natgillin/translations-raw huggingface dataset:
include when required by the competent authority, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations;
če to zahteva pristojni organ, vključujejo popoln opis uporabljenih smernic za testiranje, razen če so navedene ali opisane v tej prilogi, in popoln opis vseh odstopanj od smernic, vključno z utemeljitvijo teh odstopanj, ki je sprejemljiva za pristojni organ;
include a full and unbiased report of the studies conducted as well as a full description of them or a justification, which is acceptable to the competent authority where:
vključujejo popolno in nepristransko poročilo o izvedenih študijah s popolnim opisom ali obrazložitvijo, ki je sprejemljiva za pristojni organ, kadar:
it is not scientifically necessary, or technically possible to supply information and data;
informacij in podatkov znanstveno ni treba ali tehnično ni mogoče zagotoviti;
Tests and analyses
Testi in analize
Tests and analyses, required under points 6.2 to 6.7 of this Annex, shall be conducted by official or officially recognised testing facilities or organisations which satisfy at least the following requirements:
Teste in analize, ki so obvezni v skladu s točkami 6.2 do 6.7 te priloge, izvajajo uradne ali uradno priznane testne postaje ali organizacije, ki izpolnjujejo najmanj naslednje zahteve:
have at their disposal sufficient scientific and technical staff, having the necessary education, training, technical knowledge and experience for their assigned functions,
imajo na razpolago dovolj znanstvenega in tehničnega osebja s potrebno izobrazbo, usposobljenostjo, tehničnim znanjem in izkušnjami za dodeljene naloge,
have at their disposal suitable items of equipment required for correct performance of the tests and measurements which it claims to be competent to carry out.
imajo na razpolago ustrezno opremo, ki je potrebna za pravilno izvajanje testov in meritev, ki naj bi jih bile merodajne izvesti.
This equipment shall be properly maintained and calibrated where appropriate before being put into service and thereafter in accordance with an established programme,
Ta oprema mora biti ustrezno vzdrževana in kalibrirana, kadar je to ustrezno, pred začetkom uporabe, pozneje pa v skladu z določenim programom,
have at their disposal appropriate experimental fields and, where necessary glasshouses, growth cabinets or storage rooms.
imajo na razpolago ustrezna poskusna polja in po potrebi steklenjake, rastne omare ali skladiščne prostore.
The environment in which the tests are undertaken shall not invalidate its results or adversely effect the required accuracy of measurement,
Okolje, v katerem se izvajajo testi, ne sme razvrednotiti rezultatov ali škodljivo vplivati na zahtevano točnost meritev,
make available to all relevant personnel operating procedures and protocols used for the trials,
dajo na razpolago vsemu ustreznemu osebju postopke in protokole, ki se uporabljajo za poskuse,
make available, where requested by the competent authority, prior to the commencement of a test, detailed information on it, containing at least its location and the plant protection products included in it,
na zahtevo pristojnega organa pred začetkom izvajanja testov dajo na razpolago podrobne informacije o testu, ki vsebujejo najmanj podatke o kraju izvajanja in fitofarmacevtskih sredstvih,
ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose,
zagotovijo, da je kakovost izvedenega dela ustrezna za vrsto, obseg, količino in predvideni namen,
maintain records of all original observations, calculations and derived data, calibration records and the final test report as long as the product concerned is authorised in the Union.
hranijo evidence o vseh prvotnih opažanjih, izračunih in izpeljanih podatkov, evidence o kalibriranju ter končno poročilo o testu, dokler je zadevno sredstvo registrirano v Uniji.
Officially recognised testing facilities and organisations, and, where requested, official facilities and organisations shall:
Uradno priznane testne postaje in organizacije ter, na zahtevo, uradne postaje in organizacije:
report to the relevant national authority all detailed information necessary to demonstrate that they can satisfy the requirements provided for in point 2.2,
poročajo ustreznemu nacionalnemu pristojnemu organu vse potrebne podrobne informacije v dokaz, da lahko izpolnjujejo zahteve iz točke 2.2,
accept at any time the inspections, which each Member State shall regularly organise on its territory in order to verify the compliance with the requirement as laid down in point 2.2.
kadar koli sprejmejo inšpekcijo, ki jo vsaka država članica redno organizira na svojem ozemlju za preverjanje skladnosti z zahtevami iz točke 2.2.
By way of derogation from point 2.1, Member States may apply points 2.2 and 2.3, by extension, to tests and analyses performed on their territory in order to obtain data on the properties and/or safety of the preparations with respect to honey-bees and beneficial arthropods other than bees and actually started on or before 31 December 1999.
