natgillin/translations-raw huggingface dataset:
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 5 May 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
U skladu s člankom 7. stavkom 2. Delegirane uredbe (EU) br. 1062/2014 Odbor za biocidne proizvode 5. svibnja 2017. sastavio je mišljenje Europske agencije za kemikalije, uzimajući u obzir zaključke nadležnog ocjenjivačkog tijela.
According to that opinion, biocidal products of product-type 18 containing cypermethrin may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
U skladu s tim mišljenjem može se očekivati da će biocidni proizvodi vrste 18 koji sadržavaju cipermetrin ispuniti zahtjeve iz članka 19. stavka 1. točke (b) Uredbe (EU) br. 528/2012 ako se zadovolje određene specifikacije i uvjeti koji se odnose na njihovu uporabu.
It is therefore appropriate to approve cypermethrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.
Stoga je primjereno odobriti cipermetrin za uporabu u biocidnim proizvodima vrste 18, podložno određenim specifikacijama i uvjetima.
Furthermore, a need to further investigate the endocrine disrupting potential of cypermethrin has been identified in a screening study carried out in preparation of the impact assessment conducted by the Commission on various options to set criteria to identify endocrine disruptors.
Nadalje, tijekom studije probira provedene u okviru pripreme procjene učinka koju je provela Komisija u pogledu različitih mogućnosti utvrđivanja kriterija za određivanje endokrinih disruptora utvrđena je potreba za provođenjem daljnjih ispitivanja cipermetrina kao potencijalnog enodokrinog disruptora.
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.
Prije odobrenja aktivne tvari zainteresiranim bi stranama trebalo omogućiti primjereno razdoblje za poduzimanje pripremnih mjera potrebnih za ispunjavanje novih zahtjeva.
Cypermethrin is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.
Cipermetrin se odobrava kao aktivna tvar za uporabu u biocidnim proizvodima vrste 18, podložno specifikacijama i uvjetima iz Priloga.
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Cypermethrin, Product type: PT 18, ECHA/BPC/153/2017, Adopted on 5 May 2017
Mišljenje Odbora za biocidne proizvode o zahtjevu za odobrenje aktivne tvari cipermetrin, vrsta proizvoda: PT 18, ECHA/BPC/153/2017, doneseno 5. svibnja 2017.
Cypermethrin cis:trans 40:60; (RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate
cipermetrin cis:trans 40:60; (RS)-α-ciano-3 fenoksibenzil-(1RS)-cis,trans-3-(2,2-diklorovinil)-2,2-dimetilciklopropan karboksilat
Isomeric ratio: cis:trans 40:60
Omjer izomera: cis:trans 40:60
1 June 2020
1. lipnja 2020.
31 May 2030
31. svibnja 2030.
secondary exposure of infants and toddlers;
sekundarnoj izloženosti dojenčadi i male djece;
surface water for:
površinskim vodama u slučaju:
surface application indoors; and
i. primjene na površinama u zatvorenim prostorima; i
outdoor wall and perimeter applications in urban areas;
vanjske primjene na zidovima i oko zgrada u urbanim područjima;
soil for:
tlu u slučaju:
surface application indoors;
i. primjene na površinama u zatvorenim prostorima;
outdoor wall applications in urban and rural areas; and
vanjske primjene na zidovima u urbanim i ruralnim područjima; i
perimeter applications in rural areas;
primjene oko zgrada u ruralnim područjima;
sediment for:
sedimentima u slučaju:
surface application, chemical barrier and crack and crevice treatment indoors; and
i. primjene na površinama, primjene kemijske barijere i tretiranja napuklina i pukotina u zatvorenim prostorima; i
groundwater for outdoor wall and perimeter applications in urban areas.
podzemnim vodama u slučaju vanjske primjene na zidovima i oko zgrada u urbanim područjima.
For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
Za proizvode čiji se ostaci mogu nalaziti u hrani ili hrani za životinje treba provjeriti je li potrebno odrediti nove ili izmijeniti postojeće maksimalne razine ostataka (MRO) u skladu s Uredbom (EZ) br. 470/2009 Europskog parlamenta i Vijeća ili Uredbom (EZ) br. 396/2005 Europskog parlamenta i Vijeća te poduzeti sve odgovarajuće mjere za smanjenje rizika kako bi se osiguralo da se ne prekorače primjenjivi MRO-i.
