natgillin/translations-raw huggingface dataset:
Določba iz uredbe določa, da zainteresirane strani Komisiji, Agenciji in državam članicam v določenem roku predložijo vse potrebne podatke.
It shall require interested parties to submit all the necessary data to the Commission, the Authority and the Member States within a specified time period.
Določb o pregledu obstoječih sinergistov in varoval ne bi smeli sprejemati s komitologijo, temveč v zakonodajnem postopku na podlagi Pogodbe.
The provisions for reviewing existing synergists and safeners shall not be left to a comitology decision, but shall be established in a legislative procedure based on the Treaty.
Pomožna snov v formulaciji se prepove , če je bilo ugotovljeno, da:
A co-formulant shall be prohibited where it has been established that:
Pomožna snov v formulaciji se odobri , če je bilo ugotovljeno, da:
A co-formulant shall be approved where it has been established that:
(a) njeni ostanki, kot posledica uporabe v skladu z dobro prakso varstva rastlin, škodljivo vplivajo na zdravje ljudi ali živali, podzemno vodo ali okolje; ali
(a) its residues, consequent on application consistent with good plant protection practice, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; or
(a) pomožna snov v formulaciji ali njeni ostanki, kot posledica uporabe v skladu z realnimi pogoji uporabe, nimajo škodljivega vpliva na zdravje ljudi ali živali, podzemno vodo ali okolje; in
(a) the co-formulant or its residues, consequent on application consistent with realistic conditions of use, do not have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; and
(b) njena uporaba, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih običajnih pogojev uporabe, škodljivo vpliva na zdravje ljudi ali živali ali nesprejemljivo vpliva na rastline, rastlinske proizvode ali okolje.
(b) its use, consequent on application consistent with good plant protection practice and having regard to realistic normal conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment.
(b) njena uporaba, kot posledica uporabe v skladu z dobro prakso glede fitofarmacevtskih sredstev in ob upoštevanju realnih pogojev uporabe, nima škodljivega vpliva na zdravje ljudi ali živali ali nesprejemljivo vpliva na rastline, rastlinske proizvode ali okolje.
(b) its use, consequent on application consistent with good plant protection product practice and having regard to realistic conditions of use, does not have a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment.
Pomožne snovi v formulaciji, prepovedane v skladu z odstavkom 1, se vključijo v Prilogo III skladno s postopkom iz člena 76(3) .
Co-formulants prohibited pursuant to paragraph 1 shall be included in Annex III in accordance with the procedure referred to in Article 76(3).
Pomožne snovi v formulaciji, odobrene v skladu z odstavkom 1, se vključijo v Prilogo III skladno z regulativnim postopkom s pregledom iz člena 76(3a) .
Co-formulants approved pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a).
Dobra praksa je zaželena, vendar z njo ni mogoče računati.
Good practice should be assumed, but can not be taken for granted.
Zato bi bilo treba predvideti „realne pogoje uporabe“, kar je v skladu s trenutnimi določbami smernic za preskušanje v Direktivi 91/414, kjer se upoštevajo „praktični“ in „dejanski pogoji uporabe“.
Instead, realistic conditions of use should be foreseen in line with the current provisions included in the test guidelines in Directive 91/414, where consideration must be given to “practical conditions of use” and “realistic conditions of use”.
Kadar se v fitofarmacevtskem sredstvu, registriranem po tej uredbi, uporabi pomožna snov v formulaciji, njegova posebna uporaba v fitofarmacevtskih sredstvih velja za registrirano v skladu s členom 15(1) Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) 1 .
Where a co-formulant is used in a plant protection product authorised under this Regulation, its specific use in plant protection products shall be considered as being registered in accordance with Article 15 (1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 1 .
1 UL L 396, 30.12.2006, str.
1 OJ L 396, 30.12.2006, p.
Popravljena različica v UL L 136, 29.5.2007, str.
Corrected in OJ L 136, 29.5.2007, p.
Treba se je izogniti podvajanju predpisov za pomožne snovi v formulaciji, uporabljene v fitofarmacevtskih sredstvih, v tej uredbi in uredbi REACH.
Co-formulants used in plant protection products should not be subject to double regulation under REACH.
