natgillin/translations-raw huggingface dataset:
To poročilo lahko zajema vprašanja o usposabljanju, certificiranju in ponovnem certificiranju poklicnih uporabnikov, uvedbi informativnih točk za nepoklicne uporabnike, sprejetju nacionalnih načrtov za zmanjšanje tveganj pri uporabi biocidnih pripravkov, uporabi najboljših tehnologij, ki so na voljo, obveznosti obveščanja pristojnih organov o nesrečah, uporabi potrebne opreme in drugih ukrepih za zmanjšanje tveganja, razvoju kazalnikov tveganja za posamezno kategorijo pripravkov, ukrepih proti nezakonitim pripravkom, smernicah za shranjevanje, recikliranje in uničenje pripravkov, onesnaženju tal in zraka ter uporabi v gosto naseljenih območjih ali na območjih z visoko gostoto prehrambenih virov.
That report may cover issues concerning the training, certification and re-certification of professional users; the provision of dedicated information points for non-professional users; the adoption of national plans for reducing the risks associated with the use of biocidal products; the use of the best technologies available; the requirement to notify the competent authorities of incidents; the use of the requisite equipment and other risk-reduction measures; the development of risk indicators per product category; measures against illegal products; guidelines with regard to the storage; the recycling and disposal of products; soil and air contamination; and use in densely populated areas or in those with a high concentration of food resources.
Komisija na podlagi tega poročila po potrebi predstavi zakonodajne predloge.
On the basis of this report, the Commission should present, where appropriate, legislative proposals.
(20) Ker so pripravki, ki se uporabljajo za konzerviranje hrane ali krme z nadzorom škodljivih organizmov, predhodno zajeti v vrsto pripravka 20, zajeti v Direktivi Sveta 89/107/EGS in Uredbi (ES) št. 1831/2003 Evropskega parlamenta in Sveta, ni ustrezno, da se ta vrsta pripravka ohrani.
(20) As products used for the preservation of food or feedstocks by the control of harmful organisms, previously covered by product type 20, are covered by Council Directive 89/107/EEC and Regulation (EC) No 1831/2003 of the European Parliament and of the Council, it is not appropriate to maintain this product type.
Treba je ohraniti 20. vrsto biocidnih pripravkov iz predhodne direktive 98/80/ES („konzervansi za hrano ali krmo“), vendar je potrebna sprememba njene opredelitve, glede na to, da ti biocidni pripravki niso konzervansi, temveč dezinfekcijska sredstva (zato je stara opredelitev povzročala zmedo).
It is necessary to keep former Directive 98/80/EC’s biocidal product type 20 (‘Preservatives for food or feedstocks’), but its definition needs to be amended, given that these biocidal products are not preservatives but disinfectants (as a consequence, the older definition led to confusion).
Pripravki za razkuževanje krme, okužene s človeškimi patogeni, kakršna je salmonela, na primer ne izpolnjujejo zahtev iz predpisov o krmnih dodatkih.
For instance, products used to disinfect feed from human pathogens such as Salmonella do not meet the requirements of the feed additives regulations.
Seveda pripravki nimajo dobrega vpliva na krmo, niti ne izboljšajo njene učinkovitosti.
Indeed, the products do not ‘favourably affect the feed’ nor enhance its performance.
(45) 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.
(45) In view of the benefits for the internal market and for the consumer, it is desirable to establish harmonised rules for parallel trading of identical biocidal products which are authorised in different Member States.
Z omejevanjem dovoljenj za vzporedno trgovanje za enake proizvode, ki temeljijo na istem viru aktivnih snovi in sestavin, se doseže razumnejše ravnotežje med prosto trgovino dobrin in varnim tržnim okoljem.
By restricting parallel trade authorisation to identical products based on the same source of active substances and co-formulants, a more reasonable balance is achieved between free trade in goods and a safe market environment.
Enak pristop se je uporabil za dajanje v promet fitofarmacevtskih proizvodov.
The same approach was used for the placing of plant protection products on the market.
(48) 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 ali določbami Direktive 98/8/ES , mora 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.
(48) Applicants who 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 or those of Directive 98/8/EC should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such inclusions or authorisations is made for the benefit of subsequent applicants.
Za večjo jasnost, da ne bi izključili tistih, ki so opravili naložbe v okviru sedanjega regulativnega okvira, je koristno navesti Direktivo 98/8/ES.
In the interests of greater clarity it is worthwhile to insert a reference to Directive 98/8/EC, so as not to exclude those who have made investments under the existing regulatory framework.
(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.
Člen 1 – odstavek -1 (novo)
Article 1 – paragraph – 1 (new)
Ta uredba vzpostavlja okvir za prosti pretok biocidnih pripravkov na notranjem trgu, obenem pa zagotavlja visoko raven varovanja zdravja ljudi, živali in okolja.
This Regulation establishes a framework for achieving the free movement of biocides in the internal market, while ensuring a high level of protection of human and animal health and of the environment.
Člen 1 – odstavek 1 a (novo)
Article 1 – paragraph – 1 a (new)
Določbe te uredbe temeljijo na previdnostnem načelu, da bi zagotovili, da aktivne snovi ali pripravki, dani v promet, nimajo škodljivega vpliva na zdravje ljudi in živali ali na okolje.
The provisions of this Regulation are based on the precautionary principle in order to ensure that the active substances or products placed on the market do not adversely affect human or animal health or the environment.
Državam članicam zlasti ne onemogoča uporabe previdnostnega načela, kadar obstaja znanstvena negotovost glede tveganja za zdravje ljudi in živali ali za okolje, ki ga predstavljajo biocidni pripravki, ki naj bi bili odobreni na njihovem ozemlju.
In particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the biocidal products to be authorised in their territory.
Cilj te uredbe je visoka raven varovanja zdravja ljudi in okolja.
The aim of this Regulation shall be a high le vel of health and environmental protection.
(pa) Uredbe Evropskega parlamenta in Sveta (ES) št. 1935/2004 z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili, in o razveljavitvi direktiv 80/590/EGS in 89/109/EGS 1 ;
(p a) 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 and repealing Directives 80/590/EEC and 89/109/EEC 1 ;
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 učinka.
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.
Takšna snov bi bila, če ni drugih razlogov za njeno oporečnost, v skladu z Direktivo 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi 1 običajno opredeljena kot nevarna in bi bila v biocidnem pripravku prisotna v koncentraciji, zaradi katere bi pripravek veljal za nevarnega v skladu z določbami Direktive 1999/45/ES ali Uredbe (ES) št. 1272/2008;
Such a substance, unless there are other grounds for concern, should normally be a substance classified as dangerous within the meaning of Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 1 and be present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Directive 1999/45/EC or Regulation (EC) No 1272/2008;
Dodatek odraža že obstoječo opredelitev v Direktivi 98/8/ES in se dodaja, osvežen v skladu z novo zakonodajo, za večjo jasnost in doslednost.
The additional text reflects the definition already included in Directive 98/8/EC and has been inserted, updated in line with the existing legislation, to ensure greater clarity and consistency.
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, s ciljem , da ti pripravki opravljajo biocidno nalogo, za katero so namenjeni ;
any substance, mixture, material or article which was treated with or incorporates one or more biocidal products with the aim of performing the biocidal function for which it is intended ;
Ta predlog spremembe razširja obseg tretiranih izdelkov in materialov na izdelke, kot so premazi, ki so bili zaščiteni, ali izdelki z zunanjim učinkom, na primer komarniki, ki vsebujejo biocidni pripravek.
This amendment broadens the definition of treated articles and materials to include both articles such as paints and varnishes, which contain preserving agents, and articles with external effects, such as mosquito nets, which contain a biocidal product.
Ocena se torej izvede na kemijski ravni.
The assessment is thus a chemical one.
Člen 3 – odstavek 1 – točka q
Article 3 – paragraph 1 – point q
(q) „izjava o dostopnosti podatkov“
(q) 'letter of access' means
originalni dokument, ki so ga podpisali lastnik ali lastniki informacij, v katerem je navedeno, da lahko pristojni organi, Evropska agencija za kemikalije ali Komisija uporabljajo informacije, in sicer za ocenjevanje aktivne snovi ali podelitev dovoljenja;
an original document, signed by the owner or owners of information, which states that the information may be used by the competent authorities, the European Chemicals Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation;
originalni dokument, ki so ga podpisali lastnik ali lastniki informacij ali njihov predstavnik , v katerem je navedeno, da lahko pristojni organi, Evropska agencija za kemikalije ali Komisija uporabljajo informacije, in sicer za ocenjevanje aktivne snovi ali podelitev dovoljenja v korist tretje strani ;
an original document, signed by the owner or owners of information or their representative , which states that the information may be used by the competent authorities, the European Chemicals Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation for the benefit of a third party ;
Dodane pojasnitve imajo za cilj boljšo opredelitev izjave o dostopnosti podatkov.
The clarifications inserted into the text of this point are intended to improve the definition of 'letter of access'.
