EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 14.6.2006 
COM(2006) 286 final 
2006/0100 (COD)   
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the contained use of geneti cally modified micro-organisms 
(Codified version)  
(presented by the Commission) 
 
EN 2   EN EXPLANATORY MEMORANDUM  
1. In the context of a people’s Europe, th e Commission attaches great importance to 
simplifying and clarifying Community law so  as to make it clearer and more 
accessible to the ordinary citizen, thus gi ving him new opportunities and the chance 
to make use of the specific rights it gives him. 
This aim cannot be achieved so long as num erous provisions that have been amended 
several times, often quite substantially, remain  scattered, so that they must be sought 
partly in the original inst rument and partly in later amending ones. Considerable 
research work, comparing many different inst ruments, is thus needed to identify the 
current rules. 
For this reason a codification of rules that  have frequently been amended is also 
essential if Community law is to be clear and transparent. 
2. On 1 April 1987 the Comm ission therefore decided1 to instruct its staff that all 
legislative acts should be codified  after no more  than ten amendments, stressing that 
this is a minimum requirement and that de partments should endeavour to codify at 
even shorter intervals the texts for which they are responsible, to ensure that the 
Community rules are clear and readily understandable. 
3. The Conclusions of the Presidency of the Edinburgh European Council 
(December 1992) confirmed this2, stressing the importance of codification  as it offers 
certainty as to the law applicable to a given matter at a given time. 
Codification must be undertaken in fu ll compliance with th e normal Community 
legislative procedure. 
Given that no changes of substance may be  made to the instruments affected by 
codification , the European Parliament, the Counc il and the Commission have agreed, 
by an interinstitutional agreement date d 20 December 1994, that an accelerated 
procedure may be used for the fast-track  adoption of codification instruments. 
4. The purpose of this proposal is to  undertake a codification of Council 
Directive 90/219/EEC of 23 April 1990 on the contained use of ge netically modified 
micro-organisms3. The new Directive will supersede the various acts incorporated in 
it4; this proposal fully preser ves the content of the acts be ing codified and hence does 
no more than bring them together with only such formal amendments  as are required 
by the codification exercise itself. 
5. The codification  proposal was drawn up on the basis of a preliminary consolidation , 
in all official languages, of Directive 90/219/EEC and the instruments amending it, 
carried out by the Office for Official Pub lications of the European Communities, by 
means of a data-processing system . Where the Articles have been given new 
                                                 
1 COM(87) 868 PV. 
2 See Annex 3 to Part A of the Conclusions. 
3 Carried out pursuant to the Communication from the Commission to the European Parliament and the 
Council – Codification of the Acquis communautaire, COM(2001) 645 final. 
4 See Annex VI, Part A of this proposal. 
 
EN 3   EN numbers, the correlation between the old and the new numbers is shown in a table 
contained in Annex VII to the codified Directive. 
 
EN 4   EN  
Ð 90/219/EEC (adapted) 
2006/0100 (COD) 
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the contained use of geneti cally modified micro-organisms 
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty establishing th e European Community, and in particular 
Article ⌦ 175(1) ⌫ thereof, 
Having regard to the proposal from the Commission, Having regard to the opinion of the Eu ropean Economic and Social Committee
5, 
Having regard to the opinion of  the Committee of the Regions6, 
Acting in accordance with the procedure laid down in Article 251 of the Treaty7,  
Whereas: 
 
Ð  
(1) Council Directive 90/219/EEC of 23 Apr il 1990 on the contained use of genetically 
modified micro-organisms8 has been substantially amended several times9. In the 
interests of clarity and rationality the said Dire ctive should be codified. 
 
Ð 90/219/EEC Recital 1 (adapted) 
(2) Under the Treaty, action by the Community re lating to the environment shall be based 
on the principle that preventive action shall be taken and shall have as its objective 
                                                 
5 OJ C […], […], p. […]. 
6 OJ C […], […], p. […]. 
7 OJ C […], […], p. […]. 
8 OJ L 117, 8.5.1990, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
9 See Annex VI, Part A. 
 
EN 5   EN ⌦ , among other things, ⌫ to preserve, protect and im prove the environment and to 
protect human health. 
 
Ð 90/219/EEC Recital 2 (adapted) 
(3) Measures concerning the ev aluation and best use of biot echnology with regard to the 
environment are a priority area on whic h Community action should concentrate. 
 
Ð 90/219/EEC Recital 3 (adapted) 
(4) The development of biotechnology is such as to contribute to the economic expansion 
of the Member States. This implies that genetically modified micro-organisms ⌦ (GMMs) ⌫ will be used in operations of various types and scale. 
 
Ð 90/219/EEC Recital 4 (adapted) 
(5) The contained use of ⌦ GMMs ⌫ should be carried out in such a way as to limit 
their possible negative consequences for human health and the environment, due 
attention being given to the prevention of accidents and the control of waste. 
 
Ð 98/81/EC Recital 5 (adapted) 
(6) GMMs which are disposed of without appr opriate provisions for specific containment 
measures to limit their contact with the ge neral population and th e environment do not 
fall within the scope of the present Direc tive. Other Community legislation such as 
⌦ Directive 2001/18/EC of the European Par liament and of the Council of 12 March 
2001 ⌫ on the deliberate release into the environment of genetically modified 
organisms10 may apply. 
 
Ð 90/219/EEC Recital 5 
(7) Micro-organisms, if released into the environment in one Member State in the course 
of their contained use, may reproduce and spread, crossing national frontiers and 
thereby affecting other Member States. 
 
Ð 90/219/EEC Recital 6 (adapted) 
(8) In order to bring about the safe development of biotechnology throughout the 
Community, it is necessary to establis h common measures for the evaluation and 
                                                 
10 OJ L ⌦ 106, 17.4.2001, p. 1 ⌫. Directive as last amended by ⌦ Regulation (EC) No 1830/2003 of 
the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 24) ⌫. 
 
EN 6   EN reduction of the potential risk s arising in the course of all operations involving the 
contained use of ⌦ GMMs ⌫ and to set appropriate conditions of use. 
 
Ð 90/219/EEC Recital 7 (adapted) 
(9) The precise nature and scal e of risks associated with ⌦ the contained use of 
GMMs ⌫ are not yet fully known and the risk involved must be assessed case by 
case. To evaluate the risk to human health and the environment, it is necessary to lay down requirements for risk assessment. 
 
Ð 98/81/EC Recital 2 (adapted) 
(10) Contained uses of GMMs should be classifi ed in relation to the risks they present to 
human health and the environment. Such  classification shoul d be in line with 
international practice and based on an assessment of the risk. 
 
