natgillin/translations-raw huggingface dataset:
For all biocidal products based on preparations containing micro-organisms that are subject to application, all available relevant knowledge and information in literature should be provided.
Za vse biocidne pripravke na podlagi pripravkov iz mikroorganizmov, za katere se vloži zahtevek, je treba predložiti vsa razpoložljiva ustrezna dognanja in informacije iz literature.
The information related to the identification and characterisation of all components in a biocidal product is particularly important and must be entered in sections I to IV and provides the basis for an assessment of possible impacts on human health and the environment.
Informacije glede odkrivanja in opredelitve vseh sestavin v biocidnem pripravku so posebej pomembne in jih je treba vnesti v oddelke I do IV, saj opredeljujejo osnovo za oceno možnih vplivov na zdravje ljudi in učinkov na okolje.
Where, information is not necessary owing to the nature of the biocidal product Article 8(5) shall apply.
Če podatki zaradi narave biocidnega pripravka niso potrebni, se uporablja člen 8(5).
Information may be derived from existing data where a justification acceptable to the competent authority is provided.
Podatke je mogoče pridobiti iz obstoječih podatkov, če se pristojnemu organu predloži ustrezno utemeljitev.
In particular, the provisions of Directive 67/548/EEC and Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [1] shall be used wherever possible to minimise animal testing.
Zlasti je treba, če je mogoče, uporabiti določbe Direktive 67/548/EGS in Direktive 1999/45/ES Evropskega parlamenta in Sveta z dne 31. maja 1999 o približevanju zakonov in drugih predpisov držav članic v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov [1], da bi kar najbolj zmanjšali preskuse na živalih.
Where testing is done, a detailed description (specification) of the material used and its impurities, according to the provisions of Section II, must be provided.
Pri izvajanju preskusov je treba podrobno opisati (specifikacija) uporabljeno snov in njene nečistote v skladu z določbami točke oddelka II.
Where necessary, data as established in Annexes IIB, IIIB shall be required for all the toxicologically/eco-toxicologically relevant chemical components of the biocidal product, in particular if the components are substances of concern as defined in Article 2(1)(e).
Če je potrebno, se za vse toksikološko/ekotoksikološko pomembne kemične sestavine biocidnega pripravka, zlasti če so sestavine pogojno nevarne snovi, kakor je opredeljeno v členu 2(1)(e), zahtevajo podatki, določeni v prilogah IIB in IIIB.
In cases where a new preparation is to be dealt with, extrapolation from Annex IVA, could be acceptable, provided that all the possible effects of the components, especially on pathogenicity and infectiveness, are evaluated.
Pri obravnavanju novega pripravka je lahko sprejemljiva ekstrapolacija iz Priloge IVA, če se ocenijo vsi možni vplivi sestavin, zlasti na patogenost in kužnost.
