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送交者: 鹏归 于 2009-02-18, 02:01:34:

回答: 斑竹在21cn讲的真好! 由 littlestone 于 2009-02-18, 01:34:55:

FDA认为没问题,是正式认可了安全性. /not made its own determination regarding the GRAS status of the subject use./是为了区别法律责任问题.

http://www.caloriecontrol.org/pdf/Rulis_08.pdf

As a technical matter, when FDA responds
affirmatively to a GRAS notice, it summarizes the data relied upon
by the notifier and states that the agency has ‘‘no questions at this
time about (the notifier’s) conclusions that the material is GRAS under
the intended conditions use,” and further states that the agency
has, ‘‘not made its own determination regarding the GRAS status of
the subject use.” This format was adopted because, under the law,
it is the notifier’s burden of proof to establish the GRAS status of
the compound. The agency does not officially ‘‘approve” a GRAS notice
like the agency does for a food additive petition. This distinction
is due to the nature of the GRAS exemption. Implicit in the agency’s
response that it has no further questions is the point that the agency
believes the notifier has made a sufficiently strong case that the use
of the substance in food: (a) satisfies the reasonable certainty of no
harm safety standard, and (b) that the knowledge base concerning
that safety is generally available and generally accepted by a consensus
among qualified experts. In practical terms, when FDA does not
disagree with the notifier’s GRAS determination, it is in effect saying
that it is comfortable that the case has been made that the proposed
use of the substance in food as described by the notifier poses no
safety issues,and that the general scientificcommunity would agree.




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