Člen 28, odstavek 2, točka (b)
Article 28, paragraph 2, point (b)
(b) dajanje v promet in uporaba fitofarmacevtskih sredstev za raziskovalne ali razvojne namene v skladu s členom 51;
(b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 51;
(b) uporaba fitofarmacevtskih sredstev za raziskovalne ali razvojne namene v skladu s členom 51;
(b) use of plant protection products for research or development purposes in accordance with Article 51;
Cilj uredbe so visoki standardi za registracijo.
The Regulation aims at having high standards for authorisation.
Fitofarmacevtskih sredstev, ki so bila registrirana posebej za raziskave in razvoj, se ne bi smelo dati v promet.
Plant protection products authorised specifically for research and development purposes should not be placed on the market.
Vzporedni uvoz
Parallel imports
Ne glede na določbe člena 28(1) se lahko fitofarmacevtsko sredstva v državah članicah dajejo na trg in uporabljajo, ne da bi bila tam registrirana, če ima tisti, ki želi dati fitofarmacevtsko sredstvo v promet, zanj potrdilo o tržljivosti, ki ga izda zadevna država članica.
Notwithstanding the provisions of Article 28(1), a plant protection product may be placed on the market and used in a Member State without being authorised there if the person wishing to market the plant protection product is in possession of a marketability certificate for the plant protection product issued by that Member State.
Države članice na zahtevo izdajo potrdila o tržljivosti v smislu odstavka 1 za fitofarmacevtska sredstva, če je fitofarmacevtsko sredstvo, ki bo uvoženo iz druge države članice, v drugi državi članici že registrirano in je v državi uvoza registrirano snovno enako referenčno sredstvo (vzporedni uvoz).
Member States shall issue a marketability certificate within the meaning of paragraph 1 for a plant protection product upon request, provided the plant protection product to be imported from another Member State has already been authorised in another Member State and a reference product which is compositionally equivalent is authorised in the importing state (parallel imports).
Snovna enakost v smislu tega člena obstaja, če uvoženo in referenčno sredstvo vsebujeta enake aktivne snovi, v primerljivih količinah, z enako stopnjo najnižje dovoljene čistosti, z določenimi nečistočami iste vrste in z enako najvišjo dovoljeno vsebnostjo ter se ujemata v vrsti formulacije.
Compositional equivalence within the meaning of this Article shall be deemed to exist where imported and reference products contain the same active substances in comparable amounts with equivalent minimum purity levels and with certain impurities of the same type and equivalent maximum levels and have a matching formulation type.
Glede drugih vidikov sestave so razlike dovoljene pod pogojem, da te razlike v kakovosti in količini v pomožnih snoveh v formulaciji ne vplivajo na biološko učinkovitost, na rastline, ki bodo obravnavane, ali na človeka, živali ali naravo.
As regards other aspects of composition, differences are permissible provided these qualitative or quantitative differences in the co-formulants have no impact on biological efficacy, the plants to be treated or human beings, animals or nature.
Merila in postopek za preverjanje snovne enakosti se lahko uredijo bolj podrobno v skladu s postopkom svetovanja iz člena 76(2).
The crite ria and the procedure for verifying compositional equivalence may be regulated in greater detail under the advisory procedure referred to in Article 76(2).
Zahtevek za izdajo potrdila o tržljivosti vsebuje naslednje informacije:
The application for the issue of a marketability certificate shall contain the following information:
– državo članico izvora fitofarmacevtskega sredstva, ki bo uvoženo,
– the Member State of origin of the plant protection product to be imported;
– ime in naslov uvoznika,
– the name and address of the importer;
– oznako, s katero se bo uvoženo fitofarmacevtsko sredstvo prodajalo v državi uvoza,
– the designation under which the imported plant protection product is to be marketed in the importing country;
– oznako in številko odobritve fitofarmacevtskega sredstva, ki bo uvoženo, v državi članici izvora,
– the designation and approval number in the Member State of origin of the plant protection product to be imported;
– ime in naslov imetnika registracije v državi članici izvora,
– the name and address of the authorisation holder in the Member State of origin;
– originalna navodila za uporabo, s katerimi se fitofarmacevtsko sredstvo, ki bo uvoženo, prodaja v državi članici izvora,
– the original instructions with which the plant protection product to be imported is marketed in the Member State of origin;
– označitev in navodila za uporabo, s katerimi se bo uvoženo fitofarmacevtsko sredstvo, prodajalo,
– the designation and instructions with which the imported plant protection product is to be marketed;
– oznako in številko registracije referenčnega sredstva,
– the designation and authorisation number of the reference product;
– ime imetnika registracije referenčnega sredstva.
