natgillin/translations-raw huggingface dataset:
In order to implement the landing obligation, Article 15(6) of Regulation (EU) No 1380/2013 empowers the Commission to adopt discard plans by means of a delegated act on the basis of joint recommendations developed by Member States in consultation with the relevant Advisory Councils.
Za izvajanje obveznosti iztovarjanja člen 15(6) Uredbe (EU) št. 1380/2013 na Komisijo prenaša pooblastilo za sprejetje načrtov za zavržke z delegiranim aktom na podlagi skupnih priporočil, ki jih pripravijo države članice po posvetu z zadevnimi svetovalnimi sveti.
Commission Delegated Regulation (EU) 2016/2374 established a discard plan for certain demersal fisheries in South-Western waters following a joint recommendation submitted by Belgium, France, the Netherlands, Portugal and Spain (The South Western Waters Group) in 2016.
Delegirana uredba Komisije (EU) 2016/2374 je določila načrt za zavržke pri nekaterih vrstah pridnenega ribolova v jugozahodnih vodah na podlagi skupnega priporočila Belgije, Francije, Nizozemske, Portugalske in Španije (v nadaljnjem besedilu: skupina držav jugozahodnih voda) leta 2016.
On 2 June 2017 Belgium, France, the Netherlands, Portugal and Spain have submitted a new joint recommendation suggesting a number of amendments to the discard plan.
Belgija, Francija, Nizozemska, Portugalska in Španija so 2. junija 2017 predložile novo skupno priporočilo, ki predlaga vrsto sprememb načrta za zavržke.
Based on that, the Commission adopted Delegated Regulation (EU) 2018/44 amending Delegated Regulation (EU) 2016/2374.
Na podlagi tega je Komisija sprejela Delegirano uredbo (EU) 2018/44 o spremembi Delegirane uredbe (EU) 2016/2374.
On 26 October 2017 the South Western Waters Group communicated to the Commission the existence of a textual error in the Annex to Delegated Regulation (EU) 2018/44 as regards the description of hake fisheries subject to the landing obligation.
Skupina držav jugozahodnih voda je 26. oktobra 2017 Komisiji sporočila napako v besedilu Priloge k Delegirani uredbi (EU) 2018/44 v zvezi z opisom ribolova osliča, za katerega velja obveznost iztovarjanja.
According to the current version of that Annex, hake fisheries carried out in ICES (International Council for the Exploration of the Seas) divisions VIIIc and IXa with bottom trawls and seines are subject to the landing obligation if the total hake landings in the period 2014/2015 exceeded 5 % of all landed species and more than 5 metric tons.
V skladu s sedanjo različico navedene priloge za ribolov osliča, ki se lovi s pridnenimi vlečnimi mrežami in potegalkami v razdelkih ICES (Mednarodnega sveta za raziskovanje morja) VIIIc in IXa, velja obveznost iztovarjanja, če skupni iztovorjeni ulov osliča v obdobju 2014/2015 presega 5 % vseh iztovorjenih vrst in več kot 5 metričnih ton.
That condition however is no longer applicable.
Vendar ta pogoj ne velja več.
There is therefore a need to correct Delegated Regulation (EU) 2016/2374 as amended by Delegated Regulation (EU) 2018/44.
Zato je treba Delegirano uredbo (EU) 2016/2374, kakor je bila spremenjena z Delegirano uredbo (EU) 2018/44, popraviti.
Since the textual error in the Annex to Delegated Regulation (EU) 2016/2374 has been introduced by Delegated Regulation (EU) 2018/44, and in order to avoid any discontinuity and legal uncertainty in the application of the landing obligation, this Regulation should enter into force on the day following that of its publication and should apply retroactively from the date of application of Delegated Regulation (EU) 2018/44,
Ker je bila napaka v besedilu Priloge k Delegirani uredbi (EU) 2016/2374 uvedena z Delegirano uredbo (EU) 2018/44 ter da ne bi prišlo do prekinitve in pravne negotovosti pri uporabi obveznosti iztovarjanja, bi morala ta uredba začeti veljati dan po objavi in bi jo bilo treba uporabljati retroaktivno od datuma uporabe Delegirane uredbe (EU) 2018/44 –
In the fourth column of the table ‘3.
