natgillin/translations-raw huggingface dataset:
MRLs shall be proposed at levels that ensure that the total amount of residues from all sources likely to be ingested do not exceed the ADI.
Pri ocenjevanju takih snovi se opravi posvetovanje z Evropsko agencijo za varnost hrane (EFSA).
In the case of substances also used as plant protection products, a general guidance figure for the portion of the ADI that may be reserved for veterinary use shall be 45 % of the ADI.
Ostanki na mestu injiciranja
Where the existing pesticide product authorisation allows and sufficient data are available on intake from plant protection use, it may be possible to allocate a larger part to veterinary use without exceeding the ADI.
Najvišja mejna vrednost ostankov za mišičje se določi na ravni za spremljanje ostankov v mišičju, ki ne vključuje mesta injiciranja, saj potrošniki navadno zaužijejo mišičje, ki ne vključuje mesta injiciranja, redko pa zaužijejo mišičje, ki vključuje mesto injiciranja.
In order to identify the proportion of the ADI that is available, the MRL approved for the plant protection product shall be taken into account.
Za snovi, ki jih je mogoče injicirati in pri katerih bi se zaradi znižanja koncentracije ostankov na mestu injiciranja v primerjavi z najvišjo mejno vrednostjo ostankov v mišičju (čezmerno) podaljšala karenca, agencija določi tudi referenčno vrednost ostankov na mestu injiciranja.
As the methodology used in establishing MRLs for edible tissues for plant protection products differs to that used for veterinary use, care shall be taken when combining the estimated exposure risk from the different methodologies.
Referenčna vrednost ostankov na mestu injiciranja se določi na ravni, ki zagotavlja, da bi ob verjetni karenci standardna prehrambna košarica, ki vključuje 300 g mišičja z mestom injiciranja, vsebovala ostanke pod sprejemljivim dnevnim vnosom.
For dual-use substances used as biocides in animal husbandry, the CVMP Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides shall be followed.
Referenčna vrednost ostankov na mestu injiciranja se ne objavi v Prilogi k Uredbi (ES) št. 37/2010; na voljo je samo v evropskem javnem poročilu o oceni najvišjih mejnih vrednosti ostankov in se uporabi za izpeljavo karence pri zdravilih za uporabo v veterinarski medicini.
With regard to feed additives, consultation with the European Union Register of Feed Additives shall indicate if the substance has been authorised for use in animal feed.
PREUČITEV MOŽNOSTI EKSTRAPOLACIJE NAJVIŠJIH MEJNIH VREDNOSTI OSTANKOV
When evaluating such substances, EFSA shall be consulted.
Ekstrapolacija najvišjih mejnih vrednosti ostankov se preuči v skladu z zahtevami iz Uredbe Komisije (EU) 2017/880.
Injection site residues
Kadar so na voljo podatki, ki so lahko koristni v zvezi s preučitvijo ekstrapolacije, se predložijo kot del dokumentacije.
The muscle MRL shall be set at a level for monitoring of residues in non-injection site muscle, as consumers routinely ingest non-injection site muscle and rarely ingest injection site muscle.
Maščevje in koža v naravnem razmerju pri prašičih.
For those injectable substances for which depletion of injection site residues when compared to the muscle MRL would result in extended (prohibitive) withdrawal periods, an Injection Site Residue Reference Value (‘ISRRV’) shall also be established by the Agency.
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001, str. 1).
The ISRRV shall be set at a level that ensures that, at the likely withdrawal period, a standard food basket including 300g of injection site muscle would contain residues below the ADI.
Risk characterisation and assessment of maximum residue limits (MRL) for biocides (Opredelitev tveganja in ocena najvišjih mejnih vrednosti ostankov za biocide, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001541.jsp&mid=WC0b01ac05804aca04).
The ISRRV shall not be published in the Annex to Regulation (EU) No 37/2010; the value shall only be available in the European Public MRL Assessment Report (‘EPMAR’) and shall be used when deriving a withdrawal period for the veterinary medicinal product.
