Excipient group releases guide on reporting microplastic use in pharmaceuticals

Regulatory NewsRegulatory News | 24 March 2022 |  By 

The International Pharmaceutical Excipients Council (IPEC) has just released a how to guide to assist the pharmaceutical industry in complying with new labeling and reporting rules for microplastics that have been intentionally added to pharmaceuticals.
The document “summarizes the core elements of the restriction proposal and intends to provide guidance for excipient manufacturers and users on how to prepare for compliance,” IPEC announced.
The microplastics proposal was released by the European Chemicals Agency (ECHA) under its Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. It was prompted by environmental concerns that microplastics from medicinal products were being released into wastewater through the incorrect disposal of unused medicine. A consultation document was published by ECHA in 2019 and the rules are expected to be finalized this year.
ECHA defines microplastics as “small, usually microscopic, solid plastic particles” and include polymers, which are used in some formulations to expedite drug delivery. The regulation applies to solid polymers with a particle size smaller than 5 mm.
The guide covers the implications of the regulation on excipient manufacturers and the pharmaceutical industry, restrictions, the definition of a microplastic, derogations or exemptions, transition periods, labeling and reporting requirements
Product labeling should include “any relevant instructions for use to avoid releases of microplastic to the environment, including at the waste life-cycle stage. The instructions shall be clearly visible, legible and indelible,” according to the guide. The information also should be in the form of pictograms.
Manufacturers should send to ECHA by 31 January of each calendar year a description of their microplastic use in the previous calendar year; generic information on the identity of the polymer used; and for each use, an estimate of the quantity of the microplastics released into the environment in the previous calendar year.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) argued in a 2019 position paper that the regulation may impact the availability of certain medicines, noting that “the vast majority of solid oral dosage forms contain polymers.”
“There are limited alternatives to exchange polymers as excipients in medicinal products and the alternatives are not suitable for most formulations,” according to EFPIA.
The group further argued that “ECHA’s broad definition of microplastic puts a significant number of excipients used in the pharmaceutical industry and listed in the European Pharmacopeia into the scope of the restriction (e.g. cellulose acetate, hydroxypropylcellulose phthsalate, polymethacrylates, polyethylenglycol, and microcrystalline cellulose).”
IPEC guide


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