natgillin/translations-raw huggingface dataset:
products may be authorised for use in sewers, open area or waste dumps;
Proizvodi se lahko odobrijo za uporabo pri pulznem nastavljanju vab.
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;
Proizvodi se ne odobrijo za uporabo pri stalnem nastavljanju vab.
products may be authorised for use in pulse baiting treatments;
Osebe, ki dajejo proizvode, namenjene usposobljenim poklicnim uporabnikom, na trg, zagotovijo, da se proizvodi ne dobavljajo drugim osebam, ki niso usposobljeni poklicni uporabniki.
products shall not be authorised for use in permanent baiting treatments;
Čistost, navedena v tem stolpcu, je bila minimalna stopnja čistosti ocenjene aktivne snovi.
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.
Čistost aktivne snovi v proizvodu, danem na trg, je lahko enaka ali drugačna, če je aktivna snov dokazano tehnično enakovredna aktivni snovi iz ocene.
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Evropska komisija (2014), Bruselj, Belgija.
Commission Implementing Regulation (EU) 2017/1382
Izvedbena uredba Komisije (EU) 2017/1382
renewing the approval of difethialone as an active substance for use in biocidal products of product-type 14
o obnovitvi odobritve difetialona kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov
The active substance difethialone is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.
Aktivna snov difetialon 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 Norway as the evaluating competent authority.
To vlogo je ocenil pristojni organ Norveške, ki je bil pristojni ocenjevalni organ.
On 21 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of difethialone to the Agency.
Pristojni ocenjevalni organ je 21. marca 2016 Agenciji predložil priporočilo za obnovitev odobritve difetialona.
According to that opinion, difethialone 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 difetialon izpolnjuje merila iz Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta [3] za razvrstitev kot strupen za razmnoževanje iz kategorije 1B.
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.
Ta snov izpolnjuje tudi merila iz Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [4] za snov, ki je zelo obstojna, bioakumulativna in strupena.
Difethialone therefore meets the exclusion criteria set in points (c) and (e) of Article 5(1) of Regulation (EU) No 528/2012.
Difetialon zato izpolnjuje merili za izključitev, določeni v točkah (c) in (e) člena 5(1) Uredbe (EU) št. 528/2012.
In addition, the use of products containing difethialone raises concerns in relation to instances of primary and secondary poisoning, even where restrictive risk management measures are applied and therefore difethialone 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 difetialon, zbuja pomisleke zaradi primerov primarne in sekundarne zastrupitve, tudi ko se uporabijo omejevalni ukrepi za obvladovanje tveganja, zato difetialon 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 difethialone, 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 difetialonu, vključno z informacijami o razpoložljivih nadomestkih.
As effective rodent control cannot rely on those non-chemical controls or prevention methods only, difethialone 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 difetialon za bistveno snov pri zagotavljanju ustreznega nadzora glodalcev in kot dopolnilo navedenim alternativam.
As a consequence the use of difethialone would be to prevent or control a serious danger to human and animal health in which rodents are involved.
Posledično bi se difetialon 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 difethialone 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 difetialon, lahko zmanjša, če se ti proizvodi uporabljajo v skladu z določenimi specifikacijami in pogoji.
Therefore, the non-approval of difethialone 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 difetialona 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 difethialone for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.
Zato je primerno obnoviti odobritev difetialona za uporabo v biocidnih proizvodih 14. vrste proizvodov, pod pogojem, da je ta v skladu z določenimi specifikacijami in pogoji.
Difethialone 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.
Difetialon 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 difethialone and difenacoum for use in biocidal products of product-type 14 is now finalised, Commission Implementing Decision 2014/397/EU [6] is repealed by Implementing Regulation (EU) 2017/1379 [7].
Ker je proučitev vlog za obnovitev odobritev difetialona in difenakuma za uporabo v biocidnih proizvodih 14. vrste proizvodov zaključena, se Izvedbeni sklep Komisije 2014/397/EU [6] razveljavi z Izvedbeno uredbo (EU) 2017/1379 [7].
The approval of difethialone 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 difetialona kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov se obnovi, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
100 pp.
Izvedbena uredba Komisije (EU) 2017/1379 z dne 25. julija 2017 o obnovitvi odobritve difenakuma kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov (glej stran 27 tega Uradnega lista).
Commission Implementing Regulation (EU) 2017/1379 of 25 July 2017 renewing the approval of difenacoum as an active substance for use in biocidal products of product-type 14 (see page 27 of this Official Journal).
Ime po IUPAC
ANNEX
Identifikacijske številke
Common Name
Minimalna stopnja čistosti aktivne snovi [1]
IUPAC Name
Datum prenehanja veljavnosti odobritve
Identification Numbers
Vrsta proizvoda
Minimum degree of purity of the active substance [1]
Posebni pogoji
Expiry date of approval
difetialon
Product type
Ime po IUPAC:
Specific conditions
3-[3-(4′-bromo[1,1′bifenil]-4-il)-1,2,3,4-tetrahidronaftalen-1-il]-4-hidroksi-2H-1-benzotiopiran-2-on
Difethialone
Št.
IUPAC Name:
ES: ni na voljo
3-[3-(4′-bromo[1,1′biphenyl]-4-yl)-1,2,3,4-tetrahydronaphth-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one
Št.
CAS No: 104653-34-1
Specifikacija čistosti temelji na skupni koncentraciji obeh diastereoizomerov (cis in trans).
The specification of purity is based on the combined concentration of both diastereoisomers (cis and trans).
30. junij 2024
30 June 2024
Difetialon se šteje kot možna snov za zamenjavo v skladu s točkama (a) in (e) člena 10(1) Uredbe (EU) št. 528/2012.
