title: COMMON POSITION (EC) No 7/98 adopted by the Council on 16 December 1997 with a view to adopting Council Directive 98/.../EC amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms

eurovoc_concepts:
bio-industry
genetic engineering
genetically modified organism
occupational safety
preparation for market
public health

text: 26. 2. 98 EN Official Journal of the European Communities C 62/1 I (Information) COUNCIL COMMON POSITION (EC) No 7/98 adopted by the Council on 16 December 1997 with a view to adopting Council Directive 98/. /EC amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (98/C 62/01) THE COUNCIL OF THE EUROPEAN UNION, should be in line with international practice and based on an assessment of the risk; Having regard to the Treaty establishing the European Community, and in particular Article 103s(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), (1) Whereas, within the meaning of the Treaty, action by the Community relating to the environment should be based on the principle that preventive action is to be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health; (2) Whereas contained uses of genetically modified micro-organisms (GMMs) should be classified in relation on the risks they present for human health and the environment; whereas such classification (1) OJ C 356, 22. 11. 1997, p. 14. (2) OJ C 295, 7. 10. 1996, p. 52. (3) Opinion of the European Parliament of 12 March 1997 (OJ C 115, 14. 4. 1997, p. 59), Council Common Position of 16 December 1997 and Decision of the European Parliament of. (not yet published in the Official Journal). (3) Whereas level of in order to ensure a high protection the containment and other protective measures applied to a contained use must correspond to the classification of the contained use; whereas in case of uncertainty the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data; (4) Whereas appropriate measures should be adopted and used for the control of the disposal of material from contained uses of GMMs; (5) Whereas GMMs which are disposed of without appropriate provisions for specific containment measures to limit their contact with the general population and the environment do not fall within the present Directive; other the Community legislation such as Council Directive 90/220/EEC of 23 April 1990 on the deliberate release the environment of genetically modified organisms (4) may apply; scope of into (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). C 62/2 EN Official Journal of the European Communities 26. 2. 98 (6) Whereas exemptions pursuant to this Directive do not entail exemptions pursuant to any other Community legislation that may apply, such as Directive 90/220/EEC; (7) Whereas for all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in relevant Community legislation; accordance with (14) Whereas there is now considerable experience and the the risks associated with knowledge of contained use of GMMs; (15) Whereas Directive 90/219/EEC should therefore be amended accordingly, (8) Whereas the containment and other protective measures applied to contained uses should be reviewed periodically; Article 1 HAS ADOPTED THIS DIRECTIVE: (9) Whereas people employed in contained uses should be consulted in accordance with the requirements of relevant Community legislation, in particular Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (1); (10) Whereas weaknesses have been in Directive the notification administrative requirements should be linked to the risk of the contained uses; 90/219/EEC (2); procedures identified whereas and (11) Whereas Directive 90/219/EEC did not permit sufficient adaptation to technical progress; whereas the technical parts of that Directive need to be adapted to technical progress; (12) Whereas the of Directive implementation 90/219/EEC could benefit from the addition of a list of GMMs that are safe for human health and the environment; whereas these GMMs should meet certain criteria in order to establish their safety; Directive 90/219/EEC is hereby amended as follows: 1. Articles 2 to 16 shall be replaced by the following: ‘Article 2 For the purposes of this Directive: (a) “micro-organism” shall mean any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture; (b) “genetically modified micro-organism” (GMM) shall mean a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Within the terms of this definition: (i) genetic modification occurs at least through the use of the techniques listed in Annex I, Part A; (ii) the techniques listed in Annex I, Part B, are genetic to considered result in not modification; (13) Whereas, to take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of this list, it is appropriate for the Council to define and revise these criteria; such GMMs are (c) “contained use” shall mean any activity in which micro-organisms are genetically modified or in which stored, transported, destroyed, disposed of, or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment; cultured, (1) OJ L 374, 31. 12. 1990, p. 1. Directive as last amended by Commission Directive 97/59/EC (OJ L 282, 15. 10. 1997, p. 33). (2) OJ L 117, 8. 5. 1990, p. 1. Directive as amended by Commission Directive 94/51/EC (OJ L 297, 18. 11. 1994, p. 29). (d) “accident” shall mean any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment; 26. 2. 98 EN Official Journal of the European Communities C 62/3 (e) “user” shall mean any natural or legal person responsible for the contained use of GMMs; (f) “notification” shall mean the presentation of the requisite information to the competent authorities of a Member State. 2. To this end the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that these contained uses may incur, using as a minimum the elements of assessment and the procedure set out in Annex III, sections A and B. Article 3 Without prejudice to Article 5(1) this Directive shall not apply: — where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A, or — for contained uses involving only types of GMMs meeting the criteria listed in Annex II Part B which establish their safety to human health and the environment. These types of GMMs shall be listed in Annex II, Part C. Article 4 Articles 5(3), 5(6) and Articles 6 to 12 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air. This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*) or pursuant to other Community legislation, which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market. (*) 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). Article 5 3. The assessment referred to in paragraph 2 shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with Article 6: Class 1: Class 2: Class 3: activities of no or negligible risk, that is to say activities for which level 1 containment is appropriate to protect human health the environment. as well as activities of low risk, that is to say activities for which level 2 containment is appropriate to protect human health as well as the environment. activities of moderate risk, that is to say activities level 3 containment is appropriate to protect human health the environment. for which as well as Class 4: activities of high risk, that is to say activities for which level 4 containment is appropriate to protect human health as well as the environment. is doubt as to which class 4. Where there is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless sufficient evidence, in agreement with the competent authority, justifies the application of less stringent measures. 5. The assessment referred to in paragraph (2) shall especially take into account the question of disposal. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment. 1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs. in 6. A record of the assessment referred to paragraph (2) shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 7, 9 and 10 or on request. C 62/4 EN Official Journal of the European Communities 26. 2. 98 Article 6 1. The user shall apply, except to the extent that paragraph 2 of Annex IV allows other measures to be applied, the general principles and the appropriate containment and other protective measures set out in Annex IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured. 2. The assessment referred to in Article 5(2) and the containment and other protective measures applied shall be reviewed periodically, and forthwith if: (a) the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct, or (b) there is reason to suspect that the assessment is no longer adequate as judged in the light of new scientific or technical knowledge. Article 7 When premises are to be used for the first time for contained uses, the user shall be required to submit to the competent authorities, before commencing such use, a notification containing at least the information listed in Annex V, Part A. 3. If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of in the notification paragraph 1, or earlier with the agreement of the competent authority. referred to Article 10 1. For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part C shall be submitted. 