natgillin/translations-raw huggingface dataset:
Member States shall ensure that decisions taken to grant authorisations, take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use.
Države članice zagotovijo, da se pri odločanju o registraciji upoštevajo razmere kmetijske pridelave,zdravstvenega varstva rastlin ali okolja (vključno s podnebnimi razmerami) na območjih predvidene uporabe.
Such considerations may result in specific conditions and restrictions on use, and, in authorisation being granted for some but not other areas within the Member State in question.
Pri takem premisleku se lahko določijo posebni pogoji in omejitve uporabe, fitofarmacevtsko sredstvo pa se lahko registrira samo za nekatera območja v zadevni državi članici.
Member States shall ensure that decisions respect the principles of integrated pest control if the plant protection product is intended for use in conditions where these principles are relied on.
Države članice zagotovijo, da se pri odločitvah upoštevajo načela integriranega varstva pred škodljivci, če je fitofarmacevtsko sredstvo namenjeno za uporabo v integrirani pridelavi.
Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:
Pred izdajo odločbe o registraciji države članice zagotovijo, da oznaka fitofarmacevtskega sredstva:
fulfils the requirements setting out in Regulation (EU) No 547/2011;
izpolnjuje zahteve iz Uredbe (EU) št. 547/2011;
also contains the information on protection of users required by EU legislation on worker protection;
vsebuje tudi informacije o zaščiti uporabnikov, kakor to zahteva zakonodaja EU o varstvu pri delu;
specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 1.1 to 1.5;
določa zlasti pogoje ali omejitve, pod katerimi se fitofarmacevtsko sredstvo sme ali ne sme uporabljati, kakor je določeno v točkah od 1.1 do 1.5;
and that the authorisation shall mention the particulars indicated in Annexes II and III to Regulation (EU) 547/2011 and Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC.
in da so v odločbi o registraciji navedene zahteve iz prilog II in III Uredbe (EU) št. 547/2011 in iz člena 10(1.2), 10(2.4), 10(2.5) in 10(2.6) Direktive 1999/45/ES.
the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and
postopki za nevtralizacijo kakršnih koli škodljivih učinkov fitofarmacevtskega sredstva pri nenamernem razlitju in
No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied.
Če niso izpolnjene vse zahteve iz točke 2, se registracija ne odobri.
However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use.
Vendar če ena ali več posebnih zahtev za odločanje iz točke 2.4 ni v celoti izpolnjenih, se registracije odobrijo le, če prednosti uporabe fitofarmacevtskega sredstva pri predlaganih pogojih uporabe odtehtajo morebitne škodljive učinke njegove uporabe.
Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label.
Vse omejitve uporabe fitofarmacevtskega sredstva pri neizpolnjevanju nekaterih zahtev iz točke 2.4 je treba navesti na oznaki.
advantages for and compatibility with integrated control measures or organic farming;
prednosti pri ukrepih za integrirano varstvo rastlin ali ekološko kmetovanje in združljivost z njimi;
facilitating strategies to minimise the risk of development of resistance;
spodbujanje strategij za zmanjšanje nevarnosti razvoja odpornosti;
reduced risk for operators and consumers;
manjše tveganje za izvajalce tretiranja in potrošnike;
reduced contamination of the environment and reduced impact on non-target species.
manjše onesnaženje okolja in manjši vpliv na neciljne vrste.
Where an authorisation has been granted in accordance with the requirements provided for in this Annex, Member States may, by virtue of Article 44:
Kadar je bila registracija odobrena v skladu z zahtevami iz te priloge, lahko države članice v skladu s členom 44:
Member States shall ensure, as far as is practically possible, that for all micro-organisms that are considered for an authorisation, the applicant has taken into account all available relevant knowledge and information in literature at the time of submission.
Države članice kolikor najbolj mogoče zagotovijo, da vlagatelj glede vseh mikroorganizmov, za katere se zahteva registracija, upošteva vsa relevantna spoznanja in informacije iz literature, ki so na voljo ob vložitvi vloge.
