natgillin/translations-raw huggingface dataset:
 unique identifier (Commission Regulation (EC) No 65/2004 (where appropriate):
 posebni identifikator (Uredba Komisije (ES) št. 65/2004) (kadar je to primerno):
 either the details of any authorisation granted in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council:
 ali podrobne podatke o katerem koli dovoljenju, izdanem v skladu z Uredbo (ES) št. 1829/2003 Evropskega parlamenta in Sveta:
 or the details of any pending application for authorisation under Regulation (EC) No 1829/2003:
 ali podrobne podatke o kateri koli nerešeni vlogi za izdajo dovoljenja v skladu z Uredbo (ES) št. 1829/2003:
Use in complete feedingstuffs
Uporaba v popolnih krmnih mešanicah
Animal species or category:
Živalska vrsta ali kategorija:
Maximum age or weight:
Največja starost ali teža:
Minimum dose (if appropriate): mg or Units of activity or colony forming units (CFU) or ml/kg of complete feedingstuffs with a moisture content of 12 % …
Najmanjši odmerek (če je primerno): mg ali enot aktivnosti ali enot, ki tvorijo kolonije (CFU), ali ml/kg popolne krmne mešanice z vsebnostjo vlage 12 % …
Maximum dose (if appropriate): mg or Units of activity or CFU or ml/kg of complete feedingstuffs with moisture content of 12 %
Največji odmerek (če je primerno): mg ali enot aktivnosti ali CFU ali ml/kg popolne krmne mešanice z vsebnostjo vlage 12 %
For liquid feeds the minimum and maximum doses can be expressed per litre.
Za tekočo krmo sta lahko najmanjši in največji odmerek izražena na liter.
Use in water
Uporaba v vodi
Minimum dose (if appropriate): mg or Units of activity or CFU or ml/l of water
Najmanjši odmerek (če je primerno): mg ali enot aktivnosti ali CFU ali ml/l vode
Maximum dose (if appropriate): mg or Units of activity or CFU or ml/l of water
Največji odmerek (če je primerno): mg ali enot aktivnosti ali CFU ali ml/l vode
Special conditions of use (if appropriate)
Posebni pogoji uporabe (če je primerno)
Maximum age:
Največja starost:
Minimum dose (if appropriate): mg or Units of activity or CFU/kg of complementary feedingstuffs with moisture content of 12 %
Najmanjši odmerek (če je primerno): mg ali enot aktivnosti ali CFU/kg dopolnilne krmne mešanice z vsebnostjo vlage 12 %
Maximum dose (if appropriate): mg or Units of activity or CFU/kg of complementary feedingstuffs with moisture content of 12 %
Največji odmerek (če je primerno): mg ali enot aktivnosti ali CFU/kg dopolnilne krmne mešanice z vsebnostjo vlage 12 %
Conditions or restrictions for use (if appropriate):
Pogoji ali omejitve uporabe (če je primerno):
Specific conditions or restrictions for handling (if appropriate):
Posebni pogoji ali omejitve ravnanja (če je primerno):
Maximum residue limit (if appropriate):
Mejna vrednost ostankov (če je primerno):
animal species or category:
živalska vrsta ali kategorija:
marker residue:
ostanek označevalca:
target tissues or products:
ciljna tkiva ali proizvodi:
Maximum residue in tissues or products (μg/kg):
Mejna vrednost ostankov v tkivih ali proizvodih (μg/kg):
Withdrawal period:
Karenca:
Community Reference Laboratory (CRL) sample number (if applicable):
Številka vzorca referenčnega laboratorija Skupnosti (če je primerno):
Lot number/batch code:
Številka/koda serije:
Manufacturing date:
Datum izdelave:
Expiry date:
Rok uporabnosti:
Weight:
Teža:
Physical description:
Opis fizikalnih lastnosti:
Container description:
Opis posode:
Storage requirements:
Zahteve glede skladiščenja:
Modification requested (where appropriate)
Zahtevana sprememba (kadar je primerno)
Copy of this application has been sent directly to the Authority with the dossier and to the CRL with the reference samples.
Izvod te vloge je bil poslan neposredno Agenciji skupaj z dokumentacijo in referenčnemu laboratoriju Skupnosti skupaj z referenčnimi vzorci.
