natgillin/translations-raw huggingface dataset:
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 [4].
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 [4].
Under certain conditions, biocidal active substances are exempt from the relevant provisions of that Regulation.
Biocidne aktivne snovi so pod določenimi pogoji izvzete iz zadevnih določb navedene uredbe.
With a view to achieving a high level of protection of human health, animal health and the environment, active substances with the worst hazard profiles should not be approved for use in biocidal products except in specific situations.
Da bi dosegli visoko raven varstva zdravja človeka, zdravja živali ter okolja, se aktivne snovi z najvišjo stopnjo nevarnosti ne bi smele odobriti za uporabo v biocidnih proizvodih, razen v posebnih okoliščinah.
These should include situations when approval is justified because of the negligible risk from exposure to the substance, human health, animal health or environmental reasons or the disproportionate negative impact for society of non-approval.
Med okoliščine, v katerih bi bila odobritev upravičena, bi morali spadati zanemarljivo tveganje zaradi izpostavljenosti snovi, zdravje človeka ali zdravje živali, okoljski razlogi ali nesorazmerni negativni učinek, ki bi jih zavrnitev odobritve imela za družbo.
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.
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.
The active substances in the Union list should be regularly examined to take account of developments in science and technology.
Zaradi upoštevanja razvoja v znanosti in tehnologiji bi bilo treba aktivne snovi na seznamu Unije redno preverjati.
Where there are significant 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.
Kadar se pojavijo pomenljivi 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.
Active substances should be designated as candidates for substitution if they have certain intrinsic hazardous properties.
Aktivne snovi bi bilo treba označiti kot možne snovi za zamenjavo, če imajo določene nevarne lastnosti.
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.
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 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.
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.
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 health, animal health and the environment, are sufficiently effective and present no other significant economic or practical disadvantages.
Na podlagi takšne primerjalne ocene bi bilo treba prepovedati ali omejiti biocidni proizvod, ki vsebuje aktivne snovi, opredeljene kot možne snovi za zamenjavo, če se dokaže, da so drugi dovoljeni biocidni proizvodi, nekemične nadzorne ali preventivne metode s precej manjšim splošnim tveganjem za zdravje človeka, zdravje živali ter okolje dovolj učinkoviti in ne prinašajo nobenih bistvenih gospodarskih ali praktičnih negativnih posledic.
Appropriate phase-out periods should be provided for in such cases.
Za takšne primere bi bilo treba določiti ustrezna obdobja postopnega opuščanja.
In order to avoid unnecessary administrative and financial burdens for 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 the basis of the available information.
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.
There is a need to ensure effective coordination and management of the technical, scientific and administrative aspects of this Regulation at Union level.
Obstaja potreba po učinkovitem usklajevanju in upravljanju tehničnih, znanstvenih in upravnih vidikov te uredbe na ravni Unije.
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.
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.
Consequently, a Biocidal Products Committee should be established within the Agency to carry out certain tasks conferred on the Agency by this Regulation.
V okviru Agencije bi bilo zato treba ustanoviti odbor za biocidne proizvode, ki bo opravljal določene naloge, ki jih Agenciji nalaga ta uredba.
Certain biocidal products and treated articles as defined in the Regulation are also regulated by other Union legislation.
Določene biocidne proizvode in tretirane izdelke, kot so opredeljeni v uredbi, ureja tudi druga zakonodaja Unije.
It is therefore necessary to draw clear borderlines in order to ensure legal certainty.
Zato je treba zaradi zagotavljanja pravne varnosti potegniti jasno ločnico.
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.
Seznam vrst proizvodov, ki jih zajema ta uredba, in okvirni niz opisov posameznih vrst bi bilo treba določiti v Prilogi k 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.
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.
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 [5], Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [6] and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [7].
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 [5], Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [6] in Direktive 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih [7].
Where a product has a biocidal function that is inherent to its cosmetic function, or where that biocidal function is considered to be a secondary claim of a cosmetic product and is therefore regulated under Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products [8], that function and the product should remain outside the scope of this Regulation.
Kadar ima izdelek biocidno funkcijo, ki je naravno povezana s kozmetično funkcijo izdelka ali kadar se šteje, da ima ta biocidna funkcija sekundarni zahtevek glede kozmetičnega izdelka in jo zato ureja Uredba (ES) št. 1223/2009 Evropskega parlamenta in Sveta z dne 30. novembra 2009 o kozmetičnih izdelkih [8], ta funkcija in izdelek ne bi smela spadati v področje uporabe te uredbe.
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 [9].
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 [9].
Therefore, the present Regulation should not apply to food and feed used as repellents or attractants.
Zato se ta uredba ne bi smela uporabljati za hrano in krmo, ki se uporablja kot repelent ali atraktant.
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 [10] and Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [11].
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 [10] in Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila [11].
Therefore, it is appropriate to exclude them from the scope of this Regulation.
Zato jih je primerno izključiti iz področja uporabe te uredbe.
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 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 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.
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.
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 of the European Parliament and of the Council of 19 November 2008 on waste [12], as well as national legislation implementing that legislation.
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 Evropskega parlamenta in Sveta z dne 19. novembra 2008 o odpadkih [12], in nacionalno zakonodajo, ki izvaja to zakonodajo.
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 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.
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.
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.
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.
Komisija bi morala preučiti izkušnje z uporabo predpisov o dovoljenjih Unije in o tem do 31. decembra 2017 poročati Evropskemu parlamentu in Svetu, svojemu poročilu pa po potrebi priložiti predloge sprememb.
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 se zagotovi, da bi bili na trgu dostopni samo biocidni proizvodi, ki so skladni z ustreznimi določbami 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 encourage the use of products with a more favourable environmental or human or animal health profile, it is appropriate to provide for simplified authorisation procedures for such biocidal products.
Da bi spodbudili uporabo biocidnih proizvodov z ugodnejšimi lastnostmi za okolje ali zdravje človeka ali živali, je primerno za take proizvode uvesti poenostavljene postopke za izdajo dovoljenja.
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.
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.
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.
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.
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.
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.
It is necessary to provide common principles for the evaluation and authorisation of biocidal products to ensure a harmonised approach by competent authorities.
Da bi zagotovili usklajen pristop pristojnih organov, je treba določiti skupna načela za oceno in izdajo dovoljenj za biocidne proizvode.
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.
Da se oceni tveganje, ki bi ga povzročila predlagana uporaba biocidnih proizvodov, je ustrezno, da vlagatelji predložijo dokumentacijo, ki vsebuje potrebne informacije.
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.
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.
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.
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.
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.
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.
Applicants should provide appropriate technical and scientific justification to support their requests.
Vlagatelji bi morali svoje vloge podpreti z ustrezno tehnično in znanstveno utemeljitvijo.
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.
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.
This advice should be in addition to the operational guidance documents and other advice and assistance provided by the Agency.
To svetovanje bi moralo biti dodatek operativnim smernicam ter drugim svetovanjem in pomoči, ki jih zagotovi Agencija.
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.
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.
To facilitate access to the market it should be possible to authorise a group of biocidal products as a biocidal product family.
Za lažji dostop do trga z biocidnimi proizvodi bi bilo treba v primeru skupine biocidnih proizvodov omogočiti izdajo dovoljenja za družino biocidnih proizvodov.
Biocidal products within a biocidal product family should have similar uses and the same active substances.
Biocidni proizvodi iz iste družine biocidnih proizvodov bi se morali uporabljati za podobne namene in vsebovati enake aktivne snovi.
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.
Opredeliti bi bilo treba odstopanja v sestavi ali nadomestne neaktivne snovi, vendar te ne smejo negativno vplivati na raven tveganja ali znatno zmanjšati učinkovitosti teh proizvodov.
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 vertebrates, unnecessary suffering and pain.
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.
Furthermore, they may not have, in the light of current scientific and technical knowledge, any unacceptable effect on human health, animal health or on the environment.
Poleg tega glede na sedanje znanstveno in tehnično znanje ne smejo imeti nikakršnih nesprejemljivih vplivov na zdravje človeka, zdravje živali ali na okolje.
Where appropriate, maximum residue limits for food and feed should be established with respect to active substances contained in a biocidal product to protect human and animal health.
Po potrebi bi bilo treba zaradi varovanja zdravja ljudi in živali za aktivne snovi v biocidnem proizvodu določiti najvišje mejne vrednosti ostankov za hrano in krmo.
When these requirements are not met, biocidal products shall not be authorised unless their authorisation is justified because of the disproportionate negative impact for society of not authorising them when compared to the risks arising from their use.
Če te zahteve niso izpolnjene, se dovoljenje za biocidne proizvode ne izda, razen če je izdaja dovoljenja upravičena zaradi nesorazmernega negativnega učinka, ki bi ga neizdaja dovoljenja imela za družbo v primerjavi s tveganjem zaradi uporabe biocidnih proizvodov.
Where possible, the presence of harmful organisms should be avoided by means of suitable precautionary steps, such as proper warehousing of goods, compliance with relevant hygiene standards and immediate disposal of waste.
Kadar je mogoče, bi se bilo treba prisotnosti škodljivih organizmov izogniti z ustreznimi previdnostnimi ukrepi, na primer z ustreznim skladiščenjem blaga, upoštevanjem zadevnih higienskih standardov in takojšnjim odstranjevanjem odpadkov.