Where the micro-organism has been genetically modified, as defined in Directive 2001/18/EC, no authorisation shall be granted unless the evaluation conducted in accordance with Directive 2001/18/EC has been submitted, as required pursuant to Article 53(4) of Regulation (EC) No 1107/2009.
Kadar je mikroorganizem gensko spremenjen, kot je opredeljeno v Direktivi 2001/18/ES, se registracija ne odobri, razen če se predloži ocena, ki je bila izvedena v skladu z Direktivo 2001/18/ES, kot to zahteva člen 53(4) Uredbe (ES) št. 1107/2009.
The relevant decision taken by the competent authorities in accordance with Directive 2001/18/EC must be provided.
Predložiti je treba relevantno odločitev, ki so jo pristojni organi sprejeli v skladu z Direktivo 2001/18/ES.
In accordance with Article 53(4) of Regulation (EC) No 1107/2009, no authorisation shall be granted for a plant protection product containing a genetically modified organism unless authorisation is granted in accordance with part C of Directive 2001/18/EC under which that organism can be released into the environment.
V skladu s členom 53(4) Uredbe (ES) št. 1107/2009 se registracija za fitofarmacevtsko sredstvo, ki vsebuje gensko spremenjen organizem, ne odobri, razen če se registracija odobri v skladu z določbami iz dela C Direktive 2001/18/ES, po katerih se ta organizem lahko spusti v okolje.
No authorisation shall be granted if relevant metabolites/toxins (i.e. those expected to be of concern for human health and/or the environment) known to be formed by the micro-organism, and/or by microbial contaminants are present in the plant protection product, unless it can be shown that the amount present is at an acceptable level before and after its proposed use.
Če so v fitofarmacevtskem sredstvu prisotni relevantni metaboliti/toksini (tj. tisti, ki so predvidoma nevarni za zdravje ljudi in/ali okolje), za katere je znano, da jih tvori mikroorganizem in/ali mikrobiološki kontaminanti, se registracija ne odobri, razen če je mogoče dokazati, da je prisotna količina pred predlagano uporabo fitofarmacevtskega sredstva in po njej na sprejemljivi ravni.
Such measures must include a Hazard Analysis Critical Control Point (HACCP) system or equivalent system.
Taki ukrepi za nadzor kakovosti morajo vključevati sistem analize tveganja in kritičnih nadzornih točk (HACCP) ali ustrezen enakovreden sistem.
There must also be information as to whether or not the micro-organism is a wild type or a spontaneous or induced mutant, or a genetically modified organism.
Navesti je treba tudi informacije, ali gre za mikroorganizem divje vrste, spontanega ali induciranega mutanta ali za gensko spremenjeni organizem.
There must be sufficient information to permit assessment of the minimum and maximum content of the micro-organism in the material used for the manufacturing of plant protection products, as well as in the plant protection product.
Za oceno najmanjše in največje vsebnosti mikroorganizma v materialu, ki se uporablja za proizvodnjo fitofarmacevtskih sredstev, in fitofarmacevtskem sredstvu mora biti na voljo dovolj informacij.
Member States shall ensure that the level of contaminating organisms is controlled to an acceptable level.
Države članice zagotovijo, da se stopnja kontaminantnih mikroorganizmov nadzorovano zadržuje na sprejemljivi ravni.
In addition: the physical nature and state of the plant protection product must be specified, preferably in accordance with the ‘Catalogue of pesticide formulation types and international coding system (CropLife International Technical Monograph No 2, 5th Edition, 2002)’.
Poleg tega je treba navesti fizikalne lastnosti in stanje fitofarmacevtskega sredstva, po možnosti v skladu s „Katalogom vrst formulacij za pesticide in mednarodnim kodnim sistemom (Mednarodna tehnična monografija CropLife št. 2, 5. izdaja, 2002)“.
No authorisation shall be granted if, at any stage in the development of a microbial plant protection product, it becomes apparent, on the basis of a build-up of resistance, or transfer of resistance, or other mechanism, that there may be interference with the effectiveness of an anti-microbial agent used in human or animal medicine.
