Europaudvalget 2022-23 (2. samling)
EUU Alm.del
Offentligt
Should the pharmaceutical industry be concerned about PFAS?
Elastomeric components used for container closures are typically coated with a film to
prevent extractables from the compounds which may leach into the drug product and
adversely interact. Furthermore, the coatings are used to improve mechanical behaviors
such as prevention of stickiness and to improve friction and gliding ability on movable parts
like plunger stoppers for prefilled syringes or cartridges.
These coatings are typically made of ETFE, PFTE, or PCTFE films, and though they are currently
not listed under the OECD definition of PFAS
1
, the ongoing work with ECHA Regulation is
expected to broaden the definition of PFAS to
“substances containing at least one
-CF2 -
or -CF3 group", and hence these coatings will be included and will be impacted by the
existing and future legislative changes in both EU and in the USA
3
. In EU, some temporary
exemptions to the regulations exist until June 2023, and other exemptions, e.g. for medical
devices, exists until June 2025
4
, however the EU commission does not expect a general
essential use exemption will be substantiated.
Currently, various branch organizations and companies are arguing for the continued use
of -CF2 and/or -CF3 groups in drug products, medical devices and in primary packaging
either under the
term “essential use” and/or with the reasoning that no feasible alternative
exist. While the use of -CF2 or -CF3 groups in drug products (APIs) are not technically the
same or in many cases fall under
“essential use”
3
, there are hardly the same arguments for
the broad use in primary packaging, where there currently are commercially available
feasible alternatives, e.g, based on the use of the virtually chemically inert TPE materials
5
for
container closures. Examples are the vial stoppers by Aseptic Technologies, rigid needle
shields by Aptar, and plunger stoppers for prefilled syringes by Injecto.
ECHA defines PFAS as “forever chemicals” which are harmful by nature, both in regard to
human health but also for the environment
6
.
In short, with the regulation change by ECHA, the majority of the coatings used in parenteral
primary packaging are by definition PFAS, and there is substantial existing and ongoing
legislative work towards banning PFAS to the widest possible extent in both EU and in USA.
Consequently, the legislation and regulation will impact the ETFE, PFTE and PCTFE used as
coating in primary packaging, especially on container closure systems for prefilled syringes,
cartridges, and vials, and hence the business should potentially seek to reconcile the use of
such.
So, whether the pharmaceutical industry should be concerned about the ban of PFAS is a
highly relevant question, but moreover the questions should be, what can the
pharmaceutical business do to prevent the use and spread of PFAS? Are PFAS coatings in
primary packaging really a necessity when there are feasible alternatives? Do we wish to
participate in the environmental consequences of using PFAS based coatings?
Most companies are currently putting considerable efforts into corporate environmental
awareness, to minimize their carbon footprint and to implement various sustainability
programs, so why not also be proactive and turn this potential challenge into a value
proposition.
1) https://www.oecd.org/chemicalsafety/portal-perfluorinated-chemicals/terminology-per-and-
polyfluoroalkyl-substances.pdf
2) https://osha.europa.eu/da/legislation/directives/regulation-ec-no-1907-2006-of-the-european-parliament-
and-of-the-council
3) https://www.efpia.eu/media/636866/pfas-position-_-efpia-and-animalhealtheurope-january-2022.pdf
4) https://www.foodpackagingforum.org/news/eu-publishes-pfoa-regulation
5) Holden G., Kricheldorf H.R., Quirk R.P., Hanser, Thermoplastic elastomer, 3
rd
edition, Cincinnati, 2004, Plastics
engineering, April 2015