natgillin/translations-raw huggingface dataset:
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
Anja Weisgerber , Odbor za notranji trg in varstvo potrošnikov
Anja Weisgerber , Committee on the Internal Market and Consumer Protection
Kyösti Virrankoski , Odbor za kmetijstvo in razvoj podeželja
Kyösti Virrankoski , Committee on Agriculture and Rural Development
(*) Postopek s pridruženimi odbori – člen 47 Poslovnika
(*) Procedure with associated committees - Rule 47 of the Rules of Procedure
MNENJE ODBORA ZA PRAVNE ZADEVE O PRAVNI PODLAGI...................................124
OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE LEGAL BASIS...........134
MNENJE Odbora za industrijo, raziskave in energetiko ...........................135
OPINION of the Committee on Industry, Research and Energy .............146
MNENJE Odbora za notranji trg in varstvo potrošnikov (*) .................153
OPINION of the Committee on the Internal Market and Consumer Protection (*) 166
MNENJE Odbora za kmetijstvo in razvoj podeželja (*) ...............................186
OPINION of the COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT (*) 203
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2006)0388 )
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2006)0388 )
– ob upoštevanju člena 251(2) ter členov 37(2) in 152(4)(b) Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6-0245/2006 ),
– having regard to Article 251(2) and Articles 37(2) and 152(4)(b) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0245/2006 ),
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ter mnenj Odbora za industrijo, raziskave in energetiko, Odbora za notranji trg in zaščito potrošnikov in Odbora za kmetijstvo in razvoj podeželja ( A6–0359/2007 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy, the Committee on the Internal Market and Consumer Protection and the Committee on Agriculture and Rural Development ( A6‑0359/2007 ),
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti, zlasti člena 37(2) in člena 152(4)(b) Pogodbe,
Having regard to the Treaty establishing the European Community, and in particular Articles 37 (2) and 152 (4)(b) thereof,
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti, zlasti člena 152(4)(b) in člena 175(1) Pogodbe,
Having regard to the Treaty establishing the European Community, and in particular Articles 152 (4)(b) and 175 (1) thereof,
Glede na uvodno izjavo 8 predloga je namen te uredbe zagotoviti visoko raven varovanja zdravja ljudi in živali ter okolja.
According to Recital 8 of the proposal, the purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment.
Izbira pravne podlage bi morala odražati cilj in namen uredbe.
The choice of the legal basis should reflect the aim and the purpose of the regulation.
Dvojna pravna podlaga se uporablja le, kadar se zasleduje več neločljivo povezanih ciljev, kar velja za ta predlog.
A dual legal basis shall be used only if several objectives are pursued, which are inseparably linked, which is the case in the present proposal.
Člen 37 je bil uporabljen leta 1991, ko pogodba še ni zagotavljala posebne pravne podlage za varstvo zdravja ljudi in okolja.
Article 37 was used in 1991, when the Treaty did not yet provide for a specific legal basis for protection of human health and the environment.
Zdaj ni več potrebe, da bi ga tukaj uporabljali.
It is not anymore appropriate to be used here.
(4) Zaradi poenostavitve mora tudi novi akt razveljavljati Direktivo Sveta 79/117/EGS z dne 21. decembra 1978 o prepovedi prometa in uporabe fitofarmacevtskih sredstev, ki vsebujejo nekatere aktivne snovi.
(4) By way of simplification, the new act should also repeal Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances.
V tej uredbi pa je treba ohraniti poglavitna načela Direktive 79/117/EGS.
However, the main principles of Directive 79/117/EEC should be maintained in this Regulation.
V novem aktu je treba povzeti vsebino razveljavljene direktive.
It is necessary that the content of the repealed directive is taken up in the new act.
(6a) Različne vrste kulturnih rastlin so v Skupnosti pomembne za proizvodnjo v večjem in manjšem obsegu.
(6a) Various types of crop are of significance in the Community for both large-scale and small-scale production.
Te vrste proizvodnje je treba zaščititi z dovoljeno uporabo različnih fitofarmacevtskih sredstev.
These various types of production should be protected by allowing the use of different plant protection products.