Registracija se ne odobri, če se na kateri koli razvojni stopnji fitofarmacevtskega sredstva na podlagi mikroorganizma izkaže (na podlagi okrepljene odpornosti, prenosa odpornosti ali drugega mehanizma), da bi bila lahko motena učinkovitost protimikrobnega sredstva, ki se uporablja v humani medicini ali veterini.
In particular, the occurrence of spontaneous changes in major characteristics of the micro-organism and the absence/presence of contaminating organisms shall be considered.
Upoštevati je treba zlasti spontane spremembe glavnih značilnosti mikroorganizma in odsotnost/prisotnost kontaminantnih organizmov.
No authorisation shall be granted where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions.
Kadar predlagane uporabe vključujejo priporočila za nadzor ali varstvo pred organizmi, ki po pridobljenih izkušnjah ali znanstvenih dokazih ne veljajo za škodljive v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami) na območju predlagane uporabe, ali kadar drugi predvideni učinki fitofarmacevtskega sredstva v navedenih razmerah ne veljajo za koristne, se registracija ne odobri.
Where relevant, yield response when the plant protection product is used and reduction of loss in storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable reference products.
Kadar je relevantno, mora imeti uporaba fitofarmacevtskega sredstva podoben vpliv na količino in/ali kakovost pridelka in zmanjšanje izgub med skladiščenjem kot uporaba ustreznih referenčnih sredstev.
Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorised, and for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions).
Odločitve o delovanju pripravka morajo veljati za vsa območja države članice, v kateri se pripravek registrira, in za vse pogoje predlagane uporabe, razen kadar je na predlagani oznaki navedeno, da je fitofarmacevtsko sredstvo namenjeno le za uporabo v nekaterih posebnih okoliščinah (npr. ob lažji okužbi, na določenih vrstah tal ali posebnih rastnih razmerah).
Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4.
Kadar se na predlagani oznaki zahteva uporaba pripravka z drugimi fitofarmacevtskimi sredstvi ali dodatki v mešanici v tanku škropilnice, mora mešanica doseči želeni učinek in biti v skladu z načeli iz točk 2.4.1.1 do 2.4.1.4.
If there is evidence of a development of resistance of pathogens towards the plant protection product, the Member State shall decide if the submitted resistance management strategy addresses this adequately and sufficiently.
Če obstajajo dokazi za razvoj odpornosti patogenov proti fitofarmacevtskemu sredstvu, država članica presodi, ali predložena strategija obvladovanja odpornosti to obravnava ustrezno in zadostno.
Only plant protection products containing non-viable micro-organisms may be authorised for use to control vertebrate species.
Za zatiranje vretenčarjev se za uporabo lahko registrirajo le fitofarmacevtska sredstva, ki vsebujejo neaktivne mikroorganizme.
The intended effect on vertebrates to be controlled shall be obtained without unnecessary suffering and unnecessary pain for these animals.
Načrtovani učinek na ciljne vretenčarje se doseže brez povzročanja nepotrebnega trpljenja in bolečin zadevnim živalim.
There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation should not be applied to crops to be used for processing purposes.
Fitofarmacevtsko sredstvo ne sme imeti nesprejemljivih škodljivih učinkov na kakovost tretiranih rastlin ali rastlinskih proizvodov, razen pri škodljivih učinkih na predelavo, kadar je na predlagani oznaki izrecno navedeno, da se pripravek ne sme uporabljati na kulturah, namenjenih za nadaljnjo predelavo.
There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, should not be grown following the treated crop.
Fitofarmacevtsko sredstvo ne sme imeti nesprejemljivih učinkov na naslednje kulture, razen če je na predlagani oznaki izrecno navedeno, da se posamezne kulture, ki bi lahko bile prizadete, ne smejo gojiti za tretiranimi kulturami.
Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.4.2.1 to 2.4.2.6.
