PART APART BPART APART BCriteria 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 CA.ELEMENTS OF ASSESSMENT 1.. . . . . . . . . ....2.. . . . . . . . . ....B.PROCEDURE 3.. . . . . . . . . ....4.. . . . . . . . . ....5.. . . . . . . . . ....6.. . . . . . . . . ....7.. . . . . . . . . ....8.. . . . . . . . . ....9.. . . . . . . . . ....General principles 1.. . . . . . . . . ....2.. . . . . . . . . ....3.. . . . . . . . . ....Table I AContainment and other protective measures for laboratory activities Table I BContainment and other protective measures for glasshouses and growth-rooms Table I CContainment and other protective measures for activities in animal units...Table IIContainment and other protective measures for other activities PART APART BPART C

Council Directive

of 23 April 1990

on the contained use of genetically modified micro-organisms

(90/219/EEC) (repealed)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations: