No C 246/6 Official Journal of the European Communities 27. 9. 89 
(b) notify the competent authority of the new 
information available and/or of the modifi­
cations of the release in advance of such 
modifications being undertaken.' 
Article 5.4. is replaced by the following: 
'4. The notifier may proceed with the release only 
when he has received the written consent of the 
competent authority, in conformity with any 
conditions required in this consent.' 
Article 17.4 is replaced by the following: 
'4. The Commission and the competent authorities 
shall not divulge to third parties any confidential 
information notified or exchanged under this 
Directive.' 
Annex I is replaced by the following: 
'ANNEX I 
PARTI 
Techniques of genetic modification referred to in 
Article 2, (2) (i) are inter alia 
1. Recombinant DNA techniques using vector 
systems as previously covered by Council recom­
mendation 82/472/EEC. 2. Techniques involving the direct introduction into 
an organism of heritable material prepared 
outside the organism including micro-injection, 
macro-injection and micro-encapsulation. 
3. Cell fusion or hybridization 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 2 
Techniques referred to in Article 2 (2) (ii) which are 
not considered to result in genetic modification, on 
condition that they do not involve the use of r-DNA 
molecules or GMOs. 
1. In vitro fertilization 
2. Conjugation, transduction, transformation or any 
other natural process. 
3. Polyploidy induction. 
Annex II.3.(b), 3rd indent is replaced by: 
'— geographical, geological, hydrological and pedo-
logical characteristics.' 
Modified proposal for a Council Directive on the contained use of genetically modified micro­
organisms (') 
COM(89) 409 final — SYN 131 
(Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 23 August 1989) 
(89/C 246/07) 
The Commission, on the basis of the opinion delivered by the European Parliament on 24 May 
1989, modified its original proposal for a Council Directive on the contained use of OGM 
pursuant to Article 149 (3) of the EEC Treaty, as follows: 
Third recital is amended as follows: 
'Whereas under the Treaty, action by the Community 
relating to the environment shall be based on the 
principle that preventive action shall be taken and 
shall have the objective to preserve, protect and 
improve the quality of the environment and to 
contribute towards protecting human health.' 
(») OJ No C 198, 28. 7. 1988, p. 9. Eighth recital is amended as follows: 
'Whereas it is therefore necessary to approximate 
legislation in the Member States establishing a 
common legislative framework for the evaluation and 
the reduction of the potential risks arising in the 
course of the contained use of genetically modified 
micro-organisms in research, development, manu-
27. 9. 89 Official Journal of the European Communities No C 246/7 
facture, storage, transport, waste treatment and A 
disposal in order to enable the safe development of 
biotechnology throughout the Community.' 
Ninth recital is amended as follows: 
'Whereas the precise nature and scale of risks asso­
ciated with genetically modified micro-organisms are 
not fully known and the hazards involved must be 
assessed case by case; whereas particular attention 
must be given to operations using certain genetically 
modified micro-organisms.' 
Tenth recital is amended as follows: 
'Whereas genetically modified micro-organisms must 
be classified in relation to their hazard; whereas in 
the absence, at present of specifications necessary for 
allocation in these classes it seems appropriate to 
develop criteria for classification; whereas to evaluate 
hazard for human health and the environment it is 
necessary to lay down essential requirements for risk 
assessment and appropriate conditions of use.' 
Twelfth recital is replaced by: 
'Whereas a permanent inventory of information 
related to the contained use of GMOs within each 
Member State is necessary in order to monitor the 
contained use of GMOs and to trace the origin of 
any negative effects or'accidents that might arise.' 
Thirteenth recital is replaced by: 
'Whereas any person, before undertaking for the first 
time the contained use of genetically modified micro­
organisms, in a particular installation must forward 
to the competent authority a notification with infor­
mation allowing the authority to ensure that the 
proposed installation is appropriate to carry out an 
activity in a manner that does not present a danger to 
man and the environment.' 
The Sixteenth recital is amended as follows: 
'Whereas, if an accident occurs, the user must 
immediately inform the competent authority and 
communicate the information necessary for assessing 
the impact of that accident; whereas in the case of an 
accident that could pose a threat to human health 
and the environment, the competent authority must 
immediately inform the public' A new Article 4.5. is added: 
'5. The results of the risk-assessment cannot be 
considered as confidential. A summary of the risk-
assessment, excluding strictly confidential infor­
mation, shall be made available to the public' 
Article 6 is replaced by the following: 
'Article 6 
When a particular installation is to be used for the 
first time for operations involving the contained use 
of genetically modified micro-organisms, the user 
shall be required to submit to the competent auth­
orities, before commencing such use a notification 
containing at least the information listed in Annex 
IVA. A separate notification shall be made for first 
use of GMMs in Group I and Group II respectively.' 
Article 7 is replaced by the following: 
'Article 7 
1. Users of genetically modified mirco-organisms 
classified in Group I non-industrial scale operations 
shall be required to keep records of the work carried 
out which shall be available to the competent 
authority on request. 
2. Users of genetically modified micro-organisms 
classified in Group I industrial scale operations shall, 
before commencing the contained use, be required to 
submit to the competent authorities a notification 
containing the information listed in Annex IV B. The 
information shall be sufficient to enable the 
competent authority to assess the correctness of the 
classification.' 
Article 8 is replaced by the following: 
'Article 8 
1. Users of genetically modified micro-organisms 
classified in Group II non-industrial scale operations 
shall, before commencing the contained use, be 
required to submit to the competent authorities a 
notification containing the information listed in 
Annex IV C. 
