natgillin/translations-raw huggingface dataset:
In cases where the product label includes requirements for use of the plant protection product with other plant protection products or with adjuvants as a tank mix, it may be necessary to carry out studies for a combination of plant protection products or for the plant protection product with adjuvant.
Kadar so na oznaki proizvoda navedene zahteve za uporabo fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi ali pomožnimi sredstvi v mešanici v rezervoarju škropilnice, je morda treba izvesti študije za kombinacijo fitofarmacevtskih sredstev ali za fitofarmacevtsko sredstvo s pomožnim sredstvom.
The need to perform supplementary studies shall be discussed with the national competent authorities on a case by case basis, taking into account the results of the acute toxicity studies of the individual plant protection products and the toxicological properties of the active substances, the possibility for exposure to the combination of the products concerned, with particular regard to vulnerable groups, and available information or practical experience with the products concerned or similar products.
Potreba po dodatnih študijah se za vsak primer posebej preuči skupaj z nacionalnimi pristojnimi organi ob upoštevanju rezultatov študij akutne toksičnosti posameznih fitofarmacevtskih sredstev in toksikoloških lastnosti aktivnih snovi, možnosti izpostavljenosti mešanici zadevnih sredstev, pri čemer se posebna pozornost nameni občutljivim skupinam, in razpoložljivih informacij ali praktičnih izkušenj s temi ali podobnimi sredstvi.
For the purpose of this Regulation the following definitions apply:
V tej uredbi se uporabljajo naslednje opredelitve:
operators are people who are involved in activities relating to the application of a plant protection product, such as mixing, loading, application, or relating to cleaning and maintenance of equipment containing a plant protection product;
izvajalci tretiranja so osebe, ki izvajajo dejavnosti, povezane z nanašanjem fitofarmacevtskega sredstva, kot so mešanje, polnjenje in nanos, ali dejavnosti, povezane s čiščenjem in vzdrževanjem opreme, ki vsebuje fitofarmacevtsko sredstvo;
operators may be professionals or amateurs;
izvajalci tretiranja lahko to dejavnost opravljajo poklicno ali nepoklicno;
workers are people who, as part of their employment, enter an area that has previously been treated with a plant protection product or who handle a crop that has been treated with a plant protection product;
delavci so osebe, ki v okviru svojega dela vstopijo na območje, predhodno tretirano s fitofarmacevtskim sredstvom, ali ki ravnajo s kulturo, tretirano s fitofarmacevtskim sredstvom;
bystanders are people who casually are located within or directly adjacent to an area where application of a plant protection product is in process or has taken place, but not for the purpose of working on the treated area or with the treated commodity;
druge navzoče osebe so osebe, ki so naključno na območju, na katerem se nanaša fitofarmacevtsko sredstvo ali je na njem naneseno, ali so neposredno ob zadevnem območju, vendar njihov namen ni delo na tretiranem območju ali delo s tretiranim proizvodom;
residents are people who live, work or attend any institution near to areas that are treated with plant protection products, but not for the purpose of working on the treated area or with the treated commodity.
prebivalci so osebe, ki živijo, delajo ali obiskujejo kakršno koli ustanovo v bližini območij, tretiranih s fitofarmacevtskimi sredstvi, vendar njihov namen ni delo na tretiranem območju ali delo s tretiranim proizvodom.
In cases where the product label includes requirements for use of the plant protection product with other plant protection products or with adjuvants as a tank mix, the exposure assessment shall cover the combined exposure.
Kadar so na oznaki proizvoda navedene zahteve za uporabo fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi ali pomožnimi sredstvi v mešanici v rezervoarju škropilnice, ocena izpostavljenosti zajema skupno izpostavljenost.
Cumulative and synergistic effects shall be taken into account and reported in the dossier.
Upoštevajo se kumulativni in sinergijski učinki, pri čemer se navedejo v dokumentaciji.
Information shall be provided to permit an assessment of the extent of exposure to the active substances and toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use, taking into account cumulative and synergistic effects.
Zagotovijo se informacije, ki omogočajo oceno obsega možne izpostavljenosti aktivnim snovem in toksikološko relevantnim sestavinam fitofarmacevtskega sredstva pri predlaganih pogojih uporabe, pri čemer se upoštevajo kumulativni in sinergijski učinki.
It shall also provide a basis for the selection of the appropriate protective measures including personal protective equipment to be used by operators and to be specified on the label.
Na podlagi teh informacij se določijo tudi ustrezni zaščitni ukrepi, vključno z osebno zaščitno opremo, ki jo morajo uporabljati izvajalci tretiranja in mora biti navedena na oznaki.