Uredba Komisije (EU) 2017/880 z dne 23. maja 2017 o določitvi pravil o uporabi mejne vrednosti ostanka, določene za posamezno farmakološko aktivno snov v posameznem živilu, za drugo živilo, pridobljeno iz iste vrste, in o uporabi mejne vrednosti ostanka, določene za posamezno farmakološko aktivno snov v eni ali več vrstah, za druge vrste, v skladu z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta (UL L 135, 24.5.2017, str. 1).
CONSIDERATIONS ON POSSIBLE EXTRAPOLATION OF MRLs
se povzame in obravnava zadevna znanstvena literatura, vključno s poročili o ocenah, ki so jih izvedli drugi znanstveni organi (kot so Evropska agencija za varnost hrane (EFSA), Evropska agencija za kemikalije (ECHA) ter Skupni strokovni odbor za aditive za živila Organizacije za prehrano in kmetijstvo (FAO)/Svetovne zdravstvene organizacije (SZO)).
The extrapolation of MRLs shall be considered in line with the requirements as set out in the Commission Regulation (EU) 2017/880.
Če se uporabijo podrobni sklici na objavljeno znanstveno literaturo, morajo biti čim bolj izpolnjene vse zahteve iz točke I.5;
Data that may be useful in relation to the extrapolation considerations shall be submitted as part of the dossier, where available.
Ocene dnevne prehranske izpostavljenosti za esencialne elemente je mogoče primerjati z ustreznimi referenčnimi vrednostmi, kot so priporočeni dnevni vnos, referenčne hranilne vrednosti (prej: priporočeni dnevni vnosi), dopustni dnevni vnosi ali dopustni tedenski vnosi in začasni dopustni tedenski vnosi.
Fat and skin in natural proportions for pigs
Te vrednosti se lahko v oceni tveganja uporabijo podobno kot sprejemljivi dnevni vnos.
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
Kombinirana izpostavljenost zaradi ostankov, povezanih z zdravljenjem, in zaradi prehranskih ali naravnih virov ne presega zadevnih referenčnih vrednosti.
Risk characterisation and assessment of maximum residue limits (MRL) for biocides (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001541.jsp&mid=WC0b01ac05804aca04).
VICH GL47 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: laboratory animal comparative metabolism studies (smernica 47 VICH: Študije za oceno metabolizma in kinetike ostankov zdravil za uporabo v veterinarski medicini pri živalih, namenjenih za proizvodnjo hrane: primerjalne študije metabolizma laboratorijskih živalih, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001515.jsp&mid=WC0b01ac058002dd37).
Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 135, 24.5.2017, p. 1).
VICH GL33 Safety studies for veterinary drug residues in human food: general approach to testing (smernica 33 VICH: Študije za oceno varnosti ostankov zdravil za uporabo v veterinarski medicini v živilih: splošni pristop k preskušanju, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001480.jsp&mid=WC0b01ac058002dd37).
summarise and discuss relevant scientific literature, including reports of evaluations undertaken by other scientific bodies (such as the European Food Safety Authority (‘EFSA’), European Chemicals Agency (‘ECHA’) and the Joint Food and Agriculture Organisation (‘FAO’)/World Health Organisation (‘WHO’) Expert Committee on Food Additives (‘JECFA’)).
VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing (smernica 31 VICH: Študije za oceno varnosti ostankov zdravil za uporabo v veterinarski medicini v živilih: testiranje toksičnosti s ponovljenim odmerkom (90 dni), http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001478.jsp&mid=WC0b01ac058002dd37).
If detailed references to published scientific literature are used, all the requirements set out under point I.5 shall be met, as far as possible;
VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies (smernica 22 VICH: Študije za oceno varnosti ostankov zdravil za uporabo v veterinarski medicini v živilih: preskušanje razmnoževanja, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001475.jsp&mid=WC0b01ac058002dd37).
Daily dietary exposure estimates for essential elements may be compared with appropriate reference values, such as the recommended daily intake (‘RDI’), dietary reference values (‘DRVs’, previously: recommended daily allowances (‘RDA’)), tolerable daily intakes (‘TDIs’) or tolerable weekly intakes (‘TWIs’) and provisional tolerable weekly intakes (‘PTWI’).
VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing (smernica 32 VICH: Študije za oceno varnosti ostankov zdravil za uporabo v veterinarski medicini v živilih: preskušanje razvojne toksičnosti, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001479.jsp&mid=WC0b01ac058002dd37).
These values may be used in the risk assessment, in a way analogous to the ADI.
VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing (smernica 23 VICH: Študije za oceno varnosti ostankov zdravil za uporabo v veterinarski medicini v živilih: preskušanje genotoksičnosti, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001476.jsp&mid=WC0b01ac058002dd37).
The combined exposure resulting from treatment related residues and exposure from dietary and natural sources shall not exceed the respective reference values.
VICH GL46 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues (smernica 46 VICH: Študije za oceno metabolizma in kinetike ostankov zdravil za uporabo v veterinarski medicini pri živalih, namenjenih za proizvodnjo hrane: študija metabolizma za določitev količine in identifikacijo vrste ostankov, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001516.jsp&mid=WC0b01ac058002dd37).
VICH GL47 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: laboratory animal comparative metabolism studies (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001515.jsp&mid=WC0b01ac058002dd37).
VICH GL28 Studies to evaluate the safety of veterinary drugs in human: carcinogenicity testing (smernica 28 VICH: Študije za oceno varnosti ostankov zdravil za uporabo v veterinarski medicini v živilih: preskušanje rakotvornosti, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001477.jsp&mid=WC0b01ac058002dd37).
VICH GL33 Safety studies for veterinary drug residues in human food: general approach to testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001480.jsp&mid=WC0b01ac058002dd37).
VICH GL49 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studies (smernica 49 VICH: Študije za oceno metabolizma in kinetike ostankov zdravil za uporabo v veterinarski medicini pri živalih, namenjenih za proizvodnjo hrane: validacija analiznih metod, ki se uporabljajo v študijah znižanja koncentracije ostankov, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001513.jsp&mid=WC0b01ac058002dd37).
VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001478.jsp&mid=WC0b01ac058002dd37).
VICH GL56 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods (smernica 56 VICH: Študije za oceno metabolizma in kinetike ostankov zdravil za uporabo v veterinarski medicini v živalih, namenjenih za proizvodnjo hrane: priporočila glede zasnove študij ostankov v medu za določitev najvišjih mejnih vrednosti ostankov in karenc, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/safety_residues_pharmaceuticals/general_content_001815.jsp&mid=WC0b01ac058002dd37).
VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001475.jsp&mid=WC0b01ac058002dd37).
Standardni sklop vključuje preskuse, namenjene odkrivanju mutagenih, klastogenih ali anevgenih učinkov.Vsak odmik od uveljavljenih smernic se utemelji, njegov vpliv pa se obravnava.
Commission Implementing Regulation (EU) 2018/783
Izvedbena uredba Komisije (EU) 2018/783
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance imidacloprid
o spremembi Izvedbene uredbe (EU) št. 540/2011 glede pogojev za odobritev aktivne snovi imidakloprid
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 21(3), Article 49(2) and Article 78(2) thereof,
ob upoštevanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS ter zlasti členov 21(3), 49(2) in 78(2) Uredbe,
The active substance imidacloprid was included in Annex I to Council Directive 91/414/EEC by Commission Directive 2008/116/EC.
Aktivna snov imidakloprid je bila vključena v Prilogo I k Direktivi Sveta 91/414/EGS z Direktivo Komisije 2008/116/ES.
Commission Implementing Regulation (EU) No 485/2013 amended the conditions of approval of the active substance imidacloprid and required the applicant to provide confirmatory information as regards:
Z Izvedbeno uredbo Komisije (EU) št. 485/2013 so se spremenili pogoji za odobritev aktivne snovi imidakloprid, od vlagatelja pa se je zahtevalo, da predloži potrditvene informacije o:
the acute and long-term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen.
akutnem in dolgoročnem tveganju za preživetje kolonij in njihov razvoj ter tveganju za zalego medonosnih čebel zaradi zaužitja kontaminiranega nektarja in peloda.
