Are Amino Acids GRAS or Self-GRAS Status?
Greetings:
Trying to review a specification that contains two amino acids that are not pure or salt forms – these two amino acids are:
L-Arginine Acetate
L-Lysine Acetate
Does anyone have any feedback on these two amino acids and/or able to provide documentation of GRAS or self-GRAS status?
Per our Regulatory team, it is critical to the project to ensure we have GRAS status for the amino acids for any amino acid forms that are not free forms, hydrochloride, or Na/ K salts.
I appreciate any feedback you may have to offer! Thanks in advanced!
- PB
Sec. 172.320 Amino acids.
The food additive amino acids may be safely used as nutrients added to foods in accordance with the following conditions:
(a) The food additive consists of one or more of the following individual amino acids in the free, hydrated or anhydrous form or as the hydrochloride, sodium or potassium salts:
L-Alanine
L-Arginine
L-Asparagine
L-Aspartic acid
L-Cysteine
L-Cystine
L-Glutamic acid
L-Glutamine
Aminoacetic acid (glycine)
L-Histidine
L-Isoleucine
L-Leucine
L-Lysine
DL-Methionine (not for infant foods)
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine
Dear PremixBelle,
Out of curiosity, how is "Self-GRAS" Staus determined ? By the ER ? :smile:
Rgds / Charles.C
PS - added - OK, Google to the rescue -
●GRAS Notification. In April 1997, FDA proposed a replacement for the system under
which manufacturers may get affirmation from FDA that a food substance is generally
recognized as safe (GRAS) (Federal Register, 1997). Under this “GRAS notification
system,” manufacturers may still make a self-determined GRAS declaration, claiming
exemption from the premarket or food additive approval requirements. Instead of
petitioning FDA for affirmation, manufacturers would notify FDA of their GRAS
determination and provide evidence supporting their decision. After evaluating the
notification, FDA is to respond to the manufacturer, conveying the agency’s disposition
within 90 days. A response that does not identify a problem is not equivalent to an
affirmation of GRAS status. The proposal allows for a notification to be revisited if new
information indicates a reason for concern.
Sounds distinctly dodgy.