natgillin/translations-raw huggingface dataset:
Določiti je treba določbe o priglasitvi in izmenjavi informacij, ki lahko vplivajo na izdajo dovoljenj, da lahko pristojni organi in Komisija ustrezno ukrepajo.
Provisions on the notification and exchange of information which may affect the authorisations should be set out so as to enable the competent authorities and the Commission to take appropriate action.
Državam članicam bi moralo biti omogočeno, da za omejeno obdobje izdajo dovoljenje za biocidne pripravke, ki niso v skladu z zahtevami iz te uredbe, še posebej, če gre za nepredvideno nevarnost, ki ogroža javno zdravje ali okolje, in ki je z drugimi sredstvi ne bi mogli obvladati.
In the event of an unforeseen danger threatening public health or the environment which cannot be contained by other means, it should be possible for Member States to authorise, for a limited period of time, biocidal products which do not comply with the requirements laid down in this Regulation.
Za spodbujanje razvoja več novih aktivnih snovi postopek za ocenjevanje novo razvite aktivne snovi ne sme ovirati države članice ali Unije, da za omejeno obdobje izdajo dovoljenje za biocidne pripravke, ki vsebujejo navedeno aktivno snov, preden se aktivna snov uvrsti v Prilogo I, če je bila predložena dokumentacija, ki izpolnjuje vse zahteve, in se domneva, da aktivna snov in biocidni pripravek izpolnjujeta vse pogoje, ki so določeni zanju.
In order to encourage the development of new active substances, the procedure for the evaluation of a newly developed active substance should not prevent Member States or the Union from authorising, for a limited period of time, biocidal products containing that active substance before the active substance is entered in Annex I, provided that a dossier meeting all requirements has been submitted and it is believed that the active substance and the biocidal product satisfy the conditions set for them.
Zaradi pospešitve raziskav in razvoja aktivnih snovi v biocidnih pripravkih je treba določiti pravila, po katerih se biocidni pripravki ali aktivne snovi, ki niso odobreni, lahko dajo v promet za namene raziskav in razvoja.
In order to encourage research and development in active substances and biocidal products, it is necessary to establish rules under which unauthorised biocidal products or active substances may be placed on the market for the purposes of research and development.
Glede na koristi za notranji trg in potrošnika je zaželeno, da se oblikujejo usklajena pravila za vzporedno trgovino za med sabo ▌identične biocidne pripravke, ki so odobreni v različnih državah članicah.
In view of the benefits for the internal market and for the consumer, it is desirable to establish harmonised rules for parallel trade of ▌identical biocidal products that are authorised in different Member States.
Za zagotovitev zaščite zdravja ljudi in živali ter okolja, kot tudi zaradi nerazlikovanja med izdelki in snovmi, ki izvirajo iz Unije, in izdelki in snovi, ki se uvozijo iz tretjih držav, morajo vsi tretirani izdelki ali snovi, ki se dajo v promet na notranji trg, vsebovati le odobrene biocidne pripravke.
For the purposes of ensuring the protection of human and animal health and of the environment, and non-discrimination between articles or materials originating in the Union and articles or materials imported from third countries, all treated articles or materials placed on the internal market should contain only authorised biocidal products.
Zaradi omogočanja obveščene izbire potrošnikov in lažjega izvajanja te uredbe s strani pristojnih organov se izdelki ali snovi, tretirani z biocidnimi pripravki, ustrezno označijo.
For the purposes of enabling consumers to make informed choices and facilitating the enforcement of this Regulation by competent authorities, articles or materials treated with biocidal products should be appropriately labelled.
Predlagateljem, ki so vložili denar v podporo vključitve aktivne snovi v Prilogo I ali izdaje dovoljenja za biocidni pripravek v skladu z določbami te uredbe
Applicants that have invested in supporting the inclusion of an active substance in Annex I or in the authorisation of a biocidal product in accordance with the provisions of this Regulation
ali v skladu z Direktivo 98/8/ES
or in accordance with Directive 98/8/EC
, bi moralo biti omogočeno, da dobijo nazaj del njihove naložbe s prejetjem pravičnega nadomestila, kadar koli se zaščitena informacija, ki so jo predložili v podporo takšne vključitve ali izdaje dovoljenja, uporabi v korist poznejših predlagateljev.
should be able to recover part of their investment by receiving equitable compensation whenever use is made of proprietary information that they submitted in support of such inclusions or authorisations for the benefit of subsequent applicants.
Zaradi zagotovitve, da se vse zaščitene informacije, predložene v podporo vključitve aktivne snovi v Prilogo I ali izdaje dovoljenja za biocidni pripravek, zaščitijo od trenutka njihove predložitve in da se prepreči, da bi bile katere koli informacije nezaščitene, bi morale določbe o obdobjih za varstvo podatkov veljati tudi za informacije, predložene za namene Direktive 98/8/ES.
With a view to ensuring that all proprietary information submitted in support of the inclusion of an active substance in Annex I or an authorisation of a biocidal product is protected from the moment of its submission, and to prevent situations where some information is without protection, the provision on information protection periods should also apply to information submitted for the purposes of Directive 98/8/EC.
Za spodbujanje razvoja novih aktivnih snovi in biocidnih pripravkov, ki vsebujejo aktivne snovi, je treba zagotoviti obdobje varstva v zvezi z zaščitenimi informacijami, predloženimi v podporo vključitve aktivnih snovi ali izdaje dovoljenja za pripravke, ki je daljše od obdobja varstva informacij o obstoječih aktivnih snoveh in pripravkih, ki vsebujejo aktivne snovi.
In order to encourage the development of new active substances and biocidal products containing them, it is necessary to provide for a period of protection with respect to the proprietary information submitted in support of the inclusion of active substances or authorisations of products which is longer than the period of protection for information concerning existing active substances and products containing them.
Bistveno je, da se zmanjša število preskusov na živalih in zagotovi, da so preskusi
It is essential to minimise the number of tests on animals and to ensure that testing
z biocidnimi pripravki ali aktivnimi snovmi, ki jih vsebujejo biocidni pripravki,
with biocidal products or active substances contained in biocidal products
odvisni od namena in uporabe pripravka.
should be made dependent on the purpose and use of a product.
Če do dogovora o souporabi študij o vretenčarjih med lastnikom podatkov in zadevnim predlagateljem ne pride, agencija bodočemu predlagatelju omogoči uporabo študij ne glede na odločitev o nadomestilu, ki jo sprejmejo nacionalna sodišča.
In the absence of an agreement on sharing vertebrate animal studies between the data owner and the prospective applicant, the Agency should allow the use of the studies by the prospective applicant without prejudice to the decision on the compensation made by national courts.
Prav tako je treba spodbujati pridobivanje informacij z drugimi sredstvi, ki ne vključujejo preskusov na živalih, ki so enakovredna predpisanim preskusom in preskusnim metodam.
The generation of information by alternative means that do not involve tests on animals and that are equivalent to prescribed tests and test methods should also be encouraged.
Poleg tega je treba prilagoditve zahtevanih podatkov uporabiti za preprečevanje nepotrebnih stroškov v zvezi s preskusi.
In addition, the adaptation of data requirements should be used to prevent unnecessary costs related to testing.
Države članice morajo sprejeti ukrepe za ustrezen nadzor in ureditve inšpekcije, da bi zagotovile izpolnjevanje zahtev, predpisanih glede dovoljenih biocidnih pripravkov, ko se dajejo v promet.
In order to ensure that the requirements laid down in respect of authorised biocidal products are satisfied when they are placed on the market, the Member States should take measures for appropriate control and inspection arrangements.
Treba je zagotoviti učinkovito sporočanje informacij o tveganjih, ki jih povzročajo biocidni pripravki, in ukrepih za obvladovanje tveganj, saj to sestavlja pomemben del sistema, ki ga vzpostavlja ta uredba.
It is necessary to provide for the effective communication of information on risks resulting from biocidal products and risk management measures as it forms an essential part of the system established by this Regulation.
