Food Sanitation Act

• Additives — other than natural flavourings (天然香料) and ordinary foods used as additives — and preparations and food containing them must not be sold, or made, imported, processed, used, stored or displayed for sale, except where the Prime Minister (内閣総理大臣), after hearing the Food Safety Standards Council (食品衛生基準審議会), has specified them as unlikely to harm health. The Prime Minister may set criteria (基準) for how food and additives for sale are made, processed, used, cooked or preserved, and standards (規格) for their composition, and once they are set, food and additives that do not meet them must not be made, imported, sold or otherwise handled. Food in which components of agricultural chemicals (農薬), substances added to animal feed or drugs for animals remain above the amount the Prime Minister sets as harmless (substances the Prime Minister specifies as clearly harmless apart) must not be made, imported, sold or otherwise handled for sale, unless a standard for that food sets the limit of that residue.(Art. 12(1), Art. 13(1), Art. 13(2), Art. 13(3)) (the provisions it rests on)
• Apparatus (器具) and containers and packages (容器包装) used in business must be clean and sanitary, and those that contain or carry toxic or harmful substances that may harm health, or that may harm health by affecting the food or additives they touch, must not be sold, made or imported for sale, or used in business. Where the Prime Minister has set standards for apparatus, containers and packages or their raw materials, or criteria for how they are made, items that do not meet the standards must not be sold, made or imported for sale, or used in business, raw materials that do not meet them must not be used, and items must not be made by methods outside the criteria. A raw material of a kind a Cabinet Order (政令) specifies must not be used where the standards set no permitted amount for a substance it contains — unless the item is processed so that the substance cannot migrate into food above an amount the Prime Minister sets as harmless, an exception that does not cover a substance in the part that touches food.(Art. 15(1), Art. 16(1), Art. 18(1), Art. 18(2), Art. 18(3)) (the provisions it rests on)
• The Minister of Health, Labour and Welfare sets, by Ministry of Health, Labour and Welfare Order (厚生労働省令), hygiene standards for the facilities of every business except making apparatus or containers and packages and poultry slaughtering (食鳥処理の事業): general hygiene, such as keeping the premises clean and getting rid of rats and insects, and measures to control the processes that matter most for preventing food sanitation hazards. Every business operator those standards cover must lay down its own hygiene measures following them and keep to them. A prefectural governor, or the mayor of a city with a public health centre or of a special ward, may add rules by local ordinance (条例) that do not conflict with the standards.(Art. 51(1), Art. 51(1)(i), Art. 51(1)(ii), Art. 51(2), Art. 51(3), Art. 8(1)) (the provisions it rests on)
• A business, other than poultry slaughtering, of a kind a Cabinet Order specifies as having a significant effect on public health needs a licence (許可) from the prefectural governor (都道府県知事), who must grant it where the facility meets the standards the prefecture sets by local ordinance with reference to a Ministry of Health, Labour and Welfare Order. The governor may refuse it to someone for two years after they finish serving, or are freed from, a sentence for breaching the Act or a disposition under it, or after their licence is revoked, and to a corporation with such an officer, and may attach conditions such as a validity period of at least five years. Any other business except poultry slaughtering must notify the governor in advance of the name and address of its premises, unless a Cabinet Order specifies it as having little effect on public health.(Art. 54(1), Art. 55(1), Art. 55(2), Art. 55(3), Art. 57(1)) (the provisions it rests on)
• Where a licensed business is transferred, or passes to another by inheritance, merger or a corporate split that hands it on, the person it is transferred to, the heir (or, of several heirs, the one they all agree on) or the surviving, new or succeeding corporation takes over the licence holder's status and must notify the prefectural governor without delay, with a document proving it; the same applies to a business that has filed an advance notification. Neither applies to someone who acquired a business by transfer before Act No. 52 of 2023 came into force. For the time being, the governor must look into the business of anyone who takes over a licensed or notified business by transfer at least once within six months of taking it over.(Art. 56(1), Art. 56(2), Art. 57(2), Suppl. Prov. Art. 4(1), Suppl. Prov. Art. 4(2)) (the provisions it rests on)
• A business operator that recalls food, additives, apparatus or containers and packages it has handled because they breach, or may breach, the rules on unsafe food, diseased meat, imports, additives, criteria and standards, residues, harmful apparatus or false or exaggerated labelling and advertising (Articles 6, 10 to 12, 13(2) and (3), 16, 18(2) and (3) and 20), or a ban the Minister of Health, Labour and Welfare has placed on specific products (Articles 9(1) and 17(1)), must notify the prefectural governor without delay that the recall has begun and how it is going. This does not apply to a recall made under an order, or to a case a joint Ministry of Health, Labour and Welfare and Cabinet Office Order (厚生労働省令・内閣府令) sets as posing no risk of a food sanitation hazard.(Art. 58(1), Art. 58(1)(i), Art. 58(1)(ii)) (the provisions it rests on)

• 1 June 2025

  The text on this site

  Act on the Arrangement of Related Acts upon the Enforcement of the Act Partially Amending the Penal Code, etc.

  刑法等の一部を改正する法律の施行に伴う関係法律の整理等に関する法律

  Act No. 68 of 2022The text after this amendment, on e-Gov

• 1 April 2024

  Act on the Arrangement of Related Acts for Strengthening the Functions of Administration Relating to Environmental Health, etc.

  生活衛生等関係行政の機能強化のための関係法律の整備に関する法律

  Act No. 36 of 2023The text after this amendment, on e-Gov

• 13 December 2023

  Act Partially Amending the Hotel Business Act, etc. to Develop an Environment Contributing to the Continuation of Business Activities in the Environmental Health Industry, etc.

  生活衛生関係営業等の事業活動の継続に資する環境の整備を図るための旅館業法等の一部を改正する法律

  Act No. 52 of 2023The text after this amendment, on e-Gov

• 14 June 2023

  Act Partially Amending the Hotel Business Act, etc. to Develop an Environment Contributing to the Continuation of Business Activities in the Environmental Health Industry, etc.

  生活衛生関係営業等の事業活動の継続に資する環境の整備を図るための旅館業法等の一部を改正する法律

  Act No. 52 of 2023The text after this amendment, on e-Gov

• 26 May 2023

  Act on the Arrangement of Related Acts for Strengthening the Functions of Administration Relating to Environmental Health, etc.

  生活衛生等関係行政の機能強化のための関係法律の整備に関する法律

  Act No. 36 of 2023The text after this amendment, on e-Gov

• 17 June 2022

  Act on the Arrangement of Related Acts upon the Enforcement of the Act Partially Amending the Penal Code, etc.

  刑法等の一部を改正する法律の施行に伴う関係法律の整理等に関する法律

  Act No. 68 of 2022The text after this amendment, on e-Gov

• 1 June 2021

  Act Partially Amending the Food Sanitation Act, etc.

  食品衛生法等の一部を改正する法律

  Act No. 46 of 2018The text after this amendment, on e-Gov

• 1 June 2020

  Act Partially Amending the Food Sanitation Act, etc.

  食品衛生法等の一部を改正する法律

  Act No. 46 of 2018The text after this amendment, on e-Gov

• 1 April 2019

  Act Partially Amending the Food Sanitation Act, etc.