Z odstopanjem od točke 2.1 države članice lahko uporabijo točki 2.2 in 2.3, tako da ju razširijo na teste in analize, ki se izvajajo na njihovem ozemlju za pridobitev podatkov o lastnostih in/ali varnosti pripravkov glede čebel in drugih koristnih členonožcev, razen čebel, in ki so jih dejansko začele izvajati 31. decembra 1999 ali pred tem datumom.
By way of derogation from point 2.1, Member States may apply points 2.2 and 2.3, by extension, to supervised residue trials performed on their territory in accordance with Section 8 ‘Residues in or on treated products, food and feed’ with plant protection products containing active substances already on the market on the 26 July 1993 and actually started on or before 31 December 1997.
Z odstopanjem od točke 2.1 države članice lahko uporabijo točki 2.2 in 2.3, tako da ju razširijo na nadzorovane poskuse za določitev ostankov, ki se izvajajo na njihovem ozemlju v skladu z oddelkom 8 „Ostanki v tretiranih proizvodih, hrani in krmi ali na njih“ s fitofarmacevtskimi sredstvi, ki vsebujejo aktivne snovi, ki so na trgu od 26. julija 1993 in ki so jih dejansko začele izvajati 31. decembra 1997 ali pred tem datumom.
By way of derogation from point 2.1, for active substances consisting of micro-organisms or viruses, tests and analyses done to obtain data on the properties and/or safety with respect to other aspects than human health, may have been conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements under points 2.2 and 2.3 of the introduction to this Annex.
Z odstopanjem od točke 2.1 lahko uradne ali uradno priznane testne postaje ali organizacije, ki izpolnjujejo najmanj zahteve iz točk 2.2 in 2.3 uvoda te priloge, izvajajo teste in analize za aktivne snovi, ki so sestavljene iz mikroorganizmov ali virusov, za pridobivanje podatkov o lastnostnih in/ali varnosti v zvezi z drugimi vidiki, ki ne zajemajo zdravja ljudi.
The information required shall include the proposed classification and labelling of the plant protection product in accordance with Directive 1999/45/EC of the European Parliament and of the Council [4] or with Regulation (EC) No 1272/2008 of the European Parliament and of the Council [5].4.
Zahtevane informacije vključujejo predlagano razvrstitev in označevanje fitofarmacevtskega sredstva v skladu z Direktivo 1999/45/ES Evropskega parlamenta in Sveta [4] ali Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta [5].4.
In individual cases it may be necessary to require certain information as provided for in the Annex to Commission Regulation (EU) No 544/2011 [6], Part A, for co-formulants.
V posameznih primerih je morda za pomožne snovi v formulaciji treba zahtevati nekatere informacije iz dela A Priloge k Uredbi Komisije (EU) št. 544/2011 [6].
Before such information will be required and before possible new studies have to be performed, all information on the co-formulant, made available to the competent authority, will be considered, in particular when:
Preden se zahtevajo takšne informacije in preden se zahteva izvedba novih študij, bodo pregledane vse informacije o pomožni snovi v formulaciji, ki so na voljo pristojnemu organu, zlasti:
the use of the co-formulant is permitted in food, animal feeding stuffs, medicines or cosmetics in accordance with EU legislation, or
ali je uporaba pomožne snovi v formulaciji dovoljena v živilih, živalski krmi, zdravilih ali kozmetičnih izdelkih v skladu z zakonodajo Unije, ali
a safety data sheet is provided for the co-formulant in accordance with Article 31 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council [7].PART A
je predložen varnostni list za pomožno snov v formulaciji v skladu s členom 31 Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [7].DEL A
CHEMICAL PREPARATIONS
KEMIJSKI PRIPRAVKI
The information provided, taken together with that provided for the active substance(s), must be sufficient to precisely identify preparations and define them in terms of their specification and nature.
Predložene informacije, skupaj z informacijami o aktivnih snoveh, morajo zadoščati za natančno opredelitev pripravkov in njihovo določitev glede specifikacij in narave.
The information and data referred to, unless otherwise specified, are required for all plant protection products.
Navedene informacije in podatki, če ni določeno drugače, so obvezni za vsa fitofarmacevtska sredstva.
Applicant (name and address, etc.)
Vlagatelj (ime, naslov itd.)
Where in addition, the applicant has an office, agent or representative in the Member State in which the authorisation is being sought, the name and address of the local office, agent or representative shall be provided, as shall the name, position, telephone and telefax number of the appropriate person to contact.
