natgillin/translations-raw huggingface dataset:
Kadar se pojavijo resni znaki, da je v biocidnih pripravkih uporabljena aktivna snov, ki lahko povzroči resnejše tveganje, kot je bilo prvotno predvideno, ima Komisija možnost ponovne proučitve vključitve aktivne snovi.
Where there are serious indications that an active substance used in biocidal products may pose a higher risk than previously thought, the Commission should be able to review the inclusion of the active substance.
Aktivne snovi se lahko zaradi njihovih nevarnih lastnosti označijo kot možne snovi za zamenjavo z drugimi aktivnimi snovmi, kadar so takšne snovi, ki so učinkovite proti ciljnim škodljivim organizmom, na voljo v zadostnih različicah, da se prepreči razvoj odpornosti med škodljivimi organizmi.
Active substances can, on basis of their intrinsic hazardous properties, be designated as candidates for substitution with other active substances, whenever such substances considered as effective towards the targeted harmful organisms become available in sufficient variety to avoid the development of resistance amongst harmful organisms.
Da bi omogočili redno pregledovanje snovi, ki so označene kot možne snovi za zamenjavo, obdobje vključitve, niti z obnovitvijo, ne bi smelo presegati
In order to allow for a regular examination of substances identified as candidates for substitution, the inclusion period for these substances should not, even in the case of renewal, exceed
V času izdajanja dovoljenj za biocidne pripravke ali njihove obnovitve je treba omogočiti primerjanje dveh ali več biocidnih pripravkov glede na tveganje, ki ga predstavljajo in koristi, ki jih prinaša njihova uporaba.
In the course of the authorisation or renewal of biocidal product authorisations, it should be possible to compare two or more biocidal products with regard to risks posed by them and benefits accrued through their use.
Na podlagi takšne primerjalne ocene se dovoljeni biocidni pripravki, ki vsebujejo aktivne snovi, označene kot možne snovi za zamenjavo, lahko nadomestijo z drugimi, ki predstavljajo precej manjše tveganje za zdravje ljudi in okolje ter nimajo večjih škodljivih gospodarskih ali praktičnih učinkov.
As a result of such a comparative assessment, authorised biocidal products containing active substances indicated as candidates for substitution could be replaced with others that present significantly less risk to health or to the environment and where there are no significant adverse economic or practical impacts.
V takšnih primerih se zagotovijo 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 obnovitev vključitve aktivne snovi na seznam Unije ali za izdajo dovoljenja izvede le, če ustrezni organ, ki je bil odgovoren za prvotno oceno, na podlagi razpoložljivih informacij tako odloči.
In order to avoid unnecessary administrative and financial burden for the industry as well as competent authorities, a full in-depth evaluation of an application to renew the inclusion of an active substance in the Union list or the authorisation should be carried out only if the competent authority that was responsible for the initial evaluation decides so on the basis of the available information.
Obstaja potreba po zagotovitvi učinkovitega upravljanja 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 nadaljevanju: Agencija), opravlja posebne naloge v zvezi z ocenjevanjem aktivnih snovi in izdajo dovoljenj za nekatere vrste biocidnih pripravkov in s tem povezane naloge na ozemlju Unije.
The European Chemicals Agency set up under Regulation (EC) No 1907/2006 (hereinafter the ‘Agency’) should carry out specified tasks with regard to the evaluation of active substances as well as the authorisation of certain categories of biocidal products and related tasks in the Union territory.
V okviru agencije je treba ustanoviti odbor za biocidne pripravke, ki bo opravljal naloge, ki jih Agenciji nalaga Uredba.
Consequently, a Biocidal Products Committee should be established within the Agency to carry out the tasks attributed to the Agency by this Regulation.
Priznano je, da lahko biocidni pripravki, ki se uporabijo ne le za namene te uredbe ampak tudi v povezavi z medicinskimi pripomočki, kot so dezinfekcijska sredstva za razkuževanje bolnišničnih površin in medicinskih pripomočkov, predstavljajo drugačno tveganje, kot ga zajema ta uredba.
