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Sangkap ng pagkain US: GRAS, umiiral na tuntunin at additive petition

Hindi awtomatikong legal sa US ang foreign approval.

May-akda:
Koponan ng FDABridge
Nag-publish:
Panahon ng pagbabasa:
2 minuto

Pagsuri ng sanggunian at mahalagang pagwawasto: 2026-10-06.

Hindi awtomatikong legal sa US ang foreign approval. Suriin identidad, proseso, specifications, technical effect, pagkain, antas/exposure. Maaaring umiiral na rule, may ebidensiyang GRAS, saklaw na prior sanction o ibang paraan; hindi palaging bagong petition. Voluntary ang GRAS notification sa 170.205 ngayon. Sa 6 Oktubre 2026 proposal Agosto ay hindi mandatory law; proposed exceptions/transitions hindi current requirement. Comments hanggang 9 Disyembre 2026 electronic 23:59 Eastern Time, hindi renewal/ingredient approval deadline.

Scientific GRAS 170.30 kailangan parehong dami/kalidad ng evidence ng additive approval at general expert recognition; unpublished data puwedeng corroborate generally available/accepted. Food use bago 1958 hiwalay conditional route, foreign history kailangan available documents/independent proof. Hindi laging cheaper/faster. 171.1 may identidad/process/use/safety/analysis/label at appropriate environmental exclusion claim o assessment. Hindi lahat proprietary, disclosure/protection ayon rule, ibang unpublished data may written permission. 170.265:180 days mula filing accepted for evaluation, possible 90 extension, hindi guarantee. 24 months average guidance 2011 historical, hindi 2026 performance.

FDA may no-questions responses sa partikular high-purity steviol glycosides, hindi lahat ng stevia. Itugma identidad/purity/process/use. Prior sanction limitado, colors kailangang listed use/batch certification kung kailangan;170.39 food-contact hindi general low-dose direct exemption. Editorial worksheet, hindi FDA form: identidad/process/specs, food/levels/exposure, exact basis/limits, evidence/gaps, qualified reviewer/date, next action/owner. Food renewal 1 Oktubre–31 Disyembre 2026 hiwalay; dating update hindi pamalit/approval ng sangkap. FDA food filing fee zero, professional hiwalay; defined scope lang, walang invented scientific capability/guarantee.

https://fdabridge.com/fil/mga-artikulo/fda-food-facility-registration-renewal-2026-maghanda-ngayon-o-mag-alis-ng-pag-access-sa-mercado

https://fdabridge.com/fil/makipag-ugnayan

https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-E/section-170.205

https://www.govinfo.gov/content/pkg/FR-2026-08-11/html/2026-16296.htm

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-B/section-170.30

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-171/subpart-A/section-171.1

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-E/section-170.265

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-about-food-additive-or-color-additive-petition-process

https://www.fda.gov/food/food-additives-petitions/aspartame-and-other-sweeteners-food

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-181/subpart-A/section-181.5

https://www.fda.gov/food/food-ingredients-packaging/color-additives-information-consumers

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-170/subpart-B/section-170.39