natgillin/translations-raw huggingface dataset:
Zaradi enake obravnave oseb, ki dajejo na trg aktivne snovi, bi morale te osebe imeti dokumentacijo ali izjavo o dostopnosti do takšne dokumentacije ali do ustreznih podatkov v dokumentaciji, in sicer za vsako od teh aktivnih snovi, ki jo proizvajajo ali uvažajo za uporabo v biocidnih proizvodih.
To ensure the equal treatment of persons placing active substances on the market, they should be required to hold a dossier, or have a letter of access to a dossier, or to relevant data in a dossier, for each of the active substances they manufacture or import for use in biocidal products.
Biocidni proizvodi, ki vsebujejo aktivne snovi, za katere zadevna oseba ne izpolni navedene obveznosti, ne bi več smeli biti dostopni na trgu.
Biocidal products containing active substances for which the relevant person does not comply with that obligation should no longer be made available on the market.
V takšnih primerih bi bilo treba določiti ustrezna obdobja postopnega opuščanja za odlaganje in uporabo obstoječih zalog biocidnih proizvodov.
In such cases, there should be appropriate phase-out periods for disposal and use of existing stocks of biocidal products.
Ta uredba bi se morala uporabljati za biocidne proizvode, ki v obliki, v kakršni se dobavljajo uporabniku, vsebujejo eno ali več aktivnih snovi, so iz njih sestavljeni ali aktivne snovi tvorijo. ▌.
This Regulation should apply to biocidal products that, in the form in which they are supplied to the user, consist of, contain or generate one or more active substances. ▌.
Zaradi zagotavljanja pravne varnosti je treba na ravni Unije izdelati seznam aktivnih snovi, ki so odobrene za uporabo v biocidnih proizvodih.
In order to ensure legal certainty, it is necessary to establish a Union list of active substances approved for use in biocidal products.
Ta uredba se uporablja brez poseganja v Uredbo (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) ter o ustanovitvi Evropske agencije za kemikalije UL L 396, 30.12.2006, str.
This Regulation applies without prejudice to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency OJ L 396, 30.12.2006, p.
Biocidne aktivne snovi so pod določenimi pogoji izvzete iz zadevnih določb navedene uredbe.
Under certain conditions, biocidal active substances are exempt from the relevant provisions of that Regulation.
Da bi dosegli visoko raven varstva okolja ter zdravja človeka in živali, se aktivne snovi z najvišjo stopnjo nevarnosti ne bi smele odobriti za uporabo v biocidnih proizvodih, razen v posebnih okoliščinah.
With a view to achieving a high level of protection of the environment and human and animal health, active substances with the worst hazard profiles should not be approved for use in biocidal products except in specific situations.
Med okoliščine, v katerih bi bila odobritev upravičena, bi morali spadati zanemarljivo tveganje zaradi izpostavljenosti snovi, javno zdravje ali zdravje živali, okoljski razlogi ali nesorazmerni negativni učinki, ki bi jih zavrnitev odobritve imela za družbo.
These should include situations when approval is justified because of the negligible risk from exposure to the substance, public or animal health or environmental reasons or the disproportionate negative impact for society of non-approval.
Pri odločitvi, ali se takšne aktivne snovi lahko odobrijo, bi bilo treba upoštevati tudi, ali so na voljo primerne in zadostne nadomestne snovi ali tehnologije.
When deciding if such active substances may be approved, the availability of suitable and sufficient alternative substances or technologies should also be taken into account.
Zaradi upoštevanja razvoja v znanosti in tehnologiji bi bilo treba aktivne snovi na seznamu Unije redno preverjati.
The active substances in the Union list should be regularly examined to take account of developments in science and technology.
Kadar se pojavijo
Where there are
znaki, da je v biocidnih proizvodih ali tretiranih izdelkih uporabljena aktivna snov, ki ne izpolnjuje zahtev iz te uredbe, bi morala imeti Komisija možnost pregleda odobritve aktivne snovi.
indications that an active substance used in biocidal products or treated articles does not meet the requirements of this Regulation, the Commission should be able to review the approval of the active substance.
Aktivne snovi bi bilo treba označiti kot možne snovi za zamenjavo, če imajo določene nevarne lastnosti.
Active substances should be designated as candidates for substitution if they have certain intrinsic hazardous properties.
Da bi omogočili redno pregledovanje snovi, ki so označene kot možne snovi za zamenjavo, obdobje odobritve niti s podaljšanjem ne bi smelo presegati sedem let.
