The European Chemicals Agency (ECHA) is moving forward with proposed restrictions on the use of microplastics in products used in various market segments – including medicinal products. ECHA’s broad definition of microplastics may impact many excipients and drug products leading to increased labeling and reporting requirements. Based on current information, it is feasible that the regulation will come into force in late 2021 or early 2022.
Excipient manufacturers will need solubility and biodegradability data to confirm whether their excipients meet the definition of microplastics or not. Data will also be required to justify derogation of polymers that are permanently modified and no longer meet the definition of microplastics in end use applications. Materials that meet the definition and are derogated based on the intended use will still require labeling as microplastics. Even though medicinal products and food are derogated, there will be reporting obligations for pharmaceutical and food which include reporting quantity of microplastics released to the environment, either estimated or measured in the previous year.
All this will require strategy, collaboration and consistency; and the industry sector (excipient manufacturers and drug product manufacturers) will need to work together and coordinate efforts. Note that ECHA has stated that reporting requirements will continue until microplastics are no longer used. This implies reformulation may be needed - which is not an optimal or a justified approach for medicinal products.
Additionally, the webinar has also discuss what industry can do in the long term to collect credible data and evaluate longer term strategy for medicinal products.