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Article 48

第四十八条

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.

乳製品、第十二条の規定により内閣総理大臣が定めた添加物その他製造又は加工の過程において特に衛生上の考慮を必要とする食品又は添加物であつて政令で定めるものの製造又は加工を行う営業者は、その製造又は加工を衛生的に管理させるため、その施設ごとに、専任の食品衛生管理者を置かなければならない。ただし、営業者が自ら食品衛生管理者となつて管理する施設については、この限りでない。

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.

営業者が、前項の規定により食品衛生管理者を置かなければならない製造業又は加工業を二以上の施設で行う場合において、その施設が隣接しているときは、食品衛生管理者は、同項の規定にかかわらず、その二以上の施設を通じて一人で足りる。

A food sanitation supervisor must supervise persons who are engaged in the production or processing of food or additives at the facility to prevent violations of this Act, or orders or dispositions based on this Act concerning the food or additives that the food sanitation supervisor supervises.

食品衛生管理者は、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が行われないように、その食品又は添加物の製造又は加工に従事する者を監督しなければならない。

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.

食品衛生管理者は、前項に定めるもののほか、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の防止及び食品衛生上の危害の発生の防止のため、当該施設における衛生管理の方法その他の食品衛生に関する事項につき、必要な注意をするとともに、営業者に対し必要な意見を述べなければならない。

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.

営業者は、その施設に食品衛生管理者を置いたときは、前項の規定による食品衛生管理者の意見を尊重しなければならない。

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、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.

に基づく中等学校を卒業した者又は厚生労働省令で定めるところによりこれらの者と同等以上の学力があると認められる者で、第一項の規定により食品衛生管理者を置かなければならない製造業又は加工業において食品又は添加物の製造又は加工の衛生管理の業務に三年以上従事し、かつ、都道府県知事の登録を受けた講習会の課程を修了した者

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.

第一項に規定する営業者は、食品衛生管理者を置き、又は自ら食品衛生管理者となつたときは、十五日以内に、その施設の所在地の都道府県知事に、その食品衛生管理者の氏名又は自ら食品衛生管理者となつた旨その他厚生労働省令で定める事項を届け出なければならない。食品衛生管理者を変更したときも、同様とする。

Article 49

第四十九条

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.

前条第六項第三号の養成施設又は同項第四号の講習会の登録に関して必要な事項は政令で、受講科目その他同項第三号の養成施設又は同項第四号の講習会の課程に関して必要な事項は厚生労働省令で定める。

Article 50

第五十条

The Minister of Health, Labour and Welfare may establish the necessary criteria concerning measures to prevent toxic or harmful substances from getting mixed into the food or additives in the process of the production or processing of food or additives.

厚生労働大臣は、食品又は添加物の製造又は加工の過程において有毒な又は有害な物質が当該食品又は添加物に混入することを防止するための措置に関し必要な基準を定めることができる。

When criteria have been established pursuant to the provisions of the preceding paragraph, a business operator (excluding poultry slaughterers prescribed in ) must comply with the criteria.

営業者(に規定する食鳥処理業者を除く。)は、前項の規定により基準が定められたときは、これを遵守しなければならない。

Article 51

第五十一条

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 (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:

厚生労働大臣は、営業(器具又は容器包装を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。

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 ; 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).

食品衛生上の危害の発生を防止するために特に重要な工程を管理するための取組(小規模な営業者(器具又は容器包装を製造するに規定する食鳥処理業者を除く。次項において同じ。)その他の政令で定める営業者にあつては、その取り扱う食品の特性に応じた取組)に関すること。

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

第五十二条

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:

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。

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).

器具又は容器包装を製造する営業者は、前項の規定により定められた基準(第十八条第三項に規定する政令で定める材質以外の材質の原材料のみが使用された器具又は容器包装を製造する営業者にあつては、前項第一号に掲げる事項に限る。)に従い、公衆衛生上必要な措置を講じなければならない。

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。

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