Kadar se na predlagani oznaki zahteva uporaba pripravka z drugimi fitofarmacevtskimi sredstvi ali dodatki v mešanici v tanku škropilnice, mora biti mešanica v skladu z načeli iz točk 2.4.2.1 do 2.4.2.6.
Methods for post-authorisation monitoring shall involve the use of commonly available reagents and equipment.
Metode za spremljanje po registraciji vključujejo uporabo splošno dostopnih reagentov in opreme.
No authorisation shall be granted unless there is an adequate method of sufficient quality to identify and quantify the micro-organism and non-viable components (e.g. toxins, impurities and co-formulants) in the plant protection product.
Registracija se odobri le, če je na voljo primerna in dovolj kakovostna metoda za opredelitev in količinsko določitev mikroorganizma in neaktivnih sestavin (npr. toksinov, nečistoč in pomožnih snovi v formulaciji) v fitofarmacevtskem sredstvu.
In the case of a plant protection product containing more than one micro-organism, the recommended methods should be capable of identifying and determining the content of each one.
Kadar fitofarmacevtsko sredstvo vsebuje več mikroorganizmov, morajo priporočene metode omogočiti opredelitev in določitev vsebnosti vsakega od njih.
plants, plant products, foodstuffs of plant and animal origin and feedingstuffs if toxicologically relevant residues occur.
rastlin, rastlinskih proizvodov, živil rastlinskega in živalskega izvora in krme, če se pojavijo toksikološko relevantni ostanki.
Residues are considered relevant if a maximum residue level (MRL) or a waiting or re-entry safety period or other such precaution is required;
Ostanki se štejejo za relevantne, če se zahteva mejna vrednost ostankov, varnostna karenca, karenca za ponovni dostop ali drugi varnostni ukrepi;
soil, water, air and/or body tissues if toxicologically, ecotoxicologically or environmentally relevant residues occur.
tal, vode, zraka in/ali telesnih tkiv, če se pojavijo toksikološko, ekotoksikološko ali okoljsko relevantni ostanki.
No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals.
Registracija se ne odobri, če bi lahko mikroorganizem in/ali fitofarmacevtsko sredstvo, ki vsebuje mikroorganizem, pri priporočenih pogojih uporabe, vključno z realistično oceno najhujšega možnega primera, koloniziral ali povzročil škodljive učinke pri ljudeh ali živalih.
When making a decision on the authorisation of the microbial plant protection product, Member States shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment and at work, and animals.
Pri odločanju o registraciji mikrobiološkega fitofarmacevtskega sredstva države članice preučijo možne učinke na vse skupine ljudi, tj. na poklicne uporabnike, nepoklicne uporabnike, ljudi, ki so sredstvu izpostavljeni neposredno ali posredno v okolju in pri delu, ter na živali.
All micro-organisms shall be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals.
Vsi mikroorganizmi se obravnavajo kot možni senzibilizatorji, razen če se na podlagi relevantnih informacij ugotovi, da ni tveganja za senzibilizacijo ob upoštevanju imunsko oslabelih in drugih občutljivih posameznikov.
Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism shall not be inhaled.
V odobrenih registracijah se zato navede, da je treba uporabljati zaščitno obleko in ustrezne rokavice in da se fitofarmacevtsko sredstvo, ki vsebuje mikroorganizem, ne sme vdihavati.
Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment.
Poleg tega predlagani pogoji uporabe lahko zahtevajo uporabo dodatnih kosov zaščitnih oblačil in opreme.
Where the proposed conditions of use require use of items of protective clothing, no authorisation shall be granted unless those items are effective and in accordance with relevant EU provisions, and are readily obtainable by the user and unless it is feasible to use them under the conditions of use of the plant protection product, taking into account climatic conditions in particular.
Kadar se pri predlaganih pogojih uporabe zahteva uporaba zaščitne obleke, se registracija ne odobri, če oprema ni učinkovita in v skladu z ustreznimi določbami EU ter uporabniku dostopna in enostavna za uporabo v predvidenih okoliščinah uporabe fitofarmacevtskega sredstva, še zlasti ob upoštevanju podnebnih razmer.
