natgillin/translations-raw huggingface dataset:
On the basis of the predecessor to this empowerment, former Article 19, the Commission has laid down such rules in Article 3 of Regulation (EC) No 1825/2000;
Na podlagi predhodnika tega pooblastila, nekdanjega člena 19, je Komisija določila takšna pravila s členom 3 Uredbe (ES) št. 1825/2000;
On the basis of the predecessor to this empowerment, former Article 4(1), the Commission has adopted such requirements by Regulation (EC) No 644/2005;
Na podlagi predhodnika tega pooblastila, nekdanjega člena 4(1), je Komisija sprejela takšne zahteve z Uredbo (ES) št. 644/2005;
On the basis of the predecessor to this empowerment, former Article 19, the Commission has adopted such requirements by way of Regulation (EC) No 1825/20009;
Na podlagi predhodnika tega pooblastila, nekdanjega člena 19, je Komisija sprejela takšne zahteve z Uredbo (ES) št. 1825/20009;
On the basis of the predecessor to this empowerment, former Article 10(c), the Commission has adopted such requirements by Regulation (EC) No 911/20042;
Na podlagi predhodnika tega pooblastila, nekdanjega člena 10(c), je Komisija sprejela takšne zahteve z Uredbo (ES) št. 911/20042;
On the basis of the predecessor to this empowerment, former Article 10(a), the Commission has adopted the requirements for the conventional ear tags by Regulation (EC) No 911/2004.
Na podlagi predhodnika tega pooblastila, nekdanjega člena 10(a), je Komisija z Uredbo (ES) št. 911/2004 sprejela zahteve za običajne ušesne znamke.
On the basis of the predecessor to this empowerment, former Article 7(1), the Commission has adopted such requirements by way of Regulation (EC) No 911/20042;
Na podlagi predhodnika tega pooblastila, nekdanjega člena 7(1), je Komisija sprejela takšne zahteve z Uredbo (ES) št. 911/20042;
The percentage of non compliance was lower than in the previous report.
Odstotek neskladnosti je bil manjši kot v prejšnjem poročilu.
The data are for each Member State are available in Annex II and summarised in Figure 3.
Podatki za vsako državo članico so na voljo v Prilogi II in so povzeti v sliki 3.
a report on the information provided every year by the national supervisory authorities.
poročilo na podlagi informacij, ki jih nacionalni nadzorni organi predložijo vsako leto.
Radiant energy has differing wavelengths and degrees of power and disappears when the energy source is removed.
Sevalna energija ima različne valovne dolžine in stopnje moči in izgine, ko se odstrani vir energije.
Number of samples analysed: 11 162
Število analiziranih vzorcev: 11 162
The facilities are located in 14 Member States: five in France, four in Germany, two in Bulgaria, the Netherlands, and Spain, one in Belgium, Czech Republic, Croatia, Estonia, Italy, Hungary, Poland, Romania and United Kingdom.
Objekti se nahajajo v 14 državah članicah, in sicer pet v Franciji, štirje v Nemčiji, po dva v Bolgariji, na Nizozemskem in v Španiji ter po en v Belgiji, na Češkem, Hrvaškem, v Estoniji, Italiji, na Madžarskem, Poljskem, v Romuniji in Združenem kraljestvu.
Of those 14 Member States equipped with irradiation facilities, Bulgaria, Italy, Romania and the United Kingdom did not irradiate any foodstuffs over the period covered by this report.
Od teh 14 držav članic, ki imajo objekte za obsevanje, Bolgarija, Italija, Romunija in Združeno kraljestvo niso obsevali živil v obdobju, ki ga zajema to poročilo.
the details of the approved irradiation facilities in the Member States, as well as any changes in their status,
podrobne podatke o odobrenih objektih za obsevanje v državah članicah, pa tudi vse spremembe njihovega statusa,
It lays down specific provisions for the manufacturing, marketing and importation of treated foods and food ingredients.
Vsebuje posebne določbe za proizvodnjo, trženje in uvoz obsevanih živil in živilskih sestavin;
The non-compliance observed were mainly incorrect labelling and forbidden irradiation.
Ugotovljena neskladnost je večinoma zadevala nepravilno označevanje in prepovedano obsevanje.
