natgillin/translations-raw huggingface dataset:
According to that opinion, coumatetralyl meets the criteria in Regulation (EC) No 1272/2008 of the European Parliament and of the Council [3] to be classified as toxic for reproduction category 1B.
Agenciji je dostavilo preporuku o produljenju odobrenja kumatetralila.
Coumatetralyl therefore meets the exclusion criterion set out in Article 5(1)(c) of Regulation (EU) No 528/2012.
Mišljenje Agencije sastavio je njezin Odbor za biocidne proizvode [2] 16. lipnja 2016. uzimajući u obzir zaključke nadležnog ocjenjivačkog tijela.
In addition, the use of products containing coumatetralyl raises concerns in relation to instances of primary and secondary poisoning, even where restrictive risk management measures are applied and therefore coumatetralyl also satisfies the criterion to be a candidate for substitution in accordance with Article 10(1)(e) of Regulation (EU) No 528/2012.
U tom je mišljenju utvrđeno da kumatetralil ispunjuje kriterije iz Uredbe (EZ) br. 1272/2008 Europskog parlamenta i Vijeća [3] za razvrstavanje kao reproduktivno toksična tvar kategorije 1.B.
Pursuant to Article 12 of Regulation (EU) No 528/2012, the approval of active substances meeting the exclusion criteria may only be renewed when at least one of the conditions for derogation set out in Article 5(2) of that Regulation continues to be satisfied.
Kumatetralil stoga ispunjuje kriterij za isključivanje iz članka 5. stavka 1. točke (c) Uredbe (EU) br. 528/2012.
In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency organised a public consultation in order to collect relevant information on coumatetralyl, including information on available substitutes.
Osim toga, uporaba proizvoda koji sadržavaju kumatetralil izaziva zabrinutost u pogledu primarnog i sekundarnog trovanja, čak i ako se primjenjuju restriktivne mjere upravljanja rizikom, te stoga kumatetralil ispunjuje i kriterij za potencijalne tvari za zamjenu u skladu s člankom 10. stavkom 1. točkom (e) Uredbe (EU) br. 528/2012.
Rodents can carry pathogens that are responsible for many zoonoses, which can pose serious dangers for human or animal health.
Uredbe (EU) br. 528/2012 Agencija je organizirala javno savjetovanje radi prikupljanja relevantnih informacija o kumatetralilu, uključujući informacije o dostupnim zamjenama.
As effective rodent control cannot rely on those non-chemical controls or prevention methods only, coumatetralyl is considered essential to ensure appropriate rodent control in support of those alternatives.
Komisija je objavila doprinose prikupljene u okviru tog savjetovanja.
As a consequence the use of coumatetralyl would be to prevent or control a serious danger to human and animal health in which rodents are involved.
U okviru Stalnog odbora za biocidne proizvode s državama članicama raspravljalo se o doprinosima prikupljenima u okviru tih javnih savjetovanja i informacijama o dostupnosti alternativnih tvari za antikoagulantne rodenticide navedenih u Prilogu 1.
Therefore, the condition set out in Article 5(2)(b) of Regulation (EU) No 528/2012 is satisfied.
Izvješću Komisije o mjerama za smanjenje rizika za antikoagulantne rodenticide [4].
On the other hand, the risks to human health, animal health or the environment arising from use of products containing coumatetralyl can be mitigated if they are used according to certain specifications and conditions.
Alternativne aktivne tvari odobrene za uporabu kao rodenticidi možda nisu prikladne za sve kategorije korisnika odnosno učinkovite za sve vrste glodavaca.
Therefore, the non-approval of coumatetralyl as an active substance would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance.
Budući da se djelotvorna kontrola glodavaca ne može svesti samo na nekemijske metode kontrole ili prevencije, smatra se da je uz te alternativne metode kumatetralil neophodan za osiguravanje prikladne kontrole glodavaca.
The condition set out in Article 5(2)(c) of Regulation (EU) No 528/2012 is thus also satisfied.
Zbog toga bi se kumatetralil upotrebljavao za sprečavanje ili kontrolu ozbiljne opasnosti za zdravlje ljudi i životinja koju uzrokuju glodavci.
It is therefore appropriate to renew the approval of coumatetralyl for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.
Stoga je uvjet iz članka 5. stavka 2. točke (b) Uredbe (EU) br. 528/2012 ispunjen.
Coumatetralyl is a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012 and therefore the period of renewal set out in Article 10(4) of that Regulation should apply.
