natgillin/translations-raw huggingface dataset:
The Commission must take these measures in between the meetings of the Management Committee for Live Plants,
V obdobju med srečanji Upravnega odbora za žive rastline in cvetličarske proizvode mora Komisija sprejeti takšne ukrepe –
Regulation (EC) No 72/2005 is hereby repealed with effect from 18 January 2005.
Uredba (ES) št. 72/2005 se razveljavi z začetkom veljavnosti od 18. januarja 2005.
Regulation as last amended by Regulation (EC) No 1300/1997 (OJ L 177, 5.7.1997, p. 1).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1300/97 (UL L 177, 5.7.1997, str. 1).
OJ L 2, 5.1.2005, p. 4.
UL L 2, 5.1.2005, str. 4.
OJ L 14, 18.1.2005, p. 13.
UL L 14, 18.1.2005, str. 13.
Regulation as last amended by Regulation (EC) No 2286/2003 (OJ L 343, 31.12.2003, p. 1).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 2286/2003 (UL L 343, 31.12.2003, str. 1.)
Commission Regulation (EC) No 378/2005
Uredba Komisije (ES) št. 378/2005
on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives
o podrobnih pravilih za izvajanje Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 o dolžnostih in nalogah referenčnega laboratorija Skupnosti, ki zadevajo vloge za izdajo dovoljenj za krmne dodatke
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [1], and in particular the first subparagraph of Article 7(4) and the third subparagraph of Article 21 thereof,
ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali [1] in zlasti prvega pododstavka člena 7(4) in tretjega pododstavka člena 21 Uredbe,
Regulation (EC) No 1831/2003 lays down rules for the placing on the market and use of feed additives in animal nutrition.
Uredba (ES) št. 1831/2003 določa predpise za dajanje krmnih dodatkov na trg in za njihovo uporabo v prehrani živali.
It provides that any person seeking an authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation to the Commission in accordance with that Regulation (the application).
Ta določa, da mora vsaka oseba, ki želi pridobiti dovoljenje za krmni dodatek ali novo uporabo krmnega dodatka, posredovati vlogo za izdajo dovoljenja Komisiji v skladu s to uredbo (vloga).
Regulation (EC) No 1831/2003 provides for a Community reference laboratory (the CRL) to carry out certain duties and tasks set out in Annex II to that Regulation.
Uredba (ES) št. 1831/2003 določa, da mora referenčni laboratorij Skupnosti (CRL) izvajati nekatere dolžnosti in naloge, določene v Prilogi II k tej uredbi.
It also provides that the Joint Research Centre of the Commission is to be the CRL and that it may be assisted by a consortium of national reference laboratories to perform the duties and tasks set out in that Annex.
Uredba prav tako določa, da je Skupno raziskovalno središče Komisije CRL in da mu pri izvajanju dolžnosti in nalog, določenih v navedeni prilogi, pomaga konzorcij nacionalnih referenčnih laboratorijev.
In accordance with Regulation (EC) No 1831/2003, it is necessary to adopt detailed rules for implementing Annex II to that Regulation, including practical conditions for the duties and tasks of the CRL and to amend that Annex accordingly.
V skladu z Uredbo (ES) št. 1831/2003 je treba sprejeti podrobna pravila za izvajanje Priloge II k Uredbi, vključno s praktičnimi pogoji za izvajanje dolžnosti in nalog referenčnega laboratorija Skupnosti, in ustrezno spremeniti navedeno prilogo.
In addition, the samples to be provided in the application, in accordance with Regulation (EC) No 1831/2003, should meet specific requirements in view of the duties and tasks of the CRL.
Poleg tega morajo vzorci, ki jih je treba predložiti vlogi, v skladu z Uredbo (ES) št. 1831/2003 izpolnjevati posebne zahteve z vidika dolžnosti in nalog referenčnega laboratorija Skupnosti.
It is necessary to establish a precise timing for the delivery of the evaluation report from the CRL to the European Food Safety Authority (the Authority) in order to ensure that the procedures provided for in Regulation (EC) No 1831/2003 can be met.
Treba je opredeliti določeno časovno obdobje, v katerem bo referenčni laboratorij Skupnosti Evropski agenciji za varno hrano (Agencija) predložil ocenjevalno poročilo, da bi zagotovil izvajanje postopkov, določenih v Uredbi (ES) št. 1831/2003.
The CRL should be authorised to charge a fee to applicants towards the costs of supporting the duties and tasks of the CRL and the consortium of national reference laboratories.
Referenčni laboratorij Skupnosti se pooblasti, da vložnikom zaračuna pristojbino za stroške izvajanja dolžnosti in nalog referenčnega laboratorija Skupnosti in konzorcija nacionalnih referenčnih laboratorijev.
National reference laboratories should be part of the consortium of laboratories assisting the CRL only if they meet specific requirements in order to properly perform the duties and tasks laid down in Regulation (EC) No 1831/2003.
Nacionalni referenčni laboratoriji morajo biti del konzorcija laboratorijev, ki pomagajo referenčnemu laboratoriju Skupnosti, vendar le, če izpolnjujejo posebne zahteve v zvezi s pravilnim izpolnjevanjem dolžnosti in nalog, določenih v Uredbi (ES) št. 1831/2003.
Member States should be permitted to apply to the Commission for the designation of such laboratories.
Države članice morajo imeti možnost, da se pri Komisiji prijavijo za imenovanje takšnih laboratorijev.
In order to ensure the effective functioning of the consortium, it is necessary to appoint a rapporteur laboratory to carry out an initial assessment of the method(s) of analysis of each individual application and to establish clearly the duties and tasks of the rapporteur laboratories and the other laboratories participating in the consortium.
Da bi zagotovili učinkovito delovanje konzorcija, je treba določiti poročevalski laboratorij, ki bo izvajal začetna vrednotenja metod(e) analize za vsako posamezno vlogo ter jasno določil dolžnosti in naloge poročevalskih laboratorijev in drugih laboratorijev, ki sodelujejo v konzorciju.
It is necessary to establish special procedures for the cases where the data in the application are insufficient concerning testing or validation of the method(s) of analysis.
Treba je določiti posebne postopke za primere, ko so podatki v vlogi nepopolni za potrebe testiranja ali potrjevanja metod(e) analize.
In the interests of stability and efficacy and also in order to make the consortium operational, it is necessary to appoint the national reference laboratories participating in the consortium.
Zaradi interesa stabilnosti in učinkovitosti ter tudi za delovanje konzorcija je treba določiti nacionalne referenčne laboratorije, ki sodelujejo v konzorciju.
The relations between the members of the consortium should be defined by contract between them.
Povezava med člani konzorcija mora biti določena v pogodbi, ki jo podpišeta obe strani.
In this context the CRL may develop guidance for applicants and for the laboratories participating in the consortium.
V tem kontekstu lahko referenčni laboratorij Skupnosti razvije smernice za vložnike in laboratorije, ki sodelujejo v konzorciju.
This Regulation lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards:
Ta uredba določa podrobna pravila za izvajanje Uredbe (ES) št. 1831/2003 v zvezi z dolžnostmi in nalogami referenčnega laboratorija Skupnosti (CRL):
applications for authorisation of a feed additive or for a new use of a feed additive as provided for in Article 4(1) of that Regulation (the application); and
vloge za izdajo dovoljenja za krmne dodatke ali za novo uporabo krmnega dodatka, kot je določeno v členu 4(1) te uredbe (vloga); in
the duties and tasks of the Community Reference Laboratory (the CRL).
dolžnosti in naloge referenčnega laboratorija Skupnosti.
