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Between Domestic Fears and International Disciplines: EU Regulation of Biotechnology
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Box 3. Authorization Process for GM Food and Feed under Regulation 1829/2003
Operator
An operator submits an application to the competent authority from one of the member states.
Member State
The member state provides the file to the new European Food Safety Authority (EFSA).
EFSA
The EFSA provides a copy to the other member states and the Commission, and makes a summary of the file publicly available.
EFSA
Within six months, the EFSA submits its opinion, based on risk assessments, to the Commission, the member states, and the applicant, and, after the deletion of any confidential information, makes it publicly available.
Commission
The Commission is then to issue a draft decision, which may vary from EFSA’s opinion, to the regulatory committee consisting of member state representatives.
Regulatory Committee Council Commission
The regulatory committee is to deliver its opinion on the Commission’s draft decision. If the committee does not support the proposal by a qualified majority, the Commission must submit its proposal to the Council. If the Council does not oppose the Commission’s proposal by a qualified majority vote, then the proposed decision “shall be adopted by the Commission.”
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| | Authors: Shaffer, Gregory. |
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57
Box 3. Authorization Process for GM Food and Feed under Regulation 1829/2003
Operator
An operator submits an application to the competent authority from one of
the member states.
Member State
The member state provides the file to the new European Food Safety
Authority (EFSA).
EFSA
The EFSA provides a copy to the other member states and the
Commission, and makes a summary of the file publicly available.
EFSA
Within six months, the EFSA submits its opinion, based on risk
assessments, to the Commission, the member states, and the applicant, and,
after the deletion of any confidential information, makes it publicly
available.
Commission
The Commission is then to issue a draft decision, which may vary from
EFSA’s opinion, to the regulatory committee consisting of member state
representatives.
Regulatory
Committee
Council
Commission
The regulatory committee is to deliver its opinion on the Commission’s
draft decision. If the committee does not support the proposal by a
qualified majority, the Commission must submit its proposal to the
Council. If the Council does not oppose the Commission’s proposal by a
qualified majority vote, then the proposed decision “shall be adopted by
the Commission.”
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