The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
Aktivna tvar u proizvodu stavljenom na tržište može biti jednake ili različite čistoće ako je dokazano da je tehnički ekvivalentna ocijenjenoj aktivnoj tvari.
An assessment of the potential endocrine disrupting properties of cypermethrin will also be conducted in the context of Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and the conclusions thereof are expected before the end of 2018.
Ocjena potencijalnih endokrino štetnih svojstava cipermetrina bit će provedena i u kontekstu Uredbe (EZ) br. 1107/2009 Europskog parlamenta i Vijeća te se očekuje da će njezini zaključci biti dostupni do kraja 2018.
Depending on the outcome of that assessment, the Commission will consider the need to review the approval of cypermethrin as active substance for use in biocidal products in accordance with Article 15 of Regulation (EU) No 528/2012.
Ovisno o rezultatima te ocjene Komisija će razmotriti potrebu za preispitivanjem odobrenja cipermetrina kao aktivne tvari za uporabu u biocidnim proizvodima u skladu s člankom 15. Uredbe (EU) br. 528/2012.
≥ 92 % w/w
≥ 92 % masenog udjela
COM(2016) 350 final.
COM (2016) 350 final.
Commission Implementing Regulation (EU) 2018/1131
Provedbena uredba Komisije (EU) 2018/1131
approving penflufen as an active substance for use in biocidal products of product-type 8
o odobravanju penflufena kao aktivne tvari za uporabu u biocidnim proizvodima vrste 8
The evaluating competent authority of the United Kingdom received on 7 July 2015 an application for the approval of the active substance penflufen for use in biocidal products of product-type 8, wood preservatives, as described in Annex V to Regulation (EU) No 528/2012.
Nadležno ocjenjivačko tijelo Ujedinjene Kraljevine primilo je 7. srpnja 2015. zahtjev za odobrenje aktivne tvari penflufen za uporabu u biocidnim proizvodima vrste 8, „Sredstva za zaštitu drva”, kako je utvrđena u Prilogu V. Uredbi (EU) br. 528/2012.
The evaluating competent authority of the United Kingdom submitted the assessment report together with its recommendations on 28 February 2017 in accordance with Article 8(1) of Regulation (EU) No 528/2012.
Nadležno ocjenjivačko tijelo Ujedinjene Kraljevine u skladu s člankom 8. stavkom 1. Uredbe (EU) br. 528/2012 podnijelo je 28. veljače 2017. izvješće o ocjeni, zajedno sa svojim preporukama.
The opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
Odbor za biocidne proizvode sastavio je 14. prosinca 2017. mišljenje Europske agencije za kemikalije, uzimajući u obzir zaključke nadležnog ocjenjivačkog tijela.
According to that opinion, biocidal products of product-type 8 containing penflufen may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
U skladu s tim mišljenjem može se očekivati da će biocidni proizvodi vrste 8 koji sadržavaju penflufen ispuniti kriterije iz članka 19. stavka 1. točke (b) Uredbe (EU) br. 528/2012 ako se zadovolje određene specifikacije i uvjeti koji se odnose na njihovu uporabu.
It is therefore appropriate to approve penflufen for use in biocidal products of product-type 8, subject to compliance with certain specifications and conditions.
Stoga je primjereno odobriti penflufen za uporabu u biocidnim proizvodima vrste 8, podložno određenim specifikacijama i uvjetima.
Since the opinion of the European Chemical Agency concludes that penflufen meets the criteria for being very persistent (vP) in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council, treated articles treated with or incorporating penflufen should be labelled appropriately when placed on the market.
Budući da je u mišljenju Europske agencije za kemikalije zaključeno da penflufen ispunjava kriterije za vrlo postojane tvari (vP) u skladu s Prilogom XIII. Uredbi (EZ) br. 1907/2006 Europskog parlamenta i Vijeća, tretirane proizvode koji su tretirani penflufenom ili ga sadržavaju trebalo bi pri njihovu stavljanju na tržište propisno označiti.
Penflufen is approved as an active substance for use in biocidal products of product-type 8, subject to the specifications and conditions set out in the Annex.
Penflufen se odobrava kao aktivna tvar za uporabu u biocidnim proizvodima vrste 8, podložno uvjetima iz Priloga.
