ECHA head unveils agency priorities, promises unbiased assessment of PFAS restriction
Chemicals
| By RAYAN BHARGAVA, MSC
In her first ENVI public hearing, ECHA head Sharon McGuinness flagged the agency’s priorities for 2024 as its competency expands. In an interview with Politico, she also pledged that ECHA will prioritize its independence in the face of industry pressure on the high-profile PFAS restriction proposal.
Regulatory background
- Dr. Sharon McGuinness was appointed executive director of the European Chemicals Agency (ECHA) and started her tenure at its helm on December 1, 2022.
- On November 29, 2023, she participated in her first annual hearing with the European Parliament’s environment committee (ENVI). Her opening statement provided a review of ECHA’s achievements from 2023 while foreshadowing the agency’s aspirations for the coming year.
The future of ECHA
- Expect ECHA to extend its competency to the new Serious Cross-border Threats to Health Regulation (2022/2371/EU) soon. The director said that her agency is preparing to publish a risk assessment on the likely severity of chemical and environmental threats to public health. Although constructed as legislation to bolster coordination ensuring a more robust response to international public health threats, like the COVID-19 pandemic, the regulation also lists threats of chemical and environmental origin as key aspects of its scope. This is where ECHA will look to provide its expertise, and collaborate with other EU institutions, culminating in a risk assessment document that could guide future implementation.
- Forthcoming ECHA outputs will have a broader regulatory scope. While applauding ECHA’s recent opinions on the regulation of lead, asbestos, cadmium and cobalt, McGuinness looked to the future, stating that upcoming publications will consider a “wider spectrum of uses, such as chemicals in contact with drinking water or in batteries.”
- A new ECHA system for data availability is on the way. McGuinness stated that as ECHA’s mandate expands, its capability to provide users with interpretable data of varied sources and types must evolve at the same pace. The first version of the new system is expected to go live in early 2024. McGuinness used words like “restructuring” and “revamp” to characterize the extent of this change.
- McGuinness committed to providing more focus on the needs of small and medium enterprises (SMEs) in the future, when discussing ECHA’s longstanding industry support through its helpdesk, member-state helpdesks, IT tools, and the ECHA website.
- Authorization applications under REACH for chromium trioxide have peaked, putting ECHA committees under considerable strain. McGuiness stated that “this peak relates to so-called ‘upstream applications,’ an area subject to Court cases and Parliamentary resolutions.” While downstream applications for authorization are those submitted by the end-user of the substance for their own well-defined use, upstream applications occur when the importer or manufacturer of the substance submits in hopes that authorization will encompass the entire downstream supply chain. McGuinness qualified that ECHA is “applying mitigating measures” but reaffirmed that this is an area of particular burden for ECHA committees, which are already under pressure from the agency’s existing mandate. [for background, see AgencyIQ’s October 18, 2023 article]
- McGuinness ended her opening remarks with an endorsement of the prospective ECHA Basic Regulation. She characterized this law as a crucial component for ensuring that the agency continues to expand its remit beyond REACH without sacrificing quality, transparency, or efficiency. According to the preliminary call for evidence, this basic regulation is envisioned to provide ECHA with greater funding to take on its larger role in chemical regulation assigned in part by the Chemicals Strategy for Sustainability(CSS). Though it was slated for proposal by the second quarter of 2023, it has not yet materialized.
McGuinness promises to stand firm in the face of industry pressure
- The ENVI public hearing was not the only forum where McGuinness commented on the future of chemical regulation. In statements given to Politico Pro EU (available to subscribers), she pledged to avoid lobbying influence when contributing expertise to the decision-making process concerning the universal restriction on PFAS. ECHA’s executive director said her agency would remain above the political fray, guiding its action on this consequential regulation based purely on scientific evidence.
- NGOs have accused ECHA of giving in to industry advocacy before. The European Environmental Bureau (EEB) criticized the agency in 2020, alleging that it caved to industry pressure when it “dutifully excluded many sectors” from the REACH restriction on microplastics.
- Pressure on the proposed PFAS restriction is only likely to eclipse that associated with the microplastics ban. The PFAS consultation saw some of the most active participation in ECHA history, with the agency touting its 5,600 comments received. The relevance of the PFAS restriction cuts across a wide variety of industry sectors, as well.
- The list of affected sectors is likely to grow, if a recently leaked opinion from ECHA’s socio-economic analysis committee (SEAC) is to be trusted. Its contents convey the committee’s early sentiments that excluding the pharmaceutical and agrichemical industries is “not fully justified and inconsistent for several reasons.” Even before this leak, the European Federation of Pharmaceutical Industries and Associations (EFPIA) had voiced its opposition to the proposed PFAS restriction for its indirect effects on its covered industry. All this to say that industry pressure on ECHA for more lenient consideration will likely be intense and may only increase as the proposal makes its way through the agency’s committees. [For an in-depth analysis of the pharmaceutical industry’s reaction to the PFAS restriction, please read AgencyIQ’s October 3, 2023, article.]
Analysis
- McGuinness emphasized ECHA’s commitment to the One Health concept with the announcement of agency support for the Serious Cross-Border Threats Regulation. This is a framework that links human health to that of plants, animals, and the ecosystems they constitute. In this sense, ECHA analysis on chemical and environmental threats has direct application to human health.
- This holistic approach has recently seen an uptick in official EU references. ECHA’s Key Areas of Regulatory Challenge report and the EFSA roadmap for insect pollinators have both made direct mention of the concept in the past month. [For background on the ECHA Key Areas report or the EFSA roadmap, read AgencyIQ’s November 17, 2023, article or November 9, 2023, article.]
- The most prominent theme running through McGuinness’ remarks is ECHA’s evolution as an agency at the point of taking on significantly more responsibility. This is a development that will surely be aided by an ECHA standalone regulation. The adoption of the “basic regulation” for ECHA, whose existence so far has been based solely within REACH, is representative of its transition from an entity implementing REACH to a regulatory body administering all EU chemicals legislation. McGuinness underscored this sentiment at the top of her remarks, stating that “ECHA is now truly a chemicals agency, not just the REACH one.” ECHA’s influence in its assigned space, as well as its collaboration with other EU entities is only likely to increase in the coming years, especially when its own regulation materializes.
To contact the author of this analysis, please email Rayan Bhargava.
To contact the editor of this analysis, please email Scott Stephens.