natgillin/translations-raw huggingface dataset:
Poudarek je dan. in zagotoviti, da industrija dokaže, da snovi ali izdelki, proizvedeni ali dani v promet, nimajo škodljivega vpliva na zdravje ljudi in okolje.
Emphasis supplied. and ensure that industry demonstrates that substances or products produced or placed on the market do not adversely affect human health or the environment.
(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.
(10) Zaradi predvidljivosti, učinkovitosti in skladnosti je treba določiti podroben postopek za oceno, ali se aktivna snov lahko odobri. ....
(10) In the interest of predictability, efficiency and consistency, a detailed procedure should be laid down for assessing whether an active substance can be approved. ....
(11) Zaradi etičnih razlogov ocena aktivne snovi ali fitofarmacevtskega sredstva ne sme temeljiti na poskusih ali študijah, ki vključujejo namerno uporabo aktivne snovi ali fitofarmacevtskega sredstva na človeku z namenom določitve, da pri človeku ni opaznih učinkov aktivne snovi.
(11) For ethical reasons, the assessment of an active substance or a plant protection product should not be based on tests or studies involving the deliberate administration of the active substance or plant protection product to humans with the purpose of determining a human No Observed Effect Level of an active substance.
Prav tako se toksikološke raziskave, izvedene na ljudeh, ne smejo uporabiti za znižanje meje varnosti za aktivne snovi ali fitofarmacevtska sredstva.
Similarly, toxicological studies carried out on humans should not be used to lower the safety margins for active substances or plant protection products.
(12) Za pospešitev odobritve aktivnih snovi je treba določiti stroge roke za različne stopnje postopka.
(12) To speed up the approval of active substances, strict deadlines should be established for the different procedural steps.
Obdobje odobritve mora biti sorazmerno z morebitnimi tveganji, ki nastanejo pri uporabi takšnih snovi. ....
The approval period should be proportional to the possible risks inherent in the use of such substances. ....
(15) Ocena aktivne snovi lahko razkrije, da ta snov pomeni znatno manjše tveganje kot druge snovi.
(15) The evaluation of an active substance may reveal that it presents considerably less of a risk than other substances.
Da se podpre vključitev takšne snovi v fitofarmacevtska sredstva je takšne snovi primerno opredeliti in olajšati dajanje fitofarmacevtskih sredstev s temi snovmi v promet.
In order to favour the inclusion of such a substance in plant protection products, it is appropriate to identify such substances and to facilitate the placing on the market of plant protection products containing them.
(16) Nekatere snovi, ki se v večini ne uporabljajo kot fitofarmacevtska sredstva, so lahko pomembne za varstvo rastlin, vendar je gospodarski interes prošnje 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.
(18) Poleg aktivnih snovi lahko fitofarmacevtska sredstva vsebujejo varovala ali sinergiste, za katere je treba zagotoviti podobna pravila.
(18) In addition to active substances, plant protection products may contain safeners or synergists for which similar rules should be provided.
Določiti je treba tehnična pravila za pregled takšnih snovi.
The technical rules necessary for the review of such substances should be established.
Primerno je zagotoviti seznam pomožnih snovi v formulaciji, ki se ne smejo vključiti v fitofarmacevtska sredstva.
It is appropriate to provide a list of co-formulants which should not be included in plant protection products.
(20) Fitofarmacevtska sredstva, ki vsebujejo aktivne snovi, so lahko formulirana na različne načine in se lahko uporabijo na različnih posevkih, v različnih kmetijskih, ekoloških in podnebnih razmerah.
(20) Plant protection products containing active substances can be formulated in many ways and used on a variety of crops, under different agricultural, ecological and climatic conditions.
Zato morajo registracije za fitofarmacevtska sredstva izdati države članice.
Authorisations for plant protection products should therefore be granted by Member States.
Zlasti pri registraciji fitofarmacevtskih sredstev mora biti cilj zagotavljanja varstva zdravja ljudi ali živali in okolja pomembnejši kot cilj izboljšanja rastlinske pridelave
In particular, when granting authorisations of plant protection products, the objective of protecting human or animal health and the environment should take priority over the objective of improving plant production
Poudarek je dan. .
Emphasis supplied. .