It is recognised that biocidal products intended to be used not only for purposes of this Regulation but also in connection with medical devices, such as disinfectants used for the disinfection of surfaces in hospitals as well as medical devices, may pose risks different from those covered by this Regulation.
Zato je treba zahtevati, da takšni biocidni pripravki izpolnjujejo zahteve iz te uredbe in ustrezne bistvene zahteve Direktive 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 be required to comply, in addition to the requirements laid down in this Regulation, with the relevant essential requirements of 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.
, Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih UL L 169, 12.7.1993, str.
, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169, 12.7.1993, p.
in Direktive 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih UL L 331, 7.12.1998, str.
or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices OJ L 331, 7.12.1998, p.
Ker bi bili stroški uporabe te uredbe v zvezi s hrano ali krmo, uporabljenimi za biocidne namene, nesorazmerni glede na koristi, ta uredba ne zajema hrane in krme, uporabljenih v biocidne namene.
As the costs of the application of this Regulation to food or feedingstuffs used for biocidal purposes would be disproportionate to the benefits thereof, food and feedingstuffs used for biocidal purposes should not be covered by this Regulation.
Poleg tega za varnost hrane in krme velja 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.
Furthermore, the safety of food and feedingstuffs 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.
Pomožna tehnološka sredstva so zajeta v obstoječi zakonodaji Unije, zlasti v Uredbi Sveta 89/107/EGS z dne 21. decembra 1988 o približevanju zakonodaj držav članic o aditivih za živila, ki se smejo uporabljati v živilih, namenjenih za prehrano ljudi UL L 40, 11.2.1989, str.
Processing aids are covered by existing Union legislation, in particular Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption OJ L 40, 11.2.1989, p.
in 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.
and 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.
Zato je primerno, da se izključijo iz področja uporabe te uredbe.
Therefore, it is appropriate to exclude them from the scope of this Regulation.
Ker so pripravki, ki se uporabljajo za konzerviranje hrane ali krme z nadzorom škodljivih organizmov, ki so bili predhodno zajeti v vrsto pripravka 20, zajeti v Direktivi 89/107/EGS in Uredbi (ES) št. 1831/2003, ni ustrezno, da se ta vrsta pripravka ohrani.
As products used for the preservation of food or feedstocks by the control of harmful organisms, which were previously covered by product type 20, are now covered by Directive 89/107/EEC and Regulation (EC) No 1831/2003, it is not appropriate to maintain this product type.
Ker Mednarodna konvencija o nadzoru in upravljanju balastne vode ladij in sedimentov zagotavlja učinkovito oceno tveganja, ki ga povzročijo sistemi upravljanja z balastnimi vodami, je treba končno odobritev in poznejšo vrsto odobritve takšnih sistemov pa šteti enakovredno izdaji dovoljenja za pripravek, 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 upoštevali posebno naravo nekaterih biocidnih pripravkov in majhno tveganje, povezano z njihovo predlagano uporabo, ter spodbudili razvijanje biocidnih pripravkov, ki vsebujejo nove aktivne snovi, je za te pripravke ustrezno zagotoviti izdajo dovoljenj Unije.
In order to take account of the specific nature of some biocidal products and the low level of risk associated with their proposed use, and to encourage the development of biocidal products containing new active substances, it is appropriate to provide for a Union authorisation of those products.
Zaradi zagotovitve, da se dajo v promet samo biocidni pripravki, ki izpolnjujejo ustrezne zahteve te uredbe, morajo za biocidne pripravke, ki se dajo v promet ali uporabo na ozemlju države članice, dovoljenje izdati ustrezni organi, za dajanje v promet nekaterih vrst biocidnih pripravkov ali njihovo uporabo v Uniji pa Komisija.
In order to ensure that only biocidal products that comply with the relevant provisions of this Regulation are placed on the market, biocidal products should be subject to authorisation either by competent authorities for placing on the market or use in the territory of a Member State, or a part of it, or by the Commission for placing on the market or use in the Union.
