natgillin/translations-raw huggingface dataset:
When measuring exposure to a plant protection product in the air within the breathing area of operators, bystanders or workers the requirements of Council Directive 98/24/EC [11] and Directive 2004/37/EC of the European Parliament and of the Council [12] have to be taken into account.7.2.1. Operator exposure
Pri merjenju izpostavljenosti izvajalcev tretiranja, drugih navzočih oseb ali delavcev fitofarmacevtskemu sredstvu v zraku na območju vdihavanja je treba upoštevati zahteve iz Direktive Sveta 98/24/ES [11] in Direktive 2004/37/ES Evropskega parlamenta in Sveta [12].7.2.1 Izpostavljenost izvajalca tretiranja
The risks for those using plant protection products depend on the physical, chemical and toxicological properties of the plant protection product as well as the type of the product (undiluted/diluted), and on the route, the degree and duration of exposure.
Tveganja za tiste, ki uporabljajo fitofarmacevtska sredstva, so odvisna od fizikalnih, kemijskih in toksikoloških lastnosti sredstva kot tudi od vrste sredstva (razredčeno/nerazredčeno) ter od oblike, stopnje in trajanja izpostavljenosti.
Sufficient information and data must be generated and reported to permit an assessment of the extent of exposure to the active substance(s) and/or toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use.
Pridobiti je treba dovolj informacij in podatkov ter jih predložiti za oceno obsega izpostavljenosti aktivnim snovem in/ali toksikološko relevantnim sestavinam v fitofarmacevtskem sredstvu, ki se lahko pojavijo pri predlaganih pogojih uporabe.
It must 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.
Podatki morajo zagotoviti tudi podlago za izbiro ustreznih zaščitnih ukrepov, vključno z osebno zaščitno opremo, ki jo morajo uporabljati izvajalci tretiranja in mora biti navedena na oznaki.
Estimation of operator exposure
Ocena izpostavljenosti izvajalca tretiranja
Aim of the estimation
Namen ocene
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 pomočjo primernega matematičnega modela, kadar je ta na voljo, je treba oceniti možno izpostavljenost izvajalca tretiranja ob predlaganih pogojih uporabe.
An estimation of operator exposure must always be completed.
Oceno izpostavljenosti izvajalca tretiranja je vedno treba izvesti.
Estimation conditions
Pogoji ocene
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 the implementation of the classification and labelling provisions of Directive 1999/45/EC or Regulation (EC) No 1272/2008 for handling the undiluted or diluted product as well as the different types and sizes of containers to be used, mixing, loading operations, application of the plant protection product, the climatic conditions and cleaning and routine maintenance of application equipment.
Ocenijo se vse vrste nanašanja in predlagane opreme za uporabo fitofarmacevtskega sredstva ob upoštevanju zahtev o razvrščanju in označevanju iz Direktive 1999/45/ES ali Uredbe (ES) št. 1272/2008 v zvezi z ravnanjem z nerazredčenim ali razredčenim sredstvom in različnimi vrstami in velikostmi posod, ki se uporabljajo za mešanje, polnjenje, nanos fitofarmacevtskega sredstva, ter podnebnih razmer, čiščenja in rednega vzdrževanja opreme za nanos.
At first an estimation shall be made with the assumption that the operator is not using any personal protective equipment.
Najprej se ocena izdela ob predpostavki, da izvajalec tretiranja ne uporablja osebne zaščitne opreme.
Where appropriate, a second estimation shall be made with the assumption that the operator is using effective and readily obtainable protective equipment which is feasible to be used by the operator.
Kadar je to primerno, se izdela druga ocena ob predpostavki, da izvajalec tretiranja uporablja učinkovito in lahko dosegljivo zaščitno opremo, ki je enostavna za uporabo.
Where protective measures are specified on the label, the estimation will take these into account.
Kadar so zaščitni ukrepi navedeni na oznaki, se to v oceni upošteva.
Measurement of operator exposure
Meritve izpostavljenosti izvajalca tretiranja
The test shall provide sufficient data to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use.
Test zagotovi dovolj podatkov za oceno izpostavljenosti izvajalca tretiranja, ki se lahko pojavi ob predlaganih pogojih uporabe.
Actual exposure data for the relevant exposure route(s) must be reported where the risk assessment indicates that a health-based limit value is exceeded.
Predložiti je treba podatke o dejanski izpostavljenosti za relevantne oblike izpostavljenosti, kadar ocena tveganja pokaže, da je presežena zdravju škodljiva mejna vrednost.
This will, for example, be the case when the results of the estimation of operator exposure provided for under point 7.2.1.1 indicate that:
To se na primer zgodi, ko rezultati ocene izpostavljenosti izvajalca tretiranja iz točke 7.2.1.1 kažejo, da so:
the Acceptable Operator Exposure Level(s) (AOEL) established in the context of approval of the active substance, and/or
sprejemljive ravni izpostavljenosti izvajalca tretiranja, določene v dokumentaciji za odobritev aktivne snovi, in/ali
the limit values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product in accordance with Directives 98/24/EC and 2004/37/EC on the protection of workers,
mejne vrednosti, določene za aktivno snov in/ali toksikološko relevantne sestavine fitofarmacevtskega sredstva v skladu z direktivama 98/24/ES in 2004/37/EGS o varovanju delavcev,
may be exceeded.
morda presežene.
Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under point 7.2.1.1.
Podatke o dejanski izpostavljenosti je treba predložiti tudi, kadar ni na voljo ustreznega matematičnega modela ali ustreznih podatkov za oceno iz točke 7.2.1.1.
In cases where dermal exposure is the most important exposure route, a dermal absorption test or the results of a sub-acute dermal study, if not already available, may be a useful alternative test to provide data in order to refine the estimate provided for under point 7.2.1.1.
Kadar je izpostavljenost kože najpomembnejša oblika izpostavljenosti, so test dermalne absorpcije ali rezultati subakutne dermalne študije, če že niso na voljo, uporaben alternativni test za zagotovitev podatkov za izboljšanje ocene iz točke 7.2.1.1.
The test must be done under realistic exposure conditions taking into account the proposed conditions of use.
Test je treba izvesti v realnih pogojih izpostavljenosti ob upoštevanju predlaganih pogojev uporabe.
Bystander exposure
Izpostavljenost drugih navzočih oseb
Bystanders can be exposed during the application of plant protection products.
Pri nanašanju fitofarmacevtskih sredstev so lahko izpostavljene tudi druge navzoče osebe.
Sufficient information and data must be reported to provide a basis for the selection of appropriate conditions of use, including the exclusion of bystanders from treatment areas and separation distances.
Predložiti je treba dovolj informacij in podatkov, da se zagotovi podlaga za izbiro primernih pogojev uporabe, da se izključijo druge navzoče osebe iz območja tretiranja ter določijo varne razdalje.
An estimation shall be made, using where available a suitable calculation model in order to permit an evaluation of the bystander exposure likely to arise under the proposed conditions of use.
Ocena se izdela ob uporabi primernega matematičnega modela, kadar je ta na voljo, ter se oceni morebitna izpostavljenost drugih navzočih oseb ob predlaganih pogojih uporabe.
An estimation of bystander exposure must always be completed.
Oceno izpostavljenosti navzočih oseb je treba vedno izdelati.
An estimation of bystander exposure must be made for each type of application method.
Oceno izpostavljenosti drugih navzočih oseb je treba izdelati za vsako metodo nanosa.
The estimation shall be made with the assumption that bystanders do not use any personal protective equipment.
Ocena se izdela ob predpostavki, da te osebe ne uporabljajo osebne zaščitne opreme.
Measurement of bystander exposure may be required when estimates indicate a cause for concern.
Meritve izpostavljenosti drugih navzočih oseb se lahko zahtevajo, ko ocene pokažejo vzrok za skrb.
Worker exposure
Izpostavljenost delavca
Workers can be exposed following application of plant protection products, when entering treated fields or premises or handling treated plants or plant products on which residues remain.
Delavci so lahko izpostavljeni po nanosu fitofarmacevtskih sredstev, ko vstopajo na tretirana polja ali v prostore ali pri ravnanju s tretiranimi rastlinami ali rastlinskimi proizvodi, na katerih ostajajo ostanki.
Sufficient information and data must be reported to provide a basis for the selection of appropriate protective measures, including waiting and re-entry periods.
Predložiti je treba dovolj informacij in podatkov, da se zagotovi podlaga za izbiro primernih zaščitnih ukrepov, vključno s čakalno dobo in karencami za ponovni dostop.
