natgillin/translations-raw huggingface dataset:
By way of derogation from the first paragraph, and from Article 2, Bulgaria may maintain in force authorisations for plant protection products containing sodium tetrathiocarbonate for the uses listed in column C until 30 June 2009 provided that:
Z odstopanjem od prvega odstavka in člena 2, lahko Bolgarija ohrani v veljavi registracije fitofarmacevtskih sredstev, ki vsebujejo natrijev tetratiokarbonat, za rabe naštete v stolpcu C do 30. junija 2009, če:
The Member State concerned shall inform the Commission about the measures taken in application of paragraphs 1 and 2, and in particular about the actions taken pursuant to points (a) to (d) of each paragraph, by 31 December of each year.’
Najpozneje do 31. decembra vsako leto zadevna država članica obvesti Komisijo o ukrepih, izvedenih na podlagi odstavkov 1 in 2, in zlasti o ukrepih, izvedenih v skladu s točkami (a) do (d) vsakega odstavka.“
In Article 4 the third paragraph is replaced by the following:
V členu 4 se tretji odstavek nadomesti z naslednjim:
‘Where authorisations shall be withdrawn in accordance with Article 3(1) by 31 May 2010 at the latest, the period shall expire on 30 November 2010 at the latest.
„Če se registracije v skladu s členom 3(1) odvzamejo najpozneje do 31. maja 2010, se rok izteče najpozneje 30. novembra 2010.
Where authorisations shall be withdrawn in accordance with Article 3(3) by 30 June 2009 at the latest, the period shall expire on 31 December 2009 at the latest.’
Če se registracije v skladu s členom 3(3) odvzamejo najpozneje do 30. junija 2009, se rok izteče najpozneje 31. decembra 2009.“
In the Annex to Decision 2006/797/EC, the title to the annex is replaced by the words ‘List of authorisations referred to in Article 3(1) and 3(2)’.
V Prilogi k Odločbi 2006/797/ES se naslov Priloge nadomesti z besedilom: „Seznam registracij iz člena 3(1) in člena 3(2)“.
In the line referring to Sodium tetrathiocarbonate under column B the word ‘Bulgaria’ is added and under column C the words ‘Soil disinfection in horticulture and vineyards.’ are added.
V vrstici, ki navaja natrijev tetratiokarbonat, se v stolpcu B doda besedo „Bolgarija“ in v stolpcu C besedilo: „Razkuževanje tal v vrtnarstvu in vinogradih“.
This Regulation shall enter into force subject to and on the date of entry into force of the Treaty of Accession of Bulgaria and Romania.
Ta uredba začne veljati pod pogojem in z dnem začetka veljavnosti Pogodbe o pristopu Bolgarije in Romunije.
Regulation as last amended by Regulation (EC) No 1335/2005, (OJ L 211, 13.8.2005, p. 6).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1335/2005 (UL L 211, 13.8.2005, str. 6).
OJ L 88, 28.3.2001, p. 19.
UL L 88, 28.3.2001, str. 19.
OJ L 324, 23.11.2006, p. 8.
UL L 324, 23.11.2006, str. 8.
Commission Regulation (EC) No 1981/2006
Uredba Komisije (ES) št. 1981/2006
on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms
o podrobnih pravilih za izvajanje člena 32 Uredbe (ES) št. 1829/2003 Evropskega Parlamenta in Sveta glede referenčnega laboratorija Skupnosti za gensko spremenjene organizme
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [1], and in particular Article 32, fifth sub-paragraph, thereof,
ob upoštevanju Uredbe (ES) št. 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi [1] in zlasti petega pododstavka člena 32 Uredbe,
Regulation (EC) No 1829/2003 provides for a Community reference laboratory (CRL) to carry out certain duties and tasks set out in that Regulation.
Uredba (ES) št. 1829/2003 določa, da referenčni laboratorij Skupnosti (Community reference laboratory – CRL) opravlja nekatere naloge in dolžnosti iz navedene uredbe.
It also provides that the CRL is to be assisted by national reference laboratories.
Določa tudi, da referenčnemu laboratoriju Skupnosti pomagajo nacionalni referenčni laboratoriji.
Methods of detection and identification which have to be tested and validated by the CRL and samples and control samples have to meet the requirements laid down in Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation [2].
Metode odkrivanja in identifikacije, ki jih mora preskusiti in validirati referenčni laboratorij Skupnosti, ter vzorci in kontrolni vzorci morajo ustrezati zahtevam iz Uredbe Komisije (ES) št. 641/2004 z dne 6. aprila 2004 o podrobnih pravilih za izvajanje Uredbe (ES) št. 1829/2003 Evropskega parlamenta in Sveta v zvezi z vlogo za odobritev novih gensko spremenjenih živil in krme, uradnim obvestilom o obstoječih proizvodih in naključni ali tehnično neizogibni navzočnosti gensko spremenjene snovi, ki je prejela ugodno oceno tveganja [2].
It is necessary to provide detailed rules for implementing Article 32 of Regulation (EC) No 1829/2003.
Treba je določiti podrobna pravila za izvajanje člena 32 Uredbe (ES) št. 1829/2003.
The financial contribution to be paid by applicants in accordance with Article 32 of Regulation (EC) No 1829/2003 should be used only towards supporting the costs of the duties and tasks as set out in the Annex to that Regulation.
Finančni prispevek, ki ga morajo plačati vlagatelji v skladu s členom 32 Uredbe (ES) št. 1829/2003, je treba uporabiti samo za pokrivanje stroškov nalog in dolžnosti iz Priloge k navedeni uredbi.
The CRL should be authorised to charge a financial contribution to applicants for new authorisations, for renewal of authorisations and in the case of modification of authorisations where appropriate.
Referenčni laboratorij Skupnosti je treba pooblastiti, da vlagateljem po potrebi naloži plačevanje finančnega prispevka za nove odobritve, obnovitev odobritev in v primeru sprememb odobritev.
The determination of the amount of the financial contribution should take into account the burden of work to be carried out by the CRL in each case, depending on the level of method testing and validation already carried out prior to the submission of the application for authorisation.
Pri določitvi višine finančnega prispevka je treba upoštevati obseg dela, ki ga mora v vsakem primeru opraviti referenčni laboratorij Skupnosti, glede na način metode preskušanja in validiranja, ki sta bila že opravljena pred predložitvijo vloge za odobritev.
Applicants should be encouraged to provide data that refer to modules which have already been validated and published by the CRL in order to facilitate both the establishment of the application dossier and the validation of the detection method.
Vlagatelje je treba spodbujati, da zagotovijo podatke, ki se nanašajo na module, katere je referenčni laboratorij Skupnosti že validiral in objavil, s čimer bi se olajšalo urejanje vlog in validacija metode odkrivanja.
A financial contribution should be levied on a flat-rate basis in order to contribute to supporting the costs incurred in the comprehensive data analysis and in-house laboratory verification of the method and samples received to be carried out by the CRL in all cases where a new method is submitted.
Finančni prispevek je treba odmeriti na pavšalni podlagi, da bi prispevali k pokrivanju stroškov, nastalih pri analizi izčrpnih podatkov in internem laboratorijskem preverjanju metode in prejetih vzorcev, kar mora izvesti referenčni laboratorij Skupnosti v vseh primerih, kadar se predloži nova metoda.
An additional financial contribution should be charged to applicants where the validation of the proposed method requires the performance of a collaborative study involving national reference laboratories in order to comply with the criteria referred to in Annex I of Regulation (EC) No 641/2004.
Vlagateljem je treba naložiti plačilo dodatnega finančnega prispevka, kadar validacija predlagane metode zahteva izvedbo večstranske študije, v katero bi bili vključeni nacionalni referenčni laboratoriji, da bi se izpolnila merila iz Priloge I Uredbe (ES) št. 641/2004.
The amount of the financial contributions should cover the costs directly associated with the validation tasks to be performed.
Z zneskom finančnih prispevkov je treba pokriti stroške, ki so neposredno povezani z nalogami validacije, ki jih je treba opraviti.
Those include in particular the manpower, the reagents and other associated disposable material, the distribution of material to members of the European Network of GMO laboratories (ENGL) where appropriate and the administrative costs.
Navedene naloge obsegajo zlasti delovno silo, reagente in ostale povezane snovi za enkratno uporabo, pošiljanje materiala članom Evropskega omrežja laboratorijev GSO (European Network of GMO laboratories – ENGL), kadar je ustrezno, in administrativne stroške.
They should be calculated on the basis of the experience gained by the Commission’s Joint Research Centre in carrying out validations of detection methods, including collaboration with members of the ENGL where appropriate, and should not exceed the actual costs incurred in carrying out that validation.
Treba jih je izračunati na podlagi izkušenj, ki jih je pri izvajanju validacij metod odkrivanja pridobilo Skupno raziskovalno središče Komisije, po potrebi vključno s sodelovanjem s člani ENGL, ne smejo pa presegati dejanskih stroškov, nastalih pri izvajanju validacije.
