natgillin/translations-raw huggingface dataset:
Kadar je po mnenju Agencije potrebna dodatna informacija za izvedbo ocene tehnične enakovrednosti, Agencija pozove vlagatelja, naj predloži takšno informacijo v roku, ki ga določi Agencija.
Where, in the opinion of the Agency, additional information is necessary to carry out the assessment of technical equivalence, the Agency shall ask the applicant to submit such information within a time limit specified by the Agency.
Agencija vlogo zavrne, če vlagatelj v določenem roku ni predložil dodatnih informacij.
The Agency shall reject the application if the applicant fails to submit the additional information within the specified time limit.
Obdobje 90 dni iz odstavka 3 se prekine od dneva izdaje zahtevka do dneva prejema informacij.
The 90 day period referred to in paragraph 3 shall be suspended from the date of issue of the request until the information is received.
Prekinitev ne presega 180 dni, razen če je to upravičeno zaradi narave zahtevanih podatkov ali izrednih okoliščin.
The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances.
Predlagan predlog spremembe upošteva dejstvo, da bo treba v nekaterih primerih za dokončanje ocene tehnične enakovrednosti pridobiti več informacij in da je treba čas, potreben za pridobitev informacij, izvzeti iz določenega časovnega obdobja.
The proposed amendment acknowledges the fact that in some cases it will be necessary to get more information in order to finalise the assessment of technical equivalence and that the "clock should be stopped" while this information is generated.
Obdobje 180 dni se šteje kot primerno za pridobitev manjkajočih podatkov.
The 180 day delay introduced here is considered to be a reasonable period for the generation of the missing data.
Isti rok je uporabljen v besedilu Sveta za pridobitev dodatnih informacij v skladu z določbami (na primer s členi 8(2), 29(2) in 43(2)).
The same deadline is used in the Council text for obtaining additional information under other provisions (e.g. Articles 8(2), 29(2) and 43(2).
Člen 53 – odstavek 6
Article 53 – paragraph 6
Komisija lahko pripravi tehnična navodila zaradi lažjega izvajanja tega člena.
The Commission may draw up technical guidance notes to facilitate the implementation of this Article.
Agencija lahko pripravi tehnična navodila zaradi lažjega izvajanja tega člena.
The Agency may draw up technical guidance notes to facilitate the implementation of this Article.
Člen 53 je nov člen, ki ga je uvedel Svet.
Article 53 is a new Article introduced by the Council.
Evropska agencija za kemikalije bo izvajala ocene tehnične enakovrednosti, agencija pa bi morala prevzeti odgovornost za tehnična navodila.
Given that ECHA will be carrying out the assessments of technical equivalence, the Agency should take responsibility for the technical guidance notes.
Člen 54 – odstavek 1 – pododstavek 1
Article 54 – paragraph 1 – subparagraph 1
Z odstopanjem od členov 17 in 18 lahko pristojni organ dovoli za obdobje, ki ni daljše od 270 dni, dostopnost na trgu ali uporaba biocidnega proizvoda, ki ne izpolnjuje pogojev za dovoljenje iz te uredbe, in sicer za omejeno in nadzorovano uporabo, če je takšen ukrep potreben zaradi nevarnosti za javno zdravje ali okolje, ki je ni mogoče obvladati z drugimi sredstvi .
By way of derogation from Articles 17 and 18, a competent authority may permit, for a period not exceeding 270 days , the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use, if such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means.
Z odstopanjem od členov 17 in 18 lahko pristojni organ dovoli za obdobje, ki ni daljše od štirih mesecev dostopnost na trgu ali uporaba biocidnega proizvoda, ki ne izpolnjuje pogojev za dovoljenje iz te uredbe, in sicer za omejeno in nadzorovano uporabo, če je takšen ukrep potreben zaradi nevarnosti za javno zdravje ali okolje, ki je ni mogoče obvladati z drugimi sredstvi in če so izpolnjeni vsi od naslednjih pogojev:
By way of derogation from Articles 17 and 18, a competent authority may permit, for a period not exceeding four months , the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use, if such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means , and if all of the following conditions are met:
(a) zadevne aktivne je snovi dovoljeno vključiti v Prilogo I ali so ocenjene v skladu s členom 4 te uredbe in je zagotovljena popolna dokumentacija;
(a) the active substances concerned are approved for inclusion in Annex I or evaluated according to Article 4 of this Regulation and a full dossier is provided;
(b) če zadevne aktivne snovi spadajo v člen 5(1) ali člen 10(1), predlagatelj ali pristojni organ pripravi in izvede obvezen načrt nadomestitve, da zadevne snovi zamenja z nenevarnimi kemičnimi snovmi ali drugimi nekemičnimi možnostmi v dveh letih po datumu odobritve in
(b) if the relevant active substances fall under Article 5(1) or Article 10(1), a mandatory substitution plan is established and implemented by the applicant or competent authority in order to replace the relevant substances with non-hazardous chemical or non-chemical alternatives within two years of the date of approval; and
(c) uporaba proizvoda je omejena na pooblaščene poklicne uporabnike v skladu z zahtevami za celostno zatiranje škodljivcev ter je ustrezno nadzorovana.