Difethialone is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
Dovoljenja za biocidne proizvode se izdajo pod naslednjimi splošnimi pogoji:
The authorisations of biocidal products are subject to the following general conditions:
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 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.
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.
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 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 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.
Nominalna koncentracija difetialona v proizvodih ne presega 25 mg/kg.
The nominal concentration of difethialone in the products shall not exceed 25 mg/kg.
Proizvodi vsebujejo averzivno sredstvo in barvilo.
Products shall contain an aversive agent and a dye.
Proizvodi se ne odobrijo v obliki sredstva za posipanje.
Products shall not be authorised in the form of tracking powder.
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 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.
Odobrijo se samo proizvodi za takojšnjo uporabo.
Only ready-to-use products shall be authorised.
Primarna in sekundarna izpostavljenost ljudi, neciljnih živali in okolja se zmanjšata z upoštevanjem in uporabo vseh primernih in razpoložljivih ukrepov za zmanjšanje tveganja.
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.
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.
These include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.
Trupla in ostanki vab se odstranijo v skladu z lokalnimi zahtevami.
Dead bodies and uneaten bait shall be disposed of in accordance with local requirements.
Metoda odstranjevanja je opisana posebej v povzetku značilnosti proizvoda v nacionalnih dovoljenjih in je omenjena na etiketi proizvoda.
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.
Poleg splošnih pogojev se dovoljenja za biocidne proizvode za splošno uporabo izdajo pod naslednjimi pogoji:
In addition to the general conditions, the authorisations of biocidal products to be used by the general public are subject to the following conditions:
Proizvodi se odobrijo samo za uporabo pri nastavljanju vab na mestih, ki so zavarovana pred nepooblaščenimi posegi.
Products shall only be authorised for use in tamper-resistant bait stations.
Pri dobavi proizvodov je največja količina vabe na pakiranje:
Products shall only be supplied with a maximum quantity of bait per pack of:
samo za proizvode za zatiranje miši:
For products against mice only:
za vabe v obliki zrn, peletov ali paste: 50 g;
For grain, pellet or paste baits: 50 g.
za vabe v obliki voščenega bloka: 100 g;
For wax block baits: 100 g.
samo za proizvode za zatiranje podgan oziroma podgan in miši:
For products against rats only, or mice and rats:
za vabe v obliki zrn, peletov ali paste: 150 g;
For grain, pellet or paste baits: 150 g.
za vabe v obliki voščenega bloka: 300 g.
For wax block baits: 300 g.
Proizvodi za zatiranje Rattus norvegicus in Rattus rattus se odobrijo samo za uporabo v zaprtih prostorih ali v stavbah in okoli njih.
Products against Rattus norvegicus and Rattus rattus shall only be authorised for use indoors or in and around buildings.
Proizvodi za zatiranje Mus musculus se odobrijo samo za uporabo v zaprtih prostorih.
Products against Mus musculus shall only be authorised for use indoors.
Proizvodi se ne odobrijo za uporabo pri stalnem nastavljanju vab ali pri pulznem nastavljanju vab.
Products shall not be authorised for use in permanent or pulse baiting treatments.
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.
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, 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 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.
Poleg splošnih pogojev se dovoljenja za biocidne proizvode, ki jih uporabljajo poklicni uporabniki, izdajo pod naslednjimi pogoji:
In addition to the general conditions, the authorisations of biocidal products to be used by professionals are subject to the following conditions:
Proizvodi se ne odobrijo za uporabo v kanalizaciji, na odprtih območjih ali na odlagališčih odpadkov.
Products shall not be authorised for use in sewers, open area or waste dumps.
Osebe, ki dajejo proizvode, namenjene poklicnim uporabnikom, na trg, zagotovijo, da se proizvodi ne dobavljajo za splošno uporabo.
Persons making products for professional users available on the market shall make sure that these products are not supplied to the general public.
Poleg splošnih pogojev se dovoljenja za biocidne proizvode, ki jih uporabljajo usposobljeni poklicni uporabniki, izdajo pod naslednjimi pogoji:
In addition to the general conditions, the authorisations of biocidal products to be used by trained professionals are subject to the following conditions:
Proizvodi se lahko odobrijo za uporabo v kanalizaciji, na odprtih območjih ali na odlagališčih odpadkov.
Products may be authorised for use in sewers, open area or waste dumps.
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.
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.
Proizvodi se lahko odobrijo za uporabo pri pulznem nastavljanju vab.
Products may be authorised for use in pulse baiting treatments.
Proizvodi se ne odobrijo za uporabo pri stalnem nastavljanju vab.
Products shall not be authorised for use in permanent baiting treatments.
Osebe, ki dajejo proizvode, namenjene usposobljenim poklicnim uporabnikom, na trg, zagotovijo, da se proizvodi ne dobavljajo drugim osebam, ki niso usposobljeni poklicni uporabniki.
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.
Čistost, navedena v tem stolpcu, je bila minimalna stopnja čistosti ocenjene aktivne snovi.
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Čistost aktivne snovi v proizvodu, danem na trg, je lahko enaka ali drugačna, če je aktivna snov dokazano tehnično enakovredna aktivni snovi iz ocene.
Commission Implementing Regulation (EU) 2017/1383
Izvedbena uredba Komisije (EU) 2017/1383
renewing the approval of flocoumafen as an active substance for use in biocidal products of product-type 14
o obnovitvi odobritve flokumafena kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov
The active substance flocoumafen is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.
Aktivna snov flokumafen 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 the Netherlands as the evaluating competent authority.
To vlogo je ocenil pristojni organ Nizozemske, ki je bil pristojni ocenjevalni organ.
On 26 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of flocoumafen to the Agency.
Pristojni ocenjevalni organ je 26. marca 2016 Agenciji predložil priporočilo za obnovitev odobritve flokumafena.