Order No. 225 for approval of production using genetically modified microorganisms.

This Order applies to the authorization of production containing gentically modified microorganisms. Prior to business production, an assessment of environmental, nature and health risks shall take place in adherence to this Order's regulations. Results thereof shall be registered, authorized and classified. Microorganisms manufactured using the following techniques of genetic modification, are not covered by this Order: Mutagenesis, cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes; and cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions.
The Order contains 6 Chapter and 5 Appendices: Scope and definitions (1); Classification, assessment and approval before production begins (2); Application for approval of manufacturing (3); Decision approving production (4); Review (5); Entry into force and transitional provisions (6).
Appendix 1 - Definition of genetically modified micro-organism.
Appendix 2 - Criteria for the classification of production using genetically modified microorganisms.
Appendix 3 - Principles for risk assessment.
Appendix 4 - General principles and appropriate containment and other protective measures.
Appendix 5 - Disclosure of requirements.