On 6 March 2018, Japanese Ministry of Economy, Trade and Industry (METI) issued a notice and revised the test methods of progression-free survival (PFS) test on polymers under the Chemical Substances Control Law (CSCL). If the PFS test shows no risk of causing damage to human health or the habitat and other matters of plants and animals in the human living environment of a new chemical substance which is a polymer, then the polymer is considered a polymer of low concern (PLC) and exempted from the normal new chemical notification under CSCL. But it should be noted that the polymer also has to meet following conditions to be regarded as a PLC:
- Average molecular weight of 1,000 or more;
- No observed changes in weight under acids or alkalis;
- No metal element included, except for Na, Mg, Ca, and K;
- Insoluble in water or organic solvents.
Japanese authorities dont require enterprises to conduct the PFS tests in GLP labs. So usually enterprises could conduct the tests on their own in order to reduce the test costs. The comparison between the former test methods and the revised ones can be seen here.
Chemlinked, 23 March 2018 ;