Enclosures:
Priloge:
 complete dossier (only to the Authority);
 popolna dokumentacija (le za Agencijo);
 public summary of the dossier;
 javni povzetek dokumentacije;
 detailed summary of the dossier;
 podrobni povzetek dokumentacije;
 list of the parts of the dossier requested to be treated as confidential and a copy of the respective concerned parts of the dossier (only to Commission and Authority);
 seznam delov dokumentacije, za katere se zahteva, da se obravnavajo kot zaupni, in izvod ustreznih delov dokumentacije (le za Komisijo in Agencijo);
 copy of administrative data of applicant(s);
 izvod upravnih podatkov o vložnikih;
 three samples of the feed additive to the CRL following Article 7(3)(f) of Regulation (EC) No 1831/2003 (only to the CRL);
 trije vzorci krmnega dodatka za referenčni laboratorij Skupnosti na podlagi člena 7(3)(f) Uredbe (ES) št. 1831/2003 (le za referenčni laboratorij Skupnosti);
 material safety data sheet (only to the CRL);
 varnostni list za material (le za referenčni laboratorij Skupnosti);
 certificate of identification and analysis (only to the CRL); and
 potrdilo o identifikaciji in analizi (le za referenčni laboratorij Skupnosti); in
 confirmation that the fee to the CRL has been paid (Article 4 of Regulation (EC) No 378/2005.
 potrdilo, da je referenčnemu laboratoriju Skupnosti plačana pristojbina (člen 4 Uredbe (ES) št. 378/2005.
Complete the parts of the form where appropriate, and delete those parts that are not relevant.
Izpolnite ustrezne dele obrazca in izbrišite dele, ki niso pomembni.
The original application form (with other enclosures requested) shall be sent directly to the European Commission.
Izvirnik obrazca za vlogo (z drugimi potrebnimi prilogami) se pošlje neposredno Evropski komisiji.
ADMINISTRATIVE DATA OF APPLICANT(S)
UPRAVNI PODATKI O VLOŽNIKIH
Contact details for submitting an application for the authorisation of a feed additive under Regulation (EC) No 1831/2003
Podatki za predložitev vloge za izdajo dovoljenja za krmni dodatek v skladu z Uredbo (ES) št. 1831/2003
Applicant company or person
Gospodarska družba ali oseba, ki vloži vlogo
Name of the applicant or company
Ime vložnika ali gospodarske družbe
Address (street, number, post code, city, country)
Naslov (ulica, številka, poštna številka, mesto, država)
E-mail (if available)
Elektronska pošta (če je na voljo)
Contact person (for all correspondence with Commission, Authority and CRL)
Kontaktna oseba (za vso korespondenco s Komisijo, Agencijo in referenčnim laboratorijem Skupnosti)
Name of contact person
Ime kontaktne osebe
Address (street, number, post code, city, and country)
Naslov (ulica, številka, poštna številka, mesto in država)
For the functional group ‘other zootechnical additives’ under the category of zootechnical additives, it shall be necessary to define clearly which function is sought for the additive.
Za funkcionalno skupino „drugi zootehnični dodatki“ v kategoriji zootehničnih dodatkov je treba jasno opredeliti, katera funkcija se zahteva za dodatek.
Definition of ‘Unit’ shall be provided by the applicant.
„Enoto“ opredeli vložnik.
Commission Regulation (EC) No 378/2005 of 4 March 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 (OJ L 59, 5.3.2005, p. 8).
Uredba Komisije (ES) št. 378/2005 z dne 4. marca 2005 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 (UL L 59, 5.3.2005, str. 8).
Regulation as amended by Regulation (EC) No 850/2007 (OJ L 188, 20.7.2007, p. 3).
Uredba, kakor je bila spremenjena z Uredbo (ES) št. 850/2007 (UL L 188, 20.7.2007, str. 3).
GENERAL REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3
SPLOŠNE ZAHTEVE, KI JIH MORA IZPOLNJEVATI DOKUMENTACIJA IZ ČLENA 3
GENERAL ASPECTS
SPLOŠNI VIDIKI
This Annex sets out the requirements for establishing the list and the characteristics of studies and information on substances, micro-organisms and preparations to be submitted with dossiers under Article 7 of Regulation (EC) No 1831/2003 for:
Ta priloga določa zahteve za pripravo seznama ter lastnosti študij in informacije o snoveh, mikroorganizmih in pripravkih, ki jih je treba predložiti z dokumentacijo v skladu s členom 7 Uredbe (ES) št. 1831/2003 za:
an authorisation as a new feed additive,
dovoljenje za nov krmni dodatek,
an authorisation of a new use of a feed additive,
dovoljenje za novo uporabo krmnega dodatka,
a modification of an existing authorisation of a feed additive, or
spremembo obstoječega dovoljenja za krmni dodatek, ali
a renewal of the authorisation of a feed additive.
podaljšanje dovoljenja za krmni dodatek.
