Activites

• 1998/12/05 Final act published in Official Journal
  • Directive 1998/81
  • OJ L 330 05.12.1998, p. 0013
• #2126
• 1998/10/26 Council Meeting
• 1998/10/26 End of procedure in Parliament
• 1998/10/26 Act adopted by Council after consultation of Parliament
• 1998/07/29 Modified legislative proposal published
  • COM(1998)0479
• 1998/06/16 Decision by Parliament, 2nd reading
  • T4-0332/1998 summary

    Adopting the report by Mr Antennas TRAKATELLIS (PPE, GR), the European Parliament called for legal basis of this directive to be changed (from article 130 S, 1 to article 100 A, so that the Parliament/Council co-decision procedure applied). Although the Council retained 28 of the 35 amendments adopted by Parliament in its common position, the rapporteur re-presented a number of amendments for second reading. These amendments, which were accepted by the plenary, called for a more accurate definition of the term "contained use" and for the risks to be re-assessed where the competent authority was aware that the assessment was no longer adequate. Parliament called for the possibility for the applicant to obtain a decision within 45 days. It called for the public to be informed of emergency plans and relevant health and environmental safety measures before contained use commenced. Parliament called for inspections and controls in order to ensure that the directive was properly applied. It also insisted that users of GMMs assume full civil and criminal liability for any damage to human health or the environment caused and proposed in particular that they take out sufficient liability insurance to cover any losses occasioned before beginning their activities. With reference to the criteria for exclusion from the field of application of the directive of certain GMMs which are not considered to present a risk to human health or to the environment, the European Parliament called for the participation of the European Parliament in this procedure. The same applied to the participation of Parliament in the risk assessment procedure. The European Parliament also called for a clear definition of the risk assessment procedure which users of GMMS were required to apply. However, the European Parliament rejected the amendment tabled by the Committee on the Environment calling for users to provide a certificate of sufficient liability insurance cover to compensate everyone who may suffer as the result of GMM containment measures.�

• 1998/06/15 Debate in Parliament
  • Debate in Parliament summary

    Commissioner Brittan said that the Commission could accept Amendments Nos 5, 6, 17, 19, 25, 32 and 36. It could also partially accept Amendments Nos 8, 12, 13 and 14 and Amendments Nos 2, 18, 20, 21, 28, 33, 34 and 35 which, however, should be reworded. With particular regard to Amendment No 13, the Commission could accept a comitology procedure (2a) which was more flexible than that proposed by the Commission (3b). On the other hand, the Commission could not accept 17 amendments, particularly No 1 which proposed changing the legal basis from Article 130s to Article 100a. The scope of the directive in question did not impact on the functioning of the single market. As for Amendments Nos 4 and 9 on liability, the Commission preferred to deal with this problem in a horizontal manner to avoid any kind of fragmentation. Likewise, Amendment No 11 had to be rejected because technical amendments to Annex III needed to be made rapidly and flexibly without recourse to the ordinary legislative procedure. Finally, the Commissioner rejected Amendments Nos 3, 7, 10, 15, 16, 22, 23, 24, 26, 27, 29 and 30 to ensure consistency with the proposal as a whole and for technical reasons, namely the need to ensure that the burden of control measures was not increased.

• 1998/05/20 Vote in committee, 2nd reading
  • A4-0192/1998
• 1998/02/19 Committee referral announced in Parliament, 2nd reading
• #2062
• 1997/12/16 Council Meeting
  • 11542/1/1997 summary

    The common position provides for administrative measures, notification rules and containment and other protective measures applied to the contained use of genetically modified micro-organisms (GMMs). The Council adopted 28 of the 35 amendments proposed by the European Parliament and incorporated by the Commission in its proposal. As a result, certain aspects of the text have been strengthened: - the disposal of waste is specifically taken into account; - in cases of doubt of the classification of an activity, more stringent safety measures are applied; - the administrative control has been reinforced by the requirement to obtain explicit consent for all class 3 and class 4 work with GMMs; - the requirement for emergency plans has been extended to all cases where failure of containment could lead to serious danger; - the containment and control measures have been strengthened by the incorporation of a requirement to apply the principles of good occupational safety and hygiene; - references to the identification of potentially harmful effects to hand washing facilities and to surfaces resistant to water and decontamination agents have been introduced. The common position also provides for the possibility of specific exclusion from disclosure, after justification, for items mentioned in article 3(2) of directive 90/313/EEC on freedom of access to information on the environment to accommodate concerns on national security. The common position does not incorporate the amendments: - seeking to change the definition of contained utilisation; - making it possible for the notifier to request a decision within 45 days; - seeking the addition of the words "safety measures" as part of emergency plans with regard to information provided to organisations possibly at risk from accidents; - seeking to implement type II instead of a type III b procedure with regard to the Regulatory Committee. �

• 1997/06/12 Modified legislative proposal published
  • COM(1997)0240 summary

    The Commission's modified proposal incorporates several amendments adopted by the European Parliament at first reading, particularly those intended to: - reiterate the fact that for all operations involving genetically modified micro-organisms the principles of good microbiological practice and safety and health at work apply in accordance with the relevant Community laws; - emphasize the need to adopt and use specific measures for controlling the disposal of material from activities involving the contained use of genetically modified micro-organisms; - stress the need to provide a high level of safety for the general population and the environment; - place emphasis on the need to take account of the question of disposal when assessing the risk entailed in an activity involving genetically modified micro-organisms; - ensure that the applicant can himself request a decision on a formal authorization from the competent authority, this decision having to be made within a maximum of 45 days from the notification; - redraft the requirement on safety measures, which must be consistent with emergency plans; - limit the number of annexes which may be amended through the committee procedure; - request that, within six months of the implementation date of the directive, the criteria for the inclusion of certain types of genetically modified micro-organisms in Annex II, Part B, be laid down in accordance with Article 130s(1) of the EC Treaty; - apply commitology procedure type IIa, which allows the Council to adopt measures other than those proposed by the Commission. Regarding the annexes, the Commission agrees to add to Annex III a specific reference to Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work. In the case of Annex IV, it agrees to amend the requirements on surfaces in laboratories, which must be resistant to water and decontamination agents and must be easy to clean. On a general note, the Commission has not accepted the amendments limiting the information given to the public or the Commission, introducing specific requirements on liability insurance, changing the legal basis of the directive or complicating its operation. �

• 1997/03/12 Decision by Parliament, 1st reading/single reading
  • T4-0085/1997 summary

    In adopting the report by Mr Antonios TRAKATELLIS (EPP, GR) Parliament amended the proposal amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (GMM) mainly with the aim of specifying the way in which the risk should be assessed. An amendment thus classes the GMMs in different categories according to the risk to human health. Parliament considers that for all activities involving GMMs the principle of good microbiological practice and of safety and health at work must apply in accordance with the relevant Community laws. Furthermore specific measures should be adopted and used for the control of the disposal of material from the activities of the contained use of GMMs. Parliament considers that a contained environment should avoid and not simply limit (as proposed by the Commission) contact between GMMs and the general population and the environment. According to other amendments legally responsible users of GMMs shall have full civil and criminal liability for any damage to humans or the environment. Before the activities begin they must take out sufficient liability insurance to cover accidents. Furthermore users must draw up appropriate reports and keep a register of any serious accidents. The Commission should set up and keep at the disposal of the Member States a register of accidents involving possible serious damage to public health or the environment. Parliament also hopes that monitoring of the implementation of the directive will be by a management committee rather than a regulatory committee, which would increase the freedom of action of Parliament and the Commission vis-à-vis the Council. Lastly, Parliament called for the co-decision procedure to apply to this proposal, which should therefore be based on Articles 100a and 189b of the EC Treaty,. �

• 1997/03/11 Debate in Parliament
  • Debate in Parliament summary

    Having stressed that codecision should be applied to all issues relating to health, the rapporteur pointed out that the organisms in question (GMOs) were one of the most important tools in biotechnology. However, he stressed the need for work with these GMOs to take place in areas appropriately designed to cope with every kind of risk, in order to ensure human safety. The rapporteur also considered that the former definition of microorganism was more appropriate than that currently proposed by the Commission. He also said that not all projects in category 2 could be regarded as risk-free. Commissioner Bjerregaard emphasised the highly technical nature of the area in question which was in a process of very rapid development and could have considerable implications for employment in the EU. She then explained that the amendments made to the directive mainly concerned the administrative procedures in relation to the precautions to be taken when handling GMOs, in order to simplify the procedures without increasing the risks. As regards the amendments tabled, the Commissioner said that Amendments Nos 2, 3, 9, 10, 16, 17, 19, 31, 41, 42, 49 and 56 could be accepted. Amendments Nos 4, 11, 27, 30, 35, 37, 38, 39, 43, 47, 48, 54 and 55 could be partially accepted and Amendments Nos 7, 8, 14, 15, 17, 21-25, 64 and 68 could be accepted in principle.

• 1997/02/26 Vote in committee, 1st reading/single reading
  • A4-0070/1997
• #1978
• 1996/12/09 Council Meeting
  • 1978 summary

    The Council reached agreement on the basis of a compromise text. A common position was to be adopted once Parliament had delivered its opinion.

• #1956
• 1996/10/15 Council Meeting
  • 1956
• #1939
• 1996/06/26 Council Meeting
  • 1939
• 1996/05/09 Committee referral announced in Parliament, 1st reading/single reading
• 1995/12/06 Legislative proposal published
  • COM(1995)0640 summary

    OBJECTIVE: to rectify the shortcomings of Directive 90/219/EEC in the light of scientific progress and new experience while guaranteeing the same level of protection for the environment and human health. CONTENT: the proposal for a Council directive provides for: - notification procedures and requirements to be linked to the risk of operations involving the use of genetically-modified micro-organisms. Provision is made for four risk classes, taking account of scientific knowledge and international experience; - administrative procedures to be simplified, provided that this does not compromise safety; - minimum containment and control measures applicable to each risk class to be specified at a later date in order to guarantee harmonization and adequate environmental protection; - the possibility of introducing other derogations for safe genetically-modified micro-organisms in order to safeguard rapid adaptation to technical progress and avoid unreasonable administrative charges for users; - all the Annexes to be amended under a regulatory committee procedure, which will increase flexibility. In addition to the main changes outlined above, the proposal also updates certain technical sections of the directive in the light of scientific and technical progress.�

Documents

• Legislative proposal published: COM(1995)0640
• Debate in Council: 1939
• Debate in Council: 1956
• Debate in Council: 1978
• Committee report tabled for plenary, 1st reading/single reading: A4-0070/1997
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T4-0085/1997
• Modified legislative proposal published: COM(1997)0240
• Council position published: 11542/1/1997
• Committee recommendation tabled for plenary, 2nd reading: A4-0192/1998
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 2nd reading: T4-0332/1998
• Modified legislative proposal published: COM(1998)0479
• : Directive 1998/81
• : OJ L 330 05.12.1998, p. 0013

History

(these mark the time of scraping, not the official date of the change)