(7) Fitofarmacevtska sredstva lahko tudi neugodno vplivajo na rastlinsko pridelavo.
(7) Plant protection products can also have non-beneficial effects on plant production.
Njihova uporaba lahko vključuje tveganje in nevarnost za ljudi, živali in okolje, zlasti če se dajo v promet, ne da bi jih predhodno uradno testirali in odobrili, ter če se nepravilno uporabljajo.
Their use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorised and if incorrectly used.
Zato je treba sprejeti usklajena pravila o dajanju fitofarmacevtskih sredstev v promet.
Therefore, harmonised rules should be adopted on the placing on the market of plant protection products .
(7) Pesticidi lahko tudi neugodno vplivajo na rastlinsko pridelavo.
(7) Pesticides can also have non-beneficial effects on plant production.
Njihova uporaba lahko vključuje škodo, tveganje in stvarno nevarnost za ljudi, živali in okolje ter kratkoročne in dolgoročne škodljive vplive nanje , zlasti , vendar ne izključno, če se dajo v promet, ne da bi jih predhodno uradno testirali in odobrili, ter če se nepravilno uporabljajo.
Their use may involve harm, risks , intrinsic hazards and short and long-term adverse impacts for humans, animals and the environment, especially , but not only , if placed on the market without having been officially tested and authorised and if incorrectly used.
Zato je treba sprejeti usklajena pravila o dajanju pesticidov v promet.
Therefore, harmonised rules should be adopted on the placing of pesticides on the market.
(Ta sprememba velja za celotno zakonodajno besedilo.
(This amendment applies to the whole legislative text.
Izraz „pesticidi“ bo uporabljen v celotnem sprejetem besedilu, vključno z naslovom.)
The term "pesticides" will be used throughout the adopted text, including the title.)
Izraz „fitofarmacevtska sredstva“, ki se uporablja v celotnem predlogu in tudi v naslovu, je neprimeren, saj številni posamezniki v javnosti te terminologije ne poznajo.
The term 'plant protection products' used throughout the proposal, including the title, is inappropriate as many members of the public will not be familiar with this terminology.
Zato lahko nadaljnja raba tega izraza povzroči zmedo med posamezniki v javnosti/potrošniki.
Therefore its continued use could lead to confusion amongst members of the public/consumers.
(8) Namen te uredbe je zagotoviti visoko raven varstva zdravja ljudi in živali ter okolja.
(8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment.
Posebno pozornost je treba nameniti varstvu ranljivih skupin prebivalstva, vključno z nosečnicami, dojenčki in otroki.
Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children.
Uporabiti je treba previdnostno načelo in zagotoviti, da industrija dokaže, da snovi ali izdelki, proizvedeni ali dani v promet, nimajo škodljivega vpliva na zdravje ljudi in okolje.
The precautionary principle should be applied and ensure that industry demonstrates that substances or products produced or placed on the market do not adversely affect human health or the environment.
(8) Namen te uredbe je zagotoviti visoko raven varstva zdravja ljudi in živali ter okolja in hkrati zagotoviti konkurenčnost evropskega kmetijstva .
(8) The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment , and at the same time to ensure the competitiveness of European agriculture .
Posebno pozornost je treba nameniti varstvu ranljivih skupin prebivalstva, vključno z nosečnicami, doječimi materami, zarodki in plodovi, dojenčki in otroki.
Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant and nursing women, embryos and foetuses, infants and children.
Uporabiti je treba previdnostno načelo in zagotoviti, da industrija dokaže, da snovi ali izdelki, proizvedeni ali dani v promet, nimajo škodljivega vpliva na zdravje ljudi in okolje ter da ne obstaja sum za to .
The precautionary principle should be applied and ensure that industry demonstrates that substances or products produced or placed on the market do not adversely affect human health or the environment and are not suspected of doing so .
(8a) Zaradi preprečevanja poskusov na živalih bi bilo treba poskuse na vretenčarjih za namene te uredbe izvajati samo kot skrajni ukrep.
(8a) In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort.
