Charles River Laboratories International Inc.
10/10/2024 | News release | Distributed by Public on 10/10/2024 06:59
Upcoming REACH Polymer Regulations
The European Commission is expected to present legislative proposals to extend the duty of registration under REACH to certain polymers of concern by 2027. With approximately 200,000 polymers on the EU market requiring notification, up to 30,000 may require registration under REACH.
As things stand currently, under REACH regulations (Regulation (EC) No 1907/2006), polymers are exempt from registration and instead the separate monomers should be registered. However, Article 138 (2) of REACH already lays down the rationale for the removal of REACH polymer exemptions, "as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established".
While notification is expected to have minimum data requirements, registration will potentially involve additional testing and complexity for manufacturers and importers of polymers. Data requirements will be equivalent to those currently outlined in REACH Annex VII or X depending on the type of polymer.
Criteria for Registration of Polymers Under REACH
Polymers requiring registration (PRR) will be selected based on the following criteria:
- Polymers classified as hazardous under CLP Regulations
- Cationic, anionic, or amphoteric polymer
- Non-ionic polymers with surface-active properties
- Low molecular weight polymers or polymers containing low molecular weight oligomers
- Polymers with reactive functional groups
- Some types of degradable polymers
It is important for producers to determine if their polymers are of low concern, or if they will require registration. Producers may also want to proactively start working on grouping their PRRs. Grouping would allow manufacturers or importers of similar types of PRR to collaborate on registration to facilitate cost-effective registration in line with the "one substance, one registration" principle.
Support and Guidance on REACH Polymer Testing
At the moment, regulatory deadlines, definitive PPR criteria, and exact information requirements are not yet confirmed and clear guidance on grouping is not yet available. Our regulatory affairs affairs team is staying at the forefront of developments in the regulatory environment for polymers and is ready to answer your questions on REACH polymer exemptions and groupings to help you plan ahead.
Additionally, we can help with several tests that are already available to help determine if a polymer is likely to require future registration:
OECD 118 and 119
The number-average molecular weight (Mn), the molecular weight distribution (Mw/Mn), and the low molecular weight content of the test material are determined by gel permeation chromatography (GPC).
The number-average molecular weight is defined as the total weight of polymer divided by the total number of molecules.
Determination of these parameters will be requested for the notification of all polymers.
OECD 120 and 105
OECD 105 for water solubility is designed to test pure chemicals. However, polymeric substances are comprised of molecules of different molecular weights, with each weight fraction exhibiting its own water solubility characteristics. This often results in technical challenges (formation of inhomogeneous emulsions or gels) and questionable results for polymers.
OECD 120 is a solution/extraction behavior test that is a modified version of the shake flask method from OECD 105 and is considered to be more appropriate for polymers.
Click below to discuss how best to prepare for these upcoming changes.