natgillin/translations-raw huggingface dataset:
The holder of the authorisation of the additive salinomycin sodium (Salinomax 120G) has submitted an application which proposes changing the conditions of the authorisation by introducing a maximum residue limit (MRL) as evaluated by the Authority.
Imetnik dovoljenja za dodatek natrijev salinomicin (Salinomax 120G) je predložil zahtevek, v katerem predlaga spremembo pogojev za izdajo dovoljenja z uvedbo najvišje mejne vrednosti ostanka (MRL), kot ga je ovrednotila Agencija.
In its opinion adopted on 26 January 2005 [4], the Authority proposed to establish an MRL for the active substance concerned.
Agencija je v mnenju, ki ga je sprejela dne 26. januarja 2005 [4], predlagala uvedbo MRL za zadevno aktivno snov.
It may be necessary to review that MRL in the light of the results of a future evaluation of that active substance by the European Agency for the Evaluation of Medicinal Products.
Morda bo potrebno, da Agencija za zdravila pregleda navedene MRL z vidika rezultatov prihodnjega vrednotenja navedene aktivne snovi.
The Annex to Regulation (EC) No 600/2005 is replaced by the text in the Annex to this Regulation.
Priloga k Uredbi (ES) št. 600/2005 se zamenja z besedilom v Prilogi k tej uredbi.
Update of the Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on a new request from the Commission related to the safety of ‘Bio-Cox®120G’ based on Salinomycin sodium as a feed additive in accordance with Council Directive 70/524/EEC (Article 4g).
Posodobitev mnenja Znanstvenega odbora za dodatke in proizvode ali snovi, uporabljene v krmi na ponovno zahtevo Komisije v zvezi z varnostjo „Bio-Cox®120G“ na podlagi natrijevega salinomicina kot krmnega dodatka v skladu z Direktivo Sveta 70/524/EGS (člen 4(g)).
Adopted on 26 January 2005, The EFSA Journal (2005) 170, p. 1-4.
Sprejeto 26. januarja 2005The EFSA Journal (Bilten EFSA) (2005) 170, str. 1–4.
Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
Največje mejne vrednosti ostankov (MRL) v živilih živalskega izvora
Salinomycin sodium 120 g/kg (Salinomax 120G)
Natrijev salinomicin 120 g/kg (Salinomax 120G)
Salinomycin sodium 120 g/kg
natrijev salinomicin 120 g/kg
Calcium lignosulfonate: 40 g/kg
kalcijev lignosulfonat: 40 g/kg
Calcium sulphate dihydrate to 1000 g/kg
kalcijev sulfat dihidrat do 1000 g/kg
Salinomycin sodium, C42H69O11Na,
natrijev salinomicin, C42H69O11Na,
Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (ATCC 21838/US 9401-06), CAS No: 55 721-31-8
natrijeva sol polietra monokarboksilne kisline, proizvedene s fermentacijo Streptomyces albus (ATCC 21838/US 9401-06), CAS No: 55 721-31-8
< 42 mg elaiophylin/kg salinomycin sodium.
< 42 mg elaiofilina/kg natrijevega salinomicina.
< 40 g 17-epi-20 desoxysalinomycin/kg salinomycin sodium
< 40 g 17-epi-20 dezoksisalinomicina/kg natrijevega salinomicina
‘Dangerous for equines and turkeys’;
„Nevarno za kopitarje in purane“;
‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g.tiamulin) can be contraindicated’
„Te krmne mešanice vsebujejo ionofor: sočasna uporaba z nekaterimi zdravilnimi snovmi (npr. tiamulin) je lahko kontraindicirana“
5 μg of Salinomycin/kg for all wet tissues
5 μg salinomicina/kg za vsa mokra tkiva
Commission Regulation (EC) No 497/2007
Uredba Komisije (ES) št. 497/2007
concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive
o izdaji dovoljenja za endo-1,4-beta-ksilanaze EC 3.2.1.8 (Safizym X) kot krmnega dodatka
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.
Uredba (ES) št. 1831/2003 določa izdajo dovoljenja za dodatke za uporabo v prehrani živali ter razloge in postopke za odobritev takšnih dovoljenj.
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation.
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil predložen zahtevek za izdajo dovoljenja za pripravek iz Priloge k tej uredbi.
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
Navedenemu zahtevku so bili priloženi zahtevani podatki in dokumenti v skladu s členom 7(3) Uredbe (ES) št. 1831/2003.
