Sén£ COMMISSION OF THE EUROPEAN COMMUNITIES 
aftf^ C0M(91) 282 final 
Brussels, 23 July 1991 
mm. Proposal for a 
COUNCIL DFCIStf^ 
CONCERNING IB£ NUMMARY NOTIFICATION INFORMATION FORMAT 
REFERRED IÛ iM ARTige £ P£ DIRECTIVE 90/220/EEC 
lilt 
lbs '.&& (presented by the Commission) 
- A h*o -
EEPtANATORY MEMQRANPUM 
In accordance with the procedure laid down in Article 9 of Council Directive 
90/220/EEC*1>, the competent authorities must send to the Commission, 
within 30 days of its receipt, a summary of each notification received. The 
format of this summary must be established by the Commission in accordance 
with the procedure laid down in Article 21. 
The Commission submitted for its opinion the proposed Decision to the 
Committee for the Release of Genetically Modified Organisms to the 
Env i ronment. 
Because the delegations were divided on the issue, the vote of the Committee 
did not reach the required qualified majority and it therefore did not give 
a favourable opinion on the proposal on 5 July 1991. 
Pursuant to Article 21 of Directive 90/220/EEC, the Commission must submit 
without delay the proposal to the Council. 
The Council must act by qualified majority within three months of receiving 
the proposal. 
(1) OJ N* L117, 8.5.1990 
-4Pt 
Proposal for a Council Decision of 1991 concerning the 
Summary Notification Information Format referred to In Article 9 of 
Directive 90/220/EEC. 
THE COUNCIL OF THE EUROPEAN COMMUN IITI ES, 
Having regard to the Treaty establishing the European Economic Community, 
Having regard to Directive 90/220/EEC of 23 April 1990 on the deliberate 
release into the environment of genetically modified organ isms*1), and in 
particular articles 9 and 21 thereof, 
Having regard to the proposal from the Commission 
Whereas the Competent Authorities appointed by the Member States have to 
send to the Commission a summary of each notification received under part B 
of Directive 90/220/EEC, 
Whereas the Comisslon is required to establish, before 23 October 1991 the 
format of this summary, 
Whereas the Committee for the Release of Genetically Modified Organisms to 
the Environment did not give a favourable opinion on the draft of the 
measure which was submitted to it by the Commission, 
HAS ADOPTED THE FOLLOWING DECISION: 
Article 1 
The Competent Authorities appointed by Member States under Directive 
90/220/EEC must use the annexed Summary Notification Information Format when 
sending to the Commission the summary of a notification received, as 
specified under part B of Directive 90/220/EEC. 
Article 2 
This Decision is addressed to the Member States 
Done in Brussels, 
CD OJ N* L117, 8.5.1990 
-1s-
ANNEX 
SUMMARY NOTIFICATION INFORMATION FQRMAT 
FOR QMO RELEASES FOR RESEARCH 
AND DEVELOPMENT PURPOSES 
in accordance with Directive 90/220/EEC 
(Article 9) 
- 2 &*'o — 
INTRODUCTION 
The Summary Notification Information Format has been established for 
the purposes and according to the procedures envisaged by Directive 
90/220/EEC, article 9. 
It is recognised that the Summary Notification Information Format is 
not designed to contain all the information required for carrying out 
an environmental risk assessment in the detail necessary for such an 
assessment. The information entered should, however, adequately reflect 
(in a condensed form) the Information submitted to the Competent 
Authority according to Articles 5 and 6 of Directive 90/220/EEC under 
the conditions specified in the preface to Annex II. The space provided 
after each question is not indicative of the depth of the information 
required for the purposes of the Summary Notification Information 
Format. 
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GENERAL INFORMATION 
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1- Petal!s of Notificatif 
Member State of notification 
Not i f|cat ion number 
Date of acknowledgment of 
not ification 
Title of the project 
Proposed period of release 
2. Notifier 
Name of institution or company 
3. QMO characterisation 
a) Indicate whether the GMO is a: 
viroid 
RNA virus 
DNA virus 
bacterium 
fungus 
plant 
animal 
other, please specify ! ! 
b) Identity of the GMO: 
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4. Is the same GMO release planned elsewhere in the Community (in 
conformity with article 5.1.) ? 
YES | | NO ! | NOT KNOWN 
If Yes. Insert the country cade(s) I. 
5. Has the same GMO been notified for release e I sewhere in the 
CommunIty by the same notifier? 
YES O NO O 
If Yfi&: 
- Member State of notification:: 
- Notification number 
- 6 -
INFORMATION RELATING TO ANNEX II 
(DIRECTIVE 90/220/EEC) 
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A. INFORMATION RELATING TO THE RECIPIENT OR PARENTAL ORGANISMS FROM 
WHICH THE GMO IS DERIVED 
1. Indicate whether the recipient or parental organism is a: 
viroid 
RNA virus 
DNA virus 
bacterium 
fungus 
plant 
animal 
other, please specify ! I 
2. a) Complete name: 
order and/or higher taxon (for animals) 
family name (for plants) 
ill) genus 
iv) species 
subspecies 
stra i n 
vli) cultlvar 
vlii) pathovar (biotype, ecotype, race, etc.) 
ix) common name i) 
ii) 
v) 
vl) 
3. Geographical distribution of the organism: 
a) indigenous to the country where the notification is made 
Yes iZZl No I I Nat known I { 
b) indigenous to other EC countries: 
I ) Yes d\ 
If ves. indicate the type of ecosystem in which it is found: 
Atlantic 
ii) No !~! Mediterranean ! j Continental 
Not known i ! 
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c) is it regularly grown In the country where the notification is 
made? 
Yes !__! No |_| 
d) is it regularly used in the country where the notification is 
made? 
Yes !__! No !__! 
e) is It regularly kept in the country where the notification is 
made? 
Yes }_! No !___! 
4. Natural habitat of the organism: 
M a) if the organism is a microorganism 
water j ! 
soil, free-living I { 
soil in association with plant-root systems 
in association with plant leaf/stem systems 
in association with animals 
other (specify) 
P.A b) if the organism Is an animal or a plant: 
natural habitat or usual agroecosystem: 
5. a) Detection techniques: 
b) Identification techniques 
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6. Is the recipient organism classified under existing Community rules 
relating to the protection of human health and/or the environment? 
YES |~| NO J~| 
If yes, spec Ify : 
7. is the recipient organism pathogenic or harmful In any other way 
(including Its extracellular products), either living or dead? 
YES CZ\ NO \~\ 
if Yes. 
a) to which of the following organisms? 
humans 
an i ma I s 
plants 
b) Give the relevant information specified under Annex II, I l'A I1d/ 
8. Information concerning reproduction: 
a) Generation time in natural ecosystems 
b) Generation time in the ecosystem where the release will take 
place: 
c) Way of reproduction: 
Sexual î J , 
£ d) In the case of plants: 
I) Mode of reproduction: 
autogamous 
a Ilogamous Vegetative Î I 
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ii) In case of allogamy 
wInd po111natIon 
insect polI(nation 
other 
e) Factors affecting reproduction 
9. Survivability 
a) Ability to form structures enhancing survival or dormancy 
I) seeds 
iI) tubers 
Mi) bulbs 
iv) rhizomes 
v) endospores 
vi) cysts 
vii) sclerotia 
viii) asexual spores(fungi) 
ix) sexual spores (fungi) 
x) eggs 
x i) pupae 
xii) larvae 
x) other, please specify 
b) Relevant factors affecting survivability: 
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10. a) Ways of dissemination: 
b) Factors affecting dissemination: 
11. Previous genetic modifications of the recipient or parental 
organism already notified for release in the country where the 
notification is made (give notification numbers): 
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B. INFORMATION RELATING TO THE GENETIC MODIFICATION 
1. Type of the genetic modification: 
i) Insertion of genetic material 
II) Deletion of genetic material 
ill) Base substitution 
iv) Cell fusion 
v) Other, please specify 
2. Intended result of the genetic modification: 
3. a) Has a vector been used in the process of modification? 
