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: 
• the exploitation of existing possibilities for revising 
measures/procedures/degree of oversight/requirements, through use of the 
"light" procedure of adaptation to technical progress (Regulatory 
Committee Procedure). (Internal amendment); 
• 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) 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; 
2) strengthening more uniform decision-taking between Member States in the 
case of research and development releases; 
3) 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 
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 similar risks. Against 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 
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. 
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 releases of GMOs and refers 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) 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; 
ii) 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 flexible and specific to ensure a high 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. 
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; 
• facilitate through the preparation of teclinical documents the 
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. 
11 
Annex I 
A. HORIZONTAL LEGISLATION COVERING THE SAFE USE OF MODERN BIOTECHNOLOGY 
• 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 
ANNEX III 
GENETICALLY MODIFIED PRODUCTS PLACED ON THE MARKET IN EUROPE 
STATE OF PLAY IN SEPTEMBER 
A. Approved products: 
Product Notifier Date of Commission Decision 
1. Vaccine against Vernie Veterinàr Chemie 18.12.92 
Aujeszky's disease GmbH 
2. Vaccine against rabies Rhône-Mêrieux 19.10.93 
3. Tobacco tolerant to SEITA 08.06.94 
bromoxynil. 
4. Vaccine against Vernie Veterinàr Chemie 18.07.94 
Aujeszky's disease GmbH 
(further uses) 
5. Oilseed rape resistant to Plant Genetic Systems 06.02.96 
glufosinate ammonium 
6. Soybeans tolerant to Monsanto 03.04.96 
glyphosate 
7. Male sterile chicory Bejo-Zadcn BV 20.05.96 
Itolerant to glufosinate 
ammonium 
14 
B. PENDING APPROVALS: 
Product and date of receipt by the Commission Notifier 
I Maize tolerant to glufosinate ammonium and expressing CrylA endotoxin Ciba-Geigy 
(15.03.95) 
2. Oilseed rape tolerant to glufosinate ammonium Plant Genetic 
(20.07.95) Systems 
* uses: no conditions. 
3. Oilseed rape tolerant to glufosinate ammonium (Extension of previous Plant Genetic 
Com. Decision to other uses, including food processing) Systems 
(2007 95) 
4. Oilseed rape tolerant to glufosinate ammonium AgrEvo 
(03 05 96) 
* uses: - import of seed for processing, 
growing for breeding, 
field cropping for grain. 
5. Maize tolerant to glufosinate ammonium AgrEvo 
(24.05.96) 
*uses: no conditions 
(» Maize expressing CrylA endotoxin Monsanto 
(2405%) 
*uscs: no conditions 
7. Test kit to detect antibiotic residues in milk * Streptococcus, thermophilus Valio Oy 
with luxA 
and luxB and expressed cat gene coding for resist, to chloramphenicol 
(11.06.96) 
8 Insect resistant maize Pioneer 
(06.08.96) 
'''uses: no conditions 
9. Male sterile chicory tolerant to glufosinate ammonium Bejo-Zaden 
(20.09.96) BV 
*uscs: food and feed I 
15 
ANNEX ÏV 
GENETICALLY MODIFIED PRODIK IS PLACED ON THE MARKET OUTSIDE OF EUROPE 
STATE OF PLAY IN SEITEMIIEU 
Product Notifier Country giving approval 
1.1 Phosphinothricin AgrEvo USA 
tolerant soybean 
1.2 PRV resistant Papaya Cornell U USA 
I 3 CMV, WMV? and Asgrow USA 
/VMV icsisla.nl squash 
1.4 Potato resistant to Monsanto USA 
Colorado potato beetle 
1.5 Ripening altered tomato Agritope USA 
I 6 Sulfonylurea tolerant Du Pont USA 
cotton 
1.7 Male sterile Plant Genetic Systems USA 
phosphinothricin 
tolerant corn 
1.8 Corn resistant to Northmp King USA 
European com borer 
1.9 Ripening altered tomato Calgene USA 
I 10 Phosphinothricin DeKalb USA 
lolcianl coin 
1.11 Lepidopteran resistant Monsanto USA 
corn 
I 12 Ripening altered tomato Monsanto USA 
1.13 Glyphosatc tolerant Monsanto USA 
cotton 
1.14 Phosphinothricin AgrEvo USA 
tolerant com 
1.15 Lepidopteran resistant Ciba Geigy USA 
corn 
1.16 Lepidopteran resistant Monsanto USA 
cotton 
I 17 Polygalacturonase level Zeneca & Peloseed USA 
decieased tomato 
' '•''-. !• '• I I.in*. - — ••• . . i. . .. * • '• T---f-.. ;• 1 r-r-
Product Notifier Country giving approval 
1 IX Colcoptcran icsislant Monsanto USA 
potato 
II1) Ripening altered tomato DNA Plant lech USA 
1.20 Oil profile altered (algene USA 
rapeseed 
1.21 Glyphosate tolerant Monsanto USA 
soybean 
1.22 Bromoxynil tolerant Calgcne USA 
cotton 
1.23 WMV2andZYMV Upjohn USA 
resistant squash 
2.1 Glufosinate Agi Evo Canada Inc. Canada 
ammonnium tolerant 
canola 
? 2 Roundup* hcilxcidc Mons;mlo Canada Inc Candida 
tolerant Brassica napus 
canola line GT73 
2 3 Imida/ohnone lolcianl Pioucci Ili-lhcd Inleinalional Canada 
canola Inc 
2.4 Novel hybridization Plant Genetic Systems Inc. Canada 
system for canola 
(Brassica napus L.) 
2.5 Glyphosate tolerant Monsanto Cannada Inc. Canada 
soybean (dlycine max 
L ) line GTS 40-3-2 
2.6 Potato resistant to Nature Mark Potatoes Cannada 
Colorado potato beetle 
{Solarium tuberosum L.) 
2 7 Roundup* herbicide Monsanto Cannada Inc. Canada 
lolcianl Brassica napus 
canola line G1200 
2.X Laurate rapeseed Calgcne Inc Canada 
(Brassiai napus I. ) 
2.9 Event 176 Bi com (Zea Ciba Seeds and Mycogcn Canada 
mays L.) Corporation 
2.10 Imidazolinone tolerant Pioneer Hi-Bred International Canada 
corn 3751IR Inc. 
17 
Product Notifier Country giving approval 
2.11 Glufosinate AgrEvo Canada Inc. Canada 
ammonnium tolerant 
canola line HCN29 
3.1 Herbicide tolerant Monsanto Japan Limited Japan 
soybean 
3.2 Herbicide tolerant Monsanto Japan Limited Japan 
canola 
3.3 Insect resistant com Monsanto Japan Limited Japan 
developed by Northrup 
King 
3.4 Insect resistant potato Monsanto Japan Limited Japan 
3.5 Herbicide tolerant Hoechst Sheling AgrEvo Japan 
canola developed by 
AgrEvo Canada Inc. 
3.6 Insect resistant com Ciba Geigy Japan Japan 
3.7 Herbicide tolerant Monsanto Japan Limited Japan 
canola developed by 
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