natgillin/translations-raw huggingface dataset:
As the diseases covered by the rules laid down in those acts, namely listeriosis, salmonellosis (zoonotic salmonella), trichinellosis, verotoxigenic E. coli and transmissible spongiform encephalopathies (TSE) are already covered by sector-specify rules, they should therefore be removed from the list set out in Annex II to Regulation (EU) 2016/429.
Ker so bolezni, zajete v pravilih iz navedenih aktov, tj. listerioza, salmoneloza (zoonotska salmonela), trihineloza, verotoksigena E. coli ter transmisivne spongiformne encefalopatije, zajete že v pravilih posameznih sektorjev, bi jih bilo treba črtati s seznama iz Priloge II k Uredbi (EU) 2016/429.
The list of diseases in Annex II to Regulation (EU) 2016/429 should therefore be amended accordingly.
Seznam bolezni iz Priloge II k Uredbi (EU) 2016/429 bi bilo zato treba ustrezno spremeniti.
Regulation (EU) 2016/429 should therefore be amended.
Uredbo (EU) 2016/429 bi bilo zato treba spremeniti.
As Regulation (EU) 2016/429 applies with effect from 21 April 2021, the amendments made to it by this Regulation should also apply from that date,
Ker se Uredba (EU) 2016/429 uporablja z učinkom od 21. aprila 2021, bi se morale spremembe, ki jih uvaja ta uredba, uporabljati od navedenega datuma –
Annex II to Regulation (EU) 2016/429 is replaced by the text set out in the Annex to this Regulation.
Priloga II k Uredbi (EU) 2016/429 se nadomesti z besedilom iz Priloge k tej uredbi.
It shall apply from 21 April 2021.
Uporablja se od 21. aprila 2021.
OJ L 84, 31.3.2016, p. 1.
UL L 84, 31.3.2016, str. 1.
EFSA Journal 2010; 8(5):1595.
okužba s kompleksom Mycobacterium tuberculosis (M. bovis, M. caprae in M. tuberculosis)
Report of the Scientific Committee on Animal Health and Animal Welfare adopted on 16 April 2002, https://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scah_out73_en.pdf
okužba z virusom vozličastega dermatitisa
Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
bovina virusna diareja
Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).
goveja genitalna kampilobakterioza
Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31).
trihomoniaza
Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1).
enzootska goveja levkoza
ANNEX
osepnice ovc in koz
ANNEX II
okužba z virusom kuge drobnice
LIST OF ANIMAL DISEASES
nalezljiva plevropnevmonija koz
Infection with rinderpest virus
ovčji epididimitis (Brucella ovis)
Infection with Rift Valley fever virus
okužba z Burkholderia mallei (smrkavost)
Infection with Brucella abortus, B. melitensis and B. suis
okužba z virusom arteritisa enoprstih kopitarjev
Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis)
infekciozna anemija enoprstih kopitarjev
Infection with rabies virus
durina
Infection with bluetongue virus (serotypes 1-24)
venezuelski encefalomielitis enoprstih kopitarjev
Infestation with Echinococcus multilocularis
nalezljivi metritis kobil
Infection with epizootic haemorrhagic disease virus
encefalomielitis enoprstih kopitarjev (vzhodni in zahodni)
Anthrax
okužba z virusom bolezni Aujeszkega
Surra (Trypanosoma evansi)
okužba z virusom prašičjega reprodukcijskega in respiratornega sindroma
Ebola virus disease
okužba z virusom atipične kokošje kuge
Paratuberculosis
aviarna mikoplazmoza (Mycoplasma gallisepticum in M. meleagridis)
Japanese encephalitis
okužba s Salmonella Pullorum, S. Gallinarum in S. arizonae
West Nile fever
okužba z virusi nizkopatogene aviarne influence
Q fever
aviarna klamidioza
Infection with lumpy skin disease virus
okužba z Varroa spp.
Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia)
(varooza)
Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis
okužba z Aethina tumida (malim panjskim hroščem)
Bovine viral diarrhoea
huda gniloba čebelje zalege
Bovine genital campylobacteriosis
okužba z Tropilaelaps spp.
