Technical Considerations for Insoluble Polymer PLC Registration under K-REACH

1. Definition of Insoluble Polymer

A polymer that does not dissolve in any solvent under normal environmental conditions.

2. Required Documentation for PLC (Polymer of Low Concern) Registration under K-REACH

• Information on the insoluble polymer (including the polymer itself and its monomers).
• Solubility test report.
• Particle size analysis report.
• Gel permeation chromatography (GPC) test report for soluble fractions (as needed).

3. Experimental Workflow for Insoluble Polymers

(1) Solubility Test

Select at least 3 solvents (including polar and non-polar) based on the polymer’s properties to determine solubility.

Common solvents: Water, THF, DMF, NMP, CHCl₃, etc.

• If solubility <2%: Only particle size analysis is required; no GPC test is needed.
• If solubility ≥2%: Both particle size analysis and GPC testing are required.

(2) Particle Size Analysis

Determine the number average molecular weight (Mn) of the polymer.

(3) GPC Testing for Soluble Fractions

• If GPC testing is feasible: Calculate the weight average molecular weight (Mw) for fractions <1000 and <500.
• If no GPC signal is detected: The laboratory must issue a statement explaining the absence of detectable signals.

Challenges and Solutions

Under K-REACH, polymers meeting PLC criteria may qualify for registration exemptions by submitting GPC reports. However, many insoluble polymers face challenges due to the inability to identify suitable solvents for GPC testing, hindering compliance efforts. CIRS Group has extensive experience in PLC exemption applications and provides tailored solutions to help enterprises efficiently secure exemptions. 

About CIRS

CIRS Group is a leading provider of comprehensive regulatory compliance services and solutions for chemicals, cosmetics, food and food-related products, agrochemicals, and medical devices. Its chemical team consists of experts with extensive knowledge in chemistry, toxicology, environmental science, and related fields. They are well-versed in various international regulations, including but not limited to CSCL, EU REACH, CLP, GHS, TSCA, and K-REACH. 

CIRS operates a subsidiary in South Korea. By leveraging the expertise of CIRS Korea and the international team, CIRS can provide enterprise various South Korean chemical services, including but not limited to:

• K-REACH resigstration;
• Form 25/26 preparation;
• K-BPR compliance; and
• KOSHA SDS submission.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.