka 1 se izvaja na primernih mestih na carinskem območju Unije, vključno z:
of the operator responsible for the consignment;
vstopno točko v Unijo;
the controls that have already been performed on the animals and goods concerned; and
mejno kontrolno točko;
the guarantees that the competent authorities of the third country of origin have given with regard to compliance of the animals and goods with the requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto.
točko sprostitve v prosti promet v Uniji;
The official controls provided for in paragraph 1 shall be performed at an appropriate place within the customs territory of the Union, including:
skladišči in prostori izvajalca dejavnosti, odgovornega za pošiljko;
the point of entry into the Union;
namembnim krajem.