natgillin/translations-raw huggingface dataset:
There is a need to report all potentially adverse effects found during routine investigations of environmental effects and to undertake and report such additional studies which may be necessary to investigate the mechanisms involved and assess the significance of these effects.
Obvezno je navesti vse morebitne škodljive učinke, ugotovljene med rutinskim preučevanjem vplivov na okolje, izvajati in navesti takšne dodatne študije, ki so lahko potrebne za preučevanje mehanizmov v teh procesih, ter za ocenitev pomena teh vplivov.
In general, much of the data relating to impact on non-target species, required for authorisation of plant protection products, will have been submitted and evaluated for the approval of the micro-organism(s).
Večina podatkov v zvezi z vplivom na neciljne vrste, ki se zahtevajo za registracijo fitofarmacevtskih sredstev, se predloži in oceni zaradi odobritve mikroorganizmov.
Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 of Part B of this Annex, shall be used.
Kadar so podatki o izpostavljenosti potrebni za odločitev o tem, ali je treba opraviti študijo, se uporabijo podatki, pridobljeni v skladu z oddelkom 9 dela B te priloge.
For the estimation of exposure of organisms all relevant information on the plant protection product and on the micro-organism must be taken into account.
Pri ocenjevanju izpostavljenosti organizmov je treba upoštevati vse relevantne informacije o fitofarmacevtskem sredstvu in mikroorganizmu.
Where it appears from available data that the plant protection product has a stronger effect than the micro-organism, the data on effects on non target organisms of the plant protection product have to be used for the calculation of relevant effect/exposure ratios.
Kadar je na podlagi razpoložljivih podatkov razvidno, da ima fitofarmacevtsko sredstvo močnejši učinek kakor mikroorganizem, je treba za izračun ustreznih razmerij med učinkom in izpostavljenostjo uporabiti podatke o učinkih fitofarmacevtskega sredstva na neciljne organizme.
In order to facilitate the assessment of the significance of test results obtained, the same strain of each relevant species shall where possible be used in the various specified tests for effects on non target organisms.
Za lažjo oceno pomena pridobljenih rezultatov testov se, kadar je to mogoče, uporabi isti sev posameznih relevantnih vrst v različnih posebnih testih za učinke na neciljne organizme.
The same information as provided in point 8.1 of Part B of the Annex to Regulation (EU) No 544/2011 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of birds is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti iste informacije, kot so določene v točki 8.1 dela B Priloge k Uredbi (EU) št. 544/2011, razen če se lahko utemelji, da je izpostavljenost ptic malo verjetna.
The same information as provided in point 8.2 of Part B of the Annex to Regulation (EU) No 544/2011 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of aquatic organisms is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti iste informacije, kot so določene v točki 8.2 dela B Priloge k Uredbi (EU) št. 544/2011, razen če se lahko utemelji, da je izpostavljenost vodnih organizmov malo verjetna.
The same information as provided in point 8.3 of Part B of the Annex to Regulation (EU) No 544/2011 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of bees is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti iste informacije, kot so določene v točki 8.3 dela B Priloge k Uredbi (EU) št. 544/2011, razen če se lahko utemelji, da je izpostavljenost čebel malo verjetna.
The same information as provided in point 8.4 of Part B of the Annex to Regulation (EU) No 544/2011 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of arthropods other than bees is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti iste informacije, kot so določene v točki 8.4 dela B Priloge k Uredbi (EU) št. 544/2011, razen če se lahko utemelji, da je izpostavljenost členonožcev, razen čebel, malo verjetna.
The same information as provided in point 8.5 of Part B of the Annex to Regulation (EU) No 544/2011 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of earthworms is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti iste informacije, kot so določene v točki 8.5 dela B Priloge k Uredbi (EU) št. 544/2011, razen če se lahko utemelji, da je izpostavljenost deževnikov malo verjetna.
Effects on soil micro-organisms
Vpliv na talne mikroorganizme
The same information as provided in point 8.6 Part B of the Annex to Regulation (EU) No 544/2011 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of non target soil micro-organisms is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti iste informacije, kot so določene v točki 8.6 dela B Priloge k Uredbi (EU) št. 544/2011, razen če se lahko utemelji, da je izpostavljenost neciljnih talnih mikroorganizmov malo verjetna.
Such decision will take into consideration the available information in this and other Sections, in particular data on the specificity of the micro-organism, and the expected exposure.
Pri takšni odločitvi se upoštevajo razpoložljive informacije v tem oddelku in drugih oddelkih, zlasti podatki o specifičnosti mikroorganizma in pričakovana izpostavljenost.
Useful information may also be available from the observations carried out in efficacy testing.
Koristne informacije so lahko tudi tiste, pridobljene na podlagi opazovanj pri testih učinkovitosti.
