食品衛生法
法令全体を1ページで表示しています。 章ごとに読む
第一章 総則
Chapter I General Provisions
Article 1
The purpose of this Act is to prevent sanitation hazards resulting from eating and drinking by enforcing regulations and other measures necessary from the viewpoint of public health for ensuring food safety, thereby protecting the people's health.
この法律は、食品の安全性の確保のために公衆衛生の見地から必要な規制その他の措置を講ずることにより、飲食に起因する衛生上の危害の発生を防止し、もつて国民の健康の保護を図ることを目的とする。
Article 2
The national government, prefectures, cities specified by Cabinet Order based on the provisions of Article 5, paragraph (1) of the Community Health Act (Act No. 101 of 1947) (referred to below as "cities with public health centers") and special wards must take the necessary measures to disseminate the correct knowledge concerning food sanitation through educational and PR activities, collect, consolidate, analyze, and provide information on food sanitation, promote research on food sanitation, enhance capabilities on inspection of food sanitation, and develop human resources to be involved in the improvement of food sanitation, and enhance their capabilities.
国、都道府県、地域保健法(昭和二十二年法律第百一号)第五条第一項の規定に基づく政令で定める市(以下「保健所を設置する市」という。)及び特別区は、教育活動及び広報活動を通じた食品衛生に関する正しい知識の普及、食品衛生に関する情報の収集、整理、分析及び提供、食品衛生に関する研究の推進、食品衛生に関する検査の能力の向上並びに食品衛生の向上にかかわる人材の養成及び資質の向上を図るために必要な措置を講じなければならない。
The national government, prefectures, cities with public health centers, and special wards, must coordinate closely with each other so that measures concerning food sanitation are implemented comprehensively and promptly.
The national government is to develop a system for collecting, consolidating, analyzing, and providing information on food sanitation, conducting research, and making inspections for food sanitation on imported food, additives, apparatus, and containers and packages, take necessary measures to ensure international cooperation, and provide prefectures, cities with public health centers and special wards (referred to below as "prefectures, etc.") with the technical assistance necessary for them to pursue their responsibilities referred to in the preceding two paragraphs.
Article 3
A food business operator (meaning a person or corporation that is engaged in collecting, producing, importing, processing, cooking, storing, transporting, or selling food or additives, or manufacturing, importing, or selling apparatus, or containers and packages, or a person or corporation that continuously provides food to a large number of persons or unspecified persons at schools, hospitals, or other facilities; the same applies below) must endeavor to ensure the safety of the food, additives, apparatus, or containers and packages that they collect, produce, import, process, cook, store, transport, sell, provide to a large number of persons or unspecified persons, or use for business (referred to below as "food for sale, etc.") on their own responsibility, and endeavor to obtain the knowledge and skills for ensuring the safety of food for sale, etc., ensure the safety of raw materials of food for sale, etc., conduct voluntary inspections of food for sale, etc., and take other necessary measures.
食品等事業者(食品若しくは添加物を採取し、製造し、輸入し、加工し、調理し、貯蔵し、運搬し、若しくは販売すること若しくは器具若しくは容器包装を製造し、輸入し、若しくは販売することを営む人若しくは法人又は学校、病院その他の施設において継続的に不特定若しくは多数の者に食品を供与する人若しくは法人をいう。以下同じ。)は、その採取し、製造し、輸入し、加工し、調理し、貯蔵し、運搬し、販売し、不特定若しくは多数の者に授与し、又は営業上使用する食品、添加物、器具又は容器包装(以下「販売食品等」という。)について、自らの責任においてそれらの安全性を確保するため、販売食品等の安全性の確保に係る知識及び技術の習得、販売食品等の原材料の安全性の確保、販売食品等の自主検査の実施その他の必要な措置を講ずるよう努めなければならない。
A food business operator must endeavor to make a record of necessary information such as the name of the person who has sold food for sale, etc. or raw materials of food for sale, etc. to the food business operator and preserve the record, to the extent necessary for preventing food sanitation hazards resulting from food for sale, etc.
In order to prevent food sanitation hazards resulting from food for sale, etc., a food business operator must endeavor to appropriately and promptly take necessary measures such as providing the record prescribed in the preceding paragraph to the national government or prefectures, etc. and disposing of the food for sale, etc. that caused the food sanitation hazards.
Article 4
The term "food" as used in this Act means all foods and drinks; provided, however, that this term does not include pharmaceutical products, quasi-pharmaceutical products, and regenerative medicine products specified in the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960).
この法律で食品とは、全ての飲食物をいう。ただし、医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律(昭和三十五年法律第百四十五号)に規定する医薬品、医薬部外品及び再生医療等製品は、これを含まない。
The term "additives" as used in this Act means substances that are used by the method such as adding, mixing or being infiltrated into food in the process of producing food or for the purpose of processing or preserving food.
この法律で添加物とは、食品の製造の過程において又は食品の加工若しくは保存の目的で、食品に添加、混和、浸潤その他の方法によつて使用する物をいう。
The term "natural flavoring agents" as used in this Act means substances obtained from animals or plants, or mixtures of those substances, which are used for flavoring food.
The term "apparatus" as used in this Act means tableware, kitchen utensils, and machines, equipment, and other articles that are used for collecting, producing, processing, cooking, storing, transporting, displaying, delivering, or consuming food or additives, and come into direct contact with food or additives; provided, however, that this does not include machines, equipment, and other articles used for harvesting food for agriculture and fisheries.
The term "food sanitation" as used in this Act means sanitation for eating and drinking concerning food, additives, apparatus, and containers and packages.
The term "business" as used in this Act means collecting, producing, importing, processing, cooking, storing, transporting, or selling food or additives, or manufacturing, importing, or selling apparatus, or containers and packages, in the course of trade; provided, however, that this does not include the food collection business in agriculture and fisheries.
The term "business operator" as used in this Act means a person or corporation that engages in business.
この法律で営業者とは、営業を営む人又は法人をいう。
The term "registered conformity assessment body" as used in this Act means a corporation that has obtained a registration from the Minister of Health, Labour and Welfare pursuant to the provisions of Article 33, paragraph (1).
この法律で登録検査機関とは、第三十三条第一項の規定により厚生労働大臣の登録を受けた法人をいう。
Article 5
Collecting, producing, processing, using, cooking, storing, transporting, displaying, and delivering and receiving of food or additives to be sold (including their provision other than sales to a large number of persons or unspecified persons; the same applies below) must be made in a clean and sanitary manner.
Article 6
those that are rotten or have deteriorated, or are unripe; provided, however, that this does not apply to those that are unlikely to harm human health in general and are found to be suitable for eating and drinking;
腐敗し、若しくは変敗したもの又は未熟であるもの。ただし、一般に人の健康を損なうおそれがなく飲食に適すると認められているものは、この限りでない。
those that contain toxic or harmful substances or are adhered with those substances, or suspected to contain or adhered with them; provided, however, that this does not apply when the Minister of Health, Labour and Welfare specifies that they are unlikely to harm human health;
有毒な、若しくは有害な物質が含まれ、若しくは付着し、又はこれらの疑いがあるもの。ただし、人の健康を損なうおそれがない場合として厚生労働大臣が定める場合においては、この限りでない。
those that are contaminated with pathogens or suspected to be contaminated with them, and are likely to harm human health; and
病原微生物により汚染され、又はその疑いがあり、人の健康を損なうおそれがあるもの。
those that are likely to harm human health due to filth, contamination or addition of foreign substances, or due to other reasons.
不潔、異物の混入又は添加その他の事由により、人の健康を損なうおそれがあるもの。
Article 7
When things that have not been generally served for human consumption and have not been proved to be unlikely to harm human health, or things that include them are newly sold as food or come to be sold as food, the Minister of Health, Labour and Welfare may prohibit those things to be sold as food, after hearing the opinions of the Health Science Council, when the Minister finds it necessary for preventing the occurrence of food sanitation hazards.
厚生労働大臣は、一般に飲食に供されることがなかつた物であつて人の健康を損なうおそれがない旨の確証がないもの又はこれを含む物が新たに食品として販売され、又は販売されることとなつた場合において、食品衛生上の危害の発生を防止するため必要があると認めるときは、厚生科学審議会の意見を聴いて、それらの物を食品として販売することを禁止することができる。
When the Minister of Health, Labour and Welfare finds that there is no positive proof that the things that have been generally served for human consumption and are served in a method significantly different from the normal method for those things are unlikely to harm human health and that it is necessary for preventing the occurrence of food sanitation hazards, the Minister may prohibit those things to be sold as food, after hearing the opinions of the Health Science Council.
厚生労働大臣は、一般に食品として飲食に供されている物であつて当該物の通常の方法と著しく異なる方法により飲食に供されているものについて、人の健康を損なうおそれがない旨の確証がなく、食品衛生上の危害の発生を防止するため必要があると認めるときは、厚生科学審議会の意見を聴いて、その物を食品として販売することを禁止することができる。
When serious damage to human health suspected to have been caused by food has occurred, and it is suspected that the food contains things that have not been generally served for human consumption and are likely to cause harm from the conditions of the damage, the Minister of Health, Labour and Welfare may prohibit the sale of the food, after hearing the opinions of the Health Science Council, when the Minister finds it necessary for preventing the occurrence of food sanitation hazards.
厚生労働大臣は、食品によるものと疑われる人の健康に係る重大な被害が生じた場合において、当該被害の態様からみて当該食品に当該被害を生ずるおそれのある一般に飲食に供されることがなかつた物が含まれていることが疑われる場合において、食品衛生上の危害の発生を防止するため必要があると認めるときは、厚生科学審議会の意見を聴いて、その食品を販売することを禁止することができる。
When the Minister of Health, Labour and Welfare has made a prohibition of sales under the provisions of the preceding three paragraphs and finds that there is no likelihood of food sanitation hazards caused by things or food related to the prohibition to occur based on the application from a person having an interest in the prohibition, or as required, the Minister is to revoke the prohibition in whole or in part, after hearing the opinions of the Health Science Council, pursuant to Order of the Ministry of Health, Labour and Welfare.
When the Minister of Health, Labour and Welfare has made a prohibition of sales under the provisions of paragraphs (1) through (3), or has revoked the prohibition under the provisions of the preceding paragraph, the Minister is to issue public notice in an Official Gazette to that effect.
厚生労働大臣は、第一項から第三項までの規定による販売の禁止をしたとき、又は前項の規定による禁止の全部若しくは一部の解除をしたときは、官報で告示するものとする。
Article 8
When a business operator that handles food containing ingredients or substances that require special attention from the viewpoint of preventing food sanitation hazards and the Minister of Health, Labour and Welfare and the Prime Minister have designated after hearing the opinions of the Food Safety Standards Council (referred to as "designated ingredients, etc." in paragraph (3) and Article 70, paragraph (5)) (referred to as "food containing designated ingredients, etc." below in this paragraph) obtains information that the food containing designated ingredients, etc. handled by them causes or may cause harm to human health, they must notify a prefectural governor, a mayor of the city with public health centers or a mayor of the special ward (referred to below as the "prefectural governor, etc.") of that information without delay pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
When a notification under the provisions of the preceding paragraph has been given, the prefectural governor, etc. must report the matters related to the notification to the Minister of Health, Labour and Welfare.
Physicians, dentists, pharmacists, and other relevant persons must endeavor to grasp the state of damage to human health suspected of being caused by the ingestion of designated ingredients, etc., and when the prefectural governor, etc. conducts investigation of the damage to human health suspected of being caused by the ingestion of designated ingredients, etc. to prevent food sanitation hazards, and requests necessary cooperation for the investigation, they must endeavor to provide information on the damage or other necessary cooperation, in response to the request.
Article 9
If for specific food or additives collected, produced, processed, cooked, or stored in a specific country or region, or those collected, produced, processed, cooked, or stored by a specific person, as a result of the inspections under the provisions of Article 26, paragraphs (1) through (3), or Article 28, paragraph (1), when it is found that food or additives falling under the following items are likely to be contained to a considerable extent, in light of the fact that a considerable number of food or additives falling under the following items have been discovered and the situation of food sanitation management at the production site or other grounds specified by Order of the Ministry of Health, Labour and Welfare, and taking into account the extent of risk of causing damage to human health and other matters specified by Order of the Ministry of Health, Labour and Welfare, the Minister of Health, Labour and Welfare finds that it is particularly necessary for preventing food sanitation hazards caused by the specific food or additives, the Minister may prohibit the specific food or additives from being sold, or collected, produced, imported, processed, used, or cooked for the purpose of selling, after hearing the opinions of the Health Science Council:
厚生労働大臣は、特定の国若しくは地域において採取され、製造され、加工され、調理され、若しくは貯蔵され、又は特定の者により採取され、製造され、加工され、調理され、若しくは貯蔵される特定の食品又は添加物について、第二十六条第一項から第三項まで又は第二十八条第一項の規定による検査の結果次に掲げる食品又は添加物に該当するものが相当数発見されたこと、生産地における食品衛生上の管理の状況その他の厚生労働省令で定める事由からみて次に掲げる食品又は添加物に該当するものが相当程度含まれるおそれがあると認められる場合において、人の健康を損なうおそれの程度その他の厚生労働省令で定める事項を勘案して、当該特定の食品又は添加物に起因する食品衛生上の危害の発生を防止するため特に必要があると認めるときは、厚生科学審議会の意見を聴いて、当該特定の食品又は添加物を販売し、又は販売の用に供するために、採取し、製造し、輸入し、加工し、使用し、若しくは調理することを禁止することができる。
food prescribed in Article 12;
food or additives that do not conform to the standards established pursuant to the provisions of Article 13, paragraph (1);
food that uses additives by a method that does not conform to the criteria established pursuant to the provisions of Article 13, paragraph (1); and
food prescribed in Article 13, paragraph (3).
When the Minister of Health, Labour and Welfare intends to make a prohibition under the provisions of the preceding paragraph, the Minister must consult with the heads of the relevant administrative organs in advance.
厚生労働大臣は、前項の規定による禁止をしようとするときは、あらかじめ、関係行政機関の長に協議しなければならない。
When the Minister of Health, Labour and Welfare has made a prohibition under the provisions of paragraph (1) and finds that there is no likelihood of the specific food or additives related to the prohibition to cause food sanitation hazards based on the application from a person having an interest in the prohibition, or as required, the Minister is to revoke the prohibition in whole or in part, after hearing the opinions of the Health Science Council, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
When the Minister of Health, Labour and Welfare has ordered a prohibition under the provisions of paragraph (1), or has issued a revocation of the prohibition under the provisions of the preceding paragraph in whole or in part, the Minister is to issue public notice in an Official Gazette.
Article 10
The meat, bones, milk, organs, and blood of livestock (meaning livestock defined in Article 3, paragraph (1) of the Slaughterhouse Act (Act No. 114 of 1953) and other animals specified by Order of the Ministry of Health, Labour and Welfare; the same applies below) that have contracted or are suspected to have contracted a disease stated in item (i) or (iii), have an abnormality stated in item (i) or (iii), or have fallen dead, or the meat, bones, and organs of poultry (meaning poultry defined in Article 2, item (i) of the Poultry Slaughtering Business Control and Poultry Meat Inspection Act (Act No. 70 of 1990) and other birds specified by Order of the Ministry of Health, Labour and Welfare; the same applies below) that have contracted or are suspected to have contracted a disease stated in item (ii) or (iii), have an abnormality stated in item (ii) or (iii), or have fallen dead, must not be sold as food, or collected, processed, used, cooked, stored, or displayed as food for the purpose of selling, excluding cases specified by Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply to the meat, bones, and organs of livestock or poultry that have fallen dead which the ministry's officials find unlikely to harm human health and are suitable for eating and drinking.
