natgillin/translations-raw huggingface dataset:
Previdnostno načelo se omenja zgolj v uvodni izjavi (8) in členu 13(2); smiselno bi ga bilo omeniti v prvih členih te uredbe.
The precautionary principle is only laid out in the Recitals (8) and in Article 13(2) It is preferable to refer it in the first articles of the Regulation.
Uvoz fitofarmacevtskega sredstva iz države članice, kjer je bil registriran v skladu z določbami Direktive 91/414/EGS ali te uredbe, za dajanje na trg v državi članici uvoznici, kjer je bilo to sredstvo ali identično referenčno sredstvo registrirano v skladu z določbami Direktive 91/414/EGS ali te uredbe;
The import of a plant protection product from a Member State where the product has been authorised in accordance with the provisions of Directive 91/414/EEC or this Regulation, with the intention of placing it on the market in the importing Member State, in which that product or an identical reference product has been authorised in accordance with the provisions of Directive 91/414/EEC or this Regulation;
Potrebna je jasna opredelitev in določitev vsaj nekaterih usklajenih pravil Skupnosti o dajanju fitofarmacevtskih sredstev na trg prek vzporedne trgovine.
There is a need for a clear definition and a minimum set of harmonised Community rules governing the placing of plant protection products on the market through parallel trade.
Fitofarmacevtska sredstva se štejejo za identična, če:
Plant protection products shall be deemed identical where they:
– imajo skupni izvor,
• share a common origin,
– jih je proizvedlo isto podjetje ali povezano podjetje ali v okviru licence in
• have been manufactured by the same company or an associated undertaking or under licence, and
– so bila proizvedena vsaj po enaki formuli in z enakimi aktivnimi snovmi ter imajo enak učinek, pri tem je treba zlasti upoštevati morebitne razlike glede razmer, povezanih s kmetijstvom, zdravjem rastlin in okoljem ter zlasti podnebnimi razmerami.
• have at least been manufactured according to the same formulation, using the same active ingredient, and have the same effect with due regard, in particular, to differences which may exist in conditions relating to agriculture, plant health and the environment, in particular climatic conditions.
je upravni akt, s katerim pristojni organ države članice registrira fitofarmacevtsko sredstvo za dajanje v promet na svojem ozemlju ;
Administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory ;
je upravni akt, s katerim pristojni organ države članice registrira fitofarmacevtsko sredstvo za dajanje v promet na določenem območju ;
Administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product within a zone ;
je praksa, pri kateri se izbere, odmeri in časovno uvrsti obdelava zadevnega posevka s fitofarmacevtskimi sredstvi, v skladu s pogoji njihove registrirane uporabe za zagotovitev optimalne učinkovitosti s čim manjšo količino, ki je potrebna, ob upoštevanju obvladovanja odpornosti, lokalnih razmer ter možnosti zatiranja s pomočjo ustreznih metod pridelave in bioloških sredstev;
Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure optimum efficacy with the minimum quantity necessary, taking due account of resistance management, local conditions and of the possibilities for cultural and biological control;
Opredelitev dobre okoljske prakse ni potrebna in po nepotrebnem ustvarja zmedo.
The definition of 'Good Environmental Practice' is redundant and creates unnecessary confusion.
Varovanje okolja spada k postopku registracije.
The protection of the environment is part of the authorisation-procedure.
Varstvo okolja je tudi del "integriranega varstva rastlin pred škodljivci" in "dobre prakse varstva rastlin".
The protection of the environment is also part of 'Integrated Pest Management" and 'Good Plant Protection'.
zajema podatke v okviru poročila o poskusu ali študiji , vključno s povzetkom, in se uporablja, kadar ima imetnik pravico preprečiti uporabo teh podatkov v korist druge osebe.
A test or study report , including a summary, is covered by data protection where its owner has the right to prevent it being used for the benefit of another person.
(21a) "država članica poročevalka"
(21a) ' Rapporteur Member State '
Nalogo mora opravljati strokovno in v določenem obdobju objaviti poročilo o presoji vplivov.
It is required to carry out this task in a professional manner and to publish an impact assessment report within a specified period.
Izraz "država članica poročevalka" je treba opredeliti.
There should be a definition of rapporteur Member State.
