REPORT ON THE REVIEW OF DIRECTIVE 90/220/EEC IN THE CONTEXT OF THE COMMISSION'S COMMUNICATION ON BIOTECHNOLOGY AND THE WHITE PAPER
Date: 1996-12-10
Institutions: European Commission
Subjects: EC Directive, biotechnology, labelling, marketing, product safety

COMMISSION OF THE EUROPEAN  COMMUNITIES 

Brussels,  10.12.1996 
COM(96)630  final 

REPORT 
ON THE REVIEW OF 
DIRECTIVE 90/220/EEC 
IN THE CONTEXT OF THE COMMISSION'S 
COMMUNICATION  ON  BIOTECHNOLOGY 
AND THE WHITE  PAPER 

(presented by the Commission) 

A. 

INTRODUCTION 

In the European  Union the safety  of activities involving modern biotechnology is 
currently  ensured  through  four  horizontal  Directives  (Directives  90/219/EEC, 
90/220/EEC,  90/679/EEC  and  94/55/EC)  and  a  number  of  other  sectoral 
Directives/Regulations  (see  Annex  I). 

While  Directive  90/219/EEC  covers  the  contained  use (i.  e.  use  in  research  and 
industrial  facilities)  of genetically  modified  micro-organisms  (GMMs), Directive 
90/220/EEC  covers  the  deliberate  release  into  the  environment  of  genetically 
modified  organisms  (GMOs).  The  latter  covers  both  deliberate  releases  for 
experimental  purposes,  and  deliberate  releases  for  placing  on  the  market  of 
products.  Directive  90/220  already  foresees,  in  its  article  10(2),  that  product 
legislation  could  replace the environmental  risk  assessment  provided  for  by Part 
C of this Directive. This approach, known as "one door, one key" policy, aims at 
ensuring  that  one  assessment  and  notification  procedure  are  sufficient  for  the 
purposes  of  marketing  products  containing  or  consisting  of  GMOs.  Under  this 
policy,  products  containing  or  consisting  of  GMOs  will  be  subject  to  specific 
product  legislation,  which  will 
include  a  risk  assessment  similar  to  the  one 
provided  for  by  Directive  90/220/EEC,  while  being  specific  with  regard  to  the 
intended  use  of  product.  Annexes  I  and  II  of  this  Report  contain  a  list  of 
Community  legislation,  adopted  or under development,  relevant  for  the purposes 
of the  "one door,  one key"  policy. 

In  its  Communication  on  Biotechnology  and  the  White  Paper  on  Growth, 
Competitiveness  and  Employment  (June  1994),  the  Commission  recognises  the 
importance of modern  biotechnology,  and  confirms  that  "in the future  the whole 
network of interrelated biotechnological regulations needs to ensure that oversight 
is always appropriate to the risks involved, the building of public confidence  and 
to the competitive development  of the industries involved  while guaranteeing the 
protection of human health and the environment.1 "On this basis, the Commission 
confirmed  its  opinion"  that  the  following  two-track  approach  for  the  future 
development  of the biotechnological  regulatory  framework  should  be  applied: 

• 

• 

of 

exploitation 

the 
revising 
measures/procedures/degree  of oversight/requirements,  through use of the 
"light"  procedure  of  adaptation 
to  technical  progress  (Regulatory 
Committee Procedure).  (Internal  amendment); 

possibilities 

existing 

for 

the  bringing  forward  of  amendments  to  existing  legislation  in  order  to 
incorporate  changes  which  cannot  be  achieved  by  technical  adaptation 
while  leaving  the  basic  structure  of  the  framework  intact  (external 
amendment)"1 

Biotechnology and the White Paper on Growth, Competitiveness and Employment, 
preparing the next stage. Communication from the Commission to the CouncH, the 
European  Parliament  and the Economic  and  Social  Committee,  p. 3 

As  far  as  Directive  90/220/EEC  was  concerned,  the  Communication  concluded 
that  this  "Directive  was  flexible  enough  to  satisfy  the  needs  of  the  time  for 
adaptation  to  technical  progress  and  simplification  of  the  procedures,"  but  it 
concluded that "there were aspects of this Directive that might be improved  in the 
future/" 

It  is  in  this  context  that  the  Commission  undertook  to  carry  out  a  review  of 
Directive 90/220/EEC with the aim of assessing the need for proposals in relation 
to the following  objectives  outlined  in the  Communication: 

"1) 

2) 

