natgillin/translations-raw huggingface dataset:
– snov, ki izpolnjuje merila, da velja za obstojno organsko onesnaževalo po Uredbi (ES) št. 850/2004 ali ki izpolnjuje merila, po katerih velja, da je obstojna, se kopiči v organizmu in je strupena (PBT) ali je zelo obstojna in se zelo lahko kopiči v organizmu (vPvP), kot je določeno v Prilogi XIII k Uredbi (ES) št. 1907/2006;
- a substance which fulfils the criteria for being a POP under Regulation (EC) No 850/2004, or which fulfils the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII of Regulation (EC) No 1907/2006;
(Ponovna vložitev predloga spremembe 99 iz prve obravnave.)
(Reinstatement of amendment 99 from first reading.)
Neaktivne snovi, ki spadajo med obstojna organska onesnaževala, strupene snovi ali snovi, ki se zelo lahko kopičijo v organizmu, bi morali obravnavati kot pogojno nevarne snovi.
Non-active substances that are a POP, PBT or vPvB should be considered a substance of concern.
Člen 3 – odstavek 1 – točka m
Article 3 – paragraph 1 – point m
(m) "nacionalno dovoljenje" pomeni upravni akt, s katerim pristojni organ države članice dovoli dostopnost na trgu in uporabo biocidnega proizvoda na njenem ozemlju ali delu njenega ozemlja;
(m) "national authorisation" means an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product in its territory or in a part thereof;
(m) "nacionalno dovoljenje" pomeni upravni akt, s katerim pristojni organ države članice dovoli dostopnost na trgu in uporabo biocidnega proizvoda ali družine biocidnih proizvodov na njenem ozemlju ali delu njenega ozemlja;
(m) "national authorisation" means an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof;
Treba je pojasniti, da se lahko nacionalno dovoljenje izda tako za posamezen biocidni proizvod kot tudi za družino biocidnih proizvodov.
It should be made clear that a national authorisation can be granted both for an individual biocidal product and for a biocidal product family.
(p) "imetnik dovoljenja" pomeni osebo, ki je odgovorna za dostopnost biocidnega proizvoda na trgu v določeni državi članici ali Uniji in ki je navedena na dovoljenju.
(p) "authorisation holder" means the person responsible for the making available on the market of a biocidal product in a particular Member State or in the Union and specified in the authorisation .
Če oseba, ki je odgovorna za dajanje biocidnega proizvoda na trg, nima sedeža v Uniji, je imetnik dovoljenja oseba s sedežem v Uniji, ki jo je oseba, odgovorna za dajanje na trg, s pisnim pooblastilom imenovala za imetnika dovoljenja in ki je to imenovanje pisno potrdila;
If the person responsible for the placing on the market of the biocidal product is not established within the Union, the authorisation holder shall be a person established within the Union that the person responsible for placing on the market has designated by written mandate as the authorisation holder and who has accepted that designation in writing ;
(p) "imetnik dovoljenja" pomeni osebo, ki ima sedež v Uniji in je odgovorna za dajanje biocidnega proizvoda na trg v določeni državi članici ali Uniji in ki je navedena na dovoljenju;
(p) "authorisation holder" means the person established within the Union who is responsible for the placing on the market of a biocidal product in a particular Member State or in the Union and specified in the authorisation;
Nova opredelitev, ki jo je uvedel Svet, je po nepotrebnem zapletena.
The new definition introduced by the Council is unnecessarily complicated.
Predlog spremembe je tehnične narave in ne uvaja bistvenih sprememb v besedilo.
This amendment is of a technical nature and does not introduce substantive changes to the text.
Namen je izboljšati skladnost (tako znotraj besedila kot tudi z drugimi deli zakonodaje) ter preprečiti ponavljanje ali pojasniti ali poenostaviti besedilo.
It is intended to improve consistency (both within the text and with other pieces of legislation) to avoid repetition, or to clarify or simplify the text.
(s) "družina biocidnih proizvodov" pomeni skupino biocidnih proizvodov za podobno uporabo, katerih aktivne snovi imajo enake specifikacije, in z določenimi odstopanji v njihovi sestavi, ki ne vplivajo škodljivo na raven tveganja ali znatno ne zmanjšajo učinkovitosti teh proizvodov;
(s) "biocidal product family" means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products;
(s) "družina biocidnih proizvodov" pomeni skupino biocidnih proizvodov za podobno uporabo, katerih aktivne snovi imajo enake specifikacije, in z določenimi odstopanji v njihovi sestavi v primerjavi z referenčnim biocidnim proizvodom iz te skupine , ki vsebuje iste aktivne snovi istih specifikacij, če dovoljena določena odstopanja ne vplivajo škodljivo na raven tveganja ali znatno ne zmanjšajo učinkovitosti teh proizvodov;
(s) "biocidal product family" means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition as compared to a reference biocidal product belonging to that group which contains the same active substances of the same specifications, provided that such permitted specified variations do not adversely affect the level of risk or significantly reduce the efficacy of the products;
Člen 3 – odstavek 1 – točka v
Article 3 – paragraph 1 – point v
(v) "materiali, ki so v stiku z živili" pomenijo kateri koli material ali izdelek iz člena 1(2) Uredbe (ES) št. 1935/2004 Evropskega parlamenta in Sveta z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili;
(v) "food contact materials" means any material or article as referred to in Article 1(2) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food ;
Opredelitev "materiala za stik z živili" ni potrebna, saj se bo material za stik z živili obravnaval kot tretirani izdelki.
The definition of "food contact materials" is not necessary as food contact materials will be regarded as treated articles.
Člen 3 – odstavek 1 – točka aa
Article 3 – paragraph 1 – point aa
(aa) "nanomaterial" pomeni nanomaterial, kakor je opredeljen v Priporočilu Komisije 20../…/ES z dne … … … o opredelitvi nanomaterialov ;
(aa) ‘ nanomaterial ’ means nanomaterial as defined in Commission Recommendation 20../…/EC of … … … concerning the definition of nanomaterials ;
(aa) "nanomaterial" pomeni vsako namensko proizvedeno snov, pri kateri velikost ene ali več dimenzij znaša 100 nm ali manj ali ki je v notranjosti ali na površini sestavljena iz ločenih funkcionalnih delov, od katerih imajo številni eno ali več dimenzij velikosti 100 nm ali manj, vključno s strukturami, aglomerati ali agregati, katerih velikost lahko presega 100 nm, vendar ohranijo lastnosti, značilne za nanomerilo.
(aa) " nanomaterial " means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.
Lastnosti, ki so značilne za nanomerilo, vključujejo:
Properties that are characteristic of the nanoscale include:
(i) lastnosti v zvezi z veliko specifično površino obravnavanih materialov in/ali
(i) those related to the large specific surface area of the materials considered; and/or
Komisija najkasneje šest mesecev po sprejetju Priporočila 20../…/ES z dne … … … o opredelitvi nanomaterialov pripravi zakonodajni predlog, s katerim se spremeni ta uredba in se vanjo vključi ta opredelitev.
No later than six months after the adoption of Recommendation 20../…/EC of … … concerning the definition of nanomaterials , the Commission shall make a legislative proposal to amend th is R e gulation to include that definition in this Regulation.
(Ponovno uveden del predloga spremembe 34 iz prve obravnave.)
(Partial reinstatement of amendment 34 of first reading.)
Opredelitev nanomaterialov je bistven del te uredbe in jo mora zato sprejeti zakonodajalec.
The definition of nanomaterials is an essential element of the regulation and thus needs to be adopted by the legislator.
Razprave o opredelitvi znotraj Komisije so zelo sporne in izid ni jasen.
The discussions over the definition have been highly controversial within the Commission and the outcome is unclear.
Zaradi tega ni primerno, da bi Komisiji pustili popolnoma proste roke glede opredelitve.
It is thus inappropriate to give the Commission a "carte blanche" for whatever definition they come up with.