2. A class 3 or higher class of contained use may not proceed without the prior written consent of the competent authority: (a) at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed, (b) at the latest 90 days after submission of the notification, in other cases. Article 8 Article 11 Following the notification referred to in Article 7, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep the record of each assessment referred to in Article 5(6), which shall be made available to the competent authority on request. Article 9 1. For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part B shall be submitted. 2. If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. associated and any 1. Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Articles 7, 9 and 10. information given, 2. The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the the assessment referred to in Article 5(2) and the class of contained uses and, where appropriate, the adequacy of the containment and other protective measures, the response and waste management, measures. the correctness of emergency 3. If necessary, the competent authority may: (a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the 26. 2. 98 EN Official Journal of the European Communities C 62/5 contained use(s). In this case the competent authority may require that the contained use, if proposed, does not begin, or, if in progress, is suspended or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use; (b) limit the time for which the contained use should be permitted or subject it to certain specific conditions. 4. For the purpose of calculating the periods referred to in Articles 9 and 10, any period of time during which the competent authority: — is awaiting any further information which it may have requested from the notifier in accordance with paragraph 3(a), or — is carrying out a public inquiry or consultation in accordance with Article 13 shall not be taken into account. Article 12 the user becomes aware of If relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 7, 9 and 10 shall be modified. If information subsequently becomes available to the competent authority which could have significant consequences for the risks by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate, the contained use. Article 13 Where a Member State considers it appropriate, it may provide that the public shall be consulted on aspects of the proposed contained use, without prejudice to Article 19. Article 14 The competent authorities shall ensure that before a contained use commences: (a) an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other Community legislation; (b) information on such emergency plans is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available. to be affected by The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same information as that which is disseminated to their nationals. Article 15 1. Member States shall take the necessary measures to ensure that, in the event of an accident, the user immediately shall be the required competent authority specified in Article 11 and provide the following information: inform to — the circumstances of the accident, — the identity and quantities of the GMMs concerned, — any information necessary to assess the effects of the general the health of the accident on population and the environment, — the measures taken. 2. Where information is given pursuant to paragraph 1, the Member States shall be required to: — ensure that any measures necessary are taken, and alert immediately any Member States which could be affected by the accident, — collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof. Article 16 1. Member States shall be required to: (a) consult with other Member States, likely to be affected in the event of an accident, on the proposed implementation of emergency plans; C 62/6 EN Official Journal of the European Communities 26. 2. 98 (b) inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances of the accident, the identity and quantities of the GMMs concerned, their the effectiveness and an analysis of the accident, including recommendations to limit its effects and avoid similar accidents in the future. response measures taken and in consultation with 2. The Commission, the Member States, shall establish a procedure for the exchange of information pursuant to paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future. ’ to information on the environment (***), the notifier may indicate the information in the notifications submitted pursuant to this Directive that should be treated as confidential. Verifiable justification must be given in such cases. 2. The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision. In no case may the following information, when 3. submitted according to Articles 7, 9 or 10, be kept confidential: — the general characteristics of the GMMs, name and address of the notifier, and location of use, 2. Articles 18, 19 and 20 shall be replaced by the — class of contained use and measures of following: ‘Article 18 1. Member States shall send to the Commission, at the end of each year, a summary report on class 3 and class 4 contained uses notified during that year pursuant to Article 10 including the description, purpose and risks of the contained use(s). 2. Every three years, Member States shall send the Commission a summary report on their experience with this Directive, the first time being on. (*). containment, — the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment. 4. The Commission and the competent authorities shall not divulge to third parties any information decided to be confidential according to paragraph 2 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received. If, for whatever reasons, the notifier withdraws 5. the notification, the competent authority must respect the confidentiality of the information supplied. 3. Every three years, the Commission shall publish a in the reports referred summary based on paragraph 2, the first time being on. (**). to (***) OJ L 158, 23. 6. 1990, p. 56. 4. The Commission may publish general statistical information on the implementation of this Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user. (*) 54 months after the entry into force of this Directive. (**) 66 months after the entry into force of this Directive. Article 20 Amendments necessary to adapt Annex II, Part A, and Annexes III to V to technical progress and to in adapt Annex accordance with the procedure laid down in Article 21. ’ II, Part C, shall be decided 3. The following Article shall be inserted: Article 19 ‘Article 20a 1. Where its disclosure affects one or more of the items mentioned in Article 3(2) of Council Directive 90/313/EEC of 7 June 1990 on the freedom of access Before the. (*) Annex II, Part B, listing the criteria for inclusion of types of GMMs into Annex II, Part 26. 2. 98 EN Official Journal of the European Communities C 62/7 C, shall be adopted by the Council acting by qualified majority on a proposal from the Commission. Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority on a proposal from the Commission. (*) 24 months after the entry into force of this Directive. ’ 4. The Annexes are replaced by the Annexes shown in the Annex hereto. official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive enters into force on the day of its publication in the Official Journal of the European Communities. Article 2 Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 18 months after the date of its entry into force. They shall forthwith inform the Commission thereof. This Directive is addressed to the Member States. Done at. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their For the Council The President C 62/8 EN Official Journal of the European Communities 26. 2. 98 ANNEX ‘ANNEX I PART A Techniques of genetic modification referred to in Article 2(b)(i) are, inter alia: 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. 2. Techniques involving the direct introduction into a micro-organism of heritable material prepared outside the micro-organism including micro-injection, macro-injection and micro-encapsulation. 