natgillin/translations-raw huggingface dataset:
Commission Directive 2006/41/EC included pethoxamid as an active substance in Annex I to Council Directive 91/414/EEC.
Direktivom Komisije 2006/41/EZ petoksamid je uvršten u Prilog I. Direktivi Vijeća 91/414/EEZ kao aktivna tvar.
The approval of the active substance pethoxamid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2019.
Odobrenje aktivne tvari petoksamid, kako je navedena u dijelu A Priloga Provedbenoj uredbi (EU) br. 540/2011, istječe 31. siječnja 2019.
An application for the renewal of the approval of pethoxamid 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 petoksamid 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 31 August 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 31. kolovoza 2016.
On 30 August 2017 the Authority communicated to the Commission its conclusion on whether pethoxamid 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 Commission presented the draft renewal report for pethoxamid to the Standing Committee on Plants, Animals, Food and Feed on 6 October 2017.
Agencija je izvješće o ocjeni produljenja dostavila podnositelju zahtjeva i državama članicama na očitovanje te je primljene primjedbe proslijedila Komisiji.
The applicant was given the opportunity to submit comments on the draft renewal report.
Agencija je osim toga sažetak dodatne dokumentacije učinila dostupnim javnosti.
It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance pethoxamid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
Agencija je 30. kolovoza 2017.
It is therefore appropriate to renew the approval of pethoxamid.
Komisiji dostavila zaključak o tome može li se pretpostaviti da petoksamid ispunjava mjerila za odobravanje iz članka 4.
The risk assessment for the renewal of the approval of pethoxamid is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing pethoxamid may be authorised.
Uredbe (EZ) br. 1107/2009.
It is therefore appropriate to remove the restriction for use only as an herbicide.
Komisija je 6. listopada 2017.
In accordance with Article 14(1) 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 and restrictions.
Stalnom odboru za bilje, životinje, hranu i hranu za životinje dostavila nacrt izvješća o produljenju odobrenja za petoksamid.
Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
Za jednu ili više reprezentativnih uporaba najmanje jednog sredstva za zaštitu bilja koje sadržava aktivnu tvar petoksamid utvrđeno je da su mjerila za odobravanje predviđena člankom 4.
Commission Implementing Regulation (EU) 2018/84 extended the expiry date of pethoxamid to 31 January 2019 in order to allow the renewal process to be completed before the expiry of the approval of that active substance.
Uredbe (EZ) br. 1107/2009 ispunjena.
However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 December 2018.
Stoga je primjereno produljiti odobrenje za petoksamid.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Procjena rizika za produljenje odobrenja aktivne tvari petoksamid temelji se na ograničenom broju reprezentativnih uporaba, no time se ne ograničavaju uporabe za koje se mogu odobriti sredstva za zaštitu bilja koja sadržavaju petoksamid.
The approval of the active substance pethoxamid is renewed as set out in Annex I.
Posebno je primjereno zatražiti dodatne potvrdne informacije.
Amendments to Implementing Regulation (EU) No 540/2011
Provedbenom uredbom Komisije (EU) 2018/84 datum isteka odobrenja za petoksamid produljen je do 31. siječnja 2019. kako bi se postupak produljenja mogao dovrši prije isteka odobrenja te aktivne tvari.
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Međutim, budući da je odluka o produljenju odobrenja donesena prije novog datuma isteka odobrenja, ova Uredba trebala bi se primjenjivati od 1. prosinca 2018.
It shall apply from 1 December 2018.
Produljenje odobrenja aktivne tvari
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Odobrenje aktivne tvari petoksamid produljuje se kako je utvrđeno u Prilogu I.
Commission Directive 2006/41/EC of 7 July 2006 amending Council Directive 91/414/EEC to include clothianidin and pethoxamid as active substances (OJ L 187, 8.7.2006, p. 24).
Stupanje na snagu i datum primjene
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).
Primjenjuje se od 1. prosinca 2018.
EFSA Journal 2017;15(9):4981 [22 pp.]
Sastavljeno u Bruxellesu 20. rujna 2018.
Commission Implementing Regulation (EU) 2018/84 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide (OJ L 16, 20.1.2018, p. 8).