Ob zagotovitvi lažjega dostopa do informacij pristojni organi, agencija in Komisija spoštujejo načelo zaupnosti in preprečijo vsako razkritje informacij, ki bi utegnilo ogroziti tržne interese zadevne osebe
While facilitating access to information, competent authorities, the Agency and the Commission should respect the principle of confidentiality and avoid any disclosure of information which could be harmful for the commercial interests of the person concerned
, razen če je to potrebno za zaščito zdravja ljudi in okolja
, except where it is necessary for the protection of human health and the environment
Za večjo učinkovitost spremljanja in nadzora ter zagotovitev informacij, pomembnih pri obravnavanju tveganj biocidnih pripravkov, se od proizvajalcev, uvoznikov in poklicnih uporabnikov zahteva, da vodijo evidence o pripravkih, ki jih proizvedejo, dajo v promet ali uporabljajo.
In order to increase the effectiveness of monitoring and control, and to provide information relevant for addressing the risks of biocidal products, producers, importers and professional users should be required to keep records of the products they produce, place on the market or use.
Komisija sprejme pravila za zbiranje, prenos in obdelavo podatkov.
The Commission should adopt implementing rules on data collection, transmission and processing.
Za lažjo izmenjavo informacij med pristojnimi organi, agencijo in Komisijo se pripravi register biocidnih pripravkov Unije.
In order to facilitate the exchange of information between competent authorities, the Agency and the Commission, a Union Register for Biocidal Products should be established.
Treba je natančno določiti, da se določbe glede agencije iz Uredbe (ES) št. 1907/2006 ustrezno uporabljajo za biocidne aktivne snovi in pripravke.
It is necessary to specify that provisions concerning the Agency laid down in Regulation (EC) No 1907/2006 should apply accordingly in the context of biocidal active substances and products.
Kjer je potrebno pripraviti ločene določbe v zvezi z nalogami in delovanjem agencije v skladu s to uredbo, je treba to natančno opredeliti v določbah te uredbe.
Where separate provisions need to be made with respect to the tasks and functioning of the Agency under this Regulation, it should be specified in the provisions of this Regulation.
Treba je zagotoviti možnost pritožbe proti nekaterim odločitvam agencije.
It is necessary to provide for the possibility of an appeal against certain decisions of the Agency.
Odbor za pritožbe, ustanovljen znotraj agencije z Uredbo (ES) št. 1907/2006, zagotavlja obravnavanje pritožb proti odločitvam, ki jih sprejme Agencija na podlagi te uredbe.
The Board of Appeal set up within the Agency by Regulation (EC) No 1907/2006 should also guarantee the processing of appeals against decisions adopted by the Agency under this Regulation.
Obstaja znanstvena negotovost glede varnosti nanomaterialov za zdravje ljudi in okolja, znanstveni odbor za nastajajoča in na novo ugotovljena zdravstvena tveganja (SCENIHR) pa je za nekaj nanomaterialov opredelil nekatera specifična tveganja za zdravje, pa tudi toksične učinke na okoljske organizme.
There is scientific uncertainty about the safety of nanomaterials for human health and the environment and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has identified some specific health hazards as well as toxic effects on environmental organisms for some nanomaterials.
Odbor SCENIHR je ugotovil tudi splošno pomanjkanje visokokakovostnih podatkov o izpostavljenosti za ljudi in okolje ter zaključil, da je treba nadaljevati z razvojem, preverjanjem in standardizacijo znanja o metodologiji za ocene izpostavljenosti in ugotavljanje nevarnosti.
SCENIHR has furthermore found a general lack of high-quality exposure data for both humans and the environment, concluding that the knowledge on the methodology for both exposure estimates and hazard identification needs to be further developed, validated and standardised.
Za boljšo oceno njihove varnosti bi moral Znanstveni odbor za varstvo potrošnikov (ZOVP) v sodelovanju s pristojnimi organi določiti smernice za preizkusne metode, ki bi upoštevale posebne značilnosti nanomaterialov.
In order to better assess their safety, the Scientific Committee for Consumer Safety (SCCS) should provide guidance in cooperation with relevant bodies on test methodologies which take into account the specific characteristics of nanomaterials.
