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E.U. Directive

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as of October 17th 2002

The PDF. file of this 64 page directive is available HERE.

Directive 2001/18/EC of the European Parliament and of the Council covers the deliberate release into the environment of genetically modified organisms and repeals the earlier Council Directive 90/220/EEC

It contains the following.

Part A: General Provisions
Article 1: Objectives
Article 2: Definitions
Article 3: Exemptions
Article 4: General obligations

Part B: Deliberate Release of GMOs for any other purpose than for placing on the market
Article 5
Article 6: Standard authorisation procedure
Article 7: Differentiated procedures
Article 8: Handling of modifications and new information
Article 9: Consultation of and information to the public
Article 10: Reporting by notifiers on releases
Article 11: Exchange of information between competent authorities and the Commission
Part C: Placing on the Market of GMOs as or in products
Article 12: Sectoral legislation
Article 13: Notification Procedure
Article 14: Assessment report

Article 15: Standard procedure
Article 16: Criteria and information for specified GMOs
Article 17: Renewal of consent
Article 18: Community procedure in case of objections
Article 19: Consent
Article 20: Monitoring and handling of new information
Article 21: Labelling
Article 22: Free circulation
Article 23: Safeguard clause
Article 24: Information to the public
Part D: Final Provisions
Article 25: Confidentiality
Article 26: Labelling of GMOs referred to in Article 2(4), second subparagraph
Article 27: Adaptation of Annexes to technical progress
Article 28: Consultation of Scientific Committee(s)
Article 29: Consultation of Committee(s) on Ethics
Article 30: Committee procedure
Article 31: Exchange of information and reporting
Article 32: Implementation of the Cartagena Protocol on biosafety
Article 33: Penalties
Article 34: Transposition
Article 35: Pending notifications
Article 36: Repeal
Article 37
Article 38
It also contains the following annexations

Annex IA: Techniques referred to in Article 2(2)
Annex IB: Techniques referred to in Article 3
Annex II: Principles for the environmental risk assessment
Annex III: Information required in the notification
Annex III A: Information required in the notification concerning releases of genetically modified organisms other than higher plants
Annex III B: Information required in the notification concerning releases of genetically modified higher plants
Annex IV: Additional information
Annex V: Criteria for the application of differentiated procedures (Article 7)
Annex VI: Guidelines for the assessment reports
Annex VII: Monitoring plan
Annex VIII: Correlation table

We at also believe that Medical Molecular Farming products would also be governed by the following:- .
COUNCIL REGULATION (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.