natgillin/translations-raw huggingface dataset:
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Stupanje na snagu
Opinion proposing harmonised classification and labelling at EU level of Quinolin-8-ol; 8-hydroxyquinoline.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Available online: www.echa.europa.eu.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ L 67, 12.3.2015, p. 18).
Sastavljeno u Bruxellesu 13. studenoga 2017.
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.
Za Komisiju
Available online: www.efsa.europa.eu/efsajournal.htm
SL L 309, 24.11.2009., str. 1.
concerning the approval of mustard seeds powder as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobravanju praha sjemenki gorušice kao osnovne tvari u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja te o izmjeni Priloga Provedbenoj uredbi Komisije (EU) br. 540/2011
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 [1], and in particular Article 23(5) in conjunction with 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 [1], a posebno njezin članak 23. stavak 5. u vezi s člankom 13. stavkom 2.,
In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 6 June 2016 an application from the Institut Technique de l'Agriculture Biologique (ITAB) (France) for the approval of mustard seeds powder as a basic substance.
U skladu s člankom 23. stavkom 3.
That application was accompanied by the information required by the second subparagraph of Article 23(3) of Regulation (EC) 1107/2009.
Uredbe (EZ) br. 1107/2009 Komisija je 6. lipnja 2016. primila zahtjev od subjekta Institut Technique de l'Agriculture Biologique (ITAB) (Francuska) za odobrenje praha sjemenki gorušice kao osnovne tvari.
The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance.
Uz navedeni zahtjev priložene su tražene informacije iz članka 23. stavka 3. drugog podstavka Uredbe (EZ) br. 1107/2009.
The Authority presented to the Commission a Technical Report on the mustard seeds powder on 20 January 2017 [2].
Komisija je od Europske agencije za sigurnost hrane (dalje u tekstu: „Agencija”) zatražila znanstvenu pomoć.
The Commission presented the draft review report [3] and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 20 July 2017 and finalised them for the meeting of that Committee on 6 October 2017.
Agencija je 20. siječnja 2017.
The documentation provided by the applicant shows that mustard seeds powder fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [4].
Komisiji dostavila tehničko izvješće o prahu sjemenki gorušice [2].
Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water.
Komisija je 20. srpnja 2017.
Consequently, it is to be considered as a basic substance.
Stalnom odboru za bilje, životinje, hranu i hranu za životinje dostavila nacrt izvješća o pregledu [3] i nacrt ove Uredbe te pripremila njihove završne verzije za sastanak tog odbora održan 6. listopada 2017.
It has appeared from the examinations made that mustard seeds powder may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report.
Dokumentacija koju je dostavio podnositelj zahtjeva pokazuje da prah sjemenki gorušice ispunjava kriterije za hranu iz članka 2.
It is therefore appropriate to approve mustard seeds powder as a basic substance.
Uredbe (EZ) br. 178/2002 Europskog parlamenta i Vijeća [4].
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Provedena ispitivanja pokazala su da se za prah sjemenki gorušice može očekivati da načelno ispunjava zahtjeve utvrđene člankom 23.
Article 1
Stoga je primjereno odobriti prah sjemenki gorušice kao osnovnu tvar.
The substance mustard seeds powder is approved as a basic substance as laid down in Annex I.
Uredbe (EZ) br. 1107/2009 u vezi s njezinim člankom 6. te s obzirom na postojeća znanstvena i tehnička saznanja, potrebno je, međutim, utvrditi određene uvjete i ograničenja.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Tvar prah sjemenki gorušice, kako je navedena u Prilogu I., odobrava se kao osnovna tvar.
Done at Brussels, 13 November 2017.
Članak 2.
Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for mustard seeds powder from Sinapis alba (Brassica alba), Brassica juncea and Brassica nigra for use in plant protection as fungicide.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
EFSA supporting publication 2017:EN-1169.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN.
Za Komisiju
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 (OJ L 31, 1.2.2002, p. 1).
Predsjednik
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).
SL L 309, 24.11.2009., str. 1.
ANNEX I
EFSA, povezana publikacija 2017:EN-1169.
Common Name, Identification Numbers
35 str. doi:10.2903/sp.efsa.2017.
IUPAC Name
Uredba (EZ) br. 178/2002 Europskog parlamenta i Vijeća od 28. siječnja 2002. o utvrđivanju općih načela i uvjeta zakona o hrani, osnivanju Europske agencije za sigurnost hrane te utvrđivanju postupaka u područjima sigurnosti hrane (SL L 31, 1.2.2002., str. 1.).
Date of approval
PRILOG I.
Mustard seeds powder
Kemijski naziv prema IUPAC-u
Not applicable
Čistoća [1]
Food grade
Datum odobrenja
4 December 2017
Posebne odredbe
Mustard seeds powder shall be used in accordance with the specific conditions included in the conclusions of the review report on mustard seeds powder (SANTE/11309/2017) and in particular Appendices I and II thereof.
Prah sjemenki gorušice
Further details on identity, specification and manner of use of basic substance are provided in the review report.
Nije primjenjivo
ANNEX II
Prehrambena kvaliteta
In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
4. prosinca 2017.
Number
Prah sjemenki gorušice mora se upotrebljavati u skladu s posebnim uvjetima navedenima u zaključcima izvješća o pregledu za prah sjemenki gorušice (SANTE/11309/2017), a posebno njegovim dodacima I. i II.
Jean-Claude Juncker
U dijelu C Priloga Provedbenoj uredbi (EU) br. 540/2011 dodaje se sljedeći unos:
concerning the non-approval of paprika extract (capsanthin, capsorubin E 160 c) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
o neodobrenju ekstrakta paprike (kapsantin, kapsorubin E 160 c) kao osnovne tvari u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja
In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 19 June 2015 an application from Group Peyraud Nature for the approval of Capsicum spp. spice as a basic substance.
U skladu s člankom 23. stavkom 3.
That application was accompanied by the information required under the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.
Uredbe (EZ) br. 1107/2009 Komisija je 19. lipnja 2015. primila zahtjev od subjekta Group Peyraud Nature za odobrenje začina Capsicum spp. kao osnovne tvari.
The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance.
Uz navedeni zahtjev priložene su tražene informacije iz članka 23. stavka 3. drugog podstavka Uredbe (EZ) br. 1107/2009.
The Authority provided the Commission with a Technical Report on the substance concerned on 10 October 2016 [2].
Komisija je od Europske agencije za sigurnost hrane („Agencija”) zatražila znanstvenu pomoć.
The Commission presented the review report [3] and the draft of this Regulation on the non-approval of paprika extract (capsanthin, capsorubin E 160 c) to the Standing Committee on Plants, Animals, Food and Feed on 24 January 2017 and finalised them for the meeting of that Committee on 6 October 2017.
Agencija je 10. listopada 2016.
During the consultation organised by the Authority, the applicant agreed to modify the basic substance name to paprika extract (capsanthin, capsorubin E 160 c).
Komisiji dostavila tehničko izvješće o predmetnoj tvari [2].
The documentation provided by the applicant shows that paprika extract (capsanthin, capsorubin E 160 c) fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [4] and is not predominantly used for plant protection pruposes.
Komisija je Stalnom odboru za bilje, životinje, hranu i hranu za životinje 24. siječnja 2017. dostavila izvješće o pregledu [3] i nacrt ove Uredbe o neodobrenju ekstrakta paprike (kapsantin, kapsorubin E 160 c) te pripremila njihove završne verzije za sastanak tog odbora održan 6. listopada 2017.
Specific concerns were identified, in the Technical Report of the Authority, regarding exposure to its component capsaicin and the non-availability of exposure estimates for paprika extract (capsanthin, capsorubin E 160 c), specifically through pesticide use and, as a result, the assessment of the risk to operators, workers, bystanders and non-target organisms could not be finalised.
Tijekom savjetovanja koje je organizirala Agencija, podnositelj zahtjeva pristao je izmijeniti naziv osnovne tvari u ekstrakt paprike (kapsantin, kapsorubin E 160 c).
The Commission invited the applicant to submit its comments on the draft review report.
Dokumentacija koju je dostavio podnositelj zahtjeva pokazuje da ekstrakt paprike (kapsantin, kapsorubin E 160 c) ispunjava kriterije za hranu iz članka 2.
The applicant submitted its comments, which have been carefully examined.
Uredbe (EZ) br. 178/2002 Europskog parlamenta i Vijeća [4] i ne upotrebljava se pretežito u sredstvima za zaštitu bilja.
However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.
