28.7. 88 Official Journal of the European Communities No C 198/19 
Proposal for a Council Directive on the deliberate release to the environment of genetically 
modified organisms 
COM (88) 160 final — SYN 131 
(Submitted by the Commission to the Council on 16 May 1988) 
(88/C 198/09) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty Establishing the European 
Economic Community and in particular Article 100A 
thereof, 
Having regard to the proposal of the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas disparity between the regulation of the 
deliberate release to the environment of genetically 
modified organisms which are in effect or in preparation 
in the Member States may create unequal conditions of 
competition and thus directly affect the functioning of 
the common market; whereas, it is therefore necessary to 
approximate the laws of the Member States in this 
regard, as provided for in Article 100A of the Treaty; 
Whereas measures for the approximation of the 
provisions of the Member States which have as their 
object the establishment and functioning of the internal 
market shall, inasmuch as they concern health, safety, 
environmental and consumer protection, take a high 
level of protection as a base and provide, despite existing 
differences in economies of the Member States, for equal 
standards of protection throughout the Community; 
Whereas under the Treaty, action by the Community 
relating to the environment shall be based on the 
principle that preventive action shall be taken; 
Whereas living organisms, whether released to the en­
vironment in large or small amounts for experimental 
purposes or as commercial products, may reproduce in 
the environment and cross national frontiers thereby 
affecting bordering Member States or the Community as 
a whole; 
Whereas it is necessary to ensure the development of 
industrial products utilizing genetically modified 
organisms which do not cause harm to human health or 
the environment; whereas the new biotechnology 
promises improvements in health and the environment by 
developing more precise agricultural inputs for 
protection and nutrition and more effective treatment of 
wastes; Whereas the protection of the public and the en­
vironment requires that due attention be given to 
controlling risks from the deliberate release of gen­
etically modified organisms to the environment; 
Whereas new techniques of genetic modification are 
defined in Article 2 (2) and Annex I of this Directive; 
whereas those techniques which have conventionally 
been used with crop plants and livestock with an 
excellent safety record are not covered by the definition 
of Article 2 (2) or Annex I; 
Whereas it is necessary to establish harmonized 
procedures for the evaluation of the potential risks 
arising from the intentional introduction, for the purpose 
of research and development, of genetically modified 
organisms into the environment; 
Whereas the deliberate release of genetically modified 
organisms at the research stage is in most cases a 
necessary step in the development of new products 
derived from or containing genetically modified 
organisms; and whereas the regulatory requirements 
under which these releases take place are likely to have 
important impacts on the final cost of such products; 
Whereas it is necessary to establish a Community review 
and decision-making procedure for the placing on the 
market of the products containing or consisting of gene­
tically modified organisms, where the intended use of 
that product involves its deliberate release to the 
environment; 
Whereas any person, before undertaking a new 
deliberate release to the environment of a genetically 
modified organism, or the placing on the market of a 
product containing or consisting of genetically modified 
organisms where the intended use of that product 
involves its deliberate release to the environment, shall 
submit a notification to the national competent 
authority; 
Whereas that notification should contain a technical 
dossier of information including a full risk assessment, 
appropriate safety and emergency response, and in the 
case of products, precise instructions and conditions for 
use, and proposed labelling and packaging; 
Whereas it is important to follow closely that devel­
opment and use of genetically modified organisms, and 
that in order to do this it is necessary to list all the 
products notified under this Directive, and to provide for 
subsequent notifications and follow-up information; 
No C 198/20 Official Journal of the European Communities 28. 7. 88 
Whereas when a product containing a genetically 
modified organism or a combination of them is placed 
on the market where the intended use of that product 
involves its deliberate release to the environment, and 
where such a product has been properly notified and 
endorsed under this Directive, a Member State may not 
prohibit, restrict or impede the deliberate release of this 
organism on their territory under the conditions set out 
in the notification, except under the specific conditions 
of a safeguard procedure, in case of a serious risk to 
human health or the environment, 
HAS ADOPTED THIS DIRECTIVE: 
Part A: General provisions 
Article 1 
1. The objective of this Directive is to approximate 
the laws, regulations and administrative provisions of the 
Member States and to protect the health of the general 
population and the environment in relation with: 
— the deliberate release of genetically modified 
organisms to the environment, 
— the placing on the market of products containing or 
consisting of genetically modified organisms intended 
for subsequent deliberate release to the environment. 
2. This Directive does not apply to the carriage of 
genetically modified organisms by rail, road, inland 
waterway, sea or air. 
