natgillin/translations-raw huggingface dataset:
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2011 at the latest, with the exception of the provisions of paragraph 3 of Annex II, which shall apply as of 31 December 2013.
Države članice najpozneje do 31. decembra 2011 sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, razen določb odstavka 3 Priloge II, ki se uporabljajo od 31. decembra 2013.
Commission Directive 2010/50/EU
Direktiva Komisije 2010/50/EU
amending Directive 98/8/EC of the European Parliament and of the Council to include dazomet as an active substance in Annex I thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev dazometa kot aktivne snovi v Prilogo I k Direktivi
That list includes dazomet.
Navedeni seznam vključuje dazomet.
Pursuant to Regulation (EC) No 1451/2007, dazomet 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 that Directive.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja dazometa glede uporabe v 8. vrsti izdelkov, pripravkih za zaščito lesa, kot je opredeljena v Prilogi V k navedeni direktivi.
Belgium was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission by 16 April 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Belgija je bila imenovana za državo članico poročevalko in je do 16. aprila 2007 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 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 11 March 2010, in an assessment report.
V skladu s členom 15(4) Uredbe (ES) št. 1451/2007 so bile ugotovitve pregleda z dne 11. marca 2010 v Stalnem odboru za biocidne pripravke vključene v poročilo o oceni.
It appears from the examinations made that biocidal products used as wood preservatives and containing dazomet 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 dazomet, pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include dazomet in Annex I to that Directive.
Zato je primerno vključiti dazomet v Prilogo I k navedeni direktivi.
Not all potential uses have been evaluated at EU level.
Na ravni EU ni bila opravljena presoja vseh možnosti uporabe.
The EU level risk assessment addresses only professional use outdoors for the remedial treatment of wooden poles, such as transmission poles, by insertion of granules.
Ocena tveganja na ravni EU obravnava le poklicno uporabo na odprtem za sanacijo lesenih drogov, kot so drogovi za napeljavo, z vstavitvijo granul.
It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to the compartments and populations that have not been representatively addressed in the EU level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
Zato je primerno, da države članice ocenijo scenarije uporabe ali izpostavljenosti in tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na ravni EU, ter da pri izdaji dovoljenj za pripravke zagotovijo, da se sprejmejo ustrezni ukrepi ali naložijo posebni pogoji za zmanjšanje ugotovljenih tveganj na sprejemljivo raven.
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 dazomet 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 dazomet in se uporabljajo za zaščito lesa, uporabijo ukrepi za zmanjšanje tveganja, da se tveganja zmanjšajo na sprejemljivo raven.
In particular, it is appropriate to require that products intended for industrial or professional use be used with appropriate personal protective equipment, unless it can be demonstrated that risks for industrial or professional users can be reduced by other means.
Zlasti je primerno zahtevati, da se pripravki, namenjeni industrijski ali poklicni uporabi, uporabljajo z ustrezno osebno zaščitno opremo, razen če se lahko dokaže, da je tveganje za industrijske ali poklicne uporabnike mogoče kako drugače zmanjšati.
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 dazomet 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 dazomet, 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.
Po vključitvi je državam članicam treba dovoliti razumno dolgo obdobje za izvedbo člena 16(3) Direktive 98/8/ES.
Member States shall adopt and publish, by 31 July 2011 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. julija 2011.
They shall apply those provisions from 1 August 2012.
Navedene določbe se uporabljajo od 1. avgusta 2012.
In Annex I to Directive 98/8/EC, the following entry for the substance dazomet is added:
V Prilogi I k Direktivi 98/8/ES se doda snov dazomet:
Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)
Rok za uskladitev s členom 16(3) (razen za pripravke, ki vsebujejo več kot eno aktivno snov, za katero je rok za uskladitev s členom 16(3) enak roku, določenemu v zadnji odločitvi o vključitvi aktivnih snovi)
EC No: 208-576-7
ES št.: 208-576-7
CAS No: 533-74-4
Št. CAS: 533-74-4
1 August 2012
avgust 2012
31 July 2014
julij 2014
31 July 2022
julij 2022
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, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the EU level risk assessment.
Kadar je za določen pripravek to potrebno, države članice pri ocenjevanju vloge za izdajo dovoljenja za pripravek v skladu s členom 5 in Prilogo VI ocenijo tiste scenarije uporabe ali izpostavljenosti ter tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na ravni EU.
In particular, where relevant, Member States shall assess any other use than professional use outdoors for the remedial treatment of wooden poles by insertion of granules.
Predvsem, kjer je pomembno, države članice ocenijo vse vrste uporabe, razen poklicne uporabe na odprtem za sanacijo lesenih drogov z vstavitvijo granul.
Member States shall ensure that authorisations are subject to the following condition:
Države članice zagotovijo, da so za izdajo dovoljenj izpolnjeni naslednji pogoji:
Products authorised for industrial and/or professional use shall 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 others means.’
Pripravke z dovoljenjem za industrijsko in/ali poklicno uporabo se uporablja z ustrezno osebno zaščitno opremo, razen če ni v vlogi za izdajo dovoljenja dokazano, da se tveganja za industrijske in/ali poklicne uporabnike lahko zmanjšajo na sprejemljivo raven z drugimi sredstvi.“
Commission Directive 2010/51/EU
Direktiva Komisije 2010/51/EU
amending Directive 98/8/EC of the European Parliament and of the Council to include N,N-diethyl-meta-toluamide as an active substance in Annex I thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev N,N-dietil-meta-toluamida kot aktivne snovi v Prilogo I k Direktivi
That list includes N,N-diethyl-meta-toluamide (hereinafter ‘DEET’).
Seznam vključuje N,N-dietil-meta-toluamid (v nadaljnjem besedilu: DEET).
Pursuant to Regulation (EC) No 1451/2007, DEET has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 19, repellents and attractants, as defined in Annex V to that Directive.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja DEET glede uporabe v 19. vrsti izdelkov, repelenti in sredstva za privabljanje (atraktanti), kot je opredeljena v Prilogi V k navedeni direktivi.
Sweden was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 30 November 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Švedska, ki je bila imenovana za državo članico poročevalko, je 30. novembra 2007 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 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 11 March 2010, in an assessment report.
V skladu s členom 15(4) Uredbe (ES) št. 1451/2007 so bile ugotovitve pregleda 11. marca 2010 v Stalnem odboru za biocidne pripravke vključene v poročilo o oceni.
It appears from the examinations made that biocidal products used as repellents or attractants and containing DEET 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 repelenti in sredstva za privabljanje (atraktanti) in vsebujejo DEET, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include DEET in Annex I to that Directive.
Zato je primerno vključiti DEET v Prilogo I k navedeni direktivi.
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 DEET and used as repellents or attractants.
Glede na ugotovitve poročila o oceni je primerno zahtevati, da se pri izdaji avtorizacije za pripravek, ki vsebuje DEET in se uporablja kot repelent in sredstvo za privabljanje (atraktant), uporabijo ukrepi za zmanjšanje tveganja.
Products intended for direct application to human skin should be labelled with instructions for use including amount and frequency of application in order to minimize primary exposure of humans.
Pripravki, ki se neposredno nanesejo na človeško kožo, morajo biti opremljeni z navodili za uporabo, vključno s količino in pogostostjo uporabe, da se čim bolj zmanjša človekova osnovna izpostavljenost.
Concerns were identified during the risk assessment for human health, especially for children.
Med ocenjevanjem tveganja za zdravje ljudi, zlasti otrok, so se pojavili številni pomisleki.
Therefore, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI when used on children, products containing DEET should not be used on children less than two years old, and use should be restricted for children between two and twelve years old, except where motivated by the risk for human health through e.g. outbreaks of insect-borne diseases.
Zato se pripravki, ki vsebujejo DEET, ne smejo uporabljati pri otrocih, mlajših od dveh let, za otroke od dveh do dvanajstih let pa mora biti uporaba omejena, razen če je tvegano zdravje ljudi, npr. zaradi izbruhov bolezni, ki jih prenašajo žuželke; to ne velja, če se predložijo podatki, ki dokazujejo, da bo proizvod, ki se bo uporabljal pri otrocih, izpolnjeval zahteve iz člena 5 in Priloge VI.
Furthermore, products should contain deterrents for ingestion.
Pripravek mora tudi vsebovati denaturante.
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 DEET 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 DEET, in da se omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
They shall apply those provisions from 1 August 2012.
Navedene predpise uporabljajo od 1. avgusta 2012.
