On June 29, 2021, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) issued a decision on a compliance check case (A-001-2020) regarding registration obligations for polymer importers. ECHA rejected the adaptations by which the Appellant had sought to fulfill the standard information requirements for a sub-chronic toxicity study (Section 8.6.2. of Annex IX to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation), a pre-natal developmental toxicity (PNDT) study on one species (Section 8.7.2. of REACH Annex IX), and a simulation of ultimate degradation in surface water (Section 220.127.116.11. of REACH Annex IX). In its decision, BoA dismissed the appeal in regard to the sub-chronic toxicity study and the PNDT study, but annulled the contested decision insofar as it required the Appellant to submit information on the simulation of ultimate degradation.
ECHA announced on February 21, 2023, that it has revised its Guidance for monomers and polymers to align with BoA’s June 2021 decision and includes changes to the description of registration obligations for those importing and manufacturing polymers and monomers. ECHA states that the key changes relate to:
- The monomer that needs to be registered by the manufacturer or importer of a polymer;
- The calculation of registration tonnages of monomers ending up in the final polymer as a reacted substance; and
- The information that registrants of monomers must include in a registration chemical safety report.
ECHA states that it “encourages all importers and manufacturers of polymers and monomers to examine the updated guidance and review their registrations to make sure they are complying with these minimum requirements.”