natgillin/translations-raw huggingface dataset:
Komisija lahko na zahtevo države članice pregleda tudi odobritev aktivne snovi za eno ali več vrst proizvodov, če se pojavijo pomenljivi znaki, da uporaba aktivne snovi v biocidnem proizvodu ali tretiranem izdelku povzroča resno zaskrbljenost glede varnosti tega biocidnega proizvoda ali tretiranega izdelka.
The Commission may also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles.
Komisija lahko vključitev pregleda tudi, kadar obstajajo pomenljivi znaki, da cilji iz člena 4(1)(a)(iv), člena 4(1)(b)(i) ter člena 7(2) in (3) Direktive 2000/60/ES morda ne bodo doseženi, v skladu z novimi znanstvenimi in tehničnimi spoznanji in podatki o spremljanju pa lahko upošteva tudi zahtevo države članice, da se pregled opravi.
The Commission may also review , and shall, in the light of new scientific and technical knowledge and monitoring data, take into account the request of a Member State to review , inclusion where there are significant indications that the objectives of Article 4(1)(a)(iv), Article 4(1)(b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved.
(Ponovno se vloži predlog spremembe 74 iz prve obravnave v spremenjeni obliki.)
(Reinstatement of amendment 74 from first reading in a modified form.)
Povod za pregled bi moralo biti tudi neizpolnjevanje ustreznih določb okvirne direktive o vodah.
Non-compliance with the relevant provisions of the water framework directive should also trigger a review.
Člen 15 – odstavek 1 - pododstavek 2
Article 15 – paragraph 1 - subparagraph 2
Kadar so ti znaki potrjeni, Komisija v skladu postopkom pregleda iz člena 81(3) sprejme izvedbeno uredbo o spremembi pogojev za odobritev aktivne snovi ali o preklicu odobritve .
Where those indications are confirmed the Commission shall adopt an implementing Regulation amending the conditions of approval of an active substance or cancelling its approval .
Ta izvedbena uredba se sprejme v skladu s postopkom pregleda iz člena 81(3).
That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 81(3).
Komisija ustrezno obvesti prvotnega vlagatelja ali vlagatelje vloge za odobritev .
The Commission shall inform the initial applicant(s) for the approval accordingly.
Kadar so ti znaki potrjeni, Komisija sprejme delegirane akte v skladu s členom 82 o spremembi pogojev za vključitev aktivne snovi v Prilogo -I ali o preklicu vključitve .
Where those indications are confirmed the Commission shall adopt delegated acts in accordance with Article 82 amending the conditions of inclusion of an active substance in Annex -I or cancelling its inclusion .
Komisija ustrezno obvesti prvotnega vlagatelja ali vlagatelje za vključitev v Prilogo -I, da izvaja pregled, in vlagateljem zagotovi možnost predložitve pripomb .
The Commission shall inform the initial applicant(s) for the inclusion in Annex -I that it is carrying out a review and shall provide an opportunity for the applicant to submit comments.
Komisija te pripombe ustrezno upošteva pri pregledu.
The Commission shall take due account of those comments in its review .
Sprememba pogojev odobritve ali vključitve aktivne slovi v uredbo je ukrep splošne uporabe, ki dopolnjuje osnovni akt in bi zato moral biti predmet delegiranih, ne pa izvedbenih aktov.
The amendment of the conditions of approval/inclusion of an active substance in the Regulation is a measure of general application supplementing the basic act, and should therefore be subject to delegated rather than implementing acts.
Člen 15 – odstavek 1 – pododstavek 3
Article 15 – paragraph 1 – subparagraph 3
V ustrezno utemeljenih nujnih primerih lahko Komisija v skladu s postopkom iz člena 81(4) sprejme izvedbene akte , ki se začnejo nemudoma uporabljati .
On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 81(4) .
V ustrezno utemeljenih nujnih primerih lahko Komisija v skladu s postopkom iz člena 83 sprejme delegirane akte.
On duly justified imperative grounds of urgency the Commission shall adopt delegated acts in accordance with the procedure referred to in Article 83 .
Predlog spremembe k novemu besedilu Sveta.
Amendment to new text by the Council.
Pomembno je ohraniti postopek za nujne primere, vendar bi morali nujne odločitve o obnovitvi sprejemati z delegiranimi, ne pa z izvedbenimi akti.
While it is important to maintain an urgency procedure, urgent decisions about renewals should be taken via delegated acts, not implementing acts.