The dossiers must enable an assessment to be made of additives based on the current state of knowledge and permit verification of the compliance of these additives with the fundamental principles for authorisation, which are laid down in Article 5 of Regulation (EC) No 1831/2003.
Dokumentacija mora omogočati oceno dodatkov na podlagi sedanjega znanja in dopuščati preverjanje skladnosti teh dodatkov s temeljnimi načeli za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003.
The studies to be submitted and the extent of them will depend on the additive nature, the category and functional group, the type of authorisation (non-holder specific vs. holder specific), the substance itself, the target animals and the conditions of use.
Študije, ki jih je treba predložiti, in njihov obseg bodo odvisni od narave dodatka, kategorije in funkcionalne skupine, vrste dovoljenja (za nedoločenega imetnika ali za določenega imetnika), same snovi, ciljnih živali in pogojev uporabe.
The applicant shall refer to this Annex and to Annex III in order to evaluate which studies and information shall be submitted with the application.
Vložnik se pri oceni, katere študije in informacije se predložijo skupaj z vlogo, sklicuje na to prilogo in Prilogo III.
The applicant shall clearly provide the reasons for the omission or deviation from the dossier of any data prescribed in this Annex, Annex III and Annex IV.
Vložnik jasno navede razloge za izpustitev ali odstopanja kakršnih koli podatkov iz te priloge, Priloge III in Priloge IV v dokumentaciji.
The dossier shall include detailed reports of all the studies performed, presented in accordance with the numbering system proposed in this Annex.
Dokumentacija vključuje natančna poročila o vseh opravljenih študijah, ki se predložijo v skladu s sistemom številčenja iz te priloge.
The dossier shall include references and copies of all published scientific data mentioned and the copies of any other relevant opinions which have already been produced by any recognised scientific body.
Dokumentacija vključuje sklicevanja in izvode vseh navedenih objavljenih znanstvenih podatkov ter izvode kakršnih koli drugih ustreznih mnenj, ki jih je pripravil kateri koli priznani znanstveni organ.
Where these studies have already been evaluated by a European scientific body following the legislation in force in the Community, a reference to the result of the evaluation shall be sufficient.
Kadar je te študije že ocenil evropski znanstveni organ na podlagi zakonodaje, ki velja v Skupnosti, je dovolj sklicevanje na rezultat ocene.
Data from studies that have been conducted and published previously or coming from peer review shall clearly refer to the same additive as the one subject to the application for authorisation.
Podatki iz prej opravljenih in objavljenih študij ali študij z medsebojnim pregledom se jasno sklicujejo na dodatek, ki je isti kot dodatek, za katerega se vloži vloga za izdajo dovoljenja.
Studies, including those that have been conducted and published previously or coming from peer review, shall be performed and documented according to appropriate quality standards (e.g. Good Laboratory Practice (GLP)) in accordance with Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances or International Organisation for Standardisation (ISO).Where in vivo or in vitro studies are carried out outside the Community, the applicant shall demonstrate that the facilities concerned comply with the Organisation for Economic Cooperation and Development (OECD) principles of Good Laboratory Practice or ISO standards.
Študije, vključno s prej opravljenimi in objavljenimi študijami ali študijami z medsebojnim pregledom, se izvedejo in dokumentirajo po ustreznih standardih kakovosti (npr. dobri laboratorijski praksi) v skladu z Direktivo 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi ali Mednarodno organizacijo za standardizacijo (ISO).Kadar se študije in vivo ali in vitro izvajajo zunaj Skupnosti, vložnik dokaže, da so zadevni prostori v skladu z načeli dobre laboratorijske prakse Organizacije za gospodarsko sodelovanje in razvoj ali standardi ISO.
The determination of physico-chemical, toxicological and eco-toxicological properties must be performed in accordance with the methods established by Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, as last amended by Commission Directive 2004/73/EC, or with updated methods recognised by international scientific bodies.
Fizikalno-kemijske, toksikološke in ekotoksikološke lastnosti je treba določiti v skladu z metodami iz Direktive Sveta 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi, kakor je bila nazadnje spremenjena z Direktivo Komisije 2004/73/ES, ali v skladu s posodobljenimi metodami, ki jih priznavajo mednarodni znanstveni organi.
The use of methods other than these must be justified.The use of in vitro methods or of methods refining or replacing the usual tests using laboratory animals or reducing the number of animals used in these test shall be encouraged.
Uporabo drugih metod je treba utemeljiti.Spodbuja se uporaba metod in vitro ali metod, ki izboljšujejo ali nadomeščajo običajne preskuse z uporabo laboratorijskih živali ali zmanjšujejo število živali, ki se uporabljajo pri takšnih preskusih.