Yes CZ\ No \ZZ\ 
If No_, go straight to question 5. 
b) If Yes, is the vector wholly or partially present in the 
modified organism? 
Yes CZ\ No iZZl 
If No, go straight to question 5. 
4. If the answer to 3b is Yes, supply the following Information:: 
a) Type of vector: 
pi asm id | I 
bacteriophage I ! 
virus I I 
cosmid i | 
phasmid I I 
transposable element I I 
other, please specify î J 
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b) Identity of the vector: 
c) Host range of the vector: 
d) Presence in the vector of sequences giving a selectable or 
identifiable phenotype: 
Yes No 
Antibiotic resistance 
Heavy metal resistance 
Other, specify 
e) Constituent fragments of the vector: 
f) Method for introducing the vector into the recipient organism: 
i) transformation 
ii) electroporation 
.ill) macro inject ion 
iv) microinjection 
v) infection 
vi) other, please specify 
14 -
5. If the answer to question B.3.a) and b) is Ua, what was the method 
used to introduce the Insert into the recipient/parental cell? 
I) transformation 
ii) microinjection 
iii) microencapsulation 
iv) macroinjection 
v) other, please specify 
6. Information on the insert: 
a) Composition of the insert: 
b) Source of each constituent part of the insert 
c) Intended function of each constituent part of the insert in the 
GMO: 
d) Location of the insert in the host organism: 
- on a free pi asm id 
- integrated in the chromosome 
- other, please specify 
e) Does the Insert contain parts whose product or function are not 
known? 
Yes !~! No CZ\ 
I f Yes, pI ease spec i fy : 
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C. INFORMATION ON THE ORGANISM(S) FROM WHICH THE INSERT IS DERIVED 
(DONOR) 
Indicate whether It is a: 
vlrold C~ 
RNA virus |" 
DNA virus I. 
bacterium 
fungus I | 
plant 
animal 
other, please specify 
2. a) Complete name: 
i) order and/or higher taxon (for animals) 
ii) family name (for plants) 
i i i) genus 
iv) species 
v) subspecies 
v i ) st ra i n 
vii) cultivar 
vi11) pathovar 
ix) common name 
3. Is the organism pathogenic or harmful in any other way (including 
its extracellular products), either living or dead? 
YES CZ\ NO i~! NOT KNOWN !~! 
if yes, specify the following: 
a) to which of the following organisms? 
humans 
animals 
plants 
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b) are the donated sequences Involved in any way to the pathogenic 
or harmful properties of the organism? 
YES SZZS NO CZ\ NOT KNOWN CZ\ 
if yes, give the relevant information under Annex II. I l'A, ltd: 
4. is the donor organism classified under existing Community rules 
relating to the protection of human health and the environment? 
YES |ZJ NO ilj 
If yes, please specify: 
5. Do the donor and recipient organism exchange genetic material 
naturally? 
YES I I NO ! ! Not known |"Zj 
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D. INFORMATION RELATING TO THE GENETICALLY MODIFIED ORGANISM 
1» Genetic traits and phenotyplc characteristics of the recipient or 
parental organism which have been changed as a result of the 
genetic modification: 
a) Is the GMO different from the recipient as far as survivabi I ity 
Is concerned? 
YES | I NO 
if Yes, please specify: 
b) is the GMO in any way different from the recipient as far as 
mode and/or rate of reoroduct ion is concerned? 
YES |~! NO ! ! Not known | | 
if Yes, please specify: 
c) is the GMO in any way different from the recipient as far as 
disséminât ion is concerned? 
YES CZ\ NO i i Not known | ! 
if Yes, please specify: 
2. Genetic stability of the genetically modified organism: 
3. Is the GMO pathogenic or harmful in any other way (including its 
extracellular products), either living or dead? 
YES !~! NO ! ! Not known ! i 
if YfiS., 
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a) to which of the following organisms? 
humans 
animals 
plants 
b) Give the relevant Information specified under Annex II, IIA 11d 
and IIC 2(i) 
4. Description of Identification and detection methods: 
a) techniques used to detect the GMO in the environment 
b) techniques used to identify the GMO: 
- 19 -
E. INFORMATION RELATING TO THE RELEASE 
1. Purpose of the release: 
2. Is the site of the release different from the natural habitat or 
from the ecosystem In which the recipient organism is regularly 
used, grown, kept or found? 
YES ! i NO ! I 
if Yes, please specify: 
3. Information concerning the release and the surrounding area: 
a) Geographical location (administrative region and where 
appropriate grid reference): 
b) Size of the site (m2): 
i) actual release site (m2): 
il) wider release area (m2): 
c) Proximity to internationally recognised biotopes or protected 
areas (including drinking water reservoirs), whIch cou Id be 
iffected: 
d) Flora and fauna including crops, livestock and migratory 
species which may potentially interact with the GMO: 
- 20 -
4. Method and amount of Release: 
a) Quantities of GMOs to be released: 
b) Duration of the operation: 
c) Methods and procedures to avoid and/or minimize the spread of 
the GMOs beyond the site of the release: 
- 21 -
F. INTERACTIONS OF THE GMO WITH THE ENVIRONMENT AND POTENTIAL IMPACT 
ON THE ENVIRONMENT 
Complete name of target organisms: 
I) order and/or higher taxon (for animals) 
II) family name (for plants) 
III) genus 
iv) species 
v) subspecies 
vi) strain 
viI) cultivar 
viII) pathovar 
ix) common name 
Anticipated mechanism and result of interaction between the 
released GMOs and the target organism: 
3. Other potentially significant interactions with other organisms in 
the environment: 
4. Is post-release selection for the GMO likely to occur? 
YES O NO lZJ ~ 
if Yes, give detaiIs: 
5. Types of ecosystems to which the GMO could be disseminated from the 
site of release and in which it could become established: 
- 22 -
6. Complete name of non-target organisms which may be effected 
unwittingly: 
i) order and/or higher taxon (for animals) 
ii) family name (for plants) 
ill) genus 
iv) species 
v) subspecies 
v i) strain 
v11) cu111var 
vi i i) pathovar 
ix) common name 
7. Likelihood of genetic exchange in vivo 
a) from the GMO to other organisms in the release ecosystem: 
b) from other organisms to the GMO: 
8. Give references to relevant results from studies of the behaviour 
and characteristic of the GMO and its ecological Impact carried out 
in simulated natural environments (e.g. microcosms, etc.): 
- 23 -
G. INFORMATION RELATING TO MONITORING 
1. Methods for monitoring the GMOs : 
2. Methods for monitoring ecosystem effects: 
3. Methods for detecting transfer of the donated genetic material from 
the GMO to other organisms: 
4. Spatial extent of the monitoring area (m2) 
5. Duration of the monitoring: 
6. Frequency of the monitoring: 
- 24 -
H- INFORMATION ON POST-RELEASE AND WASTE TREATMENT 
1. Post-release treatment of the site: 
2. Post-release treatment of the GMOs: 
3a) Type and amount of waste generated: 
3b) Treatment of waste: 
- 25 -
I. INFORMATION ON EMERGENCY RESPONSE PLANS 
1. Methods and procedures for controlling GMOs in case of unexpected 
spread: 
2. Methods for decontamination of the areas affected: 
3. Methods for disposal or sanitation of plants, animals, soils etc. 
that were exposed during or after the spread: 
4. Plans for protecting human health and the environment in case of 
the occurence of an undesirable effect: 
**** 
ISSN 0254-1475 
COM(91) 282 final 
DOCUMENTS 
EN 01 
Catalogue number : CB-CO-91-326-EN-C 
ISBN 92-77-74667-X 
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