3) 

extending the flexibility  of Directive 90/220/EEC, so that its scope and the 
procedures to be followed are always appropriate to the risks involved, and 
are easily  adaptable; 

strengthening more uniform  decision-taking between Member States in the 
case of research  and  development  releases; 

introducing  further  opportunities  for  notifiers  (industry  and  researchers), 
so that they can benefit  more from  the existence of a uniform  community 
system; 

4) 

facilitating  the  link between  this  Directive  and  product  legislation !l3 

Experience  gained  since the implementation  of the Directive,  has led to a better 
understanding  of  its  functioning.  In  particular  discussions  with  the  Competent 
Authorities  under  this Directive  as well  as with  interested  parties  has  helped  to 
identify  problems and possible ways of addressing them. This experience was not 
sufficient  to carry  out  a review  of Directive  90/220/EEC  during the first  half  of 
1995 as foreseen  in the Commission's Communication  on Biotechnology  and the 
White Paper  on Growth,  Competitiveness  and Employment.3 

This  document  presents  the  results  of  the  review  exercise  which  includes 
consultations  with  the  Competent  Authorities  of  Member  States,  Industrial  and 
Research Associations, Environmental, Consumer and Trade Union Organisations 
This Analysis  carried  out below  has taken  into account  international  experience 
in this  field. 

Biotechnology and the White Paper on Growth, Competitiveness and Employment, 
preparing the next stage. Communication from the Commission to the Council, the 
European  Parliament  and the Economic  and  Social  Committee,  p. 5 
Biotechnology and the White Paper on Growth, Competitiveness and Employment, 
preparing the next stage. Communication from the Commission to the Council, the 
European  Parliament  and the Economic  and  Social  Committee,  p. 6 

B.  ANALYSIS OFimRJNCtimm<? QFPIRIXZnMkmW 

Directive  90/220/EEC  came  into  force  on  23  October  1991.  Since  then  747 
experimental  releases  have  been  notified  to  Member  Sûtes  Authorities  and  16 
product  notifications  have been  submitted  so  far  (see Annex  III). Although  this 
might look impressive, it has to be seen in perspective of international  experience 
elsewhere  (see annexe IV.) 

Fait A Of Directive 9Q/32Q/EEC;  General Provisions 

Part A of Directive  90/220/EEC  mainly  defines: 

a) 

the scope of this legal instrument.  More  specifiailly: 

the  circumstances  under  which  Directive  90/220/EEC  applies 
(Article  1  and  definitions  for  the  terms  "deliberate  release", 
"product",  " placing  on the market",  "use" provided  in Article 2); 

• 

organisms  to  which  Directive  90/220/rEEC  applies  (Article  2: 

definitions  of  "organism"  and  "GMO", Article  3 exemptions); 

b) 

the  obligations  of Member States. 

Regarding part  A, the analysis carried  out has identified  the following  points: 
• 

Experience  shows  that  some  of  the  definitions  in  article  2,  in  particular 
those  of  "placing  on  the  market"  and  "deliberate  release",  cause  some 
implementation  problems. 

More  recently,  it  has  been  suggested  that  Article  1 paragraph  1 second 
indent,  which  is  closely  linked  to  the  definition  of  "deliberate  release", 
does not  indicate  unequivocally  the  circumstances  under which  products 
fall  under Directive 90/220/EEC. The pragmatic approach followed  so far 
should  be  adapted  to  address  the  issue,  which  involvesd  a  case-by-case 
examination. 

• 

Although the whole Directive  is supposed to be concerned  with the 
assessment of risks for human and the environment, the risks covered and 
the criteria  for  such a risk assessment  are not specified.  It is to be noted 
that  product  legislation  (pharmaceuticals,  foods,  etc.)  has  traditionally 
defined  the  objectives  of  the  assessments  to  be performed  under  it. It  is 
hence  necessary  to  incorporate  these  objectives  in  the  Directive  and  in 
product legislation,  in order to strengthen harmonisation and to avoid that 
authorities  of Member  States  reach different  conclusions  on the basis of 
the same  information. 

Furthermore, the  principle  of  a scientific risk/benefit evaluation  needs to 
be  introduced  in  order  to  clarify  which  side  -  effects  of  certain  types of 
releases  would  be  acceptable,  thus  allowing  authorities  to  establish  the 
overall  beneficial  effect  or the release. 

Part  B of  Directive  90/220/EEC:  Deliberate  release  of  GMOs  into  the 
environment for research and development purposes or for any other purpose 
than for  placing  on the  market 

Part  B of Directive 90/220/EEC  defines  the procedure that  has to be followed  in 
the case of experimental  release into the environment  of GMOs (i. e.  submission 
of  a  notification,  potential  data  requirements,  risk  evaluation,  exchange  of 
comments/information  between  Member  States,  granting  of  consent  by  the 
competent  authority). 

a) 

Risk  categories  and  administrative  procedures 

similar 

At the time of the adoption of Directive 90/220/EEC there had been very 
little  experience,  and  it  was  considered,  that  all  GMO  releases  would 
potentially  present 
this  background  one 
administrative  procedure  for  research  and  development  releases  was 
foreseen.  The procedure has helped Member State Authorities to establish 
the  infrastructure  for  overseeing  this  fast-moving  sector,  and  has  built 
confidence  in  the  public  that  there  is  an  instrument  available  to  address 
risk issues 

risks.  Against 

However,  the  experience  gained  on  the  basis  of  practices  already 
implemented  at  industrial  level  indicates  that,  while  keeping  a case-by-
case  approach,  it  is  necessary  to  establish  a classification  commensurate 
with  the  identified  risks  involved  in  the  release.  Indeed,  it  is  currently 
demonstrated  that  not  all  releases  pose  the  same  level  of  risk  and, 
consequently,  do not merit the  same level  of administrative  oversight. 

Such  classification  would  allow to lay  down  administrative  requirements 
that are in all cases proportionate to the risk identified,  thereby eliminating 
unjustified  administrative  burden  without  lowering  safety  standards. 

The current Directive does not allow for  any classification  of risk and for 
differentiation  of  administrative  requirements  according  to  the  risks 
involved. Such a classification  should be introduced and the administrative 
procedures  commensurate  to  the  risks  involved.  This  approach  has  been 
already  applied  elsewhere  in the world. 

b) 

Simplified  procedures 

The  Directive  foresees  the  possibility  to  adopt  simplified  procedures 
(Article  6.5.),  in  cases  where  certain  criteria  are  met.  This  possibly  has 
only  been  used  once,  in  order  to allow  for  a  single  notification  to  cover 
the  release  of  a  combination  of  specific  genetically  modified  plants  on 
different  sites.  Although  it  is  true  that  the  possibilities  for  simplified 
procedures  may  not  have  been  fully  exploited,  the  present  situation 

illustrates  the  shortcomings  of  the  possibilities  for  simplification  as 
currently  foreseen  by the Directive: 

The fact that only one simplified procedure has been so far adopted 
demonstrates  that the procedure  for  proposing  and  adopting them 
is  cumbersome,  and  certainly  does  not  meet  the  need  for  rapid 
adaptation  in  the biotechnology field. 

these simplified  procedure cannot  replace the need for  a clear and 
well  defined  classification  system  linked  to  the  risk  involved. 
Furthermore  the  possibility  for  proposal  of  simplified  procedure 
should be extended  to all  parties involved. 

c) 

Multi-State procedures 

Directive  90/220/EEC  does  not  provide  for  the  possibility  of  a  single 
procedure for  multi-State releases. As the field develops it becomes more 
and  more necessary  to test  GMOs in  more than  one Member  State. Such 
a  procedure  would  be  especially  advantageous  for  SMEs,  which  are 
usually  not based  in more than  one Member  State. 

It is therefore  necessary  to have such a provision  introduced. 

d) 

Risk  assessment 

At the time of adoption  of the Directive it was not possible to specify  the 
basis of the risk assessment, that has to be carried  out,  (see above) or the 
methodology  to  be  followed  and  the  safety  standards  that  have  to  be 
satisfied  in the text of the Directive. Although the system of the Directive 
works  even  in  the  absence  of  commonly  accepted  objectives  and 
methodology, it has to some degree led to lack of harmonization  in  safety 
standards  in Member  States.  Consequently,  a notifier  has to comply with 
different  requirements when  releasing in  different  Member  States. 

With  the  accumulated  knowledge  and  experience  it  is  now  possible  and 
necessary 
to  establish  centralised  definition  of  the  objectives  and 
methodology  of the risk assessment. 

e) 

Exchange  of  information  between  Member  States 

Article 9 specifies  that  exchange of information  on experimental  releases 
should take place. This is already happening,  and the Commission  intends 
to  set  up  a  database.  Experience  gained  with  over  700  experimental 
releases notified to Member State authorities shows that it would be useful 
for  the  Commission  to  receive  appropriate  information  concerning  the 
subsequent  approval  of  products  in  order  to  circulate  this  to  Member 
States.  This  would  enable  Member  States  to  have  information  about 
assessment  on  safety  of  products and  more  specifically  the results of the 
releases. 

