Thursday, June 22, 2023 - 11:00am to 1:00 am EDT
Featuring
Meera Raghuram – Director, Regulatory & Sustainability Strategy, Life Science Division of Lubrizol Corporation
EU Micro particle regulations are now imminent.
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 discussed 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.