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Act on Control of Household Products Containing Harmful Substances - Act No. 49 of 2009

Act on Control of Household Products Containing

Harmful Substances

(Act No. 112 of October 12, 1973) (Purpose)


Article 1 The purpose of this Act is to contribute to protecting the health of
citizens by imposing necessary controls on household products containing harmful substances from the viewpoint of sanitation.
(Definitions)
Article 2 (1) The term "household products" as used in this Act shall mean products provided primarily for the ordinary use of general consumers
(excluding those listed in the appended table).
(2) The term "harmful substances" as used in this Act shall mean, among
substances that are contained in household products, mercuric compounds and other substances specified by Cabinet Order as likely to cause damage to
human health.
(Responsibility of Business Operators)
Article 3 A people who operates a business manufacturing or importing
household products shall understand the effects of substances contained in the household products which he/she manufactures or imports on human health,
and shall prevent damage to human health from arising due to said substances.
(Criteria for Household Products)
Article 4 (1) The Minister of Health, Labour and Welfare may designate by
Ordinance of the Ministry of Health, Labour and Welfare, from the viewpoint of sanitation, household products and establish necessary criteria for the
household products with regard to the content, elution or emission amounts for
harmful substances.
(2) The Minister of Health, Labour and Welfare may designate by Ordinance of
the Ministry of Health, Labour and Welfare, from the viewpoint of sanitation, household products containing harmful substances that are classified as
poisonous substances under Article 2, paragraph (1) of the Poisonous and Deleterious Substances Control Act (Act No. 303 of 1950) or deleterious substances under paragraph (2) of said Article, and may establish the necessary criteria for household products with regard to their containers or packaging.
(3) The Minister of Health, Labour and Welfare shall obtain the opinions of the
Pharmaceutical Affairs and Food Sanitation Council and consult with the
Secretary-General of the Consumer Affairs Agency and the competent minister
for the relevant household products before establishing criteria pursuant to the provisions of the preceding two paragraphs.
(Prohibition of Sale, etc.)
Article 5 A person who operates a business manufacturing, importing or selling household products for which criteria have been established pursuant to the
provisions of paragraphs (1) or (2) of the preceding Article shall not sell,
provide or display for the purpose of sale or provision household products that do not conform to the criteria.
(Order for Recall, etc.)
Article 6 (1) Where the Minister of Health, Labour and Welfare or a prefectural governor (with regard to a city or a special ward that has established a health
center, the city or ward mayor; hereinafter the same shall apply in this Article and the next Article) finds that damage to human health is likely to occur due
to the sale or provision of household products which do not conform to criteria
established pursuant to the provisions of Article 4, paragraph (1) or (2) by a
person who operates a business manufacturing, importing or selling household products, he/she may order said person to make an effort to recall said
household products and to take other necessary measures to prevent the
occurrence of said damage when he/she deems it particularly necessary to prevent the occurrence of said damage.
(2) Where serious damage to human health has occurred which is found to have been caused by household products, the Minister of Health, Labour and
Welfare or a prefectural governor, within the limit necessary to prevent the
expansion of said damage, may order a person who operates a business
manufacturing or importing said household products to make an effort to recall said household products and to take other necessary emergency measures to
prevent further damage when said household products are suspected of
containing a substance related to said damage which is likely to cause damage to human health.
(Inspection, etc.)
Article 7 (1) The Minister of Health, Labour and Welfare or a prefectural
governor may, when he/she deems necessary for the enforcement of this Act, require a person who operates a business manufacturing, importing or selling household products to submit a report or have a person who is designated in
advance from among food sanitation inspectors, pharmaceutical affairs
inspectors and other officials specified by Ordinance of the Ministry of Health,
Labour and Welfare enter an office, factory, workplace, store or warehouse of said business operator to inspect books, documents and other articles, question persons concerned or remove the amount of the household products necessary
for testing.
(2) A person who has been designated pursuant to the provisions of the preceding paragraph shall be called a household products sanitation inspector.
(3) Where a household products sanitation inspector conducts an inspection, questioning or removal pursuant to the provisions of paragraph (1), he/she
shall carry his/her identification card and present it to the persons concerned.
(4) The authority for the inspection, questioning and removal under the
provisions of paragraph (1) shall not be construed to have been granted for criminal investigations.
(Classification of Affairs)
Article 8 Affairs which a prefecture, a city with a health center or a special ward shall administer pursuant to the provisions of Article 6 and paragraph (1) of
the preceding Article shall be item 1 legally delegated affairs as prescribed in
Article 2, paragraph (9), item (i) of the Local Autonomy Act (Act No. 67 of 1947).
(Transitional Measures)
Article 9 Transitional measures (including transitional measures concerning penal provisions) may be provided by order to the extent deemed reasonably necessary for the establishment, revision or abolition of an order pursuant to this Act.
(Penal Provisions)
Article 10 A person who falls under any of the following items shall be punished by imprisonment with work for not more than one year or by a fine of not more than three hundred thousand yen:
(i) A person who has violated the provisions of Article 5;
(ii) A person who has violated an order under the provisions of Article 6, paragraph (1) or (2).
Article 11 A person who has failed to submit a report or submitted a false report under the provisions of Article 7, paragraph (1) who has refused, prevented or
avoided an inspection or removal under the provisions of said paragraph, or
who has failed to give an answer or has given a false answer to a question
under the provisions of said paragraph shall be punished by a fine of not more than fifty thousand yen.
Article 12 When the representative of a juridical person or an agent, employee or
other worker of a juridical person or individual has committed any of the
violations set forth in the preceding two Articles with regard to the business of said juridical person or individual, not only the offender but also said juridical person or individual shall be punished by the fine prescribed in the respective Article.
Appended Table
(i) Food prescribed in Article 4, paragraph (1) of the Food Sanitation Act (Act
No. 233 of 1947), additives prescribed in paragraph (2) of said Article,
apparatuses prescribed in paragraph (4) of said Article, containers and
packaging prescribed in paragraph (5) of said Article, toys prescribed in
Article 62, paragraph (1) of said Act and cleaning agents prescribed in paragraph (2) of said Article
(ii) Medicines prescribed in Article 2, paragraph (1) of the Pharmaceutical
Affairs Act (Act No. 145 of 1960), quasi-medicines prescribed in paragraph (2)
of said Article, cosmetics prescribed in paragraph (3) of said Article and medical equipment prescribed in paragraph (4) of said Article
(iii) In addition to what is listed in the preceding two items, products whose manufacture, import or sale is controlled by standards or criteria set
pursuant to an Act specified by Cabinet Order, and which are found unlikely to cause damage to human health due to harmful substances contained
therein owing to said control


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