V četrtem stolpcu tabele „3.
Hake (Merluccius merluccius) fisheries’ of the Annex to Delegated Regulation (EU) 2016/2374 the text:
Ribolov osliča (Merluccius merluccius)“ Priloge k Delegirani uredbi (EU) 2016/2374 se besedilo
‘Vessels which fulfil the following cumulative criteria:
„Plovila, ki izpolnjujejo naslednja kumulativna merila:
Total hake landings in the period 2014/2015 (1) consist of: more than 5 % of all landed species and more than 5 metric tons.’
skupni iztovorjeni ulov osliča v obdobju 2014/2015 (1) predstavlja več kot 5 % vseh iztovorjenih vrst in več kot 5 metričnih ton.“
‘Use mesh size larger or equal to 70 mm’.
„uporaba mrežnega očesa velikosti 70 mm ali več“.
Done at Brussels, 28 June 2018.
V Bruslju, 28. junija 2018
OJ L 354, 28.1.2013, p. 22.
UL L 354, 28.1.2013, str. 22.
Commission Delegated Regulation (EU) 2016/2374 of 12 October 2016 establishing a discard plan for certain demersal fisheries in South-Western waters (OJ L 352, 23.12.2016, p. 33.)
Delegirana uredba Komisije (EU) 2016/2374 z dne 12. oktobra 2016 o načrtu za zavržke pri nekaterih vrstah pridnenega ribolova v jugozahodnih vodah (UL L 352, 23.12.2016, str. 33).
Commission Implementing Regulation (EU) 2018/1254
Izvedbena uredba Komisije (EU) 2018/1254
concerning the denial of authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group of vitamins, pro-vitamins and chemically well-defined substances having similar effect
o zavrnitvi dovoljenja za riboflavin (80 %), ki ga proizvaja Bacillus subtilis KCCM-10445, kot krmni dodatek iz funkcionalne skupine vitaminov, provitaminov in kemijsko natančno definiranih snovi s podobnimi učinki
Riboflavin (vitamin B2) was authorised without a time limit by Directive 70/524/EEC as a feed additive belonging to the group of vitamins, pro-vitamins and chemically well-defined substances having similar effect, for all animal species.
Riboflavin (vitamin B2) je bil z Direktivo 70/524/EGS dovoljen kot krmni dodatek iz funkcionalne skupine vitaminov, provitaminov in kemijsko natančno definiranih snovi s podobnimi učinki za vse živalske vrste brez časovne omejitve.
That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
Navedeni proizvod je bil nato v skladu s členom 10(1) Uredbe (ES) št. 1831/2003 vpisan v register krmnih dodatkov kot obstoječi proizvod.
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of riboflavin, with a purity of minimum 80 %, produced by the genetically modified strain Bacillus subtilis KCCM-10445, as a feed additive for all animal species.
V skladu s členom 10(2) Uredbe (ES) št. 1831/2003 v povezavi s členom 7 navedene uredbe je bil vložen zahtevek za izdajo dovoljenja za riboflavin z najmanj 80-odstotno čistostjo, ki ga proizvaja gensko spremenjeni sev Bacillus subtilis KCCM-10445, kot krmni dodatek za vse živalske vrste.
The applicant requested that the additive be classified in the additive category ‘nutritional additives’.
Vložnik je zahteval, da se navedeni dodatek uvrsti v kategorijo dodatkov „nutritivni dodatki“.
In 2010, in accordance with Article 7(3)(f) of Regulation (EC) No 1831/2003 and Article 3 of Commission Regulation (EC) No 378/2005, the applicant sent samples of the feed additive, in a form in which the feed additive was intended to be placed on the market, to the Reference Laboratory under Regulation (EC) No 1831/2003 (‘the Reference Laboratory’).