Two previously approved irradiation facilities have been closed in 2015.
Dva že odobrena objekta za obsevanje sta bila zaprta leta 2015.
Five countries (four Member States and Norway) did not perform any analytical checks at product marketing stage in 2016-2017 due to budgetary restrictions (Croatia (2016), Denmark (2017) and Norway (2016 and 2017)), lack of laboratory capacity (Estonia and Cyprus (2016, 2017)) or other control priorities (Sweden (2016, 2017)).
Pet držav (štiri države članice in Norveška) v letih 2016 in 2017 ni izvedlo nobenih analitskih pregledov v fazi trženja proizvodov zaradi proračunskih omejitev (Hrvaška (2016), Danska (2017) in Norveška (2016 in 2017)), pomanjkanja laboratorijskih zmogljivosti (Estonija in Ciper (2016, 2017)) ali drugih prednostnih nalog nadzora (Švedska (2016, 2017)).
There are now 24 irradiation facilities in the EU.
V EU je trenutno 24 objektov za obsevanje.
To enforce correct labelling or to detect non-authorised products, several analytical methods have been standardised by the European Committee for Standardisation (CEN), following a mandate given by the European Commission.
Za izvajanje pravilnega označevanja ali odkrivanje proizvodov brez odobritve je Evropski odbor za standardizacijo (CEN) standardiziral več analitskih metod v skladu z nalogami in pooblastili, ki mu jih je podelila Evropska komisija.
products (22%)
njih (22 %)
For facilities in the EU, approval is given by the competent authorities of the Member State.
Odobritve za objekte v EU izdajajo pristojni organi držav članic.
Malta did not submit any data for the year 2017.
Malta ni predložila podatkov za leto 2017.
This report covers the period from 1 January 2016 to 31 December 2017.
To poročilo zajema obdobje od 1. januarja 2016 do 31. decembra 2017.
Quantity of products treated: 10 211 tonnes (-11.4%) compared to 2015 on average
Količina obsevanih proizvodov: 10 211 ton (-11,4 %) v primerjavi s povprečjem v letu 2015
vegetables seasoning(20.77%)
vrtna zelišča (20,77 %)
Cereals, seed, vegetables, fruits and their
žita, semena, vrtnine in sadje ter proizvodi iz
Irradiation is used for sanitary and phytosanitary purposes to kill bacteria (such as Salmonella, Campylobacter and E. coli) that can cause food poisoning and to eliminate organisms harmful to plant or plant products such as insects and other pests.
Obsevanje se uporablja za sanitarne in fitosanitarne namene, in sicer za uničenje bakterij (kot so Salmonella, Campylobacter in E. coli), ki lahko povzročijo zastrupitev s hrano, in uničenje organizmov, škodljivih za rastline ali rastlinske proizvode, kot so žuželke ali drugi škodljivi organizmi.
Number of closed facilities: 2
Število zaprtih objektov: 2
Irradiation of food cannot replace proper food handling and irradiated foods still require appropriate refrigeration and to be cooked prior to consumption when necessary.
Obsevanje živil ne more nadomestiti ustreznega ravnanja z živili, saj obsevana živila še vedno zahtevajo ustrezno hlajenje in kuhanje pred porabo, če je to potrebno.
Number of approved facilities: 24
Število odobrenih objektov: 24
The EU regulatory framework for irradiation of food ('food irradiation directives') thus consists of:
Regulativni okvir EU za obsevanje živil (v nadaljnjem besedilu: direktive o obsevanju živil) tako vključuje:
Malta did not report any sample in 2017.
Malta leta 2017 ni poročala o nobenem vzorcu.
This list currently includes one category of food: dried aromatic herbs, spices and vegetable seasonings.
Ta seznam trenutno vključuje eno kategorijo živil: posušena aromatična zelišča, začimbe in vrtna zelišča.
For the period 2016-2017, 11 162 samples were analysed by 24 Member States, i.e. overall 7.02% less in average than in 2015.
V letih 2016 in 2017 je 24 držav članic analiziralo 11 162 vzorcev, kar je skupno v povprečju za 7,02 % manj kot leta 2015.
