natgillin/translations-raw huggingface dataset:
Pursuant to Regulation (EC) No 1451/2007, IPBC has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja IPBC glede uporabe v 8. vrsti izdelkov, pripravkih za zaščito lesa, kot je opredeljena v Prilogi V k Direktivi 98/8/ES.
Denmark was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 29 September 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Danska, ki je bila imenovana za državo članico poročevalko, je 29. septembra 2006 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 Komisiji poslala poročilo pristojnega organa in priporočilo.
It appears from the examinations made that biocidal products used as wood preservatives and containing IPBC may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Preiskave so pokazale, da je za biocidne pripravke, ki se uporabljajo kot pripravki za zaščito lesa in vsebujejo IPBC, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include IPBC in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing IPBC can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
Zato je primerno vključiti IPBC v Prilogo I, da se v vseh državah članicah v skladu s členom 16(3) Direktive 98/8/ES zagotovi, da se izdajo, spremenijo ali razveljavijo dovoljenja za biocidne pripravke, ki se uporabljajo kot pripravki za zaščito lesa in vsebujejo IPBC.
In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level to products containing IPBC and used as wood preservatives to ensure that risks are reduced to an acceptable level in accordance with Article 5 of Directive 98/8/EC and Annex VI thereto.
Glede na ugotovitve poročila o oceni je primerno zahtevati, da se v skladu s členom 5 Direktive 98/8/ES in Priloge VI k Direktivi pri izdaji dovoljenj za pripravke, ki vsebujejo IPBC in se uporabljajo za zaščito lesa, uporabijo ukrepi za zmanjšanje tveganja, da se tveganja zmanjšajo na sprejemljivo raven.
In particular, appropriate measures should be taken to protect the soil and aquatic compartments after application of the products since unacceptable risks in these compartments have been identified during the evaluation and products intended for industrial and/or professional use should be used with appropriate protective equipment if the risk identified for industrial and/or professional users cannot be reduced by other means.
Ker so bila pri presoji ugotovljena nesprejemljiva tveganja za tla in vodo, je zlasti treba sprejeti ustrezne ukrepe za varovanje teh predelov po uporabi pripravkov, pripravke, namenjene industrijski in/ali poklicni uporabi, pa je treba uporabljati z ustrezno zaščitno opremo, če tveganj za industrijske in/ali poklicne uporabnike ni mogoče zmanjšati z drugimi sredstvi.
It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance IPBC and also to facilitate the proper operation of the biocidal products market in general.
Pomembno je, da se določbe te direktive uporabljajo hkrati v vseh državah članicah, da se zagotovi enako ravnanje z biocidnimi pripravki na trgu, ki vsebujejo aktivno snov IPBC, in da se omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing IPBC to ensure that they comply with Directive 98/8/EC.
Državam članicam je treba po vključitvi dati na voljo ustrezno obdobje za izvedbo člena 16(3) Direktive 98/8/ES in zlasti za izdajo, spremembo ali razveljavitev dovoljenj za biocidne pripravke v 8. vrsti izdelkov, ki vsebujejo IPBC, da se zagotovi njihova skladnost z Direktivo 98/8/ES.
The following entry ‘No 11’ is inserted in Annex I to Directive 98/8/EC:
V Prilogo I k Direktivi 98/8/ES se vstavi naslednji vnos „št. 11“:
EC No: 259-627-5
št. ES: 259-627-5
CAS No: 55406-53-6
št. CAS: 55406-53-6
In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use, must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.
Glede na ugotovitve ocene tveganja je treba pripravke z dovoljenjem za industrijsko in/ali poklicno uporabo uporabljati z ustrezno osebno zaščitno opremo, razen če v vlogi za izdajo dovoljenja ni dokazano, da se tveganja za industrijske in/ali poklicne uporabnike lahko zmanjšajo na sprejemljivo raven z drugimi sredstvi.
In particular, labels and/or safety data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hardstanding to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.’
Zlasti se na oznakah in/ali varnostnih listih pripravkov, katerih uporaba je dovoljena v industriji, navede, da je treba sveže obdelani les po obdelavi hraniti pod streho ali na neprepustni trdni podlagi, da se prepreči neposredno spiranje pripravkov v tla ali vodo in se omogoči njihovo zbiranje za ponovno uporabo ali odstranitev.“
Commission Directive 2008/80/EC
Direktiva Komisije 2008/80/ES
amending Directive 98/8/EC of the European Parliament and of the Council to include cyclohexylhydroxydiazene 1-oxide, potassium salt (K-HDO) as an active substance in Annex I thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev kalijeve soli cikloheksilhidroksidiazen 1-oksida (K-HDO) kot aktivne snovi v Prilogo I k Direktivi
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market [2] establishes a list of active substances to be assessed, with a view to their possible inclusion in Annexes I, IA or IB to Directive 98/8/EC.