Če Komisija odloči, da vključitev aktivne snovi v Prilogo -I za eno ali več vrst proizvodov prekliče ali spremeni, države članice, ali v primeru dovoljenja Unije, Komisija, prekličejo ali, kadar je potrebno, spremenijo dovoljenja biocidnih proizvodov, ki vsebujejo to aktivno snov.
Where the Commission decides to cancel or amend the inclusion of an active substance in Annex -I for one or more product-types, the Member States or, in the case of a Union authorisation, the Commission shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance.
Smiselno se uporabljata člena 29 in 43.
Article 29 and Article 43, as appropriate, shall apply mutatis mutandis.
Predlog spremembe k določbi, ki jo je predlagal Svet.
Amendment of the provision introduced by Council.
Posledice pregleda so enake kot pri obnovitvi, Komisija lahko prekliče odobritev ali spremeni pogoje odobritve.
The consequences of a review are the same as for a renewal: the Commission may cancel the approval or modify the conditions of approval.
Komisija lahko z izvedbenimi akti sprejme podrobne ukrepe za izvajanje členov 12 do 15, s katerimi se podrobneje določijo postopki za podaljšanje in pregled odobritve aktivne snovi.
The Commission may adopt , by means of implementing acts, detailed measures for the implementation of Articles 12 to 15, further specifying the procedures for the renewal and review of the approval of an active substance.
Komisijo se v skladu s členom 82 pooblasti za sprejetje delegiranih aktov, ki določajo podrobna pravila za uporabo členov od 12 do 15, s katerimi se podrobneje določijo postopki za podaljšanje in pregled vključitve aktivne snovi v Prilogo -I .
The Commission shall be empowered to adopt delegated acts in accordance with Article 82 specifying detailed rules for the application of Articles 12 to 15, further specifying the procedures for the renewal and review of the inclusion of an active substance in Annex -I .
Oblikovanje podrobnih pravil za uporabo členov od 12 do 15 je ukrep splošne uporabe, ki dopolnjuje osnovni akt, in bi zato moralo biti predmet delegiranih, ne pa izvedbenih aktov.
The drawing up of detailed rules for the application of Articles 12 to 15 is a measure of general application supplementing the basic act, and should therefore be subject to delegated rather than implementing acts.
Naprave na kraju samem niso na razpolago na trgu, razen če je biocidni proizvod, ki ga proizvajajo, odobren v skladu s to uredbo in ta naprava izpolnjuje vse ustrezne pogoje te odobritve.
In situ devices shall not be made available on the market unless the biocidal product that they generate is authorised in accordance with this Regulation and the in situ device complies with any relevant conditions of that authorisation.
Da bi lahko bili biocidni proizvodi, ki se proizvajajo s pomočjo naprave na kraju samem, obravnavani v uredbi (uvodna izjava 9), bi zanje morala veljati ločena prepoved o dajanju naprav, ki proizvajajo biocidne proizvode na kraju samem, na trg, razen če so biocidni proizvodi, ki jih naprave proizvajajo, odobreni.
To enable biocidal products generated by an in situ device to be addressed in the Regulation (recital 9), they should be subject to a separate prohibition on making devices that generate biocidal products in situ available on the market, unless the biocidal product they generate is authorised.
To je doseženo s predlaganim novim členom 17(1a).
This is achieved by the proposed new Article 17(1a).
Imetnik dovoljenja uradno obvesti vsak pristojni organ, ki je izdal nacionalno dovoljenje za družino biocidnih proizvodov, o vsakem proizvodu te družine biocidnih proizvodov, preden ga da na trg , razen takrat, kadar je določeni proizvod izrecno opredeljen v dovoljenju ali kadar se odstopanje v sestavi nanaša le na pigmente, dišave in barvila, in sicer v okviru dovoljenih odstopanj .
The authorisation holder shall notify each competent authority that has granted a national authorisation for a biocidal product family of each product within the biocidal product family before placing it on the market , except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations .
V obvestilu navede točno sestavo, trgovsko ime in pripono k številki dovoljenja.
The notification shall indicate the exact composition, trade name and suffix to the authorisation number.
V primeru dovoljenja Unije imetnik dovoljenja uradno obvesti Agencijo in Komisijo.
In the case of a Union authorisation, the authorisation holder shall notify the Agency and the Commission.
Imetnik dovoljenja uradno obvesti vsak pristojni organ, ki je izdal nacionalno dovoljenje za družino biocidnih proizvodov, o vsakem proizvodu te družine biocidnih proizvodov najmanj 30 dni , preden ga da na trg.
The authorisation holder shall notify each competent authority that has granted a national authorisation for a biocidal product family of each product within the biocidal product family at least 30 days before placing it on the market.
Da bi omogočili pravo spremljanje trga, bi moralo biti obvestilo podano najmanj 30 dni vnaprej.
The notification should be made at least 30 days in advance to allow a real market monitoring.
Namen obveščanja o proizvodih, ki sodijo v družino biocidnih proizvodov, je poznavanje vseh proizvodov, ki se dajo na trg, pa tudi njihove točne sestave.
The notification of products belonging to a biocidal product family aims to know all products that are placed on the market, as well as their exact composition.
Zato je potrebno obvestilo o vsakem proizvodu znotraj družine biocidnih proizvodov.
The notification of each product within the biocidal product family is therefore needed.
Da bi poenotili postopek odobritve v Uniji in zmanjšali upravno obremenitev za proizvajalce in pristojne organe, Komisija v skladu s členom 82 sprejme delegirane akte, ki določajo pogoje, merila in postopke za odobritev in trženje istega proizvoda za isti namen uporabe pod različnimi blagovnimi znamkami in prek različnih podjetij.
In order to unify authorisation practices in the Union and to reduce the administrative burden on manufacturers and competent authorities, the Commission shall adopt delegated acts in accordance with Article 82 specifying the conditions, criteria and procedures for authorising different undertakings to place on the market the same product for the same use.
Merila in postopki za te ukrepe temeljijo na naslednjih načelih, vendar nanje niso omejeni:
The criteria and the procedures for such measures shall be based on, but not limited to, the following principles:
(a) dodatna ocena se ne opravi, saj gre za že odobren biocidni proizvod,
(a) no additional evaluation will be performed, as the biocidal product has already been authorised;
(b) odločitve o izdaji dovoljenj se sprejmejo v kratkem roku,
(b) authorisation decisions shall be taken within a short timeframe;
(c) pristojbine za dovoljenje so ustrezno nizke glede na omejeno upravno obremenitev.
(c) authorisation fees shall be low in accordance with the limited administrative work required.
Poenostavitev trženja biocidnih proizvodov z enako recepturo in namenom uporabe pod različnimi blagovnimi znamkami in preko različnih proizvajalcev.
The aim is to make it easier for biocidal products with the same formulation and intended use to be marketed under different brand names and by different manufacturers.
Ker se takšne odobritve nanašajo na biocidne proizvode, katerih recepture so identične, ni potrebe po ponovni oceni učinkov na človekovo zdravje in okolje.
As such authorisations relate to biocidal products whose formulations are identical, there is no need to assess their impact on human health and the environment again.
Ukrepi za trajnostno uporabo biocidnih proizvodov
Measures geared to the sustainable use of biocidal products
Države članice na podlagi okvirne direktive Unije določijo obvezne ukrepe, s katerimi bi dosegli trajnostno profesionalno uporabo biocidnih proizvodov, vključujejo pa uvedbo nacionalnih akcijskih načrtov, celostno zatiranje škodljivcev, ukrepe za zmanjševanje tveganja ter spodbujanje alternativnih možnosti.
Member States shall establish and implement mandatory measures on the basis of a Union framework directive in order to achieve the sustainable professional use of biocidal products, including the introduction of National Action Plans, integrated pest management, risk reduction measures and the promotion of alternatives.
Komisija Evropskemu parlamentu in Svetu do …* poda zakonodajni predlog za v odstavku 1 navedeno okvirno direktivo.
By ...*, the Commission shall submit a legislative proposal for the framework directive referred to in paragraph 1 to the European Parliament and the Council.
*Vstaviti datum (dve leti po sprejetju te uredbe).
* Please insert date two years after adoption of this Regulation.
Obnovitev stališča Parlamenta v prvi obravnavi.
Reinstatement of Parliament’s first-reading position.
Člen 18 – odstavek 1 – točka e a (novo)
Article 18 – paragraph 1 – point e a (new)
(ea) pri uporabi nanomaterialov v tem proizvodu je bilo posebej ocenjeno tveganje za okolje in zdravje.
(ea) where nanomaterials are used in that product, the risk to the environment and to health has been assessed separately .
(Ponovna vložitev predloga spremembe 88 iz prve obravnave.)
(Reinstatement of amendment 88 from first reading.)
Nanomateriali imajo drugačne lastnosti kot enake snovi v običajni obliki.