Main place of irradiation: Belgium (68%) and the Netherlands (13%)
Glavni kraji obsevanja: Belgija (68 %) in Nizozemska (13 %)
Under category 'Other' (foods supplements and soup and sauces) the percentage was 17%.
Kategorija „drugo" (prehranska dopolnila, juhe in omake) je dosegla 17 %.
It contains a compilation of the information forwarded to the Commission by 28 Member States on 2016 and 27 Member States on 2017.
Vsebuje zbirko informacij, ki jih je Komisiji predložilo 28 držav članic za leto 2016 in 27 držav članic za leto 2017.
Food irradiation is the treatment of foodstuffs by a certain type of radiant energy known as ionising radiation.
Obsevanje živil je obdelava živil z določeno vrsto sevalne energije, imenovane ionizirajoče sevanje.
Number of non compliant samples: 87 (0.8%)
Število neskladnih vzorcev: 87 (0,8 %)
From the total of 11 162 samples, 87 were not compliant (0.8%) and 113 samples (1%) gave inconclusive results.
Od skupaj 11 162 vzorcev ni bilo skladnih 87 vzorcev (0,8 %), 113 vzorcev (1 %) pa je dalo neopredeljive rezultate.
Source: 28 Member States and Norway
Vir: 28 držav članic in Norveška
The quantities of foodstuffs (in tonnes) treated by ionising radiation in the EU are decreasing since 2010 as shown in Figure 2.
Količine živil (v tonah), obsevanih z ionizirajočim sevanjem v EU, so se od leta 2010 zmanjšale, kot je prikazano na sliki 2.
The treatment took place mainly in two Member States: Belgium, which treated two thirds of the irradiated food of the EU (68%), and the Netherlands (13%).
Obsevanje je potekalo zlasti v dveh državah članicah: v Belgiji, kjer sta bili obsevani dve tretjini obsevanih živil EU (68 %), in na Nizozemskem (13 %).
Under Article 6 of Directive 1999/2/EC, any irradiated food or any irradiated food ingredient of a compound food must be labelled with the words ‘irradiated' or ‘treated with ionising radiation'.
V skladu s členom 6 Direktive 1999/2/ES morajo biti vsa obsevana živila ali vse obsevane živilske sestavine sestavljenih živil označena z besedami „obsevano" ali „obsevano z ionizirajočim sevanjem".
the results of checks carried out in ionising irradiation facilities, including, in particular, the categories and quantities of foodstuff treated with ionising radiation and the doses administered, and
rezultate pregledov objektov za ionizirajoče obsevanje, zlasti kar zadeva skupine in količine obsevanih proizvodov in uporabljenih doz, ter
Period: 1/1/2016 - 31/12/2017
Obdobje: od 1. 1. 2016 do 31. 12. 2017
It is also used to delay fruit ripening, to stop vegetables (such as onions and potatoes) from sprouting or germination and ultimately to extend the shelf life of foods.
Uporablja se tudi za upočasnitev zorenja sadja, preprečevanje brstenja ali klitja zelenjave (kot je čebula in krompir), da se tako podaljša rok uporabnosti živil.
At marketing stage, as illustrated in Figure 4, the majority of the products analysed were 'herbs and spices' (42%) and the 'cereals, seed, vegetables, fruit and their products' (22%).
Kot je prikazano na sliki 4, je bila na stopnji trženja večina analiziranih proizvodov „zelišča in začimbe" (42 %) ter „žita, semena, vrtnine in sadje ter proizvodi iz njih" (22 %).
Article 7(3) of Directive 1999/2/EC requires Member States to inform the Commission of the list of their approved irradiation facilities.
V skladu s členom 7(3) Direktive 1999/2/ES morajo države članice Komisijo obvestiti o odobrenih objektih za obsevanje.
Main commodities analysed: Herbs and spices (42%)
Glavne analizirane kategorije proizvodov: zelišča in začimbe (42 %)
[4: OJ C 37, 30.1.2019, p. 6]
[4: UL C 37, 30.1.2019, str.
Treatment data:
Podatki o obsevanju:
[1: OJ L 66, 13.3.1999, p.
[1: UL L 66, 13.3.1999, str.