Za kontrolu glodavaca trenutačno se u velikoj mjeri upotrebljavaju antikoagulantni rodenticidi i njihovo neodobrenje moglo bi uzrokovati nedovoljnu kontrolu glodavaca.
As the examination of the applications for the renewal of the approval of bromadiolone, chlorophacinone and coumatetralyl for use in biocidal products of product-type 14 is now finalised, Commission Implementing Decision (EU) 2015/1737 [5] is repealed by Implementing Regulation (EU) 2017/1377 [6].
To bi moglo imati ozbiljne negativne posljedice za zdravlje ljudi i životinja te za okoliš, a moglo bi utjecati i na percepciju javnosti u pogledu sigurnosti ljudi kad je riječ o izloženosti glodavcima te u pogledu sigurnosti niza gospodarskih aktivnosti kojima bi glodavci mogli štetiti, što bi moglo dovesti do gospodarskih i društvenih posljedica.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
S druge strane, rizici za zdravlje ljudi i životinja te za okoliš koji su posljedica uporabe proizvoda koji sadržavaju kumatetralil mogu se ublažiti ako se ti proizvodi upotrebljavaju u skladu s određenim specifikacijama i uvjetima.
HAS ADOPTED THIS REGULATION:
Zbog toga bi neodobrenje kumatetralila kao aktivne tvari imalo nerazmjeran negativan učinak na društvo u odnosu na rizike koji su posljedica uporabe te tvari.
Article 1
Stoga je i uvjet iz članka 5. stavka 2. točke (c) Uredbe (EU) br. 528/2012 ispunjen.
The approval of coumatetralyl as an active substance for use in biocidal products of product-type 14 is renewed, subject to the specifications and conditions set out in the Annex.
Stoga je primjereno produljiti odobrenje kumatetralila za uporabu u biocidnim proizvodima vrste 14, podložno određenim specifikacijama i uvjetima.
Article 2
Kumatetralil je potencijalna tvar za zamjenu u skladu s člankom 10. stavkom 1. točkama (a) i (e) Uredbe (EU) br. 528/2012 te bi se stoga trebalo primjenjivati razdoblje produljenja utvrđeno u članku 10. stavku 4. te uredbe.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Budući da je razmatranje zahtjevā za produljenje odobrenja bromadiolona, klorofacinona i kumatetralila za uporabu u biocidnim proizvodima vrste 14 dovršeno, Provedbena odluka Komisije (EU) 2015/1737 [5] stavlja se izvan snage Provedbenom uredbom (EU) 2017/1377 [6].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za biocidne proizvode,
Done at Brussels, 25 July 2017.
DONIJELA JE OVU UREDBU:
The President
Odobrenje kumatetralila kao aktivne tvari za uporabu u biocidnim proizvodima vrste 14 produljuje se, podložno specifikacijama i uvjetima iz Priloga.
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).
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Risk mitigation measures for anticoagulant rodenticides — Final Report.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
European Commission (2014), Brussels, Belgium.
Sastavljeno u Bruxellesu 25. srpnja 2017.
100 pp.
Za Komisiju
ISBN 978-92-79-44992-5.
Predsjednik
Commission Implementing Decision (EU) 2015/1737 of 28 September 2015 postponing the expiry date of approval of bromadiolone, chlorophacinone and coumatetralyl for use in biocidal products for product-type 14 (OJ L 252, 29.9.2015, p. 58).
SL L 167, 27.6.2012., str. 1.
Commission Implementing Regulation (EU) 2017/1377 of 25 July 2017 renewing the approval of chlorophacinone as an active substance for use in biocidal products of product-type 14 (see page 15 of this Official Journal).
Uredba (EZ) br. 1272/2008 Europskog parlamenta i Vijeća od 16. prosinca 2008. o razvrstavanju, označivanju i pakiranju tvari i smjesa, o izmjeni i stavljanju izvan snage Direktive 67/548/EEZ i Direktive 1999/45/EZ i o izmjeni Uredbe (EZ) br. 1907/2006 (SL L 353, 31.12.2008., str. 1.).
ANNEX
Mjere za smanjenje rizika za antikoagulantne rodenticide – završno izvješće (Risk mitigation measures for anticoagulant rodenticides – Final Report).
Common Name
Europska komisija (2014.), Bruxelles, Belgija.
IUPAC Name
100 str.
Identification Numbers
ISBN 978-92-79-44992-5.
Minimum degree of purity of the active substance [1]
Provedbena odluka Komisije (EU) 2015/1737 оd 28. rujna 2015. o odgodi isteka odobrenja bromadiolona, klorofacinona i kumatetralila za uporabu u biocidnim proizvodima za vrstu proizvoda 14 (SL L 252, 29.9.2015., str. 58.).
Expiry date of approval
Provedbena uredba Komisije (EU) 2017/1377 оd 25. srpnja 2017. o produljenju odobrenja klorofacinona kao aktivne tvari za uporabu u biocidnim proizvodima vrste 14 (vidjeti stranicu 15. ovog Službenog lista).
Product type
PRILOG
Specific conditions
Uobičajeni naziv
Coumatetralyl
Kemijski naziv prema IUPAC-u
IUPAC Name:
Identifikacijski brojevi
ydroxy-3-(1, 2, 3, 4-tetrahydro-1-naphthyl)coumarin
Najmanji stupanj čistoće aktivne tvari [1]
EC No: 227-424-0
Datum isteka odobrenja
CAS No: 5836-29-3
Vrsta proizvoda
30 June 2024
Posebne odredbe
Coumatetralyl is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
Kumatetralil
The authorisations of biocidal products are subject to the following general conditions:
Kemijski naziv prema IUPAC-u:
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
idroksi-3-(1, 2, 3, 4-tetrahidro-1-naftil)kumarin
In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.
EZ br.: 227-424-0
Products shall only be authorised for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is satisfied.
CAS br.: 5836-29-3
The nominal concentration of coumatetralyl in the products shall not exceed 375 mg/kg in products other than contact formulations and shall not exceed 4000 mg/kg in contact formulations.
30. lipnja 2024.
Products shall contain an aversive agent and a dye.
Kumatetralil se smatra potencijalnom tvari za zamjenu u skladu s člankom 10. stavkom 1. točkama (a) i (e) Uredbe (EU) br. 528/2012.
Products shall not be authorised in the form of tracking powder.
Odobrenja za biocidne proizvode podliježu sljedećim općim uvjetima:
Products in the form of contact formulations, other than tracking powder, shall only be authorised for use by trained professionals indoors in places not accessible to children or non-target animals.
Pri ocjeni proizvoda posebna se pozornost posvećuje izloženosti, rizicima i učinkovitosti povezanima sa svim uporabama na koje se odnosi zahtjev za odobrenje, a koje nisu proučene u okviru procjene rizika za aktivnu tvar na razini Unije.
Products shall not be authorised for use in permanent or pulse baiting treatments.
Osim toga, u skladu s točkom 10.
Only ready-to-use products shall be authorised.
Priloga VI.
Primary as well as secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures.
Uredbi (EU) br. 528/2012, pri ocjeni proizvoda potrebno je ocijeniti i mogu li se zadovoljiti uvjeti iz članka 5. stavka 2.
These include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.
Uredbe (EU) br. 528/2012.
Dead bodies and uneaten bait shall be disposed of in accordance with local requirements.
Proizvodi se odobravaju za uporabu u državama članicama samo ako je ispunjen barem jedan od uvjeta iz članka 5. stavka 2.
The method of disposal shall be described specifically in the summary of the product characteristics of the national authorisation and be reflected on the product label.
Uredbe (EU) br. 528/2012.
In addition to the general conditions, the authorisations of biocidal products to be used by the general public are subject to the following conditions:
Nominalna koncentracija kumatetralila u proizvodima koji nisu kontaktne formulacije ne smije biti veća od 375 mg/kg, a u kontaktnim formulacijama ne smije biti veća od 4000 mg/kg;
Products shall only be authorised for use in tamper-resistant bait stations.
Proizvodi moraju sadržavati agens koji uzrokuje averziju i boju.
Products shall only be supplied with a maximum quantity of bait per pack of:
Proizvodi se ne smiju odobriti u obliku rasutog mamca.
for products against mice only:
Proizvodi u obliku kontaktnih formulacija, osim rasutog mamca, odobravaju se samo uz uvjet da ih upotrebljavaju osposobljeni profesionalni korisnici u zatvorenom prostoru na mjestima koja nisu dostupna djeci i neciljnim životinjama.
For grain, pellet or paste baits: 250 g;
Proizvodi se ne smiju odobriti za uporabu u trajnom izlaganju mamaca ili izlaganju mamaca u fazama.
For wax block baits: 500 g;
Odobravaju se samo proizvodi koji su spremni za uporabu.
for products against rats only, or mice and rats:
Primarna i sekundarna izloženost ljudi, neciljnih životinja i okoliša smanjuju se na najmanju moguću razinu predviđanjem i primjenom svih primjerenih i dostupnih mjera za ublažavanje rizika.
for grain, pellet or paste baits: 750 g;
Među njima su, na primjer, ograničavanje uporabe na profesionalne korisnike ili osposobljene profesionalne korisnike ako je to moguće te utvrđivanje dodatnih posebnih uvjeta po kategoriji korisnika.
for wax block baits: 1500 g.
Mrtva tijela i nepojedeni mamci moraju se zbrinuti u skladu s lokalnim uvjetima.
Products against Rattus norvegicus and Rattus rattus shall only be authorised for use indoors or in and around buildings.
Metoda zbrinjavanja mora se jasno opisati u sažetku opisa svojstava proizvoda za nacionalno odobrenje i mora se navesti na oznaci proizvoda.
Products against Mus musculus shall only be authorised for use indoors.
Na odobrenja za biocidne proizvode koje upotrebljava javnost uz opće uvjete primjenjuju se i sljedeći uvjeti:
Persons making products available on the market shall ensure that the products are accompanied by information on the risks associated with anticoagulant rodenticides in general, measures to limit their use to the minimum necessary and appropriate precautionary steps to be taken.
Proizvodi se odobravaju samo za uporabu u kutijama s mamcima zaštićenima od neovlaštenog pristupa.
Products in the form of loose bait formulations, such as grain or pellets, shall only be authorised in formulations that are supplied in sachets or other packaging to reduce exposure to humans and the environment.
Proizvodi se isporučuju samo s najvećom količinom mamca po pakiranju kako slijedi:
In addition to the general conditions, the authorisations of biocidal products to be used by professionals are subject to the following conditions:
za proizvode isključivo protiv miševa:
Products shall not be authorised for use in sewers, open area or waste dumps.
i. za mamce u obliku zrna, peleta ili paste: 250 g;
Persons making products for professional users available on the market shall make sure that these products are not supplied to the general public.
za mamce u obliku parafinskih blokova: 500 g;
In addition to the general conditions, the authorisations of biocidal products to be used by trained professionals are subject to the following conditions:
za proizvode isključivo protiv štakora ili protiv miševa i štakora:
Products may be authorised for use in sewers, open area or waste dumps.
i. za mamce u obliku zrna, peleta ili paste: 750 g;
Products may be authorised for use in covered and protected bait points as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations.
za mamce u obliku parafinskih blokova: 1500 g.
Persons making products for trained professional users available on the market shall make sure that the products are not supplied to other persons than trained professionals.
Proizvodi protiv vrsta Rattus norvegicus i Rattus rattus odobravaju se samo za uporabu u zatvorenom prostoru ili u zgradama i oko njih.
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Proizvodi protiv vrste Mus musculus odobravaju se samo za uporabu u zatvorenom prostoru.
The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
Osobe koje stavljaju proizvode na tržište dužne su osigurati da oni budu popraćeni informacijama o općenitim rizicima povezanima s antikoagulantnim rodenticidima, o mjerama kojima se njihova uporaba ograničava na najmanju moguću razinu te o prikladnim preventivnim radnjama koje treba poduzeti.
renewing the approval of difenacoum as an active substance for use in biocidal products of product-type 14
o produljenju odobrenja difenakuma kao aktivne tvari za uporabu u biocidnim proizvodima vrste 14
The active substance difenacoum is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.
Aktivna tvar difenakum odobrena je za uporabu u biocidnim proizvodima vrste 14 kao rodenticid u skladu s Uredbom (EU) br. 528/2012.
This application was evaluated by the competent authority of Finland as the evaluating competent authority.
Uredbe (EU) br. 528/2012 Europskoj agenciji za kemikalije (dalje u tekstu: „Agencija”) podnesen je zahtjev za produljenje odobrenja te aktivne tvari.
On 24 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of difenacoum to the Agency.
Taj je zahtjev u ulozi nadležnog ocjenjivačkog tijela ocijenilo finsko nadležno tijelo.
On 16 June 2016, the opinion of the Agency was formulated by its Biocidal Products Committee [2], having regard to the conclusions of the evaluating competent authority.
Nadležno ocjenjivačko tijelo 24. ožujka 2016.
According to that opinion, difenacoum meets the criteria in Regulation (EC) No 1272/2008 of the European Parliament and of the Council [3] to be classified as toxic for reproduction category 1B.
Agenciji je dostavilo preporuku o produljenju odobrenja difenakuma.
The substance also meets the criteria in Regulation (EC) No 1907/2006 of the European Parliament and of the Council [4] for being very persistent, bioaccumulative and toxic.