For the purposes of this Regulation, the following definitions shall apply:
Za izvajanje te uredbe se uporabljajo naslednje opredelitve:
‘reference sample’ means a representative sample of the feed additive, as referred to in Article 7(3)(f) of Regulation (EC) No 1831/2003, which is the object of an application;
„referenčni vzorec“ je reprezentativni vzorec krmnih dodatkov, kot je določeno v členu 7(3)(f) Uredbe (ES) št. 1831/2003, in je predmet vloge;
‘method of analysis’ means the procedure for the determination of the active substance(s) of the feed additive in feedingstuffs, and where appropriate, of its residue(s) or metabolite(s) in food, as referred to in Article 7(3)(c) of the Regulation (EC) No 1831/2003;
„metoda analize“ pomeni postopek določevanja aktivnih snovi v krmnih dodatkih in krmi ter, kjer je to primerno, ostankov ali presnovkov v prehrani, kot je določeno v členu 7(3)(c) Uredbe (ES) št. 1831/2003;
‘evaluation of the method of analysis’ means the thorough assessment of the protocol of the method of analysis as described in the application, including, if appropriate, literature research but not necessarily any experimental work;
„vrednotenje metode analize“ pomeni temeljito vrednotenje protokola metode analize, kot je opisano v vlogi, vključno z raziskovanjem obstoječe literature, če je potrebno, vendar ne nujno z izvajanjem poskusov;
‘testing of a method of analysis’ means the application of the method of analysis in a laboratory and comparison of results with those described in the application;
„testiranje metode analize“ pomeni uporabo metode analize v laboratoriju ter primerjavo rezultatov s tistimi, ki so opisani v vlogi;
‘validation of a method of analysis’ means the process of proving that a method of analysis is fit for the intended purpose, by an intercomparison study according to ISO 5725-1 to 6 or other internationally harmonised guidelines for validation of methods by intercomparison study;
„potrjevanje metode analize“ pomeni postopek, ki s primerjalno študijo v skladu s standardom ISO 5725-1 do 6 ali drugimi mednarodno usklajenimi smernicami za potrjevanje metod s primerjalno študijo dokaže, da je metoda analize primerna glede na potrebe;
‘feed test material’ means a feedingstuff sample or premixture sample with or without the inclusion of the feed additive which is the object of the application, to be used for experimental studies on the method of analysis for the determination of the feed additive in feedingstuffs and/or premixtures;
„krmna preskusna snov“ pomeni vzorec krme ali vzorec premiksa z ali brez vključenih krmnih dodatkov, ki so predmet vloge, in bodo uporabljeni za poskusne študije metode analize za določanje krmnih dodatkov v krmi in/ali premiksih;
‘food test material’ means a food sample derived from an animal that has been fed with feedingstuffs with or without the inclusion of the feed additive which is the object of the application, to be used for experimental studies on the method of analysis for the determination of the feed additive in the residue(s) or metabolite(s).
„živilska preskusna snov“ je vzorec živil, ki izhaja iz živali, krmljene s krmili z ali brez vključenih krmnih dodatkov, ki so predmet vloge in bodo uporabljeni za poskusne študije metode analize za določanje krmnih dodatkov v ostankih ali presnovkih.
Reference samples
Referenčni vzorci
Any person making an application shall send reference samples:
Katera koli oseba, ki predloži vlogo, mora poslati tudi referenčne vzorce:
in a form in which the feed additive is intended to be placed on the market by the applicant; or
v obliki, v kateri vložnik namerava dati krmni dodatek na trg; ali
that are suitable to be converted easily in a form in which the feed additive is intended to be placed on the market by the applicant.
v obliki, ki se enostavno priredi v obliko, v kateri vložnik namerava dati krmni dodatek na trg.
The three reference samples shall be accompanied by a written statement by the applicant that the fee provided for in Article 4(1) has been paid.
Trije predloženi vzorci morajo biti opremljeni z izjavo v pisni obliki, ki jo izpolni vložnik in v kateri je navedeno, da je bila pristojbina iz člena 4 plačana.
The applicant shall supply feed and/or food test materials related to the samples if requested by the CRL.
Vložnik predloži krmne in/ali živilske preskusne snovi, povezane z vzorci, če tako zahteva referenčni laboratorij Skupnosti.
