Article 54Registered Agency for Individual Examinations
第五十四条(登録個別検定機関)
The provisions of Article 46 (excluding paragraph (1) (limited to the part concerning its items) and paragraph (3) (limited to the part concerning items (i) and (ii))) and Article 46-2 apply mutatis mutandis to the registration referred to in paragraph (1) of Article 44, and the provisions of Articles 47 through 53-2 apply mutatis mutandis to a registered agency for individual examinations. In such a case, beyond the term "design review or post-manufacturing inspection" in the provisions of Article 47 (including its caption) through Article 50 and of Article 53-2 (including its caption) being deemed to be replaced with "individual examination", and the term "foreign registered agency for design reviews and post-manufacturing inspections" in the provisions of Article 52 through Article 53 being deemed to be replaced with "foreign registered agency for individual examinations", the terms in the provisions set forth in the left-hand column of the following table that are set forth in the middle column of that table are deemed to be replaced with the terms set forth in the corresponding right-hand column of that table.
| paragraph (1) of Article 46 | paragraph (3) of Article 37 | paragraph (1) of Article 44 |
| for conducting the operations specified in each of the following items according to the category of specified machinery or other such equipment set forth in that item, for each regional classification prescribed by Order of the Ministry of Health, Labour and Welfare | for each classification prescribed by Order of the Ministry of Health, Labour and Welfare | |
| a design review or post-manufacturing inspection (hereinafter referred to as a "design review or post-manufacturing inspection") | an individual examination | |
| item (iii) of paragraph (3) of Article 46 | for a person conducting post-manufacturing inspections, according to the category of machinery or other such equipment set forth in the left-hand column of Appended Table 5 | according to the category of machinery or other such equipment set forth in the left-hand column of Appended Table 11 |
| it would conduct post-manufacturing inspections | it would conduct individual examinations | |
| item (iv) of paragraph (3) of Article 46 | for a person conducting post-manufacturing inspections, the number of persons implementing post-manufacturing inspections | according to the machinery or other such equipment set forth in the left-hand column of Appended Table 12, the number of persons implementing individual examinations |
| item (i) of Appended Table 6 | the middle column of that Table | |
| inspector | examiner | |
| item (ii) of that Table | the right-hand column of that Table | |
| item (v) of paragraph (3) of Article 46 | for a person conducting post-manufacturing inspections, an inspector | an examiner |
| Appended Table 7 | Appended Table 13 | |
| instruct the inspectors | instruct the examiners | |
| supervise the post-manufacturing inspections | supervise the individual examinations | |
| item (vi) of paragraph (3) of Article 46 | specified machinery or other such equipment | machinery or other such equipment specified by Cabinet Order referred to in paragraph (1) of Article 44 |
| design reviews or post-manufacturing inspections | individual examinations | |
| paragraph (4) of Article 46 | register of the registered agency for design reviews and post-manufacturing inspections | register of the registered agency for individual examinations |
| paragraph (2) of Article 47 | in conducting design reviews, have these implemented by reviewers, and, in conducting post-manufacturing inspections, have these implemented by inspectors | in conducting individual examinations, have these implemented by examiners |
| paragraph (3) of Article 47 | the part of the standards referred to in paragraph (2) of Article 37 that relates to construction | the standards referred to in paragraph (3) of Article 44 |
| paragraph (4) of Article 47 | post-manufacturing inspection | individual examination |
| inspection method | examination method | |
| Article 51 (including its caption) | a reviewer or an inspector | an examiner |
| Article 52 | design reviews or post-manufacturing inspections | individual examinations |
| Article 52-2 | a design review or post-manufacturing inspection | an individual examination |
| the methods of design reviews or post-manufacturing inspections | the methods of individual examinations | |
| paragraph (1) and item (iii) of paragraph (2) of Article 53 | operations for design reviews or post-manufacturing inspections | operations for individual examinations |
| Article 53-2 (including its caption) | Director of the Prefectural Labour Bureau | Minister of Health, Labour and Welfare or the Director of the Prefectural Labour Bureau |
第四十六条(第一項(各号に係る部分に限る。)及び第三項(第一号及び第二号に係る部分に限る。)を除く。)及び第四十六条の二の規定は第四十四条第一項の登録について、第四十七条から第五十三条の二までの規定は登録個別検定機関について準用する。この場合において、第四十七条(見出しを含む。)から第五十条まで及び第五十三条の二(見出しを含む。)の規定中「設計審査等」とあるのは「個別検定」と、第五十二条から第五十三条までの規定中「外国登録設計審査等機関」とあるのは「外国登録個別検定機関」と読み替えるほか、次の表の上欄に掲げる規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句に読み替えるものとする。
| 第四十六条第一項 | 第三十七条第三項 | 第四十四条第一項 |
| 次の各号に掲げる特定機械等の区分に応じ当該各号に定める業務を行うことについて、厚生労働省令で定める地域の区分 | 厚生労働省令で定める区分 | |
| 設計審査又は製造時等検査(以下「設計審査等」という。) | 個別検定 | |
| 第四十六条第三項第三号 | 製造時等検査を行う者にあつては、別表第五 | 別表第十一 |
| 製造時等検査を行うもの | 個別検定を行うもの | |
| 第四十六条第三項第四号 | 製造時等検査を行う者にあつては、製造時等検査 | 別表第十二の上欄に掲げる機械等に応じ、個別検定 |
| 別表第六第一号 | 同表の中欄 | |
| 検査員 | 検定員 | |
| 同表第二号 | 同表の下欄 | |
| 第四十六条第三項第五号 | 製造時等検査を行う者にあつては、検査員 | 検定員 |
| 別表第七 | 別表第十三 | |
| 検査員を | 検定員を | |
| 製造時等検査の | 個別検定の | |
| 第四十六条第三項第六号 | 特定機械等 | 第四十四条第一項の政令で定める機械等 |
| 設計審査等 | 個別検定 | |
| 第四十六条第四項 | 登録設計審査等機関登録簿 | 登録個別検定機関登録簿 |
| 第四十七条第二項 | 設計審査を行うときは審査員にこれを実施させ、製造時等検査を行うときは検査員 | 個別検定を行うときは、検定員 |
| 第四十七条第三項 | 第三十七条第二項の基準のうち構造に係る部分 | 第四十四条第三項の基準 |
| 第四十七条第四項 | 製造時等検査 | 個別検定 |
| 検査方法 | 検定方法 | |
| 第五十一条(見出しを含む。) | 審査員又は検査員 | 検定員 |
| 第五十二条 | 設計審査等の | 個別検定の |
| 第五十二条の二 | 設計審査等を | 個別検定を |
| 設計審査等の | 個別検定の | |
| 第五十三条第一項及び第二項第三号 | 設計審査等の | 個別検定の |
| 第五十三条の二(見出しを含む。) | 都道府県労働局長 | 厚生労働大臣又は都道府県労働局長 |
Article 54-2Registered Agency for Type Examinations
第五十四条の二(登録型式検定機関)
The provisions of Article 46 (excluding paragraph (1) (limited to the part relating to each item) and paragraph (3) (limited to the part relating to items (i) and (ii))) and Article 46-2 apply mutatis mutandis to a registration referred to in paragraph (1) of Article 44-2, and the provisions of Articles 47 through 53-2 apply mutatis mutandis to a registered agency for type examinations. In such a case, the phrase "design review or post-manufacturing inspection" in the provisions of Article 47 (including its heading) through Article 50 and Article 53-2 (including its heading) is deemed to be replaced with "type examination", and the phrase "foreign registered agency for design reviews and post-manufacturing inspections" in the provisions of Articles 52 through 53 is deemed to be replaced with "foreign registered agency for type examinations", and in addition, the terms set forth in the middle column of the following table in the provisions set forth in the left-hand column of that table are deemed to be replaced with the terms set forth in the right-hand column of the table, respectively.
| paragraph (1) of Article 46 | paragraph (3) of Article 37 | paragraph (1) of Article 44-2 |
| with regard to conducting the operations specified in each of the following items according to the category of specified machinery or other such equipment set forth in that item, the category of region specified by Order of the Ministry of Health, Labour and Welfare | the category specified by Order of the Ministry of Health, Labour and Welfare | |
| design reviews or post-manufacturing inspections (hereinafter referred to as "design review or post-manufacturing inspection") | type examinations | |
| item (iii) of paragraph (3) of Article 46 | for a person conducting post-manufacturing inspections, Appended Table 5 | Appended Table 14 |
| conducts post-manufacturing inspections | conducts type examinations | |
| item (iv) of paragraph (3) of Article 46 | for a person conducting post-manufacturing inspections, post-manufacturing inspections | type examinations |
| item (i) of Appended Table 6 | item (i) of Appended Table 15 | |
| inspector | examiner | |
| item (v) of paragraph (3) of Article 46 | for a person conducting post-manufacturing inspections, an inspector | an examiner |
| Appended Table 7 | Appended Table 16 | |
| the inspectors | the examiners | |
| of post-manufacturing inspections | of type examinations | |
| item (vi) of paragraph (3) of Article 46 | specified machinery or other such equipment | machinery or other such equipment specified by the Cabinet Order referred to in paragraph (1) of Article 44-2 |
| design review or post-manufacturing inspection | type examination | |
| paragraph (4) of Article 46 | register of the registered agency for design reviews and post-manufacturing inspections | register of the registered agency for type examinations |
| paragraph (2) of Article 47 | when conducting a design review, have a reviewer carry it out, and when conducting a post-manufacturing inspection, have an inspector | when conducting a type examination, have an examiner |
| paragraph (3) of Article 47 | the part of the standards referred to in paragraph (2) of Article 37 that relates to structure | the standards referred to in paragraph (3) of Article 44-2 |
| paragraph (4) of Article 47 | post-manufacturing inspection | type examination |
| method of the inspection | method of the examination | |
| Article 51 (including its heading) | reviewer or inspector | examiner |
| Article 52 | operations for design review or post-manufacturing inspection | operations for type examination |
| Article 52-2 | to conduct design review or post-manufacturing inspection | to conduct type examination |
| method of design review or post-manufacturing inspection | method of type examination | |
| paragraph (1) and item (iii) of paragraph (2) of Article 53 | operations for design review or post-manufacturing inspection | operations for type examination |
| Article 53-2 (including its heading) | Director of the Prefectural Labour Bureau | Minister of Health, Labour and Welfare |
第四十六条(第一項(各号に係る部分に限る。)及び第三項(第一号及び第二号に係る部分に限る。)を除く。)及び第四十六条の二の規定は第四十四条の二第一項の登録について、第四十七条から第五十三条の二までの規定は登録型式検定機関について準用する。この場合において、第四十七条(見出しを含む。)から第五十条まで及び第五十三条の二(見出しを含む。)の規定中「設計審査等」とあるのは「型式検定」と、第五十二条から第五十三条までの規定中「外国登録設計審査等機関」とあるのは「外国登録型式検定機関」と読み替えるほか、次の表の上欄に掲げる規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句に読み替えるものとする。
| 第四十六条第一項 | 第三十七条第三項 | 第四十四条の二第一項 |
| 次の各号に掲げる特定機械等の区分に応じ当該各号に定める業務を行うことについて、厚生労働省令で定める地域の区分 | 厚生労働省令で定める区分 | |
| 設計審査又は製造時等検査(以下「設計審査等」という。) | 型式検定 | |
| 第四十六条第三項第三号 | 製造時等検査を行う者にあつては、別表第五 | 別表第十四 |
| 製造時等検査を行うもの | 型式検定を行うもの | |
| 第四十六条第三項第四号 | 製造時等検査を行う者にあつては、製造時等検査 | 型式検定 |
| 別表第六第一号 | 別表第十五第一号 | |
| 検査員 | 検定員 | |
| 第四十六条第三項第五号 | 製造時等検査を行う者にあつては、検査員 | 検定員 |
| 別表第七 | 別表第十六 | |
| 検査員を | 検定員を | |
| 製造時等検査の | 型式検定の | |
| 第四十六条第三項第六号 | 特定機械等 | 第四十四条の二第一項の政令で定める機械等 |
| 設計審査等 | 型式検定 | |
| 第四十六条第四項 | 登録設計審査等機関登録簿 | 登録型式検定機関登録簿 |
| 第四十七条第二項 | 設計審査を行うときは審査員にこれを実施させ、製造時等検査を行うときは検査員 | 型式検定を行うときは、検定員 |
| 第四十七条第三項 | 第三十七条第二項の基準のうち構造に係る部分 | 第四十四条の二第三項の基準 |
| 第四十七条第四項 | 製造時等検査 | 型式検定 |
| 検査方法 | 検定方法 | |
| 第五十一条(見出しを含む。) | 審査員又は検査員 | 検定員 |
| 第五十二条 | 設計審査等の | 型式検定の |
| 第五十二条の二 | 設計審査等を | 型式検定を |
| 設計審査等の | 型式検定の | |
| 第五十三条第一項及び第二項第三号 | 設計審査等の | 型式検定の |
| 第五十三条の二(見出しを含む。) | 都道府県労働局長 | 厚生労働大臣 |
Article 54-3Registered Inspection Agency
第五十四条の三(検査業者)
A person seeking to become a registered inspection agency must, pursuant to Order of the Ministry of Health, Labour and Welfare, apply for the registration of its name, address, and other information prescribed by Order of the Ministry of Health, Labour and Welfare in the register of registered inspection agencies kept at the Ministry of Health, Labour and Welfare or the Prefectural Labour Bureau.