Such methods shall be of the same quality and provide the same level of assurance as the method they aim to replace.
Takšne metode so enake kakovosti in zagotavljajo enako raven zanesljivosti kot metoda, ki jo nadomeščajo.
The description of the methods of analysis in feed or water shall be in conformity with the rules of GLP as laid down in Directive 2004/10/EC and/or EN ISO/IEC 17025.
Opis analitskih metod za krmo ali vodo je v skladu s pravili dobre laboratorijske prakse iz Direktive 2004/10/ES in/ali standarda EN ISO/IEC 17025.
These methods shall comply with the requirements laid down in Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.Each dossier shall contain a public summary and a scientific detailed summary in order to enable the additive concerned to be identified and characterised.
Te metode so v skladu z zahtevami iz člena 11 Uredbe (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali.Vsaka dokumentacija vsebuje javni povzetek in znanstveni podrobni povzetek, da se omogočita identifikacija in opis lastnosti zadevnega dodatka.
Each dossier shall contain a post-market monitoring proposal where required by Article 7(3)(g) of Regulation (EC) No 1831/2003 and a labelling proposal as referred to in Article 7(3)(e) of Regulation (EC) No 1831/2003.
Vsaka dokumentacija vsebuje predlog za poprodajni nadzor, kadar to določa člen 7(3)(g) Uredbe (ES) št. 1831/2003, in predlog za označevanje iz člena 7(3)(e) Uredbe (ES) št. 1831/2003.
This is based on studies intended to demonstrate the safety of the use of the additive in relation to:
Ocena varnosti temelji na študijah za dokazovanje varnosti uporabe dodatka glede na:
the target species at the highest proposed levels of incorporation in the feed or water and at a multiple of that level to establish a margin of safety;
ciljne vrste pri največjih predlaganih ravneh vključitve v krmo ali vodo in pri večkratni ravni glede na to raven, da se določi meja varnosti;
consumers who ingest food products obtained from animals that have received the additive, its residues or its metabolites.
potrošnike, ki zaužijejo živilske proizvode, pridobljene iz živali, ki so prejele dodatek, njegove ostanke ali metabolite.
In this case, safety will be ensured by the setting of maximum residue limits (MRLs) and withdrawal periods based on an Acceptable Daily Intake (ADI) or an Tolerable Upper Intake Level (UL);
V tem primeru se varnost zagotovi z določitvijo mejnih vrednosti ostankov (MRL) in karenc na podlagi sprejemljivega dnevnega vnosa (ADI) ali največjega dovoljenega vnosa (UL);
persons likely to be exposed to the additive by respiratory, mucosal, eye or cutaneous contact while handling the additive or incorporating it into premixtures or complete feed or water or using feed or water containing the additive concerned;
osebe, ki so pri ravnanju z dodatkom ali vključevanju dodatka v premikse ali popolno krmno mešanico ali vodo ali pri uporabi krme ali vode, ki vsebuje zadevni dodatek, najverjetneje izpostavljene dodatku z vdihavanjem, stikom s sluznico, očmi ali kožo;
animals and humans with respect to the selection and spread of antimicrobial resistance genes; and
živali in ljudi s selekcijo in širjenjem genov za odpornost proti mikrobom; in
the environment, as a result of the additive itself or products derived from the additive, either directly and/or as excreted by animals.
okolje zaradi samega dodatka ali proizvodov, pridobljenih neposredno iz dodatka in/ali kot živalski izloček.
Where an additive has multiple components, each one may be separately assessed for consumer safety and then consideration given to the cumulative effect (where it can be shown that there are no interactions between the components).
Kadar ima dodatek več sestavin, se lahko vsaka od njih posamezno oceni glede varnosti za potrošnika in se potem upošteva kumulativni učinek (kadar se lahko dokaže, da ne obstaja medsebojni vpliv med sestavinami).
Alternatively, the complete mixture shall be assessed.
Namesto tega se oceni celotna mešanica.
Efficacy assessment
Ocena učinkovitosti
This is based on studies that are intended to demonstrate the efficacy of an additive in terms of the aims of its intended use as defined in Article 6 (1) and Annex I of Regulation (EC) No 1831/2003.
Ocena učinkovitosti temelji na študijah za dokazovanje učinkovitosti dodatka glede ciljev njegove nameravane uporabe, kakor je opredeljena v členu 6(1) in Prilogi I k Uredbi (ES) št. 1831/2003.