Nanomaterials can have very different characteristics to the same substances in normal form.
Tveganje, ki ga pomenijo nanomateriali v biocidnih proizvodih, je treba zato preučiti posebej.
The risks posed by nanomaterials in biocidal products must therefore be investigated separately.
Člen 18 – odstavek 2 – točka d
Article 18 – paragraph 2 – point d
(d) kumulativni in sinergijski učinki.
(d) cumulative and synergistic effects.
(d) kumulativni učinki.
(d) cumulative effects.
Pomembno je razlikovati med kumulativnimi učinki (enake snovi v različnih proizvodih in z različno uporabo) in sinergijskimi učinki (različne snovi v eni zmesi).
It is important to differentiate cumulative effects (same substance in different products and uses) from synergistic effects (different substances in one mixture).
Člen 18 – odstavek 2 – točka d a (novo)
Article 18 – paragraph 2 – point d a (new)
(da) sinergijski učinki.
(da) synergistic effects.
Ne glede na odstavka 1 in 4 se biocidni proizvod lahko dovoli, če pogoji iz odstavka 1(b)(iii) in (iv) niso v celoti izpolnjeni, ali pa se zanj lahko izda dovoljenje za dostopnost na trgu in v splošno uporabo, če so merila iz odstavka 4(c) izpolnjena, kadar bi neizdaja dovoljenja za biocidni proizvod v primerjavi s tveganjem za zdravje človeka ali živali ali za okolje, ki izhaja iz uporabe biocidnega proizvoda pod pogoji, določenimi v dovoljenju, imela nesorazmerne negativne posledice za družbo .
Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human or animal health or to the environment arising from the use of the biocidal product under the conditions laid down in the authorisation .
Ne glede na odstavka 1 in 4 se biocidni proizvod lahko dovoli, če pogoji iz odstavka 1(b)(iii) in (iv) niso v celoti izpolnjeni, kadar dokazi kažejo, da je biocidni proizvod nujen za preprečevanje ali nadziranje resne nevarnosti za zdravje človeka ali živali ali za okolje, varnost hrane in krme ali za javni interes ter da ni na razpolago drugih učinkovitih proizvodov ali tehnologij .
Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, where it is shown by evidence that the biocidal product is necessary to prevent or control a serious danger to public or animal health or to the environment , to food and feed or to the public interest and that there are no effective alternative products or technologies available.
Za uporabo vseh biocidnih proizvodov, odobrenih v skladu s tem odstavkom, veljajo ustrezni ukrepi za zmanjšanje tveganja, da bi se zagotovila najmanjša izpostavljenost ljudi in okolja.
The use of any biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised.
Država članica, ki odobri biocidni proizvod v skladu s tem odstavkom, sestavi načrt nadomestitve za nadzorovanje resnih nevarnosti z drugimi sredstvi, vključno z nekemičnimi metodami, ki so enako učinkovita kot zadevni biocidni proizvod, ter ta načrt brez odlašanja predloži Komisiji.
A Member State authorising a biocidal product authorised pursuant to this paragraph shall draw up a substitution plan concerning the control of the serious danger by other means including non-chemical methods, which are as effective as the biocidal product concerned , and shall without delay transmit that plan to the Commission .
Uporaba katerega koli biocidnega proizvoda, odobrenega v skladu s tem odstavkom, je omejena na tiste države članice, v katerih je treba resno nevarnost preprečiti ali jo, kadar že pride do nje, nadzirati.
The use of any biocidal product authorised pursuant to this paragraph shall be restricted to those Member States where the serious danger has to be prevented or, if it occurs, controlled.
Enaki pogoji, kot so bili sprejeti v prvi obravnavi za odstopanje od meril za izključitev aktivnih snovi, bi se po analogiji morali uporabljati za vsako odstopanje od meril za izključitev za biocidne proizvode.
The same conditions as adopted in first reading for the derogations from the cut-off criteria for active substances should apply in analogy for any derogations from the cut-offs for biocidal products.
Za splošno uporabo proizvodov, ki so bili odobreni samo za poklicno uporabo, ne bi smelo biti odstopanj.
There should be no derogation for general use for products authorised for professional use only.