The application concerns a new use of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) (Safizym X), as a feed additive for piglets (weaned), to be classified in the additive category ‘Zootechnical additives’.
Zahtevek zadeva dovoljenje za uvrstitev nove uporabe pripravka endo-1,4-beta-ksilanaze EC 3.2.1.8, ki ga proizvaja Trichoderma longibrachiatum (CNCM MA 6-10W) (Safizym X), kot krmnega dodatka za pujske (odstavljene) v skupino dodatkov „zootehnični dodatki“.
The use of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1453/2004 [2], without a time limit for turkeys for fattening by Commission Regulation (EC) No 943/2005 [3] and without a time limit for laying hens by Commission Regulation (EC) No 1810/2005 [4].
Uporaba endo-1,4-beta-ksilanaze EC 3.2.1.8, ki jo proizvaja Trichoderma longibrachiatum (CNCM MA 6-10W), je bila dovoljena brez časovne omejitve za piščance za pitanje z Uredbo Komisije (ES) št. 1453/2004 [2], brez časovne omejitve za purane za pitanje z Uredbo Komisije (ES) št. 943/2005 [3] ter brez časovne omejitve za kokoši nesnice z Uredbo Komisije (ES) št. 1810/2005 [4].
New data were submitted in support of an application for authorisation for piglets (weaned).
Predloženi so bili novi podatki v podporo zahtevku za izdajo dovoljenja za pujske (odstavljene).
The European Food Safety Authority (the Authority) concluded in its opinion of 17 October 2006 that the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) (Safizym X) does not have an adverse effect on animal health, human health or the environment [5].
Evropska agencija za varnost hrane („Agencija“) je v svojem mnenju z dne 17. oktobra 2006 sklenila, da endo-1,4-beta-ksilanaza EC 3.2.1.8, ki ga proizvaja Trichoderma longibrachiatum (CNCM MA 6-10W) (Safizym X) nima škodljivega vpliva na zdravje živali, ljudi ali okolje [5].
It further concluded that that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation.
Poleg tega je ugotovila, da navedeni pripravek ne pomeni kakršnega koli drugega tveganja, ki bi v skladu s členom 5(2) Uredbe (ES) št. 1831/2003 izključevalo izdajo dovoljenja.
According to that opinion, the use of that preparation does not have an adverse effect on these additional animal categories.
V skladu z navedenim mnenjem uporaba pripravka za to dodatno kategorijo živali ni škodljiva.
It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.
Preverila je tudi poročilo referenčnega laboratorija Skupnosti, ustanovljenega z Uredbo (ES) št. 1831/2003, o analiznih metodah krmnih dodatkov v krmi.
Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.
Zato je treba uporabo navedenega pripravka dovoliti, kakor je opredeljeno v Prilogi k tej uredbi.
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Pripravek, ki je opredeljen v Prilogi ter spada v kategorijo dodatkov „zootehnični dodatki“ in funkcionalno skupino „pospeševalci prebavljivosti“, je dovoljen kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge.
Regulation as amended by Regulation (EC) No 184/2007 (OJ L 63, 1.3.2007, p. 1).
Uredba, kakor je bila spremenjena z Uredbo (ES) št. 184/2007 (UL L 63, 1.3.2007, str. 1).
Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the enzyme preparation Safizym X (endo-1,4-beta-xylanase) as feed additive for piglets in accordance with Regulation (EC) No 1831/2003.
Mnenje Znanstvenega odbora za dodatke k prehrani in proizvode ali snovi, ki se uporabljajo v prehrani živali, o varnosti in učinkovitosti encimskega pripravka Safizym X (endo-1,4-beta- ksilanaza) kot krmnega dodatka za pujske v skladu z Uredbo (ES) št. 1831/2003.
Adopted on 17 October 2006, The EFSA Journal (2006) 405, 1-10.
Sprejeto 17. oktobra 2006The EFSA Journal (Bilten EFSA) (2006) 405, str. 1–10.
Functional group: digestibility enhancers
Funkcionalna skupina: pospeševalci prebavljivosti.
Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W) having a minimum activity of:
pripravek endo-1,4-beta-ksilanaze, ki ga proizvaja Trichoderma longibrachiatum (CNCM MA 6-10W) z najmanjšo aktivnostjo:
Powder form: 70000 IFP [1]/g
v obliki prahu: 70000 IFP [1]/g
Liquid form: 7000 IFP/ml
v tekoči obliki: 7000 IFP/ml
endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W)
endo-1,4-beta-ksilanaza, ki jo proizvaja Trichoderma longibrachiatum (CNCM MA 6-10W)
Analytical method [2]Reducing sugar assay for endo-1,4-beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield.