The CRL shall charge the applicant a fee of EUR 3000 for each application (the fee).
Referenčni laboratorij Skupnosti za vsako vlogo vložniku zaračuna pristojbino v višini 3000 EUR (pristojbina).
The CRL shall use the fees towards supporting the costs of the duties and tasks as set out in Annex II to Regulation (EC) No 1831/2003, and in particular those referred to in 2.1, 2.2 and 2.3 of that Annex.
Referenčni laboratorij Skupnosti s temi pristojbinami pokriva stroške dolžnosti in nalog, določenih v Prilogi II k Uredbi (ES) št. 1831/2003, zlasti dolžnosti in nalog iz 2.1, 2.2 in 2.3 te priloge.
The amount of the fee mentioned in paragraph 1 may be adapted once a year in accordance with the procedure referred to in Article 22(2) of Regulation (EC) No 1831/2003.
Znesek pristojbine, omenjene v odstavku 1, se lahko v skladu s postopkom iz člena 22(2) Uredbe (ES) št. 1831/2003 prilagodi enkrat na leto.
The adaptation shall take into account the experience gained during the operation of this Regulation and in particular the possibility of fixing different fees for different types of applications.
Pri prilagajanju zneska se upošteva izkušnje, pridobljene med izvajanjem te uredbe, in zlasti možnosti določanja različnih pristojbin za različne vrste dovoljenj.
Evaluation reports by the CRL
Ocenjevalno poročilo s strani referenčnega laboratorija Skupnosti
The CRL shall submit a full evaluation report to the European Food Safety Authority (the Authority) for each application within three months from the date of receipt of a valid application as referred to in Article 8(1) of Regulation (EC) No 1831/2003 and the payment of the fee.
Referenčni laboratorij Skupnosti Evropski agenciji za varno hrano („Agencija“) predloži celotno ocenjevalno poročilo za vsako vlogo, in sicer v treh mesecih po datumu prejema veljavne vloge, določene v členu 8(1) Uredbe (ES) št. 1831/2003 ter po plačilu pristojbine.
However, if the CRL considers that the application is very complex, it may extend that period by an additional month.
Vendar lahko referenčni laboratorij Skupnosti, če meni, da je vloga zelo zapletena, podaljša to obdobje še za en mesec.
The CRL shall inform the Commission, the Authority and the applicant where the period is extended.
Referenčni laboratorij Skupnost o takih primerih obvesti Komisijo, Agencijo in vložnika.
The evaluation report provided for in paragraph 1 shall include in particular:
Ocenjevalno poročilo iz odstavka 1 vključuje predvsem:
an evaluation indicating if the methods of analysis in the data submitted in the application are suitable to be used for official controls;
oceno, v kateri je navedeno, ali je metoda analize za podatke, navedene v vlogi, ustrezna za uradni nadzor;
an indication if testing of a method of analysis is considered necessary;
navedbo, ali je potreben preskus metode analize;
an indication if a validation of a method of analysis by an intercomparison study is considered necessary.
navedbo, ali je potrebno potrjevanje metode analize s primerjalno študijo;
NATIONAL REFERENCE LABORATORIES
NACIONALNI REFERENČNI LABORATORIJI
National reference laboratories
Nacionalni referenčni laboratoriji
The CRL shall be assisted by a consortium of national reference laboratories (the consortium) for the duties and tasks set out in 2.2, 2.4 and 3 of Annex II to Regulation (EC) No 1831/2003.
Referenčnemu laboratoriju Skupnosti pri nalogah iz točk 2.2, 2.4 in 3 Priloge II k Uredbi (ES) št. 1831/2003 pomaga konzorcij nacionalnih referenčnih laboratorijev (konzorcij).
The consortium is open to national reference laboratories which comply with the requirements set out in Annex I. The laboratories listed in Annex II are hereby appointed national reference laboratories to take part in the consortium.