An estimation shall be made, using where available a suitable calculation model, in order to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use.
S primernim modelom izračuna, kadar je na voljo, se oceni možna izpostavljenost izvajalca tretiranja pri predlaganih pogojih uporabe.
Where relevant, this estimation shall take into account cumulative and synergistic effects resulting from the exposure to more than one active substance and toxicologically relevant compounds, including those in the product and tank mix.
Pri tej oceni se, kadar je ustrezno, upoštevajo kumulativni in sinergijski učinki izpostavljenosti več kot eni aktivni snovi in toksikološko relevantnim sestavinam, vključno z aktivnimi snovmi in toksikološko relevantnimi sestavinami v proizvodu in mešanici v rezervoarju škropilnice.
An estimation of operator exposure shall always be performed.
Ocena izpostavljenosti izvajalca tretiranja se vedno izvede.
An estimation shall be made for each type of application method and application equipment proposed for use of the plant protection product taking account of the requirements resulting from Regulation (EC) No 1272/2008, where applicable, for handling the undiluted or diluted product.
Ocena se izvede za vsako vrsto metode nanašanja in opreme za nanašanje, ki je predlagana za uporabo fitofarmacevtskega sredstva, pri čemer se, kadar je primerno, za ravnanje z razredčenim ali nerazredčenim proizvodom upoštevajo zahteve iz Uredbe (ES) št. 1272/2008.
The estimation shall address mixing/loading and application, and shall include clean-up activities and routine maintenance of the application equipment.
Ocena zajema mešanje/polnjenje in nanos ter vključuje čiščenje in redno vzdrževanje opreme za nanašanje.
Specific information on local use conditions (types and sizes of containers to be used, application equipment, typical work rates and application rates, spray concentration, field sizes, crop growing climatic conditions) shall be included.
Navedejo se tudi posebne informacije o lokalnih pogojih uporabe (vrste in velikost posod, ki se uporabljajo, oprema za nanašanje, običajni obseg dela in odmerki, koncentracija za škropljenje ali pršenje, velikost polj, podnebni pogoji za pridelavo kultur).
At first an estimation shall be made with the assumption that the operator is not using any personal protective equipment.
Najprej se ocena izvede ob predpostavki, da izvajalec tretiranja ne uporablja osebne zaščitne opreme.
Where appropriate, a further estimation shall be made with the assumption that the operator is using effective and readily obtainable protective equipment, which is feasible to be used in practice.
Kadar je primerno, se izvede dodatna ocena ob predpostavki, da izvajalec tretiranja uporablja učinkovito in lahko dostopno zaščitno opremo, ki je enostavna za uporabo.
Where protective measures are specified on the label, the estimation shall take these into account.
Kadar so zaščitni ukrepi navedeni na oznaki, se upoštevajo pri oceni.
The study shall provide data to permit an evaluation of the operator exposure likely to arise under the specific proposed conditions of use.
S študijo se zagotovijo podatki za oceno možne izpostavljenosti izvajalca tretiranja pri posebnih predlaganih pogojih uporabe.
The study shall be ethically sound.
Študija je etično sprejemljiva.
Exposure data for the relevant exposure routes shall be reported where there are no representative data in available calculation models or where the model-based risk assessment indicates that the relevant reference value is exceeded.
Podatki o izpostavljenosti za ustrezne načine izpostavljenosti se navedejo, kadar pri razpoložljivih modelih izračuna niso na voljo reprezentativni podatki ali kadar je z oceno tveganja, ki temelji na modelu, ugotovljeno, da je ustrezna referenčna vrednost presežena.
This will be the case, where the results of the estimation of operator exposure in accordance with point 7.2.1.1 indicate that one or both of the following conditions are fulfilled:
To velja, kadar je na podlagi rezultatov ocene izpostavljenosti izvajalca tretiranja iz točke 7.2.1.1 ugotovljeno, da je izpolnjen vsaj eden od naslednjih pogojev:
the AOEL established in the context of approval of the active substance may be exceeded;
dopustna izpostavljenost izvajalca tretiranja, določena v dokumentaciji za odobritev aktivne snovi, je morda presežena;
the Limit Values established for the active substance and toxicologically relevant compounds of the plant protection product in accordance with Directive 98/24/EC and Directive 2004/37/EC may be exceeded.
mejne vrednosti, določene za aktivno snov in toksikološko relevantne sestavine fitofarmacevtskega sredstva v skladu z direktivama 98/24/ES in 2004/37/ES, so morda presežene.
