natgillin/translations-raw huggingface dataset:
An application for the establishment of maximum residue limits for triptorelin acetate in porcine species has been submitted to the European Medicines Agency.
Evropski agenciji za zdravila je bil predložen zahtevek za določitev mejnih vrednosti ostankov za triptorelin acetat pri prašičih.
The Committee for Medicinal Products for Veterinary Use recommended that there is no need to establish an MRL for triptorelin acetate in porcine species.
Odbor za zdravila za uporabo v veterinarski medicini je priporočil, da ni treba določiti MRL za triptorelin acetat pri prašičih.
In accordance with Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.
V skladu s členom 5 Uredbe (ES) št. 470/2009 Evropska agencija za zdravila preuči uporabo MRL, ki so določene za farmakološko aktivno snov v posameznem živilu, tudi pri drugih živilih, pridobljenih iz iste živalske vrste, ali uporabo MRL, ki so določene za farmakološko aktivno snov pri eni ali več živalskih vrstah, tudi pri drugih živalskih vrstah.
The CVMP recommended the extrapolation of the evaluation results for triptorelin acetate from porcine species to all food producing species.
Odbor je priporočil ekstrapolacijo rezultatov ocene triptorelin acetata pri prašičih na vse živalske vrste za proizvodnjo živil.
Regulation (EU) No 37/2010 should therefore be amended to include the substance triptorelin acetate for all food producing species, while establishing the absence of the need to establish an MRL.
Uredbo (EU) št. 37/2010 bi bilo zato treba spremeniti, da se vključi snov triptorelin acetat za vse živalske vrste za proizvodnjo živil in navede, da določitev MRL ni potrebna.
‘Triptorelin acetate
„triptorelin acetat
Commission Implementing Regulation (EU) No 201/2014
Izvedbena uredba Komisije (EU) št. 201/2014
Table 1 of the Annex to Commission Regulation (EU) No 759/2010 [3] provisionally lists tildipirosin as an allowed substance for bovine, caprine and porcine species, applicable to muscle, fat (skin and fat for porcine species), liver, and kidney, excluding animals from which milk is produced for human consumption, until 1 January 2012.
V razpredelnici 1 Priloge k Uredbi Komisije (EU) št. 759/2010 [3] je navedeno, da je tildipirozin do 1. januarja 2012 dovoljen v mišičju, maščevju (koži in maščevju prašičev), jetrih in ledvicah goveda, koz in prašičev, razen živali, katerih mleko je namenjeno za prehrano ljudi.
In accordance with that Annex, the MRLs for muscle did not apply to the injection site for which higher levels are provided for.
V skladu z navedeno prilogo se MRL za mišičje niso uporabljale za mesto vbrizgavanja, za katerega so bile določene višje ravni.
Additional data were provided and assessed leading the Committee for Medicinal Products for Veterinary Use to recommend the establishment of final MRLs for tildipirosin for bovine, caprine and porcine species, applicable to muscle, fat (skin and fat in natural proportions for porcine species), liver and kidney, excluding animals from which milk is produced for human consumption.
Odbor za zdravila za uporabo v veterinarski medicini je po preučitvi predloženih dodatnih podatkov priporočil določitev končnih MRL za tildipirozin v mišičju, maščevju (koži in maščevju prašičev v naravnih deležih), jetrih in ledvicah goveda, koz in prašičev, razen živali, katerih mleko je namenjeno za prehrano ljudi.
Taking into account that the Commission and residue control authorities consider that, in order to ensure the feasibility of residue controls, a single MRL for muscle must be established, the Committee for Medicinal Products for Veterinary Use, in a revised opinion, did not recommend to provide for a separate MRL for injection site muscle as this was the case in its previous opinions.
Ker Komisija in organi za nadzor ostankov menijo, da je treba za zagotovitev učinkovitega nadzora ostankov določiti enotno MRL za mišičje, Odbor za zdravila za uporabo v veterinarski medicini v revidiranem mnenju ni priporočil ločene MRL za mesto vbrizgavanja v mišičje kot v prejšnjih mnenjih.
