Chapter III Apparatus, and Containers and Packages

Apparatus, and containers and packages used for conducting business must be clean and sanitary.

Apparatus, or containers and packages that contain toxic or harmful substances, or to which those substances are adhered and likely to harm human health, or apparatus, or containers and packages that come into contact with food or additives and are likely to harm human health due to having a harmful effect, must not be sold, manufactured or imported for the purpose of selling, or used for business.

①If for specific apparatus, or containers and packages that are manufactured in a specific country or region, or manufactured by a specific person, a considerable number of apparatus, or containers and packages falling under the following items have been discovered as a result of inspections under the provisions of Article 26, paragraphs (1) through (3) or Article 28, paragraph (1), and it is found likely that apparatus, or containers and packages falling under the following items are contained to a considerable extent due to the status of food sanitation management at the production site and other grounds specified by Order of the Ministry of Health, Labour and Welfare, and the Minister of Health, Labour and Welfare finds it particularly necessary for preventing food sanitation hazards caused by the specific apparatus, or containers and packages, taking into account the level of risk of harming human health and other matters specified by Order of the Ministry of Health, Labour and Welfare, the Minister may prohibit the sales of the specific apparatus, or containers and packages, manufacturing or import of the specific apparatus, or containers and packages for the purpose of selling, or using them for business, after hearing the opinions of the Health Science Council:

②When the Minister of Health, Labour and Welfare intends to make a prohibition under the provisions of the preceding paragraph, the Minister must consult with the heads of the relevant administrative organs in advance.

③The provisions of Article 9, paragraphs (3) and (4) apply mutatis mutandis to cases in which a prohibition under the provisions of paragraph (1) has been made. In such a case, the term "food or additives" in paragraph (3) of that Article is deemed to be replaced with "apparatus, or containers and packages".

①The Prime Minister may establish standards for apparatus, or containers and packages or their raw materials to be sold or used for business, or establish the criteria for the manufacturing method of apparatus, or containers and packages, from the viewpoint of public health, after hearing the opinions of the Food Safety Standards Council.

②When the standards or criteria have been established pursuant to the provisions of the preceding paragraph, the apparatus, or containers and packages that do not conform to the standards must not be sold, manufactured or imported for the purpose of selling, or used for business, raw materials that do not conform to the standards must not be used, and the apparatus, or containers and packages must not be manufactured by a method that does not conform to the criteria.

③Substances (excluding substances generated by chemical change of substances) which are raw materials of materials specified by Cabinet Order taking into consideration the impact on public health of the elution or seepage of the components into food must not be used for apparatus, or containers and packages, when the quantity permitted to be contained in the apparatus, or containers and packages manufactured, or the quantity permitted to be eluted or to seep into food from apparatus, or containers and packages manufactured using those substances is not specified in the standards referred to in paragraph (1) of this Article; provided, however, that this does not apply if the apparatus, or containers and packages, are processed so that the substances do not have the risk of eluting or seeping into food at a quantity exceeding the quantity specified by the Prime Minister as unlikely to harm human health after hearing the opinions of the Food Safety Standards Council (excluding the case in which the substance is used for the part of the apparatus, or containers and packages which come into contact with food).