The FFC regime came into force in 2015. Unlike Foods for Specified Health Use (Tokuho), it requires no individual approval — only a notification. The business operator labels the function on its own scientific evidence, at its own responsibility. That makes it usable by SMBs and material houses alike.

But "only a notification" is misleading. The dossier is reviewed in substance; an incomplete file gets rejected, and in the worst case you face a recall recommendation. This article walks through the filing workflow our regulatory team runs day to day.

01The regime end to end

An FFC dossier presents five elements: (1) functional ingredient identification, (2) safety scientific basis, (3) functional scientific basis, (4) manufacturing & QC, (5) label sample. Building the dossier typically runs 6–12 months.

8,000+Cumulative accepted notifications
60 daysFrom acceptance to publication
3 routesRoutes for the functional basis

02Material selection — three routes

Three routes to build the functional basis: (A) human trial on the finished product, (B) systematic review of the functional ingredient, (C) using a material with prior filings. For SMBs we recommend (C) → (B). Materials with existing filings dramatically reduce the safety burden.

FFC three routes — human trial / systematic review / pre-filed material
Fig. 1 — Three routes to functional claims.

03Systematic review

You need to comprehensively gather human intervention trials from PubMed, Ichushi, JDream III and others, and quality-assess them under PRISMA. Statistical literacy and paper-reading judgement are required; this is usually run with an external partner.

  1. Search-string design (PICO)
  2. Database search and de-duplication
  3. Paper screening (primary/secondary)
  4. Quality assessment (Cochrane Risk of Bias)
  5. Qualitative / quantitative synthesis (meta-analysis)
  6. Review report drafting
— Note

Quality of papers matters more than count. A pile of high-bias trials gives you a thin functional basis.

04Safety dossier

Three layers: (1) existing-information assessment, (2) intake-history assessment, (3) safety testing. Long-eaten ingredients can stand on (1) + (2); novel materials need (3) toxicology.

05Dossier structure

Forms I through VII, with attachments: systematic-review report, safety dossier, manufacturing flow, label sample. Total page count: roughly 200–400 pages.

Stack of FFC dossiers — wooden-desk still life
Fig. 2 — A complete registration dossier.

06Submission & publication

File electronically via the CAA notification database. After acceptance, with no rejection within 60 days, the filing is published and you can ship with the claim. On rejection you write a response and re-submit — for a first filing, two or three round trips is normal.

"One-shot submission" is a fantasy. "Plan around two round trips" is the field rule.— MZ Pharma Regulatory
— Filing service

From material selection to filing on your behalf — single point of contact. → Contact us