Trichomonosis
okužba z Batrachochytrium salamandrivorans
Enzootic bovine leukosis
epizootska hematopoetska nekroza
Sheep pox and goat pox
virusna hemoragična septikemija
Infection with peste des petits ruminants virus
infekciozna hematopoetska nekroza
Contagious caprine pleuropneumonia
okužba z virusom infekciozne anemije lososov z delecijo zelo polimorfne regije (HPR)
Ovine epididymitis (Brucella ovis)
koi herpes viroza
Infection with Burkholderia mallei (Glanders)
okužba z Mikrocytos mackini
Infection with equine arteritis virus
okužba s Perkinsus marinus
Equine infectious anaemia
okužba z Bonamia ostreae
Dourine
okužba z Bonamia exitiosa
Venezuelan equine encephalomyelitis
okužba z Marteilia refringens
Contagious equine metritis
okužba z virusom sindroma Taura
Equine encephalomyelitis (Eastern and Western)
okužba z virusom rumene glave
Infection with Aujeszky's disease virus
okužba z virusom bolezni belih pik
Infection with porcine reproductive and respiratory syndrome virus
https://ec.europa.eu/food/animals/health/expert_group_en.
Commission Implementing Regulation (EU) 2018/1630
Izvedbena uredba Komisije (EU) 2018/1630
entering a name in the register of protected designations of origin and protected geographical indications (‘Lička janjetina’ (PGI))
o vpisu imena v register zaščitenih označb porekla in zaščitenih geografskih označb („Lička janjetina“ (ZGO))
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs, and in particular Article 52(2) thereof,
ob upoštevanju Uredbe (EU) št. 1151/2012 Evropskega parlamenta in Sveta z dne 21. novembra 2012 o shemah kakovosti kmetijskih proizvodov in živil ter zlasti člena 52(2) Uredbe,
Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Croatia's application to register the name ‘Lička janjetina’ was published in the Official Journal of the European Union.
V skladu s členom 50(2)(a) Uredbe (EU) št. 1151/2012 je bil zahtevek Hrvaške za registracijo imena „Lička janjetina“ objavljen v Uradnem listu Evropske unije.
As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Lička janjetina’ should therefore be entered in the register,
Ker v skladu s členom 51 Uredbe (EU) št. 1151/2012 Komisija ni prejela nobenega ugovora, bi bilo treba ime „Lička janjetina“ registrirati –
Fresh meat (and offal), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 24. oktobra 2018
Done at Brussels, 24 October 2018.
V imenu predsednika
Member of the Commission
UL C 153, 2.5.2018, str. 11.
OJ C 153, 2.5.2018, p. 11.
Ime „Lička janjetina“ (ZGO) se registrira.
Commission Implementing Regulation (EU) 2018/1631
Izvedbena uredba Komisije (EU) 2018/1631
authorising the placing on the market of cranberry extract powder as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
o odobritvi dajanja na trg izvlečka brusnic v prahu kot novega živila v skladu z Uredbo (EU) 2015/2283 Evropskega parlamenta in Sveta ter o spremembi Izvedbene uredbe Komisije (EU) 2017/2470
Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 was adopted, which establishes a Union list of authorised novel foods.
V skladu s členom 8 Uredbe (EU) 2015/2283 je bila sprejeta Izvedbena uredba Komisije (EU) 2017/2470, s katero je bil oblikovan seznam Unije odobrenih novih živil.
On 20 September 2011, the company Ocean Spray Cranberries Inc. (‘the Applicant’) made a request to the competent authority of France to place cranberry extract powder on the Union market as a novel food within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council.
Družba Ocean Spray Cranberries Inc. (v nadaljnjem besedilu: vložnik) je 20. septembra 2011 pristojnemu organu Francije predložila zahtevo za dajanje izvlečka brusnic v prahu na trg Unije kot novega živila v smislu točke (c) člena 1(2) Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta.
The application requested for cranberry extract powder to be used in fruit-flavoured beverages, isotonic beverages, tea beverages, vitamin enhanced waters, yogurts and yogurt drinks.
Vloga se nanaša na uporabo izvlečka brusnic v prahu v pijačah z aromo sadja, izotoničnih pijačah, čajnih napitkih, vodah z dodanimi vitamini, jogurtih in jogurtovih napitkih.
On 11 December 2014, the competent authority of France issued its initial assessment report.
Pristojni organ Francije je 11. decembra 2014 izdal poročilo o začetni presoji.
In that report it came to the conclusion that cranberry extract powder meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.
V navedenem poročilu ugotavlja, da izvleček brusnic v prahu izpolnjuje merila za nove živilske sestavine iz člena 3(1) Uredbe (ES) št. 258/97.
In the same report, the competent authority of France also expressed concerns regarding possible nutritional risks associated with the overconsumption of polyphenols for children between one and three years of age resulting from the intake of polyphenols from the novel food, and from other sources of polyphenols in children's diet.
V istem poročilu je pristojni organ Francije tudi izrazil pomisleke glede morebitnih prehranskih tveganj, povezanih s čezmernim uživanjem polifenolov pri otrocih, starih od enega do treh let, ki je posledica vnosa polifenolov iz novega živila in drugih virov polifenolov v prehrani otrok.
On 16 January 2015, the Commission forwarded the initial assessment report to the other Member States.
Komisija je poročilo o začetni presoji 16. januarja 2015 poslala drugim državam članicam.
Reasoned objections were raised by the other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to insufficient data excluding the risk for young children aged between one and three years, incomplete specification of the novel food, and lack of information on the protein content needed to exclude allergy risk.
Druge države članice so v 60-dnevnem roku iz prvega pododstavka člena 6(4) Uredbe (ES) št. 258/97 vložile upravičene ugovore glede nezadostnih podatkov, ki ne vključujejo tveganja za majhne otroke, stare od enega do treh let, nepopolne specifikacije novega živila in pomanjkanja informacij o vsebnosti beljakovin, ki so potrebne za izključitev tveganja za alergije.
In view of the initial assessment report issued by the competent authority of France and the objections raised by some Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 20 April 2016, asking it to carry out an additional assessment for cranberry extract powder as a novel food in accordance with Regulation (EC) No 258/97.
Komisija se je 20. aprila 2016 na podlagi poročila o začetni presoji, ki ga je izdal pristojni organ Francije, in ugovorov, ki so jih vložile nekatere države članice, posvetovala z Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija) in jo prosila za dodatno presojo izvlečka brusnic v prahu kot novega živila v skladu z Uredbo (ES) št. 258/97.
In contacts with the Authority the Applicant has declared that the novel food is not intended to be marketed to infants, toddlers and children of below 19 years of age.
V stikih z Agencijo je vložnik izjavil, da novo živilo ni namenjeno za uporabo pri dojenčkih, malih otrocih in otrocih, mlajših od 19 let.
On 4 April 2017, the Authority adopted a ‘Scientific Opinion on the safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97’ in which it concluded that cranberry extract is safe for the uses communicated by the Applicant.
Agencija je 4. aprila 2017 sprejela Znanstveno mnenje o varnosti izvlečka brusnic v prahu kot nove živilske sestavine na podlagi Uredbe (ES) št. 258/97 (Scientific Opinion on the safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97), v katerem ugotavlja, da je izvleček brusnic varen za uporabe, ki jih je sporočil vložnik.
That opinion, although elaborated and adopted by the Authority under Regulation (EC) No 258/97, is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
Čeprav je Agencija navedeno mnenje pripravila in sprejela na podlagi Uredbe (ES) št. 258/97, je v skladu z zahtevami iz člena 11 Uredbe (EU) 2015/2283.
On 7 June 2017 the Commission informed the applicant of its and certain Member States' positions that, in view of the risk that infants, toddlers and children of below 19 years of age could consume the intended products, an authorisation would require an additional safety evaluation for these age groups.
Komisija je 7. junija 2017 obvestila vložnika o svojih stališčih in stališčih nekaterih držav članic, da je zaradi tveganja, da bi dojenčki, mali otroci in otroci, mlajši od 19 let, lahko zaužili zadevne proizvode, za odobritev potrebna dodatna ocena varnosti za te starostne skupine.
Alternatively, the Commission suggested that the risk of consumption by the age groups for which the Authority had not concluded on safety could be sufficiently contained, if cranberry extract would be authorised as a novel food supplement for the adult population.