Člen 3, odstavek 21 b (novo)
Article 3, paragraph 21 b (new)
21b. "nesprejemljiv vpliv na okolje"
21b. ‘unacceptable effect on the environment’
je vsak vpliv, ki lahko nepovratno spremeni biološko raznovrstnost in biotope, med drugim s hudimi motnjami določenih vrst, kar lahko nazadnje povzroči njihovo izumrtje.
Any effect that may irreversibly alter biodiversity and biotopes, inter alia via a significant disruption to certain species which could ultimately lead to their becoming extinct.
Izraz "nesprejemljiv" ni nikjer točno določen.
The word ‘unacceptable’ is nowhere precisely defined.
(a) nimajo škodljivih vplivov na zdravje ljudi, vključno z ranljivimi skupinami , ali zdravje živali, ob upoštevanju ugotovljenih kumulativnih in sinergijskih učinkov , kadar obstajajo metode za ocenjevanje takšnih učinkov, ali vplivov na podzemno vodo;
(a) they shall not have any harmful effects on human health, including vulnerable groups, or animal health, taking into account known cumulative and synergistic effects when the methods to assess such effects are available, or on ground water;
(a) nimajo škodljivih vplivov na zdravje ljudi, zlasti na zdravje uporabnikov, ki so v neposrednem stiku s proizvodi, pri čemer se posebna pozornost posveča ranljivim skupinam, kot so ženske v rodni dobi, plodovi in otroci v puberteti , ali zdravje živali, ob upoštevanju ugotovljenih kumulativnih in sinergijskih učinkov ali vplivov na podzemno vodo;
(a) they shall not have any harmful effects on human health, in particular on the health of users who are in direct contact with the products and with particular attention being paid to vulnerable groups such as women of reproductive age, foetuses and children up to the age of puberty , or animal health, taking into account known cumulative and synergistic effects or on ground water;
V skladu s previdnostnim načelom snovi ne smejo imeti škodljivih učinkov na zdravje ljudi, zlasti ranljivih podskupin, kot so plodovi in otroci, ali okolje, kar je v skladu z odzivom Evropskega parlamenta (resolucija EP P5_TA(2002)0276 , (4)) in Sveta na prvo sporočilo Komisije o reviziji Direktive 91/414.
In accordance with the precautionary principle, substances must not have any adverse effects on human health, particularly that of vulnerable subgroups such as foetuses and children, or the environment, in line with the reaction of the European Parliament (EP resolution P5_TA(2002)0276 , (4)) and the Council to the first Commission Communication on the revision of Directive 91/414.
K močno ogroženim skupinam je treba šteti tudi zaposlene v kmetijstvu in kmete, ki so pri škropljenju v neposrednem stiku s temi snovmi ali so jim izpostavljeni med delom na polju.
Agricultural workers and farmers who get in direct contact with the substances while filling the sprayers or who are exposed to the substances while working on the fields should also be considered as a high risk group.
(c) se za merjenje ostankov fitofarmacevtskih sredstev uporabljajo splošno razširjeni merilni postopki , ki so dovolj občutljivi glede na stopnjo nevarnosti različnih okoljskih in bioloških medijev .
(c) for residues of all plant protection products , there shall be methods in general use for measuring them which are sufficiently sensitive in relation to the level of concern of a number of environmental and biological media .
