natgillin/translations-raw huggingface dataset:
Če ni izrecno določeno drugače, ta uredba ne posega v naslednje instrumente:
Subject to any explicit provision to the contrary, this Regulation shall be without prejudice to the following instruments:
Direktivo Sveta 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi UL 196, 16.8.1967, str.
Council Directive 67/548/EEC 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances OJ 196, 16.8.1967, p.
Direktivo Sveta 79/117/EGS z dne 21. decembra 1978 o prepovedi prometa in uporabe fitofarmacevtskih sredstev, ki vsebujejo nekatere aktivne snovi UL L 33, 8.2.1979, str.
Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances OJ L 33, 8.2.1979, p.
Direktivo Sveta 89/391/EGS z dne 12. junija 1989 o uvajanju ukrepov za spodbujanje izboljšav varnosti in zdravja delavcev pri delu UL L 183, 29.6.1989, str.
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work OJ L 183, 29.6.1989, p.
Direktivo Sveta 98/24/ES z dne 7. aprila 1998 o varovanju zdravja in zagotavljanju varnosti delavcev pred tveganji zaradi izpostavljenosti kemičnim dejavnikom pri delu (štirinajsta posebna direktiva v smislu člena 16(1) Direktive 89/391/EGS) UL L 131, 5.5.1998, str.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) OJ L 131, 5.5.1998, p.
Direktivo 1999/45/ES Evropskega parlamenta in Sveta z dne 13. maja 1999 o približevanju zakonov in drugih predpisov držav članic v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov UL L 200, 30.7.1999, str.
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations OJ L 200, 30.7.1999, p.
Direktivo Evropskega parlamenta In Sveta 2000/54/ES z dne 18. septembra 2000 o varovanju delavcev pred tveganji zaradi izpostavljenosti biološkim dejavnikom pri delu(sedma posamična direktiva v smislu člena 16(1) Direktive 89/391/EGS) UL L 262, 17.10.2000, str.
Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) OJ L 262, 17.10.2000, p.
Direktive 2000/60/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2000 o določitvi okvira za ukrepe Skupnosti za doseganje trajnostne rabe pesticidov
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy
UL L 327, 22.12.2000, str .
OJ L 327, 22.12.2000, p.
Direktiva 2006/114/ES Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zavajajočem in primerjalnem oglaševanju (kodificirano besedilo) UL L 376, 27.12.2006, str.
Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising OJ L 376, 27.12.2006, p.
Uredbo (ES) št. 689/2008 Evropskega parlamenta in Sveta z dne 17. junija 2008 o izvozu in uvozu nevarnih kemikalij UL L 204, 31.7.2008, str.
Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals OJ L 204, 31.7.2008, p.
Direktivo 2009/128/ES Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o določitvi okvira za ukrepe Skupnosti za doseganje trajnostne uporabe pesticidov UL L 309, 24.11.2009, str.
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides OJ L 309, 24.11.2009, p.
Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi UL L 353, 31.12.2008, str.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures OJ L 353, 31.12.2008, p.
Člen 58 se ne uporablja za prevoz biocidnih pripravkov po železnici, cestah, notranjih plovnih poteh, morju ali zraku.
Article 58 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air.
Ta uredba se ne uporablja za hrano ali krmo, ki se uporablja za biocidne namene.
This Regulation shall not apply to food or feedingstuffs that are used for biocidal purposes.
Ta uredba se ne uporablja za pomožna tehnološka sredstva, ki se uporabljajo za biocidne namene.
This Regulation shall not apply to processing aids that are used for biocidal purposes.
Kadar proizvajalci biocidni pripravek predvidijo za namene vplivanja na škodljivi organizem, prisoten na medicinskih pripomočkih, in za druge namene iz te uredbe, se izpolnijo tudi ustrezne bistvene zahteve direktiv 90/385/EGS, 93/42/EGS ali 98/79/ES.
