Regulation on biological plant protection

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Na podlagi drugega odstavka 52. ter drugega in sedmega odstavka 53. člena Zakona o zdravstvenem varstvu rastlin (Uradni list RS, št. 23/05 – uradno prečiščeno besedilo) izdaja ministrica za kmetijstvo, gozdarstvo in prehrano v soglasju z ministrom za okolje in prostor Pursuant to paragraph two of Article 52 and paragraphs two and seven of Article 53 of the Plant Health Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 23/05 – Official Consolidated Text), the Minister of Agriculture, Forestry and Food, in agreement with the Minister of the Environment and Spatial Planning, hereby issues the following P R A V I L N I K R U L E S o biotičnem varstvu rastlin on biological plant protection I. SPLOŠNE DOLOČBE I. GENERAL PROVISIONS 1. člen Article 1 (vsebina) (Subject) Ta pravilnik določa: These Rules lay down: seznam domorodnih in tujerodnih vrst organizmov za biotično varstvo rastlin; the list of indigenous and exotic species for biological plant protection; pogoje za vnos, gojenje in uporabo domorodnih in tujerodnih vrst organizmov za biotično varstvo rastlin; the conditions for introduction, cultivation and use of native and exotic species for biological plant protection; pogoje glede strokovne in tehnične usposobljenosti oziroma pogoje glede prostorov, opreme in kadrov za vnos, gojenje ali uporabo domorodnih in tujerodnih vrst organizmov za biotično varstvo rastlin in the conditions concerning professional and technical qualification or the conditions concerning premises, equipment and staff for the introduction, cultivation or use of native and exotic species for biological plant protection, and vsebino vloge za izdajo dovoljenja za vnos in uporabo tujerodnih vrst organizmov oziroma za gojenje koristnih organizmov. the content of applications for authorisations for the introduction and use of exotic species of organisms or cultivation of beneficial organisms. 2. člen Article 2 (neuporaba določb tega pravilnika) (Non-application of provisions of these Rules) Določbe tega pravilnika se ne uporabljajo za vnos in uporabo mikroorganizmov, ki jih urejajo predpisi s področja fitofarmacevtskih sredstev. Ti mikroorganizmi so določeni na seznamu aktivnih snovi v fitofarmacevtskih sredstvih iz priloge I Direktive Sveta 91/414/ES z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet (UL L št. 230 z dne 19. 8. 1991, str. 1, z vsemi spremembami). The provisions of these Rules shall not apply to the introduction and use of microorganisms which are subject to regulations in the field of plant protection products. Such microorganisms shall be specified in the list of active substances contained in plant protection products in Annex I of Council Directive 91/414/EC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1, as amended). 3. člen Article 3 (pomen izrazov) (Definitions) Izrazi, uporabljeni v tem pravilniku, imajo naslednji pomen: For the purposes of these Rules, the following definitions shall apply: koristni organizmi so domorodne ali tujerodne vrste organizmov, kot so živi naravni sovražniki, antagonisti ali kompetitorji ali njihovi produkti, in drugi organizmi, ki se morejo sami razmnoževati, vključno s tistimi, ki so pakirani ali formulirani kot komercialni proizvod, za biotično varstvo rastlin; beneficial organisms shall mean indigenous or exotic species of organisms, such as living natural enemies, antagonists or competitors or their products, and other self-replicating biotic entities, including those that are packed and formulated as commercial products intended for biological plant protection; vnos koristnega organizma je vsaka uporaba koristnega organizma na območju, kjer ni znano, da je navzoč ali je naravno navzoč (doselitev); introduction of a beneficial organism shall mean any use of a beneficial organism within a territory where it is not known to occur or naturally occur (re-population); naselitev je vnos koristnih organizmov v ekosistem, v katerem organizmi te vrste niso bili nikoli navzoči; establishment shall mean introduction of beneficial organisms into an ecosystem where organisms of such species did not exist previously; uporaba koristnih organizmov je izvajanje ukrepov zdravstvenega varstva rastlin v kmetijstvu in gozdarstvu s koristnimi organizmi; use of beneficial organisms shall mean application of plant protection measures in agriculture and forestry by means of beneficial organisms; gojenje je namnoževanje koristnih organizmov v nadzorovanih pogojih na podlagi izdelanega protokola gojenja koristnih organizmov, ki zagotavlja, da vrsta ne spremeni svojih fizioloških in morfoloških lastnosti; cultivation shall mean replication of beneficial organisms in a controlled environment pursuant to an established protocol on cultivating beneficial organisms which ensures that species preserve their physiological and morphological properties; trženje je vnos koristnih organizmov iz držav članic EU, vnos iz tretjih - marketing shall mean introduction of beneficial organisms from EU držav in prodaja oziroma vsakršna prepustitev tretji osebi; Member States, introduction from third countries and sale or any disposal to a third person; uporabnik je imetnik rastlin ali rastlinskih proizvodov, ki izvaja ukrepe zdravstvenega varstva rastlin na način biotičnega varstva rastlin; user shall mean a holder of plants or plant products carrying out plant health measures in the manner of biological control of plant pests; profesionalno gojenje koristnih organizmov je, če oseba goji koristne organizme z namenom trženja oziroma za lastno uporabo v tržni pridelavi rastlin. professional cultivation of beneficial organisms shall mean a person cultivating beneficial organisms intended to be placed on the market or for their own use in the market production of plants. 4. člen Article 4 (seznam koristnih organizmov) (List of beneficial organisms) (1) Koristni organizmi, katerih vnos, gojenje in uporaba je, v skladu s tem pravilnikom, dovoljena v Republiki Sloveniji, so razvrščeni v seznam domorodnih in seznam tujerodnih vrst organizmov. (1) Beneficial organisms whose introduction, cultivation and use is permitted in the Republic of Slovenia under these Rules, shall be classified in the lists of native and exotic species of organisms. (2) Seznama iz prejšnjega odstavka vodi Fitosanitarna uprava Republike Slovenije (v nadaljnjem besedilu: Uprava) na podlagi rezultatov raziskav, strokovnih oziroma znanstvenih člankov ali drugih uradnih dokazov in seznama koristnih organizmov Evropske organizacije za varstvo rastlin, standarda za fitosanitarne ukrepe o varni uporabi koristnih organizmov za biotično varstvo rastlin. (2) The lists referred to in the preceding paragraph shall be maintained by the Phytosanitary Administration of the Republic of Slovenia (hereinafter referred to as: Administration) on the basis of the results of research, professional or scientific articles or other official evidence, as well as on the list of beneficial organisms of the European plant protection organisation, and the standard for plant protection measures on the safe use of beneficial biological control agents. (3) Seznama iz prvega odstavka sta dostopna pri Upravi in na njenih spletnih straneh: http://www.furs.si. (3) The lists referred to in paragraph one shall be made available by the Administration and on its website: http://www.furs.si. II. POGOJI ZA VNOS, GOJENJE IN UPORABO KORISTNIH ORGANIZMOV II. CONDITIONS FOR INTRODUCTION, CULTIVATION AND USE OF BENEFICIAL ORGANISMS 5. člen Article 5 (vnos, gojenje in uporaba koristnih organizmov) (Introduction, cultivation and use of beneficial organisms) (1) Uporabnik lahko vnese, goji in uporablja koristne organizme z namenom zatiranja ciljnih rastlinskih škodljivih organizmov, če je strokovno in tehnično usposobljen. (1) Users may introduce, cultivate and use beneficial organisms with the aim of controlling target pests, provided they possess professional and technical competence. (2) Šteje se, da je uporabnik strokovno in tehnično usposobljen (2) Users shall be considered to possess professional and http://www.furs.si/ http://www.furs.si/ za vnos, gojenje in uporabo koristnih organizmov, če: technical competence for the introduction, cultivation and use of beneficial organisms, if: upošteva načela dobre kmetijske prakse, varstva okolja oziroma ohranjanja narave, they take account of the principles of good agricultural practice, environmental protection and nature conservation, ima primerno tehnično opremo za uporabo koristnih organizmov in - they obtain appropriate technical equipment for the use of beneficial organisms, and izpolnjuje ostale pogoje iz tega pravilnika. - they meet other conditions laid down in these Rules. (3) Šteje se, da je uporabnik, ki se ukvarja s kmetijsko dejavnostjo in je tržni pridelovalec, strokovno in tehnično usposobljen, če izpolnjuje pogoje iz prejšnjega odstavka ter ima veljavno dokazilo o izpolnjevanju pogojev glede izobrazbe oziroma strokovne usposobljenosti v skladu s predpisi, ki urejajo fitofarmacevtska sredstva. (3) Users that are engaged in agricultural activity and are market producers shall be considered as possessing professional and technical competence if they meet the conditions provided in the preceding paragraph, and if they possess valid evidence of meeting the conditions regarding education or professional competence pursuant to the regulations governing plant protection products. 6. člen Article 6 (vnos in uporaba tujerodnih vrst organizmov) (Introduction and use of exotic organisms) (1) Za vnos in uporabo tujerodnih vrst organizmov na območju Republike Slovenije je potrebno pridobiti dovoljenje Uprave, ki se izda v soglasju z ministrstvom, pristojnim za ohranjanje narave, za enkratni vnos ali vnos, ki se izvede z večkratnimi, v naprej določenimi delnimi vnosi v obdobju največ petih let. (1) The introduction and use of exotic species of organisms within the territory of the Republic of Slovenia shall be subject to authorisation issued by the Administration in agreement with the ministry responsible for nature conservation, in respect of only one introduction or for an introduction carried out through several predetermined partial introductions within a maximum period of five years. (2) Vlagatelj mora za pridobitev dovoljenja iz prejšnjega odstavka zagotoviti: (2) In order to obtain the authorisation referred to in the preceding paragraph, the applicant shall provide: strokovno odgovorno osebo, ki ima veljavno dokazilo o izpolnjevanju pogojev glede izobrazbe oziroma strokovne usposobljenosti v skladu s predpisi, ki urejajo fitofarmacevtska sredstva, ter je odgovorna za vnos, uporabo, spremljanje učinkovitosti in širjenja tujerodne vrste organizma; a responsible expert, holding valid evidence of meeting the conditions regarding education or professional competence pursuant to the regulations governing plant protection products, who shall be responsible for the introduction, use and monitoring of the efficacy and spread of an exotic species of organism; oceno tveganja vnosa za naravo, v skladu s predpisom o izvedbi presoje tveganja za naravo; risk assessment for the introduction into nature, pursuant to the regulation governing implementation of the assessment of risk to nature; program vnosa ali naselitve, iz katerega je razviden vnos tujerodne vrste organizmov glede na čas in količino; the programme of introduction or establishment, indicating the introduction of an exotic species of organisms in terms of time and quantity; seznam prejemnikov oziroma uporabnikov tujerodne vrste organizma; - the list of receivers or users of an exotic species of organism; dokazila, da je organizem namenjen uporabi za biotično varstvo - evidence that the organism is intended to be used for biological rastlin z navedbo ciljnih organizmov in control of plants, by indicating target organisms, and za tujerodne organizme, ki niso na seznamu iz 4. člena tega pravilnika, dokazila, da je organizem dovoljeno uporabljati vsaj v treh ekološko primerljivih evropskih državah, če se uporabljajo v enakem ali primerljivem ekosistemu. in respect of exotic organisms which are not included in the list given in Article 4 of these Rules, evidence that the organism may be used in at least three ecologically comparable European countries, provided they are used in a similar or comparable ecosystem. (3) Če se seznam iz četrte alinee prejšnjega odstavka po pridobitvi dovoljenja spreminja ali dopolnjuje, je potrebno spremembe v pisni obliki sporočiti Upravi najkasneje do 31. marca za preteklo leto. (3) If, after obtaining authorisation, the list referred to in the fourth indent of the preceding paragraph is changed or amended, such amendments shall be notified to the Administration in writing not later than by 31 March for the previous year. 7. člen Article 7 (vsebina vloge za vnos in uporabo tujerodnih vrst organizmov) (Content of application for introduction and use of exotic species) Vloga za pridobitev dovoljenja za vnos in uporabo tujerodnih vrst organizmov mora, poleg dokazil o izpolnjevanju zahtev iz prejšnjega člena, vsebovati zlasti še: Applications for authorisation for the introduction and use of exotic species of organisms shall, in addition to evidence of meeting the requirements as laid down in the previous Article, shall also indicate: 1. podatke o vlagatelju (osebno ime in naslov stalnega ali začasnega prebivališča ali firmo in sedež) in vrsti dejavnosti; 1. data on the applicant (personal name and address of permanent or temporary residence, or company name and registered office) and the kind of activity; 2. podatke o strokovni odgovorni osebi za vnos, uporabo, spremljanje učinkovitosti in širjenja tujerodne vrste organizma (osebno ime, kontaktni podatki in potrdilo o znanju iz fitomedicine); 2. data on the responsible expert for the introduction, use, monitoring of efficacy and spread of an exotic species of organism (personal name, contact data and certificate of knowledge of phytomedicine); 3. v primeru, da je organizem pakiran ali formuliran kot komercialni proizvod: trgovsko ime komercialnega proizvoda z latinskim imenom organizma in ime proizvajalca oziroma zastopnika v Republiki Sloveniji; 3. where the organism is packed or formulated as a commercial product: trade name of the commercial product, with the Latin name of the organism and the name of the producer or representative in the Republic of Slovenia; 4. vrsto in način uporabe glede na ciljni škodljivi organizem, zlasti podatke o: 4. the kind and method of use considering the target pest organism, in particular information on: a. koristnem organizmu (latinsko ime vrste, podvrste ali druge podenote in njegovo taksonomsko uvrstitev, biologija organizma, odnos do ciljnega organizma), a. the beneficial organism (Latin name of the species, subspecies or other subunit and taxonomic classification, biology of the organism, relation to the target organism), b. razvojni stopnji koristnega organizma (jajčece, ličinka, buba, odrasel osebek) oziroma fizikalni obliki, b. development stage of the beneficial organism (egg, larvae, pupa, adult) or physical form, c. ciljnem/ih organizmu/ih (latinsko ime vrste, podvrste in njegovo taksonomsko uvrstitev), c. target organism/s (Latin name of the species, subspecies and taxonomic classification), d. načinu uporabe glede na ciljni škodljivi organizem oziroma vrsto rastlin, ki jih škodljivi organizmi napadajo oziroma pridelave na prostem ali prostoru ločenem od narave, d. the method of use with regard to the target pest organism or plant species that the pests attack, or their growing in the field or in a space separated from nature, e. najvišji predvideni količini uporabe organizmov na enoto e. the maximum foreseen quantity of the use of organisms per pridelave, production unit, f. času uporabe; f. time of use; 5. način pakiranja organizma pri transportu (opis pakiranja in odpornost embalaže pri transportu); 5. the type of packaging of the organism during transport (description of packaging and resistance of packaging during transport); 6. varnostni ukrepi pri uporabi, shranjevanju, transportu; 6. precautions in use, storing, transport; 7. dokazila, da so izpolnjeni drugi predpisani pogoji glede prostorov, opreme in kadrov v skladu z 11. in 12. členom tega pravilnika. 7. evidence that other prescribed conditions as regards premises, equipment and staff have been fulfilled pursuant to Articles 11 and 12 of these Rules. 8. člen Article 8 (gojenje koristnih organizmov) (Cultivation of beneficial organisms) (1) Za profesionalno gojenje domorodnih vrst organizmov je potrebno pridobiti dovoljenje Uprave na podlagi vloge iz 9. člena tega pravilnika. (1) For professional cultivation of native species of organisms, authorisation shall be obtained from the Administration on the basis of an application referred to in Article 9 of these Rules. (2) Za gojenje tujerodnih vrst organizmov je potrebno pridobiti dovoljenje Uprave, ki se izda s soglasjem ministrstva, pristojnega za ohranjanje narave, na podlagi vloge iz 9. člena tega pravilnika in ocene tveganja gojitve za naravo, v skladu s predpisom, ki ureja izvedbo presoje tveganja za naravo. (2) For cultivation of exotic species of organisms, authorisation shall be obtained from the Administration and shall be issued in agreement with the ministry responsible for nature conservation, on the basis of an application referred to in Article 9 of these Rules and risk assessment for introduction into nature, pursuant to the regulation governing implementation of an assessment of risk to nature. (3) Dovoljenje iz prvega odstavka tega člena se lahko pridobi za več primerov gojitve hkrati, kadar isti vlagatelj goji organizme iste taksonomske kategorije pod istimi pogoji in na isti lokaciji v obdobju petih let od začetka gojitve. (3) The authorisation referred to in paragraph one of this Article may be issued in respect of several cases of cultivation, provided that the same applicant cultivates organisms of the same taxonomic category under the same conditions and at the same location within a period of five years starting from the beginning of cultivation. 9. člen Article 9 (vsebina vloge za gojenje koristnih organizmov) (Content of application for cultivation of beneficial organisms) Vloga za pridobitev dovoljenja za gojenje koristnih organizmov mora vsebovati: Applications for authorisation for cultivating beneficial organisms shall include: 1. podatke o vlagatelju (osebno ime in naslov stalnega ali začasnega prebivališča ali firmo in sedež) in vrsti dejavnosti z navedbo pravno organizacijske oblike in z organizacijsko shemo, ki prikazuje razporeditev odgovornosti in dodelitev nalog ter pooblastil za vse zaposlene in druge osebe, ki sodelujejo v postopku gojenja; 1. data on the applicant (personal name and address of permanent residence or stay, or company name and registered office) and the type of activity, indicating the legal and organisational form and organisation chart, indicating the distribution of responsibilities and allocation of tasks and authorisations in respect of all employees and other persons involved in the cultivation procedure; 2. podatke o strokovni odgovorni osebi za gojenje koristnega organizma (osebno ime, izobrazba, delovne izkušnje in dodatna strokovna usposobljenost osebja, vključno z zunanjimi sodelavci); 2. data on the responsible expert for cultivation of the beneficial organism (personal name, education, working experience and additional training of staff, including contractual workers); 3. oceno tveganja gojitve za naravo, v skladu s predpisom, ki ureja izvedbo presoje tveganja za naravo, če želi vlagatelj gojiti tujerodne vrste organizmov; 3. assessment of risk of cultivation to nature, in accordance with the regulation governing the implementation of assessment of risk to nature, where the applicant wishes to produce exotic species of organisms; 4. protokol gojenja koristnih organizmov v skladu s 13. členom tega pravilnika; 4. the protocol on cultivation of beneficial organisms pursuant to Article 13 of these Rules; 5. dokazila, da so izpolnjeni drugi predpisani pogoji glede prostorov, opreme in kadrov, v skladu z 11. in 12. členom tega pravilnika; 5. evidence that other prescribed conditions as regards premises, equipment and staff have been fulfilled pursuant to Articles 11 and 12 of these Rules; 6. dokazila o registrirani dejavnosti (kopija obvestila o identifikaciji in razvrstitvi po dejavnosti), če je dejavnost registrirana v tujini; 6. evidence on the registered activity (a copy of the notice of identification and classification of activities), if the activity has been registered abroad; 7. potrdilo o identifikaciji oziroma determinaciji koristnega organizma. 7. certificate of identification or determination of the beneficial organism. 10. člen Article 10 (trženje koristnih organizmov) (Marketing of beneficial organisms) (1) Trženje koristnih organizmov je mogoče na podlagi dovoljenja iz: (1) The marketing of beneficial organisms shall be based on the authorisations referred to: prvega odstavka 6. člena tega pravilnika ali drugega odstavka 8. člena tega pravilnika za tujerodne vrste organizmov, če vlagatelj pridobi ugodno oceno tveganja za naravo, ki presodi vpliv trženja, in paragraph one of Article 6 of these Rules or paragraph two of Article 8 of these Rules for exotic species of organisms, provided that the applicant obtains a favourable assessment of risk to nature, which provides an assessment of the trade impact, prvega odstavka 8. člena tega pravilnika za domorodne vrste organizmov. in paragraph one of Article 8 of these Rules for indigenous species of organisms. (2) Vsako pakiranje koristnih organizmov za trženje mora biti ustrezno označeno, in sicer morajo biti razvidni zlasti podatki o: (2) Each packaging of beneficial organisms intended for marketing shall be properly labelled so as to give in particular the following information: številki dovoljenja in organu, ki ga je izdal, - on the number of the authorisation and the issuing authority, koristnem organizmu (latinsko ime vrste, podvrste ali druge podenote in njegovo taksonomsko uvrstitev), on the beneficial organism (Latin name of the species, subspecies or other subunit and taxonomic classification), razvojni stopnji koristnega organizma (jajčece, ličinka, buba, odrasel osebek) oziroma fizikalni obliki, on the development stage of the beneficial organism (egg, larvae, pupa, adult) or physical form, ciljnem/ih organizmu/ih (latinsko ime vrste, podvrste in njegovo taksonomsko uvrstitev), on target organism/s (Latin name of the species, subspecies and taxonomic classification), načinu uporabe glede na ciljni škodljivi organizem oziroma vrsto rastlin, ki jih škodljivi organizmi napadajo oziroma pridelave na prostem ali prostoru ločenem od narave, on the method of use with regard to the target organism or species of plants attacked by pests, or their growing in the field or in a space separated from nature, najvišji predvideni količini uporabe organizmov na enoto pridelave, - on the maximum foreseen quantity of used organisms per production unit, času uporabe. - on the time of use. (3) V primeru, da gre za domorodno vrsto, ki se za gojenje pridobi iz naravne populacije, je potrebno predložiti potrdilo, da je koristni organizem zdrav (ni okužen z mikroorganizmi oziroma napaden s hiperparaziti). (3) In the case of a native species obtained from a natural population for the purpose of cultivation, a certificate shall be submitted that the beneficial organism is healthy (not infected with microorganisms or infested by hyperparasites). (4) Uporabniku morajo biti zagotovljena navodila za ravnanje pri transportu, hranjenju in uporabi ter navodila z varnostnimi ukrepi, če so potrebni. (4) The user shall be provided with instructions for handling during transport, storage and use and instructions including safety measures, if necessary. III. POGOJI GLEDE PROSTOROV, OPREME IN KADROV III. CONDITIONS CONCERNING PREMISES, EQUIPMENT AND STAFF 11. člen Article 11 (pogoji glede prostorov in opreme) (Conditions concerning premises and equipment) (1) Oseba, ki želi koristne organizme gojiti z namenom uporabe ali trženja oziroma vnesti tujerodne organizme z namenom uporabe ali trženja oziroma se ukvarjati z raziskovalno dejavnostjo mora izpolnjevati pogoje glede prostorov in opreme iz tega člena. (1) A person that wishes to cultivate beneficial organisms with a view to their use or marketing, or to introduce exotic organisms with a view to their use or marketing, or to be engaged in research activity, shall meet the conditions as to premises and equipment laid down in this Article. (2) Prostori za opravljanje dejavnosti iz prejšnjega odstavka morajo biti zavarovani pred škodljivimi vplivi abiotičnih dejavnikov (vročine, vlage, pare, vibracij in podobnega) ter morajo biti redno vzdrževani. (2) Premises where the activity referred to in the preceding paragraph takes place shall be protected against the harmful effects of abiotic factors (heat, moisture, steam, vibration and similar), and shall be regularly maintained. (3) Vsa oprema, ki se uporablja za opravljanje dejavnosti iz prvega odstavka tega člena, mora biti enostavno dostopna in pravilno vzdrževana. Za pravilno uporabo opreme morajo biti na razpolago ustrezna pisna navodila in priročnik proizvajalca opreme. (3) All equipment for carrying out the activity referred to in paragraph one of this Article shall be easily accessible and properly maintained. To ensure the proper use of equipment, written instructions shall be available as well as the manual of the equipment manufacturer. (4) Za vse prostore in opremo se morajo izvajati primerni ukrepi, ki zagotavljajo red in čistočo. (4) All premises and equipment shall be subject to proper measures taken so as to ensure general order and cleanliness. (5) Prostori in oprema morajo zagotavljati primerne abiotične pogoje oziroma druge zahteve za optimalno shranjevanje koristnih organizmov, da se njihova življenjska doba ne skrajša oziroma se ne izgubi biotična aktivnost. (5) Premises and equipment shall ensure adequate abiotic conditions or satisfy other requirements for optimal storage of beneficial organisms in order to prevent their life span being reduced or their biological activity being lost. (6) Če se goji več organizmov, se morajo le-ti gojiti v med seboj ločenih prostorih, da ne prihaja do medsebojnih stikov in se za vsako vrsto organizma zagotovi njej primerne pogoje. (6) If several organisms are cultivated, this shall be done in separate rooms so as to prevent any mutual contact, and to provide adequate conditions for each species of organism. (7) Poleg izpolnjevanja zahtev iz drugega, četrtega in petega odstavka tega člena morajo biti prostori za opravljanje dejavnosti iz prvega odstavka tega člena za tujerodne organizme, urejeni tako, da se prepreči pobeg organizmov v okolje. (7) In addition to meeting the requirements referred to in paragraphs two, four and five of this Article, the premises for carrying out the activity referred to in paragraph one of this Article for exotic organisms shall be organised in such way as to prevent their escape into the environment. (8) Poleg izpolnjevanja zahtev iz tega člena morajo biti za raziskovalno dejavnost tujerodnih organizmov prostori in oprema v skladu s predpisom, ki ureja pogoje za uvoz ali premeščanje določenih škodljivih organizmov, rastlin, rastlinskih proizvodov in nadzorovanih predmetov za poskusne, raziskovalne ali razvojne namene in za delo pri žlahtnjenju rastlin. (8) In addition to meeting the requirements referred to in this Article, the premises and equipment intended for the research of exotic organisms shall comply with the regulation governing the conditions for import or movement of certain harmful organisms, plants, plant products and regulated articles for trial, research or development purposes and for work on varietal selections. 12. člen Article 12 (kadrovski pogoji) (Staffing conditions) (1) Oseba, ki se ukvarja z dejavnostjo iz prvega odstavka prejšnjega člena, mora zagotoviti dostopnost dokumentacije, iz katere je razvidno naslednje: (1) A person engaged in the activity referred to in paragraph one of the preceding Article shall ensure access to documentation that indicates the following: opis delovnih mest s specifikacijo strokovne izobrazbe, tehničnega znanja in izkušenj za vse osebe, ki rokujejo s koristnimi organizmi; the description of jobs, including specification of professional qualifications, technical knowledge and experience for all persons handling beneficial organisms; da ima za opravljanje dejavnosti iz prvega odstavka prejšnjega člena, razen za gojenje, zaposleno (v delovnem ali pogodbenem razmerju) najmanj eno strokovno odgovorno osebo z visoko strokovno izobrazbo biotehniške smeri ali osebo s strokovno izobrazbo biotehniške smeri z najmanj 5 let delovnih izkušenj na področju varstva rastlin. that at least one responsible expert is employed (being in employment or contractual relationship) for carrying out the activity referred to in paragraph one of the preceding Article, except for cultivation, with graduate qualifications in biotechnology, or a person with professional education in biotechnology with at least 5 years of working experience in the field of plant protection. (2) Oseba iz druge alinee prejšnjega odstavka mora izpolnjevati (2) The person referred to in the second indent of the preceding pogoje glede izobrazbe oziroma strokovne usposobljenosti v skladu s predpisi, ki urejajo fitofarmacevtska sredstva. paragraph shall meet the conditions in relation to education or professional qualification pursuant to the regulations governing plant protection products. (3) Za raziskovalno dejavnost tujerodnih organizmov morajo biti izpolnjeni kadrovski pogoji v skladu s predpisom, ki ureja pogoje za uvoz ali premeščanje določenih škodljivih organizmov, rastlin, rastlinskih proizvodov in nadzorovanih predmetov za poskusne, raziskovalne ali razvojne namene in za delo pri žlahtnjenju rastlin. (3) For carrying out research on exotic organisms, staffing conditions shall be met pursuant to the regulation governing the conditions for import or movement of certain harmful organisms, plants, plant products and regulated articles for trial, research or development purposes and for work on varietal selections. 13. člen Article 13 (protokol gojenja koristnih organizmov) (Protocol on cultivation of beneficial organisms) (1) Oseba, ki se ukvarja z gojenjem koristnih organizmov z namenom trženja, mora izpolnjevati pogoje glede prostorov, opreme in kadrov v skladu z 11. in 12. členom tega pravilnika ter imeti izdelan protokol gojenja koristnih organizmov. (1) Persons engaged in the cultivation of beneficial organisms with a view to marketing shall comply with the conditions concerning the premises, equipment and staff, pursuant to Articles 11 and 12 of these Rules, and shall have an established protocol on cultivation of beneficial organisms. (2) Protokol gojenja koristnih organizmov mora vsebovati najmanj naslednje podatke: (2) The protocol on cultivation of beneficial organisms shall include at least the following information: 1. lokacije na katerih se izvaja gojenje (naslov lokacije); 1. the location where the cultivation takes place (address of the location); 2. seznam gojenih koristnih organizmov; 2. the list of cultivated beneficial organisms; 3. za vsak koristni organizem latinsko ime organizma in način uporabe za biotično varstvo rastlin, ter zlasti podatke o: 3. for each beneficial organism, the Latin name and method of use for biological control, and in particular information on: a. koristnem organizmu (latinsko ime vrste, podvrste ali druge podenote in njegovo taksonomsko uvrstitev, biologija organizma in odnos do ciljnega organizma), a. the beneficial organism (Latin name of the species, subspecies or other subunit and taxonomic classification, biology of organism, relation to the target organism), b. obliki koristnega organizma, primerni za uporabo (razvojna stopnja ali fizikalna oblika) z opisom medija za ohranjanje in nanos, b. the form of the beneficial organism suitable for use (development stage or physical form) with the description of the medium for preservation and application, c. ciljnem/ih organizmu/ih (latinsko ime vrste, podvrste in njegovo taksonomsko uvrstitev), c. target organism(s) (Latin name of the species, subspecies and taxonomic classification), d. načinu uporabe glede na ciljni organizem oziroma vrsto rastlin, ki jih ciljni organizem napada oziroma pridelave na prostem oziroma prostoru ločenem od narave; d. the method of use with regard to the target organism or species of plants attacked by pests, or their growing in the field or in a space separated from nature; 4. postopek gojenja oziroma navodila za izvajanje gojenja koristnih organizmov in sicer za vsako vrsto organizma; 4. on the cultivation procedure or instructions for carrying out the cultivation of beneficial organisms by species; 5. način pakiranja organizma pri transportu (opis pakiranja in odpornost 5. the type of packaging of the organism during transport (description of embalaže pri transportu); packaging and soundness of packaging during transport); 6. varnostni ukrepi pri gojenju, uporabi, shranjevanju, transportu. 6. precautions in cultivation, use, storage and transport. (3) Protokol gojenja mora vzdrževati strokovna odgovorna oseba, ki jo imenuje oseba iz prvega odstavka tega člena. Strokovna odgovorna oseba mora protokol overiti z oznako tekoče verzije, datumom in podpisom. (3) The protocol on cultivation shall be maintained by a responsible expert appointed by the person stated in paragraph one of this Article. The responsible expert shall verify the protocol with a mark of the current version, date and signature. (4) Protokol gojenja mora biti na razpolago vsem, ki sodelujejo v postopku gojenja, Upravi in fitosanitarnemu inšpektorju pri izvajanju inšpekcijskega nadzora. (4) The protocol on cultivation shall be at the disposal of all persons engaged in the cultivation procedure, the Administration and phytosanitary inspector in carrying out inspections. (5) Protokol gojenja mora določiti postopke: (5) The protocol on cultivation shall provide for the following procedures: ravnanja za primere, ko strokovni ali drugi delavci ravnajo v nasprotju s protokolom in tako ravnanje negativno vpliva na varstvo okolja oziroma ohranjanje narave ali na poslabšanje biotične aktivnosti gojenih organizmov ter practices concerning cases where experts or other employees do not act in accordance with the protocol, resulting in a negative effect on environmental protection or nature conservation, or deterioration of biological activity of cultivated organisms, and postopke ravnanja v primeru pritožb in sporov. - the procedures to be conducted in the case of complaints or disputes. 14. člen Article 14 (vodenje evidenc) (Record keeping) (1) Osebe, ki se ukvarjajo s profesionalnim gojenjem koristnih organizmov ali z gojenjem tujerodnih organizmov, morajo voditi evidenco o količinah koristnih organizmov, ki so bile vzgojene, vnesene, prodane oziroma prepuščene tretjemu, in o tem najpozneje do 31. marca za preteklo leto obvestiti Upravo. (1) Persons engaged in professional cultivation of beneficial organisms or cultivation of exotic organisms shall keep a record concerning the quantities of beneficial organisms that have been cultivated, introduced, sold or disposed to a third person, informing the Administration thereof by 31 March for the previous year at the latest. (2) Evidenca iz prejšnjega odstavka se mora voditi ločeno po vrstah koristnih organizmov ter mora vsebovati najmanj naslednje podatke: (2) The record referred to in the preceding paragraph shall be kept separately by species of beneficial organisms and shall include at least the following information: osebno ime in naslov stalnega ali začasnega prebivališča fizične osebe ali firmo in sedež pravne osebe iz 7. oziroma 9. člena tega pravilnika, sedež, kjer se izvaja dejavnost in leto, za katero se vodi evidenca, personal name and address of permanent or temporary residence of the natural person, or company name and registered office of the legal person referred to in Articles 7 or 9 of these Rules; registered office where the activity is conducted, and the year to which the record refers, latinsko ime koristnega organizma oziroma trgovsko ime komercialnega proizvoda, Latin name of the beneficial organism or the trade name of the commercial product, količina, ki se vzgoji, kupi ali proda (merska enota, število), - quantity cultivated, purchased or sold (unit of measure, number), tržena količina glede na gojenje, glede na vnos iz držav članic EU ali vnos iz tretjih držav. marketed quantity with regard to cultivation, introduction from EU Member States or introduction from third countries. 15. člen Article 15 (svetovanje, oglaševanje ali priporočila) (Advice, advertising or recommendations) Svetovati, oglaševati ali priporočati se sme le uporaba koristnih organizmov, ki jih določa ta pravilnik. Advice, advertising or recommending shall only refer to the use of beneficial organisms provided by these Rules. IV. IZJEME IV. EXCEPTIONS 16. člen Article 16 (izjeme) (Exceptions) Uprava lahko, v soglasju z ministrstvom, pristojnim za ohranjanje narave, izda dovoljenje za vnos in uporabo tujerodnih vrst organizmov, ki niso na seznamu koristnih organizmov tega pravilnika, za namen biotičnega varstva rastlin za znanstvene in raziskovalne organizacije, če jih uporabijo za poskusne, raziskovalne ali razvojne namene, in sicer na podlagi ocene tveganja za naravo, v skladu s predpisom, ki ureja izvedbo presoje tveganja za naravo, da poseg v naravo ne ogroža naravnega ravnovesja ali biotske raznovrstnosti in predpisi, ki določajo pogoje za uvoz ali premeščanje določenih škodljivih organizmov, rastlin, rastlinskih proizvodov in nadzorovanih predmetov za poskusne, raziskovalne ali razvojne namene in za delo pri žlahtnjenju rastlin. The Administration may, in agreement with the minister responsible for nature conservation, issue an authorisation for the introduction and use of exotic species of organisms which are not included in the list of beneficial organisms of these Rules, for the purposes of biological control of plants for scientific and research organisations, provided they are used for trial, research or development purposes, on the basis of an assessment of risk to nature pursuant to the regulation governing implementation of an assessment of risk to nature, that the activity affecting nature does not pose a threat to the natural balance or biological diversity, as well as regulations governing conditions for the introduction or movement of certain harmful organisms, plants, plant products and regulated articles for trial, research or development purposes and for work on varietal selection. V. KONČNA DOLOČBA V. FINAL PROVISION 17. člen Article 17 (uveljavitev) (Entry into force) Ta pravilnik začne veljati petnajsti dan po objavi v Uradnem listu Republike Slovenije. These Rules shall enter into force on the fifteenth day following their publication in the Official Gazette of the Republic of Slovenia. Št. 327-01-439/2003 No. 327-01-439/2003 Ljubljana, dne 4. aprila 2006 Ljubljana, 4 April 2006 EVA 2005-2311-0077 EVA 2005-2311-0077 Marija Lukačič l.r. Ministrica za kmetijstvo, gozdarstvo in prehrano Marija Lukačič m.p. Minister of Agriculture, Forestry and Food Soglašam! I agree! Janez Podobnik l.r. Minister za okolje in prostor Janez Podobnik m.p. Minister of the Environment and Spatial Planning