Člen 4, odstavek 3, uvodni del
Article 4, paragraph 3, introductory part
Uporaba fitofarmacevtskih sredstev v skladu z dobro prakso varstva rastlin in ob upoštevanju običajnih pogojev uporabe izpolnjuje naslednje zahteve:
The use of the plant protection products, consequent on application consistent with good plant protection practice and having regard to normal conditions of use, shall meet the following requirements:
Uporaba fitofarmacevtskih sredstev v skladu s primerno uporabo in ob upoštevanju realnih pogojev uporabe izpolnjuje naslednje zahteve:
The use of the plant protection products, consequent on application consistent with appropriate use and having regard to realistic conditions of use, shall meet the following requirements:
(b) nima takojšnjega škodljivega vpliva ali zapoznelega škodljivega vpliva na zdravje ljudi ali živali neposredno ali preko pitne vode, hrane, krme ali zraka ali posledic na delovnem mestu ali preko drugih neposrednih vplivov, ob upoštevanju ugotovljenih kumulativnih in sinergijskih vplivov , kadar obstajajo metode za ocenjevanje takšnih vplivov; ali vpliva na podzemno vodo;
(b) it shall have no immediate or delayed harmful effect on human or animal health, directly or through drinking water, food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the methods to assess such effects are available ; or on groundwater;
(b) nima takojšnjega ali zapoznelega škodljivega vpliva :
b) it shall have no immediate or delayed harmful effect :
(i) na zdravje ljudi , pri čemer se posebna pozornost posveča ranljivim skupinam, kot so ženske v rodni dobi, plodovi in otroci v puberteti;
(i) on human health , with particular attention being paid to vulnerable groups such as women of reproductive age, foetuses and children up to the age of puberty;
(ii) ali zdravje živali neposredno ali preko pitne vode, hrane, krme ali zraka , vključno z onesnaževanjem na dolge razdalje, ki se nanaša na npr. polarne regije, ali posledic na delovnem mestu ali preko drugih neposrednih vplivov, ob upoštevanju ugotovljenih kumulativnih in sinergijskih vplivov ali vpliva na podzemno vodo;
(ii) or on animal health , directly or through drinking water, food, feed or air, including long-distance pollution affecting, for example, the polar region, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects, or on groundwater;
Člen 4, odstavek 3, točka (e), točka (ii)
Article 4, paragraph 3, point (e), point (ii)
(ii) njenega vpliva na neciljne vrste , zlasti na njihovo vedenje ;
(ii) its impact on non-target species , including on the behaviour of those species ;
Člen 4, odstavek 3, točka (e), točka (iii)
Article 4, paragraph 3, point (e), point (iii)
(iii) njenega vpliva na biološko raznovrstnost.
(iii) its impact on biodiversity
Kot izhaja iz razprav o registraciji gensko spremenjenih organizmov, ni znanstveno utemeljenega postopka za oceno vpliva na biološko raznovrstnost kot celoto.
As the discussion on the authorisation on GMO shows there is no scientifically based procedure to evaluate impacts on biodiversity as a whole.
Predlagano besedilo ustreza besedilu direktive o biocidih.
The proposed text corresponds to the text of the Biocides-Directive.
Popolna dokumentacija vključuje celotno besedilo poročil o posameznih preskusih in študijah v zvezi z vsemi informacijami iz odstavkov 1(b) in (c).
The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1.
Zavrnitev podatkov za ljudi, ki so že na voljo, znanstveno dokazani in moralno sprejemljivi, bi bila v nasprotju z dobro strokovno prakso in bi ogrožala kakovost odločanja pri obvladovanju tveganja.
To reject scientifically founded and ethically accepted human data that is already available would be to go against good scientific practice and would undermine the quality of risk-management decision-making.
Kadar manjka eden ali več elementov iz člena 8, države članice o tem obvestijo vlagatelja in določijo rok za njihovo predložitev , ki ne sme biti daljši od treh mesecev .
Where one or more of the elements provided for in Article 8 are missing, the Member State shall inform the applicant, setting a time period of no longer than three months for their submission.
Uporablja se člen 7(3).
Article 7 (3) shall apply .
Treba je določiti rok za dodajanje manjkajočih podatkov.
The period of time to add to the elements missing should be specified.
Če dokumentacija, predložena skupaj z zahtevkom, vključuje vse elemente iz člena 8, država članica poročevalka vlagatelja, Komisijo, druge države članice in Agencijo obvesti o sprejemljivosti zahtevka in začne ocenjevanje aktivne snovi.
Where the dossiers submitted with the application contain all the elements provided for in Article 8, the rapporteur Member State shall notify the applicant, the Commission, the other Member States and the Authority of the admissibility of the application and start assessing the active substance.
Država članica poročevalka lahko začne ocenjevati aktivno snov, takoj ko prejme dokumentacijo.
The rapporteur Member State may start to assess the active substance immediately on receiving the dossier .
Zaradi hitrejše izvedbe postopka lahko država članica poročevalka začne snov takoj ocenjevati.
To speed up the procedure it shall be admissible for the rapporteur Member State to start immediately with the assessment of the substance.