In accordance with Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.
V skladu s členom 5 Uredbe (ES) št. 470/2009 Evropska agencija za zdravila preuči uporabo MRL, ki so določene za farmakološko aktivno snov v posameznem živilu, tudi pri drugih živilih, pridobljenih iz iste živalske vrste, ali uporabo MRL, ki so določene za farmakološko aktivno snov pri eni ali več živalskih vrst, tudi pri drugih živalskih vrstah.
The Committee for Medicinal Products for Veterinary Use recommended the extrapolation of the MRLs for tildipirosin in bovine species to caprine species.
Odbor za zdravila za uporabo v veterinarski medicini je priporočil ekstrapolacijo MRL za tildipirozin pri govedu na koze.
It also concluded that the extrapolation to other food producing species cannot be supported for this substance.
Ugotovil je tudi, da ekstrapolacija te snovi na druge vrste za proizvodnjo živil ni utemeljena.
The entry for tildipirosin in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include final MRLs for the pharmaceutical substance tildipirosin for bovine, caprine and porcine species, applicable to muscle, fat (skin and fat in natural proportions for porcine species), liver and kidney.
Vnos za tildipirozin v razpredelnici 1 v Prilogi k Uredbi (EU) št. 37/2010 bi bilo zato treba spremeniti, da se določijo končne MRL za farmacevtsko snov tildipirozin v mišičju, maščevju (koži in maščevju prašičev v naravnih deležih), jetrih in ledvicah goveda, koz in prašičev.
The provisions on the MRLs for the injection site as regards muscle and on provisional MRLs should be removed.
Določbe o MRL za mesto vbrizgavanja v mišičje in o njihovi začasni določitvi bi bilo črtati.
It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRLs.
Primerno je določiti razumen rok, da lahko zadevni deležniki sprejmejo ukrepe, ki so morda potrebni za uskladitev z novimi MRL.
It shall apply from 3 May 2014.
Uporablja se od 3. maja 2014.
Commission Regulation (EU) No 759/2010 of 24 August 2010 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance tildipirosin (OJ L 223, 25.8.2010, p. 39).
Uredba Komisije (EU) št. 759/2010 z dne 24. avgusta 2010 o spremembi Priloge k Uredbi (EU) št. 37/2010 o farmakološko aktivnih snoveh in njihovi razvrstitvi glede mejnih vrednosti ostankov v živilih živalskega izvora v zvezi s snovjo tildipirozin (UL L 223, 25.8.2010, str. 39).
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance tildipirosin is replaced by the following:
V razpredelnici 1 Priloge k Uredbi (EU) št. 37/2010 se vnos za snov tildipirozin nadomesti z naslednjim:
Skin and fat in natural proportions
koža in maščevje v naravnem razmerju
Commission Regulation (EU) No 202/2014
Uredba Komisije (EU) št. 202/2014
amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
o spremembi Uredbe (EU) št. 10/2011 o polimernih materialih in izdelkih, namenjenih za stik z živili
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC [1], and in particular Article 5(1), Article 11(3) and Article 12(6) thereof,
ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 1935/2004 z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili, in o razveljavitvi direktiv 80/590/EGS in 89/109/EGS [1] ter zlasti člena 5(1), člena 11(3) in člena 12(6) Uredbe,
Annex I to Commission Regulation (EU) No 10/2011 [2] establishes a Union list of substances which may be used in the manufacture of plastic materials and articles (‘Union list of authorised substances’).
Priloga I k Uredbi Komisije (EU) št. 10/2011 [2] določa seznam odobrenih snovi Unije, ki se lahko uporabljajo pri proizvodnji polimernih materialov in izdelkov (v nadaljnjem besedilu: seznam odobrenih snovi Unije).
On 24 July 2012 the European Food Safety Authority issued favourable scientific evaluations for two additional substances, namely 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine [3] and 1,3-bis(isocyanatomethyl)benzene [4].