Analizna metoda [2]Test reduktivnega sladkorja za endo-1,4-beta-ksilanazo s kolorimetrično reakcijo reagenta dinitrosalicilne kisline na donos reduktivnega sladkorja.
Recommended dose per kilogram of complete feedingstuff: 1680 IFP.
Priporočeni odmerek na kilogram popolne krmne mešanice: 1680 IFP.
For piglets (weaned) up to 35 kg of body weight.
Za pujske (odstavljene) do 35 kg telesne teže.
For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 20 % wheat.
Za uporabo v krmnih mešanicah, bogatih z neškrobnimi polisaharidi (zlasti arabinoksilani), npr. z vsebnostjo več kot 20 % pšenice.
Commission Regulation (EC) No 498/2007
Uredba Komisije (ES) št. 498/2007
laying down detailed rules for the implementation of Council Regulation (EC) No 1198/2006 on the European Fisheries Fund
o določitvi podrobnih pravil za izvajanje Uredbe Sveta (ES) št. 1198/2006 o Evropskem skladu za ribištvo
Having regard to Council Regulation (EC) No 1198/2006 of 27 July 2006 on the European Fisheries Fund [1], and in particular Article 102 thereof,
ob upoštevanju Uredbe Sveta (ES) št. 1198/2006 z dne 27. julija 2006 o Evropskem skladu za ribištvo [1] in zlasti člena 102 Uredbe,
Regulation (EC) No 1198/2006 (the basic Regulation) replaces Council Regulations (EC) No 1263/1999 [2] and (EC) No 2792/1999 [3] taking into account new developments in the field of fisheries, fisheries areas and inland fishing.
Uredba (ES) št. 1198/2006 (Osnovna uredba) nadomešča Uredbo Sveta (ES) št. 1263/1999 [2] in (ES) št. 2792/1999 [3] ob upoštevanju novega razvoja na področju ribištva, ribiških območij in ribolova v celinskih vodah.
It is therefore appropriate to lay down detailed rules for implementing the basic Regulation.
Zato je tudi primerno, da se določijo nove določbe za izvajanje Osnovne uredbe.
Detailed rules should be laid down for the presentation of operational programmes.
Določiti je treba podrobna pravila za predstavitev operativnih programov.
In order to facilitate the establishment of the operational programmes and their examination and approval by the Commission, common rules should be laid down for the structure and content of such programmes, based in particular on the requirements set out in Article 20 of the basic Regulation.
Da bi bilo operativne programe lažje vzpostaviti in da bi jih Komisija lažje pregledala ter odobrila, je treba določiti skupna pravila glede zgradbe in vsebine programov, ki naj temeljijo še posebej na zahtevah, določenih v členu 20 Osnovne uredbe.
As regards support for measures for the adaptation of the Community fishing fleet, the Member States should present in their operational programmes the methods for the calculation of premiums.
Glede podpore ukrepom za prilagoditev ribiške flote Skupnosti, naj države članice v svojih operativnih programih predstavijo metode za izračun premij.
As regards the possibility provided for under Article 25(4) of the basic Regulation to achieve the reduction of engine power by a group of vessels, the conditions for this possibility should be specified.
Glede možnosti, predvidene na podlagi člena 25(4) Osnovne uredbe (da skupina plovil doseže zmanjšanje moči motorja), morajo biti pogoji za to možnost natančno določeni.
Certain terms used with special reference to aquaculture and the processing and marketing of fisheries and aquaculture products, should be defined to ensure that they are uniformly understood.
Treba je opredeliti nekatere izraze, ki se uporabljajo posebej za ribogojstvo, predelavo in trženje proizvodov ribištva in ribogojstva, da se zagotovi enotno razumevanje.
As regards support for productive investments in aquaculture and investments in processing and marketing, the Member States should explain in their operational programmes how they will ensure that priority is given to micro and small enterprises.
Glede podpore produktivnih naložb v ribogojstvo ter naložb v predelavo in trženje, naj države članice v svojih operativnih programih obrazložijo, kako bodo zagotovile, da imajo mikro in mala podjetja prednost.
As regards support for animal heath measures, detailed conditions should be laid down to ensure compliance with the Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals [4].
