natgillin/translations-raw huggingface dataset:
These chemically defined flavourings also represent an homogeneous group of feed additives in terms of their conditions of authorisation and their safety assessment to be carried out following the specific requirements for them laid down in Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives [3].
Te kemijsko opredeljene aromatične snovi so krmni dodatki, za katere veljajo podobni pogoji za izdajo dovoljenja in oceno varnosti, ki se izvede na podlagi posebnih zahtev iz Uredbe Komisije (ES) št. 429/2008 z dne 25. aprila 2008 o podrobnih pravilih za izvajanje Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 v zvezi s pripravo in predložitvijo vlog ter oceno krmnih dodatkov in izdajo dovoljenj zanje [3].
The methods of analysis used for many of these chemically defined flavourings may be of the type of multi-analyte methods.
Za številne od teh kemijsko opredeljenih aromatičnih snovi se lahko uporabljajo analitske metode za več analitov.
It is therefore appropriate to establish a system of reduced fees for groups of applications for authorisations concerning already authorised feed additives such as the chemically defined flavourings when the applications are submitted simultaneously and contain similar methods of analysis, particularly of the type multi-analyte methods.
Zato je primerno vzpostaviti sistem za manjše pristojbine po skupina vlog za izdajo dovoljenj za že dovoljene krmne dodatke, kot so kemijsko opredeljene aromatične snovi, kadar so vloge predložene hkrati in vsebujejo podobne analitske metode, zlasti analitske metode za več analitov.
For the purpose of the calculation of the different fees, the fee is considered to be composed of two components.
Za namen izračuna različnih pristojbin se šteje, da je pristojbina sestavljena iz dveh delov.
The first component is intended to support the CRL administrative costs and the costs related to the handling of the reference samples.
Prvi del je namenjen za delno kritje upravnih stroškov referenčnega laboratorija Skupnosti in njegovim stroškom v zvezi z ravnanjem z referenčnimi vzorci.
The second component is intended to support the costs of the Rapporteur Laboratory for the scientific evaluation and preparation of the evaluation report.
Drugi del je namenjen za delno kritje stroškov poročevalskega laboratorija v zvezi z znanstveno oceno in pripravo ocenjevalnega poročila.
It is also appropriate to adapt the scope of the guidance to applicants prepared by the CRL following the adoption of Regulation (EC) No 429/2008 and also to introduce other minor amendments to Regulation (EC) No 378/2005, taking into account the experience gained.
Ob upoštevanju izkušenj je primerno tudi prilagoditi obseg smernic za vložnike, ki jih v skladu z Uredbo (ES) št. 429/2008 pripravi referenčni laboratorij Skupnosti, in uvesti druge manjše spremembe Uredbe (ES) št. 378/2005.
Belgium has submitted a request to the Commission for the designation of Centre wallon de recherches agronomiques (CRA-W) in Gembloux, as a new national reference laboratory to take part in the consortium.
Belgija je Komisiji predložila zahtevo za imenovanje Centre wallon de recherches agronomiques (CRA-W) iz Gemblouxja kot novega nacionalnega laboratorija, ki sodeluje v konzorciju.
Since that laboratory complies with the requirements set out in Annex I to Regulation (EC) No 378/2005 it should be inserted in the list of laboratories set out in Annex II to that Regulation.
Ker navedeni laboratorij izpolnjuje zahteve iz Priloge I k Uredbi (ES) št. 378/2005, ga je treba uvrstiti na seznam laboratorijev iz Priloge II k navedeni uredbi.
Lithuania has informed the Commission that it wishes to withdraw Klaipėdos apskrities VMVT laboratorija, in Klaipėda, from the consortium of national reference laboratories.
Litva je obvestila Komisijo, da želi umakniti Klaipėdos apskrities VMVT laboratorija iz Klaipėde iz konzorcija nacionalnih referenčnih laboratorijev.
That laboratory should therefore be deleted from that list of laboratories.
Navedeni laboratorij je treba črtati z navedenega seznama laboratorijev.
In addition several Member States have informed the Commission that certain details of their national reference laboratories taking part in the consortium have changed.
Poleg tega so številne države članice obvestile Komisije, da so se spremenile nekatere podrobnosti njihovih nacionalnih referenčnih laboratorijev, ki sodelujejo v konzorciju.
The list in Annex II to Regulation (EC) No 378/2005 should be amended accordingly.
Seznam iz Priloge II k Uredbi (ES) št. 378/2005 je treba ustrezno spremeniti.
In the interests of clarity of Community legislation, it should be replaced in its entirety by the list in the Annex I to this Regulation.
Zaradi jasnosti zakonodaje Skupnosti ga je treba v celoti nadomestiti s seznamom iz Priloge I k tej uredbi.
This Regulation lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory (the CRL).’
Ta uredba določa podrobna pravila za izvajanje Uredbe (ES) št. 1831/2003 glede dolžnosti in nalog referenčnega laboratorija Skupnosti (CRL).“;
In Article 2, the following points (h) and (i) are added:
v členu 2 se dodata naslednji točki (h) in (i):
“multi-analyte methods” are methods based on a defined principle applicable for the single or simultaneous determination of one or more substance(s)/agent(s) in the specific matrices defined in the scope of the method.
‚analitske metode za več analitov‘ so metode, ki temeljijo na opredeljenem načelu, ki se uporablja za enkratno ali hkratno določitev ene ali več snovi/sredstev v posebnih matriksih, opredeljenem s področjem uporabe metode;
“reference standard” is a sample of a pure active agent used for calibration purposes.’
‚referenčni standard‘ je vzorec čistega aktivnega sredstva, ki se uporablja za umerjanje.“;
Any person submitting an application for an authorisation for a feed additive or for a new use of a feed additive, as provided for in Article 4(1) of Regulation (EC) No 1831/2003, shall send three reference samples in a form in which the feed additive is intended to be placed on the market by the applicant.
Vsaka oseba, ki predloži vlogo za izdajo dovoljenja za krmni dodatek ali novo uporabo krmnega dodatka, kakor je določeno v členu 4(1) Uredbe (ES) št. 1831/2003, pošlje tri referenčne vzorce v obliki, v kateri vložnik namerava dati krmni dodatek na trg.
In addition, the applicant shall provide to the CRL:
Poleg tega vložnik referenčnemu laboratoriju Skupnosti predloži:
reference standards of the pure active agents in the case of feed additives:
referenčne standarde čistih aktivnih sredstev v primeru krmnih dodatkov:
belonging to the category zootechnical additives referred to in Article 6(1)(d) of Regulation (EC) No 1831/2003, except feed additives consisting of or containing micro-organisms;
iz kategorije zootehnični dodatki iz člena 6(1)(d) Uredbe (ES) št. 1831/2003, razen krmnih dodatkov, ki so sestavljeni iz mikroorganizmov ali jih vsebujejo,
belonging to the category coccidiostats and histomonostats referred to in Article 6(1)(e) of Regulation (EC) No 1831/2003;
iz kategorije kokcidiostatiki in sredstva proti histomonijazi iz člena 6(1)(e) Uredbe (ES) št. 1831/2003,
falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from genetically modified organisms (GMOs);
s področjem uporabe zakonodaje Skupnosti o trženju proizvodov, ki so sestavljeni iz gensko spremenjenih organizmov (GSO), jih vsebujejo ali so iz njih proizvedeni,
for which Maximum Residue Limits have been established in Annex I or III of Council Regulation (EEC) No 2377/90 or following Regulation (EC) No 1831/2003.(b) where the application concerns a feed additive consisting of or containing micro-organisms, an authorisation to the CRL to access the microbial strain deposited at the internationally recognised culture collection mentioned in point 2.2.1.2. of Annex II of Commission Regulation (EC) No 429/2008, if requested by the CRL.
