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Background

One of the most profound changes proposed under the EUs Chemicals Strategy for Sustainability (CSS) is the proposal to extend the duty to register polymers. Currently, there is no requirement to register polymers per se under EU REACH, although there is a requirement to register their monomer constituents. With circa 200,000 polymers on the market in the EU, this change will potentially have a huge impact on industry.

The authorities first set up a committee to examine how to proceed with the proposed changes. The committee commissioned a report to examine the existing literature on polymers and their hazards and make some recommendations on criteria for the proposed duty to register. Some of the issues under consideration were:

• Not all polymers are non-toxic, but which ones?

• How can polymers be grouped for hazard assessment?

• The availability of test methods

• Polymer contribution to microplastics

The resulting report (Wood & Fisk Associates, 2020) proposed splitting polymers into groups: those that would require registration (PRRs) and those that would not trigger a registration requirement (Polymers of Low Concern or non-PRR). Of these, it was estimated that approximately 50% of the polymers currently on the market can be considered non-PRRs, with another 10-20% likely to be considered PRRs and a further 25-40% polymers that can be considered unique. The Report recommended 7 polymer types that were likely to fall under the PRR category and 12 hazard classes. It also proposed a registration process.

Since the publication of the report, the authorities have been holding discussions with various stakeholders to further define PRR and non-PRR and to refine the functionalities that would trigger a polymer being identified as a PRR. Throughout this process, certain issues have been highlighted. These can largely be categorised as:

Identification and Naming:

• How to define a polymer–should the EU definition or the OECD definition be used?

• How should definitions align with other global jurisdictions, for example in the case of non-PRRs? Here, industry has argued that a close alignment would allow for consistency, but NGOs have pointed out that the purpose of legislation in different countries differs, so definitions do not need to be the same. 

• Characterisation of polymers will be essential.  As a minimum we expect polymer size distribution, functional group identification and residue measurement will be required.

• The naming of and boundaries between different polymers. There is currently disagreement on how to do this, but the Substance Identity Description (SID) needs to be clear before any obligations are put in place. 

• What about polymers that do not neatly fit into either PRR or non-PRR: will there be a regulatory gap?

Testing:

• What should be tested? Should testing be restricted to the polymer, or should leachates (impurities, degradation products, residues) also be tested? 

• Testing protocols: Are standardised protocols applicable to all polymers?  Is guidance on adaptations available?

• Alternatives to testing and animal testing: will New Approach Methodologies (NAMs) be acceptable?

Specific Polymer types:

• Polymer precursors: some polymers are only used to make other polymers (e.g., uncured resins); should they face the same requirements?

• Should polyesters be considered non-PRRs by default? There is strong debate here.

• Fluorinated polymers: the most recent update is that these will all be considered PRR.

Grouping: 

• Grouping in regulations allows hazard information from a limited number of group members to be applied directly or used to predict the hazard of all group members.  Defining a group requires strong scientific justification.

• In this case, grouping is a given to ensure animal testing is minimised.

• Should grouping be defined by stakeholders such as NGOs or by industry? At the very least, there is agreement that a single group cannot contain members with different hazard classifications. However, until the regulators finalise naming and identification, there is likely to be little point to attempting to define grouping. In our experience, it is essential to first clearly define the purpose for grouping.

• The grouping has been proposed in notification according to similarity of chemical structure and in registration according to similarity of physchem/biological properties.

Timeline for registration:

• Two different procedures are under examination:

• Option 1: ‘Let’s get the show on the road!’: industry begins the PRR assessment and notification, while grouping issues are worked out concurrently. Once these issues are settled, then the registration process would begin with communication between potential registrants for grouping.

• Option 2: ‘Let’s get things sorted first!’: Regulators write full guidance documents prior to industry doing the notification followed by registration.

• Both options are likely to have pros and cons and each may have delays of different kinds. Option 2 runs the risk of regulatory obligations coming into force before industry knows how to meet them. 

Impact Assessment:

• While the Wood report provided a preliminary impact assessment on regulating polymers, an impact assessment on the different proposed regulatory measures is still needed, particularly since there have been changes to the proposed regulation since 2020. 

Summary

A REACH-like regulation for polymers is coming.  The details may be available at the end of this year but there will be time after this for industry to meet these obligations. Expect something more concrete from the EU by early 2023. 

The amount of information needed will depend on both the amount imported or manufactured and the composition of the polymer.  Many polymers may only need a simple notification, but companies will need to characterise their polymers in order to understand their obligations.  Grouping of polymers will be an essential aspect of the regulation, requiring communication between registrants, regulators and possibly other stakeholders.  How this grouping will work practically is still an area of much debate and the hope is that this will be agreed before the regulation comes into force.  

Some other global jurisdictions already impose obligations on companies regarding polymers. Authorities will be watching this issue play out in the EU and may follow with their own polymer legislation. 

At Yordas, our team can help you navigate the complex regulatory landscape that concerns polymers. Our regulatory consultants are experts in industry regulations and guidelines such as food contact materials, restricted substances, the automotive sector, emission standards, import regulations and more. Contact us today so we can help ensure you have a sustainable chemicals management plan in place. Watch our ‘How polymers are regulated under different REACH-like regulations’ webinar for more insight into the polymer requirements in different regions, including Europe, Korea, and the US. 

Also, look out for our upcoming e-learning series and webinars on the global regulation of polymers. Visit our website to stay up-to-date.

About the writer

Giselle Vincett, Managing Director Yordas Canada

Giselle Vincett leads Yordas’ North American operations. She holds a PhD in Sociology from Lancaster University, UK and worked for over a decade in academic research, teaching and writing. She has extensive experience in designing and leading both large and small publicly and privately funded social research. She has strong experience in research and engagement with a variety of organisations, including government, NGOs, and businesses. Her publication record includes popular and policy-based dissemination, along with academic dissemination in a number of disciplines and across multiple media. At Yordas, Giselle leads business development for North America.