The study shall be done under realistic exposure conditions taking into account the proposed conditions of use.
Študija se izvede v stvarnih pogojih izpostavljenosti ob upoštevanju predlaganih pogojev uporabe.
Information shall be provided to permit an assessment of the extent of exposure to the active substances and toxicologically relevant compounds likely to occur under the proposed conditions of use, taking into account, where relevant, cumulative and synergistic effects.
Zagotovijo se informacije, ki omogočajo oceno obsega možne izpostavljenosti aktivnim snovem in toksikološko relevantnim sestavinam pri predlaganih pogojih uporabe, pri čemer se, kadar je ustrezno, upoštevajo kumulativni in sinergijski učinki.
It shall also provide a basis for the selection of appropriate protective measures, including restricted entry intervals, exclusion of residents and bystanders from treatment areas and separation distances.
Na podlagi teh informacij se izberejo tudi ustrezni zaščitni ukrepi, vključno z delovno karenco za omejeni dostop, izključitvijo prebivalcev in drugih navzočih oseb z območij tretiranja in varnimi razdaljami.
An estimation shall be made, using where available a suitable calculation model in order to permit an evaluation of the bystander and resident exposure likely to arise under the proposed conditions of use.
S primernim modelom izračuna, kadar je na voljo, se oceni možna izpostavljenost drugih navzočih oseb in prebivalcev pri predlaganih pogojih uporabe.
The applicant shall take into consideration that bystanders can be exposed during or after the application of plant protection products and residents may be exposed to plant protection products, mainly, but not only, by inhalation and dermal route and that infants and toddlers exposure may also occur by the oral route (through hand-mouth transfer).
Vlagatelj upošteva, da so lahko druge navzoče osebe izpostavljene med nanosom fitofarmacevtskih sredstev ali po njem ter da so lahko prebivalci izpostavljeni fitofarmacevtskim sredstvom zlasti z vdihavanjem in prek kože, dojenčki in majhni otroci pa tudi z zaužitjem (prenos z rokami v usta).
An estimation of bystander and resident exposure shall always be performed.
Ocena izpostavljenosti drugih navzočih oseb in prebivalcev se vedno izvede.
An estimation of bystander and resident exposure shall be made for each relevant type of application method.
Ocena izpostavljenosti drugih navzočih oseb in prebivalcev se izvede za vsako ustrezno vrsto metode nanašanja.
Specific information including maximum total dose and spray concentration shall be included.
Navedejo se tudi posebne informacije, vključno z največjim skupnim odmerkom ter koncentracijo za škropljenje in pršenje.
The estimation shall be made with the assumption that bystanders and residents do not use any personal protective equipment.
Ocena se izvede ob predpostavki, da druge navzoče osebe in prebivalci ne uporabljajo osebne zaščitne opreme.
The study shall provide data to permit an evaluation of the bystander and resident exposure likely to arise under the specific proposed conditions of use.
S študijo se zagotovijo podatki za oceno možne izpostavljenosti drugih navzočih oseb in prebivalcev pri posebnih predlaganih pogojih uporabe.
Exposure data for the relevant exposure routes shall be required where the model based risk assessment indicates that the relevant reference value is exceeded or where there are no representative data in available calculation models.
Podatke o izpostavljenosti za ustrezne načine izpostavljenosti je treba navesti, kadar je z oceno tveganja, ki temelji na modelu, ugotovljeno, da je ustrezna referenčna vrednost presežena, ali kadar pri razpoložljivih modelih izračuna niso na voljo reprezentativni podatki.
Information shall be provided to permit an assessment of the extent of exposure to the active substances and toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use and agricultural practices, taking into account cumulative and synergistic effects.
Zagotovijo se informacije, ki omogočajo oceno obsega možne izpostavljenosti aktivnim snovem in toksikološko relevantnim sestavinam fitofarmacevtskega sredstva pri predlaganih pogojih uporabe in kmetijski praksi, pri čemer se upoštevajo kumulativni in sinergijski učinki.
It shall also provide a basis for the selection of appropriate protective measures, including waiting and re-entry periods.
Na podlagi teh informacij se izberejo tudi ustrezni zaščitni ukrepi, vključno s čakalno dobo in karencami za ponovni dostop.
An estimation shall be made using, where available, a suitable calculation model, in order to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use.
S primernim modelom izračuna, kadar je na voljo, se oceni možna izpostavljenost delavca pri predlaganih pogojih uporabe.
