ืžื–ื•ืŸ ืจืคื•ืื™ ื”ื•ื ืžื–ื•ืŸ ื”ืžื™ื•ืขื“ ืœืขื ื•ืช ืขืœ ื”ืฆืจื›ื™ื ื”ืชื–ื•ื ืชื™ื™ื ื”ื™ื™ื—ื•ื“ื™ื™ื ื”ื ื•ื‘ืขื™ื ืžืžื—ืœื” ืื• ืžืžืฆื‘ ืจืคื•ืื™ ืžืกื•ื™ื, ื•ื ื™ืชืŸ ืœื—ื•ืœื™ื ื”ื ืžืฆืื™ื ืชื—ืช ืžืขืงื‘ ืจืคื•ืื™. ืขืค"ื™ ื”ื”ื’ื“ืจื•ืช, ืžื–ื•ืŸ ืจืคื•ืื™ ื”ื•ื ืœืžืขืฉื” ืคื•ืจืžื•ืœืฆื™ื” ืžื™ื•ื—ื“ืช ืฉืžื™ื•ืขื“ืช ืœื—ื•ืœื™ื ืฉืขืงื‘ ืžื—ืœืชื ืื™ื ื ื™ื›ื•ืœื™ื ืœื”ื™ื•ืช ื ื™ื–ื•ื ื™ื ืžืžื–ื•ืŸ ืจื’ื™ืœ ืื• ื›ื–ื” ืฉืขื‘ืจ ืžื•ื“ื™ืคื™ืงืฆื™ื”. ืžื–ื•ืŸ ืจืคื•ืื™ ืื™ื ื• ืžื™ื•ืขื“ ืœื›ืœืœ ื”ืื•ื›ืœื•ืกื™ื™ื” ื•ื”ื•ื ืื™ื ื• "ืกืชื" ืžื–ื•ืŸ ืคื•ื ืงืฆื™ื•ื ืืœื™ ื”ืžื›ื™ืœ ืจื›ื™ื‘ ื‘ืขืœ ืืคืงื˜ ื‘ืจื™ืื•ืชื™ ื›ืœืฉื”ื•.

ื”ืื ืžื–ื•ืŸ ืžื•ืคื—ืช ืกื•ื›ืจ ื”ืžื™ื•ืขื“ ืœื—ื•ืœื™ ืกื›ืจืช, ืžื–ื•ืŸ ื ื˜ื•ืœ ื’ืœื•ื˜ืŸ ืื• ืžื–ื•ืŸ ืฉืžื›ื™ืœ ืจื›ื™ื‘ื™ื ื”ืžื™ื•ืขื“ื™ื ืœื”ืคื—ืชืช ืจืžืช ื”ื›ื•ืœืกื˜ืจื•ืœ ื‘ื“ื ืขื•ื ื™ื ืœื”ื’ื“ืจื” ืฉืœ ืžื–ื•ืŸ ืจืคื•ืื™? ื”ืชืฉื•ื‘ื” ื”ื™ื ืœื. ื›ืœ ืืœื• ื”ื ืžื–ื•ื ื•ืช ืจื’ื™ืœื™ื ืฉืขื‘ืจื• ืžื•ื“ื™ืคื™ืงืฆื™ื” ื›ืœืฉื”ื™ ืขืœ ืžื ืช ืœื”ืชืื™ื ืื•ืชื ืœืฆืจื›ื™ื ื”ืชื–ื•ื ืชื™ื™ื ืฉืœ ื—ื•ืœื™ ืกื›ืจืช, ื—ื•ืœื™ ืฆืœื™ืืง ืื• ืื ืฉื™ื ื”ืกื•ื‘ืœื™ื ืžืจืžื•ืช ื’ื‘ื•ื”ื•ืช ืฉืœ ื›ื•ืœืกื˜ืจื•ืœ ื‘ื“ื. ืขืœ ืคื™ ืจื•ื‘, ื—ื•ืœื™ื ื‘ืžื—ืœื•ืช ืืœื• ื™ื›ื•ืœื™ื ืœื”ืชืงื™ื™ื ืžืชื–ื•ื ื” ืจื’ื™ืœื” ื‘ืฉื™ื ื•ื™ื™ื ืžืกื•ื™ืžื™ื.