V devetih mesecih po datumu uradnega obvestila iz prvega pododstavka člena 9(3) država članica poročevalka pripravi in Agenciji predloži poročilo (v nadaljnjem besedilu „osnutek poročila o oceni“), v katerem oceni, ali je verjetno, da bo aktivna snov izpolnila zahteve iz člena 4.
Within nine months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Authority a report (hereafter called “draft assessment report”) assessing whether the active substance can be expected to meet the requirements of Article 4.
Uporablja se člen 7(3).
Article 7 paragraph 3 shall apply.
Namen predlaganih sprememb je pospešiti postopek in zagotoviti ustrezno varstvo podatkov.
The proposed changes are intended to accelerate the procedure and secure sufficient data protection.
Člen 13, odstavek 1, pododstavek 1
Article 13, paragraph 1 subparagraph 1
Odobritev se lahko enkrat ali večkrat obnovi za največ deset let.
The approval may be renewed once or more for a period not exceeding 10 years .
Registracija po prvi obnovitvi ne bi smela veljati za nedoločen čas.
Authorisation should not be unlimited in time after the first renewal.
Snov je treba po nadaljnjih desetih letih uporabe ponovno oceniti in preučiti, da se pristojni organi lahko odzovejo na morebitne dolgoročne učinke.
The substance must be subject to evaluation and examination after ten more years in practice, so that the responsible authorities can react to possible long term effects.
Odločitve je treba sprejemati glede na sedanje znanstvene in tehnične podatke, kakor določa člen 4(10).
Decisions should be taken in the light of current scientific and technical knowledge, as is laid down in Article 4(10).
Pri ocenjevanju se upošteva merila iz točke 4 Priloge II.
The assessment shall take account of the criteria laid down in point 4 of Annex II.
Takšna snov je v nadaljnjem besedilu „ možna nadomestna snov “.
Such a substance is referred to hereinafter as a ‘candidate for substitution’.
Aktivna snov, ki izpolnjuje merila iz člena 4 in najmanj eno od meril, določenih v točki 4 Priloge II , se odobri kot " snov, ki jo je treba nadomestiti ".
An active substance complying with the criteria laid down in Article 4 and at least one of the criteria laid down in point 4 of Annex II shall be classified and approved as a ‘candidate for substitution’.
Odobritev velja za obdobje 10 let.
The approval period is 10 years.
Za snovi, ki naj bi jih nadomestili, velja odobritev za obdobje 10 let.
The approval period shall be 10 years for candidates for substitution.
Te snovi ter njihovi vplivi na zdravje in okolje se v postopku registracije natančno preučijo.
A candidate for substitution, its health and environmental impacts, are fully examined in the authorisation procedure.
Registracija aktivne snovi se redno revidira in se lahko prekliče, kadar koli se pokažejo nove nevarnosti ali se na trgu pojavijo boljši izdelki.
The authorisation for the active substance is reviewed regularly and the authorisation may be withdrawn at any time if new concerns arise or better products appear on the market.
Proizvajalci in uporabniki fitofarmacevtskih sredstev potrebujejo varno pravno osnovo.
Producers and users of plant protection products need a secure legal basis.
(Zadnji stavek spremenjenega odstavka velja le, če pristojni odbor ne sprejme predloga spremembe 34.)
(The last sentence of the amended paragraph is only valid if AM 34 is not adopted by the lead Committee.)
Kadar se v fitofarmacevtskem sredstvu, registriranem po Direktivi 91/414/EGS 1 ali tej uredbi, uporabi pomožna snov v formulaciji, se šteje, da je bilo sredstvo v skladu s členom 15(1) Uredbe (ES) št. 1907/2006 2 registrirano za posebno uporabo v fitofarmacevtskih sredstvih .
Where a co-formulant is used in a plant protection product that has been authorised under Directive 91/414/EEC 1 or this Regulation it shall be regarded as being registered in accordance with Article 15(1) of Regulation ( EC) No 1907/2006 2 for the specific use in plant protection products .
1 Direktiva 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet (UL L 230, 19.8.1991, str.
1 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p.
2 Uredba (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH), o ustanovitvi Evropske agencije za kemikalije ter o spremembi Direktive 1999/45/ES ter razveljavitvi Uredbe Sveta (EGS) št. 793/93 in Uredbe Komisije (ES) št. 1488/94 ter Direktive Sveta 76/769/EGS in direktiv Komisije 91/155/EGS, 93/67/EGS, 93/105/ES in 2000/21/ES (UL L 396, 30.12.2006, str.
