natgillin/translations-raw huggingface dataset:
Phosphoric acid — phosphates — di-, tri- and polyphosphates
Sunset yellow FCF/Orange S S
Extracts of rosemary
Likopen
Propane-1, 2-diol alginate
Sorbinska kiselina – sorbati; Benzojeva kiselina – benzoati
Karaya gum
Samo dodaci prehrani u suhom obliku koji sadržavaju pripravke vitamina A i kombinacija vitamina A i D, osim u obliku za žvakanje
E 432-436
Fosforna kiselina – fosfati - di-, tri- i polifosfati
Polysorbates
Ekstrakti ružmarina
Beta-cyclodextrin
Propan-1,2-diol alginat
only food supplements in tablet and coated tablet form
Karaja guma
E 473-474
Polisorbati
Sucrose esters of fatty acids — sucroglycerides
Beta-ciklodekstrin
E 491-495
Umrežena natrijeva karboksi metil celuloza
E 551-559
Poliglicerolni esteri masnih kiselina
Silicon dioxide — silicates
Esteri sorbitana
E 551-553
Razdoblje primjene: do 31. siječnja 2014.
in Part D, the entries for food category 17.
U dijelu D, unosi za kategoriju hrane 17.
concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, 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 tiram i zabrani uporabe i prodaje sjemena tretiranog sredstvima za zaštitu bilja koja sadržavaju tiram, 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
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 20(1), Article 49(2) and Article 78(2) thereof,
uzimajući u obzir Uredbu (EZ) br. 1107/2009 Europskog parlamenta i Vijeća od 21. listopada 2009. o stavljanju na tržište sredstava za zaštitu bilja i stavljanju izvan snage direktiva Vijeća 79/117/EEZ i 91/414/EEZ, a posebno njezin članak 20. stavak 1., članak 49. stavak 2. i članak 78. stavak 2.,
Commission Directive 2003/81/EC included thiram as an active substance in Annex I to Council Directive 91/414/EEC.
Direktivom Komisije 2003/81/EZ tiram je uvršten u Prilog I. Direktivi Vijeća 91/414/EEZ kao aktivna tvar.
The approval of the active substance thiram, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2019.
Odobrenje aktivne tvari tiram, kako je navedena u dijelu A Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011, istječe 30. travnja 2019.
An application for the renewal of the approval of thiram was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.
Zahtjev za produljenje odobrenja aktivne tvari tiram 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 20 January 2016.
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 20. siječnja 2016.
On 27 January 2017 the Authority communicated to the Commission its conclusion on whether thiram 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 identified a high acute risk to consumers and to workers from application of thiram by foliar spraying.
Agencija je izvješće o ocjeni produljenja dostavila podnositelju zahtjeva i državama članicama na očitovanje te je primljene primjedbe proslijedila Komisiji.
Furthermore, it identified a high risk to birds and mammals from all representative uses assessed, including as a seed treatment, even taking into account the application of higher tier refinements in the risk assessment.
Agencija je uz to sažetak dodatne dokumentacije učinila dostupnim javnosti.
Residue definitions for risk assessment purposes could not be derived from the incomplete information available on metabolite M1, consequently the assessment of consumer risk through dietary intake could not be completed and maximum residue levels could not be established.
Agencija je 27. siječnja 2017.
Furthermore, the formation of N,N-dimethylnitrous amide (NDMA), a substance of concern given its intrinsic hazard, in drinking water when surface water and groundwater containing thiram and its metabolite DMCS is subject to water treatment processes could not be excluded by the Authority based on the available information and in addition a high risk to aquatic organisms from exposure to DMCS was concluded by the Authority based on the limited information available.
Komisiji dostavila zaključak o tome može li se pretpostaviti da tiram ispunjava mjerila za odobravanje iz članka 4.
Also, based on the information available the Authority could not conclude on the endocrine disrupting potential of thiram.
Uredbe (EZ) br. 1107/2009.
The Commission invited the applicant to submit its comments on the conclusion of the Authority.
Agencija je utvrdila visok akutni rizik za potrošače i radnike od primjene tirama folijarnim prskanjem.
Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report.
Nadalje, utvrđen je visok rizik za ptice i sisavce pri svim ocijenjenim reprezentativnim uporabama, uključujući tretiranje sjemena, čak i uzimajući u obzir rezultate procjene rizika provedene s najvišom razinom preciznosti.
The applicant submitted its comments, which have been carefully examined.
Na temelju nepotpunih informacija o metabolitu M1 nisu se mogle utvrditi definicije ostataka za potrebe procjene rizika, te stoga nije bilo moguće dovršiti procjenu rizika za potrošače povezanih s unosom hrane ni utvrditi maksimalne razine ostataka.
