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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If you're interested in learning how to meet REACH obligations but are unsure of where to begin or what is required, we're here to help.

Yordas offers concise, comprehensive and cost-effective up-to-date information about notification requirements, developing legislation and regulations around the world. From identifying regulatory obligations and understanding international business risks, to fully supporting your in-house regulatory teams, Yordas can help your business secure access to global markets. To reach out to our team, please don't hesitate to get in touch with us.

Additionally, more information about our Global Notifications services can be found on our website here.