Special attention shall be given to possible effects on naturally occurring and deliberately released organisms of importance in IPM.
Posebna pozornost se nameni morebitnim učinkom na naravno prisotne in namerno spuščene organizme, pomembne v IPM (integrirano zatiranje škodljivcev).
In particular the compatibility of the product with IPM shall be taken into consideration.
Upošteva se zlasti skladnost sredstva z IPM.
Additional studies might include further studies on additional species or higher tier studies such as studies on selected non-target organisms.
Dodatne študije lahko vključujejo nadaljnje študije o dodatnih vrstah ali študije o višjih stopnjah, kakor so npr. raziskave na izbranih neciljnih organizmih.
Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.
Pred začetkom izvajanja takšnih študij vlagatelj zaprosi pristojne organe za soglasje o vrsti študije, ki se bo izvajala.
A summary and evaluation of all data relevant to the environmental impact shall be carried out in accordance with the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations.
Povzetek in ocena vseh podatkov v zvezi z vplivom na okolje se pripravita v skladu s smernicami pristojnih organov držav članic o obliki takih povzetkov in ocen.
It shall include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the database.
Vključi se podrobna in kritična ocena navedenih podatkov, skladno z ustreznimi merili in smernicami za ocenjevanje in odločanje, s posebnim poudarkom na možnem tveganju za okolje in neciljne vrste ter obsegu, kakovosti in zanesljivosti podatkovne zbirke.
prediction of distribution and fate in the environment, and the time courses involved,
napoved porazdelitve in končnega stanja v okolju ter časovnega poteka,
identification of non-target species and populations at risk, and prediction of the extent of potential exposure,
opredelitev ogroženih neciljnih vrst in populacij ter napoved obsega morebitne izpostavljenosti,
Bulletin OEPP/EPPO Bulletin 23, 1-154 and Bulletin 24, 1-87.
Bulletin OEPP/EPPO Bulletin 23, 1–154, in Bulletin 24, 1–87.
FOrum for the Coordination of pesticide fate models and their USe.
FOrum for the Co-ordination of pesticide fate models and their USe (Forum za usklajevanje modelov končnega stanja pesticidov in njihove uporabe).
See page 176 of this Official Journal.
Glej stran 176 tega Uradnega lista.
USEPA Microbial Pesticide Test Guidelines, OPPTS Series 885, February 1996 (http://www.epa.gov/oppbppd1/biopesticides/guidelines/series885.htm).
Smernice USEPA za izvajanje testov mikrobnih pesticidov, serija OPPTS 885, februar 1996.
safener,
varovalna snov,
protected crops,
zavarovani prostori,
Where relevant the parameters provided for in this Section shall be used. When models are used for estimation of predicted environmental concentrations they must:
Kadar je to relevantno, se uporabijo parametri iz tega oddelka.Kadar se uporabijo modeli za oceno predvidenih koncentracij v okolju, morajo ti:
indications of danger or signal words,
znaki za nevarnost ali opozorilne besede,
risk phrases or hazard statements,
opozorilni ali obvestilni stavki,
protected crops (e.g. in glasshouses),
zavarovani prostori (npr. rastlinjaki),
International Group of National Pesticide Manufacturers’ Associations.
Mednarodna skupina nacionalnih zvez proizvajalcev pesticidov.
Proceedings of the International Seed Testing Association, Seed Science and Technology, Volume 13, No 2, 1985.
Proceedings of the International Seed Testing Association, Seed Science and Technology, zvezek 13, št. 2, 1985.
Collaborative International Pesticides Analytical Council.
Kolaborativni mednarodni svet za analizo pesticidov.
is a gas or liquified gas, is a smoke generating formulation or fumigant,
je fitofarmacevtsko sredstvo formulacija, ki proizvaja dim, ali fumigant,
is used with fogging equipment, is an aerosol,
je fitofarmacevtsko sredstvo aerosol,
In order to assess seasonal differences, if any, sufficient data must be generated and submitted to confirm the performance of the plant protection product in each agronomically and climatically different region for each particular crop (or commodity)/harmful organism combination. Normally trials on effectiveness or phytotoxicity, where relevant, in at least two growing seasons must be reported.
Za oceno sezonskih razlik, če te obstajajo, je treba pridobiti in predložiti dovolj podatkov, da se potrdi delovanje fitofarmacevtskega sredstva v vsaki agronomsko in podnebno različni regiji za vsako kombinacijo posamezne kulture (ali proizvoda) in škodljivega organizma Običajno je treba poročati o poskusih učinkovitosti ali fitotoksičnosti, kadar je relevantno, v najmanj dveh rastnih sezonah.