検査業者になろうとする者は、厚生労働省令で定めるところにより、厚生労働省又は都道府県労働局に備える検査業者名簿に、氏名又は名称、住所その他厚生労働省令で定める事項の登録を受けなければならない。
A person falling under any of the following items may not be registered as referred to in the preceding paragraph:
次の各号のいずれかに該当する者は、前項の登録を受けることができない。
a person sentenced to a fine or heavier punishment for violating the provisions of paragraph (1) or (2) of Article 45 or an order under those provisions or for violating an order under the provisions of paragraph (2) of Article 54-7, if two years have not passed since the day on which the person finished serving the sentence or ceased to be subject to its enforcement;
第四十五条第一項若しくは第二項の規定若しくはこれらの規定に基づく命令に違反し、又は第五十四条の七第二項の規定による命令に違反して、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起算して二年を経過しない者
a person whose registration has been rescinded pursuant to provisions of paragraph (2) of Article 54-7, if two years have not passed since the date of the rescission;
第五十四条の七第二項の規定により登録を取り消され、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 one of the preceding two items as an officer engaged in its business operations.
法人で、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 registration as referred to in paragraph (1) is made at the application of a person seeking to be a registered inspection agency.
The Minister of Health, Labour and Welfare or the Director of the Prefectural Labour Bureau must not effect the registration referred to in paragraph (1) unless the minister finds that an application as referred to in the preceding paragraph complies with the standards specified by Order of the Ministry of Health, Labour and Welfare.
第五十四条の四
In conducting specified inspections in response to others' requests, a registered inspection agency must have these implemented by persons that possesses the qualifications specified by Order of the Ministry of Health, Labour and Welfare.
In the case referred to in the preceding paragraph, a registered inspection agency must conduct specified inspections in accordance with the standards referred to in paragraph (3) of Article 45.
第五十四条の五
If a registered inspection agency transfers all of its business or if a registered inspection agency has become subject to a succession, merger, or company split (limited to one in which it allows another person to assume all of its business), the person acquiring all of the business, the successor (hereinafter in this paragraph, the person chosen as the successor to the business through the agreement of all parties when there are two or more successors), the corporation surviving the merger, the corporation incorporated as a result of the merger, or the person assuming all of its business as a result of the company split succeeds to the position of the registered inspection agency; provided, however, that this does not apply if the party succeeding to all of the business, successor, corporation surviving the merger, corporation incorporated as a result of the merger, or corporation assuming all of its business as a result of the company split falls under the provisions of the items of paragraph (2) of Article 54-3.
検査業者がその事業の全部を譲り渡し、又は検査業者について相続、合併若しくは分割(その事業の全部を承継させるものに限る。)があつたときは、その事業の全部を譲り受けた者又は相続人(相続人が二人以上ある場合において、その全員の同意により事業を承継すべき相続人を選定したときは、その者。以下この項において同じ。)、合併後存続する法人若しくは合併により設立された法人若しくは分割によりその事業の全部を承継した法人は、その検査業者の地位を承継する。ただし、当該事業の全部を譲り受けた者又は相続人、合併後存続する法人若しくは合併により設立された法人若しくは分割により当該事業の全部を承継した法人が第五十四条の三第二項各号のいずれかに該当するときは、この限りでない。
A person that has succeeded to the position of a registered inspection agency pursuant to the provisions of the preceding paragraph must file a notification of this with the Minister of Health, Labour and Welfare or with the Director of the Prefectural Labour Bureau, pursuant to Order of the Ministry of Health, Labour and Welfare and without delay.
第五十四条の六
If the Minister of Health, Labour and Welfare or the Director of the Prefectural Labour Bureau finds that a registered inspection agency is violating the provisions of Article 54-4, the Minister or the Director may order that registered inspection agency to take the measures necessary to improve its methods of specified inspection or other operational methods.
第五十四条の七
If a registered inspection agency has come to fall under item (i) or (iii) of paragraph (2) of Article 54-3, the Minister of Health, Labour and Welfare or the Director of the Prefectural Labour Bureau must revoke its registration.
厚生労働大臣又は都道府県労働局長は、検査業者が第五十四条の三第二項第一号又は第三号に該当するに至つたときは、その登録を取り消さなければならない。
If a registered inspection agency has come to fall under any of the following items, the Minister of Health, Labour and Welfare or the Director of the Prefectural Labour Bureau may revoke its registration or order a full or partial suspension of specified inspection operations for a fixed period not exceeding six months:
it is found to have ceased to be in conformity with the standards referred to in paragraph (4) of Article 54-3;
第五十四条の三第四項の基準に適合しなくなつたと認められるとき。
it has violated the provisions of Article 54-4;
第五十四条の四の規定に違反したとき。
it violates an order under the preceding Article;
前条の規定による命令に違反したとき。
it has violated the conditions referred to in paragraph (1) of Article 110.
第百十条第一項の条件に違反したとき。
Section 2 Regulations on Dangerous Substances and Harmful Substances
第二節 危険物及び有害物に関する規制
It is prohibited to manufacture, import, transfer, provide, or use substances that cause significant impairments of workers' health, such as yellow phosphorus matches, benzidine, preparations containing benzidine, and that are specified by Cabinet Order; provided, however, that this does not apply if any of these is manufactured, imported or used for the sake of research or examination, and fall under the requirements specified by Cabinet Order.
黄りんマツチ、ベンジジン、ベンジジンを含有する製剤その他の労働者に重度の健康障害を生ずる物で、政令で定めるものは、製造し、輸入し、譲渡し、提供し、又は使用してはならない。ただし、試験研究のため製造し、輸入し、又は使用する場合で、政令で定める要件に該当するときは、この限りでない。
Article 56Permission for Manufacturing
第五十六条(製造の許可)
A person seeking to manufacture substances that could cause significant impairments of workers' health, such as dichlorobenzidine, preparations containing dichlorobenzidine, and that are specified by Cabinet Order must obtain permission in advance from the Minister of Health, Labour and Welfare, pursuant to Order of the Ministry of Health, Labour and Welfare.
ジクロルベンジジン、ジクロルベンジジンを含有する製剤その他の労働者に重度の健康障害を生ずるおそれのある物で、政令で定めるものを製造しようとする者は、厚生労働省令で定めるところにより、あらかじめ、厚生労働大臣の許可を受けなければならない。
When a person has applied for the permission referred to in the preceding paragraph, the Minister of Health, Labour and Welfare examines that application, and must not give the permission referred to in that paragraph unless the minister finds that the manufacturing equipment, work methods, and the like comply with the standards established by the Minister of Health, Labour and Welfare.
A person that has obtained the permission referred to in paragraph (1) (hereinafter referred to as a "manufacturer") must keep its manufacturing equipment in conformity with the standards referred to in the preceding paragraph.
A manufacturer must manufacture the substances referred to in paragraph (1) using a work method that conforms to the standards referred to in paragraph (2).
On finding that a manufacturer's manufacturing equipment or work methods do not comply with the standards referred to in paragraph (2), the Minister of Health, Labour and Welfare may order that the manufacturing equipment be repaired, reconstructed, or relocated so as to conform with those standards, or that the substances referred to in paragraph (1) be manufactured using a work method that conforms with those standards.
The Minister of Health, Labour and Welfare may, if a manufacturer violates the provisions of this Act, an order under this Act or administrative dispositions under these provisions, revoke the permission referred to in paragraph (1).