natgillin/translations-raw huggingface dataset:
Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
Komisija i države članice međusobno se obavješćuju o bilo kakvim aktivnostima koje bi mogle prouzročiti povredu sigurnosti ili sumnju u povredu sigurnosti elektroničkih sustava.
Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015 supplementing Regulation (EU) No 952/2013 of the European Parliament and of the Council as regards detailed rules concerning certain provisions of the Union Customs Code (OJ L 343, 29.12.2015, p. 1).
POGLAVLJE VI.
Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558).
ZAVRŠNE ODREDBE
concerning the approval of beer as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobravanju piva kao osnovne tvari u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja te o izmjeni Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011
In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 11 November 2016 an application from the Institut Technique de l'Agriculture Biologique for the approval of beer as a basic substance.
U skladu s člankom 23. stavkom 3.
That application was accompanied by the information required by the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.
Uredbe (EZ) br. 1107/2009 Komisija je 11. studenoga 2016. primila zahtjev od subjekta Institut Technique de l'Agriculture Biologique za odobrenje piva kao osnovne tvari.
The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance.
Uz navedeni zahtjev priložene su tražene informacije iz članka 23. stavka 3. drugog podstavka Uredbe (EZ) 1107/2009.
The Authority presented to the Commission a Technical Report on beer on 9 June 2017 [2].
Komisija je od Europske agencije za sigurnost hrane („Agencija”) zatražila znanstvenu pomoć.
The Commission presented the review report [3] and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 20 July 2017 and finalised them for the meeting of that Committee on 6 October 2017.
Agencija je 9. lipnja 2017.
The documentation provided by the applicant shows that beer fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [4].
Komisiji dostavila tehničko izvješće o pivu [2].
Consequently, it is to be considered as a basic substance.
Stalnom odboru za bilje, životinje, hranu i hranu za životinje dostavila izvješće o pregledu [3] i nacrt ove Uredbe te pripremila njihove završne verzije za sastanak tog odbora održan 6. listopada 2017.
It has appeared from the examinations made that beer may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report.
Dokumentacija koju je dostavio podnositelj zahtjeva pokazuje da pivo ispunjava kriterije za hranu iz članka 2.
It is therefore appropriate to approve beer as a basic substance.
Uredbe (EZ) br. 178/2002 Europskog parlamenta i Vijeća [4].
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions.
Osim toga, predmetna tvar nije prvenstveno namijenjena zaštiti bilja, ali je korisna za tu namjenu u sredstvu koje je sastoji od te tvari i vode.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Provedena ispitivanja pokazala su da se za pivo može očekivati da načelno ispunjava zahtjeve utvrđene člankom 23.
Article 1
Stoga je primjereno odobriti pivo kao osnovnu tvar.
The substance beer is approved as a basic substance as laid down in Annex I.
Uredbe (EZ) br. 1107/2009 u vezi s njezinim člankom 6. te s obzirom na postojeća znanstvena i tehnička saznanja, potrebno je međutim utvrditi određene uvjete.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Tvar pivo, kako je navedena u Prilogu I., odobrava se kao osnovna tvar.
Done at Brussels, 14 November 2017.
Članak 2.
Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for beer for use in plant protection against slugs and snails.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
EFSA supporting publication 2017:EN-1253.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN
Sastavljeno u Bruxellesu 14. studenoga 2017.
Common Name, Identification Numbers
EFSA povezana publikacija 2017.:EN-1253.
IUPAC Name
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN.
Purity [1]
Uredba (EZ) br. 178/2002 Europskog parlamenta i Vijeća od 28. siječnja 2002. o utvrđivanju općih načela i uvjeta zakona o hrani, osnivanju Europske agencije za sigurnost hrane te utvrđivanju postupaka u područjima sigurnosti hrane (SL L 31, 1.2.2002., str. 1.)
Specific provisions
PRILOG I.
Beer
Uobičajeni naziv, identifikacijski brojevi
CAS No 8029-31-0
Kemijski naziv prema IUPAC-u
5 December 2017
Posebne odredbe
Beer shall be used in accordance with the specific conditions included in the conclusions of the review report on beer (SANTE/11038/2017) and in particular Appendices I and II thereto.
Pivo
Further details on identity, specification and manner of use of basic substance are provided in the review report.
CAS br. 8029-31-0
ANNEX II
Nije primjenjivo
In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Prehrambena kvaliteta
Number
5. prosinca 2017.
Whereas: (1) In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 11 November 2016 an application from the Institut Technique de l'Agriculture Biologique for the approval of beer as a basic substance.
Dodatni podaci o identifikaciji i specifikaciji te načinu uporabe osnove tvari navedeni su u izvješću o pregledu.
EFSA (European Food Safety Authority), 2017.
