natgillin/translations-raw huggingface dataset:
(61) Zlasti mora Komisija imeti pooblastilo za sprejetje ukrepov o odločanju o vlogah za vključitev aktivne snovi v Prilogo I ali za obnovitev ali ponovni pregled vključitve, za natančno določitev postopkov, povezanih s ponovnim pregledom ali obnovitvijo vključitve aktivne snovi v Prilogo I, za razširitev veljavnosti določb o izdaji dovoljenj Skupnosti na druge vrste biocidnih pripravkov, za natančno določitev meril in postopkov, povezanih s preklicem dovoljenja ali spremembi pogojev za dovoljenje, vključno z mehanizmom za reševanjem sporov, za natančno določitev splošno veljavnih največjih količin aktivnih snovi ali biocidnih pripravkov, ki se jih sme sprostiti med preskusi, ter najnujnejših podatkov, ki jih je treba predložiti, za oblikovanje usklajene strukture pristojbin in drugih pravil v zvezi s plačili pristojbin in stroškov pristojnim organom in agenciji, za prilagajanje prilog znanstvenemu in tehničnemu napredku, za izvajanje delovnega programa in natančno določitev povezanih pravic in dolžnosti pristojnih organov in udeležencev v programu ter za podaljšanje delovnega programa za določeno obdobje.
(61) In particular, the Commission should be empowered to adopt measures to decide on the application to include the active substance in Annex I or to renew or review the inclusion, to specify the procedures related to the renewal and review of an inclusion of an active substance in Annex I, to extend the provisions on Community authorisations to other categories of biocidal products, to specify the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation, including a dispute settlement mechanism, to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted, to establish a harmonised structure of fees and other rules concerning the payment of fees and charges to the competent authorities and the Agency, to adapt the Annexes to scientific and technical progress, to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme and to extend the duration of the work programme for a determined period.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te uredbe, med drugim z dodajanjem novih nebistvenih določb, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing this Regulation with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Uvodna izjava 61 a (novo)
Recital 61 a (new)
(61a) Obstaja znanstvena negotovost glede varnosti nanomaterialov za zdravje ljudi in okolja, znanstveni odbor EU 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.
(61a) 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 standardi s ed.
Vedno več biocidnih pripravkov vsebuje nanosrebro.
More and more biocidal products contain nanosilver.
Z nadaljnjim razvojem tehnologije lahko pride do povečanja uporabe nanomaterialov v biocidnih pripravkih.
The use of nanomaterials in biocidal products may increase with the further development of technology.
Za visoko raven varstva potrošnikov, prost pretok blaga in pravno varnost proizvajalcev je treba oblikovati enotno opredelitev nanomaterialov na mednarodni ravni.
In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level.
Unija bi si morala za dosego sporazuma o opredelitvi prizadevati v ustreznih mednarodnih forumih.
The Union should endeavour to reach an agreement on a definition in appropriate international fora.
Če pride do takšnega sporazuma, bi bilo treba opredelitev nanomaterialov v tej uredbi ustrezno prilagoditi.
Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.
Zaenkrat ni dovolj podatkov o tveganjih, povezanih z uporabo nanomaterialov.
At present, there is inadequate information on the risks associated with nanomaterials.
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 specific characteristics of nanomaterials.
Komisija bi morala redno pregledovati določbe o nanomaterialih glede na znanstveni napredek.
The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.
Uvodna izjava 61 b (novo)
Recital 61 b (new)
(61b) Zaradi vpliva na okolje, ki lahko nastane zaradi sredstev proti obraščanju v vodi, si mora 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.
(61b) In view of the environmental impact that anti-fouling products can have in the water, the Commission must 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.
Uvodna izjava 62
Recital 62
(62) Kadar v nujnih primerih ni mogoče upoštevati običajnih rokov za regulativni postopek s pregledom, je treba Komisiji na podlagi člena 13 omogočiti uporabo nujnega postopka iz člena 5a(6) Sklepa 1999/468/ES za sprejetje odločitev za spremembo vključitve aktivne snovi v Prilogo I ali njeno odstranitev iz navedene priloge.
(62) When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of decisions to amend the inclusion of an active substance in Annex I or to remove it from that Annex on basis of Article 13.
Uvodna izjava 62 a (novo)
Recital 62 a (new)
(62a) 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.
( 62a ) According to Article 291 TFEU, 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 1 , z izjemo regulativnega postopka s pregledom, ki se ne uporablja.
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 1 continues to apply , with the exception of the regulatory procedure with scrutiny, which is not applicable .