  食品衛生法等の一部を改正する法律

  Act No. 46 of 2018The text after this amendment, on e-Gov

• 1 April 2019

  Act Partially Amending the School Education Act

  学校教育法の一部を改正する法律

  Act No. 41 of 2017The text after this amendment, on e-Gov

All 14 amendments already in force

• Additives on the list of existing additives (既存添加物名簿) — additives on sale or in use when Act No. 101 of 1995 was promulgated, other than chemically synthesised ones, natural flavourings and ordinary foods used as additives, which the Minister of Health and Welfare (厚生大臣) then listed — are outside Article 12, as are preparations and food containing them. The Prime Minister may strike an additive off the list, after hearing the Food Safety Standards Council, where it may harm health. The Prime Minister may also draw up and publish a list of additives found no longer on sale, which anyone may ask to have corrected within six months of its publication, and strikes them off the list of existing additives within a year of publishing it.(Suppl. Prov. Art. 3(1), Suppl. Prov. Art. 2(1), Suppl. Prov. Art. 2-2(1), Suppl. Prov. Art. 2-3(1), Suppl. Prov. Art. 2-3(2), Suppl. Prov. Art. 2-3(3), Suppl. Prov. Art. 2-3(5)) (the provisions it rests on)
• Apparatus and containers and packages that were already on sale, made or imported for sale, or used in business when the main part of Act No. 46 of 2018 came into force are outside the rule against raw materials with substances the standards do not list (Article 18(3)) and the duty to explain to buyers that items meet it (Article 53).(Suppl. Prov. Art. 4(1), Art. 18(3), Art. 53(1)) (the provisions it rests on)
• For small business operators and other business operators a Cabinet Order specifies, the standard for controlling the processes that matter most is measures suited to the characteristics of the food they handle.(Art. 51(1)(ii)) (the provisions it rests on)
• Makers of apparatus or containers and packages follow hygiene standards of their own (Article 52) rather than Article 51's: general hygiene and measures to manage manufacturing properly. One that uses only raw materials outside the kinds a Cabinet Order specifies under Article 18(3) need follow only the general hygiene standards.(Art. 51(1), Art. 52(1), Art. 52(2)) (the provisions it rests on)
• Poultry slaughtering businesses (食鳥処理の事業), as a separate Act — the Poultry Slaughtering Business Control and Poultry Meat Inspection Act — defines them, are outside the hygiene standards of Article 51, the facility standards and licence of Articles 54 and 55, and the advance notification of Article 57, and poultry slaughterers need not keep to the Minister of Health, Labour and Welfare's criteria against toxic or harmful substances getting into food (Article 50).(Art. 51(1), Art. 54(1), Art. 55(1), Art. 57(1), Art. 50(2)) (the provisions it rests on)
• Medicines, quasi-drugs (医薬部外品) and regenerative medicine products, as a separate Act — the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices — defines them, are not food under this Act, and machines and tools used for harvesting food in farming and fishing are not apparatus.(Art. 4(1), Art. 4(4)) (the provisions it rests on)
• The labelling standards for food and additives for sale are not set under this Act but by the Food Labeling Act (食品表示法), a separate Act; this Act's labelling standards cover apparatus and containers and packages.(Art. 19(3), Art. 19(1)) (the provisions it rests on)

