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# 52012DC0398

**COMMISSION WORKING DOCUMENT 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/2012/0398 final \*/**

  

COMMISSION WORKING DOCUMENT

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

TABLE
OF CONTENTS

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

Details are available in Annex I and II of
this document, which are Commission staff working documents.

COMMISSION
WORKING DOCUMENT

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

The information contained in this report
has been compiled by the Commission from individual reports submitted by Member
States in accordance with Article 17 of Directive 2009/41/EC on the contained
use of genetically modified micro-organisms. Directive 2009/41/EC is a recast
of Directive 90/219/EEC amended by Directive 98/81/EC.[1]

PREFACE

Article 17(2) of 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) requires Member States to send
a summary report on their experience with the Directive to the Commission every
three years. According to Article 17(3), the Commission shall publish a summary
report based on the aforementioned reports.

The two new Member States which acceded in
January 2007 were required to submit reports on their experience with the
Directive for the first time in 2009. The fifth Commission summary report contained
information on their transposition into national law of Directive 98/81/EC, the
predecessor of Directive 2009/41/EC.

Neither the European Commission nor any
person acting on its behalf is responsible for any use made of the information
contained in this report.

INTRODUCTION

This report is based on a sixth series of
Member States' reports. The deadline for submission of the Member States'
reports was 30 May 2010. Few Member States submitted their reports before the
deadline, while a great number was delayed. The latest report was received on 6th
March 2012. At the time of drafting this report, national reports had been
received from all Member States with the exception of two Member States. On the
whole, Member States provided relevant information.

Member States were requested to provide
information on:

–
Activities and installations

–
Notification and approval systems

–
Risk assessment and classification of contained
uses

–
Accidents

–
Inspection and enforcement issues

–
Problems with interpretation of provisions

–
Clinical trials using the provisions of the
Directive

–
Public consultation and information

–
Protection of confidential information

–
Waste disposal

The following text summarises the
information given by Member States under the headings provided and highlights
similarities of and differences between the experiences of the Member States.
Further details from the individual Member States' three-year reports are
provided in two annexes of this report, which are Commission staff working
documents.

1.           Overview of activities and
installations

Within the framework of Directive 2009/41/EC,
contained uses must be notified to the national competent authorities. In
accordance with Article 2(c), contained use shall mean "any activity in
which micro-organisms are genetically modified or in which such GMMs are
cultured, 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".

Contained use activities are classified into
four classes: class 1 represents activities of no or negligible risk; classes 2,
3 or 4 represent activities of low, moderate or high risk, respectively.

Premises for contained use activities as well
as installations must be notified as well. Some Member States notify the
installations on the reason that activities are difficult to count. Some Member
States require notifications for activities with GM plants or GM animals under
contained use.

According to the Member States' reports, no contained
use activity involving GMMs was carried out in Bulgaria, Cyprus, Estonia,
Latvia, Malta, and Romania in the reporting period.

According to the information provided, most
activities fell into class 1 or class 2. Fewer class 3 and 4 activities were
being carried out, but the number was increasing. Most activities were related
to research. Several activities served commercial purposes such as the
manufacture of diagnostics, veterinary/medicinal products.

2.           Notification and approval
system (and relevant changes)

The national systems differed slightly in terms
of authorities involved. In many Member States, the Ministry of Environment or
agencies focusing on environmental issues were the Competent Authority. In
other Member States, Competent Authorities included the Ministry of Health, the
Ministry of Labour and Social Insurance, the Ministry of Agriculture and Rural
Development, or the Ministry of Science and Research. In Belgium and Germany
the Competent Authorities were established at regional level. In several Member
States additional authorities and in particular advisory bodies were involved
in the authorisation process.

Under the provisions of the Directive, the
first-time use of an installation for class 1 activities must be notified, the
subsequent use of a class 1 activity may proceed without further notification
(article 6 and 7). However, Czech legislation required a new notification in
case that a new GMO was to be used (not only new premises). Class 2 activities
follow a similar procedure as class 1, while class 3 and class 4 activities may
not proceed without prior consent of the Competent Authority.

In Sweden, the Competent Authority has
commenced to review the regulations on the contained use of genetically modified
organisms for simplifying the procedure for notification of GMM activities. Portugal
has started to review its national contained use legislation to strengthen the
role of experts in the whole process, and for determining fees for the
processing of notifications.

3.           Risk assessment and
classification of contained uses

Most Member States integrated into their own
national legislation the Commission risk assessment guidelines, while others referred
directly to these guidelines.

In the majority of Member States, activities
were classified into four classes as provided for by the Directive. Finland
noticed that the classification of viruses, cell cultures and of pathogens that
had been attenuated was problematic in some cases.

In general, the users are required to compile
their own risk assessment, as provided for under Article 4(2) of the Directive.
However, in some Member States the risk assessment must be carried out or at
least verified by a professional consultant and is reviewed by an expert
advisory body.

4.           Accidents

Few Member States (Finland, Ireland, the Netherlands
and United Kingdom) reported accidents according to the definition laid down in
Article 2(d) of the Directive. Finland reported one accident involving an
experiment with an enterotoxin gene from S. aureus without safety
measures which generated health consequences for the user. Ireland reported an
accident generated by the breaking of the glass end Pasteur pipette during the
aspiration of supernatant from a trypsinised genetically modified
lentivirus-infected HeLa cell culture. The content penetrated the skin of the
user. The Netherlands reported 9 incidents, without consequences on health or
environment. The United Kingdom reported 7 accidents involving GMM belonging to
class 2, namely two peristaltic pump failures (E. coli HMS174 (DE3) genetically
modified to express Neisseria meningitidis surface proteins as well as
H5N1 Influenza virus), an incubator failure (M. tuberculosis), a
blockage of a steel pipe (vaccine influenza virus), a failure of the injection
procedure (pigs injected with GM Actinobacillus pleuropneumoniae), and
two needle stick injuries (vaccinia virus and Leishmania mexicana).

All the institutions where the accidents took
place, made the necessary adjustments for improving the procedural aspects to
avoid similar events in future, such as adapting or changing the company’s
standard operating procedure; in one case the risk assessment was amended; in
another case the staff was trained for the new technical method which raised
problems.

5.           Inspection and enforcement
issues

The national reports show a varying level of
control in different Member States. In some Member States the inspections were
conducted by the Competent Authority, while in others the inspections were
managed independently from the Competent Authority. The number of inspectors
involved in GMM control varied strongly per Member States. The control
procedures were also quite different in EU 27.

In Denmark all activities were inspected upon
notification of new premises or changes of already classified locations, while
Austria only carried out spot checks. In Finland, Germany, Lithuania and the United
Kingdom the inspection intensity was based mainly on class of contained use. In
Finland the class 3 use was inspected more often (at least every second year)
than class 1 or 2 use (at least every 5 years /4 years respectively); in the United
Kingdom, sites working at class 2 were visited approximately every 5 years,
sites working at class 3 approximately every 3 years and sites working at class
4 approximately every year. Lithuania inspected the premises at least every 3
years for class 1 uses, every 2 years for class 2, and every year for class 3
and 4 uses. In Finland for some specific cases, a written inspection procedure
was in place.

Some Member States such as Cyprus, Denmark,
Romania, Portugal, the Slovak Republic, Slovenia and the United Kingdom appointed
specialist inspectors for the contained use of GMMs.

During inspections, the following improvements
were found to be necessary: Users already actively engaged in the contained use
of GMOs/GMMs without having first obtained the authorisation to do so; lack of
knowledge regarding the consent conditions issued in respect of the contained
use activity; lack of a dedicated person for dealing with legal and safety
requirements; lack of training of biosafety officers or the project leaders;
the notifying the location without notifying the activities; others.

6.           Problems with interpretation
of the provisions

Some Member States named topics which need
further clarification, in relation with a necessary update of technical and
scientific advancement and/or further harmonization on the European level.

In Austria, Bulgaria, Cyprus, Estonia, Latvia,
Lithuania, Malta, Portugal, Romania and Slovakia no specific problems with the
interpretation of the provisions were reported. For the New Member States, in
the majority of the cases the reason is the lack of activities due to the lack
of notifications.

Belgium, Czech Republic, Hungary and the
Netherlands encountered problems in assessing whether the application of
certain new techniques resulted in a genetically modified organism and fell
within the scope of Directive 2009/41/EC. At the request of the Competent
Authorities of Directive 2001/18/EC the Commission set up a New Techniques
Working Group in October 2007 to assess a non-exhaustive list of techniques as
to whether they result in the production of a genetically modified organism or
microorganism as defined under Directives 2001/18/EC and 2009/41/EC. The
outcome is expected to help to clarify whether certain new techniques result in
genetically modified organisms and fall within the scope of Directive
2009/49/EC.

The Netherlands, Spain, Hungary, Czech
Republic, Belgium, Finland saw a need for clarification of the scopes of
Directive 2009/41/EC and Directive 2001/18/EC with respect to clinical trials.

Other problems encountered in case of
implementation of the Directive 2009/41/EC were the following: difficulties
with the detection and identification of GMOs (Germany), lack of clarity of
terminology (Germany, Finland); huge number of notifications of class 1 to be
reviewed (Denmark), or huge number of inspections (Ireland); high number of
notifications for viral vectors with low risk (United Kingdom) which created a
significant administrative burden; difficulties in obtaining feedback from the
users working with GMO/GMM (Spain). Member States proposed different measures
such as to include safe organisms in Part C of the Annex II of the Directive
2009/41/EC (Slovenia), to set up a EU GMM Working Group focusing on research
activities from the perspective of Directive 2009/41/EC, and to change the
requirements for notifying class 2 activities (United Kingdom).

7.           Clinical trials using the
provisions of the Directive

The national reports showed that the Member
States addressed clinical trials in considerably different ways. Some Member
States regarded clinical trials as falling exclusively under Directive
2001/18/EC (for example Sweden), while other Member States such as Denmark and
Finland regarded them as falling exclusively within the scope of Directive 2009/41/EC.
Other Member States (Spain, UK) decide on a case by case basis whether a
clinical trial is regarded as contained use or as a deliberate release.

In terms of numbers, France has reported 228
clinical trials, a large increase in numbers compared to previous reporting
periods. No clinical trials using GMO/GMM were conducted in Bulgaria, Cyprus,
Estonia, Finland, Hungary, Ireland, Latvia, Lithuania, Malta, Portugal,
Romania, Slovakia and Slovenia.

8.           Public consultation and
information

Member States generally prescribed public
consultation as part of the authorisation procedure. The approach of the Member
States was diverse. Some Member States focussed the public consultation only on
class 3 and 4 (Austria), other Member States allowed the Competent Authorities
to decide for the rest of the classes whether the public consultation was
needed (Ireland, Portugal, Poland, Romania).

The majority of Member States established a web
based system for regular public consultation. Some Member States had electronic
registers (databases) for applications submitted under Directive 2009/41/EC. In
Belgium, Bulgaria, Czech Republic, Denmark, Ireland, Lithuania, the Netherlands,
Poland, Romania, Slovakia and the United Kingdom, the general public had access
to the summary of the applications available in these databases.

Hungary requested from the notifier a summary
of the risk assessment for public information purposes which was available for
consultation at the Secretariat of the 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
information relevant in the context of Directive 2009/41/EC included public
meetings of advisory bodies (the United Kingdom, Czech Republic), seminars (Czech
Republic, Malta), publications such as annual reports (Belgium, Germany, Czech
Republic), or leaflets (Malta). In Denmark the approved notifications were
published in national and local newspapers.

9.           Protection of confidential
information

Article 18 of Directive 2009/41/EC provides for
the protection of confidential information. The competent authority shall
determine whether information submitted by the notifier may be considered
confidential in accordance with the requirements of article 18(1) of the Directive.

Generally speaking, the operator may indicate
in his/her application to the Competent Authority those data he/she wishes to
be treated as confidential. Most Member States decided, based on the operator's
request, that some specific data be kept confidential (Ireland, Austria,
Belgium). In the Netherlands a general description of the confidential parts
had to be submitted in order to give the public insight into the risk
assessment.

Member States took appropriate measures to
protect confidential information. In the Netherlands only authorised staff had
access to the rooms where confidential information was handled. The tendency of
Member States was to ask for a technical dossier with non-sensitive information
and, if applicable, an annex with confidential data (Belgium, the Netherlands).

10.         Waste disposal

Member States addressed waste management by
class or by category of waste. The Member States who did not provide any
information on these aspects mentioned that either there were no change since the
previous report, or explained that there was no activity in this area.

According to Directive 2009/41/EC, for
laboratory activities the inactivation of GMMs in effluent from hand-washing
sinks or drains and showers and similar effluents was not required for
containment levels 1 and 2, it was optional for level 3 and obligatory for
level 4; however, for laboratory activities the inactivation of GMMs in
contaminated material and waste was optional for level 1 and obligatory for levels
2, 3 and 4. Few Member States (Belgium, Lithuania, Portugal and Spain) prescribed
that all types of residues had to be inactivated prior to disposal, thus going
beyond what the Directive requires.

Starting with level 2, Member States request a
description of the containment and other protective measures to be applied,
including information about waste management, including the wastes to be
generated, their treatment, final form and destination, in accordance with
directive 2009/41/EC. For level 1, the Directive requests information on waste
management as a summary.

Some Member States had waste treatment
facilities dedicated to GM waste inactivation (Germany, Finland, Ireland, and the
United Kingdom). In countries where there were no authorised GM waste treatment
facilities the users inactivated their GMO waste themselves (Denmark) or use
the general waste treatment facilities available (Hungary, Czech Republic).

11.         Conclusions

Most contained use activities fell within class
1 or class 2. Significantly fewer class 3 and 4 activities were being carried
out, but the number is increasing. Most activities were related to research but
several serve commercial purposes such as the manufacture of diagnostics, or veterinary
or medicinal products. On the whole, the Member States applied the Directive in
a similar fashion. Differences arose as Member States enacted additional
legislation in almost all areas covered by the Directive.

The national reports showed that the Member
States addressed clinical trials in different ways. Some Member States applied
Directive 2009/41/EC on the contained use of GMMs, others Directive 2001/18/EC
on the deliberate release of GMOs into the environment, and yet others applied
other national legislation. These differences stem from differences in the interpretation
of annexes of Directive 2001/18/EC and Directive 2009/41/EC, in particular, as
the latter Directive had not been specifically designed for clinical trials.
However, both Directives attribute the competence to regulate clinical trials
with GM microorganisms essentially with the Member States, Directive 2009/41/EC
by setting minimum standards leaving it up to the Member States to go beyond
those minimum standards, and Directive 2001/18/EC by attributing the competence
for authorising part B notifications to the Member States. Some Member States
raise the point that further harmonization would be useful. However, most
importantly, both Directives share as common objective a high level of
protection so that from a safety point of view further harmonisation at Union
level is at present not a priority for the Commission.

[1]               Every effort has been made to ensure the accuracy of
the material contained in this report. Member State national legislation
transposing Directive 2009/41/EC into national law has been the subject of a
conformity check carried out by the Commission. This report is without
prejudice to the findings of the conformity check and any potential action on
behalf of the Commission in accordance with Art 258 of the Treaty on the
functioning of the EU, where Member States have been found to have incorrectly
transposed Directive 2009/41/EC into national legislation.

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