Člen 3 – odstavek 1 – točka ad
Article 3 – paragraph 1 – point ad
(ad) "večja sprememba" pomeni spremembo obstoječega dovoljenja, ki ni niti upravna niti manjša sprememba ;
(ad) ‘major change’ means an amendment of an existing authorisation which is neither an administrative change nor a minor change ;
(ad) "večja sprememba" pomeni spremembo obstoječega dovoljenja, za katero je potrebno popolno ali obsežno ponovno ovrednotenje ocene tveganja biocidnega proizvoda ali družine biocidnih proizvodov ;
(ad) ‘major change’ means an amendment of an existing authorisation requiring a full or substantial re-evaluation of the risk assessment of the biocidal product or biocidal product family ;
Besedilo Sveta ni dovolj točno, večjo spremembo je treba natančneje opredeliti.
The Council text is inexact, it is important to define "major change" more precisely.
Člen 3 – odstavek 1 – točka ad a (novo)
Article 3 – paragraph 1 – point ad a (new)
(ada) „poklicni uporabnik“ pomeni vsako fizično ali pravno osebo, ki v svoji poklicni dejavnosti uporablja biocidne proizvode;
(ada) ‘professional user’ means any natural or legal person who/which uses biocidal products in the framework of his/its professional activity;
Ponovna vključitev stališča iz prve obravnave.
Reinstatement of first reading position.
Glej predlog spremembe k členu 2(2a) (novo).
See amendment to Article 2(2a)(new).
Določba o področju uporabe mora biti vključena v člen 2, ne člen 3 uredbe.
The provision on scope should be contained in Article 2, rather than 3 of the Regulation.
Poleg tega morajo biti tovrstni ukrepi zajeti v delegiranih in ne v izvedbenih aktih.
And in addition, measures of this kind should be subject to delegated rather than implementing acts.
Aktivna snov se odobri za začetno obdobje največ 10 let, če se lahko pričakuje , da vsaj en biocidni proizvod , ki to aktivno snov vsebuje , izpolnjuje merila iz točke (b) člena 18(1) , ob upoštevanju dejavnikov iz člena 18(2) in (5).
An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point (b) of Article 18(1) taking into account the factors set out in Article 18(2) and (5).
Aktivna snov se vključi v Prilogo -I za začetno obdobje največ 10 let, če med biocidnimi proizvodi , ki to aktivno snov vsebujejo , vsaj eden izpolnjuje pogoje iz točke (b) člena 18(1) ob upoštevanju dejavnikov iz člena 18 (2) in (5).
An active substance shall be included in Annex -I for an initial period not exceeding 10 years if at least one biocidal product containing that active substance fulfils the conditions laid down in point (b) of Article 18(1) taking into account the factors set out in Article 18(2) and (5).
Aktivna snov iz člena 5 se v Prilogo I lahko vključi le za začetno obdobje 5 let.
An active substance referred to in Article 5 may only be included in Annex - I for an initial period of 5 years.
(Opomba: Predlog spremembe velja za celotno besedilo.
(Note: This amendment applies throughout the text.
Če bo sprejet, bo treba omembo „odobritve aktivne snovi“ nadomestiti z „vključitvijo aktivnih snovi v Prilogo -I“, omembo „odobritve“ bo treba nadomestiti z „vključitvijo v prilogo -I“ itd., omembo „se odobri“ bo treba nadomestiti z „se vključi v prilogo -I“ itd. po vsem besedilu.)
If adopted, reference to "approval of an active substance" is to be replaced by reference to "inclusion of an active substance in Annex -I", reference to "approval" by "inclusion in Annex -I", reference to "approved" by "included in Annex -I" etc. throughout the text.)
(Ponovna vložitev predloga spremembe 39 iz prve obravnave.)
(Reinstatement of amendment 39 from first reading.)
Aktivne snovi bi se morale ohraniti v prilogi k uredbi.
Active substances should continue to be included in an Annex to the Regulation.
Pristop, ki ga predlaga Svet, bi Parlament prikrajšal za pravico do nadzora, kar je nesprejemljivo.
The approach proposed by Council would deprive Parliament of its control rights, which is not acceptable.
Poleg tega ni skladen s podobnimi določbami v členu 27 o vključitvi aktivnih snovi v okviru poenostavljenega postopka, kar se bo še naprej sprejemalo na podlagi delegiranih aktov.
Moreover, it is inconsistent with the analogous provision in Article 27 for the inclusion of active substances under the simplified procedure, which would continue to be adopted by way of delegated acts.