I. Identity of the biocidal product
I. Opis biocidnega pripravka
Physical, chemical and technical properties of the biocidal product
Fizikalne, kemijske in tehnične lastnosti biocidnega pripravka
Data on application
Podatki o uporabi
Further information on the biocidal product
Dodatne informacije o biocidnem pripravku
V. Analytical methods
V. Analizne metode
Efficacy data
Podatki o učinkovitosti
Effects on human health
Vplivi na zdravje ljudi
Classification, packaging and labelling of the biocidal product
Razvrščanje, pakiranje in označevanje biocidnega pripravka
Summary and evaluation of sections I to XI including conclusions of the risk assessment and recommendations
Povzetek in ocena oddelkov I do XI, vključno z zaključki ocene tveganja in priporočili
I. IDENTITY OF THE BIOCIDAL PRODUCTS
I. OPIS BIOCIDNEGA PRIPRAVKA
Manufacturer of the biocidal product and the micro-organism(s)
Proizvajalec biocidnega pripravka in mikroorganizma(-ov)
Trade name or proposed trade name, and manufacturer's development code number of the biocidal product
Blagovna znamka ali predlagana blagovna znamka in proizvajalčeva razvojna šifra biocidnega pripravka
Detailed quantitative and qualitative information on the composition of the biocidal product
Podrobne količinske in kakovostne informacije v zvezi s sestavo biocidnega pripravka
Physical state and nature of the biocidal product
Fizikalno stanje in narava biocidnega pripravka
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
FIZIKALNE, KEMIJSKE IN TEHNIČNE LASTNOSTI BIOCIDNEGA PRIPRAVKA
Appearance (colour and odour)
Videz (barva in vonj)
Storage stability and shelf-life
Obstojnost pri shranjevanju in rok uporabe
Effects of light, temperature and humidity on technical characteristics of the biocidal product
Vplivi svetlobe, temperature in vlage na tehnične lastnosti biocidnega pripravka
Other factors affecting stability
Drugi dejavniki, ki vplivajo na stabilnost
Explosivity and oxidising properties
Eksplozivne in oksidacijske lastnosti
Flash point and other indications of flammability or spontaneous ignition
Plamenišče in drugi znaki vnetljivosti ali samovžiga
Acidity, alkalinity and pH value
Kislost, bazičnost in pH vrednost
Viscosity and surface tension
Viskoznost in površinska napetost
Technical characteristics of the biocidal product
Tehnične lastnosti biocidnega pripravka
Wettability
Močljivost
Persistent foaming
Penjenje
Suspensibility and suspension stability
Sposobnost tvorjenja suspenzije in obstojnost suspenzije
Dry sieve test and wet sieve test
Suha in mokra sejalna analiza
Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)
Razporeditev delcev po velikosti (prašiva in močljivi praški, zrnca), vsebnost prahu/drobnih delcev (zrnca), drobljivost in krušljivost (zrnca)
Emulsifiability, re-emulsifiability, emulsion stability
Sposobnost emulgiranja, ponovnega emulgiranja, obstojnost emulzije
Flowability, pourability (rinsability) and dustability
Sipkost, pretočnost (izpiranje) in prašljivost
Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered
Fizikalna, kemijska in biološka združljivost z drugimi pripravki, vključno z biocidnimi pripravki, s katerimi se pripravek uporablja po izdaji dovoljenja ali registracije
Physical compatibility
Fizikalna združljivost
Chemical compatibility
Kemijska združljivost
Biological compatibility
Biološka združljivost
Summary and evaluation of physical, chemical and technical properties of the biocidal product
Povzetek in ocena fizikalnih, kemijskih in tehničnih lastnosti biocidnega pripravka
DATA ON APPLICATION
PODATKI O UPORABI
Details of intended use
Podrobnosti o predvideni uporabi
Application rate
Pogostnost uporabe
Content of micro-organism in material used (e.g. in the application device or bait)
Vsebnost mikroorganizma v uporabljenem materialu (npr. napravi za uporabo ali vabi)
Method of application
Način uporabe
Number and timing of applications and duration of protection
Število in časovna razporeditev tretiranj in trajanje varstva
Necessary waiting periods or other precautions to avoid adverse effects to human and animal health and the environment
Potrebne čakalne dobe ali drugi varnostni ukrepi za preprečevanje negativnih vplivov za zdravje ljudi in živali ter okolje
Proposed instructions for use
Predlagana navodila za uporabo
Category of users
Kategorija uporabnikov
Information on the possible occurrence of the development of resistance
Podatki o možnem razvoju odpornosti
Effects on the materials or products treated with the biocidal product
Vplivi na materiale ali pripravke, tretirane z biocidnim pripravkom
FURTHER INFORMATION ON THE BIOCIDAL PRODUCT
NADALJNJE INFORMACIJE O BIOCIDNEM PRIPRAVKU
Packaging and compatibility of the biocidal product with proposed packaging materials
Embalaža in skladnost biocidnega pripravka s predlaganimi materiali za pakiranje
Procedures for cleaning application equipment
Postopki za čiščenje opreme za nanašanje
Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment
Delovna karenca, potrebne karence ali drugi varnostni ukrepi za zaščito ljudi, živine in okolja
Recommended methods and precautions concerning: handling, storage, transport or fire
Priporočene metode in varnostni ukrepi za: rokovanje, skladiščenje, prevoz ali požar
Measures in the case of an accident
Ukrepi v primeru nesreče
Procedures for destruction or decontamination of the biocidal product and its packaging
Postopki za uničenje ali dekontaminacijo biocidnega pripravka in njegove embalaže
Controlled incineration
Nadzorovani sežig
Monitoring plan to be used for the active micro-organism and other micro-organism(s) contained in the biocidal product including handling, storage, transport and use
Načrt spremljanja, ki se uporabi za aktivne mikroorganizme in druge mikroorganizme, ki jih vsebuje biocidni proizvod, vključno s shranjevanjem, rokovanjem, prevozom in uporabo
V. ANALYTICAL METHODS
V. ANALIZNI POSTOPKI
Methods for the analysis of the biocidal product
Postopki za analizo biocidnega pripravka
Methods to determine and quantify residues
Postopki za določanje in količinsko vrednotenje ostankov
EFFICACY DATA
PODATKI O UČINKOVITOSTI
EFFECTS ON HUMAN HEALTH
VPLIVI NA ZDRAVJE LJUDI
Basic acute toxicity studies
Osnovne raziskave akutne toksičnosti
Acute oral toxicity
Akutna oralna toksičnost
Acute inhalation toxicity
Akutna toksičnost pri vdihavanju
Acute percutaneous toxicity
Akutna perkutana toksičnost
Additional acute toxicity studies
Dodatne raziskave akutne toksičnosti
Skin irritation
Draženje kože
Eye irritation
Draženje oči
Skin sensitisation
Občutljivost kože
Data on exposure
Podatki o izpostavljenosti
Available toxicological data relating to non-active substances
Razpoložljivi toksikološki podatki o neaktivnih snoveh
Supplementary studies for combinations of biocidal products
Dopolnilne raziskave za kombinacije biocidnih pripravkov
Summary and evaluation of effects on human health
Povzetek in ocena vplivov na zdravje ljudi
Additional studies on additional species or higher tier studies such as studies on selected non-target organisms
Dodatne raziskave o dodatnih vrstah ali raziskave višje stopnje, kot so raziskave o izbranih neciljnih organizmih.
CLASSIFICATION, PACKAGING AND LABELLING OF THE BIOCIDAL PRODUCT
RAZVRŠČANJE, PAKIRANJE IN OZNAČEVANJE BIOCIDNEGA PRIPRAVKA
As established in Article 20, proposals including justification for the classification and labelling of the biocidal product in accordance with the provisions set in Directive 67/548/EEC and Directive 1999/45/EC must be submitted.
Kot je določeno v členu 20, je treba predložiti predloge, vključno z obrazložitvijo razvrščanja in označevanja biocidnega pripravka, v skladu z določbami iz Direktive 67/548/EGS in Direktive 1999/45/ES.
The classification comprises of the description of the category/categories of danger and qualifying risk phrases for all dangerous properties.
Razvrščanje obsega opis kategorije/kategorij nevarnosti in omejitvene opozorilne stavke za vse nevarne lastnosti.
On the basis of the classification, a proposal for labelling including the hazard symbol(s) and indications of danger, risk phrases and safety phrases should be given.
Na podlagi razvrstitve je treba predložiti predlog za označevanje, vključno s simbolom(i) za nevarnost, omejitvenimi opozorilnimi stavki in obvestilnimi stavki o varnosti.
The classification and labelling shall be in regard to the chemical substances contained in the biocidal product.
Razvrščanje in označevanje mora biti v skladu s kemičnimi snovmi, ki jih vsebuje biocidni proizvod.
If necessary, specimens of proposed packaging shall be submitted to the competent authority of a Member State.
