natgillin/translations-raw huggingface dataset:
To je torej bistvo instrumenta in ne vzpostavitev in delovanje notranjega trga, ki je zgolj implicitni, sekundarni in posredni cilj glede na glavni cilj.
This is the centre of gravity of the instrument and not the establishment or functioning of the internal market, which is only an implicit aim and secondary and indirect in respect to the main aim.
Kar zadeva člen 37(2) , se nanj ni treba sklicevati v luči odstopanja iz člena 152(4)(b) za ukrepe na fitosanitarnem področju, katerih neposredni cilj je varstvo zdravja ljudi.
As far as Article 37(2) is concerned, there is no need to refer thereto in view of the express derogation contained in Article 152(4)(b) for measures in the phytosanitary field which have the protection of public health as their direct objective.
Glede cilja in vsebine predlagane uredbe ni dvomov, neposredni cilj ukrepa je varstvo zdravja ljudi.
There is no doubt whatsoever in view of the aim and content of the proposed regulation that protection of public heath is a direct objective of the measure.
Poleg tega se lahko zdi člen 37(2), ki predvideva postopek posvetovanja in ne soodločanja, nezdružljiv, razen če se lahko šteje, da sodna praksa za člen 133 lahko velja tudi za člen 37(2)
Furthermore, the fact that Article 37(2) provides for the consultation procedure and not co-decision might cause it to be regarded as incompatible unless the case-law on Article 133 can be construed as also applying to Article 37(2)
Glej sodbo z dne 10. januarja 2006 o zadevi C-178/03 Komisija proti Parlamentu in Svetu , odstavek 59, in sodbo istega dne o zadevi C-94/03 Komisija proti Svetu . .
See the judgment of 10 January 2006 in Case C-178/03 Commission v. Parliament and Council , at paragraph 59, and the judgment of the same date in Case C-94/03 Commission v. Council . .
Člen 152(4)(b) je torej zadostna pravna podlaga in sklicevanje na člen 175(1) potemtakem ni potrebno.
Consequently, Article 152(4)(b) suffices as legal basis and there is no need also to refer to Article 175(1) .
Za ustrezno pravno podlago se torej šteje člen 152(4)(b).
Accordingly, it is considered that the appropriate legal basis is Article 152(4)(b).
Odbor za pravne zadeve je na seji 11. junija 2007 se je soglasno
At its meeting of 11 June 2007 the Committee on Legal Affairs accordingly decided, unanimously
Pri končnem glasovanju so bili navzoči: Cristian Dumitrescu (predsednik), Lidia Joanna Geringer de Oedenberg (podpredsednica), Manuel Medina Ortega (pripravljavec mnenja), Carlo Casini, Janelly Fourtou, Luis de Grandes Pascual, Kurt Lechner, Klaus-Heiner Lehne, Antonio Masip Hidalgo, Hans-Peter Mayer, Michel Rocard, Aloyzas Sakalas, Gabriele Stauner, József Szájer, Jaroslav Zvěřina in Tadeusz Zwiefka. sprejel priporočilo, da kot ustrezno pravno podlago predloga Uredbe Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih proizvodov v promet predlaga člen 152(4)(b) Pogodbe o ES.
The following were present for the final vote: Cristian Dumitrescu (acting chairman), Lidia Joanna Geringer de Oedenberg (vice-chairwoman), Manuel Medina Ortega (draftsman), Carlo Casini, Janelly Fourtou, Luis de Grandes Pascual, Kurt Lechner, Klaus-Heiner Lehne, Antonio Masip Hidalgo, Hans-Peter Mayer, Michel Rocard, Aloyzas Sakalas, Gabriele Stauner, József Szájer, Jaroslav Zvěřina and Tadeusz Zwiefka. , to recommend that the appropriate legal basis for the proposal for a Regulation of the European Parliament and the Council concerning the placing of plant protection products on the market is Article 152(4)(b) of the EC Treaty.
o predlogu uredbe Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet
on the proposal for a regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market
Leta 1991 je bila zato uvedena obsežna zakonodaja, na podlagi katere je bil narejen popis zalog teh sredstev po vsej EU.
