natgillin/translations-raw huggingface dataset:
operates an approved QS for production, final inspection and testing
upravlja odobren sistem kakovosti za proizvodnjo, pregled končnega proizvoda in preskušanje
Accredited in-house body
Pooblaščeni interni organ ali priglašeni
declares conformity to essential requirements
Razglasi skladnost z bistvenimi zahtevami
or notified body
organ
tests on specific aspects of the product [1]
preizkusi na specifičnih vidikih proizvoda [1]
Product checks at random intervals [1]
preverjanje proizvoda v naključnih presledkih [1]
approves the QS
izvaja nadzor nad sistemom kakovosti
verifies conformity to essential requirements
preveri skladnost z bistvenimi zahtevami
issues certificate of conformity
izdaja certifikate o skladnosti
Supplementary requirements which may be used in sectoral legislation.
Dodatne zahteve, ki se lahko uporabijo v sektorski zakonodaji.
Except for subclause 7.3 and requirements relating to customer satisfaction and continual improvement.
Z izjemo točke 7.3 in zahtev v zvezi z zadovoljstvom potrošnikov in stalnimi izboljšavami.
Except for subclauses 7.1, 7.2.3, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3 and requirements relating to customer satisfaction and continual improvement.
Z izjemo točk 7.1, 7.2, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3 in zahtev v zvezi z zadovoljstvom potrošnikov in stalnimi izboljšavami.
Except for requirements relating to customer satisfaction and continual improvement.
Z izjemo zahtev v zvezi z zadovoljstvom potrošnikov in stalnimi izboljšavami.
EC DECLARATION OF CONFORMITY
ES-IZJAVA O SKLADNOSTI
No … (unique identification of the product):
Št. xxxxxx (enotna identifikacijska številka proizvoda):
Name and address of the manufacturer or his authorised representative:
Ime in naslov proizvajalca ali pooblaščenega zastopnika:
This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
Ta izjava o skladnosti se izda na lastno odgovornost proizvajalca (ali monterja):
Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):
Predmet izjave (identifikacija proizvoda, ki omogoča sledljivost; po potrebi lahko vključuje fotografijo):
The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: …
Predmet navedene izjave je v skladu z ustrezno usklajevalno zakonodajo Skupnosti: …
References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:
Sklicevanja na uporabljene harmonizirane standarde ali sklicevanja na specifikacije v zvezi s skladnostjo, ki je navedena v izjavi:
Where applicable, the notified body ... (name, number) … performed … (description of intervention) … and issued the certificate: …
Kjer je mogoče, je priglašeni organ ... (ime, številka) … izvedel … (opis intervencije) … in izdal certifikat: ….
Signed for and on behalf of: …
Podpisano za in v imenu: ….
(place and date of issue):
(kraj in datum izdaje)
(name, function) (signature):
(ime, dejavnost) (podpis)
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures.
opise postopkov, glede na katere se izvaja ugotavljanje skladnosti, ki zagotavljajo preglednosti in zmožnost reprodukcije teh postopkov.
It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;
Vpeljano mora imeti ustrezno politiko in postopke, ki razlikujejo med nalogami, izvedenimi kot priglašeni organ, in drugimi dejavnostmi;
a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied.
seznam harmoniziranih standardov in/ali drugih ustreznih tehničnih specifikacij, katerih navedbe so bile objavljene v Uradnem listu Evropske unije in ki so uporabljeni v celoti ali deloma, ter opis rešitev, sprejetih za izpolnitev bistvenih zahtev zakonodajnega instrumenta, kjer harmonizirani standardi niso bili uporabljeni.
In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
V primeru delno uveljavljenih harmoniziranih standardov je treba navesti dele, ki so bili uveljavljeni, v tehnični dokumentaciji,
the technical documentation for one model of each category of products intended to be manufactured.
tehnično dokumentacijo za en model iz vsake kategorije proizvodov, ki bodo proizvedeni.
concerning the non-inclusion of Beauveria brongniartii and potassium permanganate in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances
o nevključitvi Beauveria brongniartii in kalijevega permanganata v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo navedene aktivne snovi
(notified under document number C(2008) 5106)
(notificirano pod dokumentarno številko C(2008) 5106)
Beauveria brongniartii and potassium permanganate are substances designated in the fourth stage programme.
Beauveria brongniartii in kalijev permanganat sta aktivni snovi iz četrte faze programa.
The sole notifiers for Beauveria brongniartii and potassium permanganate informed the Commission on 5 September 2007 and 22 February 2008 respectively, that they no longer wished to participate in the programme of work for these active substances, and therefore further information will not be submitted.
