natgillin/translations-raw huggingface dataset:
For reasons of public health and hygiene, it was nevertheless found to be justified to include difenacoum and other anticoagulant rodenticides in Annex I to Directive 98/8/EC, thus allowing Member States to authorise difenacoum-based products.
Zaradi javnega zdravja in higiene je bilo kljub temu ugotovljeno, da je upravičeno vključiti difenakum in druge antikoagulantne rodenticide v Prilogo I k Direktivi 98/8/ES, kar državam članicam omogoča, da odobrijo pripravke na osnovi difenakuma.
However, Directive 2008/81/EC obliges Member States to ensure, when granting authorisation of products containing difenacoum, 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 Direktiva 2008/81/ES države članice obvezuje, da zagotovijo, da se pri izdaji dovoljenj za pripravke, ki vsebujejo difenakum, zmanjšata primarna in sekundarna izpostavljenost ljudi, neciljnih živali in okolja z upoštevanjem in izvajanjem vseh ustreznih in razpoložljivih ukrepov za zmanjšanje tveganja.
The risk mitigation measures mentioned in Directive 2008/81/EC therefore include, amongst others, restriction to professional use only.
Ukrepi za zmanjšanje tveganja iz Direktive 2008/81/ES torej med drugim vključujejo omejitev na poklicno uporabo.
The company Zapi S.p.A.
Družba Zapi S.p.A.
(‘the applicant’) has, in accordance with Article 8 of Directive 98/8/EC, submitted an application to the United Kingdom for authorisation of four rodenticides containing difenacoum (‘the products’).
(„vlagatelj“) je v skladu s členom 8 Direktive 98/8/ES Združenemu kraljestvu predložila vlogo za odobritev štirih rodenticidov, ki vsebujejo difenakum („pripravki“).
On 30 June 2010, the applicant submitted a complete application to Germany for mutual recognition of the first authorisations in respect of the products.
Vlagatelj je 30. junija 2010 predložil popolno vlogo Nemčiji za medsebojno priznavanje prvih dovoljenj za pripravke.
On 8 June 2012, 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.
8. junija 2012 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 ali 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 v 90 dneh predložijo pisne pripombe na obvestilo v skladu s členom 27(1) Direktive 98/8/ES.
The notification was also discussed between the Commission and Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 3-4 July 2012.
Priglasitev je bila obravnavana tudi med Komisijo in pristojnimi organi držav članic za biocidne pripravke na srečanju skupine za poenostavitev medsebojnega priznavanja in izdajo dovoljenj za pripravke dne 3. in 4. julija 2012.
In accordance with Directive 2008/81/EC, authorisations of biocidal products containing difenacoum are to be subject to all appropriate and available risk mitigation measures, including the restriction to professional use only.
V skladu z Direktivo 2008/81/ES bi bilo treba za odobritev biocidnih pripravkov, ki vsebujejo difenakum, upoštevati vse primerne in razpoložljive ukrepe za zmanjšanje tveganja, vključno z omejitvijo na le poklicno uporabo.
In the absence of any indication to the contrary, restriction to professional users is therefore an appropriate and available risk mitigation measure for the authorisation of products containing difenacoum in Germany.
Ker ni dokaza o nasprotnem, je omejitev uporabe na poklicne uporabnike primeren in razpoložljiv ukrep za zmanjšanje tveganja pri odobritvi pripravkov, ki vsebujejo difenakum, v Nemčiji.
This conclusion is reinforced by the arguments put forward by Germany that resistance against difenacoum in rats has been found and is thought to be developing in the country.
To ugotovitev potrjujejo tudi argumenti, ki jih je predložila Nemčija, da je bila ugotovljena odpornost proti difenakumu pri podganah in da se predvideva, da se širi po državi.
Furthermore, Germany has a well-functioning infrastructure of trained pest control operators and licensed professionals, such as farmers, gardeners and foresters who received professional training, which means that the proposed restriction does not hinder infection prevention.
Poleg tega ima Nemčija dobro delujočo infrastrukturo usposobljenih ponudnikov obvladovanja škodljivcev in poklicnih uporabnikov z dovoljenjem, kot so kmetje, vrtnarji in gozdarji, ki so se poklicno usposabljali, kar pomeni, da predlagana omejitev ne ovira preprečevanja okužb.
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 ali poklicne uporabnike z dovoljenjem.
Done at Brussels, 19 February 2013.
V Bruslju, 19. februarja 2013
Product name in UK
Ime pripravka v Združenem kraljestvu
UK application reference number in the Register for Biocidal Products
Referenčna številka vloge v registru biocidnih pripravkov v Združenem kraljestvu
German application reference number in the Register for Biocidal Products
Referenčna številka vloge v registru biocidnih pripravkov v Nemčiji
The United Kingdom granted the authorisations on 19 September 2011.
Združeno kraljestvo je 19. septembra 2011 izdalo dovoljenja.
regarding restrictions of authorisations of biocidal products containing difenacoum notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
o omejitvi dovoljenj za biocidne pripravke, ki vsebujejo difenakum, ki jih je Nemčija priglasila v skladu z Direktivo 98/8/ES Evropskega parlamenta in Sveta
(notified under document C(2013) 780)
(notificirano pod dokumentarno številko C(2013) 780)
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [1], and in particular Article 4(4) thereof,
ob upoštevanju Direktive 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet [1], zlasti člena 4(4) Direktive,
Commission Directive 2008/81/EC of 29 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include difenacoum as an active substance in Annex I thereto [2] added the active substance difenacoum to belonging to product type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.
Direktiva Komisije 2008/81/ES z dne 29. julija 2008 o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev difenakuma kot aktivne snovi v Prilogo I k Direktivi [2] je dodala aktivno snov difenakum k snovem, ki spadajo v 14. vrsto pripravkov, rodenticidi, kot je opredeljeno v Prilogi V k Direktivi 98/8/ES.
The risk mitigation measures mentioned in Directive 2008/81/EC therefore include, amongst others, restriction to professional use only.
Ukrepi za zmanjšanje tveganja iz Direktive 2008/81/ES torej vključujejo med drugim le omejitev na poklicno uporabo.
The company Kwizda France S.A.S.
Podjetje Kwizda France 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 for six rodenticides containing difenacoum (‘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 restrictions to ensure that the conditions of Article 5 of Directive 98/8/EC were met in the United Kingdom included a requirement to indicate ‘Keep away from food, drink and animal feedingstuffs’ on the label, but did not include restriction to trained or licensed professional users.
Omejitve za zagotovitev, da so izpolnjeni pogoji iz člena 5 Direktive 98/8/ES, so v Združenem kraljestvu na oznaki vsebovale zahtevo „hraniti ločeno od hrane, pijače in krme“, niso pa vključevale omejitve uporabe na usposobljene poklicne uporabnike ali poklicne uporabnike z dovoljenjem.
On 31 March 2010, the applicant submitted a complete application to Germany for mutual recognition of the first authorisations in respect of the products.
Vlagatelj je 31. marca 2010 Nemčiji predložil popolno vlogo za medsebojno priznavanje prvih dovoljenj za pripravke.
On 8 June 2012, 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.
Nemčija je 8. junija 2012 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, as well as by excluding food protection from the authorised intended uses of the contested products if the food consists of plants or plant products within the meaning of Article 3 points 5 and 6 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [3].
Nemčija je predlagala uvedbo omejitve za proizvode, da jih uporabljajo usposobljeni poklicni uporabniki ali poklicni uporabniki z dovoljenjem, ter izključitev varnosti hrane iz dovoljenih predvidenih uporab spornih proizvodov, če živilo sestavljajo rastline ali rastlinski proizvodi v smislu člena 3, točki 5 in 6 Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS [3].
The notification was also discussed between the Commission and Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 3-4 July 2012.
O obvestilu so razpravljali tudi predstavniki Komisije in pristojnih organov za biocidne pripravke držav članic na srečanju skupine za poenostavitev medsebojnega priznavanja in izdajo dovoljenj za pripravke, ki je potekalo od 3. do 4. julija 2012.
Concerning the restriction on the products to use by trained or licensed professionals, in accordance with Directive 2008/81/EC, authorisations of biocidal products containing difenacoum are to be subject to all appropriate and available risk mitigation measures, including the restriction to professional use only.
V zvezi z omejitvijo na proizvode, ki jih uporabljajo usposobljeni poklicni uporabniki ali poklicni uporabniki z dovoljenjem v skladu z Direktivo 2008/81/ES, je treba pri dovoljenjih za biocidne pripravke, ki vsebujejo difenakum, upoštevati vse ustrezne in razpoložljive ukrepe za zmanjšanje tveganja, vključno z omejitvijo na le poklicno uporabo.
This conclusion is reinforced by the arguments put forward by Germany that resistance against difenacoum in rats has been found and is thought to be developing in the country.
To ugotovitev potrjujejo argumenti, ki jih je predložila Nemčija, da je bila ugotovljena odpornost proti difenakumu pri podganah in da se predvideva, da se širi po državi.
Regarding the exclusion of food protection from the authorised intended uses, Germany argued that products used for food of plant origin protection are covered, for this purpose, by Regulation (EC) No 1107/2009 and hence excluded from the scope of Directive 98/8/EC if the protected food consists of plants or plant products within the meaning of Article 3 points 5 and 6 of Regulation (EC) No 1107/2009.
V zvezi z izključitvijo varnosti živil iz dovoljenih predvidenih rab je Nemčija navedla, da so proizvodi, ki se uporabljajo za živila rastlinskega izvora, v ta namen zajeti v Uredbi (ES) št. 1107/2009 ter tako izvzeti iz področja uporabe Direktive 98/8/ES, če zaščiteno živilo sestavljajo rastline ali rastlinski proizvodi v smislu člena 3, točki 5 in 6 Uredbe (ES) št. 1107/2009.
The Commission notes that it is undisputed that the contested products are covered by the definition of a biocidal product in Article 2(1)(a) of Directive 98/8/EC.
Komisija ugotavlja, da je nesporno, da so sporni proizvodi zajeti v opredelitev biocidnega pripravka v členu 2(1)(a) Direktive 98/8/ES.
It therefore merely should be examined whether the products are nevertheless excluded from the scope of Directive 98/8/EC by virtue of Article 1(2)(r) of that Directive for the purpose of certain uses, in which case those particular uses would require additional authorisations in accordance with Regulation (EC) No 1107/2009.
Zato bi bilo treba preučiti le, ali so pripravki vseeno izvzeti iz področja uporabe Direktive 98/8/ES, v skladu s členom 1(2)(r) navedene direktive za namene nekatere uporabe; v tem primeru bi bila za te posebne uporabe potrebna dodatna dovoljenja v skladu z Uredbo (ES) št. 1107/2009.
It follows from Article 2(1)(a) of Regulation (EC) No 1107/2009 that that Regulation does not apply to products whose main purpose is considered to be hygiene rather than the protection of plants or plant products.
V skladu s členom 2(1)(a) Uredbe (ES) št. 1107/2009 sledi, da se ta uredba ne uporablja za proizvode, katerih glavni namen je higiena in ne varstvo rastlin ali rastlinskih proizvodov.
The contested products are, inter alia, intended for use as rodenticides against mice and rats to protect food, and food can constitute plants or plant products as defined in Article 3 points 5 and 6 of Regulation (EC) No 1107/2009.
Sporni proizvodi so med drugim namenjeni za uporabo kot rodenticidi proti mišim in podganam za zaščito živil; živila lahko sestavljajo rastline ali rastlinski proizvodi, kakor je opredeljeno v členu 3, točki 5 in 6 Uredbe (ES) št. 1107/2009.
However, the contested products are also intended for a number of other purposes than food protection, and most food does not constitute plants or plant products.
Vendar so sporni proizvodi namenjeni tudi za številne druge namene, razen zaščite živil, večina živil ni sestavljena iz rastlin ali rastlinskih proizvodov.
Furthermore, the labelling requirements in the authorisations of the contested products ensure that the products are not directly applied on food [4].
Poleg tega zahteve o označevanju v dovoljenjih za sporne proizvode zagotavljajo, da se proizvodi ne uporabljajo neposredno za živila [4].
The application of the products referred to as ‘food protection’ in the authorisation should be seen as primarily intended to avoid food contamination from rodents and the consequent danger for transmission of zoonotic diseases, in line with the general hygiene requirements for all stages of production, processing and distribution according to Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs [5].
Uporaba proizvodov kot „varnost živil“ pri izdaji dovoljenj bi morala biti prvotno namenjena preprečevanju kontaminacije živil pred glodalci in posledične nevarnosti prenosa zoonotskih bolezni v skladu s splošnimi higienskimi zahtevami za vse stopnje proizvodnje, predelave in prenosa v skladu s Prilogo II k Uredbi (ES) št. 852/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o higieni živil [5].
As the main purpose of the contested products is hygiene rather than the protection of plants or plant products, the products are not excluded from the scope of Directive 98/8/EC by virtue of Article 1(2)(r) of that Directive for the purpose of its use.
Ker je glavni namen spornih proizvodov higiena in ne varstvo rastlin ali rastlinskih proizvodov, sporni proizvodi niso izključeni iz področja uporabe Direktive 98/8/ES na podlagi člena 1(2)(r) navedene direktive za namen uporabe.
The restriction requested by Germany in this respect cannot be justified on the grounds put forward.
V tem smislu omejitev, ki jo je zahtevala Nemčija, ne more biti upravičena s predloženimi razlogi.
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, without excluding food protection from the authorised intended uses of the products.
Nemčija lahko omeji dovoljenja, izdana v skladu s členom 4 Direktive 98/8/ES za pripravke iz Priloge k temu sklepu, na uporabo za usposobljene poklicne uporabnike ali poklicne uporabnike z dovoljenjem, ne da bi izključila varnost živil iz dovoljenih namernih uporab proizvodov.
See, in this respect, a published guidance document agreed between the Commission services and the competent authorities of Member States for the biocidal products Directive 98/8/EC and for the plant protection products Directive 91/414/EEC entitled ‘Borderline between Directive 98/8/EC concerning the placing on the market of Biocidal product and Directive 91/414/EEC concerning the placing on the market of plant protection products’, available on the website http://ec.europa.eu/food/plant/protection/evaluation/borderline_en.htm
V zvezi s tem glej objavljene smernice, dogovorjene med službami Komisije in pristojnimi organi držav članic o biocidnih pripravkih iz Direktive 98/8/ES in fitofarmacevtskih sredstvih iz Direktive 91/414/EGS z naslovom „Borderline between Directive 98/8/EC concerning the placing on the market of Biocidal product and Directive 91/414/EEC concerning the placing on the market of plant protection products“, na voljo na spletni strani http://ec.europa.eu/food/plant/protection/evaluation/borderline_en.htm.
The United Kingdom granted the authorisations to five products on 3 November 2011 and to another one on 14 November 2011.
Združeno kraljestvo je dne 3. novembra 2011 izdalo dovoljenja za 5 pripravkov in dne 14. novembra 2011 za še enega.
The products were authorised for general use against rats and mice for the protection of stored products, food, health and material.
Pripravki so bili odobreni za splošno uporabo proti podganam in mišim za zaščito uskladiščenih proizvodov, hrane, zdravja in materiala.
granting derogations to certain Member States with respect to the transmission of statistics pursuant to Regulation (EC) No 1338/2008 of the European Parliament and of the Council on Community statistics on public health and health and safety at work, as regards statistics based on the European Health Interview Survey (EHIS)
o odobritvi odstopanj nekaterim državam članicam glede sporočanja statističnih podatkov v skladu z Uredbo (ES) št. 1338/2008 Evropskega parlamenta in Sveta o statističnih podatkih Skupnosti v zvezi z javnim zdravjem ter zdravjem in varnostjo pri delu glede statističnih podatkov, ki temeljijo na Evropski anketi o zdravju in zdravstvenem varstvu (EHIS)
(notified under document C(2013) 784)
(notificirano pod dokumentarno številko C(2013) 784)
(Only the German, English, French, Dutch and Swedish texts are authentic)
(Besedilo v angleškem, francoskem, nemškem, nizozemskem in švedskem jeziku je edino verodostojno)
Having regard to the requests made by the Kingdom of Belgium, the French Republic, the Kingdom of the Netherlands, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland,
ob upoštevanju zahtev Kraljevine Belgije, Francoske republike, Kraljevine Nizozemske, Kraljevine Švedske in Združenega kraljestva Velika Britanija in Severna Irska,
In accordance with Article 9(2) of Regulation (EC) No 1338/2008, the Commission may grant Member States derogations and transition periods, both to be based upon objective grounds.
V skladu s členom 9(2) Uredbe (ES) št. 1338/2008 lahko Komisija državam članicam iz objektivnih razlogov odobri odstopanja in prehodna obdobja.
It emerges from the information provided to the Commission that the Member States’ requests for derogations are due to the need for major adaptations to national administrative and statistical systems in order to comply in full with Regulation (EC) No 1338/2008.
Iz informacij, predloženih Komisiji, je razvidno, da države članice zahtevajo odstopanja zaradi potrebe po obsežnejših prilagoditvah nacionalnih upravnih in statističnih sistemov, da se v celoti zagotovi skladnost z Uredbo (ES) št. 1338/2008.
Such derogations should be granted, at their request, to Belgium, France, the Netherlands, Sweden and the United Kingdom.
Takšna odstopanja bi bilo treba odobriti Belgiji, Franciji, Nizozemski, Švedski in Združenemu kraljestvu na zahtevo teh držav.
Derogations as set out in the Annex are granted to the Member States listed therein.
Odstopanja iz Priloge se odobrijo v njej navedenim državam članicam.
This Decision is addressed to the Kingdom of Belgium, the French Republic, the Kingdom of the Netherlands, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland.
Ta sklep je naslovljen na Kraljevino Belgijo, Francosko republiko, Kraljevino Nizozemsko, Kraljevino Švedsko ter Združeno kraljestvo Velika Britanija in Severna Irska.
Derogations from Regulation (EC) No 1338/2008, as implemented by the Commission, concerning statistics based on the European Health Interview Survey (EHIS)
Odstopanja od Uredbe (ES) št. 1338/2008, kakor jo izvaja Komisija, v zvezi s statističnimi podatki, ki temeljijo na Evropski anketi o zdravju in zdravstvenem varstvu (EHIS)
Belgium, France and the Netherlands shall not deliver the variables specified in the following table:
Belgija, Francija in Nizozemska ne sporočijo spremenljivk iz naslednje tabele:
INTLANG (interview language);
INTLANG (jezik anketiranja),
, PL5, PL7 of the set on physical and sensory functional limitations;
, PL5, PL7 iz niza o fizičnih in senzoričnih funkcionalnih omejitvah,
a till MH1h on mental health;
a do MH1h o duševnem zdravju,
and AM5 on ambulatory care;
in AM5 o ambulantni oskrbi,
on preventive activities;
o preventivnih dejavnostih,
a till UN2d on unmet needs.
a do UN2d o neizpolnjenih potrebah.
till AL6 on alcohol consumption;
do AL6 o uživanju alkohola,
till IC3 on informal care.
do IC3 o neformalni oskrbi.
and PL6 on physical and sensory functional limitations;
in PL6 o fizičnih in senzoričnih funkcionalnih omejitvah,
till PE8 on physical activities;
do PE8 o telesnih dejavnostih,
and AL6 on alcohol consumption.
in AL6 o uživanju alkohola.
Sweden and the United Kingdom: the reference population in Sweden and in the United Kingdom shall be individuals aged 16 and over living in private households residing in the territory of these Member States at the time of the data collection.
Švedska in Združeno kraljestvo: referenčna populacija na Švedskem in v Združenem kraljestvu so posamezniki, stari 16 let in več, ki živijo v zasebnih gospodinjstvih in v času zbiranja podatkov prebivajo na ozemlju teh držav članic.
as regards a Union financial aid towards a coordinated control plan with a view to establish the prevalence of fraudulent practices in the marketing of certain foods
o finančni pomoči Unije k usklajenemu načrtu nadzora za ugotavljanje razširjenosti goljufivih praks pri trženju nekaterih živil
(notified under document C(2013) 1035)
(notificirano pod dokumentarno številko C(2013) 1035)
Following controls being carried out since December 2012 in a number of Member States, the Commission was informed of fraudulent practices in certain foods.
Po nadzoru, ki je bil od decembra 2012 izveden v številnih državah članicah, je bila Komisija obveščena o goljufivih praksah pri nekaterih živilih.