Člen 3 – odstavek 1 – točka s
Article 3 – paragraph 1 – point s
s) „snovi, ki so v stiku z živili“
s) "food contact materials' means
vsaka snov ali predmet, ki je namenjen za stik z živili, iz Uredbe (ES) št. 1935/2004;
any material and article intended to come into contact with food which are covered by Regulation (EC) No 1935/2004;
Člen 3 – odstavek 1 – točka u a (novo)
Article 3 – paragraph 1 – point u a (new)
(ua) „upravna sprememba“
(ua) 'administrative change' means
sprememba obstoječega dovoljenja, ki je povsem upravne narave in ne zajema ponovne ocene tveganja za javno zdravje ali okolje in učinkovitosti biocidnega pripravka;
a variation to an existing authorisation of a purely administrative nature, which does not involve a reassessment of the risk for public health or the environment or the efficacy of the product;
Treba je opredeliti tipe sprememb, ki se lahko izvedejo na obstoječem dovoljenem biocidnem pripravku (sprememba naslova, imena podjetja itd.).
The kinds of variation which may be made to an existing authorised biocidal product (change of address, changes to the name of the producer, etc.) should be defined.
Člen 3 – odstavek 1 – točka u b (novo)
Article 3 – paragraph 1 – point u b (new)
(ub) „manjša sprememba“
(ub) 'minor change' means
sprememba obstoječega dovoljenja, ki je ne moremo šteti kot upravno spremembo, saj zahteva manjšo ponovno oceno tveganja za javno zdravje ali okolje ali učinkovitosti proizvoda ter ne vpliva negativno na stopnjo tveganja javnega zdravja ali okolja ali na učinkovitost pripravka;
a variation to an existing authorisation which cannot be deemed to be an administrative variation as it requires a limited reassessment of the risk for public health or the environment or of the efficacy of the product, and does not adversely affect the level of risk for public health or the environment or the efficacy of the product;
Treba je opredeliti tipe sprememb, ki se lahko izvedejo na obstoječem dovoljenem biocidnem pripravku.
The kinds of variation which may be made to an existing authorised biocidal product should be defined.
Člen 3 – odstavek 1 – točka u c (novo)
Article 3 – paragraph 1 – point u c (new)
(uc) „večja sprememba“
(uc) 'major change' means
sprememba obstoječega dovoljenja, ki je ne moremo šteti kot upravno ali manjšo spremembo.
a variation to an existing authorisation which cannot be deemed to be an administrative change or a minor change.
Bodoči zahtevki za vključitev
Prospective applications for inclusion
Bodoči predlagatelj za vključitev aktivne snovi iz Priloge I se pri agenciji pozanima, ali:
A prospective applicant seeking the inclusion of an active substance in Annex I shall inquire of the Agency whether:
(a) je aktivna snov navedena v Prilogi I,
(a) the active substance is included in Annex I;
(b) je že bila vložena zahteva za vključitev iste aktivne snovi v Prilogo I,
(b) an application has already been made to have the same active substance included in Annex I;
(c) je enaka snov registrirana v skladu z Uredbo (ES) št. 1907/2006.
(c) the same substance is registered pursuant to Regulation (EC) No 1907/2006.
Bodoči predlagatelj hkrati s zahtevkom agenciji pošlje:
The prospective applicant shall forward the following information to the Agency with the application:
(a) svoje splošne osebne podatke, kot je določeno v oddelku 1 Priloge VI Uredbe (ES) št. 1907/2006, razen oddelkov 1.2 in 1.3,
(a) the general information on the applicant’s identity as laid down in section 1 of Annex VI to Regulation (EC) No 1907/2006, with the exception of sections 1.2 and 1.3;
(b) podatke o identiteti aktivne snovi, kot je določeno v oddelku 2 Priloge VI Uredbe (ES) št. 1907/2006,
(b) the identity of the active substance as laid down in section 2 of Annex VI to Regulation (EC) No 1907/2006;
(c) zahteve za informacije, za katere so potrebne nove študije, v katerih bi bili udeleženi vretenčarji,
(c) which requests for information will require new vertebrate animal studies;
(d) zahteve za informacije, za katere so potrebne nove študije.
(d) which requests for information will require other new studies.
Če ista aktivna snov ni vključena v Prilogo I ali ni registrirana v skladu z Uredbo (ES) št. 1907/2006, agencija ustrezno obvesti bodočega predlagatelja, drugače pa mu nemudoma posreduje imena in naslove prejšnjih predlagateljev in registracijskih zavezancev ter povzetke študij, ki so že bili posredovani.
If the same active substance is not included in Annex I or is not registered pursuant to Regulation (EC) No 1907/2006 the Agency shall inform the prospective applicant accordingly, otherwise the Agency shall supply the prospective applicant, without delay, with the names and addresses of previous applicants and registrants and with the summaries of the studies already supplied.
Namen opisanih postopkov je preprečiti podvajanje testov na vretenčarjih in izpolniti zahteve po podatkih iz Priloge II.
The procedures described are necessary in order to avoid duplicating tests on vertebrate animals and to comply with requests for Annex II information.
