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ECHA releases REACH microplastic notification requirements
Time：
2025-06-10
ECHA has issued notification requirements for REACH microplastics (synthetic polymer particles (SPM)).
In April 2025, ECHA released a detailed document on the notification requirements for the restriction clause (Entry 78) on microplastics in the EU REACH regulation, version 1.1. The following is the main content of the document.
Definition of Synthetic Polymer Particles (SPM)
SPM refers to solid polymers that must simultaneously meet the following two conditions:
All dimensions of the particles are equal to or less than 5 millimeters;
The length of the particles is equal to or less than 15 millimeters, and the ratio of length to diameter is greater than 3.
Being contained within the particles and accounting for at least 1% of the particle weight; Or form a continuous surface coating on the particles.
At least 1% of the particle weight in point 1 meets one of the following conditions:
The following polymers are not included in this definition:
Polymers formed through polymerization processes in nature and not chemically modified.
Prove according to Appendix 15 that it is a biodegradable polymer.
Polymers with a solubility greater than 2 g/L as demonstrated in Appendix 16.
Polymers that do not contain carbon atoms in their chemical structure.
Applicable exemption purposes
SPM used in industrial sites: SPM used in industrial sites in the form of substances themselves or mixtures.
Pharmaceutical products: human drugs within the scope of Directive 2001/83/EC and veterinary drugs within the scope of Regulation 2019/6.
Food additives: Food additives that comply with the scope of Regulation 1333/2008/EC.
In vitro diagnostic equipment: including equipment within the scope of Regulation No. 2017/746.
If the notification is completed
Identify the reporting parties: manufacturers, industrial downstream users, and suppliers who are launching synthetic polymer particles (SPM) on the market for the first time. The same legal entity may have notification obligations for multiple purposes, but information for each legal entity needs to be submitted separately.
Clear purpose: It is necessary to select the applicable purpose from the predefined use list, such as the manufacturing or use of granules, flakes, and powders in industrial settings, consumer and/or professional use in pharmaceutical and veterinary products, etc.
Necessary information: Provide usage descriptions related to the intended use, general identity of the polymer, emission estimates, and other relevant information.
Tool: The notification will be completed in IUCLID, which includes templates for collecting the required information, such as file headers, generic reference materials, etc.
Submission through REACH-IT: Each legal entity will submit its own IUCLID folder through REACH-IT, and users of other legal entities can be authorized to submit on their behalf, but the original legal entity is responsible for the submitted data.
Format: Each legal entity will submit an IUCLID folder containing all applicable purposes, without the need to submit multiple folders for multiple purposes of the same legal entity.
Information Processing and Sharing
Information confidentiality and sharing: Information on legal entities and venues notified, as well as information provided at the request of member states, will only be accessed by ECHA and the competent authorities of member states and will not be publicly disseminated. The data reported by individual legal entities will be disclosed in a consolidated form to avoid the leakage of trade secrets.
Provide information to member states: All IUCLID folders will be accessible for member states to retrieve information. The competent authorities of member states may also request specific information on the identity and function of polymers in accordance with paragraph 14 of the directive, and the reporting entity may add the requested information as an attachment to the IUCLID folder at any time.
Timeline
Starting from 2026, manufacturers and downstream industrial users of SPM used as raw materials for plastic manufacturing in industrial settings in the form of particles, flakes, and powders are required to report emission estimates for the calendar year 2025 by May 31, 2026.
Starting from 2027: Other SPM manufacturers and downstream industrial users who use SPM in industrial settings, as well as suppliers who first introduce SPM containing products as described in Article 78, paragraphs 4 (b), (d), and (e), and paragraph 5 to professional users and the public market, are required to report emission estimates for the calendar year 2026 by May 31, 2027.
Subsequent updates and releases
Update: The tool allows for updating folders and reusing information from previous years in subsequent annual reports to improve efficiency.
Information release: After the initial submission in May 2026, ECHA will publish summary information on SPM emissions on its website. The specific publishing format is still under development and will be fully implemented after the completion of the initial notification.
The notification system is expected to be ready by December 2025, and global supply chain related enterprises need to complete compliance preparations as soon as possible, especially institutions involved in exemption fields such as industry, medicine, and food need to carefully evaluate their obligations.
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