Da bi olajšali dostop do notranjega trga, se izognili dodatnim stroškom in prihranili čas, potreben za pridobitev posameznih nacionalnih dovoljenj v posameznih državah članicah,
In order to facilitate access to the internal market and to avoid the additional costs and time involved in obtaining separate national authorisations in separate Member States, ▌the scope of the Union authorisation procedure
je treba področje uporabe postopka izdaje dovoljenj Unije razširiti na druge biocidne pripravke, z izjemo biocidnih pripravkov, ki vsebujejo določene aktivne snov
should be extended to all categories of biocidal products with the exception of biocidal products that contain certain active substances
Za zagotovitev usklajene uporabe meril manjšega tveganja, je treba ta merila čimbolj natančno določiti v Uredbi.
In order to ensure a harmonised application of the low-risk criteria by competent authorities, it is necessary to specify those criteria in the Regulation as far as possible.
Merila morajo upoštevati nevarne lastnosti biocidnih pripravkov in izpostavljenost takemu pripravku, povezane z njegovo uporabo.
The criteria should be based on the hazard characteristics of the biocidal products and the exposure to the product associated with its use.
Uporaba biocidnih pripravkov z manjšim tveganjem ne sme povzročiti resne nevarnosti, da bi ciljni organizmi razvili odpornost.
The use of low-risk biocidal products should not lead to a high risk of developing resistance in target organisms.
Glede na določbe o biocidnih pripravkih z manjšim tveganjem v tej uredbi se zdi ustrezno, da se aktivne snovi, ki so v teh pripravkih, izvzamejo iz obveznosti glede registracije v skladu z Uredbo (ES) št.1907/2006.
In view of the provisions on low-risk biocidal products in this Regulation, it seems appropriate to exempt active substances contained in those products from the registration obligations under Regulation (EC) No 1907/2006.
To je zlasti potrebno, ker te snovi ne izpolnjujejo pogojev iz člena 15(2) navedene uredbe.
This is, in particular, necessary because these substances do not fulfil the conditions in Article 15(2) of that Regulation.
Treba je določiti skupna načela za oceno in izdajo dovoljenj za biocidne pripravke, da ustrezni organi zagotovijo usklajen pristop.
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 pripravkov, je ustrezno, da predlagatelji predložijo dokumentacijo, ki vsebuje potrebne informacije.
In order to evaluate the risks that would arise from the proposed uses of biocidal products, it is appropriate that the applicants submit dossiers which contain the necessary information.
Treba je določiti niz podatkov o aktivnih snoveh in biocidnih pripravkih, ki vsebujejo aktivne snovi, v pomoč predlagateljem, ki želijo pridobiti dovoljenje, in tistim 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 the applicants seeking authorisation and competent authorities carrying out the evaluation in deciding on the authorisation.
Glede na raznovrstnost aktivnih snovi in biocidnih pripravkov morajo zahtevani podatki in preskusi ustrezati posameznim okoliščinam in omogočiti celovito oceno tveganja.
In the light of the diversity of both the active substances and the biocidal products, the data and test requirements should suit the individual circumstances and allow an overall risk assessment.
Zato mora predlagatelj imet možnost, da zahteva spremembe zahtev za podatke, če je primerno, vključno z odstopanjem od zahtevanih podatkov, ki niso potrebni ali jih ni mogoče predložiti zaradi narave predlagane uporabe pripravka.
Therefore, an applicant should be able to request adaptations of the data requirements, as appropriate, including the waiving of data requirements which are unnecessary or impossible to submit in view of the nature or the proposed uses of the product.
Predlagatelji morajo svoje zahtevke podpreti z ustrezno tehnološko in znanstveno utemeljitvijo.
Applicants should provide the appropriate technical and scientific justification to support their requests.
Za zagotovitev, da lahko predlagatelji učinkovito uveljavljajo svojo pravico do zahteve po prilagoditvi zahtevanih podatkov, pristojni organi obvestijo predlagatelja o tej možnosti in razlogih, na podlagi katerih lahko vložijo zahtevo.