Article 2 
For the purpose of this Directive: 
1. Organism includes multicellular and unicellular 
organisms. It also includes subcellular entities capable 
of replication. 
2. Genetically modified organism (hereinafter referred to 
as GMO) is an organism in which the genetic material 
is altered in a way that passes the natural barriers of 
mating and recombination. Annex I indicates the 
techniques by which such genetic alterations can be 
obtained. 
3. Deliberate release means any intentional introduction 
in the environment of a GMO or a combination of 
GMOs without provisions for containment such as 
special procedures, equipment and installations, or 
facilities that provide physical barriers to prevent their 
spread into the environment. 
4. Product means a preparation or formulation consisting 
of or containing a GMO or a combination of GMOs, 
which is placed on the market. 
5. Placing on the market mea"ns supplying or making 
available to third parties for the purpose of sale or 
commercial distribution. 6. Notification means the documents whereby the person 
who is to carry out a deliberate release of a GMO or 
a combination of GMOs for the purpose of research 
and development, or to place a product on the market 
presents the requisite information to the competent 
authority of a Member State. This person shall be 
referred to as 'the notifier'. 
7. Use means the deliberate release of a product which 
has been placed on the market. The persons carrying 
out this use will be referred to as 'users'. 
Article 3 
1. Member States shall adopt the provisions necessary 
to ensure that all persons carrying out the deliberate 
release or placing on the market of GMO(s) shall take 
all measures reasonably practicable to control any risk of 
harm to people and the environment. 
2. Member States shall designate the competent 
authority or authorities responsible for carrying out the 
requirements of this Directive and its annexes. 
Part B: Deliberate release of genetically modified 
organisms to the environment for research and 
development purposes 
Article 4 
Member States shall adopt the provisions necessary to 
ensure that: 
1. Any person, before undertaking a deliberate release of 
a GMO or a combination of GMOs for the purpose 
of research and development, must submit a notifi­
cation to the competent authority specified in Article 
3 (2) of the Member State within whose territory the 
release is to take place before carrying out the release. 
2. The notification shall include: 
(a) A technical dossier supplying the information 
specified in Annex II necessary for evaluating the 
foreseeable risks, whether immediate or delayed, 
which the GMO(s) may pose to people or the 
environment, together with the methods used and 
the bibliographic reference to them and covering, 
in particular: 
— identification and characteristics of the 
GMO(s), 
— the location of the area where the deliberate 
release is to be carried out and the 
predominant meteorological, social, environ­
mental and agricultural characteristics of the 
area, 
— the purpose and conditions of the release, 
including the quantity of the GMO(s) to be 
released, the size of the area affected, and the 
duration of the release, 
— all other information necessary for risk 
assessment, 
28. 7. 88 Official Journal of the European Communities No C 198/21 
— methods for monitoring the GMO(s) and, 
when appropriate, proposed techniques for 
elimination or inactivation of the GMO(s) at 
the end of the experiment, and for emergency 
response in case of the spread of the GMOs 
beyond the area of release. 
(b) A statement evaluating the impacts and risks 
posed by the GMOs to people or the environment 
from the uses envisaged. 
3. The experimental release of a combination of 
different GMOs for the same purpose may be notified 
in a single notification. 
4. In the case of a subsequent release of the same GMO 
or combination of GMOs previously notified as part 
of the same research programme, the notifier shall be 
required to submit a new notification. In this case, the 
notifier may refer to data from previous notifications 
or results from previous releases. 
5. The notifier may also refer to data or results form 
notifications previously submitted by other notifiers, 
provided that the latter have given their agreement in 
writing. 
6. In the event of any modification of the deliberate 
release of GMO(s) which could have consequences 
with regard to the risks for people or the environment 
or if new information has become available on such 
risks, either while the notification is being examined 
by the competent authorities or after the endor­
sement, the notifier shall: 
(a) revise the measures specified in Article 4 (2), 
(b) inform the competent authority of the modifi­
cation, in advance or as soon as the new 
information is available, in so far as it affects the 
information contained in the notification. 
Article 5 
1. The competent authority shall: 
— evaluate the risk posed by the release in the light of 
the notifier's risk assessment, 
— state its conclusions in writing, 
and, if necessary, 
— ask the notifier to provide further information or 
verification tests, explaining the reasons for it, 
— carry out such tests as may be necessary for control 
purposes. 
2. The competent authority shall respond to the noti­
fication within 90 days of its receipt, either deciding on 
its endorsement or indicating the further information 
required or measures to be taken. 3. If the competent authority is not satisfied with the 
conditions of the proposed release, it may ask the 
notifier to modify such conditions of the release so as to 
bring it into compliance with Article 3 of this Directive. 
4. The notifier may proceed with the release only 
when he has received the endorsement of the competent 
authority, subject to any conditions required in this 
endorsement. 
5. The Member States may provide for derogations 
from the provisions under Articles 4 and 5 (1) to 5 (4) 
and 6 for deliberate releases carried out by or under the 
responsibility of a public authority which is designated as 
a competent authority according to Article 3 (2). This 
derogation does not affect the obligation to assess the 
risk posed by the release concerned nor the obligation to 
submit information to the Commission as required in 
Article 7. 
Article 6 
On the completion of a release the notifier shall send to 
the competent authority an assessment of the result of 
the release in respect of any risk to man or the en­
vironment, with particular reference to any product that 
he intends to notify. 
Article 7 
1. The Commission shall set up a system of exchange 
of the information contained in the notifications. The 
competent authorities shall send to the Commission a 
summary of each notification received within 15 days of 
its receipt. 
2. The Commission shall forward these summaries to 
the other Member States. 
3. If a competent authority wants more information 
relative to releases carried out in other Member States, it 
may ask the competent authority of this Member State to 
provide them with further information. 
4. The competent authority of the other Member 
States may suggest to the competent authority which 
received the original notification any modifications to 
the conditions of the release. 
Part C: Placing on the market of products containing 
genetically modified organisms 
Article 8 
Articles 9 to 16 of this Directive do not apply to: 
— medicinal products, 
— veterinary products, 
No C 198/22 Official Journal of the European Communities 28. 7. 88 
— foodstuffs, feedingstuffs and their additives, 
— plants and animals produced or used in agriculture, 
horticulture, forestry, husbandry and fisheries, the 
reproductive material thereof and the products 
containing these organisms, 
— or to any products covered by Community legislation 
which includes a specific risk assessment. 
Article 9 
1. Before a GMO or a combination of GMOs are 
placed on the market as or in a product, the manu­
facturer or the importer to the Community shall submit a 
notification to the competent authority of the Member 
State where they are to be placed on the market for the 
first time. This notification shall contain: 
— the information required in Annex II, extended as 
necessary to take into account the diversity of sites of 
use of the product, and an assessment of any risks for 
man and/or the environment related to the GMO(s) 
contained in the product, 
— the conditions for the placing on the market of the 
product, including specific conditions of use and 
handling and a proposal for labelling and packaging 
which should comprise at least the requirements laid 
down in Annex III. 
If, on the basis of the results of any release notified 
under Part B of this Directive, or on substantive, 
reasoned scientific grounds, a notifier considers that the 
placing on the market and use of a product do not pose 
any risk to man and/or the environment, he may 
propose not to comply with one or more of the 
requirements of Annex III.B. 
2. Subject to the agreement of the competent 
authority, the notifier may refer in this notification to 
data or experiences from releases of the same GMO(s) 
previously notified at the research and development level. 
3. The notifier may also refer to data or results from 
notifications previously submitted by other notifiers, 
provided that the latter have given their agreement in 
writing. 
4. Each new product which, containing or consisting 
of the same GMO or combination of GMOs, is intended 
for a different use, shall be notified separately. 
5. If new information has become available with 
regard to the risks of the product to people or the en­
vironment, either before or after the endorsement, the 
notifier shall: 
— revise the measures specified in Article 9(1), and 
— inform the competent authority immediately. Article 10 
1. On receipt of the notification referred to in Article 
9, the competent authority shall examine it for 
compliance with this Directive, giving particular 
attention to the risk assessment and the recommended 
precautions related to the safe use of the product. 
2. The competent authority may ask the notifier for 
additional information or suggest further tests to carry 
out or changes in the conditions of placing on the 
market so as to bring these conditions into compliance 
with the Directive. 
3. "When the competent authority is satisfied that the 
placing on the market of the product under the 
conditions specified in the notification is in compliance 
with this Directive, it shall send to the Commission a 
dossier including a summary of the notification together 
with a statement of the conditions under which it 
proposes to endorse the placing on the market of the 
product. 
4. The competent authority shall respond to the noti­
fication within 90 days of receipt, either by indicating 
the need for further information and evaluation, or 
measures to bring it into compliance with this Directive, 
or forwarding the dossier referred to in Article 10 (3) to 
the Commission. 
Article 11 
1. On receipt of the dossier referred to in Article 10, 
the Commission shall forward to all Member States: 
— the summary of the dossier, 
— any other information it has collected pursuant to 
this Directive. 
2. For a period of three months after the Commission 
has circulated the dossier with the summary of the notifi­
cation and the proposed conditions for placing on the 
market, other competent authorities may request the 
competent authority which proposes the endorsement to 
provide further information or change the conditions for 
placing on the market, giving their reasons for such 
requests. 
3. If the competent authority which proposed the 
endorsement fails to comply with the requests of other 
authorities regarding further information, the risk 
assessment or the conditions of placing on the market, it 
shall give its reasons to the competent authority 
concerned. 
4. Should it not be possible for the competent auth­
orities concerned to reach an agreement, and should any 
competent authority feel, on the basis of scientific 
evidence, that the placing on the market of the product 
may pose risks to people or the environment, within this 
period of three months, the Commission shall take a 
decision in accordance with the procedure laid down in 
Article 20. 
28. 7. 88 Official Journal of the European Communities No C 198/23 
5. When the competent authority that received the 
original notification has provided a satisfactory response 
to the requests of the other competent authorities, or if 
no suggestions have been made within the 60-day period, 
or when the Commission has taken a favourable decision 
in the case of Article 11 (4), it shall endorse the notifi­
cation so that the product may be placed on the market. 
6. Once a product has been endorsed, it may be used 
without further notification throughout the European 
Community in so far as the specific conditions of use 
and the environments and/or geographical areas 
stipulated in the conditions are strictly adhered to. 
7. Member States shall adopt all necessary measures 
to ensure that users comply with the conditions of use 
specified in the endorsement. 
Article 12 
Member States shall take all necessary measures to 
ensure that products containing or consisting of GMOs 
will be placed on the market after endorsement only if 
their labelling and packaging is that endorsed under 
Article 11. 
Article 13 
The Member States may not, on grounds relating to the 
notification and endorsement of a deliberate release 
under this Directive, prohibit, restrict or impede the 
placing on the market of products containing or 
consisting of GMOs which comply with the requirements 
of this Directive. 
Article 14 
1. Where a Member State has evidence that a product 
which has been properly notified and endorsed under 
this Directive constitutes a serious risk to people or the 
environment, it may provisionally restrict or prohibit the 
use or sale of that product on its territory. It shall 
immediately inform the Commission and the other 
Member States of such action and give reasons for its 
decision. 
2. The Commission shall take a decision on the 
matter, within three months following the procedure laid 
down in Article 20. 
Article 15 
The Commission shall publish in the Official Journal of 
the European Communities a list of all the products 
receiving final endorsement under this Directive. For 
each product, the GMO(s) contained therein and the 
use(s) shall be clearly specified. 
Article 16 
1. Member States shall send to the Commission, at the 
end of each year, a brief factual report on the control of the use of all products placed on the market under this 
Directive. 
2. The Commission shall send to the European 
Parliament every three years a report on the control by 
the Member States of the products placed on the market 
under this Directive. 
Part D: Final provisions 
Article 17 
1. The notifier may indicate the information in the 
notifications submitted under Articles 4 and 9 of this 
Directive, the disclosure of which might harm his 
competitive position, that should be kept secret. Veri­
fiable justification must be given in such cases. 
2. The competent authority shall decide on its own 
responsibility which information will be kept secret. 
3. In no case may the following information be kept 
secret: 
— identity of the GMO(s), name and address of the 
notifier, purpose of the release or of the product, and 
site of release, or areas of use, 
— the evaluation of foreseeable effects, in particular any 
pathogenic and ecologically disruptive effects, 
— for experimental releases: methods and plans for 
monitoring the GMO(s), for decontaminating the 
area(s) of release, and for emergency response, 
— for placing on the market: methods for monitoring 
the GMO(s) contained in the product and for 
emergency response in case of misuse. 
4. Confidential information brought to the attention 
either of the Commission or of a competent authority 
shall be kept secret. 
Article 18 
According to the procedure laid down in Article 20, the 
Commission shall adapt the annexes of this Directive to 
technical progress by: 
— amending new techniques to be covered or deleting 
as appropriate, 
— amending the notification requirements set out in 
Annexes II and III to take into account the potential 
hazard of the GMO(s). 
No C 198/24 Official Journal of the European Communities 28. 7. 88 
Article 19 
1. The Commission shall be assisted by a Committee 
of an advisory nature composed of the representatives of 
the Member States and chaired by the representative of 
the Commission. 
2. The Commission shall function in accordance with 
the procedures laid down in Article 20. 
Article 20 
Where the procedure laid down in this Article is 
followed a representative of the Commission shall submit 
to the Committee a draft of the measures to be taken. 
The Committee shall deliver its opinion on the draft, 
within a time limit which the chairman may lay down 
according to the urgency pf the matter, if necessary by 
taking a vote. The opinion shall be recorded in the 
minutes; in addition, each Member State shall have the 
right to have its position recorded in the minutes. The 
Commission shall take the utmost account of the opinion 
delivered by the Committee. It shall inform the 
Committee of the manner in which its opinion has been 
taken into account. Article 21 
1. Member States and the Commission shall meet 
regularly and exchange information on the experience 
acquired with regard to the prevention of risks related to 
the release of GMOs to the environment. 
2. Every three years, Member States shall send the 
Commission a report on the measures taken to 
implement the provisions of this Directive, the first time 
being on 1 September 1991. 
3. Every three years, the Commission shall publish a 
summary based on the reports referred to in paragraph 
2, the first time being in 1992. 
Article 22 
1. Member States shall bring into force the laws, 
regulations and administrative provisions necessary to 
comply with this Directive within a period of 18 months 
from its notification. 
2. The Member States shall immediately inform the 
Commission of all laws, regulations and administrative 
provisions adopted in implementation of this Directive. 
Article 23 
This Directive is addressed to the Member States. 
ANNEX I 
Genetically modified organisms are organisms which can be obtained by such techniques as recombinant 
DNA, micro-injection, macro-injection, micro-encapsulation, nuclear and organal transplantation or 
genetic manipulation of viruses. 
ANNEX II 
The notifications for a deliberate release referred to in Article 4 and for placing on the market referred to 
in Article 9 must provide the information set out below. 
Not all the points included will apply to every case. It is to be expected, therefore, that individual notifi­
cations will address only the particular subset of issues that are appropriate to individual situations. In each 
case where it is not technically possible or it does not appear necessary to give the information, the reasons 
shall be stated. 
The level of detail required in response to each subset of considerations is also likely to vary according to 
the nature and the scale of the proposed release. 
The description of the methods used or the reference to standardized or internationally recognized 
methods shall also be mentioned in the dossier, together with the name of the body or bodies responsible 
for carrying out the studies. 
28. 7. 88 Official Journal of the European Communities No C 198/25 
1. Identification and characteristics of the organism 
(a) Information relating to the parental organisms: 
— scientific name, 
— taxonomy, 
— other names (usual name, strain name, cultivar name, etc.), 
— phenotypic and genetic markers. 
(b) Information relating to the recipient organism: 
— description of identification and detection techniques, 
— sensitivity, reliability (in quantitative terms) and specificity of detection and identification tech­
niques, 
— description of the geographic distribution and of the natural habitat of the organism including 
information on natural predators, preys, parasites and competitors and symbionts, 
— potential for genetic transfer and exchange with other organisms, 
— verification of the genetic stability of the organism and factors affecting it, 
— pathological, ecological and physiological traits of the organism: 
— classification according to existing Community rules, 
— generation time in natural ecosystems, sexual and asexual reproductive cycle, 
— information on survival, including seasonality and the ability to form survival structures e.g. 
seeds, spores or sclerotia, 
— pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, 
possible vectors, host range including non-target organisms. Possible activation of latent 
viruses (proviruses). Ability to colonize other organisms, 
— antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms 
for prophylaxis and therapy, 
— involvement in environmental processes: primary production, nutrient turn-over, decompo­
sition of organic matter, respiration, etc. 
(c) Information relating to the genetic modification: 
— methods used for the modification, 
— methods used to construct and introduce the insert(s) into the recipient, 
— purity of the insert from any unknown sequence, 
— functional identity and location of the altered inserted nucleic acid segment(s) in question, 
— description of any new genetic trait(s) or phenotypic characteristics which may be expressed or 
no longer expressed, 
— history of previous genetic manipulations with the parental organisms. 
2. Other information necessary for risk evaluation 
(a) Characteristics of the genetically modified organism (GMO) affecting survival, multiplication and 
dispersion: 
— biological features which affect survival, multiplication and dispersion, 
— behaviour in simulated natural environments, such as microcosms, growth rooms, greenhouses, 
etc., 
— known or predicted environmental conditions which may affect survival, multiplication and 
dissemination (wind, water, soil, etc.), 
— sensitivity to specific agents. 
No C 198/26 Official Journal of the European Communities 28. 7. 88 
(b) Interactions of the GMO with the biological systems: 
— predicted habitat of the GMO, 
— genetic transfer capability, 
— likelihood of post-release selection of genetic transfer leading to the expression of undesirable 
effects in the organisms released or/and in any other organism in the environment, 
— measures employed to ensure genetic stability; description of genetic traits which may prevent or 
minimise dispersal of genetic material, 
— routes of biological dispersal, known or potential modes of interaction with the disseminating 
agent, including inhalation, ingestion, surface contact, burrowing, etc., 
— potential for excessive population increase in the environment, 
— identification and description of the target organism, 
— anticipated mechanism and result of interaction between the released GMO(s) and the target 
organism, 
— identification and description of non-target organisms which may be affected unwittingly, 
— known or predicted effects on non-target organisms in the environment, impact on population 
levels of competitors, preys, hosts, symbionts, predators, parasites and pathogens, 
— other potentially significant interactions with the environment. 
3. Geographical location of the site of release 
(in the case of notifications for placing on the market, the site(s) of release will be the intended areas of 
use of the product) 
(a) Geographical location of the site(s), including: 
— physical or biological proximity to humans, 
— size of local population, 
— economic activities of local populations which are based on the natural resources of the area. 
(b) Description of the site, including: 
— climatic characteristics, 
— geographical, geological and pedological characteristics, 
— flora and fauna, including crops, livestock and migratory species, 
— surrounding ecosystems to which the organism could spread. 
(c) A comparison of the natural habitat of the recipient organism with the proposed site(s) of release. 
4. Conditions of the deliberate release 
(only for notifications under Article 4) 
(a) description of the proposed deliberate release, including the programme and the purpose(s) or 
objective(s), 
(b) preparation of the site previous to the release, 
(c) size of the site, 
(d) method, amount, frequency and duration of the release, 
(e) methods of human intervention (mining, cultivation methods, etc..) on the site, 
(f) worker safety measures during the release, 
(g) post-release treatment of the site. 
28. 7. 88 Official Journal of the European Communities No C 198/27 
5. Control and emergency response plans 
(a) Monitoring techniques: 
— methods for tracing the GMO(s), and for monitoring its effects, 
— detection and identification techniques to distinguish the GMO(s) from the parental organisms, 
— specificity (to identify the GMO(s), and to distinguish them from the parental ones), sensitivity 
and reliability of the monitoring techniques, 
— techniques for detecting transfer of the donated genetic material to other organisms, 
— for experimental releases, duration and frequency of the monitoring. 
(b) Response plans in case of an unexpected spread of the organism: 
— methods and procedures for controlling the GMO(s) in case of unexpected spread, 
— methods for decontamination of the areas affected, e. g. eradiction of the GMO(s), 
— methods for disposal or sanitation of plants, animals, soils, etc. . . . that were exposed during or 
after the spread, 
— methods for the isolation of the area affected by the spread, 
— plans for protecting human and environmental health in case of the occurrence of an undesirable 
effect. 
(c) Control of the release (only in case of notifications under Article 4): 
— methods and procedures to minimize the spread of the GMO(s) beyond the site of release, 
— methods and procedures to protect the site from intrusion by unauthorized individuals. 
ANNEX III 
A. The following information shall be provided in the notification for placing in the market of products, in 
addition to that of Annex II: 
1. Name of the product and name(s) of GMO(s) contained therein. 
2. Name of the manufacturer or distributor, and his legal address in the Community. 
3. Specificity of the product, exact conditions of use including, when appropriate, the type of 
environment and/or the geographical area(s) of the Community for which the product is suited. 
4. Type of expected use: industry, agriculture and skilled trades, consumer use by public at large. 
B. The following information shall be provided, when relevant, in addition to that of Annex III.A, in 
accordance with Article 9: 
1. Measures to take in case of unintended release or misuse. 
2. Specific instructions or recommendations for storage and handling. 
3. Estimated production and/or imports to the Community. 
4. Proposed packaging. This must be appropriate so as to avoid unintended release of the GMO(s) 
during storage, or at a later stage. 
5. Proposed labelling. This must include, at least in summarized form, the information referred to in 
points A(l), A(2), A(3), B(l) and B(2) of this Annex.