Predsjednik
ANNEX I
SL L 309, 24.11.2009., str. 1.
Common Name, Identification Numbers
Direktiva Komisije 2006/41/EZ od 7. srpnja 2006. o izmjeni Direktive Vijeća 91/414/EEZ radi uvrštenja klotianidina i petoksamida kao aktivnih tvari (SL L 187, 8.7.2006., str. 24.).
IUPAC Name
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.)
Purity
Provedbena uredba Komisije (EU) br. 540/2011 od 25. svibnja 2011. o provedbi Uredbe (EZ) br. 1107/2009 Europskog parlamenta i Vijeća u pogledu popisa odobrenih aktivnih tvari (SL L 153, 11.6.2011., str. 1.).
Date of approval
Provedbena uredba Komisije (EU) br. 844/2012 od 18. rujna 2012. o određivanju odredaba potrebnih za provedbu postupka obnavljanja odobrenja za aktivne tvari, kako je predviđeno Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja (SL L 252, 19.9.2012., str. 26.).
Expiration of approval
EFSA Journal 2017.;15(9):4981, [22 str.].
Pethoxamid
Provedbena uredba Komisije (EU) 2018/84 оd 19. siječnja 2018. o izmjeni Provedbene uredbe (EU) br. 540/2011 u pogledu produljenja roka valjanosti odobrenja aktivnih tvari klorpirifos, klorpirifos-metil, klotianidin, spojevi bakra, dimoksistrobin, mankozeb, mekoprop-p, metiram, oksamil, petoksamid, propikonazol, propineb, propizamid, piraklostrobin i zoksamid (SL L 16, 20.1.2018., str. 8.).
CAS No 106700-29-2
PRILOG I.
CIPAC No 665
Uobičajeni naziv, identifikacijski brojevi
2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide
Kemijski naziv prema IUPAC-u
Impurities:
Čistoća
Toluene: max 3 g/kg.
Datum odobrenja
1 December 2018
Istek odobrenja
30 November 2033
Posebne odredbe
PART A
Petoksamid
Use shall be limited to one application every two years in the same field at a maximum dose of 1200 g active substance per hectare.
CAS br.
PART B
106700-29-2
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pethoxamid, and in particular Appendices I and II thereto, shall be taken into account.
CIPAC br.
In their overall assessment Member States shall pay particular attention to:
665
the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions;
2-kloro-N-(2-etoksietil)-N-(2-metil-1-fenilprop-1-enil)acetamid
the risk to aquatic organisms and earthworms;
Nečistoće:
the risk to consumers from residues in the succeeding crops or in case of crop failure.
Toluen: najviše 3 g/kg.
Conditions of use shall include risk mitigation measures, where appropriate.
1. prosinca 2018.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:
30. studenoga 2033.
the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council, in particular as carcinogen category 2;
DIO A
the effect of water treatment processes on the nature of residues present in drinking water;
Aktivna tvar na istoj se površini smije upotrebljavati jedanput svake dvije godine, uz najveću dopuštenu dozu od 1200 g aktivne tvari po hektaru.
the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action.
DIO B.
The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested.
Za provedbu jedinstvenih načela iz članka 29. stavka 6.
The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
Uredbe (EZ) br. 1107/2009 moraju se uzeti u obzir zaključci izvješća o produljenju za petoksamid, a posebno njegovi dodaci I. i II.
The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.
U svojoj ukupnoj ocjeni države članice moraju obratiti posebnu pozornost na sljedeće:
Further details on identity and specification of active substance are provided in the renewal report.
rizik od metabolita u podzemnim vodama ako se petoksamid primjenjuje u područjima s osjetljivim tlom i/ili nepovoljnim klimatskim uvjetima;
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.
rizik za vodene organizme i gujavice;
1).
rizik za potrošače od ostataka u kulturama u plodoredu ili u slučaju propadanja usjeva.
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.
Uvjeti uporabe prema potrebi uključuju mjere za smanjenje rizika.
33).
Podnositelj zahtjeva mora Komisiji, državama članicama i Agenciji dostaviti potvrdne informacije o sljedećem:
ANNEX II
relevantnosti metabolita koji mogu biti prisutni u podzemnim vodama, uzimajući u obzir relevantno razvrstavanje petoksamida u skladu s Uredbom (EZ) br.
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
1272/2008 Europskog parlamenta i Vijeća, osobito kao karcinogene tvari kategorije 2.;
in Part A, entry 122 on pethoxamid is deleted;
učinku postupaka pročišćavanja vode na vrstu ostataka prisutnih u vodi za piće;
in Part B, the following entry is added:
potencijalu petoksamida kao endokrinog disruptora rada štitnjače i dostaviti barem podatke o mehanizmu djelovanja kako bi se razjasnilo postoji li endokrino disruptivno djelovanje na rad štitnjače.
approving the active substance fenpicoxamid 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 odobravanju aktivne tvari fenpikoksamid u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja te 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 13(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 13. stavak 2.,
In accordance with Article 7(1) of Regulation (EC) No 1107/2009 the United Kingdom received on 2 December 2014 an application from Dow AgroScience GmbH for the approval of the active substance fenpicoxamid.
U skladu s člankom 7. stavkom 1.
In accordance with Article 9(3) of that Regulation, the United Kingdom, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 13 January 2015 of the admissibility of the application.
Uredbe (EZ) br. 1107/2009 Ujedinjena Kraljevina je 2. prosinca 2014. od trgovačkog društva Dow AgroScience GmbH primila zahtjev za odobrenje aktivne tvari fenpikoksamid.
On 13 October 2016 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
U skladu s člankom 9. stavkom 3. te uredbe Ujedinjena Kraljevina je kao država članica izvjestiteljica 13. siječnja 2015. obavijestila podnositelja zahtjeva, ostale države članice, Komisiju i Europsku agenciju za sigurnost hrane („Agencija”) o prihvatljivosti zahtjeva.
The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009.
Država članica izvjestiteljica dostavila je 13. listopada 2016. nacrt izvještaja o procjeni Komisiji, pri čemu je primjerak poslala Agenciji, u kojem ocjenjuje može li se očekivati da ta aktivna tvar ispunjava mjerila za odobravanje iz članka 4.
The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 31 July 2017.
Agencija je postupila u skladu s člankom 12. stavkom 1.
On 22 December 2017 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance fenpicoxamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
Uredbe (EZ) br. 1107/2009.
On 23 March 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for fenpicoxamid and a draft Regulation providing that fenpicoxamid is approved.
Uredbe (EZ) br. 1107/2009 zatražila je da podnositelj zahtjeva državama članicama, Komisiji i Agenciji dostavi dodatne informacije.
It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
Država članica izvjestiteljica dostavila je Agenciji ocjenu dodatnih informacija 31. srpnja 2017. u obliku ažuriranog nacrta izvješća o ocjeni.
It is therefore appropriate to approve fenpicoxamid.
Agencija je 22. prosinca 2017. podnositelju zahtjeva, državama članicama i Komisiji dostavila svoj zaključak o tome može li se za aktivnu tvar fenpikoksamid očekivati da ispunjava mjerila za odobravanje iz članka 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 and restrictions.
Uredbe (EZ) br. 1107/2009.
In particular, it is appropriate to require further confirmatory information.
Agencija je svoj zaključak stavila na raspolaganje javnosti.
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 should be amended accordingly.
Komisija je 23. ožujka 2018.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Stalnom odboru za bilje, životinje, hranu i hranu za životinje predstavila izvješće o pregledu za fenpikoksamid i nacrt uredbe kojom se predviđa odobrenje fenpikoksamida.
HAS ADOPTED THIS REGULATION:
Za jednu ili više reprezentativnih uporaba najmanje jednog sredstva za zaštitu bilja koje sadržava tu aktivnu tvar, a posebno u pogledu uporaba koje su ispitane i navedene u izvješću o pregledu, utvrđeno je da su mjerila za odobravanje iz članka 4.
Article 1
Uredbe (EZ) br. 1107/2009 ispunjena.
Approval of active substance
Stoga je primjereno odobriti fenpikoksamid.
