natgillin/translations-raw huggingface dataset:
Ta uredba bi morala po potrebi upoštevati druge zadevne delovne programe v zvezi s pregledi ali dovoljenji za snovi in proizvode ali ustrezne mednarodne konvencije.
This Regulation should take account, as appropriate, of other work programmes concerned with the review or authorisation of substances and products, or relevant international Conventions.
Zlasti bi morala prispevati k izpolnitvi ciljev strateškega pristopa k mednarodnemu ravnanju s kemikalijami, sprejetega 6. februarja 2006 v Dubaju.
In particular, it should contribute to the fulfilment of the Strategic Approach to International Chemical Management adopted on 6 February 2006 in Dubai.
Da se dopolni ali spremeni ta uredba, bi bilo treba na Komisijo prenesti pooblastila, da v skladu s členom 290 Pogodbe o delovanju Evropske unije sprejme akte v zvezi z določenimi nebistvenimi elementi iz te uredbe.
In order to supplement or amend this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of certain non-essential elements of this Regulation.
Da bi se zagotovili enotni pogoji za izvajanje te uredbe, bi bilo treba na Komisijo prenesti izvedbena pooblastila.
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission.
Ta pooblastila bi se morala izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije UL L 55, 28.2.2011, str.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers OJ L 55, 28.2.2011, p.
Komisija bi morala sprejeti izvedbene akte, ki se neposredno uporabljajo, kadar v utemeljenih primerih v zvezi z odobritvijo aktivne snovi ali v zvezi s preklicem odobritve to zahtevajo izredno nujni razlogi.
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the approval of an active substance or to the cancelling of an approval, imperative grounds of urgency so require.
Ker cilja te uredbe države članice ne morejo zadovoljivo doseči, namreč izboljšati delovanje notranjega trga za biocidne proizvode, ob hkratnem zagotavljanju visoke ravni varovanja zdravja človeka in živali ter okolja, in ker ta cilj zaradi njegovega obsega in učinka lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
Since the objective of this Regulation, namely, to improve the functioning of the internal market for biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment cannot be sufficiently achieved by the Member States, and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne presega tistega, kar je potrebno za doseganje navedenega cilja –
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
PODROČJE UPORABE IN OPREDELITEV POJMOV
SCOPE AND DEFINITIONS
Namen in vsebina
Purpose and subject matter
Namen te uredbe je z uskladitvijo pravil o dostopnosti na trgu in uporabi biocidnih proizvodov izboljšati delovanje notranjega trga ter pri tem zagotoviti visoko raven varovanja zdravja človeka in živali ter okolja.
The purpose of this Regulation is to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment.
Določbe te uredbe temeljijo na načelu previdnosti, katerega cilj je zaščititi zdravje človeka in živali ter okolje.
The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, animals and the environment.
Posebno pozornost se nameni zaščiti ranljivih skupin.
Special attention shall be paid to the protection of vulnerable groups.
Ta uredba določa pravila za:
This Regulation lays down rules for:
vzpostavitev seznama aktivnih snovi na ravni Unije, ki se smejo uporabljati v biocidnih proizvodih;
the establishment at Union level of a list of active substances which may be used in biocidal products;
izdajo dovoljenj za biocidne proizvode;
the authorisation of biocidal products;
medsebojno priznavanje dovoljenj v Uniji;
the mutual recognition of authorisations within the Union;
dostopnost biocidnih proizvodov na trgu in njihovo uporabo v eni ali več državah članicah ali v Uniji;
the making available on the market and the use of biocidal products within one or more Member States or the Union;
dajanje tretiranih izdelkov na trg.
the placing on the market of treated articles.
Ta uredba se uporablja za biocidne proizvode in tretirane izdelke.
This Regulation shall apply to biocidal products and treated articles.
V Prilogi V je seznam in opis vrst biocidnih proizvodov, ki jih zajema ta uredba.
A list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V.
Če v tej uredbi ali drugi zakonodaji Unije ni izrecno določeno drugače, se ta uredba ne uporablja za biocidne proizvode ali tretirane izdelke, ki spadajo v področje uporabe naslednjih instrumentov:
Subject to any explicit provision to the contrary in this Regulation or other Union legislation, this Regulation shall not apply to biocidal products or treated articles that are within the scope of the following instruments:
Direktive Sveta 90/167/EGS z dne 26. marca 1990 o pogojih za proizvodnjo, dajanje na trg in uporabo medicirane krme v Skupnosti UL L 92, 7.4.1990, str.
Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community OJ L 92, 7.4.1990, p.
Direktive 90/385/EGS, Direktive 93/42/EGS in Direktive 98/79/ES;
Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC;
, Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini UL L 311, 28.11.2001, str.
, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001, p.
in Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila UL L 136, 30.4.2004, str.
and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency OJ L 136, 30.4.2004, p.
Uredbe Evropskega parlamenta in Sveta (ES) št. 852/2004 z dne 29. aprila 2004 o higieni živil UL L 139, 30.4.2004, str.
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs OJ L 139, 30.4.2004, p.
ter Uredbe (ES) št. 853/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o posebnih higienskih pravilih za živila živalskega izvora UL L 139, 30.4.2004, str.
and Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin OJ L 139, 30.4.2004, p.
Uredbe (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih UL L 354, 31.12.2008, str.
Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods OJ L 354, 31.12.2008, p.
Uredbe (ES) št. 767/2009 Evropskega parlamenta in Sveta z dne 13. julija 2009 o dajanju krme v promet in njeni uporabi UL L 229, 1.9.2009, str.
Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed OJ L 229, 1.9.2009, p.
Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet UL L 309, 24.11.2009, str.
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market OJ L 309, 24.11.2009, p.
Uredbe (ES) št. 1223/2009 Evropskega parlamenta in Sveta z dne 30. novembra 2009 o kozmetičnih izdelkih UL L 342, 22.12.2009, str.
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products OJ L 342, 22.12.2009, p.
Direktive 2009/48/ES Evropskega parlamenta in Sveta z dne 18. junija 2009 o varnosti igrač.
Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys.
prejšnji odstavek, se v primeru, ko biocidni proizvod spada v področje uporabe enega izmed zgoraj navedenih instrumentov in se uporablja v namene, ki jih ti instrumenti ne pokrivajo,
the previous paragraph, when a biocidal product falls within the scope of one of the above mentioned instruments and is intended to be used for purposes not covered by those instruments,
se ta uredba uporablja
this Regulation shall
ta biocidni proizvod, pod pogojem, da teh namenov ne obravnavajo navedeni instrumenti.
to that biocidal product insofar as these purposes are not addressed by those instruments.
Če v tej uredbi ali drugi zakonodaji Unije ni izrecno določeno drugače, ta uredba ne posega v naslednje instrumente:
Subject to any explicit provision to the contrary in this Regulation or other Union legislation, this Regulation shall be without prejudice to the following instruments:
Direktivo 1999/45/ES Evropskega parlamenta in Sveta z dne 31. 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 2000/54/ES Evropskega parlamenta in Sveta z dne 18. septembra 2000 o varovanju delavcev pred tveganji zaradi izpostavljenosti biološkim dejavnikom pri delu 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 OJ L 262, 17.10.2000, p.
Direktivo 2000/60/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2000 o določitvi okvira za ukrepe Skupnosti na področju vodne politike UL L 327, 22.12.2000, str.
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 OJ L 327, 22.12.2000, p.
Direktivo 2004/37/ES Evropskega parlamenta in Sveta z dne 29. aprila 2004 o varovanju delavcev pred nevarnostmi zaradi izpostavljenosti rakotvornim ali mutagenim snovem pri delu UL L 158, 30.4.2004, str.
Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work OJ L 158, 30.4.2004, p.
Uredbo (ES) št. 850/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o obstojnih organskih onesnaževalih UL L 158, 30.4.2004, str.
Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants OJ L 158, 30.4.2004, p.
Direktivo 2006/114/ES Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zavajajočem in primerjalnem oglaševanju 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.
Direktivo 2009/128/ES Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o določitvi okvira za ukrepe Skupnosti za doseganje trajnostne rabe 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. 1005/2009 Evropskega parlamenta in Sveta z dne 16. septembra 2009 o snoveh, ki tanjšajo ozonski plašč UL L 286, 31.10.2009, str.
Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer OJ L 286, 31.10.2009, p.
Direktivo 2010/63/ES Evropskega parlamenta in Sveta z dne 22. septembra 2010 o varstvu živali, ki se uporabljajo za znanstvene namene UL L 276, 20.10.2010, str.
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes OJ L 276, 20.10.2010, p.
Direktivo 2010/75/EU Evropskega parlamenta in Sveta z dne 24. novembra 2010 o industrijskih emisijah UL L 334, 17.12.2010, str.
Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions OJ L 334, 17.12.2010, p.
Člen 69 se ne uporablja za prevoz biocidnih proizvodov po železnici, cestah, notranjih plovnih poteh, morju ali zraku.
Article 69 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air.
hrano ali krmo, ki se uporablja
food or feed used as
kot repelenti ali atraktanti (sredstva za privabljanje)
repellents or attractants
biocidne proizvode, ko se uporabljajo kot
biocidal products when used as
pomožna tehnološka sredstva ▌.
processing aids ▌.
Biocidni proizvodi, ki so pridobili končno odobritev po Mednarodni konvenciji za nadzor in ravnanje z ladijskimi balastnimi vodami in sedimenti, se štejejo za odobrene v skladu s Poglavjem VII te uredbe.
Biocidal products which obtained final approval under the International Convention for the Control and Management of Ships' Ballast Water and Sediments shall be considered as authorised under Chapter VIII of this Regulation.
Ustrezno se uporabljata člena 47 in 68.
Articles 47 and 68 shall apply accordingly.
Nič v tej uredbi državam članicam ne preprečuje, da omejijo ali prepovejo uporabo biocidnih proizvodov pri javni dobavi pitne vode.
Nothing in this Regulation shall prevent Member States from restricting or banning the use of biocidal products in the public supply of drinking water.
Države članice lahko v posebnih primerih za določene biocidne proizvode kot take ali v tretiranih izdelkih dovolijo odstopanja od te uredbe, kadar je to potrebno v interesu obrambe.
Member States may allow for exemptions from this Regulation in specific cases for certain biocidal products, on their own or in a treated article, where necessary in the interests of defence.
Odstranjevanje aktivnih snovi in biocidnih proizvodov se izvede v skladu z veljavno zakonodajo o odpadkih Unije in posameznih držav.
The disposal of active substances and biocidal products shall be carried out in accordance with the Union and national waste legislation in force.
„biocidni pripravki“ pomenijo
‘biocidal product’ means
zmesi ▌v obliki, v kakršni se dobavljajo uporabniku, ki so sestavljeni iz aktivnih snovi, jih vsebujejo ali se uporabljajo za pridobivanje ene ali več aktivnih snovi in so
mixture ▌, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the
namenjeni uničevanju, odvračanju ali nevtralizaciji škodljivih organizmov, preprečevanju njihovega delovanja ali za odpravo teh organizmov na kateri koli drug način kot zgolj s fizičnim ali mehanskim delovanjem;
intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action;
snovi ali zmesi, ki se pridobivajo iz snovi ali zmesi, ki pa niso biocidni proizvodi iz prvega pododstavka, in so namenjene uničevanju, odvračanju ali nevtralizaciji škodljivih organizmov, preprečevanju njihovega delovanja ali za odpravo teh organizmov na kateri koli drug način kot zgolj s fizičnim ali mehanskim delovanjem;
any substance or mixture generated from substances or mixtures which are not themselves biocidal products under the first subparagraph to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action;
tretirani izdelki, katerih primarna funkcija je biocidna, veljajo za biocidne proizvode;
A treated article that has a primary biocidal function shall be considered a biocidal product.
„mikroorganizem“ pomeni kakršno koli celično ali necelično mikrobiološko entiteto, sposobno razmnoževanja ali prenašanja genskega materiala, vključno z nižjimi glivami, virusi, bakterijami, kvasovkami, plesnimi, algami, protozoji in mikroskopskimi parazitskimi helminti;
‘micro-organism’ means 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“ pomeni snov ali mikroorganizem, ki deluje na škodljive organizme ali proti njim;
‘active substance’ means a substance or a micro-organism that has an action on or against harmful organisms;
„obstoječa aktivna snov“ pomeni snov, ki je bila 14. maja 2000 na trgu kot aktivna snov biocidnega proizvoda za druge namene kot v proizvod in proces usmerjene znanstvene raziskave in razvoj;
‘existing active substance’ means 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“ pomeni snov, ki 14. maja 2000 ni bila na trgu kot aktivna snov biocidnega proizvoda za druge namene kot v proizvod in proces usmerjene znanstvene raziskave in razvoj;
‘new active substance’ means 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;
„snov, ki vzbuja zaskrbljenost“ pomeni kakršno koli snov, razen aktivne snovi, ki ima zaradi svojih lastnosti takojšnji ali poznejši škodljiv učinek na ljudi, zlasti na ranljive skupine, živali ali okolje, in jo vsebuje biocidni proizvod ali nastaja v biocidnem proizvodu v zadostni koncentraciji, da predstavlja nevarnost takšnega učinka.
‘substance of concern’ means any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect.
Razen če obstajajo drugi razlogi za zaskrbljenost, bi taka snov običajno bila:
Such a substance would, unless there are other grounds for concern, normally be:
snov, razvrščena kot nevarna
a substance classified as dangerous
ali ki izpolnjuje merila, po katerih je razvrščena kot nevarna
or meeting the criteria to be classified as dangerous
v skladu z Direktivo 67/548/EGS in prisotna v biocidnem proizvodu v koncentraciji, zaradi katere se proizvod šteje za nevarnega v smislu členov 5, 6 in 7 Direktive 1999/45/ES, ali
according to Directive 67/548/EEC, and present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, or
snov, razvrščena kot nevarna
a substance classified as hazardous
ali ki izpolnjuje merila, po katerih je razvrščena kot nevarna
or meeting the criteria for classification as hazardous
v skladu z Uredbo (ES) št. 1272/2008 in prisotna v biocidnem proizvodu v koncentraciji, zaradi katere se proizvod šteje za nevarnega v smislu navedene uredbe;
according to Regulation (EC) No 1272/2008, and present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation;
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 (vPvB), 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;
„škodljiv organizem“ pomeni organizem, vključno s povzročitelji bolezni, katerega prisotnost je nezaželena ali ki ima škodljiv učinek na ljudi, na njegove dejavnosti ali na proizvode, ki jih uporablja ali proizvaja, ali na živali ali okolje;
‘harmful organism’ means an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment;
„ostanek“ pomeni snov, ki je prisotna v ali na proizvodih rastlinskega ali živalskega izvora, v vodnih virih, pitni vodi, hrani, krmi ali drugod v okolju, vključno z metaboliti take snovi, razgradnimi ali reakcijskimi produkti, in je posledica uporabe biocidnega proizvoda;
‘residue’ means a substance present in or on products of plant or animal origin, water resources, drinking water, food, feed or elsewhere in the environment and resulting from the use of a biocidal product, including such a substance's metabolites, breakdown or reaction products;
„dostopnost na trgu“ pomeni kakršno koli dobavo biocidnega proizvoda ali tretiranega izdelka za distribucijo ali uporabo v okviru gospodarske dejavnosti, proti plačilu ali brezplačno;
‘making available on the market’ means any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge;
„dajanje na trg“ pomeni stanje, ko je biocidni proizvod ali tretirani izdelek prvič dostopen na trgu;
‘placing on the market’ means the first making available on the market of a biocidal product or of a treated article;
„uporaba“ pomeni vse dejavnosti v zvezi z biocidnim proizvodom, vključno s skladiščenjem, ravnanjem, mešanjem in uporabo, razen kakršnih koli takih dejavnosti, ki se opravijo z namenom izvoza biocidnega proizvoda ali tretiranega izdelka iz Unije;
‘use’ means all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union;
„tretirani izdelek“ pomeni kakršno koli snov, zmes ali izdelek, ki je bil tretiran z enim ali več biocidnimi proizvodi oziroma jih namenoma vsebuje;
‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products;