Zaradi vpliva na okolje, ki lahko nastane zaradi sredstev proti obraščanju v vodi,bi si morala Komisija na mednarodni ravni prizadevati, da bi konvencijo AFS (Mednarodno konvencija o nadzoru škodljivih sistemov proti obraščanju na ladjah) ratificirali po vsem svetu in jo ustrezno prilagodili tej uredbi.
In view of the environmental impact that anti-fouling products can have in water, the Commission should take steps at international level to ensure that the AFS Convention (International Convention on the Control of Harmful Anti-Fouling Systems on Ships) is ratified worldwide and adapted to this Regulation.
V skladu s členom 291 Pogodbe o delovanju Evropske unije se pravila in splošna načela, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije, določijo vnaprej z uredbo, sprejeto po rednem zakonodajnem postopku.
According to Article 291 of the Treaty on the Functioning of the European Union, rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure.
Do sprejetja tiste nove uredbe in glede na nujnost čimprejšnjega sprejetja te uredbe se še naprej uporablja Sklep Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil
Pending the adoption of that new regulation, and given the necessity to adopt as soon as possible this Regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission
, z izjemo regulativnega postopka s pregledom, ki se ne uporablja.
continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable.
Ustrezno je, da se zagotovi čas za prilagoditev na uporabo te uredbe, da se omogoči gladek prehod na nov sistem, ki se uporabi za vključitev aktivnih snovi v Prilogo I in izdajo dovoljenj za biocidne pripravke.
It is appropriate to provide for a deferred application of this Regulation so as to facilitate the smooth transition to the new system applying to the inclusion of active substances in Annex I and authorisation of biocidal products.
Zaradi omejenega števila novih predloženih zahtevkov za vključitev aktivnih snovi v Prilogo I agencija prevzame naloge usklajevanja in lažjega sprejemanja novih zahtevkov od dneva začetka uporabe te uredbe.
Due to the limited number of new submissions of applications for inclusion of active substances in Annex I, the Agency should take over the co-ordination and facilitation tasks for new submissions as of the date of applicability of this Regulation.
Zaradi velikega obsega arhivske dokumentacije in da se agenciji omogoči čas, da se pripravi na novo vlogo, ta prevzame naloge v zvezi z dokumentacijo, predloženo na podlagi Direktive 98/8/ES, s 1. januarjem 2014.
However, in view of the high number of historical dossiers and in order to allow some time for the Agency to prepare for the new role, it should take over the tasks related to dossiers submitted under Directive 98/8/EC as of 1 January 2014.
Zaradi upoštevanja zakonitih pričakovanj podjetij v zvezi z dajanjem v promet in uporabo biocidnih pripravkov iz Direktive 98/8/ES je podjetjem treba omogočiti, da se takšni pripravki dajo v promet, če so v skladu s pravili o registraciji biocidnih pripravkov z nizkim tveganjem na podlagi navedene Direktive.
In order to respect the legitimate expectations of companies with respect to the placing on the market and use of low-risk biocidal products covered by Directive 98/8/EC, those companies should be allowed to place such products on the market if they comply with the rules on the registration of low-risk biocidal products under that Directive.
Vendar se po izteku prve registracije uporablja ta direktiva.
However, this Regulation should apply after the expiry of the first registration.
Da se zagotovi enaka obravnava oseb, ki dajejo v promet biocidne pripravke, ki vsebujejo eno ali več obstoječih aktivnih snovi, morajo imeti dokumentacijo ali izjavo o dostopu do takšne dokumentacije ali do vsakega dela te dokumentacije, za vsako od teh aktivnih snovi, ki so v pripravku.
In order to ensure an equal treatment of persons placing on the market biocidal products containing one or more existing active substances, they should be required to hold a dossier or have a letter of access to a dossier, or to each component of the dossier, for each of the active substances contained in the product.
Osebe, ki ne izpolnijo te obveznosti do 1. januarja 2014, ne smejo več dajati svojih pripravkov v promet.
Those persons who do not comply with this obligation by 1 January 2014 should no longer be allowed to place their products on the market.
V takšnih primerih se predvidijo ustrezna obdobja postopnega opuščanja za odlaganje, skladiščenje in uporabo obstoječih zalog biocidnih pripravkov.
Appropriate phase-out periods for disposal, storage and use of existing stocks of biocidal products should be laid down in such cases.
Ta uredba upošteva, kjer je primerno, druge delovne programe v zvezi s ponovnim pregledom ali dovoljenji za snovi in pripravke 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,
dajanje v promet in uporabo biocidnih pripravkov v državah članicah ali v Uniji;
the placing on the market and use of biocidal products within the Member States or the Union;
medsebojno priznavanje dovoljenj znotraj Unije;
the mutual recognition of authorisations within the Union;
izdelavo pozitivnega seznama aktivnih snovi, ki jih je mogoče uporabljati v biocidnih pripravkih, na ravni Unije.
the establishment at Union level of a list of active substances which may be used in biocidal products.
Določbe te uredbe temeljijo na načelu previdnosti, s katerimi naj bi zaščitili zdravje ljudi in živali ter okolje.
The provisions of this Regulation are underpinned by the precautionary principle, in order to ensure that active substances or products placed on the market do not have harmful effects on humans, non-target species and the environment.
Ta uredba se uporablja za biocidne pripravke, kot so opredeljeni v točki (a) člena 3(1).
This Regulation shall apply to biocidal products as defined in point (a) of Article 3(1).
Seznam vseh vrst biocidnih pripravkov, ki jih zajema ta uredba, njihovi opisi so v Prilogi V.
A list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V.
Ta uredba se ne uporablja za biocidne pripravke, ki spadajo v področje uporabe naslednjih instrumentov:
This Regulation shall not apply to biocidal products that are within the scope of the following instruments:
Direktive Sveta 76/768/EGS z dne 27. julija 1976 o približevanju zakonodaje držav članic v zvezi s kozmetičnimi izdelki UL L 262, 27.9.1976, str.
Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products OJ L 262, 27.9.1976, p.
Direktive Sveta 82/471/EGS z dne 30. junija 1982 o nekaterih proizvodih, ki se uporabljajo v prehrani živali UL L 213, 21.7.1982, str.
Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition OJ L 213, 21.7.1982, p.
Direktive Sveta 88/388/EGS z dne 22. junija 1988 o približevanju zakonodaje držav članic o aromah za uporabo v živilih in izhodnih surovinah za njihovo proizvodnjo UL L 184, 15.7.1988, str.
Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production OJ L 184, 15.7.1988, p.
Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o zdravilih sirotah UL L 354, 31.12.2008, str.
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.
Direktive Sveta 90/167/EGS z dne 26. marca 1990, ki predpisuje pogoje za pripravo, dajanje v promet 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;
Directive 90/385/EEC;
Direktive Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet UL L 230, 19.8.1991, str.
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market OJ L 230, 19.8.1991, p.
Direktive 93/42/EGS;
Directive 93/42/EEC;
Direktive Evropskega parlamenta in Sveta 95/2/ES z dne 20. februarja 1995 o aditivih za živila razen barvil in sladil UL L 61, 18.3.1995, str.
European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners OJ L 61, 18.3.1995, p.
Direktive Sveta 96/25/ES z dne 29. aprila 1996 o obtoku posamičnih krmil UL L 125, 23.5.1996, str.
Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials OJ L 125, 23.5.1996, p.
Direktive 98/79/ES;
Directive 98/79/EC;
Direktive Sveta 98/83/ES z dne 3. novembra 1998 o kakovosti vode, namenjene za prehrano ljudi
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption
Direktive 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini UL L 311, 28.11.2001, str.
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products OJ L 311, 28.11.2001, p.
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.
Uredbe (ES) št. 852/2004 Evropskega parlamenta in Sveta 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.
Uredbe (ES) št. 853/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 posebnih higienskih pravilih za živila živalskega izvora UL L 139, 30.4.2004, str.
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. 1935/2004 Evropskega parlamenta in Sveta z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food