The estimation of worker exposure shall be completed when such exposure could arise under the proposed conditions of use.
Ocena izpostavljenosti delavca se izvede, kadar je takšna izpostavljenost pri predlaganih pogojih uporabe možna.
An estimation of worker exposure shall be made for crops and tasks to be carried out.
Ocena izpostavljenosti delavca se izvede za kulture in naloge, ki jih delavec opravlja.
Specific information including description of post-applications activities, exposure duration, application rate, number of applications, minimum spray interval and growth stage, shall be provided.
Navedejo se tudi posebne informacije, vključno z opisom dejavnosti po nanašanju, trajanjem izpostavljenosti, odmerkom, številom nanosov, najkrajšim presledkom med škropljenjem ali pršenjem in stopnjo rasti.
If data on the amount of dislodgeable residues under the proposed conditions of use are not available, default assumptions shall be used.
Kadar podatki o količini ostankov, ki jih je mogoče odstraniti, pri predlaganih pogojih uporabe niso na voljo, se uporabijo privzete predpostavke.
At first, the estimation shall be made using available data on the exposure to be expected with the assumption that the worker is not using any personal protective equipment.
Najprej se izvede ocena, pri kateri se uporabijo razpoložljivi podatki o pričakovani izpostavljenosti ob predpostavki, da delavec ne uporablja osebne zaščitne opreme.
Where appropriate, a second estimation shall be made with the assumption that the worker is using effective and readily obtainable protective equipment which is feasible to be used and will be worn habitually by workers, for example because it was necessitated by other aspects of task being undertaken.
Kadar je primerno, se izvede druga ocena ob predpostavki, da delavec uporablja učinkovito in lahko dostopno zaščitno opremo, ki je enostavna za uporabo in jo bodo delavci običajno uporabljali, ker je na primer nujna zaradi drugih vidikov naloge, ki jo mora delavec opraviti.
The study shall provide data to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use.
S študijo se zagotovijo podatki za oceno možne izpostavljenosti delavca pri predlaganih pogojih uporabe.
Exposure data for the relevant exposure routes shall be reported where the model based risk assessment indicates that the relevant reference value is exceeded or where there are no representative data in available calculation models.
Podatki o izpostavljenosti za ustrezne načine izpostavljenosti se navedejo, kadar je z oceno tveganja, ki temelji na modelu, ugotovljeno, da je ustrezna referenčna vrednost presežena, ali kadar pri razpoložljivih modelih izračuna niso na voljo reprezentativni podatki.
This will be the case, where the results of the estimation of worker exposure in accordance with point 7.2.3.1 indicate that one or both of the following conditions are fulfilled:
To velja, kadar je na podlagi rezultatov ocene izpostavljenosti delavca iz točke 7.2.3.1 ugotovljeno, da je izpolnjen vsaj eden od naslednjih pogojev:
The studies shall provide a measurement of the absorption through the skin of the active substances and toxicologically relevant compounds in the plant protection product to be authorised.
S študijami se izmeri absorpcija aktivnih snovi in toksikološko relevantnih sestavin fitofarmacevtskega sredstva, ki ga je treba registrirati, prek kože.
The study shall be conducted when dermal exposure is a significant exposure route, and no acceptable risk is estimated using default absorption value.
Študija se izvede, kadar je dermalna izpostavljenost pomemben način izpostavljenosti in kadar na podlagi privzete absorpcijske vrednosti ni ocenjeno sprejemljivo tveganje.
Data from absorption studies, preferably using human skin in vitro, shall be reported.
Navedejo se podatki iz študij o absorpciji, pri katerih se po možnosti uporablja človeška koža in vitro.
Studies shall be performed on representative plant protection products at both in use dilution (when applicable) as well as the concentrated form.
Študije se izvedejo z reprezentativnimi fitofarmacevtskimi sredstvi v razredčeni (kadar je primerno) in koncentrirani obliki.
In case studies do not correspond with the anticipated exposure situation (for example with regard to the type of co-formulant or the concentration), scientific argument shall be provided before such data can be used with confidence.
Kadar študije ne ustrezajo predvidenemu stanju izpostavljenosti (na primer glede vrste dodatka ali koncentracije), se lahko takšni podatki z zaupanjem uporabijo šele, kadar se zagotovi znanstvena utemeljitev.
Where relevant, the applicant shall submit and assess the following information:
Kadar je ustrezno, vlagatelj predloži in oceni naslednje informacije:
the registration number in accordance with Article 20(3) of Regulation (EC) No 1907/2006);
registracijsko številko v skladu s členom 20(3) Uredbe (ES) št. 1907/2006;
the safety data sheet referred to in Article 31 of Regulation (EC) No 1907/2006.
varnostni list iz člena 31 Uredbe (ES) št. 1907/2006.