So in 1991 extensive legislation was introduced, resulting in the investigation of all stocks of such products throughout the EU.
Zaradi tega je močno upadlo število snovi na trgu: od 969 snovi, ki so bile analizirane, jih je danes na trgu dovoljenih samo 77, odločitev o 420 snoveh pa še ni bila sprejeta.
This led to a marked fall in the number of substances on the market: of the 969 substances that were looked at closely, only 77 are now permitted on the market and on 420 no decision has yet been taken.
Toda fitofarmacevtska sredstva so še vedno problem za okolje.
But plant protection products are still an environmental problem.
Te snovi so skoraj vedno škodljive za živo naravo, kar lahko povzroči težave npr. v času škropljenja posevkov.
The substances are almost by definition harmful to the living environment and this can create problems, for instance when crops are being sprayed.
Industrija da vsako leto na trg približno pet novih aktivnih snovi.
Every year the industry places about five new active substances on the market.
Iz njih so proizvedena številna fitofarmacevtska sredstva.
A number of plant protection products are produced on the basis of these substances.
S tem povezane raziskave so zahtevne in veliko stanejo.
The research involved is complicated and expensive.
Stroški industrije za posamezno aktivno snov znašajo približno 200 milijonov evrov na leto.
The industry’s costs for each active substance amount to about 200 million euros a year.
Drage raziskave so eden od razlogov za to, da je po svetu in v Evropi prišlo do velike tržne koncentracije.
Partly because of the high research cost, substantial market concentration has taken place, both worldwide and in Europe.
Glede na sedanji položaj Komisija predlaga številne večje spremembe:
In view of the current situation the Commission is proposing a number of significant changes:
§ Na treh območjih držav članic (severnem, osrednjem in južnem) se bodo fitofarmacevtska sredstva odobrila z vzajemnim priznavanjem – pod pogojem, da ne bodo vsebovala snovi, ki jih je treba omejiti.
§ In three zones of Member States (North, Centre and South) plant protection products will be approved by mutual recognition – provided that the product contains no substances that need to be restricted.
§ Vključene so pobude za razvoj manj škodljivih sredstev: za snovi z nizkim profilom tveganja bo veljalo daljše obdobje varstva podatkov in daljše začetno obdobje odobritve.
§ Incentives are included to develop less harmful products: substances with a low risk profile will obtain a longer period of data protection and a longer initial approval period.
§ Za manj razširjene posevke je predvideno naslednje: kadar je očitno, da je fitofarmacevtsko sredstvo za enega od bolj razširjenih posevkov učinkovito, lahko države članice dovolijo, da se uporablja tudi za druge posevke.
§ There is provision for the minor crops: Member States can approve a plant protection product that is used for a major crop to be used for other crops if this is clearly effective.
§ Da bi preprečili ponavljanje poskusov na živalih, je treba sporočati naprej rezultate poskusov na vretenčarjih.
§ To prevent the repetition of animal testing, test results obtained from research on vertebrate animals must be shared.
§ Krajši postopek za odobritev in registracijo: po starih predpisih je postopek odobritve trajal najmanj pet let, po novi določbi pa 25 mesecev.
§ Shorter approval and authorisation procedures: while approval under the old rules takes at least five years, there is now provision for a period of 25 months.
§ Prvič, treba je določiti jasna in objektivna merila za opredelitev snovi z nizkim profilom tveganja.
§ Firstly, there is a need to lay down clear and objective criteria to define which substances can claim to have a low risk profile.
Da bi spodbudili razvoj manj škodljivih fitofarmacevtskih sredstev, mora za sredstva z nizkim profilom tveganja veljati daljše obdobje varstva podatkov in s tem daljše obdobje za povrnitev stroškov.
To encourage the development of less harmful plant protection products, those products with substances with a low risk profile can claim a longer period of data protection and thus a longer cost recovery period.
Uvede se nova kategorija "majhnega tveganja".
A new ‘low risk’ category is also introduced.
§ Drugič, treba je spodbuditi razvoj sredstev za manj razširjene posevke.
§ Secondly, there is a need to encourage the development of products for the minor crops.
V skladu s tem pripravljavka mnenja predlaga tri spremembe.
The draftswoman is accordingly proposing three amendments.
Postopek odobritve se lahko izvede brezplačno, vlagatelji lahko pričakujejo, da bo obdobje varstva podatkov podaljšano, za manj obsežne odobritve pa se ustanovi Evropski spodbujevalni sklad.
The approval procedure can be carried out free of charge, applicants can expect an extension of the data protection period, and a European promotion fund is set up for small-scale approvals.
Vendar ni nujno dobro, da se državam članicam odvzame končna odločitev o odobritvi za njihovo ozemlje, saj se lahko naravne razmere (prst, voda ali podnebje) celo v istem območju močno razlikujejo.
But it can be undesirable to withhold from Member States the ultimate decision on approval for their territory, because natural conditions (the soil, water or climate) can differ considerably, even within one zone.
§ Četrtič, pripravljavka mnenja želi dodatno omejiti uporabo poskusov na živalih pri razvoju novih fitofarmacevtskih sredstev.
§ Fourthly, the draftswoman wants to help further cut back the use of animal testing in the development of new plant protection products.
§ Nazadnje je pripravljavka mnenja preučila tudi stališče industrije – zlasti vlagateljev.
§ Finally, the draftswoman has considered the position of the industry – and more particularly of applicants.
Krajša obdobja za odobritev in registracijo sta velika pridobitev zanjo.
Shorter approval and authorisation periods are a major gain for industry.
V nekaterih primerih je obdobje odobritve mogoče še pospešiti in dodatno okrepiti vlagateljevo stališče.
But in some cases the approval period could be somewhat speeded up, thus further strengthening applicants’ position.
(8a) Zaradi preprečevanja poskusov na živalih naj bi poskuse na vretenčarjih za namene te uredbe izvajali samo kot skrajni ukrep.
(8a) To prevent animal testing, tests on vertebrate animals should for the purposes of this Regulation be carried out only as a last resort.
Obstoječe rezultate poskusov na vretenčarjev si je treba v procesu razvijanja novih fitofarmacevtskih sredstev izmenjavati.
Existing results from tests on vertebrate animals must be shared in the process of developing new plant protection products.
V skladu z določbami Direktive št. 86/609 EGS z dne 24. novembra 1986 o zbliževanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za poskusne in druge znanstvene namene*, je treba poskuse na vretenčarjih nadomestiti, omejiti ali izboljšati.
In accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes*, tests on vertebrate animals must also be replaced, restricted or refined.
Najkasneje v sedmih letih po začetku veljavnosti te uredbe mora Komisija ponovno oceniti pravila o varstvu podatkov za rezultate poskusov na vretenčarjih in jih po potrebi spremeniti.
Within at the latest seven years of the entry into force of the Regulation, the Commission must review the rules on the data protection of results from tests on vertebrate animals and where necessary change those rules .
* UL L 358, 18.12.1986, str.
* OJ L 358, 18.12.1986, p.
Ukrepe, s katerimi se preprečuje ponavljanje poskusov na živalih, je treba poostriti.
The measures to prevent the repetition of animal experiments need tightening up.
Ta uredba določa pravila za registracijo fitofarmacevtskih sredstev v komercialni obliki in za njihovo dajanje v promet, za spodbujanje razvijanja fitofarmacevtskih sredstev z manj škodljivim vplivom na okolje ter za njihovo uporabo in nadzor v Skupnosti.
This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, for encouraging the development of products with a less harmful effect on the environment, and for their use and control within the Community.
Namen uredbe je tudi spodbuditi razvoj sredstev, namenjenih za omejeno uporabo.
The Regulation also aims to encourage the development of products intended for limited use.
Namen te uredbe je zagotoviti visoko raven varovanja zdravja ljudi in živali ter okolja.
The purpose of this Regulation is to ensure a high level of protection of both human and animal health and of the environment.
Spodbujanje manj škodljivih fitofarmacevtskih sredstev je zelo pomemben cilj, ki ga je treba vključiti v to uredbo.
Encouraging the development of less harmful plant protection products is a very important aim and should form part of the regulation’s subject matter.
