natgillin/translations-raw huggingface dataset:
Furthermore, the second subparagraph of Article 60(3) of that Regulation does not indicate any period for protection of data referred to in point (b) of Article 20(1) submitted in an application pursuant to Article 26(1) thereof.
Poleg tega v drugem pododstavku člena 60(3) navedene uredbe ni navedeno obdobje za varovanje podatkov iz točke (b) člena 20(1), predloženih v vlogi na podlagi člena 26(1) Uredbe.
Article 60(3) should therefore also refer to Articles 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) and 44(5) of that Regulation.
Člen 60(3) bi se zato moral nanašati tudi na člene 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) in 44(5) navedene uredbe.
Article 66(4) of Regulation (EU) No 528/2012 should be amended to correct the cross reference to Article 67.
Člen 66(4) Uredbe (EU) št. 528/2012 bi bilo treba spremeniti, tako da bi popravili sklicevanje na člen 67.
In order to facilitate good cooperation, coordination and exchange of information between the Member States, the Agency and the Commission regarding enforcement, the Agency should also be given the task of providing support and assistance to Member States with regard to control and enforcement activities by making use of existing structures, where appropriate.
Da bi olajšali dobro sodelovanje, usklajevanje in izmenjavo informacij med državami članicami, Agencijo in Komisijo pri izvrševanju, bi morala Agencija imeti tudi nalogo zagotavljati državam članicam pomoč in podporo na področju nadzora in izvrševanja, zlasti prek uporabe obstoječih struktur, kadar je primerno.
In order to allow the preparation of applications for biocidal product authorisations by the date of approval of an active substance, as provided for by the second subparagraph of Article 89(3) of Regulation (EU) No 528/2012, the electronic public access to information on active substances, provided for by Article 67 thereof, should be available from the day when the Commission adopts the Regulation providing that the active substance is approved.
Da bi omogočili pripravo vlog za izdajo dovoljenj za biocidne proizvode do datuma odobritve aktivne snovi, kot je določeno v drugem pododstavku člena 89(3) Uredbe (EU) št. 528/2012, bi moral biti elektronski dostop javnosti do informacij o aktivnih snoveh, določen v členu 67 Uredbe, na voljo od dne, ko Komisija sprejme uredbo, da je zadevna aktivna snov odobrena.
The first subparagraph of Article 77(1) of Regulation (EU) No 528/2012 provides for appeals against decisions of the Agency taken pursuant to Article 26(2) thereof.
Prvi pododstavek člena 77(1) Uredbe (EU) št. 528/2012 omogoča pritožbe proti sklepom Agencije, sprejetim v skladu s členom 26(2) Uredbe.
However, since Article 26(2) does not empower the Agency to take any decision, the reference to that Article in Article 77(1) should be deleted.
A ker člen 26(2) Agenciji ne daje pristojnosti za sprejemanje sklepov, bi bilo treba sklicevanje na navedeni člen v členu 77(1) črtati.
Article 86 of Regulation (EU) No 528/2012 refers to active substances included in Annex I to Directive 98/8/EC of the European Parliament and of the Council [10].
Člen 86 Uredbe (EU) št. 528/2012 se nanaša na aktivne snovi, vključene v Prilogo I k Direktivi 98/8/ES Evropskega parlamenta in Sveta [10].
It should be clarified that that Article applies to all active substances for which the Commission has adopted a directive including them in that Annex, that the conditions for such inclusion are applicable to the approval, and that the approval date is the date of inclusion.
Pojasniti bi bilo treba, da se navedeni člen uporablja za vse aktivne snovi, za katere je Komisija sprejela direktivo in jih vključila v navedeno prilogo, da se pogoji za tako vključitev uporabljajo za odobritev in da je datum odobritve datum vključitve.
The first subparagraph of Article 89(2) of Regulation (EU) No 528/2012 allows Member States to apply their current system for up to two years after the date of approval of an active substance.
S prvim pododstavkom člena 89(2) Uredbe (EU) št. 528/2012 se državam članicam dovoli, da uporabljajo svoj obstoječi sistem še do dve leti po datumu odobritve aktivne snovi.
The first subparagraph of Article 89(3) thereof requires Member States to ensure that biocidal product authorisations are granted, modified or cancelled within two years of approval of an active substance.
S prvim pododstavkom člena 89(3) Uredbe se od držav članic zahteva zagotovitev, da se dovoljenja za biocidne proizvode izdajo, spremenijo ali prekličejo v dveh letih po odobritvi aktivne snovi.
However, taking into account the time required for the various steps of the authorisation process, in particular where a disagreement on mutual recognition persists between Member States and therefore has to be referred to the Commission for a decision, it is appropriate to extend those deadlines to three years and to reflect that extension in the second subparagraph of Article 37(3) of that Regulation.
A ob upoštevanju časa, potrebnega za različne korake v postopku izdaje dovoljenja, zlasti kadar med državami članicami ni dogovora o medsebojnem priznavanju dovoljenj in je zato potrebna predložitev Komisiji v odločanje, je primerno podaljšati navedene roke na tri leta in navedeno podaljšanje upoštevati v drugem pododstavku člena 37(3) navedene uredbe.
The first subparagraph of Article 89(2) of Regulation (EU) No 528/2012 allows Member States to apply their current system to existing active substances.
S prvim pododstavkom člena 89(2) Uredbe (EU) št. 528/2012 se državam članicam dovoli, da uporabljajo svoj obstoječi sistem za obstoječe aktivne snovi.
A biocidal product could contain a combination of new active substances which have been approved and existing active substances which have not yet been approved.
Biocidni proizvod bi lahko vsebovali kombinacijo novih aktivnih snovi, ki so bile odobrene, in obstoječih aktivnih snovi, ki še niso bile odobrene.
For the purpose of rewarding innovation by granting such products access to the market, Member States should be allowed to apply their current systems to such products until the existing active substance has been approved, and those products are consequently eligible for authorisation in accordance with Regulation (EU) No 528/2012.
Da bi nagradili inovacije in takim proizvodom odobrili dostop na trg, bi bilo treba državam članicam dovoliti, da uporabljajo svoje obstoječe sisteme za take proizvode, dokler ni obstoječa aktivna snov odobrena in posledično ti proizvodi izpolnjujejo pogoje za izdajo dovoljenja v skladu z Uredbo (EU) št. 528/2012.
Articles 89(4) and 93(2) of Regulation (EU) No 528/2012 provide phase-out periods for biocidal products for which no authorisation is granted.
Člen 89(4) in člen 93(2) Uredbe (EU) št. 528/2012 določata obdobja postopnega opuščanja biocidnih proizvodov, za katere izdaja dovoljenja ni odobrena.
The same periods should apply for phasing out a biocidal product already on the market, where an authorisation is granted but the conditions of the authorisation require the biocidal product to be changed.
Enaka obdobja bi se morala uporabljati za postopno opuščanje biocidnega proizvoda, ki je že na trgu, kadar je dovoljenje izdano, vendar je treba zaradi pogojev za izdajo dovoljenja biocidni proizvod spremeniti.
Article 93 of Regulation (EU) No 528/2012 should clarify that the derogation provided for therein applies only subject to Member States’ national rules.
V členu 93 Uredbe (EU) št. 528/2012 bi bilo treba pojasniti, da se v njem določeno odstopanje uporablja samo ob upoštevanju nacionalnih pravil držav članic.
Article 94(1) of Regulation (EU) No 528/2012 seeks to allow the placing on the market of articles treated with biocidal products containing active substances which, albeit not yet approved, are being evaluated, either in the context of the work programme referred to in Article 89(1) of that Regulation or based on an application submitted pursuant to Article 94(1).