Vendar je treba sklicevanja na določbe tega sklepa nadomestiti s sklicevanji na pravila in načela v novi uredbi, kakor hitro bo ta uredba začela veljati.
References to provisions of that Decision should nevertheless be replaced with references to the rules and principles set out in the new regulation as soon as that regulation enters into force.
Predlog spremembe zagotavlja prehodne ukrepe, dokler ne bodo sprejeta nova pravila o izvedbenih aktih.
To provide for transitional measures until the new rules on implementing acts are adopted.
(66) Ob upoštevanju, da nekateri pripravki niso bili predhodno zajeti v zakonodajo Skupnosti na področju biocidnih pripravkov, je primerno, da se omogoči prehodno obdobje, da se podjetja pripravijo na uporabo pravil v zvezi z aktivnimi snovmi, pridobljenimi na kraju samem, tretiranimi izdelki in snovmi ter snovmi, ki so v stiku s živili.
(66) Taking into consideration that some products were not previously covered by the Community legislation in the field of biocidal products, it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances , treated articles and materials and food contact materials .
(66) Ob upoštevanju, da nekateri pripravki niso bili predhodno zajeti v zakonodajo Skupnosti na področju biocidnih pripravkov, je primerno, da se omogoči prehodno obdobje, da se podjetja pripravijo na uporabo pravil v zvezi z aktivnimi snovmi, pridobljenimi na kraju samem, ter tretiranimi izdelki in snovmi.
(66) Taking into consideration that some products were not previously covered by the Community legislation in the field of biocidal products, it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances and treated articles and materials.
Snovi, ki so v stiku z živili, ne bi smele biti vključene v področje uporabe tega predloga, saj bi to vodilo do dvojnega urejanja in ocenjevanja.
Food contact materials should not be within the scope of the Proposal as this would lead to double regulation and assessment.
Snovi, ki so v stiku z živili, že ureja okvirna uredba (ES) št. 1935/2004 o snoveh, ki so v stiku z živili.
Food contact materials are already regulated by the Food Contact Materials Framework Regulation (EC) No 1935/2004.
Če bodo kakršne koli spremembe v zvezi s pravili, ki urejajo snovi, ki so v stiku z živili, bi jih bilo treba obravnavati z revizijo zakonodaje o snoveh, ki so v stiku z živili, ne z razširitvijo področja uporabe uredbe o biocidnih pripravkih.
Should any changes be made to the rules governing food contact materials, they should be addressed through a revision of the food contact legislation, not by extending the scope of the BPR.
Namen te uredbe je zagotoviti visoko raven varstva zdravja ljudi in živali ter okolja ter izboljšati delovanje notranjega trga z uskladitvijo predpisov o dajanju biocidnih pripravkov na trg in o njihovi uporabi.
The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market and use of 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, the aim of which is to safeguard the health of humans, animals and the environment.
Posebej je treba paziti na varstvo otrok, nosečnic in bolnikov.
Special attention shall be paid to protecting children, pregnant women and the sick.
Zagotoviti je treba, da se pri izdaji dovoljenja, dajanju v promet in uporabi biocidov uveljavi previdnostno načelo, ki zagotavlja visoko raven varstva zdravja ljudi in živali, kot tudi stvarstva.
The authorisation, marketing and use of biocidal products should be governed by the precautionary principle in order to ensure a high level of protection for human and animal health and to preserve living things.
Člen 2 – odstavek 2 – točka p a (novo)
Article 2 – paragraph 2 – point p a (new)
(pa) Uredbe (ES) št. 1935/2004 Evropskega parlamenta in Sveta z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili 1 ;
( pa ) 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 1 ;
Snovi, ki so v stiku z živili, že ureja Uredba (ES) št. 1935/2004.
Food contact materials are already governed by Regulation (EC) No 1935/2004.
Ta uredba morda ne zajema vseh vidikov ocene snovi in njihove uporabe.
This Regulation may not cover all aspects of assessment of materials and their use.
Treba je uvesti nove omejitve z revizijo zakonodaje, ki velja za snovi, ki so v stiku z živili, in v uredbi o biocidnih pripravkih, da bi preprečili podvajanje predpisov in ocen.
However, new restrictions should be introduced through a review of the legislation specific to food contact materials and in the Biocidal Products Regulation in order to avoid duplication of rules and assessments.
Člen 2 – odstavek 2 – točka p b (novo)
Article 2 – paragraph 2 – point p b (new)
(pb) Direktive Sveta 98/83/ES z dne 3. novembra 1998 o kakovosti vode, namenjene za prehrano ljudi 1 ;
( p b) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption 1 ;
Člen 2 – odstavek 3 – točka k a (novo)
Article 2 - paragraph 3 - point k a (new)
(ka) Direktive 2000/60/ES Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o določitvi okvira za ukrepe Skupnosti za doseganje trajnostne rabe pesticidov 1 .