Uredba Komisije (ES) št. 1451/2007 z dne 4. decembra 2007 o drugi fazi desetletnega delovnega programa iz člena 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta o dajanju biocidnih pripravkov v promet [2] določa seznam aktivnih snovi, ki se ocenijo glede njihove možne vključitve v prilogo I, IA ali IB k Direktivi 98/8/ES.
That list includes cyclohexylhydroxydiazene 1-oxide, potassium salt (K-HDO).
Ta seznam vključuje kalijevo sol cikloheksilhidroksidiazen 1-oksida (K-HDO).
Pursuant to Regulation (EC) No 1451/2007, K-HDO has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja K-HDO glede uporabe v 8. vrsti izdelkov, pripravkih za zaščito lesa, kot je opredeljena v Prilogi V k Direktivi 98/8/ES.
Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 22 March 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Avstrija, ki je bila imenovana za državo članico poročevalko, je 22. marca 2006 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 Komisiji poslala poročilo pristojnega organa in priporočilo.
Although the risk assessment was limited to very specific application systems, it appears from the examinations made that biocidal products used as wood preservatives and containing K-HDO may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Čeprav je bila ocena tveganja omejena le na posebne vrste uporabe, so preiskave pokazale, da je za biocidne pripravke, ki se uporabljajo kot pripravki za zaščito lesa in vsebujejo K-HDO, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include K-HDO in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing K-HDO can be granted, modified or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
Zato je primerno vključiti K-HDO v Prilogo I, da se v vseh državah članicah v skladu s členom 16(3) Direktive 98/8/ES zagotovi, da se izdajo, spremenijo ali razveljavijo dovoljenja za biocidne pripravke, ki se uporabljajo kot pripravki za zaščito lesa in vsebujejo K-HDO.
In particular, in view of the possible risks for the environment and workers, authorisations for products to be used in other systems than industrial, fully automated and closed ones should not be granted unless the application for product authorisation demonstrates that risks can be reduced to acceptable levels in accordance with Article 5 of Directive 98/8/EC and Annex VI thereto.
Zlasti zaradi možnih tveganj za okolje in delavce se lahko dovoljenja za pripravke v skladu s členom 5 Direktive 98/8/ES in Priloge VI k Direktivi izdajo samo za uporabo v industrijskih, povsem avtomatiziranih in zaprtih sistemih, razen če ni v vlogi za izdajo dovoljenja dokazano, da se lahko tveganje zmanjša na sprejemljivo raven.
In the light of the findings of the assessment report, it is appropriate to require that products containing K-HDO be used with appropriate protective equipment.
Glede na ugotovitve poročila o oceni je primerno zahtevati, da se izdelki, ki vsebujejo K-HDO uporabljajo z ustrezno zaščitno opremo.
In view of the risks identified for infants, it is also appropriate to require that K-HDO not be used for the treatment of wood that may come in direct contact with infants.
Zaradi ugotovljenih tveganj za majhne otroke je primerno zahtevati, da se K-HDO ne uporablja za obdelavo lesa, ki bi lahko prišel v neposreden stik z majhnimi otroki.
It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance K-HDO and also to facilitate the proper operation of the biocidal products market in general.
Pomembno je, da se določbe te direktive uporabljajo hkrati v vseh državah članicah, da se zagotovi enako ravnanje z biocidnimi pripravki na trgu, ki vsebujejo aktivno snov K-HDO, in da se omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing K-HDO to ensure that they comply with Directive 98/8/EC.
Državam članicam je treba po vključitvi dati na voljo ustrezno obdobje za izvedbo člena 16(3) Direktive 98/8/ES in zlasti za izdajo, spremembo ali razveljavitev dovoljenj za biocidne pripravke v 8. vrsti izdelkov, ki vsebujejo K-HDO, da se zagotovi njihova skladnost z Direktivo 98/8/ES.
The following entry ‘No 10’ is inserted in Annex I to Directive 98/8/EC
V Prilogo I k Direktivi 98/8/ES se vstavi naslednji vnos „št. 10“:
EC No: n/a
št. ES: ne obstaja
CAS No: 66603-10-9
št. CAS: 66603-10-9
(This entry also covers the hydrated forms of K-HDO)
(Ta vnos vključuje tudi hidratne oblike K-HDO).
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.
Kadar je za določen pripravek to potrebno, države članice pri ocenjevanju vlog za izdajo dovoljenja za pripravek v skladu s členom 5 in Prilogo VI ocenijo tiste populacije, ki bi lahko bile izpostavljene pripravku, ter tiste scenarije uporabe in izpostavljenosti, ki niso bili reprezentativno obravnavani v oceni tveganja na ravni Skupnosti.
in view of the possible risks for the environment and workers, products shall not be used in other systems than industrial, fully automated and closed ones unless the application for product authorisation demonstrates that risks can be reduced to acceptable levels in accordance with Article 5 and Annex VI;
Zaradi možnih tveganj za okolje in delavce se pripravkov v skladu s členom 5 in Priloge VI k Direktivi ne sme uporabljati drugje kot samo v industrijskih, povsem avtomatiziranih in zaprtih sistemih, razen če ni v vlogi za izdajo dovoljenja dokazano, da se lahko tveganja zmanjšajo na sprejemljivo raven.
in view of the assumptions made during the risk assessment, products must be used with appropriate personal protective equipment, unless the application for product authorisation demonstrates that risks to users can be reduced to acceptable levels by other means;
Glede na ugotovitve ocene tveganja je treba pripravke uporabljati z ustrezno osebno zaščitno opremo, razen če ni v vlogi za izdajo dovoljenja dokazano, da je tveganje za uporabnike mogoče zmanjšati na sprejemljivo raven z drugimi sredstvi.
in view of the risk identified for infants, products shall not be used for the treatment of wood that may enter in direct contact with infants.’
Zaradi ugotovljenih tveganj za majhne otroke pripravkov ni dovoljeno uporabljati za obdelavo lesa, ki bi lahko prišel v neposreden stik z majhnimi otroki.“
Commission Directive 2008/81/EC
Direktiva Komisije 2008/81/ES
amending Directive 98/8/EC of the European Parliament and of the Council to include difenacoum as an active substance in Annex I thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev difenakuma kot aktivne snovi v Prilogo I k Direktivi
That list includes difenacoum.
Navedeni seznam vključuje difenakum.
Pursuant to Regulation (EC) No 1451/2007, difenacoum has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja difenakuma glede uporabe v 14. vrsti izdelkov, rodenticidih, kot je opredeljena v Prilogi V k Direktivi 98/8/ES.
Finland was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 21 March 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Finska, ki je bila imenovana za državo članico poročevalko, je 21. marca 2006 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2003 Komisiji poslala poročilo pristojnega organa in priporočilo.
In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 29 November 2007, in an assessment report.
V skladu s členom 15(4) Uredbe (ES) št. 1451/2007 so bile ugotovitve pregleda 29. novembra 2007 v Stalnem odboru za biocidne pripravke vključene v poročilo o oceni.
The review of difenacoum did not reveal any open questions or concerns to be addressed by the Scientific Committee on Health and Environmental Risks.
Med pregledom difenakuma se niso pojavila nobena odprta vprašanja ali razlogi za zaskrbljenost, ki bi jih moral obravnavati Znanstveni odbor za zdravstvena in okoljska tveganja.
It appears from the examinations made that biocidal products used as rodenticides and containing difenacoum may be expected not to present a risk to humans except for accidental incidents with children.
Preiskave so pokazale, da je za biocidne pripravke, ki se uporabljajo kot rodenticidi in vsebujejo difenakum, pričakovati, da za ljudi ne pomenijo tveganja, razen pri naključnih incidentih z otroki.
However, the target rodents are vermin and thus constitute a danger to public health.
Vendar spadajo ciljni glodalci med škodljivce in bi zato lahko ogrožali javno zdravje.
Moreover, it has not yet been established that adequate alternatives to difenacoum exist, which are both equally effective and less damaging to the environment.
Poleg tega še ni bilo ugotovljeno, ali za difenakum obstajajo ustrezne nadomestne snovi, ki bi bile enako učinkovite in okolju manj škodljive.
It is therefore justified to include difenacoum in Annex I for a limited period, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing difenacoum can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
Zato je upravičeno vključiti difenakum v Prilogo I za omejeno obdobje, da se v vseh državah članicah v skladu s členom 16(3) Direktive 98/8/ES zagotovi, da se izdajo, spremenijo ali razveljavijo dovoljenja za biocidne pripravke, ki se uporabljajo kot rodenticidi in vsebujejo difenakum.
In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing difenacoum and used as rodenticides.
Glede na ugotovitve poročila o oceni je primerno zahtevati, da se pri izdaji dovoljenja za pripravek, ki vsebuje difenakum in se uporablja kot rodenticid, uporabijo posebni ukrepi za zmanjšanje tveganja.
Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals as well as the long-term effects of the substance on the environment.
Namen teh ukrepov je omejiti tveganje primarnega in sekundarnega izpostavljanja ljudi in neciljnih živali ter dolgoročne učinke snovi na okolje.
Because of the identified risks and its characteristics, which render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate difenacoum should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.
Zaradi ugotovljenih tveganj in značilnosti difenakuma, ki je potencialno obstojen, se lahko kopiči v organizmih in je strupen ali zelo obstojen in se zelo lahko kopiči v organizmih, ga je treba vključiti v Prilogo I samo za pet let, pred njegovo ponovno vključitvijo pa je treba v skladu z drugim pododstavkom člena 10(5)(i) Direktive 98/8/ES izvesti primerljivo oceno tveganja.
It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance difenacoum and also to facilitate the proper operation of the biocidal products market in general.
Pomembno je, da se določbe te direktive uporabljajo hkrati v vseh državah članicah, da se zagotovi enako ravnanje z biocidnimi pripravki na trgu, ki vsebujejo aktivno snov difenakum, in da se omogoči ustrezno delovanje trga biocidnih pripravkov na sploh.
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing difenacoum to ensure that they comply with Directive 98/8/EC.
Državam članicam je treba po vključitvi dati na voljo ustrezno obdobje za izvedbo člena 16(3) Direktive 98/8/ES in zlasti za izdajo, spremembo ali razveljavitev dovoljenj za biocidne pripravke v 14. vrsti izdelkov, ki vsebujejo difenakum, da se zagotovi njihova skladnost z Direktivo 98/8/ES.
Member States shall adopt and publish, by 31 March 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 31. marca 2009.
They shall apply those provisions from 1 April 2010.
Navedene predpise uporabljajo od 1. aprila 2010.
The following entry ‘No 9’ is inserted in Annex I to Directive 98/8/EC:
V Prilogo I k Direktivi 98/8/ES se vstavi naslednji vnos „št. 9“:
EC No: 259-978-4
št. ES: 259-978-4
CAS No: 56073-07-5
št. CAS: 56073-07-5
In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.
Zaradi značilnosti aktivne snovi, ki je potencialno obstojna, se lahko kopiči v organizmih in je strupena ali zelo obstojna in se zelo lahko kopiči v organizmih, je treba pred njeno ponovno vključitvijo izvesti primerjalno oceno tveganja v skladu z drugim pododstavkom člena 10(5)(i) Direktive 98/8/ES.
The nominal concentration of the active substance in the products shall not exceed 75 mg/kg and only ready-for-use products shall be authorised.
Nazivna koncentracija aktivne snovi v pripravkih ne presega 75 mg/kg, dovoljenje pa se izda samo za pripravke, pripravljene za uporabo.
Products shall contain an aversive agent and, where appropriate, a dye.
Pripravki vsebujejo averzivno sredstvo in po potrebi barvilo.
Products shall not be used as tracking powder.
Pripravek se ne uporablja kot sredstvo za posipanje.
Commission Directive 2008/82/EC
Direktiva Komisije 2008/82/ES
amending Directive 2008/38/EC as regards feedingstuffs intended for the support of the renal function in case of chronic renal insufficiency
o spremembi Direktive 2008/38/ES v zvezi s krmo, namenjeno za pomoč delovanju ledvic v primeru kronične renalne insuficience
Commission Directive 2008/38/EC of 5 March 2008 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes [2] includes as a particular nutritional purpose the ‘support of renal function in case of chronic renal insufficiency’.
V Direktivi Komisije 2008/38/ES z dne 5. marca 2008 o uvedbi seznama predvidenih vrst uporabe krme za posebne prehranske namene [2] je med posebnimi prehranskimi nameni navedena „pomoč delovanju ledvic v primeru kronične renalne insuficience“.
By Regulation (EC) No 163/2008 [3], the Commission authorised the preparation lanthanum carbonate octahydrate as a zootechnical feed additive for cats.
Z Uredbo (ES) št. 163/2008 [3] je Komisija izdala dovoljenje za pripravek lantanov karbonat oktahidrat kot zootehnični krmni dodatek za mačke.
This authorisation was based on an opinion of the European Food Safety Authority of 18 September 2007 [4].
Ta izdaja dovoljenja temelji na mnenju Evropske agencije za varnost hrane z dne 18. septembra 2007 [4].
In that opinion that Authority considered that supplementation of diets with that preparation results in a decrease in phosphorus excretion via urine and an increase in its excretion via faeces, linked to a decrease in apparent phosphorus digestibility.
V svojem mnenju je navedena agencija menila, da dodatek navedenega pripravka v prehrano zmanjšuje izločanje fosforja s sečnino in povečuje njegovo izločanje z blatom, zaradi česar se poslabša prava prebavljivost fosforja.
It concluded that that preparation can reduce the phosphorus absorption of adult cats.
Sklenila je, da uživanje pripravka lahko zmanjša absorbcijo fosforja pri odraslih mačkah.
Directive 2008/38/EC already includes feed with a low level of phosphorus in the line ‘support of renal function in case of chronic renal insufficiency’.
Direktiva 2008/38/ES že vključuje krmo z nizko vsebnostjo fosforja v vrstici „pomoč delovanju ledvic v primeru kronične renalne insuficience“.