(c) the application of the product is restricted to professional users who are certified pursuant to the requirements for an integrated pest management and the use is appropriately monitored.
(Ponovna vložitev predloga spremembe 175 iz prve obravnave.)
(Reinstatement of amendment 175 from first reading.)
Z odstopanjem od točke (a) člena 18(1) lahko pristojni organi in Komisija do odobritve aktivne snovi za obdobje, ki ni daljše od treh let, izdajo dovoljenje zabiocidni proizvod, ki vsebuje novo aktivno snov.
By way of derogation from point (a) of Article 18(1) and until an active substance is approved, competent authorities and the Commission may authorise, for a period not exceeding three years, a biocidal product containing a new active substance.
Takšno začasno dovoljenje se lahko izda le, če ocenjevalni pristojni organ po oceni dokumentacije v skladu s členom 8 predloži priporočilo o odobritvi nove aktivne snovi in pristojni organi, ki so prejeli vlogo za začasno dovoljenje, ali, v primeru začasnega dovoljenja Unije, Agencija, menijo, da se od biocidnega proizvoda ob upoštevanju dejavnikov iz člena 18(2) lahko pričakuje skladnost s točkami (b), (c) in (d) člena 18(1).
Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the evaluating competent authority has submitted a recommendation for approval of the new active substance and the competent authorities which received the application for the provisional authorisation or, in the case of a provisional Union authorisation, the Agency, consider that the biocidal product may be expected to comply with points (b), (c) and (d) of Article 18(1) taking into account the factors set out in Article 18(2).
Pristojni organi ali Komisija vnesejo informacije iz člena 29(4) v register biocidnih proizvodov.
The competent authorities or the Commission shall enter the information referred to in Article 29(4) in the Register for Biocidal Products.
Če se Komisija odloči, da nove aktivne snovi ne bo odobrila, pristojni organi, ki so izdali začasno dovoljenje, ali Komisija prekličejo dovoljenje.
If the Commission decides not to approve the new active substance, the competent authorities which granted the provisional authorisation or the Commission shall cancel that authorisation.
Če Komisija po preteku treh let še ni sprejela odločitve o odobritvi nove aktivne snovi, lahko pristojni organi, ki so izdali začasno dovoljenje, ali Komisija podaljšajo začasno dovoljenje za obdobje, ki ni daljše od enega leta, pod pogojem, da obstajajo tehtni razlogi za predpostavko, da bo aktivna snov ustrezala zahtevam iz člena 4(1) ali, kadar je ustrezno, člena 5(2).
Where a decision on the approval of the new active substance has not yet been adopted by the Commission when the period of three years expires, the competent authorities which granted the provisional authorisation, or the Commission, may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the requirements of Article 4(1) or, where applicable, Article 5(2).
Pristojni organi, ki podaljšajo začasno dovoljenje, o tem obvestijo druge pristojne organe in Komisijo.
Competent authorities which extend the provisional authorisation shall inform the other competent authorities and the Commission of such action.
(Ponovna vložitev predloga spremembe 176 iz prve obravnave.)
(Reinstatement of amendment 176 from first reading.)
Osebe, ki nameravajo izvesti poskus ali preskus, ki lahko vključuje ali ima za posledico sproščanje biocidnega proizvoda v okolje, o tem najprej uradno obvestijo ustrezni pristojni organ države članice, v kateri bo poskus ali preskus izveden.
Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment shall first notify the relevant competent authority of the Member State where the experiment or test will occur.
Uradno obvestilo vključuje podatke, navedene v drugem pododstavku odstavka 1 .
The notification shall include the information listed in the second subparagraph of paragraph 1 .
