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Polymer under Kashinho (Japanese Chemical Substances Control Law, CSCL)

If the manufactured or imported volume of polymers is below 1 t/y throughout Japan, Small Quantity Permit can be applied.
If the volume is over 1t/y, the Polymer Flow Scheme (PFS) Test should be conducted for polymers.
Sumika Chemical Analysis Service has a wealth of experience in handling a wide variety of polymers and has the capability to perform the Polymer Flow Scheme (PFS) Tests to meet Kanshiho (Japanese Chemical Substances Control Law, CSCL) requirements.

1. What's Polymer under Kashinho (Japanese Chemical Substances Control Law, CSCL)?

1. Definition (must fulfill all of the following criteria)

  1. Molecules consisting of at least 3 monomer units must be ≧50% by weight
  2. Molecules of the same molecular weight is <50% by weight
  3. Number average molecular weight (Mn) is ≧1,000

2. Criteria (Confirmed by Polymer Flow Scheme (PFS) Test)

Unaffected by light, heat, pH and meet one of the following conditions

  1. Insoluble in water, acid, alkali, and organic solvents
  2. If soluble in water or organic solvents, molecular weight <1,000 must be 1% or less
  3. If molecular weight <1,000 is above 1%, it should not be highly bioaccumulative.

2.Criteria for Polymers of Low Concern (Must fulfill one of the following)

Criteria 1:

  1. Found to be stable*1
  2. Insoluble in water and organic solvents, acids and alkalis*1
  3. Does not contain metals other than Na, Mg, K, and Ca

Criteria 2:

  1. Found to be stable*1
  2. Does not contain As and Se in the chemical structure
  3. Soluble in water or organic solvents, and molecular weight <1,000 is less than 1% and Mn is ≧10,000*1
  4. No knowledge indicating components with molecular weight <1,000 are highly bioaccumulative

Criteria 3:

  1. Found to be stable*1
  2. Does not contain As and Se in the chemical structure
  3. Soluble in water or organic solvents, and molecular weight <1,000 is less than 1% and Mn is ≧1,000 and <10,000*1
  4. All the monomer/s must be of existing chemical substance/s and does not contain functional groups of concern.
  5. No knowledge indicating components with molecular weight <1,000 are highly bioaccumulative
*1 Stability, Solubility, Molecular weights are confirmed by the Polymer Flow Scheme Test.

3.Functional Groups of Concern

Reference: Reference: "Creating or Submitting the prior confirmation notification form for polymers related to Article 3, paragraph (1), item (vi) of the Act" published on March 25, 2010 by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry and the Minister of the Environment.

4.Polymer Flow Scheme (PFS) Test

1. Stability Test

The test is conducted under following conditions and the changes in molecular weight distribution, IR spectra and Dissolved Oxygen Concentration (DOC) are determined.

Test concentration: 1,000 mg/L
pH4 and 9 buffer solution :40℃ ×2 weeks
Number of repetitions: n=2
Light: Indoor light

2. Solubility test

3 specified solvents: water,THF and DMF (DMSO or NMP may also be used instead of DMF)

Test concentration: 2,000 mg/L

Test condition: Weight change after 1hour of stirring the test solution at 35 to 40 ℃ and left to stand for 24 hours at 25 ℃ are determined. (DOC in water is also measured)

Solvent: If the sample is soluble in one of the 3 specified solvents, the solubility test should be conducted with one soluble organic solvent and water. If the sample is not soluble in all the 3 specified solvents, the solubility test should be conducted with all the 3 specified solvents.

3. Determination of Molecular weight

Measured by Size Exclusion Chromatography (SEC) *2

*2: SEC is a comprehensive term for GPC.

5.Advantages and Disadvantages of Low Concern Polymers

  1. Confirmation notice is issued in a shorter time.
      For the Polymer Flow Scheme Notification, confirmation notice is issued in 4 to 5 months of submission.
      For the Polymers of Low Concern Notification, confirmation notice is issued in 1 to 2 months of submission.
  2. Not announced in the Official Gazette.
  3. Submission is possible only with simplified chemical substance names and trade names.(IUPAC name is not needed.)
  4. No annual reporting of manufactured and import volumes required.
  5. May be subject to authority audits.
  6. Foreign companies outside Japan cannot be a notifier.

6.Flow Scheme of Polymer and Low Concern Polymer

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