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Case Study: Polymer Assessment - Understand your polymer and its regulatory obligations

A manufacturer of a complex product believed to be a polymer was unsure of their regulatory obligations with regard to REACH. In particular they were concerned that, if the product could not be considered a polymer, a lead registration of a new UVCB substance would be required, which would be financially prohibitive. They required a pragmatic and economical assessment to allow business decisions to be made with regards to the future of that particular product line.

Yordas Group proposed an initial desk based assessment of the client’s product. We provided a detailed list of the information needed to develop the polymer assessment and once the data was made available, it was examined by one of our experienced chemists to establish the mechanisms involved in the manufacture of the polymer. Theoretical structures for the product were deduced based on chemical understanding of the relative reactivity of the reagents involved as well as literature evidence of similar manufactures. The theoretical structures were then evaluated against the definition of a polymer presented in the REACH regulation and accompanying polymer guidance documents. It was considered that the product fulfilled the structural criteria defined by REACH for a substance to be considered a polymer; however, further consideration of the client’s data was required to confirm that it met the other criteria specified in the regulation.

The supplied manufacture details were further probed to establish theoretical maximum and minimum molecular weights for the polymer molecules based on the stoichiometry of the reagents. From this information it was clear that the client’s product was likely to be a polymer as defined by REACH; however, practical evidence was deemed necessary to confirm this. A cost-effective, targeted analytical strategy was designed to evaluate the composition of the product using chromatographic analysis to establish the molecular weight range of the polymer. The results were found to support the theoretical conclusion established in the initial phase.

As polymers are exempt from REACH registration, the output of the project reduced the regulatory burden on the client who was then able to justifiably submit joint registrations for the monomers used to manufacture the polymer rather than perform an expensive lead registration of a new substance. This ultimately ensured that the client was able to meet their regulatory obligations and their product line remained commercially viable.