3. Cell 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. PART B Techniques referred to in Article 2(b)(ii) which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs made by techniques/methods other than techniques/methods excluded by Annex II, PART A: (1) in vitro fertilisation; (2) natural processes such as: conjugation, transduction, transformation; (3) polyploidy induction. 26. 2. 98 EN Official Journal of the European Communities C 62/9 ANNEX II PART A Techniques or methods of genetic modification yielding micro-organisms to be excluded from the Directive on the condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs other than those produced by one or more of the techniques/methods listed below: 1. Mutagenesis. 2. Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes. 3. Cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions. 4. Self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants. Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms. PART B Criteria establishing the safety of GMMs to human health and the environment:. (to be completed in accordance with the procedures in Article 20a) PART C Types of GMMs which meet the criteria listed in Part B:. (to be completed in accordance with the procedure in Article 21) C 62/10 EN Official Journal of the European Communities 26. 2. 98 ANNEX III PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 5(2) This Annex describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Article 5(2). It will be supplemented, as regards in particular section B, by guidance notes to be developed by the Commission in accordance with the procedure set out in Article 21. These guidance notes shall be completed no later than the. (*). A. ELEMENTS OF ASSESSMENT 1. The following should be considered as potentially harmful effects: — disease to humans including allergenic or toxic effects, — disease to animals or plants, — adverse effects resulting from the inability to treat disease or offer effective prophylaxis, — adverse effects resulting from establishment or dissemination in the environment, — adverse effects resulting from the natural transfer of inserted genetic material to other organisms. 2. The assessment referred to in Article 5(2) should be based on the following: (a) the identification of any potentially harmful effects, in particular those associated with: (i) the recipient micro-organism; (ii) the inserted (donated) genetic material; (iii) the vector; (iv) the donor micro-organism (as long as the donor micro-organism is used during the operation); (v) the resulting GMM; (b) the characteristics of the activity; (c) the severity of the potentially harmful effects; (d) the likelihood of the potentially harmful effects being realised. B. PROCEDURE 3. The first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, any harmful properties associated with the vector or inserted material, including any alteration in the recipient’s existing properties. 4. In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Article 5: (i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants (1); (*) 18 months after the entry into force of the Directive. (1) This would only apply to animals and plants in the environment likely to be exposed. 26. 2. 98 EN Official Journal of the European Communities C 62/11 (ii) the nature of the vector and the insert is such that they do not endow the GMM with a phenotype likely to cause disease to humans, animals or plans (1), or likely to cause adverse effects in the environment; (iii) the GMM is unlikely to cause disease to humans, animals or plants (1) and is unlikely to have adverse effects on the environment. 5. In order to be informed on this process the user may firstly take into account relevant Community legislation (for example Council Directive 90/679/EEC (2) and classification schemes referring to plant and animal pathogens) and other international and national classification schemes. These schemes concern natural micro-organisms and as such are usually based on the ability of micro-organisms to cause disease to humans, animals or plants and on the severity and transmissibility of the disease likely to be caused. 6. The hazard identification process carried out in accordance with paragraphs 3 to 5, should lead to the identification of the level of risk associated with the GMM. 7. Selection of the containment and other protective measures should then be made on the basis of the level or risk associated with the GMMs together with consideration of: (i) the characteristics of the environment likely to be exposed (e. g. whether in the environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro-organisms used in the contained use activity); (ii) the characteristics of the activity (e. g. its scale; nature); (iii) any non-standard operations (e. g. the inoculation of animals with GMMs; equipment likely to generate aerosols). Consideration of items (i) to (iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the GMM as identified under paragraph 6. 8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 5(3). 9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Article 5(2). (1) This would only apply to animals and plants in the environment likely to be exposed. (2) OJ L 374, 31. 12. 1990, p. 1. Directive as last amended by Commission Directive 97/59/EC (OJ L 282, 15. 10. 1997, p. 33). C 62/12 EN Official Journal of the European Communities 26. 2. 98 ANNEX IV CONTAINMENT AND OTHER PROTECTIVE MEASURES General principles 1. These tables present the normal minimum requirements and measures necessary for each level of containment. Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene, shall apply: (i) to keep workplace and environmental exposure to any GMM to the lowest practicable level; (ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary; (iii) to test adequately and maintain control measures and equipment; (iv) to test, when necessary, for the presence of viable process organisms outside the primary physical containment; (v) to provide appropriate training of personnel; (vi) to establish biological safety committees or subcommittees, if required; (vii) to formulate and implement local codes of practice for the safety of personnel, as required; (viii) where appropriate to display biohazard signs; (ix) to provide washing and decontamination facilities for personnel; (x) to keep adequate records; (xi) to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area; (xii) to prohibit mouth pipetting; (xiii) to provide written standard operating procedures where appropriate to ensure safety; (xiv) to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs; (xv) to provide safe storage for contaminated laboratory equipment and materials, when appropriate. 2. The titles of the tables are indicative: Table I A presents minimum requirements for laboratory activities. Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs. Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs. Table II presents minimum requirements for activities other than laboratory activities. In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level. In some cases users may, with the agreement of the competent authority, not apply a specification under a particular containment level or combine specifications from two different levels. In these tables “optional” means that the user may apply these measures on a case-by-case basis, subject to the assessment referred to in Article 5(2). 26. 2. 98 EN Official Journal of the European Communities C 62/13 Table I A Containment and other protective measures for laboratory activities Specifications Containment levels 1 2 3 4 Laboratory suite: isolation (1) Not required Not required Required Required Laboratory: sealable for fumigation Not required Not required Required Required 1 2 Equipment 3 4 5 6 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required (bench) Required (bench) Required (bench, floor) Required (bench, floor, ceiling, walls) Entry to lab via airlock (2) Not required Not required Optional Required Negative pressure relative to the pressure of the immediate surroundings Not required Not required Required except for (3) Required Extract and input air from the laboratory should be HEPA-filtered Not required Not required Required (HEPA) (4) — extract air except for (3) Required (HEPA) (5) — input and extract air 7 Microbiological safety cabinet/enclosure Not required Optional Required Required 8 Autoclave On site In the building En suite (6) In lab = double-ended System of work 9 Restricted access Not required Required Required Required 11 Specific measures to control aerosol dissemination Not required Required minimise Required prevent Required prevent 13 Shower Not required Not required Optional Required 14 Protective clothing Suitable protective clothing Suitable protective clothing Suitable protective clothing Complete change of clothing and footwear before entry and exit 15 Gloves Not required Optional Required Required 18 Efficient vector control (e. g. for rodents and insects) Optional Required Required Required C 62/14 EN Official Journal of the European Communities 26. 2. 98 Specifications Containment levels 1 2 3 4 Waste 19 Inactivation of GMMs from hand-washing sinks or drains and showers and similar effluents effluent in Not required Not required Optional Required 20 Inactivation of GMMs in contamined material and waste Optional Required Required Required Other measures 21 Laboratory to contain its own equipment Not required Not required Optional Required 23 An observation window or alternative is to be Optional Optional Optional Required present so that occupants can be seen (1) Isolation = the laboratory is separated from other areas in the same building or is in a separated building. (2) Airlock = entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. (3) Activities where transmission does not occur via airborne route. (4) HEPA = High efficiency particulate air. (5) Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air. (6) With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing an equivalent level of protection. 26. 2. 98 EN Official Journal of the European Communities C 62/15 Table I B Containment and other protective measures for glasshouses and growth-rooms The terms “glasshouse” and “growth-room” refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment. All provisions of Table I A shall apply with the following additions/modifications: Specifications Containment levels 1 2 3 4 Building 1 Greenhouse: permanent structure (1) Not required Required Required Required Equipment 3 Entry via a separated room with two interlocking doors Not required Optional Optional Required 4 Control of contaminated run-off water Optional Minimise (2) run-off Prevent run-off Prevent run-off System of work 6 Measures to control undesired species such as Required Required Required Required insects, rodents, arthropods 7 Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory will control dissemination of genetically modified micro-organisms Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination (1) The glasshouse shall consist of a permanent structure with a continuous waterproofed covering, located on a site graded to prevent entry of surface run-off having self-closing lockable doors. (2) Where transmission can occur through the ground. C 62/16 EN Official Journal of the European Communities 26. 2. 98 Table I C Containment and other protective measures for activities in animal units All provisions of Table I A shall apply with the following additions/modifications: Specifications Containment levels 1 2 3 4 Facilities 1 2 3 Isolation of animal unit (1) Optional Required Required Required Animal facilities (2) separated by lockable doors Optional Required Required Required facilities Animal facilitate decontamination (waterproof and easily washable material (cages, etc. )) designed to Optional Optional Required Required 4 Floor and/or walls easily washable Optional Required (floor) Required (floor and walls) Required (floor and walls) 6 Filters on isolators or isolated room (3) Not required Optional Required Required (1) Animal unit: a building, or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves, food storage areas, etc. (2) Animal facility: a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures. (3) Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. 26. 2. 98 EN Official Journal of the European Communities C 62/17 Table II Containment and other protective measures for other activities Specification Containment levels 1 2 3 4 General 1 Viable micro-organisms should be contained in a system which separates the process from the environment (closed system) Optional Required Required Required 2 Control of exhaust gases from the closed system Not required Required, minimise release Required, prevent release Required, prevent release 3 4 5 6 7 Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system Optional Required, minimise release Required, prevent release Required, prevent release Inactivation of bulk culture fluids before removal from the closed system Optional Required, by validated means Required, by validated means Required, by validated means Seals should be designed so as to minimise or prevent release No sepecific requirement Minimise release Prevent release Prevent release The controlled area should be designed to contain spillage of the entire contents of the closed system Optional Optional Required Required The controlled area should be sealable to permit fumigation Not required Optional Optional Required Equipment 8 9 Entry via airlock Not required Not required Optional Required Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required (bench if any) Required (bench if any) Required (bench if any, floor) Required (bench floor, ceiling, walls) 10 Specific measures to adequately ventilate the controlled area to minimise air in order contamination Optional Optional Optional Required 11 The controlled area should be maintained at an air Not required Not required Optional Required pressure negative to the immediate surroundings 12 Extract and input air from the controlled area should be HEPA filtered Not required Not required Required (extract air, optional for input air) Required (input and extract air) C 62/18 EN Official Journal of the European Communities 26. 2. 98 Specification Containment levels 1 2 3 4 System of work 13 Closed systems should be located within a Not required Optional Required Required controlled area 14 Access should be restricted to nominated personnel Not required Required Required Required only 17 Personnel should shower bedore controlled area leaving the Not required Not required Optional Required 18 Personnel should wear protective clothing Required (work clothing) Required (work clothing) Required Complete change before exit and entry Waste 22 23 Inactivation of GMMs handwashing-sinks effluents and in effluent showers or from similar Not required Not required Optional Required Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge Optional Required, by validated means Required, by validated means Required, by validated means 26. 2. 98 EN Official Journal of the European Communities C 62/19 ANNEX V PART A Information required for the notification referred to in Article 7: — name of user(s) including those responsible for supervision and safety, — information on the training and qualifications of the persons responsible for supervision and safety, — details of any biological committees or subcommittees, — address and general description of the premises, — a description of the nature of the work which will be undertaken, — the class of the contained uses, — only for class 1 contained uses, a summary of the assessment referred to in Article 5(2) and information on waste management. PART B Information required for the notification referred to in Article 9: — the date of submission of the notification referred to in Article 7, — the name of the persons responsible for supervision and safety and information on the training and qualification, — the recipient, donor and/or parental micro-organism(s) used and, where applicable, the host-vector system(s) used, — the source(s) and the intended function(s) of the genetic material(s) involved in the modification(s), — identity and characteristics of the GMM, — the purpose of the contained use including the expected results, — approximate culture volumes to be used, — description of the containment and other protective measures to be applied, including information about waste management including the wastes to be generated, their treatment, ultimate form and destination, — a summary of the assessment referred to in Article 5(2), — the information necessary for the competent authority to evaluate any emergency response plans if required under Article 14. PART C Information required for the notification referred to in Article 10: (a) — the date of submission of the notification referred to in Article 7, — the name of the persons responsible for supervision and safety and information on the training and qualification; (b) — the recipient or parental micro-organism(s) to be used, — the host-vector system(s) to be used (where applicable), — the source(s) and intended functions(s) of the genetic material(s) involved in the modification(s), — identity and characteristics of the GMM, — the culture volumes to be used; C 62/20 EN Official Journal of the European Communities 26. 