27. 9. 89 Official Journal of the European Communities No C 246/5 
II 
(Preparatory Acts) 
COMMISSION 
Modified proposal for a Council Directive on the deliberate release to the environment of 
genetically modified organisms (') 
COM(89) 408 final — SYN 131 
(Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 23 August 1989) 
(89/C 246/06) 
The Commission, on the basis of the opinion delivered by the European Parliament in its first 
reading on 25 May 1989, modifies its original proposal for a Council Directive on the 
deliberate release of GMOs pursuant to Article 149 (3) of the EEC Treaty, as follows: 
A new recital 9a is inserted: 
'Whereas no product containing or consisting of 
GMOs, and intended for deliberate release shall be 
considered for placing on the market without it first 
having been subjected to satisfactory field testing at 
the research and development stage in all the 
ecosystems which could be affected by its use;' 
A new recital 12a is inserted: 
'Whereas, after notification, no deliberate release of 
GMOs shall be carried out unless the consent of the 
competent authorities has been obtained' 
A new recital 12b is inserted: 
'Whereas a competent authority shall only give its 
consent after it has been satisfied that the release will 
have no negative impact on the environment and 
humans' 
Article 2.2. is replaced by the following: 
'2. Genetically modified organism (GMO) means an 
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 1; 
(') OJ No C 198, 28. 7. 1988, p. 19. (ii) the techniques listed in Annex I Part 2, are 
not considered to result in genetic modifi­
cation.' 
A new Article 3.3. is added: 
'3. Member States shall ensure that the competent 
authority organizes inspections and other control 
measures as appropriate, to ensure compliance with 
this Directive, and shall ensure that effective penalties 
are imposed for infringement of this Directive.' 
A new Article 3.4. is added: 
4. Member States shall ensure that adequate infor­
mation is provided in advance of a planned release to 
the inhabitants of the areas concerned.' 
Article 4.6. is replaced by the following: 
'6. In the event of any modification of the deliberate 
release of GMOs which could have consequences 
with regard to the risks for man or the envi­
ronment or if new information has become 
available on such risks, either while the notifi­
cation is being examined by the competent auth­
orities or after consent for the release has been 
obtained, the notifier shall immediately: 
(a) revise the measures specified in the notifi­
cation and adopt all measures necessary to 
protect human health and the environment; 
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-