PRILOG II.
30 pp. doi:10.2903/sp.efsa.2017.EN-1253.
EFSA (Europska agencija za sigurnost hrane), 2017.
concerning the non-renewal of approval of the active substance iprodione, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
o neproduljenju odobrenja aktivne tvari iprodion u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja i o izmjeni Provedbene uredbe Komisije (EU) br. 540/2011
Commission Directive 2003/31/EC [2] included iprodione as an active substance in Annex I to Council Directive 91/414/EEC [3].
Direktivom Komisije 2003/31/EZ [2] iprodion uvršten je u Prilog I. Direktivi Vijeća 91/414/EEZ [3] kao aktivna tvar.
The approval of the active substance iprodione, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2018.
Odobrenje aktivne tvari iprodion, kako je navedena u dijelu A Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011, istječe 31. listopada 2018.
An application for the renewal of the approval of iprodione was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 [5] within the time period provided for in that Article.
Zahtjev za produljenje odobrenja aktivne tvari iprodion podnesen je u skladu s člankom 1.
The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 3 November 2015.
Provedbene uredbe (EU) br. 844/2012.
The Authority also made the supplementary summary dossier available to the public.
Država članica izvjestiteljica nakon savjetovanja s državom članicom suizvjestiteljicom pripremila je izvješće o ocjeni produljenja i dostavila ga 3. studenoga 2015.
On 8 June 2016 the Authority communicated to the Commission its conclusion [6] on whether iprodione can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
Europskoj agenciji za sigurnost hrane („Agencija”) i Komisiji.
The Authority concluded that there is a high potential for the representative uses assessed to result in groundwater exposure above the parametric drinking water limit of 0,1 μg/l by the relevant metabolites of iprodione in situations represented by all pertinent groundwater scenarios; one relevant metabolite is even predicted to exceed 0,75 μg/l in all pertinent groundwater scenarios.
Agencija je izvješće o ocjeni produljenja dostavila na podnošenje primjedbi podnositelju zahtjeva i državama članicama te je primljene primjedbe proslijedila Komisiji.
In addition, the Authority also concluded that there is a high long-term risk to aquatic organisms.
Agencija je usto sažetak dodatne dokumentacije učinila dostupnim javnosti.
Furthermore, in respect of one metabolite, found as a residue in plants and as an impurity in the technical material, the Authority concluded that the genotoxic potential cannot be excluded and therefore the setting of reference values for that metabolite cannot be confirmed based on the information available.
Agencija je 8. lipnja 2016.
Moreover, based on the available information, the dietary risk assessment could not be ﬁnalised as it is not possible to establish residue definitions for risk assessment; nevertheless, an acute consumer risk could not be excluded.
Komisiji dostavila zaključak [6] o tome može li se pretpostaviti da iprodion ispunjava mjerila za odobravanje iz članka 4.
Finally, the long-term risk assessment for wild mammals for all the relevant routes of exposure could not be ﬁnalised, based on the information submitted in the dossier.
Uredbe (EZ) br. 1107/2009.
Additionally, iprodione is classified as carcinogen category 2 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council [7] while in the conclusion of the Authority it is indicated that iprodione should be classified as carcinogen category 1B and as toxic for reproduction category 2.
Agencija je zaključila da postoji velika mogućnost da procijenjene reprezentativne uporabe dovedu do izloženosti podzemnih voda relevantnim metabolitima iprodiona koja premašuje parametarsku graničnu vrijednost za pitku vodu od 0,1μg/L u svim odgovarajućim situacijama povezanima s podzemnim vodama; predviđa se da bi jedan relevantni metabolit u svim odgovarajućim situacijama povezanima s podzemnim vodama mogao premašiti 0,75 μg/l.
For the representative uses considered, residue levels exceed the default value as referred to in point (b) of Article 18(1) of Regulation (EC) No 396/2005 of the European Parliament and of the Council [8].
Osim toga, Agencija je isto tako zaključila da postoji i visok dugoročni rizik za vodene organizme.
Consequently, the requirement set out in Points 3.6.3 and 3.6.5 of Annex II to Regulation (EC) No 1107/2009 is not fulfilled.
Nadalje, u pogledu jednog metabolita koji je utvrđen kao ostatak u biljkama i kao nečistoća u tehničkom materijalu, Agencija je zaključila da se ne može isključiti genotoksični potencijal i stoga se na temelju raspoloživih podataka ne može potvrditi određivanje referentnih vrijednosti za taj metabolit.
The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the draft renewal report.
Nadalje, na temelju raspoloživih podataka nije moguće zaključiti procjenu prehrambenog rizika jer nije moguće ustanoviti definicije ostataka za procjenu rizika, no ne može se isključiti ni akutni rizik za potrošače.