In December 2014, the applicant submitted additional information concerning bees (i.e. honey bees, bumble bees and solitary bees) to the rapporteur Member State Germany within the time period provided for its submission.
Vlagatelj je decembra 2014, tj. v roku, določenem za predložitev, državi članici poročevalki Nemčiji predložil dodatne informacije glede čebel (tj. medonosnih čebel, čmrljev in solitarskih čebel).
Germany assessed the additional information submitted by the applicant.
Nemčija je ocenila dodatne informacije, ki jih je predložil vlagatelj.
It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 18 January 2016.
Svojo oceno je v obliki dodatka k osnutku poročila o oceni 18. januarja 2016 predložila drugim državam članicam, Komisiji in Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija).
The Commission consulted the Authority which presented its conclusion on the risk assessment of imidacloprid on 13 October 2016.
Komisija se je posvetovala z Agencijo, ki je svoj sklep o oceni tveganja za imidakloprid predstavila 13. oktobra 2016.
The Authority identified for most crops high acute risks for bees from plant protection products containing the active substance imidacloprid.
Agencija je za večino kmetijskih rastlin ugotovila visoka akutna tveganja za čebele zaradi fitofarmacevtskih sredstev, ki vsebujejo aktivno snov imidakloprid.
In particular, as regards exposure via dust, the Authority identified high risks for bees for several field uses.
Agencija je zlasti kar zadeva izpostavljenost prek prahu ugotovila velika tveganja za čebele pri več uporabah na polju.
For bees foraging in the treated crop, a high risk was identified for the use on potatoes and winter cereals.
Za čebele, ki iščejo nektar ali pelod na tretiranih kmetijskih rastlinah, je bilo ugotovljeno veliko tveganje pri uporabi na krompirju in ozimnih žitih.
For almost all field uses, a high risk to bees was also identified in the succeeding crops.
Veliko tveganje za čebele je bilo ugotovljeno za skoraj vse uporabe na polju na kmetijskih rastlinah, ki sledijo v kolobarju.
In addition, the Authority identified a number of data gaps.
Poleg tega je Agencija ugotovila številne pomanjkljivosti podatkov.
As foreseen in recital 16 of Implementing Regulation (EU) No 485/2013, the Commission initiated a review of new scientific information on 11 February 2015 by mandating EFSA to organise an open call for data.
Kot je predvideno v uvodni izjavi 16 Izvedbene uredbe (EU) št. 485/2013, je Komisija 11. februarja 2015 začela pregled novih znanstvenih informacij, pri čemer je EFSA pooblastila za organizacijo javnega razpisa za zbiranje podatkov.
EFSA launched an open call for data which ended on 30 September 2015.
EFSA je začela javni razpis za zbiranje podatkov, ki se je končal 30. septembra 2015.
On 13 November 2015, the Commission requested EFSA to provide conclusions concerning an updated risk assessment for bees as regards the use of imidacloprid applied as a seed treatment or granules by organising a peer review and taking into account the data collected in the framework of the specific open call for data and any other new data from studies, research and monitoring activities that are relevant to the uses under consideration.
Komisija je 13. novembra 2015 zaprosila EFSA, naj pripravi sklepe v zvezi s posodobljeno oceno tveganja za čebele v zvezi z uporabo imidakloprida kot za tretiranje semen ali v obliki granul, in sicer z organizacijo strokovnega pregleda in ob upoštevanju podatkov, zbranih v okviru posebnega javnega razpisa za zbiranje podatkov, in katerih koli drugih novih podatkov, ki izhajajo iz študij, raziskav ter dejavnosti spremljanja in so pomembni za obravnavane uporabe.
The Authority presented its conclusion on the peer review of the updated pesticide risk assessment for bees for the active substance imidacloprid considering the uses as seed treatment and granules on 28 February 2018.
Agencija je 28. februarja 2018 predstavila svoj sklep o strokovnem pregledu posodobljene ocene tveganja pesticidov z aktivno snovjo imadikloprid za čebele v zvezi z uporabami za tretiranje semen ali v obliki granul.
The applicant was given the opportunity to comment on this conclusion.
Vlagatelj je imel možnost, da predloži pripombe na ta sklep.
The draft assessment report, the addendum to the draft assessment report and the conclusions of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 27 April 2018 in the form of a revised addendum to the Commission review report for imidacloprid.
Osnutek poročila o oceni, dodatek k osnutku poročila o oceni in sklepi Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za rastline, živali, hrano in krmo ter končno različico pripravile 27. aprila 2018 v obliki spremenjenega dodatka k poročilu Komisije o pregledu imadikloprida.
The Commission invited the applicant to submit its comments on the revised addendum to the review report for imidacloprid.
Komisija je vlagatelja pozvala, naj predloži pripombe na spremenjeni dodatek k poročilu o pregledu imadikloprida.
Having reviewed the information submitted by the applicant in 2014 the Commission has concluded that the further confirmatory information required by Implementing Regulation (EU) No 485/2013 has not been provided, and having also considered the conclusion on the updated risk assessment for bees, the Commission has concluded that further risks to bees cannot be excluded without imposing further restrictions.
Po pregledu informacij, ki jih je predložil vlagatelj, je Komisija leta 2014 sklenila, da nadaljnje potrditvene informacije, zahtevane v skladu z Izvedbeno uredbo (EU) št. 485/2013, niso bile predložene, po preučitvi sklepa o novi oceni tveganja za čebele pa je sklenila, da nadaljnjih tveganj za čebele ni mogoče izključiti brez naložitve dodatnih omejitev.
Bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection of animal health that is sought within the Union, it is appropriate to prohibit all outdoor uses.
Ob upoštevanju, da je treba zagotoviti raven varnosti in zaščite, ki je skladna z visoko ravnjo zaščite zdravja živali, za katero si prizadeva Unija, se zdi primerno, da se prepovejo vse uporabe na prostem.
Therefore, it is appropriate to limit the use of imidacloprid to permanent greenhouses and to require that the resulting crop stays its entire life cycle within a permanent greenhouse, so that it is not replanted outside.
Zato je primerno, da se uporaba imadikloprida omeji na trajne rastlinjake in zahteva, da kmetijske rastline ostanejo v trajnem rastlinjaku skozi svoj celoten življenjski cikel, s čimer se prepreči zasaditev zunaj rastlinjaka.
Taking into account the risks for bees from treated seeds, the placing on the market and the use of seeds treated with plant protection products containing imidacloprid should be subject to the same restrictions as the use of imidacloprid.
Ob upoštevanju tveganj za čebele zaradi tretiranih semen bi morale za dajanje na trg in uporabo semen, tretiranih s fitofarmacevtskimi sredstvi, ki vsebujejo imidakloprid, veljati enake omejitve kot za uporabo imidakloprida.
It is therefore appropriate to provide that seeds treated with plant protection products containing imidacloprid shall not be placed on the market or used, except where the seeds are intended to be used only in permanent greenhouses and the resulting crop stays in a permanent greenhouse during its entire life cycle.
Zato je primerno, da se zagotovi, da se semena, tretirana s fitofarmacevtskimi sredstvi, ki vsebujejo imidakloprid, ne dajejo na trg ali uporabljajo, razen kadar so semena namenjena za uporabo izključno v trajnih rastlinjakih in kmetijske rastline ostanejo v trajnem rastlinjaku skozi svoj celoten življenjski cikel.
Member States should be allowed sufficient time to amend or withdraw authorisations for plant protection products containing imidacloprid.
Državam članicam bi bilo treba omogočiti dovolj časa za spremembo ali preklic registracij fitofarmacevtskih sredstev, ki vsebujejo imidakloprid.
For plant protection products containing imidacloprid, where Member States grant a grace period pursuant to Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 19 December 2018.
Kadar države članice za fitofarmacevtska sredstva, ki vsebujejo imidakloprid, odobrijo prehodno obdobje v skladu s členom 46 Uredbe (ES) št. 1107/2009, bi se moralo navedeno obdobje izteči najpozneje 19. decembra 2018.