Evropska agencija za varnost hrane je 24. julija 2012 izdala ugodno znanstveno oceno za dve dodatni snovi, in sicer 2-fenil-3,3-bis(4-hidroksifenil)ftalimidin [3] in 1,3-bis(izocianatometil)benzen [4].
Those substances should now be added to the Union list of authorised substances as food contact material (FCM) substances Nos 872 and 988.
Navedeni snovi bi bilo treba zdaj dodati na seznam odobrenih snovi Unije kot materiale za stik z živili (FCM) s številkama 872 in 988.
From the scientific evaluation of FCM substance No 988 it follows that migration of its hydrolysis product, 1,3-benzenedimethanamine should be controlled.
Iz znanstvene ocene snovi FCM št. 988 izhaja, da bi bilo treba nadzirati migracijo njenega produkta hidrolize, tj. 1,3-benzendimetanamina.
1,3-benzenedimethanamine is already authorised as FCM substance No 421.
1,3-benzendimetanamin je že odobren kot snov FCM št. 421.
As the migration of FCM substances Nos 421 and 988 is controlled on the basis of the migration of FCM substance No 421, a group restriction including both substances should be introduced.
Ker se migracija snovi FCM št. 421 in 988 že nadzira na podlagi migracije snovi FCM št. 421, bi bilo treba uvesti skupinsko omejitev za obe snovi.
Therefore, the authorisation of FCM substance No 421 should be amended and the group restriction introduced in Table 2 of Annex I to Regulation (EU) No 10/2011.
Zato bi bilo treba spremeniti odobritev snovi FCM št. 421 in v preglednico 2 Priloge I k Uredbi (EU) št. 10/2011 uvesti skupinsko omejitev.
FCM substance No 340 (dicyanodiamide) is authorised as an additive in plastics in Table 1 of Annex I to Regulation (EU) No 10/2011 without a specific migration limit.
Snov FCM št. 340 (dicianodiamid) je odobrena kot aditiv za polimerizacijo v preglednici 1 Priloge I k Uredbi (EU) št. 10/2011 brez mejne vrednosti specifične migracije.
The Opinion reported in the 33rd series of the Scientific Committee for Food [5] established a tolerable daily intake (TDI) of 1 mg/kg body weight resulting in a specific migration limit (SML) of 60 mg/kg food.
Znanstveni odbor za hrano [5] je v 33. izdaji Poročila določil dopustni dnevni vnos (TDI) v višini 1 mg/kg telesne teže, pri čemer je mejna vrednost specifične migracije (SML) 60 mg/kg živila.
This limit coincides with the generic specific migration limit established in Article 11(2) of Regulation (EU) No 10/2011.
Ta mejna vrednost sovpada z generično mejno vrednostjo specifične migracije iz člena 11(2) Uredbe (EU) št. 10/2011.
However, since the SML of 60 mg/kg is derived from a toxicological threshold such as the TDI, the SML should be specifically mentioned in Annex I to Regulation (EU) No 10/2011.
Vendar ker SML 60 mg/kg izhaja iz toksikološke meje, kot je TDI, bi bilo treba to SML izrecno navesti v Prilogi I k Uredbi (EU) št. 10/2011.
Regulation (EU) No 10/2011 should therefore be amended accordingly.
Uredbo (EU) št. 10/2011 bi bilo zato treba ustrezno spremeniti.
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).
Uredba Komisije (EU) št. 10/2011 z dne 14. januarja 2011 o polimernih materialih in izdelkih, namenjenih za stik z živili (UL L 12, 15.1.2011, str. 1).
Reports of the Scientific Committee for Food, 33rd series, p. 31, Office for Official publications of the European Communities, Luxembourg, 1995, ISBN 92-826-9275-2.
Poročila Znanstvenega odbora za hrano, 33. izdaja, str. 31, Urad za publikacije Evropske unije, Luxembourg, 1995, ISBN 92-826-9275-2.