• Where needed to prevent a hazard, the Minister of Health, Labour and Welfare, after hearing the Health Science Council (厚生科学審議会), may ban the sale as food of a thing not generally eaten before whose safety is unproven, or of something containing it, when it is newly sold or about to be sold as food, and of a thing generally eaten whose safety is unproven when it is eaten in a way far from the usual one; and where serious harm to health suspected to come from a food suggests it contains a thing not generally eaten before, the Minister may ban the sale of that food. The Minister is to lift a ban once no hazard is likely, and may also ban the sale, and the import and other handling for sale, of specific food, additives, apparatus or containers and packages from a specific country, region or producer where, in light of inspections finding many in breach, the conditions where they are produced or other grounds a Ministry of Health, Labour and Welfare Order sets, breaches are likely to make up a considerable share, and the Minister, weighing how far health is at risk and other matters such an Order sets, finds a ban especially needed to prevent a hazard, after consulting the heads of the agencies concerned and hearing the same council. Bans and their lifting are published in the official gazette (官報).(Art. 7(1), Art. 7(2), Art. 7(3), Art. 7(4), Art. 7(5), Art. 9(1), Art. 9(2), Art. 9(4), Art. 17(1), Art. 17(2), Art. 17(3)) (the provisions it rests on)
• Products of a kind a Cabinet Order specifies, among the food, additives, apparatus and containers and packages for which standards (規格) have been set, must pass an inspection by the Minister of Health, Labour and Welfare, the prefectural governor or a registered conformity assessment body (登録検査機関) and bear the mark of it before they are sold, displayed for sale or used in business, and no request for review (審査請求) lies against the result. A governor who finds unsafe or non-conforming products may order their maker to have its products inspected where they are likely to keep failing and it is needed to prevent a hazard, and the Minister may order importers to do the same, where needed, for products of the same kind made by such a maker, or for products likely to fail given the conditions where they were produced. A person so ordered must not sell, display for sale or use the products in business until notified of the result.(Art. 25(1), Art. 25(5), Art. 26(1), Art. 26(2), Art. 26(3), Art. 26(4)) (the provisions it rests on)
• The Minister of Health, Labour and Welfare, the Prime Minister and the prefectural governor, etc. (都道府県知事等: the governor, or the mayor of a city with a public health centre or of a special ward) may, where needed, require reports from business operators and others concerned, have officials enter places of business, offices and warehouses to inspect food, facilities, books and other things, and have them take away, free of charge, the food and other items needed for testing. Officials must carry identification and show it when asked, and these powers may not be read as given for criminal investigation. Each of them appoints food sanitation inspectors (食品衛生監視員) from among its officials to use these powers and to give guidance on food sanitation.(Art. 28(1), Art. 28(2), Art. 28(3), Art. 30(1), Art. 8(1)) (the provisions it rests on)
• Where a business operator breaches the rules on unsafe food, diseased meat, imports, additives, criteria and standards, residues or harmful apparatus (Articles 6, 10 to 12, 13(2) and (3), 16 and 18(2) and (3)), or a ban on specific products (Articles 9(1) and 17(1)), the Minister of Health, Labour and Welfare or the prefectural governor may have the operator or officials dispose of the products, or order the operator to take other measures needed to remove the hazard. Where it breaches the ban on false or exaggerated labelling or advertising (Article 20), the Prime Minister or the governor may do the same.(Art. 59(1), Art. 59(2)) (the provisions it rests on)
• The prefectural governor may revoke a licence, or ban a business in whole or in part or suspend it for a set period, where the operator breaches the Act's rules on products, imports, criteria and standards, labelling and advertising, product inspections, reporting health harm from designated ingredients, food sanitation supervisors, the criteria against toxic or harmful substances, hygiene measures or explaining apparatus materials to buyers, or a ban; where it comes to fall under the grounds for refusing a licence for a sentence (for a corporation, an officer with such a sentence or a revoked licence); or where it breaches a licence condition. The Minister of Health, Labour and Welfare may ban or suspend an importing business where it breaches the same rules or a ban, except those on labelling and advertising, required product inspections, food sanitation supervisors and selling diseased meat. Where a facility breaches the prefecture's facility standards, the governor may order it improved, or revoke the licence or ban or suspend the business.(Art. 60(1), Art. 60(2), Art. 61(1), Art. 55(2)) (the provisions it rests on)
• To prevent food sanitation hazards, the Minister of Health, Labour and Welfare, the Prime Minister and the prefectural governor — in a city with a public health centre or a special ward, the mayor or ward mayor — are to endeavour to publish the names and other details of those who have breached the Act or a disposition under it, and to make clear the state of the hazard.(Art. 69(1), Art. 76(1)) (the provisions it rests on)
• The Prime Minister delegates the Act's powers, except those a Cabinet Order specifies, to the Commissioner of the Consumer Affairs Agency (消費者庁長官), and the Minister of Health, Labour and Welfare may delegate the Minister's powers to the Director-General of a Regional Bureau of Health and Welfare (地方厚生局長) as a Ministry of Health, Labour and Welfare Order provides. In a city with a public health centre (保健所を設置する市) or a special ward (特別区), the mayor or ward mayor exercises the prefectural governor's powers over food sanitation supervisor notifications, licences, business succession, business notifications, recalls, disposal orders, business sanctions and the publication of offenders, except dispositions a Cabinet Order specifies for businesses it specifies. Designated cities (指定都市) and core cities (中核市) handle the prefectural affairs a Cabinet Order specifies.(Art. 80(3), Art. 80(1), Art. 76(1), Art. 77(1)) (the provisions it rests on)
• A doctor who diagnoses a person poisoned, or suspected to be poisoned, by food, additives, apparatus or containers and packages (食中毒患者等), or examines the body of one, must notify the director of the nearest public health centre (保健所長) at once. The director reports to the prefectural governor, etc. promptly and investigates, and the governor, etc. reports to the Minister of Health, Labour and Welfare at once where the patients reach, or are likely to reach, a number a Ministry of Health, Labour and Welfare Order sets, or in other cases it sets; the Minister may require an investigation and report by a deadline where patients reach, or are likely to reach, that number or a wide area and the matter is urgent. Where needed to find the cause, the governor, etc. may have the body of a person who died of an illness caused or suspected to be caused by food or the like autopsied with the bereaved family's consent, or, after notifying them, without it where the cause cannot otherwise be found and serious harm to public health is likely.(Art. 21-2(1), Art. 63(1), Art. 63(2), Art. 63(3), Art. 65(1), Art. 64(1), Art. 64(2)) (the provisions it rests on)
• Breaking many of the Act's rules is a crime (Chapter 11). Selling or handling for sale unsafe food or additives, the meat, bones, milk, organs or blood of livestock, or the meat, bones or organs of poultry, that had or are suspected of a listed disease, had a listed abnormality or died without being slaughtered, or additives the Prime Minister has not specified, breaching a ban the Minister of Health, Labour and Welfare places under Article 7, disobeying a disposal order, or carrying on a business against a licence revocation, ban or suspension under Article 60 is punishable by imprisonment (拘禁刑) for up to three years or a fine (罰金) of up to 3 million yen, or both. Breaching the criteria and standards for food and additives or the residue limits, the ban on harmful apparatus or containers and packages, the labelling standards for them or the ban on false or exaggerated labelling or advertising, or running a business without the licence it needs, is punishable by imprisonment for up to two years or a fine of up to 2 million yen, or both.(Chapter 11, Art. 81(1), Art. 81(2), Art. 82(1), Art. 82(2)) (the provisions it rests on)
• Imprisonment for up to one year or a fine of up to 1 million yen applies to other breaches, among them importing meat without the required certificate or food without the required controls, breaching the standards for apparatus and packaging or the raw-material rule, selling a product without the inspection it needs or before an ordered inspection's result, breaching a country-specific ban, breaching facility standards, licence conditions or an improvement order, carrying on a business against a revocation, ban or suspension under Article 61, and a doctor's failure to report food poisoning. Obstructing an inspection or the taking of samples, failing to report or reporting falsely, and failing to file an import, food sanitation supervisor, business or recall notification, or filing a false one, are punishable by a fine of up to 500,000 yen. Where a representative, agent or employee commits one of these offences in the course of a corporation's or a person's business, the corporation is fined as well — up to 100 million yen for the three-year offences and for breaches of the food criteria and standards, residue limits, labelling standards for apparatus and containers and packages and the false-advertising ban, and otherwise the fine the article sets — and the person the fine the article sets.(Art. 83(1), Art. 83(1)(i), Art. 83(1)(ii), Art. 83(1)(iv), Art. 83(1)(v), Art. 85(1), Art. 88(1), Art. 88(1)(i), Art. 88(1)(ii)) (the provisions it rests on)