Figure 2 - Quantities of foodstuffs treated by ionising radiation in approved irradiation establishments within the European Union since 2010
Slika 2 - Količine živil, ki so bile od leta 2010 obsevane z ionizirajočim sevanjem v odobrenih objektih za obsevanje v Evropski uniji
According to Article 7(3) of Directive 1999/2/EC, of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation, the Member States shall forward to the Commission every year:
V skladu s členom 7(3) Direktive 1999/2/ES Evropskega parlamenta in Sveta z dne 22. februarja 1999 o približevanju zakonodaje držav članic o živilih in živilskih sestavinah, obsevanih z ionizirajočim sevanjem, države članice Komisiji vsako leto predložijo:
the results of checks carried out at product marketing stage.
rezultate pregledov v fazi trženja proizvodov.
A total quantity of 10 211 tonnes of products were treated with ionising irradiation in EU Member States during the years 2016 and 2017.
V letih 2016 in 2017 je bila v državah članicah EU z ionizirajočim sevanjem obsevana skupna količina 10 211 ton proizvodov.
Directive 1999/2/EC (framework Directive) of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation.
Direktivo 1999/2/ES (okvirno direktivo) Evropskega parlamenta in Sveta z dne 22. februarja 1999 o približevanju zakonodaje držav članic o živilih in živilskih sestavinah, obsevanih z ionizirajočim sevanjem.
Figure 1 shows the distribution of products irradiated in approved facilities in the EU Member States in 2016 and 2017.
Slika 1 prikazuje porazdelitev obsevanih proizvodov v odobrenih objektih v državah članicah EU v letih 2016 in 2017.
Directive 1999/3/EC (implementing Directive) of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising treatment.
Direktivo 1999/3/ES (izvedbeno direktivo) Evropskega parlamenta in Sveta z dne 22. februarja 1999 o izdelavi seznama Skupnosti za živila in živilske sestavine, obsevane z ionizirajočim sevanjem.
Main commodities treated: Frog legs (57%) and dried aromatic herbs, spices and
Glavne obsevane kategorije proizvodov: žabji kraki (57 %) ter posušena aromatična zelišča, začimbe in
The two main commodities irradiated in the EU are frog legs (ca 57%) and dried aromatic herbs, spices and vegetables seasoning (ca 21%).
Glavni obsevani kategoriji proizvodov v EU sta bili žabji kraki (približno 57 %) ter posušena aromatična zelišča, začimbe in vrtna zelišča (približno 21 %).
The list of national authorisations of food and food ingredients which may be treated with ionising radiation is published by the Commission in the Official Journal of the European Union .
Komisija v Uradnem listu Evropske unije objavi seznam nacionalnih dovoljenj za živila in živilske sestavine, ki se lahko obsevajo z ionizirajočim sevanjem.
Approved irradiation facilities
Odobreni objekti za obsevanje
Results of checks carried out in irradiation facilities in 2016-2017
Rezultati pregledov objektov za obsevanje v letih 2016 in 2017
Number of countries irradiating: 10 Member States & Norway
Število držav, v katerih se izvaja obsevanje: 10 držav članic in Norveška
[2: OJ L 66, 13.3.1999, p. 24][3: OJ C 283, 24.11.2009, p. 5]
][3: UL C 283, 24.11.2009, str.
Figure 4 - Foodstuffs category analysed at product marketing stage within the European Union in 2016-17
Slika 4 - Kategorija živil, analizirana v fazi trženja proizvodov v Evropski uniji v letih 2016 in 2017
Figure 3 - Samples analysed at product marketing stage within each Member State in 2016-2017
Slika 3 - Število vzorcev, analiziranih v fazi trženja proizvodov v posamezni državi članici v letih 2016 in 2017
Any food irradiated or containing irradiated ingredients must have been treated (irradiated) only at approved facilities.
Vsa obsevana živila ali tista, ki vsebujejo obsevane sestavine, morajo biti obsevana samo v odobrenih objektih.
Figure 1 - Distribution by category of irradiated foodstuffs in the EU in 2016-2017
Slika 1 - Porazdelitev po kategorijah obsevanih živil v EU v letih 2016 in 2017
The list of approved irradiation facilities in Member States is published by the Commission in the Official Journal of the European Union .
Komisija v Uradnem listu Evropske unije objavi seznam odobrenih objektov za obsevanje v državah članicah.
This report covers the period from 1 January 2014 to 31 December 2015.
To poročilo zajema obdobje od 1. januarja 2014 do 31. decembra 2015.
This is why this Regulation, is more specifically focusing on these three diseases.
Zato se ta uredba osredotoča zlasti na te tri bolezni.
Both companies transferred their HIV assets to the new company. ]
Obe podjetji sta svoja sredstva za HIV prenesli na novo podjetje. ]
Countries of destination during the reporting period were: China, Honduras, Indonesia, Kenya, Moldova, Nigeria, South Africa, and Uganda.
Namembne države v obdobju poročanja so bile: Kitajska, Honduras, Indonezija, Kenija, Moldavija, Nigerija, Južna Afrika in Uganda.
No new products were registered during the reporting period.
V obdobju poročanja ni bilo registriranih novih proizvodov.
GENERAL CRITERIA FOR THE IMPLEMENTATION OF ARTICLE 3
SPLOŠNA MERILA ZA IZVAJANJE ČLENA 3
The access price is based on the cost of producing the product.
Cena dostopa temelji na stroških proizvodnje proizvoda.
[6: COM(2015)0497 of 14 October 2015.]
[6: COM(2015) 0497 z dne 14. oktobra 2015.]
The competent authority shall inform the Commission of all decisions adopted pursuant to the Regulation.
Pristojni organ obvesti Komisijo o vseh sklepih, sprejetih na podlagi Uredbe.
The EU contributes for example to the Global Fund to fight AIDS, tuberculosis and malaria that spends USD 3.5 billion a year in developing countries to which the EU collectively contributes about 50% and the Commission contributed EUR 370 million from the Development Cooperation Instrument and the European Development Fund for 2014-2016.
EU prispeva na primer k Svetovnemu skladu za boj proti aidsu, tuberkulozi in malariji, ki letno porabi 3,5 milijarde USD na leto v državah v razvoju, katerim EU skupaj prispeva okoli 50 %, Komisija pa je prispevala 370 milijonov EUR iz instrumenta za razvojno sodelovanje in Evropskega razvojnega sklada za obdobje 2014-2016.
Information on products registered under the Regulation, instructions for pharmaceutical companies wishing to register products, and previous reports are available on-line.
Informacije o proizvodih, registriranih v skladu z Uredbo, navodila za farmacevtske družbe, ki želijo registrirati proizvode, in prejšnja poročila so na voljo na spletu.
An external contractor, Charles River Associates was commissioned to gather data to support the Commission evaluation of the Regulation,
Izbran je bil zunanji izvajalec, podjetje Charles River Associates, za zbiranje podatkov za podporo vrednotenju Uredbe s strani Komisije,
The Commission received no notification pursuant to Article 10 of the Regulation.
Komisija ni prejela nobenega uradnega obvestila v skladu s členom 10 Uredbe.
[7: GSK set up ViiV Healthcare as a joint venture with Pfizer in November 2009.
[7: Podjetje GSK je novembra 2009 ustanovilo podjetje ViiV Healthcare kot skupno podjetje s podjetjem Pfizer.
These diseases are generally considered the gravest public health concerns for developing countries and a major obstacle to development.
Te bolezni se splošno obravnavajo kot največja grožnja za javno zdravje v državah v razvoju ter kot ena večjih ovir za razvoj.
These products were registered in 2004 and all aim at the treatment of HIV/AIDS.
Ti proizvodi so bili registrirani leta 2004 in vsi so namenjeni za zdravljenje HIV/aidsa.
GlaxoSmithKline also registered Retrovir 300 mg x 60, Retrovir 250 mg x 40 and Trizivir 750 mg x 60 under the Regulation in 2004, but there were no sales under tiered prices of these products in the reporting period.
Podjetje GlaxoSmithKline je leta 2004 registriralo tudi Retrovir 300 mg x 60, Retrovir 250 mg x 40 in Trizivir 750 mg x 60 v skladu z uredbo, vendar se v obdobju poročanja prodaja teh proizvodov ni izvajala v skladu z vzporedno oblikovanimi cenami.
The Regulation complements other EU actions such as support for the World Trade Organisation's November 2015 Decision to exempt least developed countries from obligations to provide patent protection for pharmaceutical products until at least 2033, so as to support access to medicines.
Uredba dopolnjuje druge ukrepe EU, kot so podpora sklepu Svetovne trgovinske organizacije iz novembra 2015, da se najmanj razvite države izvzamejo iz obveznosti zagotavljanja patentnega varstva za farmacevtske proizvode vsaj do leta 2033, da bi se podprl dostop do zdravil.
[1: OJ L 135, 24.5.2016, p. 39 (replacing Council Regulation (EC) No 953/2003)]
[1: UL L 135, 24.5.2016, str. 39 (ki razveljavlja Uredbo Sveta (ES) št. 953/2003)]
Other actions include Commission-funded development programmes supporting low- and middle-income countries' public health systems and research and development programmes for medicines needed by these countries.
Drugi ukrepi vključujejo razvoj programov, ki jih financira Komisija in ki podpirajo sisteme javnega zdravja držav z nizkimi in srednjimi dohodki ter razvojne programe za zdravila, ki jih potrebujejo te države.
The products were sold to the countries listed at the price of production, with no mark-up, and therefore in accordance with the criteria of Article 3.
Proizvodi so bili prodani v države na seznamu po proizvodnih cenah, brez pribitka, in zato v skladu z merili iz člena 3.
One company, GlaxoSmithKline / ViiV Healthcare, has medicines registered under the Regulation.
Podjetje GlaxoSmithKline / ViiV Healthcare je registriralo zdravila v skladu s to uredbo.
This is the ninth Report under Article 12(2) of the Regulation which foresees biennially reports by the Commission to the European Parliament and to the Council on the volumes exported under tiered prices registered under the Regulation.
To je deveto poročilo v skladu s členom 12(2) Uredbe, ki določa, da Komisija vsaki dve leti poroča Evropskemu parlamentu in Svetu o količinah, izvoženih po vzporedno oblikovanih cenah, registriranih v skladu z Uredbo.
EVALUATION OF LIST OF COUNTRIES OF DESTINATION
VREDNOTENJE SEZNAMA NAMEMBNIH DRŽAV
Report on the application of Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines
Poročilo o uporabi Uredbe (EU) 2016/793 Evropskega parlamenta in Sveta z dne 11. maja 2016 za preprečevanje preusmerjanja trgovine nekaterih ključnih zdravil v Evropsko unijo
In order to achieve this, the European Commission has consistently advocated a policy of "tiered pricing" for medicines, combined with market segmentation between rich and poor countries.
Zato si Evropska komisija stalno prizadeva za politiko „vzporednega oblikovanja cen" za zdravila skupaj s segmentacijo trga med bogatimi in revnimi državami.
The Regulation allows for the registration of medicines treating HIV/AIDS, malaria and tuberculosis.
Uredba omogoča registracijo zdravil za zdravljenje okužbe z virusom HIV ali aidsa, malarije in tuberkuloze.
This approach is designed to promote sustainable supplies and continuous distribution of life-saving medicines.
Cilj tega pristopa je spodbuditi trajnostno oskrbo z življenjsko pomembnimi zdravili in njihovo neprekinjeno distribucijo.
EVALUATION OF SCOPE OF DISEASES COVERED
VREDNOTENJE OBSEGA BOLEZNI, KI JIH ZAJEMA TO POROČILO
Where there is reason to suspect that, contrary to the prohibition in Article 2, tiered priced products will be imported into the Union, customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the competent authorities on the character of the merchandise.
Kjer obstaja sum, da bodo, v nasprotju s prepovedjo iz člena 2, proizvodi z vzporedno oblikovanimi cenami, uvoženi v Unijo, carinski organi ustavijo sprostitev zadevnih proizvodov ali jih zadržijo toliko časa, kolikor je potrebno za pridobitev odločbe pristojnih organov o značaju blaga.
The Regulation notes the report shall also examine the scope of countries and diseases and general criteria for the implementation of Article 3.
Uredba navaja, da se v poročilu pregleda tudi obseg držav in bolezni ter splošna merila za izvajanje člena 3.