Directive 2001/18/EC of the European Parliament and of the Council

Direktiva 2001/18/ES Evropskega parlamenta in Sveta

of 12 March 2001

z dne 12. marca 2001

on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

o namernem sproščanju gensko spremenjenih organizmov v okolje in razveljavitvi Direktive Sveta 90/220/EGS

EVROPSKI PARLAMENT IN SVET EVROPSKE UNIJE STA –

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti in zlasti člena 95 Pogodbe,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

ob upoštevanju predloga Komisije [1],

Having regard to the proposal from the Commission(1),

ob upoštevanju mnenja Ekonomsko-socialnega odbora [2],

Having regard to the opinion of the Economic and Social Committee(2),

po postopku iz člena 251 Pogodbe ob upoštevanju skupnega besedila, ki ga je 20. decembra 2000 [3] odobril Spravni odbor,

Acting in accordance with the procedure laid down in Article 251 of the Treaty, in the light of the joint text approved by the Conciliation Committee on 20 December 2000(3),

ob upoštevanju naslednjega:

Whereas:

(1) Poročilo Komisije o pregledu Direktive Sveta 90/220/EGS z dne 23. aprila 1990 o namernem sproščanju gensko spremenjenih organizmov v okolje [4], sprejeto 10. decembra 1996, je opredelilo številna področja, na katerih so potrebna izboljšanja.

(1) The Report of the Commission on the Review of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(4), adopted on 10 December 1996, identified a number of areas where improvement is needed.

(2) Treba je razjasniti področje uporabe Direktive 90/220/EGS in opredelitve, ki jih vsebuje.

(2) There is a need for clarification of the scope of Directive 90/220/EEC and of the definitions therein.

(3) Direktiva 90/220/EGS je bila spremenjena. Sedaj, ko se izvajajo nove spremembe Direktive, je zaradi jasnosti in racionalizacije zaželeno, da se zadevne določbe preoblikujejo.

(3) Directive 90/220/EEC has been amended. Now that new amendments are being made to the Directive, it is desirable, for reasons of clarity and rationalisation, that the provisions in question should be recast.

(4) Živi organizmi, sproščeni v okolje v velikih ali majhnih količinah v poskusne namene ali kot komercialni proizvodi, se lahko v okolju razmnožujejo in preidejo nacionalne meje ter pri tem prizadenejo druge države članice. Učinki takih sproščanj v okolje so lahko nepopravljivi.

(4) Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States. The effects of such releases on the environment may be irreversible.

(5) Varovanje zdravja ljudi in okolja zahteva ustrezno pozornost nad nadzorom tveganj zaradi namernega sproščanja gensko spremenjenih organizmov (GSO) v okolje.

(5) The protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs).

(6) Po Pogodbi morajo ukrepi Skupnosti v zvezi z okoljem temeljiti na načelu preventivnega ukrepanja.

(6) Under the Treaty, action by the Community relating to the environment should be based on the principle that preventive action should be taken.

(7) Treba je približati zakonodaje držav članic glede namernega sproščanja GSO v okolje in zagotoviti varen razvoj industrijskih proizvodov, ki uporabljajo GSO.

(7) It is necessary to approximate the laws of the Member States concerning the deliberate release into the environment of GMOs and to ensure the safe development of industrial products utilising GMOs.

(8) Pri pripravi osnutka te direktive je bilo upoštevano previdnostno načelo, ki ga je treba upoštevati tudi pri njenem izvajanju.

(8) The precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it.

(9) Zlasti je pomembno spoštovanje etičnih načel, priznanih v posamezni državi članici. Države članice lahko pri namernem sproščanju ali dajanju v promet GSO kot proizvodov ali v proizvodih upoštevajo etične vidike.

(9) Respect for ethical principles recognised in a Member State is particularly important. Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products.

(10) Za obsežen in pregleden zakonodajni okvir je treba zagotoviti, da se Komisija ali države članice med pripravo ukrepov posvetujejo z javnostjo in da so obveščene o ukrepih, sprejetih med izvajanjem te direktive.

(10) For a comprehensive and transparent legislative framework, it is necessary to ensure that the public is consulted by either the Commission or the Member States during the preparation of measures and that they are informed of the measures taken during the implementation of this Directive.

(11) Dajanje v promet zajema tudi uvoz. Proizvodi, ki vsebujejo in/ali jih sestavljajo GSO, zajeti s to direktivo, se ne morejo uvoziti v Skupnost, če ne izpolnjujejo določb te direktive.

(11) Placing on the market also covers import. Products containing and/or consisting of GMOs covered by this Directive cannot be imported into the Community if they do not comply with its provisions.

(12) Dajanje GSO, primernih za uvoz ali predelavo v razsutem stanju, kot so kmetijski proizvodi, je treba za namene te direktive obravnavati kot dajanje v promet.

(12) Making GMOs available to be imported or handled in bulk quantities, such as agricultural commodities, should be regarded as placing on the market for the purpose of this Directive.

(13) Vsebina te direktive primerno upošteva mednarodne izkušnje na tem področju in mednarodne trgovinske obveznosti ter upošteva Kartagenski protokol biološke varnosti h Konvenciji o biološki raznovrstnosti. Kakor hitro je mogoče in v vsakem primeru pred julijem 2001 mora Komisija glede ratifikacije Protokola predložiti ustrezne predloge za njegovo izvajanje.

(13) The content of this Directive duly takes into account international experience in this field and international trade commitments and should respect the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. As soon as possible, and in any case before July 2001, the Commission should, in the context of the ratification of the Protocol, submit the appropriate proposals for its implementation.

(14) Navodila za izvajanje določb v zvezi z opredelitvijo dajanja v promet v tej direktivi mora zagotoviti Regulatorni odbor.

(14) Guidance on the implementation of provisions related to the definition of the placing on the market in this Directive should be provided by the Regulatory Committee.

(15) Pri opredelitvi "gensko spremenjenih organizmov" za namene te direktive se ljudi ne sme šteti za organizme.

(15) When defining "genetically modified organism" for the purpose of this Directive, human beings should not be considered as organisms.

(16) Določbe te direktive ne smejo vplivati na nacionalno zakonodajo na področju okoljske odgovornosti, zakonodajo Skupnosti na tem področju pa je treba dopolniti s pravili, ki zajemajo odgovornost za različne vrste okoljske škode na vseh območjih Evropske unije. V ta namen se je Komisija zavezala, da pred koncem leta 2001 predstavi zakonodajni predlog o okoljski odgovornosti, ki bo zajel tudi škodo zaradi GSO.

(16) The provisions of this Directive should be without prejudice to national legislation in the field of environmental liability, while Community legislation in this field needs to be complemented by rules covering liability for different types of environmental damage in all areas of the European Union. To this end the Commission has undertaken to bring forward a legislative proposal on environmental liability before the end of 2001, which will also cover damage from GMOs.

(17) Ta direktiva se ne sme uporabljati za organizme, dobljene z določenimi tehnikami genskega spreminjanja, ki se že konvencionalno uporabljajo v številnih aplikacijah in že dolgo veljajo za varne.

(17) This Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record.

(18) Vzpostaviti je treba usklajene postopke in merila za ovrednotenje potencialnih tveganj, ki izhajajo iz namernega sproščanja GSO v okolje, za vsak posamezen primer.

(18) It is necessary to establish harmonised procedures and criteria for the case-by-case evaluation of the potential risks arising from the deliberate release of GMOs into the environment.

(19) Za vsak posamezen primer naj bi se ocena tveganja za okolje vedno opravila pred sproščanjem. Ustrezno naj bi upoštevala tudi potencialne kumulativne dolgoročne učinke, povezane z vzajemnim delovanjem z drugimi GSO in okoljem.

(19) A case-by-case environmental risk assessment should always be carried out prior to a release. It should also take due account of potential cumulative long-term effects associated with the interaction with other GMOs and the environment.

(20) Treba je vzpostaviti skupno metodologijo za izvajanje ocene tveganja za okolje na podlagi neodvisnega znanstvenega svetovanja. Treba je tudi vzpostaviti skupne cilje za spremljanje GSO po njihovem namernem sproščanju ali dajanju v promet kot proizvodov ali v proizvodih. Spremljanje potencialnih kumulativnih dolgoročnih učinkov bi bilo treba obravnavati kot obvezen del načrta spremljanja.

(20) It is necessary to establish a common methodology to carry out the environmental risk assessment based on independent scientific advice. It is also necessary to establish common objectives for the monitoring of GMOs after their deliberate release or placing on the market as or in products. Monitoring of potential cumulative long-term effects should be considered as a compulsory part of the monitoring plan.

(21) Države članice in Komisija naj bi zagotovile, da se opravljajo sistematične in neodvisne raziskave o potencialnih tveganjih pri namernem sproščanju ali dajanju GSO v promet. Potrebna sredstva za te raziskave morajo zagotoviti države članice in Skupnost skladno s svojimi proračunskimi postopki, neodvisni raziskovalci pa morajo dobiti dostop do vsega ustreznega materiala ob spoštovanju pravic intelektualne lastnine.

(21) Member States and the Commission should ensure that systematic and independent research on the potential risks involved in the deliberate release or the placing on the market of GMOs is conducted. The necessary resources should be secured for such research by Member States and the Community in accordance with their budgetary procedures and independent researchers should be given access to all relevant material, while respecting intellectual property rights.

(22) Področje genov, odpornih na antibiotike, je treba zlasti upoštevati pri postopku ocene tveganja za GSO, ki vsebujejo te gene.

(22) The issue of antibiotic-resistance genes should be taken into particular consideration when conducting the risk assessment of GMOs containing such genes.

(23) Namerno sproščanje GSO na stopnji raziskav je v večini primerov potreben korak pri razvoju novih proizvodov, ki izhajajo iz ali vsebujejo GSO.

(23) The deliberate release of GMOs at the research stage is in most cases a necessary step in the development of new products derived from, or containing GMOs.

(24) Uvajanje GSO v okolje bi bilo treba opraviti skladno z načelom "postopnosti". To pomeni, da se zadrževanje GSO zmanjšuje, stopnja sproščanja pa se postopoma povečuje, vendar samo, če vrednotenje prejšnjih stopenj glede varstva zdravja ljudi in okolja kaže, da se lahko opravi naslednja stopnja.

(24) The introduction of GMOs into the environment should be carried out according to the "step by step" principle. This means that the containment of GMOs is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken.

(25) Noben GSO kot proizvod ali v proizvodih, namenjen za namerno sproščanje, ne more priti v poštev za dajanje v promet, ne da bi se najprej opravilo zadovoljivo preskušanje na polju na raziskovalni in razvojni stopnji v ekosistemih, ki bi lahko bili prizadeti zaradi njihove uporabe.

(25) No GMOs, as or in products, intended for deliberate release are to be considered for placing on the market without first having been subjected to satisfactory field testing at the research and development stage in ecosystems which could be affected by their use.

(26) Izvajanje te direktive je treba opraviti v tesni povezavi z izvajanjem drugih zadevnih instrumentov, kot so Direktiva Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [5]. S tem v zvezi morajo pristojni organi, ki se ukvarjajo z izvajanjem te direktive in navedenih instrumentov v Komisiji in na nacionalni ravni, kar se da uskladiti svoje delovanje.

(26) The implementation of this Directive should be carried out in close liaison with the implementation of other relevant instruments such as Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(5). In this context the competent authorities concerned with the implementation of this Directive and of those instruments, within the Commission and at national level, should coordinate their action as far as possible.

(27) V zvezi z oceno tveganja za okolje za del C, obvladovanjem tveganja, označevanjem, spremljanjem, informiranjem javnosti in zaščitno klavzulo mora biti ta direktiva referenčna točka za GSO kot proizvode ali v proizvodih, dovoljene po drugi zakonodaji Skupnosti, ki mora zato predvideti posebno oceno tveganja za okolje, ki naj se opravi po načelih iz Priloge II in na podlagi informacij v Prilogi III, brez vpliva na dodatne zahteve v navedeni zakonodaji Skupnosti, in zahteve v zvezi z obvladovanjem tveganja, označevanjem, spremljanjem, informiranjem javnosti in zaščitno klavzulo, ki so vsaj enakovredne tisti(m), predpisani(m) v tej direktivi. V ta namen je treba za namene izvajanja te direktive predvideti sodelovanje s Skupnostjo in organi držav članic, navedenimi v njej.

(27) Concerning the environmental risk assessment for part C, risk management, labelling, monitoring, information to the public and safeguard clause, this Directive should be a point of reference for GMOs as or in products authorised by other Community legislation which should therefore provide for a specific environmental risk assessment, to be carried out in accordance with the principles set out in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements laid down by the Community legislation mentioned above, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in this Directive. To this end it is necessary to provide for cooperation with the Community and Member State bodies mentioned in this Directive for the purpose of its implementation.

(28) Treba je vzpostaviti postopek Skupnosti za odobritev dajanja GSO v promet kot proizvodov ali v proizvodih, kjer predvidena uporaba proizvoda vključuje namerno sproščanje organizma(-ov) v okolje.

(28) It is necessary to establish a Community authorisation procedure for the placing on the market of GMOs, as or in products, where the intended use of the product involves the deliberate release of the organism(s) into the environment.

(29) Komisija se poziva, da opravi študijo, ki naj vsebuje oceno različnih možnosti za nadaljnje izboljšanje skladnosti in učinkovitosti te zasnove in bo zlasti usmerjena na centraliziran postopek odobritve za dajanje GSO v promet v Skupnosti.

(29) The Commission is invited to conduct a study which should contain an assessment of various options to improve further the consistency and efficiency of this framework, particularly focusing on a centralised authorisation procedure for the placing on the market of GMOs within the Community.

(30) Za sektorsko zakonodajo bo morda treba zahteve spremljanja prilagoditi zadevnemu proizvodu.

(30) For sectoral legislation, monitoring requirements may have to be adapted to the product concerned.

(31) Del C te direktive se ne uporablja za proizvode, ki jih ureja Uredba Sveta (EGS) št. 2309/93 z dne 22. julija 1993 o določitvi postopkov Skupnosti za odobritev in nadzor zdravil za humano in veterinarsko uporabo ter ustanovitvi Evropske agencije za vrednotenje zdravil [6], pod pogojem da vključuje oceno tveganja za okolje, enakovredno oceni iz te direktive.

(31) Part C of this Directive does not apply to products covered by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(6), provided that it includes an environmental risk assessment equivalent to that provided for by this Directive.

(32) Vsaka oseba mora pred začetkom namernega sproščanja GSO v okolje ali dajanjem GSO kot proizvodov ali v proizvodih v promet, kjer nameravana uporaba proizvoda zahteva namerno sproščanje v okolje, nacionalnemu pristojnemu organu predložiti prijavo.

(32) Any person, before undertaking a deliberate release into the environment of a GMO, or the placing on the market of GMOs, as or in products, where the intended use of the product involves its deliberate release into the environment, is to submit a notification to the national competent authority.

(33) Ta prijava mora vsebovati tehnično dokumentacijo z informacijami, vključno s polno oceno tveganja za okolje, ustrezno varnostno ukrepanje in ukrepanje v primeru nesreče ter v primeru proizvodov natančna navodila in pogoje uporabe ter predlagano označevanje in pakiranje.

(33) That notification should contain a technical dossier of information including a full environmental risk assessment, appropriate safety and emergency response, and, in the case of products, precise instructions and conditions for use, and proposed labelling and packaging.

(34) Po prijavi se ne sme opraviti namernega sproščanja GSO, razen če ni bila pridobljena odobritev pristojnega organa.

(34) After notification, no deliberate release of GMOs should be carried out unless the consent of the competent authority has been obtained.

(35) Prijavitelj mora tudi imeti možnost, da umakne svojo dokumentacijo na kateri koli stopnji upravnih postopkov, določenih v tej direktivi. Upravni postopek se mora ob umiku dokumentacije končati.

(35) A notifier should be able to withdraw his dossier at any stage of the administrative procedures laid down in this Directive. The administrative procedure should come to an end when a dossier is withdrawn.

(36) Zavrnitev prijave za dajanje v promet GSO kot proizvodov ali v proizvodih s strani pristojnega organa ne sme vplivati na predložitev prijave istega GSO drugemu pristojnemu organu.

(36) Rejection of a notification for the placing on the market of a GMO as or in products by a competent authority should be without prejudice to the submission of a notification of the same GMO to another competent authority.

(37) Na koncu obdobja dogovarjanja je treba, kadar ni nasprotovanj, doseči dogovor.

(37) An agreement should be reached at the end of the mediation period when no objections remain.

(38) Zavrnitev prijave na podlagi potrjenega negativnega poročila o oceni ne sme vplivati na prihodnje odločitve na podlagi prijave istega GSO pri drugem pristojnem organu.

(38) Rejection of a notification following a confirmed negative assessment report should be without prejudice to future decisions based on the notification of the same GMO to another competent authority.

(39) V interesu tekočega delovanja te direktive bi moralo biti državam članicam omogočeno, da koristijo različne določbe za izmenjavo informacij in izkušenj, preden se sklicujejo na zaščitno klavzulo v tej direktivi.

(39) In the interests of the smooth functioning of this Directive, Member States should be able to avail themselves of the various provisions for the exchange of information and experience before having recourse to the safeguard clause in this Directive.

(40) Za zagotavljanje, da je prisotnost GSO v proizvodu, ki vsebuje ali je sestavljen iz gensko spremenjenih organizmov, primerno določena, se morajo besede "Ta proizvod vsebuje gensko spremenjene organizme" jasno pojaviti na oznaki ali v spremljajočem dokumentu.

(40) In order to ensure that the presence of GMOs in products containing, or consisting of, genetically modified organisms is appropriately identified, the words "This product contains genetically modified organisms" should appear clearly either on a label or in an accompanying document.

(41) Z uporabo ustreznega postopka odbora je treba zasnovati sistem za dodelitev edinstvene oznake GSO ob upoštevanju ustreznega razvoja v mednarodnih krogih.

(41) A system should be designed using the appropriate committee procedure, for the assignment of a unique identifier to GMOs, taking into account relevant developments in international fora.

(42) Treba je zagotoviti sledljivost na vseh stopnjah dajanja v promet GSO kot proizvodov ali v proizvodih, odobrenih po delu C te direktive.

(42) It is necessary to ensure traceability at all stages of the placing on the market of GMOs as or in products authorised under part C of this Directive.

(43) V to direktivo je treba vpeljati obveznost izvajanja načrta spremljanja, da bi sledili in določili kakršne koli posredne ali neposredne, takojšnje, z zakasnitvijo ali nepredvidene učinke GSO kot proizvodov ali v proizvodih na zdravje ljudi ali okolje potem, ko so bili dani v promet.

(43) It is necessary to introduce into this Directive an obligation to implement a monitoring plan in order to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after they have been placed on the market.

(44) Omogočeno bi moralo biti, da države članice skladno s Pogodbo sprejmejo nadaljnje ukrepe za spremljanje in inšpekcijo, na primer z uradnimi službami, GSO kot proizvodov ali v proizvodih, danih v promet.

(44) Member States should be able, in accordance with the Treaty, to take further measures for monitoring and inspection, for example by official services, of the GMOs as or in products placed on the market.

(45) Treba je poiskati načine za zagotovitev možnosti za olajšan nadzor GSO ali njihov umik v primeru resnega tveganja.

(45) Means should be sought for providing possibilities for facilitating the control of GMOs or their retrieval in the event of severe risk.

(46) Pripombe javnosti je treba upoštevati v osnutkih ukrepov, predloženih Regulatornemu odboru.

(46) Comments by the public should be taken into consideration in the drafts of measures submitted to the Regulatory Committee.

(47) Pristojni organ sme svojo odobritev dati šele potem, ko se je zadovoljivo prepričal, da bo sproščanje varno za zdravje ljudi in okolje.

(47) The competent authority should give its consent only after it has been satisfied that the release will be safe for human health and the environment.

(48) Upravni postopek za dodeljevanje odobritev za dajanje v promet GSO kot proizvodov ali v proizvodih bi moral biti bolj učinkovit in preglednejši ter za prvič bi se odobritev dodelila za določeno obdobje.

(48) The administrative procedure for granting consents for the placing on the market of GMOs as or in products should be made more efficient and more transparent and first-time consent should be granted for a fixed period.

(49) Za proizvode, za katere je bila dodeljena odobritev za določeno obdobje, naj bi se v zvezi z obnovitvijo odobritve uporabil poenostavljen postopek.

(49) For products for which consent has been granted for a fixed period a streamlined procedure should apply as regards the renewal of consent.

(50) Obstoječe odobritve, dodeljene po Direktivi 90/220/EGS, je treba obnoviti, da bi se izognili razlikam med odobritvami, dodeljenimi po navedeni direktivi, in odobritvami po tej direktivi, ter da bi v celoti upoštevali pogoje odobritve po tej direktivi.

(50) The existing consents granted under Directive 90/220/EEC have to be renewed in order to avoid disparities between consents granted under that Directive and those pursuant to this Directive and in order to take full account of the conditions of consent under this Directive.

(51) Taka obnovitev zahteva prehodno obdobje, v katerem ni vpliva na obstoječe odobritve po Direktivi 90/220/EGS.

(51) Such renewal requires a transitional period during which existing consents granted under Directive 90/220/EEC remain unaffected.

(52) Pri obnovitvi odobritve naj bi bilo mogoče spremeniti vse pogoje prvotne odobritve, vključno s tistimi v zvezi s spremljanjem in časovno omejitvijo odobritve.

(52) When a consent is renewed, it should be possible to revise all the conditions of the original consent, including those related to monitoring and the time limitation of the consent.

(53) Pripraviti je treba predpis za posvetovanje z ustreznim(-i) znanstvenim(-i) odborom(-i), ustanovljenim(-i) s Sklepom Komisije 97/579/ES [7], o zadevah, ki lahko vplivajo na zdravje ljudi in/ali okolje.

(53) Provision should be made for consultation of the relevant Scientific Committee(s) established by Commission Decision 97/579/EC(7) on matters which are likely to have an impact on human health and/or the environment.

(54) Sistem izmenjave informacij, ki jih vsebujejo prijave, vzpostavljen po Direktivi 90/220/EGS, je bil koristen in je z njim treba nadaljevati.

(54) The system of exchange of information contained in notifications, established under Directive 90/220/EEC, has been useful and should be continued.

(55) Pomembno je skrbno slediti razvoju in uporabi GSO.

(55) It is important to follow closely the development and use of GMOs.

(56) Kadar je proizvod, ki vsebuje GSO kot proizvod ali v proizvodih, dan v promet, in kadar je bil tak proizvod pravilno odobren po tej direktivi, država članica ne sme prepovedati, omejiti ali ovirati dajanje v promet GSO kot proizvodov ali v proizvodih, ki izpolnjujejo zahteve te direktive. V primeru tveganja za zdravje ljudi ali okolje je treba poskrbeti za zaščitni postopek.

