natgillin/translations-raw huggingface dataset:
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).
Minimalna stopnja čistosti aktivne snovi [1]
ANNEX
Datum prenehanja veljavnosti odobritve
Common Name
Vrsta proizvoda
IUPAC Name
Posebni pogoji
Identification Numbers
klorofacinon
Minimum degree of purity of the active substance [1]
Ime po IUPAC:
Expiry date of approval
2-[2-(4-klorofenil)-2-fenilacetil]indan-1,3-dion
Product type
Št.
Specific conditions
ES: 223-003-0
Chlorophacinone
Št.
2-[2-(4-chlorophenyl)-2-phenylacetyl] indan-1,3-dione
30. junij 2024
EC No: 223-003-0
Klorofacinon se šteje kot možna snov za zamenjavo v skladu s točkami (a), (d) in (e) člena 10(1) Uredbe (EU) št. 528/2012.
CAS No: 3691-35-8
Dovoljenja za biocidne proizvode se izdajo pod naslednjimi splošnimi pogoji:
30 June 2024
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
Chlorophacinone is considered a candidate for substitution in accordance with points (a), (d) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
Poleg tega v skladu s točko 10 Priloge VI k Uredbi (EU) št. 528/2012 ocena proizvoda vključuje presojo, ali se lahko izpolnijo pogoji iz člena 5(2) Uredbe (EU) št. 528/2012.
The authorisations of biocidal products are subject to the following general conditions:
Proizvodi se odobrijo za uporabo samo v tistih državah članicah, kjer je izpolnjen vsaj eden od pogojev iz člena 5(2) Uredbe (EU) št. 528/2012.
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.
Nominalna koncentracija klorofacinona v proizvodih, ki niso kontaktni pripravki, ne presega 50 mg/kg, v kontaktnih pripravkih pa ne presega 2000 mg/kg.
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.
Proizvodi vsebujejo averzivno sredstvo in barvilo.
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.
Proizvodi se ne odobrijo v obliki sredstva za posipanje.
The nominal concentration of chlorophacinone in the products shall not exceed 50 mg/kg in products other than contact formulations and shall not exceed 2000 mg/kg in contact formulations.
Proizvodi v obliki kontaktnih pripravkov, ki niso sredstva za posipanje, se odobrijo samo za uporabo s strani usposobljenih poklicnih uporabnikov v zaprtih prostorih, nedostopnih otrokom ali neciljnim živalim.
Products shall contain an aversive agent and a dye.
Proizvodi se ne odobrijo za uporabo pri stalnem nastavljanju vab ali pri pulznem nastavljanju vab.
Products shall not be authorised in the form of tracking powder.
Odobrijo se samo proizvodi za takojšnjo uporabo.
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.
Primarna in sekundarna izpostavljenost ljudi, neciljnih živali in okolja se zmanjšata z upoštevanjem in uporabo vseh primernih in razpoložljivih ukrepov za zmanjšanje tveganja.
Products shall not be authorised for use in permanent or pulse baiting treatments.
Ti ukrepi na primer vključujejo omejitev na uporabo s strani poklicnih ali usposobljenih poklicnih uporabnikov (če je mogoče) ter določitev dodatnih posebnih pogojev za posamezne kategorije uporabnikov.
Only ready-to-use products shall be authorised.
Trupla in ostanki vab se odstranijo v skladu z lokalnimi zahtevami.
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.
Metoda odstranjevanja je opisana posebej v povzetku značilnosti proizvoda v nacionalnih dovoljenjih in je omenjena na etiketi proizvoda.
These include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.
Poleg splošnih pogojev se dovoljenja za biocidne proizvode za splošno uporabo izdajo pod naslednjimi pogoji:
Dead bodies and uneaten bait shall be disposed of in accordance with local requirements.
Proizvodi se odobrijo samo za uporabo pri nastavljanju vab na mestih, ki so zavarovana pred nepooblaščenimi posegi.
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.
Pri dobavi proizvodov je največja količina vabe na pakiranje:
In addition to the general conditions, the authorisations of biocidal products to be used by the general public are subject to the following conditions:
samo za proizvode za zatiranje miši:
Products shall only be authorised for use in tamper-resistant bait stations.
za vabe v obliki zrn, peletov ali paste: 250 g;
Products shall only be supplied with a maximum quantity of bait per pack of:
za vabe v obliki voščenega bloka: 500 g;
For products against mice only:
samo za proizvode za zatiranje podgan oziroma podgan in miši:
For grain, pellet or paste baits: 250 g.
za vabe v obliki zrn, peletov ali paste: 750 g;
For wax block baits: 500 g.
za vabe v obliki voščenega bloka: 1500 g.