In order to ensure that the applicant can effectively exercise his right to request an adaptation of the data requirements, the competent authorities should inform the applicant about this possibility and the grounds on which such request could be made.
Da bi olajšali pripravo zahtevka, zlasti malim in srednje velikim podjetjem (MSP), pristojni organi predlagateljem, če je mogoče, pomagajo pripraviti tak zahtevek.
Furthermore, in order to facilitate the preparation of the request, in particular by small- and medium-sized enterprises (SMEs), the competent authority should assist the applicant, where possible, in preparing such a request.
V pomoč predlagateljem, zlasti malim in srednjim podjetjem, pri izpolnjevanju zahtev te uredbe bi morale države članice vzpostaviti nacionalne službe za pomoč uporabnikom.
In order to help applicants, and in particular SMEs, to comply with the requirements of this Regulation, Member States should establish national helpdesks.
Za lažji dostop do trga z biocidnimi pripravki, ki pripadajo eni skupini pripravkov, je treba omogočiti izdajo dovoljenj za takšne skupine biocidnih pripravkov s podobnimi uporabami in dovoliti omejena odstopanja glede na zadevni biocidni pripravek, pod pogojem, da navedene spremembe ne vplivajo na stopnjo tveganja in učinkovitost pripravkov.
In order to facilitate access to the market of biocidal products belonging to one group of products, it should be possible to authorise such groups of biocidal products with similar uses and allow limited variations with regard to the reference biocidal product provided that those variations do not affect the level of the risk and the efficacy of the products.
Pri izdaji dovoljenja za biocidne pripravke je treba zagotoviti, da so ob pravilni uporabi za predviden namen dovolj učinkoviti, in nimajo nesprejemljivega učinka na ciljne organizme, kot je odpornost, in kadar gre za vretenčarje, da ne povzročajo nepotrebnega trpljenja in bolečine, ter da glede na sedanje znanstveno in tehnološko znanje nimajo nesprejemljivih učinkov na okolje in zlasti na zdravje ljudi in živali.
When biocidal products are being authorised, 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, and, in the case of vertebrate animals, unnecessary suffering and pain, and have, in the light of current scientific and technical knowledge, no unacceptable effect on the environment and on human or animal health.
Pri odločanju, ali naj se izda dovoljenje za biocidni pripravek, je treba ustrezno premisliti o koristih, ki izhajajo iz njegove uporabe.
When deciding whether a biocidal product should be authorised, due consideration should be given to the benefits resulting from its use.
Napad škodljivih organizmov bi bilo treba preprečiti z ustreznimi odvračilnimi ukrepi, da se taki organizmi izkoreninijo ali odženejo.
Infestation with harmful organisms should be avoided by means of suitable deterrents to banish or repel such organisms.
Poleg tega bi bilo treba sprejeti druge varnostne ukrepe, na primer ustrezno skladiščenje blaga, upoštevanje higienskih standardov in takojšnje odstranjevanje odpadkov.
In addition, other precautionary steps should be taken, such as proper warehousing of goods, compliance with hygiene standards and immediate disposal of waste.
Da bi se izognili podvajanju postopkov ocenjevanja in zagotovili prost pretok biocidnih pripravkov ter snovi in izdelkov, tretiranih z njimi, znotraj Unije, je treba uvesti postopke, ki bodo zagotavljali, da se dovoljenja za pripravke, ki jih izda ena država članica, priznajo v vseh drugih državah članicah.
In order to avoid duplication of the evaluation procedures and to ensure free movement of biocidal products, as well as of materials and articles treated with them, within the Union, procedures should be established to ensure that authorisations of products granted in one Member State are recognised in all other Member States.
S posebnimi določbami je treba določiti postopke, ki bodo zagotovili nemoten potek medsebojnega priznavanja dovoljenj, ki jih izdajo države članice, zlasti reševanje nesporazumov brez nepotrebnega odlašanja.
Specific provisions should lay down procedures to ensure the smooth operation of mutual recognition of authorisations granted by Member States, and in particular the resolution of any disagreements without undue delay.