In order to allow for a regular examination of substances identified as candidates for substitution, the approval period for those substances should not, even in the case of renewal, exceed seven years.
Ob izdajanju ali podaljšanju dovoljenja za biocidni proizvod, ki vsebuje aktivno snov, ki je možna snov za zamenjavo, bi moralo biti mogoče primerjati biocidni proizvod z drugimi dovoljenimi biocidnimi proizvodi, nekemičnimi sredstvi za nadzor in preventivnimi metodami glede na njihovo tveganje in koristi, ki jih prinaša njihova uporaba.
In the course of granting or renewing the authorisation of a biocidal product that contains an active substance that is a candidate for substitution, it should be possible to compare the biocidal product with other authorised biocidal products, non-chemical means of control and prevention methods with regard to risks they pose and benefits from their use.
Na podlagi takšne primerjalne ocene bi bilo treba prepovedati ali omejiti biocidni proizvod, ki vsebuje aktivne snovi, opredeljene kot možne snovi za zamenjavo, če bi se pokazalo, da so drugi dovoljeni biocidni proizvodi, nekemične nadzorne ali preventivne metode s precej manjšim splošnim tveganjem za zdravje človeka in živali ter okolje dovolj učinkoviti in ne prinašajo nobenih bistvenih gospodarskih ali praktičnih negativnih posledic.
As a result of such a comparative assessment, a biocidal product containing active substances identified as candidates for substitution should be prohibited or restricted where it is demonstrated that other authorised biocidal products or non-chemical control or prevention methods that present a significantly lower overall risk for human and animal health and the environment, are sufficiently effective and present no other significant economic or practical disadvantages.
Za takšne primere bi bilo treba določiti ustrezna obdobja postopnega opuščanja.
Appropriate phase-out periods should be provided for in such cases.
Da bi se industrija in pristojni organi izognili nepotrebnemu upravnemu in finančnemu bremenu, se popolna in poglobljena ocena vloge za podaljšanje odobritve aktivne snovi ali za izdajo dovoljenja za biocidni proizvod izvede le, če pristojni organ, ki je bil odgovoren za prvotno oceno, na podlagi razpoložljivih informacij odloči, da je to potrebno.
In order to avoid unnecessary administrative and financial burdens for the industry and competent authorities, a full in-depth evaluation of an application to renew the approval of an active substance or the authorisation of a biocidal product should be carried out only if the competent authority that was responsible for the initial evaluation decides that this is necessary on basis of the available information.
Obstaja potreba po učinkovitem usklajevanju in upravljanju tehničnih, znanstvenih in upravnih vidikov te uredbe na ravni Unije.
There is a need to ensure effective coordination and management of the technical, scientific and administrative aspects of this Regulation at Union level.
Evropska agencija za kemikalije, ustanovljena z Uredbo (ES) št. 1907/2006 (v nadaljnjem besedilu: Agencija), bi morala opravljati posebne naloge v zvezi z ocenjevanjem aktivnih snovi in izdajo dovoljenj Unije za določene kategorije biocidnih proizvodov ter s tem povezane naloge.
The European Chemicals Agency set up under Regulation (EC) No 1907/2006 (‘the Agency’) should carry out specified tasks with regard to the evaluation of active substances as well as the Union authorisation of certain categories of biocidal products and related tasks.
V okviru Agencije bi bilo zato treba ustanoviti odbor za biocidne proizvode, ki bo opravljal določene naloge, ki jih Agenciji nalaga ta uredba.
Consequently, a Biocidal Products Committee should be established within the Agency to carry out certain tasks conferred on the Agency by this Regulation.
Določene biocidne proizvode in tretirane izdelke, kot so opredeljeni v uredbi, ureja tudi druga zakonodaja Unije.
Certain biocidal products and treated articles as defined in the Regulation are also regulated by other Union legislation.
Zato je treba zaradi zagotavljanja pravne varnosti potegniti jasno ločnico.
It is therefore necessary to draw clear borderlines in order to ensure legal certainty.
Seznam vrst proizvodov, ki jih zajema ta uredba, in okvirni niz opisov posameznih vrst bi bilo treba določiti v prilogi k tej uredbi.
A list of product types covered by this Regulation with an indicative set of descriptions within each type should be set out in an Annex to this Regulation.
Biocidni proizvodi, ki se uporabljajo ne le za namene te uredbe ampak tudi v povezavi z medicinskimi pripomočki, kot so dezinfekcijska sredstva za razkuževanje bolnišničnih površin in medicinskih pripomočkov, lahko pomenijo drugačno tveganje, kot je obravnavano v tej uredbi.
Biocidal products intended to be used not only for the purposes of this Regulation, but also in connection with medical devices, such as disinfectants used to disinfect surfaces in hospitals and medical devices, may pose risks other than those with which this Regulation is concerned.
Zato bi morali takšni biocidni proizvodi poleg zahtev iz te uredbe izpolnjevati tudi ustrezne bistvene zahteve iz Priloge I k Direktivi Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev UL L 189, 20.7.1990, str.
Therefore, such biocidal products should comply, in addition to the requirements laid down in this Regulation, with the relevant essential requirements set out in Annex I to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices OJ L 189, 20.7.1990, p.
in Direktive 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o
and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on
diagnostičnih medicinskih pripomočkih UL L 331, 7.12.1998, str.
diagnostic medical devices OJ L 331, 7.12.1998, p.
Kjer je biocidna funkcija naravno povezana s kozmetično funkcijo ali šteje za sekundarni zahtevek glede kozmetičnega izdelka in jo zato ureja Uredba 1223/2009/ES, bi ta funkcija in izdelek ne bi smela spadati v področje uporabe uredbe o biocidnih proizvodih.
Where a biocidal function is inherent to the cosmetic function or is considered to be a secondary claim to a cosmetic product and is therefore regulated through Regulation 1223/2009/EC, this function and the product should remain out of the scope of the Regulation on biocidal products.
Varnost hrane in krme ureja zakonodaja Unije, zlasti Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane UL L 31, 1.2.2002, str.
The safety of food and feed is subject to Union legislation, in particular Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety OJ L 31, 1.2.2002, p.
Zato se ta uredba ne bi smela uporabljati za hrano in krmo, ki se uporabljata za biocidne namene.
Therefore, the present Regulation should not apply to food and feed used for biocidal purposes.
Pomožna tehnološka sredstva so zajeta v obstoječi zakonodaji Unije, zlasti v Uredbi (ES) št. 1831/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali UL L 268, 18.10.2003, str.
Processing aids are covered by existing Union legislation, in particular Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition OJ L 268, 18.10.2003, p.
in Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila UL L 354, 31.12.2008, str.
and Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives OJ L 354, 31.12.2008, p.
Zato jih je primerno izključiti iz področja uporabe te uredbe.
Therefore, it is appropriate to exclude them from the scope of this Regulation.
Ker so proizvodi, ki se uporabljajo za konzerviranje hrane ali krme z nadzorom škodljivih organizmov, dosedanja vrsta proizvoda 20, zajeti z Uredbo (ES) št. 1831/2003 in Uredbo (ES) št. 1333/2008, ni ustrezno ohranjati te vrste proizvoda.
As products used for the preservation of food or feed by the control of harmful organisms, previously covered by product type 20, are covered by Regulation (EC) No 1831/2003 and Regulation (EC) No 1333/2008, it is not appropriate to maintain that product type.
Ker Mednarodna konvencija za nadzor in ravnanje z ladijskimi balastnimi vodami in sedimenti omogoča učinkovito oceno tveganja, ki ga pomenijo sistemi upravljanja balastnih voda, bi bilo treba končno odobritev in naknadno tipsko odobritev takšnih sistemov šteti enakovredno izdaji dovoljenja za proizvod, ki se zahteva v skladu s to uredbo.
As the International Convention for the Control and Management of Ships' Ballast Water and Sediments provides for an effective assessment of the risks posed by ballast water management systems, the final approval and subsequent type approval of such systems should be considered equivalent to the product authorisation required under this Regulation.
Da bi se izognili morebitnim negativnim vplivom na okolje, bi bilo treba za biocidne proizvode, ki ne morejo več biti zakonito dostopni na trgu, poskrbeti v skladu z zakonodajo Unije o odpadkih, zlasti Direktivo 2008/98/ES, in nacionalno zakonodajo, ki izvaja to zakonodajo.
To avoid possible negative effects on the environment, biocidal products that can no longer lawfully be made available on the market should be dealt with in accordance with Union legislation on waste, in particular Directive 2008/98/EC, as well as national legislation implementing that legislation.
Da bi olajšali dostopnost določenih biocidnih proizvodov, ki imajo podobne pogoje uporabe v vseh državah članicah, na trgu celotne Unije, je za te proizvode ustrezno omogočiti izdajo dovoljenj Unije.
To facilitate the making available on the market throughout the Union of certain biocidal products with similar conditions of use in all Member States, it is appropriate to provide for Union authorisation of those products.
Da bi imela Agencija na voljo dovolj časa za vzpostavitev potrebnih zmogljivosti in pridobitev izkušenj v zvezi s tem postopkom, bi bilo treba možnost vlaganja vlog za dovoljenje Unije za nadaljnje kategorije biocidnih proizvodov s podobnimi pogoji uporabe v vseh državah članicah razširiti postopoma.
In order to allow some time for the Agency to build up the necessary capacity and to gain experience with this procedure, the possibility to apply for Union authorisation should be extended through a step-wise approach to further categories of biocidal products with similar conditions of use in all Member States.
Komisija bi morala preučiti izkušnje z uporabo določb o dovoljenjih Unije in o tem do 31. decembra 2017 poročati Evropskemu parlamentu in Svetu, svojemu poročilu pa po potrebi priložiti predloge sprememb.
The Commission should review experience with the provisions on Union authorisations and report to the European Parliament and the Council by 31 December 2017, accompanying its report with proposals for changes if appropriate.
Da bi bili na trgu dostopni samo biocidni proizvodi, ki izpolnjujejo ustrezne zahteve te uredbe, bi morali za biocidne proizvode, ki so dani na trg in se uporabljajo na ozemlju ali delu ozemlja države članice, dovoljenje izdati pristojni organi, za biocidne proizvode, ki so dani na trg in se uporabljajo v Uniji, pa Komisija.
To ensure that only biocidal products that comply with the relevant provisions of this Regulation are made available on the market, biocidal products should be subject to authorisation either by competent authorities, for making available on the market and use within the territory of a Member State, or part of it, or by the Commission for making available on the market and use within the Union.
Da bi spodbudili uporabo biocidnih proizvodov z ugodnejšimi lastnostmi za okolje ali človekovo zdravje, je primerno za take proizvode uvesti poenostavljene postopke za izdajo dovoljenja.
To encourage the use of products with a more favourable environmental or human health profile, it is appropriate to provide for simplified authorisation procedures for such biocidal products.
Ko je za biocidne proizvode izdano dovoljenje v vsaj eni državi članici, bi bilo treba pod določenimi pogoji omogočiti njihovo dostopnost na trgu v vseh državah članicah brez potrebe po medsebojnem priznavanju.
Once authorised in at least one Member State, those products should be allowed to be made available on the market in all Member States without the need for mutual recognition, under certain conditions.
Da bi opredelili biocidne proizvode, ki izpolnjujejo pogoje za uporabo poenostavljenih postopkov za izdajo dovoljenja, je primerno oblikovati poseben seznam aktivnih snovi, ki jih navedeni proizvodi lahko vsebujejo.
To identify biocidal products which are eligible for simplified authorisation procedures, it is appropriate to establish a specific list of the active substances that those products may contain.
Ta seznam bi moral sprva vsebovati snovi, ki so v skladu z Uredbo (ES) št. 1907/2006 ali Direktivo 98/8/ES opredeljene kot snovi z nizkim tveganjem, snovi, opredeljene kot aditivi za živila, feromoni in druge snovi z nizko stopnjo strupenosti, kot so šibke kisline, alkoholi in rastlinska olja, ki se uporabljajo v kozmetiki in hrani.
That list should, initially, contain substances identified as presenting a low risk under Regulation (EC) No 1907/2006 or Directive 98/8/EC, substances identified as food additives, pheromones and other substances considered to have low toxicity, such as weak acids, alcohols and vegetable oils used in cosmetics and food.
Da bi zagotovili usklajen pristop pristojnih organov, je treba določiti skupna načela za oceno in izdajo dovoljenj za biocidne proizvode.
It is necessary to provide common principles for the evaluation and authorisation of biocidal products to ensure a harmonised approach by competent authorities.
Da se oceni tveganje, ki bi ga povzročila predlagana uporaba biocidnih proizvodov, je ustrezno, da vlagatelji predložijo dokumentacijo, ki vsebuje potrebne informacije.
To evaluate the risks that would arise from proposed uses of biocidal products, it is appropriate that applicants submit dossiers which contain the necessary information.
