Declaration of Synthetic Polymer Microparticle (SPM) Emissions – REACH Framework

In April 2025, ECHA published the reporting requirements in the document Implementation of the reporting requirements of the REACH restriction on microplastics. This obligation stems from Entry 78 of Annex XVII of the REACH Regulation, introduced by Regulation (EU) 2023/2055, and requires concerned entities to annually report estimated SPM emissions into the environment.

The purpose of the reporting is to assess the effectiveness of risk management measures and to improve knowledge on derogated uses subject to restrictions.

Our team summarized the key concepts and timing to be ready for the submission of declarations.

Which uses are concerned?
Reporting is required for certain derogated uses as defined in paragraphs 4 and 5 of the regulation:

• SPM used on industrial sites, in medicinal and veterinary products, food additives, or in vitro diagnostic devices (paragraph 4);
• SPM that are technically confined, irreversibly modified during intended use, or permanently incorporated into a solid matrix (paragraph 5).

When?
Declarations must be submitted annually before 31 May, covering emissions from the previous calendar year.

• 2026: for pellets, flakes, or powders used as raw materials in plastic manufacturing (emissions from 2025).
• 2027: for other manufacturers, industrial users, and suppliers (emissions from 2026).

Who is concerned?
The following entities are subject to the reporting obligation:

• Manufacturers and industrial users of SPM at industrial sites (derogation 4a), for their own emissions, including those related to transport.
• Suppliers placing products on the market, for the first time, containing SPM that fall under the derogations in paragraphs 4(b), 4(d), 4(e) and 5(a), 5(b), 5(c).
  These subjects must estimate downstream emissions up to the product’s disposal, including those from transport, distributors, and end users.

! Distributors themselves are not subject to the reporting obligation.

Who reports?
Each legal entity must submit a single dossier covering all relevant uses. If the entity acts as both a user and a supplier, only one dossier is required, with a clear distinction between emissions from each activity type.

What information must be provided?
For each use, the following information is required:

a) Use description: includes the name of the use, sector(s) of use (SU), product category (PC), technical function (TC), and the industrial site, if applicable. Some information must be entered as free text, others selected from a dropdown list.

b) Generic identification of polymers: selected from a predefined list of 4-digit HS codes (3901–3914, 4001–4002) based on the Harmonized System of the WO. If the polymer is not listed, the option “other” must be selected, with a description provided in English.

c) Estimation of annual SPM emissions: by considering releases to air, water, and soil; losses during transport; intentional or operational losses; and accidental releases. The estimate must be provided using one of the following two options:

• Option A: total quantity of particles, including that of the SPM plus that of any non-polymeric component of the particles. An estimated proportion of SPM can be selected from a dropdown range; if not specified, a default value of 100% will apply.
• Option B: quantity of SPM only, reported as dry weigt, excluding additives and fillers.

Emissions must be expressed in kilograms (if <1 tonne) or in tonnes (if ≥1 tonne). There is no minimum threshold, very low or even zero emissions must still be reported.

d) Derogations: to be selected from a dropdown list. If multiple derogations apply, all relevant ones must be selected. To be noted that for cosmetic products, only derogations 4(a) and 5(b) are applicable.

How to report?
Declarations are to be submitted via IUCLID and coordinated through REACH-IT.

Each legal entity is required to submit a single IUCLID dossier covering all relevant uses and types of microplastics.

A third party may be authorized to submit the dossier on behalf of the entity, but the legal entity remains responsible for the data provided. Data aggregation between legal entities is not permitted.

Confidentiality and publication
Only ECHA and the competent authorities will have access to sensitive data (e.g. entity identity, site information, data required under paragraph 14). Other information will be published in aggregated form. Additional data on polymers may be requested upon demand.

Implementation: The reporting system will be operational by December 2025.

 

We hope that this document has been helpful!
Our team is at your disposal for any support with these requirements.

COMPLIFE. COMMITTED TO SCIENCE, COMMITTED TO YOU.