New Chemical Notification in Japan
The Chemical Substances Control Law of Japan sets out a detailed scheme for modifying substances not listed in the MITI Inventory to the appropriate Japanese authorities. The theory and practice of notification in Japan are very different from those of the EU Chemical Registration scheme.
The MITI Inventory is "open", so the first step is always to check if your chemical substance in already listed: this is not as simple as it sounds, because a number of entries in the inventory are rather generic and may be interpreted in different ways. This is especially true for polymers, and it is notable that polymers are notifiable even if all starting monomers from which they are made are already included in the inventory.
For chemicals to be made or imported at <1 tonne/year, a low-volume exemption with limited information is possible. Exemptions from notification can be available for chemicals with very limited potential for exposure/emission (e.g. certain closely controlled chemical intermediates): such exemptions are subject to official "prior verification" review.
Polymer notification can be achieved without test data for toxicity or ecotoxicity if the polymer in question gives suitable results in Polymer Flow Scheme testing (i.e. has high Mn and low-MW content <1 wt%, is not hydrolyzed or soluble in water or common solvents). Non-polymers and polymers which fail PFS testing require full notification, unless tonnage will be <10 tpa and Japanese regulators can be convinced of low risk based on certain limited data. Full notification involves:
- evaluation of ready biodegradability (readily biodegraded substances may not require further testing)
- evaluation of potential for bioaccumulation (first determination of Kow; if log Kow =/>3.5 a fish bioaccumulation test is needed except for certain high-MW substances)
- mutagenicity tests (bacterial mutation (Ames) + chromosome aberration tests)
- 28-day oral toxicity study with recovery phase
- ecotoxicity testing (acute fish and Daphnia tests + algal growth test).
The leading Japanese contract research and consulting organisation Mitsubishi Chemical Medience Corporation (MCM) have long experience of performing the tests needed for notification and preparing the necessary notification dossiers. We have a long-established and close collaboration with the relevant MCM personnel. In this way, we give our clients access to all the expertise of MCM, covering every stage from initial inventory checking to preparation and submission of the necessary notification documents (and negotiation with regulators to secure acceptance). MCM can also advise on the applicability of other chemical control laws which may necessitate data submission (e.g. the Industrial Safety and Health Law of Japan).
The full range of these services are available to our clients.