Estimation of worker exposure
Ocena izpostavljenosti delavca
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.
Oceno je treba izdelati ob uporabi primernega matematičnega modela, kadar je ta na voljo, za oceno izpostavljenosti delavca ob predlaganih pogojih uporabe.
The estimation of worker exposure must always be completed.
Oceno izpostavljenosti delavca je treba vedno izdelati.
An estimation of worker exposure must be made for each crop and task to be carried out.
Oceno izpostavljenosti delavca je treba izdelati za vsako kulturo in vsako nalogo, ki jo delavec opravi.
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 izdela ocena ob uporabi dostopnih podatkov 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.
Kadar je to primerno, se izdela druga ocena ob predpostavki, da delavec uporablja učinkovito in lahko dostopno zaščitno opremo, ki je enostavna za uporabo.
Where appropriate, a further estimation shall be made using data generated on the amount of dislodgeable residues under the proposed conditions of use.
Kadar je to primerno, se izdela nadaljnja ocena ob uporabi podatkov o količini ostankov, ki jih je mogoče odstraniti, ob predlaganih pogojih uporabe.
Measurement of worker exposure
Meritve izpostavljenosti delavca
The test shall provide sufficient data to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use.
Test zagotovi dovolj podatkov za oceno izpostavljenosti delavca, ki se lahko pojavijo ob predlaganih pogojih uporabe.
This will, for example, be the case where the results of the estimation of worker exposure provided for under point 7.2.3.1 indicate that:
To se na primer zgodi, kadar rezultati ocene izpostavljenosti delavca iz točke 7.2.3.1 kažejo, da so:
the AOEL(s) established in the context of approval of the active substance(s), and/or
sprejemljive ravni izpostavljenosti izvajalca tretiranja, določene v dokumentaciji za odobritev aktivnih snovi, in/ali
the limit values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product in accordance with Directives 98/24/EC and 2004/37/EC,
mejne vrednosti, določene za aktivno snov in/ali toksikološko relevantne sestavine fitofarmacevtskega sredstva v skladu z direktivama 98/24/ES in 2004/37/ES
Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under point 7.2.3.1.
Podatke o dejanski izpostavljenosti je treba predložiti tudi, kadar ni na voljo ustreznega matematičnega modela izračuna ali ustreznih podatkov za oceno iz točke 7.2.3.1.
Where dermal exposure is the most important exposure route, a dermal absorption test, if not already available, may be a useful alternative test to provide data in order to refine the estimate provided for under point 7.1.3.1.
Kadar je izpostavljenost kože najpomembnejša oblika izpostavljenosti, je test dermalne absorpcije, če že ni na voljo, lahko uporaben alternativni test za zagotovitev podatkov za izboljšanje ocene iz točke 7.1.3.1.
Dermal absorption
Dermalna absorpcija
The test shall provide a measurement of the absorption of the active substance and toxicologically relevant compounds through the skin.
Test zagotovi meritev absorpcije aktivne snovi in toksikološko relevantnih sestavin prek kože.
The study must be conducted when dermal exposure is a significant exposure route and where the risk assessment indicates that a health-based limit value is exceeded.
Študijo je treba izvesti, ko je dermalna izpostavljenost pomembna oblika izpostavljenosti in kadar ocena tveganja pokaže, da je presežena zdravju škodljiva mejna vrednost.
This will, for example, be the case where the results of the estimation or measurement of operator exposure provided for under points 7.2.1.1 or 7.2.1.2 indicate that:
To se na primer zgodi, kadar rezultati ocene ali meritve izpostavljenosti izvajalca tretiranja iz točk 7.2.1.1 ali 7.2.1.2 kažejo, da so:
In principle data of an in vivo rat skin absorption study must be reported.
Načeloma je treba predložiti študijo o in vivo absorpciji prek kože podgane.
If, when the results of the estimation using these in vivo skin absorption data are incorporated in the risk assessment, there remains an indication of excessive exposure, it may be necessary to perform an in vitro comparative absorption study on rat and human skin.
Če potem, ko se rezultati ocene na podlagi podatkov o in vivo absorpciji prek kože vključijo v oceno tveganja, obstaja indikacija o preseženi izpostavljenosti, je morda treba opraviti in vivo primerjalno študijo o absorpciji prek kože podgane in človeka.
The test must be carried out in accordance with Method B 44 or B 45 of Regulation (EC) No 440/2008.
