Annexes to COM(2016)808 - Experience of Member States with Directive 2009/41/EC on the contained use of genetically modified micro-organisms (recast) for the period 2009-2014 - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2016)808 - Experience of Member States with Directive 2009/41/EC on the contained use of genetically modified micro-organisms (recast) ... |
|---|---|
| document | COM(2016)808  |
| date | December 20, 2016 |
Belgium, Hungary, Lithuania, the Netherlands and the Czech Republic would welcome better explanation, early guidance and harmonised views across the EU on gene therapy, on synthetic biology, and on other new techniques or technological advances.
Lithuania, Estonia, and Malta would welcome more exchanges on experiences and training among Member States.
6. Clinical trials using the provisions of the Directive
The national reports showed that Member States addressed clinical trials in considerably different ways. Some Member States regarded clinical trials as falling exclusively under Directive 2001/18/EC (Sweden or Netherlands), while other Member States, ( Denmark and Finland) regarded them as falling exclusively within the scope of Directive 2009/41/EC.
Another reported issue was the potential borderline situation between contained use and deliberate release in clinical trials with GM-viruses in which it cannot be excluded that patients' or experimental animals' excretions may contain the tested viruses.
Other Member States (Spain, United Kingdom) decide on a case by case basis whether a clinical trial is regarded as contained use or as a deliberate release. In Austria, there are special legal national provisions for applications concerning gene therapy in clinical trials.
Bulgaria, the Czech Republic and Hungary considered that there is a need to discuss whether clinical trials fall under the scope of Directive 2009/41/EC or under the scope of Directive 2001/18/EC. Bulgaria, Finland, Hungary, Spain and the Czech Republic showed support for harmonisation of the guidance and the procedures for the evaluation and notification of clinical trials with GMMs at Union level.
Some Member States (Belgium, Denmark, France, Finland, Italy, Poland, Slovenia and Spain) reported increase in the notifications for gene therapy clinical trials, while in Germany the number has decreased.
There were no clinical trials using GMMs in Austria, Croatia, Cyprus, the Czech Republic, Estonia, Hungary, Ireland, Latvia, Lithuania, Malta, and Portugal.
Bulgaria, Spain and the Czech Republic, would like to see clarity on the legislative framework concerning clinical trials with GMMs.
7. Public consultation and information
Member States generally conducted public consultations as part of the authorisation process, as foreseen under Article 12 of Directive 2009/41/EC. The approaches of public consultations varied among the Member States. Some Member States (Austria, Czech Republic, France, Ireland, Romania and Spain) focussed the public consultation only on class 3 and 4. Others (Poland), allowed the Competent Authorities to decide whether a public consultation was needed on the basis of the Class of the activities.
The majority of Member States established a web based system for regular public consultations. Some Member States had electronic registers (databases) for applications submitted under Directive 2009/41/EC.
In Belgium, the Czech Republic, Latvia, Poland, Romania, Slovakia, Slovenia, Spain and the United Kingdom, the public had access to the information or summary of the applications available in the data bases.
In Hungary, the notifications published on the internet contain a summary of the risk assessment available at the Secretariat of Gene Technology Advisory Board.
In the Netherlands, only the notifier's name, the title of the project and the issuing date of the licence were published but members of the public could request access to an issued licence.
Other approaches to communicate to the public relevant information in the context of Directive 2009/41/EC, included public meetings of advisory bodies and seminars (the Czech Republic), publications of annual reports (Croatia, the Czech Republic, Germany, Spain and the United Kingdom), local or national newspapers (Denmark, Netherlands), brochures (Estonia), competent Ministry publications (Slovakia), and publications of the minutes of meetings (the United Kingdom). In Malta there were two radio interviews.
In some Member States (Austria, Bulgaria, Cyprus, Finland, Portugal and Sweden), no public consultations were carried out, because no application was received during the reporting period for the classes under Directive 2009/41/EC which the national provisions call for a public consultation.
With the exception of Slovenia and the United Kingdom, Member States received no responses to public consultations and information made publicly available under Directive 2009/41/EC during the reporting period. In the two Member States which received responses, the summaries of the comments were made available on the Competent Authorities' website. In Ireland, the Competent Authority received a letter from a member of the public; seeking additional information on the implications/risk associated with class 3 GMM contained use activity (GM strains of Hepatitis).
8. Waste disposal
In general, Member States declare addressing waste management by class or category of waste in accordance with the requirements of Article 5 and of Annex IV of Directive 2009/41/EC. The Member States which did not provide any information on these aspects explained that there was no activity in this area.