Where the validation costs for a specific application for authorisation exceeds substantially the amount of the financial contributions provided for in this Regulation, the CRL should be able to charge an additional contribution to the applicant.
Kadar stroški validacije za posamezno vlogo za odobritev znatno presežejo višino finančnih prispevkov iz te uredbe, mora imeti referenčni laboratorij Skupnosti možnost, da vlagatelju naloži dodatni prispevek.
In that case, the applicant should have the right to be exempted from the payment of the additional contribution if he withdraws its application within a set time limit.
V tem primeru mora imeti vlagatelj pravico do oprostitve plačila dodatnega prispevka, če svojo vlogo umakne v določenem roku.
Due consideration should be given to the specific case of biotechnological research originating in developing countries.
Ustrezno je treba upoštevati posebni primer biotehnoloških raziskav s poreklom iz držav v razvoju.
A reduction of the amount of the financial contribution should therefore be provided where the head office of the applicant for authorisation is established in a developing country.
Zato je treba zagotoviti zmanjšanje višine finančnega prispevka, kadar je sedež vlagatelja za odobritev v državi v razvoju.
In order to facilitate the participation of small and medium-sized enterprises (SMEs) to the Community procedure for authorisation of genetically modified (GM) food and feed, it is appropriate to provide for a reduced financial contribution where applicants are SMEs.
Kadar so vlagatelji mala in srednja podjetja (MSP), je primerno določiti manjši finančni prispevek, da se omogoči lažje sodelovanje MSP pri postopku za odobritev gensko spremenjenih (GS) živil in krme.
The model declaration on the information relating to the qualification of an enterprise as an SME [3] could serve for the written evidence to be provided by applicants as to their SME status.
Vzorec deklaracije o informacijah v zvezi z obravnavo podjetja kot MSP [3] je lahko podlaga za pisno dokazilo, ki ga morajo vlagatelji zagotoviti glede svojega statusa MSP.
Regulation (EC) No 1829/2003 already lays down the rule that applicants should make a financial contribution, so any applicants who have lodged applications before the entry into force of this Regulation will be aware of this rule.
Uredba (ES) št. 1829/2003 že določa pravilo, da morajo vlagatelji zagotoviti finančni prispevek, tako da mora vsak vlagatelj, ki je vlogo predložil pred začetkom veljavnosti te uredbe, to pravilo poznati.
Consequently, the financial contribution should also be required for applications for authorisation submitted before the date of entry into force of this Regulation.
Zato je treba finančni prispevek zahtevati tudi za vloge za odobritev, ki so bile predložene pred datumom začetka veljavnosti te uredbe.
National reference laboratories assisting the CRL for the duties and tasks set out in the Annex to Regulation (EC) No 1829/2003 should be part of the European Network of GMO Laboratories (ENGL), whose members represent the state-of-the-art in GMO detection, including expertise in method development, performance and validation, sampling and management of biological and analytical uncertainties.
Nacionalni referenčni laboratoriji, ki referenčnemu laboratoriju Skupnosti pomagajo pri opravljanju nalog in dolžnosti iz Priloge k Uredbi (ES) št. 1829/2003, morajo biti vključeni v Evropsko omrežje laboratorijev GSO (ENGL), katerega člani so vrhunsko usposobljeni za odkrivanje GSO ter imajo strokovno znanje za razvoj metod, izvajanju in validaciji, vzorčenju in obvladovanju negotovosti na biološkem in analitskem področju.
They should also meet specific requirements where they have to assist the CRL specifically for testing and validation of detection methods in the context of collaborative studies according to international standards.
Izpolnjevati morajo tudi posebne pogoje, kadar morajo posebej pomagati referenčnemu laboratoriju Skupnosti pri preskušanju in validaciji metod odkrivanja v okviru večstranskih študij po mednarodnih standardih.
In the interests of stability and efficacy and in order to make the validation procedure operational in accordance with this Regulation, it is necessary to designate the national reference laboratories apt to assist the CRL for testing and validation of detection methods.
Za zagotovitev stabilnosti in učinkovitosti ter delovanje postopka validacije v skladu s to uredbo je treba določiti nacionalne referenčne laboratorije, ki so sposobni pomagati referenčnemu laboratoriju Skupnosti pri preskušanju in validaciji metod odkrivanja.
The relationship between the national reference laboratories assisting the CRL for testing and validation of detection methods and between them and the CRL should be defined by a written agreement.
Odnose med nacionalnimi referenčnimi laboratoriji, ki referenčnemu laboratoriju Skupnosti pomagajo pri preskušanju in validaciji metod odkrivanja, ter med njimi in referenčnim laboratorijem Skupnosti je treba določiti s pisnim sporazumom.