Commission Regulation (EU) No 546/2011
Uredba Komisije (EU) št. 546/2011
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products
o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta glede enotnih načel za ocenjevanje in registracijo fitofarmacevtskih sredstev
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 [1], and in particular Article 29(6) and Article 84 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 [1] ter zlasti člena 29(6) in člena 84 Uredbe
In accordance with Regulation (EC) No 1107/2009 the uniform principles for evaluation and authorisation of plant protection products are to contain the requirements set out in Annex VI to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [2].
V skladu z Uredbo (ES) št. 1107/2009 morajo enotna načela za ocenjevanje in registracijo fitofarmacevtskih sredstev vsebovati zahteve iz Priloge VI k Direktivi Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [2].
It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a regulation containing the requirements, as set out in Annex VI to Directive 91/414/EEC.
Zato je treba za izvajanje Uredbe (ES) št. 1107/2009 sprejeti Uredbo z zahtevami iz Priloge VI k Direktivi 91/414/EGS.
Such a regulation is not to include any substantial modification,
V taki uredbi ne sme biti bistvenih sprememb –
The uniform principles for evaluation and authorisation of plant protection products provided for in Article 29(6) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.
Enotna načela za ocenjevanje in registracijo fitofarmacevtskih sredstev iz člena 29(6) Uredbe (ES) št. 1107/2009 se določijo v Prilogi k tej uredbi.
OJ L 309, 24.11.2009, p. 11.
UL L 309, 24.11.2009, str. 11.
UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN ARTICLE 29(6) OF REGULATION (EC) No 1107/2009
ENOTNA NAČELA ZA OCENJEVANJE IN REGISTRACIJO FITOFARMACEVTSKIH SREDSTEV IZ ČLENA 29(6) UREDBE (ES) št. 1107/2009
Uniform principles for evaluation and authorisation of chemical plant protection products
Enotna načela za ocenjevanje in registracijo kemijskih fitofarmacevtskih sredstev
Absence of unacceptable effects on plants or plant products
Odsotnost nesprejemljivih učinkov na rastline ali rastlinske proizvode
Impact on vertebrates to be controlled
Vpliv na vretenčarje, ki jih je treba zatirati
Impact on human or animal health arising from the plant protection product
Vpliv na zdravje ljudi ali živali, ki izhaja iz fitofarmacevtskega sredstva
Impact on human or animal health arising from residues
Vplivi ostankov na zdravje ljudi ali živali, ki izhajajo iz fitofarmacevtskega sredstva
Influence on the environment
Vpliv na okolje
Fate and distribution in the environment
Končno stanje in porazdelitev v okolju
Impact on non-target species
Vpliv na neciljne vrste
Physical and chemical properties
Fizikalne in kemijske lastnosti
The principles developed in this Annex aim to ensure that evaluations and decisions with regard to authorisation of plant protection products, provided they are chemical preparations, results in the implementation of the requirements of Article 29(1)(e) in conjunction with Article 4(3) and Article 29(1)(f), (g) and (h) of Regulation (EC) No 1107/2009 by all the Member States at a high level of protection of human and animal health and the environment.
Cilj načel iz te priloge je zagotoviti, da se z ocenjevanjem in odločanjem pri registraciji fitofarmacevtskih sredstev, če gre za kemijske pripravke, izvajajo zahteve člena 29(1)(e) skupaj s členom 4(3), členom 29(1)(f), (g) in (h) Uredbe (ES) št. 1107/2009 v vseh državah članicah na visoki ravni varovanja zdravja ljudi, živali ter okolja.
In evaluating applications and granting authorisations Member States shall:
Države članice pri ocenjevanju vlog in izdaji registracij:
ensure that the dossier supplied is in accordance with the requirements of the Annex to Commission Regulation (EU) No 545/2011 [1], at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to the provisions of Articles 33, 34 and 59 of Regulation (EC) No 1107/2009,
zagotovijo, da se najpozneje do dokončane ocene za namene odločanja predloži dokumentacija, ki je v skladu z zahtevami Priloge k Uredbi Komisije (EU) št. 545/2011 [1], brez poseganja, kadar je to relevantno, v določbe členov 33, 34 in 59 Uredbe (ES) št. 1107/2009,
evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;
ocenijo, kadar je relevantno, vlagateljevo utemeljitev glede nekaterih manjkajočih podatkov;
take into account the data concerning the active substance in the plant protection product of the Annex to Commission Regulation (EU) No 544/2011 [2], submitted for the purpose of approval of the active substance under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 33(3) and Articles 34 and 59 of Regulation (EC) No 1107/2009;
upoštevajo podatke o aktivni snovi v fitofarmacevtskem sredstvu iz Priloge k Uredbi Komisije (EU) št. 544/2011 [2], ki so bili predloženi za namen odobritve aktivne snovi v skladu z Uredbo (ES) št. 1107/2009, in oceno navedenih podatkov, brez poseganja, kadar je to relevantno, v določbe člena 33(3)ter členov 34 in 59 Uredbe (ES) št. 1107/2009;
take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its residues.
upoštevajo druge relevantne tehnične ali znanstvene informacije, ki jih lahko imajo o delovanju fitofarmacevtskega sredstva ali potencialno škodljivih učinkih fitofarmacevtskega sredstva, njegovih sestavin ali ostankov.