Mišljenje Agencije sastavio je njezin Odbor za biocidne proizvode [2] 16. lipnja 2016. uzimajući u obzir zaključke nadležnog ocjenjivačkog tijela.
Difenacoum therefore meets the exclusion criteria set in points (c) and (e) of Article 5(1) of Regulation (EU) No 528/2012.
U tom je mišljenju utvrđeno da difenakum ispunjuje kriterije iz Uredbe (EZ) br. 1272/2008 Europskog parlamenta i Vijeća [3] za razvrstavanje kao reproduktivno toksična tvar kategorije 1.B.
In addition, the use of products containing difenacoum raises concerns in relation to instances of primary and secondary poisoning, even where restrictive risk management measures are applied and therefore difenacoum also satisfies the criterion to be a candidate for substitution in accordance with Article 10(1)(e) of Regulation (EU) No 528/2012.
Osim toga, predmetna tvar ispunjuje kriterije iz Uredbe (EZ) br. 1907/2006 Europskog parlamenta i Vijeća [4] za vrlo postojane, bioakumulativne i toksične tvari.
Pursuant to Article 12 of Regulation (EU) No 528/2012, the approval of active substances meeting the exclusion criteria may only be renewed when at least one of the conditions for derogation set out in Article 5(2) of that Regulation continues to be satisfied.
Difenakum stoga ispunjuje kriterije za isključivanje iz članka 5. stavka 1. točaka (c) i (e) Uredbe (EU) br. 528/2012.
In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency organised a public consultation in order to collect relevant information on difenacoum, including information on available substitutes.
Osim toga, uporaba proizvoda koji sadržavaju difenakum izaziva zabrinutost u pogledu primarnog i sekundarnog trovanja, čak i ako se primjenjuju restriktivne mjere upravljanja rizikom, te stoga difenakum ispunjuje i kriterij za potencijalne tvari za zamjenu u skladu s člankom 10. stavkom 1. točkom (e) Uredbe (EU) br. 528/2012.
The contributions to the two abovementioned public consultations, as well as the information regarding the availability of alternatives to anticoagulant rodenticides included in Annex 1 to the Commission report on risk-mitigation measures for anticoagulant rodenticides [5], were discussed with Member States in the Standing Committee on Biocidal Products.
U skladu s člankom 10. stavkom 3.
Rodents can carry pathogens that are responsible for many zoonoses, which can pose serious dangers for human or animal health.
Uredbe (EU) br. 528/2012 Agencija je organizirala javno savjetovanje radi prikupljanja relevantnih informacija o difenakumu, uključujući informacije o dostupnim zamjenama.
As effective rodent control cannot rely on those non-chemical controls or prevention methods only, difenacoum is considered essential to ensure appropriate rodent control in support of those alternatives.
Komisija je objavila doprinose prikupljene u okviru tog savjetovanja.
As a consequence the use of difenacoum would be to prevent or control a serious danger to human and animal health in which rodents are involved.
U okviru Stalnog odbora za biocidne proizvode s državama članicama raspravljalo se o doprinosima prikupljenima u okviru tih javnih savjetovanja i informacijama o dostupnosti alternativnih tvari za antikoagulantne rodenticide navedenih u Prilogu 1.
Therefore, the condition set out in Article 5(2)(b) of Regulation (EU) No 528/2012 is satisfied.
Izvješću Komisije o mjerama za smanjenje rizika za antikoagulantne rodenticide [5].
On the other hand, the risks to human health, animal health or the environment arising from use of products containing difenacoum can be mitigated if they are used according to certain specifications and conditions.
Alternativne aktivne tvari odobrene za uporabu kao rodenticidi možda nisu prikladne za sve kategorije korisnika odnosno učinkovite za sve vrste glodavaca.
Therefore, the non-approval of difenacoum as an active substance would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance.
Budući da se djelotvorna kontrola glodavaca ne može svesti samo na nekemijske metode kontrole ili prevencije, smatra se da je uz te alternativne metode difenakum neophodan za osiguravanje prikladne kontrole glodavaca.
The condition set out in Article 5(2)(c) of Regulation (EU) No 528/2012 is thus also satisfied.
Zbog toga bi se difenakum upotrebljavao za sprečavanje ili kontrolu ozbiljne opasnosti za zdravlje ljudi i životinja koju uzrokuju glodavci.
It is therefore appropriate to renew the approval of difenacoum for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.
Stoga je uvjet iz članka 5. stavka 2. točke (b) Uredbe (EU) br. 528/2012 ispunjen.