Obveza informirati je vzajemna po uredbi REACH, ker bo Agencija imela potrebno infrastrukturo in izkušnje za izvajanje tega postopka.
The 'obligation to provide information' under the REACH Regulation is made mutual, as the Agency will have the requisite infrastructure and experience to apply this procedure.
Predlagana dopolnitev jasneje odraža koncept vključitve v Prilogo I.
The proposed addition reflects the concept of inclusion in Annex I more clearly.
Ob vključitvi je treba predložiti dokumentacijo o najmanj enem reprezentativnem biocidnem pripravku, katerega aktivna snov izpolnjuje predpisane pogoje.
At the time of inclusion the dossier must be submitted for at least one representative biocidal product the active substance of which meets the conditions laid down.
Aktivna snov se, kjer je to primerno, vključi v Prilogo I skupaj z navedbo katerega koli izmed naslednjih pogojev:
An active substance shall, where appropriate, be included in Annex I together with any of the following conditions:
Aktivna snov in opredelitev referenčnega vira aktivne snovi za določitev tehnične enakovrednosti, kot je opredeljena v členu 3(1)(u) , se, kjer je to primerno, vključita v Prilogo I skupaj z navedbo katerega koli izmed naslednjih pogojev:
An active substance and a statement of the reference source of the active substance, for determining technical equivalence referred to in Article 3(1)(u), shall, where appropriate, be included in Annex I together with any of the following conditions:
V skladu z informacijami iz podatkov, predloženih skupaj s prošnjo za vključitev, je zaradi tehnične enakosti treba obrazložiti, iz katerega vira prihaja aktivna snov za vpis.
To ensure consistency with the information included in the dossier submitted with the application for inclusion, for the purpose of determining technical equivalence it is necessary to specify the source of the active substance to be included.
Zaradi večje doslednosti je pomembno kemikalijo, opisano v Prilogi I, povezati s podatki, ki so bili predloženi ob njenem vpisu.
In the interests of greater consistency it is important to link the chemical substance described in Annex I to the data which have supported its inclusion in the annex.
(a) v običajnih pogojih uporabe je izpostavljenost ljudi aktivni snovi v biocidnem pripravku zanemarljiva, zlasti če se pripravek uporablja v zaprtih sistemih ali pod strogo nadzorovanimi pogoji ;
(a) the exposure of humans to that active substance in a biocidal product, under normal conditions of use, is negligible, in particular where the product is used in closed systems or strictly controlled conditions;
(a) v predpisanih pogojih uporabe je izpostavljenost ljudi aktivni snovi v biocidnem pripravku zanemarljiva ali ustrezno nadzorovana ob upoštevanju nevarnosti snovi , zlasti če se pripravek uporablja v zaprtih sistemih ali v strogo nadzorovanih pogojih ;
(a) the exposure of humans to that active substance in a biocidal product, under prescribed conditions of use, is negligible or adequately controlled, taking account of the intrinsic hazards presented by the substance , in particular where the product is used in closed systems or strictly controlled conditions;
O izključitvi je treba odločiti na temelju analize tveganja (kombinacija nevarnosti in izpostavljenosti).
Exclusion should be decided on the basis of a risk analysis (a combination of hazardousness and exposure).
Če se znanstveno dokaže, da so vsa tveganja v zvezi s tem proizvodom pod nadzorom, je treba aktivne snovi dovoliti.
If it is scientifically proven that all the risks associated with the use of these products are properly controlled, the active substances should be authorised.
Pomembno je črtati določbo, ki brez znanstvene podlage diskriminira nekatere vrste proizvodov.
The deletion of the provision which discriminates against certain types of product, when there are no scientific grounds for doing so, is a matter of importance.
Preventivna izključitev ni učinkovita za trgovanje, predvsem pa ni ustrezna za inovacije, saj krči paleto snovi, ki bi se v prihodnosti lahko uporabljale kot biocidni pripravki.
Preventive exclusion is counter-productive for trade, and above all for innovation, since it curtails the range of substances which could potentially be used as biocides in future.
Ti pripravki, od rodenticidov in razkuževalnih sredstev do insekticidov, so izredno koristni v nekaterih delih Evrope, kjer so ukrepi za odpravo podgan ali mrčesa bistveni za higieno in okolje.
Such products, ranging from rodenticides to disinfectants and insecticides, are hugely beneficial, in particular in some regions of Europe, where it is vital to combat rat or insect infestations for hygiene and environmental reasons.
Člen 5 – odstavek 2 – točka d
Article 5 – paragraph 2 – point d
Za določanje povzročiteljev endokrinih motenj se uporabljajo posebna merila v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS 1 .
The scientific criteria for determining endocrine disrupting properties pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC 1 shall apply.