natgillin/translations-raw huggingface dataset:
amending Implementing Regulation (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605
o izmjeni Provedbene uredbe (EU) br. 844/2012 s obzirom na znanstvene kriterije za određivanje svojstava endokrine disrupcije uvedene Uredbom (EU) 2018/605
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 19 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 19.,
Commission Implementing Regulation (EU) No 844/2012 provides for the implementation of the renewal procedure for active substances as provided for in Regulation (EC) No 1107/2009.
Provedbenom uredbom Komisije (EU) br. 844/2012 propisuje se provedba postupka obnavljanja odobrenja za aktivne tvari, kako je predviđeno Uredbom (EZ) br. 1107/2009.
Commission Regulation (EU) 2018/605 introduced new scientific criteria for the determination of endocrine disrupting properties, which reflect the current state of scientific and technical knowledge.
Uredbom Komisije (EU) 2018/605 uvedeni su novi znanstveni kriteriji za određivanje svojstava endokrine disrupcije, koji odražavaju trenutačna znanstvena i tehnička saznanja.
Those criteria are to apply as of 10 November 2018 to applications for the renewal of the approval of active substances in accordance with Regulation (EC) No 1107/2009, including pending applications.
Ti se kriteriji trebaju primjenjivati od 10. studenoga 2018. na zahtjeve za obnavljanje odobrenja aktivnih tvari u skladu s Uredbom (EZ) br. 1107/2009, uključujući zahtjeve u postupku rješavanja.
Applications for the renewal of the approval of an active substance which are submitted before 10 November 2018 and for which, by that date, the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 has not voted on a draft Regulation concerning the renewal or non-renewal of the approval of that active substance, should be considered pending applications.
Zahtjeve za obnavljanje odobrenja aktivne tvari podnesene prije 10. studenoga 2018. u pogledu kojih do tog dana Odbor iz članka 79. stavka 1.
For such pending applications, it is possible that the information submitted by the applicant does not allow to conclude the assessment as regards whether the scientific criteria for the determination of endocrine disrupting properties set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 are met or not and to conclude whether the approval criteria set out in those points are met or not.
Uredbe (EZ) br. 1107/2009 nije glasao o nacrtu Uredbe o obnavljanju ili neobnavljanju odobrenja te aktivne tvari trebalo bi smatrati zahtjevima u postupku rješavanja.
Therefore, the European Food Safety Authority (‘the Authority’) should be able to request additional information from the applicant in order to conclude whether the approval criteria set out in those points are met or not.
Za takve zahtjeve koji su u postupku rješavanja moguće je da se na temelju informacija koje je dostavio podnositelj zahtjeva ne može zaključiti ocjena o tome jesu li ispunjeni znanstveni kriteriji za određivanje svojstava endokrine disrupcije iz točaka 3.6.5. i 3.8.2.
Such additional information should be submitted within a time period set by the Authority, which should be as short as possible in order to avoid unjustified delays of the renewal procedure, and which should be based on the type of information to be submitted.
Priloga II.
Within the period given to provide the additional information, applicants should also be able to apply for the derogation under Article 4(7) of Regulation (EC) No 1107/2009.
Uredbi (EZ) br. 1107/2009, a ni zaključiti jesu li ispunjeni kriteriji za odobrenje utvrđeni u tim točkama.
Where, based on the information already available, the Authority has been able to conclude that the substance meets the scientific criteria for the determination of endocrine disrupting properties, applicants should be able to submit additional information as regards the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 and/or be able to submit documentary evidence showing that the conditions for the application of the derogation under Article 4(7) of that Regulation are met.
Stoga bi se Europskoj agenciji za sigurnost hrane („Agencija”) trebalo omogućiti da od podnositelja zahtjeva zatraži dodatne informacije kako bi zaključila jesu li ispunjeni kriteriji za odobrenje utvrđeni u tim točkama.