However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.
Nadalje, na temelju dostupnih informacija Agencija nije mogla isključiti mogućnost nastajanja N,N-dimetilnitrozamida (NDMA), tvari koja izaziva zabrinutost jer je po svojoj prirodi opasna, u vodi za piće kada se površinska i podzemna voda koja sadržava tiram i njegov metabolit DMCS podvrgava postupcima pročišćavanja vode, a osim toga Agencija je na temelju ograničenih dostupnih informacija utvrdila visok rizik za vodene organizme.
Consequently, 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.
Nadalje, na temelju dostupnih informacija Agencija nije mogla donijeti zaključak o potencijalu tirama kao endokrinog disruptora.
It is therefore appropriate not to renew the approval of the active substance thiram in accordance with Article 20(1)(b) of that Regulation.
Komisija je pozvala podnositelja zahtjeva da podnese primjedbe na zaključak Agencije.
On 18 May 2018 the applicant wrote to the Commission to withdraw from the renewal application the representative uses concerning application by foliar spraying.
Nadalje, u skladu s člankom 14. stavkom 1. trećim podstavkom Provedbene uredbe (EU) br. 844/2012 Komisija je pozvala podnositelja zahtjeva da podnese primjedbe na nacrt izvješća o produljenju.
Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
Podnositelj zahtjeva podnio je primjedbe, koje su detaljno pregledane.
Taking into account the risk identified for birds and wild mammals from treated seeds the placing on the market and the use of seeds treated with plant protection products containing thiram should be prohibited.
Međutim, unatoč argumentima koje je iznio podnositelj zahtjeva, bojazni u pogledu tvari nisu se mogle ukloniti.
The prohibition of placing on the market and use of treated seeds should apply as of 31 January 2020 in order to allow for a sufficient period of transition for the seed supply chain taking into account the limited availability of seeds that are not treated with products containing thiram.
Dakle, za jednu ili više reprezentativnih uporaba najmanje jednog sredstva za zaštitu bilja nije utvrđeno da su mjerila za odobravanje predviđena člankom 4.
Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing thiram.
Uredbe (EZ) br. 1107/2009 ispunjena.
For plant protection products containing thiram, 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 30 April 2019 for plant protection products used for foliar application and on 30 January 2020 for other plant protection products, including those used for seed treatment.
Stoga je u skladu s člankom 20. stavkom 1. točkom (b) te uredbe primjereno ne produljiti odobrenje za aktivnu tvar tiram.
Commission Implementing Regulation (EU) 2018/524 extended the expiry date of thiram to 30 April 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance.
Podnositelj zahtjeva uputio je 18. svibnja 2018. dopis Komisiji u kojemu traži da se iz zahtjeva za produljenje odobrenja uklone reprezentativne uporabe povezane s primjenom folijarnim prskanjem.
However, given that a decision is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.
Provedbenu uredbu (EU) br. 540/2011 trebalo bi stoga na odgovarajući način izmijeniti.
This Regulation does not prevent the submission of a further application for the approval of thiram in accordance with Article 7 of Regulation (EC) No 1107/2009.
Uzimajući u obzir utvrđeni rizik za ptice i divlje sisavce povezan s tretiranim sjemenom, trebalo bi zabraniti stavljanje na tržište i uporabu sjemena koje je tretirano sredstvima za zaštitu bilja koja sadržavaju tiram.
The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman.
Zabrana stavljanja na tržište i uporabe tretiranog sjemena trebala bi se primjenjivati od 31. siječnja 2020. kako bi se omogućilo dostatno prijelazno razdoblje za lanac opskrbe sjemenom s obzirom na ograničenu dostupnost sjemena koje nije tretirano sredstvima koja sadržavaju tiram.
An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation.
Državama članicama trebalo bi dati dovoljno vremena da oduzmu odobrenja za sredstva za zaštitu bilja koja sadržavaju tiram.
The appeal committee did not deliver an opinion,
U slučaju sredstava za zaštitu bilja koja sadržavaju tiram, ako države članice odobre razdoblje odgode u skladu s člankom 46.
HAS ADOPTED THIS REGULATION:
Uredbe (EZ) br. 1107/2009, to razdoblje trebalo bi isteći najkasnije 30. travnja 2019. za sredstva za zaštitu bilja za folijarnu primjenu i 30. siječnja 2020. za ostala sredstva za zaštitu bilja, uključujući ona koja se upotrebljavaju za tretiranje sjemena.
Article 1
Provedbenom uredbom Komisije (EU) 2018/524 datum isteka odobrenja za tiram produljen je do 30. travnja 2019. kako bi se postupak produljenja mogao završiti prije isteka odobrenja te tvari.
