Regulation (EC) No 1107/2009 of the European Parliament and of the Council

Uredba (ES) št. 1107/2009 Evropskega parlamenta in Sveta

of 21 October 2009

z dne 21. oktobra 2009

concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

EVROPSKI PARLAMENT IN SVET EVROPSKE UNIJE STA –

Having regard to the Treaty establishing the European Community, and in particular Article 37(2), Article 95 and Article 152(4)(b) thereof,

ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti ter zlasti člena 37(2), člena 95 in člena 152(4)(b) Pogodbe,

Having regard to the proposal from the Commission,

ob upoštevanju predloga Komisije,

Having regard to the opinion of the European Economic and Social Committee [1],

ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora [1],

Having regard to the opinion of the Committee of the Regions [2],

ob upoštevanju mnenja Odbora regij [2],

Acting in accordance with the procedure laid down in Article 251 of the Treaty [3],

v skladu s postopkom, določenim v členu 251 Pogodbe [3],

Whereas:

ob upoštevanju naslednjega:

(1) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [4] provides for rules governing plant protection products and the active substances contained in those products.

(1) Direktiva Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [4] določa pravila, ki urejajo fitofarmacevtska sredstva in aktivne snovi, ki jih ta sredstva vsebujejo.

(2) Following the progress report presented by the Commission under Directive 91/414/EEC, the European Parliament by its Resolution of 30 May 2002 [5] and the Council in its Conclusions of 12 December 2001 asked the Commission to review Directive 91/414/EEC and identified a number of issues for the Commission to address.

(2) V skladu s poročilom o napredku, ki ga je predstavila Komisija v skladu z Direktivo 91/414/EGS, sta Evropski parlament z Resolucijo z dne 30. maja 2002 [5] in Svet v svojih sklepih z dne 12. decembra 2001 pozvala Komisijo, naj pregleda Direktivo 91/414/EGS, in opredelila številna vprašanja, ki jih mora Komisija obravnavati.

(3) In the light of the experience gained from the application of Directive 91/414/EEC and of recent scientific and technical developments, that Directive should be replaced.

(3) Na podlagi izkušenj, pridobljenih pri uporabi Direktive 91/414/EGS, ter najnovejših znanstvenih in tehničnih spoznanj bi bilo treba navedeno direktivo nadomestiti.

(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 [6].

(4) Zaradi poenostavitve bi moral novi akt razveljavljati tudi Direktivo Sveta 79/117/EGS z dne 21. decembra 1978 o prepovedi prometa in uporabe fitofarmacevtskih sredstev, ki vsebujejo določene aktivne snovi [6].

(5) To simplify application of the new act and to ensure consistency throughout the Member States, it should take the form of a Regulation.

(5) Za poenostavitev uporabe novega akta in zagotovitev usklajenosti med državami članicami, bi moral biti ta akt v obliki uredbe.

(6) Plant production has a very important place in the Community. One of the most important ways of protecting plants and plant products against harmful organisms, including weeds, and of improving agricultural production is the use of plant protection products.

(6) Rastlinska pridelava ima v Skupnosti zelo pomembno mesto. Uporaba fitofarmacevtskih sredstev je eden od najpomembnejših načinov za varstvo rastlin in rastlinskih proizvodov pred škodljivimi organizmi, vključno s plevelom, ter za izboljšanje kmetijske proizvodnje.

(7) Plant protection products can however also have non-beneficial effects on plant production. 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.

(7) Vendar lahko fitofarmacevtska sredstva tudi neugodno vplivajo na rastlinsko pridelavo. 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 registrirali, ter če se nepravilno uporabljajo.

(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 safeguard the competitiveness of Community agriculture. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment.

(8) Namen te uredbe je zagotoviti visoko raven varstva zdravja ljudi in živali in varovanja okolja ter hkrati varovati konkurenčnost kmetijstva Skupnosti. Posebno pozornost bi bilo treba nameniti varstvu ranljivih skupin prebivalstva, vključno z nosečnicami, dojenčki in otroki. Veljati bi moralo previdnostno načelo, ta uredba pa bi morala zagotoviti, da industrija dokaže, da snovi ali sredstva, proizvedeni ali dani v promet, nimajo nobenega škodljivega vpliva na zdravje ljudi ali živali ali nobenega nesprejemljivega vpliva na okolje.

(9) In order to remove as far as possible obstacles to trade in plant protection products existing due to the different levels of protection in the Member States, this Regulation should also lay down harmonised rules for the approval of active substances and the placing on the market of plant protection products, including the rules on the mutual recognition of authorisations and on parallel trade. The purpose of this Regulation is thus to increase the free movement of such products and availability of these products in the Member States.

(9) Da bi čim bolje odstranili ovire pri trgovanju s fitofarmacevtskimi sredstvi, ki so nastale zaradi različnih ravni varovanja v državah članicah, bi bilo treba s to uredbo določiti tudi usklajene predpise za odobritev aktivnih snovi in dajanje fitofarmacevtskih sredstev v promet, vključno s predpisi za vzajemno priznavanje registracij in vzporedno trgovanje. Namen te uredbe je zato povečati prosti pretok teh sredstev in njihovo razpoložljivost v državah članicah.

(10) 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 effects on the environment. 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 on the basis of harmonised criteria. These criteria should be applied for the first approval of an active substance under this Regulation. For active substances already approved, the criteria should be applied at the time of renewal or review of their approval.

(10) Snovi bi se smele vključiti v fitofarmacevtska sredstva le takrat, kadar se dokaže, da nedvomno koristijo rastlinski pridelavi in se ne pričakuje, da bi imeli kakršen koli škodljiv vpliv na zdravje ljudi ali živali ali kakršen koli nesprejemljiv vpliv na okolje. Da se doseže enaka raven varstva v vseh državah članicah, bi bilo treba odločitev o sprejemljivosti ali nesprejemljivosti takšnih snovi na podlagi usklajenih meril sprejeti na ravni Skupnosti. Ta merila bi bilo treba uporabljati za prvo odobritev aktivne snovi na podlagi te uredbe. Za že odobrene aktivne snovi bi se ta merila morala uporabljati ob podaljšanju ali pregledu njihove odobritve.

(11) The development of non-animal test methods should be promoted in order to produce safety data relevant to humans and to replace animal studies currently in use.

(11) Treba bi bilo spodbujati razvoj preskusnih metod, pri katerih se ne uporabljajo živali, za pridobitev varnostnih podatkov, ki bi bili relevantni za ljudi, ter nadomestiti študije na živalih, ki se trenutno uporabljajo.

(12) In the interest of predictability, efficiency and consistency, a detailed procedure should be laid down for assessing whether an active substance can be approved. The information to be submitted by interested parties for the purposes of approval of a substance should be specified. In view of the amount of work connected with the approval procedure, it is appropriate that the evaluation of such information be performed by a Member State acting as a rapporteur for the Community. To ensure consistency in evaluation, an independent scientific review should be performed by the European Food Safety Authority established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [7] (the Authority). It should be clarified that the Authority performs a risk assessment whilst the Commission should perform the risk management role and take the final decision on an active substance. Provisions should be included to ensure the transparency of the evaluation process.

(12) Zaradi predvidljivosti, učinkovitosti in skladnosti bi bilo treba določiti podroben postopek za oceno, ali se aktivna snov lahko odobri. Navesti bi bilo treba informacije, ki jih morajo predložiti zainteresirane strani za odobritev snovi. Glede na obseg dela v zvezi s postopkom odobritve je primerno, da oceno takšne informacije izvede država članica, ki je v vlogi poročevalke za Skupnost. Za zagotovitev skladnosti pri ocenjevanju bi morala Evropska agencija za varnost hrane, ustanovljena z Uredbo (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [7] (Agencija) izvesti neodvisen znanstveni pregled. Pojasniti bi bilo treba, da Agencija izvaja oceno tveganja, medtem ko bi morala Komisija izvajati obvladovanje tveganja in sprejeti dokončno odločitev o aktivni snovi. Vključiti bi bilo treba določbe za zagotovitev preglednosti postopka ocenjevanja.

(13) 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. Similarly, toxicological studies carried out on humans should not be used to lower the safety margins for active substances or plant protection products.

(13) Zaradi etičnih razlogov ocena aktivne snovi ali fitofarmacevtskega sredstva ne bi smela temeljiti na preskusih ali študijah, ki vključujejo namerno uporabo aktivne snovi ali fitofarmacevtskega sredstva na ljudeh z namenom določitve "vrednosti neopaženega učinka" aktivne snovi pri ljudeh. Prav tako se toksikološke študije, izvedene na ljudeh, ne bi smele uporabiti za znižanje mej varnosti za aktivne snovi ali fitofarmacevtska sredstva.

(14) To speed up the approval of active substances, strict deadlines should be established for the different procedural steps.

(14) Za pospešitev odobritve aktivnih snovi bi bilo treba določiti stroge roke za različne stopnje postopka.

(15) In the interest of safety, the approval period for active substances should be limited in time. The approval period should be proportionate to the possible risks inherent in the use of such substances. 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. The renewal of the approval should be for a period not exceeding 15 years.

(15) Zaradi varnosti bi moralo biti obdobje odobritve aktivnih snovi časovno omejeno. Obdobje odobritve bi moralo biti sorazmerno z možnimi tveganji, ki nastanejo z uporabo takšnih snovi. Pri kakršni koli odločitvi v zvezi z obnovitvijo odobritve bi bilo treba upoštevati izkušnje, dobljene pri dejanski uporabi fitofarmacevtskih sredstev, ki vsebujejo zadevne snovi, ter kakršne koli dosežke na področju znanosti in tehnologije. Obnovitev odobritve bi morala veljati največ petnajst let.

(16) 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 [8] is compromised, should be provided for under certain conditions.

(16) Zagotoviti bi bilo treba možnost spremembe ali preklica odobritve aktivne snovi pod določenimi pogoji, kadar zadevna snov ne izpolnjuje več meril za odobritev ali kadar je ogrožena skladnost z Direktivo 2000/60/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2000 o določitvi okvira za ukrepe Skupnosti na področju vodne politike [8].

(17) The evaluation of an active substance may reveal that it presents considerably less of a risk than other substances. 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. Incentives should be given for the placing on the market of low-risk plant protection products.

(17) Ocena aktivne snovi lahko razkrije, da ta snov predstavlja znatno manjše tveganje kot druge snovi. Da bi pospešili vključitev takšne snovi v fitofarmacevtska sredstva, je primerno, da se takšne snovi opredelijo in olajša dajanje fitofarmacevtskih sredstev, ki vsebujejo te snovi, v promet. Treba bi bilo dati pobude, da se dajo v promet fitofarmacevtska sredstva z majhnim tveganjem.

(18) Certain substances which are not predominantly used as plant protection products may be of value for plant protection, but the economic interest of applying for approval may be limited. Therefore, specific provisions should ensure that such substances, as far as their risks are acceptable, may also be approved for plant protection use.

(18) Nekatere snovi, ki se pretežno ne uporabljajo kot fitofarmacevtska sredstva, so lahko pomembne za varstvo rastlin, vendar je gospodarski interes zahtevka za odobritev lahko omejen. Zato bi bilo treba s posebnimi določbami zagotoviti, da se tudi te snovi, če so tveganja sprejemljiva, lahko odobrijo za uporabo v fitofarmacevtskih sredstvih.

(19) Some active substances with certain properties should be identified at Community level as candidates for substitution. Member States should regularly examine plant protection products containing such active substances with the aim of replacing them by plant protection products containing active substances which require less risk mitigation or by non-chemical control or prevention methods.

(19) Nekatere aktivne snovi z določenimi lastnostmi bi bilo treba opredeliti na ravni Skupnosti kot kandidatke za zamenjavo. Države članice bi morale redno pregledovati fitofarmacevtska sredstva, ki vsebujejo takšne aktivne snovi, da bi jih nadomestili s fitofarmacevtskimi sredstvi z aktivnimi snovmi, ki zahtevajo manj ukrepov za zmanjšanje tveganja, ali z nekemičnimi ali preventivnimi metodami varstva rastlin.

(20) In certain Member States non-chemical control or prevention methods, which are significantly safer for human and animal health and for the environment, have been established and generally applied for certain uses. In exceptional cases Member States should also be able to apply the comparative assessment when granting authorisation for plant protection products.

(20) V nekaterih državah članicah so bile vzpostavljene nekemične ali preventivne metode varstva rastlin, ki so bistveno varnejše za zdravje ljudi, živali in za okolje, ter se splošno uporabljajo za določene namene. V izjemnih primerih bi moralo biti državam članicam dovoljeno, da pri dodeljevanju registracije za fitofarmacevtska sredstva uporabijo primerjalno oceno.

(21) In addition to active substances, plant protection products may contain safeners or synergists for which similar rules should be provided. The technical rules necessary for the evaluation of such substances should be established. Substances currently on the market should only be evaluated after those rules have been established.

(21) Poleg aktivnih snovi lahko fitofarmacevtska sredstva vsebujejo varovala ali sinergiste, za katere bi bilo treba zagotoviti podobna pravila. Določiti bi bilo treba tehnična pravila, potrebna za oceno takšnih snovi. Snovi, ki so zdaj na trgu, bi bilo treba oceniti šele po uvedbi teh pravil.

(22) Plant protection products may also contain co-formulants. It is appropriate to provide a list of co-formulants which should not be included in plant protection products.

(22) Fitofarmacevtska sredstva lahko vsebujejo tudi dodatke. Primerno je zagotoviti seznam dodatkov, ki se ne smejo vključiti v fitofarmacevtska sredstva.

(23) Plant protection products containing active substances can be formulated in many ways and used on a variety of plants and plant products, under different agricultural, plant health and environmental (including climatic) conditions. Authorisations for plant protection products should therefore be granted by Member States.

(23) Fitofarmacevtska sredstva, ki vsebujejo aktivne snovi, so lahko formulirana na različne načine in se lahko uporabljajo na različnih rastlinah in rastlinskih proizvodih, v različnih razmerah na področju kmetijstva, zdravja rastlin in okolja (vključno s podnebjem). Zato bi morale registracije za fitofarmacevtska sredstva izdajati države članice.

(24) The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment should take priority over the objective of improving plant production. 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, including that of vulnerable groups, or any unacceptable effects on the environment.

(24) Določbe, ki urejajo registracijo, morajo zagotavljati visok standard varstva. Zlasti pri izdaji registracije za fitofarmacevtska sredstva bi moral biti cilj varovanja zdravja ljudi in živali ter okolja pomembnejši kot cilj izboljšanja rastlinske pridelave. Še preden se fitofarmacevtska sredstva dajo v promet bi zato bilo treba dokazati, da nedvomno koristijo rastlinski pridelavi in nimajo nobenega škodljivega vpliva na zdravje ljudi ali živali, vključno na zdravje ranljivih skupin, ali nobenega nesprejemljivega vpliva na okolje.

(25) 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.

(25) Zaradi predvidljivosti, učinkovitosti in usklajenosti bi bilo treba merila, postopke in pogoje za registracijo fitofarmacevtskih sredstev uskladiti, ob upoštevanju splošnih načel varstva zdravja ljudi in živali ter varovanja okolja.

(26) Where the decision on approval cannot be finalised within the period provided for due to reasons not falling under the responsibility of the applicant, Member States should be able to grant the provisional authorisations for a limited period in order to facilitate the transition to the approval procedure provided for under this Regulation. In the light of the experience gained from the approval of the active substances under this Regulation, the provisions on provisional authorisations should cease to apply or be extended after the period of five years, if necessary.

(26) Če sklepa o odobritvi ni mogoče doseči v predvidenem obdobju iz razlogov, ki ne sodijo v odgovornost vlagatelja, bi morale imeti države članice možnost odobriti začasne registracije za omejeno obdobje, da bi se olajšal prehod na postopek odobritve, kakor ga določa ta uredba. Glede na izkušnje, dobljene pri odobritvi aktivnih snovi v skladu s to uredbo, bi morale po petih letih določbe o začasnih registracijah prenehati veljati ali biti po potrebi podaljšane.

(27) The active substances contained in a plant protection product can be produced by different manufacturing processes, leading to differences in specifications. Such differences may have safety implications. For efficiency reasons, a harmonised procedure at Community level should be provided for the assessment of those differences.

(27) Aktivne snovi v fitofarmacevtskem sredstvu se lahko proizvedejo z različnimi proizvodnimi postopki, kar povzroča razlike v specifikacijah. Te razlike lahko vplivajo na varnost. Zaradi učinkovitosti bi bilo treba na ravni Skupnosti zagotoviti usklajen postopek za oceno teh razlik.

(28) Good administrative cooperation between Member States should be increased during all steps of the authorisation procedure.

(28) Dobro upravno sodelovanje med državami članicami bi bilo treba okrepiti na vseh stopnjah postopka registracije.

(29) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community. To avoid any duplication of work, to reduce the administrative burden for industry and for Member States and to provide for more harmonised availability of plant protection products, authorisations granted by one Member State should be accepted by other Member States where agricultural, plant health and environmental (including climatic) conditions are comparable. Therefore, the Community should be divided into zones with such comparable conditions in order to facilitate such mutual recognition. However, environmental or agricultural circumstances specific to the territory of one or more Member States might require that, on application, Member States recognise or amend an authorisation issued by another Member State, or refuse to authorise the plant protection product in their territory, where justified as a result of specific environmental or agricultural circumstances or where the high level of protection of both human and animal health and the environment required by this Regulation cannot be achieved. It should also be possible to impose appropriate conditions having regard to the objectives laid down in the National Action Plan adopted in accordance with Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve a sustainable use of pesticides [9].

(29) Načelo vzajemnega priznavanja je eno od sredstev za zagotavljanje prostega pretoka blaga v Skupnosti. Za preprečitev podvajanja dela, zmanjšanje administrativnega bremena za industrijo in države članice ter za zagotovitev bolj izenačene dostopnosti do fitofarmacevtskih sredstev bi morale registracije, ki jih izda ena država članica, sprejeti tudi druge države članice, v katerih so razmere na področju kmetijstva, zdravja rastlin in okolja (vključno s podnebjem) primerljive. Zato bi bilo treba Skupnost razdeliti na cone s takšnimi primerljivimi razmerami, da se olajša takšno vzajemno priznavanje. Iz okoljskih in kmetijskih razmer na ozemlju ene ali več držav članic bi pa morda lahko izviralo, da države članice ob vložitvi zahtevka priznajo registracijo fitofarmacevtskega sredstva, ki jo je izdala druga država članica, jo spremenijo ali registracije fitofarmacevtskega sredstva na svojem ozemlju ne odobrijo, če je to upravičeno zaradi posebnih okoljskih ali kmetijskih razmer ali če ni mogoče doseči visoke stopnje varstva zdravja ljudi in živali ter varovanja okolja, ki jih določa ta uredba. Lahko bi se tudi sprejeli ustrezni pogoji glede ciljev iz nacionalnih akcijskih načrtov, sprejetih v skladu z Direktivo 2009/128/ES Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o določitvi okvira za ukrepe Skupnosti za doseganje trajnostne rabe pesticidov [9].

(30) The economic incentive for industry to apply for an authorisation is limited for certain uses. 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.

(30) Ekonomska spodbuda industrije v zvezi z vlogo za registracijo je omejena na določene vrste uporabe. Za zagotovitev, da manjša dostopnost do fitofarmacevtskih sredstev ne ogroža raznovrstnosti kmetijstva ter sadjarstva in vrtnarstva, bi bilo treba za manjše uporabe določiti posebna pravila.

(31) Where identical plant protection products are authorised in different Member States, a simplified procedure for granting a parallel trade permit should be provided for in this Regulation, in order to facilitate the trade between Member States of such products.

(31) V primeru registracije enakih fitofarmacevtskih sredstev v različnih državah članicah bi morala ta uredba zagotoviti poenostavljen postopek za odobritev dovoljenja za vzporedno trgovanje, da bi se olajšalo trgovanje s takšnimi sredstvi med državami članicami.

(32) In exceptional cases, Member States should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production or ecosystems which cannot be contained by any other reasonable means. Such temporary authorisations should be reviewed at Community level.

(32) V izjemnih primerih bi bilo treba državam članicam dovoliti registracijo fitofarmacevtskih sredstev, ki niso v skladu s pogoji iz te uredbe, kadar je to nujno zaradi ogroženosti rastlinske pridelave ali ekosistemov, ki jih ni mogoče obvarovati na drug ustrezen način. Takšne začasne registracije bi bilo treba pregledati na ravni Skupnosti.

(33) Community seeds legislation provides for free movement of seeds within the Community but does not contain a specific provision concerning seeds treated with plant protection products. Such a provision should therefore be included in this Regulation. If treated seeds constitute a serious risk to human or animal health or to the environment, Member States should have the possibility of taking protective measures.

(33) Zakonodaja Skupnosti o semenih zagotavlja prosti pretok semen znotraj Skupnosti, ne določa pa posebnih določb o semenih, tretiranih s fitofarmacevtskimi sredstvi. Zato bi takšna določba morala biti vključena v to uredbo. V kolikor tretirana semena resno ogrožajo zdravje ljudi ali živali ali okolje, bi moralo biti državam članicam omogočeno, da sprejmejo zaščitne ukrepe.

(34) 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.

(34) Za spodbujanje inovacij bi bilo treba določiti posebna pravila, ki dovoljujejo uporabo fitofarmacevtskih sredstev pri preskusih, tudi kadar ta sredstva še niso bila registrirana.

(35) To ensure a high level of protection of human and animal health and the environment, plant protection products should be used properly, in accordance with their authorisation, having regard to the principles of integrated pest management and giving priority to non-chemical and natural alternatives wherever possible. The Council should include in the statutory management requirement referred to in Annex III to Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers [10], the principles of integrated pest management, including good plant protection practice and non-chemical methods of plant protection and pest and crop management.

(35) Za zagotovitev visoke ravni varovanja zdravja ljudi in živali ter varovanja okolja je potrebna pravilna uporaba fitofarmacevtskih sredstev v skladu z njihovo registracijo ter upoštevanje načel integriranega varstva rastlin pred škodljivimi organizmi in dajanje prednosti nekemičnim in naravnim alternativam, kjer je to mogoče. Svet bi moral v predpisane zahteve ravnanja iz Priloge III k Uredbi Sveta (ES) št. 1782/2003 z dne 29. septembra 2003 o skupnih pravilih za sheme neposrednih podpor v okviru skupne kmetijske politike in o uvedbi nekaterih shem podpor za kmete [10] vključiti načela integriranega varstva rastlin pred škodljivimi organizmi, vključno z dobro prakso varstva rastlin in nekemičnimi metodami za varstvo rastlin, zatiranje škodljivcev in pridelavo kulturnih rastlin.

(36) In addition to this Regulation and Directive 2009/128/EC, a thematic strategy on the sustainable use of pesticides was adopted. In order to achieve coherence between these instruments, the user should know from the product label where, when and under what circumstances a plant protection product may be used.

(36) Poleg te uredbe in Direktive 2009/128/ES je bila sprejeta tudi tematska strategija o trajnostni rabi pesticidov. Za dosego usklajenosti med temi akti bi moral uporabnik z etikete pripravka razbrati, kje, kdaj in pod kakšnimi pogoji se lahko uporablja fitofarmacevtsko sredstvo.

(37) A system of exchange of information should be established. Member States should make available to each other, the Commission and the Authority the particulars and scientific documentation submitted in connection with applications for authorisation of plant protection products.

(37) Vzpostaviti bi bilo treba sistem izmenjave informacij. Države članice bi morale drugim državam članicam, Komisiji in Agenciji omogočiti dostop do podrobnosti in znanstvene dokumentacije, ki je bila predložena v zvezi z vlogami za registracijo fitofarmacevtskih sredstev.

(38) Adjuvants may be used to increase the efficacy of a plant protection product. Their placing on the market or use should be forbidden where they contain a co-formulant which has been prohibited. The technical rules necessary for the authorisation should be established.

(38) Za povečanje učinkovitosti fitofarmacevtskih sredstev se lahko uporabijo pomožna sredstva. Dajanje v promet ali uporabo teh pomožnih sredstev bi bilo treba prepovedati, če vsebujejo dodatek, ki je prepovedan. Določiti bi bilo treba tehnična pravila, potrebna za registracijo.

(39) Studies represent a major investment. This investment should be protected in order to stimulate research. For this reason, tests and studies, other than those involving vertebrate animals, which will be subject to obligatory data sharing, lodged by one applicant with a Member State should be protected against use by another applicant. This protection should, however, be limited in time in order to allow competition. It should also be limited to studies which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary. Business operators, in particular small and medium sized enterprises, should have the same opportunities in respect of market access.

(39) Študije so velika naložba. To naložbo bi bilo treba zaščititi, da se spodbudijo raziskave. Zato je treba preskuse in študije, ki jih vlagatelj predloži državi članici, razen tistih, ki vključujejo poskuse na vretenčarjih, pri katerih je obvezna izmenjava podatkov, zaščititi pred uporabo drugega vlagatelja. Vendar pa bi ta zaščita morala biti časovno omejena, da se omogoči konkurenca. Prav tako bi morala biti omejena na študije, ki so resnično nujne za regulativne namene, da se prepreči, da bi vlagatelji s predložitvijo novih študij, ki niso nujne, umetno podaljševali obdobje zaščite. Nosilci dejavnosti, zlasti mala in srednja podjetja, bi morali imeti enake možnosti glede dostopa do trga.

(40) The use of non-animal test methods and other risk assessment strategies should be promoted. Animal testing for the purposes of this Regulation should be minimised and tests on vertebrates should be undertaken as a last resort. 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 [11], tests on vertebrate animals must be replaced, restricted or refined. Therefore, rules should be laid down to avoid duplicative testing and duplication of tests and studies on vertebrates should be prohibited. For the purpose of developing new plant protection products, there should be an obligation to allow access to studies on vertebrates on reasonable terms and the results and the costs of tests and studies on animals should be shared. In order to allow operators to know what studies have been carried out by others, Member States should keep a list of such studies even where they are not covered by the above system of compulsory access.

(40) Treba je spodbujati uporabo preskusnih metod, pri katerih se ne uporabljajo živali, in drugih strategij za oceno tveganja. Preskuse na živalih za potrebe te uredbe je treba čimbolj omejiti, preskusi na vretenčarjih pa morajo biti zadnja možnost. V skladu z Direktivo Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za poskusne in druge znanstvene namene [11], je treba preskuse na vretenčarjih nadomestiti, omejiti ali izpopolniti. Zato bi bilo treba določiti pravila za preprečevanje dvojnih preskusov, podvajanje preskusov in študij na vretenčarjih pa bi bilo treba prepovedati. Za potrebe razvoja novih fitofarmacevtskih sredstev bi bilo treba sprejeti obveznost, da se pod razumnimi pogoji omogoči dostop do študij o vretenčarjih, rezultate in stroške preskusov in študij na živalih pa bi bilo treba deliti. Da se omogoči seznanjenost gospodarskih subjektov s tem, katere študije so bile izvedene, bi morale države članice hraniti seznam teh študij, čeprav niso vključene v zgoraj navedeni sistem obveznega dostopa.

(41) As different rules are applied by Member States, the Commission and the Authority 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.

(41) Ker države članice, Komisija in Agencija uporabljajo različne predpise v zvezi z dostopom 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.

(42) 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 [12] applies to the classification, packaging and labelling of plant protection products. However, to improve further 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.

(42) 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 [12] se uporablja za razvrščanje, pakiranje in označevanje pesticidov. 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.

(43) To ensure that advertisements do not mislead users of plant protection products or the public, it is appropriate to lay down rules on the advertising of those products.

(43) Za zagotovitev, da oglasi ne zavajajo uporabnikov fitofarmacevtskih sredstev ali javnosti, je primerno določiti pravila o oglaševanju teh sredstev.

(44) 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.

(44) Določiti bi bilo treba določbe o vodenju evidence in informacijah o uporabi fitofarmacevtskih sredstev, da se poveča raven varovanja zdravja ljudi in živali ter okolja z zagotovitvijo sledljivosti možne izpostavljenosti, da se poveča učinkovitost spremljanja in nadzora ter zmanjšajo stroški spremljanja kakovosti vode.

(45) 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.

(45) Določbe o ureditvah o nadzoru in o inšpekcijskih pregledih v zvezi s trženjem in uporabo fitofarmacevtskih sredstev bi morale zagotoviti pravilno, varno in usklajeno izvajanje zahtev iz te uredbe, da se doseže visoka raven varovanja zdravja ljudi in živali ter okolja.

(46) 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 [13] 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. Similar rules on monitoring and controls relating to the storage and use of plant protection products not covered by Regulation (EC) No 882/2004 should be adopted by the Commission. The bureaucratic burden on farmers should be as limited as possible.

(46) Uredba (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali [13], predvideva nadzorne ukrepe za uporabo fitofarmacevtskih sredstev na vseh stopnjah proizvodnje živil, vključno z vodenjem evidence o uporabi fitofarmacevtskih sredstev. Komisija bi morala sprejeti podobna pravila za spremljanje in nadzor v zvezi s skladiščenjem in uporabo fitofarmacevtskih sredstev, ki niso vključena v Uredbo (ES) št. 882/2004. Administrativno breme za kmete bi moralo biti čim manjše.

(47) The measures provided for in this Regulation should apply without prejudice to other Community legislation, in particular Directive 2009/128/EC, Directive 2000/60/EC, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin [14] and Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms.

(47) Ukrepi iz te uredbe bi se morali uporabljati brez poseganja v preostalo zakonodajo Skupnosti, zlasti v Direktivo 2009/128/ES, Direktivo 2000/60/ES, 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 [14] ter zakonodajo Skupnosti o varstvu delavcev in kogar koli v zvezi z omejeno uporabo in namernim sproščanjem gensko spremenjenih organizmov.

(48) 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.

(48) 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.

(49) 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.

(49) Države članice bi morale določiti pravila za kazni, ki veljajo za kršitve te uredbe, in z ustreznimi ukrepi zagotoviti, da se izvajajo.

(50) 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.

(50) V državah članicah bi morala še naprej veljati splošna civilna in kazenska odgovornost proizvajalca in, kjer je to primerno, osebe, odgovorne za dajanje fitofarmacevtskega sredstva v promet ali za uporabo tega sredstva.

(51) Member States should have the possibility of recovering the costs of the procedures associated with the application of this Regulation from those seeking to place, or placing, plant protection products or adjuvants on the market and from those applying for the approval of active substances, safeners or synergists.

(51) Države članice bi morale imeti možnost povrnitve stroškov za postopke v zvezi z uporabo te uredbe s strani tistih, ki poskušajo dati ali dajejo fitofarmacevtska sredstva ali pomožna sredstva v promet, in tistih, ki predložijo zahtevek za odobritev aktivnih snovi, varoval ali sinergistov.

(52) Member States should designate the necessary national competent authorities.

(52) Države članice bi morale imenovati pristojne nacionalne organe.

(53) The Commission should facilitate the application of this Regulation. Therefore, it is appropriate to provide for the necessary financial resources and the possibility of amending certain provisions of this Regulation in the light of experience or of developing technical notes for guidance.

(53) Komisija bi morala olajšati uporabo te uredbe. Zato je primerno zagotoviti potrebna finančna sredstva in možnost spremembe nekaterih določb te uredbe ob upoštevanju izkušenj ali možnost oblikovanja tehničnih navodil.

(54) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [15].

(54) Ukrepe, potrebne za izvajanje te uredbe, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [15].

(55) In particular, the Commission should be empowered to adopt harmonised methods to determine the nature and quantity of active substances, safeners and synergists, and where appropriate of relevant impurities and co-formulants, and maximum quantities of plant protection products to be released, and to adopt Regulations concerning labelling requirements, controls and rules for adjuvants, establishing a work programme for safeners and synergists, including their data requirements, postponing the expiry of the approval period, extending the date for provisional authorisations, setting the information requirements for parallel trade and on inclusion of co-formulants, as well as amendments to the Regulations on data requirements and on uniform principles for evaluation and authorisation and to the Annexes. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(55) Komisiji bi bilo treba zlasti podeliti pooblastila za sprejemanje usklajenih metod določanja vrste in količine aktivnih snovi, varoval in sinergistov ter po potrebi ustreznih nečistoč in dodatkov, največjih količin fitofarmacevtskih sredstev, ki se lahko sprostijo, ter za sprejemanje uredb glede zahtev za označevanje, nadzor in pravila za pomožna sredstva, določitvi delovnega programa za varovala in sinergiste, vključno z zahtevami glede podatkov za slednje, uredb o odložitvi prenehanja obdobja odobritve, podaljšanju datuma za začasne registracije, določitvi zahtev po podatkih za vzporedno trgovanje in vključitev dodatkov, kakor tudi spremembah uredb o zahtevah glede podatkov in enotnih načelih za ocenjevanje in registracijo ter spremembah prilog. Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te uredbe, med drugim z njenim dopolnjevanjem z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.

(56) On grounds of efficiency, the normal time limits for the regulatory procedure with scrutiny should be curtailed for the adoption of a Regulation postponing the expiry of the approval period for a period sufficient to examine the application.

(56) Zaradi učinkovitosti bi bilo treba običajne roke za regulativni postopek s pregledom skrajšati za sprejetje uredbe, ki prenehanje odobritve odloži za obdobje, ki zadošča za preučitev vloge.

(57) Furthermore, it is appropriate to transfer certain current provisions set out in the Annexes to Directive 91/414/EEC into separate legal instruments to be adopted by the Commission within 18 months after the entry into force of this Regulation. Since these current provisions should be, as a first step, transferred into new legal instruments and thus be adopted without any substantial modification, the advisory procedure is the most appropriate.

(57) Primerno je prenesti tudi nekatere sedanje določbe, že navedene v prilogah Direktive 91/414/EGS, v ločene pravne instrumente, ki naj bi jih Komisija sprejela v 18 mesecih po začetku veljavnosti uredbe. Ker bi bilo treba sedanje določbe v prvi fazi prenesti v nove pravne instrumente in jih tako sprejeti brez vsebinskih sprememb, se zdi svetovalni postopek najbolj primeren.

(58) It is also appropriate to use the advisory procedure to adopt some purely technical measures, in particular technical guidelines in view of their non-binding character.

(58) Prav tako je primerno, da se svetovalni postopek uporabi za sprejetje nekaterih izključno tehničnih ukrepov, zlasti tehničnih smernic, saj niso zavezujoče.

(59) Certain provisions of Directive 91/414/EEC should remain applicable during the transitional period,

(59) Nekatere določbe Direktive 91/414/EGS bi se morale v prehodnem obdobju še naprej uporabljati –

HAVE ADOPTED THIS REGULATION:

SPREJELA NASLEDNJO UREDBO:

CHAPTER I

POGLAVJE I

GENERAL PROVISIONS

SPLOŠNE DOLOČBE

Article 1

Člen 1

Subject matter and purpose

Vsebina in namen

1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community.

1. Ta uredba določa pravila za registracijo fitofarmacevtskih sredstev v komercialni obliki in za njihovo dajanje v promet, uporabo in nadzor v Skupnosti.

2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and co-formulants.

2. Ta uredba določa pravila za odobritev aktivnih snovi, varoval ali sinergistov, ki jih vsebujejo fitofarmacevtska sredstva ali so sestavljena iz njih, ter pravila za pomožna sredstva in dodatke.

3. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production.

3. Namen te uredbe je zagotoviti visoko raven zaščite zdravja ljudi in živali ter okolja ter izboljšati delovanje notranjega trga z uskladitvijo predpisov o dajanju fitofarmacevtskih sredstev na trg, hkrati pa izboljšati kmetijsko proizvodnjo.

4. The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. In particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory.

4. Določbe te uredbe temeljijo na previdnostnem načelu, da bi zagotovili, da aktivne snovi ali sredstva, dani v promet, nimajo škodljivega vpliva na zdravje ljudi ali okolje. Državam članicam se zlasti ne sme onemogočiti uporaba previdnostnega načela, kadar obstaja znanstvena negotovost glede tveganja za zdravje ljudi ali živali ali za okolje, ki ga predstavljajo fitofarmacevtska sredstva, ki naj bi bila odobrena na njihovem ozemlju.

Article 2

Člen 2

Scope

Področje uporabe

1. This Regulation shall apply to products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:

1. Ta uredba se uporablja za sredstva v obliki, v kateri se dobavljajo uporabniku, ki so sestavljena iz aktivnih snovi, varoval ali sinergistov ali te aktivne snovi vsebujejo, in so namenjena:

(a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;

(a) varstvu rastlin ali rastlinskih proizvodov pred vsemi škodljivimi organizmi ali preprečevanju delovanja takih organizmov, razen če je glavni namen uporaba v higienske namene in ne varstvo rastlin ali rastlinskih proizvodov;

(b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;

(b) vplivu na življenjske procese rastlin, kot so snovi, ki vplivajo na njihovo rast, razen hranila;

(c) preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives;

(d) destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;

(d) uničevanju nezaželenih rastlin ali delov rastlin, razen alg, razen če se sredstva nanašajo na tla ali vodo za varstvo rastlin;

(e) checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants.

(e) zadrževanju ali preprečevanju nezaželene rasti rastlin, razen alg, razen če se sredstva nanašajo na tla ali vodo za varstvo rastlin.

These products are referred to as "plant protection products".

Ta sredstva so v nadaljnjem besedilu "fitofarmacevtska sredstva".

2. This Regulation shall apply to substances, including micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as "active substances".

2. Ta uredba se uporablja za snovi, vključno z mikroorganizmi, ki imajo splošen ali poseben učinek na škodljive organizme ali rastline, dele rastlin ali rastlinske proizvode, v nadaljnjem besedilu "aktivne snovi".

3. This Regulation shall apply to the following:

3. Ta uredba se uporablja za:

(a) substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants, referred to as "safeners";

(a) snovi ali pripravke, ki se dodajo fitofarmacevtskemu sredstvu, da bi odpravili ali zmanjšali fitotoksični vpliv pripravka na določene rastline, v nadaljnjem besedilu: "varovala";

(b) substances or preparations which, while showing no or only weak activity as referred to in paragraph 1, can give enhanced activity to the active substance(s) in a plant protection product, referred to as "synergists";

(b) snovi ali pripravke, ki nimajo vpliva v smislu odstavka 1 ali je ta vpliv zelo omejen in lahko izboljšajo delovanje aktivne snovi (aktivnih snovi) v fitofarmacevtskem sredstvu, v nadaljnjem besedilu "sinergisti";

(c) substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists, referred to as "co-formulants";

(c) snovi ali pripravke, ki se uporabljajo ali so namenjeni uporabi v fitofarmacevtskem sredstvu ali pomožnemu sredstvu in niso aktivne snovi, varovala ali sinergisti, v nadaljnjem besedilu "dodatki";

(d) substances or preparations which consist of co-formulants or preparations containing one or more co-formulants, in the form in which they are supplied to the user and placed on the market to be mixed by the user with a plant protection product and which enhance its effectiveness or other pesticidal properties, referred to as "adjuvants".

(d) snovi ali pripravke, ki so sestavljeni iz dodatkov, ali pripravkov, ki vsebujejo enega ali več dodatkov, v obliki, v kateri se dobavljajo uporabniku in so dani v promet, da bi jih uporabnik lahko mešal s fitofarmacevtskimi sredstvi in ki izboljšajo učinkovitost fitofarmacevtskega sredstva ali druge pesticidne lastnosti, v nadaljnjem besedilu "pomožna sredstva".

Article 3

Člen 3

Definitions

Opredelitev pojmov

For the purposes of this Regulation, the following definitions shall apply:

V tej uredbi se uporabljajo naslednje opredelitve pojmov:

1. "residues" means one or more substances present in or on plants or plant products, edible animal products, drinking water or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites, breakdown or reaction products;

1. "ostanki" so ena ali več snovi, ki so prisotne v ali na rastlinah ali proizvodih rastlinskega izvora, užitnih živalskih proizvodih, pitni vodi ali drugod v okolju in ki so posledica uporabe fitofarmacevtskega sredstva, vključno z njegovimi metaboliti in razgradnimi ali reakcijskimi produkti;

2. "substances" means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process;

2. "snovi" so kemijski elementi in njihove spojine, kot se pojavljajo v naravi ali so izdelani industrijsko, vključno s kakršno koli nečistočo, ki je neizogibna posledica proizvodnega procesa;

3. "preparations" means mixtures or solutions composed of two or more substances intended for use as a plant protection product or as an adjuvant;

3. "pripravki" so mešanice ali raztopine dveh ali več snovi, namenjene uporabi kot fitofarmacevtska sredstva ali pomožna sredstva;

4. "substance of concern" means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a plant protection product in sufficient concentration to present risks of such an effect.

4. "problematična snov" je vsaka snov, ki ima škodljiv vpliv na ljudi, živali ali okolje in jo vsebuje fitofarmacevtsko sredstvo ali nastaja v njem v taki koncentraciji, da lahko povzroča nevarnost takšnega vpliva.

Such substances include, but are not limited to, substances meeting the criteria to be classified as hazardous in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [16], and present in the plant protection product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Directive 1999/45/EC;

Takšne snovi med drugim vključujejo snovi, ki izpolnjujejo merila za razvrstitev kot nevarne v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi [16] in so prisotne v fitofarmacevtskem sredstvu v koncentraciji, zaradi katere bi to sredstvo veljalo za nevarnega v smislu člena 3 Direktive 1999/45/ES;

5. "plants" means live plants and live parts of plants, including fresh fruit, vegetables and seeds;

5. "rastline" so žive rastline in živi deli rastlin, vključno s svežim sadjem, zelenjavo in semeni;

6. "plant products" means products of plant origin in an unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, but excluding plants;

6. "rastlinski proizvodi" so proizvodi rastlinskega izvora v nepredelanem stanju ali po enostavni obdelavi, kot je mletje, sušenje ali stiskanje, razen rastlin;

7. "harmful organisms" means any species, strain or biotype belonging to the animal kingdom or plant kingdom or pathogenic agent injurious to plants or plant products;

7. "škodljivi organizmi" so katera koli vrsta, sev ali biotip, ki pripada živalskemu ali rastlinskemu svetu, ali patogeni povzročitelj, škodljiv za rastline ali rastlinske proizvode;

8. "non-chemical methods" means alternative methods to chemical pesticides for plant protection and pest management, based on agronomic techniques such as those referred to in point 1 of Annex III to Directive 2009/128/EC, or physical, mechanical or biological pest control methods;

8. "ne-kemične metode" so alternativne metode kemičnim pesticidom za varstvo rastlin in zatiranje škodljivih organizmov, ki temeljijo na agronomskih metodah, kakršne so navedene v točki 1 Priloge III Direktive 2009/128/ES, ali fizikalne, mehanske ali biološke metode zatiranja škodljivih organizmov.

9. "placing on the market" means the holding for the purpose of sale within the Community, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves, but not the return to the previous seller. Release for free circulation into the territory of the Community shall constitute placing on the market for the purposes of this Regulation;

9. "dajanje v promet" je razpolaganje za prodajo v Skupnosti, vključno s ponudbo sredstva za prodajo ali katero koli drugo obliko prenosa, brezplačno ali ne, ter prodajo, distribucijo in drugimi oblikami prenosa, vendar ne vračilo prejšnjemu prodajalcu. Sprostitev v prosti promet na ozemlje Skupnosti se za namene te uredbe šteje za dajanje v promet;

10. "authorisation of a plant protection product" means an 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;

10. "registracija fitofarmacevtskega sredstva" je administrativni akt, s katerim pristojni organ države članice registrira fitofarmacevtsko sredstvo za dajanje v promet na svojem ozemlju;

11. "producer" means a person who manufactures plant protection products, active substances, safeners, synergists, co-formulants or adjuvants on his own, or who contracts this manufacturing to another party, or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation;

11. "proizvajalec" je oseba, ki samostojno proizvaja fitofarmacevtska sredstva, aktivne snovi, varovala, sinergiste, dodatke, ali pomožna sredstva ali za proizvodnjo pogodbeno najame drugo stranko, ali oseba, ki jo proizvajalec imenuje za svojega edinega predstavnika za zagotovitev skladnosti s to uredbo;

12. "letter of access" means an original document by which the owner of data protected under this Regulation agrees to the use of such data under the specific terms and conditions by the competent authority for the purpose of granting an authorisation of a plant protection product or an approval of an active substance, synergist or safener for the benefit of another applicant;

12. "izjava o dostopu do podatkov" je izvirni dokument, s katerim imetnik podatkov, zaščitenih v skladu s to uredbo, pristojnim organom dovoli uporabo takšnih podatkov pod določenimi pogoji za namen registracije fitofarmacevtskega sredstva ali odobritve aktivne snovi, sinergista ali varovala v korist drugega vlagatelja;

13. "environment" means waters (including ground, surface, transitional, coastal and marine), sediment, soil, air, land, wild species of fauna and flora, and any interrelationship between them, and any relationship with other living organisms;

13. "okolje" zajema vode (vključno s podzemnimi, površinskimi, obalnimi in morskimi vodami ter somornicami), sedimente, zemljo, zrak, tla, divje vrste favne in flore ter vse medsebojne odnose med njimi ter tudi vse odnose z živimi organizmi;

14. "vulnerable groups" means persons needing specific consideration when assessing the acute and chronic health effects of plant protection products. These include pregnant and nursing women, the unborn, infants and children, the elderly and workers and residents subject to high pesticide exposure over the long term;

14. "ranljive skupine" so osebe, za katere je pri ocenjevanju akutnih in kroničnih učinkov fitofarmacevtskih sredstev na zdravje potrebna posebna obravnava. To so med drugim nosečnice in doječe matere, nerojeni otroci, dojenčki in otroci, ostareli ter delavci in prebivalci, ki so dolgoročno izpostavljeni visokim koncentracijam pesticidov;

15. "micro-organisms" means any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material;

15. "mikroorganizmi" so celične ali necelične mikrobiološke entitete, vključno z nižjimi glivami in virusi, sposobne podvajanja ali prenašanja genskega materiala;

16. "genetically modified organisms" means organisms in which the genetic material has been altered within the meaning of Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms [17];

16. "gensko spremenjeni organizmi" so organizmi, katerih genski material je bil spremenjen v smislu člena 2(2) Direktive 2001/18/ES Evropskega parlamenta in Sveta z dne 12. marca 2001 o namernem sproščanju gensko spremenjenih organizmov v okolje [17];

17. "zone" means a group of Member States as defined in Annex I.

17. "cona" zajema skupino držav članic, kakor je opredeljena v Prilogi I;

For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment the zone means all zones defined in Annex I;

Za namene uporabe v rastlinjakih, za tretiranje po spravilu, za tretiranje praznih skladišč in tretiranje semen, cona pomeni vse cone, opredeljene v Prilogi I.

18. "good plant protection practice" means a practice whereby the treatments with plant protection products applied to given plants or plant products, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure acceptable efficacy with the minimum quantity necessary, taking due account of local conditions and of the possibilities for cultural and biological control;

18. "dobra praksa varstva rastlin" je praksa, pri kateri se izbere, odmeri in časovno razvrsti tretiranje zadevnih rastlin ali rastlinskih proizvodov s fitofarmacevtskimi sredstvi, v skladu s pogoji njihove registrirane uporabe za zagotovitev sprejemljive učinkovitosti s čim manjšo količino, ki je potrebna, ob ustreznem upoštevanju lokalnih razmer ter možnosti zatiranja s pomočjo ustreznih metod pridelave in bioloških sredstev;

19. "good laboratory practice" means a practice as defined in point 2.1 of Annex I to Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances [18];

19. "dobra laboratorijska praksa" je praksa, kakor je opredeljena v točki 2.1 Priloge I k Direktivi 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi [18];

20. "good experimental practice" means a practice in accordance with the provisions of European and Mediterranean Plant Protection Organisation (EPPO) Guidelines 181 and 152;

20. "dobra poskusna praksa" je praksa v skladu z določbami 152. in 181. smernic Evropske in sredozemske organizacije za varstvo rastlin (EPPO);

21. "data protection" means the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant;

21. "varstvo podatkov" je začasna pravica imetnika poročila o preskusu ali študiji, da prepreči uporabo poročila v korist drugega vlagatelja;

22. "rapporteur Member State" means the Member State which undertakes the task of evaluating an active substance, safener or synergist;

22. "država članica poročevalka" je država članica, ki izvaja nalogo ocenjevanja aktivne snovi, varovala ali sinergista;

23. "tests and studies" means investigations or experiments whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of plant protection products;

23. "preskusi in študije" je raziskovanje ali preskusi, katerih namen je določiti lastnosti in obnašanje aktivne snovi ali fitofarmacevtskih sredstev, napovedati izpostavljenost aktivnim snovem in/ali njihovim ustreznim metabolitom, določiti varne ravni izpostavljenosti in pogoje za varno uporabo fitofarmacevtskih sredstev;

24. "authorisation holder" means any natural or legal person holding an authorisation of a plant protection product;

24. "imetnik registracije" je vsaka fizična ali pravna oseba, ki je imetnik registracije fitofarmacevtskega sredstva;

25. "professional user" means a professional user as defined in Article 3(1) of Directive 2009/128/EC;

25. "poklicni uporabnik" je poklicni uporabnik, kakor je opredeljen v členu 3(1) Direktive 2009/128/ES;

26. "minor use" means use of a plant protection product in a particular Member State on plants or plant products which are:

26. "manjša uporaba" je uporaba fitofarmacevtskega sredstva v določeni državi članici na rastlinah ali rastlinskih proizvodih:

(a) not widely grown in that Member State; or

(a) ki v tej državi članici niso splošno razširjeni, ali

(b) widely grown, to meet an exceptional plant protection need;

(b) za rešitev izjemne potrebe po varstvu rastlin na splošno razširjenih rastlinah ali rastlinskih proizvodih;

27. "greenhouse" means a walk-in, static, closed place of crop production with a usually translucent outer shell, which allows controlled exchange of material and energy with the surroundings and prevents release of plant protection products into the environment.

27. "rastlinjak" je zaprt, stalen prostor, običajno s prozorno steno, v katerem se je mogoče gibati in je namenjen proizvodnji kulturnih rastlin; omogoča nadzorovano izmenjavo snovi in energije z okolico in preprečuje izpust fitofarmacevtskih sredstev v okolje.

For the purpose of this Regulation, closed places of plant production where the outer shell is not translucent (for example, for production of mushrooms or witloof) are also considered as greenhouses;

Za namen te uredbe za rastlinjak velja tudi zaprt prostor za rastlinsko pridelavo, katerega stena ni prozorna (denimo za pridelavo gob ali vitlofa);

28. "post-harvest treatment" means treatment of plants or plant products after harvest in an isolated space where no run-off is possible, for example in a warehouse;

28. "tretiranje po spravilu" je obdelava rastlin ali rastlinskih proizvodov po spravilu, v izoliranem prostoru, kjer odtekanje ni možno, na primer v skladišču;

29. "biodiversity" means variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this variability may include diversity within species, between species and of ecosystems;

29. "biotska raznovrstnost" je raznolikost med živimi organizmi iz vseh virov, vključno s kopenskimi, morskimi in drugimi vodnimi ekosistemi in ekološkimi kompleksi, katerih del so; to vključuje raznovrstnost znotraj vrst, med vrstami in ekosistemi;

30. "competent authority" means any authority or authorities of a Member State responsible for carrying out the tasks established under this Regulation;

30. "pristojni organ" je vsak organ ali organi držav članic, ki so pristojni za izvajanje nalog, določenih s to uredbo;

31. "advertisement" means a means of promoting the sale or use of plant protection products (to anyone other than the authorisation holder, the person placing the plant protection product on the market and their agents) by printed or electronic media;

31. "oglaševanje" je sredstvo za spodbujanje prodaje ali uporabe fitofarmacevtskih sredstev (vsem, razen imetniku registracije, osebi, ki daje fitofarmacevtsko sredstvo v promet, in njunim zastopnikom) s tiskanimi ali elektronskimi mediji;

32. "metabolite" means any metabolite or a degradation product of an active substance, safener or synergist, formed either in organisms or in the environment.

32. "metabolit" je vsak metabolit ali produkt, ki nastane pri razgradnji aktivne snovi, varovala ali sinergista, v organizmih ali v okolju.

A metabolite is deemed relevant if there is a reason to assume that it has intrinsic properties comparable to the parent substance in terms of its biological target activity, or that it poses a higher or comparable risk to organisms than the parent substance or that it has certain toxicological properties that are considered unacceptable. Such a metabolite is relevant for the overall approval decision or for the definition of risk mitigation measures;

Metabolit šteje za relevantnega, če obstaja razlog za domnevo, da ima glede svoje ciljne biološke aktivnosti primerljive bistvene lastnosti kot izhodiščna snov, ali če predstavlja za organizme večje ali primerljivo tveganje kot izhodiščna snov ali če ima določene toksikološke lastnosti, ki veljajo za nesprejemljive. Takšen metabolit je relevanten pri celoviti odločitvi o odobritvi ali pri opredelitvi ukrepov za zmanjšanje tveganja;

33. "impurity" means any component other than the pure active substance and/or variant which is present in the technical material (including components originating from the manufacturing process or from degradation during storage).

33. "nečistoče" so kakršne koli druge sestavine, ki niso čista aktivna snov in/ali varianta in ki jih vsebuje tehnični material (vključno s sestavinami, ki nastanejo med proizvodnim postopkom ali so posledica razgrajevanja med skladiščenjem).

CHAPTER II

POGLAVJE II

ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS

AKTIVNE SNOVI, VAROVALA, SINERGISTI IN DODATKI

SECTION 1

ODDELEK 1

Active substances

Aktivne snovi

Subsection 1

Pododdelek 1

Requirements and conditions for approval

Zahteve in pogoji za odobritev

Article 4

Člen 4

Approval criteria for active substances

Merila za odobritev aktivnih snovi

1. 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 meet the requirements provided for in paragraphs 2 and 3.

1. Aktivna snov se odobri v skladu s Prilogo II, če se lahko glede na sedanja znanstvena in tehnična spoznanja predvideva, da bodo, ob upoštevanju meril za odobritev, določenih v točkah 2 in 3 navedene priloge, fitofarmacevtska sredstva, ki vsebujejo to aktivno snov, izpolnila pogoje iz odstavkov 2 in 3.

The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied.

V oceni aktivne snovi se najprej ugotovi, ali so izpolnjena merila za odobritev iz točk 3.6.2 do 3.6.4 in 3.7 Priloge II. Če so ta merila izpolnjena, se ocenjevanje nadaljuje in ugotavlja, ali so izpolnjena druga merila iz točk 2 in 3 Priloge II za odobritev.

2. The residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:

2. Ostanki fitofarmacevtskih sredstev kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe izpolnjujejo naslednje zahteve:

(a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available, or on groundwater;

(a) nimajo škodljivih vplivov na zdravje ljudi, vključno z ranljivimi skupinami, ali zdravje živali, ob upoštevanju znanih kumulativnih in sinergijskih učinkov, kadar so na voljo znanstvene metode za ocenjevanje takšnih učinkov, ki jih priznava Agencija, ali vplivov na podzemno vodo;

(b) they shall not have any unacceptable effect on the environment.

(b) nimajo nobenega nesprejemljivega vpliva na okolje.

For residues which are of toxicological, ecotoxicological, environmental or drinking water relevance, there shall be methods in general use for measuring them. Analytical standards shall be commonly available.

Za merjenje ostankov, ki so relevantni s toksikološkega, eko-toksikološkega, okoljskega vidika in vidika pitne vode, se uporabljajo splošno razširjene metode. Analitski standardi morajo biti splošno dostopni.

3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:

3. Fitofarmacevtsko sredstvo kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe izpolnjuje naslednje zahteve:

(a) it shall be sufficiently effective;

(a) je dovolj učinkovito;

(b) it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available; or on groundwater;

(b) nima takojšnjega ali zapoznelega škodljivega vpliva na zdravje ljudi, vključno z ranljivimi skupinami, ali zdravje živali neposredno ali prek pitne vode (ob upoštevanju snovi, nastalih pri obdelavi pitne vode), hrane, krme ali zraka ali posledic na delovnem mestu ali preko drugih neposrednih vplivov, ob upoštevanju ugotovljenih kumulativnih in sinergijskih vplivov, kadar so na voljo znanstvene metode za ocenjevanje takšnih vplivov, ki jih priznava Agencija, ali vpliva na podzemno vodo;

(d) it shall not cause unnecessary suffering and pain to vertebrates to be controlled;

(d) ne povzroča nepotrebnega trpljenja in bolečin vretenčarjem, zatiranju katerih je namenjena;

(e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by the Authority to assess such effects are available:

(e) nima nesprejemljivega vpliva na okolje, zlasti ob upoštevanju naslednjih dejavnikov, kadar so na voljo znanstvene metode za ocenjevanje takšnih vplivov, ki jih priznava Agencija:

(i) its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use following long-range environmental transportation;

(i) usode in obnašanja teh sredstev v okolju, zlasti onesnaženja površinskih voda, rečnih ustij in obalnih vod, podtalne vode, zraka in tal, ob upoštevanju lokacij, oddaljenih od kraja uporabe snovi, po prenosu v okolju na velike razdalje;

(ii) its impact on non-target species, including on the ongoing behaviour of those species;

(ii) njenega vpliva na neciljne vrste, zlasti na njihovo trenutno vedenje;

(iii) its impact on biodiversity and the ecosystem.

(iii) njenega vpliva na biotsko raznovrstnost in ekosistem.

4. The requirements of paragraphs 2 and 3 shall be evaluated in the light of uniform principles as referred to in Article 29(6).

4. Zahteve iz odstavkov 2 in 3 se ocenijo skladno z enotnimi načeli iz člena 29(6).

5. For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.

5. Aktivna snov se odobri, kadar so izpolnjene zahteve iz odstavkov 1, 2 in 3, in kadar je bilo to ugotovljeno v zvezi z eno ali več reprezentativnimi rabami vsaj enega fitofarmacevtskega sredstva, ki vsebuje to aktivno snov.

6. In relation to human health, no data collected on humans shall be used to lower the safety margins resulting from tests or studies on animals.

6. V zvezi z zdravjem ljudi se podatki, pridobljeni v okviru raziskav, opravljenih na ljudeh, ne smejo uporabiti za znižanje mej varnosti, ki so posledica preskusov ali študij na živalih.

7. By way of derogation from paragraph 1, where on the basis of documented evidence included in the application an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005.

7. Z odstopanjem od odstavka 1 ter če je na podlagi dokumentiranih dokazov, priloženih zahtevku, aktivna snov potrebna za nadzor resne nevarnosti za zdravje rastlin, ki je ni mogoče obvladati na drugačen način, niti z uporabo nekemičnih metod, se takšna aktivna snov lahko odobri za omejeno obdobje, ki je potrebno za obvladovanje te nevarnosti, vendar ni daljše od petih let, čeprav ne izpolnjuje meril iz točk 3.6.3, 3.6.4, 3.6.5 ali 3.8.2 Priloge II, če za uporabo aktivne snovi veljajo ukrepi za zmanjšanje tveganja, ki zagotovijo najmanjšo možno izpostavljenost človeka in okolja. Za te snovi se mejne vrednosti ostankov določijo v skladu z Uredbo (ES) št. 396/2005.

This derogation shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A.

Odstopanje se ne uporablja za aktivne snovi, ki so ali morajo biti razvrščene v skladu z Uredbo (ES) št. 1272/2008, kot rakotvorne iz skupine 1A, rakotvorne iz skupine 1B brez določene vrednosti praga delovanja ali strupene za razmnoževanje iz skupine 1A.

Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control that serious danger to plant health in their territory.

Države članice lahko odobrijo fitofarmacevtska sredstva, ki vsebujejo aktivne snovi, odobrene v skladu s tem odstavkom, samo kadar je to nujno za obvladovanje resne nevarnosti za zdravje rastlin na njihovem ozemlju.

At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission.

Države članice hkrati oblikujejo načrt postopnega opuščanja za obvladovanje resne nevarnosti na drugačen način, zlasti z nekemičnimi metodami, in ga nemudoma posredujejo Komisiji.

Article 5

Člen 5

First approval

Prva odobritev

First approval shall be for a period not exceeding 10 years.

Prva odobritev velja največ deset let.

Article 6

Člen 6

Conditions and restrictions

Pogoji in omejitve

Approval may be subject to conditions and restrictions including:

Za odobritev lahko veljajo pogoji in omejitve, vključno z:

(a) the minimum degree of purity of the active substance;

(a) najmanjšo stopnjo čistosti aktivne snovi;

(b) the nature and maximum content of certain impurities;

(b) vrsto in najvišjo dovoljeno vsebnost določenih nečistoč;

(c) restrictions arising from the evaluation of the information referred to in Article 8 taking account of the agricultural, plant health and environmental, including climatic, conditions in question;

(c) omejitvami na podlagi ocene podatkov iz člena 8, ob upoštevanju dejanskih kmetijskih razmer, razmer varstva rastlin in okoljskimi razmerami, vključno s podnebnimi razmerami;

(d) type of preparation;

(d) vrsto pripravka;

(e) manner and conditions of application;

(e) načinom in pogoji uporabe;

(f) submission of further confirmatory information to Member States, the Commission and the European Food Safety Authority, (the Authority), where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge;

(f) predložitvijo dodatnih podatkov potrditvene narave državam članicam, Evropski agenciji za varnost hrane (Agencija) in Komisiji, kadar se zaradi novih znanstvenih in tehničnih spoznanj ali med postopkom ocenjevanja določijo nove zahteve;

(g) designation of categories of users, such as professional and non-professional;

(g) določitvijo kategorij uporabnikov, kot so poklicni in nepoklicni uporabniki;

(h) designation of areas where the use of plant protection products, including soil treatment products, containing the active substance may not be authorised or where the use may be authorised under specific conditions;

(h) določitvijo območij, na katerih se uporaba fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, vključno s sredstvi za tretiranje tal, ne sme registrirati ali kjer se uporaba lahko registrira pod posebnimi pogoji;

(i) the need to impose risk mitigation measures and monitoring after use;

(i) potrebo po uveljavitvi ukrepov za zmanjšanje tveganja ter spremljanje in nadzorovanje po uporabi;

(j) any other particular conditions that result from the evaluation of information made available in the context of this Regulation.

(j) vsemi drugimi posebnimi pogoji, ki so posledica ocenjevanja podatkov, ki so na voljo v okviru te uredbe.

Subsection 2

Pododdelek 2

Approval procedure

Postopek odobritve

Article 7

Člen 7

Application

Zahtevek

1. An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.

1. Proizvajalec aktivne snovi predloži državi članici (država članica poročevalka) zahtevek za odobritev aktivne snovi ali za spremembo pogojev za odobritev skupaj s povzetkom in popolno dokumentacijo, kakor je določeno v členu 8(1) in (2), ali na podlagi znanstvene obrazložitve utemelji, zakaj nekaterih delov te dokumentacije ne more predložiti, ter dokaže, da aktivna snov izpolnjuje merila za odobritev iz člena 4.

A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.

Združenje proizvajalcev, ki ga imenujejo proizvajalci za zagotovitev skladnosti s to uredbo, lahko predloži skupni zahtevek.

The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it.

Zahtevek preuči država članica, ki jo je predlagal vlagatelj, razen če s preučitvijo soglaša druga država članica.

2. Assessment of an application may be performed by a number of Member States together under a co-rapporteur system.

2. Zahtevek lahko oceni več držav skupaj po sistemu so-poročanja.

3. When submitting the application, the applicant may pursuant to Article 63 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.

3. Ob predložitvi zahtevka lahko vlagatelj v skladu s členom 63 zaprosi, da nekatere informacije in nekateri deli dokumentacije ostanejo zaupni, in take podatke fizično loči.

Member States shall assess the confidentiality requests. Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.

Države članice ocenijo zahtevke po zaupnosti. Ob predložitvi zahteve za dostop do informacij se država članica poročevalka odloči, katere informacije bodo ostale zaupne.

4. When submitting the application the applicant shall at the same time join a complete list of tests and studies submitted pursuant to Article 8(2) and a list of any claims for data protection pursuant to Article 59.

4. Vlagatelj ob predložitvi zahtevka predloži tudi popoln seznam preskusov in študij, predloženih v skladu s členom 8(2), in seznam zahtevkov za varovanje podatkov v skladu s členom 59.

5. When assessing the application the rapporteur Member State may at any time consult the Authority.

5. Pri oceni zahtevka se lahko država članica poročevalka kadar koli posvetuje z Agencijo.

Article 8

Člen 8

Dossiers

Dokumentacija

1. The summary dossier shall include the following:

1. Povzetek dokumentacije vključuje:

(a) information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 are met; where the information submitted does not cover all zones or concern a crop which is not widely grown, justification for this approach;

(a) informacije v zvezi z eno ali več reprezentativnimi rabami vsaj enega fitofarmacevtskega sredstva, ki vsebuje aktivno snov, na splošno razširjenem posevku v vsaki coni, ki dokazujejo, da so izpolnjena merila za odobritev iz člena 4; kadar pa predložene informacije ne zajemajo vseh con ali zadevajo posevek, ki ni splošno razširjen, pa je treba takšen pristop utemeljiti;

(b) for each point of the data requirements for the active substance, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies;

(b) za vsako točko zahtev po podatkih o aktivni snovi povzetke in rezultate preskusov in študij, ime njihovega imetnika ter osebe ali ustanove, ki je izvajal preskuse in študije;

(c) for each point of the data requirements for the plant protection product, the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria provided for in Article 4(2) and (3) for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that data gaps in the dossier, as provided for in paragraph 2 of this Article, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the approval;

(c) za vsako točko zahtev po podatkih o fitofarmacevtskih sredstvih povzetke in rezultate preskusov in študij, ime njihovega lastnika ter osebe ali ustanove, ki je izvajala preskuse in študije, ki so povezani z ocenjevanjem meril iz člena 4(2) in (3) za eno ali več fitofarmacevtskih sredstev, reprezentativnih za rabo iz točke (a), ob upoštevanju dejstva, da lahko manjkajoči podatki v dokumentaciji, kakor je določeno v odstavku 2 tega člena, ki so rezultat predlaganega omejenega obsega reprezentativnih rab aktivne snovi, privedejo do omejitev odobritve;

(d) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals;

(d) za vsak preskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev preskusov na živalih in podvajanja preskusov in študij na vretenčarjih;

(e) a checklist demonstrating that the dossier provided for in paragraph 2 of this Article is complete in view of the uses applied for;

(e) kontrolni seznam, ki dokazuje, da je dokumentacija iz odstavka 2 tega člena popolna glede na uporabo, na katero se nanaša vloga;

(f) the reasons why the test and study reports submitted are necessary for first approval of the active substance or for amendments to the conditions of the approval;

(f) razloge, zakaj so predložena poročila o preskusih in študijah nujna za prvo odobritev ali za spremembo pogojev odobritve;

(g) where relevant, a copy of an application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information;

(g) kopijo zahtevka za mejno vrednost ostankov iz člena 7 Uredbe (ES) št. 396/2005, kjer je to ustrezno, oziroma utemeljitev, zakaj ti podatki niso priloženi;

(h) an assessment of all information submitted.

(h) oceno vseh predloženih informacij.

2. 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. It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product to humans.

2. Popolna dokumentacija vključuje celotno besedilo poročil o posameznih preskusih in študijah v zvezi z vsemi informacijami iz točk (b) in (c) odstavka 1. Ne vključuje poročil o preskusih ali študijah, ki vključujejo namerni vnos aktivne snovi ali fitofarmacevtskega sredstva v ljudi.

3. The format of the summary dossier and the complete dossier shall be established in accordance with the advisory procedure referred to in Article 79(2).

3. Oblika povzetka dokumentacije in popolne dokumentacije se določi v skladu s svetovalnim postopkom iz člena 79(2).

4. The data requirements referred to in paragraphs 1 and 2 shall contain the requirements for active substances and plant protection products as set out in Annexes II and III to Directive 91/414/EEC and laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 79(2) without any substantial modifications. Subsequent amendments to these Regulations shall be adopted in accordance with Article 78(1)(b).

4. Zahteve po podatkih iz odstavkov 1 in 2 vsebujejo zahteve za aktivne snovi in fitofarmacevtska sredstva, navedena v prilogah II in III k Direktivi 91/414/EGS in določena v uredbah, ki se brez vsebinskih sprememb sprejmejo v skladu s svetovalnim postopkom iz člena 79(2). Nadaljnje spremembe teh uredb se lahko sprejmejo v skladu s členom 78(1)(b).

5. Scientific peer-reviewed open literature, as determined by the Authority, on the active substance and its relevant metabolites dealing with side-effects on health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier.

5. Vlagatelj dokumentaciji priloži strokovno pregledano javno dostopno znanstveno literaturo, kakor jo določa Agencija, o aktivnih snoveh in njihovih relevantnih metabolitih v zvezi s stranskimi učinki na zdravje, okolje in neciljne vrste, ki je bila objavljena v zadnjih desetih letih pred datumom predložitve dokumentacije.

Article 9

Člen 9

Admissibility of the application

Dopustnost zahtevka

1. Within 45 days of receiving the application, the rapporteur Member State shall send the applicant a written acknowledgement, stating the date of receipt, and check whether the dossiers submitted with the application contain all the elements provided for in Article 8, using the checklist referred to in point (e) of Article 8(1). It shall also check the requests for confidentiality referred to in Article 7(3) and the complete lists of tests and studies submitted pursuant to Article 8(2).

1. V 45 dneh po prejemu zahtevka država članica poročevalka vlagatelju pošlje pisno potrdilo z navedbo datuma prejema ter z uporabo kontrolnega seznama iz člena 8(1)(e) preveri, ali dokumentacija, predložena z zahtevkom, vsebuje vse elemente iz člena 8. Preveri tudi zahtevke glede zaupnosti podatkov iz člena 7(3) in popoln seznam predloženih preskusov in študij v skladu s členom 8(2).

2. Where one or more of the elements provided for in Article 8 are missing, the rapporteur Member State shall inform the applicant, setting a period for their submission. Such period shall be a maximum of 3 months.

2. Kadar manjka eden ali več elementov iz člena 8, država članica poročevalka o tem obvesti vlagatelja in določi rok za njihovo predložitev, ki ni daljši od treh mesecev.

Where at the end of that period, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the other Member States and the Commission that the application is inadmissible.

Če ob koncu tega obdobja vlagatelj ne predloži manjkajočih podatkov, država članica poročevalka obvesti vlagatelja, Komisijo in druge države članice, da zahtevek ni dopusten.

A new application for the same substance may be submitted at any time.

Nov zahtevek za isto snov se lahko predloži kadar koli.

3. 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 other Member States, the Commission and the Authority of the admissibility of the application and start assessing the active substance.

3. Če dokumentacija, predložena skupaj z zahtevkom, vključuje vse elemente iz člena 8, država članica poročevalka vlagatelja, Komisijo, druge države članice in Agencijo obvesti o dopustnosti zahtevka in začne ocenjevanje aktivne snovi.

After receiving that notification, the applicant shall immediately forward the dossiers as provided for in Article 8 to the other Member States, the Commission and the Authority, including the information about those parts of the dossiers in respect of which confidentiality has been requested as referred to in Article 7(3).

Po prejemu tega obvestila vlagatelj nemudoma posreduje dokumentacijo, kakor je določena v členu 8, drugim državam članicam, Agenciji in Komisiji, vključno z informacijami glede delov dokumentacije, v zvezi s katerimi je bila zahtevana zaupnost, kakor to izhaja iz člena 7(3).

Article 10

Člen 10

Access to the summary dossier

Dostop do povzetka dokumentacije

The Authority shall without delay make the summary dossier referred to in Article 8(1) available to the public, excluding any information in respect of which confidential treatment has been requested and justified pursuant to Article 63, unless there is an overriding public interest in its disclosure.

Agencija povzetek dokumentacije iz člena 8(1) nemudoma da na voljo javnosti, in izključi vse informacije, v zvezi s katerimi se zahteva in je upravičeno zaupno obravnavanje v skladu s členom 63, razen če prevlada javni interes za razkritje.

Article 11

Člen 11

Draft assessment report

Osnutek poročila o oceni

1. Within 12 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 Commission, with a copy to the Authority, a report, referred to as the "draft assessment report", assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4.

1. V dvanajstih mesecih po datumu uradnega obvestila iz prvega pododstavka člena 9(3) država članica poročevalka pripravi in Komisiji – v vednost Agenciji – predloži poročilo, (v nadaljnjem besedilu: osnutek poročila o oceni), v katerem oceni, ali je verjetno, da bo aktivna snov izpolnila merila za odobritev iz člena 4.

2. The draft assessment report shall also include where relevant, a proposal to set maximum residue levels.

2. Osnutek poročila o oceni, kjer je to ustrezno, vključuje tudi predlog za določitev mejne vrednosti ostankov.

The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge.

Država članica poročevalka opravi neodvisno, objektivno in pregledno oceno glede na trenutna znanstvena in tehnična spoznanja.

Where, pursuant to Article 4(1), the assessment establishes that the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are not satisfied, the draft assessment report shall be limited to those parts of the assessment.

Če se v skladu s členom 4(1) v okviru ocene ugotovi, da merila za odobritev iz točk 3.6.2 do 3.6.4 in 3.7 Priloge II niso izpolnjena, je osnutek poročila o oceni omejen na te dele ocene.

3. Where the rapporteur Member State needs additional studies or information, it shall set a period in which the applicant must supply those studies or that information. In that case, the 12-month period shall be extended by the additional period granted by the rapporteur Member State. The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the rapporteur Member State. It shall inform the Commission and the Authority accordingly.

3. Če država članica poročevalka potrebuje dodatne študije, določi rok, v katerem mora vlagatelj predložiti navedene študije ali informacije. V tem primeru se obdobje dvanajstih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica poročevalka. Dodatno obdobje ni daljše od šestih mesecev in preneha, ko država članica poročevalka prejme dodatne informacije. O tem ustrezno obvesti Komisijo in Agencijo.

Where at the end of the additional period, the applicant has not submitted the additional studies or information, the rapporteur Member State shall inform the applicant, the Commission and the Authority and shall state the missing elements in the assessment included in the draft assessment report.

Če ob koncu dodatnega obdobja vlagatelj ne predloži dodatnih študij ali informacij, država članica poročevalka obvesti vlagatelja, Komisijo in Agencijo ter manjkajoče elemente navede v oceni, vključeni v osnutek poročila o oceni.

4. The format of the draft assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2).

4. Oblika osnutka poročila o oceni se določi v skladu s svetovalnim postopkom iz člena 79(2).

Article 12

Člen 12

Conclusion by the Authority

Sklep Agencije

1. The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant and the other Member States at the latest 30 days after its receipt. It shall ask the applicant to circulate an update of the dossier where applicable to the Member States, the Commission and the Authority.

1. Agencija razpošlje osnutek poročila o oceni, ki ga je prejela od države članice poročevalke, vlagateljem in ostalim državam članicam najpozneje 30 dni po prejemu. Od vlagatelja zahteva, da Agenciji, Komisiji in državam članicam, kjer je to primerno, razpošlje posodobljeno dokumentacijo.

The Authority shall make the draft assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63, that certain parts of the draft assessment report be kept confidential.

Agencija da osnutek poročila o oceni na voljo javnosti, vendar pa vlagatelju omogoči rok dveh tednov, v katerih lahko v skladu s členom 63 zahteva, da nekateri deli osnutka poročila o oceni ostanejo zaupni.

The Authority shall allow a period of 60 days for the submission of written comments.

Agencija dovoli obdobje 60 dni za predložitev pisnih pripomb.

2. The Authority, where appropriate shall organise a consultation of experts, including experts from the rapporteur Member State.

2. Agencija po potrebi organizira posvetovanje s strokovnjaki, vključno s strokovnjaki iz države članice poročevalke.

Within 120 days of the end of the period provided for the submission of written comments, the Authority shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public. In the event of a consultation as provided for in this paragraph, the 120-day period shall be extended by 30 days.

Agencija v 120 dneh od konca obdobja za predložitev pisnih pripomb, glede na trenutna znanstvena in tehnična spoznanja, ob uporabi smernic, ki so na voljo v času predložitve vloge, sprejme sklep o tem, ali se pričakuje, da bo aktivna snov izpolnila merila za odobritev iz člena 4, in o tem obvesti vlagatelja, države članice in Komisijo ter sklep da na voljo javnosti. Če se organizira posvetovanje iz prvega pododstavka, se 120-dnevno obdobje podaljša za 30 dni.

Where appropriate, the Authority shall address in its conclusion the risk mitigation options identified in the draft assessment report.

Agencija po potrebi v sklepih obravnava možnosti za zmanjševanje tveganja, določene v osnutku poročila o oceni.

3. Where the Authority needs additional information, it shall set a period of a maximum of 90 days for the applicant to supply it to the Member States, the Commission and the Authority.

3. Če Agencija potrebuje dodatne informacije, določi rok, ki ni daljši od 90 dni, v katerem mora vlagatelj te informacije predložiti državam članicam, Komisiji in Agenciji.

The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within 60 days after receipt of the additional information. In that case the 120-day period provided for in paragraph 2 shall be extended by a period which shall cease at the moment when the additional assessment is received by the Authority.

Država članica poročevalka oceni dodatne informacije ter jih takoj in najpozneje v 60 dneh po prejemu dodatnih informacij predloži Agenciji. V tem primeru se obdobje 120 dni iz odstavka 2 podaljša za obdobje, ki preneha, ko Agencija prejme dodatno oceno.

The Authority may ask the Commission to consult a Community reference laboratory, designated pursuant to Regulation (EC) No 882/2004 for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and meets the requirements in Article 29(1)(g) of this Regulation. The applicant shall, if requested by the Community reference laboratory, provide samples and analytical standards.

Agencija lahko Komisijo zaprosi, da se posvetuje z referenčnim laboratorijem Skupnosti, ustanovljenim v skladu z Uredbo (ES) št. 882/2004, zaradi preverjanja, ali je analitska metoda za določitev ostankov, ki jo predlaga vlagatelj, ustrezna in izpolnjuje zahteve iz člena 29(1)(g) te uredbe. Vlagatelj na zahtevo referenčnega laboratorija Skupnosti predloži vzorce in analitske standarde.

4. The conclusion of the Authority shall include details concerning the evaluation procedure and the properties of the active substance concerned.

4. Sklep Agencije vključuje podatke o postopku ocenjevanja in lastnostih zadevne aktivne snovi.

5. The Authority shall establish the format for its conclusion which shall include details concerning the evaluation procedure and the properties of the active substance concerned.

5. Agencija določi obliko svojega sklepa, ki bo vključeval podatke o postopku ocenjevanja in lastnostih zadevne aktivne snovi.

6. The time limits for the Authority’s opinion on applications concerning maximum residue levels set out in Article 11 and for decisions on applications concerning maximum residue levels set out in Article 14 of Regulation (EC) No 396/2005 shall be without prejudice to the time limits laid down in this Regulation.

6. Roki za mnenje Agencije o vlogah glede mejnih vrednosti ostankov iz člena 11 in odločitve o vlogah glede mejnih vrednosti ostankov iz člena 14 Uredbe (ES) št. 396/2005 ne posegajo v roke, določene v tej uredbi.

7. Where the conclusion of the Authority is adopted within the time limit set out in paragraph 2 of this Article, extended by any additional period set in accordance with paragraph 3, the provisions of Article 11 of Regulation (EC) No 396/2005 shall not apply and the provisions of Article 14 of that Regulation shall apply without delay.

7. Če Agencija sprejme sklep v roku, določenem v odstavku 2 tega člena in podaljšanem za dodatno obdobje, določeno v odstavku 3, se določbe člena 11 Uredbe (ES) št. 396/2005 ne uporabljajo in se nemudoma začnejo uporabljati določbe člena 14 navedene uredbe.

8. Where the conclusion of the Authority is not adopted within the time limit set out in paragraph 2 of this Article, extended by any additional period set in accordance with paragraph 3, the provisions of Articles 11 and 14 of Regulation (EC) No 396/2005 shall apply without delay.

8. Če Agencija sklepov ne sprejme v roku, določenem v odstavku 2 tega člena in podaljšanem za dodatno obdobje, določeno v odstavku 3, se nemudoma začnejo uporabljati določbe členov 11 in 14 Uredbe (ES) št. 396/2005.

Article 13

Člen 13

Approval Regulation

Uredba o odobritvi

1. Within six months of receiving the conclusion from the Authority, the Commission shall present a report, referred to as "the review report", and a draft Regulation to the Committee referred to in Article 79(1), taking into account the draft assessment report by the rapporteur Member State and the conclusion of the Authority.

1. V šestih mesecih po prejemu sklepa Agencije Komisija Odboru iz člena 79(1) predloži poročilo, (v nadaljnjem besedilu: poročilo o pregledu), in osnutek uredbe, ob upoštevanju osnutka poročila o oceni, ki ga oblikuje država članica poročevalka, in sklepa Agencije.

The applicant shall be given the possibility to submit comments on the review report.

Vlagatelj ima možnost, da predloži pripombe na poročilo o pregledu.

2. On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:

2. Na podlagi poročila o pregledu, drugih dejavnikov, povezanih z obravnavano zadevo, in previdnostnega načela, kadar so pogoji iz člena 7(1) Uredbe (ES) št. 178/2002 relevantni, se uredba sprejme v skladu z regulativnim postopkom iz člena 79(3), če:

(a) an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate;

(a) je aktivna snov odobrena pod pogoji in omejitvami iz člena 6, kjer je to primerno;

(b) an active substance is not approved; or

(b) aktivna snov ni odobrena; ali

3. Where the approval provides for the submission of further confirmatory information as referred to in Article 6(f), the Regulation shall provide the time limit to submit the information to the Member States, the Commission and the Authority.

3. Če odobritev zajema predložitev dodatnih podatkov potrditvene narave iz člena 6(f), se v uredbi določi rok za predložitev podatkov državam članicam, Agenciji in Komisiji.

The rapporteur Member State shall assess the additional information and submit its assessment to the other Member States, the Commission and the Authority without delay and at the latest six months after the receipt of the additional information.

Država članica poročevalka oceni dodatne informacije ter oceno takoj in najpozneje šest mesecev po prejemu dodatnih informacij predloži drugim državam članicam, Komisiji in Agenciji.

4. Approved active substances shall be included in the Regulation referred to in Article 78(3) containing the list of active substances already approved. The Commission shall maintain a list of approved active substances electronically available to the public.

4. Odobrene aktivne snovi se vključijo v uredbo iz člena 78(3), ki vsebuje seznam že odobrenih aktivnih snovi. Komisija vodi seznam odobrenih aktivnih snovi, ki je javnosti na voljo v elektronski obliki.

Subsection 3

Pododdelek 3

Renewal and review

Obnovitev in pregled

Article 14

Člen 14

Renewal of approval

Obnovitev odobritve

1. On application the approval of an active substance shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied.

1. Na podlagi zahtevka se odobritev aktivne snovi obnovi, kadar se ugotovi, da so izpolnjena merila za odobritev iz člena 4.

Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.

Merila iz člena 4 se štejejo za izpolnjena, kadar je bilo to ugotovljeno v zvezi z eno ali več reprezentativnimi rabami vsaj enega fitofarmacevtskega sredstva, ki vsebuje to aktivno snov.

Such renewal of the approval may include conditions and restrictions, as referred to in Article 6.

Takšna obnovitev odobritve lahko vključuje pogoje in omejitve iz člena 6.

2. The renewal of the approval shall be for a period not exceeding 15 years. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years.

2. Obnovitev odobritve velja največ petnajst let. Odobritev aktivne snovi iz člena 4(7) se lahko obnovi za obdobje največ petih let.

Article 15

Člen 15

Application for renewal

Zahtevek za obnovitev

1. The application provided for in Article 14 shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the approval.

1. Zahtevek iz člena 14 proizvajalec aktivne snovi predloži državi članici, pri čemer pošlje po en izvod drugim državam članicam, Komisiji in Agenciji, in sicer najpozneje tri leta pred iztekom odobritve.

2. When applying for renewal, the applicant shall identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable at the time of the last approval of the active substance or because his request is for an amended approval. The applicant shall at the same time submit a timetable of any new and ongoing studies.

2. V zahtevku za obnovitev vlagatelj navede nove podatke, ki jih namerava predložiti, in dokaže, da so nujni zaradi zahtev po podatkih ali merilih, ki se pri zadnji odobritvi aktivne snovi niso uporabljala, ali ker njegov zahtevek zadeva spremembo odobritve. Vlagatelj hkrati predloži časovni razpored novih in še trajajočih študij.

The applicant shall identify, giving reasons, the parts of the information submitted that he requests to be kept confidential in accordance with Article 63 and at the same time any data protection claims pursuant to Article 59.

Vlagatelj opredeli za katere dele predloženih informacij zahteva, da v skladu s členom 63 ostanejo zaupni in to utemelji, ter hkrati vse zahteve v zvezi z varstvom podatkov v skladu s členom 59.

Article 16

Člen 16

Access to the information for renewal

Dostop do informacij za obnovitev

The Authority shall, without delay, make available to the public the information provided by the applicant under Article 15, excluding any information in respect of which confidential treatment has been requested and justified pursuant to Article 63, unless there is an overriding public interest in its disclosure.

Agencija da informacije, ki jih predloži vlagatelj v skladu s členom 15, nemudoma na voljo javnosti, in izključi vse informacije, v zvezi s katerimi se zahteva in je upravičeno zaupno obravnavanje v skladu s členom 63, razen če prevlada javni interes za razkritje.

Article 17

Člen 17

Extension of approval period for the duration of the procedure

Podaljšanje obdobja odobritve za čas trajanja postopka

Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application.

Kadar zaradi razlogov, na katere vlagatelj ne more vplivati, obstaja možnost, da bo odobritev potekla pred sprejetjem sklepa o obnovitvi, se sklep sprejme v skladu z regulativnim postopkom iz člena 79(3) in prenehanje odobritve za tega vlagatelja se odloži za obdobje, ki zadošča za preučitev vloge.

A Regulation postponing the expiry for a period sufficient to examine the application shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(5) where an applicant could not give the three years’ notice required under Article 15(1) because the active substance was included in Annex I to Directive 91/414/EEC for a duration which expired before 14 June 2014.

Uredba o odložitvi prenehanja obdobja, ki zadošča za preučitev vloge, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 79(5), kadar vlagatelji niso mogli upoštevati triletnega obdobja iz člena 15(1), ker je bila aktivna snov vključena v Prilogo I k Direktivi 91/414/EGS za obdobje, ki se je izteklo pred 14. junijem 2014.

The length of that period shall be established on the basis of the following:

Dolžina teh obdobij se določi na podlagi:

(a) the time needed to provide the information requested;

(a) časa, potrebnega za predložitev zahtevanih informacij;

(b) the time needed to complete the procedure;

(b) časa, potrebnega za zaključitev postopka;

Article 18

Člen 18

Work programme

Delovni program

The Commission may establish a work programme grouping together similar active substances setting priorities on the basis of safety concerns for human and animal health or the environment and taking into account, as far as possible, the need for an effective control and resistance management of target pest. The programme may require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a period provided for in the programme.

Komisija lahko oblikuje delovni program, ki združuje podobne aktivne snovi ter določi prednostne naloge na podlagi skrbi za varovanje zdravja ljudi in živali ali okolja ter pri tem kolikor je mogoče upošteva potrebo po učinkovitem varstvu rastlin in obvladovanju odpornosti ciljnih škodljivih organizmov. Ta program lahko od zainteresiranih strani zahteva, da državam članicam, Komisiji in Agenciji v roku, ki ga določa program, predložijo vse potrebne podatke.

The programme shall include the following:

Program vsebuje:

(a) the procedures concerning the submission and assessment of applications for renewal of approvals;

(a) postopke v zvezi s predložitvijo in ocenjevanjem vlog za obnovitev odobritev;

(b) the necessary data to be submitted, including measures to minimise animal testing, in particular the use of non-animal test methods and intelligent testing strategies;

(b) potrebne podatke, ki jih je treba predložiti, vključno z ukrepi za omejitev poskusov na živalih, zlasti z uporabo metod, pri katerih se ne uporabljajo živali, in inteligentnih strategij preskušanja;

(d) rules on the submission of new information;

(d) pravila o predložitvi novih informacij;

(e) period for assessment and decision making;

(e) obdobje za izvedbo ocene in odločanje;

(f) the allocation of evaluation of active substances to Member States, taking into account a balance in the responsibilities and work to be done among Member States acting as rapporteurs.

(f) razporeditev ocene aktivnih snovi državam članicam, ob upoštevanju ravnovesja med odgovornostjo in zahtevanim obsegom dela med državami članicami poročevalkami.

Article 19

Člen 19

Implementing measures

Izvedbeni ukrepi

A Regulation, adopted in accordance with the regulatory procedure referred to in Article 79(3), shall set out the provisions necessary for the implementation of the renewal procedure, including, where relevant, the implementation of a work programme, as provided for in Article 18.

Uredba, sprejeta v skladu z regulativnim postopkom iz člena 79(3), opredeljuje določbe, potrebne za izvedbo postopka podaljšanja, vključno z izvedbo delovnega programa iz člena 18, kadar je to primerno.

Article 20

Člen 20

Renewal Regulation

Uredba o obnovitvi

1. A Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:

1. Uredba se sprejme v skladu z regulativnim postopkom iz člena 79(3), če:

(a) the approval of an active substance is renewed, subject to conditions and restrictions where appropriate; or

(a) se odobritev aktivne snovi obnovi, kadar je to primerno, pod pogoji in omejitvami; ali

(b) the approval of an active substance is not renewed.

(b) se odobritev aktivne snovi ne obnovi.

2. Where the reasons for not renewing the approval do not concern the protection of health or the environment, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding six months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. The grace period for the sale and distribution shall take into account the normal period of use of the plant protection product but the total grace period shall not exceed 18 months.

2. Kadar razlogi za zavrnitev obnovitve odobritve ne zadevajo varovanja zdravja ali okolja, se z uredbo iz odstavka 1 zagotovi prehodno obdobje, ki ni daljše od šestih mesecev, za prodajo in distribucijo, ter dodatno prehodno obdobje, ki ni daljše od enega leta, za odstranjevanje, shranjevanje in uporabo obstoječih zalog zadevnih fitofarmacevtskih sredstev. Pri prvem obdobju se upošteva običajno obdobje uporabe fitofarmacevtskega sredstva, vendar celotno prehodno obdobje ne sme biti daljše od 18 mesecev.

In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.

V primeru preklica odobritve ali če odobritev ni obnovljena zaradi neposredne zaskrbljenosti glede zdravja ljudi ali živali ali okolja, se zadevno fitofarmacevtsko sredstvo nemudoma umakne s trga.

3. Article 13(4) shall apply.

3. Uporablja se člen 13(4).

Article 21

Člen 21

Review of approval

Pregled odobritve

1. The Commission may review the approval of an active substance at any time. It shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised.

1. Komisija lahko kadar koli pregleda odobritev aktivne snovi. Komisija upošteva prošnjo države članice za pregled odobritve aktivne snovi v skladu z novimi znanstvenimi in tehničnimi spoznanji in podatki o spremljanju, zlasti kadar je po pregledu odobritev v skladu s členom 44(1) mogoče sklepati, da je ogroženo doseganje ciljev, določenih v skladu s členom 4(1)(a)(iv) in (b)(i) ter členom 7(2) in (3) Direktive 2000/60/ES.

Where, in the light of new scientific and technical knowledge it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4, or further information required in accordance with Article 6(f) has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a period for the producer to submit its comments.

Če glede na nova znanstvena in tehnična spoznanja meni, da obstajajo znaki, da snov ne izpolnjuje več meril za odobritev iz člena 4, ali niso bile predložene zahtevane dodatne informacije v skladu s členom 6(f), o tem obvesti države članice, Agencijo in proizvajalca aktivne snovi ter določi rok, v katerem proizvajalec predloži svoje pripombe.

2. The Commission may ask the Member States and the Authority for an opinion, or for scientific or technical assistance. The Member States may provide their comments to the Commission within three months from the date of the request. The Authority shall provide its opinion or the results of its work to the Commission within three months of the date of the request.

2. Komisija lahko Agencijo in države članice prosi za mnenje ali znanstveno ali tehnično pomoč. Države članice lahko v treh mesecih od datuma predložitve prošnje Komisije pošljejo svoje pripombe. Agencija svoje mnenje ali rezultate svojega dela Komisiji zagotovi v treh mesecih po datumu predložitve prošnje.

3. Where the Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with Article 6(f) has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3).

3. Če Komisija ugotovi, da snov ne izpolnjuje več meril za odobritev iz člena 4 ali da niso bile predložene zahtevane dodatne informacije v skladu s členom 6(f), se v skladu z regulativnim postopkom iz člena 79(3) sprejme uredba o prenehanju ali spremembi odobritve.

Article 13(4) and Article 20(2) shall apply.

Uporabljata se člen 13(4) in člen 20(2).

Subsection 4

Pododdelek 4

Derogations

Odstopanja

Article 22

Člen 22

Low-risk active substances

Aktivne snovi z majhnim tveganjem

1. An active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years by way of derogation from Article 5, where it is considered a low-risk active substance and 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 47(1).

1. Z odstopanjem od člena 5 se aktivna snov, ki izpolnjuje merila za odobritev iz člena 4, odobri za največ 15 let, kadar šteje za aktivno snov z majhnim tveganjem in kadar se lahko pričakuje, da bo fitofarmacevtsko sredstvo, ki to snov vsebuje, povzročilo le majhno tveganje za zdravje ljudi in živali ter za okolje, kakor je določeno v členu 47(1).

2. Articles 4 and 6 to 21 and point 5 of Annex II shall apply. Low-risk active substances shall be listed separately in the Regulation referred to in Article 13(4).

2. Uporabljajo se členi 4 in 6 do 21 ter točka 5 Priloge II. Snovi z majhnim tveganjem se navedejo ločeno v uredbi iz člena 13(4).

3. The Commission may review and if necessary specify new criteria for approving an active substance as low-risk active substance in accordance with Article 78(1)(a).

3. Komisija lahko pregleda in po potrebi navede nova merila za odobritev aktivne snovi kot snovi z majhnim tveganjem v skladu s členom 78(1)(a).

Article 23

Člen 23

Approval criteria for basic substances

Merila za odobritev osnovnih snovi

1. Basic substances shall be approved in accordance with paragraphs 2 to 6. By way of derogation from Article 5, the approval shall be for an unlimited period.

1. Osnovne snovi se odobrijo v skladu z odstavki od 2 do 6. Z odstopanjem od člena 5 se odobritev izda za nedoločen čas.

For the purpose of paragraphs 2 to 6, a basic substance is an active substance which:

Za namene odstavkov 2 do 6 je osnovna snov aktivna snov, ki:

(a) is not a substance of concern; and

(a) ni problematična snov, in

(b) does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; and

(b) sama po sebi ne povzroča motenj hormonskega ravnovesja ter nima nevrotoksičnih ali imunotoksičnih učinkov, in

(c) is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent; and

(c) se običajno ne uporablja za namene varstva rastlin, vendar je vseeno koristna za varstvo rastlin, bodisi neposredno ali v proizvodu, ki je sestavljen iz snovi in enostavnega razredčila, in

(d) is not placed on the market as a plant protection product.

(d) se ne daje v promet kot fitofarmacevtsko sredstvo.

For the purpose of this Regulation, an active substance which fulfils the criteria of a "foodstuff" as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance.

Za namen te uredbe se aktivna snov, ki izpolnjuje merila za "živila", kot so opredeljena v členu 2 Uredbe (ES) št. 178/2002, šteje za osnovno snov.

2. By way of derogation from Article 4, a basic substance shall be approved where any relevant evaluations, carried out in accordance with other Community legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment.

2. Z odstopanjem od člena 4 se osnovna snov odobri, če ustrezna ocenjevanja, izvedena v skladu z ostalo zakonodajo Skupnosti, ki ureja uporabo te snovi za druge namene kot za fitofarmacevtska sredstva, dokažejo, da snov nima takojšnjega škodljivega vpliva ali zapoznelega škodljivega vpliva na zdravje ljudi ali živali in nobenega nesprejemljivega vpliva na okolje.

3. By way of derogation from Article 7 an application for the approval of a basic substance shall be submitted by a Member State or by any interested party to the Commission.

3. Z odstopanjem od člena 7 zahtevek za odobritev osnovne snovi zainteresirana stran ali država članica predloži Komisiji.

The application shall be accompanied by the following information:

Skupaj z zahtevkom se predložijo naslednji podatki:

(a) any evaluations of its possible effects on human or animal health or the environment carried out in accordance with other Community legislation regulating the use of the substance; and

(a) kakršne koli ocene možnih učinkov snovi na zdravje ljudi ali živali ali okolje, izvedene v skladu z določbami drugih zakonodajnih aktov Skupnosti, ki urejajo uporabo snovi; ter

(b) other relevant information on its possible effects on human or animal health or the environment.

(b) drugi ustrezni podatki o možnih učinkih snovi na zdravje ljudi ali živali ali okolje.

4. The Commission shall ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the date of the request.

4. Komisija Agencijo zaprosi za mnenje ali znanstveno ali tehnično pomoč. Agencija svoje mnenje ali rezultate svojega dela Komisiji zagotovi v treh mesecih po datumu predložitve prošnje.

5. Articles 6 and 13 shall apply. Basic substances shall be listed separately in the Regulation referred to in Article 13(4).

5. Uporabljata se člena 6 in 13. Snovi z majhnim tveganjem se navedejo ločeno v uredbi iz člena 13(4).

6. The Commission may review the approval of a basic substance at any time. It may take into account the request of a Member State to review the approval.

6. Komisija lahko kadar koli pregleda odobritev osnovne snovi. Upošteva lahko zahtevo države članice za pregled odobritve.

Where the Commission considers that there are indications that the substance no longer satisfies the criteria provided for in paragraphs 1 to 3 it shall inform the Member States, the Authority and the interested party, setting a period for their comments to be submitted.

Če Komisija meni, da obstajajo znaki, da snov ne izpolnjuje več meril iz odstavkov 1 do 3, o tem obvesti države članice, Agencijo in zainteresirano stran ter določi rok za predložitev pripomb.

The Commission shall ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within three months of the date of the request.

Komisija Agencijo zaprosi za mnenje ali znanstveno ali tehnično pomoč. Agencija svoje mnenje ali rezultate svojega dela Komisiji zagotovi v treh mesecih po datumu predložitve prošnje.

Where the Commission concludes that the criteria referred to in paragraph 1 are no longer satisfied, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3).

Če Komisija ugotovi, da snov ne izpolnjuje več meril iz odstavka 1, se v skladu z regulativnim postopkom iz člena 79(3) sprejme uredba o prenehanju ali spremembi odobritve.

Article 24

Člen 24

Candidates for substitution

Kandidatke za zamenjavo

1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years.

1. Aktivna snov, ki izpolnjuje merila iz člena 4, se odobri kot kandidatka za zamenjavo za obdobje, ki ni daljše od sedmih let, če izpolnjuje eno ali več dodatnih meril, določenih v točki 4 Priloge II. Z odstopanjem od člena 14(2) se odobritev lahko obnovi enkrat ali večkrat za obdobja, ki ne presegajo sedem let.

2. Without prejudice to paragraph 1, Articles 4 to 21 shall apply. Candidates for substitution shall be listed separately in the Regulation referred to in Article 13(4).

2. Brez poseganja v odstavek 1 se uporabljajo členi 4 do 21. Kandidatke za zamenjavo se navedejo ločeno v uredbi iz člena 13(4).

SECTION 2

ODDELEK 2

Safeners and synergists

Varovala in sinergisti

Article 25

Člen 25

Approval of safeners and synergists

Odobritev varoval in sinergistov

1. A safener or synergist shall be approved, where it complies with Article 4.

1. Varovalo ali sinergist se odobri, če je izpolnjuje pogoje iz člena 4.

2. Articles 5 to 21 shall apply.

2. Uporabljajo se členi 5 do 21.

3. Similar data requirements to those referred to in Article 8(4) shall be defined for safeners and synergists in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

3. V skladu z regulativnim postopkom s pregledom iz člena 79(4) se za varovala in sinergiste opredelijo zahteve po podatkih, podobne zahtevam iz člena 8(4).

Article 26

Člen 26

Safeners and synergists already on the market

Varovala in sinergisti na trgu

By 14 December 2014, a Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4) establishing a work programme for the gradual review of synergists and safeners on the market when that Regulation enters into force. The Regulation shall include the establishment of data requirements, including measures to minimise animal testing, notification, evaluation, assessment and decision-making procedures. It shall require interested parties to submit all the necessary data to the Member States, the Commission and the Authority within a specified period.

Do 14. decembra 2014 se v skladu z regulativnim postopkom s pregledom iz člena 79(4) sprejme uredba o vzpostavitvi delovnega programa za postopen pregled sinergistov in varoval, ki so na trgu ob začetku veljavnosti te uredbe. Uredba vključuje določitev zahtev po podatkih, vključno z ukrepi za omejitev poskusov na živalih, ter za postopke obveščanja, vrednotenja, ocenjevanja in odločanja. Od zainteresiranih strani zahteva, da Komisiji, Agenciji in državam članicam v določenem roku predložijo vse potrebne podatke.

SECTION 3

ODDELEK 3

Unacceptable co-formulants

Nesprejemljivi dodatki

Article 27

Člen 27

Co-formulants

Dodatki

1. A co-formulant shall not be accepted for inclusion in a plant protection product where it has been established that:

1. Dodatek se ne odobri za vključitev v fitofarmacevtsko sredstvo, kadar se ugotovi, da:

(a) its residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; or

(a) njegovi ostanki, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe, škodljivo vplivajo na zdravje ljudi ali živali, podzemno vodo ali okolje; ali

(b) its use, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment.

(b) njegova uporaba, kot posledica uporabe v skladu z dobro prakso varstva rastlin in ob upoštevanju realnih pogojev uporabe, škodljivo vpliva na zdravje ljudi ali živali ali nesprejemljivo vpliva na rastline, rastlinske proizvode ali okolje.

2. Co-formulants which are not accepted for inclusion in a plant protection product pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

2. Dodatki, ki niso odobreni za vključitev v fitofarmacevtska sredstva, v skladu z odstavkom 1, se v skladu z regulativnim postopkom s pregledom iz člena 79(4) vključijo v Prilogo III.

3. The Commission may review co-formulants at any time. It may take into account relevant information provided by Member States.

3. Komisija lahko kadar koli pregleda dodatke. Lahko upošteva ustrezne informacije, ki jih predložijo države članice.

4. Article 81(2) shall apply.

4. Uporablja se člen 81(2).

5. Detailed rules for the implementation of this Article may be established in accordance with the regulatory procedure referred to in Article 79(3).

5. Podrobna pravila za izvajanje tega člena se lahko sprejmejo v skladu z regulativnim postopkom iz člena 79(3).

CHAPTER III

POGLAVJE III

PLANT PROTECTION PRODUCTS

FITOFARMACEVTSKA SREDSTVA

SECTION 1

ODDELEK 1

Authorisation

Registracija

Subsection 1

Pododdelek 1

Requirements and contents

Zahteve in vsebina

Article 28

Člen 28

Authorisation for placing on the market and use

Registracija dajanja v promet in uporabe

1. A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation.

1. Fitofarmacevtsko sredstvo se ne da v promet in se ne uporabi, če ga zadevna država članica ni registrirala v skladu s to uredbo.

2. By way of derogation from paragraph 1, no authorisation shall be required in the following cases:

2. Z odstopanjem od odstavka 1 se registracija ne zahteva v naslednjih primerih:

(a) use of products containing exclusively one or more basic substances;

(a) uporaba sredstev, ki vsebujejo izključno eno ali več osnovnih snovi;

(b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 54;

(b) dajanje v promet in uporaba fitofarmacevtskih sredstev za raziskovalne ali razvojne namene v skladu s členom 54;

(c) production, storage or movement of a plant protection product intended for use in another Member State, provided that the product is authorised in that Member State and that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is not used in its territory;

(c) proizvodnja, shranjevanje ali prevoz fitofarmacevtskega sredstva, namenjenega za uporabo v drugi državi članici, če je sredstvo v tej državi članici registrirano in je država članica proizvodnje, skladiščenja ali prevoza določila inšpekcijske zahteve za zagotovitev, da se fitofarmacevtsko sredstvo ne uporablja na njenem ozemlju;

(d) production, storage or movement of a plant protection product intended for use in a third country provided that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is exported from its territory;

(d) proizvodnja, shranjevanje ali prevoz fitofarmacevtskega sredstva, namenjenega za uporabo v tretji državi, če je država članica proizvodnje, skladiščenja ali prevoza določila inšpekcijske zahteve za zagotovitev, da se fitofarmacevtsko sredstvo izvozi iz njenega ozemlja;

(e) placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52.

(e) dajanje v promet in uporaba fitofarmacevtskih sredstev, za katera je bilo izdano dovoljenje za vzporedno trgovanje v skladu s členom 52.

Article 29

Člen 29

Requirements for the authorisation for placing on the market

Zahteve za registracijo dajanja v promet

1. Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 it complies with the following requirements:

1. Brez poseganja v člen 50 se fitofarmacevtsko sredstvo registrira le, če na podlagi enotnih načel iz odstavka 6 izpolnjuje naslednje zahteve:

(a) its active substances, safeners and synergists have been approved;

(a) njegove aktivne snovi, varovala in sinergisti so bili odobreni;

(b) where its active substance, safener or synergist is produced by a different source, or by the same source with a change in the manufacturing process and/or manufacturing location:

(b) če se aktivna snov, varovalo ali sinergist proizvede v drugem viru ali v istem viru s spremenjenim postopkom izdelave in/ali mestom izdelave:

(i) the specification, pursuant to Article 38, does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist; and

(i) specifikacija v skladu s členom 38 bistveno ne odstopa od specifikacij iz uredbe o odobritvi te snovi, varovala ali sinergista; ter

(ii) the active substance, safener or synergist has no more harmful effects within the meaning of Article 4(2) and (3) due to its impurities than if it had been produced in accordance with the manufacturing process specified in the dossier that supported the approval;

(ii) aktivna snov, varovalo ali sinergist nima več škodljivih vplivov v smislu člena 4(2) in(3) zaradi nečistoč, kot če bi bil proizveden v skladu s proizvodnim postopkom, navedenim v dokumentaciji, ki je bila podlaga za registracijo;

(d) its technical formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product;

(d) njegova tehnična formulacija je takšna, da so izpostavljenost uporabnika ali druga tveganja čim bolj omejeni, ne da bi to ogrozilo delovanje sredstva;

(e) in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3);

(e) glede na sedanje znanstvena in tehnična spoznanja je v skladu z zahtevami iz člena 4(3);

(f) the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally relevant impurities and co-formulants can be determined by appropriate methods;

(f) vrsta in količina aktivnih snovi, varoval in sinergistov ter, po potrebi, katere koli toksikološko, ekotoksikološko ali okoljsko relevantne nečistoče in dodatki se lahko določijo z ustreznimi metodami;

(g) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use in all Member States, with appropriate limits of determination on relevant samples;

(g) ostanki, ki nastanejo pri registriranih uporabah in so toksikološko, ekotoksikološko ali okoljsko relevantni, se lahko določijo z ustreznimi splošno razširjenimi metodami v vseh državah članicah, s primernimi mejami določitve za ustrezne vzorce;

(h) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;

(h) določene so bile njegove fizikalne in kemijske lastnosti ter se štejejo za sprejemljive za namene primerne uporabe in shranjevanja sredstva;

(i) for plants or plant products to be used as feed or food, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005.

(i) za rastline ali rastlinske proizvode, namenjene za prehrano in krmo, so bile mejne vrednosti ostankov za kmetijske proizvode, na katere vpliva uporaba iz registracije, po potrebi določene ali spremenjene v skladu z Uredbo (ES) št. 396/2005.

2. The applicant shall demonstrate that the requirements provided for in points (a) to (h) of paragraph 1 are met.

2. Vlagatelj dokaže, da so zahteve iz odstavka 1(a) do (h) izpolnjene.

3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used.

3. Skladnost z zahtevami iz odstavka 1(b) in (e) do (h) se določi z uradnimi ali uradno priznanimi preskusi in analizami, izvedenimi v skladu s kmetijskimi in okoljskimi razmerami ter razmerami za zdravje rastlin, ki so pomembne za uporabo zadevnega fitofarmacevtskega sredstva in predstavljajo razmere, ki prevladujejo v coni, kjer se bo sredstvo uporabljalo.

4. With respect to point (f) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

4. Glede na odstavek 1(f) se lahko sprejmejo usklajene metode v skladu z regulativnim postopkom s pregledom iz člena 79(4).

5. Article 81 shall apply.

5. Uporablja se člen 81.

6. Uniform principles for evaluation and authorisation of plant protection products shall contain the requirements set out in Annex VI to Directive 91/414/EEC and shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 79(2) without any substantial modifications. Subsequent amendments to these Regulations shall be adopted in accordance with Article 78(1)(c).

6. Enotna načela za oceno in registracijo fitofarmacevtskih sredstev vključujejo zahteve iz Priloge VI k Direktivi 91/414/EGS in se določijo v uredbah, ki se sprejmejo v skladu s svetovalnim postopkom iz člena 79(2) brez bistvenih sprememb. Nadaljnje spremembe teh uredb se sprejmejo v skladu s členom 78(1)(c).

Following these principles, interaction between the active substance, safeners, synergists and co-formulants shall be taken into account in the evaluation of plant protection products.

Pri ocenjevanju fitofarmacevtskih sredstev se v skladu s temi načeli dosledno upošteva interakcija med aktivno snovjo, varovali, sinergisti in dodatki.

Article 30

Člen 30

Provisional authorisations

Začasne registracije

1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding 3 years, the placing on the market of plant protection products containing an active substance not yet approved, provided that:

1. Z odstopanjem od člena 29(1)(a) države članice v začasnem obdobju, ki ni daljše od treh let, lahko registrirajo dajanje v promet fitofarmacevtskih sredstev, ki vsebujejo še neodobreno aktivno snov, pod pogojem, da:

(a) the decision on approval could not be finalised within a period of 30 months from the date of admissibility of the application, extended by any additional period set in accordance with Article 9(2), Article 11(3) or Article 12(2) or (3); and

(a) ni mogoče končati postopkov za sprejem sklepa o odobritvi v roku 30 mesecev od datuma sprejemljivosti vloge, podaljšanega za vsako nadaljnje obdobje, določeno v skladu s členom 9(2), členom 11(3) ali členom 12(2) ali (3); ter

(b) pursuant to Article 9 the dossier on the active substance is admissible in relation to the proposed uses; and

(b) je v skladu s členom 9 dokumentacija o aktivni snovi sprejemljiva glede na predlagano uporabo; ter

(c) the Member State concludes that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product may be expected to satisfy the requirements of Article 29(1)(b) to (h); and

(c) država članica sklene, da aktivna snov izpolnjuje zahteve iz člena 4(2) in (3) ter da se lahko pričakuje, da fitofarmacevtsko sredstvo izpolnjuje zahteve iz člena 29(1)(b) do (h); ter

(d) maximum residue levels have been established in accordance with Regulation (EC) No 396/2005.

(d) so mejne vrednosti ostankov določene v skladu z Uredbo (ES) št. 396/2005.

2. In such cases 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 authorisation, giving at least the information provided for in Article 57(1).

2. V takih primerih država članica drugim državam članicam in Komisiji takoj sporoči svojo oceno dokumentacije in pogojev registracije ter pri tem navede najmanj podatke, določene v členu 57(1).

3. The provisions laid down in paragraphs 1 and 2 shall apply until 14 June 2016. If necessary, that time limit may be extended in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

3. Določbe iz odstavkov 1 in 2 se uporabljajo do 14. junija 2016. To obdobje se po potrebi lahko podaljša v skladu z regulativnim postopkom s pregledom iz člena 79(4).

Article 31

Člen 31

Contents of authorisations

Vsebina registracij

1. The authorisation shall define plants or plant products and non-agricultural areas (for example railways, public areas, storage rooms) on which and the purposes for which the plant protection product may be used.

1. Registracija opredeljuje rastline ali rastlinske proizvode in nekmetijska področja (npr. železnice, javne površine, skladišča), na katerih in za katere namene se lahko uporabi fitofarmacevtsko sredstvo.

2. The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product. Those requirements shall as a minimum 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.

2. Registracija določa zahteve v zvezi z dajanjem v promet in uporabo fitofarmacevtskega sredstva. Te zahteve vključujejo najmanj pogoje uporabe, potrebne za izpolnjevanje pogojev in zahtev iz uredbe, v skladu s katerimi se odobrijo aktivne snovi, varovala in sinergisti.

The authorisation shall include a classification of the plant protection product for the purpose of Directive 1999/45/EC. Member States may provide that authorisation holders shall classify or update the label without undue delay following any change to the classification and labelling of the plant protection product in accordance with Directive 1999/45/EC. In such cases, they shall immediately inform the competent authority thereof.

Registracija vključuje razvrstitev fitofarmacevtskega sredstva za namen Direktive 1999/45/ES. Države članice lahko določijo, da imetniki registracij brez neupravičene zamude razvrstijo ali posodobijo etiketo zaradi spremembe v razvrščanju ali označevanju fitofarmacevtskega sredstva v skladu z Direktivo 1999/45/ES. V takšnih primerih o tem nemudoma obvestijo pristojni organ.

3. The requirements referred to in paragraph 2 shall also include where applicable:

3. Zahteve iz odstavka 2 po potrebi vključujejo tudi:

(a) the maximum dose per hectare in each application;

(a) največji odmerek na hektar pri vsakem nanašanju;

(b) the period between the last application and harvest;

(b) razdobje med zadnjo uporabo in spravilom pridelka,

4. The requirements referred to in paragraph 2 may include the following:

4. Zahteve iz odstavka 2 lahko vključujejo:

(a) a restriction with respect to the distribution and use of the plant protection product in order to protect the health of the distributors, users, bystanders, residents, consumers or workers concerned or the environment, taking into consideration requirements imposed by other Community provisions; such restriction shall be indicated on the label;

(a) omejitev v zvezi z distribucijo in uporabo fitofarmacevtskih sredstev, da bi se varovalo zdravje zadevnih distributerjev, uporabnikov, navzočih oseb, prebivalcev, potrošnikov ali delavcev ter okolje ob upoštevanju zahtev iz drugih določb Skupnosti; tovrstna omejitev se navede na etiketi;

(b) the obligation before the product is used to inform any neighbours who could be exposed to the spray drift and who have requested to be informed;

(b) obveznost, da se pred uporabo sredstva obvestijo vsi sosedi, ki bi lahko bili izpostavljeni zanašanju škropiva in ki so zahtevali, da se jih obvesti;

(c) indications for proper use according to the principles of Integrated Pest Management referred to in Article 14 of and Annex III to Directive 2009/128/EC;

(c) navodila za primerno rabo glede na načela integriranega varstva rastlin pred škodljivimi organizmi iz člena 14 in iz priloge III Direktive 2009/128/ES.

(d) designation of categories of users, such as professional and non-professional;

(d) določitev kategorij uporabnikov, kot so poklicni in nepoklicni uporabniki;

(e) the approved label;

(e) odobreno etiketo;

(f) the interval between applications;

(f) obdobje med nanašanji;

(g) the period between the last application and consumption of the plant product where applicable;

(g) kjer je primerno, obdobje med zadnjim nanašanjem in porabo rastlinskega proizvoda;

(h) the re-entry interval;

(h) delovno karenco;

(i) the packaging size and material.

(i) velikost in material embalaže.

Article 32

Člen 32

Duration

Trajanje

1. The period of authorisation shall be laid down in the authorisation.

1. Obdobje registracije je določeno v dovoljenju.

Without prejudice to Article 44, the duration of an authorisation shall be set for a period not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved.

Brez poseganja v člen 44 se trajanja registracije določi za obdobje, ki ne presega enega leta od datuma poteka odobritve aktivnih snovi, varoval in sinergistov v fitofarmacevtskem sredstvu in nato dokler so aktivne snovi, varovala in sinergisti v fitofarmacevtskem sredstvu odobreni.

This period shall allow the examination as provided for in Article 43 to be carried out.

To obdobje omogoča izvajanje pregleda, določenega v členu 43.

2. Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 50.

2. Registracije se lahko izdajo za krajša obdobja, da se uskladijo ponovne ocene podobnih sredstev za namene primerjalne ocene sredstev, ki vsebujejo kandidatne snovi za zamenjavo, kakor je določeno v členu 50.

Subsection 2

Pododdelek 2

Procedure

Postopek

Article 33

Člen 33

Application for authorisation or amendment of an authorisation

Zahtevek za registracijo ali spremembo registracije

1. An applicant who wishes to place a plant protection product on the market shall apply for an authorisation or amendment of an authorisation himself, or through a representative, to each Member State where the plant protection product is intended to be placed on the market.

1. Vlagatelj, ki želi dati fitofarmacevtsko sredstvo v promet, za registracijo zaprosi sam ali prek zastopnika v vsaki posamezni državi članici, v kateri namerava dati fitofarmacevtsko sredstvo v promet.

2. The application shall include the following:

2. Zahtevek vsebuje:

(a) a list of intended uses in each zone as indicated in Annex I and the Member States where the applicant has made or intends to make an application;

(a) seznam predvidene uporabe v vsaki coni, kakor je navedeno v Prilogi I, in v državah članicah, kjer je vlagatelj predložil zahtevek ali ga namerava predložiti;

(b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request;

(b) predlog, katera država članica naj oceni zahtevek za zadevno cono. V primeru zahtevka za uporabo v rastlinjakih, za tretiranje po spravilu, za tretiranje praznih skladišč in za tretiranje semen se predlaga ena sama država članica, ki oceni uporabo upoštevajoč vse cone. V tem primeru vlagatelj drugim državam članicam na zahtevo pošlje popolno dokumentacijo ali njen povzetek iz člena 8;

(d) where relevant, a copy of any conclusion of the Member State assessing equivalence as referred to in Article 38(2).

(d) kjer je to ustrezno, kopije vseh sklepov države članice, ki ocenjuje ekvivalenco, kakor je navedeno v členu 38(2).

3. The application shall be accompanied by the following:

3. Skupaj z vlogo se predložijo:

(a) for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product;

(a) za zadevno fitofarmacevtsko sredstvo popolna dokumentacija in njen povzetek za vsako točko zahtev po podatkih o fitofarmacevtskem sredstvu;

(b) for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist;

(b) za vsako aktivno snov, varovalo in sinergist v fitofarmacevtskem sredstvu popolna dokumentacija in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi, varovalu in sinergistu;

(c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals;

(c) za vsak preskus ali študijo, ki vključuje vretenčarje, utemeljitev ukrepov, sprejetih za preprečitev poskusov na živalih in podvajanja poskusov in študij na vretenčarjih;

(d) the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation;

(d) razlogi, zakaj so predložena poročila o preskusih in študijah potrebna za prvo registracijo ali za spremembe pogojev registracije;

(e) where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information;

(e) kjer je to ustrezno, kopija zahtevka za mejno vrednost ostankov iz člena 7 Uredbe (ES) št. 396/2005, oziroma utemeljitev, zakaj ti podatki niso priloženi;

(f) where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1);

(f) ocena vseh podatkov, predloženih v skladu s členom 8(1)(h), kjer je to potrebno za spremembo registracije; ter

(g) a draft label.

(g) osnutek etikete.

4. When submitting the application, the applicant may pursuant to Article 63, request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.

4. Ob predložitvi zahtevka lahko vlagatelj v skladu s členom 63 zaprosi, da nekatere informacije in nekateri deli dokumentacije ostanejo zaupni, in te informacije fizično loči.

The applicant shall at the same time submit the complete list of studies submitted pursuant to Article 8(2) and a list of test and study reports for which any claims for data protection pursuant to Article 59 are requested.

Vlagatelj hkrati predloži tudi popoln seznam študij, predloženih v skladu s členom 8(2) in seznam poročil o preskusih in študijah, za katere se vlagajo zahtevki za varovanje podatkov v skladu s členom 59.

Upon a request for access to information the Member State examining the application shall decide what information is to be kept confidential.

Ob predložitvi zahteve za dostop do informacij, se država članica, ki preučuje vlogo za registracijo, odloči, katere informacije ostanejo zaupne.

5. Where requested by the Member State the applicant shall submit his application in the national or official languages of that Member State or one of those languages.

5. Na zahtevo države članice vlagatelj predloži zahtevek v nacionalnem ali uradnem jeziku te države članice ali v enem od teh jezikov.

6. On request, the applicant shall provide the Member State with samples of the plant protection product and analytical standards of its ingredients.

6. Na zahtevo države članice vlagatelj zagotovi vzorce fitofarmacevtskega sredstva in analitske standarde njegovih sestavin.

Article 34

Člen 34

Exemption from the submission of studies

Izjema od predložitve študij

1. Applicants shall be exempted from supplying the test and study reports referred to in Article 33(3) where the Member State to which an application is made has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article 59, 61 or 62 or that any data protection period has expired.

1. Vlagatelji so oproščeni obveznosti predložitve poročil o preskusih in študijah iz člena 33(3), če država članica, kateri je bila predložena vloga, zadevna poročila o preskusih in študijah že ima in vlagatelji dokažejo, da jim je bil dodeljen dostop v skladu s členi 59, 61 ali 62 ali da je kakršno koli obdobje varovanja podatkov poteklo.

2. However, applicants to whom paragraph 1 applies shall provide the following information:

2. Vendar vlagatelji, za katere se uporablja odstavek 1, zagotovijo:

(a) all necessary data for the identification of the plant protection product including its complete composition as well as a declaration that no unacceptable co-formulants are used;

(a) vse potrebne podatke za identifikacijo fitofarmacevtskega sredstva, vključno z njegovo celotno sestavo, in izjavo, da v formulaciji niso uporabljeni nesprejemljivi dodatki;

(b) the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with point (b) of Article 29(1), where appropriate;

(b) informacije, potrebne za ugotovitev istovetnosti aktivne snovi, varovala ali sinergista, če so bili odobreni, in za določitev, ali so pogoji za odobritev izpolnjeni in kjer je to primerno v skladu s členom 29(1)(b);

(c) on the request of the concerned Member State, the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data.

(c) na zahtevo zadevne države članice podatke, potrebne za dokaz, da ima fitofarmacevtsko sredstvo primerljive učinke kot fitofarmacevtsko sredstvo, v zvezi s katerim je odobren dostop do zaščitenih podatkov.

Article 35

Člen 35

Member State examining the application

Država članica, ki preuči vlogo

The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it. The Member State which will examine the application shall inform the applicant.

Vlogo preuči država članica, ki jo je predlagal vlagatelj, razen če jo želi preučiti druga država članica iz iste cone. Država članica, ki bo preučila vlogo, o tem obvesti vlagatelja.

At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload.

Na zahtevo države članice, ki preučuje vlogo, druge države članice v isti coni, katerim je bila vloga predložena, sodelujejo, da se zagotovi pravična razdelitev delovne obremenitve.

The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application.

Druge države članice znotraj cone, katerim je bila predložena vloga, prenehajo preučevati vlogo, dokler država članica, ki preučuje vlogo, ne predloži ocene.

Where an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions.

Če se vloga vloži v več kot eni coni, se države članice, ki vlogo ocenjujejo, sporazumejo o oceni podatkov, ki niso povezani z okoljskimi in kmetijskimi razmerami.

Article 36

Člen 36

Examination for authorisation

Preučitev za registracijo

1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of application. It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment.

1. Država članica, ki preučuje vlogo, opravi neodvisno, objektivno in pregledno oceno ob upoštevanju trenutnih znanstvenih in tehničnih spoznanj s pomočjo smernic, ki so na voljo v času vloge. Vsem državam v isti coni omogoči, da dajo pripombe, ki se bodo upoštevale pri oceni.

It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 in the same zone, where used in accordance with Article 55, and under realistic conditions of use.

Uporabi enotna načela za oceno in registracijo fitofarmacevtskih sredstev iz člena 29(6), da – kolikor je to mogoče – določi, ali fitofarmacevtsko sredstvo izpolnjuje zahteve iz člena 29 v isti coni, kadar se uporablja v skladu s členom 55 in v skladu z realnimi pogoji za uporabo.

The Member State examining the application shall make available its assessment to the other Member States within the same zone. The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2).

Država članica, ki preučuje vlogo, da svojo oceno na voljo drugim državam članicam znotraj iste cone. Oblika osnutka poročila o oceni se določi v skladu s svetovalnim postopkom iz člena 79(2).

2. The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32.

2. Zadevne države članice ustrezno izdajo ali zavrnejo registracijo na podlagi sklepov ocene države članice, ki preuči vlogo, kakor je določeno v členih 31 in 32.

3. By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use.

3. Z odstopanjem od odstavka 2 in v skladu z zakonodajo Skupnosti se lahko določijo ustrezni pogoji v zvezi z zahtevami iz člena 31(3) in (4) ter drugi ukrepi za zmanjšanje tveganja, ki se sprejmejo zaradi posebnih pogojev uporabe.

Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment.

Če se pomisleki držav članic glede zdravja ljudi ali živali ter varovanja okolja ne morejo nadzirati z uvedbo nacionalnih ukrepov za zmanjšanje tveganja iz prvega pododstavka, lahko država članica zavrne registracijo fitofarmacevtskih sredstev na svojem območju, če zaradi specifičnih okoljskih ali kmetijskih pogojev utemeljeno meni, da zadevno sredstvo še vedno predstavlja nesprejemljivo tveganje zdravju ljudi ali živali ali okolju.

That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor.

Država članica o svoji odločitvi nemudoma obvesti vlagatelja in Komisijo ter jo podpre s tehničnimi ali znanstvenimi dokazi.

Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal.

Države članice zagotovijo, da se lahko odločitev o zavrnitvi registracije takšnega sredstva izpodbija pred nacionalnim sodiščem ali drugimi organi za pritožbe.

Article 37

Člen 37

Period for examination

Rok za preučitev

1. The Member State examining the application shall decide within 12 months of receiving it whether the requirements for authorisation are met.

1. Država članica, ki preučuje vlogo, v dvanajstih mesecih od prejetja vloge odloči, ali so zahteve za registracijo izpolnjene.

Where the Member State needs additional information, it shall set a period for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the Member State. That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.

Če država članica potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti. V tem primeru se obdobje dvanajstih mesecev podaljša za dodatno časovno obdobje, ki ga odobri država članica. Dodatno časovno obdobje ni daljše od šestih mesecev in preneha, ko država članica prejme dodatne informacije. Če ob koncu tega obdobja vlagatelj ne predloži manjkajočih elementov, ga država članica obvesti, da vloga ni sprejemljiva.

2. The time limits provided for in paragraph 1 shall be suspended during the application of the procedure set out in Article 38.

2. Roki iz odstavka 1 se med uporabo postopka, določenega v členu 38, začasno ustavijo.

3. For an application for authorisation of a plant protection product containing an active substance not yet approved, the Member State examining the application shall start the evaluation as soon as it has received the draft assessment report referred to in Article 12(1). In case the application concerns the same plant protection product and the same uses as contained in the dossier referred to in Article 8, the Member State shall decide on the application at the latest within six months of the active substance being approved.

3. Po predložitvi vloge za registracijo fitofarmacevtskega sredstva, ki vsebuje aktivno snov, ki še ni odobrena, država članica, ki preuči vlogo, začne oceno takoj po prejetju osnutka poročila o oceni iz člena 12(1). Če zadeva vloga isto fitofarmacevtsko sredstvo in iste uporabe, kot jih vsebuje dokumentacija iz člena 8, država članica odloči o vlogi najpozneje v šestih mesecih od odobritve aktivne snovi.

4. The other Member States concerned shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the Member State examining the application decide on the application as referred to in Article 36(2) and (3).

4. Druge zadevne države članice najpozneje v 120 dneh od prejema poročila o oceni in kopije registracije, ki jo je izdala država članica, ki je preučila vlogo, odločijo o tej vlogi v skladu s členom 36(2) in (3).

Article 38

Člen 38

Assessment of equivalence under point (b) of Article 29(1)

Ocena ekvivalence v skladu s členom 29(1)(b)

1. Where it is necessary to establish for an active substance, safener or synergist whether a different source or, for the same source a change of the manufacturing process and/or manufacturing location complies with point (b) of Article 29(1), this shall be assessed by the Member State which acted as rapporteur for the active substance, safener or synergist as referred to in Article 7(1) unless the Member State examining the application as referred to in Article 35 agrees to assess the equivalence. The applicant shall submit all necessary data to the Member State assessing equivalence.

1. Kadar je v zvezi z aktivno snovjo, varovalom ali sinergistom treba ugotoviti, ali je drug vir, ali pa, če je sprememba v postopku izdelave in/ali mesta izdelave za isti vir, v skladu s členom 29(1)(b), to presodi država članica, ki je bila poročevalka za aktivno snov, varovalo ali sinergist, kakor je navedeno v členu 7(1), razen če se država članica, ki preučuje vlogo, kakor je navedeno v členu 35, strinja, da bo ocenila ekvivalenco. Vlagatelj državi članici, ki ocenjuje ekvivalenco, predloži vse potrebne podatke.

2. After giving the applicant the opportunity to submit comments, which the applicant shall also communicate to the rapporteur Member State or the Member State examining the application as the case may be, the Member State assessing equivalence shall prepare a report on equivalence within 60 days from receiving the application and shall communicate the report to the Commission, the other Member States and the applicant.

2. Ko se vlagatelju omogoči, da predloži pripombe, ki jih poleg tega sporoči tudi državi članici poročevalki oziroma državi članici, ki preučuje vlogo, država članica, ki preučuje ekvivalenco, v 60-ih dneh od prejema vloge pripravi poročilo o ekvivalenci in ga pošlje Komisiji, drugim državam članicam in vlagatelju.

3. In the case of a positive conclusion on equivalence and where no objection to this conclusion has been raised, point (b) of Article 29(1) shall be considered to be complied with. However, where a Member State examining the application does not agree with the conclusion of the rapporteur Member State or vice versa, it shall inform the applicant, the other Member States and the Commission stating its reasons.

3. Če je sklep o ekvivalenci pozitiven in se nanj nihče ne pritoži, se šteje, da je zahteva iz člena 29(1)(b) izpolnjena. Če pa se država članica, ki preučuje vlogo o ekvivalenci, ne strinja s sklepom države članice poročevalke, ali obratno, o tem obvesti vlagatelja, druge države članice in Komisijo ter navede razloge.

The Member States concerned shall try to reach agreement on whether point (b) of Article 29(1) is complied with. They shall provide the applicant with an opportunity to submit comments.

Zadevne države članice poskušajo doseči sporazum o tem, ali je zahteva iz člena 29(1)(b) izpolnjena. Vlagatelju omogočijo, da predloži pripombe.

4. Where the Member States concerned do not reach agreement within 45 days, the Member State assessing equivalence shall submit the matter to the Commission. A decision on whether the conditions referred to in point (b) of Article 29(1) are complied with shall be adopted in accordance with the regulatory procedure referred to in Article 79(3). The 45-day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State or vice versa that it does not agree with the conclusion of the latter, in accordance with paragraph 3.

4. Če zadevne države članice ne dosežejo sporazuma v 45 dneh, država članica, ki preučuje ekvivalenco, zadevo predloži Komisiji. Odločitev o tem, ali so zahteve iz člena 29(1)(b) izpolnjene, se sprejme v skladu z regulativnim postopkom iz člena 79(3). 45-dnevno obdobje se začne na dan, ko država članica, ki preučuje vlogo za registracijo, sporoči državi članici poročevalki ali obratno, da se ne strinja z njenim sklepom, v skladu z odstavkom 3.

Before such a decision is adopted, the Commission may ask the Authority for an opinion, or for scientific or technical assistance which shall be provided within 3 months of the request.

Pred sprejetjem te odločitve lahko Komisija prosi Agencijo za mnenje ali znanstveno ali tehnično pomoč, ki se zagotovi v treh mesecih od prošnje.

5. Detailed rules and procedures for the implementation of paragraphs 1 to 4 may be established in accordance with the regulatory procedure referred to in Article 79(3), after consultation of the Authority.

5. Podrobna pravila in postopki za izvajanje odstavkov 1 do 4 se lahko po posvetovanju z Agencijo določijo v skladu z regulativnim postopkom iz člena 79(3).

Article 39

Člen 39

Reporting and exchange of information on applications for authorisation

Poročanje in izmenjava informacij o vlogah za registracijo

1. Member States shall compile a file on each application. Each file shall contain the following:

1. Države članice pripravijo dokumentacijo za vsako vlogo. Vsaka dokumentacija vključuje:

(a) a copy of the application;

(a) kopijo vloge;

(b) a report containing information on the evaluation of and decision on the plant protection product; the format of the report shall be established in accordance with the advisory procedure referred to in Article 79(2);

(b) poročilo z informacijami o oceni fitofarmacevtskega sredstva in odločitvi v zvezi z njim; oblika poročila se določi v skladu s svetovalnim postopkom iz člena 79(2);

(c) a record of the administrative decisions taken by the Member State concerning the application and of the documentation provided for in Article 33(3) and Article 34 together with a summary of the latter;

(c) evidenco upravnih odločitev države članice v zvezi z vlogo in dokumentacijo iz členov 33(3) in 34, skupaj s povzetkom dokumentacije;

(d) the approved label, where applicable.

(d) kjer je primerno, odobreno etiketo.

2. On request, Member States shall, without delay, make available to the other Member States, the Commission and the Authority a file containing the documentation provided for in points (a) to (d) of paragraph 1.

2. Države članice na zahtevo nemudoma dajo na voljo drugim državam članicam, Komisiji in Agenciji dokumentacijo z dokumenti iz odstavka 1(a) do (d).

3. On request, applicants shall provide a copy of the documentation to be submitted with an application pursuant to Article 33(3) and Article 34 to Member States, the Commission and the Authority.

3. Vlagatelji na zahtevo zagotovijo kopijo dokumentacije, ki se predloži z vlogo v skladu s členoma 33(3) in 34 državam članicam, Komisiji in Agenciji.

4. Detailed rules for the implementation of paragraphs 2 and 3 may be established in accordance with the regulatory procedure referred to in Article 79(3).

4. Podrobna pravila za izvajanje odstavkov 2 in 3 se lahko določijo v skladu z regulativnim postopkom iz člena 79(3).

Subsection 3

Pododdelek 3

Mutual recognition of authorisations

Vzajemno priznavanje registracij

Article 40

Člen 40

Mutual recognition

Vzajemno priznavanje

1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases:

1. Imetnik registracije, izdane v skladu s členom 29, lahko zaprosi za registracijo istega fitofarmacevtskega sredstva, enako uporabo in v okviru primerljivih kmetijskih praks v drugi državi članici v skladu s postopkom vzajemnega priznavanja iz tega pododdelka, če:

(a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone;

(a) je registracijo izdala država članica (referenčna država članica), ki spada v isto cono;

(b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone;

(b) je registracijo izdala država članica (referenčna država članica), ki spada v drugo cono, če se zaprošena registracija ne uporabi za potrebe vzajemnega priznavanja v drugi državi članici iz iste cone;

(c) the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs.

(c) je registracijo izdala država članica za uporabo v rastlinjakih, ali za tretiranje po spravilu, ali za tretiranje praznih prostorov ali shramb za skladiščenje rastlin ali rastlinskih proizvodov, ali za tretiranje semen, ne glede na cono, v katero spada referenčna država članica.

2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply, with the consent of the authorisation holder, for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1. In that case the applicant must demonstrate that the use of such a plant protection product is of general interest for the Member State of introduction.

2. Če fitofarmacevtsko sredstvo v državi članici ni registrirano, ker se v tej državi članici ni predložila vloga za registracijo, lahko uradni ali znanstveni organi, ki sodelujejo v kmetijskih dejavnostih, ali strokovne kmetijske organizacije ob soglasju imetnika registracije zaprosijo za registracijo istega fitofarmacevtskega sredstva, enako uporabo in v okviru enakih kmetijskih praks v tej državi članici v skladu s postopkom vzajemnega priznavanja iz odstavka 1. V tem primeru mora vlagatelj dokazati, da je uporaba takega fitofarmacevtskega sredstva v splošnem interesu države članice vnosa.

Where the authorisation holder refuses its consent, the competent authority of the Member State concerned may accept the application, on grounds of public interest.

Če imetnik registracije zavrne soglasje, lahko pristojni organ zadevne države članice na podlagi javnega interesa vlogo kljub temu odobri.

Article 41

Člen 41

Authorisation

Registracija

1. The Member State to which an application under Article 40 is submitted shall, having examined the application and the accompanying documents referred to in Article 42(1), as appropriate with regard to the circumstances in its territory, authorise the plant protection product concerned under the same conditions as the Member State examining the application, except where Article 36(3) applies.

1. Država članica, ki ji je predložena vloga v skladu s členom 40, po preučitvi vloge in spremne dokumentacije iz člena 42(1), če je to glede na okoliščine na njenem ozemlju potrebno, registrira zadevno fitofarmacevtsko sredstvo pod enakimi pogoji kot država članica, ki je preučila vlogo, razen če se uporablja člen 36(3).

2. By way of derogation from paragraph 1, the Member State may authorise the plant protection product where:

2. Z odstopanjem od odstavka 1 lahko država članica registrira fitofarmacevtsko sredstvo, če:

(a) an authorisation under point (b) of Article 40(1) was applied for;

(a) je bil vložen zahtevek za registracijo v skladu s členom 40(1)(b);

(b) it contains a candidate of substitution;

(b) vsebuje snov, ki je kandidatka za zamenjavo;

(d) it contains a substance approved in accordance with Article 4(7).

(d) vsebuje snov, odobreno v skladu s členom 4(7).

Article 42

Člen 42

Procedure

Postopek

1. The application shall be accompanied by the following:

1. Skupaj z vlogo se predložijo:

(a) a copy of the authorisation granted by the reference Member State as well as a translation of the authorisation into an official language of the Member State receiving the application;

(a) kopija registracije, ki jo je izdala referenčna država članica, ter prevod registracije v uradni jezik države članice, ki prejme vlogo;

(b) a formal statement that the plant protection product is identical to that authorised by the reference Member State;

(b) uradna izjava, da je fitofarmacevtsko sredstvo identično tistemu, ki ga je registrirala referenčna država članica;

(d) an assessment report of the reference Member State containing information on the evaluation and decision on the plant protection product.

(d) poročilo o oceni referenčne države članice s podatki o oceni fitofarmacevtskega sredstva in odločitvi v zvezi z njim.

2. The Member State to which an application under Article 40 is submitted shall decide on the application within 120 days.

2. Država članica, ki ji je vloga predložena v skladu s členom 40, se v 120 dneh odloči o vlogi.

3. Where requested by the Member State, the applicant shall submit the application in the national or official languages of that Member State or one of those languages.

3. Na zahtevo države članice vlagatelj predloži vlogo v nacionalnem ali uradnem jeziku te države članice ali v enem od teh jezikov.

Subsection 4

Pododdelek 4

Renewal, withdrawal and amendment

Podaljšanje, preklic in sprememba

Article 43

Člen 43

Renewal of authorisation

Podaljšanje registracije

1. An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met.

1. Registracija se podaljša na podlagi vloge, ki jo predloži imetnik registracije, če so zahteve iz člena 29 še vedno izpolnjene.

2. Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information:

2. V treh mesecih od podaljšanja odobritve aktivne snovi, varovala ali sinergista v fitofarmacevtskem sredstvu vlagatelj predloži:

(a) a copy of the authorisation of the plant protection product;

(a) kopijo registracije fitofarmacevtskega sredstva;

(b) any new information required as a result of amendments in data requirements or criteria;

(b) kakršne koli nove informacije, ki so potrebne zaradi sprememb zahtev glede podatkov ali meril;

(c) evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval;

(c) utemeljitev, da so novi predloženi podatki rezultat zahtev po podatkih ali meril, ki niso veljala, ko je bila izdana registracija za fitofarmacevtsko sredstvo ali da so potrebni za spremembo pogojev za odobritev;

(d) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein;

(d) kakršne koli informacije, potrebne za dokaz, da fitofarmacevtsko sredstvo izpolnjuje zahteve iz uredbe o obnovitvi odobritve za aktivno snov, varovalo ali sinergist, ki je vsebovan v sredstvu;

(e) a report on the monitoring information, where the authorisation was subject to monitoring.

(e) poročilo o informacijah, pridobljenih z monitoringom, če je bila registracija predmet monitoringa.

3. Member States shall check compliance of all plant protection products containing the active substance, safener or synergist concerned with any conditions and restrictions provided for in the Regulation renewing the approval under Article 20.

3. Države članice preverijo skladnost vseh fitofarmacevtskih sredstev, ki vsebujejo zadevno aktivno snov, varovalo ali sinergist, z vsemi pogoji in omejitvami iz uredbe o obnovitvi odobritve v skladu s členom 20.

The Member State referred to in Article 35 within each zone shall coordinate the compliance check and assessment of the information submitted for all Member States within that zone.

Država članica iz člena 35 znotraj vsake cone usklajuje izvajanje preverjanj skladnosti in ocenjevanja informacij za vse države članice znotraj te cone.

4. Guidelines on the organisation of compliance checks may be established in accordance with the advisory procedure referred to in Article 79(2).

4. Navodila za organizacijo preverjanj skladnosti se lahko določijo v skladu s svetovalnim postopkom iz člena 79(2).

5. Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein.

5. Države članice se odločijo o podaljšanju registracije fitofarmacevtskih sredstev najpozneje dvanajst mesecev po obnovitvi odobritve aktivne snovi, varovala ali sinergista, ki ga sredstvo vsebuje.

6. Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.

6. Kadar se zaradi razlogov, na katere imetnik registracije ne more vplivati, ne sprejme odločitev o podaljšanju registracije, preden ta poteče, zadevna država članica podaljša registracijo za obdobje, potrebno za zaključitev preučitve in sprejetje odločitve o podaljšanju.

Article 44

Člen 44

Withdrawal or amendment of an authorisation

Preklic ali sprememba registracije

1. Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.

1. Države članice lahko pregledajo registracijo kadar koli, če obstajajo dokazi, da zahteva iz člena 29 ni več izpolnjena.

A Member State shall review an authorisation where it concludes that the objectives of Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved.

Država članica pregleda registracijo, kadar ugotovi, da cilji iz člena 4(1)(a)(iv) in (b)(i) ter člena 7(2) in (3) Direktive 2000/60/ES morda ne bodo doseženi.

2. Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information.

2. Če namerava država članica preklicati ali spremeniti registracijo, o tem obvesti imetnika registracije in mu da možnost, da predloži pripombe ali dodatne informacije.

3. The Member State shall withdraw or amend the authorisation, as appropriate, where:

3. Država članica prekliče ali spremeni registracijo, kot je primerno, če:

(a) the requirements referred to in Article 29 are not or are no longer satisfied;

(a) zahteve iz člena 29 niso ali niso več izpolnjene;

(b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;

(b) so bile predložene napačne ali zavajajoče informacije o dejstvih, na podlagi katerih je bila registracija izdana;

(d) on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or

(d) se na podlagi razvoja znanstvenega in tehničnega znanja lahko spremenijo uporabljeni odmerki in način njihove uporabe; ali

(e) the authorisation holder fails to comply with the obligations resulting from this Regulation.

(e) imetnik registracije ne izpolnjuje obveznosti iz te uredbe.

4. Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and the Authority. The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where the second, third or fourth subparagraphs of Article 36(3) have been applied. Article 46 shall apply where appropriate.

4. Če država članica prekliče ali spremeni registracijo v skladu z odstavkom 3, o tem nemudoma obvesti imetnika registracije, druge države članice, Agencijo in Komisijo. Druge države članice, ki sodijo v isto cono, registracijo ustrezno spremenijo ali prekličejo, pri tem pa upoštevajo nacionalne pogoje in ukrepe za zmanjšanje tveganja, razen v primerih, kadar so bili uporabljeni drugi, tretji ali četrti pododstavek člena 36(3). Člen 46 se uporablja po potrebi.

Article 45

Člen 45

Withdrawal or amendment of an authorisation at the request of the authorisation holder

Preklic ali sprememba registracije na zahtevo imetnika registracije

1. An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request.

1. Registracija se lahko prekliče ali spremeni na zahtevo imetnika registracije, ki navede razloge za svojo zahtevo.

2. Amendments may only be granted where it is established that the requirements referred to in Article 29 continue to be met.

2. Spremembe se lahko odobrijo le, če je dokazano, da so zahteve iz člena 29 še vedno izpolnjene.

3. Article 46 shall apply where appropriate.

3. Člen 46 se uporablja po potrebi.

Article 46

Člen 46

Grace period

Prehodno obdobje

Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.

Če država članica prekliče ali spremeni registracijo ali je ne podaljša, lahko odobri prehodno obdobje za odstranjevanje, shranjevanje, dajanje v promet in uporabo obstoječih zalog.

Where the reasons for withdrawal, amendment or non-renewal of the authorisation are not related to the protection of human and animal health or the environment, the grace period shall be limited and shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned.

Kadar razlogi za preklic, spremembo ali zavrnitev podaljšanja registracije niso povezani z varovanjem zdravja ljudi in živali ali okolja, je prehodno obdobje omejeno in ni daljše od šestih mesecev za prodajo in distribucijo ter dodatno največ enega leta za odstranjevanje, shranjevanje in uporabo obstoječih zalog zadevnih fitofarmacevtskih sredstev.

Subsection 5

Pododdelek 5

Special cases

Posebni primeri

Article 47

Člen 47

Placing on the market of low-risk plant protection products

Dajanje v promet fitofarmacevtskih sredstev z majhnim tveganjem

1. Where all the active substances contained in a plant protection product are low-risk active substances as referred to in Article 22, that product shall be authorised as a low-risk plant protection product provided no specific risk mitigation measures are needed following a risk assessment. This plant protection product shall also meet the following requirements:

1. Če so vse aktivne snovi v fitofarmacevtskem sredstvu aktivne snovi z majhnim tveganjem iz člena 22, se to sredstvo registrira kot fitofarmacevtsko sredstvo z majhnim tveganjem, če po opravljeni oceni tveganja niso potrebni posebni ukrepi za zmanjševanje tveganja. To fitofarmacevtsko sredstvo izpolnjuje tudi naslednje zahteve:

(a) the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II;

(a) njegove aktivne snovi, varovala in sinergisti z majhnim tveganjem so bili odobreni v skladu s poglavjem II;

(b) it does not contain a substance of concern;

(b) ne vsebuje problematične snovi;

(d) it does not cause unnecessary pain and suffering to vertebrates to be controlled;

(d) ne povzroča nepotrebnih bolečin in trpljenja vretenčarjem, zatiranju katerih je namenjeno;

(e) it complies with points (b), (c) and (f) to (i) of Article 29(1).

(e) je v skladu s členom 29(1)(b), (c) in (f) do (i).

These products are referred to as "low-risk plant protection products".

Ta sredstva so v nadaljnjem besedilu "fitofarmacevtska sredstva z majhnim tveganjem".

2. An applicant for authorisation of a low-risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall submit with the application a complete and a summary dossier for each point of the data requirements of the active substance and the plant protection product.

2. Vlagatelj za registracijo fitofarmacevtskega sredstva z majhnim tveganjem dokaže, da so zahteve iz odstavka 1 izpolnjene, in k vlogi priloži popolno dokumentacijo in njen povzetek za vsako točko zahtev po podatkih o aktivni snovi in fitofarmacevtskem sredstvu.

3. The Member State shall decide within 120 days whether to approve an application for authorisation of a low-risk plant protection product.

3. Država članica v 120 dneh sprejme odločitev o odobritvi vloge za registracijo fitofarmacevtskega sredstva z majhnim tveganjem.

Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the period specified shall be extended by the additional time limit granted by the Member State.

Če država članica potrebuje dodatne informacije, določi rok, v katerem jih mora vlagatelj predložiti. V tem primeru se predpisano obdobje podaljša za dodatno časovno obdobje, ki ga odobri država članica.

The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.

Dodatno obdobje ni daljše od šestih mesecev in preneha, ko država članica prejme dodatne informacije. Če ob koncu tega obdobja vlagatelj ne predloži manjkajočih elementov, ga država članica obvesti, da vloga ni sprejemljiva.

4. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

4. Če ni drugače določeno, se uporabljajo vse določbe v zvezi z registracijami v skladu s to uredbo.

Article 48

Člen 48

Placing on the market and use of plant protection products containing a genetically modified organism

Dajanje v promet in uporaba fitofarmacevtskih sredstev, ki vsebujejo gensko spremenjeni organizem

1. A plant protection product which contains an organism falling within the scope of Directive 2001/18/EC shall be examined in respect of the genetic modification in accordance with that Directive, in addition to the assessment under this Chapter.

1. Fitofarmacevtsko sredstvo, ki vsebuje organizem, ki sodi na področje uporabe Direktive 2001/18/ES, se preuči v zvezi z genskimi spremembami v skladu z zadevno direktivo, poleg ocene v skladu s tem poglavjem.

An authorisation under this Regulation shall not be granted for such a plant protection product unless written consent, as referred to in Article 19 of Directive 2001/18/EC, has been granted for it.

Registracija v skladu s to uredbo se za takšno fitofarmacevtsko sredstvo ne izda, razen če zanj ni bilo izdano pisno dovoljenje iz člena 19 Direktive 2001/18/ES.

2. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

2. Če ni drugače določeno, se uporabljajo vse določbe v zvezi z registracijami v skladu s to uredbo.

Article 49

Člen 49

Placing on the market of treated seeds

Dajanje v promet tretiranega semena

1. Member States shall not prohibit placing on the market and use of seeds treated with plant protection products authorised for that use in at least one Member State.

1. Države članice ne prepovejo dajanje v promet in uporabo semen, tretiranih s fitofarmacevtskimi sredstvi, registriranimi za to uporabo v vsaj eni državi članici.

2. Where there are substantial concerns that treated seeds as referred to in paragraph 1 are likely to constitute a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of such treated seeds shall be taken immediately in accordance with the regulatory procedure referred to in Article 79(3). Before taking such measures the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided.

2. V primeru utemeljenih pomislekov, da tretirana semena iz odstavka 1 verjetno resno ogrožajo zdravje ljudi ali živali ali okolje in da tega tveganja ni mogoče preprečiti v zadostni meri z ukrepi, ki jih je sprejela zadevna država članica ali so jih sprejele zadevne države članice, se v skladu z regulativnim postopkom iz člena 79(3) nemudoma izvedejo ukrepi za omejitev ali prepoved uporabe in/ali prodaje teh tretiranih semen. Pred izvedbo teh ukrepov Komisija preuči dokaze in lahko zahteva mnenje Agencije. Komisija lahko določi rok, do katerega se to mnenje predloži.

3. Articles 70 and 71 shall apply.

3. Uporabljata se člena 70 in 71.

4. Without prejudice to other Community legislation concerning the labelling of seeds, the label and documents accompanying the treated seeds shall include the name of the plant protection product with which the seeds were treated, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Directive 1999/45/EC and risk mitigation measures set out in the authorisation for that product where appropriate.

4. Brez poseganja v drugo zakonodajo Skupnosti o označevanju semen, etikete in dokumenti, ki spremljajo tretirana semena vsebujejo ime fitofarmacevtskega sredstva, s katerim je bilo seme tretirano, ime aktivne snovi oziroma aktivnih snovi v tem sredstvu, standardne obvestilne stavke, kot je določeno v Direktivi 1999/45/ES, in, kjer je to primerno, ukrepe za zmanjševanje tveganja, določene v registraciji tega sredstva.

Article 50

Člen 50

Comparative assessment of plant protection products containing candidates for substitution

Primerjalna ocena fitofarmacevtskih sredstev, ki vsebujejo kandidatke za zamenjavo

1. A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution. Member States shall not authorise or shall restrict the use of a plant protection product containing a candidate for substitution for use on a particular crop where the comparative assessment weighing up the risks and benefits, as set out in Annex IV, demonstrates that:

1. Primerjalno oceno izvedejo države članice, kadar ocenjujejo vlogo za registracijo fitofarmacevtskega sredstva, ki vsebuje aktivno snov, odobreno kot kandidatno snov za zamenjavo. Države članice ne registrirajo fitofarmacevtskega sredstva, ki vsebuje kandidatno snov za zamenjavo, ali omejijo njegovo uporabo pri zadevnih kulturnih rastlinah, če primerjalna ocena, ki preuči tveganja in koristi, kot je določeno v Prilogi IV, pokaže, da:

(a) for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, already exists which is significantly safer for human or animal health or the environment;

(a) za načine uporabe, navedene v vlogi, že obstaja registrirano fitofarmacevtsko sredstvo ali ne-kemična kontrolna ali preventivna metoda, ki je bistveno varnejša za zdravje ljudi ali živali ali za okolje; ter

(b) the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages;

(b) nadomestitev s fitofarmacevtskimi sredstvi ali ne-kemičnimi kontrolnimi ali preventivnimi metodami iz točke (a) ne pomeni bistvene gospodarske ali praktične izgube; ter

(c) the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism; and

(c) so kemijska raznolikost aktivnih snovi, če je potrebno, ali metode in prakse pridelave kulturnih rastlin in zatiranja škodljivih organizmov ustrezne za zmanjšanje nastanka odpornosti v ciljnem organizmu; ter

(d) the consequences on minor use authorisations are taken into account.

(d) se upoštevajo posledice na registracije manjših uporab.

2. By way of derogation from Article 36(2) Member States may in exceptional cases also apply the provisions of paragraph 1 of this Article when evaluating an application for authorisation of a plant protection product not containing a candidate for substitution or a low-risk active substance, if a non-chemical control or prevention method exists for the same use and it is in general use in that Member State.

2. Z odstopanjem od člena 36(2) lahko države članice pri ocenjevanju vloge za registracijo fitofarmacevtskega sredstva, ki ne vsebuje kandidatne snovi za zamenjavo ali snovi z majhnim tveganjem, izjemoma uporabijo določbe iz odstavka 1 tega člena, če ne-kemična kontrolna ali preventivna metoda obstaja za isto uporabo in se v tej državi članici splošno uporablja.

3. By way of derogation from paragraph 1, a plant protection product containing a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using that product in practice.

3. Z odstopanjem od odstavka 1 se fitofarmacevtsko sredstvo, ki vsebuje kandidatno snov za zamenjavo, registrira brez primerjalne ocene, kadar je treba najprej pridobiti izkušnje z uporabo tega sredstva v praksi.

Such authorisations shall be granted once for a period not exceeding five years.

Takšne registracije se izdajo enkrat za največ pet let.

4. For plant protection products containing a candidate for substitution Member States shall perform the comparative assessment provided for in paragraph 1 regularly and at the latest at renewal or amendment of the authorisation.

4. Za fitofarmacevtska sredstva, ki vsebujejo kandidatno snov za zamenjavo, države članice redno izvajajo primerjalno oceno, določeno v odstavku 1, najpozneje ob podaljšanju ali spremembi registracije.

Based on the results of that comparative assessment, Member States shall maintain, withdraw or amend the authorisation.

Na podlagi rezultatov te primerjalne ocene države članice registracijo potrdijo, prekličejo ali spremenijo.

5. Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 4, that withdrawal or amendment shall take effect 3 years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier.

5. Če se država članica odloči za preklic ali spremembo registracije v skladu z odstavkom 4, začne zadevni preklic ali sprememba veljati tri leta po odločitvi države članice ali na koncu obdobja odobritve kandidatne snovi za zamenjavo, če se to obdobje konča prej.

6. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

6. Če ni drugače določeno, se uporabljajo vse določbe v zvezi z registracijami v skladu s to uredbo.

Article 51

Člen 51

Extension of authorisations for minor uses

Razširitev registracij za manjše uporabe

1. The authorisation holder, official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users may ask for the authorisation of a plant protection product already authorised in the Member State concerned to be extended to minor uses not yet covered by that authorisation.

1. Imetnik registracije, uradni ali znanstveni organi, ki sodelujejo v kmetijskih dejavnostih, profesionalne kmetijske organizacije ali profesionalni uporabniki lahko zaprosijo za razširitev registracije fitofarmacevtskega sredstva, ki je že registrirano v zadevni državi članici, na manjše uporabe, ki jih registracija še ne vključuje.

2. Member States shall extend the authorisation provided that:

2. Države članice razširijo registracijo, če:

(a) the intended use is minor in nature;

(a) je predvidena uporaba po naravi manjša;

(b) the conditions referred to in points (b), (d) and (e) of Article 4(3) and Article 29(1)(i) are satisfied;

(b) so pogoji iz člena 4(3)(b), (d) in (e) ter člena 29(1)(i) izpolnjeni;

(d) the documentation and information to support the extension of use has been submitted by the persons or bodies referred to in paragraph 1, especially data on the magnitude of residues and where necessary on the risk assessment to the operator, worker and bystander.

(d) so osebe ali organi iz odstavka 1 predložili dokumentacijo in informacije v podporo razširitvi uporabe, zlasti podatke o količini ostankov in po potrebi o oceni tveganja za izvajalce, delavce in druge navzoče.

3. Member States may take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses.

3. Države članice lahko sprejmejo ukrepe, s katerimi olajšajo ali spodbujajo vlaganje zahtevkov za razširitev registracije že registriranih fitofarmacevtskih sredstev za manjše uporabe.

4. The extension may take the form of an amendment to the existing authorisation or may be a separate authorisation, in accordance with the administrative procedures of the Member State concerned.

4. Razširitev je lahko v obliki spremembe obstoječe registracije ali je lahko ločena registracija, v skladu z upravnimi postopki zadevne države članice.

5. When Member States grant an extension of authorisation for a minor use, they shall inform if necessary the authorisation holder and request him to change the labelling accordingly.

5. Če države članice odobrijo razširitev registracije na manjše uporabe, o tem po potrebi obvestijo imetnika registracije in ga prosijo, da v skladu s tem spremeni etiketo.

Where the authorisation holder declines, the Member States shall ensure that users are fully and specifically informed as to instructions for use, by means of an official publication or an official website.

Če imetnik registracije to odkloni, države članice zagotovijo, da so uporabniki polno in natančno obveščeni o navodilih za uporabo, ki se uradno objavijo ali so na voljo na uradni spletni strani.

The official publication or where applicable the label shall include a reference to the liability of the person using the plant protection product with respect to failures concerning the efficacy or to phytotoxicity of the product for which the minor use was granted. The minor use extension shall be separately identified in the label.

Uradna objava ali, kjer je primerno, etiketa vsebuje navedbo odgovornosti osebe, ki uporablja fitofarmacevtsko sredstvo, glede učinkovitosti ali fitotoksičnosti sredstva, za katero je bila odobrena manjša uporaba. Razširitev na manjšo uporabo je na etiketi navedena ločeno.

6. Extensions on the basis of this Article shall be separately identified and separate reference shall be made to liability restrictions.

6. Razširitve na podlagi tega člena se ločeno opredeli in ločeno navede omejitev odgovornosti.

7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) provided that a plant protection product concerned is authorised in that Member State. Member States shall authorise such uses in accordance with the provisions of Article 41 provided that those uses are also considered minor in the Member States of application.

7. Vlagatelji iz odstavka 1 lahko prav tako zaprosijo za registracijo fitofarmacevtskega sredstva za manjše uporabe v skladu s členom 40(1), če je fitofarmacevtsko sredstvo v tej državi članici registrirano. Države članice registrirajo navedene vrste uporabe v skladu z določbami člena 41 pod pogojem, da te štejejo za manjše uporabe tudi v državah članicah vloženega zahtevka.

8. Member States shall establish and regularly update a list of minor uses.

8. Države članice sestavijo in redno posodabljajo seznam manjših uporab.

9. By 14 December 2011, the Commission shall present a report to the European Parliament and the Council on the establishment of a European fund for minor uses, accompanied, if appropriate, by a legislative proposal.

9. Komisija Evropskemu parlamentu in Svetu najpozneje do 14. decembra 2011 predloži poročilo o ustanovitvi evropskega sklada za manjše uporabe in po potrebi poda zakonodajni predlog.

10. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.

10. Če ni drugače določeno, se uporabljajo vse določbe v zvezi z registracijami v skladu s to uredbo.

Article 52

Člen 52

Parallel trade

Vzporedno trgovanje

1. A plant protection product that is authorised in one Member State (Member State of origin) may, subject to granting a parallel trade permit, be introduced, placed on the market or used in another Member State (Member State of introduction), if this Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in its territory (reference product). The application shall be submitted to the competent authority of the Member State of introduction.

1. Fitofarmacevtsko sredstvo, registrirano v eni državi članici (država članica izvora), se lahko ob odobritvi dovoljenja za vzporedno trgovanje vnese, da v promet ali uporablja v drugi državi članici (država članica vnosa), če ta država članica določi, da je fitofarmacevtsko sredstvo po sestavi identično fitofarmacevtskemu sredstvu, ki je bilo na njenem območju že registrirano (referenčno sredstvo). Vloga se predloži pristojnemu organu v državi članici vnosa.

2. From receiving a complete application, a parallel trade permit shall be granted in a simplified procedure within 45 working days if the plant protection product to be introduced is identical in terms of paragraph 3. Member States shall on request provide each other with the information necessary to assess whether the products are identical within 10 working days of receiving the request. The procedure for granting a parallel trade permit is interrupted from the day the request for information is sent to the competent authority of the Member State of origin until the complete information required is delivered to the competent authority of the Member State of introduction.

2. Po prejemu popolne vloge se dovoljenje za vzporedno trgovanje izda v poenostavljenem postopku v 45 delovnih dneh, če je fitofarmacevtsko sredstvo, ki se bo vneslo, identično v skladu z odstavkom 3. Države članice na zahtevo druga drugi zagotovijo podatke, potrebne za oceno, ali gre za identična sredstva, v roku 10 delovnih dni po prejetju vloge. Postopek za izdajo dovoljenja za vzporedno trgovanje se prekine od dne, ko je bila pristojnemu organu v državi članici izvora poslana zahteva za podatke, do dne, ko so bili zahtevani podatki v celoti dostavljeni pristojnemu organu.

3. Plant protection products shall be considered as identical to the reference products if:

3. Šteje se, da so fitofarmacevtska sredstva identična referenčnim sredstvom, če:

(a) they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process;

(a) jih je proizvedla ista družba ali povezano podjetje ali so bili proizvedeni v okviru licence v skladu z istim proizvodnim postopkom;

(b) they are identical in specification and content to the active substances, safeners and synergists, and in the type of formulation; and

(b) so identična po specifikaciji in vsebini aktivnih snovi, varoval in sinergistov ter po vrsti formulacije; ter

(c) they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.

(c) so enaka ali ekvivalentna glede vsebovanih dodatkov in velikosti, materiala ali oblike embalaže v smislu možnega škodljivega vpliva na varnost izdelka za zdravje ljudi ali živali ali za okolje.

4. The application for a parallel trade permit shall include the following information:

4. V vlogi za dovoljenje za vzporedno trgovanje se navedejo naslednje informacije:

(a) the name and registration number of the plant protection product in the Member State of origin;

(a) ime in številka registracije fitofarmacevtskega sredstva v državi članici izvora;

(b) the Member State of origin;

(b) država članica izvora;

(d) the original label and instructions for use with which the plant protection product to be introduced is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction. This competent authority may require a translation of the relevant parts of the original instructions for use;

(d) izvirna etiketa in izvirna navodila za uporabo, skupaj s katerimi se fitofarmacevtsko sredstvo, ki naj bi se vneslo, distribuira v državi članici izvora, če se šteje, da je potrebno, da jih pristojni organ države članice vnosa preuči. Pristojni organ lahko zahteva prevod ustreznih delov izvirnih navodil za uporabo;

(e) the name and address of the applicant;

(e) ime in priimek ter naslov vlagatelja;

(f) the name to be given to the plant protection product to be distributed in the Member State of introduction;

(f) ime fitofarmacevtskega sredstva, ki naj bi se distribuiralo v državi članici vnosa;

(g) a draft label for the product intended to be placed on the market;

(g) osnutek etikete sredstva, ki naj bi ga dali v promet;

(h) a sample of the product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction;

(h) vzorec sredstva, ki naj bi se vneslo, če pristojni organ države članice vnosa meni, da je to potrebno.

(i) the name and registration number of the reference product.

(i) ime in številko registracije referenčnega sredstva.

The information requirements may be amended or completed and further details and specific requirements shall be established in cases of application for a plant protection product for which a parallel trade permit has already been granted and in cases of an application for a plant protection product for a personal use in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

Zahteve po podatkih se lahko v primeru vloge za fitofarmacevtsko sredstvo, za katero je bilo dovoljenje za vzporedno trgovanje že odobreno, in v primeru vloge za fitofarmacevtsko sredstvo za osebno uporabo spremenijo ali dopolnijo ter določijo dodatne podrobnosti in specifične zahteve v skladu z regulativnim postopkom s pregledom iz člena 79(4).

5. A plant protection product for which a parallel trade permit has been issued shall be placed on the market and used only in accordance with the provisions of the authorisation of the reference product. To facilitate monitoring and controls the Commission shall set out specific control requirements for the product to be introduced in a Regulation referred to in Article 68.

5. Fitofarmacevtsko sredstvo, za katerega je bilo izdano dovoljenje za vzporedno trgovanje, se da v promet in uporablja samo v skladu z določbami registracije referenčnega sredstva. Komisija zaradi lažjega spremljanja in nadzora z uredbo iz člena 68 določi zahteve za nadzor sredstva, ki se bo vneslo.

6. The parallel trade permit shall be valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 45(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit shall expire by the date on which the authorisation of the reference product would normally have expired.

6. Dovoljenje za vzporedno trgovanje je veljavno do poteka registracije referenčnega sredstva. Če imetnik registracije referenčnega sredstva zahteva preklic registracije v skladu s členom 45(1) in so zahteve iz člena 29 še vedno izpolnjene, veljavnost dovoljenja za vzporedno trgovanje poteče na dan, ko bi registracija referenčnega sredstva normalno potekla.

7. Without prejudice to specific provisions of this Article, Articles 44, 45, 46, and 55 and Article 56(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly.

7. Brez poseganja v posebne določbe tega člena se členi 44, 45, 46 in 55 ter člen 56(4) in poglavja VI do X ustrezno uporabljajo za fitofarmacevtska sredstva, s katerimi se vzporedno trguje.

8. Without prejudice to Article 44, a parallel trade permit may be withdrawn if the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy reasons.

8. Brez poseganja v člen 44 se dovoljenje za vzporedno trgovanje lahko prekliče, če se zaradi varnosti ali učinkovitosti v državi članici izvora prekliče registracija vnesenega fitofarmacevtskega sredstva.

9. Where the product is not identical, in terms of paragraph 3, to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 29.

9. Če sredstvo v smislu odstavka 3 ni identično referenčnemu sredstvu, lahko država članica vnosa izda le registracijo, ki je potrebna za dajanje v promet in uporabo v skladu s členom 29.

10. The provisions of this Article shall not apply to plant protection products which are authorised in the Member State of origin in accordance with Article 53 or 54.

10. Določbe tega člena se ne uporabljajo za fitofarmacevtska sredstva, ki so registrirana v državi članici izvora v skladu s členom 53 ali 54.

11. Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits.

11. Organi države članice brez poseganja v člen 63 objavijo informacije o dovoljenjih za vzporedno trgovino.

Subsection 6

Pododdelek 6

Derogations

Odstopanja

Article 53

Člen 53

Emergency situations in plant protection

Nujni primeri v zvezi z varstvom rastlin

1. By way of derogation from Article 28, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means.

1. Z odstopanjem od člena 28 lahko država članica v posebnih okoliščinah za obdobje največ 120 dni dovoli dajanje v promet fitofarmacevtskih sredstev za omejeno in nadzorovano uporabo, če je ta ukrep potreben zaradi nevarnosti, ki je ni mogoče obvladati z drugimi ustreznimi ukrepi.

The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety.

Zadevna država članica takoj obvesti druge države članice in Komisijo o sprejetih ukrepih, vključno s podrobnimi informacijami o položaju in ukrepih, sprejetih za zagotovitev varstva potrošnikov.

2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance.

2. Komisija lahko Agencijo prosi za mnenje ali znanstveno ali tehnično pomoč.

The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request.

Agencija svoje mnenje ali rezultate svojega dela Komisiji zagotovi v enem mesecu od datuma predložitve zahteve.

3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State:

3. Če je potrebno, se v skladu z regulativnim postopkom iz člena 79(3) sprejme odločitev o tem, če in pod kakšnimi pogoji država članica:

(a) may or may not extend the duration of the measure or repeat it; or

(a) sme ali ne sme podaljšati ali ponoviti ukrepa; ali

(b) shall withdraw or amend its measure.

(b) prekliče ali spremeni svoj ukrep.

4. Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC.

4. Odstavki 1 do 3 se ne uporabljajo za fitofarmacevtska sredstva, ki vsebujejo gensko spremenjene organizme ali so sestavljena iz njih, razen če je bila takšna sprostitev sprejeta v skladu z Direktivo 2001/18/ES.

Article 54

Člen 54

Research and development

Raziskave in razvoj

1. By way of derogation from Article 28, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product or involving unauthorised use of a plant protection product may be carried out if the Member State in whose territory the experiment or test is to be carried out has assessed the available data and granted a permit for trial purposes. The permit may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005.

1. Z odstopanjem od člena 28 se preskusi ali testi za raziskovalne in razvojne namene, ki vključujejo izpust neregistriranega fitofarmacevtskega sredstva v okolje ali vključujejo nedovoljeno uporabo fitofarmacevtskih sredstev, lahko izvajajo, če je država članica, v kateri se izvaja preskus ali test, ocenila razpoložljive podatke in izdala dovoljenje za preskusne namene. Dovoljenje lahko omeji uporabljeno količino in obravnavana področja ter določi dodatne pogoje za preprečevanje škodljivih vplivov na zdravje ljudi ali živali in nesprejemljivih škodljivih vplivov na okolje, kot je potreba po preprečevanju vstopa v prehranjevalno verigo hrane in krme, ki vsebuje ostanke, razen če je bila v skladu z Uredbo (ES) št. 396/2005 že uveljavljena ustrezna določba.

The Member State may authorise a programme of experiments or tests in advance or require a permit for each experiment or test.

Država članica lahko odobri program preskusov ali testov vnaprej ali zahteva dovoljenje za vsak preskus ali test.

2. An application shall be submitted to the Member State in whose territory the experiment or test is to be conducted, together with a dossier containing all the available data to permit an assessment of possible effects on human or animal health or the possible impact on the environment.

2. Vloga se predloži državi članici, v kateri se izvaja preskus ali test, vključno z dokumentacijo, ki vsebuje vse razpoložljive podatke, za odobritev ocene možnih posledic za zdravje ljudi ali živali ali možen vpliv na okolje.

3. A permit for trial purposes shall not be granted for experiments or tests involving the release into the environment of a genetically modified organism unless such release has been accepted under Directive 2001/18/EC.

3. Dovoljenje v preskusne namene se ne izda za preskuse ali teste, ki vključujejo izpust gensko spremenjenih organizmov v okolje, razen če je bil ta izpust sprejet v skladu z Direktivo 2001/18/ES.

4. Paragraph 2 shall not apply if the Member State has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken.

4. Odstavek 2 se ne uporablja, če je država članica zadevni osebi dala pravico do opravljanja nekaterih poskusov in testov ter določila pogoje, v katerih je preskuse in teste treba opraviti.

5. Detailed rules for the implementation of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

5. Podrobna pravila za izvajanje tega člena, zlasti največje količine fitofarmacevtskih sredstev, ki se lahko sproščajo med preskusi ali testi, ter najmanjše število podatkov, ki jih je treba predložiti v skladu z odstavkom 2, se lahko sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 79(4).

SECTION 2

ODDELEK 2

Use and information

Uporaba in informacije

Article 55

Člen 55

Use of plant protection products

Uporaba fitofarmacevtskih sredstev

Plant protection products shall be used properly.

Fitofarmacevtska sredstva se pravilno uporabljajo.

Proper use shall include the application of the principles of good plant protection practice and compliance with the conditions established in accordance with Article 31 and specified on the labelling. It shall also comply with the provisions of Directive 2009/128/EC and, in particular, with general principles of integrated pest management, as referred to in Article 14 of and Annex III to that Directive, which shall apply at the latest by 1 January 2014.

Pravilna uporaba vključuje uporabo načel dobre prakse varstva rastlin in skladnost s pogoji iz člena 31, ki so navedeni na etiketi. Sklada se tudi z določili Direktive 2009/128/ES in zlasti s splošnimi načeli integriranega varstva rastlin pred škodljivimi organizmi, kot je določeno v členu 13 in Prilogi III k navedeni direktivi, ki se začne uporabljati najpozneje s 1. januarjem 2014.

Article 56

Člen 56

Information on potentially harmful or unacceptable effects

Informacije o možnih škodljivih ali nesprejemljivih vplivih

1. The holder of an authorisation for a plant protection product shall immediately notify the Member States that granted an authorisation of any new information concerning that plant protection product, the active substance, its metabolites, a safener, synergist or co-formulant contained in the plant protection product, which suggests that the plant protection product no longer complies with the criteria set out in Articles 29 and 4 respectively.

1. Imetnik registracije za fitofarmacevtsko sredstvo takoj obvesti države članice, ki so izdale registracijo, o kakršnih koli novih informacijah v zvezi s fitofarmacevtskim sredstvom, aktivno snovjo, metaboliti, varovalom, sinergistom ali dodatki, ki jih vsebuje fitofarmacevtsko sredstvo, iz katerih je razvidno, da fitofarmacevtsko sredstvo ne izpolnjuje več meril iz člena 29 oziroma 4.

In particular, potentially harmful effects of that plant protection product, or of residues of an active substance, its metabolites, a safener, synergist or co-formulant contained in it, on human or animal health or on groundwater, or their potentially unacceptable effects on plants or plant products or the environment shall be notified.

Zlasti je pomembno obvestilo o možnih škodljivih učinkih tega fitofarmacevtskega sredstva ali ostankov aktivne snovi, metabolitov, varovala, sinergista ali dodatka, ki jih vsebuje, na zdravje ljudi ali živali ali na podzemno vodo, ali njihovih možnih nesprejemljivih učinkih na rastline ali rastlinske proizvode ali okolje.

To this end the authorisation holder shall record and report all suspected adverse reactions in humans, in animals and the environment related to the use of the plant protection product.

Zato imetnik registracije zabeleži vse mogoče škodljive reakcije pri ljudeh, živalih in v okolju, povezane z uporabo fitofarmacevtskega sredstva, in poroča o njih.

The obligation to notify shall include relevant information on decisions or assessments by international organisations or by public bodies which authorise plant protection products or active substances in third countries.

Obveznost uradnega obveščanja zajema ustrezne informacije o odločitvah ali ocenah mednarodnih organizacij in javnih organov, ki registrirajo fitofarmacevtska sredstva ali aktivne snovi v tretjih državah.

2. The notification shall include an assessment of whether and how the new information would result in the plant protection product or the active substance, its metabolites, a safener, or synergist or co-formulant no longer complying with the requirements set out in Article 29 and Article 4 or Article 27, respectively.

2. Uradno obvestilo zajema oceno o tem, ali in kako nove informacije povzročijo, da fitofarmacevtsko sredstvo ali aktivna snov, metaboliti, varovalo, sinergist ali dodatek niso več v skladu z zahtevami iz člena 29 in člena 4 oziroma 27.

3. Without prejudice to the right of Member States to adopt interim protective measures, the Member State which first granted an authorisation within each zone shall evaluate the information received and inform the other Member States, belonging to the same zone, where it decides to withdraw or amend the authorisation under Article 44.

3. Brez poseganja v pravico držav članic, da sprejmejo začasne varnostne ukrepe, država članica, ki je prva izdala registracijo v vsaki coni, oceni prejete informacije in obvesti druge države članice, ki sodijo v isto cono, kjer se odloči za preklic ali spremembo registracije v skladu s členom 44.

That Member State shall inform the other Member States and the Commission where it considers that the conditions of the approval of the active substance, safener or synergist contained in the plant protection product are no longer fulfilled or whether in the case of a co-formulant it has been considered unacceptable and propose that the approval be withdrawn or the conditions amended.

Ta država članica obvesti druge države članice in Komisijo, če meni, da pogoji za odobritev aktivne snovi, varovala, sinergista v fitofarmacevtskem sredstvu niso izpolnjeni – ali, v primeru dodatka, štejejo za nesprejemljive – in predlaga, da se prekliče registracija ali spremenijo pogoji.

4. The holder of an authorisation for a plant protection product shall report annually to the competent authorities of the Member States which authorised his plant protection product if he has any information available relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment.

4. Imetnik registracije za fitofarmacevtsko sredstvo letno poroča pristojnim organom države članice, ki je registrirala fitofarmacevtsko sredstvo, če ima kakršne koli razpoložljive informacije, povezane s pomanjkanjem pričakovane učinkovitosti, razvojem odpornosti in katerim koli nepričakovanim vplivom na rastline, rastlinske proizvode ali okolje.

Article 57

Člen 57

Obligation to keep information available

Obveznost dajanja informacij na voljo

1. Member States shall keep information electronically available to the public on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least:

1. Države članice dajejo javnosti na voljo v elektronski obliki informacije o fitofarmacevtskih sredstvih, registriranih ali preklicanih v skladu s to uredbo, ki vključujejo vsaj:

(a) the name or business name of the holder of the authorisation and the authorisation number;

(a) ime ali naziv podjetja imetnika registracije in številko registracije;

(b) the trade name of the product;

(b) trgovsko ime sredstva;

(d) the name and amount of each active substance, safener or synergist which it contains;

(d) ime in količino vseh aktivnih snovi, varoval ali sinergistov, ki jih vsebuje;

(e) the classification, risk and safety phrases in accordance to Directive 1999/45/EC and to the Regulation referred to in Article 65;

(e) razvrstitev, opozorilne in obvestilne stavke v skladu z Direktivo 1999/45/ES in uredbo, omenjeno v členu 65;

(f) the use or uses for which it is authorised;

(f) uporabo ali več vrst uporabe, za katere je registrirano;

(g) the reasons for withdrawal of an authorisation if they are related to safety concerns;

(g) razloge za preklic registracije, če so povezani s skrbjo za varnost;

(h) the list of minor uses referred to in Article 51(8).

(h) seznam manjših uporab iz člena 51(8).

2. The information referred to in paragraph 1 shall be readily accessible and updated at least once every 3 months.

2. Informacije iz odstavka 1 so zlahka dostopne in posodobljene najmanj enkrat na tri mesece.

3. In accordance with the regulatory procedure referred to in Article 79(3), an authorisation information system may be set up to facilitate the application of paragraphs 1 and 2 of this Article.

3. V skladu z regulativnim postopkom iz člena 79(3) se lahko za lažjo uporabo odstavkov 1 in 2 tega člena vzpostavi informacijski sistem za registracije.

CHAPTER IV

POGLAVJE IV

ADJUVANTS

POMOŽNA SREDSTVA

Article 58

Člen 58

Placing on the market and use of adjuvants

Dajanje v promet in uporaba pomožnih sredstev

1. An adjuvant shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with the conditions established in the Regulation referred to in paragraph 2.

1. Pomožno sredstvo se ne da v promet in se ne uporabi, če ga zadevna država članica ni registrirala v skladu s pogoji uredbe iz odstavka 2.

2. Detailed rules for the authorisation of adjuvants, including data requirements, notification, evaluation, assessment and decision making procedures shall be set out in a Regulation to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

2. Podrobna pravila za registracijo pomožnih sredstev, tudi zahteve po podatkih, obveščanje, vrednotenje, ocenjevanje in odločanje se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 79(4).

3. Article 81(3) shall apply.

3. Uporablja se člen 81(3).

CHAPTER V

POGLAVJE V

DATA PROTECTION AND DATA SHARING

VARSTVO IN IZMENJAVA PODATKOV

Article 59

Člen 59

Data protection

Varstvo podatkov

1. Test and study reports shall benefit from data protection under the conditions laid down in this Article.

1. Za poročila o preskusih in študijah velja varstvo podatkov v skladu s pogoji iz tega člena.

The protection shall apply to test and study reports concerning the active substance, safener or synergist, adjuvants and the plant protection product as referred to in Article 8(2) when they are submitted to a Member State by an applicant for authorisation under this Regulation, (the first applicant), provided that those test and study reports were:

Varstvo se uporablja za poročila o preskusih in študijah v zvezi z aktivno snovjo, varovalom ali sinergistom, dodatkom in s fitofarmacevtskim sredstvom, kakor je navedeno v členu 8(2), kadar jih državi članici predloži vlagatelj registracije v skladu s to uredbo (prvi vlagatelj), če so bila ta poročila o preskusih in študijah:

(a) necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop; and

(a) potrebna za registracijo ali spremembo registracije, da se dovoli uporaba na drugem pridelku, in

(b) certified as compliant with the principles of good laboratory practice or of good experimental practice.

(b) potrjena kot skladna z načeli dobre laboratorijske prakse ali dobre preskusne prakse.

Where a report is protected, it may not be used by the Member State which received it for the benefit of other applicants for authorisation of plant protection products, safeners or synergists and adjuvants, except as provided in paragraph 2 of this Article, in Article 62 or in Article 80.

Če je poročilo zaščiteno, ga država članica, ki ga je prejela, ne sme uporabljati v korist drugih vlagateljev za registracijo fitofarmacevtskih sredstev, varoval ali sinergistov in pomožnih sredstev, razen v skladu z odstavkom 2, členom 62 ali členom 80.

The period of data protection is 10 years starting at the date of first authorisation in that Member State, except as provided in paragraph 2 of this Article or in Article 62. That period is extended to 13 years for plant protection products covered by Article 47.

Obdobje varstva podatkov je deset let od datuma prve registracije v zadevni državi članici, razen kot je določeno v odstavku 2 ali v členu 62. Za fitofarmacevtska sredstva iz člena 47 se obdobje podaljša na 13 let.

Those periods shall be extended by 3 months for each extension of authorisation for minor uses as defined in Article 51(1), except where the extension of authorisation is based on extrapolation, if the applications for such authorisations are made by the authorisation holder at the latest 5 years after the date of the first authorisation in that Member State. The total period of data protection may in no case exceed 13 years. For plant protection products covered by Article 47 the total period of data protection may in no case exceed 15 years.

Ta obdobja se podaljšajo za tri mesece za vsako razširitev registracije na manjšo uporabo, kakor je opredeljeno v členu 51(1), razen če razširitev registracije temelji na ekstrapolaciji, če imetnik registracije vloži vlogo za tako registracijo najpozneje 5 let po datumu prve registracije v zadevni državi članici. Celotno obdobje varstva podatkov ne sme v nobenem primeru biti daljše od 13 let. Za fitofarmacevtska sredstva iz člena 47 celotno obdobje varstva podatkov ne sme v nobenem primeru biti daljše od 15 let.

The same data protection rules as for the first authorisation shall also apply to test and study reports submitted by third parties for the purpose of extension of authorisation for minor uses as referred to in Article 51(1).

Ista pravila o varstvu podatkov kot za prvo registracijo se uporabijo tudi za poročila o preskusih in študijah, ki jih predložijo tretje strani za razširitev registracije na manjše uporabe iz člena 51(1).

A study shall also be protected if it was necessary for the renewal or review of an authorisation. The period for data protection shall be 30 months. The first to fourth subparagraphs shall apply mutatis mutandis.

Študija se tudi zaščiti, če je bilo to potrebno za podaljšanje ali pregled registracije. Obdobje varovanja podatkov je 30 mesecev. Prvi do četrti pododstavek se uporabljajo smiselno.

2. Paragraph 1 shall not apply:

2. Odstavek 1 se ne uporablja:

(a) to test and study reports for which the applicant has submitted a letter of access; or

(a) za poročila o preskusih in študijah, za katere je vlagatelj predložil izjavo o dostopu; ali

(b) where any period of data protection granted for the test and study reports concerned in relation to another plant protection product has expired.

(b) če je poteklo obdobje varstva podatkov, odobreno za zadevna poročila o preskusih in študijah v zvezi z drugim fitofarmacevtskim sredstvom.

3. Data protection under paragraph 1 shall only be granted where the first applicant has claimed data protection for test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product at the time of submitting the dossier and has provided to the Member State concerned for each test or study report the information referred to in point (f) of Article 8(1) and in point (d) of Article 33(3) as well as confirmation that a period of data protection has never been granted for the test or study report or that any period granted has not expired.

3. Varstvo podatkov iz odstavka 1 se odobri le, kadar prvi vlagatelj predloži zahtevo za varstvo podatkov za poročila o preskusih in študijah v zvezi z aktivno snovjo, varovalom ali sinergistom, pomožnim sredstvom in s fitofarmacevtskim sredstvom istočasno s predložitvijo dokumentacije in zadevni državi članici za vsako poročilo o preskusih ali študijah zagotovi informacije iz členov 8(1)(f) in 33(3)(d) ter potrditev, da obdobje varstva podatkov za poročilo o preskusih in študijah nikoli ni bilo odobreno ali da odobreno obdobje varstva ni poteklo.

Article 60

Člen 60

List of test and study reports

Seznam poročil o preskusih in študijah

1. For each active substance, safener and synergist and adjuvant, rapporteur Member States shall prepare a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and make it available to the Member States and the Commission.

1. Država članica poročevalka za vsako aktivno snov, varovalo, sinergist in pomožno sredstvo pripravi seznam poročil o preskusih in študijah, potrebnih za prvo odobritev, spremembo pogojev za odobritev ali podaljšanje odobritve, in ga da na voljo državam članicam in Komisiji.

2. For each plant protection product which they authorise, Member States shall keep and make available to any interested party upon request:

2. Na zahtevo katere koli zainteresirane strani dajo države članice za vsako fitofarmacevtsko sredstvo, ki ga registrirajo, hranijo in dajo na voljo:

(a) a list of the test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; and

(a) seznam poročil o preskusih in študijah v zvezi z aktivno snovjo, varovalom ali sinergistom, pomožnim sredstvom in fitofarmacevtskim sredstvom, potrebnih za prvo registracijo, spremembo pogojev registracije ali podaljšanje registracije; ter

(b) a list of test and study reports for which the applicant claimed data protection under Article 59 and any reasons submitted in accordance with that Article.

(b) seznam poročil o preskusih in študijah, v zvezi s katerimi je vlagatelj predložil zahtevo za varstvo podatkov v skladu s členom 59, in utemeljitve, predložene v skladu s tem členom.

3. The lists provided for in paragraphs 1 and 2 shall include information on whether those test and study reports were certified as compliant with the principles of good laboratory practice or of good experimental practice.

3. Seznami iz odstavkov 1 in 2 zajemajo informacije o tem, ali so bila ta poročila o preskusih in študijah potrjena kot skladna z načeli dobre laboratorijske prakse ali načeli dobre preskusne prakse.

Article 61

Člen 61

General rules on avoidance of duplicative testing

Splošna pravila o izogibanju podvajanja preskusov

1. In order to avoid duplicative testing, any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the information referred to in Article 57 to ascertain if and to whom an authorisation has already been granted for a plant protection product containing the same active substance, safener or synergist or for an adjuvant. The competent authority shall on request from the prospective applicant provide him with the list of test and study reports prepared in accordance with Article 60 for that product.

1. Da bi se izognili podvajanju preskusov, osebe, ki želijo pridobiti registracijo za fitofarmacevtsko sredstvo, pred izvajanjem preskusov ali študij preverijo informacije iz člena 57, da ugotovijo, če in komu je bila registracija za fitofarmacevtsko sredstvo, ki vsebuje enako aktivno snov, varovalo ali enak sinergist, ali za pomožno sredstvo že odobrena. Na zahtevo morebitnega vlagatelja mu pristojni organ zagotovi seznam poročil o preskusih in študijah, pripravljenih za to sredstvo v skladu s členom 60.

The prospective applicant shall submit all data regarding the identity and impurities of the active substance he proposes to use. The enquiry shall be supported by evidence that the prospective applicant intends to apply for an authorisation.

Morebitni vlagatelj predloži podatke v zvezi z vrsto in nečistočami aktivne snovi, ki jo želi uporabiti. Pri takšni poizvedbi se predložijo dokazi, da namerava morebitni vlagatelj vložiti vlogo za registracijo.

2. The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or review thereof, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant.

2. Če ima pristojni organ države članice dokaz, da morebitni vlagatelj namerava vložiti zahtevek za registracijo, njeno podaljšanje ali pregled, mu zagotovi ime in naslov imetnika ali imetnikov obstoječih zadevnih registracij ter hkrati sporoči imetnikom registracij ime in naslov vlagatelja.

3. The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 59, in a fair, transparent and non-discriminatory way.

3. Morebitni vlagatelj registracije, njenega podaljšanja ali pregleda, ter imetnik ali imetniki zadevnih registracij sprejmejo vse ustrezne ukrepe za dosego dogovora o izmenjavi poročil o preskusih in študijah, varovanih v skladu s členom 59, na pravičen, pregleden in nediskriminatoren način.

Article 62

Člen 62

Sharing of tests and studies involving vertebrate animals

Izmenjava preskusov in študij, ki vključujejo vretenčarje

1. Testing on vertebrate animals for the purposes of this Regulation shall be undertaken only where no other methods are available. Duplication of tests and studies on vertebrates undertaken for the purposes of this Regulation shall be avoided in accordance with paragraphs 2 to 6.

1. Preskusi na vretenčarjih za potrebe te uredbe se izvajajo samo takrat, kadar ni na voljo nobena druga metoda. V skladu z odstavki 2 do 6 se podvajanju preskusov na vretenčarjih in študij o njih za potrebe te uredbe izogiba.

2. Member States shall not accept duplication of tests and studies on vertebrate animals or those initiated where conventional methods described in Annex II to Directive 1999/45/EC could reasonably have been used, in support of applications for authorisations. Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated.

2. Države članice ne sprejmejo podvajanja preskusov na vretenčarjih in študij o njih, oziroma začetih preskusov in študij, pri katerih bi se lahko ustrezno uporabljale konvencionalne metode v podporo vlogam za registracijo iz Priloge II k Direktivi 1999/45/ES. Oseba, ki namerava izvajati preskuse in študije, ki vključujejo vretenčarje, sprejme ukrepe, potrebne za potrditev, da se ti preskusi in študije še niso začeli ali so že bili izvedeni.

3. The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements.

3. Morebitni vlagatelj in imetnik ali imetniki zadevnih registracij si prizadevajo za zagotovitev izmenjave preskusov in študij, ki vključujejo vretenčarje. Stroški izmenjave poročil o preskusih in študijah se določijo pošteno, pregledno in nediskriminatorno. Morebitni vlagatelj krije stroške le za tiste informacije, ki jih mora predložiti za izpolnitev zahtev za registracijo.

4. Where the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist, or of adjuvants cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State referred to in Article 61(1).

4. Če se morebitni vlagatelj in imetnik ali imetniki zadevnih registracij fitofarmacevtskih sredstev, ki vsebujejo enako aktivno snov, varovalo ali enak sinergist, ali pomožnih sredstev ne morejo sporazumeti o izmenjavi poročil o preskusih in študijah, ki vključujejo vretenčarje, morebitni vlagatelj obvesti pristojni organ države članice iz člena 61(1).

The failure to reach agreement, as provided in paragraph 3, shall not prevent the competent authority of that Member State from using the test and study reports involving vertebrate animals for the purpose of the application of the prospective applicant.

Če morebitni vlagatelj in imetniki zadevnih registracij ne uspejo doseči dogovora, v skladu z odstavkom 3, to pristojnim organom države članice ne prepreči uporabe poročil o preskusih in študijah, ki vključujejo vretenčarje, s strani pristojnega organa za namene vloge morebitnega vlagatelja.

5. By 14 December 2016, the Commission shall report on the effects of the provisions in this Regulation concerning data protection of tests and studies involving vertebrate animals. The Commission shall submit this report to the European Parliament and the Council accompanied, if necessary, by an appropriate legislative proposal.

5. Komisija najpozneje do 14. decembra 2016 poroča o učinkih določb te uredbe, ki se nanašajo na varstvo podatkov o preskusih in študijah na vretenčarjih. Komisija Evropskemu parlamentu in Svetu skupaj s poročilom po potrebi predloži ustrezen zakonodajni predlog.

6. The holder or holders of the relevant authorisation shall have a claim on the prospective applicant for a fair share of the costs incurred by him. The competent authority of the Member State may direct the parties involved to resolve the matter by formal and binding arbitration administered under national law. Otherwise the parties may resolve the matter through litigation in the courts of the Member States. Awards from arbitration or litigation shall have regard to the principles determined in paragraph 3 and shall be enforceable in the courts of the Member States.

6. Imetnik ali imetniki zadevne registracije lahko od morebitnega vlagatelja zahteva(-jo) plačilo pravičnega deleža stroškov, kot jih je(so) imel(-i) sam(-i). Pristojni organ države članice lahko zadevnim strankam predlaga, da zadevo reši s formalno in zavezujočo arbitražo v skladu z nacionalno zakonodajo. Stranke lahko zadevo rešijo tudi v okviru sodnega postopka na sodiščih držav članic. Arbitražne ali sodne odločbe bodo upoštevale načela iz odstavka 3 in bodo izvršljive na sodiščih držav članic.

CHAPTER VI

POGLAVJE VI

PUBLIC ACCESS TO INFORMATION

JAVNI DOSTOP DO INFORMACIJ

Article 63

Člen 63

Confidentiality

Zaupnost

1. A person requesting that information submitted under this Regulation is to be treated as confidential shall provide verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual.

1. Oseba, ki zahteva, da se informacije, predložene v skladu s to uredbo, obravnavajo kot zaupne, zagotovi preverljivo utemeljitev, da lahko razkritje informacij ogrozi poslovne interese ali varstvo zasebnosti in integritete posameznika.

2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned:

2. Za razkritje naslednjih informacij običajno velja, da ogroža zaščito poslovnih interesov ali zasebnosti in integriteto zadevnega posameznika:

(a) the method of manufacture;

(a) način proizvodnje;

(b) the specification of impurity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;

(b) specifikacija nečistosti aktivne snovi, razen nečistoč, ki se štejejo za toksikološko, ekotoksikološko ali okoljsko relevantne;

(d) methods of analysis for impurities in the active substance as manufactured except for methods for impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;

(d) metode analiz nečistoč v aktivni snovi, kakor je proizvedena, razen metod za nečistoče, ki se štejejo za toksikološko, ekotoksikološko ali okoljsko relevantne;

(e) links between a producer or importer and the applicant or the authorisation holder;

(e) povezave med proizvajalcem ali uvoznikom in vlagateljem ali imetnikom registracije;

(f) information on the complete composition of a plant protection product;

(f) informacije o celotni sestavi fitofarmacevtskega sredstva;

(g) names and addresses of persons involved in testing on vertebrate animals.

(g) imena in naslovi oseb, ki so povezani z izvajanjem preskusov na vretenčarjih.

3. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information [19].

3. Ta člen ne posega v Direktivo 2003/4/ES Evropskega parlamenta in Sveta z dne 28. januarja 2003 o dostopu javnosti do informacij o okolju [19].

CHAPTER VII

POGLAVJE VII

PACKAGING, LABELLING AND ADVERTISING OF PLANT PROTECTION PRODUCTS AND ADJUVANTS

PAKIRANJE, OZNAČEVANJE IN OGLAŠEVANJE FITOFARMACEVTSKIH SREDSTEV IN POMOŽNIH SREDSTEV

Article 64

Člen 64

Packaging and presentation

Pakiranje in predstavitev

1. Plant protection products and adjuvants that may be mistaken for food, drink or feed shall be packaged in such a way as to minimise the likelihood of such a mistake being made.

1. Fitofarmacevtska sredstva in pomožna sredstva, ki jih je mogoče zmotno imeti za hrano, pijačo ali krmo, se pakirajo tako, da se zmanjša verjetnost take zmote.

2. Plant protection products and adjuvants available to the general public that may be mistaken for food, drink or feed shall contain components to discourage or prevent their consumption.

2. Fitofarmacevtska sredstva in pomožna sredstva, ki so na voljo splošni javnosti in jih je mogoče zmotno imeti za hrano, pijačo ali krmo, vsebujejo sestavne dele za omejevanje ali preprečevanje njihove porabe.

3. Article 9 of Directive 1999/45/EC shall also apply to plant protection products and adjuvants not covered by that Directive.

3. Člen 9 Direktive 1999/45/ES se uporablja tudi za fitofarmacevtska sredstva, ki niso zajeta v navedeni direktivi.

Article 65

Člen 65

Labelling

Označevanje

1. The labelling of plant protection products shall include the classification, labelling and packaging requirements of Directive 1999/45/EC and shall comply with the requirements set out in a Regulation adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

1. Označevanje fitofarmacevtskih sredstev vključuje zahteve glede razvrščanja, označevanja in pakiranja iz Direktive 1999/45/ES in je v skladu z zahtevami, določenimi v uredbi, sprejeti v skladu z regulativnim postopkom s pregledom iz člena 79(4).

That Regulation shall also contain standard phrases for special risks and safety precautions which supplement the phrases provided for by Directive 1999/45/EC. It shall incorporate the text of Article 16 of and the text of the Annexes IV and V to Directive 91/414/EEC with any necessary modifications.

Ta uredba vključuje tudi standardne stavke za posebna tveganja in varnostne ukrepe, ki dopolnjujejo stavke iz Direktive 1999/45/ES. Zajema besedilo člena 16 ter prilog IV in V k Direktivi 91/414/EGS z vsemi potrebnimi spremembami.

2. Member States may require samples or mock-ups of the packaging and drafts of labels and leaflets to be submitted before the authorisation is granted.

2. Države članice lahko zahtevajo vzorce ali modele embalaže ter osnutke etiket in letakov, ki jih je treba predložiti pred izdajo registracije.

3. Where a Member State considers that additional phrases are necessary to protect human or animal health or the environment, it shall notify the other Member States and the Commission forthwith and shall forward the additional phrase or phrases and the reasons for these requirements.

3. Če država članica meni, da so potrebni dodatni stavki za varovanje zdravja ljudi ali živali ali okolja, o tem obvesti druge države članice in Komisijo ter posreduje dodaten stavek ali stavke in razloge za te zahteve.

Such phrases shall be considered for inclusion in the Regulation referred to in paragraph 1.

Pretehta se vključitev takšnih stavkov v uredbo iz odstavka 1.

Pending that inclusion, the Member State may require the use of the additional phrase or phrases.

Do te vključitve lahko država članica zahteva uporabo dodatnega stavka ali stavkov.

Article 66

Člen 66

Advertising

Oglaševanje

1. Plant protection products which are not authorised shall not be advertised. Every advertisement for a plant protection product shall be accompanied by the sentences "Use plant protection products safely. Always read the label and product information before use". These sentences shall be easily legible and clearly distinguishable in relation to the whole advertisement. The words "plant protection products" may be replaced by a more precise description of the product-type, such as fungicide, insecticide or herbicide.

1. Fitofarmacevtska sredstva, ki niso registrirana, se ne oglašujejo. V vsako oglaševanje fitofarmacevtskega sredstva se vključita stavka "Fitofarmacevtsko sredstvo uporabljajte varno. Pred uporabo vedno preberite etiketo in informacije o sredstvu". Oba stavka morata biti jasno berljiva in jasno ločena od celotnega oglasa. Izraz "fitofarmacevtska sredstva" lahko nadomesti podrobnejši opis vrste proizvoda, kot so fungicid, insekticid ali herbicid.

2. The advertisement shall not include information in text or graphic form which could be misleading as regards possible risks to human or animal health or to the environment, such as the terms "low risk", "non-toxic" or "harmless".

2. Oglas ne vključuje informacij v tekstovni ali grafični obliki, ki bi bile lahko zavajajoče v zvezi z možnimi tveganji za zdravje ljudi ali živali ali okolje, kot so izrazi "majhno tveganje", "nestrupeno" ali "neškodljivo".

Only in the case of low-risk plant protection products shall the term "authorised as low-risk plant protection product in accordance with Regulation (EC) No 1107/2009" be allowed in the advertisement. It cannot be used as a claim on the label of the plant protection product.

Samo v primeru fitofarmacevtskih sredstev z majhnim tveganjem se izraz "registrirano kot fitofarmacevtsko sredstvo z majhnim tveganjem v skladu z Uredbo (ES) št. 1107/2009" dovoli v oglaševanju. Ne sme pa se uporabiti na etiketi fitofarmacevtskega sredstva.

3. Member States may prohibit or restrict the advertising of plant protection products in certain media, subject to Community law.

3. Države članice lahko v skladu z zakonodajo Skupnosti prepovejo ali omejijo oglaševanje fitofarmacevtskih sredstev v nekaterih sredstvih javnega obveščanja.

4. All statements used in advertising shall be technically justifiable.

4. Vse izjave, ki se uporabljajo pri oglaševanju, so tehnično utemeljene.

5. Advertisements shall not contain any visual representation of potentially dangerous practices, such as mixing or application without sufficient protective clothing, nor any use near food or use by or in the vicinity of children.

5. Oglasi ne vsebujejo prikazov morebitnih nevarnih postopkov, kot je mešanje ali uporaba brez ustrezne zaščitne obleke, uporabe v bližini hrane ali uporabe s strani otrok ali v njihovi bližini.

6. Advertising or promotional material shall draw attention to the appropriate warning phrases and symbols as laid down in the labelling.

6. Oglas ali promocijski material opozarja na ustrezne opozorilne stavke in simbole, navedene na etiketi.

CHAPTER VIII

POGLAVJE VIII

CONTROLS

NADZOR

Article 67

Člen 67

Record-keeping

Vodenje evidence

1. Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used.

1. Proizvajalci, dobavitelji, distributerji, uvozniki in izvozniki fitofarmacevtskih sredstev vodijo evidenco v zvezi s fitofarmacevtskimi sredstvi, ki jih proizvajajo, uvažajo, izvažajo, skladiščijo, uporabljajo ali dajejo v promet in jo hranijo najmanj pet let. Poklicni uporabniki fitofarmacevtskih sredstev vodijo evidenco o fitofarmacevtskih sredstvih, ki jih uporabljajo in jo hranijo najmanj tri leta, vključno z imenom fitofarmacevtskega sredstva, časom nanašanja in odmerkom ter površino in kulturo, na kateri je bilo uporabljeno fitofarmacevtsko sredstvo.

They shall make the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority.

Na zahtevo pristojnega organa dajo na voljo ustrezne podatke iz teh evidenc. Tretje strani, kot je sektor za gospodarjenje s pitno vodo, trgovci na drobno in prebivalci, lahko od pristojnega organa zahtevajo dostop do teh informacij.

The competent authorities shall provide access to such information in accordance with applicable national or Community law.

Pristojni organi zagotovijo dostop do teh informacij v skladu z veljavno nacionalno zakonodajo ali zakonodajo Skupnosti.

By 14 December 2012, the Commission shall present a report to the European Parliament and the Council on the costs and benefits of the traceability of information from users to retailers concerning the applications of plant protection products on agricultural products, accompanied, if necessary, by appropriate legislative proposals.

Komisija Evropskemu parlamentu in Svetu najpozneje do 14. decembra 2012 predloži poročilo o stroških in koristih sledljivosti informacij glede uporabe fitofarmacevtskih sredstev na kmetijskih proizvodih od uporabnikov do trgovcev na drobno, skupaj s poročilom pa po potrebi predloži ustrezne zakonodajne predloge.

2. Producers of plant protection products shall undertake post-authorisation monitoring on the request of the competent authorities. They shall notify the competent authorities of the relevant results.

2. Po registraciji proizvajalci fitofarmacevtskih sredstev na zahtevo pristojnih organov zagotovijo spremljanje. Pristojne organe obvestijo o ustreznih rezultatih.

3. Authorisation holders shall provide the competent authorities of the Member States with all data relating to the volume of sales of plant protection products in accordance with Community legislation concerning statistics on plant protection products.

3. Imetniki registracij zagotovijo pristojnim organom držav članic potrebne podatke o obsegu prodaje fitofarmacevtskih sredstev v skladu z zakonodajo Skupnosti o statistki fitofarmacevtskih sredstev.

4. Implementing measures to ensure the uniform application of paragraphs 1, 2 and 3 may be adopted in accordance with the regulatory procedure referred to in Article 79(3).

4. Izvedbeni ukrepi za zagotovitev enotne uporabe odstavkov 1, 2 in 3 se lahko sprejmejo v skladu z regulativnim postopkom iz člena 79(3).

Article 68

Člen 68

Monitoring and controls

Spremljanje in nadzor

Member States shall carry out official controls in order to enforce compliance with this Regulation. They shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the reports relate.

Države članice izvajajo uradni nadzor za zagotavljanje skladnosti s to uredbo. Prav tako dokončajo poročilo o področju uporabe in rezultatih teh nadzorov ter ga posredujejo Komisiji v šestih mesecih od konca leta, na katerega se to poročilo navezuje.

Commission experts shall carry out general and specific audits in the Member States for purposes of verifying the official controls carried out by the Member States.

Strokovnjaki Komisije izvedejo splošne in posebne revizije v državah članicah za preverjanje uradnih nadzorov, ki jih te izvajajo.

A Regulation, adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4), shall set out provisions for the controls, in particular on the production, packaging, labelling, storage, transport, marketing, formulation, parallel trade and use of plant protection products. It shall also contain provisions concerning the collection of information and reporting on suspected poisonings.

Uredba, sprejeta v skladu z regulativnim postopkom s pregledom iz člena 79(4), določa določbe za nadzor, predvsem v zvezi s proizvodnjo, pakiranjem, označevanjem, skladiščenjem, prevozom, trženjem, formulacijo, vzporedno trgovino in uporabo fitofarmacevtskih sredstev. Vsebuje tudi določbe v zvezi z zbiranjem podatkov in poročanjem o sumu zastrupitve.

CHAPTER IX

POGLAVJE IX

EMERGENCIES

IZREDNE RAZMERE

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