Where the Authority requires such additional information from the applicant, the period foreseen for the preparation of the conclusion by the Authority should be extended in order for that information to be taken into account.
Te dodatne informacije trebalo bi dostaviti u razdoblju koje odredi Agencija, a koje bi trebalo biti što kraće kako bi se izbjegla neopravdana kašnjenja u postupku obnavljanja odobrenja i trebalo bi ovisiti o vrsti informacija koje je potrebno dostaviti.
When requesting additional information from the applicant, the Authority should consider that animal testing is to be minimised and tests on vertebrates are to be undertaken only as a last resort, in accordance with Article 62 of Regulation (EC) No 1107/2009.
U razdoblju određenom za dostavljanje dodatnih informacija podnositeljima zahtjeva trebalo bi omogućiti i da zatraže izuzeće iz članka 4. stavka 7.
Taking into account that the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605 apply as of 10 November 2018, this Regulation should enter into force as soon as possible and apply from 10 November 2018.
Uredbe (EZ) br. 1107/2009.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Ako je na temelju već dostupnih informacija Agencija mogla zaključiti da predmetna tvar ispunjava znanstvene kriterije za određivanje svojstava endokrine disrupcije, podnositeljima zahtjeva trebalo bi omogućiti dostavu dodatnih informacija o kriterijima za odobrenje iz točaka 3.6.5. i 3.8.2.
Article 1
Uredbi (EZ) br. 1107/2009 i/ili dokumentiranih dokaza o ispunjavanju uvjeta za primjenu izuzeća iz članka 4. stavka 7. te uredbe.
Implementing Regulation (EU) No 844/2012 is amended as follows:
Ako Agencija zatraži takve dodatne informacije od podnositelja zahtjeva, razdoblje koje je predviđeno za izradu zaključka Agencije trebalo bi produljiti kako bi se te informacije uzele u obzir.
The following Article is inserted after Article 11:
Pri traženju dodatnih informacija od podnositelja zahtjeva Agencija bi trebala imati na umu da se ispitivanje na životinjama mora svesti na najmanju moguću mjeru, a ispitivanje na kralježnjacima provoditi samo kao krajnja mjera, u skladu s člankom 62.
‘Article 11a
Uredbe (EZ) br. 1107/2009.
For the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605, in relation to applications submitted in accordance with Article 1 before 10 November 2018 for which the draft renewal assessment report has not been submitted by that date, where the information available in the supplementary dossiers is not sufficient for the rapporteur Member State to conclude the assessment on whether these approval criteria are met and, where applicable, whether application of Article 4(7) is justified, the rapporteur Member State shall specify in the draft renewal assessment report, in a detailed way, the additional information which is necessary in order to make the assessment concerned.;
Budući da se znanstveni kriteriji za određivanje svojstava endokrine disrupcije uvedeni Uredbom (EU) 2018/605 primjenjuju od 10. studenoga 2018., ova bi Uredba trebala stupiti na snagu što prije i primjenjivati se od 10. studenoga 2018.
The following paragraph is inserted after Article 13(3):
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
For the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605, in relation to applications submitted in accordance with Article 1 before 10 November 2018, for which the draft renewal assessment report has been submitted but the conclusion by the Authority is not yet adopted by that date, where the information available in the dossier is not sufficient for the Authority to conclude the assessment on whether these approval criteria are met, the Authority shall, in consultation with the Member States, request from the applicant the additional information to be submitted to the rapporteur Member State, the other Member States, the Commission, and the Authority in the form of an updated supplementary dossier including the additional information.
DONIJELA JE OVU UREDBU:
The Authority shall, in consultation with the rapporteur Member State and the applicant, set a period for the submission of that information.
Članak 1.
Such period shall be at least of 3 months, shall not exceed 30 months, and shall be justified in relation to the type of information which has to be submitted.
Provedbena uredba (EU) br. 844/2012 mijenja se kako slijedi:
Within this period set by the Authority, the applicant may also submit where applicable, documentary evidence showing that the conditions for the application of the derogation under Article 4(7) of Regulation (EC) No 1107/2009 are met.
nakon članka 11. dodaje se sljedeći članak:
Where the Authority, in consultation with the Member States, is able to conclude without requesting additional information that the scientific criteria for the determination of endocrine disrupting properties set out in point 3.6.5 and/or point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 are met, it shall inform the applicant.
„Članak 11.a
Within 3 months after being informed by the Authority, the applicant may submit to the rapporteur Member State, the other Member States, the Commission, and the Authority, additional information to address the approval criteria set in point 3.6.5 and/or point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, and/or documentary evidence showing that the conditions for the application of the derogation under Article 4(7) of that Regulation are met.
Za potrebe ocjene kriterija za odobrenje utvrđenih u točkama 3.6.5. i 3.8.2.
Where the first or third subparagraphs apply, the period referred to in paragraph 1 shall be extended by the period set for submission of the additional information.
Priloga II.
Where no additional information is submitted in accordance with the first, second or third subparagraph within the period set for its submission, the Authority shall, without delay, inform the applicant, the rapporteur Member State, the Commission and the other Member States and conclude the assessment based on the available information.
Uredbi (EZ) br. 1107/2009, kako je izmijenjen Uredbom Komisije (EU) 2018/605, kada je riječ o zahtjevima podnesenima u skladu s člankom 1. prije 10. studenoga 2018. za koje do tog dana nije dostavljen nacrt izvješća o ocjeni obnavljanja odobrenja, ako podaci dostupni u dopunskoj dokumentaciji nisu dostatni kako bi država članica izvjestiteljica zaključila ocjenu o tome jesu li ispunjeni ti kriteriji za odobrenje i, prema potrebi, je li opravdana primjena članka 4. stavka 7., država članica izvjestiteljica u nacrtu izvješća o ocjeni obnavljanja odobrenja detaljno navodi dodatne informacije koje su potrebne za donošenje predmetne ocjene.
Where additional information is submitted in accordance with the first, second or third subparagraph within the period set for its submission, the rapporteur Member State shall, within 90 days from the date of receipt of the additional information evaluate the information received and send its evaluation to the Authority in the form of a revised draft renewal assessment report.
nakon članka 13. stavka 3. umeće se sljedeći stavak:
The Authority shall conduct a consultation on the revised draft renewal assessment report with all the Member States and the applicant in accordance with Article 12.
Za potrebe ocjene kriterija za odobrenje utvrđenih u točkama 3.6.5. i 3.8.2.
The Authority shall adopt the conclusion referred to in paragraph 1, within 120 days from the date of receipt of the revised draft renewal assessment report, using the guidance for identification of endocrine disruptors applicable at the date of the submission of the updated supplementary dossier referred to in the first subparagraph.’;
Priloga II.
Paragraph 5 of Article 13 is replaced by the following:
Uredbi (EZ) br. 1107/2009, kako je izmijenjen Uredbom Komisije (EU) 2018/605, kada je riječ o zahtjevima podnesenima u skladu s člankom 1. prije 10. studenoga 2018. za koje je dostavljen nacrt izvješća o ocjeni obnavljanja odobrenja, ali za koje Agencija do tog dana još nije donijela zaključak, ako podaci dostupni u dokumentaciji nisu dostatni kako bi Agencija zaključila ocjenu o tome jesu li ispunjeni ti kriteriji za odobrenje, Agencija će, uz savjetovanje s državama članicama, od podnositelja zahtjeva zatražiti dodatne informacije koje je potrebno dostaviti državi članici izvjestiteljici, drugim državama članicama, Komisiji te Agenciji u obliku ažurirane dopunske dokumentacije koja obuhvaća dodatne informacije.
Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first subparagraph of paragraph 3 or in accordance with the first or third subparagraphs of paragraph 3a of this Article, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.’;
Agencija, uz savjetovanje s državom članicom izvjestiteljicom i podnositeljem zahtjeva, određuje razdoblje za dostavljanje tih informacija.
The following paragraph is inserted after Article 14(1):
To razdoblje nije kraće od 3 mjeseca, ni dulje od 30 mjeseci, a obrazlaže se s obzirom na vrstu informacija koje se moraju dostaviti.
For the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605, in relation to applications for which the conclusion by the Authority is adopted before 10 November 2018, and where the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 has not yet voted on a draft Regulation concerning the renewal or non-renewal of that active substance by that date, the Commission may consider that additional information is necessary to assess whether these approval criteria are met.
U tom razdoblju koje odredi Agencija podnositelj zahtjeva može, prema potrebi, dostaviti i dokumentirane dokaze o ispunjavanju uvjeta za primjenu izuzeća u skladu s člankom 4. stavkom 7.
In such cases, the Commission shall request that the Authority reassesses within a reasonable time period the available information and shall inform the applicant of that request.
Uredbe (EZ) br. 1107/2009.
When requested by the Commission in accordance with the first subparagraph, the Authority may, in consultation with the rapporteur Member State, decide whether additional information is required and request the applicant to submit such information to the rapporteur Member State, the other Member States, the Commission and the Authority in the form of an updated supplementary dossier including the additional information.
Ako Agencija, uz savjetovanje s državama članicama, može bez traženja dodatnih informacija zaključiti da su ispunjeni znanstveni kriteriji za određivanje svojstava endokrine disrupcije iz točaka 3.6.5. i/ili 3.8.2.
Within 3 months after being informed by the Authority, the applicant may submit to the rapporteur Member State, the other Member States, the Commission, and the Authority, additional information to address the approval criteria set out in point 3.6.5 and/or point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, and/or documentary evidence showing that the conditions for the application of the derogation under Article 4(7) of that Regulation are met.
Priloga II.
The rapporteur Member State shall, within 90 days from the date of receipt of the additional information evaluate the information received and send its evaluation to the Authority in the form of a revised draft renewal assessment report.
Uredbi (EZ) br. 1107/2009, ona o tome obavješćuje podnositelja zahtjeva.
The Authority shall conduct a consultation of the revised renewal assessment report with all the Member States and the applicant in accordance with Article 12.
Unutar 3 mjeseca od primitka obavijesti od Agencije podnositelj zahtjeva može državi članici izvjestiteljici, drugim državama članicama, Komisiji i Agenciji dostaviti dodatne informacije koje se odnose na kriterije za odobrenje iz točke 3.6.5. i/ili točke 3.8.2.
The Authority shall adopt an addendum to the conclusion referred to in paragraph 1, within 120 days from the date of receipt of the revised draft renewal assessment report, using the guidance for identification of endocrine disruptors applicable at the date of the submission of the updated supplementary dossier referred to in the second subparagraph.
Priloga II.
Where no additional information is submitted in accordance with the second, the third or the fourth subparagraph within the period set for its submission, the Authority shall, without delay, inform the applicant, the rapporteur Member State, the co-rapporteur Member State, the Commission and the other Member States and conclude the assessment based on the available information within 30 days from the expiry of the period referred to in the second or fourth subparagraph.
Uredbi (EZ) br. 1107/2009 i/ili dokumentirane dokaze o ispunjavanju uvjeta za primjenu izuzeća iz članka 4. stavka 7. te uredbe.
Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the second or fourth subparagraph of this Article, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.’
Ako se primjenjuje prvi ili treći podstavak, razdoblje navedeno u stavku 1. produljuje se za razdoblje određeno za dostavljanje dodatnih informacija.
Article 2
Ako se u razdoblju određenom za dostavljanje dodatnih informacija ne dostave dodatne informacije u skladu s prvim, drugim ili trećim podstavkom, Agencija bez odgađanja o tome obavješćuje podnositelja zahtjeva, državu članicu izvjestiteljicu, Komisiju i druge države članice te zaključuje ocjenu na temelju dostupnih informacija.
