natgillin/translations-raw huggingface dataset:
The relevant person to whom a letter of access to a dossier on the active substance has been issued shall be entitled to allow applicants for the authorisation of a biocidal product containing that active substance to make reference to that letter of access for the purposes of Article 20(1).
Zadevna oseba, ki ji je bila podeljena izjava o dostopnosti do dokumentacije o aktivni snovi, sme vlagateljem vloge za dovoljenje za biocidni proizvod, ki vsebuje to aktivno snov, dovoliti, da se za namene člena 20(1) sklicujejo na to izjavo o dostopnosti.
By way of derogation from Article 60 of this Regulation, all data protection periods for substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but not yet approved under this Regulation shall end on 31 December 2025.
Z odstopanjem od člena 60 te uredbe vsa obdobja varstva podatkov za kombinacije snovi/vrst proizvodov iz Priloge II k Uredbi (ES) št. 1451/2007, ki še niso odobrene v skladu s to uredbo, potečejo 31. decembra 2025.
The Agency shall make publicly available the list of persons that have made a submission in accordance with paragraph 1 or for whom it has taken a decision in accordance with Article 63(3).
Agencija da javnosti na voljo seznam oseb, ki so predložile dokumentacijo v skladu z odstavkom 1 ali za katere je sprejela odločitev v skladu s členom 63(3).
The list shall also contain the names of persons who are participants in the work programme established under the first subparagraph of Article 89(1) or have taken over the role of the participant.
Seznam vsebuje tudi imena oseb, ki sodelujejo v delovnem programu, opredeljenem v prvem pododstavku člena 89(1), ali so prevzeli vlogo udeležencev.
Without prejudice to Article 93, as of 1 September 2015, a biocidal product shall not be made available on the market if the manufacturer or importer of the active substance(s) contained in the product, or where relevant, the importer of the biocidal product, is not included in the list referred to in paragraph 2.
Brez poseganja v člen 93 od 1. septembra 2015 biocidni proizvod ni dostopen na trgu, če proizvajalec ali uvoznik aktivne oziroma aktivnih snovi, ki jo vsebuje proizvod, ali, kjer je primerno, uvoznik biocidnega proizvoda ni vključen v seznam iz odstavka 2.
Without prejudice to Articles 52 and 89, disposal and use of existing stocks of biocidal products containing an active substance, for which no relevant person is included in the list referred to in paragraph 2, may continue until 1 September 2016.
Brez poseganja v člena 52 in 89 sta odstranitev in uporaba obstoječih zalog biocidnih proizvodov, ki vsebujejo aktivno snov, za katero nobena zadevna oseba ni vključena v seznam iz odstavka 2, še naprej dovoljeni do 1. septembra 2016.
This Article shall not apply to active substances listed in Annex I in categories 1 to 5 and 7 or to biocidal products containing only such active substances.
Ta člen se ne uporablja za aktivne snovi s seznama v Prilogi I iz kategorij 1 do 5 in 7 ali za biocidne proizvode, ki vsebujejo le takšne aktivne snovi.
Without prejudice to Articles 86, 89, 90, 91 and 92 of this Regulation, Directive 98/8/EC is hereby repealed with effect from 1 September 2013.
Brez poseganja v člene 86, 89, 90, 91 in 92 te uredbe se Direktiva 98/8/ES razveljavi z učinkom od 1. septembra 2013.
References to the repealed Directive shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VII.
Sklicevanja na razveljavljeno direktivo se razumejo kot sklicevanja na to uredbo in se razumejo v skladu s korelacijsko tabelo iz Priloge VII.
It shall apply from 1 September 2013.
Uporablja se od 1. septembra 2013.
OJ C 347, 18.12.2010, p. 62.
UL C 347, 18.12.2010, str. 62.
Position of the European Parliament of 22 September 2010 (OJ C 50 E, 21.2.2012, p. 73) and position of the Council at first reading of 21 June 2011 (OJ C 320 E, 1.11.2011, p. 1).
Stališče Evropskega parlamenta z dne 22. septembra 2010 (UL C 50 E, 21.2.2012, str. 73) in stališče Sveta v prvi obravnavi z dne 21. junija 2011 (UL C 320 E, 1.11.2011, str. 1).
Position of the European Parliament of 19 January 2012 (not yet published in the Official Journal) and decision of the Council of 10 May 2012.
Stališče Evropskega parlamenta z dne 19. januarja 2012 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 10. maja 2012.
OJ L 342, 22.12.2009, p. 59.
UL L 342, 22.12.2009, str. 59.
OJ L 275, 20.10.2011, p. 38.
UL L 275, 20.10.2011, str. 38.
Guidance on data sharing established in accordance with Regulation (EC) No 1907/2006.
Smernice o izmenjavi podatkov, določenih v skladu z Uredbo (ES) št. 1907/2006.
LIST OF ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 25(a)
SEZNAM AKTIVNIH SNOVI IZ ČLENA 25(a)
Name/group
Ime/skupina
Category 1 — Substances authorised as food additives according to Regulation (EC) No 1333/2008
Kategorija 1 – Snovi, ki so v skladu z Uredbo (ES) št. 1333/2008 odobrene kot aditivi za živila
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008
Koncentracija se omeji, tako da ni treba vsakega biocidnega proizvoda razvrstiti v skladu z Direktivo 1999/45/ES ali Uredbo (ES) št. 1272/2008.
(+)-Tartaric acid
(+)-Vinska kislina
Category 2 — Substances included in Annex IV to Regulation (EC) No 1907/2006
Kategorija 2 – Snovi, vključene v Prilogo IV k Uredbi (ES) št. 1907/2006
Category 3 — Weak acids
Kategorija 3 – Šibke kisline
Category 4 — Traditionally used substances of natural origin
Kategorija 4 – Snovi naravnega izvora, ki se uporabljajo tradicionalno
Natural oil
Naravno olje
Category 5 — Pheromones
Kategorija 5 – Feromoni
Webbing clothes moths pheromone
Feromon tekstilnih moljev
Category 6 — Substances included in Annex I or IA to Directive 98/8/EC
Kategorija 6 – Snovi, vključene v Prilogo I ali IA k Direktivi 98/8/ES
Only for use in ready-for-use gas canisters functioning together with a trapping device
Samo za uporabo v plinskih posodah za takojšnjo uporabo, ki delujejo skupaj s pastjo
Only for use in limited quantities in ready-for-use canisters
Samo za uporabo v omejenih količinah v posodah za takojšnjo uporabo
(Z,E)-Tetradec-9,12-dienyl acetate
(Z,E)-tetradeka-9,12-dienil acetat
Category 7 — Other
Kategorija 7 – Drugo
INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
ZAHTEVE GLEDE INFORMACIJ O AKTIVNIH SNOVEH
This Annex sets out the information requirements for the preparation of the dossier referred to in point (a) of Article 6(1).
V tej prilogi so navedene zahteve glede informacij za pripravo dokumentacije iz točke (a) člena 6(1).
The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS).
Podatki, navedeni v tej prilogi, sestavljajo zbirko osnovnih podatkov (ZOP) in zbirko dodatnih podatkov (ZDP).
The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all active substances.
Podatki, ki spadajo v ZOP, štejejo za osnovne podatke, ki bi morali biti načeloma na voljo za vse aktivne snovi.
However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS.
V nekaterih primerih pa fizikalne ali kemijske lastnosti snovi lahko pomenijo, da je nemogoče ali nepotrebno zagotoviti specifične podatke, ki spadajo v ZOP.
With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used and the exposure patterns related to these uses.
Kar zadeva ZDP, se podatki, ki se navedejo za določeno aktivno snov, določijo z obravnavo vsakega od podatkov iz ZDP, navedenih v tej prilogi, med drugim ob upoštevanju fizikalnih in kemijskih lastnosti snovi, obstoječih podatkov, informacij, ki so del ZOP, in vrst proizvodov, v katerih bo aktivna snov uporabljena, ter vzorcev izpostavljenosti, povezanih s to uporabo.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex II table.
Posebne določbe za vključitev nekaterih podatkov so v stolpcu 1 tabele v Prilogi II.
The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply.
Uporabljajo se tudi splošni preudarki za prilagoditev zahtev glede informacij, kot so navedeni v Prilogi IV.
In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.
Zaradi pomembnosti zmanjšanja števila preskusov na vretenčarjih so v stolpcu 3 tabele iz Priloge II navedene posebne določbe o prilagoditvi zahtev glede nekaterih podatkov, za katere bi lahko bili potrebni takšni preskusi na vretenčarjih.
The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met.
Predložene informacije morajo biti v vsakem primeru zadostne, da se opravi ocena tveganja, ki naj bi pokazala, da so merila iz člena 4(1) izpolnjena.
The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6(1), which is available on the website of the Agency.
Vlagatelj bi moral pri uporabi te priloge in pripravi dokumentacije iz točke (a) člena 6(1) upoštevati podrobne tehnične smernice, ki so na voljo na spletni strani Agencije.
The applicant has the obligation to initiate a pre-submission consultation.
Vlagatelj se mora pred oddajo posvetovati.
In addition to the obligation set down in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out.
Poleg obveznosti iz člena 62(2) se lahko vlagatelji prav tako posvetujejo s pristojnim organom, ki bo ocenil dokumentacijo glede na predlagane zahteve glede informacij in zlasti glede preskusov na vretenčarjih, za katere vlagatelj predlaga, da jih bo izvedel.
Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in Article 8(2).
Če je treba opraviti oceno iz člena 8(2), utegnejo biti potrebne dodatne informacije.
A detailed and full description of the studies conducted or referred to and of the methods used shall be included.
Vključi se podroben in popoln opis izvedenih ali navedenih študij in uporabljenih metod.
It is important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements.
Pomembno je zagotoviti, da so razpoložljivi podatki primerni in zadostne kakovosti za izpolnjevanje zahtev.
Evidence should also be provided to demonstrate that the active substance upon which the tests have been carried out is the same as the substance for which the application has been submitted.
Prav tako bi bilo treba predložiti dokaz, da je aktivna snov, na kateri so bili opravljeni preskusi, enaka snovi, za katero je bila predložena vloga.
The formats made available by the Agency must be used for submission of the dossiers.
Dokumentacija mora biti predložena v formatih, ki jih predpiše Agencija.
In addition, IUCLID must be used for those parts of the dossiers to which IUCLID applies.
Poleg tega je treba uporabiti IUCLID za tiste dele dokumentacije, za katere se lahko uporablja IUCLID.
Formats and further guidance on data requirements and dossier preparation are available on the website of the Agency.
Formati in nadaljnja navodila glede zahtevanih podatkov in priprave dokumentacije so na voljo na domači spletni strani Agencije.
Tests submitted for the purpose of the approval of an active substance shall be conducted according to the methods described in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [1].
Preskusi, predloženi v odobritev aktivne snovi, se izvedejo po metodah iz Uredbe Komisije (ES) št. 440/2008 z dne 30. maja 2008 o določitvi testnih metod v skladu z Uredbo (ES) št. 1907/2006 Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) [1].
However, if a method is inappropriate or not described, other methods shall be used which are scientifically appropriate, whenever possible internationally recognised, and their appropriateness must be justified in the application.
Vendar se, če je metoda neustrezna ali ni opisana, uporabijo druge metode, ki so znanstveno ustrezne, kjer je to mogoče, mednarodno priznane, njihova ustreznost pa mora biti utemeljena v vlogi.
When test methods are applied to nanomaterials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these materials.
Kadar se preskusne metode uporabljajo za nanomateriale, se razloži njihova znanstvena ustreznost in, kjer je ustrezno, tehnične prilagoditve, izvedene zaradi posebnih lastnosti teh materialov.
Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes [2] and in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances [3] or other international standards recognised as being equivalent by the Commission or the Agency.
Opravljeni preskusi bi morali biti v skladu z ustreznimi zahtevami za varstvo laboratorijskih živali iz Direktive 2010/63/EU Evropskega parlamenta in Sveta z dne 22. septembra 2010 o zaščiti živali, ki se uporabljajo v znanstvene namene [2], ekotoksikološki in toksikološki preskusi pa v skladu z dobro laboratorijsko prakso iz Direktive 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi [3] ali z drugimi mednarodnimi standardi, ki sta jih Komisija ali Agencija priznali kot enakovredne.
Tests on physico-chemical properties and safety-relevant substance data should be performed at least according to international standards.
Preskusi v zvezi s fizikalno-kemijskimi lastnostmi in podatki o snovi v zvezi z varnostjo bi morali biti opravljeni vsaj v skladu z mednarodnimi standardi.
Where testing is done, a detailed description (specification) of the active substance used and its impurities must be provided.
