Chapter VIII Registered Conformity Assessment Bodies
第八章 登録検査機関
第三十一条
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。
第三十二条
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
第三十三条
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.
第三十四条
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。
第三十五条
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.
第三十六条
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。
第三十七条
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.
第三十八条
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.
第三十九条
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.
第四十条
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。
第四十一条
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.
第四十二条
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.
第四十三条
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。
第四十四条
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.
第四十五条
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.
第四十六条
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.
第四十七条
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.
food
「食品」
All food and drink, except the pharmaceutical products, quasi-pharmaceutical products and regenerative medicine products defined in the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Defined inArticle 4, paragraph (1)· applies throughout the law
additives
「添加物」
A substance used in or on food, by adding, mixing, soaking or any other method, in the course of producing food or to process or preserve it.
Defined inArticle 4, paragraph (2)· applies throughout the law
apparatus
「器具」
Tableware, kitchen utensils and other machines, equipment and articles that are used in collecting, producing, processing, cooking, storing, transporting, displaying, handing over or consuming food or additives and that touch the food or additives directly; those used to harvest food in farming and fisheries are not included.
Defined inArticle 4, paragraph (4)· applies throughout the law
containers and packages
「容器包装」
Anything that holds or wraps food or additives and is handed over with them, as it is, when the food or additives change hands.
Defined inArticle 4, paragraph (5)· applies throughout the law
business operator
「営業者」
A person or corporation that runs a business (営業) as this Act defines it: collecting, producing, importing, processing, cooking, storing, transporting or selling food or additives, or making, importing or selling apparatus or containers and packages, as a trade.
Defined inArticle 4, paragraph (8)· applies throughout the law
registered conformity assessment body
「登録検査機関」
A corporation registered by the Minister of Health, Labour and Welfare under Article 33, paragraph (1) as a body that carries out product inspections (製品検査).
Defined inArticle 4, paragraph (9)· applies throughout the law
product inspections
「製品検査」
The inspections by the Minister of Health, Labour and Welfare, a prefectural governor or a registered conformity assessment body (登録検査機関) that certain food, additives, apparatus and containers and packages a Cabinet Order (政令) names must pass before they are sold or used in business (Article 25, paragraph (1)), or that may be ordered for products likely to break the rules: further products of a maker whose product was found in breach, imports of the same kind of products made by such a maker, or imports that the conditions where they are produced make likely to be in breach (Article 26, paragraphs (1) to (3)).
Short name set inArticle 29, paragraph (1)
applicant for registration
「登録申請者」
In Article 33, paragraph (1), a person who has applied under Article 31 to be registered as a registered conformity assessment body (登録検査機関), whom the Minister of Health, Labour and Welfare must register if it meets every requirement on equipment and staff, on measures to keep product inspections reliable, and on not being controlled by the business operators whose products it inspects.
Short name set inArticle 33, paragraph (1)· applies only in this paragraph
business operator subject to inspections
「受検営業者」
In Article 33, paragraph (1), item (iii) and Article 39, paragraph (2), a business operator that sells, makes, imports, processes or displays for sale, or uses in its business, food, additives, apparatus or containers and packages that must undergo product inspections (製品検査) under Article 25, paragraph (1) or Article 26, paragraphs (1) to (3).
Short name set inArticle 33, paragraph (1), item (iii)· applies only in this item and in Article 39, paragraph (2)
operational rules
「業務規程」
The rules on carrying out product inspections (製品検査) that a registered conformity assessment body (登録検査機関) must set and have approved by the Minister of Health, Labour and Welfare before it starts that work, and again whenever it changes them.
Short name set inArticle 37, paragraph (1)
financial statements, etc.
「財務諸表等」
The inventory of property, balance sheet, profit and loss or income and expenditure statement, and business report (including electronic or magnetic records made in their place) that a registered conformity assessment body (登録検査機関) must prepare within three months after each business year ends and keep at its office for five years (Article 39, paragraph (1)).
Short name set inArticle 39, paragraph (1)· applies only in this provision and in Article 39, paragraph (2); and Article 89
electronic or magnetic record
「電磁的記録」
A record made in electronic, magnetic or any other form people cannot perceive directly, for use in computer processing.
Defined inArticle 39, paragraph (1)· applies only in this article
entrusted affairs
「委託事務」
In Article 40, the testing of food, additives, apparatus or containers and packages taken away for testing under Article 28, paragraph (1), which the Minister of Health, Labour and Welfare, the Prime Minister or a prefectural governor, etc. entrusts to a registered conformity assessment body (登録検査機関) under Article 28, paragraph (4).
Short name set inArticle 40, paragraph (1)· applies only in this provision and in Article 40, paragraph (2)
fine
罰金
A criminal punishment of paying money to the state, of 10,000 yen or more, or less where it is reduced (Penal Code, Article 15). It ranks below imprisonment (拘禁刑) and above penal detention (拘留) and a petty fine (科料) (Articles 9 and 10, paragraph (1)). A person who cannot pay it in full is held in a workhouse (労役場) for one day to two years, or up to three years where fines are imposed together, a period set when the sentence is passed (Article 18, paragraphs (1), (3) and (4)); not within thirty days of the sentence becoming final without the person's consent (paragraph (5)). If it is not enforced for three years after the sentence becomes final, the person is released from it by prescription (Articles 31 and 32, item (v)); the three years do not run while its execution is suspended under law or the person is abroad, and an act of execution interrupts them (Articles 33 and 34, paragraph (2)).
Written by AI using Penal Code, Arts. 9, 10, 15, 18, 31 to 34 as a reference.