第一号若しくは第三号に掲げる疾病にかかり、若しくはその疑いがあり、第一号若しくは第三号に掲げる異常があり、又はへい死した獣畜(と畜場法(昭和二十八年法律第百十四号)第三条第一項に規定する獣畜及び厚生労働省令で定めるその他の物をいう。以下同じ。)の肉、骨、乳、臓器及び血液又は第二号若しくは第三号に掲げる疾病にかかり、若しくはその疑いがあり、第二号若しくは第三号に掲げる異常があり、又はへい死した家きん(食鳥処理の事業の規制及び食鳥検査に関する法律(平成二年法律第七十号)第二条第一号に規定する食鳥及び厚生労働省令で定めるその他の物をいう。以下同じ。)の肉、骨及び臓器は、厚生労働省令で定める場合を除き、これを食品として販売し、又は食品として販売の用に供するために、採取し、加工し、使用し、調理し、貯蔵し、若しくは陳列してはならない。ただし、へい死した獣畜又は家きんの肉、骨及び臓器であつて、当該職員が、人の健康を損なうおそれがなく飲食に適すると認めたものは、この限りでない。
disease or abnormality stated in the items of Article 14, paragraph (6) of the Slaughterhouse Act;
と畜場法第十四条第六項各号に掲げる疾病又は異常
disease or abnormality stated in the items of Article 15, paragraph (4) of the Poultry Slaughtering Business Control and Poultry Meat Inspection Act;
食鳥処理の事業の規制及び食鳥検査に関する法律第十五条第四項各号に掲げる疾病又は異常
disease or abnormality other than one stated in the preceding two items which are specified by Order of the Ministry of Health, Labour and Welfare.
前二号に掲げる疾病又は異常以外の疾病又は異常であつて厚生労働省令で定めるもの
The meat, milk, and organs of livestock, and the meat and organs of poultry, and their products specified by Order of the Ministry of Health, Labour and Welfare (referred to as "livestock meat, etc." below in this paragraph) must not be imported as food for the purpose of selling, unless they are attached with a certificate issued by a governmental organization of an exporting country or its copy stating that they are not the meat, milk, or organs of livestock, or the meat or organs of poultry, or their products that have contracted or are suspected to have contracted a disease stated in each item of the preceding paragraph, have an abnormality stated in each item of that paragraph, or have fallen dead, and stating other matters specified by Order of the Ministry of Health, Labour and Welfare (referred to as "matters on sanitation" below in this paragraph); provided, however, that this does not apply to livestock meat, etc. imported from a country specified by Order of the Ministry of Health, Labour and Welfare, and the matters on sanitation for the livestock meat, etc. have been sent from a governmental organization of the country via a telecommunications line to a computer used by the Ministry of Health, Labour and Welfare (including an input and output device) and have been recorded in a file stored on the computer.
獣畜の肉、乳及び臓器並びに家きんの肉及び臓器並びに厚生労働省令で定めるこれらの製品(以下この項において「獣畜の肉等」という。)は、輸出国の政府機関によつて発行され、かつ、前項各号に掲げる疾病にかかり、若しくはその疑いがあり、同項各号に掲げる異常があり、又はへい死した獣畜の肉、乳若しくは臓器若しくは家きんの肉若しくは臓器又はこれらの製品でない旨その他厚生労働省令で定める事項(以下この項において「衛生事項」という。)を記載した証明書又はその写しを添付したものでなければ、これを食品として販売の用に供するために輸入してはならない。ただし、厚生労働省令で定める国から輸入する獣畜の肉等であつて、当該獣畜の肉等に係る衛生事項が当該国の政府機関から電気通信回線を通じて、厚生労働省の使用に係る電子計算機(入出力装置を含む。)に送信され、当該電子計算機に備えられたファイルに記録されたものについては、この限りでない。
Article 11
The food and additives specified by Order of the Ministry of Health, Labour and Welfare as those that require measures to control particularly important processes for preventing food sanitation hazards to be taken, must not be imported for the purpose of selling, unless they have been produced or processed in a country or region, or facilities specified by the Minister of Health, Labour and Welfare as being certain that those measures have been taken.
The food and additives specified by Order of the Ministry of Health, Labour and Welfare as those that require proof of the state of food sanitation management at the production site to confirm that they do not fall under any of the food and additives stated in the items of Article 6 and confirm other matters specified by Order of the Ministry of Health, Labour and Welfare, must not be imported for the purpose of selling, unless they are attached with a certificate issued by a governmental organization of the exporting country, and stating those matters, or its copy.
Article 12
Additives (excluding natural flavoring agents and things that have been generally served for human consumption, and are used as additives) and formulations and food containing those additives must not be sold or be produced, imported, processed, used, stored, or displayed for the purpose of selling, unless the Prime Minister specifies them as those unlikely to harm human health after hearing the opinions of the Food Safety Standards Council.
Article 13
The Prime Minister may establish the criteria for the method of producing, processing, using, cooking, or preserving food or additives to be sold, or the standards for the ingredients of food or additives to be sold, from the viewpoint of public health, after hearing the opinions of the Food Safety Standards Council.
When the criteria or standards have been established pursuant to the provisions of the preceding paragraph, food or additives must not be produced, processed, used, cooked, or preserved using a method that does not conform to the criteria, food or additives made using a method that does not conform to the criteria must not be sold or imported, and food or additives that do not conform to the standards must not be produced, imported, processed, used, cooked, preserved, or sold.
Food in which agricultural chemicals (meaning agricultural chemicals defined in Article 2, paragraph (1) of the Agricultural Chemicals Regulation Act (Act No. 82 of 1948), the same applies in the following Article), substances that are used by being added, mixed or infiltrated into feed (meaning feed prescribed in Article 2, paragraph (2) of the Act on Safety Assurance and Quality Improvement of Feed (Act No. 35 of 1953)) or are used by other methods for the purpose of usage specified by Order of the Ministry of Agriculture, Forestry and Fisheries based on Article 2, paragraph (3) of that Act, and substances that are ingredients of pharmaceuticals defined in Article 2, paragraph (1) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and are to be used for animals (including substances generated by chemical change of that substance, and excluding those specified by the Prime Minister as those clearly not likely to harm human health) remain in a quantity exceeding the quantity that the Prime Minister has specified as being unlikely to harm human health after hearing the opinions of the Food Safety Standards Council, must not be produced, imported, processed, used, cooked, or preserved for the purpose of selling, or be sold; provided, however, that this does not apply when standards for the ingredients of food referred to in paragraph (1) have been established concerning the limit of the amount of residue of those substances in the food.
農薬(農薬取締法(昭和二十三年法律第八十二号)第二条第一項に規定する農薬をいう。次条において同じ。)、飼料の安全性の確保及び品質の改善に関する法律(昭和二十八年法律第三十五号)第二条第三項の規定に基づく農林水産省令で定める用途に供することを目的として飼料(同条第二項に規定する飼料をいう。)に添加、混和、浸潤その他の方法によつて用いられる物及び医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律第二条第一項に規定する医薬品であつて動物のために使用されることが目的とされているものの成分である物質(その物質が化学的に変化して生成した物質を含み、人の健康を損なうおそれのないことが明らかであるものとして内閣総理大臣が定める物質を除く。)が、人の健康を損なうおそれのない量として内閣総理大臣が食品衛生基準審議会の意見を聴いて定める量を超えて残留する食品は、これを販売の用に供するために製造し、輸入し、加工し、使用し、調理し、保存し、又は販売してはならない。ただし、当該物質の当該食品に残留する量の限度について第一項の食品の成分に係る規格が定められている場合については、この限りでない。
Article 14
When the Prime Minister establishes a limit on the amount of substances (including substances generated by the chemical change of those substances) that are ingredients of agricultural chemicals, feed additives defined in Article 2, paragraph (3) of the Act on Safety Assurance and Quality Improvement of Feed, or pharmaceuticals defined in Article 2, paragraph (1) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and are to be used for the purpose of using solely for animals (referred to as "agricultural chemicals, etc." below in this Article) which remain in food, as standards for the ingredients of food referred to in paragraph (1) of the preceding Article, and specifies the scope of meat, milk and other products of the target animals (meaning the target animals prescribed in Article 14, paragraph (2), item (iii), sub-item (b) of that Act pursuant to Article 83, paragraph (1) of that Act following the deemed replacement of terms) for which regenerative medicine products defined in Article 2, paragraph (9) of that Act which are to be used for the purpose of using solely for animals (referred to as "animal regenerative medicine products" below in this Article) have been used, and in other cases the Prime Minister finds to be necessary, the Prime Minister may request the Minister of Agriculture, Forestry and Fisheries to provide materials on the ingredients of the agricultural chemicals, etc. or the component cells and transgenes of the animal regenerative medicine products, or other things specified by Cabinet Office Order, and provide other necessary cooperation.
内閣総理大臣は、前条第一項の食品の成分に係る規格として、食品に残留する農薬、飼料の安全性の確保及び品質の改善に関する法律第二条第三項に規定する飼料添加物又は医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律第二条第一項に規定する医薬品であつて専ら動物のために使用されることが目的とされているもの(以下この条において「農薬等」という。)の成分である物質(その物質が化学的に変化して生成した物質を含む。)の量の限度を定めるとき、同法第二条第九項に規定する再生医療等製品であつて専ら動物のために使用されることが目的とされているもの(以下この条において「動物用再生医療等製品」という。)が使用された対象動物(同法第八十三条第一項の規定により読み替えられた同法第十四条第二項第三号ロに規定する対象動物をいう。)の肉、乳その他の生産物について食用に供することができる範囲を定めるときその他必要があると認めるときは、農林水産大臣に対し、農薬等の成分又は動物用再生医療等製品の構成細胞、導入遺伝子その他内閣府令で定めるものに関する資料の提供その他必要な協力を求めることができる。
第三章 器具及び容器包装
Chapter III Apparatus, and Containers and Packages
Article 15
Apparatus, and containers and packages used for conducting business must be clean and sanitary.
Article 16
Apparatus, or containers and packages that contain toxic or harmful substances, or to which those substances are adhered and likely to harm human health, or apparatus, or containers and packages that come into contact with food or additives and are likely to harm human health due to having a harmful effect, must not be sold, manufactured or imported for the purpose of selling, or used for business.
Article 17
If for specific apparatus, or containers and packages that are manufactured in a specific country or region, or manufactured by a specific person, a considerable number of apparatus, or containers and packages falling under the following items have been discovered as a result of inspections under the provisions of Article 26, paragraphs (1) through (3) or Article 28, paragraph (1), and it is found likely that apparatus, or containers and packages falling under the following items are contained to a considerable extent due to the status of food sanitation management at the production site and other grounds specified by Order of the Ministry of Health, Labour and Welfare, and the Minister of Health, Labour and Welfare finds it particularly necessary for preventing food sanitation hazards caused by the specific apparatus, or containers and packages, taking into account the level of risk of harming human health and other matters specified by Order of the Ministry of Health, Labour and Welfare, the Minister may prohibit the sales of the specific apparatus, or containers and packages, manufacturing or import of the specific apparatus, or containers and packages for the purpose of selling, or using them for business, after hearing the opinions of the Health Science Council:
厚生労働大臣は、特定の国若しくは地域において製造され、又は特定の者により製造される特定の器具又は容器包装について、第二十六条第一項から第三項まで又は第二十八条第一項の規定による検査の結果次に掲げる器具又は容器包装に該当するものが相当数発見されたこと、製造地における食品衛生上の管理の状況その他の厚生労働省令で定める事由からみて次に掲げる器具又は容器包装に該当するものが相当程度含まれるおそれがあると認められる場合において、人の健康を損なうおそれの程度その他の厚生労働省令で定める事項を勘案して、当該特定の器具又は容器包装に起因する食品衛生上の危害の発生を防止するため特に必要があると認めるときは、厚生科学審議会の意見を聴いて、当該特定の器具又は容器包装を販売し、販売の用に供するために製造し、若しくは輸入し、又は営業上使用することを禁止することができる。
apparatus, or containers and packages prescribed in the preceding Article;
apparatus, or containers and packages that do not conform to the standards established pursuant to the provisions of paragraph (1) of the following Article; and
apparatus, or containers and packages that violate the provisions of paragraph (3) of the following Article.
When the Minister of Health, Labour and Welfare intends to make a prohibition under the provisions of the preceding paragraph, the Minister must consult with the heads of the relevant administrative organs in advance.
厚生労働大臣は、前項の規定による禁止をしようとするときは、あらかじめ、関係行政機関の長に協議しなければならない。
The provisions of Article 9, paragraphs (3) and (4) apply mutatis mutandis to cases in which a prohibition under the provisions of paragraph (1) has been made. In such a case, the term "food or additives" in paragraph (3) of that Article is deemed to be replaced with "apparatus, or containers and packages".
Article 18
The Prime Minister may establish standards for apparatus, or containers and packages or their raw materials to be sold or used for business, or establish the criteria for the manufacturing method of apparatus, or containers and packages, from the viewpoint of public health, after hearing the opinions of the Food Safety Standards Council.
When the standards or criteria have been established pursuant to the provisions of the preceding paragraph, the apparatus, or containers and packages that do not conform to the standards must not be sold, manufactured or imported for the purpose of selling, or used for business, raw materials that do not conform to the standards must not be used, and the apparatus, or containers and packages must not be manufactured by a method that does not conform to the criteria.
Substances (excluding substances generated by chemical change of substances) which are raw materials of materials specified by Cabinet Order taking into consideration the impact on public health of the elution or seepage of the components into food must not be used for apparatus, or containers and packages, when the quantity permitted to be contained in the apparatus, or containers and packages manufactured, or the quantity permitted to be eluted or to seep into food from apparatus, or containers and packages manufactured using those substances is not specified in the standards referred to in paragraph (1) of this Article; provided, however, that this does not apply if the apparatus, or containers and packages, are processed so that the substances do not have the risk of eluting or seeping into food at a quantity exceeding the quantity specified by the Prime Minister as unlikely to harm human health after hearing the opinions of the Food Safety Standards Council (excluding the case in which the substance is used for the part of the apparatus, or containers and packages which come into contact with food).
器具又は容器包装には、成分の食品への溶出又は浸出による公衆衛生に与える影響を考慮して政令で定める材質の原材料であつて、これに含まれる物質(その物質が化学的に変化して生成した物質を除く。)について、当該原材料を使用して製造される器具若しくは容器包装に含有されることが許容される量又は当該原材料を使用して製造される器具若しくは容器包装から溶出し、若しくは浸出して食品に混和することが許容される量が第一項の規格に定められていないものは、使用してはならない。ただし、当該物質が人の健康を損なうおそれのない量として内閣総理大臣が食品衛生基準審議会の意見を聴いて定める量を超えて溶出し、又は浸出して食品に混和するおそれがないように器具又は容器包装が加工されている場合(当該物質が器具又は容器包装の食品に接触する部分に使用される場合を除く。)については、この限りでない。
第四章 表示及び広告
Chapter IV Labeling and Advertising
Article 19
The Prime Minister may establish necessary criteria for the labeling of apparatus, or containers and packages for which standards or criteria have been established pursuant to the provisions of paragraph (1) of the preceding Article, from the viewpoint of accurately conveying necessary information on public health concerning apparatus, or containers and packages to general consumers, after hearing the opinions of the Consumer Commission.
Apparatus, or containers and packages for which the criteria for labeling have been established pursuant to the provisions of the preceding paragraph must not be sold, displayed for the purpose of selling, or used for business, if they do not have a labeling that conforms to the criteria.
Article 20
第五章 食品添加物公定書
Chapter V Japan's Specifications and Standards for Food Additives
Article 21
The Prime Minister is to prepare Japan's Specifications and Standards for Food Additives and list the criteria and standards for the additives for which the criteria and standards have been established pursuant to the provisions of Article 13, paragraph (1), and additives for which the criteria have been established pursuant to the provisions of Article 4, paragraph (1) of the Food Labeling Act.
第六章 監視指導
Chapter VI Monitoring and Guidance
Article 21-2
The national government and prefectures, etc. must work together in cooperation with each other to ensure that the monitoring or guidance concerning food sanitation (referred to below as "monitoring and guidance") will be comprehensively and promptly conducted, in order to prevent persons poisoned by food, additives, apparatus, or containers and packages or persons suspected of being poisoned by them (referred to below as "patients with food poisoning, etc.") from spreading or increasing across wide areas, and prevent violations of this Act, or orders or dispositions based on this Act, concerning food, additives, apparatus, or containers and packages that are distributed over wide areas.
Article 21-3
The Minister of Health, Labour and Welfare may establish a wide-area cooperation council consisting of the national government, prefectures, etc., and other relevant organizations pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare (referred to as "the council" below in this Article and Article 66), in order to ensure the development of a coordination and cooperation system in implementing monitoring and guidance.
When the council finds it necessary, the council may add persons other than the members of the council who are persons found to be necessary by the council and prefectures, etc. as members.
The members of the council must respect the results of discussions concerning the matters agreed upon at the council meetings.