S to uredbo in zakonodajo, ki uvaja zahteve po podatkih o aktivnih snoveh, fitofarmacevtskih sredstvih, varovalih in sinergistih, je treba poskuse na vretenčarjih čim bolj omejiti, se izogibati podvajanju poskusov ter spodbujati uporabo metod, pri katerih se ne uporabljajo živali, in inteligentnih strategij poskusov.
This Regulation, and the legislation establishing data requirements for active substances, plant protection products, safeners and synergists, should ensure that testing on vertebrate animals is minimised and that double-testing is avoided, and promote the use of non-animal test methods and intelligent testing strategies.
Obstoječe rezultate poskusov na vretenčarjih 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 Direktivo 86/609 EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za preskusne in druge znanstvene namene 1 , je treba poskuse na vretenčarjih nadomestiti, omejiti ali izpopolniti.
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 1 , tests on vertebrate animals must also be replaced, restricted or refined.
Določbe te uredbe je treba, kolikor je mogoče, izvajati ob uporabi ustreznih alternativnih poskusnih metod.
Implementation of this Regulation must where possible be based on the use of appropriate alternative testing methods.
Komisija mora najkasneje do ...* ponovno pregledati pravila o varstvu podatkov za rezultate poskusov na vretenčarjih in jih po potrebi spremeniti.
Not later than ...*, the Commission must review the rules on the data protection of results from tests on vertebrate animals and where necessary change those rules .
Sedem let po začetku veljavnosti te uredbe.
Seven years after the entry into force of this Regulation.
V skladu z zahtevo iz protokola o zaščiti in dobrem počutju živali, po kateri Skupnost in države članice pri oblikovanju in izvajanju svoje politike v celoti upoštevajo zahteve glede dobrega počutja živali, je treba dodati, da so poskusi na živalih karseda omejeni, da se izvajajo le kot skrajni ukrep in da se spodbuja uporaba alternativ.
In line with the requirement in the Protocol on the Protection and Welfare of Animals that the Community and the Member States pay full regard to the welfare requirements of animals in formulating and implementing policies, it should be included that animal testing is kept to an absolute minimum and carried out only as a last resort, and that the use of alternatives is promoted.
To je tudi v skladu z zahtevami iz uredbe REACH.
This is also in line with the requirements under REACH.
(9) Snovi se vključijo v fitofarmacevtska sredstva le na podlagi dokazov, da nedvomno koristijo rastlinski pridelavi, in se ne pričakuje , da bi škodljivo vplivale na zdravje ljudi ali živali ter okolje.
(9) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and they are not expected to have any harmful effect on human or animal health or any unacceptable influence on the environment.
Da se doseže enaka raven varstva v vseh državah članicah, je treba odločitev o sprejemljivosti ali nesprejemljivosti takšnih snovi sprejeti na ravni Skupnosti.
In order to achieve the same level of protection in all Member States, the decision on acceptability or non-acceptability of such substances should be taken at Community level.
(9) Snovi se vključijo v fitofarmacevtska sredstva le na podlagi dokazov, da nedvomno koristijo rastlinski pridelavi, in je bilo ugotovljeno , da ne bodo škodljivo vplivale na zdravje ljudi ali živali ter okolje.
(9) Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and it has been established that they will not have any harmful effect on human or animal health or any unacceptable influence on the environment.
Da se doseže visoka in identična raven varstva v vseh državah članicah, je treba odločitev o sprejemljivosti ali nesprejemljivosti takšnih snovi sprejeti na ravni Skupnosti.
In order to achieve a high and identical level of protection in all Member States, the decision on acceptability or non-acceptability of such substances should be taken at Community level.
(9a) Za uporabo načela, da plača povzročitelj obremenitve, mora Komisija preučiti, kako morajo proizvajalci fitofarmacevtskih sredstev ali aktivnih snovi, ki jih fitofarmacevtska sredstva vsebujejo, ustrezno sodelovali pri obravnavi ali odpravi škode, ki jo zdravju ljudi ali okolju lahko povzroči uporaba fitofarmacevtskih sredstev.
(9a) To apply the 'polluter pays' principle, the Commission should examine how manufacturers of plant protection products or of the active substances they contain should be appropriately involved in dealing with or rectifying harm to human health or to the environment which may result from the use of plant protection products.
Kot na drugih področjih evropske zdravstvene in okoljske politike bi moralo tudi pri fitofarmacevtskih sredstvih in njihovih aktivnih snoveh veljati, da je odgovoren proizvajalec.
As in other areas of European health and environment policy, manufacturer responsibility should also apply to plant protection products and their active substances.
(11a) Treba je spodbujati razvoj poskusnih metod in vitro (v epruveti), pri katerih se ne uporabljajo živali, da bi pridobili več varnostnih podatkov, relevantnih za človeka, kot jih nudijo rezultati živalskih študij, ki se trenutno uporabljajo.
(11a) The development of non-animal in vitro (test tube) test methods should be promoted in order to produce safety data more relevant to humans than results of animal studies currently in use.
Številne poskusne metode na živalih niso bile nikoli ocenjene glede na moderne standarde in v številnih primerih je njihova ustreznost in zanesljivost dvomljiva.
The vast majority of animal test methods have never been validated to modern standards, and in many cases their relevance and reliability are in doubt.
Spodbujanje poskusnih metod, pri katerih se ne uporabljajo živali, je pomembno za varovanje zdravja ljudi in tudi za preprečitev trpljenja živali.
The promotion of non animal test methods is important for the protection of human health, as well as to prevent animal suffering.
(13) Zaradi varnosti mora biti obdobje odobritve aktivnih snovi časovno omejeno.
(13) In the interest of safety, the approval period for active substances should be limited in time.
Obdobje odobritve mora biti sorazmerno z možnimi tveganji, ki nastanejo z uporabo takšnih snovi.
The approval period should be proportional to the possible risks inherent in the use of such substances.
Pri kakršni koli odločitvi v zvezi z obnovitvijo odobritve je treba upoštevati izkušnje, dobljene pri dejanski uporabi fitofarmacevtskih sredstev, ki vsebujejo zadevne snovi, ter kakršne koli dosežke na področju znanosti in tehnologije.
Experience gained from the actual use of plant protection products containing the substances concerned and any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken.
Po prvi obnovitvi odobritve je treba takšne snovi ponovno pregledati le, če obstajajo dokazi, da ne izpolnjujejo več zahtev te uredbe .
After the first renewal, such substances should only be reviewed further where there are indications that they no longer meet the requirements of this Regulation .
Obdobje odobritve mora biti sorazmerno z možnimi tveganji, ki nastanejo z uporabo takšnih snovi in omejeno na največ 15 let za snovi z majhnim tveganjem, 5 let za snovi, ki jih je treba nadomestiti, in 10 let za druge snovi .
The approval period should be proportional to the possible risks inherent in the use of such substances and should be limited to a maximum of 15 years for low risk substances, 5 years for candidates for substitution and 10 years for other substances.
Po prvi obnovitvi odobritve je treba snovi redno pregledovati .
After the first renewal, a regular review of substances should take place .
Tako se zagotovita reden pregled in ocena tveganja novih in starih snovi, ki so se vpisovale v pozitivni seznam od leta 1991 (priloga I Direktive 91/414).
This is to guarantee that new and old substances that have been included on the positive list since 1991 (Annex 1 of Directive 91/414) are regularly reviewed and their hazard assessed.
(14) Predvideti je treba možnost spremembe ali preklica odobritve aktivne snovi, kadar zadevna snov ne izpolnjuje več meril za odobritev.
(14) The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied should be provided for.
(14) Predvideti je treba možnost spremembe ali preklica odobritve aktivne snovi, kadar zadevna snov ne izpolnjuje več meril za odobritev ali kadar je ogroženo ravnanje v skladu z Direktivo 2000/60/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2000 o določitvi okvira za ukrepe Skupnosti na področju vodne politike 1 in njenimi hčerinskimi direktivami .
(14) The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied or where compliance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy 1 and its daughter directives may be compromised, should be provided for.
Direktiva, kakor je bila spremenjena z Odločbo št. 2455/2001/ES (UL L 331, 15.12.2001, str.
Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p.
Direktiva 2000/60/ES določa standarde kakovosti za kemikalije, med katere spadajo tudi fitofarmacevtska sredstva, v podtalnici in površinskih vodah.
Directive 2000/60/EC sets quality standards for chemicals in groundwater and surface water, among them plant protection products.
Za primer neizpolnjevanja teh standardov kakovosti mora obstajati mehanizem neposrednega odziva, na podlagi katerega se lahko odobritev aktivne snovi spremeni ali umakne in ki je usklajen z mehanizmom, ki je v uredbi REACH pri registraciji kemikalij predviden za Direktivo 2000/60/ES.
If these quality standards are not met, there must be a direct feedback-mechanism to amend or withdraw the approval of an active substance, in line with the existing feedback-mechanism to Directive 2000/60/EC in the authorisation of chemicals (REACH).
(15a) Da bi spodbudili razvoj fitofarmacevtskih sredstev, je treba ustvariti spodbude za dajanje v promet sredstev z nizkim profilom tveganja ali profilom tveganja, manjšim od tistega, ki ga imajo sredstva, ki so že na trgu.
(15a) To encourage the development of plant protection products, incentives must be incorporated for placing on the market products with a low risk profile or a risk profile that is lower than that of products already on the market.
Treba je vzpostaviti jasna in objektivna merila, katerim sredstvom se lahko določi tak profil.
Clear and objective criteria must be laid down to define which products may claim such a profile.
Člen 22 vsebuje zelo široko opredelitev, ki se jo lahko razlaga zelo različno.
Article 22 comes up with a very broad definition that is likely to be interpreted in a number of different ways.
Podjetja pa potrebujejo jasnost in pravno gotovost, zlasti zaradi dragih naložb v raziskave, povezanih z razvijanjem novih snovi.
But businesses need clarity and legal certainty, especially in view of the costly investment in research that is involved in developing new substances.
(16) Nekatere snovi, ki se v večini ne uporabljajo kot fitofarmacevtska sredstva, so lahko pomembne za varstvo rastlin, vendar je gospodarski interes zaprositve za odobritev lahko omejen.
(16) Certain substances which are not predominantly used as a plant protection product may be of value for plant protection, but the economic interest of applying for approval may be limited.
Zato je treba s posebnimi določbami zagotoviti, da se tudi te snovi, če so tveganja sprejemljiva, lahko odobrijo za uporabo v fitofarmacevtskih sredstvih.
Therefore, specific provisions should ensure that such substances, as far as their risks are acceptable, may also be approved for plant protection use.
Zato je treba s posebnimi določbami zagotoviti, da se tudi te snovi, če vse zainteresirane strani menijo, da so tveganja sprejemljiva, lahko odobrijo za uporabo v fitofarmacevtskih sredstvih.
Therefore, specific provisions should ensure that such substances, as far as their risks are deemed acceptable by all relevant stakeholders , may also be approved for plant protection use.
Družba bi morala biti tista, ki določi kaj je sprejemljivo tveganje in če družba meni, da je tveganje nesprejemljivo, je treba ponovno opredeliti, kaj je sprejemljivo, in temu ustrezno oceniti tveganje.
It is supposed to be society that designates what is an “acceptable risk” and so if society feels that a risk is not acceptable, then what is considered acceptable is redefined and the risk assessed accordingly.
Tako o sprejemljivosti tveganja odločajo le vse zainteresirane strani.
Therefore risks can only be deemed acceptable by all relevant Stakeholders.
To mora vključevati tudi predstavnike podeželskih skupnosti in prebivalcev, skupin kmetov (tako za ekološko kot konvencionalno kmetovanje), okoljevarstvenih skupin in skupin potrošnikov ter tudi javnosti na splošno.
This must include representatives of rural residents and communities, farmers groups, (both organic and conventional) and environmental and consumer groups as well as the public in general.
(17) Nekatere aktivne snovi so lahko sprejemljive le, če se sprejmejo obsežni ukrepi za zmanjšanje tveganja.
(17) Some active substances may only be acceptable when extensive risk mitigation measures are taken.
Takšne snovi je treba opredeliti na ravni Skupnosti.
Such substances should be identified at Community level.