Glede podpore ukrepom za zdravstveno varstvo živali je treba določiti podrobne pogoje, da se zagotovi skladnost z Direktivo Sveta 2006/88/ES z dne 24. oktobra 2006 o zdravstvenem varstvu živali za živali in proizvode iz ribogojstva ter o preprečevanju in nadzoru nekaterih bolezni pri vodnih živalih [4].
As regards support for measure of common interest, the eligible expenditure should be defined.
Glede podpore ukrepa skupnega interesa je treba opredeliti upravičene izdatke.
As regards the fisheries areas referred to in Article 43 of the basic Regulation, the conditions for their selection should be specified.
Glede ribiških območij iz člena 43 Osnovne uredbe je treba določiti pogoje za izbor območij.
The public-private partnerships supported under Article 45 of the basic Regulation should comply with certain detailed conditions.
Podpirana javno-zasebna partnerstva iz člena 45 Osnovne uredbe morajo izpolnjevati določene podrobne pogoje.
As regards support for the sustainable development of fisheries areas, the procedures for selecting groups should be transparent in order to ensure that pertinent and high quality local development strategies are selected for support.
Kar zadeva podporo trajnostnemu razvoju ribiških območij, morajo biti postopki za izbiro skupin pregledni, da bodo za podporo zagotovo izbrane relevantne in visoko kakovostne razvojne strategije na lokalni ravni.
Rules common to several measures should be laid down.
Določiti je treba pravila, skupna več ukrepom.
In particular, in order to ensure a better targeting of investment operations, a set of common rules for the definition of eligible expenditure should be made available.
Da bi zagotovili boljše ciljanje naložbenih dejavnosti, je treba dati na razpolago skupni niz pravil za opredelitev upravičenih stroškov.
In order to guarantee that information on possible funding opportunities is disseminated widely to all interested parties and for the sake of transparency, the minimum content of the information measures needed to inform potential beneficiaries about the financing opportunities offered jointly by the Community and the Member States through the European Fisheries Fund (EFF), including an obligation to publicise the steps that a potential beneficiary should take in order to submit an application for funding and the selection criteria that are to be used, should be set out taking into account the principle of proportionality.
Da se zagotovi, da vse zainteresirane stranke dobijo informacije o možnem financiranju, in zaradi preglednosti je treba, ob upoštevanju načela sorazmernosti, določiti minimalno vsebino ukrepov, ki so potrebni za informiranje vseh morebitnih upravičencev o možnostih financiranja, ki jih prek Evropskega sklada za ribištvo (ESR) skupaj nudijo Skupnost in države članice, vključno z obveznostjo obveščanja javnosti o načinih, kako morebitni upravičenci vložijo vlogo za financiranje in kakšna merila za izbor se uporabijo.
In order to enhance transparency regarding the use of EFF assistance, the list of beneficiaries, the names of the operations and the amount of the public funding allocated to operations should be published annually by Member States, electronically or otherwise.
Da se poveča preglednost glede uporabe pomoči ESR, naj države članice vsako leto objavijo seznam upravičencev, imena operacij in znesek javnega financiranja, dodeljenega operacijam, v elektronski obliki ali kako drugače.
Making such information accessible to the public aims to strengthen the transparency of the Community's action in the area of the development of the fisheries sector, fisheries areas and inland fishing, to enhance the sound financial management of the public funds involved and, in particular, to reinforce control of the public money used and finally to avoid any distortion of competition between beneficiaries of EFF measures.
Cilj dostopnosti takšnih informacij javnosti je krepitev preglednosti ukrepov Skupnosti na področju razvoja ribiškega sektorja, na ribiških območjih in pri ribolovu v celinskih vodah, povečanje solidnega finančnega upravljanja javnih sredstev in zlasti okrepitev nadzora nad javnim denarjem ter nenazadnje preprečevanje vsakršnega izkrivljanja konkurence med upravičenci sredstev ESR.
Given the overriding weight of the objectives pursued, it is justified with regard to the principle of proportionality and the requirement of the protection of personal data, to provide for the general publication of the relevant information as it does not go beyond what is necessary in a democratic society and for prevention of irregularities.
Glede na zelo pomembno vlogo zastavljenih ciljev, je glede na načelo proporcionalnosti in zahtevo po varovanju osebnih podatkov upravičeno, da se določi javna objava pomembnih informacij, saj se s tem ne prekoračijo pravila demokratične družbe in preprečijo nepravilnosti.