In Annex I to Directive 98/8/EC, the following entry for the substance N,N-diethyl-meta-toluamide is added:
V Prilogo I k Direktivi 98/8/ES se doda snov N,N-dietil-meta-toluamid:
EC No: 205-149-7
ES št.: 205-149-7
CAS No: 134-62-3
Št. CAS: 134-62-3
primary exposure of humans shall be minimized by considering and applying appropriate risk mitigation measures, including, where applicable, instructions for the amount and frequency of application of the product on human skin;
Osnovna izpostavljenost ljudi se do skrajnosti zmanjša z upoštevanjem in uporabo ustreznih ukrepov za zmanjšanje tveganja, vključno z navodili za količino in pogostostjo nanosa pripravka na človeško kožo, kjer je ustrezno.
labels on products intended for application on human skin, hair or clothing shall indicate that the product is intended only for restricted use on children between two and twelve years old, and that it is not intended for use on children less than two years old, unless it can be demonstrated in the application for product authorisation that the product will meet the requirements of Article 5 and Annex VI without such measures;
Na oznakah pripravkov, ki so namenjeni uporabi na človeški koži, laseh ali oblačilih, je treba navesti, da je pripravek namenjen le za omejeno uporabo pri otrocih od dveh do dvanajstih let, ni pa namenjen za uporabo pri otrocih, mlajših od dveh let; razen če se v vlogi za izdajo dovoljenja dokaže, da bo proizvod brez teh ukrepov izpolnjeval zahteve iz člena 5 in Priloge VI.
products must contain deterrents for ingestion.’
Pripravki morajo vsebovati denaturante.“
Directive 2010/45/EU of the European Parliament and of the Council
Direktiva 2010/45/EU Evropskega parlamenta in Sveta
on standards of quality and safety of human organs intended for transplantation
o standardih kakovosti in varnosti človeških organov, namenjenih za presaditev
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(4) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 168(4) Pogodbe,
Over the past 50 years organ transplantation has become an established worldwide practice, bringing immense benefits to hundreds of thousands of patients.
V zadnjih petdesetih letih je presajanje organov postalo ustaljena praksa po celem svetu, kar sto tisočim bolnikom prinaša izjemne koristi.
The use of human organs (hereinafter ‘organs’) for transplantation has steadily increased during the last two decades.
Uporaba človeških organov (v nadaljnjem besedilu: organi) za presajanje se je v zadnjih dveh desetletjih postopoma povečala.
Organ transplantation is now the most cost-effective treatment for end-stage renal failure, while for end-stage failure of organs such as the liver, lung and heart it is the only available treatment.
Presajanje organov je trenutno stroškovno najučinkovitejše zdravljenje končne ledvične odpovedi, za končne odpovedi organov, kot so jetra, pljuča in srce pa je celo edino razpoložljivo zdravljenje.
Risks are, however, associated with the use of organs in transplantation.
Vendar pa je uporaba organov pri presajanju povezana s tveganji.
The extensive therapeutic use of organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases.
Razširjena uporaba organov za presajanje pri zdravljenju zahteva takšno kakovost in varnost, da se tveganja, povezana s prenosom bolezni, čim bolj zmanjšajo.
Well organised national and international transplantation systems and use of the best available expertise, technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for recipients.
Dobro organizirani nacionalni in mednarodni sistemi za presajanje in uporaba najboljšega razpoložljivega strokovnega znanja in izkušenj, tehnologije in inovativnega zdravljenja lahko za prejemnike znatno zmanjšajo tveganja, povezana s presajenimi organi.
In addition the availability of organs used for therapeutic purposes is dependent on citizens of the Union being prepared to donate them.
Poleg tega je razpoložljivost organov, ki se uporabljajo za zdravljenje, odvisna od pripravljenosti državljanov Unije za darovanje.
In order to safeguard public health and to prevent the transmission of diseases by these organs, precautionary measures should be taken during their procurement, transport and use.
Da se zavaruje javno zdravje in prepreči prenos bolezni s temi organi, bi bilo treba sprejeti varnostne ukrepe pri njihovem pridobivanju, prevozu in uporabi.
Every year organs are exchanged between Member States.
Vsako leto se med državami članicami izmenjujejo organi.
The exchange of organs is an important way of increasing the number of organs available and ensuring a better match between donor and recipient and therefore improving the quality of the transplantation.
Izmenjava organov je pomemben način za povečevanje števila razpoložljivih organov in zagotavljanje večje skladnosti med darovalcem in prejemnikom, zaradi česar je kakovost presaditve večja.
This is particularly important for the optimum treatment of specific patients such as patients requiring urgent treatment, hypersensitised patients or paediatric patients.
To je še posebno pomembno za optimalno zdravljenje posebnih bolnikov, kot so to bolniki, ki potrebujejo nujno zdravljenje, hipersenzibilni ali pediatrični bolniki.
Available organs should be able to cross borders without unnecessary problems and delays.
Razpoložljivim organom bi moral biti omogočen prehod meje brez nepotrebnih zapletov in zamud.
However, transplantation is carried out by hospitals or professionals falling under different jurisdictions and there are significant differences in quality and safety requirements between Member States.
Vendar presaditve izvajajo bolnišnice ali strokovnjaki, ki so pod različnimi jurisdikcijami, med državami članicami pa obstajajo znatne razlike v zahtevah glede kakovosti in varnosti.
There is therefore a need for common quality and safety standards for the procurement, transport and use of organs at Union level.
Zato so na ravni Unije potrebni skupni standardi kakovosti in varnosti pri pridobivanju, prevozu in uporabi organov.
Such standards would facilitate exchanges of organs to the benefit of thousands of European patients in need of this type of therapy each year.
Navedeni standardi bi olajšali izmenjave organov, kar bi koristilo tisočem evropskih bolnikov, ki vsako leto potrebujejo tovrstno zdravljenje.
Union legislation should ensure that organs comply with recognised standards of quality and safety.
Zakonodaja Unije bi morala zagotavljati, da so organi v skladu s priznanimi standardi kakovosti in varnosti.
Such standards would help to reassure the public that organs procured in another Member State carry the same basic quality and safety guarantees as those obtained in their own country.
Navedeni standardi bi zato lahko pomagali prepričati javnost, da imajo organi, pridobljeni od darovalca v drugi državi članici, enaka jamstva glede kakovosti in varnosti kakor tisti, pridobljeni v lastni državi.
Unacceptable practices in organ donation and transplantation include trafficking in organs, sometimes linked to trafficking in persons for the purpose of the removal of organs, which constitutes a serious violation of fundamental rights and, in particular, of human dignity and physical integrity.
Nesprejemljive prakse pri darovanju in presajanju organov vključujejo trgovino s človeškimi organi, ki je včasih povezana s trgovino z ljudmi z namenom, da se jim odvzamejo organi, kar je huda kršitev temeljnih pravic in zlasti človekovega dostojanstva ter telesne nedotakljivosti.
This Directive, although having as its first objective the safety and quality of organs, contributes indirectly to combating organ trafficking through the establishment of competent authorities, the authorisation of transplantation centres, the establishment of conditions of procurement and systems of traceability.
Čeprav sta glavna cilja te direktive kakovost in varnost organov, z ustanovitvijo pristojnih organov, odobritvijo transplantacijskih centrov ter vzpostavitvijo pogojev za pridobivanje in sistemov sledljivosti posredno prispeva k boju proti trgovini s človeškimi organi.
According to Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the measures adopted pursuant to Article 168(4)(a) thereof shall not affect national provisions on the medical use of organs, nor therefore the surgical act of transplantation itself.
V skladu s členom 168(7) Pogodbe o delovanju Evropske unije (PDEU) ukrepi, sprejeti na podlagi člena 168(4)(a) PDEU, ne posegajo v nacionalne določbe o medicinski uporabi organov niti v sam kirurški poseg presaditve.
However, in view of the objective of reducing the associated risks of the transplanted organs, it is necessary to include in the scope of this Directive certain provisions concerning transplantation and, in particular, provisions aimed at addressing those unintended and unexpected situations occurring during the transplantation that might affect the quality and safety of organs.
Vendar je treba ob upoštevanju cilja zmanjšanja tveganja, povezanega s presajenimi organi, v področje uporabe te direktive vključiti nekatere določbe, ki zadevajo presaditve, zlasti določbe, ki obravnavajo neželene in nepričakovane situacije, ki nastanejo med presajanjem in ki bi lahko vplivale na kakovost in varnost organov.
In order to reduce the risks and maximise the benefits of transplantation, Member States need to operate an effective framework for quality and safety.
Da bi se zmanjšala tveganja in čim bolj povečale koristi presaditev, morajo imeti države članice učinkovit okvir za kakovost in varnost.
That framework should be implemented and maintained throughout the entire chain from donation to transplantation or disposal, and should cover the healthcare personnel and organisation, premises, equipment, materials, documentation and record-keeping involved.
Ta okvir bi bilo treba izvajati in ohranjati skozi ves postopek od darovanja do presaditve ali uničenja, in bi moralo zajemati vključeno zdravstveno osebje, organizacijo, prostore, opremo, materiale, dokumentacijo in shranjevanje podatkov.
The framework for quality and safety should include auditing where necessary.
Okvir za kakovost in varnost bi moral po potrebi zajemati tudi revizijo.