On 17th October 2023, a comprehensive restriction on intentionally added microplastics (Commission Regulation (EU) 2023/2055), came into effect. Contained within the restriction are certain exemptions. For these exemptions, specific reporting obligations have been imposed on the manufacturers, importers, and downstream users.
The reporting requirements concern estimated annual emissions of synthetic polymer microparticles (SPM) to the environment, and applies to manufacturers, industrial downstream users and suppliers placing SPM on the market for consumer and professional uses for the first time. including transportation. The information will be submitted annually to ECHA which will make it available to the Member States.
The reporting requirements apply to the following SPM uses:
- Use at industrial sites
- Medicinal products and veterinary medicinal products
- Food additives
- In vitro diagnostic devices
- SPM contained by technical means
- SPM which are modified during use in such in such a way that the polymer no longer falls within the scope of the restriction
- SPM which are permanently incorporated into a solid matrix during intended end use
ECHA has prepared a proposal for the implementation of the reporting requirements and would like to collect views regarding its practicality and how it is implemented. The consultation will start on 18 December 2024 and ends on 20 January 2025. This consultation is intended especially for parties that will be subject to or otherwise affected by the reporting requirements in the microplastic restriction and is open to any other interested party.
Reporting Timelines
The information shall be submitted to ECHA by 31 May each year, starting from 2026 or 2027, depending on the uses for the previous calendar year.
Starting from 2026: manufacturers and industrial downstream users of SPM in the form of pellets, flakes, and powders used as feedstock in plastic manufacturing at industrial sites (meaning that by the end of May 2026 they should report estimated emissions for the calendar year of 2025);
Starting from 2027: other manufacturers of SPM and other industrial downstream users using SPM at industrial sites (meaning that by the end of May 2027 they should report estimated emissions for the calendar year of 2026);
Starting from 2027: suppliers of products containing SPM referred to in paragraph 4 of the restriction, points (b), (d), and (e), and paragraph 5 of the entry, that place those products on the market for the first time to professional users and the general public (meaning that by the end of May 2027, they should report estimated emissions and related information for the calendar year of 2026).
Reporting Requirements
Manufacturers will report estimated emissions of SPM from their own use, including during transportation. They will report estimated emissions per legal entity, indicating the site(s) where the emissions take place.
Suppliers, in addition to their own estimated emissions, will report the estimated downstream SPM emissions occurring until the product is disposed of as waste, including from transportation.
Distributors do not have reporting obligations under this restriction.
Full details of the information required, and the structure of the reports are given in the ECHA document. Two options are being considered for the generic identification of the polymer, one being the CAS number and CAS name of the polymer and the other a pre-selected list of entries (codes and descriptions) from the Harmonised System developed by the World Customs Organisation.
There are also 2 options proposed for the information required for the annual estimated emissions. Option A – Quantity of particles and concentration of SPM in the particles and Option B – Quantity of SPM. In option A, the reported total volume of the particles includes that of the SPM plus that of any non-polymeric component of the particles and in Option B, the reported total volume only includes that of the SPM (i.e. the polymer(s) contained in or coating the particles.
It is proposed that the reporting will be done using IUCLID and the submission of the dossiers will be coordinated via REACH-IT, with one dossier per legal entity. Dossier updates will be possible.
ECHA has a target to disseminate the aggregated information. Options are under development and will be revisited when the data has been submitted for 2025.
For the full text refer to the link provided:
https://echa.europa.eu/calls-for-comments-and-evidence/-/substance-rev/78701/term
Published January 6, 2025
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