2 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), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p.
Začasna registracija
Provisional authorisation
Da se olajša dostop do novih pripravkov za uporabo v kmetijstvu, lahko država članica z odstopanjem od člena 28(1) na osnovi osnutka poročila o oceni iz člena 11 za prehodno obdobje največ treh let dovoli, da se dajo v promet fitofarmacevtska sredstva, ki vsebujejo aktivno snov, ki še ni bila odobrena, če dokumentacija o aktivni snovi izpolnjuje zahteve iz členov 4 in 8 ter glede predvidenih načinov uporabe.
By way of derogation from Article 28(1), a Member State may, to make it easier for new preparations to be made available for use in agriculture, authorise, on the basis of the draft assessment report referred to in Article 11, for a provisional period not exceeding three years, the placing on the market of plant protection products containing an active substance not yet approved, provided that the dossier on the active substance satisfies the requirements of Articles 4 and 8 and in relation to the projected uses.
Registracija po potrebi vključuje začasne mejne vrednosti ostankov v skladu s členom 15(1)(b) Uredbe (ES) št. 396/2005.
Where relevant, the authorisation shall include temporary maximum residue levels in accordance with Article 15(1)(b) of Regulation (EC) No 396/2005.
Država članica nemudoma obvesti druge države članice in Komisijo o svoji oceni dokumentacije in pogojih začasne registracije.
The Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the provisional authorisation.
Po oceni dokumentacije se lahko v skladu s postopkom iz člena 76(3) sprejme odločitev, da aktivna snov ne izpolnjuje zahtev iz člena 4.
Following the evaluation of the dossier it may be decided, in accordance with the procedure laid down in Article 76(3), that the active substance does not satisfy the requirements laid down in Article 4.
V takih primerih države članice zagotovijo, da se začasna registracija prekliče.
In such cases the Member States shall ensure that the povisional authorisation is withdrawn.
Če se po preteku triletnega obdobja ne sprejme odločitev glede registracije aktivne snovi, lahko država članica poročevalka določi dodatno obdobje treh let za začasno registracijo.
If, on expiry of the three-year period, a decision has not been taken concerning the authorisation of an active substance, a further provisional authorisation for a period of three years may be ordered by the rapporteur Member State .
Uporabljata se člena 56 in 60.
Articles 56 and 60 shall apply.
Poročevalec predlaga, da se ohrani člen 8 Uredbe ES št. 91/414 o prehodni registraciji.
The rapporteur proposes to retain Article 8 of Regulation EC no 91/414 on provisional authorisation.
Izkušnje kažejo, da njegovo črtanje ni upravičeno.
Experience does not justify its deletion.
Nobenega zagotovila ni, da registracija ne bo trajala več kot dve leti ali eno leto in pol, kot je predlagal poročevalec.
There is no guarantee that the authorisation will not take longer than two years - or 1 ½ as proposed by the rapporteur.
Kmetje potrebujejo za varstvo pred škodljivci in boj proti njihovi odpornosti široko paleto izdelkov.
Farmers need a wide range of products to control pests and combat resistances.
Neupravičeno omejevanje izbora bo privedlo do neželenih težav s škodljivci ali nezakonite uporabe.
An unjustified limitation of their choices will lead to unwanted pest-problems or illegal uses.
Snov bi morala biti dostopna, takoj ko se prvič ugotovi, da je njena uporaba varna, zato da bodo kmetom na voljo novi in inovativni proizvodi.
A substance should be made available as soon as the first safe use has been identified to provide farmers with new and innovative products.
Ta načela dosledno upoštevajo medsebojno vplivanje aktivne snovi, varoval, sinergistov in pomožnih snovi v formulaciji.
The uniform principles shall take into due account the interaction between the active substance, safeners, synergists and co-formulants.
Biti mora jasno, da se pri postopku registracije upošteva medsebojno vplivanje različnih snovi.
It shall be made clear that the interaction between different substances is taken into account in the authorisation process.
Predlog spremembe ima predvsem pojasnjevalno vrednost.
The amendment is mainly meant to clarify.
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 pridelke, 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 mora biti standardizirana in enaka v državah članicah.
The authorisation form should be standardised and identical for the Member States.
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.