Ð 98/81/EC Recital 3 
(11) In order to ensure a high level of pr otection, the containment and other protective 
measures applied to a contained use must  correspond to the classification of the 
contained use. In case of uncertainty, the appropriate containmen t and other protective 
measures for the higher classification shoul d be applied until less stringent measures 
are justified by appropriate data. 
 
Ð 98/81/EC Recital 7 
(12) For all activities involving GMMs the pr inciples of good microb iological practice and 
good occupational safety and hygiene should apply in accordance with relevant Community legislation. 
 
Ð 90/219/EEC Recital 9 and 
98/81/EC Recital 4 (adapted) 
(13) Appropriate containment measures should be applied at the various stages of an 
operation to control emissions ⌦ and the disposal of materi al from contained uses of 
GMMs, ⌫ and to prevent accidents. 
 
Ð 90/219/EEC Recital 10 
(adapted) 
(14) Any person, before undertaking for the first time the contained use of a ⌦ GMM ⌫ 
in a particular installation, should forward to the competent author ity a notification so 
that the authority may satisfy itself that the proposed installation is  appropriate to carry 
 
EN 7   EN out the activity in a manner that does not present a hazard to human health and the 
environment. 
 
Ð 90/219/EEC Recital 11 
(adapted) 
(15) It is also necessary to establish appropriate procedures for the case-by-case 
notification of specific operations  involving the contained use of ⌦ GMMs ⌫, 
taking account of the degree of risk involved. 
 
Ð 90/219/EEC Recital 12 
(16) In the case of operations  involving high risk, the consen t of the competent authority 
should be given. 
 
Ð 98/81/EC Recital 8 
(17) The containment and other protective meas ures applied to contained uses should be 
reviewed periodically. 
 
Ð 90/219/EEC Recital 13 
(adapted) 
(18) It may be considered appropriate to consult the public on the contained use of 
⌦ GMMs ⌫. 
 
Ð 98/81/EC Recital 9 (adapted) 
(19) People employed in contained uses should be consulted in accordance with the 
requirements of relevant Commun ity legislation, in particular ⌦ Directive 
2000/54/EC of the European Parliament and of the Council of 18 September 2000 ⌫ 
on the protection of workers from risks rela ted to exposure to biological agents at 
work (seventh individual Directive within the meaning of Article  16(1) of Directive 
89/391/EEC)11. 
 
Ð 90/219/EEC Recital 14 
(20) Appropriate measures should be taken to in form any person liable to be affected by an 
accident on all matters relating to safety. 
                                                 
11 OJ L ⌦ 262, 17.10.2000, p. 21 ⌫. 
 
EN 8   EN  
Ð 90/219/EEC Recital 15 
(21) Emergency plans should be established to deal effectively with accidents. 
 
Ð 90/219/EEC Recital 16 
(22) If an accident occurs, the user should i mmediately inform the competent authority and 
communicate the information necessary for a ssessing the impact of that accident and 
for taking the appropriate action. 
 
Ð 90/219/EEC Recital 17 
(23) It is appropriate for the Commission, in  consultation with the Member States, to 
establish a procedure for the exchange of information on accidents and for the 
Commission to set up a regi ster of such accidents. 
 
Ð 90/219/EEC Recital 18 
(adapted) 
(24) The contained use of ⌦ GMMs ⌫ throughout the Community should be monitored, 
and to this end Member States should s upply certain information to the Commission. 
 
Ð 98/81/EC Recitals 12 and 13 
(adapted) and 2001/204/EC 
Recital 2 (adapted) 
(25) ⌦ In order to be considered safe for human health and the environment, GMMs 
should meet the list of criteria as defined in  Annex II, Part B. To take account of the 
pace at which biotechnology is advancing, the nature of the criteria to be developed 
and the limited scope of this list, it is a ppropriate for the Council to revise those 
criteria, which should, where necessar y, be supplemented by guidance notes to 
facilitate their application. ⌫ 
 
Ð  
(26) The measures necessary for the implementation and for the adaptation to technical 
progress of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying dow n the procedures for the exercise of 
implementing powers conferred on the Commission
12. 
                                                 
12 OJ L 184, 17.7.1999, p. 23. 
 
EN 9   EN (27) This Directive should be without prejudice to the obliga tions of the Member States 
relating to the time-limits for transposition into  national law of the Di rectives set out in 
Annex VI, Part B, 
 
Ð 90/219/EEC (adapted) 
⌦ HAVE ⌫ ADOPTED THIS DIRECTIVE: 
 
Ð 90/219/EEC 
Article 1 
This Directive lays down common measures for the contained use of genetically modified 
micro-organisms with a view to protec ting human health and the environment. 
 
Ð 98/81/EC Art. 1 pt. 1 (adapted) 
Î1 Corrigendum, 98/81/EC 
(OJ L 93, 8.4.1999, p. 27) 
(adapted) 
Article 2 
For the purposes of this Directive ⌦ the following definitions shall apply ⌫: 
(a) “micro-organism” ⌦ means ⌫ any microbiological entit y, cellular or non-cellular, 
capable of replication or of transferring ge netic material, includi ng viruses, viroids, 
animal and plant cells in culture; 
(b) “genetically modified micro-organism” (GMM) ⌦ means ⌫ a micro-organism in 
which the genetic material has been altered in a way that does not occur naturally by 
mating and/or natural recombination; within the terms of this definition: 
(i) genetic modification occurs at least th rough the use of the te chniques listed in 
Annex I, Part A; 
(ii) the techniques listed in Annex I, Part B, are not cons idered to result in genetic 
modification; 
(c) “contained use” ⌦ means ⌫ any activity in which micro-organisms are genetically 
modified or in which such GMMs are cu ltured, stored, tran sported, destroyed, 
disposed of or used in any other way, a nd for which specific containment measures 
are used Î1 to limit their contact with, and to provi de a high level of safety for, the 
general population and the environment; Í  
 
EN 10   EN (d) “accident” ⌦ means ⌫ any incident involving a sign ificant and unintended release 
of GMMs in the course of their containe d use which could pres ent an immediate or 
delayed hazard to human health or the environment; 
(e) “user” ⌦ means ⌫ any natural or legal person res ponsible for the contained use of 
GMMs; 
(f) “notification” ⌦ means ⌫ the presentation of the requisite information to the 
competent authorities of a Member State. 
Article 3 
1. Without prejudice to Article 4(1) this Dir ective shall not apply: 
(a) where genetic modification is obtained through the use of th e techniques/methods 
listed in Annex II, Part A; or 
(b) for contained uses involving only type s of GMMs meeting the criteria listed in 
Annex II, Part B which establish their safe ty for human health and the environment. 
These types of GMMs shall be listed in Annex II, Part C. 
2. Article 4(3) and (6) and Articles 5 to 11 sha ll not apply to the transport of GMMs by road, 
rail, inland waterway, sea or air. 
 
Ð 98/81/EC, Art. 1 pt. 1 (adapted) 
3. This Directive shall not apply to the storage, culture, transport, destruction, disposal or use 
of GMMs which have been placed on the market in accordance with 
Directive ⌦ 2001/18/EC ⌫ or pursuant to other Community legislation, which provides for 
a specific environmental risk assessment simila r to that laid down in the said Directive, 
provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market. 
 
Ð 98/81/EC, Art. 1 pt. 1 
Article 4 
1. Member States shall ensure that all appropria te measures are taken to avoid adverse effects 
on human health and the environment which mi ght arise from the contained use of GMMs. 
2. To this end the user shall carry out an assessm ent of the contained uses as regards the risks 
to human health and the environment that these contained uses may pose , using as a 
minimum the elements of assessment and the pro cedure set out in Annex III, sections A and 
B. 
3. The assessment referred to in paragraph 2 sh all result in the final classification of the 
contained uses in four classes applying the pro cedure set out in Annex III, which will result in 
the assignment of containment levels in accordance with Article 5: 
 
EN 11   EN Class 1: activities of no or negligible risk, that is to say activities for which level 1 
containment is appropriate to protect hu man health as well as the environment. 
Class 2: activities of low risk, that is to say activities for which level 2 containment is 
appropriate to protect human hea lth as well as the environment. 
Class 3: activities of moderate risk, that is to say activities for which level 3 containment 
is appropriate to protect human h ealth as well as the environment. 
Class 4: activities of high risk, that is to say activities for which level 4 containment is 
appropriate to protect human hea lth as well as the environment. 
4. Where there is doubt as to which class is ap propriate for the proposed contained use, the 
more stringent protective measures shall be ap plied unless sufficient evidence, in agreement 
with the competent authority, justifies the application of less stringent measures. 
5. The assessment referred to in paragraph 2 sh all especially ta ke into account the question of 
disposal of waste and effluents.  Where appropriate, the necessary safety measures shall be 
implemented in order to protect hum an health and the environment. 
6. A record of the assessment referred to in paragraph 2 shall be kept  by the user and made 
available in an appropriate form to the competen t authority as part of the notification pursuant 
to Articles 6, 8 and 9 or on request. 
Article 5 
1. The user shall apply, except to the extent that point 2 of Annex IV allows other measures to 
be applied, the general principles and the appropriate containment and other protective 
measures set out in Annex IV corresponding to the class of the contained use, so as to keep 
workplace and environmental exposure to any GMMs to the lowest reasonably practicable 
level, and so that a high level of safety is ensured. 
2. The assessment referred to in Article 4(2)  and the containment and other protective 
measures applied shall be reviewed  periodically, a nd forthwith if: 
(a) the containment measures applied are no l onger adequate or the class assigned to the 
contained uses is no longer correct, or 
(b) there is reason to suspec t that the assessment is no l onger appropriate judged in the 
light of new scientific or technical knowledge. 
Article 6 
When premises are to be used for the first time for contained uses, the user shall be required 
to submit to the competent authorities, before commencing such use, a notification containing at least the information list ed in Annex V, Part A. 
 
EN 12   EN Article 7 
Following the notification referred to in Artic le 6, subsequent cla ss 1 contained use may 
proceed without further notification. Users of  GMMs in class 1 contained uses shall be 
required to keep the record of each assessment re ferred to in Article 4(6) , which shall be made 
available to the competent authority on request. 
Article 8 
1. For first and subsequent class 2 contained uses  to be carried out in premises notified in 
accordance with Article 6, a notification containi ng the information listed in Annex V, Part B 
shall be submitted. 
2. If the premises have been the subject of a previous notification to carry out class 2 or a 
higher class of contained uses and any associat ed consent requirements have been satisfied, 
the class 2 contained use may proceed im mediately following the new notification. 
The applicant can, however, himself request a decision on a formal authorisation from the 
competent authority. The decision must be ma de within a maximum of 45 days from the 
notification. 
3. If the premises have not been the subject of a previous notification to  carry out class 2 or a 
higher class of contained uses, the class 2 contained use may, in  the absence of any indication 
to the contrary from the competent authority , proceed 45 days after submission of the 
notification referred to in paragraph 1, or earlier with the agreement of the competent authority. 
Article 9 
1. For first and subsequent class 3 or class 4 c ontained uses to be carried out in premises 
notified in accordance with Article 6, a notificat ion containing the inform ation listed in Annex 
V, Part C shall be submitted. 
2. A class 3 or higher cl ass of contained use may not procee d without the prio r consent of the 
competent authority which shall co mmunicate its decision in writing: 
(a) at the latest 45 days after submission of the new notification, in the case of premises 
which have been the subject of a previous notification to carry out class 3 or a higher 
class of contained uses and where any a ssociated consent requi rements have been 
satisfied for the same or a higher class th an the contained use with which it is 
intended to proceed; 
(b) at the latest 90 days after submissi on of the notification, in other cases. 
 
EN 13   EN  
Ð 98/81/EC, Art. 1 pt. 1 
Article 10 
1. Member States shall designate the authority  or authorities competent to implement the 
measures which they adopt in application of this Directive and to receive and acknowledge 
the notifications referred to in Articles 6, 8 and 9. 
2. The competent authorities shall examine the conformity of the notifications with the 
requirements of this Directive, the accuracy and completeness of the information given, the 
correctness of the assessment referred to in Article 4(2) and the class of contained uses and, where appropriate, the suitability of the cont ainment and other protective measures, the waste 
management, and emergency response measures. 
3. If necessary, the competent authority may: (a) ask the user to provide further informa tion or to modify the conditions of the 
proposed contained use or to amend the class assigned to th e contained use(s). In this 
case the competent authority may require that the contai ned use, if proposed, does 
not begin, or, if in progress, is suspended or terminated, until the competent authority 
has given its approval on the basis of the further information ob tained or of the 
modified conditions of the contained use; 
(b) limit the time for which the contained use should be permitted or subject it to certain 
specific conditions. 
4. For the purpose of calculating the periods referre d to in Articles 8 and 9, any period of time 
during which the competent authority: 
(a) is awaiting any further information which it may have requested from the notifier in 
accordance with paragraph 3(a), or 
(b) is carrying out a public inquiry or consultation in accordance with Article 12 
shall not be taken into account. 
Article 11 
1. If the user becomes aware of relevant new in formation or modifies the contained use in a 
way which could have significan t consequences for the risks posed by it, the competent 
authority shall be informed as soon as possibl e and the notification purs uant to Articles 6, 8 
and 9 shall be modified. 
2. If information subsequently becomes availa ble to the competent authority which could 
have significant consequences for the risks posed by the contained use, the competent 
authority may require the user to modify the conditions of, or suspend or terminate, the 
contained use. 
 
