Pharma industry raises concerns as EU consults on plan to ban PFAS

Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals.

The widely used substances are sometimes used in the production of pharmaceuticals, including being found in some active pharmaceutical ingredients (APIs), raw materials used for chemical synthesis, as well as in reagents and manufacturing equipment.

ECHA is accepting public comment from 26 March-25 May on a recent draft opinion by its Socio-Economic Analysis Committee (SEAC) about the feasibility, benefits and costs of proposed EU-wide Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) restrictions on PFAS.

The SEAC draft followed the 2 March release of a final opinion on the topic by ECHA’s Risk Assessment Committee (RAC).

As part of the process for getting a REACH restriction on a substance that harms human health or the environment, authorities in EU member countries explain the background and risks in a dossier, which is then reviewed by the SEAC and RAC. Both committees recommended a ban on PFAS across the EU, allowing for targeted derogations.

In its draft opinion, SEAC noted that continuous emissions of PFAS lead to “unavoidable exposure of humans and related negative effects on human health,” including on:

• liver and serum cholesterol levels
• developmental effects such as birth weight and neurodevelopmental effects
• immune function
• antibody response after vaccination
• ability to fight infection

“Once present in the environment, the removal of PFAS from surface water, groundwater, soil, sediment and biota is technically extremely difficult and very costly, if at all possible,” SEAC wrote.

In a statement, the ECHA noted that SEAC acknowledges the need for targeted derogations for specific PFAS uses “when this is justified by the available evidence that alternatives are not available as well as by the assessment of costs and benefits, to ensure the restriction remains proportionate.”

A final decision from SEAC is expected by end-2026.

In its final opinion, published 10 March, the RAC noted the growing and highly persistent health risks of PFAS, including cancer and reproductive harm. It called for EU-wide regulatory action to protect people and the environment as well as risk management requirements if derogations for specific uses are allowed, including emissions monitoring and reporting of PFAS emissions from manufacturing and industrial sites.

While SEAC also supports risk management measures to minimize PFAS emissions for derogated uses, it “cannot conclude whether these specific measures are proportionate.”

EFPIA “deeply concerned”

The restrictions can also apply to packaging materials using fluoropolymers, or combination products such as pre-filled syringes. (RELATED: EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS ban, Regulatory Focus 28 September 2023)

The coalition of EU countries that prepared the PFAS dossier had suggested a time-unlimited derogation for APIs. However, SEAC concluded in its draft opinion that the exclusion of APIs in human and veterinary medicinal products from the PFAS ban via a time-unlimited derogation “has not been justified.”

The European Federation of Pharmaceutical Industries and Associations (EFPIA) said that it was “deeply concerned” about the ECHA opinions in a 26 March statement. It will take time to find alternatives to PFAS and the pharma industry needs a time-unlimited derogation, in EFPIA’s view.

“Without a time-unlimited derogation for pharmaceutical active pharmaceutical ingredients (APIs) containing fluorine could see many withdrawn from the market as early as 18 months after entry into force,” EFPIA wrote.

At least 139 active pharmaceutical ingredients (APIs) containing PFAS are in use and more than 650 medicines on the World Health Organization Essential Medicines List could be lost, according to EFPIA.

“PFAS materials are essential for manufacturing processes, medicinal products, APIs, delivery devices and packaging used by millions of Europeans,” EFPIA said. “Medicines and their components cannot be substituted on a one-to-one basis without going through R&D, legal and regulatory approval processes.”

SEAC questioned the assumption in the dossier that diagnostic laboratory testing – including in vitro diagnostic medical devices and calibration of measurement instruments and as analytical reference materials – were fully covered under a scientific research & development (SR&D) exemption.

SEAC’s proposals for medical devices include a 13.5-year derogation after entry into force (EiF) for implantable medical devices, including medical implants and meshes, and invasive medical devices, such as tubes and catheters and polychlorotrifluoroethylene (PCTFE)-based packaging for medical devices.

MedTech Europe told Focus that it is reviewing the RAC and SEAC opinions and will “continue active engagement in the process to ensure sector-specificities are taken into account in the final decision.”

Consultation process

For the consultation, ECHA is soliciting comments via responses to separate surveys covering 14 specific sectors analyzed in the draft opinion – including medical devices – and PFAS manufacturing. There is also a general survey, which touches on all sectors, including those not specifically evaluated.

Respondents will need to keep their answers to each question under a limit of 5,000 characters with no attachments and may fill out as many surveys as they want, based on applicability to their products.

In a LinkedIn post, Ales Bartl, partner at Keller & Heckman in Brussels, highlighted on LinkedIn that the SEAC draft flags where justifications for many derogations are not entirely justified.

“Thus, there is a risk that some of the derogations will ultimately not be granted by the [European] Commission,” Bartl wrote. “Consequently, a contribution in public consultation is definitely warranted,” Bartl wrote.

Bartl advises companies to check the proposed derogations in SEAC’s draft opinion and determine if they are long enough to find an alternative.

“Most of the exemptions are granted for 13.5 years after the date of publication of the future PFAS restriction regulation (which we expect to take place 2029/2030), but this may not be enough,” Bartl wrote. “Also, information on available alternatives may not be accurate, so any new information should be provided.”

PFAS SEAC draft opinion consultation, SEAC draft opinion and RAC final opinion, SEAC sector evaluation: medical devices, Background dossier reviewed by SEAC and RAC