Zato je treba pred dajanjem fitofarmacevtskih sredstev v promet dokazati, da nedvomno koristijo rastlinski pridelavi ter nimajo škodljivega vpliva na zdravje ljudi ali živali ter okolje.
Therefore, it should be demonstrated, before plant protection products are placed on the market, that they present a clear benefit for plant production and do not have any harmful effect on human or animal health or any unacceptable influence on the environment.
(22) Zaradi predvidljivosti, učinkovitosti in usklajenosti je treba merila, postopke in pogoje za registracijo fitofarmacevtskih sredstev uskladiti, ob upoštevanju splošnih načel varstva zdravja ljudi in živali ter okolja.
(22) In the interest of predictability, efficiency and consistency, criteria, procedures and conditions for the authorisation of plant protection products should be harmonised, account being taken of the general principles of protection of human and animal health and the environment.
(23) Aktivne snovi v fitofarmacevtskem sredstvu se lahko proizvedejo z različnimi proizvodnimi postopki, kar povzroča različne specifikacije.
(23) The active substances contained in a plant protection product can be produced by different manufacturing processes, leading to differences in specifications.
Te razlike lahko vplivajo na varnost.
Such differences may have safety implications.
Zaradi učinkovitosti je treba na ravni Skupnosti zagotoviti usklajen postopek za oceno teh razlik.
For efficiency reasons, a harmonised procedure at Community level should be provided for the assessment of those differences.
(24) Za preprečitev podvajanja dela, zmanjšanje upravnega bremena za industrijo in države članice ter za zagotovitev bolj usklajene dostopnosti do fitofarmacevtskih sredstev morajo registracije, ki jih izda ena država članica, sprejeti tudi druge države članice s primerljivimi ekološkimi in podnebnimi razmerami.
(24) To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to ensure more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where ecological and climatic conditions are comparable.
Za lažje vzajemno priznavanje je zato treba Evropsko unijo razdeliti na območja registracije s primerljivimi razmerami.
Therefore, the European Union should be divided in authorisation zones with comparable conditions in order to facilitate such mutual recognition.
(25) Gospodarski interes industrije v zvezi z zaprositvijo za registracijo je omejen na nekatere vrste uporabe.
(25) The economic interest for industry to apply for an authorisation is limited in certain uses.
Da manjša dostopnost do fitofarmacevtskih sredstev ne bi ogrožala raznovrstnosti kmetijstva ter sadjarstva in vrtnarstva, je treba za uporabe v manjši meri določiti posebna pravila.
In order to ensure that diversification of agriculture and horticulture is not jeopardised by the lack of availability of plant protection products, specific rules should be established for minor uses.
(27) Za spodbujanje inovacij je treba določiti posebna pravila, ki dovoljujejo uporabo fitofarmacevtskih sredstev pri poskusih, tudi kadar ta sredstva še niso bila registrirana.
(27) To promote innovation, special rules should be established permitting the use of plant protection products in experiments even where they have not yet been authorised.
(28) Za zagotovitev visoke ravni zdravstvenega varstva ljudi in okolja je potrebna ustrezna uporaba fitofarmacevtskih sredstev ob upoštevanju načel integriranega varstva rastlin pred škodljivci. ....
(28) In order to ensure a high level of protection of human health and the environment, plant protection products should be used properly having regard to the principles of integrated pest management. ....
(29) Vzpostaviti je treba sistem izmenjave informacij. ...
(29) A system of exchange of information should be established. ...
(30) Za povečanje učinkovitosti fitofarmacevtskih sredstev se lahko uporabijo dodatki.
(30) Adjuvants may be used to increase the efficacy of a plant protection product.
Dajanje v promet ali uporabo teh dodatkov je treba prepovedati, če vsebujejo pomožno snov v formulaciji, ki je prepovedana.
Their placing on the market or use should be forbidden where they contain a co-formulant which has been prohibited.
Zato je treba študije, ki jih vlagatelj predloži državi članici, zaščititi pred uporabo drugega vlagatelja. ...
For this reason, studies lodged by one applicant with a Member State should be protected against use by another applicant. ...
V zvezi s tem je treba sprejeti obveznost, da se pod razumnimi pogoji omogoči dostop do študij o vretenčarjih.
In this context, there should be an obligation to allow access to studies on vertebrates on reasonable terms.
(33) Ker države članice, Agencija ali Komisija uporabljajo različne predpise o dostopu do dokumentov in zaupnostjo dokumentov, je primerno pojasniti določbe v zvezi z dostopom do informacij iz dokumentov, ki jih imajo ti organi, in zaupnostjo teh dokumentov.
(33) As different rules are applied by Member States, the Authority or the Commission in relation to access to and confidentiality of documents, it is appropriate to clarify the provisions concerning access to information contained in the documents in the possession of these authorities and the confidentiality of these documents.
(34) Direktiva 1999/45/ES Evropskega parlamenta in Sveta z dne 31. maja 1999 o približevanju zakonov in drugih predpisov držav članic v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov
(34) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
UL L 200, 30.7.1999, str.
OJ L 200, 30.7.1999, p.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2006/8/ES (UL L 19, 24.1.2006, str.
Directive as last amended by Commission Directive 2006/8/EC (OJ L 19, 24.1.2006, p.
12). se uporablja za razvrščanje, pakiranje in označevanje pesticidov.
12). applies to the classification, packaging and labelling of pesticides.
Vendar so za nadaljnje izboljšanje varstva uporabnikov fitofarmacevtskih sredstev, potrošnikov rastlin in rastlinskih proizvodov ter okolja primerna dodatna posebna pravila, ki upoštevajo posebne pogoje uporabe fitofarmacevtskih sredstev.
However, to further improve the protection of users of plant protection products, of consumers of plants and plant products and of the environment, further specific rules are appropriate which take account of the specific conditions of use of plant protection products.
(35) Da oglasi ne bi zavajali uporabnikov fitofarmacevtskih sredstev, je primerno zagotoviti pravila o njihovem oglaševanju.
(35) To ensure that advertisements do not mislead users of plant protection products, it is appropriate to provide rules on the advertising of those products.
(36) Zagotoviti je treba določbe o vodenju evidence in informacijah o uporabi fitofarmacevtskih sredstev, da se poveča raven varovanja zdravja ljudi in živali ter okolja in zagotovi sledljivost morebitne izpostavljenosti ter s tem poveča učinkovitost spremljanja in nadzora ter zmanjšajo stroški spremljanja kakovosti vode.
(36) Provisions on record keeping and information about the use of plant protection products should be established in order to raise the level of protection of human and animal health and the environment by ensuring the traceability of potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality.
(37) Določbe o ureditvi o nadzoru in o inšpekcijskih pregledih v zvezi s trženjem in uporabo fitofarmacevtskih sredstev morajo zagotoviti pravilno, varno in usklajeno izvajanje zahtev iz te uredbe, da se doseže visoka raven varstva zdravja ljudi in živali ter okolja.
(37) Provisions on control and inspection arrangements with regard to the marketing and use of plant protection products should ensure correct, safe and harmonised implementation of the requirements laid down in this Regulation in order to achieve a high level of protection of both human and animal health and the environment.
(38) Uredba (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora za preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali
(38) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
Popravljena različica v UL L 191, 28.5.2004, str.
Corrected version in OJ L 191, 28.5.2004, p.
1. , predvideva nadzorne ukrepe za uporabo fitofarmacevtskih sredstev na vseh stopnjah proizvodnje živil, vključno z vodenjem evidence o uporabi fitofarmacevtskih sredstev.
1. provides for control measures for the use of plant protection products at all stages of the production of food, including record keeping on the use of plant protection products.
(39) Zagotoviti je treba čim boljšo uskladitev s preostalo zakonodajo Skupnosti, zlasti z Uredbo (ES) št. 396/2005 Evropskega parlamenta in Sveta z dne 23. februarja 2005 o mejnih vrednostih ostankov pesticidov v ali na hrani in krmi rastlinskega in živalskega izvora ter o spremembi Direktive Sveta 91/414/EGS
(39) Close coordination should be ensured with other Community legislation, in particular Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residues levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
1. , ter zakonodajo Skupnosti o varstvu delavcev in kogar koli v zvezi z uporabo v zaprtih sistemih in namernim sproščanjem gensko spremenjenih organizmov.
1. , and Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms.
(40) Vzpostaviti je treba postopke za sprejetje izrednih ukrepov, kadar je verjetno, da odobrena aktivna snov, varovalo, sinergist ali fitofarmacevtsko sredstvo predstavlja resno tveganje za zdravje ljudi ali živali ali okolje.
(40) It is necessary to establish procedures for the adoption of emergency measures in situations where an approved active substance, a safener, a synergist or a plant protection product is likely to constitute a serious risk to human or animal health or the environment.
(41) Države članice morajo določiti pravila za kazni za kršitve te uredbe in z ustreznimi ukrepi zagotoviti njihovo izvajanje.
(41) Member States should lay down rules on penalties applicable to infringements of this Regulation and should take the measures necessary to ensure that they are implemented.
(42) V državah članicah mora še naprej veljati splošna civilna in kazenska odgovornost proizvajalca in po potrebi osebe, odgovorne za dajanje fitofarmacevtskega sredstva v promet ali za uporabo tega sredstva.
(42) General civil and criminal liability in the Member States of the manufacturer and, where applicable, of the person responsible for placing the plant protection product on the market or using it should remain applicable.
(43) Države članice morajo imeti možnost, da jim tisti, ki skušajo dati ali dajejo fitofarmacevtska sredstva v promet, in tisti, ki predložijo zahtevek za odobritev aktivnih snovi, varoval ali sinergistov, povrnejo stroške za postopke v zvezi z uporabo Uredbe.
(43) Member States should have the possibility of recovering the costs of the procedures associated with the application of the Regulation from those seeking to place, or placing, plant protection products on the market and from those applying for the approval of active substances, safeners or synergists.
(44) Države članice morajo imenovati pristojne nacionalne organe.
(44) Member States should designate the necessary national authorities.
(45) Komisija mora olajšati uporabo te uredbe.
(45) The Commission should facilitate the application of this Regulation.
Zato je primerno zagotoviti potrebna finančna sredstva in možnost spremembe nekaterih določb Uredbe ob upoštevanju izkušenj ali možnost oblikovanja tehničnih navodil.
Therefore, it is appropriate to provide for the necessary financial resources and the possibility of amending certain provisions of the Regulation in the light of experience or of developing technical notes for guidance.
Iz uvodnih izjav in normativnega dela predloga uredbe bi lahko sklepali, da je glavni cilj uredbe zagotoviti varstvo zdravja ljudi in živali ter okolja tako, da se fitofarmacevtskih sredstev, ki so za kmetijstvo izjemnega pomena, ne daje na trg ne da bi jih predhodno uradno testirali in odobrili ter če se nepravilno uporabljajo.
It would appear from the recitals and the enacting terms of the proposed regulation that its main objective is to ensure the protection of human and animal health and the environment by ensuring that plant-protection products, which are of vital importance for agriculture, are not placed on the market without being officially tested and authorised and are correctly used.
Jasno so za to potrebna usklajena pravila o dajanju fitofarmacevtskih sredstev na trg, vendar uredba v prvi vrsti ne obravnava dobrega delovanja notranjega trga, saj ni omenjeno ne v preambuli ne v normativnem delu.
Clearly, this will necessitate harmonised rules for the placing of plant protection products on the market, but the regulation is not primarily concerned with ensuring the sound functioning of the internal market, of which no mention is made in either the preamble or the enacting terms.
Določbe predlaganega instrumenta se pravzaprav nanašajo na zahteve in pogoje za odobritev fitofarmacevtskih sredstev, postopek odobritve, ponovno odobritev in revizijo odobritve, odstopanja, odobritev varoval in sinergistov, prepoved nesprejemljivih pomožnih snovi v formulaciji, dajanje v promet in uporabo, postopke registracije in izjeme, vzajemno priznavanje registracij, podaljšanje ali zavrnitev registracije, posebne primere (sredstva z nizko stopnjo tveganja, sredstva, ki vsebujejo GSO, sredstva, ki vsebujejo snovi, ki jih je treba nadomestiti, registracije za uporabo v manjši meri), odstopanja zaradi nujnosti, raziskav in razvoja, zahteve za uporabo in informacije o mogočih škodljivih vplivih fitofarmacevtskih sredstev, dodatke, varstvo in izmenjavo podatkov, dostop javnosti do informacij, pakiranje, označevanje in oglaševanje, nadzor, nujne primere ter upravne in finančne določbe (vključno z določbami civilne in kazenske odgovornosti).
In fact, the provisions of the proposed instrument are concerned with requirements and conditions for the approval of plant-protection products, the approval procedure, the renewal and review of approvals, derogations, approvals of safeners and synergists, a ban on unacceptable co-formulants, authorisation for placing on the market and use, procedures for authorisation and exemption, mutual recognitions of authorisations, renewal and withdrawal of authorisations, special cases (low-risk products, products containing GMOs, products containing candidates for substitution, authorisations for minor uses), derogations for emergency use and research and development, requirements relating to the use of and information on potentially harmful effects of plant protection products, adjuvants, data protection and data sharing, public access to information, packaging, labelling and advertising, controls, emergencies, and administrative and financial provisions (including provisions on civil and criminal liability).
Iz ustaljene prakse Sodišča je razvidno, da izbira pravne podlage ni stvar proste presoje zakonodajalca Skupnosti, pač pa mora temeljiti na objektivnih dejavnikih, ki jih je mogoče sodno preskusiti
It is clear from settled case-law of the Court of Justice that the choice of legal basis is not at the discretion of the Community legislator but must be determined by objective factors which are amenable to judicial review
V luči zgoraj omenjenega je treba določiti pravno podlago predlagane uredbe.
In the light of the above, it is to be established what is the proper legal basis for the proposed regulation.
Evropska komisija predlaga dvojno pravno podlago, in sicer člen 37(2) in člen 152(4)(b).
The European Commission proposed a dual legal basis, namely Article 37(2) together with Article 152(4)(b).
Odbor za okolje predlaga, da se črta člen 37(2) in se kot pravna podlaga uporabita člena 152(4)(b) in 175(1).
The Environment Committee proposes deleting Article 37(2) and using Article 152(4)b) and Article 175(1) as the legal basis.
Odbor za notranji trg in varstvo potrošnikov predlaga člene 37(2), 152(4)(b) in 95.
For its part, the Committee on the Internal Market and Consumer Protection suggests Article 37(2), Article 152(4)(b) and Article 95.
Glede na sodno prakso Sodišča Evropskih skupnosti splošni člen Pogodbe predstavlja ustrezno pravno podlago, čeprav obravnavani ukrep skuša na podrejen način doseči tudi cilj, ki si ga prizadeva doseči specifični člen Pogodbe
As far as Article 95 is concerned, in view of the case-law to the effect that a general Treaty article constitutes a sufficient legal basis even though the measure in question also seeks, in a subordinate manner, to attain an aim sought by a specific Treaty article
Zadeva C-377/98, Nizozemska proti Evropskemu parlamentu in Svetu , [2001] Poročila Sodišča Evropskih skupnost I-7079, odstavka 27 in 28; Zadeva C-491/01, British American Tobacco (Investments) in Imperial Tobacco [2002] Poročila Sodišča Evropskih skupnosti I-11453, odstavka 93 in 94. , zato sklicevanje na člen 95 ni potrebno.
Case C-377/98 Netherlands v. European Parliament and Council [2001] ECR I-7079, paras 27-28; Case C-491/01 British American Tobacco (Investments) and Imperial Tobacco [2002] ECR I-11453, paras 93-94. , it is considered that there is no need to refer to Article 95.
Čeprav je samo po sebi razumljivo, da določbe o dajanju fitofarmacevtskih sredstev na trg, njihovo označevanje in medsebojno priznavanje zagotavljajo varno delovanje notranjega trga, je glavni cilj uredbe zagotoviti varstvo zdravja ljudi in živali ter okolja tako, da se fitofarmacevtskih proizvodov, ki so za kmetijstvo izjemnega pomena, ne daje na trg ne da bi jih predhodno uradno testirali in odobrili ter če se nepravilno uporabljajo.
Even though it is implicit that the provisions on placing plant-protection products on the market, labelling and mutual recognition are designed to secure the functioning of the internal market, the prime purpose of the regulation is to secure the protection of human and animal health and the environment by ensuring that plant-protection products, which are of vital importance for agriculture, are not placed on the market without being officially tested and authorised and are correctly used.