Leta 2010 je vložnik v skladu s členom 7(3)(f) Uredbe (ES) št. 1831/2003 in členom 3 Uredbe Komisije (ES) št. 378/2005 referenčnemu laboratoriju, ustanovljenemu z Uredbo (ES) št. 1831/2003, (v nadaljnjem besedilu: referenčni laboratorij) poslal vzorce krmnega dodatka v obliki, v kateri naj bi se krmni dodatek dal na trg.
In 2013, in accordance with Article 3(3) of Regulation (EC) No 378/2005, the applicant supplied the Reference Laboratory with new samples to replace those expired.
Leta 2013 je vložnik v skladu s členom 3(3) Uredbe (ES) št. 378/2005 referenčnemu laboratoriju predložil nove vzorce za nadomestitev poteklih.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 December 2013 that neither the production strain nor its recombinant DNA (‘rDNA’) was detected in the final product having regard to the information provided by the applicant and that therefore, the final product did not raise any safety concern with regard to the genetic modification of the production strain.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: agencija) je v svojem mnenju z dne 4. decembra 2013 ugotovila, da v končnem proizvodu glede na informacije, ki jih je predložil vložnik, nista bila zaznana niti proizvodni sev niti njegov rekombinatni DNK (v nadaljnjem besedilu: rDNK), zato končni proizvod ni vzbujal varnostnih pomislekov glede genske spremembe proizvodnega seva.
It was also concluded that the additive did not have an adverse effect on animal health, human health or the environment.
Prav tako je bilo ugotovljeno, da dodatek nima škodljivega učinka na zdravje živali in ljudi ali okolje.
However, the Commission was informed by the Reference Laboratory that, in the context of an official control performed by a national competent authority, the presence of viable cells and of rDNA from the production strain was detected in some reference samples of the additive by a national laboratory competent for official controls.
Vendar je referenčni laboratorij Komisijo obvestil, da je nacionalni laboratorij, pristojen za uradni nadzor, v okviru uradnega nadzora, ki ga je izvedel pristojni nacionalni organ, v nekaterih referenčnih vzorcih dodatka zaznal prisotnost živih celic in rDNK proizvodnega seva.
Such detection resulted from the use of a polymerase chain reaction (‘PCR’) analysis method developed by a national laboratory competent for official controls in accordance with Article 11(2) of Regulation (EC) No 882/2004 of the European Parliament and of the Council.
V ta namen je vložnik številne laboratorije na Kitajskem in v državah članicah prosil za izvedbo novih analiz vzorcev.
The Commission and the Reference Laboratory informed the applicant on those findings and gave him the opportunity to provide a suitable method of analysis both for the detection of rDNA and for the presence of viable cells from the production strain in order to proceed to further analysis of various samples of the additive.
Rezultati teh analiz so bili negativni, kar zadeva zaznavanje rDNK in živih celic specifičnih proizvodnih sevov.
For that purpose, the applicant requested several laboratories, established both in China and in a Member State, to perform new analyses of the samples.
Vendar se je izkazalo, da nove analize, ki jih je opravil vložnik, niso zadevale vzorcev, ki so bili referenčnemu laboratoriju predloženi leta 2010.
The results of those analyses were negative as regards the detection of both rDNA and viable cells from the specific production strain.
Hkrati je nacionalni laboratorij, pristojen za uradni nadzor, na zahtevo Komisije in referenčnega laboratorija opravil nadaljnje analize vzorcev dodatka.
However, it appeared that the new analyses carried out by the applicant did not concern the samples submitted in 2010 to the Reference Laboratory.
Na njihovi podlagi je bilo ugotovljeno, da so bile v vzorcih iz leta 2010 prisotne žive celice proizvodnega seva in da je bil rDNK proizvodnega seva prisoten tako v vzorcih iz leta 2010 kot vzorcih iz leta 2013.
In parallel, at the request of the Commission and the Reference Laboratory, further analyses of the samples of the additive were carried out by a national laboratory competent for official controls.
Da bi rešili vprašanje razlik med rezultati so se Komisija in referenčni laboratorij na eni strani ter vložnik na drugi leta 2015 dogovorili, da bosta obe strani neodvisen laboratorij, akreditiran za metodo PCR, zaprosila za nadaljnjo analizo dodatka.
That laboratory sent samples to another national laboratory competent for official controls for further analysis, which confirmed the presence of rDNA from the production strain in the samples of 2010 and 2013.
Po dogovoru naj bi si vložnik in nacionalni laboratoriji, pristojni za uradni nadzor, izmenjali in uporabili analizne metode, ki so jih uporabili.
Those results were obtained through the use of a PCR analysis method developed by a national laboratory competent for official controls in accordance with Article 11(2) of Regulation (EC) No 882/2004.
V skladu z Uredbo (ES) št. 1831/2003 mora vložnik ustrezno in zadostno dokazati, da dodatek izpolnjuje pogoje za dovoljenje iz navedene uredbe, njenih izvedbenih ukrepov in veljavnih smernic agencije, in sicer zlasti tako, da predloži ustrezne vzorce dodatka, vse informacije glede genske spremembe proizvodnega seva, uporabljeno metodo na osnovi PCR, protokol za ekstrakcijo DNK in druge relevantne podatke, ki bi agenciji pomagali ugotoviti odsotnost rDNK in živih celic proizvodnega seva.
In 2015, in order to resolve the divergence of results, it was agreed between the Commission and the Reference Laboratory on one hand and the applicant on the other hand that each of them would request an independent laboratory accredited for a PCR method to perform further analysis of the additive.
Komisija je na podlagi navedenih podatkov, ki kažejo na prisotnost živih celic in rDNK proizvodnega seva v dodatku, avgusta 2016 agencijo pozvala k pripravi novega menja o varnosti riboflavina (80 %), ki ga proizvaja gensko spremenjeni sev Bacillus subtilis KCCM-10445, kot krmnega dodatka za vse živalske vrste.
It was agreed that both the analytical methods used by the applicant and by the national laboratories competent for official controls would be shared and used.
Vložnik je predložil te dodatne informacije in podatke.
However, the applicant subsequently refused to have the samples submitted in 2010 and 2013 analysed and to provide samples corresponding to the additive placed on the market in 2015.
Agencija je pozvala tudi referenčni laboratorij, naj predloži dodatne informacije in podatke glede analiz, ki so jih izvedli nacionalni laboratoriji, pristojni za uradni nadzor; te informacije in podatki so bili predloženi.
The applicant refused to further cooperate with the Commission and the Reference Laboratory as long as a ‘unified analysis standard’ method for the detection of rDNA in riboflavin was not established under Union legislation.
Agencija je v svojem mnenju z dne 7. marca 2018 ugotovila, da novi podatki, ki jih je zagotovil nacionalni laboratorij, pristojen za uradni nadzor, kažejo, da referenčni vzorci dodatka vsebujejo žive celice in/ali DNK proizvodnega seva.
Under Regulation (EC) No 1831/2003, the burden is on the applicant to adequately and sufficiently demonstrate that the additive satisfies the conditions for authorisation laid down in that Regulation, its implementing measures and applicable Authority's guidance, in particular through the submission of relevant samples of the additive, all information related to the genetic modification of the production strain, the PCR-based method used, the protocol for extraction of the DNA and other relevant data allowing the Authority to determine the absence of rDNA or viable cells from the production strain.
Proizvodni sev Bacillus subtilis KCCM-10445 nosi štiri gene za odpornost proti antimikrobikom, od katerih so bili trije vneseni z genskimi spremembami.
On the basis of those data indicating the presence of viable cells and rDNA from the production strain in the additive, in August 2016 the Commission requested the Authority to deliver a new opinion on the safety of riboflavin (80 %) produced by the genetically modified strain Bacillus subtilis KCCM-10445 as a feed additive for all animal species.
Zato je agencija ugotovila, da dodatek predstavlja tveganje za ciljne vrste, potrošnike, uporabnike in okolje zaradi možnosti za širjenje živih celic in DNK gensko spremenjenega seva, ki nosi gene za kodiranje odpornosti proti antimikrobikom, pomembnim za uporabo v humani medicini in veterini.
In order to undertake its assessment, the Authority requested the applicant to provide supplementary information and data, related in particular to the method of analysis for the detection of the presence of viable cells of the production strain in the additive.
Zato ni bilo ugotovljeno, da riboflavin (80 %), ki ga proizvaja Bacillus subtilis KCCM-10445, nima škodljivega učinka na zdravje živali in ljudi ali okolje, kadar se uporablja kot krmni dodatek iz funkcionalne skupine „vitamini, provitamini in kemijsko natančno definirane snovi s podobnimi učinki“.
Such supplementary information and data was submitted by the applicant.
Kakor je navedeno v členu 7(3)(i) Uredbe (ES) št. 1831/2003, mora imeti dodatek, ki spada v obseg zakonodaje Skupnosti, ki se nanaša na trženje proizvodov, sestavljenih iz, vsebujočih ali proizvedenih iz gensko spremenjenih organizmov, dovoljenje, dodeljeno v skladu z navedeno zakonodajo.
The Authority also requested the Reference Laboratory to provide further information and data concerning the analyses performed by the national laboratories competent for official controls, which was also furnished.
Takšno dovoljenje ni bilo izdano za gensko spremenjeni sev Bacillus subtilis KCCM-10445, zaznan v dodatku.
The Authority concluded in its opinion of 7 March 2018 that the new data provided by the national laboratory competent for official controls show that reference samples of the additive contain viable cells and/or DNA from the production strain.
Ocena riboflavina (80 %), ki ga proizvaja gensko spremenjeni sev Bacillus subtilis KCCM-10445, kaže, da pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 zato niso izpolnjeni.
The production strain Bacillus subtilis KCCM-10445 carries four antimicrobial resistance genes, three of them introduced by genetic modifications.
Zato bi bilo treba zavrniti izdajo dovoljenja za riboflavin (80 %), ki ga proizvaja Bacillus subtilis KCCM-10445, kot krmni dodatek iz funkcionalne skupine „vitaminov, provitaminov in kemijsko natančno definiranih snovi s podobnimi učinki“.
Therefore, the Authority concluded that the additive poses a risk for the target species, consumers, users and the environment due to the potential for the spread of viable cells and DNA of a genetically modified strain-harbouring genes coding for resistance to antimicrobials of human and veterinary importance.
Kot je bilo vložniku pojasnjeno v korespondenci s Komisijo po sprejetju mnenja agencije z dne 7. marca 2018, zavrnitev izdaje dovoljenja za dodatek iz te izvedbene uredbe ne posega v možnost vložitve novega zahtevka za izdajo dovoljenja v skladu z Uredbo (ES) št. 1831/2003.
Consequently, it has not been established that riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 does not have an adverse effect on animal health, human health or the environment, when used as a feed additive belonging to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’.
Zato bi bilo treba dodatek riboflavin (80 %), ki ga proizvaja Bacillus subtilis KCCM-10445, in krmo, ki ga vsebuje, čim prej umakniti s trga.
As referred to in Article 7(3)(i) of Regulation (EC) No 1831/2003, an additive falling within the scope of the Union legislation relating to the marketing of products consisting of, containing or produced from genetically modified organisms should be subject to an authorisation granted in accordance with that legislation.