Non-renewal of approval of active substance
Međutim, budući da je odluka donesena prije novog datuma isteka odobrenja, ova bi se Uredba trebala primijeniti što je prije moguće.
The approval of the active substance thiram is not renewed.
Ova Uredba nije prepreka ponovnom podnošenju zahtjeva za odobrenje tirama u skladu s člankom 7.
Amendment to Implementing Regulation (EU) No 540/2011
Stalni odbor za bilje, životinje, hranu i hranu za životinje nije donio mišljenje u roku koji je odredio njegov predsjednik.
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 73, on thiram, is deleted.
Smatralo se potrebnim donijeti provedbeni akt te je predsjednik odbora podnio nacrt provedbenog akta žalbenom odboru na daljnje razmatranje.
Article 3
Žalbeni odbor nije donio mišljenje,
Prohibition of placing on the market of treated seeds
DONIJELA JE OVU UREDBU:
Seeds which have been treated with plant protection products containing thiram shall not be used or placed on the market.
Članak 1.
Transitional measures
Odobrenje za aktivnu tvar tiram ne produljuje se.
Member States shall withdraw authorisations for plant protection products containing thiram as active substance by 30 January 2019 at the latest.
Članak 2.
Article 5
Izmjena Provedbene uredbe (EU) br. 540/2011
Grace period
U dijelu A Priloga Provedbenoj uredbi (EU) br. 540/2011 briše se unos 73. za tiram.
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 30 April 2019 for plant protection products used for foliar application and on 30 January 2020 for other plant protection products, including those used for seed treatment, at the latest.
Članak 3.
Article 6
Zabrana stavljanja na tržište tretiranog sjemena
Entry into force
Sjeme koje je tretirano sredstvima za zaštitu bilja koja sadržavaju tiram ne smije se upotrebljavati ni stavljati na tržište.
Article 3 shall apply as of 31 January 2020.
Prijelazne mjere
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Države članice oduzimaju odobrenja za sredstva za zaštitu bilja koja kao aktivnu tvar sadržavaju tiram najkasnije do 30. siječnja 2019.
Done at Brussels, 9 October 2018.
Članak 5.
OJ L 309, 24.11.2009, p. 1.
Uredbe (EZ) br. 1107/2009 moraju biti što kraća i moraju isteći najkasnije 30. travnja 2019. za sredstva za zaštitu bilja za folijarnu primjenu i 30. siječnja 2020. za ostala sredstva za zaštitu bilja, uključujući ona za tretiranje sjemena.
Commission Directive 2003/81/EC of 5 September 2003 amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances (OJ L 224, 6.9.2003, p. 29).
Članak 6.
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).
Stupanje na snagu
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 3. primjenjuje se od 31. siječnja 2020..
Conclusion on the peer review of the pesticide risk assessment of the active substance thiram.
Sastavljeno u Bruxellesu 9. listopada 2018.
EFSA Journal 2017;15(7):4700 [29 pp.]. doi:10.2903/j.efsa.2017.4700.
Za Komisiju
Commission Implementing Regulation (EU) 2018/524 of 28 March 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram.
Predsjednik
(OJ L 88, 4.4.2018, p. 4).
SL L 309, 24.11.2009., str. 1.
concerning the non-renewal of approval of the active substance pymetrozine, 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 pimetrozin 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
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 20(1) and Article 78(2) thereof,
uzimajući u obzir Uredbu (EZ) br. 1107/2009 Europskog parlamenta i Vijeća od 21. listopada 2009. o stavljanju na tržište sredstava za zaštitu bilja i stavljanju izvan snage direktiva Vijeća 79/117/EEZ i 91/414/EEZ, a posebno njezin članak 20. stavak 1. i članak 78. stavak 2.,
Commission Directive 2001/87/EC included pymetrozine as an active substance in Annex I to Council Directive 91/414/EEC.
Direktivom Komisije 2001/87/EZ pimetrozin je uvršten u Prilog I. Direktivi Vijeća 91/414/EEZ kao aktivna tvar.
The approval of the active substance pymetrozine, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 June 2019.
Odobrenje aktivne tvari pimetrozin, kako je navedena u dijelu A Priloga Provedbenoj uredbi (EU) br. 540/2011, istječe 30. lipnja 2019.
An application for the renewal of the approval of pymetrozine was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 within the time period provided for in that Article.
Zahtjev za produljenje odobrenja aktivne tvari pimetrozin podnesen je u skladu s člankom 4.
The application was found to be complete by the rapporteur Member State.