The provisions of Implementing Regulation (EU) No 844/2012 inserted by Article 1 of this Regulation shall apply in addition to the other provisions of Implementing Regulation (EU) No 844/2012.
Ako se dodatne informacije dostave u skladu s prvim, drugim ili trećim podstavkom u razdoblju određenom za njihovo dostavljanje, država članica izvjestiteljica unutar 90 dana od datuma primitka dodatnih informacija ocjenjuje primljene informacije i šalje svoju ocjenu Agenciji u obliku revidiranog nacrta izvješća o ocjeni obnavljanja odobrenja.
Article 3
Agencija u skladu s člankom 12. provodi savjetovanje o revidiranom nacrtu izvješća o ocjeni obnavljanja odobrenja sa svim državama članicama i podnositeljem zahtjeva.
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
Zaključak iz stavka 1.
It shall apply from 10 November 2018.
Agencija donosi unutar 120 dana od dana primitka revidiranog nacrta izvješća o ocjeni obnavljanja odobrenja i to koristeći se smjernicama za utvrđivanje endokrinih disruptora koje se primjenjuju na dan dostavljanja ažurirane dopunske dokumentacije iz prvog podstavka.”;
This Regulation shall be binding in its entirety and directly applicable in all Member States.
u članku 13. stavak 5. zamjenjuje se sljedećim:
Done at Brussels, 7 November 2018.
Informacije koje podnositelj zahtjeva dostavi, a koje se od njega nisu zahtijevale, ili koje dostavi nakon isteka razdoblja određenog za njihovo dostavljanje u skladu s prvim podstavkom stavka 3. ili u skladu s prvim ili trećim podstavkom stavka 3.a ovog članka, ne uzimaju se u obzir, osim ako su dostavljene u skladu s člankom 56.
For the Commission
Uredbe (EZ) br. 1107/2009.”;
The President
nakon članka 14. stavka 1. umeće se sljedeći stavak:
OJ L 309, 24.11.2009, p. 1.
Za potrebe ocjene kriterija za odobrenje utvrđenih u točkama 3.6.5. i 3.8.2.
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).
Priloga II.
Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).
Uredbi (EZ) br. 1107/2009, kako je izmijenjen Uredbom Komisije (EU) 2018/605, kada je riječ o zahtjevima u pogledu kojih Agencija donese zaključak prije 10. studenoga 2018. i u pogledu kojih do tog dana Odbor iz članka 79. stavka 1.
Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33)’.
Uredbe (EZ) br. 1107/2009 još nije glasao o nacrtu Uredbe o obnavljanju ili neobnavljanju odobrenja te aktivne tvari, Komisija može smatrati da su potrebne dodatne informacije kako bi ocijenila jesu li ti kriteriji za odobrenje ispunjeni.
imposing special conditions governing the import of certain food of non-animal origin from certain third countries due to the risks of contamination with pesticides residues, amending Regulation (EC) No 669/2009 and repealing Implementing Regulation (EU) No 885/2014
o uvođenju posebnih uvjeta kojima se uređuje uvoz određene hrane neživotinjskoga podrijetla iz određenih trećih zemalja zbog rizika od kontaminiranosti ostacima pesticida, o izmjeni Uredbe (EZ) br. 669/2009 i o stavljanju izvan snage Provedbene uredbe (EU) br. 885/2014
Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, and in particular Article 53(1)(b)(ii) thereof,
uzimajući u obzir Uredbu (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, a posebno njezin članak 53. stavak 1. točku (b) podtočku ii.,
Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, and in particular Article 15(5) thereof,
uzimajući u obzir Uredbu (EZ) br. 882/2004 Europskog parlamenta i Vijeća od 29. travnja 2004. o službenim kontrolama koje se provode radi provjeravanja poštivanja propisa o hrani i hrani za životinje te propisa o zdravlju i dobrobiti životinja, a posebno njezin članak 15. stavak 5.,