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.
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)