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Penflufen, Product type: 8, ECHA/BPC/184/2017, Adopted on 14 December 2017.
Mišljenje Odbora za biocidne proizvode o zahtjevu za odobrenje aktivne tvari penflufen, vrsta proizvoda: 8, ECHA/BPC/184/2017, doneseno 14. prosinca 2017.
5-fluoro-1,3-dimethyl-N-2-[(2RS)-4-methylpentan-2-yl]phenyl-1H-pyrazole-4-carboxamide
5-fluoro-1,3-dimetil-N-2-[(2RS)-4-metilpentan-2-il]fenil-1H-pirazol-4-karboksamid
CAS No: 494793-67-8
CAS br.: Faks:494793-67-8
980 g/kg (1:1 ratio (R:S) ratio of enantiomers)
980 g/kg (enantiomeri u omjeru 1:1 (R:S))
31 January 2029
31. siječnja 2029.
In view of the risks identified for soil, labels, and, where provided, safety data sheets of product authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hardstanding, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.
S obzirom na rizike utvrđene za tlo, na oznakama i, ako su dostupni, sigurnosno-tehničkim listovima odobrenog proizvoda mora se navesti da se industrijska uporaba mora provoditi na ograničenom području ili na ograđenoj nepropusnoj tvrdoj podlozi te da se svježe obrađeno drvo nakon obrade mora skladištiti natkriveno i/ili na nepropusnoj tvrdoj podlozi kako bi se spriječili izravni gubici u tlo ili vodu te kako bi se svi gubici od primjene proizvoda prikupili za ponovnu uporabu ili odlaganje.
The person responsible for the placing on the market of a treated article treated with or incorporating penflufen shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
Osoba odgovorna za stavljanje na tržište tretiranog proizvoda koji je tretiran penflufenom ili koji ga sadržava mora osigurati da su na oznaci tog tretiranog proizvoda navedene informacije iz članka 58. stavka 3. drugog podstavka Uredbe (EU) br. 528/2012.
Commission Implementing Regulation (EU) 2018/1132
Provedbena uredba Komisije (EU) 2018/1132
authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
o odobravanju promjene označivanja i posebnog zahtjeva za označivanje nove hrane sintetski zeaksantin u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and updating the Union list.
Komisija je na temelju članka 12. Uredbe (EU) 2015/2283 dužna podnijeti nacrt provedbenog akta o stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
Natural zeaxanthin is a component of the normal human diet as it is found in many fruits and green vegetables as well as in egg yolk.
Prirodni zeaksantin sastavni je dio uobičajene ljudske prehrane jer je prisutan u mnogim vrstama voća i zelenog povrća te u žumanjku jajeta.
It is also currently used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council.
Trenutačno se upotrebljava i u dodacima prehrani u smislu Direktive 2002/46/EZ Europskog parlamenta i Vijeća.
Commission Implementing Decision 2013/49/EU authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council, the placing on the market of synthetic zeaxanthin as a novel food ingredient in food supplements at the maximum intake of up to 2 mg per day.
Provedbenom odlukom Komisije 2013/49/EU odobreno je, u skladu s Uredbom (EZ) br. 258/97 Europskog parlamenta i Vijeća, stavljanje na tržište sintetskog zeaksantina kao novog sastojka hrane u dodacima prehrani pri najvećoj razini unosa do 2 mg dnevno.
The designation of synthetic zeaxanthin authorised by Implementing Decision 2013/49/EU on the labelling of the foodstuffs containing it is ‘synthetic zeaxanthin’.
Pri označivanju hrane koja sadržava sintetski zeaksantin odobren Provedbenom odlukom 2013/49/EU navodi se „sintetski zeaksantin”.
On 23 February 2018, the company DSM Nutritional Products Europe (‘the Applicant’) made a request to the Commission to authorise the amendment of the designation and of the specific labelling requirements for synthetic zeaxanthin within the meaning of Article 10(1) of Regulation (EU) 2015/2283.
Društvo DSM Nutritional Products Europe („podnositelj zahtjeva”) podnijelo je 23. veljače 2018. zahtjev Komisiji za odobrenje promjene označivanja i posebnih zahtjeva za označivanje sintetskog zeaksantina u smislu članka 10. stavka 1. Uredbe (EU) 2015/2283.