V konzorciju lahko sodelujejo nacionalni referenčni laboratoriji, ki izpolnjujejo zahteve, določene v Prilogi I. Laboratoriji, našteti v Prilogi II, so določeni kot nacionalni referenčni laboratoriji, ki bodo sodelovali v konzorciju.
The members of the consortium, including the CRL, shall enter into a contract to define the relations between them, particularly in financial matters.
Člani konzorcija, vključno z referenčnim laboratorijem Skupnosti, podpišejo pogodbo, v kateri določijo razmerja med njimi, zlasti v zvezi s finančnimi zadevami.
In particular, the contract may provide that the CRL is to distribute a share of the fees it receives to the other members of the consortium.
Pogodba zlasti določa, da referenčni laboratorij Skupnosti razdeli del pristojbin, ki jih prejme, drugim članom konzorcija.
Subject to this contract, the CRL may issue guidance to the members of the consortium as provided for in Article 12.
V skladu s to pogodbo lahko referenčni laboratorij Skupnosti sestavi smernice za člane konzorcija, kot je določeno v členu 12.
Any Member State may submit requests to the Commission for the designation of further national reference laboratories to take part in the consortium.
Zahtevo za določitev nacionalnih referenčnih laboratorijev, ki bodo sodelovali v konzorciju, lahko Komisiji predloži katera koli država članica.
If it considers that such laboratories comply with the requirements set out in Annex I, the Commission shall amend the list in Annex II in accordance with the procedure referred to in Article 22(2) of Regulation (EC) No 1831/2003.
Če meni, da takšni laboratoriji izpolnjujejo zahteve iz Priloge I, Komisija spremeni seznam v Prilogi II v skladu s postopkom, določenim v členu 22(2) Uredbe (ES) št. 1831/2003.
The same procedure shall apply if a Member State wishes to withdraw one of its national reference laboratories from the consortium.
Enak postopek se uporabi, če želi država članica umakniti enega od nacionalnih referenčnih laboratorijev iz konzorcija.
The contractual arrangements between the members of the consortium shall be adjusted to reflect any changes to the consortium.
Pogodbene obveznosti med člani konzorcija se prilagodijo tako, da odražajo kakršne koli spremembe v konzorciju.
Rapporteur laboratories
Poročevalski laboratoriji
The CRL shall appoint one laboratory to act as rapporteur laboratory for each application (the rapporteur laboratory).
Referenčni laboratorij Skupnosti za vsako vlogo določi laboratorij, ki deluje kot poročevalski laboratorij (poročevalski laboratorij).
However, the CRL may also act as rapporteur laboratory for applications.
Vendar lahko tudi referenčni laboratorij Skupnosti deluje kot poročevalski laboratorij za vloge.
When appointing a rapporteur laboratory, the CRL shall take into account the expertise, experience and workload of the laboratory.
Pri izbiri poročevalskega laboratorija referenčni laboratorij Skupnosti upošteva strokovno znanje, izkušnje in delovno obremenitev laboratorija.
The laboratories shall send comments to the rapporteur laboratory within 20 days from the date of receipt of the initial evaluation report provided for in Article 8(a).
Laboratoriji poročevalskemu laboratoriju v dvajsetih dneh od datuma prejema začetnega ocenjevalnega poročila iz člena 8(a) pošljejo pripombe.
Duties and tasks of rapporteur laboratories
Dolžnosti in naloge poročevalskih laboratorijev
The rapporteur laboratories shall be responsible for:
Poročevalski laboratoriji so odgovorni za:
drafting an initial evaluation report concerning the data submitted in each application and submitting it for comments to the other laboratories;
sestavo začetnega ocenjevalnega poročila v zvezi s podatki, ki jih je poslal vsak vložnik, ter za posredovanje tega poročila drugim laboratorijem, da dajo svoje pripombe;
compiling the comments received from the other laboratories and preparing a revised evaluation report;
zbiranje pripomb, ki jih pošljejo drugi laboratoriji, in pripravo pregledane različice ocenjevalnega poročila;
submitting the revised evaluation report to the CRL in sufficient time to allow the CRL to submit its full evaluation report to the Authority within the deadline referred to in Article 5(1).
posredovanje pregledane različice ocenjevalnega poročila referenčnemu laboratoriju Skupnosti dovolj zgodaj, da lahko ta Agenciji pravočasno pošlje popolno ocenjevalno poročilo, določeno v členu 5(1).