The applicant submitted its comments, which have been carefully examined.
Naposljetku, na temelju podataka iz dokumentacije nije moguće zaključiti procjenu dugoročnog rizika za divlje sisavce u pogledu svih odgovarajućih načina izlaganja.
However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.
Osim toga, iprodion je u skladu s Uredbom (EZ) br. 1272/2008 Europskog parlamenta i Vijeća [7] klasificiran kao karcinogena tvar 2. kategorije, a u zaključku Agencije utvrđuje se da bi iprodion trebalo klasificirati kao karcinogenu tvar 1.B kategorije i kao reproduktivno toksičnu tvar kategorije 2.
Based on the concerns identified, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
Kad je riječ o predmetnim reprezentativnim uporabama, razina ostataka premašuje zadanu vrijednost iz članka 18. stavka 1. točke (b) Uredbe (EZ) br. 396/2005 Europskog parlamenta i Vijeća [8].
It is therefore appropriate not to renew the approval of iprodione in accordance with Article 20(1)(b) of that Regulation.
Stoga, zahtjevi utvrđeni u točkama 3.6.3. i 3.6.5.
Member States should be given time to withdraw authorisations for plant protection products containing iprodione.
Priloga II.
For plant protection products containing iprodione, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 5 June 2018.
Uredbi (EZ) br. 1107/2009 nisu ispunjeni.
Commission Implementing Regulation (EU) 2017/1511 [9] extended the expiry date of iprodione to 31 October 2018 in order to allow the renewal process to be completed before the expiry of the approval of that substance.
Komisija je pozvala podnositelja zahtjeva da podnese svoje primjedbe o zaključku Agencije i o nacrtu izvješća o produljenju u skladu s člankom 14. stavkom 1. trećim podstavkom Provedbene uredbe (EU) br. 844/2012.
However, given that a decision has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.
Podnositelj zahtjeva podnio je primjedbe, koje su detaljno pregledane.
This Regulation does not prejudice the submission of a further application for the approval of iprodione pursuant to Article 7 of Regulation (EC) No 1107/2009.
Međutim, unatoč argumentima koje je iznio podnositelj zahtjeva, bojazni u pogledu tvari nisu se mogle ukloniti.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
S obzirom na utvrđene bojazni, za jednu ili više reprezentativnih uporaba najmanje jednog sredstva za zaštitu bilja nije utvrđeno da su mjerila za odobravanje predviđena člankom 4.
Article 1
Stoga je prikladno ne obnoviti odobrenje za iprodion u skladu s člankom 20. stavkom 1. točkom (b) te Uredbe.
Non-renewal of approval of active substance
Državama članicama trebalo bi dati vremena da oduzmu odobrenja za sredstva za zaštitu bilja koja sadržavaju iprodion.
The approval of the active substance iprodione is not renewed.
U slučaju sredstava za zaštitu bilja koja sadržavaju iprodion, ako države članice odobre razdoblje odgode u skladu s člankom 46.
Article 2
Uredbe (EZ) br. 1107/2009, to bi razdoblje trebalo isteći najkasnije 5. lipnja 2018.
Amendments to Implementing Regulation (EU) No 540/2011
Provedbenom uredbom Komisije (EU) 2017/1511 [9] rok valjanosti odobrenja za iprodion produljen je do 31. listopada 2018. kako bi se postupak produljenja mogao završiti prije isteka roka valjanosti odobrenja te tvari.
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 50, on iprodione, is deleted.
Međutim, s obzirom na to da je odluka donesena prije novog datuma prestanka odobrenja, ova bi se Uredba trebala primijeniti što je prije moguće.
Article 3
Ovom se Uredbom ne dovodi u pitanje ponovno podnošenje zahtjeva za odobrenje iprodiona u skladu s člankom 7.
Transitional measures
Uredbe (EZ) br. 1107/2009.
Member States shall withdraw authorisations for plant protection products containing iprodione as active substance by 5 March 2018 at the latest.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Grace Period
Članak 1.
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 5 June 2018 at the latest.
Neproduljenje odobrenja aktivne tvari
Article 5
Odobrenje za aktivnu tvar iprodion ne produljuje se.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Izmjene Provedbene uredbe (EU) br. 540/2011
This Regulation shall be binding in its entirety and directly applicable in all Member States.
U dijelu A Priloga Provedbenoj uredbi (EU) br. 540/2011 briše se redak 50. o iprodionu.
Done at Brussels, 14 November 2017.
Članak 3.
The President
Države članice oduzimaju odobrenja za sredstva za zaštitu bilja koja kao aktivnu tvar sadržavaju iprodion najkasnije do 5. ožujka 2018.
OJ L 309, 24.11.2009, p. 1.
Članak 4.
Commission Directive 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to include 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin as active substances (OJ L 101, 23.4.2003, p. 3).
Razdoblje odgode
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).
Sva razdoblja odgode koja države članice odobre u skladu s člankom 46.
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
Uredbe (EZ) br. 1107/2009 moraju biti što kraća i moraju isteći najkasnije 5. lipnja 2018.
Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).
Članak 5.
Conclusion on the peer review of the pesticide risk assessment of the active substance iprodione.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
EFSA Journal 2016;14(11):4609, 31 pp. doi:10.2903/j.efsa.2016.4609.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Sastavljeno u Bruxellesu 14. studenoga 2017.
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p.
Za Komisiju
Whereas: (1) Commission Directive 2003/31/EC [2] included iprodione as an active substance in Annex I to Council Directive 91/414/EEC [3].
Direktiva Vijeća 91/414/EEZ od 15. srpnja 1991. o stavljanju sredstava za zaštitu bilja na tržište (SL L 230, 19.8.1991., str. 1.).
Regulation (EU) 2017/2092 of the European Parliament and of the Council
Uredba (EU) 2017/2092 Europskog parlamenta i Vijeća
of 15 November 2017
od 15. studenoga 2017.
amending Regulation (EU) No 1380/2013 on the common fisheries policy
o izmjeni Uredbe (EU) br. 1380/2013 o zajedničkoj ribarstvenoj politici
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof,
uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 43. stavak 2.,
Article 15(1) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council establishes the obligation to land all catches of species which are subject to catch limits and, in the Mediterranean, also catches of species which are subject to minimum sizes (‘the landing obligation’).
Člankom 15. stavkom 1.
Multiannual plans referred to in Article 9 of Regulation (EU) No 1380/2013 and management plans referred to in Article 18 of Council Regulation (EC) No 1967/2006 are to lay down detailed provisions intended to facilitate the implementation of the landing obligation (‘discard plans’).
Uredbe (EU) br. 1380/2013 Europskog parlamenta i Vijeća utvrđena je obveza iskrcavanja svih ulova vrsta koje podliježu ograničenjima ulova te, u Sredozemnom moru, i ulova vrsta koje podliježu minimalnim veličinama („obveza iskrcavanja”).
Article 15(6) of Regulation (EU) No 1380/2013 provides that, in the absence of multiannual plans or management plans, the Commission may adopt discard plans on a temporary basis and for a period of no more than three years.
U višegodišnjim planovima iz članka 9.
Experience has demonstrated that the preparation and adoption of multiannual plans or management plans that include discard plans takes longer than was envisaged at the time of the adoption of Regulation (EU) No 1380/2013.
Uredbe (EU) br. 1380/2013 i planovima upravljanja iz članka 18.
It is therefore appropriate to set the period for which the Commission may adopt discard plans in the absence of multiannual plans or management plans.
Uredbe Vijeća (EZ) br. 1967/2006 treba utvrditi detaljne odredbe za lakšu provedbu obveze iskrcavanja („planovi za odbačeni ulov”).
Regulation (EU) No 1380/2013 should therefore be amended accordingly,
Člankom 15. stavkom 6.
HAVE ADOPTED THIS REGULATION:
Uredbe (EU) br. 1380/2013 predviđeno je da, ako nema višegodišnjih planova ili planova upravljanja, Komisija može donijeti privremene planove za odbačeni ulov za razdoblje od najviše tri godine.
Article 1
Iskustvo je pokazalo da izrada i donošenje višegodišnjih planova ili planova upravljanja koji uključuju planove za odbačeni ulov traje dulje nego što je bilo predviđeno u trenutku donošenja Uredbe (EU) br. 1380/2013.
In Article 15 of Regulation (EU) No 1380/2013, paragraph 6 is replaced by the following:
Stoga je primjereno utvrditi razdoblje za koje Komisija može donositi planove za odbačeni ulov ako nema višegodišnjih planova ili planova upravljanja.
Where no multiannual plan, or no management plan in accordance with Article 18 of Regulation (EC) No 1967/2006, is adopted for the fishery in question, the Commission shall be empowered to adopt, in accordance with Article 18 of this Regulation, delegated acts in accordance with Article 46 of this Regulation, laying down on a temporary basis specific discard plans containing the specifications referred to in points (a) to (e) of paragraph 5 of this Article for an initial period of no more than three years that may be renewed for a further total period of three years.
Uredbu (EU) br. 1380/2013 trebalo bi stoga na odgovarajući način izmijeniti,
Member States may cooperate, in accordance with Article 18 of this Regulation, in the drawing-up of such a plan with a view to the Commission adopting such acts or submitting a proposal in accordance with the ordinary legislative procedure.’.
DONIJELI SU OVU UREDBU: