natgillin/translations-raw huggingface dataset:
That opinion gives sufficient grounds to establish that heat-treated milk products fermented with Bacteroides xylanisolvens (DSM 23964) as a novel food complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
Znanstveno mnenje je zadosten razlog, da se toplotno obdelani mlečni proizvodi, fermentirani z Bacteroides xylanisolvens (DSM 23964), kot novo živilo štejejo za skladne z merili iz člena 3(1) Uredbe (ES) št. 258/97.
Heat-treated milk products fermented with Bacteroides xylanisolvens (DSM 23964) as specified in the Annex may be placed on the market in the Union as a novel food in liquid, semi-liquid and spray-dried powder forms.
Toplotno obdelani mlečni proizvodi, fermentirani z Bacteroides xylanisolvens (DSM 23964), kakor so določeni v Prilogi, se lahko dajejo na trg Unije kot novo živilo v tekoči obliki, poltekoči obliki in v obliki prahu, posušenega z razprševanjem.
Done at Brussels, 23 July 2015.
Član Komisije
Member of the Commission
EFSA Journal (2015);
OJ L 43, 14.2.1997, p. 1.
PRILOGA
EFSA Journal 2015;
SPECIFIKACIJA TOPLOTNO OBDELANIH MLEČNIH PROIZVODOV, FERMENTIRANIH Z BACTEROIDES XYLANISOLVENS (DSM 23964)
ANNEX
Opredelitev
SPECIFICATION OF HEAT-TREATED MILK PRODUCTS FERMENTED WITH BACTEROIDES XYLANISOLVENS (DSM 23964)
Toplotno obdelani mlečni proizvodi so fermentirani z Bacteroides xylanisolvens (DSM 23964) kot starter kulturo.
Heat-treated fermented milk products are produced with Bacteroides xylanisolvens (DSM 23964) as starter culture.
Polposneto mleko (med 1,5 % in 1,8 % maščobe) ali posneto mleko (0,5 % maščobe ali manj) je pasterizirano ali ultra toplotno obdelano pred začetkom fermentacije z Bacteroides xylanisolvens (DSM 23964).
Description
Fermentirani mlečni proizvod se homogenizira in nato toplotno obdela, da se inaktivira Bacteroides xylanisolvens (DSM 23964).
Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before starting the fermentation with Bacteroides xylanisolvens (DSM 23964).
Končni proizvod ne vsebuje živih celic Bacteroides xylanisolvens (DSM 23964) [1].
The resulting fermented milk product is homogenised and then heat-treated to inactivate Bacteroides xylanisolvens (DSM 23964).
Spremenjen DIN EN ISO 21528-2.
The final product does not contain viable cells of Bacteroides xylanisolvens (DSM 23964) [1].
Člen 2
Modified DIN EN ISO 21528-2.
Ta sklep je naslovljen na podjetje Avitop GmbH, Robert Rössle Str.
Article 2 This Decision is addressed to Avitop GmbH, Robert Rössle Str.
10, 13125 Berlin, Nemčija
Council Decision (EU) 2015/1292
Sklep Sveta (EU) 2015/1292
on the conclusion, on behalf of the European Union and its Member States, of the Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Serbia, of the other part, to take account of the accession of the Republic of Croatia to the European Union
o sklenitvi, v imenu Evropske unije in njenih držav članic, Protokola k Stabilizacijsko-pridružitvenemu sporazumu med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 217, in conjunction with point (a)(i) of the second subparagraph of Article 218(6) and the second subparagraph of Article 218(8), thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 217 v povezavi s točko (a)(i) drugega pododstavka člena 218(6) in drugim pododstavkom člena 218(8) Pogodbe,
In accordance with Council Decision 2014/517/EU [1], the Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Serbia, of the other part, to take account of the accession of the Republic of Croatia to the European Union [2] (the ‘Protocol’), has been signed, subject to its conclusion.
V skladu s Sklepom Sveta 2014/517/EU [1] je bil podpisan Protokol k Stabilizacijsko-pridružitvenemu sporazumu med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji [2] (v nadaljnjem besedilu: Protokol), s pridržkom njegove sklenitve.
The Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Serbia, of the other part, to take account of the accession of the Republic of Croatia to the European Union is hereby approved on behalf of the Union and its Member States.
Protokol k Stabilizacijsko-pridružitvenemu sporazumu med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji se odobri v imenu Unije in njenih držav članic.
The President of the Council is hereby authorised to designate the person(s) empowered to deposit, on behalf of the Union and its Member States, the instruments of approval provided for in Article 13(2) of the Protocol.
Predsednik Sveta je pooblaščen, da imenuje osebo(-e), pooblaščeno(-e), da v imenu Unije in njenih držav članic deponira(-jo) listine o odobritvi, kot je predvideno v členu 13(2) Protokola.
Council Decision 2014/517/EU of 14 April 2014 on the signing, on behalf of the European Union and its Member States, and provisional application of the Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Serbia, of the other part, to take account of the accession of the Republic of Croatia to the European Union (OJ L 233, 6.8.2014, p.
Sklep Sveta 2014/517/EU z dne 14. aprila 2014 o podpisu, v imenu Evropske unije in njenih držav članic, ter začasni uporabi Protokola k Stabilizacijsko-pridružitvenemu sporazumu med Evropskima skupnostma in njunimi državami članicami na eni strani ter Republiko Srbijo na drugi strani zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji (UL L 233, 6.8.2014, str.
Council Decision (EU) 2015/1293
Sklep Sveta (EU) 2015/1293
on the conclusion, on behalf of the European Union, of the European Convention on the legal protection of services based on, or consisting of, conditional access
o sklenitvi Evropske konvencije o pravnem varstvu storitev, ki temeljijo na pogojnem dostopu ali vključujejo pogojni dostop, v imenu Evropske unije
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti prvega pododstavka člena 207(4) v povezavi s členom 218(6)(a)(v) Pogodbe,
On 16 July 1999, the Council authorised the Commission to negotiate within the Council of Europe, on behalf of the European Community, a convention concerning the legal protection of services based on, or consisting of, conditional access.
Svet je 16. julija 1999 pooblastil Komisijo, da se v imenu Evropske skupnosti v Svetu Evrope pogaja o konvenciji o pravnem varstvu storitev, ki temeljijo na pogojnem dostopu ali vključujejo pogojni dostop.
The European Convention on the legal protection of services based on, or consisting of, conditional access (‘the Convention’) was adopted by the Council of Europe on 24 January 2001 and entered into force on 1 July 2003.
Evropsko konvencijo o pravnem varstvu storitev, ki temeljijo na pogojnem dostopu ali vključujejo pogojni dostop (v nadaljnjem besedilu: Konvencija), je Svet Evrope sprejel 24. januarja 2001 in veljati je začela 1. julija 2003.
The Convention establishes a regulatory framework which is almost identical to that set out in Directive 98/84/EC of the European Parliament and of the Council [1].
Konvencija vzpostavlja normativni okvir, ki je skoraj enak okviru iz Direktive Evropskega parlamenta in Sveta 98/84/ES [1].
On 21 December 2011, the Convention was signed on behalf of the Union [2].
Konvencija je bila 21. decembra 2011 podpisana v imenu Unije [2].
The conclusion of the Convention could help to extend the application of provisions similar to those in Directive 98/84/EC beyond the borders of the Union, and establish a law on services based on conditional access which would be applicable throughout the European continent.
S sklenitvijo Konvencije bi lahko uporabo določb, podobnih tistim iz Direktive 98/84/ES, razširili prek meja Unije in oblikovali zakonodajo o storitvah, ki temeljijo na pogojnem dostopu, ki bi se uporabljala po vsej evropski celini.
The Convention should be approved on behalf of the Union,
Zato bi bilo treba Konvencijo v imenu Unije odobriti –
The European Convention on the legal protection of services based on, or consisting of, conditional access [3] is hereby approved on behalf of the Union.Article 2
Evropska konvencija o pravnem varstvu storitev, ki temeljijo na pogojnem dostopu ali vključujejo pogojni dostop [3], se odobri v imenu Unije.Člen 2
The President of the Council is hereby authorised to designate the person(s) empowered to deposit on behalf of the Union the instrument of approval provided for in Article 12 of the Convention, in order to express the consent of the Union to be bound.
Predsednik Sveta je pooblaščen, da imenuje osebo(-e), pooblaščeno(-e), da v imenu Unije deponira(-jo) listino o odobritvi iz člena 12 Konvencije in s tem izrazi(-jo) soglasje Unije o tem, da je ta konvencija zavezujoča.
Directive 98/84/EC of the European Parliament and of the Council of 20 November 1998 on the legal protection of services based on, or consisting of, conditional access (OJ L 320, 28.11.1998, p. 54).
Direktiva Evropskega parlamenta in Sveta 98/84/ES z dne 20. novembra 1998 o pravnem varstvu storitev, ki temeljijo na pogojnem dostopu ali vključujejo pogojni dostop (UL L 320, 28.11.1998, str. 54).
The Convention was signed on the basis of Council Decision 2011/853/EU of 29 November 2011 on the signing, on behalf of the Union, of the European Convention on the legal protection of services based on, or consisting of, conditional access (OJ L 336, 20.12.2011, p. 1).
Konvencija je bila podpisana na podlagi Sklepa Sveta 2011/853/EU z dne 29. novembra 2011 o podpisu Evropske konvencije o pravnem varstvu storitev, ki temeljijo na pogojnem dostopu ali vključujejo pogojni dostop, v imenu Unije (UL L 336, 20.12.2011, str. 1).
That Decision has since been replaced by Council Decision 2014/243/EU of 14 April 2014 on the signing, on behalf of the European Union, of the European Convention on the legal protection of services based on, or consisting of, conditional access (OJ L 128, 30.4.2014, p. 61).
Navedeni sklep pa je nadomestil Sklep Sveta 2014/243/EU z dne 14. aprila 2014 o podpisu Evropske konvencije o pravnem varstvu storitev, ki temeljijo na pogojnem dostopu ali vključujejo pogojni dostop, v imenu Evropske unije (UL L 128, 30.4.2014, str. 61).
DECLARATION OF THE EU [1]
IZJAVA EU [1]
While fully recognising the objectives pursued by the European Convention on the legal protection of services based on, or consisting of, conditional access, the Union expresses its concern regarding the application of Article 9 and Article 10(3) of the Convention, following the accession of the Union thereto, on the basis of its exclusive competence.
Čeprav Unija v celoti priznava cilje Evropske konvencije o pravnem varstvu storitev, ki temeljijo na pogojnem dostopu ali vključujejo pogojni dostop, ima pomisleke glede uporabe člena 9 in člena 10(3) Konvencije po pristopu Unije h Konvenciji, na podlagi svoje izključne pristojnosti.
This Declaration is without prejudice to the voting procedures within the Committee of Ministers of the Council of Europe.
Ta izjava ne vpliva na postopek glasovanja v Odboru ministrov Sveta Evrope.
To be communicated to the Secretary-General of the Council of Europe at the time of deposition of the instrument of approval of the Convention.
Predložiti generalnemu sekretarju Sveta Evrope ob deponiranju listine o odobritvi Konvencije.