協議会において協議が調つた事項については、協議会の構成員は、その協議の結果を尊重しなければならない。
Beyond what is provided for in the preceding three paragraphs, the matters necessary for operating the council are decided by the council.
Article 22
The Minister of Health, Labour and Welfare and the Prime Minister are to establish guidelines concerning the monitoring and guidance to be implemented by the national government and prefectures, etc. (referred to below as the "guidelines").
The guidelines are to specify the following matters:
指針は、次に掲げる事項について定めるものとする。
basic direction on the implementation of monitoring and guidance;
監視指導の実施に関する基本的な方向
matters concerning items for which monitoring and guidance should be intensively implemented;
重点的に監視指導を実施すべき項目に関する事項
matters concerning the system for implementing monitoring and guidance;
監視指導の実施体制に関する事項
matters concerning ensuring of coordination and cooperation between the national government, prefectures, etc., and other relevant organizations in implementing monitoring and guidance; and
other important matters concerning the implementation of monitoring and guidance.
その他監視指導の実施に関する重要事項
When the Minister of Health, Labour and Welfare and the Prime Minister have established or amended the guidelines, they must publicize that fact and notify prefectural governors, etc. of that fact without delay.
Article 23
Each fiscal year, the Minister of Health, Labour and Welfare is to establish a plan on the monitoring and guidance to be implemented by the national government concerning the following fiscal year's import of food, additives, apparatus, and containers and packages (referred to below as the "imported food monitoring and guidance plan"), based on the guidelines.
The imported food monitoring and guidance plan is to specify the following matters:
輸入食品監視指導計画は、次に掲げる事項について定めるものとする。
matters concerning items for which monitoring and guidance should be intensively implemented, in view of the circumstances at the production site and other circumstances;
生産地の事情その他の事情からみて重点的に監視指導を実施すべき項目に関する事項
matters concerning guidance of the implementation of voluntary sanitation management for a business operator engaged in import; and
輸入を行う営業者に対する自主的な衛生管理の実施に係る指導に関する事項
other necessary matters for implementing monitoring and guidance.
その他監視指導の実施のために必要な事項
When the Minister of Health, Labour and Welfare has established or amended the imported food monitoring and guidance plan, the Minister is to publicize that fact without delay.
厚生労働大臣は、輸入食品監視指導計画を定め、又はこれを変更したときは、遅滞なく、これを公表するものとする。
The Minister of Health, Labour and Welfare is to publicize the implementation status of the imported food monitoring and guidance plan.
厚生労働大臣は、輸入食品監視指導計画の実施の状況について、公表するものとする。
Article 24
Each fiscal year, the prefectural governor, etc. must establish a plan concerning the following fiscal year's monitoring and guidance to be implemented by that prefecture, etc. (referred to below as "prefectural plan for monitoring and guidance of food sanitation"), based on the guidelines.
A prefectural plan for monitoring and guidance of food sanitation is to specify the following matters:
都道府県等食品衛生監視指導計画は、次に掲げる事項について定めるものとする。
matters concerning items for which monitoring and guidance should be intensively implemented;
重点的に監視指導を実施すべき項目に関する事項
matters concerning guidance on the implementation of voluntary sanitation management for food business operators;
食品等事業者に対する自主的な衛生管理の実施に係る指導に関する事項
matters concerning the ensuring of coordination and cooperation with the national government, other prefectures, etc., and other relevant organizations in implementing monitoring and guidance; and
other necessary matters for implementing monitoring and guidance.
その他監視指導の実施のために必要な事項
A prefectural plan for monitoring and guidance of food sanitation must be established by taking into account the situation of establishment of facilities by food business operators in the areas of that prefecture, etc., the status of occurrence of food sanitation hazards, and other actual circumstances of the regions.
都道府県等食品衛生監視指導計画は、当該都道府県等の区域における食品等事業者の施設の設置の状況、食品衛生上の危害の発生の状況その他の地域の実情を勘案して定められなければならない。
When a prefectural governor, etc. has established or amended the prefectural plan for monitoring and guidance of food sanitation, the prefectural governor, etc. must publicize that fact and report that fact to the Minister of Health, Labour and Welfare and the Prime Minister, without delay, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare and Cabinet Office Order.
都道府県知事等は、都道府県等食品衛生監視指導計画を定め、又はこれを変更したときは、遅滞なく、これを公表するとともに、厚生労働省令・内閣府令で定めるところにより、厚生労働大臣及び内閣総理大臣に報告しなければならない。
The prefectural governor, etc. must publicize the implementation status of the prefectural plan for monitoring and guidance of food sanitation pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare and Cabinet Office Order.
都道府県知事等は、都道府県等食品衛生監視指導計画の実施の状況について、厚生労働省令・内閣府令で定めるところにより、公表しなければならない。
第七章 検査
Chapter VII Inspections
Article 25
Food or additives for which standards have been established pursuant to the provisions of Article 13, paragraph (1), or apparatus, or containers and packages for which standards have been established pursuant to the provisions of Article 18, paragraph (1), which are specified by Cabinet Order, must not be sold, displayed for the purpose of selling, or used for business, unless they have undergone an inspection by the Minister of Health, Labour and Welfare, a prefectural governor, or a registered conformity assessment body, in accordance with the classification specified by Cabinet Order and are attached with the labeling specified by Order of the Ministry of Health, Labour and Welfare certifying that they have passed the inspection.
A person who intends to undergo an inspection conducted by the Minister of Health, Labour and Welfare or a registered conformity assessment body under the provisions of the preceding paragraph must pay a fee specified by the Minister in consideration of the actual costs required for the inspections for an inspection conducted by the Minister, and must pay a fee specified by the registered conformity assessment body by obtaining approval from the Minister in consideration of the actual costs required for the inspection for the inspection conducted by a registered conformity assessment body.
The fees referred to in the preceding paragraph to be paid by a person who intends to undergo an inspection by the Minister of Health, Labour and Welfare will be the national treasury's income and those to be paid by a person who intends to undergo an inspection by a registered conformity assessment body will be the registered conformity assessment body's income.
Beyond what is provided for in the preceding three paragraphs, the necessary matters for the inspection referred to in paragraph (1) and the measures to be taken after passing the inspection are specified by Cabinet Order.
A request for examination may not be made for the results of the inspection referred to in paragraph (1).
第一項の検査の結果については、審査請求をすることができない。
Article 26
When a prefectural governor discovers food, additives, apparatus, or containers and packages stated in the following items, and finds that the food, additives, apparatus, or containers and packages that the person produced or processed are likely to continue to fall under those stated in the following items in view of the capability, etc. for conducting inspections of the person who produced or processed them and necessary for preventing occurrence of food sanitation hazards, the prefectural governor may order that the person should undergo an inspection by the prefectural governor or a registered conformity assessment body on the food, additives, apparatus, or containers and packages, in accordance with the requirements and procedures specified by Cabinet Order:
food or additives that do not conform to the standards established pursuant to the provisions of Article 13, paragraph (1);
food for which additives are used in a method that does not conform to the criteria established pursuant to the provisions of Article 13, paragraph (1);
food prescribed in Article 13, paragraph (3);
apparatus, or containers and packages prescribed in Article 16;
apparatus, or containers and packages that do not conform to standards established pursuant to the provisions of Article 18, paragraph (1); and
apparatus, or containers and packages violating Article 18, paragraph (3).
When the Minister of Health, Labour and Welfare finds it necessary for preventing the occurrence of food sanitation hazards, the Minister may order a person who imports food, additives, apparatus, or containers and packages that are the same type as those produced or processed by a person who has produced or processed food, additives, apparatus, or containers and packages stated in each item of the preceding paragraph or food prescribed in Article 12 to undergo an inspection conducted by the Minister or a registered conformity assessment body on the food, additives, apparatus, or containers and packages.
When the Minister of Health, Labour and Welfare finds it necessary for preventing the occurrence of food sanitation hazards, the Minister may order a person who imports food, additives, apparatus, or containers and packages that are found to be likely to fall under food, additives, apparatus, or containers and packages stated in each item of paragraph (1) or food prescribed in Article 12, in view of circumstances at production sites and other circumstances to undergo an inspection conducted by the Minister or a registered conformity assessment body on the food, additives, apparatus, or containers and packages.
A person who has received the order referred to in the preceding three paragraphs must not sell the food, additives, apparatus, or containers and packages, display them for the purpose of selling, or use them for business until after the person has undergone the inspection and has received the notice of the results of the inspection.
The notice referred to in the preceding paragraph which is given by a registered conformity assessment body is to be given through the prefectural governor or the Minister of Health, Labour and Welfare who has ordered that the person should undergo the inspection.
A person who intends to undergo an inspection conducted by the Minister of Health, Labour and Welfare or a registered conformity assessment body under the provisions of paragraphs (1) through (3), must pay a fee specified by the Minister in consideration of the actual costs of the inspections for an inspection conducted by the Minister, and must pay a fee specified by the registered conformity assessment body by obtaining an approval from the Minister in consideration of the actual costs of the inspections for an inspection conducted by a registered conformity assessment body.
第一項から第三項までの規定による厚生労働大臣又は登録検査機関の行う検査を受けようとする者は、検査に要する実費の額を考慮して、厚生労働大臣の行う検査にあつては厚生労働大臣が定める額の、登録検査機関の行う検査にあつては当該登録検査機関が厚生労働大臣の認可を受けて定める額の手数料を納めなければならない。
The provisions of paragraphs (3) through (5) of the preceding Article apply mutatis mutandis to inspections referred to in paragraphs (1) through (3).
前条第三項から第五項までの規定は、第一項から第三項までの検査について準用する。
Article 27
A person who intends to import food, additives, apparatus, or containers and packages for the purpose of selling or to use for business must notify the Minister of Health, Labour and Welfare each time they import the articles pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
Article 28
When the Minister of Health, Labour and Welfare, the Prime Minister, or a prefectural governor, etc. finds it necessary, they may request a business operator or other relevant persons to make the necessary report, have their officials conduct an inspection of the place of business, office, warehouse, and other places, inspect food, additives, apparatus, or containers and packages to be used for selling or used for business, business facilities, books and documents, and other objects, or have the officials collect and remove food, additives, apparatus, or containers and packages to be used for selling or used for business, to the extent necessary for using them for testing, without compensation for the food, additives, apparatus, or containers and packages.
When having officials conduct on-site inspection, or collect and remove objects pursuant to the provisions of the preceding paragraph, the Minister of Health, Labour and Welfare, the Prime Minister, or the prefectural governor, etc. must have the officials carry their identification card, and, present it when requested by the relevant persons.
前項の規定により当該職員に臨検検査又は収去をさせる場合においては、これにその身分を示す証票を携帯させ、かつ、関係者の請求があるときは、これを提示させなければならない。
The authority under the provisions of paragraph (1) must not be construed as having been granted for the purpose of a criminal investigation.
第一項の規定による権限は、犯罪捜査のために認められたものと解釈してはならない。
The Minister of Health, Labour and Welfare, the Prime Minister, or a prefectural governor, etc. may entrust the affairs concerning the testing of food, additives, apparatus, or containers and packages that have been collected and removed pursuant to the provisions of paragraph (1) to a registered conformity assessment body.
Article 29
The national government and prefectures must establish necessary facilities for inspections to conduct the affairs concerning the inspections referred to in Article 25, paragraph (1) or Article 26, paragraphs (1) through (3) (referred to below as "product inspections") and the testing of food, additives, apparatus, or containers and packages that have been collected and removed pursuant to the provisions of paragraph (1) of the preceding Article.
Cities with public health centers and special wards must establish necessary facilities for inspections to conduct the affairs concerning the testing of food, additives, apparatus, or containers and packages that have been collected and removed pursuant to the provisions of paragraph (1) of the preceding Article.
The necessary matters for food sanitation inspection facilities of prefectures, etc. are specified by Cabinet Order.
都道府県等の食品衛生検査施設に関し必要な事項は、政令で定める。
Article 30
The Minister of Health, Labour and Welfare, the Prime Minister, or a prefectural governor, etc. is to appoint food sanitation inspectors from among their officials to have those officials enforce the authority prescribed in Article 28, paragraph (1) and perform the duties of providing guidance on food sanitation.
A prefectural governor, etc. must have food sanitation inspectors they have appointed implement monitoring and guidance pursuant to the provisions of the prefectural plan for monitoring and guidance of food sanitation.
都道府県知事等は、都道府県等食品衛生監視指導計画の定めるところにより、その命じた食品衛生監視員に監視指導を行わせなければならない。
The Prime Minister is to have food sanitation inspectors appointed by the Prime Minister implement monitoring and guidance related to the labeling or advertising of food, additives, apparatus, and containers and packages, in accordance with the guidelines.
The Minister of Health, Labour and Welfare is to have food sanitation inspectors appointed by the Minister of Health, Labour and Welfare implement monitoring and guidance related to the import of food, additives, apparatus, and containers and packages, as provided for in the imported food monitoring and guidance plan.
Beyond what is provided for in the preceding paragraphs, the qualifications of food sanitation inspectors and other necessary matters concerning food sanitation inspectors are specified by Cabinet Order.
前各項に定めるもののほか、食品衛生監視員の資格その他食品衛生監視員に関し必要な事項は、政令で定める。
第八章 登録検査機関
Chapter VIII Registered Conformity Assessment Bodies
Article 31
A person who seeks to obtain registration as a registered conformity assessment body must pay a fee specified by Cabinet Order in consideration of the actual costs and apply for registration with the Minister of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
登録検査機関の登録を受けようとする者は、厚生労働省令で定めるところにより、実費を勘案して政令で定める額の手数料を納付して、厚生労働大臣に登録の申請をしなければならない。
Article 32
A corporation falling under any of the following items may not obtain registration as a registered conformity assessment body:
次の各号のいずれかに該当する法人は、登録検査機関の登録を受けることができない。
a corporation or an officer engaged in its business has violated this Act or a disposition based on this Act, has been sentenced to a fine or severer punishment, and two years have not passed since they finished serving the sentence or ceased to be subject to the sentence;
その法人又はその業務を行う役員がこの法律又はこの法律に基づく処分に違反し、罰金以上の刑に処せられ、その執行を終わり、又は執行を受けることがなくなつた日から二年を経過しないもの
a corporation that has had its registration revoked pursuant to the provisions of Article 43, and two years have not passed since the date of the revocation; or
第四十三条の規定により登録を取り消され、その取消しの日から二年を経過しない法人
a corporation for which a person who was an officer engaged in the business of the corporation related to the revocation of registration under the provisions of Article 43 within 30 days before the date of the revocation, and two years have not passed since the date of the revocation, is an officer engaged in its business.
第四十三条の規定による登録の取消しの日前三十日以内にその取消しに係る法人の業務を行う役員であつた者でその取消しの日から二年を経過しないものがその業務を行う役員となつている法人
Article 33
When a person who has applied for registration pursuant to the provisions of Article 31 (referred to as an "applicant for registration" below in this paragraph) satisfies all of the following requirements, the Minister of Health, Labour and Welfare must register that person. In such a case, the necessary procedures for registration are specified by Order of the Ministry of Health, Labour and Welfare.
厚生労働大臣は、第三十一条の規定により登録を申請した者(以下この項において「登録申請者」という。)が次に掲げる要件のすべてに適合しているときは、その登録をしなければならない。この場合において、登録に関して必要な手続は、厚生労働省令で定める。
the applicant for registration possesses the machines, equipment, and other facilities respectively listed in column 2 of the Appended Table for each type of product inspection listed in column 1 of that Table, and product inspections are conducted by persons who have the knowledge and experience that satisfy the conditions listed in column 3 of that Table, and the number of those persons is not less than the number listed in column 4 of that Table;
別表の第一欄に掲げる製品検査の種類ごとに、それぞれ同表の第二欄に掲げる機械器具その他の設備を有し、かつ、製品検査は同表の第三欄に掲げる条件に適合する知識経験を有する者が実施し、その人数が同表の第四欄に掲げる数以上であること。
measures to ensure the credibility of product inspections stated in the following sub-items have been taken:
次に掲げる製品検査の信頼性の確保のための措置が執られていること。
a full-time administrator is appointed for each type of product inspection at a department that conducts inspections;
検査を行う部門に製品検査の種類ごとにそれぞれ専任の管理者を置くこと。
documents on management of operation of product inspections and securing of precision of product inspections have been prepared;
製品検査の業務の管理及び精度の確保に関する文書が作成されていること。
a specialized department is established for managing the operation of product inspections and securing precision of product inspections, in accordance with what is stated in the documents stated in sub-item (b);
ロに掲げる文書に記載されたところに従い製品検査の業務の管理及び精度の確保を行う専任の部門を置くこと。
the applicant for registration does not fall under any of the following sub-items as a person controlled by a business operator that sells, or manufactures, imports, processes, or displays for the purpose of selling, or uses for business (referred to as a "business operator subject to inspections" below in this item and Article 39, paragraph (2)) food, additives, apparatus, or containers and packages for which product inspections must be undertaken pursuant to the provisions of Article 25, paragraph (1) or Article 26, paragraphs (1) through (3):
if an applicant for registration is a stock company, a business operator subject to inspections is its parent corporation (meaning a parent corporation prescribed in Article 879, paragraph (1) of the Companies Act (Act No. 86 of 2005));
登録申請者が株式会社である場合にあつては、受検営業者がその親法人(会社法(平成十七年法律第八十六号)第八百七十九条第一項に規定する親法人をいう。)であること。
officers or employees of a business operator subject to inspections (including persons who were officers or employees of a business operator subject to inspections in the past two years) account for more than half of the officers of an applicant for registration (for a membership company (meaning a membership company prescribed in Article 575, paragraph (1) of the Companies Act), members that execute its business);
登録申請者の役員(持分会社(会社法第五百七十五条第一項に規定する持分会社をいう。)にあつては、業務を執行する社員)に占める受検営業者の役員又は職員(過去二年間に当該受検営業者の役員又は職員であつた者を含む。)の割合が二分の一を超えていること。
officers who have the right to represent the applicant for registration are officers or employees of a business operator subject to inspections (including those who were officers or employees of a business operator subject to inspections in the past two years).
Registration is made by entering the following matters in the register:
登録は、次に掲げる事項を登録台帳に記帳して行う。
the date of registration and registration number;
登録年月日及び登録番号
the name of the registered conformity assessment body, the name of its representative, and the location of its principal office;
登録検査機関の名称、代表者の氏名及び主たる事務所の所在地
the type of product inspections that the registered conformity assessment body conducts; and
the name and the location of the office in which the registered conformity assessment body conducts product inspections.
Article 34
Unless registration of a registered conformity assessment body is renewed at the end of each period of not less than three years which is specified by Cabinet Order, the registration ceases to be effective upon the expiration of the period.
登録検査機関の登録は、三年を下らない政令で定める期間ごとにその更新を受けなければ、その期間の経過によつて、その効力を失う。
The provisions of Article 31 through the preceding Article apply mutatis mutandis to the renewal of registration referred to in the preceding paragraph.
第三十一条から前条までの規定は、前項の登録の更新について準用する。
Article 35
A registered conformity assessment body must conduct product inspections without delay, when requested to conduct a product inspection, excluding cases in which there are legitimate grounds not to do so.
A registered conformity assessment body must conduct product inspections in a fair manner, and by a method that conforms to the technical criteria specified by Order of the Ministry of Health, Labour and Welfare.
Article 36
When a registered conformity assessment body intends to newly establish or abolish an office in which it conducts product inspections, or change the location of the office, it must notify the Minister of Health, Labour and Welfare of that fact by no later than one month before the day of the establishment, abolition, or change.
When there has been any change to the matters stated in Article 33, paragraph (2), items (ii) and (iv) (limited to the part related to the name of the office), the registered conformity assessment body must notify the Minister of Health, Labour and Welfare of that fact without delay, and when it intends to change the matters stated in item (iii) of that paragraph, it must notify the Minister of that fact by no later than one month before the day of the change.
登録検査機関は、第三十三条第二項第二号及び第四号(事業所の名称に係る部分に限る。)に掲げる事項に変更があつたときは、遅滞なく、同項第三号に掲げる事項を変更しようとするときは、変更しようとする日の一月前までに、その旨を厚生労働大臣に届け出なければならない。
Article 37
A registered conformity assessment body must establish rules concerning the operation of product inspections (referred to below as "operational rules") and obtain an approval from the Minister of Health, Labour and Welfare before commencing the operation of product inspections. The same applies when the registered conformity assessment body intends to change the operational rules.
Operational rules must specify the method of conducting product inspections, fees concerning product inspections, and other matters specified by Order of the Ministry of Health, Labour and Welfare.
When the Minister of Health, Labour and Welfare finds that the operational rules for which the Minister has granted approval referred to in paragraph (1) have become inappropriate for conducting product inspections in a fair manner, the Minister may order the registered conformity assessment body to change the operational rules.
Article 38
A registered conformity assessment body must not suspend the operation of product inspections in whole or in part or abolish the operation of product inspections, without obtaining the approval of the Minister of Health, Labour and Welfare.
Article 39
A registered conformity assessment body must prepare an inventory of property, balance sheet, and profit and loss statement, or income and expenditure account statement, and business report (including the electronic or magnetic record (meaning a record created in electronic form, magnetic form, or any other form that cannot be perceived by the human senses which is to be used for information processing by computers; the same applies below in this Article) when electronic or magnetic records are prepared in lieu of those documents; referred to as "financial statements, etc." in the following paragraph and Article 89) for the business year within three months after the end of each business year, and keep them at the office for five years.
A business operator subject to inspections and other interested persons may make the following requests at any time within the business hours of a registered conformity assessment body; provided, however, that when making a request referred to in item (ii) or (iv), they must pay fees specified by the registered conformity assessment body.
when financial statements, etc. are prepared as documents, a request to inspect or copy the documents;
財務諸表等が書面をもつて作成されているときは、当該書面の閲覧又は謄写の請求
a request for a transcript or an extract of the documents referred to in the preceding item;
前号の書面の謄本又は抄本の請求
when financial statements, etc. are prepared as electronic or magnetic records, a request to inspect or copy the media that displays the matters recorded on the electronic or magnetic records by the means specified by Order of the Ministry of Health, Labour and Welfare;
a request for provision of the matters recorded on the electronic or magnetic records referred to in the preceding item by electronic or magnetic means specified by Order of the Ministry of Health, Labour and Welfare, or a request for delivery of the documents stating the matters.
Article 40
Officers or employees of a registered conformity assessment body or persons who formerly held those positions must not divulge any secret concerning the operation of product inspections, or affairs entrusted to them pursuant to the provisions of Article 28, paragraph (4) (referred to as "entrusted affairs" in the following paragraph), which they have learned.
Officers or employees of a registered conformity assessment body who are engaged in the operation of product inspections or entrusted affairs are deemed to be officials engaged in public services under laws and regulations in applying the Penal Code (Act No. 45 of 1907) and other penal provisions.
製品検査の業務又は委託事務に従事する登録検査機関の役員又は職員は、刑法(明治四十年法律第四十五号)その他の罰則の適用については、法令により公務に従事する職員とみなす。
Article 41
When the Minister of Health, Labour and Welfare finds that a registered conformity assessment body no longer satisfies any of the items of Article 33, paragraph (1), the Minister may order the registered conformity assessment body to take necessary measures in order to satisfy those provisions.
Article 42
When the Minister of Health, Labour and Welfare finds that a registered conformity assessment body has violated the provisions of Article 35, or that product inspections conducted by a registered conformity assessment body, labeling under the provisions of Article 25, paragraph (1), or the statement in the notice under the provisions of Article 26, paragraph (4) is not appropriate, the Minister may order that the registered conformity assessment body should conduct product inspections or take necessary measures for improving the method of product inspections or other operational methods.
Article 43
When a registered conformity assessment body falls under any of the following items, the Minister of Health, Labour and Welfare may revoke the registration of the registered conformity assessment body, or order the suspension of the operation of product inspections in whole or in part, by specifying a period:
when a registered conformity assessment body has violated the provisions of this Chapter;
この章の規定に違反したとき。
when a registered conformity assessment body has come to fall under Article 32, item (i) or (iii);
when a registered conformity assessment body has conducted product inspections without following the operational rules that obtained the approval referred to in Article 37, paragraph (1);
when a registered conformity assessment body has violated an order under the provisions of Article 37, paragraph (3) or the preceding two Articles;
when a registered conformity assessment body has rejected a request under the provisions of each item of Article 39, paragraph (2) without legitimate grounds; or
正当な理由がないのに第三十九条第二項各号の規定による請求を拒んだとき。
when a registered conformity assessment body has obtained registration referred to in Article 33, paragraph (1) by wrongful means.
不正の手段により第三十三条第一項の登録を受けたとき。
Article 44
A registered conformity assessment body must keep books, enter the matters concerning product inspections specified by Order of the Ministry of Health, Labour and Welfare in the books, and preserve them, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
Article 45
In any of the following cases, the Minister of Health, Labour and Welfare must issue public notice of those matters in an Official Gazette:
厚生労働大臣は、次の場合には、その旨を官報に公示しなければならない。
when the Minister has granted the registration referred to in Article 33, paragraph (1);
第三十三条第一項の登録をしたとき。
when registration of a registered conformity assessment body has ceased to be effective pursuant to the provisions of Article 34, paragraph (1);
when a notification under the provisions of Article 36, paragraph (1) or (2) has been given;
when the Minister has granted the approval referred to in Article 38;
第三十八条の許可をしたとき。
when the Minister has revoked the registration or ordered the suspension of product inspections, pursuant to the provisions of Article 43.
Article 46
A person other than a registered conformity assessment body must not use labeling, advertising, or conduct other acts that may cause people to misunderstand the operation the person conducts to be product inspection.
The Minister of Health, Labour and Welfare may order a person other than a registered conformity assessment body that they should take measures so as not to cause people to misunderstand the operation the person conducts to be product inspection.
Article 47
The Minister of Health, Labour and Welfare may have a registered conformity assessment body make a report on its operation or accounting situation, or have their officials enter the office or place of business of a registered conformity assessment body to inspect the status of operations or books, documents, and other objects, or question the relevant persons, to the extent necessary for the enforcement of this Act.
厚生労働大臣は、この法律の施行に必要な限度において、登録検査機関に対し、その業務若しくは経理の状況に関し報告をさせ、又は当該職員に、登録検査機関の事務所若しくは事業所に立ち入り、業務の状況若しくは帳簿、書類その他の物件を検査させ、若しくは関係者に質問させることができる。
The provisions of Article 28, paragraphs (2) and (3) apply mutatis mutandis to the case referred to in the preceding paragraph.
Article 48
A business operator that produces or processes dairy products, additives specified by the Prime Minister pursuant to the provisions of Article 12, or other food or additives that require sanitary consideration in particular in the process of production or processing, which are specified by Cabinet Order, must have a full-time food sanitation supervisor for each facility to supervise the production or processing in a sanitary manner; provided, however, that this does not apply to facilities which the business operator personally supervises as a food sanitation supervisor.
If a business operator conducts production or processing business that requires having a full-time food sanitation supervisor pursuant to the provisions of the preceding paragraph at two or more facilities, and those facilities are adjacent to each other, it is sufficient to have one food sanitation supervisor for those two or more facilities, notwithstanding the provisions of that paragraph.
Beyond what is provided for in the preceding paragraph, a food sanitation supervisor must pay necessary attention to sanitation management method at the facility and other matters concerning food sanitation, in order to prevent violations of this Act or orders or dispositions based on this Act and prevent food sanitation hazards concerning the food or additives the food sanitation supervisor manages at the facility, and express necessary opinions to a business operator.
When a food sanitation supervisor has been placed at a facility, a business operator must respect the opinions of the food sanitation supervisor expressed under the provisions of the preceding paragraph.
Only persons falling under any of the following items may become a food sanitation supervisor:
次の各号のいずれかに該当する者でなければ、食品衛生管理者となることができない。
a physician, dentist, pharmacist, or veterinarian;
医師、歯科医師、薬剤師又は獣医師
a person who has graduated from a university under the School Education Act (Act No. 26 of 1947), a university under the former University Order (Imperial Order No. 388 of 1918), or a technical college under the former Technical College Order (Imperial Order No. 61 of 1903) after completing a course in medical science, dentistry, pharmacy, veterinary medicine, animal science, fisheries science, or agricultural chemistry (including a person who has completed the course and has completed the first-semester course of a professional and vocational university under that Act);
学校教育法(昭和二十二年法律第二十六号)に基づく大学、旧大学令(大正七年勅令第三百八十八号)に基づく大学又は旧専門学校令(明治三十六年勅令第六十一号)に基づく専門学校において医学、歯学、薬学、獣医学、畜産学、水産学又は農芸化学の課程を修めて卒業した者(当該課程を修めて同法に基づく専門職大学の前期課程を修了した者を含む。)
a person who has completed the prescribed course at a training institute for food sanitation supervisors that has obtained registration from a prefectural governor;
都道府県知事の登録を受けた食品衛生管理者の養成施設において所定の課程を修了した者
a person who has graduated from a high school or secondary education school under the School Education Act or a secondary school under the former Secondary School Order (Imperial Order No. 36 of 1943), or a person who is found to have equal or higher scholastic ability than those persons pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare and has been engaged in sanitation management of production or processing of food or additives for three years or more at a production business or processing business for which full-time food sanitation supervisors are required to be placed pursuant to the provisions of paragraph (1), and, has completed the training session that has obtained the registration from a prefectural governor.
A person who possesses the qualifications of a food sanitation supervisor because the person falls under item (iv) of the preceding paragraph may become a food sanitation supervisor only at a facility for the same type of production business or processing business as the business for which the person has been engaged in sanitation management work for three years or more.
前項第四号に該当することにより食品衛生管理者たる資格を有する者は、衛生管理の業務に三年以上従事した製造業又は加工業と同種の製造業又は加工業の施設においてのみ、食品衛生管理者となることができる。
When a business operator prescribed in paragraph (1) has placed a food sanitation supervisor or has become a food sanitation supervisor themselves at their facility, they must notify the prefectural governor that has jurisdiction over the locality of the facility of the name of the food sanitation supervisor or the fact that the business operator themselves have become a food sanitation supervisor and other matters specified by Order of the Ministry of Health, Labour and Welfare within 15 days. The same applies when the business operator has changed the food sanitation supervisor.
Article 49
Necessary matters concerning registration of training facilities referred to in paragraph (6), item (iii) of the preceding Article or registration of training sessions referred to in item (iv) of that paragraph are specified by Cabinet Order, and the subjects to be taken and other necessary matters concerning courses at training facilities referred to in item (iii) of that paragraph and courses for training sessions referred to in item (iv) of that paragraph are specified by Order of the Ministry of Health, Labour and Welfare.
Article 50
When criteria have been established pursuant to the provisions of the preceding paragraph, a business operator (excluding poultry slaughterers prescribed in Article 6, paragraph (1) of the Poultry Slaughtering Business Control and Poultry Meat Inspection Act) must comply with the criteria.
Article 51
The Minister of Health, Labour and Welfare is to establish criteria for the following matters related to the sanitary management of facilities for business (excluding businesses that manufacture apparatus, or containers and packages and businesses of poultry slaughtering defined in Article 2, item (v) of the Poultry Slaughtering Business Control and Poultry Meat Inspection Act (referred to as "poultry slaughtering businesses" in Article 54 and Article 57, paragraph (1))) and other necessary measures for public health (referred to as "measures necessary for public health" below in this Article) under Order of the Ministry of Health, Labour and Welfare:
matters concerning the maintenance of cleanliness and extermination of rats and insects of the interior and exterior of the facilities, and other general sanitation management;
施設の内外の清潔保持、ねずみ及び昆虫の駆除その他一般的な衛生管理に関すること。
matters concerning initiatives to control processes that are particularly important for preventing food sanitation hazards (for a small scale business operator (excluding a business operator that manufactures apparatus, or containers and packages, and a poultry slaughterer prescribed in Article 6, paragraph (1) of the Poultry Slaughtering Business Control and Poultry Meat Inspection Act; the same applies in the following paragraph) and other business operators specified by Cabinet Order, initiatives in accordance with the characteristics of the food handled by the business operator).
A business operator must establish the necessary measures for public health in compliance with the criteria established pursuant to the provisions of the preceding paragraph and pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, and comply with those measures.
営業者は、前項の規定により定められた基準に従い、厚生労働省令で定めるところにより公衆衛生上必要な措置を定め、これを遵守しなければならない。
The prefectural governor, etc. may establish necessary provisions on necessary measures for public health by Prefectural or Municipal Ordinance, provided that the provisions do not violate the criteria established pursuant to the provisions of paragraph (1).
