natgillin/translations-raw huggingface dataset:
The contributions to the two above-mentioned 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 [4], were discussed with Member States in the Standing Committee on Biocidal Products.
V okviru Stalnega odbora za biocidne pripravke so z državami članicami potekala posvetovanja o prispevkih k obema zgoraj omenjenima javnima posvetovanjema ter o informacijah glede razpoložljivih alternativ za antikoagulantne rodenticide iz Priloge 1 k poročilu Komisije o ukrepih za zmanjšanje tveganja za antikoagulantne rodenticide [4].
Rodents can carry pathogens that are responsible for many zoonoses, which can pose serious dangers for human or animal health.
Glodalci lahko prenašajo patogene, ki povzročajo številne zoonoze, ki lahko resno ogrozijo zdravje ljudi in živali.
Non-chemical controls or prevention methods for rodent control, such as mechanical, electrical or glue traps, may not be sufficiently efficient and may raise further questions as to whether they are humane or whether they cause unnecessary suffering to rodents.
Nekemične metode kontrole ali preprečevanja pri nadzoru glodalcev, kot so mehanske, električne ali lepilne pasti, morda niso dovolj učinkovite in lahko odprejo nadaljnja vprašanja o njihovi humanosti in morebitnem nepotrebnem trpljenju glodalcev.
Alternative active substances approved for use as rodenticides may not be suitable for all user categories or efficient for all rodent species.
Alternativne aktivne snovi, odobrene za uporabo kot rodenticidi, morda niso primerne za vse kategorije uporabnikov ali učinkovite za vse vrste glodalcev.
As effective rodent control cannot rely on those non-chemical controls or prevention methods only, warfarin 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 varfarin za bistveno snov pri zagotavljanju ustreznega nadzora glodalcev in kot dopolnilo navedenim alternativam.
As a consequence the use of warfarin would be to prevent or control a serious danger to human and animal health in which rodents are involved.
Posledično bi se varfarin 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) is satisfied.
Zato je izpolnjen pogoj iz člena 5(2)(b).
Rodent control currently relies largely on the use of anticoagulant rodenticides, the non-approval of which could lead to insufficient rodent control.
Nadzor glodalcev trenutno v veliki meri temelji na uporabi antikoagulantnih rodenticidov, kar lahko v primeru njihove neodobritve privede do nezadostnega nadzora glodalcev.
This may not only cause significant negative impacts on human or animal health or the environment, but also affect the public's perception of its safety with regard to exposure to rodents or the security of a number of economic activities that could be vulnerable to rodents, resulting in economic and social consequences.
To lahko občutno negativno vpliva ne le na zdravje ljudi ali živali oziroma na okolje, temveč tudi na to, kako javnost dojema svojo varnost glede na izpostavljenost glodalcem ali varnost številnih gospodarskih dejavnosti, ki jim glodalci lahko škodijo, kar ima gospodarske in socialne posledice.
On the other hand, the risks to human health, animal health or the environment arising from use of products containing warfarin 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 varfarin, lahko zmanjša, če se ti proizvodi uporabljajo v skladu z določenimi specifikacijami in pogoji.
Therefore, the non-approval of warfarin 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 varfarina 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) is thus also satisfied.
Zato je izpolnjen tudi pogoj iz člena 5(2)(c).
It is therefore appropriate to renew the approval of warfarin for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.
Zato je primerno obnoviti odobritev varfarina za uporabo v biocidnih proizvodih 14. vrste proizvodov, pod pogojem, da je ta v skladu z določenimi specifikacijami in pogoji.
Warfarin 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.
Varfarin 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 those approvals is now finalised, it is appropriate to repeal Implementing Decision (EU) (EU) 2016/135.
SPREJELA NASLEDNJO UREDBO:
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
Člen 1
HAS ADOPTED THIS REGULATION:
Odobritev varfarina kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov se obnovi, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
The approval of warfarin 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.
Izvedbeni sklep (EU) 2016/135 se razveljavi.
Implementing Decision (EU) 2016/135 is repealed.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 25. julija 2017
Done at Brussels, 25 July 2017.
Predsednik
OJ L 167, 27.6.2012, p. 1.
Ukrepi za zmanjšanje tveganja za antikoagulantne rodenticide – končno poročilo (Risk mitigation measures for anticoagulant rodenticides – Final Report).
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).
Evropska komisija (2014), Bruselj, Belgija.
Risk mitigation measures for anticoagulant rodenticides — Final Report.
100 str.
100 pp.
Izvedbeni sklep Komisije (EU) 2016/135 z dne 29. januarja 2016 o odložitvi datuma izteka odobritve flokumafena, brodifakuma in varfarina za uporabo v biocidnih proizvodih v vrsti proizvodov 14 (UL L 25, 2.2.2016, str. 65).
ISBN 978-92-79-44992-5.
PRILOGA
Commission Implementing Decision (EU) 2016/135 of 29 January 2016 postponing the expiry date of approval of flocoumafen, brodifacoum and warfarin for use in biocidal products for product-type 14 (OJ L 25, 2.2.2016, p. 65).
Splošno ime
ANNEX
Ime po IUPAC
Common Name
Identifikacijske številke
IUPAC Name
Minimalna stopnja čistosti aktivne snovi [1]
Identification Numbers
Datum prenehanja veljavnosti odobritve
Minimum degree of purity of the active substance [1]
Vrsta proizvoda
Expiry date of approval
Posebni pogoji
Product type
varfarin
Specific conditions
Ime po IUPAC:
Warfarin
(RS)-4-hidroksi-3-(3-okso-1-fenilbutil)kumarin
(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl) coumarin
ES: 201-377-6
EC No: 201-377-6
Št.
Warfarin is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
Varfarin se šteje kot možna snov za zamenjavo v skladu s točkama (a) in (e) člena 10(1) Uredbe (EU) št. 528/2012.
The authorisations of biocidal products are subject to the following general conditions:
Dovoljenja za biocidne proizvode se izdajo pod naslednjimi splošnimi pogoji:
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.
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.
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.
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 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 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 nominal concentration of warfarin in the products shall not exceed 790 mg/kg.
Nominalna koncentracija varfarina v proizvodih ne presega 790 mg/kg.
Products shall contain an aversive agent and a dye.
Proizvodi vsebujejo averzivno sredstvo in barvilo.
Products shall not be authorised in the form of tracking powder.
Proizvodi se ne odobrijo v obliki sredstva za posipanje.
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 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 not be authorised for use in permanent or pulse baiting treatments.
Proizvodi se ne odobrijo za uporabo pri stalnem nastavljanju vab ali pri pulznem nastavljanju vab.
Only ready-to-use products shall be authorised.
Odobrijo se samo proizvodi za takojšnjo uporabo.
These include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.
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.
Dead bodies and uneaten bait shall be disposed of in accordance with local requirements.
Trupla in ostanki vab se odstranijo v skladu z lokalnimi zahtevami.
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.
Metoda odstranjevanja je opisana posebej v povzetku značilnosti proizvoda v nacionalnih dovoljenjih in je omenjena na etiketi proizvoda.
In addition to the general conditions, the authorisations of biocidal products to be used by the general public are subject to the following conditions:
Poleg splošnih pogojev se dovoljenja za biocidne proizvode za splošno uporabo izdajo pod naslednjimi pogoji:
Products shall only be authorised for use in tamper-resistant bait stations.
Proizvodi se odobrijo samo za uporabo pri nastavljanju vab na mestih, ki so zavarovana pred nepooblaščenimi posegi.
Products shall only be supplied with a maximum quantity of bait per pack of:
Pri dobavi proizvodov je največja količina vabe na pakiranje:
For products against mice only:
samo za proizvode za zatiranje miši:
For grain, pellet or paste baits: 250 g.
za vabe v obliki zrn, peletov ali paste: 250 g;
For wax block baits: 500 g.
za vabe v obliki voščenega bloka: 500 g;
For products against rats only, or mice and rats:
samo za proizvode za zatiranje podgan oziroma podgan in miši:
For grain, pellet or paste baits: 750 g.
za vabe v obliki zrn, peletov ali paste: 750 g;
For wax block baits: 1500 g.
za vabe v obliki voščenega bloka: 1500 g.
Products against Rattus norvegicus and Rattus rattus shall only be authorised for use indoors or in and around buildings.
Proizvodi za zatiranje Rattus norvegicus in Rattus rattus se odobrijo samo za uporabo v zaprtih prostorih ali v stavbah in okoli njih.
Products against Mus musculus shall only be authorised for use indoors.
Proizvodi za zatiranje Mus musculus se odobrijo samo za uporabo v zaprtih prostorih.
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.
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 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, 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.
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 poklicni uporabniki, izdajo pod naslednjimi pogoji:
Products shall not be authorised for use in sewers, open area or waste dumps.
Proizvodi se ne 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.
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 trained 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 may 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.
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 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.
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.
Osebe, ki dajejo proizvode, namenjene usposobljenim poklicnim uporabnikom, na trg, zagotovijo, da se proizvodi ne dobavljajo drugim osebam, ki niso usposobljeni poklicni uporabniki.
Commission Implementing Regulation (EU) 2017/1377
Izvedbena uredba Komisije (EU) 2017/1377
renewing the approval of chlorophacinone as an active substance for use in biocidal products of product-type 14
o obnovitvi odobritve klorofacinona kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov
The active substance chlorophacinone is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.
Aktivna snov klorofacinon 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 Spain as the evaluating competent authority.
To vlogo je ocenil pristojni organ Španije, ki je bil pristojni ocenjevalni organ.
On 25 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of chlorophacinone to the Agency.
Pristojni ocenjevalni organ je 25. marca 2016 Agenciji predložil priporočilo za obnovitev odobritve klorofacinona.
According to that opinion, chlorophacinone 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 klorofacinon izpolnjuje merila iz Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta [3] za razvrstitev kot strupen za razmnoževanje iz kategorije 1B.
Chlorophacinone therefore meets the exclusion criterion set out in Article 5(1)(c) of Regulation (EU) No 528/2012.
Klorofacinon zato izpolnjuje merilo za izključitev, določeno v členu 5(1)(c) Uredbe (EU) št. 528/2012.
In addition, the substance also meets the criteria in Regulation (EC) No 1907/2006 of the European Parliament and of the Council [4] for being persistent and toxic.
Poleg tega ta snov izpolnjuje tudi merila iz Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [4] za snov, ki je obstojna in strupena.
The use of products containing chlorophacinone raises concerns in relation to instances of primary and secondary poisoning, even where restrictive risk management measures are applied.
Uporaba proizvodov, ki vsebujejo klorofacinon, zbuja pomisleke zaradi primerov primarne in sekundarne zastrupitve, tudi ko se uporabijo omejevalni ukrepi za obvladovanje tveganja.
Therefore chlorophacinone also satisfies the criterion to be a candidate for substitution in accordance with points (d) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
Zato klorofacinon prav tako izpolnjuje merilo za možno snov za zamenjavo v skladu s točkama (d) in (e) člena 10(1) 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 chlorophacinone, 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 klorofacinonu, vključno z informacijami o razpoložljivih nadomestkih.
The contributions to the two above-mentioned 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.
V okviru Stalnega odbora za biocidne pripravke so z državami članicami potekala posvetovanja o prispevkih k obema zgoraj omenjenima javnima posvetovanjema ter o informacijah glede razpoložljivih alternativ za antikoagulantne rodenticide iz Priloge 1 k poročilu Komisije o ukrepih za zmanjšanje tveganja za antikoagulantne rodenticide [5].
As effective rodent control cannot rely on those non-chemical controls or prevention methods only, chlorophacinone 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 klorofacinon za bistveno snov pri zagotavljanju ustreznega nadzora glodalcev in kot dopolnilo navedenim alternativam.
As a consequence the use of chlorophacinone would be to prevent or control a serious danger to human and animal health in which rodents are involved.
Posledično bi se klorofacinon uporabljal za preprečevanje ali nadzor resne nevarnosti za zdravje ljudi in živali, ki jo povzročajo glodalci.
On the other hand, the risks to human health, animal health or the environment arising from use of products containing chlorophacinone 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 klorofacinon, lahko zmanjša, če se ti proizvodi uporabljajo v skladu z določenimi specifikacijami in pogoji.
Therefore, the non-approval of chlorophacinone 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 klorofacinona kot aktivne snovi nesorazmeren negativen učinek na družbo v primerjavi s tveganjem, ki izhaja iz uporabe snovi.
It is therefore appropriate to renew the approval of chlorophacinone for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.
Zato je primerno obnoviti odobritev klorofacinona za uporabo v biocidnih proizvodih 14. vrste proizvodov, pod pogojem, da je ta v skladu z določenimi specifikacijami in pogoji.
Chlorophacinone is a candidate for substitution in accordance with points (a), (d) 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.
Klorofacinon je možna snov za zamenjavo v skladu s točkami (a), (d) 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 those approvals is now finalised, it is appropriate to repeal Implementing Decision (EU) 2015/1737.
SPREJELA NASLEDNJO UREDBO:
HAS ADOPTED THIS REGULATION:
Odobritev klorofacinona kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov se obnovi, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
The approval of chlorophacinone 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.
Izvedbeni sklep (EU) 2015/1737 se razveljavi.
Implementing Decision (EU) 2015/1737 is repealed.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
OJ L 167, 27.6.2012, p. 1.
Uredba (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) ter o ustanovitvi Evropske agencije za kemikalije in o spremembi Direktive 1999/45/ES ter o razveljavitvi Uredbe Sveta (EGS) št. 793/93 in Uredbe Komisije (ES) št. 1488/94 ter Direktive Sveta 76/769/EGS in direktiv Komisije 91/155/EGS, 93/67/EGS, 93/105/ES in 2000/21/ES (UL L 396, 30.12.2006, str. 1).
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).
Ukrepi za zmanjšanje tveganja za antikoagulantne rodenticide – končno poročilo (Risk mitigation measures for anticoagulant rodenticides – Final Report).
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
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).
European Commission (2014), Brussels, Belgium.
Splošno ime
100 pp.
Ime po IUPAC
ISBN 978-92-79-44992-5.
Identifikacijske številke