The active substance fenpicoxamid, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
U skladu s člankom 13. stavkom 2.
Article 2
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 i ograničenja.
Amendment to Implementing Regulation (EU) No 540/2011
Posebno je primjereno zatražiti dodatne potvrdne informacije.
Article 3
Uredbe (EZ) br. 1107/2009 trebalo bi na odgovarajući način izmijeniti Prilog Provedbenoj uredbi Komisije (EU) br. 540/2011.
Done at Brussels, 20 September 2018.
Odobrenje aktivne tvari
For the Commission
Aktivna tvar fenpikoksamid, kako je navedena u Prilogu I., odobrava se u skladu s uvjetima utvrđenima u tom prilogu.
OJ L 309, 24.11.2009, p. 1.
Izmjena Provedbene uredbe (EU) br. 540/2011
Conclusion on the peer review of the pesticide risk assessment of the active substance fenpicoxamid (XDE-777).
Članak 3.
EFSA Journal 2018;16(1):5146, 27 pp. https://doi.org/10.2903/j.efsa.2018.5146.
Stupanje na snagu
Common Name, Identification Numbers
Sastavljeno u Bruxellesu 20. rujna 2018.
Expiration of approval
EFSA Journal 2018.;16(1):5146, 27 str. https://doi.org/10.2903/j.efsa.2018.5146.
Fenpicoxamid
PRILOG I.
CAS No: 517875-34-2
Uobičajeni naziv, identifikacijski brojevi
CIPAC No: 991
Kemijski naziv prema IUPAC-u
(3S,6S,7R,8R)-8-benzyl-3-3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate
Čistoća
11 October 2018
Datum odobrenja
11 October 2028
Prestanak odobrenja
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpicoxamid, and in particular Appendices I and II thereto, shall be taken into account.
Posebne odredbe
In this overall assessment Member States shall pay particular attention to:
Fenpikoksamid
the impact of processing on the consumer risk assessment,
CAS br.: 517875-34-2
the risk to aquatic organisms.
CIPAC br.: 991
Conditions of use shall include risk mitigation measures, where appropriate.
(3S,6S,7R,8R)-8-benzil-3-3-[(izobutiriloksi)metoksi]-4-metoksipiridin-2-karboksamido-6-metil-4,9-diokso-1,5-dioksonan-7-il izobutirat
The applicant shall submit confirmatory information as regards:
11. listopada 2018.
the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;
11. listopada 2028.
the effect of water treatment processes on the nature of residues present in drinking water;
Za provedbu jedinstvenih načela iz članka 29. stavka 6.
the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605, whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action.
Uredbe (EZ) br. 1107/2009 moraju se uzeti u obzir zaključci izvješća o pregledu za fenpikoksamid, a posebno njegovi dodaci I. i II.
The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.
U toj ukupnoj ocjeni države članice moraju obratiti posebnu pozornost na sljedeće:
Further details on identity and specification of active substance are provided in the review report.
utjecaj prerade na procjenu rizika za potrošače,
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).
rizik za vodene organizme.
ANNEX II
Uvjeti uporabe prema potrebi uključuju mjere za smanjenje rizika.
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Podnositelj zahtjeva mora dostaviti potvrdne informacije o sljedećem:
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpicoxamid, and in particular Appendices I and II thereto, shall be taken into account.
tehnička specifikacija aktivne tvari kako se proizvodi (na temelju komercijalne razine proizvodnje) i sukladnost serija toksičnosti s potvrđenom tehničkom specifikacijom;
The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.’
učinak postupaka pročišćavanja vode na vrstu ostataka prisutnih u vodi za piće;
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.
potencijalna endokrina štetnost fenpikoksamida za rad štitnjače, uz posebno pružanje podataka o mehanizmu djelovanja kojima se pojašnjava, u skladu s točkama 3.6.5. i 3.8.2.
(OJ L 101, 20.4.2018, p. 33).
Priloga II.
Jean-Claude Juncker
1107/2009, kako je izmijenjena Uredbom Komisije (EU) 2018/605, jesu li učinci opaženi u studijama koje su podnesene na odobrenje povezani s endokrinom disrupcijom štitnjače.