For products against rats only, or mice and rats:
Proizvodi za zatiranje Rattus norvegicus in Rattus rattus se odobrijo samo za uporabo v zaprtih prostorih ali v stavbah in okoli njih.
For grain, pellet or paste baits: 750 g.
Proizvodi za zatiranje Mus musculus se odobrijo samo za uporabo v zaprtih prostorih.
For wax block baits: 1500 g.
Osebe, ki dajejo proizvode na trg, zagotovijo, da so proizvodom priložene informacije o tveganjih, na splošno povezanih z antikoagulantnimi rodenticidi, o ukrepih za omejitev njihove uporabe na nujni minimum in o ustreznih previdnostnih ukrepih.
Products against Rattus norvegicus and Rattus rattus shall only be authorised for use indoors or in and around buildings.
Proizvodi, ki so pripravki v razsuti obliki vab, kot so zrna ali peleti, se odobrijo samo v pripravkih, ki se dobavijo v vrečkah ali drugi embalaži, da se zmanjša izpostavljenost ljudi in okolja.
Products against Mus musculus shall only be authorised for use indoors.
Poleg splošnih pogojev se dovoljenja za biocidne proizvode, ki jih uporabljajo poklicni uporabniki, izdajo pod naslednjimi pogoji:
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 ne odobrijo za uporabo v kanalizaciji, na odprtih območjih ali na odlagališčih odpadkov.
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.
Osebe, ki dajejo proizvode, namenjene poklicnim uporabnikom, na trg, zagotovijo, da se proizvodi ne dobavljajo za splošno uporabo.
In addition to the general conditions, the authorisations of biocidal products to be used by professionals are subject to the following conditions:
Poleg splošnih pogojev se dovoljenja za biocidne proizvode, ki jih uporabljajo usposobljeni poklicni uporabniki, izdajo pod naslednjimi pogoji:
Products shall not be authorised for use in sewers, open area or waste dumps.
Proizvodi se lahko odobrijo za uporabo v kanalizaciji, na odprtih območjih ali na odlagališčih odpadkov.
Persons making products for professional users available on the market shall make sure that these products are not supplied to the general public.
Proizvodi se lahko odobrijo za uporabo na pokritih in zaščitenih točkah nastavitve vab, če neciljnim vrstam in ljudem zagotavljajo enako raven zaščite kot mesta nastavitve vab, ki so zavarovana pred nepooblaščenimi posegi.
In addition to the general conditions, the authorisations of biocidal products to be used by trained professionals are subject to the following conditions:
Osebe, ki dajejo proizvode, namenjene usposobljenim poklicnim uporabnikom, na trg, zagotovijo, da se proizvodi ne dobavljajo drugim osebam, ki niso usposobljeni poklicni uporabniki.
Products may be authorised for use in sewers, open area or waste dumps.
Čistost, navedena v tem stolpcu, je bila minimalna stopnja čistosti ocenjene aktivne snovi.
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.
Čistost aktivne snovi v proizvodu, danem na trg, je lahko enaka ali drugačna, če je aktivna snov dokazano tehnično enakovredna aktivni snovi iz ocene.
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.
Z Izvedbenim sklepom Komisije (EU) 2015/1737 [6] je bil datum izteka odobritve bromadiolona, klorofacinona in kumatetralila za uporabo v biocidnih proizvodih v 14. vrsti proizvodov odložen do 30. junija 2018.
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Ker je proučitev vlog za obnovitev navedenih odobritev zaključena, je primerno razveljaviti Izvedbeni sklep (EU) 2015/1737.
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.
Evropska komisija (2014), Bruselj, Belgija.
By Commission Implementing Decision (EU) 2015/1737 [6], the initial expiry date of approval of bromadiolone, chlorophacinone and coumatetralyl for use in biocidal products of product-type 14 was postponed to 30 June 2018.
100 str.
Commission Implementing Regulation (EU) 2017/1378
Izvedbena uredba Komisije (EU) 2017/1378
renewing the approval of coumatetralyl as an active substance for use in biocidal products of product-type 14
o obnovitvi odobritve kumatetralila kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov
The active substance coumatetralyl is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.
Aktivna snov kumatetralil je odobrena za uporabo v biocidnih proizvodih 14. vrste proizvodov kot rodenticid v skladu z Uredbo (EU) št. 528/2012.
This application was evaluated by the competent authority of Denmark as the evaluating competent authority.
To vlogo je ocenil pristojni organ Danske, ki je bil pristojni ocenjevalni organ.
On 23 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of coumatetralyl to the Agency.
Pristojni ocenjevalni organ je 23. marca 2016 Agenciji predložil priporočilo za obnovitev odobritve kumatetralila.
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.
V skladu z navedenim mnenjem kumatetralil izpolnjuje merila iz Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta [3] za razvrstitev kot strupen za razmnoževanje iz kategorije 1B.
Coumatetralyl therefore meets the exclusion criterion set out in Article 5(1)(c) of Regulation (EU) No 528/2012.
Kumatetralil zato izpolnjuje merilo za izključitev, določeno v členu 5(1)(c) Uredbe (EU) št. 528/2012.
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.
Poleg tega uporaba proizvodov, ki vsebujejo kumatetralil, zbuja pomisleke zaradi primerov primarne in sekundarne zastrupitve, tudi ko se uporabijo omejevalni ukrepi za obvladovanje tveganja, zato kumatetralil prav tako izpolnjuje merilo za možno snov za zamenjavo v skladu s členom 10(1)(e) Uredbe (EU) št. 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.
V skladu s členom 10(3) Uredbe (EU) št. 528/2012 je Agencija organizirala javno posvetovanje, da bi zbrala ustrezne informacije o kumatetralilu, vključno z informacijami o razpoložljivih nadomestkih.
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.
Ker uspešen nadzor glodalcev ne more temeljiti le na navedenih nekemičnih metodah kontrole ali preprečevanja, velja kumatetralil za bistveno snov pri zagotavljanju ustreznega nadzora glodalcev in kot dopolnilo navedenim alternativam.
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.
Posledično bi se kumatetralil uporabljal za preprečevanje ali nadzor resne nevarnosti za zdravje ljudi in živali, ki jo povzročajo glodalci.
Therefore, the condition set out in Article 5(2)(b) of Regulation (EU) No 528/2012 is satisfied.
Zato je izpolnjen pogoj iz člena 5(2)(b) Uredbe (EU) št. 528/2012.
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.
Po drugi strani pa se tveganje za zdravje ljudi, zdravje živali oziroma okolje, ki izhaja iz uporabe proizvodov, ki vsebujejo kumatetralil, lahko zmanjša, če se ti proizvodi uporabljajo v skladu z določenimi specifikacijami in pogoji.
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.
Zato bi imela neodobritev kumatetralila kot aktivne snovi nesorazmeren negativen učinek na družbo v primerjavi s tveganjem, ki izhaja iz uporabe snovi.
The condition set out in Article 5(2)(c) of Regulation (EU) No 528/2012 is thus also satisfied.
Zato je izpolnjen tudi pogoj iz člena 5(2)(c) Uredbe (EU) št. 528/2012.
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.
Zato je primerno obnoviti odobritev kumatetralila za uporabo v biocidnih proizvodih 14. vrste proizvodov, pod pogojem, da je ta v skladu z določenimi specifikacijami in pogoji.
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.
Kumatetralil je možna snov za zamenjavo v skladu s točkama (a) in (e) člena 10(1) Uredbe (EU) št. 528/2012, zato bi bilo treba uporabiti obdobje obnovitve iz člena 10(4) navedene uredbe.
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].
Ker je proučitev vlog za obnovitev odobritev bromadiolona, klorofacinona in kumatetralila za uporabo v biocidnih proizvodih 14. vrste proizvodov zaključena, se Izvedbeni sklep Komisije (EU) 2015/1737 [5] razveljavi z Izvedbeno uredbo (EU) 2017/1377 [6].
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.
Odobritev kumatetralila kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov se obnovi, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
Risk mitigation measures for anticoagulant rodenticides — Final Report.
Ukrepi za zmanjšanje tveganja za antikoagulantne rodenticide – končno poročilo (Risk mitigation measures for anticoagulant rodenticides – Final Report).
European Commission (2014), Brussels, Belgium.
Evropska komisija (2014), Bruselj, Belgija.
100 pp.
100 str.
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).
Izvedbeni sklep Komisije (EU) 2015/1737 z dne 28. septembra 2015 o odložitvi datuma izteka odobritve bromadiolona, klorofacinona in kumatetralila za uporabo v biocidnih proizvodih v vrsti proizvodov 14 (UL L 252, 29.9.2015, str. 58).
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).
Izvedbena uredba Komisije (EU) 2017/1377 z dne 25. julija 2017 o obnovitvi odobritve klorofacinona kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov (glej stran 15 tega Uradnega lista).
EC No: 227-424-0
Št.
CAS No: 5836-29-3
ES: 227-424-0
30 June 2024
Št.
