Featuring
Meera Raghuram – Director, Regulatory & Sustainability Strategy, Life Science Division of Lubrizol Corporation
The European Chemicals Agency (ECHA) is moving forward with proposed restrictions focused on synthetic polymer microparticles under the EU Restriction Evaluation Authorization of Chemicals (REACH) regulations. The restriction proposal was approved in the REACH Committee vote on April 26, 2023, and the timeline for publication of the final regulation is 3Q 2023. This webinar will discuss key aspects of compliance strategy for both excipient makers and users.
The proposed REACH regulation is extensive and is going to create a significant compliance burden on a large industry segment. Medicinal products are derogated from restrictions on use of synthetic polymer microparticles. ECHA’s broad definition of microplastics, which includes synthetic solid polymers and/or polymer containing particles, will result in excipients and potentially whole tablets (< 5mm in size) to be classified as a microparticle. Certain polymeric materials which are natural, soluble, and biodegradable are excluded from scope but there are stringent data requirements which will be discussed in the webinar. There will be reporting obligations for medicinal products on the use and release of microparticles into the environment which will rely on data. The EU commission has clearly indicated that reporting is intended to collect data on sector specific releases, and they could impose additional restrictions if they deem it necessary. Both users and suppliers are obligated to provide documentation and justification for compliance purposes.
Learning/Awareness Objectives
> Update on ECHA’s proposed restrictions for synthetic polymer microparticles under REACH.
> ECHA’s broad definition of microplastics, as related to medicinal products.
> EU commission’s current thinking on data collection and potential restrictions for both users and suppliers.
> Collaboration between excipient and medicinal product manufacturers to develop a scientifically sound and consistent strategy.
Who should attend?
Personnel from excipient manufacturer, user and distributor regulatory, quality, R&D, formulation, purchasing, manufacturing and supply chain areas would benefit from attending this webinar.
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