The Annex to Regulation (EC) No 1829/2003 should be amended accordingly.
Prilogo k Uredbi (ES) št. 1829/2003 je zato treba ustrezno spremeniti.
This Regulation lays down detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 as regards:
Ta uredba določa podrobna pravila za izvajanje člena 32 Uredbe (ES) št. 1829/2003 glede:
the contribution to the costs of the tasks of the Community reference laboratory (CRL) and of the national reference laboratories, as referred to in the Annex to the said Regulation; and
prispevka za stroške nalog referenčnega laboratorija Skupnosti (CRL) in nacionalnih referenčnih laboratorijev, kot je navedeno v Prilogi k omenjeni uredbi; ter
the establishment of national reference laboratories.
določitve nacionalnih referenčnih laboratorijev.
For the purposes of this Regulation, the following definitions apply:
Za namene te uredbe se uporabljajo naslednje opredelitve:
‘full validation procedure’ means the assessment through a ring trial involving national reference laboratories of the method performance criteria set by the applicant as compliant with the document entitled ‘Definition of minimum performance requirements for analytical methods of GMO testing’ referred to in point 1(B) of Annex I to Regulation (EC) No 641/2004, and the assessment of the repeatability and trueness of the method provided by the applicant;
„popolni postopek validacije“ je ocenjevanje s pomočjo primerjalnega preskušanja meril za izvajanje metode, v katerega so vključeni nacionalni referenčni laboratoriji, pri čemer metodo določi vlagatelj kot pritožnik v skladu z dokumentom z naslovom „Opredelitev minimalnih zahtev za izvajanje analiznih metod preskušanja GSO“ iz točke 1(B) Priloge I k Uredbi (ES) št. 641/2004, ter ocenjevanje ponovljivosti in pravilnosti metode, ki jo določi vlagatelj;
‘small and medium-sized enterprise (SME)’ means small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC [4];
„majhna in srednja podjetja (MSP)“ so majhna in srednja podjetja, kakor so opredeljena v Priporočilu Komisije 2003/361/ES [4];
‘developing countries’ means beneficiary countries as referred to in Article 2 of Council Regulation (EC) No 980/2005 of 27 June 2005 applying a scheme of generalised tariff preferences [5];
„država v razvoju“ je država upravičenka, kot je navedeno v členu 2 Uredbe (ES) št. 980/2005 z dne 27. junija 2005 o uporabi sheme splošnih tarifnih preferencialov [5];
‘application’ where used without further specification, means an application for authorisation submitted in accordance with Article 5 or 17 of Regulation (EC) No 1829/2003, including applications submitted under other Community legislation which are transformed or supplemented in accordance with Article 46 of that Regulation.
„vloga“, kadar se uporablja brez natančnejšega opisa, je vloga za odobritev, predložena v skladu s členom 5 ali 17 Uredbe (ES) št. 1829/2003, vključno z vlogami, predloženimi v okviru ostale zakonodaje Skupnosti, ki so preoblikovane ali dopolnjene v skladu s členom 46 navedene uredbe.
It also refers to applications for renewal of authorisations according to Article 11 or 23 of Regulation (EC) No 1829/2003 and modifications of authorisations according to Articles 9(2), 10, 21(2) or 22 of that Regulation, where the CRL is requested to test and validate a method of detection and identification.
Prav tako se nanaša na vloge za obnovitev odobritev v skladu s členom 11 ali 23 Uredbe (ES) št. 1829/2003 in spremembe odobritev v skladu s členi 9(2), 10, 21(2) ali 22 navedene uredbe, po katerih mora referenčni laboratorij Skupnosti preskusiti in validirati metodo odkrivanja in identifikacije.
Contributions
Prispevki
For each application, a flat-rate contribution of EUR 30000 shall be paid by the applicant to the CRL.
Vlagatelj mora za vsako vlogo referenčnemu laboratoriju Skupnosti plačati pavšalni prispevek v višini 30000 EUR.
Where a full validation procedure of a method of detection and identification for a single GMO event according to the requirements laid down in Annex I of Regulation (EC) No 641/2004 is required, the CRL shall request the applicant to pay an additional contribution of EUR 60000.
Kadar je potreben popolni postopek validacije metode odkrivanja in identifikacije za posamezen primer GSO v skladu z zahtevami iz Priloge I k Uredbi (ES) št. 641/2004, referenčni laboratorij Skupnosti zahteva od vlagatelja, da plača dodatni prispevek v višini 60000 EUR.
This amount shall be multiplied by the number of GMO events to be fully validated.
Ta znesek se pomnoži s številom primerov GSO, ki jih je treba v celoti validirati.
The CRL shall reduce the amount of the additional contribution, in proportion of the costs saved:
Referenčni laboratorij Skupnosti zmanjša višino dodatnega prispevka sorazmerno s prihranjenimi stroški:
where the material needed to perform the full validation procedure is supplied by the applicant; and/or
kadar vlagatelj zagotovi vse potrebne snovi za izvajanje popolnega postopka validacije; in/ali
where the applicant provides data that refer to modules, such as DNA extraction protocols and species specific reference systems, already validated and published by the CRL.
kadar vlagatelj zagotovi podatke o modulih, kot so postopki ekstrakcije DNK in vrstno specifičnih referenčnih sistemov, ki jih je referenčni laboratorij Skupnosti že validiral in objavil.
Where the costs of the validation of the detection method proposed by the applicant exceed substantially the amount of the financial contributions mentioned under paragraphs 1 and 2, an additional contribution shall be requested.
Kadar stroški validacije metode odkrivanja, ki jo predlaga vlagatelj, znatno presežejo višino finančnih prispevkov iz odstavkov 1 in 2, se zahteva dodatni prispevek.
The additional contribution shall cover 50 % of the part of the costs exceeding the amount of the contributions referred to in paragraphs 1 and 2.
Dodatni prispevek pokrije 50 % delež stroškov, ki presegajo višino prispevkov iz odstavkov 1 in 2.
The contributions provided for in paragraphs 1 and 2 remain due in case of withdrawal of the application.
Tudi v primeru umika vloge se morajo prispevki iz odstavkov 1 in 2 plačati.
Reductions and exemptions
Zmanjšanja in oprostitve
Where the applicant is a SME or has its head office established in a developing country, the financial contributions referred to in Article 3(1) and (2) shall be reduced by 50 %.
Kadar je vlagatelj MSP ali ima glavni sedež v državi v razvoju, se finančni prispevki iz člena 3(1) in (2) zmanjšajo za 50 %.
Where the same method of detection and identification has already been included in a previous application by the same applicant for products related to the same GMO and that method has been validated and published by the CRL or its validation is pending, that applicant shall be exempted from the payment of the financial contributions referred to Article 3.
Kadar je isti vlagatelj vključil isto metodo odkrivanja in identifikacije v prejšnjo vlogo za proizvode v zvezi z istimi GSO in če je referenčni laboratorij Skupnosti že validiral in objavil navedeno metodo ali pa če ta postopek še teče, se vlagatelja oprosti plačila finančnih prispevkov iz člena 3.
However, where costs are incurred by the CRL in carrying out the validation tasks laid down in Regulation (EC) No 1829/2003, the CRL may charge the applicant a maximum contribution of EUR 30000.
Kadar pa stroški nastanejo pri izvajanju nalog validacije referenčnega laboratorija Skupnosti iz Uredbe (ES) št. 1829/2003, lahko referenčni laboratorij Skupnosti vlagatelju naloži najvišji znesek prispevka v višini 30000 EUR.
Article 3(3) shall not apply where the applicant is a SME or has its head office established in a developing country, nor to applications submitted before the entry into force of this Regulation.
Člen 3(3) se ne uporablja, kadar je vlagatelj MSP ali ima glavni sedež v državi v razvoju ali kadar so bile vloge predložene pred datumom začetka veljavnosti te uredbe.
The applicant shall provide evidence that the flat-rate contribution of EUR 30000 referred to in Article 3(1) has been paid to the CRL when it submits the samples of the food and feed and their control samples to the CRL in accordance with Article 5(3)(j) or Article 17(3)(j) of Regulation (EC) No 1829/2003.
Vlagatelj predloži dokazilo, da je referenčnemu laboratoriju Skupnosti plačal pavšalni prispevek v višini 30000 EUR iz člena 3(1), ko referenčnemu laboratoriju Skupnosti predloži vzorce živil in krme in njihove kontrolne vzorce v skladu s členom 5(3)(j) ali členom 17(3)(j) Uredbe (ES) št. 1829/2003.
Where, as provided for in Article 3(2), a full validation procedure is required, the CRL shall notify the applicant in writing of this fact and require the payment of the amount due in accordance with that provision.
Kadar je potreben popolni postopek validacije metode, kot je določeno v členu 3(2), referenčni laboratorij Skupnosti o tem pisno obvesti vlagatelja in v skladu z navedeno določbo od njega zahteva plačilo dolgovanega zneska.