Council Decision (EU) 2015/1294
Sklep Sveta (EU) 2015/1294
on the conclusion, on behalf of the European Union and its Member States, of the Additional Protocol to the Agreement on Trade, Development and Cooperation between the European Community and its Member States, of the one part, and the Republic of South Africa, of the other part, to take account of the accession of the Republic of Croatia to the European Union
o sklenitvi Dodatnega protokola k Sporazumu o trgovini, razvoju in sodelovanju med Evropsko skupnostjo in njenimi državami članicami na eni strani in Republiko Južno Afriko na drugi zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji, v imenu Evropske unije in njenih držav članic
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 217, in conjunction with Article 218(6) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 217 v povezavi s členom 218(6) Pogodbe,
In accordance with Council Decision (EU) 2015/733 [1], the Additional Protocol to the Agreement on Trade, Development and Cooperation between the European Community and its Member States, of the one part, and the Republic of South Africa, of the other part [2], to take account of the accession of the Republic of Croatia to the European Union (‘the Protocol’) has been signed, subject to its conclusion.
V skladu s Sklepom Sveta (EU) 2015/733 [1] je bil podpisan Dodatni protokol k Sporazumu o trgovini, razvoju in sodelovanju med Evropsko skupnostjo in njenimi državami članicami na eni strani in Republiko Južno Afriko na drugi [2] zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji (v nadaljnjem besedilu: Protokol), s pridržkom njegove sklenitve.
The Additional Protocol to the Agreement on Trade, Development and Cooperation between the European Community and its Member States, of the one part, and the Republic of South Africa, of the other part, to take account of the accession of the Republic of Croatia to the European Union [3] is hereby approved on behalf of the Union and its Member States.Article 2
Dodatni protokol k Sporazumu o trgovini, razvoju in sodelovanju med Evropsko skupnostjo in njenimi državami članicami na eni strani in Republiko Južno Afriko na drugi zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji [3] se odobri v imenu Unije in njenih držav članic.Člen 2
The President of the Council is hereby authorised to designate the person(s) empowered to give, on behalf of the Union and its Member States, the notification provided for in Article 6(2) of the Protocol [4].Article 3
Predsednik Sveta je pooblaščen, da imenuje osebo(-e), pooblaščeno(-e), da v imenu Unije in njenih držav članic poda(-jo) uradno obvestilo iz člena 6(2) Protokola [4].Člen 3
Council Decision (EU) 2015/733 of 9 October 2014 on the signing, on behalf of the European Union and its Member States, and provisional application of the Additional Protocol to the Agreement on Trade, Development and Cooperation between the European Community and its Member States, of the one part, and the Republic of South Africa, of the other part, to take account of the accession of the Republic of Croatia to the European Union (OJ L 117, 8.5.2015, p.
Sklep Sveta (EU) 2015/733 z dne 9. oktobra 2014 o podpisu Dodatnega protokola k Sporazumu o trgovini, razvoju in sodelovanju med Evropsko skupnostjo in njenimi državami članicami na eni strani in Republiko Južno Afriko na drugi zaradi upoštevanja pristopa Republike Hrvaške k Evropski uniji, v imenu Evropske unije in njenih držav članic ter o njegovi začasni uporabi (UL L 117, 8.5.2015, str. 1).
1).
Besedilo Sporazuma je objavljeno v UL L 311, 4.12.1999, str. 3.
The text of the Agreement is published in OJ L 311, 4.12.1999, p. 3.
Besedilo Protokola je bilo objavljeno v UL L 117, 8.5.2015, str. 3, skupaj s sklepom o njegovem podpisu.
The text of the Protocol has been published in OJ L 117, 8.5.2015, p.
Generalni sekretariat Sveta bo v Uradnem listu Evropske unije objavil datum začetka veljavnosti Protokola.