ืื– ืžื” ื›ืŸ? ื“ื•ื’ืžื” ื˜ื•ื‘ื” ืœืžื–ื•ืŸ ืจืคื•ืื™ ื”ื•ื ืžื–ื•ืŸ ื”ืžื™ื•ืขื“ ืœื—ื•ืœื™ PKU ( Phenylketonuria), ืžื—ืœื” ืžื˜ืื‘ื•ืœื™ืช ืฉื”ื—ื•ืœื™ื ื‘ื” ื ื“ืจืฉื™ื ืœื“ื™ืื˜ื” ืงืคื“ื ื™ืช ื ื˜ื•ืœืช ื—ื•ืžืฆืช ื”ืืžื™ื ื• ืคื ื™ืœืืœื ื™ืŸ, ื”ืงื™ื™ืžืช ื‘ื›ืœ ื”ืžื–ื•ื ื•ืช ื”ืขืฉื™ืจื™ื ื‘ื—ืœื‘ื•ืŸ. ื—ื•ืœื™ื ืืœื• ื–ืงื•ืงื™ื ืœืคื•ืจืžื•ืœืฆื™ื” ื™ื™ื—ื•ื“ื™ืช ืืฉืจ ืื™ื ื” ืžื›ื™ืœื” ืคื ื™ืœืืœืื ื™ืŸ. ย ื“ื•ื’ืžื” ื ื•ืกืคืช ื”ื™ื ื”ืคื•ืจืžื•ืœื•ืช ื”ืžื™ื•ืขื“ื•ืช ืœื—ื•ืœื™ื ืœืื—ืจ ื ื™ืชื•ื— ื”ื–ืงื•ืงื™ื ืœื”ืขืฉืจื” ืงืœื•ืจื™ืช, ืื• ืœืื ืฉื™ื ืžื‘ื•ื’ืจื™ื ื”ืกื•ื‘ืœื™ื ืžืชืช ืชื–ื•ื ื”.

ื”ื”ื’ื“ืจื” ืฉืœ ืžื–ื•ืŸ ืจืคื•ืื™ ืคื—ื•ืช ืื• ื™ื•ืชืจ ืื—ื™ื“ื” ื‘ื™ืŸ ื”ืžื“ื™ื ื•ืช. ื‘ืืจื”"ื‘ ืžื–ื•ืŸ ืจืคื•ืื™ โ€“ Medical food, ืื™ื ื• ื ื“ืจืฉ ืœืื™ืฉื•ืจ ืžืŸ ื” FDA ื˜ืจื ืฉื™ื•ื•ืงื•. ื›ื›ืœ ืžื–ื•ืŸ ืื—ืจ ื‘ืืจื”"ื‘, Medical food ื ื“ืจืฉ ืœืขืžื•ื“ ื‘ื›ืœ ื”ื“ืจื™ืฉื•ืช ื”ื ื•ื’ืขื•ืช ืœืžื–ื•ืŸ ื•ื›ื•ืœืœื•ืช ืฉื™ืžื•ืฉ ื‘ืจื›ื™ื‘ื™ื ืžืื•ืฉืจื™ื ืœืžื–ื•ืŸ (Food additive ืื• GRAS), ื™ื™ืฆื•ืจ ืชื—ืช ืชืงืŸ GMP, ื”ืชื•ื•ื™ื” ืฉืœ ืžื•ืฆืจื™ ืžื–ื•ืŸ ื•ื›ื•'. Medical foods ืคื˜ื•ืจื™ื, ืขื ื–ืืช, ืžื”ืชืงื ื•ืช ื”ื ื•ื’ืขื•ืช ืœืžืกืจื™ื ื‘ืจื™ืื•ืชื™ื™ื ื•ืื™ื ื ื ื“ืจืฉื™ื ืœืงื‘ืœ ืื™ืฉื•ืจ ืžืจืืฉ ืขืœ ื”ื”ืชื•ื•ื™ื” ื”ื‘ืจื™ืื•ืชื™ืช ืฉื”ื ื ื•ืฉืื™ื.

ื‘ืขื•ื“ ื” FDA ืžืฆื”ื™ืจ ืขืœ ื”ืชื™ื™ื—ืกื•ืช ืฆืจื” ืœื”ื’ื“ืจื” ืฉืœ Medical food, ื“ื•ืžื” ืฉื”ื™ื›ื•ืœืช, ืœื›ืื•ืจื”, ืœื”ืฉืชืžืฉ ื‘ื”ืชื•ื•ื™ื•ืช ืจืคื•ืื™ื•ืช ืขืœ ื’ื‘ื™ ืžื•ืฆืจ ืžื–ื•ืŸ ืžื‘ืœื™ ืœื”ื–ื“ืงืง ืœืื™ืฉื•ืจ ืžื•ืงื“ื ืžืŸ ื” FDA ื”ื‘ื™ืื” ืœืคืจื™ื—ื” ื‘ืชื—ื•ื ื” Medical foods ื‘ืืจื”"ื‘. ืžื•ืฆืจื™ื ืจื‘ื™ื ืฉื”ืชืืžืชื ืœื”ื’ื“ืจื” ืฉืœ Medical food ืžื•ื˜ืœืช ื‘ืกืคืง, ื ืžื›ืจื™ื ื‘ืฉื•ืง ื•ืœื ืžืขื˜ ื—ื‘ืจื•ืช ืืฃ "ื–ื›ื•" ืœืžื›ืชื‘ื™ ืื–ื”ืจื” ืžืŸ ื” FDA.

ื‘ืื™ืจื•ืคื”, ืžื–ื•ืŸ ืจืคื•ืื™ โ€“ Food for special medical purposes, ืžืคื•ืงื— ืชื—ืช ืชืงื ื” 1999/21/EC. ื‘ื”ืชืื ืœืชืงื ื” ื–ื•, ืžื–ื•ืŸ ืจืคื•ืื™ ื‘ืื™ืจื•ืคื” ื—ื™ื™ื‘ ืœื”ื›ื™ืœ ืจื›ื™ื‘ื™ื ื”ืžื•ืชืจื™ื ืœืฉื™ืžื•ืฉ ืกืคืฆื™ืคื™ ื–ื” ื•ื—ื™ื™ื‘ ืœืฉืืช ืขืœ ื”ืชื•ื•ื™ืช ืžืกืคืจ ืื–ื”ืจื•ืช ื”ืžื‘ื˜ื™ื—ื•ืช ืฉื™ืžื•ืฉ ืข"ื™ ืื•ื›ืœื•ืกื™ื™ืช ื”ื™ืขื“ ื‘ืœื‘ื“ ื•ืชื—ืช ืคื™ืงื•ื— ืจืคื•ืื™. ื”ืชืงื ื” ืžื—ื™ื™ื‘ืช ื’ื ื”ืœื™ืš ืฉืœ ื”ื•ื“ืขื” ืžืจืืฉ ืœืจืฉื•ื™ื•ืช ื”ืžื“ื™ื ื” ื‘ื” ืขืชื™ื“ ื”ืžื•ืฆืจ ืœื”ื™ื•ืช ืžืฉื•ื•ืง ืขืœ ืฉื™ื•ื•ืงื• ืฉืœ ื”ืžื•ืฆืจ, ืชื•ืš ืคื™ืจื•ื˜ ื”ื”ืชื•ื•ื™ื•ืช ื•ื”ืžื™ื“ืข ื”ืžื“ืขื™ ื”ืชื•ืžืš ื‘ื”ืŸ.

ื‘ื™ืฉืจืืœ ืžื–ื•ืŸ ืจืคื•ืื™ ื”ื™ื” ืžืคื•ืงื— ืขื“ ืœืื—ืจื•ื ื” ืข"ื™ ืื’ืฃ ื”ืจื•ืงื—ื•ืช ื•ื”ื—ืœ ืž 1.1.10 ืขื‘ืจ ืœืื—ืจื™ื•ืช ืฉืจื•ืช ื”ืžื–ื•ืŸ ื”ืืจืฆื™ ื•ืžื˜ื•ืคืœ ื› "ืžื–ื•ืŸ ื™ื™ืขื•ื“ื™".

ื™ืฉ ืœื›ื ืฉืืœื•ืช ื ื•ืกืคื•ืช ื‘ื ื•ืฉื?

ืคื ื• ืืœื™ โ€“ iris@food-regulations.co.il.