Test je treba izvajati v skladu z metodo B 44 ali B 45 Uredbe (ES) št. 440/2008.
Where relevant, the following information shall be submitted for each co-formulant:
Kadar je to relevantno, se za vsako pomožno snov v formulaciji predložijo naslednje informacije:
the registration number as referred to in Article 20(3) of Regulation (EC) No 1907/2006;
registracijska številka iz člena 20(3) Uredbe (ES) št. 1907/2006;
the study summaries included in the technical dossier as referred to in Article 10(a)(vi) of Regulation (EC) No 1907/2006; and
povzetki študije, vključeni v tehnično dokumentacijo, kot je določeno v členu 10(a)(vi) Uredbe (ES) št. 1907/2006, in
the safety data sheet as referred to in Article 31 of Regulation (EC) No 1907/2006.
varnostni list iz člena 31 Uredbe (ES) št. 1907/2006.
All other available information shall be submitted.
Predložijo se tudi vse druge dostopne informacije.
The provisions of the introduction to Section 6 of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se določbe uvoda oddelka 6 Priloge k Uredbi (EU) št. 544/2011.
Metabolism, distribution and expression of residue in plants or livestock
Presnova, porazdelitev in izražanje ostanka pri rastlinah ali živini
The objectives of these studies are:
Cilja teh študij sta:
to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed,
pripraviti oceno skupnih končnih ostankov v ustreznem deležu kultur ob spravilu po predlagani uporabi fitofarmacevtskih sredstev,
to identify the major components of the total terminal residue in crops and in edible animal products respectively,
opredeliti glavne sestavine skupnih končnih ostankov pri kulturah oziroma užitnih proizvodih živalskega izvora,
to indicate the distribution of residues between relevant crop parts and between relevant edible animal products respectively,
pokazati porazdelitev ostankov med ustreznimi deli kultur in med ustreznimi užitnimi proizvodi živalskega izvora,
to generate data from which a decision on the need for livestock feeding studies as provided for in point 8.3 can be made,
pridobiti podatke, na podlagi katerih se je mogoče odločiti o potrebi po študijah o krmljenju živine, kakor je določeno v točki 8.3,
Supplementary metabolism studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance with the requirements of points 6.1 and 6.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Dodatne študije o presnovi se izvedejo le, če podatkov ni mogoče ekstrapolirati iz podatkov o aktivni snovi, pridobljenih v skladu z zahtevami iz točk 6.1 in 6.2 dela A Priloge k Uredbi (EU) št. 544/2011.
This might be the case for crops or for livestock for which data were not submitted in the framework of approval of the active substance(s) under Regulation (EC) No 1107/2009 or were not necessary for amending the conditions of its approval or where it could be expected that a different metabolism will occur.
To bi lahko veljalo za kulture ali živino, za katero niso bili predloženi podatki v okviru odobritve aktivnih snovi v skladu z Uredbo (ES) št. 1107/2009 ali niso bili potrebni za spremembo pogojev njihove odobritve ali kadar bi bilo mogoče pričakovati, da bo presnova drugačna.
The same provisions as provided under the corresponding paragraphs of points 6.1 and 6.2 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se določbe iz ustreznih odstavkov točk 6.1 in 6.2 dela A Priloge k Uredbi (EU) št. 544/2011.
to determine, when appropriate, the rate of decline of pesticide deposits.
določiti, kadar je to primerno, hitrost upadanja nakopičenih pesticidov.
Supplementary residue trials only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of point 6.3 of Part A of the Annex to Regulation (EU) No 544/2011.
Dodatni poskusi ostankov se izvedejo le, če podatkov ni mogoče ekstrapolirati iz podatkov o aktivni snovi, pridobljenih v skladu z zahtevami iz točke 6.3 dela A Priloge k Uredbi (EU) št. 544/2011.
This might be the case for special formulations, for special application methods or for crops for which data were not submitted in the framework of approval of the active substance or were not necessary for amending the conditions of its approval.
To velja za posebne formulacije, posebne metode nanašanja ali za kulture, za katere niso bili predloženi podatki v okviru odobritve aktivne snovi ali če niso bili potrebni za spremembo pogojev njihove odobritve.
The same provisions as provided under the corresponding paragraphs of point 6.3 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se določbe iz ustreznih odstavkov točke 6.3 Priloge k Uredbi (EU) št. 544/2011.
