PROPOSAL FOR A COUNCIL DECISION CONCERNING THE SUMMARY NOTIFICATION INFORMATION FORMAT REFERRED TO IN ARTICLE 9 OF DIRECTIVE 90/220/EEC
Date: 1991-07-23
Institutions: European Commission
Subjects: environmental protection, genetic engineering, genetically modified organism, public health

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COMMISSION  OF THE EUROPEAN  COMMUNITIES 

C0M(91) 282  final 

Brussels, 23  July  1991 

Proposal  for a 

C O U N C IL  D F C I S t f^ 

CONCERNING IB£ NUMMARY  NOTIFICATION  INFORMATION  FORMAT 

REFERRED IÛ iM A R T i ge £ P£ DIRECTIVE 90/220/EEC 

(presented  by  the Commission) 

lilt 

lbs '.&& 

mm. 

- 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. 

This Decision  is addressed  to the Member  States 

Article 2 

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. 

-  3  -

G E N E R AL 

I N F O R M A T I ON 

-  4 -

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: 

-  5 -

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) 

-  7  -

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) 

i) 
ii) 
ill)  genus 
iv) 
v) 
vl) 
vli)  cultlvar 
vlii) pathovar  (biotype, ecotype,  race, etc.) 
ix) 

species 
subspecies 
stra i n 

common  name 

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 

Mediterranean  !  j  Continental 

ii) No  !~! 

Not  known  i  ! 

-  8 -

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 

- 9 -

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 

, 

Vegetative 

Î  I 

£  d)  In the case of plants: 

I) Mode of  reproduction: 

autogamous 

a Ilogamous 

-  10 -

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 

M i)  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: 

-  111 -

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): 

- 12 -

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, 
modified  organism? 

is 

the  vector  wholly  or  p a r t i a l ly  present 

in 

the 

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 

bacteriophage 

virus 

cosmid 

phasmid 

|  I 

I  ! 

I  I 

i  | 

I  I 

transposable element 

I  I 

other, please specify  î J 

-  13 -

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 : 

-  15  -

C. 

INFORMATION  ON  THE  ORGANISM(S)  FROM  W H I CH  THE  INSERT  IS  DERIVED 
(DONOR) 

Indicate  w h e t h er  It  is a: 

vlrold 

C~ 

RNA virus 

|" 

DNA virus 

I. 

bacterium 

fungus 

plant 

animal 

I  | 

other, please specify 

2.  a)  Complete name: 

order and/or  higher  taxon  (for  animals) 
family name (for plants) 

i) 
ii) 
i i i)  genus 
species 
iv) 
subspecies 
v) 
st ra i n 
v i ) 
v i i)  cultivar 
v i 1 1)  pathovar 
ix) 

common  name 

3. 

Is  the  organism  pathogenic  or  harmful  in  any  other  way  (including 
its  extracellular  p r o d u c t s ),  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 

- 16 -

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 

-  17 -

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., 

-  18 -

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: 

order  and/or  higher  taxon  (for  animals) 
family name  (for  plants) 

I) 
II) 
III)  genus 
iv) 
v) 
vi) 
viI)  cultivar 
viII) pathovar 
ix) 

species 
subspecies 
strain 

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: 

order  and/or  higher  taxon  (for  animals) 
family name  (for  plants) 

i) 
ii) 
ill)  genus 
iv) 
v) 
v i) 
v11)  cu111var 
vi i i) pathovar 
ix) 

species 
subspecies 
strain 

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 

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