Podnositelj zahtjeva dostavio je dodatnu dokumentaciju u skladu s člankom 9.
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 28 June 2013.
Uredbe (EU) br. 1141/2010.
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 28. lipnja 2013.
On 28 August 2014 the Authority communicated to the Commission its conclusion on whether pymetrozine 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 toxicologically relevant metabolite CGA371075 in all pertinent groundwater scenarios.
Agencija je izvješće o ocjeni produljenja dostavila podnositelju zahtjeva i državama članicama na očitovanje te je primljene primjedbe proslijedila Komisiji.
The Authority further concluded that several other toxicologically relevant metabolites of pymetrozine are also predicted to occur above 0,1 μg/L in some or all pertinent groundwater scenarios for the representative uses evaluated.
Agencija je usto sažetak dodatne dokumentacije učinila dostupnim javnosti.
It also concluded that the toxicological profile of metabolites included in the plant residue definition for risk assessment could not be confirmed and that the assessment of the risk to aquatic organisms from exposure to metabolite M3MF could not be ﬁnalised for all representative uses considered based on the information available in the dossier.
Agencija je 28. kolovoza 2014.
Additionally, the Authority concluded that pymetrozine caused adverse effects on endocrine organs across different species and timelines.
Komisiji dostavila zaključak o tome može li se pretpostaviti da pimetrozin ispunjava mjerila za odobravanje iz članka 4.
However, the scientific assessment for potential endocrine disruption properties of pymetrozine could not be finalised by the Authority based on the information available in the dossier.
Uredbe (EZ) br. 1107/2009.
The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 17(1) of Regulation (EU) No 1141/2010, on the draft review report.
Agencija je zaključila da postoji velika mogućnost da procijenjene reprezentativne uporabe dovedu do izloženosti podzemnih voda toksikološki relevantnom metabolitu CGA371075 koja premašuje parametarsku graničnu vrijednost za pitku vodu od 0,1 μg/L u svim relevantnim scenarijima povezanima s podzemnim vodama.
The applicant submitted its comments, which have been carefully examined.
Agencija je nadalje zaključila da se u odnosu na reprezentativne uporabe obuhvaćene evaluacijom predviđa pojava još nekoliko toksikološki relevantnih metabolita pimetrozina na razinama iznad 0,1 μg/L u nekim ili svim relevantnim scenarijima povezanima s podzemnim vodama.
However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.
Zaključila je i to da se nije mogao potvrditi toksikološki profil metabolita uključenih u definiciju biljnih rezidua za procjenu rizika i da se procjena rizika za vodene organizme od izloženosti metabolitu M3MF nije mogla dovršiti za sve razmatrane reprezentativne uporabe na temelju informacija dostupnih u dokumentaciji.
Consequently, 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.
Agencija je usto zaključila da pimetrozin ima negativne učinke na endokrine organe različitih vrsta i u različitim vremenskim okvirima.
It is therefore appropriate not to renew the approval of the active substance pymetrozine in accordance with Article 20(1)(b) of that Regulation.
Međutim, agencija na temelju informacija dostupnih u dokumentaciji nije mogla dovršiti znanstvenu procjenu potencijalnih svojstava pimetrozina u pogledu endokrine disrupcije.
Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
Komisija je pozvala podnositelja zahtjeva da podnese primjedbe o zaključku Agencije i, u skladu s člankom 17. stavkom 1.
Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing pymetrozine.
Uredbe (EU) br. 1141/2010, o nacrtu izvješća o ponovnoj ocjeni.
For plant protection products containing pymetrozine, 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 30 January 2020.
Podnositelj zahtjeva podnio je primjedbe, koje su detaljno pregledane.
Commission Implementing Regulation (EU) 2018/917 extended the expiry date of pymetrozine to 30 June 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance.
Međutim, unatoč argumentima koje je iznio podnositelj zahtjeva, bojazni povezane s tom tvari nisu se mogle ukloniti.
However, given that a decision is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.
Slijedom toga, nije utvrđeno da su ispunjena mjerila za odobravanje iz članka 4.
This Regulation does not prevent the submission of a further application for the approval of pymetrozine pursuant to Article 7 of Regulation (EC) No 1107/2009.
Uredbe (EZ) br. 1107/2009 u odnosu na jednu ili više reprezentativnih uporaba najmanje jednog sredstva za zaštitu bilja.
The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman.
Stoga je primjereno ne produljiti odobrenje za aktivnu tvar pimetrozin u skladu s člankom 20. stavkom 1. točkom (b) te uredbe.
An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation.
Provedbenu uredbu (EU) br. 540/2011 trebalo bi stoga na odgovarajući način izmijeniti.