都道府県知事等は、公衆衛生上必要な措置について、第一項の規定により定められた基準に反しない限り、条例で必要な規定を定めることができる。
Article 52
The Minister of Health, Labour and Welfare is to establish criteria for the following matters related to the sanitary management of facilities for business that manufactures apparatus, or containers and packages, and other necessary measures for public health (referred to as "measures necessary for public health" below in this Article) under Order of the Ministry of Health, Labour and Welfare:
matters concerning the maintenance of the cleanliness and other general sanitation management of the interior and exterior of the facilities;
施設の内外の清潔保持その他一般的な衛生管理に関すること。
matters concerning measures to appropriately manage manufacturing necessary for preventing occurrence of food sanitation hazards.
食品衛生上の危害の発生を防止するために必要な適正に製造を管理するための取組に関すること。
A business operator that manufactures apparatus, or containers and packages must take necessary measures for public health in compliance with the criteria established pursuant to the provisions of the preceding paragraph (for a business operator that manufactures apparatus, or containers and packages made only from raw materials of materials other than those specified by Cabinet Order prescribed in Article 18, paragraph (3), limited to the matters stated in item (i) of the preceding paragraph).
The prefectural governor, etc. may establish necessary provisions on necessary measures for public health by Prefectural or Municipal Ordinance, provided that the provisions do not violate the criteria established pursuant to the provisions of paragraph (1).
都道府県知事等は、公衆衛生上必要な措置について、第一項の規定により定められた基準に反しない限り、条例で必要な規定を定めることができる。
Article 53
A person who sells, or manufactures or imports for the purpose of selling, apparatus, or containers and packages made from raw materials of materials specified by Cabinet Order prescribed in Article 18, paragraph (3), pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, must explain that the apparatus, or containers and packages the person handles falls under either of the following items to the other party to the sale:
for the raw materials of materials specified by Cabinet Order prescribed in Article 18, paragraph (3), the apparatus, or containers and packages have been manufactured by using only raw materials that conform to the standards established pursuant to the provisions of paragraph (1) of that Article; or
the apparatus, or containers and packages have undergone processing prescribed in the proviso to Article 18, paragraph (3).
When a person who sells, or produces or imports for the purpose of selling, raw materials of apparatus, or containers and packages and made from materials specified by Cabinet Order prescribed in Article 18, paragraph (3) receives a request from a person who manufactures apparatus, or containers and packages using those raw materials for confirmation that the raw materials conform to the standards established pursuant to the provisions of paragraph (1) of that Article, they must endeavor to provide necessary explanations pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
Article 54
Prefectures must establish criteria necessary from the viewpoint of public health for facilities of the business that have a significant impact on public health (excluding poultry slaughtering businesses) and are specified by Cabinet Order by Prefectural Ordinance, taking into consideration the criteria specified by Order of the Ministry of Health, Labour and Welfare.
Article 55
A person who seeks to conduct a business prescribed in the preceding Article must obtain approval from the prefectural governor pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
In the case referred to in the preceding paragraph, the prefectural governor must grant approval when the prefectural governor finds that the business facilities conform to the criteria under the provisions of the preceding Article; provided, however, that the prefectural governor may refuse to grant the approval referred to in that paragraph when the person who seeks to conduct the business prescribed in the preceding Article falls under any of the following items:
a person who has been punished for violating this Act or a disposition based on this Act, and two years have not passed since the person finished serving the sentence or ceased to be subject to the sentence;
この法律又はこの法律に基づく処分に違反して刑に処せられ、その執行を終わり、又は執行を受けることがなくなつた日から起算して二年を経過しない者
a person who has had their approval revoked pursuant to the provisions of Articles 59 through 61, and for whom two years have not passed since the date of the revocation; or
第五十九条から第六十一条までの規定により許可を取り消され、その取消しの日から起算して二年を経過しない者
a corporation that has a person falling under any of the preceding two items among the officers in charge of its business.
法人であつて、その業務を行う役員のうちに前二号のいずれかに該当する者があるもの
A prefectural governor may attach necessary conditions such as a valid period of not less than five years to the approval referred to in paragraph (1).
都道府県知事は、第一項の許可に五年を下らない有効期間その他の必要な条件を付けることができる。
Article 56
When a person who has obtained the approval referred to in paragraph (1) of the preceding Article (referred to as an "approved business operator" below in this Article) has transferred their business, or an inheritance, a merger, or a split (limited to one by which the business is succeeded to) for an approved business operator has been implemented, a person who has been transferred the business, or an heir (if there are two or more heirs, and an heir that is to succeed to the business has been selected by the consent of all the heirs, that heir), a corporation surviving the merger, a corporation established by the merger, or a corporation succeeding to the business by the split is to succeed to the status of the approved business operator.
A person who has succeeded to the status of the approved business operator pursuant to the provisions of the preceding paragraph must notify the prefectural governor to that effect without delay, by attaching a document proving that fact.
Article 57
A person who seeks to conduct business (excluding business prescribed in Article 54, a business that has a small impact on public health and is specified by Cabinet Order, and a poultry slaughtering business) must notify a prefectural governor of the name and the location of their business office and other matters specified by Order of the Ministry of Health, Labour and Welfare, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare in advance.
The provisions of the preceding Article apply mutatis mutandis to a person who has made a notification under the provisions of the preceding paragraph. In such a case, the terms "a person who has obtained the approval referred to in paragraph (1) of the preceding Article" and "an approved business operator" in paragraph (1) of that Article are deemed to be replaced with "a person who has made a notification under the provisions of paragraph (1) of the following Article" and "a notifying business operator", respectively, and the term "an approved business operator" in paragraph (2) of that Article is deemed to be replaced with "a notifying business operator".
Article 58
When a business operator falls under either of the following items and recalls food or additives they have collected, produced, imported, processed or sold, or apparatus, or containers and packages they have manufactured, imported, or sold (excluding cases in which the recall is made by receiving an order under the provisions of paragraph (1) or (2) of the following Article and cases specified by Order of the Ministry of Health, Labour and Welfare and Cabinet Office Order as those unlikely to cause food sanitation hazards), they must notify a prefectural governor of the fact that they have commenced the recall and the status of the recall, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare and Cabinet Office Order, without delay.
when the business operator violates or is likely to violate the provisions of Article 6, Articles 10 through 12, Article 13, paragraph (2) or (3), Article 16, Article 18, paragraph (2) or (3), or Article 20; or
when the business operator violates or is likely to violate a prohibition under the provisions of Article 9, paragraph (1) or Article 17, paragraph (1).
When a notification under the provisions of the preceding paragraph has been filed, a prefectural governor must report the matters notified to the Minister of Health, Labour and Welfare or the Prime Minister pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare and Cabinet Office Order.
都道府県知事は、前項の規定による届出があつたときは、厚生労働省令・内閣府令で定めるところにより、当該届出に係る事項を厚生労働大臣又は内閣総理大臣に報告しなければならない。
Article 59
When a business operator violates the provisions of Article 6, Articles 10 through 12, Article 13, paragraph (2) or (3), Article 16 or Article 18, paragraph (2) or (3), or violates a prohibition under the provisions of Article 9, paragraph (1) or Article 17, paragraph (1), the Minister of Health, Labour and Welfare or a prefectural governor may order the business operator or the officials of the Ministry or the prefecture to dispose of the food, additives, apparatus, or containers and packages, or order the business operator to take other necessary measures to eliminate the food sanitation hazards.
When a business operator has violated the provisions of Article 20, the Prime Minister or a prefectural governor may order the business operator or the relevant officials to dispose of the food, additives, apparatus, or containers and packages, or order the business operator to take other necessary measures to eliminate the food sanitation hazards caused by the false or exaggerated labeling or advertising.
Article 60
When a business operator violates the provisions of Article 6, Article 8, paragraph (1), Articles 10 through 12, Article 13, paragraph (2) or (3), Article 16, Article 18, paragraph (2) or (3), Article 19, paragraph (2), Article 20, Article 25, paragraph (1), Article 26, paragraph (4), Article 48, paragraph (1), Article 50, paragraph (2), Article 51, paragraph (2), Article 52, paragraph (2) or Article 53, paragraph (1), violates a prohibition under the provisions of Article 7, paragraphs (1) through (3), Article 9, paragraph (1) or Article 17, paragraph (1), has come to fall under Article 55, paragraph (2), item (i) or (iii), or violates the conditions under the provisions of paragraph (3) of that Article, a prefectural governor may revoke the approval referred to in paragraph (1) of that Article, prohibit the business in whole or in part, or suspend the business by specifying a period.
都道府県知事は、営業者が第六条、第八条第一項、第十条から第十二条まで、第十三条第二項若しくは第三項、第十六条、第十八条第二項若しくは第三項、第十九条第二項、第二十条、第二十五条第一項、第二十六条第四項、第四十八条第一項、第五十条第二項、第五十一条第二項、第五十二条第二項若しくは第五十三条第一項の規定に違反した場合、第七条第一項から第三項まで、第九条第一項若しくは第十七条第一項の規定による禁止に違反した場合、第五十五条第二項第一号若しくは第三号に該当するに至つた場合又は同条第三項の規定による条件に違反した場合においては、同条第一項の許可を取り消し、又は営業の全部若しくは一部を禁止し、若しくは期間を定めて停止することができる。
When a business operator (limited to a person or corporation that is engaged in import of food, additives, apparatus, or containers and packages) violates the provisions of Article 6, Article 8, paragraph (1), Article 10, paragraph (2), Article 11, Article 12, Article 13, paragraph (2) or (3), Article 16, Article 18, paragraph (2) or (3), Article 26, paragraph (4), Article 50, paragraph (2), Article 51, paragraph (2), Article 52, paragraph (2) or Article 53, paragraph (1), or violates a prohibition under the provisions of Article 7, paragraphs (1) through (3), Article 9, paragraph (1) or Article 17, paragraph (1), the Minister of Health, Labour and Welfare may prohibit the business in whole or in part, or suspend the business by specifying a period.
Article 61
When a business operator violates the criteria under the provisions of Article 54 for their business facilities, a prefectural governor may order the business operator to develop and improve the facilities, revoke the approval referred to in Article 55, paragraph (1), prohibit the business in whole or in part, or suspend the business by specifying a period.
Article 62
The national treasury is to bear half of the following expenses of prefectures or cities with public health centers, pursuant to the provisions of Cabinet Order:
国庫は、政令で定めるところにより、次に掲げる都道府県又は保健所を設置する市の費用に対して、その二分の一を負担する。
expenses required for collection and removal under the provisions of Article 28, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3));
expenses required for placing food sanitation inspectors under the provisions of Article 30, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3));
expenses required for the approval of business under the provisions of Article 55, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1));
expenses required for disposal under the provisions of Article 59 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3));
expenses required for autopsies of corpses under the provisions of Article 64, paragraph (1) or (2) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)); and
expenses required for lawsuits concerning the enforcement of this Act and cost for compensation to be paid as a result of the lawsuits.
この法律の施行に関する訴訟事件に要する費用及びその結果支払う賠償の費用
Article 63
A physician who has diagnosed a patient with food poisoning, etc., or has examined the corpse of a patient with food poisoning, etc. must immediately notify the director of the nearest public health center to that effect.
食中毒患者等を診断し、又はその死体を検案した医師は、直ちに最寄りの保健所長にその旨を届け出なければならない。
When the director of a public health center has received a notification referred to in the preceding paragraph, or finds that patients with food poisoning, etc. have been found, the director must promptly make a report to a prefectural governor, etc., and conduct an investigation, pursuant to the provisions of Cabinet Order.
When a prefectural governor, etc. has received a report from the director of a public health center pursuant to the provisions of the preceding paragraph, and finds that the number of patients with food poisoning, etc. who have been found is equal to or higher than the number specified by Order of the Ministry of Health, Labour and Welfare, it is likely that such a situation will occur, or in other cases specified by Order of the Ministry of Health, Labour and Welfare, the prefectural governor, etc. must immediately make a report to the Minister of Health, Labour and Welfare.
When the director of a public health center has conducted an investigation under the provisions of paragraph (2), the director must make a report to a prefectural governor, etc. pursuant to the provisions of Cabinet Order.
When a prefectural governor, etc. has received a report under the provisions of the preceding paragraph, the prefectural governor, etc. must make a report to the Minister of Health, Labour and Welfare, pursuant to the provisions of Cabinet Order.
Article 64
When a prefectural governor, etc. finds it necessary for investigating the cause of death, the prefectural governor, etc. may have the corpse of a person who has died of a disease that was or is suspected to have been caused by food, additives, apparatus, or containers and packages be autopsied with the consent of the bereaved family.
In the case referred to in the preceding paragraph, when the cause of death cannot be determined without performing an autopsy on the corpse and as a result of not determining the cause, it is likely that serious public sanitation hazards will occur, the prefectural governor, etc. may perform an autopsy on the corpse even without obtaining the consent of the bereaved family, after notifying them.
前項の場合において、その死体を解剖しなければ原因が判明せず、その結果公衆衛生に重大な危害を及ぼすおそれがあると認めるときは、遺族の同意を得ないでも、これに通知した上で、その死体を解剖に付することができる。
The provisions of the preceding two paragraphs must not preclude compulsory dispositions under the provisions concerning criminal proceedings to be made.
前二項の規定は、刑事訴訟に関する規定による強制の処分を妨げない。
When performing an autopsy on a corpse pursuant to the provisions of paragraph (1) or (2), care must be taken not to lose respect for the deceased.
Article 65
If the number of patients with food poisoning, etc. who have been confirmed is equal to or higher than the number specified by Order of the Ministry of Health, Labour and Welfare, it is likely that such a situation will occur, or patients with food poisoning, etc. have been found over a wide area or are likely to spread over a wide area, and there is an urgency to prevent the occurrence of food sanitation hazards, the Minister of Health, Labour and Welfare may request prefectural governors, etc. to investigate the causes of food poisoning and report the investigation results, by specifying a time limit.
Article 66
In the case prescribed in the preceding Article, when the Minister of Health, Labour and Welfare finds it necessary, the Minister must hold a council meeting, share necessary information on the investigation of the causes of food poisoning and the results of the investigation, aim at closer cooperation among the relevant organizations, and endeavor to conduct discussions on necessary measures to prevent patients with food poisoning, etc. to be found over a wide area, or their increase.
Article 67
A prefecture, etc. is to endeavor to provide necessary advice, guidance, and other assistance to food business operators, in order to prevent the occurrence of food poisoning and improve food sanitation in the region.
A prefecture, etc. may appoint a food sanitation promoter from among the persons who have public reputation, and have enthusiasm, knowledge and experience for improving food sanitation, in order to promote voluntary activities by food business operators concerning the improvement of food sanitation.
A food sanitation promoter is to cooperate in the policy measures of prefectures, etc., respond to requests for consultation from food business operators, and give advice to them concerning sanitation management method of facilities for restaurant business and other matters concerning food sanitation.
Article 68
The provisions of Article 6, Article 9, Article 12, Article 13, paragraphs (1) and (2), Articles 16 through 20 (excluding Article 18, paragraph (3)), Articles 25 through 61 (excluding Article 51, Article 52, paragraph (1), item (ii) and paragraph (2), and Article 53), and Articles 63 through 65 apply mutatis mutandis to toys designated by the Minister of Health, Labour and Welfare and the Prime Minister as those likely to harm the health of infants when they touch the toys. In such a case, the term "Additives (excluding natural flavoring agents and things that have been generally served for human consumption, and are used as additives)" in Article 12 is deemed to be replaced with "Chemically synthesized compounds intended to be used as additives for toys (meaning substances obtained by causing a chemical reaction other than a decomposition reaction to elements or compounds by chemical means)".
第六条、第九条、第十二条、第十三条第一項及び第二項、第十六条から第二十条まで(第十八条第三項を除く。)、第二十五条から第六十一条まで(第五十一条、第五十二条第一項第二号及び第二項並びに第五十三条を除く。)並びに第六十三条から第六十五条までの規定は、乳幼児が接触することによりその健康を損なうおそれがあるものとして厚生労働大臣及び内閣総理大臣の指定するおもちやについて、これを準用する。この場合において、第十二条中「添加物(天然香料及び一般に食品として飲食に供されている物であつて添加物として使用されるものを除く。)」とあるのは、「おもちやの添加物として用いることを目的とする化学的合成品(化学的手段により元素又は化合物に分解反応以外の化学的反応を起こさせて得られた物質をいう。)」と読み替えるものとする。
The provisions of Article 6, and Article 13, paragraphs (1) and (2) apply mutatis mutandis to detergents used for washing vegetables, fruits, or tableware.