The application requests the deletion of the term ‘synthetic’ from the designation of the novel food as listed in the Union list and from the labelling of foodstuffs containing it.
U zahtjevu je zatraženo brisanje pojma „sintetski” iz označivanja te nove hrane kako je navedeno na popisu Unije te iz označivanja hrane koja sadržava taj pojam.
The Applicant considers that the change of the designation and the labelling requirements of zeaxanthin is necessary to alleviate any potential negative economic impact that the use of the term ‘synthetic’ on the labelling of food supplements containing synthetic zeaxanthin may cause due to the negative connotation of the term ‘synthetic’.
Podnositelj zahtjeva tvrdi da je promjena označivanja i zahtjeva za označivanje zeaksantina nužna kako bi se ublažio mogući negativan gospodarski učinak koji bi mogao nastati zbog uporabe pojma „sintetski” na oznakama dodataka prehrani koji sadržavaju sintetski zeaksantin, i to zbog negativne konotacije pojma „sintetski”.
The Applicant also claims that such potential negative economic impact is most probably not experienced by economic operators placing on the market food supplements containing authorised synthetic novel foods which do not carry the term ‘synthetic’ on their labelling.
Podnositelj zahtjeva također tvrdi da gospodarski subjekti koji na tržište stavljaju dodatke prehrani koji sadržavaju odobrenu sintetsku novu hranu koja nije označena pojmom „sintetski”, najvjerojatnije nisu izloženi tom mogućem negativnom gospodarskom učinku.
There are a number of synthetic substances currently authorised and listed in the Union list of novel foods, of which the counterparts from natural origin exist, and both forms are used in food supplements.
Trenutačno se na Unijinu popisu odobrene nove hrane nalaze brojne sintetske tvari koje imaju ekvivalente prirodnog podrijetla, a oba se oblika upotrebljavaju kao dodaci prehrani.
However those synthetic substances are not designated as synthetic in the Union list and are not labelled as such.
Međutim, te sintetske tvari na Unijinu popisu nisu navedene kao sintetske tvari niti su tako označene.
The change in the designation and labelling of synthetic zeaxanthin will ensure consistency with the designation and labelling of those synthetic substances.
Promjenom označivanja sintetskog zeaksantina osigurat će se dosljednost u označivanju tih sintetskih tvari.
There are no changes in the proposed uses and use levels of zeaxanthin when used as an ingredient in food supplements, the safety considerations that supported the authorisation of synthetic zeaxanthin by Implementing Decision 2013/49/EU remain valid and therefore this change does not pose any safety concerns.
Nema promjena u predloženim uporabama i razinama uporabe zeaksantina ako se upotrebljava kao sastojak u dodacima prehrani i razmatranja u pogledu sigurnosti na kojima se temeljilo odobrenje sintetskog zeaksantina Provedbenom odlukom 2013/49/EU i dalje su valjana, stoga ta promjena ne izaziva zabrinutost u pogledu sigurnosti.
Taking into account these legitimate factors, the proposed changes comply with Article 12(1) of Regulation (EU) 2015/2283.
Uzimajući te legitimne čimbenike u obzir, predložene promjene u skladu su s člankom 12. stavkom 1. Uredbe (EU) 2015/2283.
The implementation of the new labelling requirement in accordance with this Implementing Regulation might involve changes for the business operators who currently place synthetic zeaxanthin on the market.
Provedba novog zahtjeva za označivanje u skladu s tom provedbenom uredbom mogla bi uključivati promjene za subjekte koji trenutačno stavljaju sintetski zeaksantin na tržište.
Therefore, it is appropriate to provide for a transitional period.
Stoga je primjereno predvidjeti prijelazno razdoblje.
Directive 2002/46/EC lays down requirements on food supplements.
Direktivom 2002/46/EZ utvrđuju se zahtjevi o dodacima prehrani.
The change of designation and of specific labelling requirement for zeaxanthin should be authorised without prejudice to that Directive.
Promjenu označivanja i posebnog zahtjeva za označivanje zeaksantina trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the substance zeaxanthin shall be amended as specified in the Annex to this Regulation.
Unos na Unijin popis odobrene nove hrane kako je predviđeno člankom 8. Uredbe (EU) 2015/2283 koji se odnosi na tvar zeaksantin mijenja se kako je navedeno u Prilogu ovoj Uredbi.
The entry in the Union list referred to in the first paragraph shall include conditions of use and the labelling requirements laid down in the Annex to this Regulation.
Unos na popis Unije iz prvog stavka uključuje uvjete uporabe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
Food supplements containing synthetic zeaxanthin and complying with Regulation (EU) 2015/2283 as applicable before the entry into force of this Regulation may be placed on the market until 3 September 2019 and may remain on the market until exhaustion of stocks.
Dodaci prehrani koji sadržavaju sintetski zeaksantin i koji su u skladu s Uredbom (EU) 2015/2283 kako se primjenjivala prije stupanja na snagu ove Uredbe mogu se stavljati na tržište do 3. rujna 2019. i mogu ostati na tržištu do iscrpljenja zaliha.
Commission Implementing Decision 2013/49/EU of 22 January 2013 authorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 21, 24.1.2013, p. 32).
Provedbena odluka Komisije 2013/49/EU od 22. siječnja 2013. o odobravanju stavljanja na tržište sintetskog zeaksantina kao novog sastojka hrane u skladu s Uredbom (EZ) br. 258/97 Europskog parlamenta i Vijeća (SL L 21, 24.1.2013., str. 32.).
Regulation (EC) No 258/97 of the European Parliament and of the Council concerning novel food and novel food ingredients (OJ L 43, 14.2.1997, p. 1).
Uredba (EZ) br. 258/97 Europskog parlamenta i Vijeća o novoj hrani i sastojcima nove hrane (SL L 43, 14.2.1997., str. 1.).
In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 the entry for ‘Zeaxanthin’ is replaced by the following:
U tablici 1. (Odobrena nova hrana) Priloga Provedbenoj uredbi (EU) 2017/2470 unos za „Zeaksantin” zamjenjuje se sljedećim:
‘Zeaxanthin
„Zeaksantin
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Zeaxanthin”.’
Pri označivanju hrane koja sadržava novu hranu navodi se ‚Zeaksantin’.”
Commission Implementing Regulation (EU) 2018/1133
Provedbena uredba Komisije (EU) 2018/1133
authorising the placing on the market of dried aerial parts of Hoodia parviflora 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 odobravanju stavljanja na tržište osušenih nadzemnih dijelova biljke Hoodia parviflora kao nove hrane u skladu s Uredbom (EU) 2015/2283 Europskog parlamenta i Vijeća i o izmjeni Provedbene uredbe Komisije (EU) 2017/2470
Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.
Na temelju članka 12. Uredbe (EU) 2015/2283 Komisija odlučuje o odobravanju i stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
On 21 October 2014, the company Desert Labs, Ltd (‘the applicant’) made a request to the competent authority of Ireland to place dried aerial parts of Hoodia parviflora on the Union market as a novel food within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council.
Društvo Desert Labs, Ltd. („podnositelj zahtjeva”) podnijelo je 21. listopada 2014. nadležnom tijelu Irske zahtjev za stavljanje na tržište Unije osušenih nadzemnih dijelova biljke Hoodia parviflora kao nove hrane u smislu članka 1. stavka 2. točke (e) Uredbe (EZ) br. 258/97 Europskog parlamenta i Vijeća.
The application requests for dried aerial parts of Hoodia parviflora to be used in foods including beverages, biscuits, confectionary, savoury snacks, soups and broths, tea, coffee and water.
Zahtjevom se tražilo odobrenje uporabe osušenih nadzemnih dijelova biljke Hoodia parviflora u hrani uključujući pića, kekse, slatkiše, pikantne grickalice, juhe i mesne juhe, čaj, kavu i vodu.
It is also intended for use in food supplements.
Namijenjeni su i za uporabu u dodacima prehrani.
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.
U skladu s člankom 35. stavkom 1. Uredbe (EU) 2015/2283 svi zahtjevi za stavljanje nove hrane na tržište Unije koji su podneseni državi članici u skladu s člankom 4. Uredbe (EZ) br. 258/97 i za koje nije donesena konačna odluka prije 1. siječnja 2018. tretiraju se kao zahtjevi podneseni u skladu s Uredbom (EU) 2015/2283.