NAM&NAM | Overseas Chemical Regulations | Japan Chemical Substance Control Law (CSCL)
Japan Chemical
Substance Control
Law (CSCL)
Chemical Substance Control Law (CSCL)
CSCL Chemical Substance Control Law
  • Act on the regulation of examination and manufacturing of chemicals
  • The purpose of this law is to prevent environmental pollution by chemicals that are likely to harm human health or interfere with the habitat and growth of animals and plants
Notice process
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System of Chemicals
System of Chemicals
Chemicals designated in ‘Class-I’ (31 substances)
Persistent,
bioaccumul-ative and
long-term toxicity to
the human body or
apex predators
Chemicals subject to Monitoring (37 substances)
Persistent,
bioaccumulative and
unknown toxicity
Chemicals designated in
‘Class-II’ (23 substances)
Toxic and high risk to
human health and
ecosystem
Priority Assessment Chemicals
(201 substances)
Risk assessment
by Japanese
government
General Chemical Substances
(around 28,000substances)
Specified General Chemicals
Notice of small volume of non-Phase-in substances
  • Notice the total volume of national environmental emissions (up to 1 ton)
  • Notice each use per substance, and a certificate of use must be attached
  • The number of online applications increased from 4 times a year to 10 times a year
Notice of Non-Phase-in substances with low-output
  • Notice the total volume of national environmental emissions (up to 10 ton) (13 times/year)
  • Notice each use per substance
  • Document to be submitted : Letter of Low-volume New Chemicals Notification, Use Confirmation Letter
Pre-confirmation of low-concern polymer
What is polymer?
  • The total weight of three or more bound molecules is at least 50% of the total, and the total weight of the same molecule is less than 50% of the total
  • Number average molecular weight (Mn) of 1,000 or more
  • Regardless of tonnage, the test proceeds according to the independent safety assessment test method [Polymer Flow-Scheme]
View details of low-concern polymer
Advantages of pre-confirmation of low-concern polymer
  • No need for pre-examination on the manufacture and import of non-Phase-in substances
  • No restrictions on manufacturing and import volume
  • Relatively short review period due to frequent receipt of application
  • Substance name not disclosed (information protection)
  • There is no obligation to [notice Annual Manufacturing and Import Volume] conducted in June of each year
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Substances subject to pre-confirmation
  • Non-Phase-in chemicals with low production: subject to the substance in ‘less than 10 tpa’ and ‘not bio-accumulative’
  • Small volume of non-Phase-in chemicals: subject to the substance in ‘less than 1 tpa’
  • Intermediate: No volume limit in manufacture or import
  • Polymer of Low Concern(PLC): No volume limit in manufacture or import
Subject of low-concern polymer
In case of the following Ⅰ or Ⅱ
Ⅰ. A polymer compound that satisfies all of the following requirements
  • ① Corresponds to physicochemical stability standards
  • ② Insoluble in acid/alkali solutions.
  • ③ Insoluble in water and organic solvents.
  • ④ No metals other than Na, Mg, K, and Ca.
Ⅱ. A polymer compound that satisfies all requirements of ①, ②, and ④ of Ⅰ and ① ~ ③ below
  • ① Soluble in water and organic solvents, with a content of less than 1% of components with a molecular weight of less than 1,000 and not highly accumulating in the body
  • ② Substances that do not contain arsenic or selenium
  • ③ Substances with an Mn of 10,000 or more or all monomers that do not contain epoxy groups or sulfonic acid groups as Phase-in chemicals