Edina prijavitelja Beauveria brongniartii in kalijevega permanganata sta 5. septembra 2007 oziroma 22. februarja 2008, obvestila Komisijo, da ne želita več sodelovati v delovnem programu za ti aktivni snovi in zato ne bosta predložila nadaljnjih informacij.
In cases where a longer advance notice period is provided, such period can be shortened to expire at the end of the growing season.
V primerih daljšega roka predhodnega obvestila se ta rok lahko skrajša tako, da se izteče na koncu rastne sezone.
authorisations for plant protection products containing the active substances listed in Annex I are withdrawn by 30 March 2009;
se registracije za fitofarmacevtska sredstva, ki vsebujejo aktivne snovi, naštete v Prilogi I, prekličejo do 30. marca 2009;
Any period of grace granted by Member States in accordance with Article 4(6) of Directive 91/414/EEC, shall be as short as possible and shall expire not later than 30 March 2010.
Morebitno podaljšanje roka, ki ga odobrijo države članice v skladu s členom 4(6) Direktive 91/414/EGS, je čim krajše in traja največ do 30. marca 2010.
concerning the non-inclusion of propanil in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance
o nevključitvi propanila v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo navedeno snov
(notified under document number C(2008) 5107)
(notificirano pod dokumentarno številko C(2008) 5107)
That list includes propanil.
Navedeni seznam vključuje propanil.
For propanil the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifier.
Vplivi propanila na zdravje ljudi in okolje so bili ocenjeni v skladu z določbami uredb (ES) št. 451/2000 in (ES) št. 1490/2002 za vrste uporab, ki jih je predlagal prijavitelj.
For propanil the rapporteur Member State was Italy and all relevant information was submitted on 13 June 2007.
Država članica poročevalka za propanil je bila Italija, vse ustrezne informacije pa so bile predložene 13. junija 2007.
The Commission examined propanil in accordance with Article 11a of Regulation (EC) No 1490/2002.
Komisija je preučila propanil v skladu s členom 11a Uredbe (ES) št. 1490/2002.
During the examination of this active substance by the Committee, taking into account comments received from Member States, it was concluded that there are clear indications that it may be expected that it has harmful effects on human health and in particular on operators, because the exposure is greater than 100 % of the acceptable operator exposure level (AOEL).
Odbor je med preučevanjem te aktivne snovi ob upoštevanju pripomb držav članic ugotovil, da obstajajo jasni znaki, na podlagi katerih se lahko pričakuje, da ima aktivna snov škodljive učinke na zdravje ljudi in zlasti na izvajalce tretiranja, ker je izpostavljenost večja od 100 % AOEL.
Moreover, other concerns which were identified by the rapporteur Member States in its assessment report are included in the review report for the substance.
Poleg tega so drugi pomisleki, ki jih je država članica poročevalka izrazila v poročilu o oceni, vključeni v poročilo o pregledu za to snov.
The Commission invited the notifier to submit its comments on the results of the examination of propanil and on its intention or not to further support the substance.
Komisija je prijavitelja pozvala, naj predloži pripombe o rezultatih preučitve propanila in sporoči, ali bo še naprej vztrajal pri vključitvi navedene snovi na seznam.
However, despite the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing propanil satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Toda kljub argumentom, ki jih je prijavitelj predložil, se navedenih pomislekov ni dalo odpraviti, po ocenah na podlagi predloženih informacij pa ne kaže pričakovati, da bi lahko fitofarmacevtska sredstva, ki vsebujejo propanil, pod predvidenimi pogoji uporabe na splošno izpolnjevala zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS.
Propanil should therefore not be included in Annex I to Directive 91/414/EEC.
Propanil se zato ne sme vključiti v Prilogo I k Direktivi 91/414/EGS.
Measures should be taken to ensure that authorisations granted for plant protection products containing propanil are withdrawn within a fixed period of time and are not renewed and that no new authorisations for such products are granted.
Sprejeti je treba ukrepe za zagotovitev, da se registracije fitofarmacevtskih sredstev, ki vsebujejo propanil, prekličejo v predpisanem roku in se ne podaljšajo ali izdajo nove registracije takih sredstev.
Any period of grace granted by a Member State for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing propanil should be limited to 12 months in order to allow existing stocks to be used in one further growing season, which ensures that plant protection products containing propanil remain available for 18 months from the adoption of this Decision.
Če države članice odobrijo podaljšanje roka za odstranjevanje, skladiščenje, dajanje v promet in uporabo obstoječih zalog fitofarmacevtskih sredstev, ki vsebujejo propanil, ga je treba omejiti na obdobje 12 mesecev, da se omogoči uporaba obstoječih zalog v naslednji rastni sezoni, s čimer se zagotovi, da fitofarmacevtska sredstva, ki vsebujejo propanil, ostanejo na razpolago 18 mesecev po sprejetju te odločbe.