Da se državam članicam omogoči sodelovale pri ocenjevanju biocidnih pripravkov in da se olajša dostop biocidnih pripravkov do trga, se mora omogočiti začetek postopka medsebojnega priznavanja ob prvi vlogi za dovoljenje.
In order to enable Member States to co-operate in the evaluation of biocidal products and to facilitate the access of biocidal products to the market, it should be possible to launch the process of mutual recognition together with the application for the first authorisation.
Treba je zagotoviti mehanizem za reševanje sporov na ravni Unije, da se zagotovi učinkovito delovanje medsebojnega priznavanja.
There is a need to provide for a dispute settlement mechanism at Union level to ensure the effective functioning of mutual recognition.
Komisija mora biti pooblaščena, da odloči v primeru, če pristojni organ noče sprejeti medsebojnega priznavanja dovoljenja ali predlaga njegovo omejitev.
If a competent authority refuses to mutually recognise an authorisation or proposes to restrict it, the Commission should be empowered to take a decision.
Preden Komisija pripravi odločitev se o morebitnih tehničnih in znanstvenih vprašanjih lahko posvetuje z agencijo.
In the event of technical or scientific questions, the Commission may consult the Agency before preparing the decision.
Kljub predvidenemu usklajevanju določb za vse vrste biocidnih pripravkov, vključno s pripravki za obvladovanje vretenčarjev, lahko dejanska uporaba tovrstnih pripravkov povzroči zaskrbljenost.
While envisaging harmonised provisions for all biocidal product types, including those intended to control vertebrates, the actual use of such product types might give rise to concern.
Zato bi bilo državam članicam treba omogočiti, da ob upoštevanju Pogodbe odstopajo od načela medsebojnega priznavanja biocidnih pripravkov, ki sodijo v tri posebne vrste biocidov za obvladovanje nekaterih vrst vretenčarjev, če je tako odstopanje utemeljeno in ne ogroža cilja te uredbe glede ustrezne ravni varstva notranjega trga.
Therefore, Member States should be allowed to derogate from the principle of mutual recognition for biocidal products that fall under certain particular types of biocides when intended to control particular kinds of vertebrates, in so far as such derogations are justified and do not jeopardise the purpose of this Regulation regarding an appropriate level of protection of the internal market.
Da se olajša izdaja dovoljenj in medsebojno priznavanje, je primerno vzpostaviti sistem za medsebojno izmenjavo informacij, države članice, Komisija in agencija pa morajo na zahtevo druga drugi omogočiti dostop do podatkov in znanstvene dokumentacije, predložene v zvezi z zahtevki za izdajo dovoljenj za biocidne pripravke.
In order to facilitate the functioning of the authorisation and mutual recognition procedures, it is appropriate to establish a system for the mutual exchange of information, and Member States, the Commission and the Agency should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorisation of biocidal products.
Če je uporaba biocidnega pripravka v interesu države članice, a v državi članici ni zainteresiranega predlagatelja, ki bi takšen pripravek dal v promet, je treba organom za zatiranje škodljivcev in drugim strokovnim organizacijam dovoliti, da zaprosijo za izdajo dovoljenja.
If the use of a biocidal product is in the interest of a Member State, but there is no applicant interested in the placing on the market of such product in the Member State, pest control bodies and other professional organisations should be allowed to apply for an authorisation.
Če dovoljenje dobijo, morajo imeti enake pravice in dolžnosti kot pooblaščeni imetnik.
In the event that they are granted an authorisation, they should possess the same rights and obligations as any other authorisation holder.
Zaradi upoštevanja tehnološkega napredka in znanstvenega razvoja ter potrebe imetnikov dovoljenj je treba določiti, pod kakšnimi pogoji se dovoljenja lahko prekličejo, ponovno pregledajo ali spremenijo.
In order to take account of the scientific and technical developments as well as the needs of the authorisation holders, it should be specified under what conditions authorisations can be cancelled, reviewed or amended.