Če je potrebno, se pristojnemu organu države članice predloži vzorce predlaganega pakiranja.
The dossier shall be accompanied by a reasoned proposal for allocation to one of the risk groups specified in Article 2 of Directive 2000/54/EC together with indications on the need for products to carry the biohazard sign specified in Annex II to that Directive.
Dokumentacijo mora spremljati utemeljeni predlog za razvrstitev v eno od skupin tveganja, opisanih v členu 2 Direktive 2000/54/ES, skupaj z navedbami, ali mora bit pripravek opremljen z znakom za bionevarnost, ki je določen v Prilogi II k navedeni direktivi.
SUMMARY AND EVALUATION OF SECTIONS I TO XI INCLUDING CONCLUSIONS OF THE RISK ASSESSMENT AND RECOMMENDATIONS
POVZETEK IN OCENA ODDELKOV I DO IX, VKLJUČNO Z ZAKLJUČKI OCENE TVEGANJA IN PRIPOROČILI
Commission Directive 2006/51/EC
Direktiva Komisije 2006/51/ES
of 6 June 2006
z dne 6. junija 2006
amending for the purposes of adapting to technical progress Annex I to Directive 2005/55/EC of the European Parliament and of the Council and Annexes IV and V to Directive 2005/78/EC as regards requirements for the emission control monitoring system for use in vehicles and exemptions for gas engines
o spremembi Priloge I k Direktivi 2005/55/ES Evropskega parlamenta in Sveta ter Prilog IV in V k Direktivi 2005/78/ES v zvezi z zahtevami za sistem spremljanja nadzora emisij za uporabo v vozilih in izjeme za plinske motorje zaradi prilagajanja tehničnemu napredku
Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers [1], and in particular the second indent of Article 13(2) thereof,
ob upoštevanju Direktive Sveta 70/156/EGS z dne 6. februarja 1970 o približevanju zakonodaje držav članic o homologaciji motornih in priklopnih vozil [1], in zlasti druge alinee člena 13(2) Direktive,
Having regard to Directive 2005/55/EC of the European Parliament and of the Council of 28 September 2005, on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles [2], and in particular Article 7 thereof,
ob upoštevanju Direktive 2005/55/ES Evropskega parlamenta in Sveta z dne 28. septembra 2005 o približevanju zakonodaje držav članic v zvezi z ukrepi, ki jih je treba sprejeti proti emisijam plinastih in trdnih onesnaževal iz motorjev na kompresijski vžig, ki se uporabljajo v vozilih, ter emisijam plinastih onesnaževal iz motorjev na prisilni vžig, ki za gorivo uporabljajo zemeljski plin ali utekočinjeni naftni plin in se uporabljajo v vozilih [2], in zlasti člena 7 Direktive,
Directive 2005/55/EC is one of the separate directives in the context of the Community type approval procedure laid down by Directive 70/156/EEC.
Direktiva 2005/55/ES je ena od direktiv, ki se nanaša na postopek Skupnosti za podelitev homologacije, določenega v Direktivi 70/156/EGS.
Commission Directive 2005/78/EC of 14 November 2005 implementing Directive 2005/55/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles and amending Annexes I, II, III, IV and VI thereto introduced amending and implementing measures in relation to the durability of emission control systems, in-use conformity over a defined useful period and on-board diagnostic (OBD) systems for new heavy duty vehicles and engines.
Direktiva Komisije 2005/78/ES z dne 14. novembra 2005 o izvajanju Direktive Evropskega parlamenta in Sveta 2005/55/ES o približevanju zakonodaje držav članic v zvezi z ukrepi, ki jih je treba sprejeti proti emisijam plinastih in trdnih onesnaževal iz motorjev na kompresijski vžig, ki se uporabljajo v vozilih, ter emisijah plinastih onesnaževal iz motorjev na prisilni vžig, ki za gorivo uporabljajo zemeljski plin ali utekočinjen naftni plin in se uporabljajo v vozilih, ter o spremembi prilog I, II, III, IV in VI k Direktivi uvaja spremembe in izvedbene ukrepe glede trajnosti sistema za nadzor emisij, skladnosti med uporabo v določenem uporabnem obdobju in vgrajenih diagnostičnih sistemov (OBD) za nova težka vozila in motorje.
In view of the technical progress it is now appropriate to introduce improved requirements relating to the verification of the operational conditions, failures and demonstration of the emission control monitoring system at the moment of the type approval.
Glede na tehnični napredek je zdaj primerno uvesti izboljšane zahteve za potrjevanje delovnih pogojev, okvar in predstavitev sistema za spremljanje nadzora emisij v trenutku homologacije.
It is necessary to ensure that the functioning of the emission control monitoring system is not impaired by a defeat strategy.
Zagotoviti je treba, da se delovanje sistema za spremljanje nadzora emisij ne poslabša zaradi odklopne strategije.
Gas engines do not use the exhaust gas recirculation or selective catalytic reduction technologies in order to fulfil the current standards for NOx emissions.
Plinski motorji ne uporabljajo vračanja izpušnih plinov v valj ali selektivnih katalitskih tehnologij za zmanjšanje emisij, da bi izpolnile trenutno veljavne standarde za emisije NOx.
Therefore, it is considered that, at this stage, gas engines and vehicles fuelled with gas should be exempted from the requirements to ensure correct operation of NOx control measures.
Zato na tej stopnji velja, da se plinski motorji in vozila na plinsko gorivo izvzamejo iz zahtev, da se zagotovi pravilno delovanje nadzornih ukrepov za NOx.
The exemption might be revoked when taking into consideration further emission stages.
Izjema se lahko prekliče ob upoštevanju nadaljnjih emisijskih stopenj.
It is appropriate to adjust the date of application of sections 6.5.3, 6.5.4 and 6.5.5 of Annex I to Directive 2005/55/EC in case of new type approvals.
Pri novih homologacijah je primerno prilagoditi datum uporabe točk 6.5.3, 6.5.4 in 6.5.5 Priloge I k Direktivi 2005/55/ES.
The Commission intends to review the OBD threshold limit values in order to adapt them to the technological progress.
Komisija namerava pregledati mejne vrednosti vgrajenih diagnostičnih sistemov zaradi njihove prilagoditve tehnološkemu napredku.
Directives 2005/55/EC and 2005/78/EC should therefore be amended accordingly.
Direktivi 2005/55/ES in 2005/78/ES je zato treba ustrezno spremeniti.
The measures provided for in this Regulation are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 13(1) of Directive 70/156/EEC,
Ukrepi iz te direktive so v skladu z mnenjem Odbora za prilagajanje tehničnemu napredku, ustanovljenega s členom 13(1) Direktive 70/156/EGS –
Annex I to Directive 2005/55/EC is amended in accordance with Annex I to this Directive.
Priloga I k Direktivi 2005/55/ES se spremeni v skladu s Prilogo I k tej direktivi.
Annex IV to Directive 2005/78/EC is amended in accordance with Annex II to this Directive.
Priloga IV k Direktivi 2005/78/ES se spremeni v skladu s Prilogo II k tej direktivi.
Member States shall adopt and publish, by 8 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 8. novembra 2006.
They shall apply those provisions from 9 November 2006.
Navedene predpise uporabljajo od 9. novembra 2006.
Done at Brussels, 6 June 2006.
V Bruslju, 6. junija 2006
Directive as last amended by Commission 2006/28/EC (OJ L 65, 7.3.2006, p. 27).
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2006/28/ES (UL L 65, 7.3.2006, str. 27).
Directive as amended by Commission Directive 2005/78/EC (OJ L 313, 29.11.2005, p. 1).
Direktiva, kakor je bila spremenjena z Direktivo Komisije 2005/78/ES (UL L 313, 29.11.2005, str. 1).