2. Users of genetically modified micro-organisms 
classified in Group II in industrial scale operations 
shall, before commencing the contained use, be 
required to submit to the competent authorities a 
notification containing: 
— information on the genetically modified micro­
organism^), 
— information on personnel and training, 
— information on the installation, 
No C 246/8 Official Journal of the European Communities 27. 9. 89 
— information on waste management, 
— information on accident prevention and 
emergency response plans, 
— the safety assessment referred to in Article 4, 
the details of which are listed in Annex IV D.' 
Article 9 is replaced by the following: 
'Article 9 
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 Article 6, Article 7 (2) and Article 8. 
2. The Competent Authorities shall examine the 
conformity of the notifications with the requirements 
of this Directive, the accuracy and completeness of 
the information given, the correctness of the classifi­
cation and, where appropriate, the adequacy of the 
waste management, safety, and emergency response 
measures, and provide for adequate information and 
consultation of the public, where necessary. 
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. In this case, the proposed contained use 
cannot proceed 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. In the case of first-time use in an installation as 
referred to in Article 6: 
— where such use involves GMMs in Group I, the 
contained use may, in the absence of any indi­
cation to the contrary from the competent 
authority, proceed 90 days after submission of the 
notification, or earlier with the agreement of the 
competent authority, 
— where such use involves GMMs in Group II, the 
contained use may not proceed without the 
consent of the competent authority. The 
competent authority shall communicate its 
decision in writing at the latest 90 days after 
submission of the notification. 5. (a) Operations notified under Article 7 (2) and 
Article 8 (1), may, in the absence of any indi­
cation to the contrary from the competent 
authority, proceed 60 days after submission of 
the notification, or earlier with the agreement 
of the competent authority; 
(b) Operations notified under Article 8 (2) may 
not proceed without the consent of the 
competent authority. 
The competent authority shall communicate its 
decision in writing at the latest 90 days after 
submission of the notification. 
6. For the calculation of the periods referred to in 
paragraphs 4 and 5 above, the periods during which 
the competent authority: 
— is awaiting any further information which it may 
have requested from the notifier in accordance 
with paragraph 3a of this Article 
or 
— is carrying out a public enquiry or consultation in 
accordance with Article 11.2. 
shall not be taken into account.' 
Article 10 is replaced by the following: 
Article 10 
1. The user has an obligation to inform as soon as 
possible the competent authority of any relevant new 
information or modification of the contained use, or 
of any change in the' category of genetically modified 
micro-organisms used and to modify accordingly the 
notification submitted under Articles 6, 7 and 8. 
2. If information becomes available subsequently 
to the competent authority by whatever means indi­
cating that there may be consequences for the risks 
posed by the contained use or for the conditions 
under which the contained use should be carried out, 
the competent authority must re-examine the notifi­
cation and may require the user to provide additional 
information, modify the conditions of, suspend or 
terminate the contained use.' 
Article 11 is replaced by: 
Article 11 
1. The competent authorities shall ensure that, 
where necessary, before an operation commences: 
(a) an emergency plan is drawn up to deal with bio­
logical hazards outside the installation in the 
event of an accident and the emergency services 
are aware of the hazards and informed thereof in 
writing and that the emergency services are 
adequately trained and equipped for dealing with 
such accidents; 
27. 9. 89 Official Journal of the European Communities No C 246/9 
(b) information on safety measures and on the 
correct behaviour to adopt in the case of an 
accident is supplied in an appropriate manner, 
and without their having to request it, to persons 
liable to be affected by the accident. The infor­
mation shall be repeated and updated at appro­
priate intervals. It shall also be made publicly 
available, together with the summary of the 
proposed project. 
The Member States concerned shall at the same 
time make available to other Member States 
concerned, as a basis for all necessary consul­
tation within the framework of their bilateral 
relations, the same information as that which is 
disseminated to their own nationals. 
2. Where the competent auhtority considers it 
appropriate, it may consult groups or the public on 
any aspect of the proposed contained use. 
Article 12 is replaced by: 
'Article 12 
1. Member States shall take the necessary 
measures to ensure that, in the event of an accident, 
the user shall be required immediately to inform the 
competent authority specified in Article 9 and 
provide the following information: 
— the circumstances of the accident, 
— the identity and quantities of the genetically 
modified micro-organism(s) released, 
— any information necessary to assess the effects of 
the accident on the health of the general popu­
lation and the environment, 
— the emergency measures taken, 
— subsequent steps taken to avoid future accidents. 
2. The Member States shall be required to: 
— ensure that any emergency, medium and 
long-term measures necessary are taken, and 
immediately alert any Member States which could 
be affected by the accident, — collect, where possible, the information necessary 
for a full analysis of the accident and ensure that 
measures are taken to avoid similar accidents in 
the future and to limit the effects thereof.' 
Article 13.1. point (c) is modified as follows: 
'(c) 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 gen­
etically modified micro-organisms released, the 
emergency response measures employed and 
their effectiveness, and an analysis of the 
accident including requirements to limit its 
effects and avoid similar accidents in the future.' 
A new Article 14a is inserted: 
'Article 14a 
1. The Commission and the competent authorities 
shall not divulge to third parties any confidential 
information notified or otherwise provided under this 
Directive. 
2. The notifier may indicate the information in the 
notifications submitted under this Directive, the 
disclosure of which might harm his competitive 
position, that should be treated as confidential. Veri­
fiable justification must be given in such cases. 
3. The competent auhtority shall decide, after 
prior consultation with the notifier, which infor­
mation will be kept confidential and shall inform the 
notifier of its decision. 
4. In no case may the following information be 
kept confidential. 
— description of the GMMs, name and address of 
the notifier, purpose of the contained use, and 
location of use; 
— methods and plans for monitoring of the GMMs 
and for emergency response; 
— the evaluation of foreseeable effects, in particular 
any pathogenic and/or ecologically disruptive 
effects.'