Polymer Analysis Laboratory under REACH: secure your regulatory compliance
Polymers and REACH: why the regulation is accelerating
Currently, polymers are exempt from registration and evaluation under REACH, on the grounds that high-molecular-weight molecules are generally considered to pose a low risk. But this exemption is evolving
.The European Commission is preparing a proposal to amend REACH
to establish registration requirements for polymers, under the concept of “Polymers Requiring Registration” (PRR).- In the first stage , notification will be required for all polymers manufactured in or imported into the EU above 1 tonne/year.
- In the second stage , full registration will be required for PRRs, with differentiated information requirements depending on molecular weight: Type 1 (low MW), Type 2 (medium MW), Type 3 (high MW). Type 1 polymers will have the same obligations as conventional non-polymeric substances.
The current REACH framework: the rules applicable to polymers
REACH registration is required when an unreacted monomer accounts for more than 2% of the polymer’s total composition and exceeds 1 tonne or more per year — both conditions being cumulative. This requires quantifying residual monomers in polymer formulations.
A substance is considered a polymer within the meaning of REACH only if it meets the so-called 3M+1 rule (at least 3 covalently bound monomer units), if more than 50% of the weight consists of polymer molecules, and if fewer than 50% of these molecules have the same molecular weight. This verification is based on the molecular weight distribution by GPC.
The central role of OECD 119 and GPC
OECD Guideline 119 describes GPC as a method for determining molecular weight distribution and average molecular weights (Mn, Mw).
OECD 119 specifically addresses the determination of low molecular weight polymer content (oligomers) by GPC. This is essential for two reasons:
- Characterize the polymer (verify that it meets the ECHA/OECD definition)
- Assess PRR risk : under the proposed PRR criteria, a polymer with an Mn between 1,000 and 10,000 Da is considered a PRR if it contains more than 10% oligomers below a defined molecular weight threshold. Oligomer content is therefore a decisive parameter.
Our GPC/SEC analysis services within the REACH framework
By combining a series of detectors (RI and UV concentration, light scattering RALS/LALS, viscometer), the technique GPC/SEC makes it possible to accurately determine the size and molecular mass, the intrinsic viscosity as well as the structure of polymers. This covers the control of average molecular masses (Mn, Mw, Mp, polydispersity index), structural characterization, including the study of macromolecular chain branching, as well as the optimization of manufacturing processes.
Our services and technical capabilities for polymer analysis under REACH
Client need | Method / Standard | FILAB capability |
Verify polymer status (ECHA definition) | GPC / OECD 118 | ✅ Multi-detector GPC |
Oligomer / low MW content | GPC / OECD 119 | ✅ GPC |
Molecular mass distribution (Mn, Mw, PDI) | ISO 13885 / NF T 51-505 | ✅ |
Quantification of residual monomers | LC-MS, GC-MS | ✅ |
Identification of impurities / SVHC substances | ✅ Strong differentiator | |
REACH toxicological assessment | ✅ | |
Various | ✅ REACH nano |
Why choose FILAB for polymer analysis under REACH
- COFRAC ISO 17025 accreditation : legally defensible results, essential for a REACH/ECHA dossier
- Multi-detector GPC equipment : complete data in a single analysis (Mn, Mw, intrinsic viscosity, structure)
- Orbitrap / LC-HRMS : non-targeted identification of oligomers and impurities, particularly valuable for Type 1 PRRs
- Consulting support : help with regulatory interpretation (PRR or non-PRR?), useful for SMEs without in-house regulatory resources
- Anticipating PRR requirements : FILAB positioned as a proactive partner before the obligation comes into force, a strong argument for plastics processors and specialty chemical companies
Our FAQ
To request a quote, you can contact our teams via our contact form, by phone, or by email.
Simply send us your requirements (material type, desired analysis, any applicable standard, urgency, number of samples, etc.). We will then send you a tailored technical and pricing proposal within 24-48 hours.
Lead times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times adapted to your constraints and industrial urgencies.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the European regulation designed to ensure control of the risks related to chemical substances placed on the European market. In particular, it requires the registration of substances manufactured or imported at more than one tonne per year.
To date, polymers are exempt from registration and evaluation under REACH. However, this exemption does not necessarily apply to monomers and other substances used in their manufacture, which may be subject to regulatory obligations.
The analysis makes it possible to:
- characterize the polymer;
- identify residual monomers and impurities;
- document the chemical composition;
- compile or complete a regulatory dossier;
- verify compliance with REACH requirements and the supply chain.
Yes. When certain concentration (≥ 2% w/w) and tonnage (> 1 tonne/year) conditions are met, monomers or other chemically bound substances must be registered with ECHA if they have not already been registered upstream.
Similarity analysis consists of comparing two substances to demonstrate that they have an equivalent composition. This approach is frequently used in data sharing or when preparing a REACH dossier.
Regulation (EU) 2023/2055 (amending Annex XVII to REACH) severely restricts the use of intentionally added microplastics (threshold limit of 0.01% by weight). FILAB supports the cosmetics, detergents and plastics processing sectors in particular with specific protocols for detection, characterization and quantification of plastic microbeads and solid polymer particles smaller than 5 mm.