EN 14   EN Article 12 
Where a Member State considers it appropriate, it may provi de that the public shall be 
consulted on aspects of the proposed contai ned use, without prejudice to Article 18. 
Article 13 
1. The competent authorities shall ensure that before a contained use commences: 
(a) an emergency plan is drawn up for contai ned uses where failure of the containment 
measures could lead to serious danger, whether immediate or delayed, to humans 
outside the premises and/or to the envi ronment, except where such an emergency 
plan has been drawn up under ot her Community legislation; 
(b) information on such emergency plans, incl uding the relevant safe ty measures to be 
applied, is supplied in an appropriate manner, and without  their having to request it, 
to bodies and authorities liable  to be affected by the acc ident. The information shall 
be updated at appropriate intervals. It shall also be made publicly available. 
2. The Member States concerned shall at the same time make available to other Member 
States concerned, as a basis for all necessary  consultation within the framework of their 
bilateral relations, the same information as that which is disseminated to their nationals. 
Article 14 
1. Member States shall take the necessary measures  to ensure that, in th e event of an accident, 
the user shall be required to inform immediately the competent authority specified in Article 10 and provide the following information: 
(a) the circumstances of the accident; (b) the identity and quantities of the GMMs concerned; (c) any information necessary to assess the e ffects of the accident on the health of the 
general population and the environment; 
(d) the measures taken. 
2. Where information is given pursuant to para graph 1, the Member States shall be required 
to: 
(a) ensure that any measures necessary ar e taken, and immediately alert any Member 
States which could be affected by the accident; 
(b) collect, where possible, the information n ecessary for a full analysis of the accident 
and, where appropriate, make  recommendations to avoid similar accidents in the 
future and to limit the effects thereof. 
 
EN 15   EN Article 15 
1. Member States shall be required to: 
(a) consult with other Member States likely to  be affected in the event of an accident on 
the proposed implementation of emergency plans; 
(b) inform the Commission as soon as possible of any accident within the scope of this 
Directive, giving details of the circumst ances of the accident,  the identity and 
quantities of the GMMs concerned, the response measures taken and their 
effectiveness and an analysis of the acci dent, including recommendations to limit its 
effects and avoid similar accidents in the future. 
2. The Commission, in consultation with the Memb er States, shall establish a procedure for 
the exchange of information pu rsuant to paragraph 1. It sha ll also set up and keep at the 
disposal of the Member States a register of accidents within the scope of this Directive, 
including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future. 
 
Ð 90/219/EEC 
Article 16 
Member States shall ensure that the compet ent authority organises inspections and other 
control measures to ensure user compliance with this Directive. 
 
Ð 98/81/EC, Art. 1 pt. 2 
Article 17 
1. Member States shall send to the Commission, at the end of each year, a summary report on 
class 3 and class 4 contained uses notified during that year pursuant to Article 9 including the 
description, purpose and risks of the contained use(s). 
2. Every three years, Member States shall send the Commission a summary report on their 
experience with this Di rective, the first time being on 5 June 2003. 
3. Every three years, the Commi ssion shall publish a summary base d on the reports referred to 
in paragraph 2, the first time being on 5 June 2004. 
4. The Commission may publish general statistical  information on the implementation of this 
Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user. 
 
EN 16   EN Article 18 
 
Ð 98/81/EC, Art. 1 pt. 2 (adapted) 
1. Where its disclosure a ffects one or more of the items men tioned in Article 4(2) of Directive 
⌦ 2003/4/EC of the European Pa rliament and of the Council ⌫13, the notifier may indicate 
the information in the notifications submitted pursu ant to this Directive that should be treated 
as confidential. Verifiable justifi cation should be given in such cases. 
 
Ð 98/81/EC, Art. 1 pt. 2 
The competent authority shall decide, after consultation with the notifier, which information 
will be kept confidentia l and shall inform the notifier of its decision. 
2. In no case may the following information, when submitted according to Articles 6, 8 or 9, 
be kept confidential: 
(a) the general characteristic s of the GMMs, name and ad dress of the notifier, and 
location of use; 
(b) the class of contained use and the containment measures ; (c) the evaluation of foreseeable effects, in particular any harmful effects on human 
health and the environment. 
 
Ð 98/81/EC Art. 1 pt. 2 (adapted) 
3. The Commission and the competent authoritie s shall not divulge to third parties any 
information ⌦ deemed ⌫ to be confidential according to ⌦ the second subparagraph of ⌫ 
paragraph 1 and notified or otherwise provided pursuant to this Directive, and shall protect 
intellectual property rights re lating to the data received. 
4. If, for whatever reasons, th e notifier withdraws the notifi cation, the competent authority 
must respect the confidentiality of the information supplied. 
Article 19 
Amendments necessary to adapt Annex II, Part A, and Annexes III to V to technical progress 
and to adapt Annex II, Part C, shall be decided in accordance with the procedure ⌦ referred 
to ⌫ in Article 21 ⌦ (2) ⌫. 
                                                 
13 OJ L ⌦ 41, 14.2.2003, p. 26 ⌫. 
 
EN 17   EN  
Ð 98/81/EC Art. 1 pt. 3 (adapted) 
Article 20 
Amendments to Annex II, Part B, shall be adopted by the Council acti ng by qualified majority 
on a proposal from the Commission. 
 
Ð 1882/2003, Art. 3, Annex III, 
pt. 19 
Article 21 
1. The Commission shall be assisted by a committee. 
2. Where reference is made to this paragraph,  Articles 5 and 7 of Decision 1999/468/EC shall 
apply, having regard to the pr ovisions of Article 8 thereof. 
The period laid down in Article  5(6) of Decision 1999/468/EC sh all be set at three months. 
3. The Committee shall adopt its rules of procedure. 
 
Ð  
Article 22 
Directive 90/219/EEC, as amended by the acts listed in Annex VI, Part A, is repealed, without 
prejudice to the obligatio ns of the Member States relating to the time-limits for transposition 
into national law of the Directives  set out in Annex VI, Part B. 
References to the repealed Directive shall be construed as references to this Directive and 
shall be read in accordance with th e correlation table in Annex VII. 
Article 23 
This Directive shall enter into force on the tw entieth day following that  of its publication in 
the Official Journal of  the European Union . 
 
Ð 90/219/EEC 
Article 24 
This Directive is addressed to the Member States. 
 
EN 18   EN Done at Brussels,  
For the European Parliament For the Council 
The President The President   
 
EN 19   EN  
Ð 98/81/EC Art. 1 pt. 4 
ANNEX I  
PART A 
Techniques of genetic modification re ferred to in Article 2(b)(i) are, inter alia : 
1. Recombinant nucleic acid techniques invol ving the formation of new combinations 
of genetic material by the in sertion of nucleic acid mol ecules produced by whatever 
means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but 
in which they are capable of continued propagation. 
2. Techniques involving the dire ct introduction into a micr o-organism of heritable 
material prepared outside the micro-or ganism, including micro-injection, macro-
injection and micro-encapsulation. 
3. Cell fusion or hybridisation techniques wher e live cells with new combinations of 
heritable genetic material are formed th rough the fusion of two or more cells by 
means of methods that do not occur naturally. 
PART B 
Techniques referred to in Article 2(b)(ii) wh ich are not considered to result in genetic 
modification, on condition that they do not in volve the use of recombinant-nucleic acid 
molecules or GMMs made by techniques/methods other than the techniques/methods 
excluded by Annex II, PART A: 
(1) in vitro  fertilisation; 
(2) natural processes such as: conj ugation, transduction, transformation; 
(3) polyploidy induction. 
_______________ 
 
EN 20   EN ANNEX II  
PART A 
Techniques or methods of genetic modification yi elding micro-organisms to be excluded from 
the Directive on condition that they do not in volve the use of reco mbinant-nucleic acid 
molecules or GMMs other than those produced by one or more of the techniques/methods 
listed below: 
1. Mutagenesis. 2. Cell fusion (including protoplast fusion) of prokaryotic species th at exchange genetic 
material by known physiological processes. 
3. Cell fusion (including protoplast fusion) of cel ls of any eukaryotic  species, including 
production of hybridomas and plant cell fusions. 
4. Self-cloning consisting in the removal of  nucleic acid sequences from a cell of an 
organism which may or may not be followed by reinsertion of all or part of that 
nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical 
steps, into cells of the same species or into cells of phylogenetic ally closely related 
species which can exchange genetic mate rial by natural physiological processes 
where the resulting micro-organism is unlikely to cause disease to humans, animals or plants. 
 Self-cloning may include the use of recombinant vectors with an extended history of 
safe use in the particular micro-organisms. 
 
Ð 2001/204/EC Art. 1 (adapted) 
PART B 
Criteria establishing the safety of G MMs for human health and the environment 
This Annex describes in general terms the criteri a to be met when establishing the safety of 
types of GMMs for human health and the envir onment and their suitabili ty for inclusion in 
Part C. It will be supplement ed by guidance notes for the easy application of such criteria, 
such notes being developed and, if necessar y, amended by the Commission in accordance 
with the procedure referred to in Article 21 ⌦ (2) ⌫. 
1. INTRODUCTION 
 Types of GMMs listed in Part C in accord ance with the procedure referred to in 
Article 21 ⌦ (2) ⌫ are excluded from the scope of this Directive. GMMs will be 
added to the list on a case-by-case basis and exclusion will relate only to each clearly identified GMM. This exclusion applies only when the GMM is used under conditions of contained use as defined in  Article 2(c). It does not apply to the 
deliberate release of GMMs. For a GMM to be listed in Part C, it must be proved that 
it meets the criteria given below. 
 
EN 21   EN  
Ð 2001/204/EC Art. 1 
2. GENERAL  CRITERIA 
2.1. Strain verification/authentication 
 Identity of the strain mu st be precisely established. Modification must be known and 
verified. 
2.2. Documented and established evidence of safety 
 Documented evidence of the safety of the organism must be provided. 
2.3. Genetic stability 
 Where any instability could adversely affect  safety, evidence of stability is required. 
3. SPECIFIC  CRITERIA 
3.1. Non-pathogenic 
 The GMM should not be capable of causi ng disease or harm to a healthy human, 
plant or animal. Since pathogenicity includes  both toxigenicity and allergenicity, the 
GMM should therefore be: 
3.1.1. Non-toxigenic 
 The GMM should not produce increased toxi genicity as a result of the genetic 
modification nor be noted for its toxigenic properties. 
 
Ð 2001/204/EC Art. 1 (adapted) 
3.1.2. Non-allergenic 
 The GMM should not produce increased alle rgenicity as a resu lt of the genetic 
modification nor be a noted allergen, havi ng, for example, allergenicity comparable 
in particular with that of the micro-organisms identified in Directive ⌦ 2000/54/EC ⌫. 
 
Ð 2001/204/EC Art. 1 
3.2. No harmful adventitious agents 
 The GMM should not harbour known harmful adventitious  agents such as other 
micro-organisms, active or latent, existing alongside or inside the GMM that could 
cause harm to human health and the environment. 
 
EN 22   EN 3.3. Transfer of genetic material 
 The modified genetic material must not give  rise to harm if transferred nor should it 
be self transmissible or transferable at a frequency greater than other genes of the 
recipient or parent al micro-organism. 
3.4. Safety for the environment in the even t of a significant and unintended release 
 GMMs must not produce adverse effects on the environment, immediate or delayed, 
should any incident involving a signi ficant and unintended release occur. 
 GMMs that do not meet the above criteria may not be included in Part C. 
 
Ð 98/81/EC, Art. 1 pt. 4 (adapted) 
PART C 
Types of GMMs which meet the criteria listed in Part B: 
… (to be completed in accord ance with the procedure ⌦ referred to ⌫ in Article 21 
⌦ (2) ⌫) 
_______________ 
 
EN 23   EN ANNEX III  
PRINCIPLES TO BE FOLLOWED FOR TH E ASSESSMENT RE FERRED TO IN 
ARTICLE 4(2) 
This Annex describes in general terms the elements to be consid ered and the procedure to be 
followed to perform the assessment referred to in  Article 4(2). It will be supplemented, as 
regards in particular section B, by guidance notes to be developed by the Commission in 
accordance with the procedure ⌦ referred to ⌫ in Article 21 ⌦ (2) ⌫. 
 
Ð 98/81/EC, Art. 1 pt. 4 
A. ELEMENTS  OF ASSESSMENT 
1. The following should be considered  as potentially ha rmful effects: 
– disease to humans including al lergenic or toxic effects, 
– disease to animals or plants, 
– deleterious effects due to the impossibili ty of treating a dise ase or providing an 
effective prophylaxis, 
– deleterious effects due to establishment or disseminat ion in the environment, 
– deleterious effects due to the natural transfer of inserted genetic material to 
other organisms. 
2. The assessment referred to in Articl e 4(2) should be based on the following: 
(a) the identification of any potentially harmful effects, in  particular those 
associated with: 
(i) the recipient micro-organism; (ii) the genetic material inserted (originating from the donor organism); 
(iii) the vector; (iv) the donor micro-organism (as long as the donor micro-organism is used 
during the operation); 
(v) the resulting GMM; 
(b) the characteristics of the activity; (c) the severity of the pot entially harmful effects; 
(d) the likelihood of the potentially  harmful effects being realised. 
 
EN 24   EN B. PROCEDURE 
3. The first stage in the assessment process should be to identify the harmful properties 
of the recipient and, where appropriate,  the donor micro-organism, any harmful 
properties associated with the vector or in serted material, including any alteration in 
the recipient's existing properties. 
4. In general, only GMMs which show th e following characteristics would be 
considered appropriate for inclusion in  class 1 as defined in Article 4(3): 
(i) the recipient or parental  micro-organism is unlikely to cause disease to humans, 
animals or plants14; 
(ii) the nature of the vector and the inse rt is such that they do not endow the GMM 
with a phenotype likely to cause dis ease to humans, animals or plants15, or 
likely to cause deleterious effects in the environment; 
(iii) the GMM is unlikely to cause disease to humans, animals or plants16 and is 
unlikely to have deleterious effects on the environment. 
 
Ð 98/81/EC, Art. 1 pt. 4 (adapted) 
5. In order to obtain the necessary informati on to implement this process the user may 
firstly take into account relevant Community legislation (in particular Directive ⌦ 2000/54/EC ⌫). International or national cl assification schemes (e.g. WHO, 
NIH, etc.) and their revisions due to new scientific knowledge and technical progress 
may also be considered. 
 These schemes concern natural micro-organi sms and as such are usually based on the 
ability of micro-organisms to cause diseas e to humans, animals or plants and on the 
severity and transmissibility of the disease likely to be caused. Directive 
⌦ 2000/54/EC ⌫ classifies micro-organisms, as bi ological agents, into four classes 
of risk on the basis of potential effects on a healthy human adult. These classes of 
risk can be used as guidance to the categor isation of the contai ned use activities in 
the four classes of risk referred to in Ar ticle 4(3). The user may also take into 
consideration classification sc hemes referring to plant a nd animal pathogens (which 
are usually established on a national ba sis). The abovementi oned classification 
schemes give only a provisional indication of  the risk class of the activity and the 
corresponding set of containm ent and control measures. 
 
Ð 98/81/EC, Art. 1 pt. 4 
6. The hazard identification process carried out  in accordance with points 3 to 5, should 
lead to the identification of the leve l of risk associated with the GMM. 
                                                 
14 This would only apply to animals and plants in the environment likely to be exposed. 
15 This would only apply to animals and plants in the environment likely to be exposed. 
16 This would only apply to animals and plants in the environment likely to be exposed. 
 
EN 25   EN 7. Selection of the containmen t and other protective measur es should then be made on 
the basis of the level of ri sk associated with the GMMs together with consideration 
of: 
(i) the characteristics of the environment likely to be exposed (e.g. whether in the 
environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro- organisms used in the contained use 
activity); 
(ii) the characteristics of the activity (e.g. its scale; nature); (iii) any non-standard opera tions (e.g. the inoculation of animals with GMMs; 
equipment likely to generate aerosols). 
 Consideration of items (i) to (iii) for th e particular activity may increase, reduce or 
leave unaltered the level of ri sk associated with the GMM as identified under point 6. 
8. The analysis carried out as described above will finally l ead to the assignment of the 
activity to one of the classe s described in Article 4(3). 
9. The final classification of the containe d use should be confir med by reviewing the 
completed assessment referred to in Article 4(2). 
_______________ 
 
EN 26   EN ANNEX IV  
CONTAINMENT AND OTHER PROTECTIVE MEASURES 
General principles 
1. These tables present the normal minimum requirements and measures necessary for 
each level of containment. 
 Containment is also achi eved through the use of good wo rk practices, training, 
containment equipment and special insta llation design. For all activities involving 
GMMs the principles of good microbiological  practice and the following principles 
of good occupational safety and hygiene, shall apply: 
(i) to keep workplace and environmenta l exposure to any GMM to the lowest 
practicable level; 
(ii) to exercise engineering control me asures at source and to supplement these 
with appropriate personal protective clothing and equipment when necessary; 
(iii) to test adequately and mainta in control measures and equipment; 
(iv) to test, when necessary, for the pres ence of viable process organisms outside 
the primary physical containment; 
(v) to provide appropria te training of personnel; 
(vi) to establish biological safety comm ittees or subcommittees, if required; 
(vii) to formulate and implement local code s of practice for the safety of personnel, 
as required; 
(viii) where appropriate to display biohazard signs; (ix) to provide washing and decont amination facilities for personnel; 
(x) to keep adequate records; (xi) to prohibit eating, drinking, smoking, a pplying cosmetics or the storing of food 
for human consumption in the work area; 
(xii) to prohibit mouth pipetting; 
(xiii) to provide written st andard operating procedures wh ere appropriate to ensure 
safety; 
(xiv) to have effective disinfectants and specified disinfection procedures available 
in case of spillage of GMMs; 
(xv) to provide safe storage for contamin ated laboratory equipment and materials, 
when appropriate. 
 
EN 27   EN 2. The titles of the tables are indicative: 
 Table I A presents minimum requirements for laboratory activities.  Table I B presents additions to and modifications of Table I A for 
glasshouse/growth-room ac tivities involving GMMs. 
 Table I C presents additions to and modi fications of Table I A for activities with 
animals involving GMMs. 
 Table II presents minimum requirement s for activities other than laboratory 
activities. 
 In some particular cases, it might be nece ssary to apply a combination of measures, 
from Table I A and Table II, of the same level. 
 In some cases users may, with the agreemen t of the competent authority, not apply a 
specification under a particular containment level or combine specifications from 
two different levels. 
 In these tables “optional” means that the user may apply these measures on a case-
by-case basis, subject to the assessm ent referred to in Article 4(2). 
3. Member States may, in implementing this Annex, incorporate in addition the general 
principles in points 1 and 2 in the followi ng tables for the sake of clarity of the 
requirements. 
Table I A 
Containment and other protective me asures for laboratory activities 
Containment levels 
Specifications 
1 2 3 4 
1 Laboratory suite: 
isolation1 Not 
required Not 
required Required Required 
2 Laboratory: sealable 
for fumigation Not 
required Not 
required Required Required 
Equipment 
3 Surfaces resistant to 
water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required 
(bench) Required 
(bench) Required 
(bench, floor) Required 
(bench, floor, ceiling, walls) 
 
EN 28   EN 4 Entry to lab via 
airlock2 Not 
required Not 
required Optional Required 
5 Negative pressure 
relative to the pressure of the immediate environment Not 
required Not 
required Required 
except for
3 Required 
6 Extract and input air 
from the laboratory should be HEPA-filtered Not 
required Not 
required Required 
(HEPA)
4 — 
extract air except for
3 Required 
(HEPA)5 — 
input and extract air 
7 Microbiological safety 
post Not 
required Optional Required Required 
8 Autoclave On site In the 
building En suite6 In lab = 
double-ended 
System of work 
9 Restricted access Not 
required Required Required Required 
10 Biohazard sign on the 
door Not 
required Required Required Required 
11 Specific measures to 
control aerosol dissemination Not 
required Required 
minimise Required 
prevent Required 
prevent 
13 Shower Not 
required Not 
required Optional Required 
 
Ð Corrigendum, 98/81/EC 
(OJ L 93, 8.4.1999, p. 27) 
14 Protective clothing Suitable 
protective clothing Suitable 
protective clothing Suitable 
protective clothing and (optional) footwear Complete 
change of clothing and footwear before entry and exit 
 
EN 29   EN  
Ð 98/81/EC Art. 1 pt. 4 
15 Gloves Not 
required Optional Required Required 
18 Efficient vector 
control (e.g. for rodents and insects) Optional Required Required Required 
Waste 
19 Inactivation of GMMs 
in effluent from hand-washing sinks or drains and showers and similar effluents Not 
required Not 
required Optional Required 
20 Inactivation of GMMs 
in contamined material and waste Optional Required Required Required 
Other measures 
21 Laboratory to contain 
its own equipment Not 
required Not 
required Optional Required 
23 An observation 
window or alternative is to be present so that occupants can be seen Optional Optional Optional Required 
1 Isolation = the laboratory is separated from other areas in the same building or is in a separate 
building. 
2 Airlock = entry must be through an airlock which is a chamber isolated from the laboratory. The 
clean side of the airlock must be separated from the restricted side by changing or showering 
facilities and preferably by interlocking doors. 
3 Activities where transmission does not occur via airborne route. 
4 HEPA = High efficiency particulate air. 
5 Where viruses which are not retain ed by HEPA filters are used, ex tra requirements will be necessary 
for extract air. 
6 With validated procedures, allowing the safe transf er of material into an autoclave outside the lab, 
and providing an equivalent level of protection.  
 
EN 30   EN Table I B 
Containment and other protective meas ures for glasshouses and growth-rooms 
The terms “glasshouse” and “growth-room” refer to  a structure with walls, a roof and a floor 
designed and used principally for growing plants  in a controlled and protected environment. 
 
Ð 98/81/EC (adapted) 
All provisions of Table I A shall apply with the following additions/modifications: 
Containment levels Specifications 
1 2 3 4 
Building 
1 ⌦ Glasshouse ⌫: 
permanent structure1 Not 
required Required Required Required 
Equipment 
3 Entry via a separate 
room with two interlocking doors Not 
required Optional Optional Required 
4 Control of 
contaminated run-off water Optional Minimise
2 run-off Prevent 
run-off Prevent 
run-off 
System of work 
6 Measures to control 
undesired species such as insects, rodents, arthropods Required Required Required Required 
 
EN 31   EN 7 Procedures for 
transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of ⌦ GMMs ⌫ Minimise 
dissemination Minimise 
dissemination Prevent 
dissemination Prevent 
dissemination 
1 The glasshouse shall consist of a permanent struct ure with a continuous waterproof covering, located 
on a site graded to prevent entry of surface-water run-off ⌦ , and with ⌫ self-closing lockable 
doors. 
2 Where transmission can occur through the ground.  
 
EN 32   EN  
Ð 98/81/EC Art. 1 pt. 4 
Table I C 
Containment and other protective measu res for activities in animal units 
All provisions of Table I A shall apply with the following additions/modifications: 
Containment levels Specifications 
1 2 3 4 
Facilities 
1 Isolation of animal unit1 Optional Required Required Required 
2 Animal facilities2 
separated by lockable doors Optional Required Required Required 
3 Animal facilities 
designed to facilitate decontamination (waterproof and easily 
washable material 
(cages, etc.)) Optional Optional Required Required 
4 Floor and/or walls easily 
washable Optional Required 
(floor) Required 
(floor and walls) Required 
(floor and walls) 
5 Animals kept in 
appropriate containment facilities such as cages, pens or tanks Optional Optional Optional Optional 
6 Filters on isolators or 
isolated room3 Not 
required Optional Required Required 
1 Animal unit: a building, or separate area within a building containing facilities and other areas such 
as changing rooms, showers, auto claves, food storage areas, etc. 
2 Animal facility: a facility norma lly used to house stock, breeding or experimental animals or one 
which is used for the performance of minor surgical procedures. 
3 Isolators: transparent boxes where small animals are contained within or outside a cage; for large 
animals, isolated rooms may be more appropriate.  
 
EN 33   EN Table II 
Containment and other protective measures for other activities 
Containment levels Specifications 
1 2 3 4 
General 
1 Viable micro-
organisms should be contained in a system which separates the process from the environment (closed system) Optional Required Required Required 
2 Control of exhaust 
gases from the closed system Not 
required Required, 
minimise dissemination Required, 
prevent dissemination Required, 
prevent dissemination 
3 Control of aerosols 
during sample 
collection, addition of material to a closed system or transfer of material to another closed system Optional 
Required, 
minimise 
dissemination  Required, 
prevent 
dissemination Required, 
prevent 
dissemination 
4 Inactivation of bulk 
culture fluids before removal from the 
closed system Optional Required, by 
validated means Required, by 
validated means Required, by 
validated means 
5 Seals should be 
designed so as to minimise or prevent release No 
sepecific 
requirement Minimise 
dissemination Prevent 
dissemination Prevent 
dissemination 
6 The controlled area 
should be designed to contain spillage of the entire contents of the closed system Optional Optional Required Required 
7 The controlled area 
should be sealable to permit fumigation Not 
required Optional Optional Required 
 
EN 34   EN Equipment 
8 Entry via airlock Not 
required Not required Optional Required 
9 Surfaces resistant to 
water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required 
(bench if any) Required 
(bench if any) Required 
(bench if any, floor) Required 
(bench, floor, ceiling, walls)
10 Specific measures to 
adequately ventilate the controlled area in order to minimise air contamination Optional Optional Optional Required 
11 The controlled area 
should be maintained at an air pressure negative to the immediate surroundings Not 
required Not required Optional Required 
12 Extract and input air 
from the controlled area should be HEPA filtered Not 
required Not required Required 
(extract air, optional for input air) Required 
(input and extract air) 
System of work 
13 Closed systems should 
be located within a 
controlled area Not 
required Optional Required Required 
14 Access should be 
restricted to nominated personnel only Not 
required Required Required Required 
15 Biohazard signs should 
be posted Not 
required Required Required Required 
17 Personnel should 
shower before leaving the controlled area Not 
required Not required Optional Required 
18 Personnel should wear 
protective clothing Required 
(work clothing) Required 
(work clothing) Required Complete 
change before exit and entry 
 
EN 35   EN Waste 
22 Inactivation of GMMs 
in effluent from handwashing sinks and showers or similar effluents Not 
required Not required Optional Required 
23 Inactivation of GMMs 
in contaminated material and waste including those in process effluent before final discharge Optional Required, by 
validated means Required, by 
validated means Required, by 
validated means 
_______________ 
 
EN 36   EN ANNEX V  
 
Ð 98/81/EC, Art. 1 pt. 4 (adapted) 
⌦ INFORMATION REQUIRED FOR THE NOTIFICATION REFERRED TO IN 
ARTICLES 6, 8 AND 9  ⌫ 
 
Ð 98/81/EC Art. 1 pt. 4 
PART A 
Information required for the notifi cation referred to in Article 6: 
– name of user(s) includin g those responsible for supervision and safety, 
– information on the training and qualifica tions of the persons responsible for 
supervision and safety, 
– details of any biological co mmittees or subcommittees, 
– address and general descri ption of the premises, 
– a description of the nature of the work which will be undertaken, 
– the class of the contained uses, 
– only for class 1 contained uses, a summa ry of the assessment referred to in 
Article 4(2) and information on waste management. 
PART B 
Information required for the notifi cation referred to in Article 8: 
– the date of submission of the notification referred to in Article 6, 
– the names of the persons responsible for supervision and safety and information on 
their training and qualification, 
– the recipient, donor and/or parental micro-organism(s) used and, where applicable, 
the host-vector system(s) used, 
– the source(s) and the intended function(s) of  the genetic material(s) involved in the 
modification(s), 
– the identity and characteristics of the GMM, 
– the purpose of the contained use,  including the expected results, 
– the approximate culture volumes to be used, 
 
EN 37   EN – a description of the containment and othe r protective measures to be applied, 
including information about waste mana gement, including the wastes to be 
generated, their treatment, final form and destination, 
– a summary of the assessment referred to in Article 4(2), 
– the information necessary for the competent authority to evaluate any emergency 
response plans, if required under Article 13(1). 
PART C 
Information required for the notifi cation referred to in Article 9: 
(a) – the date of submission of the notification referred to in Article 6, 
– the names of the persons responsible  for supervision and safety and 
information on their trai ning and qualification; 
(b) – the recipient or parental micro-organism(s) to be used, 
– the host-vector system(s) to be used (where applicable), 
– the source(s) and intended function(s) of  the genetic material (s) involved in the 
modification(s), 
– the identity and characteristics of the GMM, 
– the culture volumes to be used; 
(c) – a description of the containment and other protective measures to be applied, 
including information about waste manage ment, including the type and form of 
wastes to be generated, their trea tment, final form and destination, 
– the purpose of the contained use,  including the expected results, 
– a description of the part s of the installation; 
(d) information about accident prevention a nd emergency response plans, if any: 
– any specific hazards arising from the location of the installation, 
– the preventive measures applied, such as  safety equipment, alarm systems and 
containment methods, 
– the procedures and plans for verifyi ng the continuing eff ectiveness of the 
containment measures, 
– a description of information provided to workers, 
– the information necessary for the competent authority to evaluate any 
emergency response plans, if required under Article 13(1); 
 
EN 38   EN (e) a copy of the assessment referred to in Article 4(2). 
_______________ 
 
EN 39   EN  
Ï 
ANNEX VI  
Part A 
Repealed Directive with its successive amendments  
(referred to in Article 22) 
Council Directive 90/219/EEC 
(OJ L 117, 8.5.1990, p. 1)  
Commission Directive 94/51/EC 
(OJ L 297, 18.11.1994, p. 29)  
Council Directive 98/81/EC 
(OJ L 330, 5.12.1998, p. 13)  
Council Decision 2001/204/EC 
(OJ L 73, 15.3.2001, p. 32)  
Regulation (EC) No 188 2/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) Annex III, point 19, only 
Part B  
List of time-limits for tran sposition into national law  
(referred to in Article 22) 
Directive Time-limit for transposition 
90/219/EEC 23 October 1991 
94/51/EC 30 April 1995 
98/81/EC 5 June 2000 
_____________ 
 
EN 40   EN ANNEX VII  
CORRELATION TABLE  
Directive 90/219/EEC This Directive 
Article 1 Article 1 
Article 2 Article 2 
Article 3, introductory phrase Ar ticle 3(1), introductory phrase 
Article 3, first indent Article 3(1)(a) 
Article 3, second indent Article 3(1)(b) 
Article 4, first paragraph Article 3(2) 
Article 4, second paragraph Article 3(3) 
Article 5 Article 4 
Article 6 Article 5 
Article 7 Article 6 
Article 8 Article 7 
Article 9 Article 8 
Article 10 Article 9 
Article 11(1), (2) and (3) Article 10(1), (2) and (3) 
Article 11(4), introductory phrase Article 10(4), introductory phrase 
Article 11(4), first indent Article 10(4)(a) 
Article 11(4), second indent Article 10(4)(b) 
Article 12, first paragraph Article 11(1) 
Article 12, second paragraph Article 11(2) 
Article 13 Article 12 
Article 14, first paragraph Article 13(1) 
Article 14, second paragraph Article 13(2) 
Article 15(1), introductory phrase Article 14(1), introductory phrase 
 
EN 41   EN Article 15(1), first indent Article 14(1)(a) 
Article 15(1), second indent Article 14(1)(b) 
Article 15(1), third indent Article 14(1)(c) 
Article 15(1), fourth indent Article 14(1)(d) 
Article 15(2), introductory phrase Article 14(2), introductory phrase 
Article 15(2), first indent Article 14(2)(a) 
Article 15(2), second indent Article 14(2)(b) 
Article 16 Article 15 
Article 17 Article 16 
Article 18 Article 17 
Article 19(1) Article 18(1), first subparagraph 
Article 19(2) Article 18(1), second subparagraph 
Article 19(3), introductory phrase Article 18(2), introductory phrase 
Article 19(3), first indent Article 18(2)(a) 
Article 19(3), second indent Article 18(2)(b) 
Article 19(3), third indent Article 18(2)(c) 
Article 19(4) Article 18(3)  
Article 19(5) Article 18(4)  
Article 20 Article 19 
Article 20 a Article 20 
Article 21 Article 21 
Article 22 _________ 
_________ Article 22 
_________ Article 23 
Article 23 Article 24 
 
EN 42   EN Annexes I-V Annexes I-V 
_________ Annex VI 
_________ Annex VII 
_____________