ืื ืคื™ืชื—ืชื ืžืจื›ื™ื‘ ื—ื“ืฉ ื•ืืชื ืžืขื•ื ื™ื™ื ื™ื ืœืฉื•ื•ืง ืื•ืชื• ื›ืžืจื›ื™ื‘ ืœืžื–ื•ืŸ ื‘ืืจื”"ื‘, ืจื•ื‘ ื”ืกื™ื›ื•ื™ื™ื ืฉืชื™ื“ืจืฉื• ืœืืฉืจ ืื•ืชื• ื› GRAS ื˜ืจื ืฉื™ื•ื•ืงื•. ื‘ืžื™ืœื™ื ืคืฉื•ื˜ื•ืช ืžื“ื•ื‘ืจ ื‘ื”ื•ื›ื—ื”, ื‘ืืžืฆืขื•ืช ืชื”ืœื™ืš ืžื•ื‘ื ื”, ืฉื”ืžืจื›ื™ื‘ ื”ื—ื“ืฉ ื‘ื˜ื•ื— ืœืฆืจื™ื›ื” ืชื—ืช ืชื ืื™ ื”ืฉื™ืžื•ืฉ ืฉื”ื•ื’ื“ืจื•, ื›ืœื•ืžืจ, ื‘ืฉื™ืœื•ื‘ ื‘ืžื•ืฆืจื™ ืžื–ื•ืŸ ืžื•ื’ื“ืจื™ื ื•ื‘ืžื™ื ื•ื ื™ื ืžื•ื’ื“ืจื™ื. ื—ืฉื•ื‘ ืœื“ืขืช ื›ื™ GRAS ืžืชื™ื™ื—ืก ืจืง ืœืžืจื›ื™ื‘ื™ื ื”ืžื™ื•ืขื“ื™ื ืœืžื•ืฆืจื™ ืžื–ื•ืŸ ื•ืœื ืœืชื•ืกืคื™ ืชื–ื•ื ื”.

ืื– ืžื” ื›ื•ืœืœ ื”ืชื”ืœื™ืš?

ื”ืฉืœื‘ ื”ืจืืฉื•ืŸ ื›ื•ืœืœ ื”ื›ื ื” ืฉืœ ืชื™ืง ื‘ื˜ื™ื—ื•ืช (GRAS dossier) ื”ื›ื•ืœืœ ืืคื™ื•ืŸ ื•ื ื™ืชื•ื— ืžืคื•ืจื˜ ืฉืœ ื”ืžืจื›ื™ื‘ ืขืฆืžื• ื•ืชื”ืœื™ืš ื”ื™ื™ืฆื•ืจ ืฉืœื•, ื”ื’ื“ืจื” ืฉืœ ืžื•ืฆืจื™ ื”ืžื–ื•ืŸ ื‘ื”ื ื™ืฉื•ืœื‘ ื”ืžืจื›ื™ื‘ ื•ืžื™ื“ืช ื”ื—ืฉื™ืคื” ื”ืฆืคื•ื™ื”, ื•ืกืงื™ืจื” ืžืงื™ืคื” ืฉืœ ื”ืื™ื ืคื•ืจืžืฆื™ื” ื”ืžื“ืขื™ืช ื”ืคื•ืžื‘ื™ืช (ืžื‘ื—ื ื™ื ืงืœื™ื ื™ื™ื ื•ื˜ื•ืงืกื™ืงื•ืœื•ื’ื™ื™ื) ื”ืชื•ืžื›ืช ื‘ื‘ื˜ื™ื—ื•ืช ื”ืžื•ืฆืจ.