– the name of the authorisation holder of the reference product.
Fitofarmacevtsko sredstvo, za katerega je bilo izdano potrdilo o tržljivosti, se uporablja na enak način kot referenčno sredstvo.
A plant protection product for which a marketability certificate has been issued shall be used in the same manner as the reference product.
Potrdilo o tržljivosti velja za čas trajanja registracije referenčnega sredstva.
The marketability certificate shall apply for the duration of the authorisation of the reference product.
Če imetnik registracije referenčnega sredstva v skladu s členom 44(1) zahteva preklic registracije in če so zahteve iz člena 29 še vedno izpolnjene, veljavnost potrdila o tržljivosti preneha eno leto po preklicu registracije in najkasneje ob poteku veljavnosti registracije.
If the authorisation holder of the reference product applies, pursuant to Article 44(1), for authorisation to be withdrawn and if the requirements under Article 29 continue to be met, the validity of the marketing certificate shall end one year after the revocation of the authorisation, and, at the latest, when the authorisation has expired.
Določbe členov 43, 45 in 53(4) in Poglavje VII se ustrezno uporabljajo za vzporedni uvoz.
The provisions of Articles 43, 45 and 53(4) and Chapter VII shall apply, mutatis mutandis, to parallel imports.
Predlog Komisije ne vsebuje pravil o vzporednem uvozu fitofarmacevtskih sredstev.
The Commission’s proposal contains no rules on parallel imports of plant protection products.
Zaradi odprave sedanje pravne negotovosti je nujno potrebna pravna ureditev na ravni EU.
However, legal provisions are urgently needed at EU level in order to put an end to the existing legal uncertainty.
Nasprotujoče si odločbe sodišč in različni pristopi držav članic do vzporednega uvoza terjajo dopolnitev predloga z ureditvijo vzporednega uvoza.
Conflicting court decisions and the variety of approaches taken to parallel imports by the Member States mean that the proposal must be supplemented by rules on parallel imports.
Člen 29, odstavek 1, točka (c)
Article 29, paragraph 1, point (c)
(c) pomožne snovi v formulaciji niso prepovedane v skladu s členom 27;
(c) its co-formulants have not been prohibited under Article 27;
(c) pomožne snovi v formulaciji so odobrene v skladu s členom 27;
(c) its co-formulants have been approved under Article 27;
Glej obrazložitev predloga spremembe k členu 27.
See justification on Amendment to Article 27 above.
Člen 29, odstavek 1, točka (c a) (novo)
Article 29, paragraph 1, point (c a) (new)
(ca) njegova (tehnična) formulacija je takšna, da so izpostavljenost uporabnika ali druga tveganja čim bolj omejeni, ne da bi to ogrozilo delovanje sredstva;
(ca) its (technical) formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product;
Različne formulacije se glede tveganja precej razlikujejo – npr. prašek v primerjavi z granulami ter formulacija, ki vsebuje organsko topilo, v primerjavi z vodotopnimi emulzijami.
Different formulations vary considerably in risk - e.g. powder compared to granule formulation and formulation containing organic solvent compared to water soluble emulsions.
Formulacija sama na sebi ne bi smela povečevati tveganja, povezanega z uporabo posameznega fitofarmacevtskega sredstva, če se je temu mogoče izogniti.
If it can be avoided, the formulation in itself should not increase the risk involved with the use of a specific plant protection product.
Predlagano besedilo bi pomagalo zagotoviti uporabo formulacije z najnižjo možno stopnjo tveganja, ko bo sredstvo dano v promet.
The proposed text would help ensure that the formulation with the lowest possible risk is used when a product is placed on the market.
Člen 29, odstavek 1, točka (e a) (novo)
Article 29, paragraph 1, point (e a) (new)
(ea) vsi metaboliti aktivne (aktivnih) snovi, ki so navzoči v fazi uporabe, so bili opredeljeni in so v skladu z enotnimi načeli iz odstavka 6;
(ea) all metabolites of the active substance(s) present in the use-phase have been determined and comply with criteria of the uniform principles referred to in paragraph 6;
Enotna načela so ključen dejavnik v postopku registracije.
The Uniform principles are a key element in the authorisation process.