Duties and tasks of the laboratories participating in the consortium
Dolžnosti in naloge laboratorijev, ki sodelujejo v konzorciju
The laboratories participating in the consortium shall be responsible for contributing to the initial evaluation report prepared by the rapporteur laboratory by sending comments to the rapporteur laboratory within 20 days of the reception of the initial report.
Laboratoriji, ki sodelujejo v konzorciju, prispevajo k začetnemu ocenjevalnemu poročilu, ki ga pripravi poročevalski laboratorij tako, da poročevalskemu laboratoriju pošljejo pripombe v dvajsetih dneh od prejema začetnega poročila.
Each laboratory shall communicate to the CRL by 30 January each year an estimate of the number of applications for which the laboratory considers itself able to carry out the tasks of rapporteur laboratory for that year.
Vsak laboratorij referenčnemu laboratoriju Skupnosti vsako leto do 30. januarja posreduje oceno števila vlog, za katere bo lahko laboratorij deloval v vlogi poročevalskega laboratorija.
The CRL shall make available annually to all the laboratories a compilation of the estimates provided.
Referenčni laboratorij Skupnosti da vsem laboratorijem na voljo skupne letne ocene, ki so bile posredovane.
TESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE
TESTIRANJE IN POTRJEVANJE METOD ANALIZE, POROČANJA IN USMERJANJA
Testing of methods of analysis and validation of methods of analysis
Testiranje in potrjevanje metod analize
The CRL shall indicate in its evaluation report to the Authority, as provided for in Article 5(2), and shall inform the applicant and the Commission, if it considers that the following are necessary:
Referenčni laboratorij Skupnosti bo v ocenjevalnem poročilu, ki ga predloži Agenciji navedel, kot je določeno v členu 5(2), ter o tem obvestil vložnika in Komisijo, če meni, da je potrebno naslednje:
testing of methods of analysis;
testiranje metode analize;
validation of methods of analysis.
potrjevanje metode analize.
In doing so, the CRL shall provide the applicant with a document describing the work to be carried out through the consortium including a time schedule and an estimate of a special fee to be paid by the applicant.
Pri tem referenčni laboratorij Skupnosti vložniku predloži dokument, v katerem je opisan postopek, ki se bo izvedel preko konzorcija, vključno s časovnim razporedom ter približno oceno posebne pristojbine, ki jo mora plačati vložnik.
The applicant shall inform the CRL about his agreement to the document within 15 days of receipt of the communication.
Vložnik mora referenčni laboratorij Skupnosti v petnajstih dneh po prejemu dokumenta obvestiti, ali se z dokumentom strinja.
The CRL shall supplement the report to the Authority, as provided for in Article 5(1), with an addendum concerning the outcome of the application of the procedure foreseen in paragraph 1 within 30 days of the availability to the CRL of the results of the testing and validation work.
Referenčni laboratorij Skupnosti mora Agenciji predložiti poročilo, kot je določeno v členu 5(1), z dodatkom o rezultatu vloge za postopek, predviden v odstavku 1, in sicer v tridesetih dneh po tem, ko referenčni laboratorij Skupnosti da na voljo rezultate testiranja in potrjevanja.
The CRL shall be responsible for preparing an annual report on each year’s activities carried out for the implementation of this Regulation and shall submit it to the Commission.
Referenčni laboratorij Skupnosti je pristojen za pripravo letnega poročila o dejavnostih izvajanja te uredbe in ga posreduje Komisiji.
The consortium shall contribute to this annual report.
Konzorcij prav tako prispeva k temu letnemu poročilu.