Namen člena 94(1) Uredbe (EU) št. 528/2012 je omogočiti, da se dajejo na trg izdelki, tretirani z biocidnimi proizvodi, ki vsebujejo aktivne snovi, ki sicer še niso odobrene, vendar se že ocenjujejo bodisi v okviru delovnega programa iz člena 89(1) navedene uredbe bodisi na podlagi vloge, predložene v skladu s členom 94(1).
However, the reference in Article 94(1) to Article 58 of Regulation (EU) No 528/2012 could be interpreted as an unintended derogation from the labelling and information requirements in Article 58(3) and (4).
Vendar bi se lahko sklicevanje v členu 94(1) na člen 58 Uredbe (EU) št. 528/2012 razlagalo kot nepredvideno odstopanje od zahtev glede označevanja in informacij iz člena 58(3) in (4).
Article 94(1) of that Regulation should therefore refer only to Article 58(2).
Člen 94(1) navedene uredbe bi se zato moral sklicevati le na člen 58(2).
As Article 94(1) of Regulation (EU) No 528/2012 applies only to treated articles already placed on the market, an unintended ban on most new treated articles was introduced from 1 September 2013 until the approval of the last active substance contained in those treated articles.
Ker se člen 94(1) Uredbe (EU) št. 528/2012 uporablja samo za tretirane izdelke, ki so bili že dani na trg, je bila vpeljana nepredvidena prepoved za večino novih tretiranih izdelkov, in sicer od 1. septembra 2013 do odobritve zadnje aktivne snovi v teh tretiranih izdelkih.
The scope of Article 94(1) should therefore be extended to include new treated articles.
Zato bi bilo treba področje uporabe člena 94(1) razširiti tako, da vključuje nove tretirane izdelke.
That Article should also provide for a phasing-out period for treated articles for which no application for the approval of the active substance for the relevant product-type is submitted by 1 September 2016.
V navedenem členu bi bilo treba določiti tudi obdobje postopnega opuščanja tretiranih izdelkov, za katere do 1. septembra 2016 ni predložena vloga za odobritev aktivne snovi za ustrezno vrsto proizvoda.
To avoid potentially serious adverse effects on economic operators and whilst fully respecting the principle of legal certainty, provision should be made for those modifications to apply from 1 September 2013.
Da se preprečijo morebitni resni škodljivi vplivi na gospodarske subjekte in da se v celoti spoštuje načelo pravne varnosti, bi bilo treba urediti, da se spremembe uporabljajo od 1. septembra 2013.
The first subparagraph of Article 95(1) of Regulation (EU) No 528/2012 requires the submission of a complete substance dossier.
Prvi pododstavek člena 95(1) Uredbe (EU) št. 528/2012 zahteva predložitev popolne dokumentacije o snovi.
It should be possible for such a complete dossier to include data referred to in Annex IIIA or IVA to Directive 98/8/EC.
V tako popolno dokumentacijo bi moralo biti možno vključiti podatke iz Priloge IIIA ali IVA k Direktivi 98/8/ES.
Under the third subparagraph of Article 95(1) of Regulation (EU) No 528/2012, the right to refer to data provided for in the second subparagraph of Article 63(3) thereof is extended to all studies required for the human health and environmental risk assessment, to allow prospective relevant persons to be included in the list referred to in Article 95(2) thereof.
V tretjem pododstavku člena 95(1) Uredbe (EU) št. 528/2012 je pravica do sklicevanja na podatke iz drugega pododstavka člena 63(3) Uredbe razširjena na vse študije, potrebne za oceno tveganja za zdravje človeka in okolje, da bo mogoče morebitne zadevne osebe vključiti na seznam iz člena 95(2) Uredbe.
Without such a right to refer, many prospective relevant persons would not be able to comply with Article 95(1) in time to be included in that list by the date referred to in Article 95(3).
Brez take pravice do sklicevanja številne morebitne zadevne osebe ne bi mogle pravočasno izpolniti zahtev iz člena 95(1), da bi bile lahko vključene na ta seznam do datuma iz člena 95(3).
However, the third subparagraph of Article 95(1) fails to include studies on environmental fate and behaviour.
Tretji pododstavek člena 95(1) pa ne vključuje študij o usodi in obnašanju v okolju.
Moreover, since prospective relevant persons are to pay for the right to refer in accordance with Article 63(3), they should be entitled to fully benefit from that right by passing it onto applicants for product authorisation.
Ker morajo morebitne zadevne osebe pravico do sklicevanja v skladu s členom 63(3) plačati, bi morale biti upravičene, da izkoristijo to pravico v celoti, in sicer tako, da jo predajo vlagateljem vloge za dovoljenje za proizvod.
Article 95 should therefore be amended accordingly.
Člen 95 bi bilo zato treba ustrezno spremeniti.
The fifth subparagraph of Article 95(1) of Regulation (EU) No 528/2012 intends to limit the protection period for data which can be shared from 1 September 2013 for the purpose of compliance with the first subparagraph of Article 95(1), but which on that date could not yet be shared for the purpose of substantiating applications for product authorisations.
Namen petega pododstavka člena 95(1) Uredbe (EU) št. 528/2012 je omejiti obdobje varovanja podatkov, ki se lahko izmenjujejo od 1. septembra 2013, zaradi uskladitve s prvim pododstavkom člena 95(1), vendar ki jih na ta dan še ni bilo možno izmenjevati z namenom utemeljitve vlog za izdajo dovoljenj za proizvode.
Such is the case for data relating to active substance/product-type combinations for which a decision on inclusion in Annex I to Directive 98/8/EC was not taken before 1 September 2013.
Tako veljala za podatke, ki se nanašajo na kombinacije aktivnih snovi / vrst proizvodov, za katere pred 1. septembra 2013 ni bila sprejeta odločitev o vključitvi v Prilogo I k Direktivi 98/8/ES.
Article 95(1) of that Regulation should therefore refer to that date.
Člen 95(1) navedene uredbe bi se zato moral nanašati na navedeni datum.
Pursuant to Article 95(2) of Regulation (EU) No 528/2012, the list published by the Agency is to contain the names of the participants in the work programme referred to in Article 89(1) thereof.
Na podlagi člena 95(2) Uredbe (EU) št. 528/2012 seznam, ki ga objavi Agencija, vsebuje imena udeležencev v delovnem programu iz člena 89(1) Uredbe.
Article 95(2) thereby allows those participants to benefit from the cost compensation mechanism set out in that Regulation.
Člen 95(2) s tem omogoča navedenim udeležencem, da izkoristijo mehanizem nadomestila stroškov, določene v navedeni uredbi.
The possibility of benefitting from a cost compensation mechanism should be open to all persons who have submitted a complete substance dossier in accordance with Regulation (EU) No 528/2012 or with Directive 98/8/EC, or a letter of access to such a dossier.
Ta možnost, da se izkoristi mehanizem nadomestila stroškov, bi morala biti odprta za vse osebe, ki so predložile popolno dokumentacijo o snovi v skladu z Uredbo (EU) št. 528/2012 ali Direktivo 98/8/ES ali izjavo o dostopnosti dokumentacije.
It should be open to those who submitted dossiers for any substance which is not itself an active substance but which generates active substances.
Odprta bi morala biti za vse, ki so predložili dokumentacijo, za vsako snov, ki sama sicer ni aktivna snov, vendar se uporablja za pridobivanje aktivnih snovi.
The first subparagraph of Article 95(3) of Regulation (EU) No 528/2012 prohibits the placing on the market of biocidal products containing active substances for which the manufacturer or importer (‘the relevant person’) is not included in the list referred to in that Article.
S prvim pododstavkom člena 95(3) Uredbe (EU) št. 528/2012 se prepoveduje dajanje na trg biocidnih proizvodov, ki vsebujejo aktivne snovi, za katere proizvajalec ali uvoznik (v nadaljnjem besedilu: zadevna oseba) ni vključen na seznam iz navedenega člena.
