CELEX: 52002PC0362
Language: en
Date: 2002-07-04
Title: Proposal for a Council Decision establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products

Avis juridique important

|

52002PC0362

Proposal for a Council Decision establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products  /* COM/2002/0362 final */  

Official Journal 262 E , 29/10/2002 P. 0360 - 0389

Proposal for a COUNCIL DECISION establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in productsEXPLANATORY MEMORANDUM1. Under Part C of Directive 2001/18/EC, prior notification must be given to the competent national authority of the planned placing on the market of a genetically modified organism (GMO), or a combination of such organisms.2. That notification comprises, inter alia, a summary of the relevant dossier, which the competent authority must send to the competent authorities of the other Member States and to the Commission, and which the Commission must immediately make available to the public. That summary must be drawn up in accordance with a particular format.3. That format should reflect the need to enable the fullest possible exchange of relevant information, presented in a standardised and easily comprehensible manner, without prejudice to the fact that the information thus provided cannot serve as the basis for an environmental risk assessment.4. Article 13(2)(h) of the Directive stipulates that the summary notification information format must be drawn up in accordance with the procedure laid down in Article 30. A draft of the measures to be taken has accordingly been submitted for opinion to the committee set up under Article 30 of the Directive.5. The committee has not delivered an opinion on the proposal. In such a case, Article 30 stipulates that the Commission must forthwith propose to the Council the measures to be adopted and inform the European Parliament thereof. The Council must then act by qualified majority.6. If, by the expiry of the time limit, the Council has not adopted the proposed implementing measures or has not indicated its opposition to the proposed implementing measures, they shall be adopted by the Commission.Proposal for a COUNCIL DECISION establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in productsTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community,Having regard to Directive 2001/18/EC of the European Parliament and of the Council [1] of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EEC, and in particular Article 13(2)(h) thereof,[1]  OJ L 106, 17. 4. 2001, p. 1.Having regard to the proposal from the Commission,Whereas:(1) Under Part C of Directive 2001/18/EC, prior notification must be given to the competent national authority of the planned placing on the market of a genetically modified organism (GMO), or a combination of such organisms.(2) That notification comprises, inter alia, a summary of the relevant dossier, which the competent authority must send to the competent authorities of the other Member States and to the Commission, and which the Commission must immediately make available to the public. That summary must be drawn up in accordance with a particular format.(3) That format should reflect the need to enable the fullest possible exchange of relevant information, presented in a standardised and easily comprehensible manner, without prejudice to the fact that the information thus provided cannot serve as the basis for an environmental risk assessment.(4) The committee set up under Article 30(2) of Directive 2001/18/EC was consulted on 12 June 2002 and has not delivered an opinion on the Commission's proposal for a Decision,HAS ADOPTED THIS DECISION:Article 1For the purposes of drawing up the summary of the dossier for submission to the competent national authority pursuant to Article 13(2)(h) of Directive 2001/18/EC, the notifier shall use the Summary Information Format set out in the Annex to this Decision.Article 2This Decision is addressed to the Member States.Done at Brussels, [...]For the CouncilThe President[...]ANNEXSUMMARY INFORMATION FORMAT IN RELATION TO THE PLACING ON THE MARKET OF A GMO OR A COMBINATION OF GMOs AS OR IN PRODUCTSINTRODUCTIONThe following format must be used for the summary of the dossier to accompany a notification, for submission to the competent national authority, concerning the placing on the market of a GMO or a combination of GMOs as or in products.This document, when completed, will present a summary of the information entered under the corresponding points of the full dossier. It is recognized, therefore, that the risk assessment required under Directive 2001/18/EC cannot be carried out solely on the basis of this document.The space provided after each question is not indicative of the depth of the information required for the purposes of the Summary Information Format.The Summary Information Formatis divided into Parts 1 and 2.Part 1 applies to products consisting of or containing genetically modified organisms other than higher plants and contains the following sections:A General InformationB Nature of the GMOs contained in the productC Predicted behaviour of the productD Information relating to previous releasesE Information relating to the monitoring planPart 2 applies to products consisting of or containing genetically modified higher plants. The term "higher plants" means plants which belong to the taxonomic group Gymnospermae and Angiospermae. Part 2 contains the following sections:A General InformationB Nature of the GMHP contained in the productC Information relating to previous releasesD Information relating to the monitoring planPART 1SUMMARY INFORMATION FORMAT FOR PRODUCTS CONTAINING GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTSA. GENERAL INFORMATION1. Details of notificationa) Member State of notificationb) Notification numberc) Name of the product (commercial and other names)d) Date of acknowledgement of notification2. Notifier/Producer/Importera) Name of notifierb) Address of notifierc) The notifier is : domestic producer | |  importer | |d) In the case of an import(i) Name of producer(ii) Address of producer3. Characterisation of the GMOs contained in the productIndicate the name and nature of each type of GMO contained in the product4. General description of the producta) Type of productb) Composition of the productc) Specificity of the productd) Types of userse) Any special conditions of use and handling suggested as a condition of the authorisation applied forf) If applicable, geographical areas within the EU to which the product is intended to be confined under the terms of the authorisation applied forg) Any type of environment to which the product is unsuitedh) Estimated potential annual demand(i) in the Community(ii) in export markets fo EC suppliesi) Unique identification code(s) of the GMO(s)5. Has the combination of GMOs contained in the product been notified under Part B of Directive 2001/18/EC by the same notifier-Yes | |  //  No | |(i) If yes, give country and notification number(ii) If no, refer to risk analysis data on the basis of the elements of Part B of Directive 2001/18/EC.6. Is the product being simultaneously notified to another Member State by the same notifier -Yes | |  //  No | |If yes, please specify:7. Has another product with the same combination of GMOs been placed on the EC market by another notifier -&gt;TABLE POSITION&gt;8. Information on releases of the same GMOs or of the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or outside the Community9. Specify instructions and or recommendations for storage and handling, including any mandatory restrictions proposed as a condition of the authorisation applied for10. Proposed packaging11. Any proposed labelling requirements, in addition to those required by law12. Measures to take in the event of unintended release or misuse13. Measures for waste disposal and treatment (if applicable)B. NATURE OF THE GMOS CONTAINED IN THE PRODUCTINFORMATION RELATING TO THE RECIPIENT OR PARENTAL ORGANISM(S) FROM WHICH THE GMO IS DERIVED14. Scientific name and common names15. Phenotypic and genetic traits16. Geographical distribution and natural habitat of the organism17. Genetic stability of the organism and factors affecting it18. Potential for genetic transfer and exchange with other organisms and the likely  consequences of gene transfer19. Information concerning reproduction and factors affecting it20. Information on survival and factors affecting it21. Ways of dissemination and factors affecting it22. Interactions with the environment23. a) Detection techniques23. b) Identification techniques24. Classification under existing Community rules concerning the protection of human health and/or environment25. a) Pathogenic characteristics25. b) Other harmful characteristics of the organisms living or dead, including its extracellular products26. Nature and description of known extrachromosomal genetic elements27. Summary of known history of previous genetic modificationsINFORMATION RELATING TO THE GENETIC MODIFICATION28. Methods used for the genetic modification29. Characteristics of the vectora) Nature and source of the vectorb) Description of the vector constructionc) Genetic map and/or restriction map of the vectord) Sequence datae) Information on the degree to which the vector contains sequences whose product or function area is not knownf) Genetic transfer capabilities of the vectorg) Frequency of mobilization of the vectorh) Part of the vector which remains in the GMO30. Information on the inserta) Methods used to construct the insertb) Restriction sitesc) Sequence of the insertd) Origin and function of each constituent part of the insert in the GMOe) Information on the degree to which the insert is limited to the required functionf) Location of the insert in the GMOINFORMATION ON THE ORGANISM(S) FROM WHICH THE INSERT IS DERIVED (DONOR)31. Scientific and other names32. a) Pathogenic characteristics of the donor organism32. b) Other harmful characteristics of the organism living or dead, including its extracellular products33. If the donor organism has any pathogenic or harmful characteristics, indicate whether the donated sequences are in any way involved in them34. Classification under existing Community rules relating to the protection of human health and the environment35. Potential for natural exchange of genetic material between the donor(s) and recipient organismINFORMATION RELATING TO THE GMO(S) CONTAINED IN THE PRODUCT36. Description of genetic traits or phenotypic characteristics, if different from that of the recipient or parental organism(s)37. Genetic stability of the GMO, if different from that of the recipient or parental organism(s)38. Rate and level of expression of the new genetic material39. Activity of the expressed proteins40. a) Description of detection techniques for the GMO in the environment, if different from that of the recipient or parental organism(s)40. b) Description of identification techniques to distinguish the GMO from the recipient or parental organism41. Health considerationsa) Toxic or allergenic effects of the non-viable GMOs and/or their metabolic products, if significantly different from those of the recipient/parental organismb) Product hazards, if significantc) Comparison of the GMO with the donor, recipient or parental organism regarding pathogenicity, if significantly differentd) Capacity for colonization, if significantly different from the recipient or parental organism(s)e) If the organism is more pathogenic than the recipient or parental organism(s) to humans who are immuno competent, supply the information specified in Annex III A, Part II C 2(I) (iv)INTERACTIONS OF THE GMO WITH THE ENVIRONMENT42. Survival, multiplication and dissemination of the GMO(s) in the environment if different from the recipient or parental organism43. Environmental impacts of the GMOS(s) if different from the recipient or parental organismC. PREDICTED BEHAVIOUR OF THE PRODUCT, IF DIFFERENT FROM THE RECIPIENT OR PARENT ORGANISM(S)ENVIRONMENTAL IMPACT OF THE PRODUCTHUMAN HEALTH EFFECTS OF THE PRODUCT, IF DIFFERENT FROM THE RECIPIENT OR PARENT ORGANISM(S)D. INFORMATION RELATING TO PREVIOUS RELEASESHISTORY OF PREVIOUS RELEASES NOTIFIED UNDER PART B OF THE DIRECTIVE (IF APPLICABLE)1. Notification number2. Release site3. Aim of the release4. Duration of the release5. Duration of post-release monitoring6. Aim of post-release monitoring7. Conclusions of post-release monitoring8. Results of the release with respect to any risk to human heath and the environment according to Article 8 of Directive 90/220/EEC or Article 10 of Directive 2001/18/ECHISTORY OF PREVIOUS RELEASES CARRIED OUT INSIDE OR OUTSIDE THE COMMUNITY1. Release country2. Authority overseeing the release3. Release site4. Aim of the release5. Duration of post-release monitoring6. Aim of post-release monitoring7. Conclusions of post-release monitoring8. Results of the release with respect to any risk to human health and the environmentHISTORY OF PREVIOUS WORK RELEVANT TO RISK ASSESSMENT PRIOR TO COMMERCIALISATIONE. Information relating to the monitoring plan - identified traits, characteristics and uncertainties related to the GMO or its interaction with the environment that should be addressed in the post commercialisation monitoring planPART 2SUMMARY INFORMATION FORMAT FOR PRODUCTS CONTAINING GENETICALLY MODIFIED HIGHER PLANTS (GMHPs)A. GENERAL INFORMATION1. Details of notificationa) Member State of notificationb) Notification numberc) Name of the product (commercial and other names)d) Date of acknowledgement of notification2. Notifiera) Name of notifierb) Address of notifierc) Is the notifier domestic manufacturer ( importer (d) In the case of an import the name and address of the manufacturer shall be given3. General description of the producta) Name of the recipient or parental plant and the intended function of the genetic modificationb) Any specific form in which the product must not be placed on the market (seeds, cut-flowers, vegetative parts, etc.) as a proposed condition of the authorisation applied forc) Intended use of the product and types of usersd) Any specific instructions and/or recommendations for use, storage and handling, including mandatory restrictions proposed as a condition of the authorisation applied fore) If applicable, geographical areas within the EU to which the product is intended to be confined under the terms of the authorisation applied forf) Any type of environment to which the product is unsuitedg) Any proposed packaging requirementsh) Any proposed labelling requirements in addition to those required by lawi) Estimated potential demand(i) in the Community(ii) in export markets for EC suppliesj) Unique identification code(s) of the GMO(s)4. Has the GMHP referred to in this product been notified under Part B of Directive 2001/18/EC and/or Directive 90/220/EEC-Yes | |  //  No | |(i) If no, refer to risk analysis data on the basis of the elements of Part B of Directive 2001/18/EC5. Is the product being simultaneously notified to another Member State -Yes | |  //  No | |(i) If no, refer to risk analysis data on the basis of the elements of Part B of Directive 2001/18/ECOrHas the product been notified in a third country either previously or simultaneously-Yes | |  //  No | |If yes, please specify6. Has the same GMHP been previously notified for marketing in the Community-Yes | |  //  No | |If yes, give notification number and Member State7. Measures to take in case of unintended release or misuse as well as measures for disposal and treatmentB. NATURE OF THE GMHP CONTAINED IN THE PRODUCTINFORMATION RELATING TO THE RECIPIENT OR (WHERE APPROPRIATE) PARENTAL PLANTS8. Complete namea) Family nameb) Genusc) Speciesd) Subspeciese) Cultivar/breeding linef) Common name9. a) Information concerning reproduction(i) Mode(s) of reproduction(ii) Specific factors affecting reproduction, if any(iii) Generation time9. b) Sexual compatibility with other cultivated or wild plant species10. Survivabilitya) Ability to form structures for survival or dormancyb) Specific factors affecting survivability, if any11. Disseminationa) Ways and extent of disseminationb) Specific factors affecting dissemination, if any12. Geographical distribution of the plant13. 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 symbionts14. Potentially significant interactions of the plant with other organisms in the ecosystem where it is usually grown, including information on toxic effects on humans, animals and other organisms15. Phenotypic and genetic traitsINFORMATION RELATING TO THE GENETIC MODIFICATION16. Description of the methods used for the genetic modification17. Nature and source of the vector used18. Size, source [name of donor organism(s)] and intended function of each constituent fragment of the region intended for insertionINFORMATION RELATING TO THE GMHP19. Description of the trait(s) and characteristics which have been introduced or modified20. Information on the sequences actually inserted/deleted/modifieda) 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 GMHPb) In case of deletion, size and function of the deleted region(s)c) Location of the insert in the plant cells (integrated in the chromosome, chloroplast, mitochondrion, or maintained in a non-integrated form), and methods for its determinationd) Copy number and genetic stability of the inserte) In case of modifications other than insertion or deletion, describe function of the modified genetic material before and after the modification as well as direct changes in expression of genes as a result of the modification21. Information on the expression of the inserta) Information on the expression of the insert and methods used for its characterisationb) Parts of the plant where the insert is expressed (e.g. roots, stem, pollen, etc.)22. Information on how the GMHP differs from the recipient plant ina) Mode(s) and/or rate of reproductionb) Disseminationc) Survivabilityd) Other differences23. Potential for transfer of genetic material from the GMHP to other organisms24. Information on any harmful effects on human health and the environment, arising from the genetic modification25. Information on the safety of the GMHP to animal health, where the GMHP is intended to be used in animal feedstuffs, if different from that of the recipient/parental organism(s)26. Mechanism of interaction between the GMHP and target organisms (if applicable) , if different from that of the recipient/parental organism(s)27. Potentially significant interactions with non-target organisms, if different from the recipient or parental organism(s)28. Description of detection and identification techniques for the GMHP, to distinguish it from the recipient or parental organism(s)INFORMATION ON THE POTENTIAL ENVIRONMENTAL IMPACT FROM THE RELEASE OF THE GMHP29. Potential environmental impact from the release or the placing on the market of GMOs (Annex II, D2 of Directive 2001/18/EC), if different from a similar release or placing on the market of the recipient or parental organism(s)30. Potential environmental impact of the interaction between the GMHP and target organisms (if applicable), if different from that of the recipient or parental organism(s)31. Possible environmental impact resulting from potential interactions with non-target organisms, if different from that of the recipient or parental organism(s)a) Effects on biodiversity in the area of cultivationb) Effects on biodiversity in other habitatsc) Effects on pollinatorsd) Effects on endangered speciesC. INFORMATION RELATING TO PREVIOUS RELEASES32. History of previous releases notified under Part B of the Directive 2001/18/EC  and under Part B of Directive 90/220/EEC by the same notifiera) Notification numberb) Conclusions of post-release monitoringc) Results of the release in respect to any risk to human health and the environment (submitted to the Competent Authority according to Article 10 of Directive 2001/18/EC)33. History of previous releases carried out inside or outside the Community by the same notifiera) Release countryb) Authority overseeing the releasec) Release sited) Aim of the releasee) Duration of the releasef) Aim of post-releases monitoringg) Duration of post-releases monitoringh) Conclusions of post-release monitoringi) Results of the release in respect to any risk to human health and the environmentE Information relating to the monitoring plan - identified traits, characteristics and uncertainties related to the GMO or its interaction with the environment that should be addressed in the post commercialisation monitoring plan