Uradno obvestilo vključuje opis biocidnega proizvoda ali aktivne snovi, podatke na oznaki in dobavljene količine.
The notification shall include the identity of the biocidal product or active substance, labelling data and quantities supplied.
Zadevna oseba tudi zbere dokumentacijo , ki vsebuje vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali ali vplivu na okolje .
The person concerned shall also compile a dossier containing all available data on possible effects on human or animal health or impact on the environment.
Te podatke na zahtevo da na voljo pristojnemu organu.
They shall make this information available to the competent authorities on request.
Čeprav je vodenje evidence o imenih in naslovih potrošnikov pomembno, teh podrobnosti ni mogoče zagotoviti vnaprej, zlasti ker ta člen zadeva sproščanje v okolje, ne pa zdravja ljudi.
While it is important to maintain a record of the names and addresses of consumers, it is not feasible to supply these details in advance, particularly given that this article concerns release into the environment rather than human health.
Člen 57 – odstavki 3-5
Article 57 – paragraph 3-5
Če se aktivne snovi, ki so vsebovane v biocidnih proizvodih, s katerimi je bil tretirani izdelek tretiran ali jih tretirani izdelek vsebuje, sproščajo v običajnih ali smiselno predvidljivih pogojih uporabe, oseba, ki je odgovorna za dajanje tega tretiranega izdelka na trg, zagotovi, da so na oznaki navedene naslednje informacije:
Where the release of the active substances contained in the biocidal products with which a treated article was treated or which it incorporates, is intended or expected under normal or reasonably foreseeable conditions of use, the person responsible for the placing on the market of that treated article shall ensure that the label provides the following information:
Če tretirani izdelek vsebuje biocidni proizvod , oseba, ki je odgovorna za dajanje tega tretiranega izdelka na trg, zagotovi, da so na oznaki navedene naslednje informacije:
Where a treated article contains a biocidal product, the person responsible for the placing on the market of that treated article shall ensure that the label provides the following information:
(a) izjava, da tretirani izdelek vsebuje biocidne proizvode;
(a) a statement that the treated article incorporates biocidal products;
(b) biocidna lastnost tretiranega izdelka, če je utemeljena;
(b) where substantiated, the biocidal property attributed to the treated article;
(c) brez poseganja v člen 24 Uredbe (ES) št. 1272/2008 imena vseh aktivnih snovi, ki jih vsebujejo biocidni proizvodi;
(c) without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products;
(ca) beseda „nano“ se postavi v oklepaju pred imeni vseh nanomaterialov;
(ca) the name of all nanomaterials , followed by the word "nano" in brackets;
(d) vsa zadevna navodila za uporabo, vključno z vsemi previdnostnimi ukrepi, ki jih je treba sprejeti zaradi biocidnih proizvodov, s katerimi je bil tretirani izdelek tretiran ali jih tretirani izdelek vsebuje.
(d) any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.
(d) vsa zadevna navodila za uporabo, vključno z vsemi previdnostnimi ukrepi, ki jih je treba sprejeti zaradi biocidnih proizvodov, ki jih tretirani izdelek vsebuje.
(d) any relevant instructions for use, including any precautions to be taken because of the biocidal products which a treated article incorporates.
Ta odstavek se ne uporablja, če v sektorski zakonodaji že obstajajo vsaj enakovredne zahteve za označevanje za biocidne proizvode v tretiranih izdelkih, da se izpolnijo zahteve za informacije v zvezi z aktivnimi snovmi.
This paragraph shall not apply where at least equivalent labelling requirements for biocidal products in treated articles to meet information requirements concerning those active substances already exist under sector - specific legislation.
Če se aktivne snovi, ki so vsebovane v biocidnih proizvodih, s katerimi je bil tretirani izdelek tretiran ali jih tretirani izdelek vsebuje, v običajnih ali razumno predvidljivih pogojih uporabe ne sproščajo ali se njihovo sproščanje ne pričakuje, oseba, ki je odgovorna za dajanje tretiranega izdelka na trg, zagotovi, da so na oznaki navedene naslednje informacije:
Where the release of the active substances contained in the biocidal products with which a treated article was treated or which it incorporates, is not intended or expected under normal or reasonably foreseeable conditions of use, the person responsible for the placing on the market of the treated article shall ensure that the label provides the following information:
(a) izjava, da je bil tretirani izdelek tretiran z biocidnimi proizvodi in
(a) a statement that the treated article was treated with biocidal products; and
(b) naslov spletne strani z imeni vseh aktivnih snovi, ki so bile uporabljene pri tretiranju, brez poseganja v člen 24 Uredbe (ES) št. 1272/2008.