(9a) "vzporedna trgovina"
(9a) 'parallel trade'
pomeni uvoz fitofarmacevtskega sredstva iz države članice, kjer je bilo sredstvo registrirano v skladu z določbami Direktive 91/414/EGS ali te uredbe, ter njegovo dajanje na trg v državi članici uvoznici, kjer je bilo to sredstvo ali istovetno 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;
fitofarmacevtska sredstva se štejejo za istovetna, če:
Plant protection products shall be deemed identical where they:
– imajo skupen izvor,
• share a common origin,
– so bila proizvedena v istem ali v povezanem podjetju ali po licenci in
• have been manufactured by the same company or an associated undertaking or under licence, and
- so bila proizvedena vsaj po enaki formuli in ob uporabi enake aktivne snovi in imajo enak učinek, predvsem glede na razlike v pogojih, povezanih s kmetijstvom, zdravjem rastlin in okoljem, zlasti pa v podnebnih razmerah;
• 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;
(22) „dobra okoljska praksa“
(20a) ‘Good Experimental Practice’
pomeni prakso v skladu z Direktivo 2004/10/ES;
Practice in accordance with Directive 2004/10/EC;
(21a) „dobra kmetijska praksa“
(21a) ‘Good Agricultural Practice’
pomeni varne načine uporabe fitofarmacevtskih sredstev, registrirane na nacionalni ravni, pod dejanskimi pogoji, ki so potrebni za učinkovito varstvo pred škodljivci.
Nationally authorised safe uses of plant protection products, under actual conditions necessary for effective pest control.
Obsega vrsto ravni uporabe fitofarmacevtskih sredstev, vse do najvišje dovoljene ravni, ki mora biti takšna, da ostanki nastajajo v najmanjših možnih količinah.
It encompasses a range of levels of plant protection product applications up to the highest authorised use, applied in a manner which leaves a residue which is the smallest amount practicable.
Registrirani načini varne uporabe so določeni na nacionalni ravni in vključujejo nacionalno registrirane ali priporočene načine uporabe, ki upoštevajo vidike javnega zdravja in zdravja pri delu ter varstva okolja.
Authorised safe uses are determined at the national level and include nationally registered or recommended uses, which take into account public and occupational health and environmental safety considerations.
Dejanski pogoji obsegajo vse stopnje proizvodnje, skladiščenja, prevoza in distribucije živil in krmil.
Actual conditions include any stage in the production, storage, transport and distribution of food commodities and animal feed.
V uredbo bi bilo treba vključiti opredelitev "dobre kmetijske prakse" Organizacije ZN za prehrano in kmetijstvo.
The Food and Agriculture Organisation’s definition of ‘good agricultural practice’ should be incorporated in the regulation.
(25) „uporaba v manjši meri“
(21b) ‘Minor Uses’
pomeni uporabo fitofarmacevtskega sredstva na posevku, ki v neki državi članici ni močno razširjen, ali na splošno razširjenem posevku, če za to obstajajo omejene ali občasne in izjemne potrebe, ali na semenu.
The use of a plant protection product on a crop which is not widely grown in a Member State, or on a widely grown crop to meet a limited or sporadic and exceptional need, or on seed.
Opredelitev izraza "uporaba v manjši meri", uporabljenega v členu 49.
Definition of the term ‘minor uses’ used in Article 49.
Aktivna snov se odobri v skladu s Prilogo II, če se glede na sedanje znanstvene in tehnične dosežke predvideva, da bodo, ob upoštevanju meril za odobritev, določenih v točkah 2 in 3 te priloge, fitofarmacevtska sredstva, ki vsebujejo to aktivno snov, izpolnila pogoje iz odstavkov 2 in 3.
An active substance shall be approved in accordance with Annex II, if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance will fulfil the conditions provided for in paragraphs 2 and 3.
Te pogoje je treba uporabljati kot merila za izključitev.
These conditions have to be used as a cut-off criterion.
Nobena snov, ki ima domnevno ali dejansko rakotvorne, mutagene in reproduktivno toksične lastnosti ali povzroča endokrine motnje in preobčutljivost, ali snov, ki je obstojna, bioakumulativna in strupena ali kako drugače nevarna, ne sme biti odobrena.
All substances with or suspected carcinogenic, mutagenic, reprotoxic, endocrine disrupting, sensitising properties and substances that are persistent, bio-accumulative or toxic or otherwise give grounds for concern should not be approved.
(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 ogroženih skupin, kot so nosečnice, zarodki in otroci , 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 that of vulnerable groups such as pregnant women, embryos and children , or animal health, taking into account known cumulative and synergistic effects, or on ground water;
V skladu s previdnostnim načelom snovi ne bi smele škodljivo vplivati na zdravje ljudi, zlasti ogroženih skupin, kot so zarodki in otroci.
According to the precautionary principle substances should not have any negative impact on human health, in particular vulnerable groups such as embryos and children .
To je v skladu z odzivom Evropskega parlamenta (Resolucijo Evropskega parlamenta P5_TA(2002)0276 ) na prejšnje sporočilo Komisije o reviziji Direktive 91/414.
This is in line with the reaction of the EP (EP Resolution P5_TA(2002)0276 ) to the earlier Commission Communication on the revision of Directive 91/414.
Zahtevek lahko oceni več držav skupaj po postopku skupnega poročanja.
Assessment of an application may be performed by a number of Member States together under the co-rapporteur system.
To pravilo se uporablja tudi pri oceni zahtevkov v skladu z Direktivo 91/414/EGS in močno vpliva na obseg in kakovost poročila o oceni aktivnih snovi.
The same provision applies to assessments under Directive 91/414/EEC and has a considerable influence on the speed and quality of the assessment reports on active substances.
V desetih 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 ten 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.
V tem primeru se obdobje dvanajstih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica.
In that case, the twelve - months period shall be extended by the additional time period granted by the Member State.
Če država članica potrebuje dodatne informacije, določi razumen rok, v katerem jih mora vlagatelj predložiti.
Where the Member State needs additional information, it shall set a reasonable time period for the applicant to supply it.
V tem primeru se obdobje desetih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica.
In that case, the ten-month period shall be extended by the additional time period granted by the Member State.
O tem obvesti Komisijo in agencijo , ki nato s tem seznanita ostale države članice .
It shall inform the Commission and the Authority , which shall notify the other Member States .
Pomembno je, da se za nova, inovativna sredstva pospeši dostop na trg.
It is important to speed up the access of new, innovative products to the market.
Države članice poročevalke bi lahko začele vrednotiti razpoložljive informacije pred prejetjem obvestila, določenega v členu 9(3).
Rapporteur Member States could already start the evaluation of available information before the date of the notification provided in Article 9(3).
Zato se zdi omejitev na deset mesecev razumna in zaželena.
Therefore a 10-month limit seems reasonable and desirable.
Obnovitev se odobri za nedoločen čas .
The renewal shall be for an unlimited period of time .
Obnovitev se odobri za obdobje največ desetih let .
The renewal shall be for a period not exceeding 10 years.
Odobritev se lahko obnovi več kot enkrat.
The approval may be renewed more than once .
V skladu s členom 4(1) je treba odločitve sprejemati ob upoštevanju znanstvenega in tehničnega napredka.
Decisions should be taken in the light of current scientific and technical knowledge, as is laid down in Art. 4(10).
Zahtevek iz člena 14 proizvajalec aktivne snovi predloži ustrezni državi članici, pri čemer pošlje en izvod drugim državam članicam, Komisiji in Agenciji, in sicer najpozneje tri leta pred iztekom prve odobritve.
The application provided for in Article 14 shall be submitted by a producer of the active substance to the Member State concerned , with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the first approval.
Z odstopanjem od člena 5 se aktivna snov, ki izpolnjuje merila iz člena 4, odobri za največ 15 let, kadar se lahko pričakuje, da bo fitofarmacevtsko sredstvo, ki to snov vsebuje, povzročilo le majhno tveganje za zdravje ljudi in živali ter za okolje , kot je določeno v členu 46(1) .
By way of derogation from Article 5, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment , as provided for in Article 46(1) .