Therefore  strengthened provisions on the issue of exchange of information 
between  Member  States should be  introduced. 

f) 

Link between  experimental  and product  releases 

The Directive foresees that experimental  releases of GMOs should pose no 
risk to human  health and the environment under the purpose or conditions 
in  accordance  with  Article  6.  It  could  be  explored  how  the  experience 
gained  under  part  B could  be  used  for  possible  environmental  problems 
that could  arise at the stage of commercialisation.  This could  be done by 
collecting  information  or data to address them.  (See paragraph  e) above.) 

Therefore,  the  possibility 
could  be  explored  of  introducing  in  the 
Directive  an  incentive  or  an  obligation  to gather  data/information  which 
could  be  of  relevance  to the  subsequent  evaluation  of the  GMO in  view 
of  its  placing  on  the  market  as  product  under  part  C  of  Directive 
90/220/EEC or under the relevant  product  legislation,  as appropriate. 

releases  of  GMOs  and  refers 

It is worth underlining that in the case of placing on the market of GMOs, 
Community  legislation on products currently discussed in the Council and 
the Parliament  does not foresee  a specific  environmental  risk  assessment 
for  research  and  experimental 
to 
"authorisations  that  have  been  given  to  part  B  releases  under  Directive 
90/220/EEC"  Therefore,  it  could  be  useful  that  the  assessment  of  the 
environmental  effects  of  GMOs to be  placed  on  the  market,  be prepared 
and,  if  possible,  be  completed  at  the  research  and  development  stage 
under  Directive  90/220/EEC.  Therefore,  in  certain  cases  the  possibility 
should  be  explored  of  including  into  product  legislation  which  already 
foresees  an environmental  and human  health assessment  for  experimental 
releases of products under  development,  a risk assessment  similar to that 
laid  down  in  part B of Directive 90/220/EEC. 

Part  C of  Directive  90/220/EEC:  Placing  on  the  market  of  products 
containing  GMOs 

Part C of Directive 90/220/EEC defines  the procedure to be followed  in the case 
of the placing on the market of products containing or consisting  of GMOs. This 
procedure  involves  the  submission  of  a notification  to  a competent  authority  of 
the  choice  of  the  notifier,  and  in  the  case  of  a  favourable  opinion  by  this 
authority,  involvement  of  all  the  other  authorities  and  possibility  to  raise 
objections  within  a  set  deadline.  In  the  case  of  an  objection  being  raised  the 
Commission  has to table  a proposal  for  a decision. 

a) 

Risk  categorisation  and  administrative  procedures 

Since the entry  into force  of the Directive,  16 applications for  placing on 
the  market  of  products  containing  or  consisting  of  GMOs  have  been 
submitted  under  this  Directive.  The  administrative  procedure  which  the 
Directive foresaw as the general rule (marketing possible after the 90-days 
period during which CAs may comment) has not been used a single time. 

In one case, it has even be necessary  for the Commission  to submit to the 
Council  a proposal  for  a Council  decision  (Maize).  So far the assessment 
carried  out  by  one  Competent  Authority  to  which  the  notification  was 
submitted,  has  not  been  able  to  satisfy  all  other  Competent  Authorities, 
which again carry out their own assessment, often  on the basis of  different 
criteria  (see  analysis  concerning  part  A).  It  should  also  be  noted,  that 
although deadlines are given  to Member States for examining the dossiers 
and pronouncing their opinion, no deadlines are given to the Commission 
despite its crucial role in the granting of consents for products. Experience 
has  shown  that  the  procedure  followed  is  difficult  to  implement,  time-
consuming,  and  cumbersome  to follow  both  for  users and  authorities. 

Furthermore,  the  Directive  foresees  only  one  procedure  which  is 
indistinctly  applied  to  all  types  of  products,  irrespective  of  the  risk 
identified  or whether  similar  products are already  on the market. It has to 
be  remembered  that  in  this  fast-moving,  high-tech  field,  not  only  future 
notifications  but  also  current  ones  already  concern  products  which  are 
similar to authorised ones in the EU, as well as products which themselves 
have been  used elsewhere in the world and which have proven to be safe 

There is therefore  a need to provide for  streamlined  procedures for  those 
products  posing  no,  negligible  or  low  risk.  Such  a  possibility  exists 
elsewhere  in  the  world.  For  example,  there  are  GMOs  -  with  which 
familiarity  exists (along the lines of the concept  of familiarity  as  defined 
within OECD work,  especially  for the assessment of genetically  modified 
crop plants). 

