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Articles 13 (GMMs) and 36 (GMOs) of the GMO (Contained Use) Regulations 2001 to 2010 require the user to carry out an assessment of the risks to human health and the environment before commencing a contained use activity.
The risk assessment considers the exposure of humans or the environment to GMMs/GMOs, or the possible unintended release of GMMs/GMOs, from a contained use facility.
The Third Schedule of the above mentioned Regulations describes in general terms the elements to be considered and the procedure to be followed in carrying out a Risk Assessment for the contained use of GMMs.
In addition, the European Commission has produced “guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of GMMs" (Commission Decision 2000/608/EC).
Included here are some prepared examples of Risk Assessments for Class 1 and Class 2 GMMs.
Example of a Risk Assessment for Class 1 GMMs
Example of a Risk Assessment for Class 2 GMMs
In addition to a Risk Assessment, the following additional information, as set out under Part A of the 5th Schedule of the Regulations, is required for Class 1, Class 2 and Class 3 GMMs:
Additional information for the contained use of a Class 1/Class 2 GMM
Additional information for the contained use of a Class 3 GMM
Part II of the Seventh Schedule of the Regulations sets out the principles to be followed for the purposes of performing a risk assessment for the contained use of GMOs
In addition to a Risk Assessment, the following additional information as set out under Part I of the 7th Schedule of the Regulations is required for GMOs:
Additional information for the contained use of a GMO
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