Kadar ima vlagatelj poleg tega poslovalnico, zastopnika ali predstavnika v državi članici, v kateri želi pripravek registrirati, se navedejo ime in naslov lokalne poslovalnice, zastopnika ali predstavnika ter ime, položaj, telefonska številka in številka telefaksa ustrezne kontaktne osebe.
Manufacturer of the preparation and the active substance(s) (names and addresses etc. including location of plants)
Proizvajalec pripravka in aktivnih snovi (imena, naslovi itd., vključno z lokacijo obratov)
The name and address of the manufacturer of the preparation and of each active substance in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and active substance are manufactured.
Navesti je treba ime in naslov proizvajalca pripravka in vsake aktivne snovi v pripravku, kakor tudi ime in naslov vsakega proizvodnega obrata, kjer se pripravek in aktivna snov izdelujeta.
A contact point (preferable a central contact point, to include name, telephone and telefax numbers) must be provided for each.
Pri vsakem je treba navesti tudi kontaktno točko (po možnosti centralno kontaktno točko, vključno z imenom, telefonsko številko in številko telefaksa).
If the active substance originates from a manufacturer from which data in accordance with the Annex to Regulation (EU) 544/2011 had not been submitted previously, a statement of purity and detailed information on the impurities referred to in the Annex to Regulation 544/2011 have to be provided.
Če aktivna snov izvira od proizvajalca, ki še ni predložil podatkov v skladu s Prilogo k Uredbi (EU) 544/2011, je treba predložiti izjavo o čistosti in podrobne informacije o nečistočah iz Priloge k Uredbi 544/2011.
Trade name or proposed trade name, and manufacturer’s development code number of the preparation if appropriate
Trgovsko ime ali predlagano trgovsko ime in, če je primerno, proizvajalčeva razvojna šifra pripravka
All former and current trade names and proposed trade names and development code numbers of the preparation as well as the current names and numbers must be provided.
Navesti je treba vsa prejšnja in sedanja trgovska imena, predlagana imena in razvojne šifre pripravka ter sedanja imena in številke.
Where trade names and code numbers referred to, relate to similar but different preparations (possibly obsolete), full details of the differences, must be provided.
Kadar se navedena trgovska imena in šifre nanašajo na podobne, vendar različne pripravke (npr. pripravke, ki niso več v uporabi), je razlike treba v celoti navesti.
(The proposed trade name may not give rise to confusion with the trade name of already registered plant protection products.)
(Predlagano trgovsko ime ne sme povzročati zmede zaradi zamenjave s trgovskim imenom že registriranih fitofarmacevtskih sredstev.)
For preparations the following information must be reported:
Za pripravke je treba predložiti naslednje informacije:
the content of both technical active substance(s) and pure active substance(s),
vsebnost tehničnih aktivnih snovi in čistih aktivnih snovi,
the content of co-formulants.
vsebnost pomožnih snovi v formulaciji.
The concentrations shall be expressed in terms as provided for in Directive 1999/45/EC.
Koncentracije se izrazijo v enotah iz Direktive 1999/45/ES.
For active substances their ISO common names or proposed ISO common names and their CIPAC [8] numbers, and, where available, the EC (Einecs or ELINCS) numbers must be provided.
Za aktivne snovi je treba navesti splošna imena ali predlagana splošna imena po ISO in njihove številke CIPAC [8] ter številke ES (EINECS ali ELINCS), kadar so na voljo.
Where relevant it must be stated which salt, ester, anion or cation is present.
Kadar je to relevantno, je treba navesti vsebovano sol, ester, anion ali kation.
Co-formulants must where possible, be identified by their International Chemical Identification as given in Annex VI to Regulation (EC) No 1272/2008, or, if not included in that Regulation, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided.
Pomožne snovi v formulaciji je treba, kadar je to primerno, opredeliti z Mednarodno kemijsko opredelitvijo iz Priloge VI k Uredbi (ES) št. 1272/2008 ali, kadar niso vključene v navedeno uredbo, v skladu z nomenklaturama IUPAC in CA. Navesti je treba njihovo strukturo ali strukturno formulo.
For each component of the co-formulants the relevant EC (Einecs or ELINCS) number and CAS number where they exist, must be provided.
Za vsako sestavino pomožnih snovi v formulaciji je treba navesti ustrezno številko ES (EINECS ali ELINCS) in številko CAS, kadar obstajata.
Where the information provided does not fully identify a co-formulant, an appropriate specification must be provided.
Kadar predložene informacije ne opredelijo pomožne snovi v formulaciji v celoti, je treba predložiti ustrezno specifikacijo.
The trade name of co-formulants, where they exist, must also be provided.
Kadar obstajajo trgovska imena pomožnih snovi v formulaciji, jih je treba tudi predložiti.