This Decision does not prejudice the submission of an application for propanil in accordance with Article 6(2) of Directive 91/414/EEC and Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [4], in view of a possible inclusion in its Annex I.
Ta odločba ne vpliva na predložitev zahtevka za propanil v skladu s členom 6(2) Direktive 91/414/EGS in Uredbo Komisije (ES) št. 33/2008 z dne 17. januarja 2008 o podrobnih pravilih za izvajanje Direktive Sveta 91/414/EGS glede rednega in pospešenega postopka za oceno aktivnih snovi, ki so bile del programa dela iz člena 8(2) navedene direktive, vendar niso bile vključene v Prilogo I [4], zaradi morebitne uvrstitve v Prilogo I k navedeni direktivi.
Propanil shall not be included as an active substance in Annex I to Directive 91/414/EEC.
Propanil se ne vključi kot aktivna snov v Prilogo I k Direktivi 91/414/EGS.
authorisations for plant protection products containing propanil are withdrawn by 30 March 2009;
se registracije fitofarmacevtskih sredstev, ki vsebujejo propanil, prekličejo do 30. marca 2009;
no authorisations for plant protection products containing propanil are granted or renewed from the date of publication of this Decision.
se od datuma objave te odločbe nobene registracije fitofarmacevtskih sredstev, ki vsebujejo propanil, ne odobrijo ali podaljšajo.
concerning the non-inclusion of tricyclazole in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance
o nevključitvi triciklazola v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo navedeno snov
(notified under document number C(2008) 5108)
(notificirano pod dokumentarno številko C(2008) 5108)
That list includes tricyclazole.
Navedeni seznam vključuje triciklazol.
For tricyclazole the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifier.
Vplivi triciklazola na zdravje ljudi in okolje so bili ocenjeni v skladu z določbami uredb (ES) št. 451/2000 in (ES) št. 1490/2002 za vrste uporab, ki jih je predlagal prijavitelj.
For tricyclazole the rapporteur Member State was France and all relevant information was submitted on 26 June 2006.
Država članica poročevalka za triciklazol je bila Francija, vse ustrezne informacije pa so bile predložene 26. junija 2006.
The Commission examined tricyclazole in accordance with Article 11a of Regulation (EC) No 1490/2002.
Komisija je preučila triciklazol v skladu s členom 11a Uredbe (ES) št. 1490/2002.
During the examination of this active substance by the Committee, taking into account comments received from Member States, it was concluded that there are clear indications that it may be expected that it has harmful effects on human health and in particular the crucial missing data does not allow to set reliable ADI, ARfD and AOEL and such values are necessary to conduct the risk assessment.
Odbor je med preučevanjem te aktivne snovi ob upoštevanju pripomb držav članic ugotovil, da obstajajo jasni znaki, na podlagi katerih se lahko pričakuje, da ima aktivna snov škodljive učinke na zdravje ljudi, ter da vrednosti ADI, ARfD in AOEL, ki so nujne za oceno tveganja, zaradi odsotnosti bistvenih podatkov ni mogoče zanesljivo določiti.
The Commission invited the notifier to submit its comments on the results of the examination of tricyclazole and on its intention or not to further support the substance.
Komisija je prijavitelja pozvala, naj predloži pripombe o rezultatih preučitve triciklazola in sporoči, ali bo še naprej vztrajal pri vključitvi navedene snovi na seznam.
However, despite the arguments put forwards by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing tricyclazole satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Toda kljub argumentom, ki jih je prijavitelj predložil, se navedenih pomislekov ni dalo odpraviti, po ocenah na podlagi predloženih informacij pa ne kaže pričakovati, da bi lahko fitofarmacevtska sredstva, ki vsebujejo triciklazol, pod predvidenimi pogoji uporabe na splošno izpolnjevala zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS.
Tricyclazole should therefore not be included in Annex I to Directive 91/414/EEC.
Triciklazol se zato ne sme vključiti v Prilogo I k Direktivi 91/414/EGS.
Measures should be taken to ensure that authorisations granted for plant protection products containing tricyclazole are withdrawn within a fixed period of time and are not renewed and that no new authorisations for such products are granted.
Sprejeti je treba ukrepe za zagotovitev, da se registracije fitofarmacevtskih sredstev, ki vsebujejo triciklazol, prekličejo v predpisanem roku in se ne podaljšajo ali izdajo nove registracije takih sredstev.
Any period of grace granted by a Member State for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing tricyclazole should be limited to 12 months in order to allow existing stocks to be used in one further growing season, which ensures that plant protection products containing tricyclazole remain available for 18 months from the adoption of this Decision.