SECTION I: SUMMARY OF THE DOSSIER
ODDELEK I: POVZETEK DOKUMENTACIJE
Public summary according to Article 7(3)(h) of Regulation (EC) No 1831/2003
Javni povzetek v skladu s členom 7(3)(h) Uredbe (ES) št. 1831/2003
The applicant shall submit a summary indicating the main features of the additive concerned.
Vložnik predloži povzetek, v katerem so navedene glavne lastnosti zadevnega dodatka.
The summary shall not contain any confidential information and shall be structured as follows:
Povzetek ne vključuje nobenih zaupnih informacij in je strukturiran na naslednji način:
Contents
Vsebina:
name of the applicant(s);
imena vložnikov;
identification of the additive;
identifikacija dodatka;
method of production and method of analysis;
postopek proizvodnje in analitska metoda;
studies on safety and efficacy of the additive;
študije o varnosti in učinkovitosti dodatka;
proposed conditions for use; and
predlagani pogoji uporabe; in
proposal for post-market monitoring.
predlog za poprodajni nadzor.
name and address of the applicant(s)
Imena in naslovi vložnikov
This information shall be provided in all cases, independent of the type of feed additive authorisation (holder-specific or non-holder specific).
Ti podatki se navedejo v vseh primerih ne glede na vrsto dovoljenja za krmni dodatek (za določenega imetnika ali za nedoločenega imetnika).
When a dossier is submitted by a group of applicants, the name of each of them shall be indicated.
Kadar dokumentacijo predloži skupina vložnikov, se navedejo imena vseh vložnikov.
identification of the additive
Identifikacija dodatka
The identification of the additive shall contain a summary of the information required according to Annex II or III, depending on the type of the feed additive authorisation.
Identifikacija dodatka vključuje povzetek informacij, ki jih je treba navesti v skladu s Prilogo II ali III, glede na vrsto dovoljenja za krmni dodatek.
In particular: name of the additive, proposed classification by category and functional group, target species/animal categories and doses.
Te so zlasti: ime dodatka, predlagana razvrstitev glede na kategorijo in funkcionalno skupino, ciljne vrste/kategorije živali in odmerki.
method of production and method of analysis
Postopek proizvodnje in analitska metoda
The manufacturing process shall be described.
Opiše se postopek izdelave.
The general procedures of the analytical methods to be used for the analysis for the official controls of the additive as such, in premixtures, and in feedingstuffs, as required in this Annex and Annex III shall be described.
Opišejo se splošni postopki analitskih metod, ki se uporabljajo za analizo za uradni nadzor dodatka kot takega, v premiksih in krmi, kot je določeno v tej prilogi in Prilogi III.
If appropriate, on the basis of the information submitted in this Annex and Annex III, the procedure of the method(s) to be used for the analysis for the official controls of the additives or its metabolites in food of animal origin shall be included.
Če je primerno, se na podlagi informacij iz te priloge in Priloge III vključi postopke metod, ki se uporabljajo za analizo za uradni nadzor dodatkov ali njihovih metabolitov v živilih živalskega izvora.
studies on safety and efficacy of the additive
Študije o varnosti in učinkovitosti dodatka
The conclusion regarding the safety and efficacy of the additive based on the different studies performed shall be given.
Navede se ugotovitev glede varnosti in učinkovitosti dodatka, ki temelji na različnih opravljenih študijah.
The results of the studies may be included in a tabular form to support the conclusion of the applicant(s).
Rezultati študij se lahko navedejo v obliki tabele, da se podpre ugotovitev vložnikov.
Only studies required according to Annex III shall be indicated in the summary.
V povzetku se navedejo le študije, potrebne v skladu s Prilogo III.
proposed conditions for use
Predlagani pogoji uporabe
The proposal for conditions of use shall be provided by the applicant(s).
Predlog za pogoje uporabe predložijo vložniki.
In particular the applicant shall describe the level of use in water or feed, together with the detailed conditions of use in complementary feedingstuffs.
Vložnik opiše zlasti raven uporabe v vodi ali krmi, skupaj z natančnimi pogoji uporabe v dopolnilni krmni mešanici.
Information is also required where other methods of administration or incorporation in feed or water are used.
Informacije so potrebne tudi, kadar se uporabljajo druge metode dajanja ali vključevanja v krmo ali vodo.
Any specific conditions for use (e.g. incompatibilities), specific labelling requirements and animal species for which the additive is intended shall be described.
Opišejo se vsi posebni pogoji uporabe (npr. nezdružljivosti), posebne zahteve za označevanje in živalske vrste, ki jim je dodatek namenjen.
proposal for post-market monitoring
Predlog za poprodajni nadzor