Where a biocidal product is intended by its manufacturer to be used for the purpose of exerting a controlling effect on any harmful organism present on medical devices and for other purposes covered by this Regulation, the relevant essential requirements of Directives 90/385/EEC, 93/42/EEC or 98/79/EC shall also be fulfilled.
Biocidni pripravki, ki so pridobili končno odobritev po Mednarodni konvenciji o nadzoru in upravljanju balastne vode ladij in sedimentov, se štejejo za odobrene v skladu s Poglavjem VII te uredbe.
Biocidal products which obtained the final approval under the International Convention for the Control and Management of Ships' Ballast Water and Sediments shall be considered as authorised under Chapter VII of this Regulation.
Ustrezno se uporabita člena 38 in 57.
Articles 38 and 57 shall apply accordingly.
„biocidni pripravki“
‘biocidal products’ means
aktivne snovi ali zmesi, ki vsebujejo eno ali več aktivnih snovi, pripravljene v obliki, v kakršni se dobavljajo uporabniku, in predvidene
active substances or mixtures containing one or more active substances, put up in the form in which they are supplied to the user,
za to, da se z njimi uničuje, odvrača, naredi neškodljivo, prepreči delovanje, ali kako drugače vpliva na škodljivi organizem na kemičen ali biološki način.
intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.
vsaka mikrobiološka entiteta, celična ali necelična, sposobna podvajanja ali prenašanja genskega materiala, vključno z nižjimi glivami, virusi, bakterijami, kvasovkami, plesnimi, algami, protozoji in mikroskopskimi parazitskimi helminti;
any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths;
„aktivna snov“
‘active substance’ means
snov ali mikroorganizem z delovanjem proti škodljivim organizmom;
a substance or a micro-organism with an action against harmful organisms;
„obstoječa aktivna snov“
‘existing active substance’ means
snov, ki je bila v prometu 14. maja 2000 kot aktivna snov biocidnega pripravka za namene, ki niso bili znanstveni razvoj ali v pripravek in proces usmerjene raziskave in razvoj;
a substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product- and process-orientated research and development;
„nova aktivna snov“
‘new active substance’ means
snov, ki 14. maja 2000 ni bila v prometu kot aktivna snov biocidnega pripravka za namene, ki niso znanstveni razvoj ali v pripravek in uporabo usmerjena raziskovanje in razvoj;
a substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product- and process-orientated research and development;
„pogojno nevarna snov“
‘substance of concern’ means
vsaka snov, razen aktivne snovi, ki ima
any substance, other than an active substance, which has an inherent capacity to cause an adverse effect
takojšnje ali poznejše
, immediately or in the more distant future,
neželene učinke na ljudi,
on humans,
zlasti otroke,
especially children,
živali ali okolje in jo vsebuje biocidni pripravek ali nastaja v njem v taki koncentraciji, da lahko povzroča nevarnost takšnega vpliva
animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present a risk of causing such an effect
Če ni drugih razlogov za zaskrbljenost, bi bila takšna snov običajno razvrščena kot nevarna v skladu z Direktivo 67/548/EGS in bi bila v biocidnem pripravku prisotna v koncentraciji, zaradi katere bi ta pripravek veljal za nevarnega v skladu z Direktivo 1999/45/ES ali Uredbo (ES) št. 1272/2008
Such a substance would, unless there are other grounds for concern, normally be a substance classified as dangerous according to Directive 67/548/EEC and be present in the biocidal product at a concentration leading to the product being regarded as dangerous within the meaning of Directive 1999/45/EC or Regulation (EC) No 1272/2008
„škodljiv organizem“
‘harmful organism’ means
organizmi, vključno s povzročitelji bolezni, katerih prisotnost je nezaželena, ali ki imajo
organisms, including pathogenic agents, which have an unwanted presence or a detrimental effect
takojšen ali kasnejši
, immediately or in the more distant future,
škodljiv učinek na človeka
on humans,
, zlasti na otroke
especially children, human
ali njegove dejavnosti, ali na proizvode, ki jih uporablja ali proizvaja, ali na živali ali okolje;
activities or the products they use or produce, or on animals or the environment;
snovi, ki so prisotne v ali na rastlinah ali proizvodih rastlinskega izvora, užitnih živalskih proizvodih
substances present in or on plants or products of plant origin, edible animal products,
vodnih virih,
water resources,
pitni vodi ali drugod v okolju in ki so posledica uporabe biocidnega pripravka, vključno z njegovimi metaboliti in proizvodi, ki so posledica njihovega razgrajevanja ali reakcije;
drinking water or elsewhere in the environment and resulting from the use of a biocidal product, including their metabolites, breakdown or reaction products;
„dajanje v promet“
‘placing on the market’ means
▌dobava izdelka
to third parties
tretji osebi ali dajanje tega izdelka na razpolago tretjim osebam
, whether in return for payment or free of charge,
proti plačilu ali ne
or the making available of a biocidal product to third parties
Za dobavo tretji osebi ne gre, kadar proizvajalec
No supply to third parties is involved when
v okviru gospodarske dejavnosti
in the course of a commercial activity
posamezno proizvede in nato vgradi tretirane snovi ali izdelke
treated materials or products are individually manufactured and then incorporated by the manufacturer
vse dejavnosti v zvezi z biocidnim pripravkom, vključno s skladiščenjem, ravnanjem, mešanjem in uporabo, razen vsake takšne dejavnosti, ki se opravi z namenom izvoza biocidnega pripravka iz Unije;
all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with view to exporting the biocidal product outside the Union;
„tretirana snov ali izdelek“
‘treated material or article’ means
vsaka snov, mešanica, material ali izdelek, ki je bil tretiran z biocidnimi pripravki ali jih vsebuje ▌;
any substance, mixture, material or article which was treated with or incorporates one or more biocidal products ▌;
„zunanje biocidno delovanje“
‘external biocidal effect’ means
učinek uporabe, pri kateri se biocidni pripravek izpusti ob običajnih pogojih uporabe ali ob pogojih, ki jih je mogoče razumljivo predvideti;
the effect of applications whereby the incorporated biocidal product is intended to be released under normal or reasonably foreseeable conditions of use;
„izdaja nacionalnih dovoljenj“
‘national authorisation’ means
upravni akt, s katerim pristojni organ države članice na podlagi vloge predlagatelja izda dovoljenje za dajanje v promet in uporabo biocidnega pripravka na ozemlju ali delu ozemlja države članice;
an administrative act by which the competent authority of a Member State authorises the placing on the market and the use of a biocidal product in its territory or in a part thereof;
„izdaja dovoljenja Unije“
‘Union authorisation’ means
upravni akt, s katerim Komisija na podlagi vloge predlagatelja izda dovoljenje za dajanje v promet in uporabo biocidnega pripravka na ozemlju ali delu ozemlja Unije;
an administrative act by which the Commission authorises the placing on the market and the use of a biocidal product in the territory of the Union or in a part thereof;
nacionalno dovoljenje ali dovoljenje Unije;
national authorisation or Union authorisation;
„edinstvena formulacija pripravka“
‘unique product formulation’ means
biocidni pripravek brez odstopanj glede odstotka aktivne snovi, strukturnega odstotka neaktivnih snovi, ali dišav, barvil ali pigmentov, ki jih vsebuje;
a biocidal product with no variations as to the percentage of the active substance, the percentage composition of the non-active substances, or the perfumes, dyes or pigments it contains;
„okvirna formulacija“
‘frame formulation’ means
skupina biocidnih pripravkov, ki imajo podobne uporabe in so omejene različice referenčnega biocidnega pripravka iz te skupine, ki vsebuje iste aktivne snovi istih specifikacij, ki pa ne vplivajo škodljivo na raven tveganja, povezano z njimi, in njihovo učinkovitost zaradi dovoljenih razlik v njihovi sestavi;
a group of biocidal products that have similar uses and that present limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications, where such permitted variations do not adversely affect the level of risk or the efficacy of these products;
„izjava o dostopnosti podatkov“
‘letter of access’ means
originalni dokument, ki so ga podpisali lastnik ali lastniki informacij
an original document, signed by the owner or owners of information
ali njihov pooblaščeni predstavnik
or their authorised representative
, v katerem je navedeno, da lahko
, which states that the information may be used by the
, Agencija ali Komisija uporabljajo informacije, in sicer za ocenjevanje aktivne snovi ali podelitev dovoljenja
, the Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation
v korist tretje strani
for the benefit of a third party
„hrana in krma“
‘food and feedingstuff’ means
hrana, kot je opredeljena v členu 2 Uredbe (ES) št. 178/2002, in krma, kot je opredeljena v členu 3(4) navedene uredbe;
food as defined in Article 2 of Regulation (EC) No 178/2002 and feedingstuff as defined in Article 3(4) of that Regulation.
„snovi, ki so v stiku z živili“
‘food contact materials’ means
vsaka snov ali predmet, ki je namenjen za stik z živili, iz Uredbe (ES) št. 1935/2004;
any material or article, intended to come into contact with food, that is covered by Regulation (EC) No 1935/2004;
„pomožna tehnološka sredstva“
‘processing aid’ means
vsaka snov, ki:
any substance which:
se samostojno ne uživa kot hrana ali krma;
is not consumed as a food or feedingstuff by itself;
se namenoma uporablja pri predelavi surovin, živil ali krme ali njihovih sestavin za nekatere tehnološke namene med obdelavo ali predelavo; ter
is intentionally used in the processing of raw materials, foods or feedingstuff or their ingredients to fulfil a certain technological purpose during treatment or processing; and
lahko povzroči nenamerno, vendar tehnično neizogibno prisotnost ostankov snovi ali njenih derivatov v končnem proizvodu, če ti ostanki niso nevarni za zdravje ljudi in nimajo nobenega tehnološkega učinka na končni proizvod;
may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives, provided they do not present any health risk and do not have any technological effect on the final product;
'manjša sprememba„
‘minor change’ means
sprememba obstoječega dovoljenja, ki je ne moremo šteti za upravno spremembo, saj zajema manjšo ponovno oceno tveganja za javno zdravje ali okolje ali učinkovitosti pripravka ter ne vpliva negativno na stopnjo tveganja za javno zdravje ali okolje in na učinkovitost pripravka;
a modification of an existing authorisation which cannot be deemed to be an administrative change as it involves a limited re-assessment of the risk for public health or the environment or of the efficacy of the product, and does not adversely affect the level of risk for public health or the environment and the efficacy of the product;
„večja sprememba“
‘major change’ means
sprememba obstoječega dovoljenja, ki je ne moremo šteti kot upravno ali manjšo spremembo;
a modification of an existing authorisation which cannot be deemed to be an administrative change or a minor change;
„tehnična enakovrednost“
‘technical equivalence’ means
namensko proizvedena snov, pri kateri je velikost ene ali več dimenzij 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 pa ohranijo lastnosti, značilne za nanomerilo.
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 v zvezi z veliko specifično površino zadevnih materialov; in/ali
those related to the large specific surface area of the materials considered; and/or
pri aktivnih snoveh, proizvedenih v Uniji in danih na trg, proizvajalec te aktivne snovi ali oseba s sedežem v Uniji, ki jo je proizvajalec določil za svojega edinega zastopnika za namene te uredbe;
in the case of an active substance produced within the Union and placed on the market, the manufacturer of that active substance or a person established within the Union designated by the manufacturer as his sole representative for the purposes of this Regulation,
pri aktivnih snoveh, proizvedenih zunaj Unije, oseba s sedežem v Uniji, ki jo je proizvajalec te aktivne snovi določil za svojega edinega zastopnika za namene te uredbe, ali, kadar taka oseba ni bila določena, uvoznik te aktivne snovi v Unijo;
in the case of an active substance produced outside the Union, the person established within the Union and designated by the manufacturer of that active substance as his sole representative for the purposes of this Regulation or, where no such person has been so designated, the importer into the Union of that active substance,
“poklicni uporabnik„
'professional user' means
vsaka fizična ali pravna oseba, ki v svoji poklicni dejavnosti uporablja biocidne pripravke;
any natural or legal person who uses biocidal products in the framework of his professional activity;
„ranljive skupine“
‘vulnerable groups’ means
osebe, za katere je pri ocenjevanju akutnih in kroničnih učinkov biocidnih pripravkov na zdravje potrebna posebna obravnava.
persons needing specific consideration when assessing the acute and chronic health effects of biocidal products.
mala in srednja podjetja, kakor so opredeljena v priporočilu Komisije 2003/361/ES z dne 6. maja 2003 o opredelitvi mikro, malih in srednje velikih podjetij
small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises
Za namene te uredbe se opredelitve iz člena 3 Uredbe (ES) št. 1907/2006 uporabljajo za naslednje postavke:
For the purposes of this Regulation, the definitions laid down in Article 3 of Regulation (EC) No 1907/2006 shall apply for the following terms:
v proizvod in proces usmerjene raziskave in razvoj;
product and process-orientated research and development;
znanstvene raziskave in razvoj.
scientific research and development.
Aktivno snov se vključi v Prilogo I za začetno obdobje največ 10 let, če
An active substance shall be included in Annex I for an initial period not exceeding 10 years if
med biocidnimi
at least one of
pripravki, ki to aktivno snov vsebujejo,
the biocidal products containing that active substance
pogoje iz točke (b) člena 16(1).
the conditions laid down in point (b) of Article 16(1).
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 be included in Annex I only for an initial period of 5 years.
Vključitev aktivne snovi v Prilogo I se omeji na tiste vrste pripravkov iz Priloge V, za katere so bili v skladu s členom 6 predloženi ustrezni podatki.
The inclusion in Annex I of an active substance shall be restricted to those product types in Annex V for which relevant data have been submitted in accordance with Article 6.
Aktivne snovi kot take ali v biocidnih pripravkih se lahko dajo v promet v Uniji za uporabo v biocidnih pripravkih samo, če so bile vključene v Prilogo I v skladu z določbami te uredbe.
Active substances, as such or in biocidal products, may be placed on the market in the Union for use in biocidal products only if they have been included in Annex I in accordance with the provisions of this Regulation.
Aktivna snov
An active substance
in opredelitev referenčnega vira aktivne snovi za določitev tehnične enakovrednosti,
and the definition of the reference source for the active substance for the purposes of determining technical equivalence
se, kjer je to primerno, vključi v Prilogo I skupaj z navedbo pogojev, ki se nanašajo na karkoli od naslednjega:
shall, where appropriate, be included in Annex I together with conditions relating to any of the following:
najmanjša stopnja čistote aktivne snovi;
the minimum degree of purity of the active substance;
vrsta in najvišja vsebnost določenih nečistot;
the nature and maximum content of certain impurities;
vrsta pripravka, kot je navedena v Prilogi V;
the product type as outlined in Annex V;
način in področje uporabe;
manner and area of use;
oznaka vrst uporabnikov;
designation of categories of users;
opredelitev kemijske identitete glede na stereoizomere;
characterisation of the chemical identity with regard to stereoisomers;
drugi posebni pogoji na podlagi ocene informacij v zvezi s to aktivno snovjo.
other particular conditions based on the evaluation of the information related to that active substance.
Kjer je primerno, se za aktivne snovi, vključene v Prilogo I, skladno z Uredbo (ES) št. 396/2005 Evropskega parlamenta in Sveta z dne 23. februarja 2005 o mejnih vrednostih ostankov pesticidov v ali na hrani in krmi rastlinskega in živalskega izvora UL L 70, 16.3.2005, str.
Where appropriate, maximum residue limits shall be established with respect to active substances included in Annex I in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin OJ L 70, 16.3.2005, p.