Kadar se preskus opravi, je treba predložiti podroben opis (specifikacijo) uporabljene aktivne snovi in nečistot, ki jih vsebuje.
Testing should be performed with the active substance as manufactured or, in the case of some of the physical and chemical properties (see indications given in column I of the table), with a purified form of the active substance.
Preskusi bi morali biti opravljeni z aktivno snovjo, kot se proizvaja, glede nekaterih fizikalnih in kemijskih lastnosti (glej navedbe iz stolpca 1 tabele) pa s prečiščeno obliko aktivne snovi.
Where test data exist that have been generated before 1 September 2013 by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member State concerned, on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrates.
Kadar obstajajo podatki o preskusih, pridobljeni pred 1. septembrom 2013 z metodami, ki niso določene v Uredbi (ES) št. 440/2008, mora pristojni organ zadevne države članice odločiti o primernosti takšnih podatkov za namene te uredbe ter o potrebi po izvedbi novih preskusov v skladu z Uredbo (ES) št. 440/2008, in sicer za vsak posamezen primer posebej, pri čemer se med drugim upošteva tudi potreba po zmanjšanju števila preskusov na vretenčarjih.
New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted.
Novi preskusi na vretenčarjih zaradi izpolnjevanja zahtev iz te priloge glede podatkov se izvedejo kot zadnja razpoložljiva možnost, ko so bili izčrpani vsi ostali viri podatkov.
In-vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided.
Preskušanju in vivo z jedkimi snovmi pri ravneh koncentracije/odmerka, ki povzročajo jedkost, se je treba izogibati.
Core data set and additional data set for active substances
Zbirka osnovnih podatkov in zbirka dodatnih podatkov za aktivne snovi
Information required to support the approval of an active substance is listed in the table below.
Informacije, ki so potrebne za odobritev snovi, so naštete v spodnji tabeli.
Conditions for not requiring a specific test that are set out in the appropriate test methods in the Regulation (EC) No 440/2008 and are not repeated in column 3, also apply.
Prav tako se uporabljajo pogoji, pod katerimi se določen preskus ne zahteva in so določeni v ustreznih preskusnih metodah v Uredbi (ES) št. 440/2008 in se v stolpcu 3 ponovno ne navajajo.
Information required
Zahtevane informacije:
All data is CDS unless indicated as ADS
Vsi podatki so del ZOP, razen če so označeni kot ZDP
Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates
Posebna pravila za prilagoditev glede standardnih informacij v zvezi z nekaterimi zahtevami glede informacij, za katere je morda potrebna uporaba preskusov na vretenčarjih
APPLICANT
VLAGATELJ
Active substance manufacturer (name, address and location of manufacturing plant(s))
Proizvajalec aktivne snovi (ime, naslov, kraj proizvodnega obrata ali obratov)
IDENTITY OF THE ACTIVE SUBSTANCE
OPIS (IDENTITETA) AKTIVNE SNOVI
For the active substance, the information given in this Section shall be sufficient to enable the active substance to be identified.
Informacije, navedene v tem oddelku, zadostujejo za identifikacijo aktivne snovi.
If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated
Če predložitev informacij o eni ali več točkah, ki so navedene v nadaljevanju, tehnično ni mogoča ali če se z znanstvenega vidika zdi, da predložitev informacij o njih ni potrebna, se razlogi za to jasno navedejo.
Common name proposed or accepted by ISO and synonyms (usual name, trade name, abbreviation)
Splošno ime, ki ga je predlagala ali sprejela ISO, in sinonimi (običajno ime, trgovsko ime, kratica)
Chemical name (IUPAC and CA nomenclature or other international chemical name(s))
Kemijsko ime (po nomenklaturi IUPAC in CA ali drugo mednarodno kemijsko ime oziroma imena)
Manufacturer’s development code number(s)
Razvojna šifra oziroma šifre proizvajalca
CAS number plus EC, INDEX and CIPAC numbers
Ime in številka CAS ter številke EC, INDEX in CIPAC
Molecular and structural formula (including SMILES notation, if available and appropriate)
Molekulska in strukturna formula (vključno s sistemom simbolov SMILES, če je na voljo in če je to primerno)
Information on optical activity and full details of any isomeric composition (if applicable and appropriate)
Informacije o optični aktivnosti in celotnem opisu možnih izomer (če je to ustrezno in primerno)
Molar mass
Molarna masa
Method of manufacture (syntheses pathway) of active substance including information on starting materials and solvents including suppliers, specifications and commercial availability
Proizvodni postopek (opis sinteze) aktivne snovi vključno z informacijami o vhodnih sestavinah in topilih pa tudi o dobaviteljih, specifikacijah in razpoložljivosti na trgu
Specification of purity of the active substance as manufactured in g/kg, g/l or %w/w (v/v) as appropriate, providing inclusively the upper and lower limit
Čistost aktivne snovi, kot je bila proizvedena (v g/kg, g/l ali % – m/m ali v/v), kakor je ustrezno, vključno z navedbo zgornje in spodnje meje
The identity of any impurities and additives including by-products of synthesis, optical isomers, degradation products (if the substance is unstable) un-reacted and end-groups etc. of polymers and un-reacted starting materials of UVC-substances
Opis nečistoti in dodatkov, vključno s stranskimi produkti sinteze, optičnimi izomeri, produkti razgradnje (če je snov nestabilna), nezreagiranimi in končnimi skupinami itd. polimerov ter nezreagiranimi vhodnimi sestavinami snovi z neznano ali spremenljivo sestavo
Analytical profile of at least five representative batches (g/kg active substance) including information on content of the impurities referred to in 2.10.
Analitski profil vsaj petih reprezentativnih partij (g/kg aktivne snovi) vključno z informacijami o vsebnosti nečistot iz 2.10
The origin of the natural active substance or the precursor(s) of the active substance, e.g. an extract of a flower
Izvor naravne aktivne snovi ali predhodne oziroma predhodnih sestavin (prekurzorja(-ev)) aktivne snovi, na primer rastlinski izvleček
PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE
FIZIKALNE IN KEMIJSKE LASTNOSTI AKTIVNE SNOVI
Appearance [4]
Videz [4]
Aggregate state (at 20 °C and 101,3 kPa)
Agregatno stanje (pri 20 °C in 101,3 kPa)
Physical state (i.e. viscous, crystalline, powder) (at 20 °C and 101,3 kPa)
Fizikalno stanje (npr. viskoznost, kristaliničnost, prah) (pri 20 °C in 101,3 kPa)
Colour (at 20 °C and 101,3 kPa)
Barva (pri 20 °C in 101,3 kPa)
Odour (at 20 °C and 101,3 kPa)
Vonj (pri 20 °C in 101,3 kPa)
Melting/freezing point [5]
Tališče/ledišče [5]
Acidity, alkalinity
Kislost, bazičnost
Boiling point [5]
Vrelišče [5]
Relative Density [5]
Relativna gostota [5]
Absorption spectra data (UV/VIS, IR, NMR) and a mass spectrum, molar extinction coefficient at relevant wavelengths, where relevant [5]
Podatki o absorpcijskih spektrih (UV/VIS, IR, NMR) in masna spektrometrija, koeficient molarne ekstinkcije pri ustreznih valovnih dolžinah, kadar je to ustrezno [5]
Vapour pressure [5]
Parni tlak [5]
Henry’s law constant must always be stated for solids and liquids if it can be calculated
Za trdne snovi in tekočine je treba vedno navesti konstanto Henryjevega zakona, če jo je mogoče izračunati.
Surface tension [5]
Površinska napetost [5]
Water solubility [5]
Topnost v vodi [5]
Partition coefficient (n-octanol/water) and its pH dependency [5]
Porazdelitveni koeficient (n-oktanol/voda) in njegova odvisnost od pH [5]
Thermal stability, identity of breakdown products [5]
Toplotna stabilnost, določitev produktov razgradnje [5]
Reactivity towards container material
Reaktivnost na material za embalažo
Dissociation constant
Konstanta disociacije
ADS
ZDP
Solubility in organic solvents, including effect of temperature on solubility [5]
Topnost v organskih topilih, vključno z učinkom temperature na topnost [5]
Stability in organic solvents used in biocidal products and identity of relevant breakdown products [4]
Obstojnost v organskih topilih, ki se uporabljajo v biocidnih proizvodih, in določitev pomembnih produktov razgradnje [4]
PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS
FIZIKALNE NEVARNOSTI IN ZADEVNE ZNAČILNOSTI
Flammable gases
Vnetljivi plini
Oxidising gases
Oksidativni plini