The provisions of Articles 15 through 18, Article 25, paragraph (1), Articles 28 through 30, Article 51, Article 54, Article 57, and Articles 59 through 61 apply mutatis mutandis to cases other than business in which food is continuously provided to a large number of persons or unspecified persons at schools, hospitals, or other facilities.
第十五条から第十八条まで、第二十五条第一項、第二十八条から第三十条まで、第五十一条、第五十四条、第五十七条及び第五十九条から第六十一条までの規定は、営業以外の場合で学校、病院その他の施設において継続的に不特定又は多数の者に食品を供与する場合に、これを準用する。
Article 69
In order to prevent the occurrence of food sanitation hazards, the Minister of Health, Labour and Welfare, the Prime Minister, and a prefectural governor are to endeavor to publicize the name, etc. of the person who has violated this Act or a disposition based on this Act and disclose the circumstances of the food sanitation hazard.
厚生労働大臣、内閣総理大臣及び都道府県知事は、食品衛生上の危害の発生を防止するため、この法律又はこの法律に基づく処分に違反した者の名称等を公表し、食品衛生上の危害の状況を明らかにするよう努めるものとする。
Article 70
When the Minister of Health, Labour and Welfare intends to conduct the following acts, the Minister is to publicize the purpose, content, and other necessary matters and broadly seek the opinions of the public; provided, however, that this does not apply if there is an urgency to prevent the occurrence of food sanitation hazards and there is no time to broadly seek the opinions of the public in advance:
厚生労働大臣は、次に掲げる行為をしようとするときは、その趣旨、内容その他の必要な事項を公表し、広く国民の意見を求めるものとする。ただし、食品衛生上の危害の発生を防止するため緊急を要する場合で、あらかじめ広く国民の意見を求めるいとまがないときは、この限りでない。
to specify cases that are unlikely to harm human health prescribed in the proviso to Article 6, item (ii) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (2));
to prohibit the sales pursuant to the provisions of Article 7, paragraphs (1) through (3), or revoke the prohibition in whole or in part pursuant to the provisions of paragraph (4) of that Article;
第七条第一項から第三項までの規定により販売を禁止し、又は同条第四項の規定により禁止の全部若しくは一部を解除すること。
to enact, amend, or repeal Order of the Ministry of Health, Labour and Welfare referred to in Article 10, paragraph (1), Article 51, paragraph (1), Article 52, paragraph (1), or Article 54;
to establish or amend the imported food monitoring and guidance plan prescribed in Article 23, paragraph (1); and
第二十三条第一項に規定する輸入食品監視指導計画を定め、又は変更すること。
to establish the criteria prescribed in Article 50, paragraph (1).
第五十条第一項に規定する基準を定めること。
When the Prime Minister intends to conduct the following acts, the Prime Minister is to publicize the purpose, content, and other necessary matters and broadly seek the opinions of the public; provided, however, that this does not apply if there is an urgency to prevent the occurrence of food sanitation hazards and there is no time to broadly seek the opinions of the public in advance:
内閣総理大臣は、次に掲げる行為をしようとするときは、その趣旨、内容その他の必要な事項を公表し、広く国民の意見を求めるものとする。ただし、食品衛生上の危害の発生を防止するため緊急を要する場合で、あらかじめ広く国民の意見を求めるいとまがないときは、この限りでない。
to specify cases that are unlikely to harm human health prescribed in Article 12;
第十二条に規定する人の健康を損なうおそれのない場合を定めること。
to establish the criteria or standards prescribed in Article 13, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (2));
to specify substances that are clearly unlikely to harm human health, or the quantity that is unlikely to harm human health, prescribed in Article 13, paragraph (3);
第十三条第三項に規定する人の健康を損なうおそれのないことが明らかである物質又は人の健康を損なうおそれのない量を定めること。
to establish the criteria or standards prescribed in Article 18, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3));
to specify the quantity that is unlikely to harm human health prescribed in the proviso to Article 18, paragraph (3); and
第十八条第三項ただし書に規定する人の健康を損なうおそれのない量を定めること。
to establish the criteria for labeling prescribed in Article 19, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)).
When a prefectural governor, etc. intends to establish or change the prefectural plans for the monitoring and guidance of food sanitation prescribed in Article 24, paragraph (1), the prefectural governor, etc. must publicize the purpose, content, and other necessary matters, and broadly seek the opinions of the residents.
都道府県知事等は、第二十四条第一項に規定する都道府県等食品衛生監視指導計画を定め、又は変更しようとするときは、その趣旨、内容その他の必要な事項を公表し、広く住民の意見を求めなければならない。
In the case referred to in the proviso to paragraph (1) or the proviso to paragraph (2), the Minister of Health, Labour and Welfare or the Prime Minister is to broadly seek the opinions of the public without delay, after the fact.
The provisions of paragraph (1) and the preceding paragraph apply mutatis mutandis when the Minister of Health, Labour and Welfare and the Prime Minister intend to designate a designated ingredient, etc. pursuant to the provisions of Article 8, paragraph (1) and to establish or change the guidelines.
Article 71
In order to reflect the people's or the residents' opinions in the policy measures concerning food sanitation and promote the exchange of information and opinions between relevant persons, the Minister of Health, Labour and Welfare, the Prime Minister, and the prefectural governor, etc. must publicize the implementation status of the policy measures, and broadly seek the opinions of the people or the residents concerning the policy measures.
Article 72
When the Minister of Health, Labour and Welfare intends to conduct the acts stated in the items of Article 70, paragraph (1), the Minister must consult with the Prime Minister in advance.
厚生労働大臣は、第七十条第一項各号に掲げる行為をしようとするときは、あらかじめ、内閣総理大臣に協議しなければならない。
When the Prime Minister intends to conduct the acts stated in the items of Article 70, paragraph (2), the Prime Minister must consult with the Minister of Health, Labour and Welfare in advance.
内閣総理大臣は、第七十条第二項各号に掲げる行為をしようとするときは、あらかじめ、厚生労働大臣に協議しなければならない。
When the Minister of Health, Labour and Welfare finds it necessary, the Minister may request the Prime Minister to conduct the acts stated in the items of Article 70, paragraph (2).
厚生労働大臣は、必要があると認めるときは、内閣総理大臣に対し、第七十条第二項各号に掲げる行為をすることを求めることができる。
When the Prime Minister finds it necessary, the Prime Minister may request the Minister of Health, Labour and Welfare to conduct the acts stated in the items of Article 70, paragraph (1).
内閣総理大臣は、必要があると認めるときは、厚生労働大臣に対し、第七十条第一項各号に掲げる行為をすることを求めることができる。
Article 73
The Minister of Health, Labour and Welfare and the Prime Minister are to endeavor to ensure close cooperation with each other through the exchange of necessary information, such as reports under the provisions of Article 8, paragraph (2) and Article 63, paragraph (5), in order to prevent the occurrence of sanitation hazards resulting from eating and drinking.
この部分の英訳はまだありません。
削除
Article 76
The term "prefectural governor" in Article 48, paragraph (8), Article 55, Article 56, paragraph (2) (including as applied mutatis mutandis pursuant to Article 57, paragraph (2) following the deemed replacement of terms), Article 57, paragraph (1), Article 58, Article 59, Article 60, paragraph (1), Article 61, and Article 69 is deemed to be replaced with "mayor" for cities with public health centers and "ward mayor" for special wards; provided, however, that this does not apply to dispositions on business specified by Cabinet Order which are specified by Cabinet Order.
Article 77
Beyond what is provided for in the main clause of the preceding Article, affairs specified by Cabinet Order as those to be handled by prefectures in this Act are to be handled by designated cities or core cities (referred to below as "designated cities, etc.") in designated cities referred to in Article 252-19, paragraph (1) of the Local Autonomy Act (Act No. 67 of 1947) (referred to below as "designated cities") and core cities referred to in Article 252-22, paragraph (1) of the same Act (referred to below as "core cities"), pursuant to the provisions of Cabinet Order. In such a case, the provisions of this Act concerning prefectures apply to designated cities, etc. as the provisions concerning designated cities, etc.
前条本文に規定するもののほか、この法律中都道府県が処理することとされている事務で政令で定めるものは、地方自治法(昭和二十二年法律第六十七号)第二百五十二条の十九第一項の指定都市(以下「指定都市」という。)及び同法第二百五十二条の二十二第一項の中核市(以下「中核市」という。)においては、政令の定めるところにより、指定都市又は中核市(以下「指定都市等」という。)が処理するものとする。この場合においては、この法律中都道府県に関する規定は、指定都市等に関する規定として指定都市等に適用があるものとする。
Article 78
A person who is dissatisfied with the ruling on request for examination of a disposition (limited to a disposition related to type 1 statutory entrusted functions defined in Article 2, paragraph (9), item (i) of the Local Autonomy Act (referred to as "type 1 statutory entrusted functions" in the following paragraph and the following Article)) made by the head of a local government (excluding prefectures; the same applies in the following paragraph) pursuant to the provisions of this Act, may make a request for re-examination to the Minister of Health, Labour and Welfare (for a disposition under the provisions of Article 59, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), the Prime Minister; the same applies in the following paragraph).
When the head of a local government delegates the authority to make dispositions related to type 1 statutory entrusted functions among the affairs to be handled by them pursuant to the provisions of this Act to an official positioned as their subsidiary body or to the head of an administrative organ under their control, and a ruling on a request for re-examination which is referred to in Article 255-2, paragraph (2) of the Local Autonomy Act against a disposition taken by the official or head of the administrative organ based on the authority delegated has been made, a person who is dissatisfied with the ruling may make a request for further re-examination to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 252-17-4, paragraphs (5) through (7) of that Act.
地方公共団体の長がこの法律の規定によりその処理することとされた事務のうち第一号法定受託事務に係る処分をする権限をその補助機関である職員又はその管理に属する行政機関の長に委任した場合において、委任を受けた職員又は行政機関の長がその委任に基づいてした処分につき、地方自治法第二百五十五条の二第二項の再審査請求の裁決があつたときは、当該裁決に不服がある者は、同法第二百五十二条の十七の四第五項から第七項までの規定の例により、厚生労働大臣に対して再々審査請求をすることができる。
Article 79
The affairs that are to be handled by prefectures pursuant to the provisions of Article 25, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), Article 26, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)), Article 28, paragraph (1) (including as applied mutatis mutandis under Article 68, paragraphs (1) and (3)), Article 30, paragraph (2) (excluding the part related to monitoring and guidance incidental to the approval of conducting business (limited to business specified by Cabinet Order by taking into consideration the status of distribution of food or additives) prescribed in Article 54, and including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), Article 59 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), Article 63 (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)), and Article 64, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)) are deemed to be type 1 statutory entrusted functions.
第二十五条第一項(第六十八条第一項及び第三項において準用する場合を含む。)、第二十六条第一項(第六十八条第一項において準用する場合を含む。)、第二十八条第一項(第六十八条第一項及び第三項において準用する場合を含む。)、第三十条第二項(第五十四条に規定する営業(食品又は添加物の流通の状況を考慮して政令で定めるものに限る。)の許可に付随する監視指導に係る部分を除くものとし、第六十八条第一項及び第三項において準用する場合を含む。)、第五十九条(第六十八条第一項及び第三項において準用する場合を含む。)、第六十三条(第六十八条第一項において準用する場合を含む。)及び第六十四条第一項(第六十八条第一項において準用する場合を含む。)の規定により都道府県が処理することとされている事務は、第一号法定受託事務とする。
The affairs that are to be handled by cities with public health centers or special wards pursuant to the provisions of Article 28, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), Article 30, paragraph (2) (excluding the part related to monitoring and guidance incidental to the approval of conducting business (limited to business specified by Cabinet Order by taking into consideration the status of distribution of food or additives) prescribed in Article 54, and including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), Article 59 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), Article 63 (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)), and Article 64, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)) are to be type 1 statutory entrusted functions.
Article 80
The authority of the Minister of Health, Labour and Welfare prescribed in this Act may be delegated to the Director-General of a Regional Bureau of Health and Welfare pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
この法律に規定する厚生労働大臣の権限は、厚生労働省令で定めるところにより、地方厚生局長に委任することができる。
The authority delegated to the Director-General of a Regional Bureau of Health and Welfare pursuant to the provisions of the preceding paragraph may be delegated to the head of a Regional Branch Bureau of Health and Welfare pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.
前項の規定により地方厚生局長に委任された権限は、厚生労働省令で定めるところにより、地方厚生支局長に委任することができる。
The Prime Minister is to delegate the authority under this Act (excluding the authority specified by Cabinet Order) to the Commissioner of the Consumer Affairs Agency.
内閣総理大臣は、この法律による権限(政令で定めるものを除く。)を消費者庁長官に委任する。
第十一章 罰則
Chapter XI Penal Provisions
Article 81
A person falling under any of the following items is punished by imprisonment for a period not exceeding three years or a fine not exceeding three million yen:
次の各号のいずれかに該当する者は、三年以下の拘禁刑又は三百万円以下の罰金に処する。
a person who violates the provisions of Article 6 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (2)), Article 10, paragraph (1), or Article 12 (including as applied mutatis mutandis pursuant to Article 68, paragraph (1));
a person who violates the prohibition under the provisions of Article 7, paragraphs (1) through (3);
第七条第一項から第三項までの規定による禁止に違反した者
a business operator that disobeys an order issued by the Minister of Health, Labour and Welfare or a prefectural governor (when the terms are deemed to be replaced pursuant to the provisions of Article 76, a mayor or a ward mayor; the same applies below in this item) under the provisions of Article 59, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)) or an order issued by the Prime Minister or a prefectural governor under the provisions of Article 59, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)) (including persons who furnish food prescribed in Article 68, paragraph (3)), or a person who conducts business in violation of a disposition under the provisions of Article 60 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)).
A person who has committed a crime referred to in the preceding paragraph may be punished by both imprisonment and a fine depending on the circumstances.
前項の罪を犯した者には、情状により拘禁刑及び罰金を併科することができる。
Article 82
A person who violates the provisions of Article 13, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (2)) or paragraph (3), Article 16 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), Article 19, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)), Article 20 (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)), or Article 55, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)) is punished by imprisonment for a period not exceeding two years or a fine not exceeding two million yen.
A person who has committed a crime referred to in the preceding paragraph may be punished by both imprisonment and a fine depending on the circumstances.
前項の罪を犯した者には、情状により拘禁刑及び罰金を併科することができる。
Article 83
A person falling under any of the following items is punished by imprisonment for a period not exceeding one year or a fine not exceeding one million yen:
次の各号のいずれかに該当する者は、一年以下の拘禁刑又は百万円以下の罰金に処する。
a person who violates the provisions of Article 10, paragraph (2), Article 11, Article 18, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)) or paragraph (3), Article 25, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)), Article 26, paragraph (4) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)), or Article 63, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1));
a person who violates the prohibition under the provisions of Article 9, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)) or Article 17, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3));
a person who divulges any secret they have learned in the course of duty in violation of the provisions of Article 40, paragraph (1);
第四十条第一項の規定に違反して、その職務に関して知り得た秘密を漏らした者
a person who violates the criteria under the provisions of Article 54 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)) or violates the conditions under the provisions of Article 55, paragraph (3) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)); or
a business operator that disobeys an order issued by a prefectural governor (when the terms are deemed to be replaced pursuant to the provisions of Article 76, a mayor or a ward mayor) under the provisions of Article 61 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)) (including persons who furnish food prescribed in that paragraph), or a person who conducts business in violation of a disposition under the provisions of Article 61 (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)).
Article 84
If an order of suspension of business under the provisions of Article 43 is violated, an officer or employee of the registered conformity assessment body who has committed the violation is punished by imprisonment for a period not exceeding one year, or a fine not exceeding one million yen.
Article 85
A person falling under any of the following items is punished by a fine not exceeding 500 thousand yen:
次の各号のいずれかに該当する者は、これを五十万円以下の罰金に処する。
a person who has refused, obstructed or evaded an on-site inspection or collection and removal by an official under the provisions of Article 28, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3));
a person who has not made a report under the provisions of Article 28, paragraph (1) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3)) or has made a false report;
a person who has not made a notification under the provisions of Article 27, Article 48, paragraph (8) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1) for both cases), Article 57, paragraph (1), or Article 58, paragraph (1), or has made a false notification; or
a person who violates an order under the provisions of Article 46, paragraph (2).
