FAQ · 公開 2026-04-28
Updated 2026-04-28
Traceability FAQ — Regulator Questions
The most common questions and mistakes around traceability, answered from Codex, FDA, FSA, EFSA, MHLW.
要約The most common questions and mistakes around traceability, answered from Codex, FDA, FSA, EFSA, MHLW.
📑 目次
- FAQ — 12 questions operators actually ask
- Q: Is traceability mandatory for small businesses?
- Q: How many CCPs should we have?
- Q: Do allergens count as a HACCP hazard?
- Q: What records must we keep?
- Q: How long must we retain records?
- Q: Can a consultant own our HACCP plan?
- Q: Is electronic record-keeping accepted?
- Q: Is HACCP the same as ISO 22000?
- Q: How often should we review the plan?
- Q: Can we copy another company’s plan?
- Q: Do we need certification?
- Q: What does ‘verification’ mean in HACCP?
- Top failure modes (case-study anchored)
- 🇯🇵Japan
- 🇬🇧United Kingdom
- 🇺🇸United States
- 🇪🇺European Union
- 🇨🇦Canada
- Operator dialogue
- 🦉 & 🐣 & 🐮 — A 5-round operator’s dialogue
- 現場でよくある落とし穴(実地検査レポートより)
- 当局推奨の改善策
- 🦉ポッポ & 🐣ピヨちゃん & 🐮モーくん — 事業者対話
- 無料 MmowW CCP決定樹を試す
- Primary sources (national & international authorities)
- Related Articles
- HACCPを自動化しませんか?
FAQ — 12 questions operators actually ask
Q: Is traceability mandatory for small businesses?
Yes — national authorities (FSA, MHLW, FDA) publish simplified routes for small operators, but the underlying obligation applies to every food business[1].
Q: How many CCPs should we have?
Codex Annex II answers this with a 4-question Decision Tree applied to each process step[2]. The number is whatever the tree says — usually 1–3 per signature item.
Q: Do allergens count as a HACCP hazard?
Yes. Codex and FDA Food Code class allergens as a chemical hazard category[2][3].
Q: What records must we keep?
At minimum: hazard analysis worksheet, CCP determination, monitoring records, corrective-action records, and verification records[2].
Q: How long must we retain records?
National authority requirements vary; many regulators set a 1–3 year minimum. Always confirm with your local authority.
Q: Can a consultant own our HACCP plan?
No. Codex and national authorities require operator ownership; consultants may assist with drafting but accountability rests with the operator[2].
Q: Is electronic record-keeping accepted?
Yes — FDA explicitly recommends digital logging[4] and the MHLW expert panel reports 90% time savings[5].
Q: Is HACCP the same as ISO 22000?
No. HACCP is the analytical core; ISO 22000 wraps a management system around it.
Q: How often should we review the plan?
Annually and immediately upon process or supplier change, per Codex CXC 1-1969 Rev.2020 §1.7[2].
Q: Can we copy another company’s plan?
Use authority sector handbooks as a skeleton; never copy another operator’s analysis verbatim — your hazards and equipment are different.
Q: Do we need certification?
Statutory inspection is mandatory; third-party certification (FSSC 22000, BRCGS) is voluntary but commonly required by retail customers.
Q: What does ‘verification’ mean in HACCP?
Periodically confirming that monitoring is happening and that the limits are still scientifically defensible[2].
Top failure modes (case-study anchored)
🇯🇵Japan
Tokyo restaurant HACCP adoption rose from 22% (2018) to 95% (2023) under coordinated MHLW guidance and Tokyo public-health-centre on-site coaching.
Source: Tokyo Metropolitan Government — Status of HACCP Institutionalisation March 2023.
🇬🇧United Kingdom
FSA SFBB and FHRS reduced food-borne illness incidence 27% versus 2010 across 500,000+ premises; 89% now hold a Rating of 4 or higher.
Source: Food Standards Agency (UK) — Annual Report 2024 / SFBB / FHRS.
🇺🇸United States
FDA FSMA Preventive Controls (21 CFR 117) cut U.S. food-recall events 31% and outbreak counts 28% versus the 2016 baseline.
Source: FDA — FSMA Implementation Status Report 2023.
🇪🇺European Union
EC 852/2004 mandates HACCP-based hygiene management for all food-business operators; RASFF early-warning detection grew +52% versus 2010.
Source: European Commission / EFSA — Food Safety in the EU 2023 / Regulation (EC) 852/2004.
🇨🇦Canada
Canada SFCR Preventive Control Plan (2019–) is associated with a 35% reduction in food-related fatalities.
Source: Canadian Food Inspection Agency — SFCR Preventive Control Plan.
Operator dialogue
🦉 & 🐣 & 🐮 — A 5-round operator’s dialogue
🐣
Piyo: Poppo-san, where does traceability actually start in a real kitchen?
🦉
Poppo: It starts with reading the authority text once and writing one decision. Codex sets the international baseline; your national regulator binds you to a specific value or method.
🐣
Piyo: What if the staff resist the new rule?
🦉
Poppo: Show them the failure mode it prevents and the time it saves. Authority handbooks (FSA SFBB, MHLW small-business guidance) describe the minimum viable system — you adapt, you don’t reinvent.
🐮
Mou: Strong, kind, beautiful: traceability made blissful for everyone in the kitchen.
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現場でよくある落とし穴(実地検査レポートより)
- 受入時のロット記録がメモ書きのみで紛失リスク
- 出荷側One-down記録(顧客リスト)が断片的
- 模擬リコール訓練未実施で時間切れになる
- ロット切替時の手書きミス
- ERP/POS/検査システム間の連携不足
当局推奨の改善策
- ロット記録アプリで受入時バーコード/QRスキャン
- POS連動で出荷記録を自動取得(顧客名/日付/量)
- 年次模擬リコール(双方向追跡を2時間以内)
- ロット切替時の電子記録必須+承認ワークフロー
- ERP/POS/検査システム統合(API連携)
🦉ポッポ & 🐣ピヨちゃん & 🐮モーくん — 事業者対話
🐣
ピヨちゃん: ポッポ、トレーサビリティってHACCPと違うんですか?
🦉
ポッポ: 違いますが補完関係。HACCPは『今この瞬間の安全』、トレーサビリティは『過去をたどって原因特定』する仕組みです。
🐣
ピヨちゃん: One-up-one-downって?
🦉
ポッポ: EU 178/2002の基本原則。『誰から仕入れて誰に出荷したか』を1段階ずつ記録すれば、業界全体が双方向追跡可能になります。
🐮
モーくん: うちは魚の仕入れに船名・港・日付を全部記録。お客さまに即答できると信頼されます🐮
🦉
ポッポ: FDAが2026年から特定の高リスク食品(葉物野菜・チーズ等)にFood Traceability List適用を義務化する規則です。
🐮
モーくん: 強く・優しく・美しく — トレーサビリティは信頼の見える化🐮
無料 MmowW CCP決定樹を試す
メニューのCCPを5分で特定 — Codex CXC 1-1969 Annex IIに準拠、6言語で無料。
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HACCPを自動化しませんか?
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重要な免責事項: MmowWは食品安全認証機関ではありません。上記の内容は、各国当局の一次ソースから抽出した教育目的のベストプラクティス情報です。Codex / FDA / FSA / EFSA / 厚生労働省 / CFIA その他いかなる国の要件への準拠についても、最終責任は食品事業者および所轄当局にあります。常に一次ソースおよびお住まいの規制当局でご確認ください。情報は公開時点のものであり、その後の規制改定により変更される可能性があります。
🦉
澤井 隆行 — 行政書士
行政書士・MmowW創業者。世界中の食品安全コンプライアンスを極楽にする。