2. 98 (c) — description of the containment and other protective measures to be applied, including information about waste management including the type and form of wastes to be generated, their treatment, ultimate form and destination, — the purpose of the contained use including the expected results, — description of the sections of the installation; (d) information about accident prevention and emergency response plans, if any: — any specific hazards arising from the location of the installation, — the preventive measures applied such as safety equipment, alarm systems and containment methods, — procedures and plans for verifying the continuing effectiveness of the containment measures, — a description of information provided to workers, — the information necessary for the competent authority to evaluate any emergency response plans if required under Article 14; (e) a copy of the assessment referred to in Article 5(2). ’ 26. 2. 98 EN Official Journal of the European Communities C 62/21 STATEMENT OF THE COUNCIL’S REASONS I. INTRODUCTION 1. On 28 March 1996 the Commission submitted to the Council a proposal for a Directive based on Article 130s(1) of the EC Treaty, amending Directive 90/219/EEC. 2. The European Parliament delivered its opinion at first reading on 12 March 1997 while the Economic and Social Committee delivered its opinion on 10 July 1996. 3. Following the opinion of the European Parliament, the Commission submitted an amended proposal to the Council on 13 June 1997. 4. On 16 December 1997 the Council adopted its common position in accordance with Article 189c of the Treaty. II. AIM The aim of this Directive is to revise Directive 90/219/EEC to take account of developments in scientific knowledge and experience acquired since the introduction of Directive 90/219/EEC and to simplify the administrative procedures linked to the contained use of genetically modified micro-organisms (hereinafter referred to as ‘GMMs’) while maintaining a level of protection of the environment and of human health at least equal to that of the Directive in force. To reach this goal the proposal provides for administrative procedures, rules of notification, and containment and protection measures according to the risk posed by the contained uses of GMMs. III. ANALYSIS OF THE COMMON POSITION Supporting the aim stated in section II, the Council’s common position includes 28 of the 35 amendments adopted by the European Parliament and incorporated by the Commission in its amended proposal, either verbatim or in substance. A. Amendments not adopted by the Council 1. Amendment 68 The Council preferred to keep the wording (‘. to limit their contact. ’) contained in Article 2(c) of the original Commission proposal. It furthermore considered that the reference to the various types of barrier was pointless since the various containment measures were set out in detail in Annex IV. 2. Amendment 15 This amendment was deemed superfluous inasmuch as ‘good microbiological practice’ was included in the ‘containment and other protective measures’, and had to be reviewed periodically within the meaning of Article 6(2), and the relevant Community legislation already provided for staff consultation (see reminder in recital 9 of the common position). C 62/22 EN Official Journal of the European Communities 26. 2. 98 3. Amendment 17 This amendment appeared to run counter to the aim of administrative simplification and did not contribute towards enhancing the safety of contained uses. 4. Amendment 27 As the safety measures referred to here formed part of the emergency plans, the wording of the amendment could lead to confusion by presenting them as a separate element. 5. Amendment 38 While agreeing with the approach of the European Parliament and the Commission as regards the need for a specific provision to define the criteria applicable to the inclusion of types of GMM in Annex II, Part C, and the time limit for carrying this out, the Council considered that in order to take account of the rate at which biotechnology was progressing, the nature of the criteria to be laid down and the limited scope of this list of GMMs, the Council should define and revise these criteria. 6. Amendment 39 The Council considered that the type III (b) Committee set up pursuant to Directive 90/219/EEC currently in force and which the Commission had itself adopted in its original proposal, represented the right balance between control over the Annexes subject to this procedure and their rapid adaptation to technical progress. 7. Amendment 43 In general, the Council considered that the section on the Annex III procedure needed to be substantially reorganised if there were to be an effective assessment of risks to the environment and to human health and not simply a superposing of risk assessment for human health and risk assessment for the environment. It was therefore necessary to distinguish between the risk identification procedure as such (Annex III, section B, paragraphs 3 to 6, and section A as regards the elements to be taken into account during the assessment) and the classification of the operation in one of the classes described in Article 5 (Annex III, section B, paragraphs 7 to 9). Moreover, given the quantitative significance of class 1 uses, which in principle involved less costly obligations, the Council deemed it necessary to specify the characteristics of the GMMs which could be put into that class. B. Amendments made by the Council to the amended proposal Apart from the changes resulting from the non-incorporation of certain amendments, the Council made some changes to the amended proposal for the sake of clarity and in order to avoid having provisions without any practical effect, or to enhance the level of protection resulting from the Directive. This applies to: 1. Article 2(g), in that the definition of ‘significant changes’ proposed in it is superfluous in view of the wording of Article 6(2) of the common position; 2. Article 4, first paragraph, in which the list of provisions that do not apply to the transport of GMMs has been adjusted to include the provisions relating to the classification of contained uses (Article 5(3) and Article 6); 26. 2. 98 EN Official Journal of the European Communities C 62/23 3. the wording of Article 5(2) and (3), which has been amended to reflect the procedure described in Annex III; 4. Article 6(1), which by referring to Annex IV, paragraph 2, reflects the possibility of applying to a containment class measures other than those laid down for that class in Annex IV; 5. Article 10, in which the wording of the common position clarifies that prior written consent by the competent authority is necessary for class 3 or class 4 uses also in the case of premises which have already been the subject of notification; 6. Article 14(a), in which the common position specifies that an emergency plan must be drawn up irrespective of the class and not only for classes 3 and 4; 7. Article 19, the wording of which has been clarified and aligned with Directive 90/313/EEC; 8. the transposition date, set at 18 months after the entry into force of the Directive; 9. Annex III, where in section A, paragraph 1, allergenic or toxic effects have been added to what are to be considered as ‘potentially harmful effects’ and where more generally the Commission has been asked to develop guidance notes, to supplement the assessment procedure in particular; 10. Annex IV, paragraph 1, where it appeared useful to give a reminder of about 15 safety and hygiene principles to be observed at the workplace; 11. Annex V, where information is to be added on wastes for class 1 and emergency plans for class 2


title: 98/123/EF: Kommissionens beslutning af 16. december 1997 om godkendelse af det flerårige udviklingsprogram for Italiens fiskerflåde for perioden 1. januar 1997 til 31. december 2001 (Kun den italienske udgave er autentisk)