For co-formulants the function must be given:
Za pomožne snovi v formulaciji je treba navesti delovanje:
adhesive (sticker),
adhezit,
carrier,
nosilec,
dye,
barvilo,
emetic,
emetik,
fertiliser,
gnojilo,
preservative,
konzervans,
propellant,
potisni plin,
solvent,
topilo,
synergist,
sinergist,
thickener,
zgoščevalo,
wetting agent,
močilo,
miscellaneous (specify).
razno (navesti).
Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution, etc.)
Fizikalno stanje in oblika pripravka (emulzivni koncentrat, močilni prašek, raztopina itd.)
The type and code of preparation must be designated in accordance with the ‘Catalogue of pesticide formulation types and international coding system (GIFAP [9] Technical Monograph No 2. 1989)’.
Vrsto in šifro pripravka je treba označiti v skladu s „Katalogom vrst formulacij za pesticide in mednarodnim kodnim sistemom (Tehnična monografija EKUJS [9] št. 2, 1989)“.
Where a particular preparation is not defined precisely in that publication a full description of the physical nature and state of the preparation must be provided, together with a proposal for a suitable description of the type of preparation and a proposal for its definition.
Kadar določeni pripravek v navedeni publikaciji ni natančno opredeljen, je treba predložiti izčrpen opis fizikalne oblike in fizikalnega stanja pripravka skupaj s predlogom za ustrezen opis vrste pripravka in predlogom za njegovo opredelitev.
Function (herbicide, insecticide, etc.)
Delovanje (herbicid, insekticid itd.)
acaricide,
akaricid,
bactericide,
baktericid,
fungicide,
fungicid,
insecticide,
insekticid,
molluscicide,
moluskicid,
nematicide,
nematicid,
plant growth regulator,
regulator rasti in razvoja rastlin,
rodenticide,
rodenticid,
semio-chemicals,
semio-kemikalija,
talpicide,
talpicid,
viricide,
viricid,
The extent to which plant protection products for which authorisation is sought, comply with relevant FAO specifications as agreed by the Group of Experts on Pesticide Specifications, of the FAO Panel of Experts on Pesticide Specifications, Registration Requirements and Application Standards, must be stated.
Navesti je treba stopnjo skladnosti fitofarmacevtskih sredstev, za katere se zahteva registracija, z ustreznimi specifikacijami FAO, dogovorjenimi v Skupini strokovnjakov za specifikacijo pesticidov Strokovnega odbora FAO za specifikacijo pesticidov, zahtev za registracijo in standardov za zahtevke.
A description of both the colour and odour, if any, and the physical state of the preparation, must be provided.
Predložiti je treba opis barve in vonja, če ju pripravek ima, ter fizikalno stanje pripravka.
The explosive properties of preparations must be reported in accordance with method A 14 of Regulation (EC) No 440/2008.
Eksplozivne lastnosti pripravkov je treba navesti v skladu z metodo A 14 Uredbe (ES) št. 440/2008.
Where available thermodynamic information establishes beyond reasonable doubt that the preparation is incapable of exothermic reaction, it is sufficient to provide that information as a justification for not determining the explosive properties of the preparation.
Kadar se na osnovi razpoložljivih podatkov o termodinamiki nedvoumno ugotovi, da pripravek ne more eksotermno reagirati, zadošča, če se navedene informacije predložijo kot utemeljitev, zakaj eksplozivne lastnosti pripravka niso navedene.
Oxidising properties of preparations which are solids must be determined and reported in accordance with method A 17 of Regulation (EC) No 440/2008.
Oksidacijske lastnosti trdnih pripravkov je treba določiti in navesti v skladu z metodo A 17 Uredbe (ES) št. 440/2008.
For other preparations the method used must be justified.
Za druge pripravke je treba utemeljiti uporabljeno metodo.
The oxidising properties do not have to be determined if it can be shown without reasonable doubt on the basis of thermodynamic information, that the preparation is incapable of reacting exothermically with combustible materials.
Oksidacijskih lastnosti ni treba določiti, če se lahko na osnovi termodinamičnih podatkov nedvoumno dokaže, da pripravek ne more eksotermno reagirati z vnetljivimi snovmi.
The flash point of liquids which contain flammable solvents, must be determined and reported in accordance with method A 9 of Regulation (EC) No 440/2008.
Plamenišče tekočin, ki vključujejo vnetljiva topila, je treba določiti in navesti v skladu z metodo A 9 Uredbe (ES) št. 440/2008.
The flammability of solid preparations and gases must be determined and reported in accordance with methods A 10, A 11 and A 12 of Regulation (EC) No 440/2008 as appropriate.
Vnetljivost trdnih in plinastih pripravkov je treba določiti in navesti v skladu z metodami A 10, A 11 in A 12 Uredbe (ES) št. 440/2008, kakor je primerno.
The auto-flammability of preparations must be determined and reported in accordance with method A 15 or A 16 of Regulation (EC) No 440/2008 as appropriate, and or, where necessary, in accordance with the UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, No 14.3.4).
Samovžig pripravkov je treba določiti in navesti v skladu z metodo A 15 ali A 16 Uredbe (ES) št. 440/2008, kakor je primerno in/ali kadar je to potrebno v skladu s testom UN–Bowes–Cameron–Cage (Priporočila ZN o prevozu nevarnega blaga, poglavje 14, št. 14.3.4).
Acidity/alkalinity and if necessary pH value
Kislost/bazičnost in po potrebi vrednost pH
In the case of preparations which are acidic (pH < 4) or alkaline (pH > 10) the acidity or alkalinity and the pH value must be determined and reported in accordance with CIPAC Methods MT 31 and MT 75 respectively.
Pri pripravkih s kislo (pH < 4) ali bazično reakcijo (pH > 10) je treba kislost ali bazičnost in vrednost pH določiti in navesti v skladu z metodo CIPAC MT 31 oz. MT 75.
Where relevant (if to be applied as aqueous dilution) the pH of a 1 % aqueous dilution, emulsion or dispersion of the preparation, must be determined and reported in accordance with CIPAC Method MT 75.
Kadar je to relevantno (če se bo pripravek uporabljal kot vodna raztopina), je treba vrednost pH 1-odstotne vodne raztopine, emulzije ali disperzije pripravka določiti in navesti v skladu z metodo CIPAC MT 75.
In the case of liquid preparations for Ultra Low Volume use (ULV) the kinematic viscosity must be determined and reported in accordance with OECD Test Guideline 114.
Pri tekočih pripravkih za ULV uporabo (Ultra Low Volume) je treba določiti in navesti kinematsko viskoznost v skladu s smernicami za testiranje št. 114 OECD.
For non-newtonian liquids the viscosity must be determined and reported together with the test conditions.
Za ne-newtonske tekočine je treba določiti in navesti viskoznost in pogoje testiranja.
In the case of liquid preparations the surface tension has to be determined and reported in accordance with method A 5 of Regulation (EC) No 440/2008.
Pri tekočih pripravkih je treba določiti in navesti površinsko napetost v skladu z metodo A 5 Uredbe (ES) št. 440/2008.
Relative density and bulk density
Relativna gostota in nasipna teža
The relative density of liquid preparations must be determined and reported in accordance with method A 3 of Regulation (EC) No 440/2008.
Relativno gostoto tekočih pripravkov je treba določiti in navesti v skladu z metodo A 3 Uredbe (ES) št. 440/2008.
The bulk (tap) density of preparations which are powders or granules, must be determined and reported in accordance with CIPAC Methods MT 33, MT 159 or MT 169 as appropriate.
Nasipno težo pripravkov v obliki praška ali zrn je treba določiti in navesti v skladu z metodami CIPAC MT 33, MT 159 ali MT 169, kakor je primerno.
Storage — stability and shelf-life: Effects of light, temperature and humidity on technical characteristics of the plant protection product
Stabilnost pri shranjevanju in rok uporabe: vplivi svetlobe, temperature in vlage na tehnične značilnosti fitofarmacevtskega sredstva
The stability of the preparation after storage for 14 days at 54 °C must be determined and reported in accordance with CIPAC Method MT 46.
Stabilnost pripravka po štirinajstdnevnem shranjevanju pri 54 °C je treba določiti in navesti v skladu z metodo CIPAC MT 46.
Other times and/or temperatures may be needed (e.g. 8 weeks at 40 °C or 12 weeks at 35 °C or 18 weeks at 30 °C) if the preparation is heat sensitive.
Če je pripravek občutljiv na toploto, se čas shranjevanja in/ali temperature lahko ustrezno spremenijo (npr. 8 tednov pri 40 °C ali 12 tednov pri 35 °C ali 18 tednov pri 30 °C).
If the active substance content after the heat stability test has decreased by more than 5 % of the initially found content, the minimum content shall be declared and information on the degradation products shall be supplied.
Če se vsebnost aktivne snovi po opravljenem testu toplotne stabilnosti zmanjša za več kot 5 % od prvotno ugotovljene vsebnosti, je treba navesti najnižjo vsebnost aktivne snovi in predložiti podatke o razgradnih produktih.