Polymer Registration and Exemption
Challenge
Our client, a chemical company, was looking to determine whether their polymer, polybutylene, was exempt under K-REACH or required a polymer registration.
The following aspects of the polymer must be considered to determine if a Polymer of Low Concern (PLC) exemption applies:
Is the polymer cationic?
Is the number of average molecular weight (Mn) ≥ 1000 Daltons or 10,000 Daltons?
What is the percentage of oligomers with a mass <500 Daltons?
What is the percentage of oligomers with a mass <1000 Daltons?
Does the polymer contain hazardous, priority control or new chemicals?
Our Solution
Step 1 - Gel Permeation Chromatography (GPC) analysis of the polymer to the required guidelines
A suitable GPC method was rapidly developed and conducted in accordance with guidance. The analysis demonstrated that the polymer had a Mn ≥ 1,000 and < 10,000 Daltons. Integration of the results established the relevant oligomer content and allowed a firm conclusion to be drawn regarding the exemption status of the polymer under K-REACH. In addition, analytical results were included in line with K-REACH recommendations. The data showed that the polymer did not meet the exemption criteria and required registration.
Further information as to whether the monomers were considered hazardous, priority control or new chemicals was no longer considered relevant as the polymer was not exempt.
Step 2 - Polymer registration requirements
To register the polymer, the residual monomer content of the polymer was determined and the stability of the polymer under acidic and alkaline conditions was assessed.
Step 2a. Residual monomer analysis
Based on the structure of the polymer and its manufacturing process, Yordas chemists confirmed the relevant monomers. With a thorough understanding of their chemical properties, a suitable analytical method was developed to detect and quantify the monomer within the polymer. In this case, quantitative gas chromatography with mass spectrometry detection was successfully employed. This analysis demonstrated that residual monomer levels would not impact the overall classification of the polymer.
Step 2b. - Polymer stability analysis to the required guidelines
The stability of the polymer was investigated at pH 1, 4, 7 and 9 using GPC, Infrared (IR) and total and dissolved organic carbon (TOC and DOC) to understand whether the polymer was stable under acidic and alkaline conditions. The polymer was unchanged in the various pHs and thus considered stable in both acidic and alkaline conditions.
Benefits to the Client
Our client received:
☑ Clear and timely guidance on testing requirements
☑ Tailored polymer and monomer analyses whilst adhering to guidelines
☑ Detailed report of analytical results and conclusions suitable for K-REACH polymer registration
☑ Post submission support with authority communication
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