By virtue of Articles 89(2) and 93(2) of that Regulation, certain active substances will be legally present on the market in biocidal products even though no complete substance dossier has yet been submitted.
Na podlagi členov 89(2) in 93(2) navedene uredbe bodo določene aktivne snovi zakonito prisotne na trgu v biocidnih proizvodih, čeprav popolna dokumentacija o snovi še ni bila predložena.
The prohibition under Article 95(3) should not apply to such substances.
Prepoved na podlagi člena 95(3) se za take snovi ne bi smela uporabljati.
Furthermore, where no substance manufacturer or importer is listed for a substance for which a complete substance dossier has been submitted, the possibility should be allowed for another person to place biocidal products containing that substance on the market, subject to the submission of a dossier, or a letter of access to a dossier, by that person or the manufacturer or importer of the biocidal product.
Kadar ni na seznamu naveden noben proizvajalec ali uvoznik snovi, za katero je bila predložena popolna dokumentacija o snovi, bi bilo treba drugi osebi dovoliti, da lahko daje na trg biocidne proizvode, ki vsebujejo navedeno snov, če navedena oseba, proizvajalec ali uvoznik biocidnega proizvoda predloži dokumentacijo ali izjavo o dostopnosti do dokumentacije.
Article 95(4) of Regulation (EU) No 528/2012 provides that Article 95 applies to active substances listed under category 6 in Annex I to that Regulation.
Člen 95(4) Uredbe (EU) št. 528/2012 določa, da se člen 95 uporablja za aktivne snovi iz kategorije 6 v Prilogi I k navedeni uredbi.
Those substances have been included in that Annex based on submissions of complete substance dossiers, the owners of which should be entitled to benefit from the cost compensation mechanism established under that Article.
Te snovi so bile vključene v navedeno prilogo na podlagi predložitve popolne dokumentacije o snovi, katerih lastniki bi morali biti upravičeni, da izkoristijo mehanizem nadomestila stroškov, uveden z navedenim členom.
In the future, other substances may be included in that Annex based on such submissions.
Druge snovi bi se lahko v prihodnje vključile v navedeno prilogo na podlagi takih predložitev.
Category 6 of that Annex should therefore regulate all such substances.
Zato bi morala vse take snovi urejati kategorija 6 v navedeni prilogi.
The description in Annex V to Regulation (EU) No 528/2012 of biocidal products used in food contact materials should be consistent with the terminology used in Regulation (EC) No 1935/2004.
Opis biocidnih proizvodov, uporabljenih v materialih, namenjenih za stik z živili, v Prilogi V k Uredbi (EU) št. 528/2012 bi moral biti skladen s terminologijo v Uredbi (ES) št. 1935/2004.
It should be clarified in the first paragraph of Article 96 of Regulation (EU) No 528/2012 that Directive 98/8/EC is repealed without prejudice to the provisions of Regulation (EU) No 528/2012 referring to Directive 98/8/EC.
V prvem odstavku člena 96 Uredbe (EU) št. 528/2012 bi bilo treba pojasniti, da se Direktiva 98/8/ES razveljavi brez poseganja v določbe Uredbe (EU) št. 528/2012, ki se nanašajo na Direktivo 98/8/ES.
