VIII. Chemical Products and Dangerous Objects
1. Examination of New Chemical Substances


Q8-1

What kinds of examinations are necessary for the import of new chemical substances? 

Answer

When importing new chemical substances, you have to supply information such as the name, structure, quantity of chemical substances scheduled to be imported and test data on biodegradation,etc.

(Law Concerning the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.)

1. In the case of importing a chemical substance which has not been manufactured or imported in Japan (new chemical substance), you should submit a notification with data on the new chemical substance to the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of Environment in advance.
Persistency (chemical stableness in natural environment), bio-accumulativeness (tendency to be accumulated in animate beings), long-term toxicity for humans (harmfulness to humans in the case of continual intake) and toxicity to animals and plants (also called ecotoxicity: magnitude of threat against inhabitation or growth of animals and plants) will be examined. An examination would then be taken to determine in which category the said substance falls: Monitoring Chemical Substances (Type I, II or III), Specified Chemical Substances(Class I or II), or other chemical substances.

2. If the substance is designated as a Class I Specified Chemical Substance, its manufacture and importation are strictly restricted. If the substance is designated as a Type II or Type III Monitoring Chemical Substance, notification of the actual quantity for importation must be made to the Minister of Economy, Trade and Industry.

3. Chemical substances which have low bio-accumulation but are persistent and suspicious in long-term toxicity in humans are identified as Type II Monitoring Chemicals; subject to notification of quantity of import. In the case that the subject chemical substances are likely to be harmful to human health, the importers may be instructed to investigate the toxicity (long-term toxicity for humans). If it is determined that the substance is toxicitic and that its toxicity has potential to cause damage to human health, it will be designated as a Class II Specified Chemical Substance.

4. Chemical substances which have low bio-accumulation but are persistent and toxicity to the general animal and plant populations are identified as Type III Monitoring Chemicals; subject to notification of quantity of importation. In the case that the subject chemical substances are likely to be harmful to plants or animals through environmental pollution, the importers may be instructed to investigate the toxicity (long-term ecotoxicity). If the study determines the toxicity and that the toxicity has potential to cause damage, the subject is designated as a Class II Specified Chemical Substance.

5. In the case of notification of a new chemical substance, the name, structure, planned import quantity, the data on persistency, and bioconcentration, and the results of Ames (bacterial reverse mutation) assay, chromosome aberration test, repeated dose 28-day toxicity study, algae growth inhibition test, daphnia acute natatorial prevention test, and fish-acute toxic test will be required.

6. However, in the case of a new chemical substance of which the total annual quantity of production and importation is less than the quantity provided in Ministrial Ordinance (10t), and if the subject substance is proved persistent and not highly bio-accumulative, it has a low likelihood of release of toxicity into the environment. Therefore, despite the possibility that long-term toxicity for humans or plants/animals has not been clarified, the import amount less than provided in Ministerial Ordinance (10t) is allowed by test data of concentration.

7. Those chemical substances that were produced or imported up to and including 1974 are in the List of Existing Chemical Substances. The decision of notification as a new substance is made based on the list. Notification is required if the substance is not in the list, even if it has been in long-term use in foreign countries.

8. If the hazard assessment by the government finds persistence and bio-accumulation in an Existing Chemical Substance, the substance is designated as a Type I Monitoring Chemical Substance and notification of quantitiy of import is required. In such cases where the substance may cause the damage to the environment, the importer may be instructed to undertake a study on toxicity (to humans and/or top predators). If the result shows toxicity, the substance is designated as a Class I Specified Substance. In addition, an Existing Chemical Substance will be subject to regulation if the substance is identified as a Type II or Type III Monitoring Chemical Substance or Class II Specified Chemical Substance based on the extent of long-term toxicity and toxicity for plants and animals.

9. Reliability of test data that are required for notification of a new chemical substance should be assured by the OECD Principle of Good Laboratory Practice (GLP). Based on this system, test data generated by GLP-accredited test facilities by OECD members is accepted for notification.