Commission Decision (EU) 2015/1300
Sklep Komisije (EU) 2015/1300
on the aid scheme — aid to German pharmaceutical companies in financial difficulties through the exemptions from mandatory rebates SA.34881 (2013/C) (ex 2013/NN) (ex 2012/CP) — implemented by Germany
o shemi pomoči – pomoč nemškim farmacevtskim družbam v finančnih težavah z izvzetjem dajanja obveznih rabatov SA.34881 (2013/C) (ex 2013/NN) (ex 2012/CP) –, ki jo je izvedla Nemčija
(notified under document C(2015) 1975)
(notificirano pod dokumentarno številko C(2015) 1975)
Having called on interested parties to submit their comments pursuant to the provisions cited above [1], and having regard to their comments,
po pozivu zainteresiranim stranem, naj predložijo svoje pripombe v skladu z navedenimi določbami [1], in ob upoštevanju teh pripomb,
On 24 May 2012, the Commission received a complaint from a German pharmaceutical company that alleges that the exemption from the manufacturer's rebate for pharmaceuticals granted to its competitors under German law constitutes State aid.
Komisija je 24. maja 2012 prejela pritožbo nemške farmacevtske družbe, ki trdi, da izvzetje od rabata proizvajalca za farmacevtske izdelke, odobreno njegovim konkurentom po nemškem pravu, pomeni državno pomoč.
On 8 June 2012, the Commission submitted a non-confidential version of the complaint to the German authorities, asked for comments on the complaint and requested additional information.
Komisija je 8. junija 2012 predložila nezaupno različico pritožbe nemškim organom ter zahtevala pripombe na pritožbo in dodatna pojasnila.
By letter dated 27 July 2012, Germany provided comments on the complaint and submitted the additional information requested.
Nemčija je z dopisom z dne 27. julija 2012 predložila pripombe na pritožbo in zahtevana dodatna pojasnila.
On 31 July 2012 Germany submitted a non-confidential version of this reply.
Nemčija je 31. julija 2012 predložila nezaupno različico tega odgovora.
On 24 August 2012, the Commission sent this non-confidential version to the complainant, inquiring if the complainant wanted to pursue the matter in the light of the explanations provided by Germany.
Komisija je 24. avgusta 2012 to nezaupno različico poslala pritožniku, da bi ugotovila, ali je pritožnik želel obravnavo zadeve glede na pojasnila, ki jih je zagotovila Nemčija.
The complainant maintained his allegations.
Pritožnik je vztrajal pri svojih navedbah.
By letter dated 26 September 2012, he provided comments on Germany's arguments.
Z dopisom z dne 26. septembra 2012 je predložil pripombe o trditvah Nemčije.
On 21 November 2012, the Commission submitted the complainant's reply to Germany, on which the German authorities commented by letter dated 13 December 2012.
Komisija je 21. novembra 2012 Nemčiji poslala odgovor pritožnika.
A meeting with the complainant took place on 6 December 2012.
Nemški organi so svoje pripombe nanj poslali z dopisom z dne 13. decembra 2012.
On 30 January 2013 and 5 April 2013 the complainant submitted additional information.
Sestanek s pritožnikom je potekal 6. decembra 2012.
By letter dated 24 July 2013 the Commission informed Germany that it had decided to initiate the procedure laid down in Article 108(2) of the TFEU in respect of the aid.
Pritožnik je 30. januarja in 5. aprila 2013 predložil dodatne informacije.
The Commission decision to initiate the procedure was published in the Official Journal of the European Union [2].
Komisija je z dopisom z dne 24. julija 2013 sporočila Nemčiji, da bo začela postopek v skladu s členom 108(2) PDEU glede pomoči.
The Commission invited interested parties to submit their comments on the measure.
Odločitev Komisije, da začne postopek, je bil objavljen v Uradnem listu Evropske unije [2].
By letter dated 30 September 2013 Germany submitted comments on the decision to initiate the formal investigation procedure.
Komisija je pozvala zainteresirane strani, naj predložijo svoje pripombe o ukrepu.
Furthermore, the Commission received several comments by interested third parties as well as by the complainant.
Nemčija je z dopisom z dne 30. septembra 2013 predložila pripombe v zvezi s sklepom o začetku formalnega postopka preiskave.