Vendar bi bilo treba iz praktičnih razlogov dovoliti omejeno obdobje za umik obstoječih zalog dodatka in krme, ki vsebujejo riboflavin (80 %), ki ga proizvaja Bacillus subtilis KCCM-10445, s trga, da se gospodarskim subjektom omogoči ustrezno izpolnjevanje obveznosti umika ob upoštevanju zakonitih dejavnikov, ki so pomembni za obravnavano zadevo.
Such authorisation has not been granted for the genetically modified strain Bacillus subtilis KCCM-10445 detected in the additive.
Zlasti, ker riboflavin (80 %), ki ga proizvaja Bacillus subtilis KCCM-10445, predstavlja znaten del trga Unije riboflavina, ki se uporablja v krmi, bi se bilo treba izogniti tveganju škodljivih učinkov na zdravje ali dobrobit živali zaradi premajhne oskrbe živali z riboflavinom tako, da se gospodarskim subjektom omogoči dovolj časa za prilagoditev razmeram.
The assessment of riboflavin (80 %) produced by the genetically modified strain Bacillus subtilis KCCM-10445 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are therefore not satisfied.
Treba bi bilo upoštevati tudi čas in sredstva, potrebne za pridobitev in umik premiksov, ki vsebujejo dodatek riboflavin (80 %), ki ga proizvaja Bacillus subtilis KCCM-10445, ter nižje v krmni verigi posamičnih krmil in krmnih mešanic, proizvedenih z navedenim dodatkom ali navedenimi premiksi, s trga.
Accordingly, the authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, should be denied.
Takšne praktične omejitve za umik proizvodov s trga so še bolj pereče pri krmi za živali, ki niso namenjene za proizvodnjo hrane, saj ta vrsta krme običajno vključuje višje stopnje vsebnosti riboflavina, daljši rok trajanja in kompleksnejše metode uničevanja.
As explained to the applicant on the occasion of exchanges with the Commission which took place after the adoption of the Authority's opinion of 7 March 2018, the denial of authorisation of the additive set out in this Implementing Regulation is without prejudice to the possibility of submitting a new application for authorisation in accordance with Regulation (EC) No 1831/2003.
Zato bi bilo treba določiti ustrezna časovna obdobja za umik ustreznih zadevnih krmnih proizvodov s trga.
Therefore, the additive riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 and feed containing it should be withdrawn from the market as soon as possible.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
For practical reasons, however, a limited period should be allowed for the withdrawal from the market of the existing stocks of the additive and feed containing riboflavin (80 %) produced by Bacillus subtilis KCCM-10445, in order to enable operators to comply properly with the withdrawal obligation while taking into account legitimate factors relevant to the matter under consideration.
SPREJELA NASLEDNJO UREDBO:
In particular, as riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 represents a significant part of the Union market concerning riboflavin to be used in feed, any risk of adverse effects on animal health or welfare due to an undersupply of animals with riboflavin should be avoided by providing the operators sufficient time to adapt to the situation.
Člen 1
In addition, the time and resources needed to retrieve and withdraw from the market premixtures containing the additive riboflavin (80 %) produced by Bacillus subtilis KCCM-10445, and further down in the feed chain feed materials and compound feed produced with that additive or those premixtures, should be considered.
Zavrnitev izdaje dovoljenja
Such practical constraints for withdrawing the products from the market are even more acute for feed intended for non-food producing animals, as this type of feed usually involves higher inclusion rates of riboflavin, longer shelf life and more complex destruction methods.
Izdaja dovoljenja za riboflavin (80 %), ki ga proizvaja Bacillus subtilis KCCM-10445, kot krmni dodatek iz funkcionalne skupine „vitaminov, provitaminov in kemijsko natančno definiranih snovi s podobnimi učinki“ (v nadaljnjem besedilu: dodatek), se zavrne.
Therefore, the time periods for the withdrawal from the market of the respective feed products concerned should be provided accordingly.
Člen 2
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Umik s trga
HAS ADOPTED THIS REGULATION:
Obstoječe zaloge dodatka iz člena 1 se umaknejo s trga do 10. novembra 2018.