Člen 29, odstavek 1, točka (f)
Article 29, paragraph 1, point (f)
(f) ostanki, ki nastanejo pri odobrenih uporabah in so toksikološko, ekotoksikološko ali okoljsko pomembni, se lahko določijo z ustreznimi splošno razširjenimi metodami;
(f) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental significance, can be determined by appropriate methods in general use;
(f) ostanki, ki nastanejo pri registriranih uporabah, se lahko določijo s standardiziranimi splošno razširjenimi metodami , ki se uporabljajo v vseh državah članicah in so dovolj občutljive kar zadeva kakršne koli tehnično zaznavne količine, ki bi lahko bile prisotne v katerem koli okoljskem in biološkem mediju.
(f) its residues, resulting from authorised uses, can be determined by standardised methods in general use in all Member States , which are sufficiently sensitive with respect to any technically detectable levels that could be present in any environmental and biological media .
Vsebnost ostankov se določa z ustaljenimi multirezidualnimi metodami, kot jih uporabljajo referenčni laboratoriji EU.
The residues shall be detectable with the common multi-residue methods as applied by EU reference laboratories;
To je v skladu s prej predlaganim predlogom spremembe člena 4(2)(c) in spremno obrazložitvijo.
This is in line with the earlier amendment suggested at Article 4, paragraph 2, point c and the related justification.
Metode za določanje vsebnosti ostankov bi morale biti dovolj občutljive glede na stopnje nevarnosti v raznih okoljskih in bioloških medijih, da ne bi spregledale učinkov, ki jih je težko odkriti s splošno razširjenimi metodami.
Methods to detect all residues of active substances should be sufficiently sensitive with respect to levels of concern in various environmental and biological media in order not to overlook effects that are not easily detected by methods in general use.
Člen 29, odstavek 1, točka (h a) (novo)
Article 29, paragraph 1, point (h a) (new)
(ha) njegova registracija ni v nasprotju z nacionalnimi načrti, pripravljenimi v skladu z Direktivo 2007/XXX7EC [o določitvi okvira za ukrepe Skupnosti za dosego trajnostne uporabe pesticidov].
(ha) its authorisation does not counteract the national plans developed under Directive 2007/XXX/EC [establishing a framework for Community action to achieve a sustainable use of pesticides].
Pred registracijo fitofarmacevtskega sredstva bi morale imeti možnost, da upoštevajo regionalne razmere.
Member states should be allowed to take regional conditions into account before authorising plant protection products.
Z odstopanjem od točke 1(a) lahko država članica v petih letih po sprejetju delovnega programa iz člena 26 odobri dajanje v promet na svojem ozemlju fitofarmacevtskih sredstev, ki vsebujejo sinergiste in varovala, ki niso odobreni, vendar so vključeni v program.
By way of derogation from point (a) of paragraph 1, a Member State may, during a period of 5 years following the adoption of the programme of work referred to in Article 26 authorise the placing on the market in its territory of plant protection products containing synergists and safeners which are not approved, but which are included in that programme.
Ker pesticidi pogosto vsebujejo več različnih snovi, ki lahko spremenijo delovanje aktivne sestavine/snovi v formulaciji, ni možno domnevati, da nobeden od različnih sredstev in formulacij, ki vsebujejo določen sinergist ali določeno varovalo, vključen v program pregleda iz člena 26, ne bo imel škodljivih vplivov na ljudi in živali ali okolje.
Considering that pesticide products often contain a number of different substances potentially altering the action of an active ingredient/substance within the formulation, it cannot be assumed that all different products and formulations containing an specific synergist or safener which is included in the review programme referred to in Article 26 will have no harmful effects on humans and animals or the environment.
Morebitne škodljive vplive na zdravje je treba ugotoviti pred registracijo, s čimer se zagotovi, da ne bo prišlo do škodljivih vplivov na ljudi in živali.
The potential adverse health must be assessed prior to their authorization to establish that there will be no harmful effects on humans and animals.
Člen 29, odstavek 5
Article 29, paragraph 5
Glede na točko 1(e) se lahko sprejmejo usklajene metode v skladu s postopkom iz člena 76(3) .
With respect to point (e) of paragraph 1, harmonised methods may be adopted in accordance with the procedure referred to in Article 76(3).
Glede na točko 1(e) se lahko sprejmejo usklajene metode v skladu z regulativnim postopkom s pregledom iz člena 76(3a) .
With respect to point (e) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 76(3a) .