(ka) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy 1 .
Člen 3 - odstavek 1 - točka a
Article 3 - paragraph 1 - point a
(a) „biocidni pripravki“
(a) 'biocidal product' means
aktivne snovi ali zmesi, ki vsebujejo eno ali več aktivnih snovi, pripravljene v obliki, v kakršni se dobavljajo uporabniku, in predvideni , da se z njimi uničuje, odvrača, naredi neškodljivo, prepreči delovanje, ali kako drugače vpliva na škodljivi organizem na kemičen ali biološki način.
active substances or mixtures containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.
aktivne snovi ali zmesi, ki vsebujejo eno ali več aktivnih snovi, pripravljene v obliki, v kakršni se dobavljajo uporabniku, in predvidene predvsem za to , da se z njimi uničuje, odvrača, naredi neškodljivo, prepreči delovanje, ali kako drugače vpliva na škodljivi organizem na kemičen ali biološki način.
active substances or mixtures containing one or more active substances, put up in the form in which they are supplied to the user, primarily intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.
vse snovi, zmesi in pripomočki, ki se dajo v promet z namenom pridobivanja aktivnih snovi, se prav tako štejejo za biocidne pripravke;
All substances, mixtures and devices placed on the market with the intention to generate active substances shall also be considered biocidal products;
Za pojasnitev, da so tudi tretirane snovi in izdelki z zunanjim biocidnim delovanjem (npr. tretirane mreže proti komarjem) biocidni pripravki in da jih je kot take treba dovoliti.
Clarification that treated materials and articles with an external biocidal effect (e.g. treated mosquito nets) are biocidal products and must be authorised as such.
Člen 3 – odstavek 1 – točka f
Article 3 - paragraph 1 - point f
(f) „pogojno nevarna snov“
(f) 'substance of concern' means
vsaka snov, razen aktivne snovi, ki ima neželene učinke na ljudi, živali ali okolje in jo vsebuje biocidni pripravek ali nastaja v njem v taki koncentraciji, da lahko povzroča nevarnost takšnega vpliva;
any substance, other than the active substance, which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect;
vsaka snov, razen aktivne snovi, ki ima takojšnje ali poznejše neželene učinke na ljudi, zlasti otroke, živali ali okolje in jo vsebuje biocidni pripravek ali nastaja v njem v taki koncentraciji, da lahko povzroča nevarnost takšnega vpliva .
any substance, other than the active substance, which has an inherent capacity to cause an adverse effect , immediately or in the more distant future , on humans, especially children, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect .
Če ni drugih razlogov za zaskrbljenost, bi bila takšna snov običajno razvrščena kot nevarna v skladu z Direktivo 67/548/EGS in bi bila v biocidnem pripravku prisotna v koncentraciji, zaradi katere bi ta pripravek veljal za nevarnega v skladu z Direktivo 1999/45/ES ali Uredbo (ES) št. 1272/2008 ;
Such a substance, unless there are other grounds for concern, would normally be a substance classified as dangerous according to Directive 67/548/EEC and present in the biocidal product at a concentration leading to the product being regarded as dangerous within the meaning of Directive 1999/45/EC or Regulation (EC) No 1272/2008 ;
Ta opredelitev je navedena že v Direktivi 98/8/ES in je tu dodana zaradi pojasnitve.
This definition is already contained in Directive 98/8/EC and is inserted again for the sake of clarification.
Člen 3 – odstavek 1 – točka g
Article 3 – paragraph 1 – point g
(g) „škodljiv organizem“
(g) 'harmful organism' means
organizmi, vključno s povzročitelji bolezni, katerih prisotnost je nezaželena, ali ki imajo škodljiv učinek na človeka ali njegove dejavnosti, ali na proizvode, ki jih uporablja ali proizvaja, ali na živali ali okolje.
organisms, including pathogenic agents, which have an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, or on animals or the environment;
organizmi, vključno s povzročitelji bolezni, katerih prisotnost je nezaželena, ali ki imajo takojšen ali kasnejši škodljiv učinek na človeka , zlasti na otroke , ali njegove dejavnosti, ali na proizvode, ki jih uporablja ali proizvaja, ali na živali ali okolje.
organisms, including pathogenic agents, which have an unwanted presence or a detrimental effect , immediately or in the more distant future , on humans, especially children, human activities or the products they use or produce, or on animals or the environment;
Koristna pojasnitev, ki poudari manjšo tolerančno stopnjo otrok za škodljive proizvode v primerjavi z odraslimi, na katerih po predlogu uredbe slonijo merila tolerančne stopnje škodljivosti.
It would seem appropriate to highlight the fact that children are more vulnerable to harmful products than adults, on whom the proposal for a regulation is basing tolerance criteria.
Otroci se pogosto, ne da bi to vedeli, znajdejo na krajih, ki so škropljeni z biocidi in pesticidi in se na njih takoj ali na dolgi rok pokažejo posledice, ki jih je mogoče neposredno ali posredno pripisati škodljivim snovem.
Children often find themselves in places which have been sprayed with biocidal products and pesticides, and show reactions - immediately or in the longer term - which are directly or indirectly attributable to the harmful substances.
Člen 3 – odstavek 1 – točka h
Article 3 – paragraph 1 – point h
snovi, ki so prisotne v ali na rastlinah ali proizvodih rastlinskega izvora, užitnih živalskih proizvodih ali drugod v okolju in ki so posledica uporabe biocidnega pripravka, vključno z njegovimi metaboliti in proizvodi, ki so posledica njihovega razgrajevanja ali reakcije;
substances present in or on plants or products of plant origin, edible animal products, drinking water or elsewhere in the environment and resulting from the use of a biocidal product, including their metabolites, breakdown or reaction products;
snovi, ki so prisotne v ali na rastlinah ali proizvodih rastlinskega izvora, užitnih živalskih proizvodih, vodnih virih , pitni vodi ali drugod v okolju in ki so posledica uporabe biocidnega pripravka, vključno z njegovimi metaboliti in proizvodi, ki so posledica njihovega razgrajevanja ali reakcije;
substances present in or on plants or products of plant origin, edible animal products, water resources , drinking water or elsewhere in the environment and resulting from the use of a biocidal product, including their metabolites, breakdown or reaction products;
Člen 3 – odstavek 1 – točka (i)
Article 3 – paragraph 1 – point i
(i) „dajanje v promet“
(i) 'placing on the market' means
prva dobava izdelka za distribucijo ali uporabo na trgu Skupnosti v okviru gospodarske dejavnosti, proti plačilu ali ne;
the first supply of a biocidal product for distribution or for use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;
dobava izdelka tretji osebi ali dajanje tega izdelka na razpolago tretjim osebam proti plačilu ali ne.
the supply of a biocidal product to third parties , whether in return for payment or free of charge, or the making available of a biocidal product to third parties .
Uvoz šteje za dajanje v promet.
Importation shall be deemed to be placing on the market.
Za dobavo tretji osebi ne gre, kadar proizvajalec v okviru gospodarske dejavnosti posamezno proizvede in nato vgradi tretirane snovi ali izdelke .
No supply to third parties is involved when in the course of a commercial activity treated materials or products are individually manufactured and then incorporated by the manufacturer .
Za dajanje v promet ne šteje samo prva, ampak vsaka dobava, podobno kot v drugih predpisih o kemikalijah (glej REACH).
Not just the 'first supply', but 'any supply' should be deemed to be placing on the market, as in other chemicals legislation (see REACH).
Izjeme so dopustne samo, kadar na primer obrtnik dobi naročilo za barvanje fasade s snovjo, ki vsebuje odobreni biocidni pripravek.
Derogations should only be admitted when, for example, a craftsman is commissioned by a client to paint a façade with a substance that contains an authorised biocidal product.
Pojasnitev je nujno potrebna.
This clarification is necessary.
Člen 3 – odstavek 1 – točka (k)
Article 3 - paragraph 1 - point k
(k) „tretirana snov ali izdelek“
(k) 'treated material or article' means
vsaka snov, mešanica, material ali izdelek, ki je bil tretiran z biocidnimi pripravki ali jih vsebuje , z namenom, da se snov, mešanica, material ali izdelek zaščiti pred kvarjenjem, ki ga povzročajo škodljivi organizmi;
any substance, mixture, material or article which was treated with or incorporates one or more biocidal products with the intention to protect the substance, mixture, material or article from deterioration caused by harmful organisms ;
vsaka snov, mešanica, material ali izdelek, ki je bil tretiran z biocidnimi pripravki ali jih vsebuje;
any substance, mixture, material or article which was treated with or incorporates one or more biocidal products;
V nemški različici beseda „izdelek“ ni bila ustrezno izbrana, kar pa ne zadeva slovenske različice.
The German translation of the English word 'article' is brought into line with Article 3(3) of the Reach Regulation No 1907/2006.