The objective of these studies is to determine the residue in products of animal origin which will result from residues in feedingstuffs or fodder crops.
Cilj teh študij je določiti ostanke v proizvodih živalskega izvora, ki so posledica ostankov v krmi ali krmnih rastlinah.
Supplementary feeding studies for the purpose of assessing maximum residue levels for products of animal origin are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of point 6.4 of Part A of the Annex to Regulation (EU) No 544/2011.
Dodatne študije o krmljenju za oceno mejnih vrednostih ostankov v proizvodih živalskega izvora se izvedejo le, če podatkov ni mogoče ekstrapolirati iz podatkov o aktivni snovi, pridobljenih v skladu z zahtevami iz točke 6.4 dela A Priloge k Uredbi (EU) št. 544/2011.
This might be the case where additional fodder crops are to be authorised which leads to an increased intake of residues of livestock for which data were not submitted in the framework of approval of the active substance(s) or were not necessary for amending the conditions of its approval.
To velja za primere, kadar se zahteva dodatna registracija za uporabo fitofarmacevtskega sredstva na novih krmnih rastlinah, kar vodi k povečanemu vnosu ostankov v živino, za katere niso bili predloženi podatki v okviru odobritve aktivnih snovi ali če niso bili potrebni za spremembo pogojev njihove odobritve.
The same provisions as provided under the corresponding paragraphs of point 6.4 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se določbe iz ustreznih odstavkov točke 6.4 dela A Priloge k Uredbi (EU) št. 544/2011.
to establish whether or not breakdown or reaction products arise from residues in the raw products during processing which may require a separate risk assessment,
ugotoviti, ali med predelavo iz ostankov v surovih proizvodih nastajajo razgradni ali reakcijski produkti, ki bi zahtevali ločeno oceno tveganja,
Supplementary studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of point 6.5 of Part A of the Annex to Regulation (EU) No 544/2011.
Dodatne študije se izvedejo le, če podatkov o presnovi ni mogoče ekstrapolirati iz podatkov o aktivni snovi, predloženih v skladu z zahtevami iz točke 6.5 dela A Priloge k Uredbi (EU) št. 544/2011.
This might be the case for crops for which data were not submitted in the framework of approval of the active substance or were not necessary for amending the conditions of its approval.
To velja za kulture, za katere niso bili predloženi podatki v okviru odobritve aktivne snovi ali če niso bili potrebni za spremembo pogojev njene odobritve.
The same provisions as provided under the corresponding paragraphs of point 6.5 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se določbe iz ustreznih odstavkov točke 6.5 dela A Priloge k Uredbi (EU) št. 544/2011.
Supplementary studies are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of point 6.6 of Part A of the Annex to Regulation (EU) No 544/2011.
Dodatne študije se izvedejo le, če podatkov o presnovi ni mogoče ekstrapolirati iz podatkov o aktivni snovi, pridobljenih v skladu z zahtevami iz točke 6.6 dela A Priloge k Uredbi (EU) št. 544/2011.
The same provisions as provided under the corresponding paragraphs of point 6.6 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se določbe iz ustreznih odstavkov točke 6.6 dela A Priloge k Uredbi (EU) št. 544/2011.
Proposed maximum residue levels (MRLs) and residue definition
Predlagane mejne vrednosti ostankov (MRL) ter opredelitev ostankov
A full justification for the proposed MRLs must be provided, including, where relevant, full details of the statistical analysis used.
Predložiti je treba popolno utemeljitev predlaganih mejnih vrednosti ostankov, skupaj z vsemi podrobnostmi statistične analize, kadar je to relevantno.
If the metabolism studies submitted in accordance with the provisions of point 8.1 indicate that the residue definition shall be changed taking into account the actual residue definition and the necessary judgement as outlined under the corresponding paragraph of point 6.7 of Part A of the Annex to Regulation (EU) No 544/2011, a re-evaluation of the active substance may be necessary.
Če študije o presnovi, predložene v skladu z določbami točke 8.1, pokažejo, da je treba spremeniti opredelitev ostankov ob upoštevanju dejanske opredelitve ostankov in potrebne ocene, kot je opisana v ustreznem odstavku točke 6.7 dela A Priloge k Uredbi (EU) št. 544/2011, bo morda potrebna ponovna ocena aktivne snovi.