Člen 29, odstavek 6
Article 29, paragraph 6
Enotna načela za oceno in registracijo fitofarmacevtskih sredstev se opredelijo v uredbah, ki se sprejmejo v skladu s postopkom iz člena 76(2) , ki vključuje zahteve iz Priloge VI k Direktivi 91/41/EGS s kakršnimi koli potrebnimi spremembami.
Uniform principles for evaluation and authorisation of plant protection products shall be defined in Regulations adopted in accordance with the procedure referred to in Article 76(2) , incorporating the requirements in Annex VI to Directive 91/41 4/EEC with any necessary modifications.
Enotna načela za oceno in registracijo fitofarmacevtskih sredstev se opredelijo v uredbi Evropskega parlamenta in Sveta , ki vključuje zahteve iz Priloge VI k Direktivi 91/414/EGS s kakršnimi koli potrebnimi spremembami.
Uniform principles for evaluation and authorisation of plant protection products shall be defined in a Regulation of the European Parliament and of the Council , incorporating the requirements in Annex VI to Directive 91/414/EEC with any necessary modifications.
Enotna načela se ne bodo določala s postopkom komitologije.
The Uniform Principles shall not be established by the Comitology procedure.
V letu 1996 je moral Evropski parlament na sodišče, ker prva enotna načela, ki jih je določila Komisija, niso bila v skladu z Direktivo 91/414.
In 1996 the European Parliament had to go to Court because the first Uniform Principles which were established by the Commission did not comply with Directive 91/414.
Sodišče je (v zadevi C-303/94) potrdilo stališče Parlamenta in tako so se načela, zlasti merila za pitno vodo, spremenila.
The Court (case C-303/94) confirmed the Parliament’s position and the Principles were changed, especially for drinking water criteria.
Uredba, ki določa nova enotna načela, se ne bi smela sprejeti s postopkom komitologije, ampak bi jo morala v ustreznem zakonodajnem postopku sprejeti Evropski parlament in Svet.
The Regulation establishing the new Uniform Principles should be adopted by the European Parliament and the Council in an adequate legislative procedure, and not by Comitology.
Člen 29, odstavek 6, pododstavek 1 a (novo)
Article 29, paragraph 6, subparagraph 1 a (new)
Enotna načela dosledno upoštevajo interakcijo med aktivno snovjo, varovali, sinergisti in pomožnimi snovmi v formulaciji.
The uniform principles shall take due account of the interaction between the active substance, safeners, synergists and co-formulants.
Pojasniti je treba, da se pri postopku registracije upošteva interakcija med različnimi snovmi.
It shall be made clear that the interaction between different substances is taken into account in the authorisation process.
Posamična obravnava uporabljenih snovi ne zadostuje.
It is not sufficient to look at the involved substances separately.
Predlog spremembe je namenjen predvsem pojasnitvi.
The amendment is mainly meant to clarify.
Posredno je omenjen že v členu 25(2) v povezavi s členom 8(1)(a), členom 29(4) in enotnimi načeli.
It is already indirectly mentioned in Article 25 paragraph 2 in connection with Article 8 paragraph 1 point a), Article 29 paragraph 4 and in the uniform principles.
Člen 30, naslov in odstavek 1
Article 30, title and paragraph 1
Vsebina registracije
Contents of the authorisation
Registracija opredeljuje pridelke , na katerih se fitofarmacevtsko sredstvo lahko uporabi, in namene uporabe.
The authorisation shall define the crops on which and the purposes for which the plant protection product may be used.
Registracija v standardizirani obliki opredeljuje kulturne rastline , na katerih se fitofarmacevtsko sredstvo lahko uporabi, in namene uporabe.
The authorisation , which shall use a standardised form, shall define the crops on which and the purposes for which the plant protection product may be used.
Oblika registracije bi morala biti v državah članicah standardizirana in identična.
The authorisation form should be standardised and identical for the Member States.
Registracija določa zahteve v zvezi z dajanjem v promet in uporabo fitofarmacevtskega sredstva.
The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product.
Te zahteve vključujejo pogoje uporabe, potrebne za skladnost s pogoji in zahtevami iz Uredbe , ki dovoljuje aktivne snovi, varovala in sinergiste.
Those requirements shall include the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists.
Registracija vključuje razvrstitev fitofarmacevtskih sredstev za namene Direktive 1999/45/ES.
The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC .
Te zahteve vključujejo vsaj:
Those requirements shall as a minimum include: