Regulations related to Importing Chemicals

Importing chemicals into Japan is regulated by the following laws: the Chemical Substances Control Law, the Pollutant Release and Transfer Register Law (PRTR Law), and the Poisonous and Deleterious Substances Control Law.

 

The Chemical Substances Control Law

The import of chemical substances is regulated by the “Chemical Substance Control Law”, as shown in the following table.

New chemical substances

・In the case of imports, notification is basically required (Law 3). Upon receiving the notification, a safety assessment is conducted and the results are notified to the notifier (Law 4).

・Foreign manufacturers may also submit notifications of new chemical substances (Law 7).

General chemical substances

・Importers must submit a notification of the amount imported for each general chemical substance every fiscal year (Law 8).

Priority Assessment Chemical Substances8

・Importers must submit a notification of the import quantity for each priority assessment chemical substance every fiscal year (Law 9).

Monitored chemical substances

・Importers must submit a notification of the import quantity for each monitored chemical substance every fiscal year (Law 13).

 

Class 1 chemical substances

・Any person who intends to import shall obtain a permit.

However, this shall not apply in the case of import for the purpose of testing and research (Same as the proviso).

Products using Class 1 chemical substances

Import is Prohibited (Law 24).

Class 2 chemical substances

・Notification is required. In case of importing more than the notified quantity, notification of change is required.

Products using Class 2 chemical substances

・Same as above.

Substances to be reported (Priority Assessment, Monitoring, Class II and General Chemical Substances)

・The importer shall report the results of the hazard investigation when it has been conducted and the hazard has been confirmed (Law 41).

If you would like to know more, please refer to the Ministry of Economy, Trade and Industry’s “What is the Chemical Substances Control Law?”

 

The Pollutant Release and Transfer Register Law (PRTR Law)        

In accordance with the Law Concerning Reporting of Releases to the Environment of Specific Chemical Substances and Promoting Improvements in Their Management, certain businesses are required to report the amount of Class I Designated Chemical Substances released into the environment and the amount transferred as waste (Article 5).

In addition, when a business operator provides a Class I Designated Chemical Substance, a Class II Designated Chemical Substance, and certain products containing these substances to another business operator, it is required to provide the other party with information on the chemical substance (Article 14). A Security Data Sheet (SDS) will be provided to provide this information.

Targeted businesses are defined according to the type of business, number of employees, and annual handling volume of target chemical substances. It should be noted that importers may also fall under the category of covered entities.

If you want to know more, you can refer to the Ministry of the Environment’s “PRTR Information Plaza” website.

 

The Poisonous and Deleterious Substances Control Law

1 Definition of Poisonous and Deleterious Substances

Among chemical substances, those with high toxicity are called poisons and those with low toxicity are called deleterious substances, and the scope of each is specified in Appended Table 1 and Appended Table 2 of the Poisonous and Deleterious Substances Control Law9.  the product is a drug or quasi-drug, it is not subject to the Poisonous and Deleterious Substances Control Law, but is regulated by the Pharmaceutical Affairs Law.

 

2 Importation of Poisonous and Deleterious Substances

(1) General Information

According to the Poisonous and Deleterious Substances Control Law, only companies registered as importers of poisonous10 and deleterious substances11 may import poisonous and deleterious substances for the purpose of selling or giving them away (Article 3.2). This means that anyone who imports poisonous or deleterious substances for the purpose of transferring ownership to a third party, whether for a fee or free of charge, is required to register as an importer. 

 Those who are not registered as importers are in violation of the above regulations unless they are importing for their own use or purpose.

 

(2) Import of poisonous or deleterious substances for the purpose of sale or award by a registered importer

 For importation by a registered importer, a copy of the registration certificate for the importation of poisonous and deleterious substances is required.

 When a person intends to import a poisonous or deleterious substance of an item other than a pre-registered item, he/she must obtain a change in the registration of the poisonous or deleterious substance (Article 9).

 

(3) Importation for purposes other than selling or giving away

(a) Import of ordinary poisonous and deleterious substances

In the case of importation for purposes other than sale or award, the issuance of an import confirmation certificate may be permitted in the following cases: ① for testing and research, ② for internal samples, ③ for personal use, ④ for personal use by medical personnel12, ⑤ for re-imported or returned goods, and ⑥ for personal consumption13.

 

(b) Import of specified deleterious substances

With regard to specific poisons14, only researchers of specific poisons are allowed to import specific poisons.

 

(4) Sales and distribution

After importation, those who sell or give away deleterious or poisonous substances are required, in principle, to register as a distributor for each business office or store(Article 3.3)15. This means that importers have to wholesale to registered [distributors].

 

(5) Main duties of importers and distributors

Sellers and importers of poisonous and deleterious substances are required to appoint a person in charge16 of handling each business office or store where they are directly handled, and take charge of the prevention of harm(Article 7). A person in charge of handling poisonous and deleterious materials shall be appointed from among those who meet the qualification requirements of a pharmacist and a person who has passed the examination for handling poisonous and deleterious materials (Article 8).

In addition, sellers and importers are obligated to (1) take measures to prevent theft and loss of poisonous and deleterious substances (Article 11, Paragraph 1), (2) take measures to prevent dispersal and leakage (Article 11, Paragraph 2), (3) properly store poisonous and deleterious substances during transportation (Article 11, Paragraph 3 and Article 16), and (4) label poisonous and deleterious substances on containers and packaging (Article 12).

 

(6) Relationship with import approval under the Foreign Exchange and Foreign Trade Law

For poisons and deleterious substances, import approval is basically required.  The items that require import approval are explained in another section, but the phrase “poisonous and deleterious substances” does not appear there, so it is difficult to understand that import approval is required, but depending on the type of poisonous and deleterious substances, they fall under the substances specified in the Chemical Substances Control Law (Approval of No. 2 and No. 2-2), the substances specified in the Montreal Protocol (Approval No. 2 and No. 3), and the substances specified in the Agricultural Chemicals Control Law (Approval No. 3). In the case of approval No. 3, import confirmation is sufficient, but an application for a certificate of confirmation of import of poisonous or deleterious substances is required, and the procedures related to the application are carried out in accordance with the Guidelines for Confirmation of Import of Poisonous and Deleterious Substances.


Please contact us if you have any questions.

1See “Ministerial Ordinance Determining Cases Not Requiring Registration under Article 3, Paragraph (1) of the Agricultural Chemicals Control Act“.
2 See Ministry of Agriculture, Forestry and Fisheries, “Handling at the time of import customs clearance of agricultural chemicals based on the Agricultural Chemicals Control Law,” 4(3).
3 The Minister of Agriculture, Forestry and Fisheries and the Minister of the Environment designate as specified pesticides those that do not pose a risk of harm to humans, livestock, or crops in light of their raw materials, and exclude them from registration. Currently, five types of pesticides are designated: baking soda, vinegar, natural enemies that live in the area, ethylene, and hypochlorite water (limited to that obtained by electrolysis of hydrochloric acid or potassium chloride solution).
4 It appears that the submission of documents for import verification is not required (see 4(3) of the Ministry of Agriculture, Forestry and Fisheries’ “Handling of Import Customs Clearance of Agricultural Chemicals under the Agricultural Chemicals Control Law”).
5 Import and Export of Agricultural Chemicals” (Notification of the Director-General of the Production Bureau, Ministry of Agriculture, Forestry and Fisheries, No. 14 Production No. 9525, dated February 28, 2003)
6 Import and Export of Agricultural Chemicals” (Notification of the Director-General of the Production Bureau, Ministry of Agriculture, Forestry and Fisheries, No. 14 Production No. 9525, dated February 28, 2003)
7 Import and Export of Agricultural Chemicals” (Notification of the Director-General of the Production Bureau, Ministry of Agriculture, Forestry and Fisheries, No. 14 Production No. 9525, dated February 28, 2003)
8 Excluding Class 2 Specified Chemical Substances.
9 Be sure to pay attention to the extension of the scope of poisonous and deleterious substances in accordance with the revision of the Cabinet Order on June 24, 2020.
10 The term “poison” refers to substances listed in Appended Table 1 of the Poisonous and Deleterious Substances Control Law, other than pharmaceuticals, quasi-pharmaceuticals, and in vitro diagnostic pharmaceuticals. For example, yellow phosphorus, sodium cyanide, mercury, arsenic, etc.
11 The term “deleterious substances” means substances listed in Appended Table 2 of the Poisonous and Deleterious Substances Control Law, other than drugs, quasi-drugs, and in vitro diagnostic drugs. For example, ammonia, hydrogen chloride, carbon tetrachloride, sulfuric acid, etc.
12 This refers to cases where there is an urgent need for treatment, no alternative products are available in Japan, and the medical personnel who imported the product intend to use it for the diagnosis or treatment of their own patients under their own responsibility. Cases in which veterinarians import products for the purpose of diagnosing or treating their own animals under their own responsibility are also treated in the same way.
13 This refers to cases where the product is used as a raw material for the company’s own products, or for the manufacture of the company’s own drugs, etc. for which approval, etc. has been obtained.
14The term “specified deleterious substances” refers to the deleterious substances listed in Appended Table 3 of the Poisonous and Deleterious Substances Control Law (and Article 3 of the Poisonous and Deleterious Substances Control Order). Octamethyl Pyrophosphoramide (also known as Schlardin), tetraalkyl lead, monofluoroacetic acid, etc.
15 However, if a registered importer or a registered manufacturer sells only to a registered manufacturer, a registered importer, or a registered distributor, registration as a distributor is not required.
16 Sellers who do not directly handle poisonous or deleterious substances, but only receive orders and make shipping arrangements (=ordered sellers), do not need to appoint a person in charge of handling poisonous or deleterious substances.