Microplastics reporting IUCLID 6 and REACH-IT
From checking your obligations to preparing your annual report. We help you organise data on synthetic polymer microparticles and submit your report to the European Chemicals Agency (ECHA).
Does your company need to report?
The obligation depends on the polymer, its use and your role in the supply chain. The fact that a product contains plastic or that you import it into Slovenia is not sufficient to determine your obligations.
Paragraph 11 of entry 78 covers manufacturers of synthetic polymer microparticles (SPMs) and industrial downstream users using SPMs at industrial sites, under the derogation in paragraph 4(a).
Paragraph 12 covers suppliers placing products containing SPMs referred to in paragraphs 4(b), 4(d), 4(e) or 5 on the market for the first time for professional users or the general public. This includes certain medicinal products, food additives, in vitro diagnostic devices and uses involving technical containment, permanent modification of physical properties or permanent incorporation into a solid matrix.
When must the report be submitted?
| Who must report | First deadline | Reporting year |
|---|---|---|
| Manufacturers and industrial downstream users of SPMs in the form of pellets, flakes and powders used as feedstock in plastic manufacturing at industrial sites | 31 May 2026 | 2025 |
| Other manufacturers of SPMs and other industrial downstream users using SPMs at industrial sites | 31 May 2027 | 2026 |
| Suppliers meeting the conditions of paragraph 12 of entry 78 | 31 May 2027 | 2026 |
Thereafter, annually by 31 May for the previous year. Source: ECHA: reporting launch and deadlines.
Prepare for 31 May 2027: organise your data for 2026. The first group's deadline for 2025 has already passed; if you have not submitted your report, check your obligations and arrange the next steps as soon as possible.
What does REACH entry 78 require?
Commission Regulation (EU) 2023/2055 added entry 78 to Annex XVII of REACH and entered into force on 17 October 2023. It restricts placing SPMs on the market as substances on their own or in mixtures where they are present to confer a sought-after characteristic at a concentration of at least 0.01% by weight. It includes derogations and transitional periods.
The definition covers solid polymers in particles or forming a continuous surface coating on particles: at least 1% by weight of those particles must meet the size criteria (all dimensions up to 5 mm, or a length up to 15 mm and a length-to-diameter ratio greater than 3). Polymer-content criteria also apply. Exclusions cover certain naturally occurring, chemically unmodified polymers, polymers with demonstrated degradability, polymers with demonstrated solubility above 2 g/L and polymers containing no carbon atoms in their chemical structure.
Reporting does not replace a check on whether a product may be placed on the market. We assess product-specific ban dates, derogation conditions and information requirements separately. Reference: ECHA: conditions of restriction under entry 78.
From data to submission
Obligation review
We review your products, uses and company role to identify the applicable reporting basis.
Data preparation
We review supplier documentation, identify gaps and help prepare emission estimates.
IUCLID 6 dossier
We prepare the dataset and reporting dossier and review the validation results.
REACH-IT submission
With your authorisation, we help submit the report and check its status. We provide the dossier and submission evidence.
We define the scope of work and quotation after reviewing the products, number of uses and available data.
What data do we need?
- Company and contact details, and your role in the supply chain.
- A product list, supplier documentation and information on polymers and particles.
- SPM quantities and concentrations for the reporting year.
- Descriptions of uses, the relevant derogation and industrial site details where required.
- Estimated releases to the environment for each use, including transportation, with the methods and assumptions used.
- Information on emission-control measures and any previous dossiers and submission confirmations.
Frequently asked questions
Can reporting apply to non-hazardous products?
Yes. CLP classification alone does not determine the obligation. The presence of SPMs, their use and the conditions of entry 78 must be assessed.
Must all importers report?
Not automatically. It must be established whether the company falls under paragraph 11 or 12. The first placing on the market for a particular use and the applicable derogation also matter.
Is this a REACH registration or a PCN notification?
This is a separate annual microplastics reporting obligation. We prepare the dossier in IUCLID 6 and submit it through REACH-IT. Any other company obligations are assessed separately.
Is uploading the dossier enough?
After submission, the status in REACH-IT must be checked and the documentation retained. Technical validation or successful submission alone does not confirm that the product may be sold.
How much does report preparation cost?
We prepare a quotation based on the number of polymers and uses, data quality and the complexity of emission estimates. Send us a description of your portfolio so we can define the scope of work.
Let us help with your microplastics reporting.
In your enquiry, describe your products, your role (manufacturer, importer, user or supplier), the reporting year and the data you already have.
info@bisafe.si · BiSafe d.o.o.