Table 1 is amended as follows:
preglednica 1 se spremeni:
the entry concerning FCM substance No 340 (dicyanodiamide) is replaced by the following:
vnos za snov FCM št. 340 (dicianodiamid) se nadomesti z naslednjim:
the entry concerning FCM substance No 421 (1,3-benzenedimethanamine) is replaced by the following:
vnos za snov FCM št. 421 (1,3-benzendimetanamin) se nadomesti z naslednjim:
the following entry is inserted in accordance with the numerical order:
v skladu s številčnim vrstnim redu se vstavi naslednji vnos:
To be used only as a co-monomer in polycarbonate copolymers
Samo za uporabo kot komonomer v polikarbonatnih kopolimerih.
SML(T) applies to the migration of its hydrolysis product, 1,3-benzenedimethanamine
SML(T) se uporablja za migracijo njegovega produkta hidrolize, tj. 1,3-benzendimetanamina.
To be used only as co-monomer in the manufacture of a middle layer coating on a poly(ethylene terephthalate) polymer film in a multilayer film’
Samo za uporabo kot komonomer pri proizvodnji premaza srednje plasti poli(etilenterefalatne) folije, ki je v večplastni foliji.“
In Table 2, the following entry is added:
v preglednici 2 se doda naslednji vnos:
Expressed as 1,3-benzenedimethanamine’
izraženo kot 1,3-benzendimetanamin“
In Table 3, the following entry is added:
v preglednici 3 se doda naslednji vnos:
The substance contains aniline as an impurity; verification of compliance with the restriction set for primary aromatic amines in Annex II (2) is necessary.’
Za snovi, ki vsebujejo anilin kot nečistočo, je potrebno preverjanje skladnosti z omejitvijo za primarne aromatske amine iz Priloge II(2).“
In order to limit the administrative burden to business operators, plastic materials and articles which have been lawfully placed on the market based on the requirements set out in Regulation (EU) No 10/2011 and which do not comply with this Regulation should be able to be placed on the market until 24 March 2015.
Za zmanjšanje upravne obremenitve nosilcev dejavnosti bi bilo treba omogočiti, da se polimerni materiali in izdelki, ki so bili zakonito dani v promet v skladu z zahtevami iz Uredbe (EU) št. 10/2011 in ki niso v skladu s to uredbo, dajejo v promet do 24. marca 2015.
Plastic materials and articles which have been lawfully placed on the market before 24 March 2014 and which do not comply with this Regulation may be placed on the market until 24 March 2015.
Polimerni materiali in izdelki, ki so bili zakonito dani v promet do 24. marca 2014, in ki niso v skladu s to uredbo, se lahko dajejo v promet do 24. marca 2015.
Those plastic materials and articles may remain on the market after that date until the exhaustion of stocks.
Navedeni polimerni materiali in izdelki lahko po navedenem datumu ostanejo v prometu do odprodaje zalog.
Commission Implementing Regulation (EU) No 203/2014
Izvedbena uredba Komisije (EU) št. 203/2014
Commission Implementing Regulation (EU) No 204/2014
Izvedbena uredba Komisije (EU) št. 204/2014
entering a name in the register of protected designations of origin and protected geographical indications [Aceituna de Mallorca/Aceituna Mallorquina/Oliva de Mallorca/Oliva Mallorquina (PDO)]
o vpisu imena v register zaščitenih označb porekla in zaščitenih geografskih označb [Aceituna de Mallorca / Aceituna Mallorquina / Oliva de Mallorca / Oliva Mallorquina (ZOP)]
Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Spain’s application to register the name ‘Aceituna de Mallorca’/‘Aceituna Mallorquina’/‘Oliva de Mallorca’/‘Oliva Mallorquina’ was published in the Official Journal of the European Union [2].
V skladu s členom 50(2)(a) Uredbe (EU) št. 1151/2012 je bila vloga Španije za registracijo imena „Aceituna de Mallorca“ / „Aceituna Mallorquina“ / „Oliva de Mallorca“ / „Oliva Mallorquina“ objavljena v Uradnem listu Evropske unije [2].
As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Aceituna de Mallorca’/‘Aceituna Mallorquina’/‘Oliva de Mallorca’/‘Oliva Mallorquina’ should therefore be entered in the register,
Ker Komisija ni prejela nobenega ugovora v skladu s členom 51 Uredbe (ES) št. 1151/2012, bi bilo treba ime „Aceituna de Mallorca“ / „Aceituna Mallorquina“ / „Oliva de Mallorca“ / „Oliva Mallorquina“ registrirati –
OJ C 276, 25.9.2013, p. 17.
UL C 276, 25.9.2013, str. 17.
Aceituna de Mallorca/Aceituna Mallorquina/Oliva de Mallorca/Oliva Mallorquina (PDO)
Aceituna de Mallorca / Aceituna Mallorquina / Oliva de Mallorca / Oliva Mallorquina (ZOP)
Commission Implementing Regulation (EU) No 205/2014
Izvedbena uredba Komisije (EU) št. 205/2014
laying down uniformed conditions for the implementation of Regulation (EU) No 1260/2013 of the European Parliament and the Council on European demographic statistics, as regards breakdowns of data, deadlines and data revisions
o določitvi enotnih pogojev za izvajanje Uredbe (EU) št. 1260/2013 Evropskega parlamenta in Sveta o evropski demografski statistiki, kar zadeva razčlenitve podatkov, roke in revizije podatkov
Having regard to Regulation (EU) No 1260/2013 of the European Parliament and of the Council of 20 November 2013 on European demographic statistics [1], and in particular Article 3(4) thereof,
ob upoštevanju Uredbe (EU) št. 1260/2013 Evropskega parlamenta in Sveta z dne 20. novembra 2013 o evropski demografski statistiki [1] in zlasti člena 3(4) Uredbe,
Regulation (EU) No 1260/2013 establishes a common legal framework for the development, production and dissemination of European statistics on population and vital events.
Uredba (EU) št. 1260/2013 določa skupni pravni okvir za razvoj, pripravo in razširjanje evropske statistike o prebivalstvu in ključnih dogodkih.
In order to ensure that data on population and on vital events provided by Member States, as required by Regulation (EU) No 1260/2013, are of high quality, comparable, consistent and in order to allow reliable Union-wide overviews to be drawn up, the data should be broken down.
Da se zagotovijo visokokakovostni, primerljivi in dosledni podatki o prebivalstvu in ključnih dogodkih, ki jih predložijo države članice, kakor je določeno v Uredbi (EU) št. 1260/2013, in se omogoči izdelava zanesljivih pregledov na ravni Unije, bi bilo treba podatke razčleniti.
Data should be therefore provided to the Commission broken down by territorial units in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) [2].
Zato bi bilo treba Komisiji zagotoviti podatke, razvrščene po teritorialnih enotah v skladu z Uredbo (ES) št. 1059/2003 Evropskega parlamenta in Sveta z dne 26. maja 2003 o oblikovanju skupne klasifikacije statističnih teritorialnih enot (NUTS) [2].
This Regulation establishes uniform conditions for the breakdowns of data required by Regulation (EU) No 1260/2013, as well as for deadlines and for revisions of those data.
Ta uredba določa enotne pogoje za razčlenitev podatkov iz Uredbe (EU) št. 1260/2013 ter za roke in revizije navedenih podatkov.
Definitions laid down in Regulation (EU) No 1260/2013 shall apply.
Uporabljajo se opredelitve iz Uredbe (EU) št. 1260/2013.
