Article 1. . . . . . . . . ....
Article 2. . . . . . . . . ....
Article 3. . . . . . . . . ....
Article 4. . . . . . . . . ....
Article 5. . . . . . . . . ....
Article 6. . . . . . . . . ....
Article 7. . . . . . . . . ....
Article 8. . . . . . . . . ....
Article 9. . . . . . . . . ....
Article 10. . . . . . . . . ....
Article 11. . . . . . . . . ....
Article 12. . . . . . . . . ....
Article 13. . . . . . . . . ....
Article 14. . . . . . . . . ....
Article 15. . . . . . . . . ....
Article 16. . . . . . . . . ....
Article 17. . . . . . . . . ....
Article 18. . . . . . . . . ....
Article 19. . . . . . . . . ....
Article 20. . . . . . . . . ....
Article 20a. . . . . . . . . ....
Article 21. . . . . . . . . ....
Article 22. . . . . . . . . ....
Article 23. . . . . . . . . ....
ANNEX I
PART A
PART B
ANNEX II
PART A
PART B
Criteria establishing the safety of GMMs for human health and...
1.
INTRODUCTION
2.
GENERAL CRITERIA
2.1.
Strain verification/authentication
2.2.
Documented and established evidence of safety
2.3.
Genetic stability
3.
SPECIFIC CRITERIA
3.1.
Non-pathogenic
3.1.1.
Non-toxigenic
3.1.2.
Non-allergenic
3.2.
No harmful adventitious agents
3.3.
Transfer of genetic material
3.4.
Safety for the environment in the event of a significant...
Guidance notes supplementing part B of Annex II to Directive...
INTRODUCTION
1.
GENERAL CRITERIA
1.1.
Strain verification/authentication
1.2.
Documented and established safety
1.3.
Genetic stability
2.
SPECIFIC CRITERIA
2.1.
Non-pathogenic
2.1.1.
Non-toxigenic
2.1.2.
Non-allergenic
2.2.
No harmful adventitious agents
2.3.
Transfer of genetic material
2.4.
Safety for the environment in the event of an escape...
2.4.1.
Organism survival
2.4.2.
Dispersal
2.4.3.
Organism establishment in the environment
2.4.4.
Transfer of genetic material
APPENDIX 1
Definitions of terms used in this document
PART C
ANNEX III
PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 5(2)
. . . . . . . . . ..... . . . . . . . . ....
A.
ELEMENTS OF ASSESSMENT
1.. . . . . . . . . ....
2.. . . . . . . . . ....
B.
PROCEDURE
3.. . . . . . . . . ....
4.. . . . . . . . . ....
5.. . . . . . . . . ....
6.. . . . . . . . . ....
7.. . . . . . . . . ....
8.. . . . . . . . . ....
9.. . . . . . . . . ....
ANNEX IV
CONTAINMENT AND OTHER PROTECTIVE MEASURES
General principles
1.. . . . . . . . . ....
2.. . . . . . . . . ....
3.. . . . . . . . . ....
Table I A
Containment and other protective measures for laboratory activities
Table I B
Containment and other protective measures for glasshouses and growth-rooms
Table I C
Containment and other protective measures for activities in animal units...
Table II
Containment and other protective measures for other activities
ANNEX V
PART A
PART B
PART C
Council Directive
of 23 April 1990
on the contained use of genetically modified micro-organisms
(90/219/EEC) (repealed)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repealed by Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance).