natgillin/translations-raw huggingface dataset:
Germany also considered that, since the ratio of the active substances and non-active substances in the working solutions of the product is variable, the product does not meet the definition of biocidal products in Article 2(a) of Directive 98/8/EC and should have been authorised as a frame formulation as defined by Article 2(j) of Directive 98/8/EC.
V oceni, ki jo je opravila Nemčija, je bilo ugotovljeno nesprejemljivo tveganje za okolje na 30. dan po uporabi proizvoda (v nadaljnjem besedilu: čas 1), kar je zbujalo pomisleke tudi glede morebitne uporabe lesa, obdelanega s spornim proizvodom, na podlagi pogojev razredov uporabe 2 in 3.
The Commission invited 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.
Poleg tega je Nemčija menila, da proizvod zaradi spremenljivega razmerja med aktivnimi in neaktivnimi snovmi v delovni raztopini ne ustreza opredelitvi biocidnih pripravkov iz člena 2(a) Direktive 98/8/ES in bi mu moralo biti izdano dovoljenje kot okvirni formulaciji, kakor je opredeljena s členom 2(j) Direktive 98/8/ES.
Comments were submitted within that deadline by Germany, The United Kingdom and the applicant.
Komisija je povabila druge države članice in vlagatelja, naj predložijo pisne pripombe na obvestilo v 90 dneh v skladu s členom 27(1) Direktive 98/8/ES.
The notification was also discussed on 24 September 2013 in the meeting of the coordination group established under Article 35 of Regulation (EU) No 528/2012.
Nemčija, Združeno kraljestvo in vlagatelj so pripombe predložili v navedenem roku.
With regard to the risks for the environment, from those discussions and comments it follows that the evaluation carried out by the United Kingdom, in the absence of an agreed model for temporary wood protection, followed the best guidance available at the time [7], which is based on models for treated wood to be placed on the market under Use Classes 2 and 3 conditions.
O obvestilu so razpravljali tudi 24. septembra 2013 na sestanku koordinacijske skupine, ustanovljene s členom 35 Uredbe (EU) št. 528/2012.
The assessment was also based on a worst-case assumption of a complete release of the active substances at time 1.
Glede tveganj za okolje je iz navedenih razprav in pripomb razvidno, da je ocena, ki jo je opravilo Združeno kraljestvo, brez dogovorjenega modela za začasno zaščito lesa upoštevala najboljše smernice, ki so bile v danem trenutku na voljo [7] in temeljijo na modelih za dajanje obdelanega lesa na trg na podlagi pogojev razredov uporabe 2 in 3.
It also follows that the evaluation performed by the United Kingdom following those models is compatible with current guidance [8].
Ocena je temeljila tudi na najslabšem scenariju popolne sprostitve aktivnih snovi v okolje v času 1.
Where a risk is identified at time 1 as a result of a worst-case assumption, safe use of treated wood under Use Classes 2 and 3 conditions can be assumed when the risk for the environment at the end of the service life is considered acceptable.
Poleg tega je razvidno, da je ocena, ki jo je opravilo Združeno kraljestvo na podlagi navedenih modelov, skladna s trenutnimi smernicami [8].
The Commission also notes that cases where an unacceptable risk is identified at time 1 are currently under discussion at Union level in order to establish a harmonised approach.
Kjer je na podlagi najslabšega scenarija ugotovljeno tveganje v času 1, se lahko predvideva varna uporaba obdelanega lesa na podlagi pogojev razredov uporabe 2 in 3, kadar velja tveganje za okolje na koncu življenjske dobe za sprejemljivo.
Against this background the Commission considers that, until such an approach is formally adopted, the conclusions of the assessment of the contested product by the United Kingdom should be considered as valid until the renewal of the product authorisation.
Komisija ugotavlja tudi, da se o primerih, kjer je v času 1 ugotovljeno nesprejemljivo tveganje, trenutno razpravlja na ravni Unije, da bi se določil usklajen pristop.
With regard to the identity of the product, from those discussions and comments it follows that the contested product, in the form in which it is supplied to the industrial users, has specific fixed concentrations of the active and non-active substances.
Glede na navedeno Komisija meni, da se do uradnega sprejetja takšnega pristopa ugotovitve ocene spornega proizvoda, ki jo je pripravilo Združeno kraljestvo, štejejo za veljavne do obnovitve dovoljenja za proizvod.
The Commission considers that the fact that industrial users can prepare different solutions of the product at the work place, which are process dependant, cannot be interpreted in a way as if the authorisation holder was placing on the market a group of different biocidal products as referred to in Article 2(j) of Directive 98/8/EC.
Glede identitete proizvoda je iz navedenih razprav in pripomb razvidno, da ima sporni proizvod v obliki, v kakršni se dostavi industrijskim uporabnikom, posebne nespremenljive koncentracije aktivnih in neaktivnih snovi.
In the light of those arguments, the Commission supports the conclusions of the evaluation carried out by the United Kingdom and the other Member States having approved the product through mutual recognition, considering that the contested product meets the definition in Article 2(a) of Directive 98/8/EC and fulfils the requirements set by Article 5(1) of that Directive with regard to the environment.
Komisija meni, da dejstva, da lahko industrijski uporabniki na delovnem mestu pripravijo različne raztopine proizvoda, ki so odvisne od postopka, ni mogoče razlagati tako, da je imetnik dovoljenja dajal na trg skupino različnih biocidnih proizvodov, kot je navedeno v členu 2(j) Direktive 98/8/ES.
The Commission therefore considers that the request by Germany to refuse the authorisation cannot be justified on the grounds put forward.
Z vidika navedenih utemeljitev Komisija podpira ugotovitve ocene, ki so jo izvedli Združeno kraljestvo in druge države članice, ki so medsebojno odobrile proizvod, saj meni, da sporni proizvod ustreza opredelitvi iz člena 2(a) Direktive 98/8/ES in izpolnjuje zahteve iz člena 5(1) navedene direktive v zvezi z okoljem.
Finally, on the basis of the discussions held, it appears necessary to explicitly mention in the product authorisation that the use of the product is for temporary wood protection and to ensure, as a condition for the authorisation, that specific instructions for use of the product are provided to industrial users taking into consideration the characteristics of the industrial sites where the product is to be used.
Zato Komisija meni, da zahtevka Nemčije za zavrnitev izdaje dovoljenja ni mogoče utemeljiti na podlagi predloženih razlogov.
Regulation (EU) No 528/2012 applies to the contested product in accordance with the provisions of Article 92(2) of that Regulation.
Poleg tega se na podlagi dosedanjih razprav zdi potrebno, da se v dovoljenju za proizvod izrecno navede, da je proizvod namenjen začasni zaščiti lesa, in da se kot pogoj za izdajo dovoljenja zagotovi, da so industrijskim uporabnikom na voljo posebna navodila za uporabo proizvoda, pri čemer se upoštevajo značilnosti industrijskih objektov, v katerih se bo proizvod uporabljal.
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.
Uredba (EU) št. 528/2012 se za sporni proizvod uporablja v smislu določb člena 92(2) navedene uredbe.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,
Ker je pravna podlaga za ta sklep člen 36(3) navedene uredbe, bi moral biti ta sklep naslovljen na vse države članice v smislu člena 36(4) navedene uredbe.
HAS ADOPTED THIS DECISION:
Ukrepi iz tega sklepa so v skladu z mnenjem Stalnega odbora za biocidne pripravke –
This Decision applies to products identified by the following application reference number in the Reference Member State, as provided for by the Register for Biocidal Products:
Člen 1
Article 2
Ta sklep se uporablja za proizvode, ki imajo v referenčni državi članici naslednjo referenčno številko vloge, kakor je določena v registru biocidnih pripravkov:
The proposal by Germany to refuse the authorisation granted by the United Kingdom on 7 June 2012 of the products referred to in Article 1, is rejected.
Člen 2
Article 3
Predlog Nemčije za zavrnitev izdaje dovoljenja, ki ga je Združeno kraljestvo 7. junija 2012 izdalo za proizvode, navedene v členu 1, se zavrne.
The intended use described in the product authorisation shall be amended as follows:
Člen 3
‘For temporary wood protection use against wood staining fungi and surface moulds on freshly sawn/felled wood and unseasoned timber only.
Predvidena uporaba, opisana v dovoljenju za proizvod, se spremeni na naslednji način:
Wood treated with this product can be used for Use Classes 2 and 3 (i.e. timbers not in ground contact, either continually exposed to the weather or protected from the weather but subject to frequent wetting).’ .
„Za začasno zaščito lesa pred glivami, ki spreminjajo barvo lesa, in površinskimi plesnimi samo na sveže žaganem/posekanem in neposušenem lesu.
Article 4
Les, obdelan s tem proizvodom, se lahko uporabi za razreda uporabe 2 in 3 (tj. les, ki ni v stiku s tlemi in je trajno izpostavljen vremenskim pojavom oziroma zaščiten pred vremenskimi pojavi, vendar pogosto izpostavljen vlagi).“
The following condition for authorisation is imposed to the products referred to in Article 1:
Člen 4
‘As a condition of the authorisation, the authorisation holder must ensure that detailed instructions for use of the product, taking into account the characteristics of the industrial site where the product is to be used, are provided to users at the site of application.’ .
Za proizvode iz člena 1 se uvede naslednji pogoj za izdajo dovoljenja:
Article 5
„Kot pogoj za izdajo dovoljenja mora imetnik dovoljenja zagotoviti, da so uporabnikom na kraju uporabe na voljo podrobna navodila za uporabo proizvoda, ki upoštevajo značilnosti industrijskega objekta, v katerem se bo proizvod uporabljal.“
This Decision is addressed to the Member States.
Člen 5
Done at Brussels, 29 October 2014.
Ta sklep je naslovljen na države članice.
For the Commission
V Bruslju, 29. oktobra 2014
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 (OJ L 123, 24.4.1998, p. 1).
UL L 167, 27.6.2012, str. 1.
Commission Directive 2008/78/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include propiconazole as an active substance in Annex I thereto (OJ L 198, 26.7.2008, p. 44).
Direktiva 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet (UL L 123, 24.4.1998, str. 1).
Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include IPBC as an active substance in Annex I thereto (OJ L 200, 29.7.2008, p. 12).
Direktiva Komisije 2008/78/ES z dne 25. julija 2008 o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev propikonazola kot aktivne snovi v Prilogo I k Direktivi (UL L 198, 26.7.2008, str. 44).
Commission Directive 2008/86/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include tebuconazole as an active substance in Annex I thereto (OJ L 239, 6.9.2008, p. 9).
Direktiva Komisije 2008/79/ES z dne 28. julija 2008 o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev IPBC kot aktivne snovi v Prilogo I k Direktivi (UL L 200, 29.7.2008, str. 12).
Available on the website http://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg-product-evaluation_en.pdf
Direktiva Komisije 2008/86/ES z dne 5. septembra 2008 o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev tebukonazola kot aktivne snovi v Prilogo I k Direktivi (UL L 239, 6.9.2008, str. 9).
See OECD Emission Scenario Documents (EDS) for Wood Preservatives:
Na voljo na spletišču http://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg-product-evaluation_en.pdf.
Part 1 — 4 (2003), available on the website http://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents
Glej dokumente OECD o scenarijih emisij (Emission Scenario Documents – EDS) za pripravke za zaščito lesa:
amending Annex III to Decision 2007/777/EC as regards animal health requirements for Trichinella in the model veterinary certificate for imports into the Union of certain meat products derived from domestic porcine animals
o spremembi Priloge III k Odločbi 2007/777/ES glede zahtev za zdravje živali v zvezi s trihinelo v vzorcu veterinarskega spričevala za uvoz v Unijo nekaterih mesnih izdelkov, pridobljenih iz domačih prašičev
(notified under document C(2014) 7921)
(notificirano pod dokumentarno številko C(2014) 7921)
Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption [1], and in particular Article 9(4) thereof,
ob upoštevanju Direktive Sveta 2002/99/ES z dne 16. decembra 2002 o predpisih v zvezi z zdravstvenim varstvom živali, ki urejajo proizvodnjo, predelavo, distribucijo in uvoz proizvodov živalskega izvora, namenjenih prehrani ljudi [1], in zlasti člena 9(4) Direktive,
Commission Decision 2007/777/EC [2] lays down, inter alia, the model certificates for imports into the Union of certain meat products.
Odločba Komisije 2007/777/ES [2] med drugim določa vzorce spričeval za uvoz v Unijo nekaterih mesnih izdelkov.
It provides that only consignments of meat products complying with the requirements of the model animal and public health certificate set out in Annex III in that Decision are imported into the Union.
Določa, da se lahko v Unijo uvozijo samo pošiljke mesnih izdelkov, ki izpolnjujejo zahteve iz vzorca veterinarskega spričevala in spričevala o zdravstveni ustreznosti iz Priloge III k navedeni odločbi.
That model includes guarantees for Trichinella.
Navedeni vzorec vključuje jamstva za trihinelo.
Commission Regulation (EC) No 2075/2005 [3] lays down rules for the sampling of carcases of species susceptible to Trichinella infection and for the determination of the status of holdings keeping domestic swine.
Uredba Komisije (ES) št. 2075/2005 [3] določa pravila za vzorčenje trupov vrst, ki so dovzetne za okužbo s trihinelo, in za določanje statusa gospodarstev, na katerih se gojijo domači prašiči.
Commission Regulation (EU) No 216/2014 [4] amending Regulation (EC) No 2075/2005 grants derogation from testing provisions at slaughter to holdings which are officially recognised as applying controlled housing conditions.
Uredba Komisije (EU) št. 216/2014 [4] o spremembi Uredbe (ES) št. 2075/2005 določa odstopanje od določb o testiranju pri zakolu na gospodarstvih, ki so uradno priznana kot gospodarstva, ki uporabljajo nadzorovane pogoje bivanja.
In addition, the Regulation (EU) No 216/2014 lays down that a holding where domestic swine are kept, can only be recognised as applying controlled housing conditions if, inter alia, the food business operator introduces new domestic swine onto this holding only if they come from other holdings also officially recognised as applying controlled housing conditions.
Poleg tega Uredba (EU) št. 216/2014 določa, da se lahko gospodarstvo, na katerem se gojijo domači prašiči, prizna kot gospodarstvo, ki uporablja nadzorovane pogoje bivanja, le če nosilec živilske dejavnosti med drugim vnese na to gospodarstvo le nove domače prašiče, ki prihajajo iz drugih gospodarstev, prav tako uradno priznanih kot gospodarstva, ki uporabljajo nadzorovane pogoje bivanja.
The model animal and public health certificate set out in Annex III to Decision 2007/777/EC should be amended to reflect the requirements relating to imports of meat products laid down in Regulation (EC) No 2075/2005, as amended by Regulation (EU) No 216/2014.
Vzorec veterinarskega spričevala in spričevala o zdravstveni ustreznosti iz Priloge III k Odločbi 2007/777/ES bi bilo treba spremeniti, da bo odražal zahteve glede uvoza mesnih izdelkov iz Uredbe (ES) št. 2075/2005, kakor je bila spremenjena z Uredbo (EU) št. 216/2014.
To avoid any disruption of imports into the Union of consignments of meat products from domestic porcine animals, the use of certificates issued in accordance with Decision 2007/777/EC in its version prior to the amendments being introduced by this Decision should be authorised during a transitional period subject to certain conditions.
Za preprečitev motenj pri uvozu v Unijo pošiljk mesnih izdelkov iz domačih prašičev bi bilo treba v prehodnem obdobju pod nekaterimi pogoji odobriti uporabo spričeval, izdanih v skladu z Odločbo 2007/777/ES v različici pred spremembami, ki jih uvaja ta sklep.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Ukrepi iz tega sklepa so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
The model animal and public health certificate in Annex III to Decision 2007/777/EC is amended as follows:
Vzorec veterinarskega spričevala in spričevala o zdravstveni ustreznosti iz Priloge III k Odločbi 2007/777/ES se spremeni:
point II.2.3.1 is replaced by the following:
točka II.2.3.1 se nadomesti z naslednjim:
‘either
„bodisi
the meat products have been obtained from domestic porcine animals meat which either has been subject to an examination for trichinosis with negative results or has been subject to a cold treatment in accordance with Regulation (EC) No 2075/2005;]
so bili mesni izdelki pridobljeni iz mesa domačih prašičev, ki je bilo pregledano na trihinozo, rezultati pa so bili negativni, ali je bilo obdelano s postopkom hlajenja v skladu z Uredbo (ES) št. 2075/2005;
in Part II of the Notes, the following footnote is added after footnote (5):
Uporablja se le za tretje države z navedbo ‚K‘ v stolpcu ‚PJ‘ dela 1 Priloge II k Uredbi (ES) št. 206/2010.“
Only for third countries with the entry “K” in column “SG” in Part 1 of Annex II to Regulation (EU) No 206/2010.’ .
Člen 2
Article 2
V prehodnem obdobju do 31. marca 2015 se lahko še naprej v Unijo vnašajo pošiljke mesnih izdelkov, ki jih spremlja ustrezno spričevalo, izdano najpozneje 1. marca 2015 v skladu z vzorcem veterinarskega spričevala in spričevala o zdravstveni ustreznosti iz Priloge III k Odločbi 2007/777/ES v različici, ki je veljala pred začetkom veljavnosti tega sklepa.
For a transitional period until 31 March 2015, consignments of meat products accompanied by the relevant certificate issued no later than 1 March 2015 in accordance with the model animal and public health certificate set out in Annex III to Decision 2007/777/EC in its version before the entry into force of this Decision, may continue to be introduced into the Union.
Člen 3
This Decision is addressed to the Member States.
V Bruslju, 29. oktobra 2014
Done at Brussels, 29 October 2014.
Za Komisijo
Member of the Commission
UL L 18, 23.1.2003, str. 11.
OJ L 18, 23.1.2003, p. 11.
Odločba Komisije 2007/777/ES z dne 29. novembra 2007 o pogojih v zvezi z zdravstvenim varstvom živali in javnozdravstvenim varstvom ter vzorcih spričeval za uvoz iz tretjih držav nekaterih mesnih izdelkov in obdelanih želodcev, mehurjev in črev za prehrano ljudi in o razveljavitvi Odločbe 2005/432/ES (UL L 312, 30.11.2007, str. 49).
Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC (OJ L 312, 30.11.2007, p. 49).
Uredba Komisije (ES) št. 2075/2005 z dne 5. decembra 2005 o določitvi posebnih predpisov za uradni nadzor trihinel v mesu (UL L 338, 22.12.2005, str. 60).
Commission Regulation (EC) No 2075/2005 of 5 December 2005 laying down specific rules on official controls for Trichinella in meat (OJ L 338, 22.12.2005, p. 60).
Uredba Komisije (EU) št. 216/2014 z dne 7. marca 2014 o spremembi Uredbe (ES) št. 2075/2005 o določitvi posebnih predpisov za uradni nadzor trihinele v mesu (UL L 69, 8.3.2014, str. 85).
Commission Regulation (EU) No 216/2014 of 7 March 2014 amending Regulation (EC) No 2075/2005 laying down specific rules on official controls of Trichinella in meat (OJ L 69, 8.3.2014, p. 85).
so bili mesni izdelki pridobljeni iz mesa domačih prašičev, ki bodisi prihajajo z gospodarstva, uradno priznanega kot gospodarstvo, ki uporablja nadzorovane pogoje bivanja v skladu s členom 8 Uredbe (ES) št. 2075/2005 bodisi niso odstavljeni in so mlajši od 5 tednov;]“
on a measure taken by Germany in accordance with Article 7 of Council Directive 89/686/EEC withdrawing from the market and prohibiting the placing on the market of heat protection suits ‘Hitzeschutzanzug FW Typ 3’
o ukrepu, ki ga je sprejela Nemčija v skladu s členom 7 Direktive Sveta 89/686/EGS za umik s trga in prepoved dajanja na trg zaščitne obleke „Hitzeschutzanzung FW Typ 3“
(notified under document C(2014) 7977)
(notificirano pod dokumentarno številko C(2014) 7977)
In January 2014, the German authorities notified to the Commission a measure of withdrawal from the market and prohibition of placing on the market of a heat protection suit model ‘Hitzeschutzanzug FW Typ 3’ manufactured by KONTEX Textile Hitze- und Isolierprodukte GmbH, Olgastrasse 46-48, 73614 Schorndorf (Germany)
Januarja 2014 so nemški organi obvestili Komisijo o sprejetju ukrepa o umiku s trga in prepovedi dajanja na trg zaščitne obleke pred vročino modela „Hitzeschutzanzug FW Typ 3“, ki ga izdeluje družba KONTEX Textile Hitze- und Isolierprodukte GmbH, Olgastrasse 46–48, 73614 Schorndorf (Nemčija)
The products bore CE marking, according to Directive 89/686/EEC on personal protective equipment, having been tested and type-examined according to harmonised standard EN 1486:2007 Protective clothing for fire-fighters — Test method and requirements for reflective clothing for specialised fire-fighting.
Izdelek je imel oznako CE v skladu z Direktivo 89/686/EGS o osebni zaščitni opremi, bil je preverjen, narejen je imel ES-tipski preskus v skladu s harmoniziranim standardom EN 1486:2007 Zaščitna obleka za gasilce – Preskusne metode in zahteve za odsevno obleko za posebne načine gašenja požarov.
Protective clothing for fire-fighters is personal protective equipment (PPE) classified as Certification Category III.
Zaščitna obleka za gasilce je osebna zaščitna oprema (OZO), razvrščena v III. kategorijo certificiranja.
PPE of this kind, which is designed to protect against fatal hazards or serious and irreversible risks to health, the direct effect of which the manufacturer assumes that users will be unable to recognise in time, are subject to an EC type-approval examination and an EC quality assurance check by the notified body commissioned by the manufacturer.
OZO te vrste, ki je zasnovana za zaščito pred smrtno nevarnostjo ali resnim tveganjem za zdravje z nepopravljivimi posledicami, ki jih po mnenju proizvajalca uporabniki ne morejo pravočasno prepoznati, so predmet ES-pregleda tipa in preverjanja za zagotavljanje kakovosti ES s strani priglašenega organa po naročilu proizvajalca.
The audit carried out by the Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA — Institute for Occupational Health and Safety of the German Statutory Accident Insurance Fund) in St Augustin (test ref.
Revizija, ki jo je opravil Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA – Inštitut za zdravje in varnost pri delu nemške zavarovalnice za obvezno nezgodno zavarovanje) v St.