REACH registrations – updated guidance for polymers and monomers
In brief
In accordance with the outcomes of the compliance check case (A-001-2020) decision issued by the Board of Appeal (BoA) on 29 June 2021 regarding the registration obligations of importers of polymers, the ECHA Guidance on monomers and polymers has been amended. This includes changes to the description of the registration obligations of polymer and monomer manufacturers and importers.
Main changes to the Guidance:
Registration obligation
The changes to the guidance clarify that manufacturers, importers and Only Representatives have no obligation to register unreacted monomers under Article 6 (1) and (2) of the REACH Regulation and that the registration obligation only applies to reacted monomer and other substance(s) in line with Article 6 (3):
The manufacturer or importer of a polymer must submit a registration to the Agency for the monomer substance(s) or any other substance(s) that have not already been registered by an actor up the supply chain, if both the following conditions are met:
(a) the polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);
(b) the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year (the total quantity in this context is the total quantity of monomer or other substance ending up chemically bound to the polymer).
The calculation of registration tonnages of monomers as reacted substances in the final polymer
The updated guidance includes examples on how to determine tonnages for registration, further demonstrating that only volumes of reacted monomer and not volumes of unreacted monomer within the polymer need to be taken into account.
Chemical Safety Report
The updated guidance states that the chemical safety assessment does not have to consider the exposure arising from the use(s) of the polymer, including exposure to remaining unreacted monomer(s) or to any monomer released following degradation of the polymer.
However, when registrants of monomers rely on exposure-based adaptation (EBA) as a means for fulfilling the standard REACH information requirements, they are required to provide information on the exposure to the monomer also after polymerisation. The exposure assessment is required to cover all relevant exposures throughout the life-cycle of the monomer, including the potential exposure to the monomer as an unreacted monomer in the polymer, or as a degradation product of the polymer, even after polymerisation.
ECHA’s updated guidance can be found here. The BoA decision can be found here.
Blue Frog Scientific would recommend that companies should review the recommendations to ensure their dossiers are compliant – if you require any assistance on this matter please get in touch.