Določiti je treba niz podatkov o aktivnih snoveh in biocidnih proizvodih, ki te snovi vsebujejo, da bi bili v pomoč vlagateljem, ki želijo pridobiti dovoljenje, in pristojnim organom, ki jih ocenjujejo zaradi odločitve o dovoljenju.
Defining a data set for active substances and for biocidal products in which they are contained is necessary so as to assist both applicants seeking authorisation and competent authorities carrying out an evaluation to decide on authorisation.
Glede na raznovrstnost aktivnih snovi in biocidnih proizvodov, za katere se ne uporablja poenostavljeni postopek za izdajo dovoljenja, bi morali zahtevani podatki in preskusi ustrezati posameznim okoliščinam in omogočiti celovito oceno tveganja.
In the light of the diversity of both active substances and biocidal products not subject to the simplified authorisation procedure, the data and test requirements should suit the individual circumstances and allow an overall risk assessment.
Zato bi moral vlagatelj imeti možnost, da zahteva prilagoditev zahtev glede podatkov, če je primerno, vključno z odstopom od zahtev glede podatkov, ki niso potrebni ali jih ni mogoče predložiti zaradi narave predlaganih uporab proizvoda.
Therefore, an applicant should be able to request the adaptation of the data requirements, as appropriate, including the waiving of data requirements which are not necessary or are impossible to submit in view of the nature or the proposed uses of the product.
Vlagatelji bi morali svoje vloge podpreti z ustrezno tehnično in znanstveno utemeljitvijo.
Applicants should provide appropriate technical and scientific justification to support their requests.
Da bi države članice pomagale vlagateljem in zlasti malim in srednjim podjetjem (MSP) pri izpolnjevanju zahtev iz te uredbe, bi jim morale zagotoviti svetovanje, na primer z vzpostavitvijo služb za pomoč uporabnikom.
In order to help applicants, and in particular small and medium-sized enterprises (SMEs), to comply with the requirements of this Regulation, Member States should provide advice, for example by establishing helpdesks.
To svetovanje bi moralo biti dodatek operativnim smernicam ter drugim svetovanjem in pomoči, ki jih zagotovi Agencija.
This advice should be in addition to the operational guidance documents and other advice and assistance provided by the Agency.
Da bi lahko vlagatelji učinkovito uveljavljali pravico do zahteve za prilagoditev zahtev glede podatkov, bi morale države članice obvestiti vlagatelje o tej možnosti in razlogih, na podlagi katerih lahko vložijo take zahteve.
In particular, to ensure that applicants can effectively exercise the right to request the adaptation of data requirements, Member States should provide advice on this possibility and the grounds on which such requests could be made.
Za lažji dostop do trga z biocidnimi proizvodi bi bilo treba v primeru skupine biocidnih proizvodov omogočiti izdajo dovoljenja za družino biocidnih proizvodov.
To facilitate access to the market it should be possible to authorise a group of biocidal products as a biocidal product family.
Biocidni proizvodi iz iste družine biocidnih proizvodov bi se morali uporabljati za podobne namene in vsebovati enake aktivne snovi.
Biocidal products within a biocidal product family should have similar uses and the same active substances.
Opredeliti bi bilo treba odstopanja v sestavi ali nadomestne neaktivne snovi, vendar te ne smejo škodljivo vplivati na raven tveganja ali znatno zmanjšati učinkovitosti teh proizvodov.
Variations in the composition or the replacement of non-active substances should be specified, but may not adversely affect the level of risk or significantly reduce the efficacy of the products.
Pri izdaji dovoljenja za biocidne proizvode je treba zagotoviti, da so ti ob pravilni uporabi za predviden namen dovolj učinkoviti in nimajo nesprejemljivega učinka na ciljne organizme, kot je odpornost, ali, kadar gre za vretenčarje, da ne povzročajo nepotrebnega trpljenja in bolečine.
When authorising biocidal products it is necessary to ensure that, when properly used for the purpose intended, they are sufficiently effective and have no unacceptable effect on the target organisms such as resistance, or, in the case of vertebrate animals, unnecessary suffering and pain.
Poleg tega glede na sedanje znanstveno in tehnično znanje ne smejo imeti nikakršnih nesprejemljivih vplivov na okolje ali na zdravje človeka ali živali.
Furthermore, they may not have, in the light of current scientific and technical knowledge, any unacceptable effect on the environment or on human or animal health.