Komisija je tudi predlagala, da bi bilo tveganje za zaužitje pri starostnih skupinah, za katere Agencija ni podala ugotovitev glede varnosti, mogoče zadostno omejiti, če bi bil izvleček brusnic odobren kot novo prehransko dopolnilo za odraslo populacijo.
On 22 December 2017, the Applicant informed the Commission of its decision to, at this stage, pursue the authorisation of cranberry extract for use in food supplements for the general adult population, without prejudice to a subsequent further application for an extension of the conditions of use based on a further safety assessment by the Authority.
Vložnik je 22. decembra 2017 Komisijo obvestil o svoji odločitvi, da na tej stopnji nadaljuje z zahtevo za odobritev izvlečka brusnic za uporabo v prehranskih dopolnilih za splošno odraslo populacijo, brez poseganja v naknadno vlogo za razširitev pogojev uporabe na podlagi nadaljnje ocene Agencije glede varnosti.
Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.The application also meets the requirements laid down in Regulation (EU) 2015/2283.
V skladu s členom 35(1) Uredbe (EU) 2015/2283 se kakršna koli zahteva za dajanje novega živila na trg v Uniji, ki se predloži državi članici v skladu s členom 4 Uredbe (ES) št. 258/97 in za katero končna odločitev ni bila sprejeta pred 1. januarjem 2018, obravnava kot vloga, predložena v skladu z Uredbo (EU) 2015/2283.
The opinion of the Authority gives sufficient grounds to establish that cranberry extract powder, when used in food supplements for general adult population, complies with Article 12(1) of Regulation (EU) 2015/2283.
Vloga izpolnjuje tudi zahteve iz Uredbe (EU) 2015/2283.
On 2 May 2018, the applicant made a request to the Commission for protection of proprietary data for three studies submitted in support of the application namely, a ten-week clinical study in healthy adults, a twelve-week clinical study in adults with low to moderate cardiovascular disease risk and a report on the influence on systemic immune functions, urinary and systemic biomarkers of health and faecal characteristics of human subjects during a 10 weeks administration.
V navedenem mnenju Agencije je dovolj dokazov za ugotovitev, da je izvleček brusnic v prahu, kadar se uporablja v prehranskih dopolnilih za splošno odraslo populacijo, skladen s členom 12(1) Uredbe (EU) 2015/2283.
The applicant also made a request to the Commission for protection of proprietary data for consumption information of their cranberry juice cocktail product in Europe, as well as consumption information relating to children.
Vložnik je 2. maja 2018 Komisijo zaprosil za varstvo pravno zaščitenih podatkov iz treh študij v podporo vlogi, in sicer iz desettedenske klinične študije na zdravih odraslih, dvanajsttedenske klinične študije na odraslih z nizkim do zmernim tveganjem za bolezni srca in ožilja ter poročila o vplivu na sistemske funkcije imunskega sistema, na urinarne in sistemske biomarkerje zdravstvenega stanja ter na značilnosti blata pri ljudeh med desettedensko aplikacijo.
A request to the Commission for protection of proprietary data was also made for the compositional data and the intake estimate on cranberry beverage consumption.
Vložnik je Komisijo zaprosil tudi za varstvo pravno zaščitenih podatkov glede porabe njihovega brusničnega soka v Evropi in porabe pri otrocih.
On 27 June 2018, the Authority considered that in elaborating its opinion on cranberry extract powder as a novel food, the compositional information (Table IX.b-1, original application, dated June 2011, page 24) and the intake estimate on cranberry beverage consumption (File: ‘Ocean Spray's response to Member States' objections’, dated November 2015) were needed for the characterisation and setting of specifications of the novel food, as well as for hazard identification, and for the assessment whether the potential intake of proanthocyanidins (PAC) from the novel food is comparable to the PAC intake from the consumption of cranberry juice products.
Komisijo je prav tako zaprosil za varstvo pravno zaščitenih podatkov glede sestave in ocene vnosa z zaužitjem brusničnih pijač.
Therefore, it is considered that the conclusions on the safety of cranberry extract powder could not have been reached without the aforementioned data.