Regulation (EU) No 528/2012 should therefore be amended accordingly,
Uredbo (EU) št. 528/2012 bi bilo zato treba ustrezno spremeniti –
Regulation (EU) No 528/2012 is amended as follows:
Uredba (EU) št. 528/2012 se spremeni:
biocidal products when used as processing aids within the meaning of Regulation (EC) No 1831/2003 and Regulation (EC) No 1333/2008.’;
biocidne proizvode, kadar se uporabljajo kot pomožna tehnološka sredstva v smislu Uredbe (ES) št. 1831/2003 in Uredbe (ES) št. 1333/2008.“;
point (s) is replaced by the following:
točka (s) nadomesti z naslednjim:
“biocidal product family” means a group of biocidal products having:
‚družina biocidnih proizvodov‘ pomeni skupino biocidnih proizvodov:
similar uses;
s podobno uporabo;
the same active substances;
z enakimi aktivnimi snovmi;
similar composition with specified variations; and
s podobno sestavo z določenimi odstopanji, in
similar levels of risk and efficacy;’;
s podobno ravnjo tveganja in učinkovitosti;“;
point (v) is deleted;
točka (v) se črta;
the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met;’;
aktivne snovi so vključene v Prilogo I ali odobrene za zadevno vrsto proizvoda in izpolnjeni so vsi pogoji, ki so določeni za te aktivne snovi;“;
where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93, Regulation (EC) No 396/2005 of the European Parliament and of the Council, Regulation (EC) No 470/2009 of the European Parliament and of the Council or Directive 2002/32/EC of the European Parliament and of the Council, or specific migration limits or limits for the residual content in food contact materials have been established with respect to such active substances in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council.
po potrebi se za aktivne snovi v biocidnem proizvodu določijo najvišje mejne vrednosti ostankov za hrano in krmo v skladu z Uredbo Sveta (EGS) št. 315/93, Uredbo Evropskega parlamenta in Sveta (ES) št. 396/2005, Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta ali Direktivo 2002/32/ES Evropskega parlamenta in Sveta ali se za te aktivne snovi določijo posebne mejne vrednosti migracije ali mejne vrednosti za ostanek v materialih, ki prihajajo v stik z živili, v skladu z Uredbo Evropskega parlamenta in Sveta (ES) št. 1935/2004.
in paragraph 4, points (b) and (c) are replaced by the following:
v odstavku 4 se točki (b) in (c) nadomesti ta z naslednjim:
acute oral toxicity category 1, 2 or 3,
z akutno oralno toksičnostjo kategorije 1, 2 ali 3,
acute dermal toxicity category 1, 2 or 3,
z akutno dermalno toksičnostjo kategorije 1, 2 ali 3,
acute inhalation toxicity (gases and dust/mist) category 1, 2 or 3,
z akutno toksičnostjo pri vdihavanju (plini in prah/meglice) kategorije 1, 2 ali 3,
specific target organ toxicity by single or repeated exposure category 1,
s toksičnostjo za posamezne organe ob enkratni ali ponavljajoči se izpostavljenosti kategorije 1,
it consists of, contains or generates, a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;’;
biocidni proizvod je sestavljen iz snovi, ki izpolnjuje merila za PBT ali vPvB v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006, vsebuje to snov ali se uporablja za njeno pridobivanje;“;
The assessment of the biocidal product family conducted according to the common principles set out in Annex VI shall consider the maximum risks to human health, animal health and the environment and the minimum level of efficacy over the whole potential range of products within the biocidal product family.
Ocena družine biocidnih proizvodov, opravljena v skladu s splošnimi načeli iz Priloge VI, upošteva največja tveganja za zdravje človeka, zdravje živali in okolje in najmanjše ravni učinkovitosti za ves potencialen razpon proizvodov iz družine biocidnih proizvodov.
A biocidal product family shall be authorised only if:
Dovoljenje za družino biocidnih proizvodov se izda le, če:
the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and
vloga izrecno opredeljuje največja tveganja za zdravje človeka, zdravje živali in okolje ter najmanjšo raven učinkovitosti, na kateri temelji ocena, ter tudi dovoljena odstopanja v sestavi in uporabah iz točke (s) člena 3(1), skupaj z ustrezno razvrstitvijo, izjavami o nevarnosti in previdnostnimi izjavami ter vsemi ustreznimi ukrepi za zmanjševanje tveganj, in
it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within the family comply with the conditions set out in paragraph 1.
je na podlagi ocene iz prvega pododstavka tega odstavka mogoče ugotoviti, da vsi biocidni proizvodi v družini izpolnjujejo pogoje iz odstavka 1.