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The European Chemicals Agency (ECHA) published a proposal restricting the use of 10,000 PFAS at the beginning of February 2023. It aims to reduce the presence of PFAS in the environment and to make manufacturing processes and products safer for people. This proposal would update the REACH Regulation Annex XVII Restricted List.
ECHA officials have called this proposal “landmark,” and for good reason. Its sweeping scope will have a major impact on manufacturers located or selling into the EU. There is enormous pressure to pass this proposal, and it’s imperative manufacturers prepare their supply chains now.
Background on the Proposal
PFAS are a family of synthetic chemical substances that are durable, persistent, and bioaccumulative. Some scientists estimate that there are over 12,000 substances in this family. They don’t break down easily and could contribute to health issues.
Concerns about PFAS usage are growing, and governments around the world are restricting their usage. Authorities in Denmark, Germany, the Netherlands, Norway, and Sweden have spearheaded the ECHA proposal, which offers two options for restricting usage:
- A full ban, with no exemptions, and an 18-month transition period after the regulation enters into force
- A full ban with use-specific, time-limited exemptions that would carry an 18-month transition period and a five- or 12-year derogation period, depending on the application
Option two is the submitters’ preferred choice. They believe it is the most balanced option because it gives manufacturers enough time to transition to alternative substances.
The next step after publishing the proposal is evaluation and consultation. Two ECHA committees, Risk Assessment and Socio-Economic Analysis, will assess whether the proposal meets REACH legal requirements. If the proposal does fulfill REACH’s legal requirements, the two committees will begin a scientific evaluation of the proposal.
A six-month consultation process begins on March 22, 2023. ECHA’s committees will take the stakeholder opinions from that consultation into account before submitting their final thoughts to the European Commission. It’s essential that manufacturers submit comments regarding essential PFAS uses in products and operations to ensure the committees understand the impact of this proposal on industry.
Proactively prepare for changing PFAS restrictions. Download our guide, How to Prepare for PFAS Risks, now.
The Impact on Manufacturers
The ECHA proposal to update REACH Annex XVII to restrict an enormous number of substances of the PFAS family will have a major impact on manufacturers.
As a result, manufacturers will need to:
- Gain deeper insights into the composition of their products
- Create a proactive compliance program to avoid PFAS risks
- Potentially redesign their products to meet new requirements
- Recertify/requalify redesigned products
Gain Deeper Insight Into Product Composition
PFAS could be hidden deep in your supply chain, and you might not be aware of it. Manufacturers must identify their PFAS risks to maintain EU market access.
Understanding product composition and performance is crucial. Do your products have non-stick coatings? Are they waterproof? Are you using heat-proof materials, including electrical insulation?
Determining where PFAS are in your supply chain is the first step to mitigating risks.
Create a Proactive Compliance Program to Avoid PFAS Risks
Proactive compliance will be key to mitigating PFAS risks. Manufacturers must start planning now for the regulatory compliance processes, even if they won’t come into effect for over a year.
Being ahead of the curve offers a competitive advantage. When other manufacturers are scrambling to find PFAS-free parts, you’ll be able to sell into the EU without trouble.
Redesigning & Recertifying Products
Products containing PFAS may need to be redesigned to meet new specifications. Product redesign is a lengthy and expensive process, so it’s best to determine redesign requirements as soon as possible.
Redesigned products will also need to be evaluated to ensure they can be sold in the EU. That can also be a lengthy process. However, this process is crucial, as there’s no market access without certification/qualification.
How Assent Helps
There are thousands of PFAS chemicals used globally, and it’s difficult to understand where they are in the supply chain. This makes regulatory compliance, or anticipating the other business drivers like early obsolescence risk, an overwhelming challenge.
Assent offers manufacturers deep visibility into their supply chain, making it easier to identify their risks and demonstrate due diligence. They can provide defensible due diligence regarding PFAS risk in their supply chain to customers, regulators, investors, and insurers.
Cally Edgren, Director of Regulatory & Sustainability Experts at Assent shares how the latest PFAS announcement affects manufacturers. Watch the video now.