On 6 January non-confidential versions of these observations were forwarded to Germany, which was given the opportunity to react.
Poleg tega je Komisija od zainteresiranih tretjih strani in pritožnika prejela več pripomb.
Germany's comments were received by letter dated 14 February 2014.
Nezaupne različice teh pripomb je Nemčiji posredovala 6. januarja 2014 in ji dala možnost odgovora.
THE COMPLAINT
Nemčija je odgovorila z dopisom z dne 14. februarja 2014.
The complainant, Allergopharma Joachim Ganzer KG, based in Reinbek near Hamburg, is engaged and specialised in research, manufacturing and distribution of products for diagnosis and therapy of allergic diseases.
PRITOŽBA
The complainant alleges that the exemption from the manufacturer's rebate for pharmaceuticals granted to its competitors under Section 130a of Book V of the German Social Security Code constitutes State aid.
Pritožnik, družba Allergopharma Joachim Ganzer KG s sedežem v Reinbeku blizu Hamburga, je dejaven na področju raziskav, proizvodnje in razširjanja izdelkov za diagnostiko in zdravljenje alergijskih bolezni, za kar je tudi specializiran.
Furthermore, the complainant alleges that the beneficiaries of the exemption are companies in difficulty.
Pritožnik trdi, da izvzetje od rabata proizvajalca za farmacevtske izdelke, odobreno njegovim konkurentom v skladu z razdelkom 130a knjige V nemškega zakonika o socialni varnosti, pomeni državno pomoč.
According to the complainant the measure has to be considered as illegal operating aid since the aid does not meet the legal requirements of the Community guidelines on State aid for rescuing and restructuring firms in difficulty [3] (hereinafter ‘R&R Guidelines’).
Poleg tega pritožnik trdi, da so upravičenci do izvzetja podjetja v težavah.
DESCRIPTION OF THE MEASURE
Po mnenju pritožnika je treba ukrep šteti za nezakonito pomoč za tekoče poslovanje, saj ne izpolnjuje pravnih zahtev iz Smernic Skupnosti o državni pomoči za reševanje in prestrukturiranje podjetij v težavah [3] (v nadaljnjem besedilu: smernice za reševanje in prestrukturiranje).
The measure under scrutiny consists of a German scheme on the exemption from a mandatory rebate on certain pharmaceutical products.
OPIS UKREPA
Health insurance system in Germany
Obravnavani ukrep zajema nemško shemo izvzetja od dajanja obveznega rabata za nekatere farmacevtske izdelke.
Public sickness funds:
Javno zdravstveno zavarovanje:
85-90 % of the population in Germany is covered by public sickness funds.
85–90 % nemškega prebivalstva je vključenega v javno zdravstveno zavarovanje.
The public health insurance system is financed by a combination of contributions by members on the one hand and funds from the State's general budget on the other hand.
Sistem javnega zdravstvenega zavarovanja se financira s kombinacijo prispevkov članov na eni strani ter sredstev iz splošnega državnega proračuna na drugi.
Every individual member and his/her employer pay a percentage of that person's gross monthly salary as contribution.
Vsak posamezni član in njegov delodajalec plačata delež bruto mesečne plače te osebe kot prispevek.
The percentage is determined by law and applies equally to all public providers.
Delež je določen z zakonom in velja za vse javne ponudnike enako.
In addition, the State contributes a certain amount for so-called non-insurance-related expenses.
Poleg tega država prispeva določen znesek za stroške, ki niso povezani z zavarovanjem.
The contributions of all members of the public system and the State contributions are pooled in the central ‘health fund’ (Gesundheitsfonds), administered by the Federal Insurance Authority (Bundesversicherungsamt).
Prispevki vseh članov javnega sistema in prispevki države se združijo v osrednji „zdravstveni sklad“ (Gesundheitsfonds), ki ga upravlja zvezna zavarovalnica (Bundesversicherungsamt).