The safety data sheet under point (c) shall also be submitted and assessed for the plant protection product.
Varnostni list iz točke (c) se predloži in oceni tudi za fitofarmacevtsko sredstvo.
Any other available information shall be submitted.
Predložijo se tudi vse druge razpoložljive informacije.
Data and information on residues in or on treated products, food and feed in accordance with Section 6 of Part A of the Annex to Regulation (EU) No 283/2013 shall be submitted, unless the applicant shows that the data and information already submitted for the active substance can be applied.
Predložijo se podatki in informacije o ostankih v tretiranih proizvodih, živilih in krmi ali na njih v skladu z oddelkom 6 dela A Priloge k Uredbi (EU) št. 283/2013, razen če vlagatelj dokaže, da se lahko uporabijo podatki in informacije, ki so predložene že za aktivno snov.
Predicted environmental concentrations (PEC).
Predvidene okoljske koncentracije (PEC)
A realistic worst-case estimation shall be made of the expected concentrations of the active substance and metabolites, breakdown and reaction products:
Izvede se realistična ocena v najhujšem možnem primeru za pričakovane koncentracije aktivne snovi in metabolitov ter razgradnih in reakcijskih produktov:
which account for more than 10 % of the amount of active substance added,
ki predstavljajo več kot 10 % količine dodane aktivne snovi,
which account for more than 5 % of the amount of active substance added, in at least two sequential measurements,
ki pri vsaj dveh zaporednih merjenjih predstavljajo več kot 5 % količine dodane aktivne snovi,
for whose individual components (> 5 %) the maximum of formation is not yet reached at the end of the study, in soil, surface in soil, groundwater, surface water, sediment and air, following use as proposed or already occurring.
katerih posamezne sestavine (> 5 %) se ob koncu študije še ne tvorijo v največjem obsegu v tleh, na površini tal, v podtalnici, površinskih vodah, usedlini in zraku po predlagani uporabi ali trenutni uporabi.
Predicted environmental concentration in soil (PEC S)
predvidena okoljska koncentracija v tleh (PEC S)
the level of residues in the top layer of the soil and to which non-target soil organisms may be exposed (acute and chronic exposure).
koncentracija ostankov v zgornjem sloju tal, ki so jim lahko izpostavljeni neciljni talni organizmi (akutna in kronična izpostavljenost);
Predicted environmental concentration in surface water (PEC SW)
predvidena okoljska koncentracija v površinskih vodah (PEC SW)
the level of residues, in surface water to which non-target organisms may be exposed (acute and chronic exposure).
koncentracija ostankov v površinskih vodah, ki so jim lahko izpostavljeni neciljni organizmi (akutna in kronična izpostavljenost);
Predicted environmental concentration in sediment (PEC SED)
predvidena okoljska koncentracija v usedlini (PEC SED)
the level of residues, in sediment to which non-target benthic organisms may be exposed (acute and chronic exposure).
koncentracija ostankov v usedlini, ki so jim lahko izpostavljeni neciljni bentoški organizmi (akutna in kronična izpostavljenost);
Predicted environmental concentration in groundwater (PEC GW)
predvidena okoljska koncentracija v podtalnici (PEC GW)
the level of residues in groundwater.
koncentracija ostankov v podtalnici;
Predicted environmental concentration in air (PEC A)
predvidena okoljska koncentracija v zraku (PEC A)
the level of residues in air, to which man, animals and other non-target organisms may be exposed (acute and chronic exposure).
koncentracija ostankov v zraku, ki so jim lahko izpostavljeni ljudje, živali in drugi neciljni organizmi (akutna in kronična izpostavljenost).
For the estimation of these concentrations all relevant information on the plant protection product and on the active substance shall be taken into account.
Pri oceni teh koncentracij se upoštevajo vse relevantne informacije o fitofarmacevtskem sredstvu in aktivni snovi.
Where relevant the parameters set out in Section 7 of Part A of the Annex to Regulation (EU) No 283/2013 shall be used.
Kadar je ustrezno, se uporabljajo parametri iz oddelka 7 dela A Priloge k Uredbi (EU) št. 283/2013.
When models are used for estimation of predicted environmental concentrations they shall:
Kadar se za oceno predvidenih okoljskih koncentracij uporabijo modeli, zanje velja naslednje: