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Article 33

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):

登録申請者が、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規定により製品検査を受けなければならないこととされる食品、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でないこと。

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).

登録申請者の代表権を有する役員が、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。)であること。

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

登録検査機関が行う製品検査の種類

the name and the location of the office in which the registered conformity assessment body conducts product inspections.

登録検査機関が製品検査を行う事業所の名称及び所在地

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