The  establishment  of  categories  according  to  the  risk  identified,  the 
streamlining  of  administrative  procedures  in  those  cases  where  no, 
negligible or low risk is involved, without lowering the safety level, should 
be  introduced.  In  the  same  time,  the  Commission  should  consider  an 
adaptation of its internal  rules in order to speed its stage of the procedure. 

It  should  also  be  noted  that  the  current  procedure  according  to  which 
notifiers  have no other  option  but to submit a new notification  to another 
Member  State  in  case  of  an  unfavourable  opinion  by  the  authorities  to 
which  they  had  first  submitted  the  notification,  is  disadvantageous  for 
SMEs as they  are not based  in  more than  one country. 

b) 

Risk  assessment  and  scientific  advice 

The lack  of  a common  definition  of the  objectives  and  the  methodology 
of  the  risk  assessment  (see  analysis  concerning  part  B)  allows  Member 
States to carry out a risk assessment on the basis of different  criteria. This 
is  one  reason  for  the  delivery  of diverging  opinions  and the  difficulty  in 
reaching  consensus  among Member  States. 

These  questions,  have  to  be  further  clarified  in  particular,  by  including, 
along  the  lines  of  what  is proposed  for  Part  B,  a  clear  definition  of  the 
objectives  and  methodology  of the risk  assessment. 

In  any  case,  and  in  view  of the fact  that  in the future  the  environmental 
assessment  for  many  products  currently  covered  by  part  C  of  Directive 
90/220/EEC,  will  be  carried  out  under  appropriate  sectoral  legislation 
(where it exists), it is of utmost  importance that the objectives  of the risk 
assessment  be clearly  defined  for  the following  reasons: 

i) 

ii) 

sectoral  Community  legislation  will  foresee  an environmental risk 
assessment "similar to that foreseen by Directive 90/220/EEC" (i.e. 
without  lowering  safety  standards).  If  the  objectives  of  this 
assessment  is  not  clarified  enough  in  Directive  90/220/EEC,  the 
current problems concerning the assessment of risks of GMOs will 
be transferred  to  sectoral  legislation; 

well  defined  objectives  in  Directive  90/220/EEC  will  ensure  that 
the risk assessment  is carried  out on the same basis throughout all 
stages of the  development  of a product  containing GMOs. 

Currently,  the  Directive  does  not  provide  the  possibility  to  discuss,  at 
Community  level,  scientific  controversy  within  an  independent  scientific 
group,  as it  is the  case in  Community  legislation  dealing  with  marketing 
authorisations  (foods,  pharmaceuticals,  feed,  etc.).  This  leads  to  an 
anomalous situation where application controversy cannot be dealt with by 
an independent system of conflict  resolution which would allow to discuss 
and  solve  problems  on  a scientific  basis. This  specific  issue merits to be 
specifically  considered  in  the  context  of  developing  a  proposal  for 
amendment  to the  Directive 

c) 

Labelling 

The  issue  of  labelling  of products  under Directive  90/220/EEC  has been 
the subject  of controversy.  Some Member  State Authorities  object  to the 
placing  on the market  of a product  whose labelling  will  not indicate that 
it is genetically  modified.  The current  provisions  of the Directive  do not 
allow  the  imposition  of  such  labelling  in the  absence  of  any  link  to  risk 
assessment.  Specific  provisions  on  labelling  are,  however,  foreseen  in 
product  legislation. 

It will  be  essential  to  address this issue in  order to take into  account the 
need to inform  consumers and to comply with the international  obligations 
of  the  Community.  The  issue  of  labelling  will  be  considered  when 
preparing the amendment of Directive 90/220/EEC and the final provisions 
of other  relevant  product  legislation  will  be taken  into account. 

Part  D and Annexes of Directive 90/220/EEC: 

The flexibility of the Directive  appears to be  limited  as it  does not  provide  for 
easy adaptation to technical  progress of one of its Technical  Annexes  In a so fast-
moving and  continually  evolving  field,  it  is important  to ensure that Community 
provisions  are  always  based  on  the  latest  stage  of  experience  and  scientific 
knowledge.  Therefore,  the  possibility  of  adapting  all  annexes  of  the  Directive 
though  a Regulatory  Committee Procedure,  could  enhance flexibility and permit 
timely  adaptation  of  these  highly  technical  parts  of  the  Directive  to  rapidly 
advancing  scientific  and technical  progress. 

C. 

CONCLUSIONS 

Directive  90/220/EEC  regulates  a  high-technology  field,  which  is  developing 
rapidly.  The Directive  covers both the stages of development  and placing on the 
market  of  products  containing  GMOs.  In  this  light,  there  is  a  need  for  regular 
updating and adaptation of this Directive in order to keep pace with scientific and 
technological  progress. 

Directive  90/220/EEC  has helped  Member  States to introduce the  infrastructure 
for  assessing  potential  human  health  and  environmental  effects  from  the placing 
on the market  of products containing GMOs, but its implementation  has revealed 
a number  of problem  areas. These  include 

• 

• 

• 

• 

• 

• 

• 

• 

insufficient  clarification  concerning  the  objectives  for  risk  assessment, 
which  has  hindered  full  harmonisation  between  Member  States  at  the 
research  and  development  stages  and  which  has  led  to  disagreements 
between Member States at the stage of placing on the market of products; 
absence of a risk classification  as well as of a link between administrative 
procedures  and  identified  risk,  which  may  result  in  cumbersome 
procedures for  low risk releases; 
weak  link  between  parts B and  C of  the Directive,  which  means that 
experimental  releases  under  part  B  do  not  always  provide  the  relevant 
data  for  the  environmental  assessment  necessary  for  the  placing  on  the 
market under part C; 
cumbersome administrative procedures and approval system for placing on 
the market  of products, which  have led to delays in approving products; 
absence  of  an  active  role  for  the  Commission  on  a  number  of  aspects, 
including the right to propose  simplified  procedures and to  acknowledge 
part  C  dossiers  and  objections,  which  has  led  to  delays  in  exploiting 
existing  possibilities  for  simplification  and to  problems  in  implementing 
part C; 
absence  of  a  possibility  to  resolve  controversy  through  consultation  of 
independent  Scientific  Committee(s),  which  has  caused  problems  in 
implementing  part C; 
absence  of  sufficient  flexibility  for  technical  adaptation,  which  prevents 
regular updating  of the Directive to  scientific  and technical  progress; 
current  labelling requirements. 

10 

Recognising  the above-mentioned  points and the need for  a regulatory  horizontal 
framework  sufficiently 
level  of 
environmental  and  human  health  safety  and  transparency,  while  facilitating  the 
development of this important technology, the Commission intends to adopt in the 
course  of  1997 a Proposal  for  an amendment  of Directive  90/220/EEC. 

flexible  and  specific 

to  ensure  a  high 

At  the  same  time,  while  undergoing  the  procedure  for  adopting  an  amended 
Directive, which will involve a co-decision of the Council and the Parliament, the 
Commission is committed to making full use of all the tools and flexibility  of the 
current  Directive. More specifically  the Commission will 

• 

• 

• 

• 

intensify  the  work  of  the  Risk  Assessment  Group  established  in  the 
framework  of the Committee of Competent Authorities, so that a common 
approach  to risk assessment  objectives  and methodology  can be  adopted 
as guidance  in March  1997; 
encourage  and  facilitate  the  submission  by  Competent  Authorities  of  a 
proposal  for  simplified  procedure  allowing  multi-State  experimental 
releases of certain  GMOs to take place under a single consent; 
the  preparation  of 
facilitate 
implementation  of Directive 90/220/EEC; 
take a proactive role in the case of product notifications and encourage the 
exchange  of  views  between  competent  authorities  much  earlier  than 
foreseen  in the Directive; 
ensure  that  its internal procedures  will  be applied  in an efficient  manner 
to ensure the  speedy adoption of Decisions on products. 

teclinical  documents 

through 

the 

11 

A. 

HORIZONTAL LEGISLATION COVERING THE SAFE USE OF MODERN  BIOTECHNOLOGY 

Annex I 

• 

• 

• 

• 

Directive 90/219/EEC on the contained use of genetically modified  micro 
organisms (GMMs) 

Directive  90/220/EEC  on  the  deliberate  release  into  the  environment  of 
genetically  modified  organisms (GMOs). 

Directive 90/679/EEC on the protection  of workers from  the risks related 
to exposure  of workers to biological  agents at work. 

Directive  94/55/EC  on  the  transport  of  dangerous  goods  by  road,  where 
GMMs are classified  as infectious  substances for the purposes of transport. 

B. 

SECTORAL LEGISLATION COVERING THE SAFETY CTHMDUCTS OF MODERN BKHECH^OLOGY 

• 

• 

• 

• 

Council  Regulation 93/2309/EEC laying down Community procedures for 
the  authorisation  and  supervision  of  medicinal  products  for  human  and 
veterinary  use and  establishing  a European  Agency  for  the evaluation  of 
medicinal  products. 

Directive 91/414/EEC concerning the placing of plant protection  products 
on  the  market  (needs  to  be  amended  to  incorporate  the  environmental 
safety  of GMOs). 

Directive  93/114/EEC  amending  Directive  70/254/EEC  concerning 
additives in feeding  stuffs. 

Directive 94/40/EC amending Directive 87/153/EEC fixing  guidelines for 
the assessment  of additives in  animal  nutrition. 

12 

Annex H 

Sectoral legislation currently at the stage of discussion in the Council and the 
Parliament 

• 

• 

Proposal  for a Council  Regulation  concerning novel  foods  and novel  food 
ingredients. 

Proposal  for  a  Council  Directive  amending  Directives  66/400/EEC, 
66/401/EEC,  66/402/EEC,  66/403/EEC,  69/208/EEC,  70/457/EEC  and 
70/458/EEC on the marketing of beet seed, fodder  plant seed, cereal seed, 
seed potatoes,  seed of  oil  and fibre plants  and vegetable  seed and on the 
common  catalogue of varieties of agricultural  plant species. 

13 

GENETICALLY  MODIFIED  PRODUCTS  PLACED  ON  THE  MARKET  IN  EUROPE 
STATE  OF  PLAY  IN  SEPTEMBER 

ANNEX  III 

A. 

Approved  products: 

Product 

Notifier 

Date  of Commission  Decision 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

I

Vaccine against 
Aujeszky's  disease 

Vernie Veterinàr Chemie 
GmbH 

Vaccine against  rabies 

Rhône-Mêrieux 

Tobacco  tolerant to 
bromoxynil. 

SEITA 

Vaccine  against 
Aujeszky's  disease 
(further  uses) 

Vernie Veterinàr  Chemie 
GmbH 

Oilseed  rape resistant to  Plant Genetic  Systems 
glufosinate  ammonium 

Soybeans tolerant to 
glyphosate 

Male sterile  chicory 
tolerant to  glufosinate 

Monsanto 

Bejo-Zadcn  BV 

ammonium 

18.12.92 

19.10.93 

08.06.94 

18.07.94 

06.02.96 

03.04.96 

20.05.96 

14 

B. 

PENDING  APPROVALS: 

I 

2. 

3. 

4. 

5. 

(» 

7. 

8 

9. 

Product  and  date  of  receipt  by  the  Commission 

Maize tolerant  to glufosinate  ammonium  and expressing  CrylA  endotoxin 
(15.03.95) 

Oilseed  rape tolerant to glufosinate  ammonium 
(20.07.95) 

* uses:  no conditions. 

Oilseed  rape tolerant to  glufosinate  ammonium  (Extension  of previous 
Com.  Decision  to other uses,  including  food  processing) 
(2007 95) 

Oilseed  rape tolerant to glufosinate  ammonium 
(03 05 96) 

* uses:  - 

import  of seed  for  processing, 
growing  for breeding, 
field  cropping  for grain. 

Maize tolerant  to glufosinate  ammonium 
(24.05.96) 

*uses:  no conditions 

Maize expressing  CrylA endotoxin 
(2405%) 

*uscs:  no conditions 

Test kit to detect antibiotic  residues in milk  * Streptococcus, thermophilus 
with luxA 
and  luxB and expressed  cat gene coding for  resist, to  chloramphenicol 
(11.06.96) 

Insect  resistant  maize 
(06.08.96) 

'''uses:  no conditions 

Notifier 

Ciba-Geigy 

Plant  Genetic 
Systems 

Plant  Genetic 
Systems 

AgrEvo 

AgrEvo 

Monsanto 

Valio Oy 

Pioneer 

Male sterile chicory tolerant to glufosinate  ammonium 
(20.09.96) 

Bejo-Zaden 
BV 

*uscs:  food  and  feed 

I 

15 

GENETICALLY  MODIFIED  PRODIK  IS  PLACED  ON  THE  M A R K ET  OUTSIDE  OF  EUROPE 

STATE  OF  PLAY  IN  SEITEMIIEU 

Product 

Notifier 

Country  giving  approval 

ANNEX 

ÏV 

1.1 

1.2 

I  3 

1.4 

Phosphinothricin 
tolerant  soybean 

AgrEvo 

PRV  resistant  Papaya 

Cornell  U 

CMV,  WMV?  and 
/VMV  icsisla.nl  squash 

Asgrow 

Potato  resistant 
Colorado  potato  beetle 

to 

Monsanto 

1.5 

Ripening  altered  tomato  Agritope 

Sulfonylurea  tolerant 
cotton 

Du  Pont 

I  6 

1.7 

USA 

USA 

USA 

USA 

USA 

USA 

Male  sterile 
phosphinothricin 
tolerant  corn 

Plant  Genetic  Systems 

USA 

1.8 

Corn  resistant  to 
European  com  borer 

Northmp  King 

1.9 

Ripening  altered  tomato  Calgene 

I  10 

1.11 

Phosphinothricin 
lolcianl  coin 

DeKalb 

Lepidopteran  resistant 
corn 

Monsanto 

I  12 

Ripening  altered  tomato  Monsanto 

1.13  Glyphosatc  tolerant 

Monsanto 

1.14 

1.15 

1.16 

I  17 

cotton 

Phosphinothricin 
tolerant  com 

AgrEvo 

Lepidopteran  resistant 
corn 

Ciba Geigy 

Lepidopteran  resistant 
cotton 

Monsanto 

Polygalacturonase  level 
decieased  tomato 

Zeneca  &  Peloseed 

USA 

USA 

USA 

USA 

USA 

USA 

USA 

USA 

USA 

USA 

' 

' • '

' -. 

!• 

'• 

I 

I . i n *. 

-  — 

• •• 

. 

.  i.  .  .. 

* 

• 

'• 

T - - - f - .. 

;• 

1 

r-r-

Product 

Notifier 

Country  giving  approval 

1 IX  Colcoptcran  icsislant 

Monsanto 

potato 

II1)  Ripening altered  tomato  DNA  Plant  lech 

1.20  Oil  profile  altered 
rapeseed 

(algene 

1.21  Glyphosate  tolerant 

Monsanto 

soybean 

1.22  Bromoxynil tolerant 

Calgcne 

cotton 

1.23  WMV2andZYMV 

Upjohn 

USA 

USA 

USA 

USA 

USA 

USA 

2.1 

? 2 

2 3 

2.4 

2.5 

2.6 

2 7 

2.X 

2.9 

resistant  squash 

Glufosinate 
ammonnium  tolerant 
canola 

Roundup* hcilxcidc 
tolerant  Brassica  napus 
canola  line GT73 

Agi Evo Canada  Inc. 

Canada 

Mons;mlo Canada  Inc 

Candida 

Imida/ohnone  lolcianl 
canola 

Pioucci  Ili-lhcd  Inleinalional  Canada 
Inc 

Novel hybridization 
system  for  canola 
(Brassica napus L.) 

Glyphosate tolerant 
soybean  (dlycine max 
L  ) line GTS 40-3-2 

Potato resistant to 
Colorado potato beetle 
{Solarium  tuberosum L.) 

Roundup* herbicide 
lolcianl  Brassica  napus 
canola line G1200 

Plant Genetic  Systems  Inc. 

Canada 

Monsanto  Cannada Inc. 

Canada 

Nature Mark  Potatoes 

Cannada 

Monsanto  Cannada  Inc. 

Canada 

Laurate rapeseed 
(Brassiai napus I.  ) 

Calgcne  Inc 

Event  176 Bi com  (Zea  Ciba Seeds and  Mycogcn 
mays L.) 

Corporation 

Canada 

Canada 

2.10 

Imidazolinone tolerant 
corn  3751IR 

Pioneer Hi-Bred International  Canada 
Inc. 

17 

Product 

Notifier 

Country  giving  approval 

2.11  Glufosinate 

AgrEvo  Canada Inc. 

Canada 

ammonnium  tolerant 
canola line HCN29 

Herbicide tolerant 
soybean 

Herbicide tolerant 
canola 

Insect resistant com 
developed  by  Northrup 
King 

Monsanto Japan  Limited 

Japan 

Monsanto Japan  Limited 

Japan 

Monsanto Japan  Limited 

Japan 

Insect resistant potato 

Monsanto Japan  Limited 

Herbicide tolerant 
canola developed by 
AgrEvo  Canada Inc. 

Hoechst  Sheling AgrEvo 

Insect resistant com 

Ciba Geigy  Japan 

Herbicide  tolerant 
canola developed  by 
P GS 

I 

Monsanto Japan  Limited 

Japan 

Japan 

Japan 

Japan 

| 

I 

3.1 

3.2 

3.3 

3.4 

3.5 

3.6 

3.7 

| 

ISSN 0254-1475 

COM(96) 630 final 

DOCUMENTS 

EN 

14  05  15  03 

Catalogue number  :  CB-C0-96-711-EN-C 

ISBN  92-78-13826-6 

Office  for Official  Publications of the European Communities 

L-2985 Luxembourg 

n