No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms may lead to adverse effects on human and animal health, including resistance to known therapeutic substances.
Registracija se ne odobri, če je znano, da prenos genskega materiala iz mikroorganizma na druge organizme lahko povzroči škodljive učinke na zdravje ljudi in živali, vključno z odpornostjo proti znanim zdravilnim učinkovinam.
Plant protection products which, because of particular properties, or which, if mishandled or misused, could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use.
Fitofarmacevtska sredstva, ki zaradi nekaterih lastnosti, napačnega ravnanja ali napačne uporabe lahko povzročijo veliko tveganje, je treba omejiti, npr. z omejitvami glede velikosti embalaže, vrste formulacije, distribucije, uporabe ali načina uporabe.
Moreover, plant protection products which are classified as very toxic shall not be authorised for use by non-professional users.
Poleg tega se fitofarmacevtska sredstva, ki so opredeljena kot zelo toksična, registrirajo samo za profesionalno uporabo.
Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on bystanders or workers exposed after application of the plant protection product are expected.
Varnostne karence in karence za ponovni dostop ali druge varnostne ukrepe je treba določiti tako, da preprečijo koloniziranje ali škodljive učinke na navzoče osebe ali delavce, ki so izpostavljeni po nanosu fitofarmacevtskega sredstva.
Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on animals are expected.
Varnostne karence in karence za ponovni dostop ali druge varnostne ukrepe je treba določiti tako, da preprečijo koloniziranje ali škodljive učinke na živali.
Waiting and re-entry periods or other precautions to ensure that no colonisation or adverse effects are expected must be realistic; if necessary, special precautionary measures must be prescribed.
Varnostne karence in karence za ponovni dostop ali drugi varnostni ukrepi, ki zagotavljajo preprečevanje koloniziranja ali škodljive učinke, morajo biti realistični; če je potrebno, se predpišejo posebni previdnostni ukrepi.
The conditions of authorisation shall be in compliance with Directive 98/24/EC and Directive 2000/54/EC of the European Parliament and of the Council [14].
Pogoji za registracijo so v skladu z Direktivo Sveta 98/24/ES in Direktivo 2000/54/ES Evropskega parlamenta in Sveta [14].
The experimental data and information relevant to the recognition of the symptoms of infection or pathogenicity and on the effectiveness of first aid and therapeutic measures provided shall be considered.
Preučijo se eksperimentalni podatki in informacije, pomembni za prepoznavanje simptomov okužbe ali patogenosti ter o učinkovitosti prve pomoči in terapevtskih ukrepov.
The conditions of authorisation shall also be in compliance with Directive 2004/37/EC.
Pogoji za registracijo so v skladu tudi z Direktivo 2004/37/ES.
The conditions of authorisation shall also be in compliance with Council Directive 89/656/EEC [15].2.6.2. Effects on human and animal health arising from residues
Pogoji za registracijo so v skladu tudi z Direktivo Sveta 89/656/EGS [15].2.6.2 Učinki ostankov na zdravje ljudi in živali
No authorisation shall be granted unless there is sufficient information for plant protection products containing the micro-organism, to decide that there is no harmful effect on human or animal health arising from exposure to the micro-organism, its residual traces and metabolites/toxins remaining in or on plants or plant products.
Registracija se odobri le, če je za odločitev na voljo dovolj informacij o fitofarmacevtskih sredstvih, ki vsebujejo mikroorganizem, da zaradi izpostavljenosti mikroorganizmu, njegovim ostankom in metabolitom/toksinom, ki ostanejo v rastlinah ali rastlinskih proizvodih ali na njih, ni škodljivih vplivov na zdravje ljudi ali živali.
No authorisation shall be granted if the available information indicates that there may be unacceptable adverse environmental effects due to the fate and behaviour of the plant protection product in the environment.
Registracija se ne odobri, če razpoložljive informacije kažejo, da zaradi končnega stanja in obnašanja fitofarmacevtskega sredstva v okolju obstaja možnost za nesprejemljive škodljive učinke na okolje.