In order to ensure a better implementation of the information measures and to allow a better exchange of information between the Member States and the Commission on the information and publicity strategies and results, contact persons responsible for the information and publicity measures should be designated.
Da se zagotovi boljše izvajanje ukrepov informiranja in izmenjava informacij med državami članicami in Komisijo o strategiji informiranja in objave ter rezultatih, je treba določiti kontaktne osebe, odgovorne za ukrepe informiranja in objave.
Building on the experience of the 2000-2006 programming period, it is necessary to set out in detail the conditions which financial engineering instruments should fulfil in order to be funded under an operational programme.
Na podlagi izkušenj programskega obdobja 2000–2006 je treba podrobno določiti pogoje, ki jih morajo izpolnjevati instrumenti finančnega inženiringa, da se financirajo iz operativnega programa.
With regard to Article 59 of the basic Regulation and in the light of the experience gained, it is necessary to lay down the obligations which the managing authorities should have with regard to beneficiaries in the phase leading to the selection and approval of the operations to be funded, with regard to the aspects which the verifications of the expenditure declared by the beneficiary should cover, including administrative verifications of the applications for reimbursement, and on-the-spot verifications of individual operations and with regard to the conditions to be observed when on-the-spot verifications are carried out on a sample basis.
Z ozirom na člen 59 Osnovne uredbe in z vidika pridobljenih izkušenj je treba določiti obveznosti, ki naj jih imajo organi za upravljanje glede upravičencev v fazi, ki vodi k izboru in odobritvi operacij, ki bodo financirane z ozirom na vidike, ki naj jih zajemajo preverjanja izdatkov, ki jih prijavijo upravičenci, vključno z upravnimi preverjanji vlog za povračilo in preverjanji posameznih operacij na kraju samem; ter z ozirom na pogoje, ki jih je treba upoštevati pri preverjanjih na kraju samem na podlagi vzorca.
It is also necessary to set out in detail the information which should be included in the accounting records of operations and the information to be kept as data on implementation which the managing authorities should record, store and submit to the Commission upon request.
Podrobno je treba določiti tudi informacije, ki naj se vključijo v računovodske podatke operacij ter informacije, ki jih je treba hraniti, kot so podatki o izvajanju, ki jih morajo organi za upravljanje zapisovati, hraniti in jih na zahtevo predložiti Komisiji.
In order to ensure that expenditure under operational programmes can be properly audited, it is necessary to set out the criteria that an audit trail should comply with in order to be considered adequate.
Da bi zagotovili ustrezno revidiranje izdatkov iz operativnih programov, je treba določiti merila, ki jih mora revizijska sled izpolnjevati, da se šteje za primerno.
The audit of operations is carried out under the responsibility of the audit authority.
Za revizijo operacij je odgovoren revizijski organ.
To ensure that the scope and effectiveness of those audits are adequate and that they are carried out according to the same standards in all Member States, it is necessary to set out the conditions which those audits should fulfil.
Da bi zagotovili, da sta obseg in učinkovitost navedenih revizij ustrezna in da se v vseh državah članicah izvajajo v skladu z istimi standardi, je treba določiti pogoje, ki naj jih navedene revizije izpolnjujejo.
Experience has shown that it is necessary to set out in detail the basis for the sampling of operations to be audited, which the audit authority should observe in establishing or approving the sampling method, including certain technical criteria to be used for a random statistical sample and factors to be taken into account for a complementary sample.
Izkušnje so pokazale, da je treba podrobno določiti podlago za vzorčenje operacij, ki bodo revidirane, ki jih revizijski organ mora upoštevati pri oblikovanju ali odobritvi metode vzorčenja, vključno z nekaterimi tehničnimi merili, ki naj se uporabljajo za naključni statistični vzorec in dejavnike, ki jih je treba upoštevati za dopolnilni vzorec.
In order to simplify and harmonise standards for the preparation and presentation of the audit strategy, the annual control report and the closure declarations for which the audit authority is responsible under Article 61 of the basic Regulation, it is necessary to lay down detailed rules concerning their content and specify the nature and quality of the information on which they rely.
Da bi poenostavili in uskladili standarde za pripravo in predstavitev revizijske strategije, letnega nadzornega poročila in izjav o zaprtju, za katere je revizijski organ odgovoren na podlagi člena 61 Osnovne uredbe, je treba določiti podrobna pravila glede njihove vsebine in opredeliti naravo in kakovost informacij, na katere se opirajo.