ื‘ืฉืœื‘ ืฉื ื™ ื”ืชื™ืง ื ื‘ื—ืŸ ืข"ื™ ืฆื•ื•ืช ืžื•ืžื—ื™ื (ื‘ื“"ื› 3) ื‘ืขืœื™ ื”ื›ืฉืจื” ืžื“ืขื™ืช ืจืœื•ื•ื ื˜ื™ืช ื•ื‘ืขืœื™ ื ื™ืกื™ื•ืŸ ื‘ื”ืขืจื›ืช ื‘ื˜ื™ื—ื•ืช ืฉืœ ืžื•ืฆืจื™ ืžื–ื•ืŸ.ย ืœืจื•ื‘ ืฆื•ื•ืช ื”ืžื•ืžื—ื™ื ืžื‘ืงืฉ ื”ื‘ื”ืจื•ืช ืื• ืื™ื ืคื•ืจืžืฆื™ื” ื ื•ืกืคืช, ืื•ืชื” ื™ืฉ ืœื”ื•ืกื™ืฃ ืœืชื™ืง ื•ืœื›ืœื•ืœ ื‘ื ื™ืชื•ื— ื”ื›ื•ืœืœ. ื‘ืกื™ื•ื ื”ืฉืœื‘ ืžื›ื™ืจ ืฆื•ื•ืช ื”ืžื•ืžื—ื™ื ืคื” ืื—ื“ ื‘ื›ืš ืฉื”ืžืจื›ื™ื‘ ื‘ื˜ื•ื— ืœืฉื™ืžื•ืฉ ืชื—ืช ื”ืชื ืื™ื ืฉื”ื•ื’ื“ืจื• ื•ืžืจื’ืข ื–ื” ื”ืžืจื›ื™ื‘ ืžื•ื›ืจ ื› GRAS ื•ืžื•ืชืจ ืœืฉื™ื•ื•ืง ื‘ืืจื”"ื‘.ย 

ื”ืฉืœื‘ ื”ื‘ื, ื”ื›ื•ืœืœ ื”ื•ื“ืขื” ืœ FDA, ืื™ื ื• ืžื—ื™ื™ื‘. ื”ื›ืจื” ื‘ืžืจื›ื™ื‘ ื› GRAS ืข"ื™ ืฆื•ื•ืช ืžื•ืžื—ื™ื, ืœืœื ืžืขื•ืจื‘ื•ืช ืฉืœ ื” FDA, ืžื›ื•ื ื” self-GRAS.

ืฉืœื‘ ืฉืœื™ืฉื™ – ื”ื•ื“ืขื” ืœ FDA ื‘ืืžืฆืขื•ืช ื”ื’ืฉืช GRAS notification ืœ FDA. ื” notification ืžื”ื•ื•ื” ืžืกืžืš ืžืžืฆื” ืฉืœ ื”ืื™ื ืคื•ืจืžืฆื™ื” ื”ื›ืœื•ืœื” ื‘ืชื™ืง ื” GRAS ื›ืืฉืจ ืชื™ืง ื” GRAS ืขืฆืžื• ืžื•ืคื™ืข ื›ื ืกืคื—.

ืœืื—ืจ ืฉืงื™ื‘ืœ ืืช ื” notification ื” FDA ืžืงืฆื” ืœื” ืžืกืคืจ ื•ืžืชื—ื™ืœ ื‘ื‘ื—ื™ื ืช ื”ืžื™ื“ืข ื”ื ื›ืœืœ ื‘ื”. ื”ืชื”ืœื™ืš ืื•ืจืš ื›ื—ืฆื™ ืฉื ื” (ื” FDA ืžื—ื•ื™ื‘ ืœืชืฉื•ื‘ื” ื‘ืชื•ืš 180 ื™ื•ื ืืš ืœืขืชื™ื ื™ืฉ ืขื™ื›ื•ื‘ื™ื) ื•ื‘ืžืกื’ืจืชื• ื” FDA ื‘ื•ื—ืŸ ื”ืื ื”ืžื™ื“ืข ืฉื ื›ืœืœ ื‘ืชื™ืง ืžื”ื•ื•ื” ื‘ืกื™ืก ืžืกืคืง ืœืงื‘ื™ืขื” ื›ื™ ื”ืžืจื›ื™ื‘ ื‘ื˜ื•ื— ืœืฉื™ืžื•ืฉ ื•ื”ืื, ืขืœ ื‘ืกื™ืก ื”ืžื™ื“ืข ื”ืงื™ื™ื ื‘ืชื™ืง ืื• ื‘ื™ื“ื™ ื” FDA, ืขื•ืœื•ืช ืฉืืœื•ืช ื›ืœืฉื”ืŸ ืœื’ื‘ื™ ื‘ื˜ื™ื—ื•ืช ื”ืžืจื›ื™ื‘.ย  ื” FDA ืขืฉื•ื™ ืœื”ืคื ื•ืช ืืœ ืžื’ื™ืฉ ื” notification ืฉืืœื•ืช, ืื• ืœื‘ืงืฉ ืื™ื ืคื•ืจืžืฆื™ื” ื ื•ืกืคืช.

ื‘ืกื™ื•ื ื”ืชื”ืœื™ืš ื” FDA ื ื•ืชืŸ ืืช ืชืฉื•ื‘ืชื• ื‘ืื—ืช ืžืฉืชื™ ื”ืืคืฉืจื•ื™ื•ืช:

โ€œFDA has no questionsโ€ – ื” FDA ืžื›ื™ืจ ื‘ืงื‘ื™ืขื” ื›ื™ ื”ืžืจื›ื™ื‘ ื‘ื˜ื•ื— ืœืฉื™ืžื•ืฉ.

โ€œNotice does not provide a basis for a GRAS determinationโ€ – ื” FDA ืื™ื ื• ืžืกื›ื™ื ืขื ื”ืงื‘ื™ืขื” ื›ื™ ื”ืžืจื›ื™ื‘ ื‘ื˜ื•ื— ืœืฉื™ืžื•ืฉ.

ืžื›ืชื‘ ื”ืชืฉื•ื‘ื” ืฉืœ ื” FDA, ื›ืžื• ื’ื ื” GRAS notification ื–ืžื™ื ื™ื ืœืฆื™ื‘ื•ืจ ื“ืจืš ืืชืจ ื”ืื™ื ื˜ืจื ื˜ ืฉืœ ื” FDA.

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GRASย  –ย ืจืืฉื™ ืชื™ื‘ื•ืช ืฉืœ – Generally Recognized As Safe. ืชื—ืช ื”ืชืงื ื•ืช ื”ืืžืจื™ืงืื™ื•ืช, ื›ืœ ืžืจื›ื™ื‘ ื”ืžื•ืกืฃ ืœืžื–ื•ืŸ ืžื•ื’ื“ืจ ื›ืชื•ืกืฃ ืžื–ื•ืŸ ื•ื ื“ืจืฉ ืœืงื‘ืœ ืื™ืฉื•ืจ ืžืŸ ื” FDA ืœื›ืš ืฉื”ื•ื ื‘ื˜ื•ื— ืœืฉื™ืžื•ืฉ. ื–ืืช, ืืœื ืื ื›ืŸ ื”ืžืจื›ื™ื‘ ื ื‘ื“ืง ื•ื”ื•ื›ืจ ืข"ื™ย ืฆื•ื•ืช ืžื•ืžื—ื™ื ื›ื‘ื˜ื•ื— ืœืฉื™ืžื•ืฉ ื•ื”ื•ื›ืจื– ื› GRAS ืชื—ืช ืชื ืื™ ืฉื™ืžื•ืฉ ืกืคืฆื™ืคื™ื™ื (ืจืฉื™ืžื” ืžื•ื’ื“ืจืช ืฉืœ ืžื–ื•ื ื•ืช ืืœื™ื”ื ืžื•ืกืฃ ื”ืžืจื›ื™ื‘ ื•ืžื™ื ื•ื ื™ื ืžื•ื’ื“ืจื™ื). ื—ื•ืžืจื™ ื”ื“ื‘ืจื”, ืชื•ืกืคื™ ืชื–ื•ื ื” ื•ืฆื‘ืขื™ ืžืื›ืœ ืื™ื ืย ื ื•ืคืœื™ื ื‘ืืจื”"ื‘ ืชื—ืช ื”ื”ื’ื“ืจื” ืฉืœย ืชื•ืกืฃ ืžื–ื•ืŸ ื•ืขืœ ื›ืŸ ืœื ื™ื›ื•ืœื™ื ืœื”ื™ื•ืช ืžื•ื›ืจื™ื ื› GRAS.