NOTIFICATION
Addendum
The following communication,
received on 14 September 2018, is being
circulated at the request of the Delegation of the United
States of America.
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Current
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food; Partial withdrawal, Final Rule
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The
Food and Drug Administration (FDA) is removing instruction 13 from the
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food (Preventive Controls for Human Food)
regulation. Instruction 13 directs the Federal Register to remove and reserve
as of 17 September 2018, the Current Good Manufacturing Practice in
Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation.
Removal of instruction 13 is necessary because the compliance dates for
certain facilities subject to the modernized current good manufacturing
practice requirements in the Preventive Controls for Human Food regulation
have been extended. Retaining the Human Food CGMP regulation will maintain
the status quo while these facilities prepare for compliance with the new
CGMP requirements and will avoid an unintended gap in public health protection.
https://members.wto.org/crnattachments/2018/SPS/USA/18_4868_00_e.pdf
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