U tehničkom izvješću Agencije navedene su određene bojazni u pogledu izlaganja sastojku kapsaicinu i nedostatka procjena izlaganja za ekstrakt paprike (kapsantin, kapsorubin E 160 c), posebno pri uporabi kao pesticid, te, kao posljedica toga, procjena rizika za gospodarske subjekte, radnike, druge prisutne osobe i neciljne organizme nije mogla biti dovršena.
Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied.
Komisija je pozvala podnositelja zahtjeva da dostavi primjedbe o nacrtu izvješća o pregledu.
It is therefore appropriate not to approve paprika extract (capsanthin, capsorubin E 160 c) as a basic substance.
Podnositelj zahtjeva podnio je primjedbe, koje su detaljno pregledane.
This Regulation does not prejudice the submission of a further application for the approval of paprika extract (capsanthin, capsorubin E 160 c) as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.
Međutim, unatoč argumentima koje je iznio podnositelj zahtjeva, bojazni u pogledu tvari ne mogu se ukloniti.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Stoga, kako je navedeno u Komisijinu izvješću o pregledu, nije utvrđeno da su zahtjevi iz članka 23.
HAS ADOPTED THIS REGULATION:
Uredbe (EZ) br. 1107/2009 ispunjeni.
Article 1
Stoga je primjereno ne odobriti ekstrakt paprike (kapsantin, kapsorubin E 160 c) kao osnovnu tvar.
The substance paprika extract (capsanthin, capsorubin E 160 c) is not approved as a basic substance.
Ovom se Uredbom ne dovodi u pitanje ponovno podnošenje zahtjeva za odobrenje ekstrakta paprike (kapsantin, kapsorubin E 160 c) kao osnovne tvari u skladu s člankom 23. stavkom 3.
Done at Brussels, 13 November 2017.
Članak 1.
For the Commission
Tvar ekstrakt paprike (kapsantin, kapsorubin E 160 c) ne odobrava se kao osnovna tvar.
Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for paprika extract, capsanthin, capsorubin E 160 c (admissibility accepted when named Capsicum spp. spice) for use in plant protection as repellent various invertebrates, mammals and birds.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
EFSA supporting publication 2016:EN-1096.
Sastavljeno u Bruxellesu 13. studenoga 2017.
54 pp.
Za Komisiju
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN
Predsjednik
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 (OJ L 31, 1.2.2002, p. 1).
SL L 309, 24.11.2009., str. 1.
concerning the non-approval of potassium sorbate as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
o neodobrenju kalijeva sorbata kao osnovne tvari u skladu s Uredbom (EZ) br. 1107/2009 Europskog parlamenta i Vijeća o stavljanju na tržište sredstava za zaštitu bilja
In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 9 October 2015 an application from Decco Iberica Post Cosecha S.A.U for the approval of potassium sorbate as a basic substance.
U skladu s člankom 23. stavkom 3.
On 14 July 2016 the Commission received an updated application.
Uredbe (EZ) br. 1107/2009 Komisija je 9. listopada 2015. primila zahtjev od subjekta Decco Iberica Post Cosecha S.A.U za odobrenje kalijeva sorbata kao osnovne tvari.
That application was accompanied by the information required under the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.
Komisija je 14. srpnja 2016. primila ažurirani zahtjev.
The Authority provided the Commission with a Technical Report on potassium sorbate on 12 May 2017 [2].
1107/2009.
The Commission presented the review report [3] and the draft of this Regulation on the non-approval of potassium sorbate to the Standing Committee on Plants, Animals, Food and Feed on 20 July 2017 and finalised them for the meeting of that Committee on 6 October 2017.
Komisija je od Europske agencije za sigurnost hrane („Agencija”) zatražila znanstvenu pomoć.
The documentation provided by the applicant shows that potassium sorbate fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [4].
Agencija je 12. svibnja 2017.
Specific concerns however were identified, in the Technical Report of the Authority, regarding exposure to potassium sorbate specifically through residues of pesticide use.
Komisiji dostavila tehničko izvješće o kalijevu sorbatu [2].
The Authority concluded that the information on residues was very limited and, as a result, it could not conduct a reliable consumer risk assessment.
Komisija je Stalnom odboru za bilje, životinje, hranu i hranu za životinje 20. srpnja 2017. dostavila izvješće o pregledu [3] i nacrt ove Uredbe o neodobrenju kalijeva sorbata te pripremila njihove završne verzije za sastanak tog odbora održan 6. listopada 2017.
An exceedance of the temporary Acceptable Daily Intake of potassium sorbate due to the additional consumer exposure to residues from pesticide use of potassium sorbate cannot be excluded.
Dokumentacija koju je dostavio podnositelj zahtjeva pokazuje da kalijev sorbat ispunjava kriterije za hranu iz članka 2.
The applicant submitted no comments.
Međutim u tehničkom izvješću Agencije navedene su određene bojazni u pogledu izlaganja kalijevu sorbatu, posebno putem ostataka pri uporabi kao pesticid.
Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied.
Agencija je zaključila da su podaci o ostacima bili vrlo ograničeni te stoga nije mogla provesti pouzdanu procjenu rizika za potrošače.
It is therefore appropriate not to approve potassium sorbate as basic substance.
Ne može se isključiti premašivanje privremenog prihvatljivog dnevnog unosa kalijeva sorbata zbog dodatnog izlaganja potrošača ostacima iz uporabe kalijeva sorbata kao pesticid.
This Regulation does not prejudice the submission of a further application for the approval of potassium sorbate as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.
Komisija je pozvala podnositelja zahtjeva da podnese svoje primjedbe o tehničkom izvješću Agencije i o nacrtu izvješća o pregledu.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Podnositelj zahtjeva nije dostavio nikakve primjedbe.
The substance potassium sorbate is not approved as basic substance.
Stoga je primjereno ne odobriti kalijev sorbat kao osnovnu tvar.
Article 2
Ovom se Uredbom ne dovodi u pitanje ponovno podnošenje zahtjeva za odobrenje kalijeva sorbata kao osnovne tvari u skladu s člankom 23. stavkom 3.
Done at Brussels, 13 November 2017.
DONIJELA JE OVU UREDBU:
The President
Tvar kalijev sorbat ne odobrava se kao osnovna tvar.
Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for potassium sorbate for use in plant protection as fungicide on citrus, stone and pome fruits.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN
Za Komisiju
EFSA (European Food Safety Authority), 2017.
SL L 309, 24.11.2009., str. 1.
Jean-Claude Juncker
Uredba (EZ) br. 178/2002 Europskog parlamenta i Vijeća od 28. siječnja 2002. o utvrđivanju općih načela i uvjeta zakona o hrani, osnivanju Europske agencije za sigurnost hrane te utvrđivanju postupaka u područjima sigurnosti hrane (SL L 31, 1.2.2002., str. 1.).
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances flonicamid (IKI-220), metalaxyl, penoxsulam and proquinazid
o izmjeni Provedbene uredbe (EU) br. 540/2011 u pogledu produljenja roka valjanosti odobrenja aktivnih tvari flonikamid (IKI-220), metalaksil, penoksulam i prokinazid
Applications for the renewal of the approval of the active substances included in this Regulation were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 [3].
Zahtjevi za obnavljanje odobrenja aktivnih tvari obuhvaćenih ovom Uredbom podneseni su u skladu s Provedbenom uredbom Komisije (EU) br. 844/2012 [3].
In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals of the large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C(2016)6104 [4] established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.
Uredbe (EZ) br. 1107/2009.
As the active substances included in this Regulation do not fall in the prioritised categories of Implementing Decision C(2016)6104, the approval period should be extended by either two or three years, taking into account the current date of expiry, the fact that in accordance with Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance is to be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making.
S obzirom na vrijeme i sredstva potrebna za dovršenje procjene zahtjevâ za produljenje odobrenja velikog broja aktivnih tvari za koje odobrenja istječu između 2019. i 2021., Provedbenom odlukom Komisije C(2016)6104 [4] utvrđen je program rada u kojemu se grupiraju slične aktivne tvari i određuju prioriteti na temelju pitanjâ sigurnosti za zdravlje ljudi i životinja ili za okoliš, kako je predviđeno člankom 18.
It is therefore appropriate to extend the approval period for active substance proquinazid by two years, and to extend the approval periods of the active substances flonicamid (IKI-220), metalaxyl and penoxsulam by three years.
Uredbe (EZ) br. 1107/2009.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.
Budući da aktivne tvari iz ove Uredbe nisu obuhvaćene prioritetnim kategorijama u Provedbenoj odluci C(2016)6104, rok valjanosti odobrenja trebalo bi produljiti za dvije ili tri godine, uzimajući u obzir postojeći datum prestanka odobrenja, činjenicu da u skladu s člankom 6. stavkom 3.