Za aktivne snovi, ki sodijo pod člen 5, bi moralo veljati krajše obdobje za vključitev v Prilogo I.
Active substances that fall under Article 5 should have a shorter period for the inclusion in Annex I.
Člen 4 – odstavek 3 – točka g a (novo)
Article 4 – paragaph 3 – point g a (new)
(ga) datum vključitve v Prilogo -I;
(ga) the date of inclusion in Annex -I;
To so pomembne informacije o aktivni snovi in njeni odobritvi ali vključitvi, zato jih je treba vključiti kot pogoj za odobritev ali vključitev.
This is important information concerning the active substance and its approval/inclusion and so should be included as a condition of approval/inclusion
Ob upoštevanju odstavka 2 se naslednje aktivne snovi ne odobrijo:
Subject to paragraph 2, the following active substances shall not be approved:
(a) aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot rakotvorne snovi kategorije 1A ali 1B oziroma izpolnjujejo merila za tako razvrstitev;
(a) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B;
(b) aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot mutagene snovi kategorije 1A ali 1B oziroma izpolnjujejo merila za tako razvrstitev;
(b) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B;
(c) aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot strupene snovi za razmnoževanje kategorije 1A ali 1B oziroma izpolnjujejo merila za tako razvrstitev;
(c) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;
(d) aktivne snovi, opredeljene v skladu s členoma 57(f) in 59(1) Uredbe (ES) št. 1907/2006 kot snovi, ki so po svojih lastnostih endokrini motilci ;
(d) active substances identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties ;
(d) aktivne snovi, ki so na podlagi ocene Unije ali mednarodno dogovorjenih smernic za preskuse ali drugih strokovno pregledanih znanstvenih podatkov in informacij, vključno s pregledom znanstvene literature, ki ga opravi Agencija, opredeljene kot snovi, ki lahko povzročijo endokrine motnje in imajo tako negativne učinke na ljudi, ali ki so opredeljene v skladu s členoma 57(f) in 59(1) Uredbe (ES) št. 1907/2006 kot snovi, ki so po svojih lastnostih endokrini motilci .
(d) active substances which, on the basis of the assessment of Union or internationally agreed test guidelines or other peer-reviewed scientific data and information, including a review of the scientific literature, reviewed by the Agency, are considered as having endocrine-disrupting properties that may cause adverse effect s in humans, or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties .
(e) aktivne snovi, ki izpolnjujejo merila, da se štejejo za obstojne, bioakumulativne in strupene (PBT), ali snovi, ki so zelo obstojne, ter zelo bioakumulativne (vPvB) v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006.
(e) active substances which fulfil the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) according to Annex XIII to Regulation (EC) No 1907/2006.
Aktivne snovi iz odstavka 1 tega člena se brez poseganja v člen 4(1) lahko odobrijo, če je dokazano, da je izpolnjen vsaj eden od naslednjih pogojev:
Without prejudice to Article 4(1), active substances referred to in paragraph 1 of this Article may be approved if it is shown that at least one of the following conditions is met:
(a) v realno najslabših možnih pogojih uporabe je tveganje za ljudi ali okolje zaradi izpostavljenosti aktivni snovi v biocidnem proizvodu zanemarljiva, zlasti če se proizvod uporablja v zaprtih sistemih ali pod strogo nadzorovanimi pogoji ;
(a) the risk to humans or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or strictly controlled conditions;
(a) v običajnih pogojih uporabe je izpostavljenost ljudi ali okolja zadevni aktivni snovi v biocidnem proizvodu zanemarljiva, kar pomeni, da se proizvod uporablja v zaprtih sistemih ali v drugih pogojih, pri katerih ni stika z ljudmi ;
(a) the exposure of humans or the environment to the active substance in question in a biocidal product, under normal conditions of use, is negligible, meaning that the product is used in closed systems or under other conditions excluding contact with humans ;
(b) aktivna snov je nujna za preprečevanje ali obvladovanje resne nevarnosti za javno zdravje ali zdravje živali ali okolje ; ali
(b) the active substance is essential to prevent or to control a serious danger to public or animal health or the environment ; or
(b) dokazano je, da je aktivna snov potrebna za preprečitev ali nadziranje resne nevarnosti za javno zdravje ali zdravje živali ali okolje , za varnost hrane in krme ali za javni interes ter da ni na razpolago drugih učinkovitih snovi ali tehnologij.
(b) it is shown by evidence that the active substance is necessary to prevent or control a serious danger to public or animal health or to the environment , to food and feed safety, or to the public interest and that there are no effective alternative substances or technologies available.
Za uporabo vseh biocidnih proizvodov, ki vsebujejo aktivne snovi iz Priloge -I, 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 containing active substances included in Annex - I 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, ki vsebuje aktivne snovi iz Priloge I 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 nemudoma predloži Komisiji.
Member State authorising a biocidal product containing an active substance included in Annex I 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 biocidnih proizvodov z zadevno aktivno snovjo je omejena na tiste države članice, v katerih je treba resno nevarnost preprečiti ali, kadar že pride do nje, jo nadzirati.
The use of the biocidal product with the active substance concerned shall be restricted to those Member States where the serious danger has to be prevented or, if it occurs, controlled.
(c) neodobritev aktivne snovi bi imela v primerjavi s tveganjem za zdravje človeka ali okolje, ki izhaja iz uporabe snovi, nesorazmerne negativne posledice za družbo.
(c) not approving the active substance would cause disproportionate negative impacts for society when compared with the risk to human health or the environment arising from the use of the substance.
Pri odločitvi, ali se aktivna snov lahko odobri v skladu s prvim pododstavkom, se upošteva tudi, ali so na voljo primerne in zadostne nadomestne snovi ali tehnologije.
When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall also be taken into account.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 82, ki določajo znanstvena merila za odkrivanje lastnosti endokrinih motilcev.
The Commission shall be empowered to adopt delegated acts in accordance with Article 82 specifying scientific criteria for the determination of endocrine disrupting properties.
Komisija najkasneje 13. decembra 2013 sprejme delegirane akte v skladu s členom 82, ki določajo znanstvena merila za odkrivanje lastnosti endokrinih motilcev.
No later than 13 December 2013, the Commission shall adopt delegated acts in accordance with Article 82 specifying scientific criteria for the determination of endocrine disrupting properties.
Aktivne snovi, ki so razvrščene v skladu z določbami Uredbe (ES) št. 1272/2008 kot rakotvorne kategorije 2 in strupene za razmnoževanje kategorije 2 ali izpolnjujejo merila za tako razvrstitev, do sprejetja teh meril štejejo za snovi, ki imajo lastnosti endokrinih motilcev.
Pending the adoption of those criteria, active substances that are classified in accordance with the provisions of Regulation (EC) No 1272/2008 as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties.
Snovi, kot so snovi, razvrščene v skladu z določbami iz Uredbe (ES) št. 1272/2008 kot strupene za razmnoževanje kategorije 2 in ki imajo strupen učinek na endokrine žleze ali izpolnjujejo merila za tako razvrstitev, lahko štejejo za snovi, ki imajo lastnosti endokrinih motilcev.
Substances such as those that are classified in accordance with the provisions of Regulation (EC) No 1272/2008 as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs, may be considered as having endocrine-disrupting properties.
Člen 6 – odstavek 2 – pododstavek 1 – točka a
Article 6 – paragraph 2 – subparagraph 1 – point a
(a) podatki zaradi izpostavljenosti, povezane s predlagano uporabo, niso potrebni;
(a) the data are not necessary owing to the exposure associated with the proposed uses;
(a) podatki niso potrebni, saj je mogoče izključiti vsako bistveno izpostavljenost, povezano s predlagano uporabo;
(a) the data are not necessary as all relevant exposure associated with the proposed uses can be ruled out ;
(Ponovna vložitev predloga spremembe 47 iz prve obravnave.)
(Reinstatement of amendment 47 of first reading.)
Besedilo Sveta je dvoumno.
The Council wording is ambiguous.
Takšno odstopanje od zahteve za podatke je dopustno samo, če je mogoče izključiti vsako bistveno izpostavljenost.
Such data waiving should only occur if all relevant exposure ban be ruled out.