The long-awaited revision of the EU REACH regulation is expected in Q4 2025, and all eyes are on how it will finally address polymers.
Although polymers are currently exempt from REACH registration, the monomers that make them, and certain polymer-like substances, are already subject to regulation. For instance, oligomers, and polymers within complex mixtures (UVCBs) may already be registered under other substance categories.
As of February 2024, there are approximately 80,000 unique substances registered under REACH, with ECHA having evaluated just 21% of them. If polymers are brought within the scope of REACH, the regulatory burden will increase significantly. Estimates from Cefic suggest there are between 200,000 and 400,000 polymers currently on the EU market. Even assuming a strategy of grouping polymers, the scale of potential new registrations is substantial for both industry and regulators.
Why Are Polymers Being Included in REACH?
Mounting concerns include microplastics, environmental persistence, and end-of-life – these impacts make the inclusion of polymers in REACH increasingly likely. The most probable approach will be a phased one, beginning with a notification requirement. Polymers deemed low-hazard may be exempt from full registration, while those presenting potential risks could be subjected to further regulatory obligations.
The expected pathway mirrors the original REACH rollout: a multi-year, tiered system prioritised by hazard and volume. Grouping of polymers will likely necessitate the formation of dedicated REACH consortia, responsible for data sharing and compliance under both REACH and EU competition laws.
This will place a new onus on industry and regulators alike to adapt current test methods (EU, UN, OECD) and develop new ones tailored to the complexity and diversity of polymers; including predictive models.
What Should Industry Do to Prepare for Polymer REACH?
While we await the formal proposal, industry should not remain idle. Monitoring developments is important, but preparation starts with understanding your polymer portfolio. Grouping similar polymers into clusters can help streamline future notification or registration processes.
At the core of REACH compliance is the accurate identification of substances. For polymers, this means thorough characterisation, despite the challenges posed by high molecular weights, cross-linking, and insolubility. Knowing your materials inside and out is crucial.
Polymers may require alternative or enhanced analytical approaches. Traditional methods like IR, UV, NMR, GC, HPLC, and MS may be suitable in some cases, but will often fall short. Techniques such as Gel Permeation Chromatography (GPC), thermal analysis, and MALDI-MS may offer better insights for more complex materials.
Major Shift for Polymer Industry & REACH Regulators
Bringing polymers under REACH will mark a major shift for both industry and regulators. It signals the EU's intent to close a longstanding gap in chemical regulation, driven by increasing societal and environmental scrutiny. Those who begin preparation now, through grouping, characterisation, and method development, will be best positioned to meet the challenges of the REACH revision head-on.
If you'd like external support in characterising polymers, preparing for the changes to EU REACH, or developing your regulatory strategy, our REACH consultants are ready to help. Call or email and speak with one of our regulatory experts early.