AMENDMENTS TO DIRECTIVE 2005/55/EC
SPREMEMBE DIREKTIVE 2005/55/ES
section 2.1 is amended as follows:
Točka 2.1 se spremeni:
the definition of ‘defeat strategy’ is replaced by the following:
Opredelitev izraza „odklopna strategija“ se nadomesti:
‘“defeat strategy” means:
„‚odklopna strategija‘ pomeni:
a BECS that discriminates between operation on a standardised type-approval test and other operations and provides a lesser level of emission control under conditions not substantially included in the applicable type-approval test procedures, or
BECS, ki razlikuje med delovanjem na standardiziranem homologacijskem preskusu in siceršnjim delovanjem ter zagotavlja nižjo raven nadzora emisij pod pogoji, ki niso vključeni v postopke homologacijskih preskusov, ki se uporabljajo, ali
an OBD or an emission control monitoring strategy that discriminates between operation on a standardised type-approval test and other operations and provides a lower level of monitoring capability (timely and accurately) under conditions not substantially included in the applicable type-approval test procedures;’
OBD ali strategija spremljanja nadzora emisij, ki razlikuje med delovanjem na standardiziranem homologacijskem preskusu in drugim delovanjem ter omogoča nižjo raven zmogljivosti spremljanja (pravočasno in natančno) pod pogoji, ki niso bistveno vključeni v uporabljene postopke homologacijskega preskusa“.
in the definition of ‘permanent emission default mode’‘permanent emission default mode’ is replaced by ‘emission default mode’;
V opredelitvi izraza „stalni privzeti način emisij“ se besede „stalni privzeti način emisij“ nadomestijo z besedilom „privzeti način emisij“.
the following definition is added:
Doda se naslednja opredelitev:
‘“emission control monitoring system” means the system that ensures correct operation of the NOx control measures implemented in the engine system according to the requirements of section 6.5 of Annex I.’;
„‚sistem za spremljanje nadzora emisij‘ pomeni sistem, ki zagotavlja pravilno delovanje nadzornih ukrepov za NOx, ki se izvajajo v sistemu motorja v skladu z zahtevami iz točke 6.5 Priloge I.“
in the second indent of section 6.1.5.6 ‘permanent emission default modes’ is replaced by ‘emission default modes’.
V drugi alinei točke 6.1.5.6 se besede „stalni privzeti načini emisij“ nadomestijo z besedilom „privzeti načini emisij“.
section 6.5 is replaced by the following:
Točka 6.5 se nadomesti:
Requirements to ensure correct operation of NOx control measures
Zahteve za zagotovitev pravilnega delovanja nadzornih ukrepov za NOx.
This section is applicable to compression-ignition engine systems irrespective of the technology used to comply with the emission limit values provided in the tables in section 6.2.1.
Ta točka se uporablja za sisteme z motorji na kompresijski vžig, ne glede na uporabljeno tehnologijo, s katero se izpolnijo mejne vrednosti emisij iz tabel v točki 6.2.1.
The requirements of sections 6.5.3, 6.5.4 and 6.5.5 shall apply from 9 November 2006 for new type approvals and from 1 October 2007 for all registrations of new vehicles.
Zahteve točk 6.5.3, 6.5.4 in 6.5.5 se uporabljajo od 9. novembra 2006 za nove homologacije in od 1. oktobra 2007 za vse registracije novih vozil.
Any engine system covered by this section shall be designed, constructed and installed so as to be capable of meeting these requirements over the useful life of the engine.
Vsi sistemi motorjev iz te točke so zasnovani, konstruirani in nameščeni tako, da so sposobni izpolniti te zahteve v celotnem uporabnem življenjskem obdobju motorja.
Information that fully describes the functional operational characteristics of an engine system covered by this section shall be provided by the manufacturer in Annex II.
Informacije, ki v celoti opisujejo funkcionalne značilnosti delovanja sistema motorja iz te točke, preskrbi proizvajalec iz Priloge II.