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text: 12. 2. 98 DA De Europæiske Fællesskabers Tidende L 39/27 KOMMISSIONENS BESLUTNING af 16. december 1997 om godkendelse af det flerårige udviklingsprogram for Italiens fiskerflåde for perioden 1. januar 1997 til 31. december 2001 (Kun den italienske udgave er autentisk) (98/123/EF) KOMMISSIONEN FOR DE EUROPÆISKE FÆLLESSKABER HAR — under henvisning til traktaten om oprettelse af Det Euro- pæiske Fællesskab, under henvisning til Rådets forordning (EF) nr. 3699/93 af 21. december 1993 om kriterier og betingelser for EF-strukturinterventioner inden for fiskeri, akvakultur og forarbejdning og afsætning af fiskerivarer og akvakultur- produkter (1), senest ændret ved forordning (EF) nr. 25/ 97 (2) særlig artikel 5 og 6, under henvisning til Rådets beslutning 97/413/EF af 26. juni 1997 om mål og detaljerede regler for en omstrukturering af Fællesskabets fiskerisektor i perioden 1. januar 1997 til 31. december 2001 med henblik på at opnå en bæredygtig ligevægt mellem ressourcerne og udnyttelsen heraf (3), særlig artikel 9, stk. 1, og ud fra følgende betragtninger: Beslutning 97/413/EF blev vedtaget i henhold til bestem- melserne i artikel 11 i Rådets forordning (EØF) nr. 3760/ 92 af 20. december 1992 om en fællesskabsordning for fiskeri og akvakultur (4), ændret ved akten vedrørende Østrigs, Finlands og Sveriges tiltrædelse; Italien, i det følgende benævnt »medlemsstaten«, fore- lagde den 30. juni 1997 i henhold til artikel 6, stk. 1, i beslutning 97/413/EF Kommissionen et program for reduktion af fiskeriindsatsen for perioden 1. januar 1997 til 31. december 2001 og har senere suppleret dette program med yderligere information; i henhold til arti- kel 9, stk. 1, i beslutning 97/413/EF vedtager Kommissio- nen de flerårige udviklingsprogammer (FUP) for fiskerflå- derne i de enkelte medlemsstater senest den 30. november 1997; ifølge artikel 6, stk. 2, i beslutning 97/413/EF sikres kapacitetsreduktionerne ved, at der i hver medlemsstat (1) EFT L 346 af 31. 12. 1993, s. 1. (2) EFT L 6 af 10. 1. 1997, s. 7. (3) EFT L 175 af 3. 7. 1997, s. 27. (4) EFT L 389 af 31. 12. 1992, s. 1. indføres en permanent ordning for kontrolleret fornyelse af flåden, hvori til- og fragangskoefficienten fastlægges for hver enkelt fartøjskategori; de programmer, medlems- staterne har forelagt, indeholder enten slet ingen informa- tion om dette spørgsmål eller er utilfredsstillende; med- lemsstaterne bør derfor meddele Kommissionen den nød- vendige information på et senere stadium; ifølge artikel 7 i beslutning 97/413/EF er udgangspunktet for målene for medlemsstaternes flåder pr. 31. december 2001 de flådemål, som i det forudgående program er fastsat pr. 31. december 1996; de mål, der er fastsat i det forudgående program, bør tilpasses, i tilfælde hvor dette er berettiget på grundlag af ny information, som den pågældende medlemsstat frem- kommer med; i henhold til artikel 7, stk. 2, i beslutning 97/413/EF skal der ved fastsættelsen af målene for hver enkelt medlems- stats flåde tages hensyn til de enkelte flåders særlige karakteristika; i henhold til beslutning 97/413/EF, særlig artikel 9, stk. 1, skal der fastsættes årlige mellemliggende mål; eftersom en stor del af det første år af den periode, der er omfattet af programmerne, vil være gået på tidspunktet for vedtagel- sen af denne beslutning, er det ikke relevant at opstille et mellemliggende mål for 1997; i henhold til artikel 9, stk. 1, i beslutning 97/413/EF fastsætter Kommissionen detaljerede regler for gennemfø- relsen af den pågældende beslutning; det er hensigtsmæs- sigt at klargøre visse begreber; udgangspunktet for beregningen af de mellemliggende og endelige flådemål under FUP IV er de flådemål, der er fastsat i de foregående programmer pr. 31. december 1996 (FUP III); tonnagemålene i FUP III var udtrykt i bruttoregistertons (BRT), medens målene i FUP IV skal udtrykkes i bruttotons (GT); ikke alle medlemsstater har indgivet GT-værdier for alle fiskerfartøjer i den pågæl- dende flåde uanset deres forpligtelse til at måle eller skønne over GT for alle fartøjer i deres flåde og meddele Kommissionen disse oplysninger; L 39/28 DA De Europæiske Fællesskabers Tidende 12. 2. 98 under disse omstændigheder må Kommissionen ved hjælp af en praktisk metode skønne over de manglende GT- værdier med henblik på foreløbigt at fastsætte den på- gældende medlemsstats mellemliggende og endelige mål under FUP IV på grundlag af disse skøn; Kommissionen kan ikke acceptere påstande fra medlems- staterne om, at fiskeriindsatsen og/eller fiskerikapaciteten er blevet reduceret, når der er tale om fartøjer, for hvilke den pågældende medlemsstat ikke har opfyldt sin forplig- telse til at meddele Kommissionen en GT-værdi eller et GT-skøn, da det præcise omfang af denne reduktion ikke kan kontrolleres; hvis de krævede GT-tonnager, målt eller skønnet i over- ensstemmelse med bestemmelserne i Rådets forordning (EØF) nr. 2930/86 af 22. september 1986 om definition af fiskerfartøjers karakteristika (1), ændret ved forordning (EF) nr. 3259/94 (2) og iværksat ved Kommissionens beslutning 95/84/EF (3) ikke foreligger, er Kommissionen ude af stand til at kontrollere de procentvise ændringer i flådekapaciteten eller fiskeriindsatsen repræsenteret ved ændringer i enkeltfartøjers kapacitet eller aktivitet eller ved tilgang til og fragang fra flåden af fartøjer; Kommis- sionen må derfor skønne over, om reduktionen af fiskeri- indsatsen for fartøjer, for hvilke de krævede GT-værdier foreligger, har været tilstrækkelig til at opnå tilnærmel- sesvis sikkerhed for, at en medlemsstat har nået sine FUP IV-mål; eftersom udgangspunktet for FUP IV-målene er de endelige FUP III-mål, kan en medlemsstat ikke anses for at have nået hverken de mellemliggende eller de endelige FUP IV-mål, før den har opfyldt sine forpligtelser under FUP III, navnlig forpligtelsen til at nå mindst 55 % af forpligtelserne i FUP III ved kapacitetsreduktioner; der må med opdelingen af flåden i fartøjskategorier tages hensyn til opdelingen i fartøjskategorier i det foregående program; i henhold til Kommissionens forordning (EF) nr. 109/94 af 19. januar 1994 om Fællesskabets fortegnelse over fiskerfartøjer (4), senest ændret ved forordning (EF) nr. 493/96 (5), skal hver medlemsstat give meddelelse om alle ændringer i fiskerflådens situation og udviklingen i fiskeriindsatsen for hver enkelt fiskeritype; beregningen af programmets mål er baseret på oplys- ninger fra medlemsstaten; det kan være nødvendigt at revidere målene, hvis det senere viser sig, at disse oplys- ninger var ukorrekte; (1) EFT L 274 af 25. 9. 1986, s. 1. (2) EFT L 339 af 29. 12. 1994, s. 11. (3) EFT L 67 af 25. 3. 1995, s. 33. (4) EFT L 19 af 22. 1. 1994, s. 5. (5) EFT L 72 af 21. 3. 1996, s. 12. de i denne beslutning fastsatte foranstaltninger er i over- ensstemmelse med udtalelse fra Forvaltningskomitéen for Fiskeri og Akvakultur — VEDTAGET FØLGENDE BESLUTNING: Artikel 1 Det flerårige udviklingsprogram for Italiens fiskerflåde for perioden 1. januar 1997 til 31. december 2001, som blev fremsendt den 30. juni 1997 og senere suppleret, godkendes herved under forudsætning af overholdelse af betingelserne i denne beslutning og i bilaget hertil. Artikel 2 Medlemsstaten skal sikre, at reduktioner i kapaciteten eller fiskeriindsatsen, der er nødvendige for at nå pro- grammets endelige mål, gennemføres gradvist. Med hen- blik herpå vil der blive opstillet mellemliggende mål, således at mindst en fjerdedel af reduktionerne skal være foretaget den 31. december 1998, halvdelen af reduktio- nerne skal være foretage den 31. december 1999 og tre fjerdedele af reduktionerne skal være foretaget den 31. december 2000. For at sikre at programmets mellemliggende og endelige mål nås, skal medlemsstaten med henblik på godkendelse meddele Kommissionen den ordning for fartøjers til- og fragang, der er omhandlet i artikel 6, stk. 2, i beslutning 97/413/EF. Artikel 3 1. Følgende enheder anvendes til at måle, om de endelige og mellemliggende mål i FUP IV er blevet opfyldt: i) et fartøjs kapacitet måles både som dets tonnage udtrykt i bruttotons (GT) og som dets maskineffekt udtrykt i kW i overensstemmelse med bestemmel- serne i forordning (EF) nr. 2930/86 ii) et fartøjs fiskeriaktivitet måles i antal havdage i overensstemmelse med bilag VI til forordning (EF) nr. 109/94 iii) i overensstemmelse med bilag VI til forordning (EF) nr. 109/94 måles et fartøjs fiskeriindsats både som fiskeriindsats i tonnage, defineret som produktet af dets aktivitet og tonnage udtrykt i GT, og som fiskeriindsats i maskineffekt defineret som produktet af dets aktivitet og dets maskineffekt udtrykt i kW. 2. Ikke-faststående og faststående redskaber svarer til listerne over henholdsvis trukne og faststående redskaber i bilag I, tabel 2, til forordning (EF) nr. 109/94 med undtagelse af noter, der i denne beslutning betragtes som ikke faststående redskaber. 12. 2. 98 DA De Europæiske Fællesskabers Tidende L 39/29 Fartøjskategorierne og i givet fald fiskerityperne 3. defineres som anført i bilaget og i overensstemmelse med punkt 1 i de supplerende bestemmelser heri. Artikel 4 1. Indtil en medlemsstat har opfyldt sine forpligtelser i henhold til forordning (EØF) nr. 2930/86 til af fremlægge en målt eller behørigt skønnet GT-værdi for et fartøj i forbindelse med FUP IV, skal dette fartøjs GT skønnes af Kommissionen som svarende til fartøjets tonnage udtrykt i BRT. Reduktioner i fiskeriindsatsen, herunder reduktioner 2. af kapaciteten, som påberåbes af en medlemsstat, skal ikke tages i betragtning af Kommissionen, medmindre medlemsstaten har opfyldt sin forpligtelse i henhold til forordning (EØF) nr. 2930/86 til at meddele Kommissio- nen det pågældende fartøjs GT-værdi eller et skøn her- over. 3. Hvis en medlemsstat ikke har indsendt alle de GT-værdier eller skøn herover, der kræves i henhold til forordning (EØF) nr. 2930/86, og som er nødvendige for at tage stilling til, om den pågældende medlemsstat har nået et mellemliggende eller endeligt mål, vil Kommissio- nen vurdere, om de oplysninger om tonnage, den har modtaget, ikke desto mindre er tilstrækkelige til at antage, at den pågældende medlemsstat har nået dette mål. Hvis Kommissionen konkluderer, at dette er tilfæl- det, går den ud fra, at betingelserne for ydelse af moder- niserings- og bygningsstøtte i artikel 10 i forordning (EF) nr. 3699/93 er opfyldt. Artikel 5 Så længe en medlemsstat ikke har opfyldt sine samlede endelige forpligtelser under FUP III, navnlig forpligtelsen til at nå mindst 55 % af reduktionsmålene i FUP III ved kapacitetsreduktioner, anses den for ikke at have opfyldt sine samlede mellemliggende og/eller endelige forpligtelser under FUP IV. Artikel 6 Med henblik på at overvåge og kontrollere gennemførel- sen af programmet skal medlemsstaterne give meddelelse om alle ændringer i fiskerflådens situation og udviklingen i fiskeriindsatsen for hver fiskeritype i overensstemmelse med procedurerne i forordning (EF) nr. 109/94. Den årlige meddelelse fra Kommissionen til Rådet og Europa-Parlamentet om forløbet af FUP IV, der er omhandlet i artikel 6 i forordning (EF) nr. 3699/93, vil blive baseret på oplysningerne i Fællesskabets fortegnelse over fiskerfartøjer og kan inddrage yderligere oplysninger fra de rapporter, medlemsstaterne indsender i overens- stemmelse med artikel 6 i forordning (EF) nr. 3699/93. Artikel 7 Programmets mål er anført i bilaget. Disse mål kan revideres af Kommissionen efter proceduren i artikel 18 i forordning (EØF) nr. 3760/92, hvis det viser sig, at oplysninger, der er indsamlet med henblik på beregning af disse mål, navnlig vedrørende sammensætningen af fangsterne pr. fartøjskategori eller fiskeritype, udgangs- niveauerne for fiskeriindsatsen og GT-værdierne eller skønnene herover er ukorrekte. Artikel 8 Denne beslutning er rettet til Den Italienske Republik. Den finder anvendelse fra den 1. januar 1997. Udfærdiget i Bruxelles, den 16. december 1997. På Kommissionens vegne Emma BONINO Medlem af Kommissionen L 39/30 DA De Europæiske Fællesskabers Tidende 12. 2. 98 BILAG FLERÅRIGT UDVIKLINGSPROGRAM FOR DEN ITALIENSKE FISKERFLÅDE FOR PERIODEN 1997-2001 Oversigterne med angivelse af de gældende reduktionsmål findes i slutningen af dette bilag. I. OVERSIGT OVER MÅL 1. Identifikation af fartøjskategorier og fiskerityper II. SUPPLERENDE BESTEMMELSER Fartøjskategorierne defineres i overensstemmelse med artikel 1, stk. 4, og artikel 4 i beslutning 97/413/EF. En eller flere fiskerityper kan identificeres for fartøjskategorier, der bruger ikke-faststående redskaber. Mål opstillet i form af fiskeriindsats pr. fiskeritype er gyldige, forudsat at de foranstaltninger til begrænsning af fiskeriindsatsen, der er beskrevet i det program, der er forelagt i henhold til artikel 6 i beslutning 97/413/EF, og som er godkendt af Kommissionen, overholdes. De opstillede mål skal nås for hver fartøjskategori og hvor relevant for hver fiskeritype ved programmets afslutning. Hver fartøjskategori får et kodenummer, som bruges til at registrere den fartøjskategori, som hvert fartøj tilhører, i Fællesskabets fartøjsregister. Alle ændringer i fordelingen af fartøjer på fartøjskatego- rier skal meddeles i overensstemmelse med procedurerne i forordning (EF) nr. 109/94). 2. Omregning af tonnagemål fra BRT til GT Målene i FUP III pr. 31. december 1996 tjener som udgangspunkt for beregningen af målene for FUP IV. Tonnagemålene for FUP III omregnes fra BRT til GT ved hjælp af følgende formel for hver af fartøjskategorierne eller de relevante underopdelinger af fartøjskategorierne i FUP III: Mål pr. 31. 12. 1996 (GT) = mål pr. 31. 12. 1996 (BRT) × situationen pr. 31. 12. 1996 (GT) situationen pr. 31. 12. 1996 (BRT) hvor der med situationen pr. 31. 12. 1996 i BRT om nødvendigt tages hensyn til beregninger foretaget i overensstemmelse med Kommissionens beslutning 97/259/EF (1). 3. Beregning af målene Målene udtrykkes for tonnagens vedkommende i GT og for maskineffektens vedkommende som defineret i forordning (EØF) nr. 2930/86 i kW. 3. 1. Mål pr. fartøjskategori Når en fartøjskategori, der omfatter små kystfartøjer, er blevet identificeret i overensstemmelse med artikel 3 i beslutning 97/413/EF, er målene i FUP IV at stabilisere kapaciteten på dens niveau pr. 1. januar 1997 eller efter medlemsstatens valg at begrænse kapaciteten til et niveau svarende til målene i FUP III for denne fartøjskategori. Kapacitetsmålene pr. 31. december 2001 for alle andre fartøjskategorier beregnes ved at anvende den relevante reduktionssats for de kapacitetsmål pr. fartøjskategori pr. 31. december 1996, der er fastsat i FUP III. Hvis fartøjerne i en eller flere af fartøjskategorierne i FUP III omfordeles til en eller flere fartøjskategorier under FUP IV, giver summen af målene pr. 31. december 1996 for de pågældende FUP III-fartøjskategorier summen af målene pr. målene pr. 31. december 1996 for de nye FUP IV- fartøjskategorier, der således er skabt. Målene for FUP IV-fartøjskategorierne pr. 31. december 1996 beregnes ved at dele denne sum blandt FUP IV-fartøjskategorierne i overensstemmelse med størrelsen af disse fartøjskategorier pr. 31. december 1996. (1) EFT L 104 af 22. 4. 1997, s. 28. 12. 2. 98 DA De Europæiske Fællesskabers Tidende L 39/31 Den nedsættelsessats, der anvendes for hver fartøjskategori, beregnes i overensstemmelse med den metode, der er beskrevet i bilag II til beslutning 97/413/EF, i hvilken målreduktionssatsen for fartøjskategorien multipliceres med den andel af fartøjskategoriens fangst i vægt, der udgøres af kritiske bestande. 3. 2. Mål pr. fiskeritype Hvis forskellige fiskerityper er blevet identificeret i en eller flere fartøjskategorier, og det program til begrænsning af fiskeriindsatsen i hver af disse fiskerityper, som er indgivet i henhold til artikel 6 i beslutning 97/413/EF, er blevet godkendt af Kommissionen, beregnes der adskilte satser for reduktion af indsatsen for hver af disse fiskerityper. Metoden for beregning af reduktionssatsen i hver fiskeritype er identisk med metoden for kapacitetsreduktioner for hver fartøjskategori. Målene for indsatsen for hver fiskeritype beregnes ved at multiplicere basisniveauet for fiskeriindsatsen for denne fiskeritype med den relevante reduktionssats. Basisniveauet for indsatsen for fiskerityperne i en fartøjskategori beregnes ved at fordele målet for indsatsen for den pågældende fartøjskategori pr. 31. december 1996 blandt fiskerityperne. Målet for indsatsen for fartøjskategorien fremkommer som produktet af målet for fartøjskategoriens kapacitet pr. 31. december 1996 og gennemsnitsaktiviteten for fartøjskategoriens fartøjer i den referenceperiode, der er aftalt med Kommissionen. Den andel af målet for indsatsen for fartøjskategorien, der tildeles hver fiskeritype, besluttes af medlemsstaten under forudsætning af Kommissionens godkendelse og er fast for programmets løbetid. Uanset bestemmelserne i artikel 4 og 5 i nærværende beslutning anses de mellemliggende mål udtrykt som fiskeriindsats for at være nået, hvis den samlede fiskeriindsats fra programmets start til datoen for det mellemliggende mål er lig med eller mindre end den samlede fiskeriindsats, der ville være blevet udøvet, hvis alle de årlige mellemliggende mål var blevet opfyldt præcist. Uanset bestemmelserne i artikel 4 og 5 i nærværende beslutning anses de endelige mål udtrykt som fiskeriindsats for at være nået, hvis den samlede fiskeriindsats i programmets løbetid er lig med eller mindre end den samlede fiskeriindsats, der ville være blevet udøvet, hvis alle de årlige mellemliggende mål var blevet opfyldt præcist. 3. 3. Tilladte tilpasninger af målene Medlemsstaterne kan til enhver tid forelægge Kommissionen et program for forbedringer af sikkerhe- den. I overensstemmelse med artikel 3 og 4 i beslutning 97/413/EF træffer Kommissionen beslutning om, hvorvidt en eventuel kapacitetsforøgelse i et sådant program berettiger en tilsvarende forøgelse af målene i FUP IV. Hvis en medlemsstat gennemfører tekniske foranstaltninger, der medfører en reduktion af bifangsten af kritiske bestande, tager Kommissionen på anmodning af den pågældende medlemsstat stilling til, om disse foranstaltninger berettiger en revision af de vejede reduktionssatser, der anvendes for de pågælgende fartøjskategorier eller fiskerier. Kommissions beslutninger vedrørende bestemmelserne i dette afsnit skal træffes i overensstemmelse med procedurerne i artikel 18 i forordning (EØF) nr. 3760/92. 3. 4. Efterslæb fra det foregående program I de tilfælde, hvor målene pr. 31. december 1996 ikke er blevet nået, kan efterslæbet i en given fartøjskategori indhentes ved en blanding af reduktioner af kapacitet og aktivitet, forudsat at et program for reduktion af indsatsen indgives til Kommissionen til godkendelse i overensstemmelse med artikel 4 i forordning (EF) nr. 109/94 og forudsat, at mindst 55 % af efterslæbet for alle fartøjskategorier under ét indhentes ved kapacitetsreduktioner. Der er taget hensyn til reduktioner af aktiviteten som følge af et sådant program ved fastsættelsen af basisaktivitetsniveauet for FUP IV. 4. Gennemførelse og overvågning Gennemførelsen af foranstaltningerne til reduktion af fiskeriindsatsen for visse af flådens fartøjskate- gorier kræver, at medlemsstaterne over for Kommissionen godtgør, at følgende oplysninger er til rådighed for hver af de pågældende fartøjskategorier: — oplysninger vedrørende aktivitetens omfang før foranstaltningernes ikrafttræden — effektive hjælpemidler til forvaltning af tiden til havs og evne til at forvalte fiskerilicensordninger — oplysninger, som gør det muligt at følge virkningen af de gennemførte foranstaltninger. Disse virkninger skal kunne kontrolleres af Kommissionen, jf. bestemmelserne i Rådets forordning (EØF) nr. 2847/93 (1) vedrørende kontrol. (1) EFT L 261 af 20. 10. 1993, s. 1. Område Bestande Kategori Fangstsammen- sætning Målsats Vejet reduktionssats Situation 1. 1. 1997 Målsætning 31. 12. 1996 Målsætning 31. 12. 2001 GT (*) kW GT (*) kW GT (*) kW Kystfarvande Demersale og Pelagiske Mindre kystfartøjer , 12 meter Kystfarvande Demersale og Pelagiske Bundtrawlere Demersale og Pelagiske Demersale og Pelagiske Parflydetrawlere Mindre notfartøjer Demersale Fartøjer med hydrauliske skrabere Demersale og Pelagiske Kombinations- fartøjer Middelhavet Demersale Bundtrawlere Demersale Pelagiske Kombinations- fartøjer (ikke trawlere) Notfartøjer til tunfiskeri Demersale og Pelagiske Sværdfiskfartøjer 0 % NR: OF: 0 % Andre: 100 % 0 % NR: OF: 0 % Andre: 100 % 0 % NR: OF: 0 % Andre: 100 % NR: OF: Andre: 0 % 1 % 99 % 0 % NR: OF: 0 % Andre: 100 % 0 % NR: OF: 0,4 % Andre: 99,6 % NR: 0 % 0 % OF: Andre: 100 % 0 % NR: OF: 0 % Andre: 100 % NR: OF: Andre: NR: OF: Andre: 0 % 55 % 45 % 0 % 60 % 40 % 0 % 0 % 33 272 283 390 31 747 269 625 31 747 269 625 Subtotal 33 272 283 390 31 747 269 625 31 747 269 625 0 % 77 914 365 444 57 525 269 407 57 525 269 407 0 % 1 066 6 012 1 763 9 952 1 763 9 952 0 % 0 % 20 % 0,2 % 1 825 11 654 1 741 11 088 1 738 11 066 0 % 0 % 7 881 79 818 7 520 75 941 7 520 75 941 20 % 0,1 % 68 432 500 437 65 295 476 130 65 230 475 749 0 % 0 % 0 % 6 289 17 825 15 416 42 015 15 416 42 015 0 % 333 1 736 318 1 652 318 1 652 20 % 11,0 % 9 412 34 587 8 980 32 907 7 992 29 287 20 % 12,0 % 17 505 111 825 16 702 106 393 14 698 93 626 L 3 9 3 2 / D A D e E u r o p æ i s k e F æ l l e s s k a b e r s T i d e n d e 1 2. 2. 9 8 Område Bestande Kategori Fangstsammen- sætning Målsats Vejet reduktionssats Situation 1. 1. 1997 Målsætning 31. 12. 1996 Målsætning 31. 12. 2001 GT (*) kW GT (*) kW GT (*) kW Oceanerne Demersale og Pelagiske Trawlere og notfartøjer 0 % NR: OF: 0 % Andre: 100 % 0 % 0 % 9 524 21 012 28 656 54 043 28 656 54 043 NR: Nedfiskningsrisiko. OF: Overfisket. (*) Omfatter skønnede GT-værdier i overensstemmelse med artikel 4 i nærværende beslutning. Målsætningerne vil blive revideret, efterhånden som de faktiske GT-værdier foreligger. Disse tal vil muligvis blive ændret i lyset af konklusionerne fra den arbejdsgruppe, der er blevet nedsat mellem Kommissionen og de italienske myndigheder med mandat til at revidere og ajourføre data fra det italienske fartøjsregister fra og med 1. januar 1992. Arbejdsgruppen vil også se på sammenhængen mellem data fra fartøjsregisteret og data indsendt af Italien i forbindelse med FUP III. Arbejdsgruppen vil senest afslutte sine opgaver pr. 31. december 1998. Subtotal 200 181 1 150 350 203 916 1 079 528 200 855 1 062 738 I alt 233 453 1 433 740 235 663 1 349 153 232 602 1 332 363. 1 2 2 9 8. D A D e E u r o p æ i s k e F æ l l e s s k a b e r s T i d e n d e L 3 9 / 3 3


title: 98/69/EG: Entscheidung der Kommission vom 16. Dezember 1997 über die Einfuhrlizenzen für aus Botsuana, Kenia, Madagaskar, Swasiland, Simbabwe und Namibia stammende Erzeugnisse des Sektors Rindfleisch

eurovoc_concepts:
ACP countries
Germany
United Kingdom
beef
import licence
quantitative restriction

text: L 10/42 ‹ ‹DE Amtsblatt der Europäischen Gemeinschaften 16. 1. 98 ENTSCHEIDUNG DER KOMMISSION vom 16. Dezember 1997 über die Einfuhrlizenzen für aus Botsuana, Kenia, Madagaskar, Swasiland, Simbabwe und Namibia stammende Erzeugnisse des Sektors Rindfleisch (98/69/EG) DIE KOMMISSION DER EUROPÄISCHEN GEMEINSCHAFTEN — gestützt auf den Vertrag zur Gründung der Europäischen Gemeinschaft, gestützt auf die Verordnung (EWG) Nr. 715/90 des Rates vom 5. März 1990 über die Regelung für landwirtschaft- liche Erzeugnisse und bestimmte aus landwirtschaftlichen Erzeugnissen hergestellte Waren mit Ursprung in den AKP-Staaten oder in den überseeischen Ländern und Gebieten (ÜLG) (1), zuletzt geändert durch die Verordnung (EG) Nr. 619/96 (2), insbesondere auf Artikel 27, gestützt auf die Verordnung (EG) Nr. 589/96 der Kommission vom 2. April 1996 zur Festlegung der Durchführungsbestimmungen im Sektor Rindfleisch zu der Verordnung (EWG) Nr. 715/90 des Rates über die und Regelung bestimmte aus landwirtschaftlichen Erzeugnissen herge- stellte Waren mit Ursprung in den AKP-Staaten sowie in den überseeischen Ländern und Gebieten (3), insbesondere auf Artikel 4, landwirtschaftliche Erzeugnisse für in Erwägung nachstehender Gründe: Artikel 1 der Verordnung (EG) Nr. 589/96 sieht die Möglichkeit vor, für Erzeugnisse des Sektors Rindfleisch Einfuhrlizenzen zu erteilen. Allerdings müssen die Einfuhren im Rahmen der für jedes einzelne exportie- rende Drittland vorgesehenen Mengen erfolgen. in Die vom 1. bis 10. Dezember 1997 eingereichten, Fleisch ohne Knochen ausgedrückten Anträge auf Ertei- lung einer Lizenz im Sinne der Verordnung (EG) Nr. 589/96 für aus Botsuana, Kenia, Madagaskar, Swasiland, Simbabwe und Namibia stammende Erzeugnisse über- steigen nicht die für diese Staaten verfügbaren Mengen. Es ist daher möglich, Einfuhrlizenzen für die beantragten Mengen auszustellen. Es ist die Festsetzung der Mengen vorzunehmen, für welche ab dem 1. Januar 1998 Lizenzen im Rahmen der Gesamtmenge von 52 100 Tonnen beantragt werden können. dieser Es wird in diesem Zusammenhang daran erinnert, daß Richtlinie mit 72/462/EWG des Rates vom 12. Dezember 1972 zur Regelung tierseuchenrechtlicher und gesundheitlicher Entscheidung nicht die Fragen bei der Einfuhr von Rindern, Schweinen, Schafen und Ziegen, von frischem Fleisch oder Fleischerzeug- nissen aus Drittländern (4), zuletzt geändert durch die Richtlinie 96/91/EG (5), beeinträchtigt wird — HAT FOLGENDE ENTSCHEIDUNG ERLASSEN: Artikel 1 Die nachstehenden Mitgliedstaaten stellen am 22. Dezember 1997 für Erzeugnisse des Sektors Rindfleisch mit Ursprung in bestimmten Staaten in Afrika, im karibi- schen Raum und im Pazifischen Ozean Einfuhrlizenzen für die angegebenen Mengen und Ursprungsländer aus, ausgedrückt in Fleisch ohne Knochen: Deutschland — 100,000 Tonnen mit Ursprung in Botsuana, — 45,000 Tonnen mit Ursprung in Namibia; Vereinigtes Königreich: — 50,000 Tonnen mit Ursprung in Botsuana, — 1 400,000 Tonnen mit Ursprung in Simbabwe, — 470,000 Tonnen mit Ursprung in Namibia, — 15,000 Tonnen mit Ursprung in Swasiland. Artikel 2 Die Lizenzen können gemäß Artikel 3 Absatz 3 der Verordnung (EG) Nr. 589/96 in den ersten zehn Tagen des Monats Januar 1998 für folgende Mengen beantragt werden (ausgedrückt in Fleisch ohne Knochen): — Botsuana: — Kenia: — Madagaskar: — Swasiland: — Simbabwe: — Namibia: 18 916,000 Tonnen, 142,000 Tonnen, 7 579,000 Tonnen, 3 363,000 Tonnen, 9 100,000 Tonnen, 13 000,000 Tonnen. Diese Entscheidung ist an alle Mitgliedstaaten gerichtet. Artikel 3 Brüssel, den 16. Dezember 1997 Für die Kommission Franz FISCHLER Mitglied der Kommission (1) ABl. L 84 vom 30. 3. 1990, S. 85. (2) ABl. L 89 vom 10. 4. 1996, S. 1. (3) ABl. L 84 vom 3. 4. 1996, S. 22. (4) ABl. L 302 vom 31. 12. 1972, S. 28. (5) ABl. L 13 vom 16. 1. 1997, S. 26