(b) the address of a website containing the name of all active substances used for the treatment, without prejudice to Article 24 of Regulation (EC) No 1272/2008.
Na oznaki za tovrsten tretirani izdelek niso navedene kakršne koli biocidne lastnosti.
The label of such a treated article shall not lay claim to any biocidal property.
Oznaka mora biti jasno vidna, lahko čitljiva in dovolj obstojna.
The labelling shall be clearly visible, easily legible and appropriately durable.
Kadar je to potrebno zaradi velikosti ali funkcije tretiranega izdelka, se oznaka natisne na embalažo, na navodila za uporabo ali na garancijski list.
Where necessary because of the size or the function of the treated article, the labelling shall be printed on the packaging, on the instructions for use or on the warranty.
Kadar je to potrebno zaradi velikosti ali funkcije tretiranega izdelka, se oznaka natisne na embalažo, na navodila za uporabo ali na garancijski list v nacionalnem jeziku ali jezikih države članice, na katere trg se da tretirani izdelek .
Where necessary because of the size or the function of the treated article, the labelling shall be printed on the packaging, on the instructions for use or on the warranty in the national language or languages of the Member State on whose market the treated article is to be placed.
Pri tretiranem blagu, ki ni načrtovano in proizvedeno serijsko, temveč na podlagi posebnega naročila, se lahko proizvajalec s stranko dogovori o drugih načinih zagotavljanja informacij.
In the case of treated goods which are not produced as part of a series, but rather designed and manufactured to meet a specific order, the manufacturer may agree other methods of providing the customer with the relevant information.
Če obstajajo resni znaki, da aktivna snov v biocidnem proizvodu, s katero je bil tretirani izdelek tretiran ali jo tretirani izdelek vsebuje, ne izpolnjuje pogojev iz členov 4(1), 5(2) ali 24, Komisija v skladu s členom 15(1) ali 27(2) pregleda odobritev te aktivne snovi ali njeno vključitev v Prilogo I.
Where there are serious indications that an active substance contained in a biocidal product with which a treated article is treated or which it incorporates does not meet the conditions laid down in Article 4(1), 5(2) or 24, the Commission shall review the approval of that active substance or its inclusion in Annex I in accordance with Article 15(1) or 27(2).
Če obstajajo pomenljivi znaki, da aktivna snov v biocidnem proizvodu, s katero je bil tretirani izdelek tretiran ali jo tretirani izdelek vsebuje, ne izpolnjuje pogojev iz členov 4(1), 5(2) ali 24, Komisija v skladu s členom 15(1) ali 27(2) pregleda odobritev te aktivne snovi ali njeno vključitev v Prilogo I.
Where there are significant indications that an active substance contained in a biocidal product with which a treated article is treated or which it incorporates does not meet the conditions laid down in Article 4(1), 5(2) or 24, the Commission shall review the approval of that active substance or its inclusion in Annex I in accordance with Article 15(1) or 27(2).
(Predlog spremembe v skladu z delom predloga spremembe 74 iz prve obravnave v spremenjeni obliki.)
(Amendment in line with part of amendment 74 of first reading in a modified form.)
Novo besedilo, ki ga predlaga Svet.
New text by the Council.
Člen 58 – odstavek 1 – uvodni del
Article 58 – paragraph 1 – introductory part
Brez poseganja v člena 61 in 62 pristojni organi ali Agencija podatkov, predloženih za namene te uredbe, ne uporabljajo v korist poznejšega vlagatelja, razen če:
Without prejudice to Articles 61 and 62, data submitted for the purposes of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where:
Brez poseganja v člena 61 in 62 pristojni organi ali Agencija podatkov, predloženih za namene Direktive 98/8/ES ali te uredbe, ne uporabljajo v korist poznejšega vlagatelja, razen če:
Without prejudice to Articles 61 and 62, data submitted for the purposes of Directive 98/8/EC or of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where:
Ker člen 59 razširja varstvo podatkov na podatke, predložene na podlagi Direktive 98/8/ES, bi morali v vseh pogledih izkoristiti prednosti enake ravni varstva.
Since Article 59 extends data protection to data submitted under Directive 98/8/EC they should benefit from the same level of protection in all respects.
Člen 58 – odstavek 1 – točka a
Article 58 – paragraph 1 – point a
(a) je poznejši vlagatelj pridobil izjavo o dostopnosti; ali
(a) the subsequent applicant has a letter of access; or
(a) je poznejši vlagatelj pridobil in predložil izjavo o dostopnosti; ali
(a) the subsequent applicant has and submits a letter of access ; or
Točka (a) bi morala vključevati podatek, da je izjava o dostopu treba predložiti organom, da bi ga lahko uporabili v prid naslednjega predlagatelja.
Point a) should include that the letter of access has to be submitted to the authorities in order to be used for the benefit of a subsequent applicant.
Podatki, ki so varovani v skladu z Direktivo 98/8/ES ali tem členom ali za katere obdobje varovanja poteče v skladu z Direktivo 98/8/ES ali tem členom, se ponovno ne zavarujejo.
Data protected under Directive 98/8/EC or under this Article or for which the protection period expired under Directive 98/8/EC or under this Article shall not be protected again.
Podatki, ki so varovani v skladu s tem členom ali za katere obdobje varovanja poteče v skladu s tem členom, se ponovno ne zavarujejo.
Data protected under this Article for which the protection period expired under this Article shall not be protected again.
Svet je spremenil člen 59.
Article 59 has been changed by the Council.
S predlaganim predlogom spremembe se želi zagotoviti, da lahko za podatke, predložene v državi članici za odobritev biocidnih proizvodov v okviru nacionalnih sistemov ali praks, velja ista ureditev varstva podatkov kot za podatke, predložene za namene Direktive 98/8/ES.
The proposed amendment is a consequence of that amendment to ensure that data submitted to a Member State under national systems or practices for approval of biocidal products can benefit from the same regime of data protection as data submitted for the purposes of Directive 98/8/EC.
Vsaka oseba, ki namerava izvesti preskuse ali študije, ki vključujejo vretenčarje ali nevretenčarje (v nadaljnjem besedilu: morebitni vlagatelj), Agencijo vpraša , ali so bili takšni preskusi ali študije že predloženi v povezavi s prejšnjo vlogo v skladu s to uredbo ali Direktivo 98/8/ES.
Any person intending to perform tests or studies involving vertebrate animals or non‑vertebrate animals ("the prospective applicant") shall ask the Agency whether such tests or studies have already been submitted in connection with a previous application under this Regulation or Directive 98/8/EC.
Vsaka oseba, ki namerava izvesti preskuse ali študije, ki vključujejo vretenčarje ali nevretenčarje (v nadaljnjem besedilu: morebitni vlagatelj), predloži pisno zahtevo Agenciji , da ta določi, ali so takšni preskusi ali študije že bili predloženi Agenciji, ali pristojnemu organu v povezavi s prejšnjo vlogo v skladu s to uredbo ali z Direktivo 98/8/ES za enak ali tehnično enakovreden proizvod .
Any person intending to perform tests or studies involving vertebrate animals or non‑vertebrate animals, ("the prospective applicant"), shall submit a written request to the Agency to determine whether such tests or studies have already been submitted to the Agency, or to a competent authority in connection with a previous application under this Regulation or Directive 98/8/EC for an identical or technically equivalent product .
Ob zahtevi se plačajo tudi pristojbine iz člena 79(1).
The request shall be accompanied by fees in accordance with Article 79(1).
Če vlagatelj ne plača pristojbine, Agencija ne obravnava zahteve.
If the applicant fails to pay the fees, the Agency shall not consider the request.
Pristojni organ ali Agencija preveri, ali so bili takšni preskusi ali študije že predloženi.
The competent authority or the Agency shall verify whether such tests or studies have already been submitted.
Agencija preveri, ali so bili takšni preskusi ali študije že predloženi.
The Agency shall verify whether such tests or studies have already been submitted.
Če so bili takšni preskusi ali študije že predloženi v povezavi s prejšnjo vlogo v skladu s to uredbo ali Direktivo 98/8/ES, pristojni organ ali Agencija morebitnemu vlagatelju nemudoma sporoči ime in kontaktne podatke lastnika podatkov.
Where such tests or studies have already been submitted in connection with a previous application, under this Regulation or Directive 98/8/EC, the competent authority or the Agency shall, without delay, communicate the name and contact details of the data owner to the prospective applicant.