Če države članice odobrijo podaljšanje roka za odstranjevanje, skladiščenje, dajanje v promet in uporabo obstoječih zalog fitofarmacevtskih sredstev, ki vsebujejo triciklazol, ga je treba omejiti na obdobje 12 mesecev, da se omogoči uporaba obstoječih zalog v naslednji rastni sezoni, s čimer se zagotovi, da fitofarmacevtska sredstva, ki vsebujejo triciklazol, ostanejo na razpolago 18 mesecev po sprejetju te odločbe.
This Decision does not prejudice the submission of an application for tricyclazole in accordance with Article 6(2) of Directive 91/414/EEC and Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [4], in view of a possible inclusion in its Annex I.
Ta odločba ne vpliva na predložitev zahtevka za triciklazol v skladu s členom 6(2) Direktive 91/414/EGS in Uredbo Komisije (ES) št. 33/2008 z dne 17. januarja 2008 o podrobnih pravilih za izvajanje Direktive Sveta 91/414/EGS glede rednega in pospešenega postopka za oceno aktivnih snovi, ki so bile del programa dela iz člena 8(2) navedene direktive, vendar niso bile vključene v Prilogo I [4], zaradi morebitne uvrstitve v Prilogo I k navedeni direktivi.
Tricyclazole shall not be included as an active substance in Annex I to Directive 91/414/EEC.
Triciklazol se ne vključi kot aktivna snov v Prilogo I k Direktivi 91/414/EGS.
authorisations for plant protection products containing tricyclazole are withdrawn by 30 March 2009;
se registracije fitofarmacevtskih sredstev, ki vsebujejo triciklazol, prekličejo do 30. marca 2009;
no authorisations for plant protection products containing tricyclazole are granted or renewed from the date of publication of this Decision.
se od datuma objave te odločbe nobene registracije fitofarmacevtskih sredstev, ki vsebujejo triciklazol, ne odobrijo ali podaljšajo.
concerning the non-inclusion of buprofezin in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance
o nevključitvi buprofezina v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo navedeno snov
(notified under document number C(2008) 5109)
(notificirano pod dokumentarno številko C(2008) 5109)
Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I of that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work.
Člen 8(2) Direktive 91/414/EGS določa, da lahko država članica v obdobju 12 let po notifikaciji navedene direktive registrira za dajanje v promet fitofarmacevtska sredstva z aktivnimi snovmi, ki niso uvrščene v Prilogo I k navedeni direktivi in so v prometu že dve leti po datumu notifikacije, medtem ko se navedene snovi postopno preučujejo v okviru delovnega programa.
That list includes buprofezin.
Navedeni seznam vključuje buprofezin.
For buprofezin the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifier.
Vplivi buprofezina na zdravje ljudi in okolje so bili ocenjeni v skladu z določbami uredb (ES) št. 451/2000 in (ES) št. 1490/2002 za vrste uporab, ki jih je predlagal prijavitelj.
For buprofezin the rapporteur Member State was Finland and all relevant information was submitted on 7 July 2005.
Država članica poročevalka za buprofezin je bila Finska, vse ustrezne informacije pa so bile predložene 7. julija 2005.
The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 3 March 2008 in the format of the EFSA conclusion regarding the peer review of the pesticide risk assessment of the active substance buprofezin [4].
Poročilo o oceni so v okviru delovne skupine za ocenjevanje pregledali strokovnjaki držav članic in EFSA ter ga 3. marca 2008 predložili Komisiji v obliki sklepa EFSA o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo buprofezin [4].
This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 20 May 2008 in the format of the Commission review report for buprofezin.
To poročilo so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 20. maja 2008 v obliki poročila Komisije o pregledu glede buprofezina.
In particular it was not possible to perform a reliable consumer exposure assessment as data are missing to determine an appropriate residue definition.
Zlasti ni bila možna zanesljiva ocena izpostavljenosti potrošnikov, saj manjkajo podatki za ustrezno opredelitev ostankov.
Consequently, it was not possible to conclude on the basis of the information available that buprofezin met the criteria for inclusion in Annex I to Directive 91/414/EEC.
Zato buprofezin na podlagi razpoložljivih informacij ne izpolnjuje pogojev za vključitev v Prilogo I k Direktivi 91/414/EGS.
However, despite the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing buprofezin satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Toda kljub argumentom, ki jih je prijavitelj predložil, se navedenih pomislekov ni dalo odpraviti, po ocenah na podlagi predloženih informacij, preučenih na srečanjih strokovnjakov EFSA, pa ne kaže pričakovati, da bi lahko fitofarmacevtska sredstva, ki vsebujejo buprofezin, pod predvidenimi pogoji uporabe na splošno izpolnjevala zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS.
Buprofezin should therefore not be included in Annex I to Directive 91/414/EEC.
Buprofezin se zato ne sme vključiti v Prilogo I k Direktivi 91/414/EGS.