In addition, for the purpose of this Regulation, the following definitions shall also apply:
Za namene te uredbe se prav tako uporabljajo naslednje opredelitve:
‘age’ at a given date (either reference time or date of the event) means the interval of time between the date of birth and the given date, expressed in completed years;
„starost“ na določen datum (referenčni čas ali datum dogodka) pomeni časovni interval med datumom rojstva in določenim datumom, izražen v dopolnjenih letih;
‘country of birth’ of an individual means the country of usual residence (in its current borders, if the information is available) of the individual’s mother at the time of the delivery, or, failing this, the country (in its current borders, if the information is available) in which the birth took place;
„država rojstva“ posameznika pomeni državo običajnega prebivališča (znotraj trenutnih meja, če je ta podatek na voljo) posameznikove matere v času rojstva, ali, če ni na voljo, državo (znotraj trenutnih meja, če je ta podatek na voljo), v kateri je bila oseba rojena;
‘country of birth of the mother’ means the ‘country of birth’ of the mother;
„država rojstva matere“ pomeni „državo rojstva“ matere;
‘live-birth order’ means the numerical order of the live birth being recorded in relation to all previous live births of the mother;
„vrstni red rojstva“ pomeni številčno zaporedje živorojenega otroka, glede na prejšnje živorojene otroke matere;
‘month of occurrence’ means the calendar month of occurrence of the event;
„mesec dogodka“ pomeni koledarski mesec dogodka;
‘year of birth’ means the calendar year of occurrence of the birth;
„leto rojstva“ pomeni koledarsko leto rojstva;
‘Member State’ means a country that is a member of the European Union at the end of the reference year.
„država članica“ pomeni državo, ki je konec referenčnega leta članica Evropske unije.
Breakdowns and statistical tables
Razčlenitve in statistične tabele
The breakdowns of the data to be provided to the Commission (Eurostat) under Regulation (EU) No 1260/2013 are set out in Annex I.
Razčlenitve podatkov, ki jih je treba predložiti Komisiji (Eurostatu) v skladu z Uredbo (EU) št. 1260/2013, so določene v Prilogi I.
The statistical tables to be provided to the Commission (Eurostat) are set out in Annex II.
Statistične tabele, ki jih je treba predložiti Komisiji (Eurostatu), so določene v Prilogi II.
Each year Member States shall provide the Commission (Eurostat) with provisional data on total population, total live births and total deaths at national level, as described in Annex II, point 1, within six months of the end of the reference year.
Države članice vsako leto Komisiji (Eurostatu) predložijo začasne podatke o celotnem prebivalstvu, vseh živorojenih in vseh umrlih na nacionalni ravni, kakor je opisano v točki 1 Priloge II, v šestih mesecih po koncu referenčnega leta.
Each year Member States shall provide the Commission (Eurostat) with data at national and regional level as described in Annex II, point 2, and related standard reference metadata (in the metadata structure definition defined for the Euro SDMX Metadata Structure) for the reference year within 12 months of the end of the reference year.
Države članice vsako leto Komisiji (Eurostatu) predložijo podatke na nacionalni in regionalni ravni, kakor je opisano v točki 2 Priloge II, in povezane standardne referenčne metapodatke (glede na opredelitev strukture metapodatkov, določene za standardni sistem za izmenjavo podatkov in metapodatkov (Euro SDMX)), za referenčno leto v 12 mesecih po koncu referenčnega leta.
Each year Member States shall provide the Commission (Eurostat) with provisional monthly data on total live births and total deaths, as described in Annex II, point 3, each covering at least the first six months of the reference year, by 30 November of the same reference year.
Države članice vsako leto Komisiji (Eurostatu) predložijo začasne mesečne podatke o vseh živorojenih in vseh umrlih, kakor je opisano v točki 3 Priloge II, pri čemer vsaka od kategorij zajema vsaj prvih šest mesecev referenčnega leta, do 30. novembra istega referenčnega leta.
Data revisions
Revizije podatkov
Member States shall inform the Commission (Eurostat) of any planned revision of the data supplied under Article 4(2) no later than one week before the release of the revised data in the Member State concerned.
Države članice Komisijo (Eurostat) obvestijo o vsaki načrtovani reviziji podatkov, predloženih v skladu s členom 4(2), najpozneje teden dni pred objavo revidiranih podatkov zadevne države članice.