Agencija je 27. junija 2018 navedla, da so bile pri pripravi mnenja o izvlečku brusnic v prahu kot novega živila informacije o sestavi (Tabela IX.b-1, prvotna vloga iz junija 2011, stran 24) in ocena vnosa z zaužitjem brusničnih pijač (spis glede odziva družbe Ocean Spray na ugovore držav članic iz novembra 2015) potrebne za opredelitev značilnosti, določitev specifikacij novega živila, opredelitev nevarnosti in oceno, ali je morebitni vnos proantocianidinov z novim živilom primerljiv vnosu proantocianidinov z uživanjem brusničnega soka.
Following the receipt of the Authority's opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the data, and their claim to an exclusive right of reference to that data, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.
Zato se šteje, da ugotovitve o varnosti izvlečka brusnic v prahu brez navedenih podatkov ne bi mogle biti dosežene.
The applicant declared that, at the time the application was submitted, it held proprietary and exclusive rights of reference to the evidence and data under national law and that therefore third parties could not lawfully access or use that scientific evidence or scientific data.
Po prejemu mnenja Agencije je Komisija od vložnika zahtevala, naj dodatno pojasni predloženo utemeljitev v zvezi s svojo zahtevo za pravno zaščitene podatke in svojo zahtevo za izključno pravico do sklicevanja na navedene podatke, kot je navedeno v točkah (a) in (b) člena 26(2) Uredbe (EU) 2015/2283.
The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.
Vložnik je izjavil, da je imel v času vložitve vloge v skladu z nacionalno zakonodajo pravico do pravno zaščitenih dokazov in podatkov in izključno pravico do sklicevanja nanje ter da tretje osebe zato niso mogle zakonito dostopati ali uporabljati navedenih znanstvenih dokazov ali znanstvenih podatkov.
Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the compositional data and the intake estimate contained in the applicant's file and without which the novel food could not have been assessed by the Authority should not be used by for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation.
Komisija je ocenila vse informacije, ki jih je predložil vložnik, in ugotovila, da je ta zadovoljivo utemeljil izpolnjevanje zahtev iz člena 26(2) Uredbe (EU) 2015/2283.
As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the applicant for a period of five years.
V skladu s tem, kot je določeno v členu 26(2) Uredbe (EU) 2015/2283, Agencija ne bi smela uporabiti podatkov o sestavi in ocenah vnosa, ki so vključeni v vložnikovo dokumentacijo in brez katerih ne bi mogla oceniti novega živila, v korist poznejšega vložnika v obdobju petih let od datuma začetka veljavnosti te uredbe.
However, restricting the authorisation of this novel food and of the reference to the scientific evidence or scientific data contained in the applicant's file for the sole use of the applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting the authorisation under this Regulation.
Zato bi bilo treba dajanje novega živila, odobrenega s to uredbo, na trg v Uniji omejiti na vložnika za obdobje petih let.
Directive 2002/46/EC lays down requirements on food supplements.
Vendar omejitev odobritve za to novo živilo in sklicevanja na znanstvene dokaze ali znanstvene podatke, vključene v vložnikovo dokumentacijo, na izključno uporabo vložnika drugim vložnikom ne preprečuje vložitve vloge za odobritev dajanja na trg istega novega živila, če njihova vloga temelji na zakonito pridobljenih informacijah, ki podpirajo odobritev v skladu s to uredbo.
The use of cranberry extract powder should be authorised without prejudice to the requirements of that Directive.
Direktiva 2002/46/ES določa zahteve glede prehranskih dopolnil.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Uporabo izvlečka brusnic v prahu bi bilo treba odobriti brez poseganja v določbe navedene direktive.
Cranberry extract powder as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
Člen 1
For a period of five years from the date of entry into force of this Regulation only the Applicant:
Izvleček brusnic v prahu, kakor je opredeljen v Prilogi k tej uredbi, se vključi na seznam Unije odobrenih novih živil, oblikovan z Izvedbeno uredbo (EU) 2017/2470.
Company: Ocean Spray Cranberries Inc.
V obdobju petih let od datuma začetka veljavnosti te uredbe je samo vložniku:
Address: One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA
družba: Ocean Spray Cranberries Inc.