Coumatetralyl is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
CAS: 5836-29-3
The authorisations of biocidal products are subject to the following general conditions:
30. junij 2024
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.
Kumatetralil se šteje kot možna snov za zamenjavo v skladu s točkama (a) in (e) člena 10(1) Uredbe (EU) št. 528/2012.
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.
Dovoljenja za biocidne proizvode se izdajo pod naslednjimi splošnimi pogoji:
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.
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
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.
Poleg tega v skladu s točko 10 Priloge VI k Uredbi (EU) št. 528/2012 ocena proizvoda vključuje presojo, ali se lahko izpolnijo pogoji iz člena 5(2) Uredbe (EU) št. 528/2012.
Products shall contain an aversive agent and a dye.
Proizvodi se odobrijo za uporabo samo v tistih državah članicah, kjer je izpolnjen vsaj eden od pogojev iz člena 5(2) Uredbe (EU) št. 528/2012.
Products shall not be authorised in the form of tracking powder.
Nominalna koncentracija kumatetralila v proizvodih, ki niso kontaktni pripravki, ne presega 375 mg/kg, v kontaktnih pripravkih pa ne presega 4000 mg/kg.
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.
Proizvodi vsebujejo averzivno sredstvo in barvilo.
Products shall not be authorised for use in permanent or pulse baiting treatments.
Proizvodi se ne odobrijo v obliki sredstva za posipanje.
Only ready-to-use products shall be authorised.
Proizvodi v obliki kontaktnih pripravkov, ki niso sredstva za posipanje, se odobrijo samo za uporabo s strani usposobljenih poklicnih uporabnikov v zaprtih prostorih, nedostopnih otrokom ali neciljnim živalim.
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.
Proizvodi se ne odobrijo za uporabo pri stalnem nastavljanju vab ali pri pulznem nastavljanju vab.
These include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.
Odobrijo se samo proizvodi za takojšnjo uporabo.
Dead bodies and uneaten bait shall be disposed of in accordance with local requirements.
Primarna in sekundarna izpostavljenost ljudi, neciljnih živali in okolja se zmanjšata z upoštevanjem in uporabo vseh primernih in razpoložljivih ukrepov za zmanjšanje tveganja.
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.
Ti ukrepi na primer vključujejo omejitev na uporabo s strani poklicnih ali usposobljenih poklicnih uporabnikov (če je mogoče) ter določitev dodatnih posebnih pogojev za posamezne kategorije uporabnikov.
In addition to the general conditions, the authorisations of biocidal products to be used by the general public are subject to the following conditions:
Trupla in ostanki vab se odstranijo v skladu z lokalnimi zahtevami.
Products shall only be authorised for use in tamper-resistant bait stations.
Metoda odstranjevanja je opisana posebej v povzetku značilnosti proizvoda v nacionalnih dovoljenjih in je omenjena na etiketi proizvoda.
Products shall only be supplied with a maximum quantity of bait per pack of:
Poleg splošnih pogojev se dovoljenja za biocidne proizvode za splošno uporabo izdajo pod naslednjimi pogoji:
for products against mice only:
Proizvodi se odobrijo samo za uporabo pri nastavljanju vab na mestih, ki so zavarovana pred nepooblaščenimi posegi.
For grain, pellet or paste baits: 250 g;
Pri dobavi proizvodov je največja količina vabe na pakiranje:
For wax block baits: 500 g;
samo za proizvode za zatiranje miši:
for products against rats only, or mice and rats:
za vabe v obliki zrn, peletov ali paste: 250 g;
for grain, pellet or paste baits: 750 g;
za vabe v obliki voščenega bloka: 500 g;
for wax block baits: 1500 g.
samo za proizvode za zatiranje podgan oziroma podgan in miši:
Products against Rattus norvegicus and Rattus rattus shall only be authorised for use indoors or in and around buildings.
za vabe v obliki zrn, peletov ali paste: 750 g;
Products against Mus musculus shall only be authorised for use indoors.
za vabe v obliki voščenega bloka: 1500 g.
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 za zatiranje Rattus norvegicus in Rattus rattus se odobrijo samo za uporabo v zaprtih prostorih ali v stavbah in okoli njih.
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 za zatiranje Mus musculus se odobrijo samo za uporabo v zaprtih prostorih.
In addition to the general conditions, the authorisations of biocidal products to be used by professionals are subject to the following conditions:
Osebe, ki dajejo proizvode na trg, zagotovijo, da so proizvodom priložene informacije o tveganjih, na splošno povezanih z antikoagulantnimi rodenticidi, o ukrepih za omejitev njihove uporabe na nujni minimum in o ustreznih previdnostnih ukrepih.