Few Member States (Belgium, Lithuania, Poland and Portugal), prescribed that all types of residues had to be inactivated prior to disposal. In Spain, the waste inactivation is optional for class 1 and obligatory for class 2, 3 and 4 but the Competent Authority recommends operators to inactivate the GMOs in all cases.
Most Member States use autoclave or chemical treatment to dispose of GMM waste, and/or incinerate GM plants and animals. In Germany, there are two genetic engineering facilities where large animals can be disposed of with the help of a digester (alkaline hydrolysis).
Some Member States (Germany, France, Ireland, Lithuania and the United Kingdom), had waste treatment facilities dedicated to GM waste inactivation. In Austria, the Netherlands, and Finland, there is one waste treatment facility dedicated to GM waste inactivation, otherwise the operators inactivate it themselves. In countries where there are no authorised GM waste treatment facilities, the users inactivate their GMO waste themselves (Denmark, Estonia) or use the general waste treatment facilities available (Belgium, Bulgaria, Hungary, the Czech Republic, Spain and Sweden).
9. Summary and Conclusions
During the period 2009-2014 most contained use activities declared by Member States fell within class 1 or class 2. Although there are significantly fewer class 3 and 4 activities being carried out, their number is increasing. Most activities were related to research but several served commercial purposes such as the manufacture of diagnostics, veterinary and medicinal products.
Member States applied the Directive in a similar fashion in terms of administration, handling of the notifications, inspections, waste disposal and public consultation and information. Differences arose in those areas covered by the Directive on which Member States have either enacted additional legislation as for example, in extending the provisions of Directive 2009/41/EC to cover GM plants and animals, maintaining the requirements for notification for each Class 1 activity, or when they apply the provisions of 2009/41/EC as in requiring for all Classes, inactivation of waste before disposal or employing independent advisory scientific bodies for the assessment of notifications.
The national reports showed that, in the Member States, several and at times different authorities, ministries and/or agencies are involved in the notification and approval process and in inspection and enforcement. The process of notification and approval is similar and timelines well respected. Inspections are conducted systematically and on an ad hoc basis in all premises or in specific class (classes 3 and 4) activities using specialised staff.
When inspections identified areas for improvement, national reports indicated that the competent authorities ensured that notifiers acted to rectify the situation within set deadlines.
Accidents in the reporting Member States were few and minor in significance in terms of human health and the environment. In all reported cases, Member States reported that the appropriate corrective measures were undertaken in all accidents involving humans/personnel, on the processes and operating procedures, and the contained used premises and/or installations.
The national reports show that problems of interpretation of the provisions of the Directive arise in some reporting Member States, particularly in the cases of the definition of genetic modification in the Directive, in the case of notifications involving modifications using novel techniques, in the assessment of the various classes of GMMs, in the subsequent 'contained use' activity, and as regards to clinical trials in the context of the Directive. In their reports, several Member States, stressed that the problems mentioned above and the actual administration of the process (number of notifications, processing of notifications and approval, inspections, etc.) result in a significant administrative burden which merits examination with the view to harmonise and simplify to the extent possible.
In terms of public consultation and information, almost all reporting Member States have implemented provisions for conducting public consultations, and for informing the public on the outcome of their activities under the Directive. Although the internet was primarily used, other means of communication (seminars, meetings, brochures, etc.) were employed. In general, there were no responses to public consultations.
Finally, in terms of waste disposal, all reporting Member States have declared having enacted waste management provisions according to the GM class. In some instances, Member States required the most stringent waste management treatment for all classes of GMMs. Both specialised and no specialised waste treatment facilities were used.
(1)
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast), OJ L 125, 21.5.2009, p. 75
(2)
Article 17(3) of Directive 2009/41/EC
(3)
Article 17(2) of Directive 2009/41/EC.
(4)
Report on the experience of Member States with Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2006 – 2009, COM(2012) 398 final, 17.7.2012.
(5)
The information for each Member State, as submitted, is available on …(internet site)
(6)
In particular, this report is without prejudice to any potential action in accordance with Article 258 of the Treaty on the Functioning of the European Union.
(7)
Article 4(3) of Directive 2009/41/EC
(8)
Together with the Danish Working Authority
(9)
Together with the Ministry of Science, Research and Economy
(10)
Together with the Ministry of Science, Education and Sports
(11)
Article 2(a) of Directive 2009/41/EC