Where in the specific principles on evaluation reference is made to data of the Annex to Regulation (EU) No 544/2011, this shall be understood as being the data referred to in point 2 (b).
Kadar se posebna načela za ocenjevanje sklicujejo na podatke iz Priloge k Uredbi Komisije (EU) št. 544/2011, se to razume kot podatki iz točke 2(b).
Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use.
Kadar je predloženih dovolj podatkov in informacij za dokončno oblikovanje ocene za eno od predlaganih uporab, je treba vloge oceniti in sprejeti odločitev za predlagano uporabo.
Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses.
Države članice ob upoštevanju predloženih utemeljitev in morebitnih poznejših pojasnil zavrnejo vloge, pri katerih manjka toliko podatkov, da ni mogoče dokončati ocenjevanja in sprejeti zanesljive odločitve za vsaj eno od predlaganih uporab.
During the process of evaluation and decision-making, Member States shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of Regulation (EC) No 1107/2009.
Države članice med ocenjevanjem in odločanjem sodelujejo z vlagatelji, da lahko hitro dobijo odgovore na vprašanja o dokumentaciji ali da na začetni stopnji opredelijo vse dodatne študije, potrebne za pravilno oceno dokumentacije, ali da spremenijo kakršne koli predlagane pogoje uporabe fitofarmacevtskega sredstva ali spremenijo njegovo naravo ali sestavo, da bi zagotovile popolno izpolnitev zahtev iz te priloge k Uredbi (ES) št. 1107/2009.
Member States shall come to a reasoned decision within 12 months of receiving a technically complete dossier.
Države članice sprejmejo utemeljeno odločitev v 12 mesecih po prejemu tehnično popolne dokumentacije.
A technically complete dossier is one that satisfies all the requirements of the Annex to Regulation (EU) No 545/2011.
Tehnično popolna dokumentacija izpolnjuje vse zahteve iz Priloge k Uredbi (EU) št. 545/2011.
The judgements made by the competent authorities of the Member States during the evaluation and decision-making process must be based on scientific principles, preferably recognised at international level (for example, by the EPPO), and be made with the benefit of expert advice.
Odločitve, ki jih pristojni organi držav članic sprejmejo med ocenjevanjem in odločanjem, morajo temeljiti na znanstvenih načelih, po možnosti priznanih na mednarodni ravni (na primer v Evropski in sredozemski organizaciji za varstvo rastlin (EPPO)), ter ob upoštevanju strokovnih nasvetov.
Having regard to current scientific and technical knowledge, Member States shall evaluate the information referred to in point 2 of Part A and in particular:
Države članice ob upoštevanju trenutnega znanstvenega in tehničnega znanja ocenijo informacije iz točke 2 dela A in zlasti:
assess the performance in terms of efficacy and phytotoxicity of the plant protection product for each use for which authorisation is sought; and
ocenijo delovanje glede učinkovitosti in fitotoksičnosti fitofarmacevtskega sredstva za vsak posamezen način uporabe, za katerega je bila vložena vloga za registracijo, in
identify the hazard arising, assess their significance and make a judgment as to the likely risks to humans, animals or the environment.
opredelijo morebitne nevarnosti, ocenijo njihov pomen in sprejmejo odločitev o morebitnem tveganju za ljudi, živali ali okolje.
In accordance with the terms of Article 29 of Regulation (EC) No 1107/2009, which, inter alia, specifies that Member States shall have regard to all normal conditions under which the plant protection product may be used, and to the consequences of its use, Member States shall ensure that evaluations carried out have regard to the proposed practical conditions of use and in particular to the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and composition of the preparation.
Države članice pod pogoji člena 29 Uredbe (ES) št. 1107/2009, ki med drugim določa, da države članice upoštevajo vse razmere, v katerih se fitofarmacevtsko sredstvo uporablja, in posledice njegove uporabe, zagotovijo, da se pri ocenjevanju upoštevajo predlagani praktični pogoji uporabe in zlasti namen uporabe, odmerek, način, pogostost in časovni razpored nanašanja ter narava in sestava pripravka.
Whenever possible Member States shall also take into account the principles of integrated control.
Države članice upoštevajo tudi načela integriranega varstva, kadar koli je to mogoče.
In the evaluation of applications submitted, Member States shall have regard to the agricultural, plant health or environmental (including climatic) conditions in the areas of use.
Pri ocenjevanju vloženih vlog države članice upoštevajo razmere kmetijske pridelave, zdravstvenega varstva rastlin ali okolja (vključno s podnebnimi razmerami) na območjih uporabe.