Člen 18 – odstavek 7 a (novo)
Article 18 – paragraph 7 a (new)
Kadar za aktivne snovi, zajete v členu 10(1)(a) Uredbe (ES) št. 470/2009, v času vključitve aktivne snovi v Prilogo -I ni mogoče določiti najvišje mejne vrednosti v skladu s členom 9 navedene uredbe ali kadar je treba spremeniti mejno vrednost, določeno v skladu s členom 9 navedene uredbe, se v skladu s postopkom iz člena 8 navedene uredbe in na podlagi vloge morebitnega imetnika dovoljenja ali njegovega zastopnika v skladu s členom 3 navedene uredbe določi ali spremeni najvišja mejna vrednost.
Where, for active substances covered by Article 10(1)(a) of Regulation (EC) No 470/2009, it is not possible to establish a maximum residue limit in accordance with Article 9 of that Regulation at the time of the inclusion of the active substance in Annex -I, or where a limit established in accordance with Article 9 of that Regulation needs to be amended, the maximum residue limit shall be established or amended following the procedure referred to in Article 8 of that Regulation and on the basis of an application submitted by the prospective authorisation holder or its representative in accordance with Article 3 of that Regulation.
Besedilo Sveta ni skladno s postopki iz Uredbe 470/2009.
The Council text is not compatible with the procedures established under Regulation 470/2009.
Predlagano besedilo zagotavlja usklajenost besedila uredbe o biocidih in Uredbe 470/2009.
The proposed text ensures that the text of Biocides Regulation and that of Regulation 470/2009 are aligned.
Namen je izboljšati skladnost (tako znotraj besedila kot tudi z drugimi deli zakonodaje).
It is intended to improve consistency (both within the text and with other pieces of legislation).
Za vloge za izdajo dovoljenja Unije, predložene v skladu s členom 42, se povzetek značilnosti biocidnega proizvoda iz točke (ii) odstavka 1(a) tega člena zagotovi v enem od uradnih jezikov Unije, sprejemljivem za ocenjevalni pristojni organ ob oddaji vloge.
For applications for Union authorisations submitted under Article 42, the summary of the characteristics of the biocidal product referred to in point (ii) of paragraph(1)(a) of this Article shall be provided in one of the official language s of the Union accepted by the evaluating competent authority at the time of application.
Agencija ta povzetek pošlje Komisiji v vseh uradnih jezikih v 30 dneh po predložitvi mnenja iz člena 43(3).
The Agency shall transmit that summary to the Commission in all official languages within 30 days of the submission of the opinion referred to in Article 43(3).
Stroške za zagotovitev teh prevodov bi moral nositi predlagatelj.
The costs of providing such translations should be borne by the applicant.
Člen 21 – odstavek 2 – točka qa (novo)
Article 21 – paragraph 2 – point q a (new)
(qa) analitske metode, vključno z odstotki izkoristka in mejami določanja za toksikološko in ekotoksikološko pomembne sestavine biocidnih proizvodov in/ali njihove ostanke;
(qa) for toxicologically and ecotoxicologically relevant components of biocidal products and/or residues thereof, analytical methods including recovery rates and the limits of determination (LOD);
V vsebini dovoljenja morajo biti zajeti tudi podatki o analitskih metodah in ustrezne meje določanja.
Zum Inhalt von Zulassungen soll auch die Angabe der Analysemethoden und die jeweiligen Bestimmungsgrenzen zählen.
V primeru družine biocidnih proizvodov se za vse biocidne proizvode, ki spadajo vanjo, določi enotna številka dovoljenja.
In the case of a biocidal product family, one single authorisation number shall be provided for all biocidal products which belong to that product family.
Ker obstaja enotno dovoljenje za družino biocidnih proizvodov, mora biti izrecno omenjeno, da ima družina proizvodov eno samo številko dovoljenja.
Since there is single authorisation for biocidal product families, it should be expressly mentioned that the product family has one single authorisation number.
Komisija je pooblaščena, da v skladu s členom 82 sprejme delegirane akte, s katerimi opredeli merila in algoritme, ki se uporabijo v primerjalni oceni iz odstavka 3, za zagotovitev enotnega izvajanja po vsej Uniji.
The Commission shall be empowered to adopt delegate d acts in accordance with Article 82 defining the criteria and algorithms to be used in the comparative assessments referred to in paragraph 3, in order to ensure that there is a uniform application throughout the Union .
(Delna ponovna vložitev predloga spremembe 124 iz prve obravnave.)
(Partial reinstatement of amendment 124 from first reading.)
Pomembno je, da države članice pri primerjalnih ocenah uporabljajo enako metodologijo.
It is important that Member States follow the same methodology in comparative assessments.
Člen 22 – odstavek 7
Article 22 – paragraph 7