natgillin/translations-raw huggingface dataset:
It has been identified as potentially persistent, liable to bioaccumulate and toxic (‘PBT’), or very persistent and very liable to bioaccumulate (‘vPvB’).
Ugotovljeno je bilo, da je potencialno obstojen, da se lahko kopiči v organizmih in je strupen („PBT“), ali zelo obstojen in se zelo lahko kopiči v organizmih („vPvB“).
For reasons of public health and hygiene, it was nevertheless found to be justified to include difethialone and other anticoagulant rodenticides in Annex I to Directive 98/8/EC, thus allowing Member States to authorise difethialone-based products.
Zaradi javnega zdravja in higiene je bilo kljub temu ugotovljeno, da je upravičeno vključiti difetialon in druge antikoagulantne rodenticide v Prilogo I k Direktivi 98/8/ES, ki državam članicam omogoča, da odobrijo pripravke na osnovi difetialona.
However, Directive 2007/69/EC obliges Member States to ensure, when granting authorisation of products containing difethialone, that primary as well as secondary exposure of humans, non-target animals and the environment is minimised, by considering and applying all appropriate and available risk mitigation measures.
Vendar pa Direktiva 2007/69/ES države članice obvezuje, da zagotovijo, da se pri izdaji dovoljenj za pripravke, ki vsebujejo difetialon, zmanjšata primarna in sekundarna izpostavljenost ljudi, neciljnih živali in okolja z upoštevanjem in izvajanjem vseh ustreznih in razpoložljivih ukrepov za zmanjšanje tveganja.
The scientific evaluation leading to the adoption of Directive 2007/69/EC concluded that the most significant reductions in exposure to and risks posed by difethialone are achieved by restricting its use to treatment campaigns of limited duration, limiting access of non-target animals to the bait and removing unused bait and dead and moribund rodents during a baiting campaign in order to minimise the opportunity of primary or secondary exposure of non-target animals.
Glede na znanstveno oceno za sprejetje Direktive 2007/69/ES se največje zmanjšanje izpostavljenosti in tveganj, ki jih predstavlja difetialon, doseže z omejitvijo uporabe na krajše omejeno obdobje, omejitvijo dostopa za neciljne živali do vabe in odstranjevanjem neuporabljene vabe ter poginulih in umirajočih glodavcev med nastavljanjem vab, da se zmanjša možnost primarne in sekundarne izpostavljenosti neciljnih živali.
The evaluation also concluded that only professional users are expected to follow such instructions.
Pri oceni je bilo ugotovljeno tudi, da se le od poklicnih uporabnikov pričakuje, da bodo upoštevali ta navodila.
The risk mitigation measures mentioned in Directive 2007/69/EC therefore include restriction to professional use only.
Ukrepi za zmanjšanje tveganj iz Direktive 2007/69/ES torej vključujejo le omejitev na poklicno uporabo.
The company LiphaTech S.A.S.
Podjetje LiphaTech S.A.S.
(‘the applicant’) has, in accordance with Article 8 of Directive 98/8/EC, submitted an application to the United Kingdom for authorisation of nine rodenticides containing difethialone (‘the products’).
(„vlagatelj“) je v skladu s členom 8 Direktive 98/8/ES predložilo vlogo Združenemu kraljestvu za odobritev devetih rodenticidov, ki vsebujejo difetialon („pripravki“).
The products’ names and reference numbers in the Register for Biocidal Products (‘R4BP’) are indicated in the Annex to this decision.
Imena in referenčne številke pripravkov v registru biocidnih pripravkov („R4BP“) so navedene v Prilogi k temu sklepu.
The United Kingdom granted the authorisations on 20 April 2011 (Generation Pat’), on 26 April 2011 (Generation Block) and on 27 April 2011 (Generation Grain’Tech and Rodilon Trio) (‘the first authorisations’).
Združeno kraljestvo je izdalo dovoljenja dne 20. aprila 2011 (Generation Pat’), dne 26. aprila 2011 (Generation Block) in dne 27. aprila 2011 (Generation Grain’Tech in Rodilon Trio) („prva dovoljenja“).
The products were authorised with restrictions to ensure that the conditions of Article 5 of Directive 98/8/EC were met in the United Kingdom.
Pripravki so bili odobreni z omejitvami, da se zagotovi upoštevanje pogojev iz člena 5 Direktive 98/8/ES v Združenem kraljestvu.
Those restrictions did not include a restriction to trained professional users with a license.
Omejitve niso vključevale omejitve uporabe na usposobljene poklicne uporabnike z dovoljenjem.
The applicant submitted a complete application to Denmark for mutual recognition of the first authorisations in respect of seven of the products (Rodilon Paste, Kvit Muse-Pasta, Rodilon Block, Generation Korn’Tech, Rodilon Trio and Kvit Røde Musekorn, and the product now referred to as Generation Blok) on 9 June 2011, and in respect of two of the products (Generation Museblok and Generation Musekorn) on 14 October 2011.
Vlagatelj je predložil popolno vlogo Danski za medsebojno priznavanje prvih dovoljenj za sedem pripravkov (Rodilon Paste, Kvit Muse-Pasta, Rodilon Block, Generation Korn’Tech, Rodilon Trio in Kvit Røde Musekorn in za pripravek, ki se sedaj imenuje Generation Blok) dne 9. junija 2011 ter za dva pripravka (Generation Museblok in Generation Musekorn) dne 14. oktobra 2011.
On 2 November 2011, Denmark notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisations in accordance with Article 4(4) of Directive 98/8/EC.
2. novembra 2011 je Danska obvestila Komisijo, druge države članice in vlagatelja o svojem predlogu za omejitev prvih dovoljenj v skladu s členom 4(4) Direktive 98/8/ES.
Denmark proposed to impose a restriction on the products to use by trained professionals with a license.
Danska je predlagala, da se uvede omejitev uporabe pripravkov na usposobljene poklicne uporabnike z dovoljenjem.
The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC.
Komisija je povabila druge države članice in vlagatelja, da predložijo pisne pripombe na obvestilo v 90 dneh v skladu s členom 27(1) Direktive 98/8/ES.
Only the applicant submitted comments within that deadline.
Do roka je pripombe predložil le vlagatelj.
The notification was also discussed between Commission representatives, representatives of Member States’ Competent Authorities for biocidal products and the applicant in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 6-7 December 2011 and in the meeting of the Competent Authorities for Biocidal Products of 29 February to 2 March 2012.
O obvestilu so se posvetovali predstavniki Komisije, predstavniki pristojnih organov za biocidne pripravke držav članic in vlagatelj na srečanju Skupine za poenostavitev medsebojnega priznavanja in izdajo dovoljenj za pripravke, ki je potekalo od 6. do 7. decembra 2011, in na srečanju pristojnih organov za biocidne pripravke, ki je potekalo od 29. februarja do 2. marca 2012.
The applicant has argued that the restriction to use by trained professionals with a license is unjustified and should not be accepted, since its products are also suitable for rodent control by non-trained professionals and non-professionals.
Vlagatelj je trdil, da je omejitev uporabe pripravkov na usposobljene poklicne uporabnike z dovoljenjem neupravičena in ne bi smela biti sprejeta, saj so njegovi pripravki primerni tudi za nadzor glodavcev, ki ga izvajajo neusposobljeni poklicni uporabniki in nepoklicni uporabniki.
Furthermore, the applicant has put forward the arguments that the products are ready-to-use products; that the active ingredient content in the products is low; that an antidote exists; that the products can easily be kept out of the reach of children and non-target animals; that non-professional users are likely to remove dead rodents and that non-professional users can be trained.
Poleg tega je vlagatelj predložil utemeljitve, da so pripravki primerni za takojšno uporabo; da je vsebnost aktivne snovi v pripravkih nizka; da obstaja protistrup; da se pripravke zlahka hrani zunaj dosega otrok in neciljnih živali; da nepoklicni uporabniki verjetno odstranijo poginule glodavce in da se nepoklicne uporabnike lahko usposobi.
The Commission notes that, in accordance with Directive 2007/69/EC, authorisations of biocidal products containing difethialone are to be subject to all appropriate and available risk mitigation measures, including the restriction to professional use only.
Komisija ugotavlja, da je treba v skladu z Direktivo 2007/69/ES za odobritev biocidnih pripravkov, ki vsebujejo difetialon, upoštevati vse primerne in razpoložljive ukrepe za zmanjšanje tveganja, vključno z omejitvijo na le poklicno uporabo.
The scientific evaluation leading to the adoption of Directive 2007/69/EC concluded that only professional users could be expected to follow the instructions leading to the most significant reductions in exposure and risk.
Glede na znanstveno oceno za sprejetje Direktive 2007/69/ES se lahko le od poklicnih uporabnikov pričakuje, da upoštevajo navodila, ki vodijo do največjega zmanjšanja izpostavljenosti in tveganja.
A restriction to professional users should therefore in principle be considered to be an appropriate risk mitigation measure.
Omejitev uporabe na poklicne uporabnike bi morala načeloma veljati za ustrezen ukrep za zmanjšanje tveganja.
The arguments put forward by the applicant do not undermine that conclusion.
Utemeljitve vlagatelja ne omajajo tega sklepa.
In the absence of any indication to the contrary, the Commission therefore considers that a restriction to professional users is an appropriate and available risk mitigation measure for the authorisation of products containing difethialone in Denmark.
Ker ni dokaza o nasprotnem, Komisija meni, da je omejitev uporabe na poklicne uporabnike primeren in razpoložljiv ukrep za zmanjšanje tveganja pri odobritvi pripravkov, ki vsebujejo difetialon, na Danskem.
The fact that the United Kingdom did not consider such a restriction to be appropriate and available for an authorisation in its territory is immaterial for that conclusion.
Dejstvo, da se Združenemu kraljestvu taka omejitev ni zdela primerna in razpoložljiva za odobritev na svojem ozemlju, je nebistveno za omenjeni sklep.
The decision of the United Kingdom to authorise non-professional use was based in particular on the risk of a delay in treatment of household infestations due to the costs involved in hiring trained professionals, and the associated risks to public hygiene.
Odločitev Združenega kraljestva, da odobri nepoklicno uporabo, temelji predvsem na tveganju zamude pri obravnavi napadov gospodinjstev zaradi stroškov najema usposobljenih poklicnih uporabnikov in s tem povezanih tveganjih za javno higieno.
Denmark, however, has explained that that risk is less prevalent in Denmark, thanks to a system of mandatory rat infestation reporting and tax financed controlling by trained professionals, together with the general public’s access to alternative methods for control of minor mice infestations.
Danska pa je pojasnila, da je tveganje na Danskem manjše zaradi sistema obveznega poročanja napadov podgan in nadzora usposobljenih poklicnih uporabnikov, ki se financirajo z davki, obenem pa ima širša javnost dostop do alternativnih metod za nadzor manjših napadov miši.
Denmark may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC for the products mentioned in the Annex to this Decision to use by trained professionals with a license.
Danska lahko omeji izdana dovoljenja za uporabo v skladu s členom 4 Direktive 98/8/ES za pripravke iz Priloge k temu sklepu na usposobljene poklicne uporabnike z dovoljenjem.
Done at Brussels, 18 June 2012.
V Bruslju, 18. junija 2012
Products for which Denmark may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC to use by trained professionals with a license
Pripravki, za katere lahko Danska omeji izdana dovoljenja za uporabo pripravkov v skladu s členom 4 Direktive 98/8/ES na usposobljene poklicne uporabnike z dovoljenjem
Product name in the United Kingdom
Ime pripravka v Združenem kraljestvu
United Kingdom application reference number in R4BP
Referenčna številka vloge v R4BP v Združenem kraljestvu
Product name in Denmark
Ime pripravka na Danskem
Danish application reference number in R4BP
Referenčna številka danske vloge v R4BP
approving restrictions of authorisations of biocidal products containing difethialone notified by Germany in accordance with Article 4(4) of Directive 98/8/EC of the European Parliament and of the Council
o odobritvi omejitev dovoljenj za biocidne pripravke, ki vsebujejo difetialon, ki jih je Nemčija priglasila v skladu s členom 4(4) Direktive 98/8/ES Evropskega parlamenta in Sveta
(notified under document C(2012) 4026)
(notificirano pod dokumentarno številko C(2012) 4026)
The active substance difethialone was approved for inclusion in products belonging to product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC, by Commission Directive 2007/69/EC of 29 November 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include difethialone as an active substance in Annex I thereto [2].
Aktivna snov difetialon je bila odobrena za uporabo v pripravkih, ki spadajo v 14. vrsto pripravkov, rodenticide, kot je opredeljeno v Prilogi V k Direktivi 98/8/ES, z Direktivo Komisije 2007/69/ES z dne 29. novembra 2007 o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev difetialona kot aktivne snovi v Prilogi I k Direktivi [2].
It has been identified as potentially persistent, liable to bioaccumulate and toxic (‘PBT’), or very persistent and very liable to bioaccumulate (‘vPvB’).
Bilo je ugotovljeno, da je potencialno obstojen, da se lahko kopiči v organizmih in je strupen („PBT“), ali zelo obstojen in se zelo lahko kopiči v organizmih („vPvB“).
(‘the applicant’) has, in accordance with Article 8 of Directive 98/8/EC, submitted an application to the United Kingdom for authorisation of six rodenticides containing difethialone (‘the products’).
(„vlagatelj“) je v skladu s členom 8 Direktive 98/8/ES predložilo vlogo Združenemu kraljestvu za odobritev šestih rodenticidov, ki vsebujejo difetialon („pripravki“).
The products’ names and reference numbers in the Register for Biocidal Products (‘R4BP’) are indicated in the Annex to this Decision.
Imena in referenčne številke pripravkov v registru biocidnih pripravkov („R4BP“) so navedene v Prilogi k temu sklepu.
The United Kingdom granted the authorisations on 20 April 2011 (Generation Pat’), on 26 April 2011 (Generation Block, Generation B’Block and Generation S’Block) and on 27 April 2011 (Generation Grain’Tech and Rodilon Trio) (‘the first authorisations’).
Združeno kraljestvo je izdalo dovoljenja dne 20. aprila 2011 (Generation Pat’), dne 26. aprila 2011 (Generation Block, Generation B’Block in Generation S’Block) in dne 27. aprila 2011 (Generation Grain’Tech in Rodilon Trio) („prva dovoljenja“).
The products were authorised with restrictions to ensure the conditions of Article 5 of Directive 98/8/EC were met in the United Kingdom.
Pripravki so bili odobreni z omejitvami, da se zagotovi upoštevanje pogojev iz člena 5 Direktive 98/8/ES v Združenem kraljestvu.
Those restrictions did not include restriction to trained or licensed professional users.
Omejitve niso vključevale omejitve uporabe na usposobljene poklicne uporabnike ali poklicne uporabnike z dovoljenjem.
On 6 November 2009, the applicant submitted a complete application to Germany for mutual recognition of the first authorisations in respect of the products.
6. novembra 2009 je vlagatelj predložil popolno vlogo Nemčiji za medsebojno priznavanje prvih dovoljenj za pripravke.
On 22 November 2011, Germany notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisations in accordance with Article 4(4) of Directive 98/8/EC.
22. novembra 2011 je Nemčija obvestila Komisijo, druge države članice in vlagatelja o svojem predlogu za omejitev prvih dovoljenj v skladu s členom 4(4) Direktive 98/8/ES.
Germany proposed to impose a restriction on the products to use by trained or licensed professionals.
Nemčija je predlagala, da se uvede omejitev uporabe pripravkov na usposobljene poklicne uporabnike z dovoljenjem.
The notification was also discussed between Commission representatives, representatives of Member States’ Competent Authorities for biocidal products and the applicant in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 6-7 December 2011, in which the applicant participated, and in the meeting of the Competent Authorities for Biocidal Products of 29 February to 2 March 2012.
O obvestilu so se posvetovali predstavniki Komisije, predstavniki pristojnih organov za biocidne pripravke držav članic in vlagatelj na srečanju Skupine za poenostavitev medsebojnega priznavanja in izdajo dovoljenj za pripravke, ki je potekalo od 6. do 7. decembra 2011 in na katerem je sodeloval tudi vlagatelj, in na srečanju pristojnih organov za biocidne pripravke, ki je potekalo od 29. februarja do 2. marca 2012.
The applicant has argued that the restriction to use by trained or licensed professionals is unjustified and should not be accepted, since its products are also suitable for rodent control by non-trained professionals and non-professionals.
Vlagatelj je trdil, da je omejitev uporabe pripravkov na usposobljene poklicne uporabnike z dovoljenjem neupravičena in ne bi smela biti sprejeta, saj so njegovi pripravki primerni za nadzor glodavcev, ki ga izvajajo neusposobljeni poklicni uporabniki in nepoklicni uporabniki.
Furthermore, the applicant has put forward the arguments that the products are ready-to-use products; that the active ingredient content in the products is low; that an antidote exists; that the products can easily be kept out of the reach of children and non-target animals; that non-professional users are likely to remove dead rodents; and that non-professional users can be trained.
Poleg tega je vlagatelj predložil utemeljitve, da so pripravki primerni za takojšno uporabo; da je vsebnost aktivne snovi v pripravkih nizka; da obstaja protistrup; da se pripravke zlahka hrani zunaj dosega otrok in neciljnih živali; da nepoklicni uporabniki verjetno odstranijo poginule glodavce; in da se nepoklicne uporabnike lahko usposobi.
In the absence of any indication to the contrary, the Commission therefore considers that restriction to professional users is an appropriate and available risk mitigation measure for the authorisation of products containing difethialone in Germany.
Ker ni dokaza o nasprotnem, Komisija meni, da je omejitev uporabe na poklicne uporabnike primeren in razpoložljiv ukrep za zmanjšanje tveganja pri odobritvi pripravkov, ki vsebujejo difetialon, v Nemčiji.
Germany, however, has explained that that risk is less prevalent in Germany thanks to Germany’s well functioning infrastructure of trained pest control operators and licensed professionals, such as farmers, gardeners and foresters, together with the availability of alternative methods for pest control within buildings, especially for control of mice.
Nemčija je pojasnila, da je tveganje v Nemčiji manjše zaradi zelo dobre nemške infrastrukture usposobljenih ponudnikov obvladovanja škodljivcev in poklicnih uporabnikov z dovoljenjem, kot so kmetje, vrtnarji in gozdarji, obenem pa obstajajo alternativne metode za obvladovanje škodljivcev znotraj zgradb, še posebej za nadzor miši.
Germany may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC for the products mentioned in the Annex to this Decision to use by trained or licensed professionals.
Nemčija lahko omeji izdana dovoljenja za uporabo v skladu s členom 4 Direktive 98/8/ES za pripravke iz Priloge k temu sklepu na usposobljene poklicne uporabnike z dovoljenjem.
Products for which Germany may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC to use by licensed or trained professionals
Pripravki, za katere lahko Nemčija omeji izdana dovoljenja za uporabo pripravkov v skladu s členom 4 Direktive 98/8/ES na usposobljene poklicne uporabnike z dovoljenjem
Product name in Germany
Ime pripravka v Nemčiji
German application reference number in R4BP
Referenčna številka nemške vloge v R4BP
approving restrictions of authorisations of biocidal products containing difethialone notified by Sweden in accordance with Article 4(4) of Directive 98/8/EC of the European Parliament and of the Council
o odobritvi omejitev dovoljenj za biocidne pripravke, ki vsebujejo difetialon, ki jih je Švedska priglasila v skladu s členom 4(4) Direktive 98/8/ES Evropskega parlamenta in Sveta
(notified under document C(2012) 4027)
(notificirano pod dokumentarno številko C(2012) 4027)
The scientific evaluation leading to the adoption of Directive 2007/69/EC concluded that the most significant reductions in exposure to and risks posed by difethialone are achieved by restricting its use to treatment campaigns of limited duration, limiting access of non-target animals to the bait and removing unused bait and dead and moribund rodents during a baiting campaign in order to minimise the opportunity of primary or secondary exposure of non-target animals.
Glede na znanstveno oceno, ki je vodila do sprejetja Direktive 2007/69/ES, se največje zmanjšanje izpostavljenosti in tveganj, ki jih predstavlja difetialon, doseže z omejitvijo uporabe na krajše omejeno obdobje, omejitvijo dostopa za neciljne živali do vabe in odstranjevanjem neuporabljene vabe ter poginulih in umirajočih glodavcev med nastavljanjem vab, da se zmanjša možnost primarne in sekundarne izpostavljenosti neciljnih živali.
The evaluation also concluded that only professional users are expected to follow such instructions.
V oceni je bilo ugotovljeno tudi, da se le od poklicnih uporabnikov pričakuje, da bodo upoštevali ta navodila.
(‘the applicant’) has, in accordance with Article 8 of Directive 98/8/EC, submitted an application to the United Kingdom for authorisation of eight rodenticides containing difethialone (‘the products’).
(„vlagatelj“) je v skladu s členom 8 Direktive 98/8/ES predložilo vlogo Združenemu kraljestvu za odobritev osmih rodenticidov, ki vsebujejo difetialon („pripravki“).
Those restrictions did not include a restriction to trained professional users with a license.
Omejitve niso vključevale omejitve na usposobljene poklicne uporabnike z dovoljenjem.
On 9 June 2011, the applicant submitted a complete application to Sweden for mutual recognition of the first authorisations of the products.
9. junija 2011 je vlagatelj predložil popolno vlogo Švedski za medsebojno priznavanje prvih dovoljenj pripravkov.
For the products with the Swedish product names Rodilon Block, Rodilon Trio and Rodilon Paste, the applications were restricted to authorisation for professional use only.
Za pripravke s švedskimi imeni Rodilon Block, Rodilon Trio in Rodilon Paste so bile vloge omejene na odobritev le za poklicno uporabo.
On 11 October 2011, Sweden notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisations in accordance with Article 4(4) of Directive 98/8/EC.
11. oktobra 2011 je Švedska obvestila Komisijo, druge države članice in vlagatelja o svojem predlogu za omejitev prvih dovoljenj v skladu s členom 4(4) Direktive 98/8/ES.
Sweden proposed to impose a restriction on the products to use by trained professionals with a license.
Švedska je predlagala, da se uvede omejitev uporabe pripravkov na usposobljene poklicne uporabnike z dovoljenjem.