(56) When a product containing a GMO, as or in products, is placed on the market, and where such a product has been properly authorised under this Directive, a Member State may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive. A safeguard procedure should be provided in case of risk to human health or the environment.

(57) Treba se je posvetovati s Skupino za etiko v znanosti in novih tehnologijah pri Evropski komisiji z namenom pridobitve nasveta o etičnih vprašanjih splošne narave glede namernega sproščanja ali dajanja GSO v promet. Takšna posvetovanja ne smejo vplivati na pristojnost držav članic glede etičnih vprašanj.

(57) The Commission's European Group on Ethics in Science and New Technologies should be consulted with a view to obtaining advice on ethical issues of a general nature regarding the deliberate release or placing on the market of GMOs. Such consultations should be without prejudice to the competence of Member States as regards ethical issues.

(58) Državam članicam mora biti omogočeno, da se posvetujejo s katerim koli odborom, ki so ga ustanovile za pridobitev nasveta o etičnih posledicah biotehnologije.

(58) Member States should be able to consult any committee they have established with a view to obtaining advice on the ethical implications of biotechnology.

(59) Ukrepe, potrebne za izvajanje te direktive, je treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [8].

(59) The measures necessary for the implementation of this Directive are to 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(8).

(60) Izmenjava informacij po tej direktivi mora zajeti tudi izkušnje, dobljene z upoštevanjem etičnih vidikov.

(60) The information exchange set up under this Directive should also cover experience gained with the consideration of ethical aspects.

(61) Da bi okrepili učinkovito izvajanje določb, sprejetih s to direktivo, je primerno predvideti sankcije, ki naj jih države članice uporabljajo, kar naj vključuje tudi primere sproščanja ali dajanja v promet v nasprotju z določbami te direktive, zlasti zaradi malomarnosti.

(61) In order to increase the effective implementation of the provisions adopted under this Directive it is appropriate to provide for penalties to be applied by Member States, including in the event of release or placing on the market contrary to the provisions of this Directive, particularly as a result of negligence.

(62) Poročilo, ki naj ga Komisija izda vsaka tri leta ob upoštevanju informacij, ki jih zagotovijo države članice, mora vsebovati ločeno poglavje v zvezi s socialnoekonomskimi prednostmi in pomanjkljivostmi vsake kategorije GSO, odobrene za dajanje v promet, ki bo ustrezno upoštevalo interese kmetov in potrošnikov.

(62) A report to be issued every three years by the Commission, taking into account the information provided by Member States, should contain a separate chapter regarding the socioeconomic advantages and disadvantages of each category of GMOs authorised for placing on the market, which will take due account of the interest of farmers and consumers.

(63) Treba je pregledati normativni okvir za biotehnologijo, da bi določili možnosti nadaljnjega izboljševanja skladnosti in učinkovitosti tega okvira. Morda bo treba prilagoditi postopke, da bi optimirali učinkovitost, in proučiti vse možnosti, s katerimi bi to lahko dosegli –

(63) The regulatory framework for biotechnology should be reviewed so as to identify the feasibility of improving further the consistency and efficiency of that framework. Procedures may need to be adapted so as to optimise efficiency, and all options which might achieve that should be considered,

SPREJELA NASLEDNJO DIREKTIVO:

HAVE ADOPTED THIS DIRECTIVE:

DEL A

SPLOŠNE DOLOČBE

PART A

Člen 1

GENERAL PROVISIONS

Cilj

Article 1

Skladno s previdnostnim načelom je cilj te direktive približati zakone in druge predpise držav članic ter varovati zdravje ljudi in okolje, kadar se:

Objective

- opravlja namerno sproščanje gensko spremenjenih organizmov v okolje iz katerega koli drugega razloga, kot je dajanje v promet v Skupnosti,

In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:

- dajejo v promet gensko spremenjeni organizmi kot proizvodi ali v proizvodih v Skupnosti.

- carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community,

Člen 2

- placing on the market genetically modified organisms as or in products within the Community.

Opredelitve pojmov

V tej direktivi pomenijo:

Article 2

"organizem" katero koli biološko enoto, sposobno razmnoževanja ali prenosa genskega materiala;

Definitions

"gensko spremenjeni organizem (GSO)" (a) genska sprememba se dogodi vsaj z uporabo tehnik iz seznama v Prilogi I A, del 1;

For the purposes of this Directive:

(b) za tehnike iz seznama v Prilogi I A, del 2, velja, da njihov rezultat ni genska sprememba;

(1) "organism" means any biological entity capable of replication or of transferring genetic material;

"namerno sproščanje" vsak nameren vnos GSO ali kombinacije GSO v okolje, za katerega se ne uporabljajo posebni zadrževalni ukrepi za omejitev stika s prebivalstvom in okoljem in za zagotovitev visoke ravni varnosti za prebivalstvo in okolje;

(2) "genetically modified organism (GMO)" means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination;

"dajanje v promet" - dajanje gensko spremenjenih mikroorganizmov na voljo za dejavnosti, urejene po Direktivi Sveta 90/219/EGS z dne 23. aprila 1990 o uporabi gensko spremenjenih mikroorganizmov v zaprtih sistemih [9], vključno z zbirkami kultur,

Within the terms of this definition:

- dajanje GSO na voljo, razen mikroorganizmov iz prve alinee, za uporabo izključno za dejavnosti, kjer se uporabljajo ustrezni strogi zadrževalni ukrepi za omejitev njihovega stika s prebivalstvom in okoljem in za zagotovitev visoke ravni varnosti prebivalstva in okolja, pri čemer morajo ukrepi temeljiti na istih načelih zadrževanja, kot so določena v Direktivi 90/219/EGS,

(a) genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1;

- dajanje GSO na voljo za uporabo izključno za namerno sproščanje, ki izpolnjujejo zahteve iz dela B te direktive;

(b) the techniques listed in Annex I A, part 2, are not considered to result in genetic modification;

"prijava" predložitev informacij, zahtevanih po tej direktivi, pristojnemu organu države članice;

(3) "deliberate release" means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment;

"prijavitelj" osebo, ki predloži prijavo;

(4) "placing on the market" means making available to third parties, whether in return for payment or free of charge;

"proizvod" pripravek, sestavljen iz GSO ali ki vsebuje GSO ali kombinacijo GSO, ki se daje v promet;

The following operations shall not be regarded as placing on the market:

"ocena tveganja za okolje" vrednotenje tveganj za zdravje ljudi in okolje, posrednih ali neposrednih, takojšnjih ali z zakasnitvijo, ki jih lahko predstavlja namerno sproščanje ali dajanje GSO v promet, ter se opravlja skladno s Prilogo II.

- making available genetically modified microorganisms for activities regulated under Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified microorganisms(9) including culture collections,

Člen 3

- making available GMOs other than microorganisms referred to in the first indent, to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment, the measures should be based on the same principles of containment as laid down in Directive 90/219/EEC,

Izjeme

- making available GMOs to be used exclusively for deliberate releases complying with the requirements laid down in part B of this Directive;

1. Ta direktiva se ne uporablja za organizme, dobljene s tehnikami genskega spreminjanja iz seznama v Prilogi I B.

(5) "notification" means the submission of the information required under this Directive to the competent authority of a Member State;

2. Ta direktiva se ne uporablja za prevoz gensko spremenjenih organizmov po železnici, cesti, celinskih plovnih poteh, morju ali zraku.

(6) "notifier" means the person submitting the notification;

Člen 4

(7) "product" means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market;

Splošne obveznosti

(8) "environmental risk assessment" means the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II.

1. Države članice po previdnostnem načelu zagotovijo sprejem vseh ustreznih ukrepov, da se izognejo škodljivim vplivom za zdravje ljudi in okolje, ki bi lahko izhajali iz namernega sproščanja GSO ali njihovega dajanja v promet. GSO se lahko namerno sproščajo ali dajejo v promet samo skladno z delom B oziroma delom C.

2. Vsaka oseba mora pred predložitvijo prijave po delu B ali C opraviti oceno tveganja za okolje. Informacije, ki so lahko potrebne za opravljanje ocene tveganja za okolje, so določene v Prilogi III. Države članice in Komisija zagotovijo, da se GSO, ki vsebujejo gene, ki izražajo odpornost na antibiotike, ki se uporabljajo za medicinsko ali veterinarsko zdravljenje, zlasti upoštevajo pri oceni tveganja, z namenom določiti in postopoma odpraviti označevalce odpornosti na antibiotike v GSO, ki lahko škodljivo vplivajo na zdravje ljudi in okolje. Ta postopna odprava se bo opravila do 31. decembra 2004 v primeru GSO, danih v promet skladno z delom C, in do 31. decembra 2008 v primeru GSO, odobrenih po delu B.

Article 3

3. Države članice in, kadar je primerno, Komisija zagotovijo, da se možni škodljivi učinki za zdravje ljudi in okolje, ki se lahko pojavijo posredno ali neposredno s prenosom genov iz GSO na druge organizme, natančno ocenijo za vsak posamezen primer. Ta ocena se opravi skladno s Prilogo II ob upoštevanju vpliva na okolje glede na naravo vnešenega organizma in prejemnega okolja.

Exemptions

4. Države članice imenujejo pristojni organ ali organe, odgovorne za izpolnjevanje zahtev iz te direktive. Pristojni organ prouči prijave po delu B in delu C glede skladnosti z zahtevami te direktive in glede ustreznosti ocene iz odstavka 2.

1. This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex I B.

5. Države članice zagotovijo, da pristojni organ organizira ustrezne inšpekcije in vse druge nadzorne ukrepe za zagotovitev skladnosti s to direktivo. V primeru sproščanja GSO ali njihovega dajanja v promet kot proizvodov ali v proizvodih, za katerega ni bilo izdano dovoljenje, zadevna država članica zagotovi sprejetje potrebnih ukrepov za prenehanje sproščanja ali dajanja v promet, za uvedbo sanacijskih ukrepov, če so potrebni, in za obveščanje svoje javnosti, Komisije in drugih držav članic.

2. This Directive shall not apply to the carriage of genetically modified organisms by rail, road, inland waterway, sea or air.

6. Države članice skladno z zahtevami iz Priloge IV sprejmejo ukrepe za zagotovitev sledljivosti na vseh stopnjah dajanja GSO, dovoljenih po delu C, v promet.

DEL B

Article 4

NAMERNO SPROŠČANJE GSO ZA KATERI KOLI NAMEN, RAZEN ZA DAJANJE V PROMET

General obligations

Člen 5

1. Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively.

1. Členi 6 do 11 se ne uporabljajo za medicinske snovi in sestavine za humano uporabo, ki so sestavljene ali vsebujejo GSO ali kombinacijo GSO, pod pogojem, da njihovo namerno sproščanje za katerikoli namen, razen za dajanje v promet, dovoli zakonodaja Skupnosti, ki predvideva:

2. Any person shall, before submitting a notification under part B or part C, carry out an environmental risk assessment. The information which may be necessary to carry out the environmental risk assessment is laid down in Annex III. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. This phasing out shall take place by the 31 December 2004 in the case of GMOs placed on the market according to part C and by 31 December 2008 in the case of GMOs authorised under part B.

(a) posebno oceno tveganja za okolje po Prilogi II in na podlagi vrste informacij, navedenih v Prilogi III, ne da bi to vplivalo na dodatne zahteve navedene zakonodaje;

3. Member States and where appropriate the Commission shall ensure that potential adverse effects on human health and the environment, which may occur directly or indirectly through gene transfer from GMOs to other organisms, are accurately assessed on a case-by-case basis. This assessment shall be conducted in accordance with Annex II taking into account the environmental impact according to the nature of the organism introduced and the receiving environment.

(b) izrecno odobritev pred sproščanjem;

4. Member States shall designate the competent authority or authorities responsible for complying with the requirements of this Directive. The competent authority shall examine notifications under part B and part C for compliance with the requirements of this Directive and whether the assessment provided for in paragraph 2 is appropriate.

5. Member States shall ensure that the competent authority organises inspections and other control measures as appropriate, to ensure compliance with this Directive. In the event of a release of GMO(s) or placing on the market as or in products for which no authorisation was given, the Member State concerned shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission and other Member States.

(d) na ustrezen način zahteve glede ravnanja s posameznimi novimi informacijami, obveščanja javnosti, informacij o rezultatih sproščanj in izmenjave informacij, ki so vsaj enakovredne vsebovanim v tej direktivi in v ukrepih, sprejetih skladno z njo.

6. Member States shall take measures to ensure traceability, in line with the requirements laid down in Annex IV, at all stages of the placing on the market of GMOs authorised under part C.

2. Ocena tveganj za okolje, ki jih predstavljajo te snovi in sestavine, se opravi ob usklajevanju z nacionalnimi organi in organi Skupnosti, navedenimi v tej direktivi.

3. Navedena zakonodaja, ki se mora sklicevati na to direktivo, mora predvideti postopke, ki zagotavljajo skladnost določene ocene tveganja za okolje in enakovrednost z določbami te direktive.

PART B

Člen 6

DELIBERATE RELASE OF GMOs FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

Standardni postopek odobritve

Article 5

1. Brez poseganja v člen 5 mora vsaka oseba, preden začne z namernim sproščanjem GSO ali kombinacije GSO, predložiti prijavo pristojnemu organu države članice, na katere ozemlju bo prišlo do sproščanja.

1. Articles 6 to 11 shall not apply to medicinal substances and compunds for human use consisting of, or containing, a GMO or combination of GMOs provided that their deliberate release for any purpose other than that of being placed on the market is authorised by Community legislation which provides:

2. Prijava iz prvega odstavka vključuje:

(a) for a specific environmental risk assessment in accordance with Annex II and on the basis of the type of information specified in Annex III without prejudice to additional requirements provided for by the said legislation;

(a) tehnično dokumentacijo, ki daje informacije iz Priloge III, potrebne za opravljanje ocene tveganja za okolje pri namernem sproščanju GSO ali kombinacije GSO, zlasti:

(b) for explicit consent prior to release;

(i) splošne informacije, vključno z informacijami o osebju in njegovi usposobljenosti,

(c) for a monitoring plan in accordance with the relevant parts of Annex III, with a view to detecting the effects of the GMO or GMOs on human health or the environment;

(ii) informacije v zvezi z GSO,

(d) in an appropriate manner for requirements relating to treatment of new items of information, information to the public, information on the results of releases, and exchanges of information at least equivalent to those contained in this Directive and in the measures taken in accordance therewith.

(iii) informacije v zvezi s pogoji sproščanja in potencialnega prejemnega okolja,

2. Assessment of the risks to the environment presented by such substances and compounds shall be carried out in coordination with the national and Community authorities mentioned in this Directive.

(iv) informacije o medsebojnem vplivanju GSO in okolja,

3. Procedures ensuring conformity of the specific environmental risk assessment and equivalence with the provisions of this Directive must be provided for by the said legislation, which must refer to this Directive.

(v) načrt spremljanja skladno z ustreznimi deli Priloge III za določitev učinkov GSO na zdravje ljudi ali okolje,

(vi) informacije o nadzoru, metodah sanacije, ravnanju z odpadki in načrtih ukrepov za primer nesreče,

Article 6

(vii) povzetek dokumentacije;

Standard authorisation procedure

(b) oceno tveganja za okolje in zaključke, zahtevane v Prilogi II, oddelek D, skupaj z morebitnimi bibliografskimi sklici ter navedbami uporabljenih metod.

1. Without prejudice to Article 5, any person must, before undertaking a deliberate release of a GMO or of a combination of GMOs, submit a notification to the competent authority of the Member State within whose territory the release is to take place.

3. Prijavitelj se lahko sklicuje na podatke ali rezultate iz prejšnjih prijav, ki so jih predložili drugi prijavitelji, pod pogojem, da te informacije, podatki in rezultati niso zaupni ali da so ti prijavitelji dali pisno privoljenje, ali lahko predloži dodatne informacije, za katere meni, da so pomembne.

2. The notification referred to in paragraph 1 shall include:

4. Pristojni organ lahko privoli, da se sproščanja istega GSO ali kombinacije GSO na istem mestu ali različnih mestih za isti namen in v določenem obdobju, prijavijo v eni sami prijavi.

(a) a technical dossier supplying the information specified in Annex III necessary for carrying out the environmental risk assessment of the deliberate release of a GMO or combination of GMOs, in particular:

5. Pristojni organ potrdi datum prejema prijave in potem, ko je proučil, kjer je to primerno, morebitne pripombe drugih držav članic po členu 11, prijavitelju pisno odgovori v 90 dneh od prejema prijave z:

(i) general information including information on personnel and training,

(a) navedbo, da se je prepričal, da je prijava v skladu s to direktivo in da se lahko prične s sproščanjem; ali

(ii) information relating to the GMO(s),

(b) navedbo, da sproščanje ne izpolnjuje pogojev te direktive in se prijava zato zavrne.

(iii) information relating to the conditions of release and the potential receiving environment,

6. Za izračun 90 dnevnega obdobja iz odstavka 5 se ne upoštevajo obdobja, v katerih pristojni organ:

(iv) information on the interactions between the GMO(s) and the environment,

(a) čaka na dodatne informacije, ki jih je morda zahteval od prijavitelja; ali

(v) a plan for monitoring in accordance with the relevant parts of Annex III in order to identify effects of the GMO(s) on human health or the environment,

(b) ugotavlja javno mnenje ali se posvetuje z javnostjo v skladu s členom 9; to ugotavljanje javnega mnenja ali posvetovanje z javnostjo ne podaljšata 90-dnevnega roka iz odstavka 5 za več kot 30 dni.

(vi) information on control, remediation methods, waste treatment and emergency response plans,

7. Če pristojni organ zahteva nove informacije, mora hkrati navesti razloge za to.

(vii) a summary of the dossier;

8. Prijavitelj lahko prične s sproščanjem samo, ko prejme pisno odobritev pristojnega organa, in samo pod pogoji, zahtevanimi v tej odobritvi.

(b) the environmental risk assessment and the conclusions required in Annex II, section D, together with any bibliographic reference and indications of the methods used.

9. Države članice zagotovijo, da se noben material, ki izhaja iz GSO, namerno sproščenih po delu B, ne da v promet, če ni v skladu z delom C.

3. The notifier may refer to data or results from notifications previously submitted by other notifiers, provided that the information, data and results are non confidential or these notifiers have given their agreement in writing, or may submit additional information he considers relevant.

Člen 7

4. The competent authority may accept that releases of the same GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification.

Spremenjeni postopki

5. The competent authority shall acknowledge the date of receipt of the notification and, having considered, where appropriate, any observations by other Member States made in accordance with Article 11, shall respond in writing to the notifier within 90 days of receipt of the notification by either:

1. Če je bilo pridobljenih dovolj izkušenj glede sproščanja določenih GSO v določenih ekosistemih in zadevni GSO izpolnjujejo merila iz Priloge V, lahko pristojni organ Komisiji predloži utemeljen predlog za uporabo spremenjenih postopkov za te vrste GSO.

(a) indicating that it is satisfied that the notification is in compliance with this Directive and that the release may proceed; or

2. Na lastno pobudo ali najkasneje 30 dni po prejemu predloga pristojnega organa Komisija:

(b) indicating that the release does not fulfil the conditions of this Directive and that notification is therefore rejected.

(a) posreduje predlog pristojnim organom, ki lahko v 60 dneh predstavijo svoja stališča, in istočasno;

6. For the purpose of calculating the 90 day period referred to in paragraph 5, no account shall be taken of any periods of time during which the competent authority:

(b) napravi predlog dostopen javnosti, ki lahko v 60 dneh da pripombe; in

(a) is awaiting further information which it may have requested from the notifier, or

(b) is carrying out a public inquiry or consultation in accordance with Article 9; this public inquiry or consultation shall not prolong the 90 day period referred to in paragraph 5 by more than 30 days.

3. O vsakem predlogu se sprejme odločitev po postopku iz člena 30(2). Ta odločitev določa minimalno količino tehničnih informacij iz Priloge III, potrebnih za ovrednotenje kakršnih koli predvidljivih tveganj zaradi sproščanja, še zlasti:

7. If the competent authority requests new information it must simultaneously give its reasons for so doing.

(a) informacije v zvezi z GSO;

8. The notifier may proceed with the release only when he has received the written consent of the competent authority, and in conformity with any conditions required in this consent.

(b) informacije v zvezi s pogoji sproščanja in potencialnim prejemnim okoljem;

9. Member States shall ensure that no material derived from GMOs which are deliberately released in accordance with part B is placed on the market, unless in accordance with part C.

(d) oceno tveganja za okolje.

Article 7

4. Ta odločitev se sprejme v 90 dneh od datuma predloga Komisije ali od prejema predloga pristojnega organa. Ta 90-dnevni rok ne upošteva obdobja, v katerem Komisija čaka na stališča pristojnih organov, pripombe javnosti ali mnenje znanstvenega odbora, kot je predvideno v odstavku 2.

Differentiated procedures

5. Odločitev, sprejeta po odstavkih 3 in 4, določa, da lahko prijavitelj prične s sproščanjem šele, ko prejme pisno odobritev pristojnega organa. Prijavitelj prične s sproščanjem skladno z vsemi pogoji, zahtevanimi v tej odobritvi.

1. If sufficient experience has been obtained of releases of certain GMOs in certain ecosystems and the GMOs concerned meet the criteria set out in Annex V, a competent authority may submit to the Commission a reasoned proposal for the application of differentiated procedures to such types of GMOs.

Odločitev, sprejeta po odstavkih 3 in 4, lahko predvideva, da se sproščanja GSO ali kombinacije GSO na istem mestu ali različnih mestih za isti namen in v določenem obdobju lahko prijavijo v eni sami prijavi.

2. Following its own initiative or at the latest 30 days following the receipt of a competent authority's proposal, the Commission shall,

6. Brez poseganja v odstavke 1 do 5 se še naprej uporablja Odločba Komisije 94/730/ES z dne 4. novembra 1994 o določitvi poenostavljenih postopkov za namerno sproščanje gensko spremenjenih rastlin v okolje po členu 6(5) Direktive Sveta 90/220/EGS [10].

(a) forward the proposal to the competent authorities, which may, within 60 days, present observations and at the same time;

7. Ko se država članica odloči, da bo za sproščanja GSO na svojem ozemlju uporabila ali ne bo uporabila postopek, določen v odločitvi po odstavkih 3 in 4, o tem obvesti Komisijo.

(b) make available the proposal to the public which may, within 60 days, make comments; and

Člen 8

Postopek pri spremembah in novih informacijah

3. A decision shall be taken on each proposal in accordance with the procedure laid down in Article 30(2). This decision shall establish the minimum amount of technical information from Annex III necessary for evaluating any foreseeable risks from the release, in particular:

1. V primeru kakršne koli spremembe ali nenamerne spremembe namernega sproščanja GSO ali kombinacije GSO, ki bi lahko imela posledice glede tveganj za zdravje ljudi in okolje, potem ko je pristojni organ dal svojo pisno odobritev, ali če so na voljo nove informacije o teh tveganjih, medtem ko prijavo proučuje pristojni organ države članice ali potem ko je ta organ dal svojo pisno odobritev, prijavitelj takoj:

(a) information relating to the GMO(s);

(a) sprejme potrebne ukrepe za varstvo zdravja ljudi in okolja;

(b) information relating to the conditions of release and the potential receiving environment;

(b) obvesti pristojni organ o vsaki spremembi vnaprej ali takoj, ko je nenamerna sprememba znana ali so na voljo nove informacije;

(d) the environmental risk assessment.

2. Če v odstavku 1 naveden pristojni organ dobi na voljo informacije, ki bi lahko imele precejšnje posledice glede tveganj za zdravje ljudi in okolje, ali v okoliščinah, opisanih v odstavku 1, pristojni organ ovrednoti te informacije in jih da na voljo javnosti. Od prijavitelja lahko zahteva, da spremeni pogoje, začasno ustavi ali preneha z namernim sproščanjem ter o tem obvesti javnost.

4. This decision shall be taken within 90 days of the date of the Commission's proposal or of receipt of the competent authority's proposal. This 90 day period shall not take into account the period of time during which the Commission is awaiting the observations of competent authorities, the comments of the public or the opinion of Scientific Committees, as provided for in paragraph 2.

Člen 9

5. The decision taken under paragraphs 3 and 4 shall provide that the notifier may proceed with the release only when he has received the written consent of the competent authority. The notifier shall proceed with the release in conformity with any conditions required in this consent.

Posvetovanje z in obveščanje javnosti

The decision taken under paragraphs 3 and 4 may provide that releases of a GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification.

1. Brez poseganja v določbe členov 7 in 25 se države članice o predlaganem namernem sproščanju posvetujejo z javnostjo in, če je to primerno, s skupinami. Pri tem države članice določijo ureditev za to posvetovanje, vključno z ustreznim rokom, da bi dali javnosti ali skupinam priložnost izraziti svoje mnenje.

6. Without prejudice to paragraphs 1 to 5, Commission Decision 94/730/EC of 4 November 1994 establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6(5) of Council Directive 90/220/EEC(10) shall continue to apply.

2. Brez poseganja v določbe člena 25:

7. Where a Member State decides to make use or not of a procedure established in a decision taken in accordance with paragraphs 3 and 4 for releases of GMOs within its territory, it shall inform the Commission thereof.

- države članice dajo javnosti na voljo informacije o vseh sproščanjih GSO po delu B na svojem ozemlju,

- Komisija da javnosti na voljo informacije iz sistema izmenjave informacij po členu 11.

Article 8

Člen 10

Handling of modifications and new information

Poročanje prijaviteljev o sproščanjih

1. In the event of any modification of, or unintended change to, the deliberate release of a GMO or of a combination of GMOs which could have consequences with regard to risks for human health and the environment after the competent authority has given its written consent, or if new information has become available on such risks, either while the notification is being examined by the competent authority of a Member State or after that authority has given its written consent, the notifier shall immediately:

Po zaključenem sproščanju in zatem v presledkih, določenih v odobritvi na podlagi rezultatov ocene tveganja za okolje, prijavitelj pristojnemu organu pošlje rezultat sproščanja glede kakršnega koli tveganja za zdravje ljudi in okolje, če je to primerno, s posebnim poudarkom na kakršnikoli vrsti proizvoda, ki ga prijavitelj namerava prijaviti na poznejši stopnji. Oblika za predstavitev tega rezultata se določi po postopku iz člena 30(2).

(a) take the measures necessary to protect human health and the environment;

Člen 11

(b) inform the competent authority in advance of any modification or as soon as the unintended change is known or the new information is available;

Izmenjava informacij med pristojnimi organi in Komisijo

1. Komisija vzpostavi sistem za izmenjavo informacij, ki jih vsebujejo prijave. Pristojni organi Komisiji v 30 dneh po prejemu pošljejo povzetek vsake prijave, prejete po členu 6. Oblika tega povzetka se določi in spremeni, če je to primerno, po postopku iz člena 30(2).

2. If information becomes available to the competent authority referred to in paragraph 1 which could have significant consequences with regard to risks for human health and the environment or under the circumstances described in paragraph 1, the competent authority shall evaluate such information and make it available to the public. It may require the notifier to modify the conditions of, suspend or terminate the deliberate release and shall inform the public thereof.

2. Komisija te povzetke najkasneje 30 dni po prejemu posreduje drugim državam članicam, ki lahko v 30 dneh preko Komisije ali neposredno izrazijo svoje pripombe. Državi članici se na njeno zahtevo dovoli, da od pristojnega organa ustrezne države članice prejme kopijo celotne prijave.

3. Pristojni organi Komisijo obvestijo o končnih odločitvah po členu 6(5), vključno z razlogi za zavrnitev prijave, če je to ustrezno, in o rezultatih sproščanj, prejetih po členu 10.

Article 9

4. Za sproščanja GSO iz člena 7 države članice enkrat letno pošljejo seznam GSO, sproščenih na njihovih ozemljih, in seznam zavrnjenih prijav Komisiji, ki jih posreduje pristojnim organom drugih držav članic.

Consultation of and information to the public

DEL C

1. Member States shall, without prejudice to the provisions of Articles 7 and 25, consult the public and, where appropriate, groups on the proposed deliberate release. In doing so, Member States shall lay down arrangements for this consultation, including a reasonable time-period, in order to give the public or groups the opportunity to express an opinion.

DAJANJE GSO KOT PROIZVODOV ALI V PROIZVODIH V PROMET

2. Without prejudice to the provisions of Article 25:

Člen 12

- Member States shall make available to the public information on all part B releases of GMOs in their territory;

Sektorska zakonodaja

- the Commission shall make available to the public the information contained in the system of exchange of information pursuant to Article 11.

1. Členi 13 do 24 se ne uporabljajo za GSO kot proizvode ali v proizvodih, v kolikor jih dovoljuje zakonodaja Skupnosti, ki predvideva posebno oceno tveganja za okolje, opravljeno po načelih iz Priloge II in na podlagi informacij iz Priloge III, brez poseganja v dodatne zahteve, predvidene v zgoraj navedeni zakonodaji Skupnosti, in zahteve v zvezi z obvladovanjem tveganja, označevanjem, ustreznim spremljanjem, obveščanjem javnosti in zaščitno klavzulo, ki so vsaj enakovredne tistim, določenim v tej direktivi.

2. Kar zadeva Uredbo Sveta (EGS) št. 2309/93, se členi 13 do 24 te direktive ne uporabljajo za GSO kot proizvode ali v proizvodih, v kolikor so dovoljeni z navedeno uredbo, pod pogojem, da se opravi posebna ocena tveganja za okolje po načelih iz Priloge II k tej direktivi in na podlagi vrste informacij, navedenih v Prilogi III k tej direktivi, brez poseganja v druge ustrezne zahteve v zvezi z oceno tveganja, obvladovanjem tveganja, označevanjem, ustreznim spremljanjem, obveščanjem javnosti in zaščitno klavzulo, predvidene po zakonodaji Skupnosti glede zdravil za humano in veterinarsko uporabo.

Article 10

3. Postopki, ki zagotavljajo, da so ocena tveganja, zahteve v zvezi z obvladovanjem tveganja, označevanje, ustrezno spremljanje, obveščanje javnosti in zaščitna klavzula enakovredni tistim, določenim v tej direktivi, se uvedejo v Uredbi Evropskega parlamenta in Sveta. Prihodnja sektorska zakonodaja na podlagi določb navedene uredbe se sklicuje na to direktivo. Dokler uredba ne začne veljati, se GSO kot proizvodi ali v proizvodih, v kolikor so dovoljeni po drugi zakonodaji Skupnosti, dajo v promet šele potem, ko so bili sprejeti za dajanje v promet po tej direktivi.

Reporting by notifiers on releases

4. Med vrednotenjem zahtev za dajanje GSO iz odstavka 1 v promet se je treba posvetovati z organi, ki jih Skupnost ustanovi po tej direktivi, države članice pa za izvajanje te direktive.

After completion of a release, and thereafter, at any intervals laid down in the consent on the basis of the results of the environmental risk assessment, the notifier shall send to the competent authority the result of the release in respect of any risk to human health or the environment, with, where appropriate, particular reference to any kind of product that the notifier intends to notify at a later stage. The format for the presentation of this result shall be established in accordance with the procedure laid down in Article 30(2).

Člen 13

Postopek prijavljanja

Article 11

1. Preden se GSO ali kombinacija GSO kot proizvodi ali v proizvodih dajo v promet, se pristojnemu organu države članice, kjer naj bi se ta GSO prvič dal v promet, predloži prijava. Pristojni organ potrdi datum prejema prijave in pristojnim organom drugih držav članic in Komisiji takoj posreduje povzetek dokumentacije iz odstavka 2(h).

Exchange of information between competent authorities and the Commission

Pristojni organ brez odlašanja prouči, ali je prijava v skladu z odstavkom 2, in, če je treba, prijavitelja zaprosi za dodatne informacije.

1. The Commission shall set up a system of exchange of the information contained in the notifications. The competent authorities shall send to the Commission, within 30 days of its receipt, a summary of each notification received under Article 6. The format of this summary shall be established and modified if appropriate in accordance with the procedure laid down in Article 30(2).

Ko je prijava skladna z odstavkom 2 in najkasneje ko pošlje svoje poročilo o oceni po členu 14(2), posreduje pristojni organ kopijo prijave Komisiji, ki jo v 30 dneh po prejemu posreduje pristojnim organom drugih držav članic.

2. The Commission shall, at the latest 30 days following their receipt, forward these summaries to the other Member States, which may, within 30 days, present observations through the Commission or directly. At its request, a Member State shall be permitted to receive a copy of the full notification from the competent authority of the relevant Member State.

2. Prijava vsebuje:

3. The competent authorities shall inform the Commission of the final decisions taken in compliance with Article 6(5), including where relevant the reasons for rejecting a notification, and of the results of the releases received in accordance with Article 10.

(a) informacije, zahtevane v prilogah III in IV. Te informacije upoštevajo raznolikost mest uporabe GSO kot proizvoda ali v proizvodu ter vključujejo informacije o podatkih in rezultatih, dobljenih pri raziskovalnih in razvojnih sproščanjih, v zvezi z vplivom sproščanja na zdravje ljudi in okolje;

4. For the releases of GMOs referred to in Article 7, once a year Member States shall send a list of GMOs which have been released on their territory and a list of notifications that were rejected to the Commission, which shall forward them to the competent authorities of the other Member States.

(b) oceno tveganja za okolje in zaključke, zahtevane v Prilogi II, del D;

PART C

(d) sklicujoč se na člen 15(4), predlagano obdobje odobritve, ki ne sme presegati deset let;

PLACING ON THE MARKET OF GMOs AS OR IN PRODUCTS

(e) načrt spremljanja po Prilogi VII, vključno s predlogom za časovno obdobje načrta spremljanja; to časovno obdobje se lahko razlikuje od predlaganega obdobja odobritve;

Article 12

(f) predlog za označevanje, ki izpolnjuje zahteve, določene v Prilogi IV. Označevanje jasno navaja prisotnost GSO. Besede "ta proizvod vsebuje gensko spremenjene organizme" se pojavijo na oznaki ali na spremljajočem dokumentu;

Sectoral legislation

(g) predlog za pakiranje, ki obsega zahteve, določene v Prilogi IV;

1. Articles 13 to 24 shall not apply to any GMO as or in products as far as they are authorised by Community legislation which provides for a specific environmental risk assessment carried out in accordance with the principles set out in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements provided for by the Community legislation mentioned above, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in this Directive.

(h) povzetek dokumentacije. Oblika povzetka se določi po postopku iz člena 30(2).

2. As far as Council Regulation (EEC) No 2309/93 is concerned, Articles 13 to 24 of this Directive shall not apply to any GMO as or in products as far as they are authorised by that Regulation provided that a specific environmental risk assessment is carried out in accordance with the principles set out in Annex II to this Directive and on the basis of the type of information specified in Annex III to this Directive without prejudice to other relevant requirements as regards risk assessment, risk management, labelling, monitoring as appropriate, information to the public and safeguard clause provided by Community legislation concerning medicinal products for human and veterinary use.

Če na podlagi rezultatov sproščanja, prijavljenega po delu B, ali iz drugih bistvenih, utemeljenih znanstvenih razlogov prijavitelj meni, da dajanje GSO kot proizvodov ali v proizvodih v promet ne predstavlja tveganja za zdravje ljudi in okolje, lahko pristojnemu organu predlaga, da ne bo zagotovil dela ali vseh informacij, zahtevanih v Prilogi IV, oddelek B.

3. Procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in this Directive shall be introduced, in a Regulation of the European Parliament and of the Council. Future sectoral legislation based on the provisions of that Regulation shall make a reference to this Directive. Until the Regulation enters into force, any GMO as or in products as far as they are authorised by other Community legislation shall only be placed on the market after having been accepted for placing on the market in accordance with this Directive.

3. Prijavitelj v to prijavo vključi informacije o podatkih ali rezultatih sproščanj istih GSO ali iste kombinacije GSO, ki so bila prej ali so trenutno prijavljena in/ali jih prijavitelj opravlja znotraj ali zunaj Skupnosti.

4. During evaluation of the requests for the placing on the market of the GMOs referred to in paragraph 1, the bodies established by the Community under this Directive and by Member States for the purpose of implementing this Directive shall be consulted.

4. Prijavitelj se lahko sklicuje tudi na podatke ali rezultate prijav, ki so jih prej predložili drugi prijavitelji, ali predloži dodatne informacije, ki se mu zdijo pomembne, pod pogojem, da informacije, podatki in rezultati niso zaupni in da so se ti prijavitelji podali svoje pisno soglasje.

5. Da bi se GSO ali kombinacija GSO uporabila za namen, ki se razlikuje od že opredeljenega v prijavi, se predloži ločena prijava.

Article 13

6. Če so na voljo nove informacije glede tveganj GSO za zdravje ljudi ali okolje pred pisno odobritvijo, prijavitelj takoj sprejme potrebne ukrepe za varstvo zdravja ljudi in okolja ter o tem obvesti pristojni organ. Poleg tega prijavitelj pregleda informacije in pogoje, navedene v prijavi.

Notification procedure

Člen 14

1. Before a GMO or a combination of GMOs as or in products is placed on the market, a notification shall be submitted to the competent authority of the Member State where such a GMO is to be placed on the market for the first time. The competent authority shall acknowledge the date of receipt of the notification and immediately forward the summary of the dossier referred to in paragraph 2(h) to the competent authorities of the other Member States and the Commission.

Poročilo o oceni

The competent authority shall without delay examine whether the notification is in accordance with paragraph 2 and shall, if necessary, ask the notifier for additional information.

1. Ob prejemu in po potrditvi prijave po členu 13(2) pristojni organ prouči, ali je usklajena s to direktivo.

When the notification is in accordance with paragraph 2, and at the latest when it sends its assessment report in accordance with Article 14(2), the competent authority shall forward a copy of the notification to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

2. V 90 dneh po prejemu prijave pristojni organ:

2. The notification shall contain:

- pripravi poročilo o oceni in ga pošlje prijavitelju. Naknadni umik s strani prijavitelja ne vpliva na morebitno nadaljnjo predložitev prijave drugemu pristojnemu organu,

(a) the information required in Annexes III and IV. This information shall take into account the diversity of sites of use of the GMO as or in a product and shall include information on data and results obtained from research and developmental releases concerning the impact of the release on human health and the environment;

- v primeru iz odstavka 3(a) pošlje svoje poročilo skupaj z informacijami iz odstavka 4 in vsemi drugimi informacijami, na katerih je osnoval svoje poročilo, Komisiji, ki ga v 30 dneh po prejemu posreduje pristojnim organom drugih držav članic.

(b) the environmental risk assessment and the conclusions required in Annex II, section D;

V primeru iz odstavka 3(b) pristojni organ Komisiji pošlje svoje poročilo skupaj z informacijami iz odstavka 4 in vsemi drugimi informacijami, na katerih je osnoval svoje poročilo, ne prej kot 15 dni potem, ko je poročilo o oceni poslal prijavitelju, in ne kasneje kot 105 dni po prejemu prijave. Komisija v 30 dneh od njegovega prejema posreduje poročilo pristojnim organom drugih držav članic.

3. Poročilo o oceni navaja, ali:

(d) with reference to Article 15(4), a proposed period for the consent which should not exceed ten years;

(a) se zadevni GSO sme dati v promet in pod katerimi pogoji; ali

(e) a plan for monitoring in accordance with Annex VII, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent;

(b) se zadevni GSO ne sme dati v promet.

(f) a proposal for labelling which shall comply with the requirements laid down in Annex IV. The labelling shall clearly state that a GMO is present. The words "this product contains genetically modified organisms" shall appear either on a label or in an accompanying document;

Poročila o oceni so narejena v skladu z navodili, določenimi v Prilogi VI.

(g) a proposal for packaging which shall comprise the requirements laid down in Annex IV;

4. Za izračun 90-dnevnega roka iz odstavka 2 se ne upošteva obdobij, med katerimi pristojni organ čaka dodatne informacije, ki jih je morda zahteval od prijavitelja. Pristojni organ v morebitni zahtevi po dodatnih informacijah navede razloge.

(h) a summary of the dossier. The format of the summary shall be established in accordance with the procedure laid down in Article 30(2).

Člen 15

If on the basis of the results of any release notified under part B, or on other substantive, reasoned scientific grounds, a notifier considers that the placing on the market and use of a GMO as or in a product do not pose a risk to human health and the environment, he may propose to the competent authority not to provide part or all of the information required in Annex IV, section B.

Standardni postopek

3. The notifier shall include in this notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or outside the Community.

1. V primerih iz člena 14(3) pristojni organ ali Komisija lahko zaprosi za dodatne informacije, poda pripombe ali predstavi utemeljene ugovore zoper dajanje zadevnih GSO v promet v obdobju 60 dni od datuma razpošiljanja poročila o oceni.

4. The notifier may also refer to data or results from notifications previously submitted by other notifiers or submit additional information he considers relevant, provided that the information, data and results are non-confidential or these notifiers have given their agreement in writing.

Pripombe ali utemeljene ugovore in odgovore se posreduje Komisiji, ki jih nemudoma razpošlje vsem pristojnim organom.

5. In order for a GMO or combination of GMOs to be used for a purpose different from that already specified in a notification, a separate notification shall be submitted.

Pristojni organi in Komisija lahko razpravljajo o vseh odprtih vprašanjih zaradi doseganja dogovora v 105 dneh od razpošiljanja poročila o oceni.

6. If new information has become available with regard to the risks of the GMO to human health or the environment, before the written consent is granted, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof. In addition, the notifier shall revise the information and conditions specified in the notification.

Za izračun končnega 45-dnevnega roka za dosego dogovora se ne upošteva obdobij, v katerih se čaka na dodatne informacije prijavitelja. V zahtevkih za dodatne informacije se navedejo razlogi.

2. Če se v primeru iz člena 14(3)(b) pristojni organ, ki je pripravil poročilo, odloči, da se GSO ne sme dati v promet, se prijava zavrne. Tako odločitev je treba utemeljiti.

Article 14

3. Če se pristojni organ, ki je pripravil poročilo, odloči, da se proizvod sme dati v promet, in če v 60 dneh po datumu razpošiljanja poročila o oceni iz člena 14(3)(a) države članice ali Komisija ne navedejo utemeljenega ugovora ali če se odprta vprašanja iz odstavka 1 razrešijo v obdobju 105 dni, pristojni organ, ki je pripravil poročilo, izda pisno odobritev za dajanje v promet, ga preda prijavitelju in o tem obvesti druge države članice in Komisijo v 30 dneh.

Assessment report

4. Odobritev se da za največ deset let od datuma, na katerega je odobritev izdana.

1. On receipt and after acknowledgement of the notification in accordance with Article 13(2), the competent authority shall examine it for compliance with this Directive.

Za odobritev GSO ali potomstva tega GSO, namenjenega samo za trženje njunih semen po ustreznih določbah Skupnosti, se obdobje prve odobritve konča najkasneje deset let po datumu prve vključitve prve rastlinske sorte, ki vsebuje GSO, v uradni nacionalni katalog sort rastlin v skladu z direktivama Sveta 70/457/EGS [11] in 70/458/EGS [12].

2. Within 90 days after receipt of the notification the competent authority shall:

V primeru gozdnega reprodukcijskega materiala se obdobje prve odobritve zaključi najkasneje deset let po datumu prve vključitve osnovnega materiala, ki vsebuje GSO, v uradni nacionalni register osnovnega materiala v skladu z Direktivo Sveta 1999/105/ES [13].

- prepare an assessment report and send it to the notifier. A subsequent withdrawal by the notifier shall be without prejudice to any further submission of the notification to another competent authority;

Člen 16

- in the case referred to in paragraph 3(a), send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

Merila in informacije za določene GSO

In the case referred to paragraph 3(b), the competent authority shall send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission no earlier than 15 days after sending the assessment report to the notifier and no later than 105 days after receipt of the notification. The Commission shall, within 30 days of its receipt, forward the report to the competent authorities of the other Member States.

1. Pristojni organ ali Komisija na svojo pobudo lahko izdela predlog o merilih in zahtevanih informacijah, ki morajo biti izpolnjene za prijavo, z odstopanjem od člena 13, za dajanje v promet nekaterih vrst GSO kot proizvodov ali v proizvodih.

3. The assessment report shall indicate whether:

2. Ta merila in zahtevane informacije kot tudi ustrezne zahteve za povzetek se sprejmejo po posvetovanju z ustreznim(-i) znanstvenim(-i) odborom(-i) v skladu s postopkom iz člena 30(2). Merila in zahtevane informacije so take, da zagotavljajo visoko raven varnosti za zdravje ljudi in okolje, ter temeljijo na znanstvenih dokazih, ki so na voljo za tako varnost, ter na izkušnjah, pridobljenih pri sproščanju primerljivih GSO.

(a) the GMO(s) in question should be placed on the market and under which conditions; or

Zahteve iz člena 13(2) se nadomestijo z zgoraj sprejetimi, uporabi pa se postopek iz člena 13(3), (4), (5) in (6) ter členov 14 in 15.

(b) the GMO(s) in question should not be placed on the market.

3. Preden se začne postopek iz člena 30(2) za odločanje o merilih in zahtevanih informacijah iz odstavka 1, da Komisija predlog na voljo javnosti. Javnost lahko Komisiji poda pripombe v 60 dneh. Komisija te pripombe skupaj z analizo posreduje odboru, ustanovljenemu po členu 30.

The assessment reports shall be established in accordance with the guidelines laid down in Annex VI.

Člen 17

4. For the purpose of calculating the 90 day period referred to in paragraph 2, any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier shall not be taken into account. The competent authority shall state the reasons in any request for further information.

Obnovitev odobritve

1. Z odstopanjem od členov 13, 14 in 15 se postopek iz odstavkov 2 do 9 uporabi za obnovitev:

Article 15

(a) odobritev, izdanih po delu C; in

Standard procedure

(b) pred 17. oktobrom 2006 odobritev, izdanih po Direktivi 90/220/EGS za dajanje v promet GSO kot proizvodov ali v proizvodih pred 17. oktobrom 2002.

1. In the cases referred to in Article 14(3), a competent authority or the Commission may ask for further information, make comments or present reasoned objections to the placing on the market of the GMO(s) in question within a period of 60 days from the date of circulation of the assessment report.

2. Prijavitelj po tem členu najkasneje devet mesecev pred potekom veljavnosti odobritve za odobritve iz odstavka 1(a) in pred 17. oktobrom 2006 za odobritve iz odstavka 1(b) predloži pristojnemu organu, ki je prejel prvotno prijavo, prijavo, ki vsebuje:

Comments or reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities.

(a) kopijo odobritve za dajanje v promet GSO;

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 105 days from the date of circulation of the assessment report.

(b) poročilo o rezultatih spremljanja, ki je bilo opravljeno po členu 20. V primeru odobritev iz odstavka 1(b) se to poročilo predloži, kjer je bilo spremljanje izvedeno;

Any periods of time during which further information from the notifier is awaited shall not be taken into account for the purpose of calculating the final 45 day period for arriving at an agreement. Reasons shall be stated in any request for further information.

2. In the case referred to in Article 14(3)(b), if the competent authority which prepared the report decides that the GMO(s) should not be placed on the market, the notification shall be rejected. This decision shall state the reasons.

(d) kot je primerno, predlog za spremembo ali dopolnitev pogojev iz prvotne odobritve, med drugim pogojev glede prihodnjega spremljanja in časovne omejitve odobritve.

3. If the competent authority which prepared the report decides that the product may be placed on the market, in the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the assessment report referred to in Article 14(3)(a) or if outstanding issues are resolved within the 105 day period referred to in paragraph 1, the competent authority which prepared the report shall give consent in writing for placing on the market, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

Pristojni organ potrdi datum prejema prijave in, če je prijava skladna s tem odstavkom, nemudoma posreduje kopijo prijave in svoje poročilo o oceni Komisiji, ki ju v 30 dneh od prejema posreduje pristojnim organom drugih držav članic. Prav tako pošlje svoje poročilo o oceni prijavitelju.

4. The consent shall be given for a maximum period of ten years starting from the date on which the consent is issued.

3. Poročilo o oceni navaja, ali:

For the purpose of approval of a GMO or a progeny of that GMO intended only for the marketing of their seeds under the relevant Community provisions, the period of the first consent shall end at the latest ten years after the date of the first inclusion of the first plant variety containing the GMO on an official national catalogue of plant varieties in accordance with Council Directives 70/457/EEC(11) and 70/458/EEC(12).

(a) GSO smejo ostati v prometu in pod kakšnimi pogoji; ali

In the case of forest reproductive material, the period of the first consent shall end at the latest ten years after the date of the first inclusion of basic material containing the GMO on an official national register of basic material in accordance with Council Directive 1999/105/EC(13).

(b) GSO ne smejo ostati v prometu.

4. Drugi pristojni organi ali Komisija lahko zaprosijo za dodatne informacije, podajo pripombe ali predstavijo utemeljene ugovore v 60 dneh od datuma razpošiljanja poročila o oceni.

Article 16

5. Vse pripombe, utemeljene ugovore in odgovore se posreduje Komisiji, ki jih takoj razpošlje vsem pristojnim organom.

Criteria and information for specified GMOs

6. V primeru odstavka 3(a) in ko v 60 dneh od razpošiljanja poročila o oceni ni utemeljenega ugovora države članice ali Komisije, pristojni organ, ki je pripravil poročilo o oceni, prijavitelju pošlje končno pisno odločitev ter o tem v 30 dneh obvesti druge države članice in Komisijo. Veljavnost odobritve praviloma ne sme presegati deset let in se lahko iz posebnih razlogov omeji ali podaljša, kot je primerno.

1. A competent authority, or the Commission on its own initiative, may make a proposal on criteria and information requirements to be met for the notification, by way of derogation from Article 13, for the placing on the market of certain types of GMOs as or in products.

7. Pristojni organi in Komisija lahko razpravljajo o vseh odprtih vprašanjih zaradi doseganja dogovora v 75 dneh od datuma razpošiljanja poročila o oceni.

2. These criteria and information requirements as well as any appropriate requirements for a summary shall be adopted, after consultation of the relevant Scientific Committee(s), in accordance with the procedure laid down in Article 30(2). The criteria and the information requirements shall be such as to ensure a high level of safety to human health and the environment and be based on the scientific evidence available on such safety and on the experience gained from the release of comparable GMOs.

8. Če se odprta vprašanja razrešijo v 75-dnevnem obdobju, navedenem v odstavku 7, pristojni organ, ki je pripravil poročilo, prijavitelju pošlje svojo končno odločitev v pisni obliki in o tem v 30 dneh obvesti druge države članice in Komisijo. Veljavnost odobritve je lahko omejena, kot je primerno.

The requirements set out in Article 13(2) shall be replaced by those adopted above, and the procedure set out in Article 13(3), (4), (5) and (6) and Articles 14 and 15 shall apply.

9. Po prijavi za obnovitev odobritve v skladu z odstavkom 2 lahko prijavitelj še naprej daje GSO v promet pod pogoji iz navedene odobritve do končne odločitve o prijavi.

3. Before the procedure laid down in Article 30(2) for a decision on criteria and information requirements referred to in paragraph 1 is initiated, the Commission shall make the proposal available to the public. The public may make comments to the Commission within 60 days. The Commission shall forward any such comments, together with an analysis, to the Committee set up pursuant to Article 30.

Člen 18

Postopek Skupnosti v primeru ugovorov

Article 17

1. Če pristojni organ ali Komisija v skladu s členi 15, 17 in 20 ugovarja in vztraja pri tem, se odločitev sprejme in objavi v 120 dneh v skladu s postopkom iz člena 30(2). Ta odločitev vsebuje enake informacije, kot so naštete v členu 19(3).

Renewal of consent

Za izračun obdobja 120 dni se ne upošteva obdobja, v katerem Komisija čaka na dodatne informacije, ki jih je morda zahtevala od prijavitelja, ali pa pridobiva mnenje Znanstvenega odbora, s katerim se posvetuje po členu 28. Komisija v vsaki zahtevi za dodatne informacije navede razloge in pristojne organe obvesti o svojih zahtevah prijavitelju. Obdobje, v katerem Komisija čaka na mnenje Znanstvenega odbora, ne sme presegati 90 dni.

1. By way of derogation from Articles 13, 14 and 15, the procedure set out in paragraphs 2 to 9 shall be applied to the renewal of:

Čas, ki ga Svet potrebuje za ukrepanje po postopku iz člena 30(2), se ne upošteva.

(a) consents granted under part C; and

2. Če je bila sprejeta pozitivna odločitev, pristojni organ, ki je pripravil poročilo, da pisno odobritev za dajanje v promet ali za obnovitev odobritve, jo pošlje prijavitelju in v 30 dneh po objavi ali obvestilu o odločitvi obvesti druge države članice in Komisijo.

(b) before 17 October 2006 of consents granted under Directive 90/220/EEC for placing on the market of GMOs as or in products before 17 October 2002,

Člen 19

2. At the latest nine months before the expiry of the consent, for the consents referred to in paragraph 1(a), and before 17 October 2006, for the consents referred to in paragraph 1(b), the notifier under this Article shall submit a notification to the competent authority which received the original notification, which shall contain:

Odobritev

(a) a copy of the consent to the placing on the market of the GMOs;

1. Brez poseganja v zahteve po drugi zakonodaji Skupnosti in samo, če je bila dana pisna odobritev za dajanje v promet GSO kot proizvoda ali v proizvodu, se ta proizvod lahko brez nadaljnje prijave uporablja v vsej Skupnosti, če se dosledno upoštevajo posebni pogoji uporabe ter okolja in/ali zemljepisna območja, določena v teh pogojih.

(b) a report on the results of the monitoring which was carried out according to Article 20. In the case of consents referred to in paragraph 1(b), this report shall be submitted when the monitoring was carried out;

2. Prijavitelj lahko prične z dajanjem v promet šele, ko prejme pisno odobritev pristojnega organa po členih 15, 17 in 18, ter po pogojih, zahtevanih v tej odobritvi.

(c) any other new information which has become available with regard to the risks of the product to human health and/or the environment; and

3. Pisna odobritev iz členov 15, 17 in 18 mora v vseh primerih izrecno vsebovati naslednje:

(d) as appropriate, a proposal for amending or complementing the conditions of the original consent, inter alia the conditions concerning future monitoring and the time limitation of the consent.

(a) področje uporabe odobritve, vključno z vrsto GSO, ki se dajejo v promet kot proizvodi ali v proizvodih, in njihove posebne oznake;

The competent authority shall acknowledge the date of receipt of the notification and when the notification is in accordance with this paragraph it shall without delay forward a copy of the notification and its assessment report to the Commission, which shall, within 30 days of their receipt, forward them to the competent authorities of the other Member States. It shall also send its assessment report to the notifier.

(b) obdobje veljavnosti odobritve;

3. The assessment report shall indicate whether:

(c) pogoje za dajanje v promet proizvoda vključno z morebitnimi posebnimi pogoji uporabe, ravnanja in pakiranja GSO kot proizvodov ali v proizvodu in pogoje za varstvo posebnih ekosistemov/okolij in/ali zemljepisnih območij;

(a) the GMO(s) should remain on the market and under which conditions; or

(d) da prijavitelj ne glede na člen 25 pristojnemu organu na njegovo zahtevo da na voljo kontrolne vzorce;

(b) the GMO(s) should not remain on the market.

(e) zahteve glede označevanja v skladu z zahtevami, določenimi v Prilogi IV. Označevanje jasno navaja prisotnost GSO. Besede "Ta proizvod vsebuje gensko spremenjene organizme" se pojavijo ali na oznaki ali v dokumentu, ki spremlja proizvod ali druge proizvode, ki vsebujejo GSO;

4. The other competent authorities or the Commission may ask for further information, make comments, or present reasoned objections within a period of 60 days from the date of circulation of the assessment report.

(f) zahteve glede spremljanja v skladu s Prilogo VII, vključno z obveznostmi glede poročanja Komisiji in pristojnim organom, časovno obdobje načrta spremljanja in, če je primerno, obveznosti oseb, ki proizvod prodajajo ali uporabljajo, med drugim, v primeru gojenih GSO, v zvezi z nivojem informacij, ki se zdijo ustrezne na njihovem mestu.

5. All comments, reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities.

4. Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da sta pisna odobritev in, kadar je primerno, odločitev iz člena 18 dostopna javnosti ter da se izpolnjujejo pogoji iz pisne odobritve in, kadar je primerno, odločitve.

6. In the case of paragraph 3(a) and in the absence of any reasoned objection from a Member State or the Commission within 60 days from the date of circulation of the assessment report, the competent authority which prepared the report shall transmit to the notifier the final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent should not, as a general rule, exceed ten years and may be limited or extended as appropriate for specific reasons.

Člen 20

7. The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

Spremljanje in ravnanje z novimi informacijami

8. If outstanding issues are resolved within the 75 day period referred to in paragraph 7, the competent authority which prepared the report shall transmit to the notifier its final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent may be limited as appropriate.

1. Po dajanju v promet GSO kot proizvoda ali v proizvodu prijavitelj zagotovi, da se spremljanje in poročanje o njem opravlja po pogojih iz odobritve. Poročila o tem spremljanju se predložijo Komisiji in pristojnim organom držav članic. Na podlagi teh poročil lahko pristojni organ, ki je prejel prvotno prijavo, skladno z odobritvijo in v okviru načrta spremljanja, določenega v odobritvi, načrt spremljanja prilagodi po prvem obdobju spremljanja.

9. Following a notification for the renewal of a consent in accordance with paragraph 2, the notifier may continue to place the GMOs on the market under the conditions specified in that consent until a final decision has been taken on the notification.

2. Če so na voljo nove informacije od uporabnikov ali iz drugih virov glede tveganj GSO za zdravje ljudi ali okolje potem, ko je bila dana pisna odobritev, prijavitelj takoj sprejme potrebne ukrepe za varstvo zdravja ljudi in okolja ter o tem obvesti pristojni organ.

Poleg tega prijavitelj pregleda informacije in pogoje, navedene v prijavi.

Article 18

3. Če pristojni organ dobi na voljo informacije, ki bi lahko imele posledice glede tveganj GSO za zdravje ljudi ali okolje, ali v okoliščinah iz odstavka 2, pristojni organ informacije takoj predloži Komisiji in pristojnim organom drugih držav članic ter lahko koristi določbe členov 15(1) in 17(7), kjer je to primerno, ko je informacije dobil na voljo pred pisno odobritvijo.

Community procedure in case of objections

Če se informacije dobijo na voljo po tem, ko je bila dana odobritev, pristojni organ v 60 dneh po prejemu novih informacij Komisiji pošlje svoje poročilo o oceni ter navede, ali in kako bi bilo treba spremeniti pogoje odobritve ali da je treba odobritev preklicati, Komisija pa ga v 30 dneh od prejema posreduje pristojnim organom drugih držav članic.

1. In cases where an objection is raised and maintained by a competent authority or the Commission in accordance with Articles 15, 17 and 20, a decision shall be adopted and published within 120 days in accordance with the procedure laid down in Article 30(2). This decision shall contain the same information as in Article 19(3).

Pripombe ali utemeljeni ugovori zoper nadaljnje dajanje v promet GSO ali predlog za spremembo pogojev odobritve se v 60 dneh po razpošiljanju poročila o oceni predložijo Komisiji, ki jih takoj posreduje vsem pristojnim organom.

For the purpose of calculating the 120 day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee which has been consulted in accordance with Article 28 shall not be taken into account. The Commission shall state reasons in any request for further information and inform the competent authorities of its requests to the notifier. The period of time during which the Commission is awaiting the opinion of the Scientific Committee shall not exceed 90 days.

Pristojni organi in Komisija lahko razpravljajo o vseh odprtih vprašanjih, da bi v 75 dneh od razpošiljanja poročila o oceni dosegli dogovor.

The period of time that the Council takes to act in accordance with the procedure laid down in Article 30(2) shall not be taken into account.

Če v 60 dneh od datuma razpošiljanja novih informacij ne pride do utemeljenega ugovora držav članic ali Komisije ali pa so odprta vprašanja razrešena v 75 dneh, pristojni organ, ki je poročilo o oceni pripravil, spremeni odobritev, kot je predlagano, prijavitelju pošlje spremenjeno odobritev ter o tem v 30 dneh obvesti druge države članice in Komisijo.

2. Where a favourable decision has been taken, the competent authority which prepared the report shall give consent in writing to the placing on the market or to the renewal of the consent, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days following the publication or notification of the decision.

4. Za zagotovitev preglednosti so rezultati spremljanja, opravljeni po delu C Direktive, dostopni javnosti.

Člen 21

Article 19

Označevanje

Consent

1. Države članice sprejmejo vse potrebne ukrepe za zagotovitev, da na vseh stopnjah dajanja v promet označevanje in pakiranje GSO, danih v promet kot proizvodi ali v proizvodih, izpolnjuje ustrezne zahteve iz pisne odobritve, navedene v členih 15(3), 17(5) in (8), 18(2) in 19(3).

1. Without prejudice to requirements under other Community legislation, only if a written consent has been given for the placing on the market of a GMO as or in a product may that product be used without further notification throughout the Community in so far as the specific conditions of use and the environments and/or geographical areas stipulated in these conditions are strictly adhered to.

2. Za proizvode, kjer ni mogoče izključiti naključnih ali tehnično neizogibnih sledov dovoljenih GSO, se lahko določi vrednost praga, pod katerim teh proizvodov ni treba označevati po določbi v odstavku 1. Vrednosti praga se določijo glede na zadevni proizvod po postopku iz člena 30(2).

2. The notifier may proceed with the placing on the market only when he has received the written consent of the competent authority in accordance with Articles 15, 17 and 18, and in conformity with any conditions required in that consent.

Člen 22

3. The written consent referred to in Articles 15, 17 and 18 shall, in all cases, explicitly specify:

Prosti promet

(a) the scope of the consent, including the identity of the GMO(s) to be placed on the market as or in products, and their unique identifier;

Brez poseganja v člen 23 države članice ne smejo prepovedati, omejiti ali preprečiti dajanja v promet GSO kot proizvodov ali v proizvodih, kadar izpolnjujejo zahteve te direktive.

(b) the period of validity of the consent;

Člen 23

(c) the conditions for the placing on the market of the product, including any specific condition of use, handling and packaging of the GMO(s) as or in products, and conditions for the protection of particular ecosystems/environments and/or geographical areas;

Zaščitna klavzula

(d) that, without prejudice to Article 25, the notifier shall make control samples available to the competent authority on request;

1. Ko ima država članica kot rezultat novih ali dodatnih informacij, ki so postale razpoložljive po datumu odobritve in vplivajo na oceno tveganja za okolje ali ponovno oceno obstoječih informacij na podlagi novega ali dodatnega znanstvenega znanja, podrobne razloge za domnevo, da GSO kot proizvod ali v proizvodu, ki je bil pravilno prijavljen in je prejel pisno odobritev po tej direktivi, predstavlja tveganje za zdravje ljudi ali okolje, lahko ta država članica začasno omeji ali prepove uporabo in/ali prodajo tega GSO kot proizvoda ali v proizvodu na svojem ozemlju.

(e) the labelling requirements, in compliance with the requirements laid down in Annex IV. The labelling shall clearly state that a GMO is present. The words "This product contains genetically modified organisms" shall appear either on a label or in a document accompanying the product or other products containing the GMO(s);

Država članica zagotovi, da se v primeru resnega tveganja uporabijo nujni ukrepi, kot je prekinitev ali prenehanje dajanja v promet, vključno z obveščanjem javnosti.

(f) monitoring requirements in accordance with Annex VII, including obligations to report to the Commission and competent authorities, the time period of the monitoring plan and, where appropriate, any obligations on any person selling the product or any user of it, inter alia, in the case of GMOs grown, concerning a level of information deemed appropriate on their location.

Država članica takoj obvesti Komisijo in druge države članice o ukrepih, sprejetih po tem členu, in navede razloge za svojo odločitev, pri čemer dostavi svoj pregled ocene tveganja za okolje in navede, ali in kako je treba spremeniti pogoje odobritve ali odobritev preklicati, ter, kjer je to primerno, nove ali dodatne informacije, na katerih temelji njena odločitev.

4. Member States shall take all necessary measures to ensure that the written consent and the decision referred to in Article 18, where applicable, are made accessible to the public and that the conditions specified in the written consent and the decision, where applicable, are complied with.

2. O zadevi se v 60 dneh sprejme odločitev po postopku iz člena 30(2). Za izračun 60-dnevnega obdobja se ne upošteva čas, v katerem Komisija čaka dodatne informacije, ki jih je morda zahtevala od prijavitelja, ali pridobiva mnenje znanstvenega(-ih) odbora(-ov), s katerim(-i) se je posvetovala. Čas, v katerem Komisija čaka mnenje znanstvenega(-ih) odbora(-ov), ne sme presegati 60 dni.

Prav tako se ne upošteva obdobje, ki ga Svet potrebuje za ukrepanje po postopku iz člena 30(2).

Article 20

Člen 24

Monitoring and handling of new information

Obveščanje javnosti

1. Following the placing on the market of a GMO as or in a product, the notifier shall ensure that monitoring and reporting on it are carried out according to the conditions specified in the consent. The reports of this monitoring shall be submitted to the Commission and the competent authorities of the Member States. On the basis of these reports, in accordance with the consent and within the framework for the monitoring plan specified in the consent, the competent authority which received the original notification may adapt the monitoring plan after the first monitoring period.

1. Brez poseganja v člen 25 Komisija po prejemu prijave v skladu s členom 13(1) da javnosti takoj na voljo povzetek iz člena 13(2)(h). Komisija da javnosti na voljo tudi poročila o oceni v primeru iz člena 14(3)(a). Javnost lahko Komisiji daje pripombe v 30 dneh. Komisija pripombe takoj posreduje pristojnim organom.

2. If new information has become available, from the users or other sources, with regard to the risks of the GMO(s) to human health or the environment after the written consent has been given, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof.

2. Brez poseganja v člen 25 se za vse GSO kot proizvode ali v proizvodih, ki so po tej direktivi prejeli pisno odobritev za dajanje v promet ali katerih dajanje v promet je bilo zavrnjeno, poročila o oceni, opravljena za te GSO, in mnenje(a) znanstvenih odborov, s katerimi se je posvetovalo, dajo na voljo javnosti. Za vsak proizvod je treba jasno navesti v njem vsebovan GSO ali GSO-je ter njihovo uporabo ali uporabe.

In addition, the notifier shall revise the information and conditions specified in the notification.

DEL D

3. If information becomes available to the competent authority which could have consequences for the risks of the GMO(s) to human health or the environment, or under the circumstances described in paragraph 2, it shall immediately forward the information to the Commission and the competent authorities of the other Member States and may avail itself of the provisions in Articles 15(1) and 17(7) where appropriate, when the information has become available before the written consent.

KONČNE DOLOČBE

When the information has become available after the consent has been given, the competent authority shall within 60 days after receipt of the new information, forward its assessment report indicating whether and how the conditions of the consent should be amended or the consent should be terminated to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

Člen 25

Comments or reasoned objections to further placing on the market of the GMO or on the proposal for amending the conditions of the consent shall, within 60 days following the circulation of the assessment report, be forwarded to the Commission which shall immediately forward them to all competent authorities.

Zaupnost

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

1. Komisija in pristojni organi tretjim osebam ne smejo razkriti zaupnih informacij, prijavljenih ali izmenjanih po tej direktivi, in varujejo pravice intelektualne lastnine v zvezi s prejetimi podatki.

In the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the new information or if outstanding issues are resolved within 75 days, the competent authority which prepared the report shall amend the consent as proposed, shall transmit the amended consent to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

2. Prijavitelj lahko v prijavi, predloženi po tej direktivi, navede informacije, katerih razkritje bi lahko škodovalo njegovemu konkurenčnemu položaju in jih je zato treba obravnavati kot zaupne. V takih primerih je treba navesti preverljivo utemeljitev.

4. So as to ensure its transparency, the results of the monitoring carried out under part C of the Directive shall be made publicly available.

3. Pristojni organ po posvetovanju s prijaviteljem odloči, katere informacije bodo ostale zaupne, in prijavitelja obvesti o svojih odločitvah.

4. V nobenem primeru pa ne smejo ostati zaupne naslednje informacije, predložene po členih 6, 7, 8, 13, 17, 20, ali 23:

Article 21

- splošen opis GSO, ime in naslov prijavitelja, namen sproščanja, mesto sproščanja in predvidene uporabe,

Labelling

- metode in načrti za spremljanje GSO in za ukrepanje za primer nesreče,

1. Member States shall take all necessary measures to ensure that at all stages of the placing on the market, the labelling and packaging of GMOs placed on the market as or in products comply with the relevant requirements specified in the written consent referred to in Articles 15(3), 17(5) and (8), 18(2) and 19(3).

- ocena tveganja za okolje.

2. For products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded, a minimum threshold may be established below which these products shall not have to be labelled according to the provision in paragraph 1. The threshold levels shall be established according to the product concerned, under the procedure laid down in Article 30(2).

5. Če prijavitelj iz kakršnega koli razloga umakne prijavo, morajo pristojni organi in Komisija spoštovati zaupnost dostavljenih informacij.

Člen 26

Article 22

Označevanje GSO iz člena 2(4), drugi pododstavek

Free circulation

1. Pri GSO, ki jih je treba dati na voljo za postopke po členu 2(4), drugi pododstavek, je treba upoštevati ustrezne zahteve za označevanje v skladu z ustreznimi oddelki Priloge IV, da se na oznaki ali spremljajočem dokumentu zagotovijo jasne informacije o prisotnosti GSO. V ta namen se besede "Ta proizvod vsebuje gensko spremenjen organizme" pojavijo na oznaki ali spremljajočem dokumentu.

Without prejudice to Article 23, Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive.

2. Pogoji za izvajanje odstavka 1 se brez podvajanja ali ustvarjanja neskladnosti z obstoječo zakonodajo Skupnosti glede označevanja določijo po postopku iz člena 30(2). Pri tem se ustrezno upoštevajo predpisi glede označevanja, ki so jih države članice določile v skladu z zakonodajo Skupnosti.

Člen 27

Article 23

Prilagoditve prilog tehničnemu napredku

Safeguard clause

Oddelka C in D Priloge II, Priloge III do VI in oddelek C Priloge VII se prilagajajo tehničnemu napredku v skladu s postopkom, določenim v členu 30(2).

1. Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.

Člen 28

The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.

Posvetovanja z znanstvenim(-i) odborom(-i)

The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based.

1. Ko pristojni organ ali Komisija po členih 15(1), 17(4), 20(3) ali 23 ugovarja v zvezi s tveganji GSO za zdravje ljudi ali okolje ter vztraja pri tem ali kadar poročilo o oceni iz člena 14 kaže, da GSO ne bi smel biti dan v promet, se Komisija na lastno pobudo ali na zahtevo države članice o ugovoru posvetuje z ustreznim(-i) znanstvenim(-i) odborom(-i).

2. A decision shall be taken on the matter within 60 days in accordance with the procedure laid down in Article 30(2). For the purpose of calculating the 60 day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee(s) which has/have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee(s) consulted shall not exceed 60 days.

2. Z ustreznim(-i) znanstvenim(-i) odborom(-i) se lahko Komisija na lastno pobudo ali na zahtevo države članice posvetuje tudi o vsaki zadevi po tej direktivi, ki lahko škodljivo vpliva na zdravje ljudi in okolje.

Likewise, the period of time the Council takes to act in accordance with the procedure laid down in Article 30(2) shall not be taken into account.

3. Odstavek 2 ne vpliva na administrativne postopke, določene v tej direktivi.

Člen 29

Article 24

Posvetovanje z Odborom(-i) za etična vprašanja

Information to the public

1. Brez poseganja v pristojnost držav članic glede etičnih vprašanj se Komisija na lastno pobudo ali na zahtevo Evropskega parlamenta ali Sveta posvetuje o etičnih vprašanjih splošne narave s katerim koli odborom, ki ga je imenovala za posvetovanje z njim o etičnih posledicah biotehnologije, kot na primer Evropsko skupino za etiko na področju znanosti in novih tehnologij.

1. Without prejudice to Article 25, upon receipt of a notification in accordance with Article 13(1), the Commission shall immediately make available to the public the summary referred to in Article 13(2)(h). The Commission shall also make available to the public assessment reports in the case referred to in Article 14(3)(a). The public may make comments to the Commission within 30 days. The Commission shall immediately forward the comments to the competent authorities.

To posvetovanje se lahko opravi tudi na zahtevo države članice.

2. Without prejudice to Article 25, for all GMOs which have received written consent for placing on the market or whose placing on the market was rejected as or in products under this Directive, the assessment reports carried out for these GMOs and the opinion(s) of the Scientific Committees consulted shall be made available to the public. For each product, the GMO or GMOs contained therein and the use or uses shall be clearly specified.

2. To posvetovanje se vodi po jasnih pravilih odprtosti, preglednosti in dostopnosti za javnost. Izid je dostopen javnosti.

3. Odstavek 1 ne vpliva na administrativne postopke, predvidene v tej direktivi.

PART D

Člen 30

FINAL PROVISIONS

Postopek odbora

Article 25

1. Komisiji pomaga odbor.

Confidentiality

2. Kadar se sklicuje na ta odstavek, se uporabi člena 5 in 7 Sklepa 1999/468/ES ob upoštevanju določb člena 8 Sklepa.

1. The Commission and the competent authorities shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.

Obdobje iz člena 5(6) Sklepa 1999/468/ES se določi na tri mesece.

2. The notifier may indicate the information in the notification submitted under this Directive, the disclosure of which might harm his competitive positionand which should therefore be treated as confidential. Verifiable justification must be given in such cases.

3. Odbor sprejme svoj poslovnik.

3. The competent authority shall, after consultation with the notifier, decide which information will be kept confidential and shall inform the notifier of its decisions.

Člen 31

4. In no case may the following information when submitted according to Articles 6, 7, 8, 13, 17, 20 or 23 be kept confidential:

Izmenjava informacij in poročanje

- general description of the GMO or GMOs, name and address of the notifier, purpose of the release, location of release and intended uses;

1. Države članice in Komisija se redno srečujejo in izmenjujejo informacije o izkušnjah, pridobljenih glede preprečevanja tveganj, povezanih s sproščanjem in dajanjem GSO v promet. Ta izmenjava informacij zajema tudi izkušnje, pridobljene pri izvajanju člena 2(4), drugi pododstavek, oceno tveganja za okolje, spremljanje ter posvetovanje z javnostjo in njeno obveščanje.

- methods and plans for monitoring of the GMO or GMOs and for emergency response;

Po potrebi lahko odbor, ustanovljen po členu 30(1), predvidi navodila za izvajanje člena 2(4), drugi pododstavek.

- environmental risk assessment.

2. Komisija vzpostavi enega ali več registrov za namene evidentiranja informacij o genskih spremembah v GSO, navedenih v točki A št. 7 Priloge IV. Brez poseganja v člen 25 register(i) vsebuje(jo) del, ki je dostopen javnosti. O podrobni ureditvi za delovanje registra(ov) se odloča po postopku iz člena 30(2).

5. If, for whatever reasons, the notifier withdraws the notification, the competent authorities and the Commission must respect the confidentiality of the information supplied.

3. Brez poseganja v odstavek 2 in točko A št. 7 Priloge IV,

(a) države članice vzpostavijo javne registre, v katerih se evidentirajo mesta sproščanja GSO po delu B;

Article 26

(b) države članice tudi vzpostavijo registre za evidentiranje mest GSO, ki se gojijo po delu C, med drugim tako, da je mogoče spremljati možne učinke teh GSO na okolje v skladu z določbami členov 19(3)(f) in 20(1). Brez poseganja v te določbe iz členov 19 in 20 se navedena mesta:

Labelling of GMOs referred to in Article 2(4), second subparagraph

- prijavijo pristojnim organom in

1. The GMOs to be made available for operations referred to under Article 2(4), second subparagraph, shall be subject to adequate labelling requirements in accordance with the relevant sections of Annex IV in order to provide for clear information, on a label or in an accompanying document, on the presence of GMOs. To that effect the words "This product contains genetically modified organisms" shall appear either on a label or in an accompanying document.

- dajo v vednost javnosti

2. The conditions for the implementation of paragraph 1 shall, without duplicating or creating inconsistencies with existing labelling provisions laid down in existing Community legislation, be determined in accordance with the procedure laid down in Article 30(2). In doing so, account should be taken, as appropriate, of labelling provisions established by Member States in accordance with Community legislation.

na način, ki ga pristojni organi v skladu z nacionalnimi predpisi štejejo za ustreznega.

4. Vsaka tri leta države članice Komisiji pošljejo poročilo o ukrepih, sprejetih za izvajanje določb te direktive. To poročilo vključuje kratko stvarno poročilo o njihovih izkušnjah z GSO, danimi v promet kot proizvodi ali v proizvodih po tej direktivi.

Article 27

5. Vsaka tri leta Komisija objavi povzetek na podlagi poročil iz odstavka 4.

Adaptation of Annexes to technical progress

6. Komisija pošlje Evropskemu parlamentu in Svetu v letu 2003 in zatem vsaka tri leta poročilo o izkušnjah držav članic z GSO, danimi v promet po tej direktivi.

Sections C and D of Annex II, Annexes III to VI, and section C of Annex VII shall be adapted to technical progress in accordance with the procedure laid down in Article 30(2).

7. Ob predložitvi poročila v letu 2003 Komisija istočasno predloži posebno poročilo o izvajanju dela B in dela C, vključno z oceno:

(a) vseh njegovih posledic, zlasti ob upoštevanju raznovrstnosti evropskih ekosistemov ter potrebe po dopolnitvi ureditvenega okvira na tem področju;

Article 28

(b) izvedljivosti različnih možnosti za nadaljnje izboljšanje skladnosti in učinkovitosti tega okvira, vključno s centraliziranim postopkom Skupnosti za odobritve in ureditvijo za končno odločanje Komisije;

Consultation of Scientific Committee(s)

(c) ali se je nabralo dovolj izkušenj z izvajanjem spremenjenih postopkov iz dela B, da se upraviči določba o implicitni odobritvi v teh postopkih, in o delu C, da se upraviči uporaba spremenjenih postopkov; in

1. In cases where an objection as regards the risks of GMOs to human health or to the environment is raised by a competent authority or the Commission and maintained in accordance with Article 15(1), 17(4), 20(3) or 23, or where the assessment report referred to in Article 14 indicates that the GMO should not be placed on the market, the relevant Scientific Committee(s) shall be consulted by the Commission, on its own initiative or at the request of a Member State, on the objection.

(d) socialno-ekonomskih posledic namernih sproščanj in dajanja GSO v promet.

2. The relevant Scientific Committee(s) may also be consulted by the Commission, on its own initiative or at the request of a Member State, on any matter under this Directive that may have an adverse effect on human health and the environment.

8. Komisija Evropskemu parlamentu in Svetu vsako leto pošlje poročilo o etičnih vprašanjih iz člena 29(1); če ustreza, to poročilo lahko spremlja predlog za spremembo te direktive.

3. The administrative procedures laid down in this Directive shall not be affected by paragraph 2.

Člen 32

Izvajanje Kartagenskega protokola o biološki varnosti

Article 29

1. Komisija je pozvana, da čimprej in v vsakem primeru pred julijem 2001 predloži zakonodajni predlog za podrobno izvajanje Kartagenskega protokola o biološki varnosti. Predlog dopolnjuje in po potrebi spreminja določbe te direktive.

Consultation of Committee(s) on Ethics

2. Ta predlog zlasti vključuje ustrezne ukrepe za izvajanje postopkov, določenih v Kartagenskem protokolu, in v skladu s Protokolom zahteva, da izvozniki Skupnosti zagotovijo izpolnjevanje vseh zahtev postopka soglasja po vnaprejšnjem obveščanju v skladu s členi 7 do 10, 12 in 14 Kartagenskega protokola.

1. Without prejudice to the competence of Member States as regards ethical issues, the Commission shall, on its own initiative or at the request of the European Parliament or the Council, consult any committee it has created with a view to obtaining its advice on the ethical implications of biotechnology, such as the European Group on Ethics in Science and New Technologies, on ethical issues of a general nature.

Člen 33

This consultation may also take place at the request of a Member State.

Sankcije

2. This consultation is conducted under clear rules of openness, transparency and public accessibility. Its outcome shall be accessible to the public.

Države članice določijo sankcije, ki se uporabljajo za kršitve nacionalnih določb, sprejetih po tej direktivi. Te kazni so učinkovite, sorazmerne in odvračilne.

3. The administrative procedures provided for in this Directive shall not be affected by paragraph 1.

Člen 34

Prenos

Article 30

1. Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, do 17. oktobra 2002. O tem takoj obvestijo Komisijo.

Committee procedure

Države članice se v sprejetih predpisih sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi. Način sklicevanja določijo države članice.

1. The Commission shall be assisted by a committee.

2. Države članice sporočijo Komisiji besedila temeljnih določb nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Člen 35

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Nerešene prijave

3. The committee shall adopt its own rules of procedure.

1. Za prijave glede dajanja GSO kot proizvodov ali v proizvodih v promet po Direktivi 90/220/EGS, v zvezi s katerimi postopki po navedeni direktivi niso bili zaključeni do 17. oktobra 2002, veljajo določbe te direktive.

2. Do 17. januarja 2003 prijavitelji dopolnijo svojo prijavo skladno s to direktivo.

Article 31

Člen 36

Exchange of information and reporting

Razveljavitev

1. Member States and the Commission shall meet regularly and exchange information on the experience acquired with regard to the prevention of risks related to the release and the placing on the market of GMOs. This information exchange shall also cover experience gained from the implementation of Article 2(4), second subparagraph, environmental risk assessment, monitoring and the issue of consultation and information of the public.

1. Direktiva 90/220/EGS se 17. oktobra 2002 razveljavi.

Where necessary, guidance on the implementation of Article 2(4), second subparagraph, may be provided by the committee established under Article 30(1).

2. Sklici na razveljavljeno direktivo se razlagajo kot sklici na to direktivo in jih je treba brati v skladu s korelacijsko tabelo v Prilogi VIII.

2. The Commission shall establish one or several register(s) for the purpose of recording the information on genetic modifications in GMOs mentioned in point A No 7 of Annex IV. Without prejudice to Article 25, the register(s) shall include a part which is accessible to the public. The detailed arrangements for the operation of the register(s) shall be decided in accordance with the procedure laid down in Article 30(2).

Člen 37

3. Without prejudice to paragraph 2 and point A No 7 of Annex IV,

Ta direktiva začne veljati na dan objave v Uradnem listu Evropskih skupnosti.

(a) Member States shall establish public registers in which the location of the release of the GMOs under part B is recorded.

Člen 38

(b) Member States shall also establish registers for recording the location of GMOs grown under part C, inter alia so that the possible effects of such GMOs on the environment may be monitored in accordance with the provisions of Articles 19(3)(f) and 20(1). Without prejudice to such provisions in Articles 19 and 20, the said locations shall:

Ta direktiva je naslovljena na države članice.

- be notified to the competent authorities, and

- be made known to the public

V Bruslju, 12. marca 2001

in the manner deemed appropriate by the competent authorities and in accordance with national provisions.

Za Evropski parlament

4. Every three years, Member States shall send the Commission a report on the measures taken to implement the provisions of this Directive. This report shall include a brief factual report on their experience with GMOs placed on the market in or as products under this Directive.

Predsednica

5. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 4.

N. Fontaine

6. The Commission shall send to the European Parliament and the Council, in 2003 and thereafter every three years, a report on the experience of Member States with GMOs placed on the market under this Directive.

Za Svet

7. When submitting this report in 2003, the Commission shall at the same time submit a specific report on the operation of part B and part C including an assessment of:

Predsednik

(a) all its implications, particularly to take account of the diversity of European ecosystems and the need to complement the regulatory framework in this field;

L. Pagrotsky

(b) the feasibility of various options to improve further the consistency and efficiency of this framework, including a centralised Community authorisation procedure and the arrangements for the final decision making by the Commission;

[1] UL C 139, 4.5.1998, str. 1.

(c) whether sufficient experience has accumulated on the implementation of part B differentiated procedures to justify a provision on implicit consent in these procedures and on part C to justify the application of differentiated procedures; and

[2] UL C 407, 28.12.1998, str. 1.

(d) the socioeconomic implications of deliberate releases and placing on the market of GMOs.

[3] Mnenje Evropskega parlamenta z dne 11. februarja 1999 (UL C 150, 28.5.1999, str. 363), Skupno stališče Sveta z dne 9. decembra 1999 (UL C 64, 6.3.2000, str. 1) in Sklep Evropskega parlamenta z dne 12. aprila 2000 (UL C 40, 7.2.2001, str. 123), Sklep Evropskega parlamenta z dne 14. februarja 2001 in Sklep Sveta z dne 15. februarja 2001.

8. The Commission shall send to the European Parliament and the Council every year, a report on the ethical issues referred to in Article 29(1); this report may be accompanied, if appropriate, by a proposal with a view to amending this Directive.

[4] UL L 117, 8.5.1990, str. 15. Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 97/35/ES (UL L 169, 27.6.1997, str. 72).

[5] UL L 230, 19.8.1991, str. 1. Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 1999/80/ES (UL L 210, 10.8.1999, str. 13).

Article 32

[6] UL L 214, 24.8.1993, str. 1. Uredba, kakor je bila spremenjena z Uredbo Komisije (ES) št. 649/98 (UL L 88, 24.3.1998, str. 7).

Implementation of the Cartagena Protocol on biosafety

[7] UL L 237, 28.8.1997, str. 18.

1. The Commission is invited to bring forward as soon as possible and in any case before July 2001 a legislative proposal for implementing in detail the Cartagena Protocol on biosafety. The proposal shall complement and, if necessary, amend the provisions of this Directive.

[8] UL L 184, 17.7.1999, str. 23.

2. This proposal shall, in particular, include appropriate measures to implement the procedures laid down in the Cartagena Protocol and, in accordance with the Protocol, require Community exporters to ensure that all requirements of the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Cartagena Protocol, are fulfilled.

[9] UL L 117, 8.5.1990, str. 1. Direktiva, kakor je bila spremenjena z Direktivo 98/81/ES (UL L 330, 5.12.1998, str. 13).

[10] UL L 292, 12.11.1994, str. 31.

Article 33

[11] Direktiva Sveta 70/457/EGS z dne 29. septembra 1970 o skupnem katalogu sort poljščin (UL L 225, 12.10.1970, str. 1). Direktiva, kakor je bila nazadnje spremenjena z Direktivo 98/96/ES (UL L 25, 1.2.1999, str. 27).

Penalties

[12] Direktiva Sveta 70/458/EGS z dne 29. septembra 1970 o trženju semena zelenjadnic (UL L 225, 12.10.1970, str. 7). Direktiva, kakor je bila nazadnje spremenjena z Direktivo 98/96/ES.

Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. Those penalties shall be effective, proportionate and dissuasive.

[13] Direktiva Sveta 1999/105/ES z dne 22. decembra 1999 o trženju gozdnega reprodukcijskega materiala (UL L 11, 15.11.2000, str. 17).

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Article 34

PRILOGA I A

Transposition

TEHNIKE IZ ČLENA 2(2)

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 October 2002. They shall forthwith inform the Commission thereof.

DEL 1

When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

Tehnike genskega spreminjanja iz člena 2(2)(a) so med drugim:

2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field covered by this Directive.

(1) tehnike rekombinacije nukleinske kisline, ki vključujejo oblikovanje novih kombinacij genskega materiala z vnašanjem molekul nukleinske kisline, proizvedene na kakršenkoli način zunaj organizma, v katerikoli virus, bakterijski plazmid ali drug vektorski sistem ter njihovo vgradnjo v organizem gostitelja, v katerem se v naravi ne pojavljajo, vendar pa se lahko v njem naprej razmnožujejo;

(2) tehnike, ki vključujejo neposreden vnos dednega materiala, pripravljenega zunaj organizma, v ta organizem, vključno z mikro-injiciranjem, makro-injiciranjem in mikro-inkapsulacijo;

Article 35

(3) tehnike fuzije celic (vključno s fuzijo protoplastov) ali hibridizacije, pri katerih se s fuzijo dveh ali več celic na načine, ki se ne pojavljajo v naravi oblikujejo žive celice z novimi kombinacijami dednega genskega materiala.

Pending notifications

DEL 2

1. Notifications concerning placing on the market of GMOs as or in products received pursuant to Directive 90/220/EEC, and in respect of which the procedures of that Directive have not been completed by 17 October 2002 shall be subject to the provisions of this Directive.

Tehnike iz člena 2(2)(b), za katere velja, da njihov rezultat ni genska sprememba, pod pogojem, da ne vključujejo uporabe molekul rekombinantnih nukleinskih kislin ali gensko spremenjenih organizmov, pridobljenih z drugimi tehnikami/metodami, kot so tiste, ki jih izključuje Priloga I B:

2. By 17 January 2003 notifiers shall have complemented their notification in accordance with this Directive.

(1) "in vitro" oploditev (umetna oploditev),

(2) naravni postopki kot so: konjugacija, transdukcija, transformacija,

Article 36

(3) indukcija poliploidije.

Repeal

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1. Directive 90/220/EEC shall be repealed on 17 October 2002.

PRILOGA I B

2. References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex VIII.

TEHNIKE IZ ČLENA 3

Tehnike/metode genskega spreminjanja, s katerimi se dobijo organizmi, ki naj se izključijo iz Direktive, pod pogojem, da ne vključujejo uporabe molekul rekombinantnih nukleinskih kislin ali drugih gensko spremenjenih organizmov, kot so tisti, ki nastanejo z uporabo ene ali več spodaj navedenih tehnik/metod, so:

Article 37

(1) mutageneza,

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

(2) fuzija celic (vključno s fuzijo protoplastov) rastlinskih celic organizmov, ki lahko izmenjajo genski material preko tradicionalnih metod gojenja.

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Article 38

PRILOGA II

This Directive is addressed to the Member States.

NAČELA ZA OCENO TVEGANJA ZA OKOLJE

Ta priloga na splošno opisuje cilj, ki naj se doseže, elemente, ki naj se proučijo, in splošna načela in metodologijo, ki jim je treba slediti za izvedbo ocene tveganja za okolje (OTO) iz členov 4 in 13. Dopolnjena bo z navodili, ki naj se pripravijo po postopku iz člena 30(2). Ta navodila se izdelajo do 17. oktobra 2002.

Done at Brussels, 12 March 2001.

Da bi prispevali k skupnemu razumevanju izrazov "neposreden, posreden, takojšen in z zakasnitvijo" pri izvajanju te Priloge, ne da bi to vplivalo na nadaljnja navodila v tej zvezi in zlasti kar zadeva obseg, v katerem se lahko in je treba upoštevati posredne učinke, so ti izrazi opisani, kot sledi:

- "neposredni učinki" se nanašajo na primarne učinke na zdravje ljudi ali okolje, ki so posledica GSO samega in ne vzročne verige dogodkov;

For the European Parliament

- "posredni učinki" se nanašajo na učinke na zdravje ljudi ali okolje, ki nastopijo zaradi vzročne verige dogodkov skozi mehanizme, kot so medsebojno vplivanje z drugimi organizmi, prenos genskega materiala ali spremembe v uporabi ali upravljanju.

N. Fontaine

Opazovanje posrednih učinkov, ki bodo verjetno z zakasnitvijo;

The President

- "takojšnji učinki" se nanašajo na učinke na zdravje ljudi ali okolje, ki so opaženi med obdobjem sproščanja GSO. Takojšnji učinki so lahko neposredni ali posredni;

- "učinki z zakasnitvijo" se nanašajo na učinke na zdravje ljudi ali okolje, ki jih ni mogoče opaziti v obdobju sproščanja GSO, temveč postanejo očitni kot neposredni ali posredni učinki v kasnejši fazi ali po koncu sproščanja.

For the Council

Splošno načelo za oceno tveganja za okolje je tudi, da je treba opraviti analizo "kumulativnih dolgoročnih učinkov", ki se nanašajo na sproščanje in dajanje v promet. "Kumulativni dolgoročni učinki" se nanašajo na akumulirane učinke odobritev na zdravje ljudi in okolje, med drugim vključno z živalstvom in rastlinstvom, rodovitnostjo tal, razgradnjo organskih snovi v tleh, krmno/prehranjevalno verigo, biološko raznovrstnostjo, zdravjem živali in problemi odpornosti na antibiotike.

L. Pagrotsky

A. Cilj

The President

Cilj OTO je po načelu presoje posameznega primera določiti in ovrednotiti potencialno škodljive učinke GSO, neposredne ali posredne, takojšnje ali z zakasnitvijo, na zdravje ljudi in okolje, ki jih lahko ima namerno sproščanje ali dajanje GSO v promet. OTO je treba opravljati zaradi ugotavljanja potrebe po obvladovanju tveganja in, če je ugotovljena, najustreznejše metode, ki naj se uporabi.

B. Splošna načela

(1) OJ C 139, 4.5.1998, p. 1.

Po načelu previdnosti je treba pri izvajanju OTO slediti naslednjim splošnim načelom:

(2) OJ C 407, 28.12.1998, p. 1.

- ugotovljene značilnosti GSO in njegove uporabe, ki bi lahko povzročila škodljive učinke, je treba primerjati s tistimi, ki jih predstavlja nespremenjeni organizem, iz katerega izhaja, in njegove uporabe v ustreznih razmerah;

(3) Opinion of the European Parliament of 11 February 1999 (OJ C 150, 28.5.1999, p. 363), Council Common Position of 9 December 1999 (OJ C 64, 6.3.2000, p. 1) and Decision of the European Parliament of 12 April 2000 (OJ C 40, 7.2.2001, p. 123). Decision of the European Parliament of 14 February 2001 and Decision of the Council of 15 February 2001.

- OTO je treba opraviti na znanstveno temeljit in pregleden način na podlagi razpoložljivih znanstvenih in tehničnih podatkov;

(4) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

- OTO je treba opraviti po načelu presoje posameznega primera, kar pomeni, da se lahko zahtevane informacije razlikujejo glede na vrsto zadevnih GSO, njihovo predvideno uporabo in možno prejemno okolje ob upoštevanju, med drugim, GSO, ki so že v okolju;

(5) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 1999/80/EC (OJ L 210, 10.8.1999, p. 13).

- če so na voljo nove informacije o GSO in njegovih učinkih na zdravje ljudi ali okolje, bo morda treba OTO ponovno izvesti, da bi:

(6) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

- ugotovili, ali se je tveganje spremenilo;

(7) OJ L 237, 28.8.1997, p. 18.

- ugotovili, ali je treba ustrezno spremeniti obvladovanje tveganja.

(8) OJ L 184, 17.7.1999, p. 23.

C. Metodologija

(9) OJ L 117, 8.5.1990, p. 1. Directive as amended by Directive 98/81/EC (OJ L 330 5.12.1998, p. 13).

C.1 Značilnosti GSO in sproščanj

(10) OJ L 292, 12.11.1994, p. 31.

Odvisno od primera mora OTO upoštevati ustrezne tehnične in znanstvene podrobnosti v zvezi z značilnostmi:

(11) Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species (OJ L 225, 12.10.1970, p. 1). Directive as last amended by Directive 98/96/EC (OJ L 25, 1.2.1999, p. 27).

- prejemnega ali starševskega organizma(-ov);

(12) Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (OJ L 225, 12.10.1970, p. 7). Directive as last amended by Directive 98/96/EC.

- genske(-ih) sprememb(-e), naj bo to vključevanje ali izločanje genskega materiala, ter ustrezne informacije o vektorju in dajalcu;

(13) Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material (OJ L 11, 15.1.2000, p. 17).

- GSO;

- predvidenega sproščanja ali uporabe vključno z obsegom;

- možnega prejemnega okolja; in

- medsebojnega vplivanja med njimi.

ANNEX I A

Pri OTO lahko pomagajo informacije o sproščanjih podobnih organizmov ali organizmov s podobnimi značilnostmi in njihovem medsebojnem vplivanju s podobnimi okolji.

C.2 Koraki v OTO

TECHNIQUES REFERRED TO IN ARTICLE 2(2)

Pri oblikovanju zaključkov za OTO iz členov 4, 6, 7 in 13 je treba obravnavati naslednje točke:

PART 1

1. Določitev značilnosti, ki lahko povzročijo škodljive učinke

Techniques of genetic modification referred to in Article 2(2)(a) are inter alia:

Treba je določiti vsako značilnost GSO, povezano z gensko spremembo, ki lahko povzroči škodljive učinke na zdravje ljudi ali okolje. Primerjava značilnosti GSO z značilnostmi nespremenjenega organizma v ustreznih pogojih sproščanja ali uporabe pomaga posebej določiti potencialne škodljive učinke, ki izhajajo iz genske spremembe. Pomembno je, da se ne zanemarijo potencialni škodljivi učinki na podlagi tega, da obstaja majhna verjetnost za njihov pojav.

(1) recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

Možni škodljivi učinki GSO se bodo spreminjali od primera do primera in lahko vključujejo:

(2) techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation;

- bolezni ljudi, vključno z alergenimi in toksičnimi učinki (glej, na primer, postavke II.A.11. in II.C.2(i) v Prilogi III A, in B 7 v Prilogi III B);

(3) cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

- bolezni živali in rastlin, vključno s toksičnimi in, če je ustrezno, alergenimi učinki (glej, na primer, postavke II.A.11. in II.C.2(i) v Prilogi III A, ter B 7 in D 8 v Prilogi III B);

PART 2

- učinke na populacijsko dinamiko vrst v prejemnem okolju in gensko raznovrstnost vsake od teh populacij (glej na primer postavke IV B 8, 9 in 12 v Prilogi III A);

Techniques referred to in Article 2(2)(b) which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms made by techniques/methods other than those excluded by Annex I B:

- spremenjeno občutljivost na patogene, ki pospešuje širjenje infekcijskih bolezni in/ali ustvarjanje novih bazenov za zbiranje ali vektorjev;

(1) in vitro fertilisation,

- ogrožanje profilaktičnih ali terapevtskih medicinskih in veterinarskih postopkov ali postopkov varstva rastlin, na primer s prenosom genov, ki dajejo odpornost na antibiotike, uporabljane v medicini ali veterini (glej na primer postavke II.A.11(e) in II.C2(i)(iv) v Prilogi III A);

(2) natural processes such as: conjugation, transduction, transformation,

- učinke na biogeokemijo (biogeokemijska kroženja), še zlasti ponovno kroženje ogljika in dušika preko sprememb v razgradnji organskih snovi v tleh (glej na primer postavke II.A.11(f) in IV.B.15 v Prilogi III A in D 11 v Prilogi III B).

(3) polyploidy induction.

Škodljivi učinki se lahko pojavijo neposredno ali posredno preko mehanizmov, ki lahko vključujejo:

- širjenje GSO v okolje,

- prenos vključenega genskega materiala na druge organizme ali isti organizem, gensko spremenjen ali ne,

ANNEX I B

- fenotipsko in gensko nestabilnost,

- medsebojno vplivanje z drugimi organizmi,

TECHNIQUES REFERRED TO IN ARTICLE 3

- spremembe v gospodarjenju, če je ustrezno vključno s kmetijskimi praksami.

Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are:

2. Vrednotenje možnih posledic vsakega škodljivega učinka, če do njega pride

(1) mutagenesis,

Treba je ovrednotiti razsežnost posledic vsakega možnega škodljivega učinka.

(2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.

To vrednotenje mora predpostavljati, da bo do takega škodljivega učinka prišlo. Na razsežnost posledic bo verjetno vplivalo okolje, v katerega se namerava sproščati GSO, in način sproščanja.

3. Vrednotenje verjetnosti pojava vsakega določenega možnega škodljivega učinka

Pomemben dejavnik pri vrednotenju verjetnosti ali verjetnosti pojava škodljivih učinkov so značilnosti okolja, v katerega se namerava sproščati GSO, in način sproščanja.

ANNEX II

4. Ocena tveganja, ki ga predstavlja vsaka ugotovljena značilnost GSO

Ocena tveganja za zdravje ljudi ali okolje, ki ga predstavlja vsaka ugotovljena značilnost GSO, ki lahko povzroči škodljive učinke mora biti narejena v kar največji meri s podanim najnovejšim stanjem združevanja verjetnosti pojava škodljivih učinkov in razsežnosti posledic, če bi do njih prišlo.

PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT

5. Uporaba strategij za obvladovanje tveganja zaradi namernega sproščanja ali dajanja GSO v promet

This Annex describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental risk assessment (e.r.a.) referred to in Articles 4 and 13. It will be supplemented by guidance notes to be developed in accordance with the procedure laid down in Article 30(2). These guidance notes shall be completed by 17 October 2002.

Ocena tveganja lahko ugotovi tveganja, ki potrebujejo obvladovanje, in načine za njihovo najboljše obvladovanje, poleg tega pa bi bilo treba opredeliti strategijo za obvladovanje tveganja.

With a view to contributing to a common understanding of the terms "direct, indirect, immediate and delayed" when implementing this Annex, without prejudice to further guidance in this respect and in particular as regards the extent to which indirect effects can and should be taken into account, these terms are described as follows:

6. Določitev skupnega tveganja GSO

- "direct effects" refers to primary effects on human health or the environment which are a result of the GMO itself and which do not occur through a causal chain of events;

Treba je izdelati vrednotenje skupnega tveganja GSO ob upoštevanju katerih koli predlaganih strategij obvladovanja tveganja.

- "indirect effects" refers to effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management.

D. Zaključki o možnem vplivu sproščanja ali dajanja GSO v promet na okolje

Observations of indirect effects are likely to be delayed;

Na podlagi OTO, opravljene po načelih in metodologiji iz oddelkov B in C, je treba v prijave ustrezno vključiti informacije o točkah iz oddelkov D1 ali D2 z namenom pomagati pri oblikovanju zaključkov o potencialnem vplivu sproščanja ali dajanja GSO v promet na okolje.

- "immediate effects" refers to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect;

D.1 V primeru GSO, ki niso višje rastline

- "delayed effects" refers to effects on human health or the environment which may not be observed during the period of the release of the GMO, but become apparent as a direct or indirect effect either at a later stage or after termination of the release.

1. Verjetnost, da bo GSO postal obstojen in invaziven v naravnih habitatih v pogojih predlaganega(-ih) sproščanj(-a).

A general principle for environmental risk assessment is also that an analysis of the "cumulative long-term effects" relevant to the release and the placing on the market is to be carried out. "Cumulative long-term effects" refers to the accumulated effects of consents on human health and the environment, including inter alia flora and fauna, soil fertility, soil degradation of organic material, the feed/ food chain, biological diversity, animal health and resistance problems in relation to antibiotics.

2. Vsaka selektivna prednost ali pomanjkljivost, prenesena na GSO, in verjetnost, da se uresniči v pogojih predlaganega sproščanja.

A. Objective

3. Potencial za genski prenos na druge vrste pod pogoji predlaganega sproščanja GSO in morebitne selektivne prednosti ali pomanjkljivosti, prenesene na te vrste.

The objective of an e.r.a. is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of GMOs may have. The e.r.a. should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used.

4. Možen takojšnji in/ali z zakasnitvijo vpliv na okolje posrednega in neposrednega medsebojnega vplivanja med GSO in ciljnimi organizmi (če ustreza).

B. General Principles

5. Možen takojšnji in/ali z zakasnitvijo vpliv na okolje posrednega in neposrednega medsebojnega vplivanja med GSO in neciljnimi organizmi, vključno s vplivi na populacijske ravni tekmecev, plena, gostiteljev, simbiontov, plenilcev, parazitov in patogenov.

In accordance with the precautionary principle, the following general principles should be followed when performing the e.r.a.:

6. Možni takojšnji in/ali z zakasnitvijo učinki na zdravje ljudi kot posledica možnega neposrednega in posrednega medsebojnega vplivanja GSO in oseb, ki delajo z njimi, prihajajo v stik z njim(-i) ali v njegovo (njihovo) bližino pri sproščanju(-jih) GSO.

- identified characteristics of the GMO and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations;

7. Možni takojšnji in/ali z zakasnitvijo učinki na zdravje živali in posledice za krmno/prehransko verigo, ki izhajajo iz porabe GSO in vsakega proizvoda, ki izhaja iz njega, če je predviden za uporabo kot živalska krma.

- the e.r.a. should be carried out in a scientifically sound and transparent manner based on available scientific and technical data;

8. Možni takojšnji in/ali z zakasnitvijo učinki na biogeokemijske procese kot posledica možnega neposrednega in posrednega medsebojnega vplivanja GSO ter ciljnih in neciljnih organizmov v bližini sproščanj(a) GSO.

- the e.r.a. should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the GMOs concerned, their intended use and the potential receiving environment, taking into account, i.a., GMOs already in the environment;

9. Možni takojšnji in/ali z zakasnitvijo neposredni in posredni vplivi posebnih tehnik za upravljanje GSO na okolje, kadar so te drugačne od tistih, ki se uporabljajo za ne-GSO.

- if new information on the GMO and its effects on human health or the environment becomes available, the e.r.a. may need to be readdressed in order to:

D.2. V primeru gensko spremenjenih višjih rastlin (GSVR)

- determine whether the risk has changed;

1. Verjetnost, da GSVR postanejo obstojnejše od prejemnih ali starševskih rastlin v kmetijskih habitatih ali invazivnejše v naravnih habitatih.

- determine whether there is a need for amending the risk management accordingly.

2. Morebitna selektivna prednost ali pomanjkljivost, prenesena na GSVR.

C. Methodology

3. Potencial za genski prenos na isto ali drugo spolno združljivo sorto rastlin v pogojih sajenja GSVR in selektivna prednost ali pomanjkljivost, prenesena na te sorte rastlin.

C.1. Characteristics of GMOs and releases

4. Potencial takojšnjega in/ali z zakasnitvijo vpliva na okolje, ki izhaja iz neposrednega in posrednega medsebojnega vplivanja med GSVR in ciljnimi organizmi, kot so plenilci, parazitoidi in patogeni (če ustreza).

Depending on the case the e.r.a. has to take into account the relevant technical and scientific details regarding characteristics of:

5. Možnost takojšnjega in/ali z zakasnitvijo vpliva na okolje, ki izhaja iz neposrednega in posrednega medsebojnega vplivanja med GSVR in neciljnimi organizmi (tudi upoštevaje organizme, ki medsebojno vplivajo s ciljnimi organizmi), vključno z vplivom na populacijske ravni tekmecev, rastlinojedcev, simbiontov (kjer to ustreza), parazitov in patogenov.

- the recipient or parental organism(s);

6. Možni takojšnji in/ali z zakasnitvijo učinki na okolje, ki izhajajo iz neposrednega in posrednega medsebojnega vplivanja med GSVR in osebami, ki delajo, prihajajo v stik z njimi ali v njihovo bližino pri sproščanju GSVR.

- the genetic modification(s), be it inclusion or deletion of genetic material, and relevant information on the vector and the donor;

- the GMO;

8. Možni takojšnji in/ali z zakasnitvijo učinki na biogeokemijske procese kot posledica potencialnega posrednega in neposrednega medsebojnega vplivanja GSO ter ciljnih in neciljnih organizmov v bližini sproščanj(-a) GSO.

- the intended release or use including its scale;

9. Možni takojšnji in ali zakasnjeni neposredni in posredni vplivi posebnih tehnik za obdelovanje, upravljanje in spravilo pridelka, ki se uporabljajo za GSVR, kadar so te drugačne od tistih, ki se uporabljajo za ne-GSVR, na okolje.

- the potential receiving environment; and

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- the interaction between these.

PRILOGA III

Information from releases of similar organisms and organisms with similar traits and their interaction with similar environments can assist the e.r.a.

INFORMACIJE, ZAHTEVANE V PRIJAVI

C.2. Steps in the e.r.a.

Prijava iz dela B ali dela C Direktive mora ustrezno vključevati informacije, določene v nadaljevanju v podprilogah.

In drawing conclusions for the e.r.a. referred to in Articles 4, 6, 7 and 13 the following points should be addressed:

Vse točke ne bodo veljale za vsakega od primerov. Pričakovati je treba, da bodo posamezne prijave obravnavale samo poseben podniz vidikov, ki ustreza posameznim razmeram.

1. Identification of characteristics which may cause adverse effects:

Raven podrobnosti, zahtevanih v odgovoru na vsak podniz vidikov, se bo verjetno razlikovala tudi glede na naravo in obseg predlaganega sproščanja.

Any characteristics of the GMOs linked to the genetic modification that may result in adverse effects on human health or the environment shall be identified. A comparison of the characteristics of the GMO(s) with those of the non-modified organism under corresponding conditions of the release or use, will assist in identifying the particular potential adverse effects arising from the genetic modification. It is important not to discount any potential adverse effect on the basis that it is unlikely to occur.

Nadaljnji razvoj v genskih spremembah lahko zahteva prilagoditev te priloge tehničnemu napredku ali pripravo navodil za to prilogo. Nadaljnja diferenciacija informacijskih zahtev za različne vrste GSO, na primer za enocelične organizme, ribe ali insekte, ali za posebno uporabo GSO, kot je razvoj cepiv, bo mogoč, ko bo v Skupnosti pridobljenih dovolj izkušenj s prijavami za sproščanje posebnih GSO.

Potential adverse effects of GMOs will vary from case to case, and may include:

V dokumentaciji se omeni tudi opis uporabljenih metod ali sklic na standarizirane ali mednarodno priznane metode skupaj z imenom organa ali organov, odgovornih za opravljanje študij.

- disease to humans including allergenic or toxic effects (see for example items II.A.11. and II.C.2(i) in Annex III A, and B 7 in Annex III B);

Priloga III A se uporablja za sproščanja vseh vrst gensko spremenjenih organizmov, razen višjih rastlin. Priloga III B se uporablja za sproščanje gensko spremenjenih višjih rastlin.

- disease to animals and plants including toxic, and where appropriate, allergenic effects (see for example items II.A.11. and II.C.2(i) in Annex III A, and B 7 and D 8 in Annex III B);

Izraz "višje rastline" pomeni rastline, ki sodijo v taksonomsko skupino Semenk – Spermatofitov (Glosemenke – Gymnospermae in Kritosemenke – Angiospermae).

- effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations (see for example items IV B 8, 9 and 12 in Annex III A);

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- altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or creating new reservoirs or vectors;

PRILOGA III A

- compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine (see for example items II.A.11(e) and II.C.2(i)(iv) in Annex III A);

INFORMACIJE, ZAHTEVANE V PRIJAVAH V ZVEZI S SPROŠČANJEM GENSKO SPREMENJENIH ORGANIZMOV, RAZEN VIŠJIH RASTLIN

- effects on biogeochemistry( biogeochemical cycles), particularly carbon and nitrogen recycling through changes in soil decomposition of organic material (see for example items II.A.11(f) and IV.B.15 in Annex III A, and D 11 in Annex III B).

I. SPLOŠNE INFORMACIJE

Adverse effects may occur directly or indirectly through mechanisms which may include:

A. Ime in naslov prijavitelja (podjetje ali inštitut)

- the spread of the GMO(s) in the environment,

B. Ime, usposobljenost in izkušnje odgovornega(ih) znanstvenika(ov)

- the transfer of the inserted genetic material to other organisms, or the same organism whether genetically modified or not,

C. Naslov projekta

- phenotypic and genetic instability,

II. INFORMACIJE V ZVEZI Z GSO

- interactions with other organisms,

A. Značilnosti (a) dajalca, (b) prejemnika ali (c) (če je primerno) starševskega(-ih) organizma(-ov):

- changes in management, including, where applicable, in agricultural practices.

1. znanstveno ime

2. Evaluation of the potential consequences of each adverse effect, if it occurs

2. taksonomska razvrstitev

The magnitude of the consequences of each potential adverse effect should be evaluated.

3. druga imena (običajno ime, ime seva itd.)

This evaluation should assume that such an adverse effect will occur. The magnitude of the consequences is likely to be influenced by the environment into which the GMO(s) is (are) intended to be released and the manner of the release.

4. fenotipski in genski označevalci,

3. Evaluation of the likelihood of the occurrence of each identified potential adverse effect

5. stopnja sorodnosti med dajalcem in prejemnikom ali med starševskimi organizmi,

A major factor in evaluating the likelihood or probability of adverse effects occurring is the characteristics of the environment into which the GMO(s) is intended to be released, and the manner of the release.

6. opis tehnik identifikacije in odkrivanja,

4. Estimation of the risk posed by each identified characteristic of the GMO(s)

7. občutljivost, zanesljivost (količinska) in specifičnost tehnik odkrivanja in identifikacije,

An estimation of the risk to human health or the environment posed by each identified characteristic of the GMO which has the potential to cause adverse effects should be made as far as possible, given the state of the art, by combining the likelihood of the adverse effect occurring and the magnitude of the consequences, if it occurs.

8. opis geografske porazdelitve in naravnega habitata organizma vključno z informacijami o naravnih plenilcih, plenu, parazitih in tekmecih, simbiontih in gostiteljih,

5. Application of management strategies for risks from the deliberate release or marketing of GMO(s)

9. organizmi, za katere je poznan prenos genskega materiala v naravnih pogojih,

The risk assessment may identify risks that require management and how best to manage them, and a risk management strategy should be defined.

10. preverjanje genske stabilnosti organizmov in dejavniki, ki vplivajo nanjo,

6. Determination of the overall risk of the GMO(s)

11. patološke, ekološke in fiziološke lastnosti:

An evaluation of the overall risk of the GMO(s) should be made taking into account any risk management strategies which are proposed.

(a) razvrstitev nevarnosti po obstoječih pravilih Skupnosti v zvezi z varstvom zdravja ljudi in/ali okolja;

D. Conclusions on the potential environmental impact from the release or the placing on the market of GMOs

(b) generacijski čas v naravnih ekosistemih, spolni in nespolni reprodukcijski ciklus;

On the basis of an e.r.a. carried out in accordance with the principles and methodology outlined in sections B and C, information on the points listed in sections D1 or D2 should be included, as appropriate, in notifications with a view to assisting in drawing conclusions on the potential environmental impact from the release or the placing on the market of GMOs:

D.1. In the case of GMOs other than higher plants

(d) patogenost: nalezljivost, toksičnost, virulentnost, alergenost, nosilec (vektor) patogena, možni vektorji, nabor gostiteljev, vključno z neciljnim organizmom. Možno aktiviranje latentnih virusov (provirusov). Sposobnost naselitve drugih organizmov;

1. Likelihood of the GMO to become persistent and invasive in natural habitats under the conditions of the proposed release(s).

(e) odpornost na antibiotike in možna uporaba teh antibiotikov na ljudeh in domačih organizmih zaradi profilakse in terapije;

2. Any selective advantage or disadvantage conferred to the GMO and the likelihood of this becoming realised under the conditions of the proposed release(s).

(f) vpletenost v okoljske procese: osnovna proizvodnja, obrat hranil, razgradnja organske snovi, dihanje itd.

3. Potential for gene transfer to other species under conditions of the proposed release of the GMO and any selective advantage or disadvantage conferred to those species.

12. Narava avtohtonih vektorjev:

4. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the GMO and target organisms (if applicable).

(a) zaporedje;

5. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the GMO with non-target organisms, including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.

(b) pogostnost mobilizacije;

6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the GMO and persons working with, coming into contact with or in the vicinity of the GMO release(s).

7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the GMO and any product derived from it, if it is intended to be used as animal feed.

(d) prisotnost genov, ki dajejo odpornost.

8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the GMO and target and non-target organisms in the vicinity of the GMO release(s).

13. Zgodovina predhodnih genskih sprememb.

9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific techniques used for the management of the GMO where these are different from those used for non-GMOs.

B. Značilnosti vektorja

D.2. In the case of genetically modified higher plants (GMHP)

1. narava in vir vektorja,

1. Likelihood of the GMHP becoming more persistent than the recipient or parental plants in agricultural habitats or more invasive in natural habitats.

2. zaporedje transpozonov, vektorjev in drugih nekodirnih genskih odsekov, ki se uporabljajo za izgranjo GSO in delovanje vnešenega vektorja in vključka v GSO,

2. Any selective advantage or disadvantage conferred to the GMHP.

3. pogostnost mobilizacije vključenega vektorja in/ali sposobnosti genskega prenosa ter metode določanja,

3. Potential for gene transfer to the same or other sexually compatible plant species under conditions of planting the GMHP and any selective advantage or disadvantage conferred to those plant species.

4. informacije o stopnji, do katere je vektor omejen na DNK, potrebno za izvajanje predvidene funkcije.

4. Potential immediate and/or delayed environmental impact resulting from direct and indirect interactions between the GMHP and target organisms, such as predators, parasitoids, and pathogens (if applicable).

C. Značilnosti spremenjenega organizma

5. Possible immediate and/or delayed environmental impact resulting from direct and indirect interactions of the GMHP with non-target organisms, (also taking into account organisms which interact with target organisms), including impact on population levels of competitors, herbivores, symbionts (where applicable), parasites and pathogens.

1. Informacije v zvezi z gensko spremembo:

6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the GMHP and persons working with, coming into contact with or in the vicinity of the GMHP release(s).

(a) metode, uporabljene za spremembo,

7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the GMO and any products derived from it, if it is intended to be used as animal feed.

(b) metode, uporabljene za izgradnjo in vnos vključka(-ov) v prejemnika ali za odstranitev zaporedja

9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific cultivation, management and harvesting techniques used for the GMHP where these are different from those used for non-GMHPs.

(d) čistost vključka od katerega koli neznanega zaporedja ter informacija o stopnji, do katere je vključeno zaporedje omejeno na DNK, potrebno za izvajanje predvidene funkcije;

(e) metode in uporabljena merila za izbiro;

(f) zaporedje, funkcijska identiteta in lokacija spremenjenega(-ih)/vključenega(-ih)/odstranjenega(-ih) odseka(-ov) nukleinske kisline s posebnim ozirom na katero koli znano škodljivo zaporedje.

ANNEX III

2. Informacije o končnem GSO:

(a) opis genske(-ih) lastnosti ali fenotipskih značilnosti in še zlasti kakršne koli nove lastnosti in značilnosti, ki se lahko ali ne morejo več izraziti;

INFORMATION REQUIRED IN THE NOTIFICATION

(b) struktura in količina katerega koli vektorja in/ali nukleinske kisline dajalca, preostale v končni zgradbi spremenjenega organizma;

A notification referred to in part B or part C of the Directive is to include, as appropriate, the information set out below in the sub-Annexes.

Not all the points included will apply to every case. It is to be expected that individual notifications will address only the particular subset of considerations which is appropriate to individual situations.

(d) hitrost in stopnja izražanja novega genskega materiala. Metoda in občutljivost meritve;

The level of detail required in response to each subset of considerations is also likely to vary according to the nature and the scale of the proposed release.

(e) aktivnost izraženega(-ih) proteina(-ov);

Future developments in genetic modification may necessitate adapting this Annex to technical progress or developing guidance notes on this Annex. Further differentiation of information requirements for different types of GMOs, for example single celled organisms, fish or insects, or for particular use of GMOs like the development of vaccines, may be possible once sufficient experience with notifications for the release of particular GMOs has been gained in the Community.

(f) opis tehnik identifikacije in odkrivanja vključno s tehnikami za identifikacijo in odkrivanje vključenega zaporedja in vektorja;

The description of the methods used or the reference to standardised or internationally recognised methods shall also be mentioned in the dossier, together with the name of the body or bodies responsible for carrying out the studies.

(g) občutljivost, zanesljivost (glede količine) in specifičnost tehnik odkrivanja in identifikacije;

Annex III A applies to releases of all types of genetically modified organisms other than higher plants. Annex III B applies to release of genetically modified higher plants.

(h) zgodovina predhodnih sproščanj ali uporab GSO;

The term "higher plants" means plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae).

(i) premisleki glede zdravja ljudi in živali, prav tako tudi rastlin:

(i) toksični ali alergeni učinki GSO in/ali njihovih produktov metabolizma;

(ii) primerjava spremenjenega organizma z dajalcem, prejemnikom ali (če je primerno) starševskim organizmom glede patogenosti;

ANNEX III A

(iii) zmožnost kolonizacije;

(iv) če je organizem patogen za ljudi, ki so imunokompetentni:

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

- povzročene bolezni in mehanizmi patogenosti vključno z invazivnostjo in virulentnostjo,

I. GENERAL INFORMATION

- nalezljivost,

A. Name and address of the notifier (company or institute)

- infektivna doza,

B. Name, qualifications and experience of the responsible scientist(s)

- nabor gostiteljev, možnost spremembe,

C. Title of the project

- možnost preživetja zunaj človeka kot gostitelja,

II. INFORMATION RELATING TO THE GMO

- prisotnost vektorjev ali načinov razširjanja,

A. Characteristics of (a) the donor, (b) the recipient or (c) (where appropriate) parental organism(s):

- biološka stabilnost,

1. scientific name,

- vzorci odpornosti na antibiotike,

2. taxonomy,

- alergenost,

3. other names (usual name, strain name, etc.),

- razpoložljivost ustreznih terapij;

4. phenotypic and genetic markers,

(v) druge nevarnosti, povezane s proizvodom.

5. degree of relatedness between donor and recipient or between parental organisms,

III. INFORMACIJE V ZVEZI S POGOJI SPROŠČANJA IN PREJEMNIM OKOLJEM

6. description of identification and detection techniques,

A. Informacije o sproščanju

7. sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques,

1. opis predlaganega namernega sproščanja, vključno z namenom(i) in predvidenimi proizvodi,

8. description of the geographic distribution and of the natural habitat of the organism including information on natural predators, preys, parasites and competitors, symbionts and hosts,

2. predvideni datumi sproščanja in časovno načrtovanje poskusa vključno s pogostnostjo in trajanjem sproščanj,

9. organisms with which transfer of genetic material is known to occur under natural conditions,

3. priprava mesta sproščanja pred sproščanjem,

10. verification of the genetic stability of the organisms and factors affecting it,

4. velikost mesta sproščanja,

11. pathological, ecological and physiological traits:

5. metoda(-e), ki se bo(-do) uporabila(-e) za sproščanje,

(a) classification of hazard according to existing Community rules concerning the protection of human health and/or the environment;

6. količine GSO, ki se bodo sprostile,

(b) generation time in natural ecosystems, sexual and asexual reproductive cycle;

7. motnje na mestu sproščanja (vrsta in metoda gojenja, rudarjenje, namakanje ali druge dejavnosti),

8. ukrepi za zaščito delavcev med sproščanjem,

(d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organism. Possible activation of latent viruses (proviruses). Ability to colonise other organisms;

9. ravnanje z mestom sproščanja po sproščanju,

(e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy;

10. tehnike, predvidene za odstranjevanje ali inaktivacijo GSO po zaključenem poskusu,

(f) involvement in environmental processes: primary production, nutrient turnover, decomposition of organic matter, respiration, etc.

11. informacije in rezultati predhodnih sproščanj GSO, še posebej pri različnih obsegih in v različnih ekosistemih.

12. Nature of indigenous vectors:

B. Informacije o okolju (na mestu sproščanja in v širšem okolju):

(a) sequence;

1. geografska lega in koordinate mest(-a) sproščanj(-a) (v primeru prijav po delu C bo(-do) mesto(-a) sproščanja predvideno(-a) območje(-a) uporabe proizvoda),

(b) frequency of mobilisation;

2. fizična ali biološka neposredna bližina ljudem in drugim pomembnim organizmom na določenem prostoru,

3. neposredna bližina pomembnim biotopom, zaščitenim območjem ali zalogam pitne vode,

(d) presence of genes which confer resistance.

4. podnebne značilnosti regij(-e), ki bo(-do) verjetno prizadeta(-e),

13. History of previous genetic modifications.

5. geografske, geološke in pedološke značilnosti,

B. Characteristics of the vector

6. živalstvo in rastlinstvo, vključno s pridelki, živino in migracijskimi vrstami,

1. nature and source of the vector,

7. opis ciljnih in neciljnih ekosistemov, ki bodo verjetno prizadeti,

2. sequence of transposons, vectors and other non-coding genetic segments used to construct the GMO and to make the introduced vector and insert function in the GMO,

8. primerjava naravnega habitata prejemnega organizma s predlaganim(-i) mestom(-i) sproščanja,

3. frequency of mobilisation of inserted vector and/or genetic transfer capabilities and methods of determination,

9. vsak znan načrtovan razvoj ali posegi v prostor v regiji, ki bi lahko delovali na vpliv sproščanja na okolje.

4. information on the degree to which the vector is limited to the DNA required to perform the intended function.

IV. INFORMACIJE V ZVEZI Z MEDSEBOJNIM VPLIVANJEM GSO IN OKOLJA

C. Characteristics of the modified organism

A. Značilnosti, ki vplivajo na preživetje, razmnoževanje in širjenje

1. Information relating to the genetic modification:

1. biološke oblike, ki vplivajo na preživetje, razmnoževanje in razširjenost,

(a) methods used for the modification;

2. znani ali predvideni okoljski pogoji, ki lahko vplivajo na preživetje, razmnoževanje in širjenje (veter, voda, tla, temperatura, pH itd.),

(b) methods used to construct and introduce the insert(s) into the recipient or to delete a sequence;

3. občutljivost na specifične povzročitelje.

B. Medsebojno vplivanje z okoljem

(d) purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function;

1. predvideni habitat GSO,

(e) methods and criteria used for selection;

2. študije obnašanja in značilnosti GSO ter njihovega ekološkega vpliva, ki se opravljajo v simuliranih naravnih okoljih, kot so mikrokozmosi, rastna komora, rastlinjaki,

(f) sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known harmful sequence.

3. sposobnost genskega prenosa

2. Information on the final GMO:

(a) prenos genskega materiala z GSO v organizme v prizadetih ekosistemih po sproščanju;

(a) description of genetic trait(s) or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed;

(b) prenos genskega materiala z avtohtonih organizmov na GSO po sproščanju;

(b) structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified organism;

4. verjetnost selekcije po sproščanju, ki vodi v izražanje nepričakovanih in/ali neželenih lastnosti v spremenjenem organizmu;

5. ukrepi, uporabljeni za zagotovitev in preverjanje genske stabilnosti. Opis genskih lastnosti, ki lahko preprečijo ali zmanjšajo razširjanje genskega materiala. Metode za preverjanje genske stabilnosti,

(d) rate and level of expression of the new genetic material. Method and sensitivity of measurement;

6. poti biološkega razširjanja, znani ali možni načini medsebojnega vplivanja s povzročiteljem širjenja, vključno z vdihavanjem, zaužitjem, površinskim stikom, vkopavanjem itd.,

(e) activity of the expressed protein(s);

7. opis ekosistemov, v katere bi se GSO lahko razširili,

(f) description of identification and detection techniques including techniques for the identification and detection of the inserted sequence and vector;

8. možnost prekomernega povečanja populacije v okolju,

(g) sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;

9. konkurenčna prednost GSO v primerjavi z nespremenjenim(-i) sprejemnim(-i) ali starševskim(-i) organizmom(-i).

(h) history of previous releases or uses of the GMO;

10. identifikacija in opis ciljnih organizmov, če je primerno,

(i) considerations for human health and animal health, as well as plant health:

11. pričakovani mehanizem in rezultat medsebojnega vplivanja sproščenih GSO in ciljnega(-ih) organizma(-ov), če je primerno,

(i) toxic or allergenic effects of the GMOs and/or their metabolic products;

12. identifikacija in opis neciljnih organizmov, na katere bi lahko sproščanje GSO škodljivo vplivalo, ter pričakovani mehanizmi katerega koli ugotovljenega škodljivega medsebojnega vplivanja,

(ii) comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

13. verjetnost sprememb v biološkem medsebojnem vplivanju ali naboru gostiteljev po sproščanju,

(iii) capacity for colonisation;

14. znana ali predvidena medsebojna vplivanja z neciljnimi organizmi v okolju, vključno s tekmeci, žrtvami, gostitelji, simbionti, plenilci, zajedavci in patogeni,

(iv) if the organism is pathogenic to humans who are immunocompetent:

15. znana ali predvidena vpletenost v biogeokemične procese,

- diseases caused and mechanism of pathogenicity including invasiveness and virulence,

16. druga možna medsebojna vplivanja z okoljem.

- communicability,

V. INFORMACIJE O SPREMLJANJU, NADZORU, RAVNANJU Z ODPADKI IN NAČRTIH UKREPOV ZA PRIMER NESREČE

- infective dose,

A. Tehnike spremljanja

- host range, possibility of alteration,

1. metode ugotavljanja GSO in spremljanja njihovih učinkov,

- possibility of survival outside of human host,

2. specifičnost (za identifikacijo GSO in njihovo ločevanje od darovalca, prejemnika ali, če je primerno, starševskih organizmov), občutljivost in zanesljivost tehnik spremljanja,

- presence of vectors or means of dissemination,

3. tehnike za odkrivanje prenosa darovanega genskega materiala na druge organizme,

- biological stability,

4. trajanje in pogostnost spremljanja.

- antibiotic resistance patterns,

B. Nadzor sproščanja

- allergenicity,

1. metode in postopki za preprečevanje in/ali zmanjšanje širjenja GSO na najmanjšo možno mero izven mesta sproščanja ali določenega območja uporabe,

- availability of appropriate therapies.

2. metode in postopki za zaščito mesta sproščanja pred vdorom nepooblaščenih oseb,

(v) other product hazards.

3. metode in postopki za preprečevanje vstopa drugim organizmom na mesto sproščanja.

III. INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT

C. Ravnanje z odpadki

A. Information on the release

1. vrsta nastalih odpadkov,

1. description of the proposed deliberate release, including the purpose(s) and foreseen products,

2. pričakovana količina odpadkov,

2. foreseen dates of the release and time planning of the experiment including frequency and duration of releases,

3. opis predvidenega ravnanja.

3. preparation of the site previous to the release,

D. Načrti ukrepov za primer nesreče

4. size of the site,

1. metode in postopki za nadzor GSO v primeru nepričakovanega širjenja,

5. method(s) to be used for the release,

2. metode dekontaminacije prizadetih območij, na primer zatiranje GSO,

6. quantities of GMOs to be released,

3. metode za odstranitev ali sanitacijo rastlin, živali, tal itd., izpostavljenih med ali po širjenju,

7. disturbance on the site (type and method of cultivation, mining, irrigation, or other activities),

4. metode za izolacijo območja, prizadetega zaradi širjenja,

8. worker protection measures taken during the release,

5. načrti za varstvo zdravja ljudi in okolja v primeru pojava neželenega učinka.

9. post-release treatment of the site,

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10. techniques foreseen for elimination or inactivation of the GMOs at the end of the experiment,

PRILOGA III B

11. information on, and results of, previous releases of the GMOs, especially at different scales and in different ecosystems.

INFORMACIJE, ZAHTEVANE V PRIJAVAH V ZVEZI S SPROŠČANJEM GENSKO SPREMENJENIH VIŠJIH RASTLIN (GSVR) (GOLOSEMENKE – GYMNOSPERMAE IN KRITOSEMENKE – ANGIOSPERMAE)

B. Information on the environment (both on the site and in the wider environment):

A. SPLOŠNE INFORMACIJE

1. geographical location and grid reference of the site(s) (in case of notifications under part C the site(s) of release will be the foreseen areas of use of the product),

1. Ime in naslov prijavitelja (podjetje ali inštitut)

2. physical or biological proximity to humans and other significant biota,

2. Ime, usposobljenost in izkušnje odgovornega(-ih) znanstvenika(-ov)

3. proximity to significant biotopes, protected areas, or drinking water supplies,

3. Naslov projekta

4. climatic characteristics of the region(s) likely to be affected,

B. INFORMACIJE V ZVEZI Z (A) PREJEMNIKOM ALI (B) (ČE JE PRIMERNO) STARŠEVSKIMI RASTLINAMI

5. geographical, geological and pedological characteristics,

1. Celotno ime

6. flora and fauna, including crops, livestock and migratory species,

(a) družina

7. description of target and non-target ecosystems likely to be affected,

(b) rod

8. a comparison of the natural habitat of the recipient organism with the proposed site(s) of release,

9. any known planned developments or changes in land use in the region which could influence the environmental impact of the release.

(d) podvrsta

IV. INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GMOs AND THE ENVIRONMENT

(e) kultivar/linija žlahtnjenja

A. Characteristics affecting survival, multiplication and dissemination

(f) domače ime

1. biological features which affect survival, multiplication and dispersal,

2. (a) Informacije o reprodukciji:

2. known or predicted environmental conditions which may affect survival, multiplication and dissemination (wind, water, soil, temperature, pH, etc.),

(i) način(-i) reprodukcije

3. sensitivity to specific agents.

(ii) specifični dejavniki, ki vplivajo na reprodukcijo, če obstajajo

B. Interactions with the environment

(iii) generacijski čas

1. predicted habitat of the GMOs,

(b) Spolna združljivost z drugimi gojenimi ali prosto živečimi rastlinskimi vrstami, vključno z razširjenostjo združljivih sort v Evropi.

2. studies of the behaviour and characteristics of the GMOs and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms, greenhouses,

3. Sposobnost preživetja

3. genetic transfer capability

(a) sposobnost oblikovanja struktur za preživetje ali mirovanje

(a) postrelease transfer of genetic material from GMOs into organisms in affected ecosystems;

(b) posebni dejavniki, ki vplivajo na zmožnost preživetja, če obstajajo.

(b) postrelease transfer of genetic material from indigenous organisms to the GMOs;

4. Razširjanje:

4. likelihood of postrelease selection leading to the expression of unexpected and/or undesirable traits in the modified organism,

(a) načini in obseg (na primer ocena, kako možnost preživetja peloda in/ali semen pada z razdaljo) razširjanja

5. measures employed to ensure and to verify genetic stability. Description of genetic traits which may prevent or minimise dispersal of genetic material. Methods to verify genetic stability,

(b) specifični dejavniki, ki vplivajo na razširjanje, če obstajajo.

6. routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact, burrowing, etc.,

5. Zemljepisna razširjenost rastline.

7. description of ecosystems to which the GMOs could be disseminated,

6. V primeru, da rastlinska vrsta običajno ne rastej v državi(-ah) članici(-ah), opis naravnega habitata rastline, vključno z informacijami o naravnih plenilcih, zajedavcih, tekmecih in simbiontih.

8. potential for excessive population increase in the environment,

7. Drugo možno medsebojno vplivanje, ki je za GSO pomembno, je med rastlino in organizmi v ekosistemih, kjer navadno raste, ali drugje, vključno z informacijami o toksičnih učinkih pri ljudeh, živalih in drugih organizmih.

9. competitive advantage of the GMOs in relation to the unmodified recipient or parental organism(s),

C. INFORMACIJE V ZVEZI Z GENSKO SPREMEMBO

10. identification and description of the target organisms if applicable,

1. Opis uporabljenih metod genskega spreminjanja.

11. anticipated mechanism and result of interaction between the released GMOs and the target organism(s) if applicable,

2. Vrsta in vir uporabljenega vektorja.

12. identification and description of non-target organisms which may be adversely affected by the release of the GMO, and the anticipated mechanisms of any identified adverse interaction,

3. Velikost, vir (ime) organizma(-ov) dajalca(-ev) in predvidena funkcija vsakega sestavnega dela območja, namenjenega za vključitev.

13. likelihood of postrelease shifts in biological interactions or in host range,

D. INFORMACIJE V ZVEZI Z GENSKO SPREMENJENO RASTLINO

14. known or predicted interactions with non-target organisms in the environment, including competitors, preys, hosts, symbionts, predators, parasites and pathogens,

1. Opis značilnosti in lastnosti, ki so bile vnesene ali spremenjene.

15. known or predicted involvement in biogeochemical processes,

2. Informacije o dejansko vključenih/izbrisanih zaporedjih:

16. other potential interactions with the environment.

(a) velikost in struktura vključka ter metode, uporabljene za njegovo karakterizacijo, vključno z informacijami o katerih koli delih vektorja, vnesenih v GSVR, ali katerega koli nosilca ali tuje DNK, ki je ostala v GSVR;

V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS

(b) v primeru izbrisa velikost in funkcija izbrisane(-ih) regij(-e);

A. Monitoring techniques

1. methods for tracing the GMOs, and for monitoring their effects,

(d) lokacija(-e) vključka(-ov) v rastlinskih celicah (vezanega v kromosom, kloroplaste, mitohondrije ali ohranjenega v nevezani obliki) ter metode za njegovo določanje.

2. specificity (to identify the GMOs, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques,

3. Informacije o izražanju vključka:

3. techniques for detecting transfer of the donated genetic material to other organisms,

(a) informacije o izražanju vključka v razvoju med življenjskim ciklusom rastline in metode, uporabljene za njegovo karakterizacijo;

4. duration and frequency of the monitoring.

(b) deli rastline, kjer je vključek izražen (na primer korenine, steblo, pelod, itd.).

B. Control of the release

4. Informacije o tem, kako se gensko spremenjena rastlina razlikuje od prejemne rastline v:

1. methods and procedures to avoid and/or minimise the spread of the GMOs beyond the site of release or the designated area for use,

(a) načinu(-ih) in/ali hitrosti razmnoževanja;

2. methods and procedures to protect the site from intrusion by unauthorised individuals,

(b) razširjanju;

3. methods and procedures to prevent other organisms from entering the site.

C. Waste treatment

5. Genska stabilnost vključka in fenotipska stabilnost GSVR.

1. type of waste generated,

6. Kakršna koli sprememba sposobnosti GSVR za prenos genskega materiala v druge organizme.

2. expected amount of waste,

7. Informacije o katerih koli toksičnih, alergenih ali drugih škodljivih učinkih na zdravje ljudi, ki izhajajo iz genske spremembe.

3. description of treatment envisaged.

8. Informacije o varnosti GSVR za zdravje živali, še zlasti glede toksičnih, alergenih ali drugih škodljivih učinkov, ki izhajajo iz genske spremembe, kadar se GSVR namerava uporabljati v živalski krmi.

D. Emergency response plans

9. Mehanizmi medsebojnega učinkovanja gensko spremenjene rastline in ciljnih organizmov (če je primerno).

1. methods and procedures for controlling the GMOs in case of unexpected spread,

10. Možne spremembe v medsebojnem učinkovanju GSVR z neciljnimi organizmi, ki so posledica genske spremembe.

2. methods for decontamination of the areas affected, for example eradication of the GMOs,

11. Možno medsebojno učinkovanje z abiotskim okoljem.

3. methods for disposal or sanitation of plants, animals, soils, etc., that were exposed during or after the spread,

12. Opis tehnik odkrivanja in identifikacije gensko spremenjene rastline.

4. methods for the isolation of the area affected by the spread,

13. Informacije o prejšnjih sproščanjih gensko spremenjene rastline, če je primerno.

5 plans for protecting human health and the environment in case of the occurrence of an undesirable effect.

E. INFORMACIJE V ZVEZI Z MESTOM SPROŠČANJA (SAMO ZA PRIJAVE, PREDLOŽENE PO ČLENIH 6 IN 7)

1. Mesto in velikost mest(-a) sproščanja.

2. Opis ekosistema mesta sproščanja, vključno s podnebjem, rastlinstvom in živalstvom.

ANNEX III B

3. Prisotnost spolno združljivih prosto živečih sorodnikov ali gojenih vrst rastlin.

4. Neposredna bližina uradno priznanih biotopov ali zaščitenih območij, ki bi lahko bila prizadeta.

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE)

F. INFORMACIJE V ZVEZI S SPROŠČANJEM (SAMO ZA PRIJAVE, PREDLOŽENE PO ČLENIH 6 IN 7)

A. GENERAL INFORMATION

1. Namen sproščanja.

1. Name and address of the notifier (company or institute),

2. Predvideni datum(-i) in trajanje sproščanja.

2. Name, qualifications and experience of the responsible scientist(s),

3. Metoda, po kateri bo potekalo sproščanje gensko spremenjenih rastlin.

3. Title of the project,

4. Metoda za pripravo in upravljanje mesta sproščanja pred, med in po sproščanju, vključno s praksami gojenja in metodami spravila pridelka.

B. INFORMATION RELATING TO (A) THE RECIPIENT OR (B) (WHERE APPROPRIATE) PARENTAL PLANTS

5. Približno število rastlin (ali rastlin na m2).

1. Complete name:

G. INFORMACIJE O NADZORU, SPREMLJANJU, NAČRTIH ZA RAVNANJE PO SPROŠČANJU IN ZA RAVNANJE Z ODPADKI (SAMO ZA PRIJAVE PREDLOŽENE PO ČLENIH 6 IN 7)

(a) family name

1. Morebitni sprejeti previdnostni ukrepi:

(b) genus

(a) razdalja(-e) od spolno združljivih vrst rastlin, tako prosto živečih sorodnikov kot pridelkov

(b) morebitni ukrepi za zmanjšanje/preprečevanje razširjanja reprodukcijskega organa GSVR (na primer peloda, semen, gomoljev).

(d) subspecies

2. Opis metod ravnanja z mestom po sproščanju.

(e) cultivar/breeding line

3. Opis metod ravnanja po sproščanju za gensko spremenjeni rastlinski material vključno z odpadki.

(f) common name.

4. Opis načrtov in tehnik spremljanja.

2. (a) Information concerning reproduction:

5. Opis morebitnih načrtov ukrepov za primer nesreče.

(i) mode(s) of reproduction

6. Metode in postopki za zavarovanje mesta sproščanja.

(ii) specific factors affecting reproduction, if any

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(iii) generation time.

PRILOGA IV

(b) Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of the compatible species.

DODATNE INFORMACIJE

3. Survivability:

Ta priloga na splošno opisuje dodatne informacije, ki jih je treba zagotoviti v primeru prijave za dajanje v promet, in informacije o zahtevah označevanja glede GSO kot proizvodov ali v proizvodih, ki se nameravajo dati v promet, in GSO, izvzetih po členu 2(4), drugi pododstavek. Dopolnjena bo z navodili, med drugim glede opisa, kako se namerava uporabljati proizvod, ki bo pripravljena skladno s postopkom iz člena 30(2). Označevanje izvzetih organizmov, kot zahteva člen 26, se izpolni z zagotovitvijo ustreznih priporočil za uporabo in njeno omejitev:

(a) ability to form structures for survival or dormancy

A. Poleg informacij iz Priloge III se v prijavi za dajanje GSO kot proizvodov ali v proizvodih v promet zagotovijo naslednje informacije:

(b) specific factors affecting survivability, if any.

1. predlagana komercialna imena proizvodov in imena GSO, ki jih vsebuje, ter kakršnakoli posebna identifikacija, ime ali šifra, ki jih prijavitelj uporablja za identifikacijo GSO. Po odobritvi je treba pristojnemu organu sporočiti kakršna koli nova komercialna imena,

4. Dissemination:

2. ime in polni naslov osebe s sedežem v Skupnosti, odgovorne za dajanje v promet, ne glede na to ali je proizvajalec, uvoznik ali distributer,

(a) ways and extent (for example an estimation of how viable pollen and/or seeds declines with distance) of dissemination

3. ime in polni naslov dobavitelja(-ev) kontrolnih vzorcev,

(b) specific factors affecting dissemination, if any.

4. opis tega, kako se proizvod in GSO kot proizvod ali v proizvodu namerava uporabiti. Poudariti je treba razlike v uporabi ali ravnanju z GSO v primerjavi s podobnim, gensko nespremenjenim proizvodom,

5. Geographical distribution of the plant.

5. opis geografskega(-ih) območja(-ij) in vrste okolja, kjer se namerava uporabljati proizvod v Skupnosti, kjer je mogoče vključno z oceno obsega uporabe na vsakem območju,

6. In the case of plant species not normally grown in the Member State(s), description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

6. predvidene kategorije uporabnikov proizvoda, npr. industrija, kmetijstvo in strokovni poklici, široka potrošniška uporaba,

7. Other potential interactions, relevant to the GMO, of the plant with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

7. informacije o genski spremembi za namene vnosa v register ali več registrov za spremembe v organizmih, ki se lahko uporabljajo za odkrivanje in identifikacijo določenih proizvodov GSO za lažji nadzor in inšpekcijo po dajanju v promet. Če je primerno, naj se poleg teh informacij pri pristojnem organu predložijo vzorci GSO ali njegov genski material in podrobnosti o nukleotidnih zaporedjih ali druge vrste informacij, ki so potrebne za identifikacijo proizvoda GSO in njegovega potomca, na primer metodologija za odkrivanje in identifikacijo proizvoda GSO, vključno s poskusnimi podatki, ki kažejo specifičnost metodologije. Treba je določiti informacije, ki jih zaradi zaupnosti ni mogoče vnesti v javno dostopen del registra,

C. INFORMATION RELATING TO THE GENETIC MODIFICATION

8. predlagano označevanje na oznaki ali v spremljajočem dokumentu. To mora vključevati, vsaj v povzeti obliki, komercialno ime proizvoda, izjavo "Ta proizvod vsebuje gensko spremenjene organizme", ime GSO in informacije iz točke 2, označevanje pa mora navajati, kako priti do informacij v javno dostopnem delu registra.

1. Description of the methods used for the genetic modification.

B. Če je to primerno, se po členu 13 te direktive v prijavi poleg informacij iz točke A zagotovi še naslednje:

2. Nature and source of the vector used.

1. ukrepi, ki se sprejmejo v primeru nenamernega sproščanja ali zlorabe,

3. Size, source (name) of donor organism(s) and intended function of each constituent fragment of the region intended for insertion.

2. posebna navodila ali priporočila za hranjenje in rokovanje,

D. INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT

3. posebna navodila za izvajanje spremljanja in poročanja prijavitelju ter, če je zahtevano, pristojnemu organu, tako da je mogoče pristojne organe učinkovito obvestiti o kakršnih koli škodljivih učinkih. Ta navodila se morajo skladati s Prilogo VII, del C,

1. Description of the trait(s) and characteristics which have been introduced or modified.

4. predlagane omejitve v odobreni uporabi GSO, na primer, kje se sme proizvod uporabiti in za kakšne namene,

2. Information on the sequences actually inserted/deleted:

5. predlagana embalaža,

(a) size and structure of the insert and methods used for its characterisation, including information on any parts of the vector introduced in the GMHP or any carrier or foreign DNA remaining in the GMHP;

6. ocenjena proizvodnja in/ali uvoz v Skupnost,

(b) in case of deletion, size and function of the deleted region(s);

7. predlagano dodatno označevanje. To lahko vključuje, vsaj v povzeti obliki, informacije iz točk A 4, A 5, B 1, B 2, B 3 in B 4.

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(d) location(s) of the insert(s) in the plant cells (integrated in the chromosome, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its determination.

PRILOGA V

3. Information on the expression of the insert:

MERILA ZA UPORABO SPREMENJENIH POSTOPKOV (ČLEN 7)

(a) information on the developmental expression of the insert during the lifecycle of the plant and methods used for its characterisation;

Merila iz člena 7(1) so navedena v nadaljevanju.

(b) parts of the plant where the insert is expressed (for example roots, stem, pollen, etc.).

1. Dobro mora biti poznan taksonomski položaj in biologija (na primer, način razmnoževanja in opraševanja, sposobnost križanja s sorodnimi vrstami, patogenost) nespremenjenih (prejemnih) organizmov.

4. Information on how the genetically modified plant differs from the recipient plant in:

2. Dovolj dobro mora biti poznavanje glede varnosti za zdravje ljudi in okolje starševskih, če je to primerno, in prejemnih organizmov v okolju sproščanja.

(a) mode(s) and/or rate of reproduction;

3. Na voljo morajo biti informacije o kakršnem koli medsebojnem vplivanju, ki je posebej pomembno za oceno tveganja, vključno s starševskim, če je to primerno, in prejemnim organizmom ter drugimi organizmi v ekosistemu poskusnega sproščanja.

(b) dissemination;

4. Na voljo morajo biti informacije, ki dokazujejo, da je vneseni genski material dobro karakteriziran. Na voljo morajo biti informacije o konstrukciji kakršnih koli vektorskih sistemov ali zaporedij genskega materiala, uporabljenega z nosilno DNK. Kjer genska sprememba vključuje izbris genskega materiala, mora biti znan obseg izbrisa. Prav tako morajo biti na voljo zadostne informacije o genski spremembi, ki omogočajo identifikacijo GSO in njegovega potomca med sproščanjem.

5. GSO ne sme predstavljati dodatnih ali povečanih tveganj za zdravje ljudi ali okolje v pogojih poskusnega sproščanja, do katerih ne pride pri sproščanju ustreznih starševskih, če je to primerno, in prejemnih organizmov. Nobena sposobnost širjenja v okolje in zavzemanja drugih nesorodnih ekosistemov ter zmožnost prenosa genskega materiala na druge organizme v okolju ne sme povzročati škodljivih učinkov.

5. Genetic stability of the insert and phenotypic stability of the GMHP.

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6. Any change to the ability of the GMHP to transfer genetic material to other organisms.

PRILOGA VI

7. Information on any toxic, allergenic or other harmful effects on human health arising from the genetic modification.

NAVODILA ZA POROČILA O OCENI

8. Information on the safety of the GMHP to animal health, particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the GMHP is intended to be used in animal feedstuffs.

Poročilo o oceni, predvideno v členih 13, 17, 19 in 20, naj bi vključevalo predvsem naslednje:

9. Mechanism of interaction between the genetically modified plant and target organisms (if applicable).

1. Določitev značilnosti prejemnega organizma, pomembnih za oceno zadevnega(-ih) GSO. Določitev kakršnih koli poznanih tveganj za zdravje ljudi in okolje, ki izhajajo iz sproščanja prejemnega nespremenjenega organizma v okolje.

10. Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic modification.

2. Opis rezultata genske spremembe v spremenjenem organizmu.

11. Potential interactions with the abiotic environment.

3. Ocena, ali je bila genska sprememba dovolj karakterizirana za namene vrednotenja kakršnega koli tveganja za zdravje ljudi in okolje.

12. Description of detection and identification techniques for the genetically modified plant.

4. Določitev kakršnih koli novih tveganj za zdravje ljudi in okolje, ki lahko izhajajo iz sproščanja zadevnih GSO v primerjavi s sproščanjem ustreznega(-ih) nespremenjenega(-ih) organizma(-ov) na podlagi ocene tveganja za okolje, izdelane po Prilogi II.

13. Information about previous releases of the genetically modified plant, if applicable.

5. Zaključek, ali naj se zadevni GSO kot proizvod(-i) ali v proizvodu(-ih) da(-jo) v promet in pod kakšnimi pogoji, ali naj se zadevni GSO ne dajo v promet ali pa se zaprosi za mnenja drugih pristojnih organov ali Komisije o posebnih vprašanjih OTO. Te vidike je treba opredeliti. Zaključek mora jasno navajati predlagano uporabo, obvladovanje tveganja in predlagani načrt spremljanja. Če je sklenjeno, da se GSO ne smejo dati v promet, pristojni organ navede razloge za svoj zaključek.

E. INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7)

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1. Location and size of the release site(s).

PRILOGA VII

2. Description of the release site ecosystem, including climate, flora and fauna.

NAČRT SPREMLJANJA

3. Presence of sexually compatible wild relatives or cultivated plant species.

Ta priloga na splošno opisuje cilj, ki naj se doseže, in splošna načela, ki jim je treba slediti pri oblikovanju načrta spremljanja iz členov 13(2), 19(3) in 20. Dopolnjen bo z navodili, ki jih je treba pripraviti po postopku iz člena 30(2).

4. Proximity to officially recognised biotopes or protected areas which may be affected.

Ta navodila se dokončajo do 17. oktobra 2002.

F. INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7)

A. Cilj

1. Purpose of the release.

Cilj načrta spremljanja je:

2. Foreseen date(s) and duration of the release.

- potrditi, da so kakršna koli predvidevanja glede pojava in vpliva potencialno škodljivih učinkov GSO ali njegove uporabe v OTO pravilna, in

3. Method by which the genetically modified plants will be released.

- določiti pojav škodljivih učinkov GSO ali njegove uporabe na zdravje ljudi ali okolje, ki v OTO niso bili pričakovani.

4. Method for preparing and managing the release site, prior to, during and postrelease, including cultivation practices and harvesting methods.

B. Splošna načela

5. Approximate number of plants (or plants per m2).

Spremljanje iz členov 13, 19 in 20 se izvaja po odobritvi dajanja GSO v promet.

G. INFORMATION ON CONTROL, MONITORING, POSTRELEASE AND WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7)

Pri razlagi podatkov, zbranih s spremljanjem, je treba upoštevati druge obstoječe pogoje in dejavnosti v okolju. Če se opazijo spremembe v okolju, je treba upoštevati nadaljnjo oceno, da se ugotovi, ali so posledica GSO ali njegove uporabe, kajti take spremembe so lahko posledica okoljskih dejavnikov in ne dajanja GSO v promet.

1. Any precautions taken:

Izkušnje in podatki, pridobljeni s spremljanjem poskusnega sproščanja GSO, lahko pomagajo pri oblikovanju režima spremljanja po dajanju v promet, zahtevanega za dajanje GSO kot proizvodov ali v proizvodih v promet.

(a) distance(s) from sexually compatible plant species, both wild relatives and crops

C. Zasnova načrta spremljanja

(b) any measures to minimise/prevent dispersal of any reproductive organ of the GMHP (for example pollen, seeds, tuber).

Zasnova načrta spremljanja mora:

2. Description of methods for postrelease treatment of the site.

1. biti podrobno razčlenjena na podlagi vsakega posameznega primera ob upoštevanju OTO,

3. Description of postrelease treatment methods for the genetically modified plant material including wastes.

2. upoštevati značilnosti GSO, značilnosti in obseg njegove predvidene uporabe ter niz ustreznih okoljskih pogojev, v katerih se pričakuje sproščanje GSO,

4. Description of monitoring plans and techniques.

3. vključevati splošni nadzor glede nepričakovanih škodljivih učinkov in, če je treba, posebno spremljanje (glede na posamezen primer), ki se usmerja na škodljive učinke, določene v OTO:

5. Description of any emergency plans.

3.1. ker je treba opravljati spremljanje glede na posamezen primer v zadostnem časovnem obdobju, da bi odkrili takojšnje in neposredne pa tudi, če je primerno, z zakasnitvijo ali posredne učinke, ki so bili določeni v OTO,

6. Methods and procedures to protect the site.

3.2. ker bi se pri nadzoru lahko, če je primerno, uporabile že vzpostavljene prakse rutinskega nadzora, kot so spremljanje kmetijskih kultivarjev, varstva rastlin ali veterinarskih in medicinskih proizvodov. Pojasniti je treba, kako bodo ustrezne informacije, zbrane preko vzpostavljenih praks rutinskega nadzora, dane na voljo imetniku odobritve;

4. sistematsko olajšati opazovanje sproščanja GSO v prejemnem okolju in razlago teh opažanj glede na varnost za zdravje ljudi ali okolje,

5. določiti kdo (prijavitelj, uporabniki) bo izvajalec različnih nalog, ki jih zahteva načrt spremljanja, in kdo je odgovoren za zagotavljanje, da se načrt spremljanja primerno vzpostavi in izvaja, ter zagotoviti pot, po kateri se bo imetnika odobritve in pristojni organ obvestilo o morebitnih opaženih škodljivih učinkih na zdravje ljudi in okolje (Navesti je treba roke in časovne intervale za poročila o rezultatih spremljanja),

ANNEX IV

6. razmisliti o mehanizmih za identifikacijo in potrjevanje morebitnih opaženih škodljivih učinkov na zdravje ljudi in okolje ter omogočiti imetniku odobritve ali pristojnemu organu, kjer to ustreza, sprejem ukrepov, potrebnih za varstvo zdravja ljudi in okolja.

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ADDITIONAL INFORMATION

PRILOGA VIII

This Annex describes in general terms the additional information to be provided in the case of notification for placing on the market and information for labelling requirements regarding GMOs as or in product to be placed on the market, and GMO exempted under Article 2(4), second subparagraph. It will be supplemented by guidance notes, as regards i.a. the description of how the product is intended to be used, to be developed in accordance with the procedure laid down in Article 30(2). The labelling of exempted organisms as required by Article 26 shall be met by providing appropriate recommendations for, and restrictions on, use:

KORELACIJSKA TABELA

A. The following information shall be provided in the notification for placing on the market of GMOs as or in product in addition to that of Annex III:

Direktiva 90/220/EGS | Ta direktiva |

1. proposed commercial names of the products and names of GMOs contained therein, and any specific identification, name or code used by the notifier to identify the GMO. After the consent any new commercial names should be provided to the competent authority,

Člen 1(1) | Člen 1 |

2. name and full address of the person established in the Community who is responsible for the placing on the market, whether it be the manufacturer, the importer or the distributor,

Člen 1(2) | Člen 3(2) |

3. name and full address of the supplier(s) of control samples,

Člen 2 | Člen 2 |

4. description of how the product and the GMO as or in product are intended to be used. Differences in use or management of the GMO compared to similar non-genetically modified products should be highlighted,

Člen 3 | Člen 3(1) |

5. description of the geographical area(s) and types of environment where the product is intended to be used within the Community, including, where possible, estimated scale of use in each area,

Člen 4 | Člen 4 |

6. intended categories of users of the product e.g. industry, agriculture and skilled trades, consumer use by public at large,

— | Člen 5 |

7. information on the genetic modification for the purposes of placing on one or several registers modifications in organisms, which can be used for the detection and identification of particular GMO products to facilitate post-marketing control and inspection. This information should include where appropriate the lodging of samples of the GMO or its genetic material, with the competent authority and details of nucleotide sequences or other type of information which is necessary to identify the GMO product and its progeny, for example the methodology for detecting and identifying the GMO product, including experimental data demonstrating the specificity of the methodology. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the register should be identified,

Člen 5 | Člen 6 |

8. proposed labelling on a label or in an accompanying document. This must include, at least in summarised form, a commercial name of the product, a statement that "This product contains genetically modified organisms", the name of the GMO and the information referred to in point 2, the labelling should indicate how to access the information in the publicly accessible part of the register.

Člen 6(1) do (4)} |

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