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FAQ · 公開 2026-04-28 Updated 2026-04-28

Regulatory News FAQ — Regulator Questions

The most common questions and mistakes around regulatory news, answered from Codex, FDA, FSA, EFSA, MHLW.

要約

The most common questions and mistakes around regulatory news, answered from Codex, FDA, FSA, EFSA, MHLW.

📑 目次
  1. FAQ — 12 questions operators actually ask
    1. Q: Is regulatory news mandatory for small businesses?
    2. Q: How many CCPs should we have?
    3. Q: Do allergens count as a HACCP hazard?
    4. Q: What records must we keep?
    5. Q: How long must we retain records?
    6. Q: Can a consultant own our HACCP plan?
    7. Q: Is electronic record-keeping accepted?
    8. Q: Is HACCP the same as ISO 22000?
    9. Q: How often should we review the plan?
    10. Q: Can we copy another company’s plan?
    11. Q: Do we need certification?
    12. Q: What does ‘verification’ mean in HACCP?
  2. Top failure modes (case-study anchored)
    1. 🇯🇵Japan
    2. 🇬🇧United Kingdom
    3. 🇺🇸United States
    4. 🇪🇺European Union
    5. 🇨🇦Canada
  3. Operator dialogue
    1. 🦉 & 🐣 & 🐮 — A 5-round operator’s dialogue
  4. 現場でよくある落とし穴（実地検査レポートより）
  5. 当局推奨の改善策
  6. 🦉ポッポ & 🐣ピヨちゃん & 🐮モーくん — 事業者対話
    1. 無料 MmowW CCP決定樹を試す
  7. Primary sources (national & international authorities)
    1. Related Articles
    2. HACCPを自動化しませんか？

FAQ — 12 questions operators actually ask

Q: Is regulatory news 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 regulatory news 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: regulatory news 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）

  1. 規制ニュース監視が個人任せで漏れ多発
  2. 法令変更を出荷後に発見し対応遅れ
  3. 影響評価がスキップされ全社対応にならない
  4. リコール情報の店内伝達遅延
  5. 業界団体ニュース購読なしで業界動向不明

当局推奨の改善策

  1. 週次規制ニュース定例レビュー（30分）＋年次再点検
  2. 法令変更通知メール／RSS／Slack統合で即時情報取得
  3. 影響評価テンプレ（営業／生産／品質／法務）で全社対応
  4. リコール対応SOP＋年次訓練
  5. 主要3団体（業種別）の購読＋月次回覧

🦉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、RASFFって聞いたことないですが何ですか？
🦉
ポッポ: Rapid Alert System for Food and Feedの略で、EU加盟国＋EFSA／ECが食品リスクを即時共有する仕組みです。日本にも参考になります。
🐣
ピヨちゃん: FDA Recallsって？
🦉
ポッポ: FDAのリコール情報がリアルタイムで公開されているサイトで、毎日数件〜数十件更新されます。輸入品取扱業者は必須チェック。
🐮
モーくん: うちはRASFF＋FDA Recalls＋FSAの3つを毎週月曜10分でレビュー。世界の食品リスクが一望できる🐮
🐣
ピヨちゃん: INFOSANって？
🦉
ポッポ: WHOが運営するInternational Food Safety Authorities Networkで、180カ国以上が緊急情報を国際共有する仕組みです。
🐮
モーくん: 強く・優しく・美しく — 情報は最強の武器🐮

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。

無料ツールを開く →

Primary sources (national & international authorities)

  1. Codex Alimentarius — General Principles of Food Hygiene CXC 1-1969 Rev.2020 (HACCP Annex II). https://www.fao.org/fao-who-codexalimentarius/
  2. FAO — HACCP System and Guidelines for its Application. https://www.fao.org/3/y1390e/y1390e0a.htm
  3. WHO — Five Keys to Safer Food Manual (2006). https://www.who.int/publications/i/item/9789241594639
  4. CDC — Food Safety Surveillance & Outbreak Reports. https://www.cdc.gov/foodsafety/
  5. FDA — Managing Food Safety: Voluntary Use of HACCP Principles 2006. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/managing-food-safety-manual-voluntary-use-haccp-principles
  6. Food Standards Agency (UK) — Annual Report 2024 / SFBB / FHRS. https://www.food.gov.uk/business-guidance/safer-food-better-business
  7. MHLW — HACCP Guidance for Small-Scale Food Operators (2020). https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000179028_00007.html

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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。

安全で、愛される。