natgillin/translations-raw huggingface dataset:
Germany has notified the Commission, the other Member States and the applicants of its proposal to refuse the authorisations in accordance with Article 4(4) of Directive 98/8/EC, as Germany considers that the contested products do not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to effects on human health.
Nemčija je obvestila Komisijo, druge države članice in vlagatelja o predlogu za zavrnitev izdaje dovoljenj v skladu s členom 4(4) Direktive 98/8/ES, saj Nemčija meni, da sporni proizvodi ne izpolnjujejo zahtev iz člena 5(1) Direktive 98/8/ES glede učinkov na zdravje ljudi.
According to the notifications, Germany disagrees with the evaluation carried out by the United Kingdom regarding the dermal absorption value used in such evaluation (0,04 %).
Nemčija je v obvestilu navedla, da se ne strinja z oceno Združenega kraljestva, kar zadeva vrednost dermalne absorpcije, ki se je uporabila v oceni (0,04 %).
Germany considers this value as inappropriate according to OEDC standards on in vitro dermal absorption methods [4] and pointed out that based on a more conservative value of 0,36 % as per these standards the assessment results in an unacceptable dermal exposure to bromadiolone for professional users.
Nemčija meni, da je ta vrednost neprimerna glede na standarde OECD o in vitro metodah dermalne absorpcije [4], in je izpostavila, da uporaba bolj konzervativne vrednosti 0,36 % iz teh standardov vodi k oceni, da je dermalna izpostavljenost profesionalnih uporabnikov bromadiolonu nesprejemljiva.
For each notification, the Commission invited the other Member States and the applicants to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC.
Komisija je za vsako obvestilo 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.
Comments were submitted within that deadline by the United Kingdom, Belgium, Germany and one of the applicants.
Pripombe so v roku vložili Združeno kraljestvo, Belgija, Nemčija in eden od vlagateljev.
The notification was also discussed between Commission representatives and representatives of Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 14 May 2013.
Obvestilo so obravnavali tudi predstavniki Komisije in organov držav članic, pristojnih za biocidne pripravke, na srečanju Skupine za poenostavitev medsebojnega priznavanja in izdajo dovoljenj za proizvode 14. maja 2013.
From the abovementioned discussions and comments, it follows that the United Kingdom carried out the evaluation of the dermal absorption in a way which is compatible with the latest agreed EU guidance [5], pursuant to which the possibility of reading across existing data from the active substance approval is accepted.
Iz zgoraj omenjenih razprav in pripomb izhaja, da je Združeno kraljestvo opravilo oceno dermalne absorpcije na način, ki je skladen z zadnjimi sprejetimi smernicami EU [5], na podlagi katerih je možnost sklepanja iz obstoječih podatkov iz odobritve aktivne snovi sprejemljiva.
First, the United Kingdom used a dermal absorption value from a study considered as reliable in the context of the EU approval of the active substance bromadiolone, to which the applicants held the required letter of access from the data owner.
Prvič, Združeno kraljestvo je uporabilo vrednost dermalne absorpcije iz študije, ki šteje za zanesljivo v smislu odobritve EU za aktivno snov bromadiolon, za katero sta vložnika imela potrebno dovoljenje za dostop od lastnika podatkov.
Second, the dermal absorption study from which that value was obtained was carried out with a similar bait formulation to that of the contested products, as recommended by the abovementioned guidance.
Drugič, študija o dermalni absorpciji, iz katere je navedena vrednost bila pridobljena, je bila opravljena s podobno formulo za vabo, kot je v spornih proizvodih, kakor priporočajo zgoraj omenjene smernice.
Finally, the United Kingdom evaluated the product with the benefit of expert judgment to justify that the specific conditions of the study from which the dermal absorption value was obtained resembled more closely the actual exposure conditions for professional users loading wax blocks in bait stations.
Združeno kraljestvo je tudi ocenilo proizvod z uporabo strokovne presoje, zato da opraviči bistvo, da so posebni pogoji iz študije, na podlagi katerih je bila pridobljena vrednost dermalne absorpcije, bili bolj podobni dejanski izpostavljenosti profesionalnih uporabnikov, ki vabe polnijo z voščenimi bloki.
This approach is compatible with the abovementioned guidance and the common principles for the evaluation of dossiers for biocidal products as provided for by paragraph 12 of Annex VI to Regulation (EU) No 528/2012.
Ta pristop je skladen z zgoraj omenjenimi smernicami in skupnimi načeli ocenjevanja dokumentacije za biocidne pripravke, kot je določeno z odstavkom 12 Priloge VI Uredbe (EU) št. 528/2012.
In the light of the above arguments, the Commission supports the conclusions of the assessment carried out by the United Kingdom and the other Member States having authorised the contested products through mutual recognition that they do not have unacceptable effects on human health, as required by Article 5(1) of Directive 98/8/EC.
Z vidika zgornjih utemeljitev Komisija podpira ugotovitve ocene, ki jo je izvedlo Združeno kraljestvo in druge države članice, ki so medsebojno odobrile sporne proizvode in potrdile, da ti nimajo nesprejemljivih učinkov na zdravje ljudi, kot zahteva člen 5(1) Direktive 98/8/ES.
The Commission therefore considers that the request by Germany to refuse the authorisations cannot be justified on the grounds put forward.
Zato Komisija meni, da zahtevka Nemčije za zavrnitev izdaje dovoljenj ni mogoče utemeljiti na podlagi predloženih razlogov.
Regulation (EU) No 528/2012 shall apply to the contested products in accordance with the provisions of Article 92(2) of that Regulation.
Uredba (EU) št. 528/2012 se za sporne proizvode uporablja v smislu določb člena 92(2) navedene Uredbe.
Since the legal basis for this Decision is Article 36(3) of that Regulation, this decision should be addressed to all Member States by virtue of Article 36(4) of that Regulation.
Ker je pravna podlaga za ta sklep člen 36(3) navedene Uredbe, bi moral ta sklep biti naslovljen na vse države članice v smislu člena 36(4) navedene Uredbe.
The proposal by Germany to refuse the authorisations granted by the United Kingdom of the products mentioned in the Annex, is rejected.
Predlog Nemčije za zavrnitev izdaje dovoljenj, ki jih je Združeno kraljestvo izdalo za proizvode, navedene v Prilogi, se zavrne.
This Decision is addressed to all Member States.
Ta sklep je naslovljen na vse države članice.
See OECD Guideline for the testing of chemicals 428 on skin absorption: in vitro method, available on the website http://www.oecd-ilibrary.org/environment/test-no-428-skin-absorption-in-vitro-method_9789264071087-en
Glej OECD Guideline for the testing of chemicals 428 on skin absorption: in vitro Method, na voljo na spletni strani http://www.oecd-ilibrary.org/environment/test-no-428-skin-absorption-in-vitro-method_9789264071087-en
See CA-July13-Doc.6.2.b — Final on Approach to dermal absorption assessment for biocidal products authorisation, available on the website https://circabc.europa.eu/w/browse/884abd60-d8f9-48ad-8600-cd0bd5485cec
Glej CA-July13-Doc.6.2.b – Final on Approach to dermal absorption assessment for biocidal products authorisation, na voljo na spletni strani https://circabc.europa.eu/w/browse/884abd60-d8f9-48ad-8600-cd0bd5485cec
Products for which the proposal by Germany to refuse the authorisations granted by the United Kingdom, is rejected:
Proizvodi, za katere se predlog Nemčije za zavrnitev izdaje dovoljenj, ki jih je izdalo Združeno kraljestvo, zavrne:
Application reference number in the Register for Biocidal Products in the United Kingdom
Sklicna številka vloge v registru biocidnih pripravkov v Združenem kraljestvu
Application reference number in the Register for Biocidal Products in Germany
Sklicna številka vloge v registru biocidnih pripravkov v Nemčiji
Other Member States where the contested products have been authorised through mutual recognition
Druge države članice, kjer so sporni proizvodi bili odobreni z medsebojnim priznavanjem
8 April 2013
8. april 2013
Lithuania, Cyprus, Denmark and Belgium
Litva, Ciper, Danska in Belgija
19 April 2013
19. april 2013
Estonia, Poland, Malta, Latvia and Sweden
Estonija, Poljska, Malta, Latvija in Švedska
The United Kingdom authorised before 1 September 2013 the contested products for a number of uses including professional application in and around buildings and in sewers.
Pristojni organi Združenega kraljestva so pred 1. septembrom 2013 izdali dovoljenje za sporne proizvode za številne oblike uporabe, vključno s profesionalno uporabo v stavbah in okoli njih ter v kanalizaciji.
A number of Member States have subsequently authorised the contested products through mutual recognition.
Številne države članice so posledično izdale dovoljenja za sporne proizvode na podlagi medsebojnega priznavanja.
of 12 March 2014
z dne 12. marca 2014
concerning certain protective measures relating to African swine fever in Poland
o nekaterih zaščitnih ukrepih v zvezi z afriško prašičjo kugo na Poljskem
(notified under document C(2014) 1657)
(notificirano pod dokumentarno številko C(2014) 1657)
Accordingly, the infected territories in Poland should be listed in the Annex to this Decision and the duration of that regionalisation established in accordance with Article 15 of Directive 2002/60/EC.
Zato bi bilo treba v skladu s členom 15 Direktive 2002/60/ES v Prilogi k temu sklepu navesti okužena območja na Poljskem in določiti trajanje navedene regionalizacije.
Commission Implementing Decision 2014/100/EU [4] should be confirmed following consultation of the Standing Committee on the Food Chain and Animal Health.
Izvedbeni sklep Komisije 2014/100/EU [4] bi bilo treba potrditi po posvetovanju s Stalnim odborom za prehranjevalno verigo in zdravje živali.
Done at Brussels, 12 March 2014.
V Bruslju, 12. marca 2014
Commission Implementing Decision 2014/100/EU of 18 February 2014 concerning certain interim protective measures relating to African swine fever in Poland (OJ L 50, 20.2.2014, p. 35).
Izvedbeni sklep Komisije 2014/100/EU z dne 18. februarja 2014 o nekaterih zaščitnih ukrepih v zvezi z afriško prašičjo kugo na Poljskem (UL L 50, 20.2.2014, str. 35).
The following territories in the Republic of Poland:
Naslednja območja v Republiki Poljski:
in voivodship podlaskie: the poviat sejneński; in poviat augustowski, the municipalities of Płaska, Lipsk and Sztabin; the poviat sokólski; in poviat białostocki, the municipalities Czarna Białostocka, Supraśl, Zabłudów, Michałowo and Gródek; and the poviats hajnowski, bielski and siemiatycki,
v Podlaškem vojvodstvu: poviat sejneński; poviat augustowski: občine Płaska, Lipsk in Sztabin; poviat sokólski; poviat białostocki: občine Czarna Białostocka, Supraśl, Zabłudów, Michałowo in Gródek; ter poviat hajnowski, poviat bielski in poviat siemiatycki;
in voivodship mazowieckie: the poviat łosicki,
v Mazovijskem vojvodstvu: poviat łosicki;
in voivodship lubelskie: the poviats bialski, Biała Podlaska and włodawski.
v Lublinskem vojvodstvu: poviat bialski, poviat Biała Podlaska in poviat włodawski.
Council Decision No 136/2014/EU
Sklep Sveta št. 136/2014/EU
laying down rules and procedures to enable the participation of Greenland in the Kimberley Process certification scheme
o določitvi pravil in postopkov, ki omogočajo udeležbo Grenlandije v sistemu potrjevanja procesa Kimberley
The European Union is a participant in the Kimberley Process certification scheme for the international trade in rough diamonds (‘KP certification scheme’).
Evropska unija je udeleženec v sistemu potrjevanja procesa Kimberley za mednarodno trgovino s surovimi diamanti (v nadaljnjem besedilu: KP sistem potrjevanja).
As a participant it has to ensure that a certificate accompanies each shipment of rough diamonds imported into or exported from the territory of the Union.
Kot udeleženec mora zagotavljati, da vsako pošiljko surovih diamantov, ki se uvozi na ozemlje Unije ali se z njega izvozi, spremlja potrdilo.
Council Regulation (EC) No 2368/2002 [2] sets up a Union system of certification and import and export controls for rough diamonds for the purposes of implementing the KP certification scheme.
Uredba Sveta (ES) št. 2368/2002 [2] določa sistem, ki ga Unija uporablja pri potrjevanju ter uvoznem in izvoznem nadzoru nad surovimi diamanti za namene izvajanja KP sistema potrjevanja.
Greenland is not part of the Union territory but it is included in the list of overseas countries and territories set out in Annex II to the Treaty on the Functioning of the European Union (TFEU).
Grenlandija ni del ozemlja Unije, vendar je vključena v seznam čezmorskih držav in ozemelj, kakor so določeni v Prilogi II k Pogodbi o delovanju Evropske unije (PDEU).
In accordance with Article 198 TFEU, the purpose of the association of the overseas countries and territories with the Union is to promote the economic and social development of the overseas countries and territories and to establish close economic relations between them and the Union as a whole.
V skladu s členom 198 PDEU je namen pridruževanja čezmorskih držav in ozemelj k Uniji spodbujanje gospodarskega in socialnega razvoja čezmorskih držav in ozemelj ter vzpostavitev tesnih gospodarskih odnosov med njimi in Unijo kot celoto.
Denmark and Greenland have requested to enable the participation of Greenland in the KP certification scheme on rough diamonds through its cooperation with the Union.
Danska in Grenlandija sta zahtevali, da se Grenlandiji v okviru njenega sodelovanja z Unijo omogoči udeležba v KP sistemu potrjevanja za mednarodno trgovino s surovimi diamanti.
Such cooperation would strengthen economic relations between the Union and Greenland in the diamond industry, and in particular it would enable Greenland to export rough diamonds accompanied by the EU Certificate issued for the purposes of the certification scheme, with a view to promoting the economic development of Greenland.
Tako sodelovanje bi okrepilo gospodarske odnose med Unijo in Grenlandijo na področju industrije diamantov, Grenlandiji pa bi omogočila izvoz surovih diamantov, opremljenih s potrdilom EU, izdanim za namene sistema potrjevanja, kar naj bi spodbudilo gospodarski razvoj Grenlandije.
Trade in rough diamonds in Greenland should, therefore, be conducted in compliance with Union rules implementing the KP certification scheme for the international trade in rough diamonds.
Trgovino s surovimi diamanti na Grenlandiji bi bilo zato treba izvajati v skladu s pravili Unije o izvajanju KP sistema potrjevanja za mednarodno trgovino s surovimi diamanti.
Accordingly, the scope of application of Regulation (EC) No 2368/2002 will be extended by Regulation (EU) No 257/2014 of the European Parliament and of the Council [3] to the territory of Greenland for the purpose of the certification scheme.
V skladu s tem se bo z Uredbo (EU) št. 257/2014 Evropskega parlamenta in Sveta [3] za namene sistema potrjevanja področje uporabe Uredbe (ES) št. 2368/2002 razširilo na ozemlje Grenlandije.
In particular, Greenland should only export rough diamonds to other participants in the KP certification scheme after they have been certified by a Union authority listed in Annex III to Regulation (EC) No 2368/2002.
Grenlandija bi smela izvažati surove diamante v druge udeležence v KP sistemu potrjevanja le, ko bi pristojni organ Unije, naveden v Prilogi III k Uredbi (ES) št. 2368/2002, zanje izdal potrdilo.
Imports of rough diamonds into Greenland should also be verified by the Union authorities.
Uvoz surovih diamantov na Grenlandijo bi prav tako morali preverjati organi Unije.
In order to permit the international trade in rough diamonds in Greenland, in accordance with the rules on trade within the Union, Greenland should undertake to transpose the relevant provisions of Regulation (EC) No 2368/2002 into the national law of Greenland so as to allow the application of this Decision,
Da bi Grenlandiji omogočili mednarodno trgovino s surovimi diamanti v skladu s pravili na področju trgovine znotraj Unije, se mora Grenlandija zavezati, da bo v svoje nacionalno pravo prenesla ustrezne določbe Uredbe (ES) št. 2368/2002, da bi s tem omogočila uporabo tega sklepa –
This Decision sets out the general rules and conditions for the participation of Greenland in the system of certification and import and export controls for rough diamonds set out in Regulation (EC) No 2368/2002.
Ta sklep določa splošna pravila in pogoje za udeležbo Grenlandije v sistemu potrjevanja ter uvoznega in izvoznega nadzora nad surovimi diamanti, kakor so določeni v Uredbi (ES) št. 2368/2002.
To that end, this Decision lays down rules and procedures for the application of the Kimberley Process certification scheme (‘KP certification scheme’) for rough diamonds imported into or exported from Greenland, either to the Union or to other participants in the KP certification scheme.
Zato ta sklep določa pravila in postopke za uporabo sistema potrjevanja procesa Kimberley (v nadaljnjem besedilu: KP sistem potrjevanja) za surove diamante, uvožene na Grenlandijo ali izvožene z nje, bodisi v Unijo bodisi v druge udeležence v KP sistemu potrjevanja.
the definition of ‘Participant’ means ‘Participant’ as set out in point (c) of Article 2 of Regulation (EC) No 2368/2002;
„udeleženec“ pomeni „udeleženec“, kot je določeno v točki (c) člena 2 Uredbe (ES) št. 2368/2002;
the definition of ‘Union authority’ means the ‘Community authority’ as set out in point (f) of Article 2 of Regulation (EC) No 2368/2002;
„pristojni organ Unije“, pomeni „pristojni organ Skupnosti“, kot je določeno v točki (f) člena 2 Uredbe (ES) št. 2368/2002;
the definition of ‘EU certificate’ means the ‘Community certificate’ as set out in point (g) of Article 2 of Regulation (EC) No 2368/2002.
„potrdilo EU“ pomeni „potrdilo Skupnosti“, kot je določeno v točki (g) člena 2 Uredbe (ES) št. 2368/2002.
Greenland shall ensure that Regulation (EC) No 2368/2002 is transposed in the legislative provisions applicable to Greenland as regards the conditions and formalities for importing and exporting rough diamonds, their transit through the Union from and to a participant other than the Union, the participation of the Union, including Greenland, in the KP certification scheme, obligations relating to due diligence, anti-circumvention, exchange of information, and ensuring compliance with such provisions.
Grenlandija zagotovi, da se Uredba (ES) št. 2368/2002, kar zadeva pogoje in formalnosti za uvoz in izvoz surovih diamantov, njihov tranzit preko Unije od in do udeleženca, ki ni Unija, udeležbo Unije, vključno z Grenlandijo, v KP sistemu potrjevanja ter obveznosti glede primerne skrbnosti, preprečevanja izogibanja, izmenjave informacij in zagotavljanja spoštovanja teh določb, prenese v zakonodajo, ki se uporablja za Grenlandijo.
Greenland shall designate the authorities responsible for implementing the relevant provisions of Regulation (EC) No 2368/2002 within its territory and communicate to the Commission the designation and the contact details of such authorities.
Grenlandija določi organe, pristojne za izvajanje ustreznih določb Uredbe (ES) št. 2368/2002 na njenem ozemlju, ter Komisiji sporoči njihova imena in kontaktne podatke.
Import into the Union of rough diamonds mined or extracted in Greenland
Uvoz surovih diamantov, izkopanih ali pridobljenih na Grenlandiji, v Unijo
Rough diamonds mined or extracted in Greenland may be imported into the Union only where:
Surovi diamanti, izkopani ali pridobljeni na Grenlandiji, se lahko v Unijo uvozijo le, če:
they are accompanied by the attesting document referred to in paragraph 2;
jih spremlja potrdilo iz odstavka 2;
they are contained in tamper-resistant containers and the seals applied at export are not broken;
so shranjeni v posodah, zavarovanih pred posegi, pečati, nameščeni pri izvozu, pa niso pretrgani;
the attesting document referred to in paragraph 2 clearly identifies the consignment to which it refers;
v potrdilu iz odstavka 2 je jasno opredeljena pošiljka, na katero se nanaša;
the rough diamonds have not been previously exported to a participant other than the Union.
surovi diamanti niso bili predhodno izvoženi v udeleženca, ki ni Unija.
To allow rough diamonds mined or extracted in Greenland to be imported into the Union, the competent authority for Greenland listed in Annex II (‘Greenland authority’) shall upon request issue an attesting document conforming to the requirements set out in Annex I.
Da bi omogočil uvoz surovih diamantov, izkopanih ali pridobljenih na Grenlandiji, v Unijo, pristojni organ za Grenlandijo, naveden v Prilogi II (v nadaljnjem besedilu: organ Grenlandije), na zahtevo izda potrdilo, ki je v skladu z zahtevami iz Priloge I.
The Greenland authority shall deliver the attesting document to the applicant and shall keep a copy for three years for record-keeping purposes.
Organ Grenlandije potrdilo izroči kandidatu in v knjigovodske namene tri leta hrani izvod potrdila.
Acceptance of a customs declaration for release for free circulation pursuant to Council Regulation (EEC) No 2913/92 [4] of rough diamonds referred to in paragraph 1 of this Article shall be subject to the verification by a Union authority listed in Annex III to Regulation (EC) No 2368/2002 of the attesting document issued in accordance with paragraph 2 of this Article.
Sprejem carinske deklaracije za sprostitev v prosti promet v skladu z Uredbo Sveta (EGS) št. 2913/92 [4] za surove diamante iz odstavka 1 tega člena nadzira pristojni organ Unije, naveden v Prilogi III k Uredbi (ES) št. 2368/2002, pri čemer preveri potrdilo, izdano v skladu z odstavkom 2 tega člena.
To this effect, containers of rough diamonds mined or extracted in Greenland shall, on import to the Union, be submitted without delay for verification to an appropriate Union authority.
V ta namen so zabojniki s surovimi diamanti, izkopanimi ali pridobljeni na Grenlandiji, pri uvozu v Unijo nemudoma predloženi v preverjanje ustreznemu organu Unije.
If a Union authority establishes that the conditions in paragraph 1 are fulfilled, it shall confirm this on the original attesting document and provide the importer with an authenticated and forgery-resistant copy of that attesting document.
Če pristojni organ Unije ugotovi, da so pogoji iz odstavka 1 izpolnjeni, to potrdi na izvirniku potrdila ter uvozniku izda overjeno in pred ponarejanjem varno kopijo tega potrdila.
This confirmation procedure shall take place within ten working days of the submission of the attesting document.
Ta postopek potrditve se opravi v desetih delovnih dnevih po predložitvi potrdila;
The Member State into which rough diamonds are imported from Greenland shall ensure their submission to the appropriate Union authority.
Država članica, ki uvaža surove diamante z Grenlandije, zagotovi, da se ti predložijo ustreznemu pristojnemu organu Unije.
The exporter shall be responsible for the proper movement of the rough diamonds and the costs thereof.
Izvoznik je odgovoren za pravilno potovanje surovih diamantov in za stroške v zvezi s tem.
In case of doubts relating to the authenticity or correctness of an attesting document issued in accordance with paragraph 2, and in cases where further advice is required, the customs authorities shall contact the Greenland authority.
V primeru dvomov o pristnosti ali pravilnosti potrdila, izdanega v skladu z odstavkom 2, in v primerih kjer so potrebna dodatna navodila, carinski organi vzpostavijo stik z organom Grenlandije.
The Union authority shall keep the originals of attesting documents referred to in paragraph 2 submitted for verification for at least three years.
Pristojni organ Unije vsaj tri leta hrani izvirnike potrdil iz odstavka 2, ki so predložena v preverjanje.