第四十六条第二項の規定による命令に違反した者
Article 86
When a violation stated in any of the following items has been committed, the officer or the employee of a registered conformity assessment body who has committed the violation is punished by a fine not exceeding 500 thousand yen:
次の各号のいずれかに掲げる違反があつた場合には、その違反行為をした登録検査機関の役員又は職員は、五十万円以下の罰金に処する。
when they have abolished all the operations for product inspections without obtaining the approval referred to in Article 38;
when they have failed to state the matters prescribed in Article 44, have made a false statement, or have failed to preserve books, in violation of that Article;
when they have failed to make a report under the provisions of Article 47, paragraph (1) or have made a false report;
第四十七条第一項の規定による報告をせず、又は虚偽の報告をしたとき。
when they have refused, obstructed, or evaded inspections under the provisions of Article 47, paragraph (1), have not given answers to questions under the provisions of that paragraph, or have given false answers.
Article 87
When a food sanitation supervisor has neglected their duties under the provisions of Article 48, paragraph (3), and there have been acts falling under violations referred to in Articles 81 through 83 concerning food or additives related to their supervision at the facility, the food sanitation supervisor is punished by a fine prescribed in the respective Articles depending on the manner of the acts; provided, however, that this does not apply when the food sanitation supervisor is the person who has committed the acts.
食品衛生管理者が第四十八条第三項に規定する職務を怠つたときは、当該施設においてその管理に係る食品又は添加物に関し第八十一条から第八十三条までの違反に該当する行為があつた場合において、その行為の態様に応じ各本条の罰金刑を科する。ただし、その食品衛生管理者がその行為を行つた者であるときは、この限りでない。
Article 88
When a representative of a corporation, an agent, an employee or any other worker of a corporation or a person has committed an act in violation of the provisions stated in the following items in relation to the business of the corporation or the person, in addition to the offender being punished, the corporation is punished by a fine prescribed in each of those items, and the person is punished by a fine referred to in the respective Articles; provided, however, that this does not apply when the person is to be punished by a fine as a food sanitation supervisor pursuant to the provisions of the preceding Article:
法人の代表者又は法人若しくは人の代理人、使用人その他の従業者が、その法人又は人の業務に関し、次の各号に掲げる規定の違反行為をしたときは、行為者を罰するほか、その法人に対して当該各号に定める罰金刑を、その人に対して各本条の罰金刑を科する。ただし、その人が食品衛生管理者として、前条の規定により罰金刑を科せられるべきときは、その人については、この限りでない。
the provisions of Article 81 or Article 82 (limited to the part related to the provisions of Article 13, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (2)) or paragraph (3), Article 19, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)), and Article 20 (including as applied mutatis mutandis pursuant to Article 68, paragraph (1))):a fine not exceeding 100 million yen; and
the provisions of Article 82 (excluding the part related to the provisions of Article 13, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (2)) or paragraph (3), Article 19, paragraph (2) (including as applied mutatis mutandis pursuant to Article 68, paragraph (1)), and Article 20 (including as applied mutatis mutandis pursuant to Article 68, paragraph (1))), Article 83, or Article 85:a fine referred to in the respective Articles.
Article 89
A person who has not kept financial statements in violation of the provisions of Article 39, paragraph (1), has not entered the matters that should be entered in financial statements, has made a false statement in them, or has refused a request under the provisions of each item of paragraph (2) of that Article without legitimate grounds, is punished by a civil fine not exceeding 200 thousand yen.
略称規定第二条第一項
国、都道府県、地域保健法(昭和二十二年法律第百一号)第五条第一項の規定に基づく政令で定める市(以下「保健所を設置する市」という。)及び特別区は、教育活動及び広報活動を通じた食品衛生に関する正しい知識の普及、食品衛生に関する情報の収集、整理…
わかりやすく言うと
地域保健法第五条第一項に基づく政令で定められた、保健所を設置する市のことです。同項では、地方自治法の指定都市、中核市その他の政令で定める市が保健所を設置するとされています。
略称規定第二条第三項
…添加物、器具及び容器包装についての食品衛生に関する検査の実施を図るための体制を整備し、国際的な連携を確保するために必要な措置を講ずるとともに、都道府県、保健所を設置する市及び特別区(以下「都道府県等」という。)に対し前二項の責務が十分に…
わかりやすく言うと
都道府県、保健所を設置する市(地域保健法に基づく政令で定める市)及び特別区のことです。
略称規定第三条第一項
…その採取し、製造し、輸入し、加工し、調理し、貯蔵し、運搬し、販売し、不特定若しくは多数の者に授与し、又は営業上使用する食品、添加物、器具又は容器包装(以下「販売食品等」という。)について、自らの責任においてそれらの安全性を確保するため…
わかりやすく言うと
食品等事業者が採取、製造、輸入、加工、調理、貯蔵、運搬、販売し、不特定又は多数の人に授与し、又は営業で使う食品、添加物、器具又は容器包装のことです。
定義第三条第一項
食品若しくは添加物を採取し、製造し、輸入し、加工し、調理し、貯蔵し、運搬し、若しくは販売すること若しくは器具若しくは容器包装を製造し、輸入し、若しくは販売することを営む人若しくは法人又は学校、病院その他の施設において継続的に不特定若しくは多数の者に食品を供与する人若しくは法人
わかりやすく言うと
食品や添加物の採取、製造、輸入、加工、調理、貯蔵、運搬若しくは販売、又は器具や容器包装の製造、輸入若しくは販売を営む人や法人のことです。学校、病院その他の施設で、継続的に不特定又は多数の人に食品を提供する人や法人も含みます。
定義第四条第四項・法令全体に適用
飲食器、割ぽう具その他食品又は添加物の採取、製造、加工、調理、貯蔵、運搬、陳列、授受又は摂取の用に供され、かつ、食品又は添加物に直接接触する機械、器具その他の物
定義第四条第七項・法令全体に適用
業として、食品若しくは添加物を採取し、製造し、輸入し、加工し、調理し、貯蔵し、運搬し、若しくは販売すること又は器具若しくは容器包装を製造し、輸入し、若しくは販売すること
定義第四条第九項・法令全体に適用
第三十三条第一項の規定により厚生労働大臣の登録を受けた法人
わかりやすく言うと
設備、検査を行う人、検査の信頼性を確保する措置などの要件を満たし、厚生労働大臣の登録を受けた法人のことです(第三十三条第一項)。製品検査や、委託を受けた食品などの試験を行います。
略称規定第八条第一項・この規定及び第八条第三項及び第七十条第五項の中だけ
食品衛生上の危害の発生を防止する見地から特別の注意を必要とする成分又は物であつて、厚生労働大臣及び内閣総理大臣が食品衛生基準審議会の意見を聴いて指定したもの(第三項及び第七十条第五項において「指定成分等」という。)を含む食品(以下この項に…
わかりやすく言うと
食品衛生上の危害の発生を防ぐ観点から特別の注意が必要な成分や物で、厚生労働大臣と内閣総理大臣が食品衛生基準審議会の意見を聴いて指定したもののことです。
略称規定第八条第一項・この項の中だけ
…厚生労働大臣及び内閣総理大臣が食品衛生基準審議会の意見を聴いて指定したもの(第三項及び第七十条第五項において「指定成分等」という。)を含む食品(以下この項において「指定成分等含有食品」という。)を取り扱う営業者は…
わかりやすく言うと
食品衛生上の危害の発生を防ぐ観点から特別の注意が必要な成分や物として、厚生労働大臣と内閣総理大臣が食品衛生基準審議会の意見を聴いて指定したもの(指定成分等)を含む食品のことです。
略称規定第八条第一項
…その取り扱う指定成分等含有食品が人の健康に被害を生じ、又は生じさせるおそれがある旨の情報を得た場合は、当該情報を、厚生労働省令で定めるところにより、遅滞なく、都道府県知事、保健所を設置する市の市長又は特別区の区長(以下「都道府県知事等」…
わかりやすく言うと
都道府県知事、保健所を設置する市の市長、又は特別区の区長のことです。
定義第十条第一項
と畜場法(昭和二十八年法律第百十四号)第三条第一項に規定する獣畜及び厚生労働省令で定めるその他の物
わかりやすく言うと
と畜場法で定める牛、馬、豚、めん羊及び山羊と、厚生労働省令で定めるその他の物のことです。
略称規定第十条第二項・この項の中だけ
獣畜の肉、乳及び臓器並びに家きんの肉及び臓器並びに厚生労働省令で定めるこれらの製品(以下この項において「獣畜の肉等」という。)は、輸出国の政府機関によつて発行され、かつ、前項各号に掲げる疾病にかかり、若しくはその疑いがあり…
わかりやすく言うと
獣畜(牛、馬、豚、めん羊、山羊など)の肉、乳及び臓器と、家きん(鶏、あひる、七面鳥などの食鳥など)の肉及び臓器、そして厚生労働省令で定めるこれらの製品のことです。
略称規定第十条第二項・この項の中だけ
…前項各号に掲げる疾病にかかり、若しくはその疑いがあり、同項各号に掲げる異常があり、又はへい死した獣畜の肉、乳若しくは臓器若しくは家きんの肉若しくは臓器又はこれらの製品でない旨その他厚生労働省令で定める事項(以下この項において「衛生事項」…
わかりやすく言うと
輸入される獣畜の肉等が、一定の疾病(第十条第一項各号)にかかり若しくはその疑いがあり、一定の異常があり、又はへい死した獣畜や家きんの肉、乳、臓器やそれらの製品ではないこと、その他厚生労働省令で定める事項のことです。
定義第十三条第三項・この規定及び第十四条の中だけ
農薬取締法(昭和二十三年法律第八十二号)第二条第一項に規定する農薬
わかりやすく言うと
農薬取締法に規定する農薬のことで、農作物などを害する病害虫の防除に使う殺菌剤、殺虫剤、除草剤などの薬剤(政令で定める資材を含みます)と、農作物などの生理機能を増進又は抑制する成長促進剤、発芽抑制剤などの薬剤(肥料を除きます)をいいます。
略称規定第十四条第一項・この条の中だけ
…同法第二条第九項に規定する再生医療等製品であつて専ら動物のために使用されることが目的とされているもの(以下この条において「動物用再生医療等製品」という。)が使用された対象動物(同法第八十三条第一項の規定により読み替えられた同法第十四条第…
わかりやすく言うと
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律に規定する再生医療等製品(治療などのため細胞に培養などの加工をしたものや、細胞に導入する遺伝子を含むもので、政令で定めるもの)のうち、専ら動物のために使うことを目的とするもののことです。
略称規定第十四条第一項・この条の中だけ
…医療機器等の品質、有効性及び安全性の確保等に関する法律第二条第一項に規定する医薬品であつて専ら動物のために使用されることが目的とされているもの(以下この条において「農薬等」という。)の成分である物質(その物質が化学的に変化して生成した物…
わかりやすく言うと
農薬、飼料添加物(飼料の品質の低下の防止などのため飼料に加える物で農林水産大臣が指定するもの)、又は医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律に規定する医薬品で専ら動物のために使うことを目的とするもののことです。
略称規定第二十一条の二第一項
…及び広域にわたり流通する食品、添加物、器具又は容器包装に関してこの法律又はこの法律に基づく命令若しくは処分に係る違反を防止するため、その行う食品衛生に関する監視又は指導(以下「監視指導」という。)が総合的かつ迅速に実施されるよう…
わかりやすく言うと
国と、都道府県、保健所を設置する市及び特別区(都道府県等)が行う、食品衛生に関する監視や指導のことです。
略称規定第二十一条の二第一項
国及び都道府県等は、食品、添加物、器具又は容器包装に起因する中毒患者又はその疑いのある者(以下「食中毒患者等」という。)の広域にわたる発生又はその拡大を防止し、及び広域にわたり流通する食品、添加物…
わかりやすく言うと
食品、添加物、器具又は容器包装が原因の中毒にかかった人と、その疑いのある人のことです。
略称規定第二十一条の三第一項・この条及び第六十六条の中だけ
厚生労働大臣は、監視指導の実施に当たつての連携協力体制の整備を図るため、厚生労働省令で定めるところにより、国、都道府県等その他関係機関により構成される広域連携協議会(以下この条及び第六十六条において「協議会」という。)を設けることができる。
わかりやすく言うと
国や都道府県等が行う食品衛生に関する監視や指導で連携・協力する体制を整えるため、厚生労働大臣が厚生労働省令に従って設けることができる広域連携協議会のことです。国、都道府県、保健所を設置する市、特別区その他の関係機関で構成されます。
略称規定第二十二条第一項
厚生労働大臣及び内閣総理大臣は、国及び都道府県等が行う監視指導の実施に関する指針(以下「指針」という。)を定めるものとする。
略称規定第二十三条第一項
厚生労働大臣は、指針に基づき、毎年度、翌年度の食品、添加物、器具及び容器包装の輸入について国が行う監視指導の実施に関する計画(以下「輸入食品監視指導計画」という。)を定めるものとする。
略称規定第二十四条第一項
都道府県知事等は、指針に基づき、毎年度、翌年度の当該都道府県等が行う監視指導の実施に関する計画(以下「都道府県等食品衛生監視指導計画」という。)を定めなければならない。
略称規定第二十九条第一項
国及び都道府県は、第二十五条第一項又は第二十六条第一項から第三項までの検査(以下「製品検査」という。)及び前条第一項の規定により収去した食品、添加物、器具又は容器包装の試験に関する事務を行わせるために、必要な検査施設を設けなければならない。
わかりやすく言うと
規格が定められたもののうち政令で定める食品、添加物、器具又は容器包装が販売などの前に受けなければならない検査(第二十五条第一項)と、食品衛生上の危害を防ぐため都道府県知事又は厚生労働大臣が受けるよう命じた検査(第二十六条第一項から第三項まで)のことです。
略称規定第三十三条第一項・この項の中だけ
厚生労働大臣は、第三十一条の規定により登録を申請した者(以下この項において「登録申請者」という。)が次に掲げる要件のすべてに適合しているときは、その登録をしなければならない。この場合において、登録に関して必要な手続は、厚生労働省令で定める。
わかりやすく言うと
登録検査機関になるため、厚生労働省令の定めに従い手数料を納めて、厚生労働大臣に登録を申請した者のことです(第三十一条)。
略称規定第三十三条第一項第三号・この号及び第三十九条第二項の中だけ
…添加物、器具又は容器包装を販売し、販売の用に供するために製造し、輸入し、加工し、若しくは陳列し、又は営業上使用する営業者(以下この号及び第三十九条第二項において「受検営業者」という。)に支配されているものとして次のいずれかに該当するもの…
わかりやすく言うと
製品検査(規格が定められたもののうち政令で定める食品などに義務付けられた検査や、都道府県知事又は厚生労働大臣が受けるよう命じた検査)を受けなければならない食品、添加物、器具又は容器包装を、販売し、販売のために製造、輸入、加工、陳列し、又は営業で使う営業者のことです。
略称規定第三十七条第一項
登録検査機関は、製品検査の業務に関する規程(以下「業務規程」という。)を定め、製品検査の業務の開始前に、厚生労働大臣の認可を受けなければならない。これを変更しようとするときも、同様とする。
略称規定第三十九条第一項・この規定及び第三十九条第二項及び第八十九条の中だけ
登録検査機関は、毎事業年度経過後三月以内に、その事業年度の財産目録、貸借対照表及び損益計算書又は収支計算書並びに事業報告書(その作成に代えて電磁的記録(電子的方式、磁気的方式その他の人の知覚によつては認識することができない方式で作られる記…
わかりやすく言うと
登録検査機関が毎事業年度の終了後三か月以内に作成し、五年間事業所に備えて置く、財産目録、貸借対照表、損益計算書又は収支計算書、事業報告書のことです。書面に代えて作られた電磁的記録も含みます。
定義第三十九条第一項・この条の中だけ
電子的方式、磁気的方式その他の人の知覚によつては認識することができない方式で作られる記録であつて、電子計算機による情報処理の用に供されるもの
略称規定第四十条第一項・この規定及び第四十条第二項の中だけ
登録検査機関の役員若しくは職員又はこれらの職にあつた者は、その製品検査の業務又は第二十八条第四項の規定により委託を受けた事務(次項において「委託事務」という。)に関して知り得た秘密を漏らしてはならない。
わかりやすく言うと
登録検査機関が厚生労働大臣、内閣総理大臣、都道府県知事、保健所を設置する市の市長又は特別区の区長から委託を受けた、職員が試験のため無償で持ち帰った(収去した)食品、添加物、器具又は容器包装の試験に関する事務のことです(第二十八条第四項)。
略称規定第五十一条第一項・この条の中だけ
厚生労働大臣は、営業(器具又は容器包装を製造する営業及び食鳥処理の事業の規制及び食鳥検査に関する法律第二条第五号に規定する食鳥処理の事業(第五十四条及び第五十七条第一項において「食鳥処理の事業」という。)を除く。)の施設の衛生的な管理その…
わかりやすく言うと
営業(器具や容器包装を製造する営業と食鳥処理の事業を除きます)の施設の衛生的な管理など、公衆衛生のために必要な措置のことです。厚生労働省令で、一般的な衛生管理と、危害の発生防止に特に重要な工程を管理する取組(小規模な営業者などは扱う食品の特性に応じた取組)の基準が定められます。
略称規定第五十一条第一項・この規定及び第五十四条及び第五十七条第一項の中だけ
厚生労働大臣は、営業(器具又は容器包装を製造する営業及び食鳥処理の事業の規制及び食鳥検査に関する法律第二条第五号に規定する食鳥処理の事業(第五十四条及び第五十七条第一項において「食鳥処理の事業」という。)を除く。)の施設の衛生的な管理その…
わかりやすく言うと
食鳥処理の事業の規制及び食鳥検査に関する法律に規定する食鳥処理、つまり食鳥(鶏、あひる、七面鳥その他一般に食用にする家きんで政令で定めるもの)をとさつして羽毛を除くことや、その内臓を摘出することを行う事業のことです。
略称規定第五十二条第一項・この条の中だけ
厚生労働大臣は、器具又は容器包装を製造する営業の施設の衛生的な管理その他公衆衛生上必要な措置(以下この条において「公衆衛生上必要な措置」という。)について、厚生労働省令で、次に掲げる事項に関する基準を定めるものとする。
わかりやすく言うと
器具や容器包装を製造する営業の施設の衛生的な管理など、公衆衛生のために必要な措置のことです。厚生労働省令で、一般的な衛生管理と、食品衛生上の危害の発生を防ぐために必要な、製造を適正に管理する取組の基準が定められます。
略称規定第五十六条第一項・この条の中だけ
前条第一項の許可を受けた者(以下この条において「許可営業者」という。)が当該営業を譲渡し、又は許可営業者について相続、合併若しくは分割(当該営業を承継させるものに限る。)があつたときは…
わかりやすく言うと
公衆衛生に与える影響が著しい営業(食鳥処理の事業を除きます)として政令で定めるものを営むため、都道府県知事などの許可を受けた者のことです(第五十四条、第五十五条第一項)。
略称規定第七十七条第一項
…この法律中都道府県が処理することとされている事務で政令で定めるものは、地方自治法(昭和二十二年法律第六十七号)第二百五十二条の十九第一項の指定都市(以下「指定都市」という。)及び同法第二百五十二条の二十二第一項の中核市(以下「中核市」と…
わかりやすく言うと
地方自治法に基づき、政令で指定される人口二十万以上の市のことです(地方自治法第二百五十二条の二十二第一項)。
略称規定第七十七条第一項
前条本文に規定するもののほか、この法律中都道府県が処理することとされている事務で政令で定めるものは、地方自治法(昭和二十二年法律第六十七号)第二百五十二条の十九第一項の指定都市(以下「指定都市」という。)及び同法第二百五十二条の二十二第一…
わかりやすく言うと
地方自治法に基づき、政令で指定される人口五十万以上の市のことです(地方自治法第二百五十二条の十九第一項)。
略称規定第七十七条第一項
…政令の定めるところにより、指定都市又は中核市(以下「指定都市等」という。)が処理するものとする。この場合においては、この法律中都道府県に関する規定は、指定都市等に関する規定として指定都市等に適用があるものとする。
わかりやすく言うと
政令で指定される人口五十万以上の市(指定都市)又は人口二十万以上の市(中核市)のことです。この法律で都道府県が行う事務のうち政令で定めるものは、政令の定めに従いこれらの市が行います。
略称規定第七十八条第一項・この規定及び第七十八条第二項及び第七十九条の中だけ
この法律の規定により地方公共団体(都道府県を除く。次項において同じ。)の長が行う処分(地方自治法第二条第九項第一号に規定する第一号法定受託事務(次項及び次条において「第一号法定受託事務」という。)に係るものに限る。)についての審査請求の裁…
わかりやすく言うと
法律やそれに基づく政令で都道府県、市町村又は特別区が処理するとされる事務のうち、本来は国が果たすべき役割に関わり、国が適正な処理を特に確保する必要があるとして法律や政令で特に定めたもののことです(地方自治法第二条第九項第一号)。
消費者委員会
内閣府に置かれる委員会です(消費者庁及び消費者委員会設置法第六条第一項)。内閣総理大臣が任命する十人以内の委員で組織し、委員は独立してその職権を行います(消費者庁及び消費者委員会設置法第七条・第九条第一項・第十条第一項)。消費者の利益の擁護と増進、景品類等の適正化、物価などに関する重要事項について、自ら調査審議して内閣総理大臣、関係各大臣または消費者庁長官に建議し、また、その諮問に応じて調査審議します。消費者庁及び消費者委員会設置法第六条第二項第四号に掲げる法律によってその権限とされた事項も処理します(消費者庁及び消費者委員会設置法第六条第二項第一号・第二号・第四号)。不当景品類及び不当表示防止法では、内閣総理大臣は、景品類や表示の指定、景品類の制限や禁止をしようとするときは、消費者委員会の意見を聴かなければなりません(不当景品類及び不当表示防止法第三条・第六条)。特定商取引に関する法律では、主務大臣は、一定の政令の制定や改廃の立案をしようとするときは、消費者委員会に諮問しなければなりません(特定商取引に関する法律第六十四条)。
消費者庁及び消費者委員会設置法第6条・第7条・第9条・第10条、不当景品類及び不当表示防止法第3条・第6条、特定商取引に関する法律第64条を参考にAIが作成。
罰金
金銭を国に納めさせる刑罰で、一万円以上です。減軽する場合は一万円未満に下げることができます(刑法第十五条)。拘禁刑より軽く、拘留や科料より重い刑です(同法第九条・第十条第一項)。完納できない人は、一日以上二年以下(罰金を併科した場合などは三年以下)の期間、労役場に留置され、その期間は刑の言渡しのときに定められます(同法第十八条第一項・第三項・第四項)。裁判が確定した後三十日以内は、本人の承諾がなければ留置の執行はできません(同条第五項)。刑の言渡しが確定した後、三年間執行を受けないと時効が完成し、執行の免除を得ます(同法第三十一条・第三十二条第五号)。ただし、法令により執行を猶予し又は停止した期間や、本人が国外にいる期間は時効が進行せず、執行行為をすると時効は中断します(同法第三十三条・第三十四条第二項)。
刑法第9条・第10条・第15条・第18条・第31条〜第34条を参考にAIが作成。
拘禁刑
刑事施設に拘置する刑です。無期と有期があり、有期は一月以上二十年以下です(刑法第十二条第一項・第二項)。刑を加重するときは三十年まで上げ、減軽するときは一月未満に下げることができます(同法第十四条第二項)。改善更生を図るため、必要な作業を行わせ、又は必要な指導を行うことができます(同法第十二条第三項)。主刑の中では死刑の次に重く、罰金より重い刑です(同法第九条・第十条第一項)。刑法等の一部を改正する法律(令和四年法律第六十七号)の施行により、懲役と禁錮に代わって設けられました(同法第二条)。懲役又は禁錮に処せられた人は、人の資格に関する法令の適用については、刑期を同じくする拘禁刑に処せられた人とみなされます(令和四年法律第六十八号第四百四十三条第一項)。
刑法第9条・第10条・第12条・第14条、令和4年法律第67号第2条、令和4年法律第68号第443条を参考にAIが作成。
条例
地方公共団体が自ら定めるきまりです。都道府県、市町村、東京都の特別区がそれぞれ定めます(地方自治法第一条の三・第二百八十一条・第二百八十三条)。住民が選挙した議員でつくる議会(同法第八十九条)の議決で制定され(同法第九十六条第一項第一号)、知事や市町村長などその団体の長(同法第百三十九条)が公布します(同法第十六条)。憲法は、地方公共団体が法律の範囲内で条例を制定できるとしており(日本国憲法第九十四条)、法律・政令・省令などの法令に違反することはできません(地方自治法第十四条第一項)。法令に特別の定めがある場合を除き、地方公共団体が人に義務を課したり権利を制限したりするには、条例によらなければなりません(同条第二項)。条例に違反した人に対する罰則も、同法が定める範囲で設けることができます(同条第三項)。条例はその地方公共団体の事務について定めるもの(同法第二条第二項・第十四条第一項)なので、同じ事柄でも地域によって扱いが違うことがあります。国の法令である省令(「施行規則」など)とは別のものです。
日本国憲法第94条、地方自治法第1条の3・第2条・第14条・第16条・第89条・第96条・第139条・第281条・第283条を参考にAIが作成。
内閣総理大臣
内閣の首長です。国会議員の中から国会の議決で指名され、天皇が任命します(第六十七条第一項・第六条第一項)。国務大臣を任意に任命し罷免することができ、その過半数は国会議員でなければなりません(第六十八条)。国務大臣は、その在任中、内閣総理大臣の同意がなければ訴追されません(第七十五条)。
日本国憲法第6条・第67条・第68条・第75条、Wikipedia「内閣総理大臣」を参考にAIが作成。
再審査請求
処分についての審査請求の裁決に不服がある者が、さらに不服を申し立てることです。法律にその処分について再審査請求をすることができる旨の定めがある場合にだけすることができます(行政不服審査法第六条第一項)。再審査請求は、審査請求の裁決(原裁決)又はその処分を対象として、その法律が定める行政庁に対してします(同条第二項)。たとえば厚生年金保険法は、被保険者の資格、標準報酬又は保険給付に関する処分について社会保険審査官がした決定に不服がある者は、社会保険審査会に対して再審査請求をすることができるとし、行政不服審査法の再審査請求についての規定を適用しないとしています(厚生年金保険法第九十条第一項・第九十一条の二)。ほかの法律がこのように別の定めを置くこともあります(行政不服審査法第一条第二項)。行政不服審査法では、再審査請求は、原裁決があったことを知った日の翌日から一か月を過ぎるとすることができず、原裁決があった日の翌日から一年を過ぎてもすることができません。ただし、正当な理由があるときは別です(同法第六十二条)。再審査請求を受けた行政庁は、裁決で判断します。期間を過ぎたものなど不適法な再審査請求は却下し、理由のないものや、原裁決が審査請求を却下又は棄却したことは違法又は不当でも処分自体は違法でも不当でもないものは棄却し、理由のあるものは原裁決又は処分の全部又は一部を取り消します。ただし、取り消し、又は撤廃すると公の利益に著しい障害が生じるときは、原裁決又は処分が違法又は不当であることを宣言した上で棄却することができます(同法第六十四条第一項から第四項まで・第六十五条第一項)。事実上の行為についての再審査請求に理由があるときは、裁決でその行為が違法又は不当であることを宣言し、処分庁に対してその全部又は一部を撤廃するよう命じます(同条第二項)。再審査請求をすることができる裁決をする行政庁は、裁決書に、再審査請求をすることができる旨と、再審査請求をすべき行政庁、再審査請求ができる期間を記載して教示しなければなりません(同法第五十条第三項)。
行政不服審査法第1条・第6条・第50条・第62条・第64条・第65条、厚生年金保険法第90条・第91条の2を参考にAIが作成。
審査請求
行政庁の処分に不服がある者や、法令に基づいて処分の申請をしたのに相当の期間が経過しても行政庁が何の処分もしない(不作為)ときにその申請をした者が、行政庁に対して不服を申し立て、見直しを求めることです(行政不服審査法第二条・第三条)。法律(条例に基づく処分については、条例)に特別の定めがある場合を除き、処分をした行政庁(処分庁)や不作為に係る行政庁に上級行政庁がないとき、又はその行政庁が主任の大臣や一定の庁の長などであるときはその行政庁に、主任の大臣や一定の庁の長などが上級行政庁であるときはその大臣や長に、それ以外のときは最上級行政庁に対してします(同法第四条)。ほかの法律が、審査請求をする先の機関や手続について別の定めを置くこともあります(同法第一条第二項・第四条)。たとえば厚生年金保険法は、厚生労働大臣による被保険者の資格、標準報酬又は保険給付に関する処分(厚生年金保険原簿の訂正の請求についての決定を除きます)についての審査請求を社会保険審査官に対してするものとし、行政不服審査法の規定の多くを適用しないとしています(厚生年金保険法第九十条第一項・第九十一条の二)。行政不服審査法では、処分についての審査請求は、処分があったことを知った日の翌日から三か月(先に再調査の請求をしたときは、その決定があったことを知った日の翌日から一か月)を過ぎるとすることができず、処分(再調査の請求をしたときはその決定)があった日の翌日から一年を過ぎてもすることができません。ただし、正当な理由があるときは別です(行政不服審査法第十八条第一項・第二項)。審査請求をしても、それだけでは処分の効力や執行、手続の続行は止まりません(同法第二十五条第一項)。ただし、審査庁は、審査請求人の申立てにより(処分庁又はその上級行政庁である審査庁は職権でも)その全部又は一部を停止すること(執行停止)ができ、審査請求人の申立てがあった場合で、重大な損害を避けるために緊急の必要があるときは、公共の福祉に重大な影響を及ぼすおそれがあるときや本案に理由がないとみえるときを除き、執行停止をしなければなりません(同条第二項から第四項まで)。審査請求を受けた行政庁(審査庁)は、裁決で判断します。期間を過ぎたものなど不適法な審査請求は却下し、理由のないものは棄却し、理由のあるものは処分の全部若しくは一部を取り消し、又は変更します。ただし、審査請求人の不利益に変更することはできず、処分庁でも処分庁の上級行政庁でもない審査庁は処分を変更することができません(同法第四十五条第一項・第二項、第四十六条第一項、第四十八条)。事実上の行為についての審査請求に理由があるときは、裁決でその行為が違法又は不当であることを宣言し、その全部若しくは一部を撤廃し、若しくは変更するよう命じ、又は自ら撤廃し、若しくは変更します(同法第四十七条)。不作為についての審査請求に理由があるときは、審査庁は、裁決でその不作為が違法又は不当であることを宣言し、一定の処分をすべきと認めるときは、その処分をするよう命じ、又は自らその処分をします(同法第四十九条第三項)。処分が違法又は不当でも、取り消し、又は撤廃すると公の利益に著しい障害が生じるときは、そのことを裁決で宣言した上で審査請求を棄却することができます(同法第四十五条第三項)。裁決は、審査請求人に送達された時(処分の相手方以外の者がした審査請求について、処分を取り消し、若しくは変更し、又は事実上の行為について判断する裁決をするときは、審査請求人と処分の相手方の両方に送達された時)に効力を生じ、関係行政庁を拘束します(同法第五十一条第一項・第五十二条第一項)。
行政不服審査法第1条〜第4条・第18条・第25条・第45条〜第49条・第51条・第52条、厚生年金保険法第90条・第91条の2を参考にAIが作成。
特別区
都の区のことです(地方自治法第二百八十一条第一項)。今ある特別区は、東京都の二十三区だけです。特別区は、市町村と同じく住民に身近な地方公共団体(基礎的な地方公共団体)で、都が特別区のある区域全体でまとめて行う仕事を除き、ふつうは市町村が行う仕事を行います(同法第二百八十一条の二第二項)。市の仕事について定めた法令の規定は、その仕事を特別区が行う場合には特別区にも当てはまります(同法第二百八十一条第二項・第二百八十三条第二項)。そのまま当てはめにくいときは、政令で特別の定めを置くことができます(同法第二百八十三条第三項)。
地方自治法第281条・第281条の2・第283条、Wikipedia「特別区」を参考にAIが作成。