REACH registration of polymers
In the REACH Regulation, polymers (as defined in Article 3(5)) are not subject to Registration or Evaluation (Article 2(9)), but Article 138(2) indicates that the European Commission (EC) “may present legislative proposals 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, and after publishing a report on the following:
(a) the risks posed by polymers in comparison with other substances.
(b) the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other.”
The EC started this process publishing reports prepared in 2012 (Review of REACH with regard to the registration requirements on polymers) and 2015 (Technical assistance related to the review of REACH regarding the registration requirements on polymer). Wood plc and Vitis Regulatory Brussels were selected by the EC (DG Environment) to provide ‘Scientific and technical support for the development of criteria to identify and group polymers for Registration/ Evaluation under REACH and their impact assessment’ in 2019 and the Commission and have recently made the final report of that work publicly available. The report is available to download here.
The report considers the potential risks to human health and the environment posed by polymers and reviews the need to register them under REACH. The report was discussed at the 35th CARACAL meeting in which it became clear that the prospect of polymers requiring a registration under REACH may become a reality as soon as 2022. The aims of the Wood-PFA project were to define a set of criteria that would allow screening for Polymers Requiring Registration (PRR) and examine how the process and implementation of registering polymers would be addressed.
The main challenges to bringing polymers into REACH registration are predicted to be around the complexity of substance identity and adapting standard testing regimes to accommodate polymers. The main strategy being to minimise the number of PRRs by adequately defining their composition and then grouping and categorising them. This will help to determine when and if testing is appropriate, ultimately reducing the number of animal tests required through the utilisation of read across, QSARs and other regulatory adaptations.
Polymer Expertise Provided by Vitis Regulatory
Preparing our clients for the registration of polymers under a revised REACH will allow them to answer important business questions regarding vulnerabilities in their substance portfolios, what data do they have? how can polymers be grouped? how can existing data be used most effectively? what new data may be required? Understanding polymers and how they fit in the current regulatory landscape at an EU or global level will be pivotal for the polymer industry and will allow for long range planning for regulatory compliance and product stewardship. The team at PFA has the expertise and creativity to help businesses of any size develop a strategy for polymers and to be prepared for the implementation of regulations related to polymers.
We are eager to assist our clients with polymer specific services such as:
Substance identity analytical data review for PRR registrations
Horizon scanning and development of portfolio specific risk registers (EU and Global)
Grouping strategies to reduce both the number of PRRs and substances tested
Testing strategy development and review of existing data
Development and application of QSARs
Consortium management