za katere so bili v Prilogi I ali III Uredbe Sveta (EGS) št. 2377/90 ali v skladu z Uredbo (ES) št. 1831/2003 določene najvišje mejne vrednosti ostankov;(b) na zahtevo referenčnega laboratorija Skupnosti dovoljenje referenčnemu laboratoriju Skupnosti za dostop do mikrobnega seva, ki je deponiran v mednarodni priznani zbirki kultur iz točke 2.2.1.2 Priloge II k Uredbi Komisije (ES) št. 429/2008, kadar vloga zadeva krmni dodatek, ki je sestavljen iz mikroorganizmov ali jih vsebuje.
Where the application concerns a feed additive belonging to the category sensory additives and allocated within the functional group flavouring compounds referred to at point 2(b) of Annex I to Regulation (EC) No 1831/2003, subject to Article 10(2) of that Regulation, which forms part of a group of applications, the reference samples must be representative of all the compounds/substances in the group.
Kadar vloga iz skupine vlog zadeva krmni dodatek iz kategorije senzorični dodatki iz funkcionalne skupine aromatične snovi iz točke 2(b) Priloge I k Uredbi (ES) št. 1831/2003, za katero se uporablja člen 10(2) navedene uredbe, morajo biti referenčni vzorci reprezentativni za vse snovi/spojine iz skupine.
The three reference samples of the feed additive shall be accompanied by a written statement by the applicant that the fee provided for in Article 4(1) has been paid.
Trije referenčni vzorci krmnega dodatka so opremljeni s pisno izjavo vložnika, da je bila pristojbina iz člena 4(1) plačana.
The applicant shall maintain the reference samples valid for the entire period of the authorisation of the feed additive by supplying new reference samples to the CRL to replace those expired.
Vložnik ohranja veljavne referenčne vzorce skozi vse obdobje dovoljenja za krmni dodatek, tako da referenčnemu laboratoriju Skupnosti predloži nove referenčne vzorce za nadomestitev tistih, ki potečejo.
The applicant shall supply additional reference samples, reference standards, feed and/or food test materials, as defined in Article 2, if requested by the CRL.
Vložnik na zahtevo referenčnega laboratorija Skupnosti predloži dodatne referenčne vzorce, referenčne standarde ter krmne in/ali živilske preskusne snovi, kakor določa člen 2.
Upon justified request of the national reference laboratories of the consortium and without prejudice of Articles 11, 32 and 33 of Regulation (EC) No 882/2004, the CRL may request to the applicant additional reference samples, reference standards, feed and/or food test materials.
Referenčni laboratorij Skupnosti lahko na upravičeno zahtevo nacionalnih referenčnih laboratorijev iz konzorcija in brez poseganja v člene 11, 32 in 33 Uredbe (ES) št. 882/2004 od vložnika zahteva dodatne referenčne vzorce, referenčne standarde ter krmne in/ali živilske preskusne snovi.
Reference samples shall not be required for:
Referenčni vzorci se ne zahtevajo za:
an application for a new use of a feed additive, already authorised for another use, submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when reference samples have been previously sent to the CRL for that other use;
vlogo za novo uporabo krmnega dodatka, že dovoljenega za drugo uporabo, predloženo v skladu s členom 4(1) Uredbe (ES) št. 1831/2003, kadar so bili referenčni vzorci poslani referenčnemu laboratoriju Skupnosti v zvezi z navedeno drugo uporabo;
an application for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change is not related to the characteristics of the feed additive previously sent to the CRL as reference sample of the feed additive concerned.
vlogo za spremembo pogojev obstoječega dovoljenja, predloženo v skladu s členom 13(3) Uredbe (ES) št. 1831/2003, kadar predlagana sprememba ni povezana z značilnostmi krmnega dodatka, poslanega referenčnemu laboratoriju Skupnosti kot referenčni vzorec zadevnega krmnega dodatka.
In Article 4, paragraph 1 is replaced by the following:
v členu 4 se odstavek 1 nadomesti z naslednjim:
The CRL shall charge the applicant a fee in accordance with the rates set out in Annex IV (“the fee”).’
Referenčni laboratorij Skupnosti vložniku zaračuna pristojbino v skladu s Prilogo IV (‚pristojbina‘).“;
The CRL shall submit a full evaluation report to the European Food Safety Authority (the Authority) for each application, or for each group of applications, 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 varnost hrane (v nadaljevanju: Agencija) za vsako vlogo ali vsako skupino vlog predloži popolno ocenjevalno poročilo v treh mesecih od datuma prejema veljavne vloge, kakor določa člen 8(1) Uredbe (ES) št. 1831/2003, in po plačilu pristojbine.
However, if the CRL considers the application to be 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 za en mesec.
The CRL shall inform the Commission, the Authority, and the applicant when the period is extended.
Referenčni laboratorij Skupnost o takih primerih obvesti Komisijo, Agencijo in vložnika.
The time limits provided for in this paragraph may be further extended with the agreement of the Authority, whenever the CRL requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the CRL within those time limits.
Roki iz tega odstavka se lahko dodatno podaljšajo po dogovoru z Agencijo, kadar koli referenčni laboratorij Skupnosti zahteva dodatne informacije, ki jih vložnik ne more predložiti in/ali jih referenčni laboratorij Skupnosti ne more oceniti v navedenih rokih.
However, the time limit for the CRL to submit the evaluation report to the Authority shall not exceed the time limit for Authority to provide its opinion, as provided for in Article 8(1) of Regulation (EC) No 1831/2003.’
Vendar rok za predložitev ocenjevalnega poročila referenčnega laboratorija Skupnosti Agenciji ne sme presegati roka za predložitev mnenja Agencije iz člena 8(1) Uredbe (ES) št. 1831/2003.“;
The evaluation report provided for in paragraph 1 may be amended by the CRL at the request of the Commission or the Authority where:
Referenčni laboratorij Skupnosti lahko na zahtevo Komisije ali Agencije spremeni ocenjevalno poročilo iz odstavka 1, kadar:
the conditions for placing the feed additive on the market resulting from the Authority's opinion in accordance with Article 8(3)(a) of Regulation (EC) No 1831/2003 differ from those originally proposed by the applicant;
se pogoji za dajanje krmnega dodatka na trg zaradi mnenja Agencije v skladu s členom 8(3)(a) Uredbe (ES) št. 1831/2003 razlikujejo od tistih, ki jih je predlagal vložnik;
supplementary information relevant to the method of analysis have been provided by the applicant to the Authority.
je vložnik Agenciji predložil dodatne informacije o analitski metodi.
An evaluation report shall not be required for:
Ocenjevalno poročilo se ne zahteva za:
applications for a new use of a feed additive submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when the proposed conditions for placing the feed additive on the market for the new use fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL;
vloge za novo uporabo krmnega dodatka, predložene v skladu s členom 4(1) Uredbe (ES) št. 1831/2003, kadar predlagani pogoji za dajanje krmnega dodatka na trg za novo uporabo vključujejo analitsko metodo, ki je predložena v skladu z odstavkom 2.6 Priloge II k Uredbi (ES) št. 429/2008 in jo je referenčni laboratorij Skupnosti že ocenil;
applications for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change or the new conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL.
vloge za spremembo pogojev obstoječega dovoljenja, predložene v skladu s členom 13(3) Uredbe (ES) št. 1831/2003, kadar predlagana sprememba ali novi pogoji za dajanje krmnega dodatka na trg vključujejo analitsko metodo, ki je predložena v skladu z odstavkom 2.6 Priloge II k Uredbi (ES) št. 429/2008 in jo je referenčni laboratorij Skupnosti že ocenil.
Notwithstanding paragraph 4, the Commission, the CRL or the Authority may, on the basis of legitimate factors relevant to the application, consider that a new evaluation of the methods of analysis is necessary.
