Published June 28, 2023 | Version v1
Project deliverable Open

PlasticsFatE Deliverable Report D4.1 Compilation of existing regulatory documents applicable to microplastic particles of various origin

  • 1. STAMI
  • 2. BOKU
  • 3. UNILJ
  • 4. UBT
  • 5. UFZ
  • 6. ROR icon Helmholtz Centre for Environmental Research


This report aims to compile relevant regulatory documents to provide an overview on (I) the current practices in European regulatory frameworks for non-natural polymers in general; and (II) review the current state of nano- and microplastic  risk  assessment  according to ongoing research activities. 

The formation of microplastic particles from larger polymer items is considered an inherent property of most artificial polymers. Currently, polymers are exempted from registration under REACH. However, the registration of selected polymers is anticipated and concepts such as the Polymers of Low Concern (PLC) and the Polymers Requiring Registration (PRR) concept are under consideration to allow scientifically sound justifications for selecting polymers that will require registration. In that regard, criteria describing the physical and chemical properties relevant for risk assessment have been formulated. However, primary as well as secondary nano- and microplastic particles are currently not considered explicitly in regulatory frameworks. 

In addition, risk assessment strategies specifically for nano and microplastic have been proposed by several scientists. These approaches are summarized here and put into the context of WP4 goals and the work conducted in the experimental WPs.

This report shows also the need for progress in our scientific understanding to clarify the connection between physico-chemical properties and potential hazardous effects of polymers, and identify the potential for read-across from pristine materials used in laboratory testing to the weathered or aged material found in the environment that humans are ultimately exposed to. In addition, new EU initiatives fostering the development of restriction and mitigation measures to reduce plastic use and prevent plastic product release into the environment are highlighted, such as the EU Plastics Strategy or the Towards zero pollution action plan, as part of the EU Green Deal (see also D6.3). 

This overview on the current regulatory situation provides a starting point and basis for the work planned within WP4, specifically for the development of an integrated risk assessment strategy for human and environmental health within T4.1 and T4.2.


PlasticsFatE D4.1 State of the art in microplastic risk assessment.pdf

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PlasticsFatE – Plastics fate and effects in the human body 965367
European Commission