Brez poseganja v odstavek 4 lahko Komisija, referenčni laboratorij Skupnosti ali Agencija na podlagi upravičenih dejavnikov v zvezi z vlogo sklene, da je potrebna nova ocena analitske metode.
In such cases the applicant shall be informed by the CRL.’
V takih primerih referenčni laboratorij Skupnosti obvesti vložnika.“;
In Article 8, the following point (d) is added:
v členu 8 se doda naslednja točka (d):
if requested by the CRL, submitting an amendment to the evaluation report concerning the supplementary data submitted by the applicant to the CRL or to the Authority.’
na zahtevo referenčnega laboratorija Skupnosti predložitev spremembe ocenjevalnega poročila glede dodatnih podatkov, ki jih vložnik predloži referenčnemu laboratoriju Skupnosti ali Agenciji.“;
In Article 12, paragraph 1, the following point (d) is added:
v členu 12(1) se doda naslednja točka (d):
requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008;’
zahteve za analitske metode, ki se predložijo v skladu z odstavkom 2.6 Priloge II k Uredbi (ES) št. 429/2008.“;
Annex II is replaced by the text in Annex I to this Regulation.
Priloga II se nadomesti z besedilom iz Prilogi I k tej uredbi;
A new Annex IV, the text of which is set out in Annex II to the present Regulation, is added.
doda se nova Priloga IV, katere besedilo je navedeno v Prilogi II k tej uredbi.
OJ L 133, 22.5.2008, p. 1.’
UL L 133, 22.5.2008, str. 1.“;
Community Reference Laboratory and consortium of national reference laboratories, as referred to in Article 6(2)
Referenčni laboratorij Skupnosti in konzorcij nacionalnih referenčnih laboratorijev iz člena 6(2)
NATIONAL REFERENCE LABORATORIES OF THE MEMBER STATES
NACIONALNI REFERENČNI LABORATORIJI DRŽAV ČLANIC
Laboratoire de Contrôle et d’essais – ASTA, Ettelbruck.
Laboratoire de Contrôle et d'essais – ASTA, Ettelbruck
Państwowy Instytut Weterynaryjny, Pulawy.
Państwowy Instytut Weterynaryjny, Puławy
Foderavdelningen, Statens Veterinärmedicinska Anstalt (SVA), Uppsala.
Foderavdelningen, Statens Veterinärmedicinska Anstalt (SVA), Uppsala
NATIONAL REFERENCE LABORATORIES OF EFTA COUNTRIES
NACIONALNI REFERENČNI LABORATORIJI DRŽAV EFTA
RATES FOR FEES AS REFERRED TO IN ARTICLE 4(1)
PRISTOJBINE IZ ČLENA 4(1)
Composition of the fee
Sestava pristojbine
For the purpose of the calculation of the fee, the fee is composed of the following two components:
Za namen izračuna je pristojbina sestavljena iz dveh delov:
This first component amounts to EUR 2000.
Višina prvega dela je 2000 EUR.
This second component amounts to EUR 4000.
Višina drugega dela je 4000 EUR.
The two components are applied as detailed below to calculate the fee rates.
Pri izračunu višine pristojbine se dela uporabljata, kot je navedeno spodaj.
Rates according to the type of application for authorisations of feed additives in accordance with Regulation (EC) No 1831/2003
Višina pristojbine glede na tip vloge za izdajo dovoljenja za krmni dodatek v skladu z Uredbo (ES) št. 1831/2003
Authorisation of a new feed additive (Article 4(1) of Regulation (EC) No 1831/2003):
Dovoljenje za nov krmni dodatek (člen 4(1) Uredbe (ES) št. 1831/2003):
Fee = Component 1 + Component 2 = EUR 6000
pristojbina = del 1 + del 2 = 6000 EUR
Authorisation of a new use of a feed additive (Article 4(1) of Regulation (EC) No 1831/2003):
Dovoljenje za novo uporabo krmnega dodatka (člen 4(1) Uredbe (ES) št. 1831/2003):
when Article 3 (4)(a) and Article 5(4)(a) apply:
kadar se uporabljata člena 3(4)(a) in 5(4)(a):
Fee = EUR 0
pristojbina = 0 EUR
when only Article 3 (4)(a) applies, only Component 2 is applicable:
kadar se uporablja le člen 3(4)(a), se uporablja le del 2:
Fee = EUR 4000
pristojbina = 4000 EUR
Authorisation of an already authorised feed additive (Article 10(2) of Regulation (EC) No 1831/2003):
Dovoljenje za že dovoljen krmni dodatek (člen 10(2) Uredbe (ES) št. 1831/2003):
For groups of applications concerning more than one feed additive submitted simultaneously belonging to the same category of feed additives, functional group and sub classification, if applicable, and other than chemically defined flavourings, zootechnical additives, coccidiostats and histomonostats, and when the methods of analysis used for these feed additives are of the multi-analyte type of methods of analysis, the fee shall be calculated as follows:
Za skupine vlog, ki so predložene hkrati in zadevajo več kot en krmni dodatek iz iste kategorije krmnih dodatkov, iste funkcionalne skupine in podskupine, če se uporablja, razen kemijsko opredeljenih aromatičnih snovi, zootehničnih dodatkov, kokcidiostatikov in sredstev proti histomonijazi, ter kadar se za te krmne dodatke uporablja analitska metoda za več analitov, se pristojbina izračuna na naslednji način:
The first component is multiplied by the number (n) of feed additives in the group:
Prvi del se pomnoži s številom krmnih dodatkov (n) v skupini:
Component 1 = (EUR 2000 × n) = N
del 1 = (2000 EUR × n ) = N
The second component is multiplied by the number (m) of methods of analysis to be evaluated by the CRL:
Drugi del se pomnoži s številom analitskih metod (m), ki jih oceni referenčni laboratorij Skupnosti:
Component 2 = (EUR 4000 × m) = M
del 2 = (4000 EUR × m ) = M
The fee shall be the sum of the two components:
Pristojbina je vsota dveh delov:
Fee = N + M
pristojbina = N + M
For groups of applications concerning more than one chemically defined flavouring submitted simultaneously and when the methods of analysis used for these feed additives are of the multi-analyte type of methods of analysis, the fee shall be calculated as follows:
Za skupine vloge, ki so predložene hkrati in zadevajo več kot eno kemijsko opredeljeno aromatično snov ter kadar se za te krmne dodatke uporablja analitska metoda za več analitov, se pristojbina izračuna na naslednji način:
The first component is multiplied by the number (n) of reference samples, as specified in Article 3 paragraph 1, submitted to the CRL:
Prvi del se pomnoži s številom referenčnih vzorcev (n) iz člena 3(1), predloženih referenčnemu laboratoriju Skupnosti:
Applications for changing the terms of an existing authorisation (Article 13(3) of Regulation (EC) No 1831/2003):
Vloge za spremembo pogojev obstoječega dovoljenja (člen 13(3) Uredbe (ES) št. 1831/2003):
when Article 3(4)(b) and Article 5(4)(b) apply:
kadar se uporabljata člena 3(4)(b) in 5(4)(b):
when only Article 3(4)(b) applies, only Component 2 applies:
kadar se uporablja le člen 3(4)(b), se uporablja le del 2:
Renewal of an authorisation of a feed additive (Article 14 of Regulation (EC) No 1831/2003):
Podaljšanje dovoljenja za krmni dodatek (člen 14 Uredbe (ES) št. 1831/2003):
Fee = EUR 4000’
pristojbina = 4000 EUR“
Lietuvos
Litva
Mezőgazdasági Szakigazgatási Hivatal Központ, Élelmiszer- és Takarmány-biztonsági Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest.
Mezőgazdasági Szakigazgatási Hivatal Központ, Élelmiszer- és Takarmány-biztonsági Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest