Under REACH Annex XVII Entry 78, the EU has banned the placing on the market of synthetic polymer microparticles (SPMs) unless a specific derogation applies. Derogations exist for essential uses such as:
• Industrial feedstock (where microplastics remain contained within industrial sites)
• Medicinal products and veterinary medicines
• Food additives (within EU food laws)
• In vitro diagnostic devices
• Uses where microplastics are permanently embedded or contained in a solid matrix (e.g., certain construction materials)
Even if your use falls under a derogation, you are not automatically exempt from reporting. For derogated uses, the regulation requires an annual report to ECHA. This report must include the type of use, the specific derogation claimed, the generic identity of the polymer (using Harmoniz ed System codes), and an estimate of annual emissions – both during transport and at end‑use.
Key Deadlines to Keep in Mind
| Deadline | Who it applies to | Emissions period covered |
|---|---|---|
| 31.05.26 | Manufacturers and industrial users of pellets, flakes, and powders used as a feedstock in plastic manufacturing at industrial sites | Calendar year 2025 |
| 31.05.27 | Other manufacturers and downstream users using SPM at industrial sites | Calendar year 2026 |
| 31.05.27 | Products in Paragraphs 4b, 4d, 4e and Paragraphs 5a–5c | Calendar year 2026 |
The restriction is designed to reduce intentionally added microplastics released into the environment. It does not cover unintentional microplastics (e.g., from tyre wear or textile washing), nor does it apply to polymers that are biodegradable, water‑soluble, or have no particles below 5 mm (about 0.2 in).
However, proving that your product falls outside the scope often requires analytical data or technical justification.
Reference:
https://gpcregulatory.com/microplastics-restriction-reporting-services/
Today we announce that Exim is rebranding as ExSyn. We are presenting a new brand identity and website as a reflection of our relentless transformation over the course of 30 years serving the pharma and chemical industries. The new brand builds upon our core strengths as a sourcing company and captures our most essential duty: helping improve people’s health and lives.
Under REACH Annex XVII Entry 78, the EU has banned the placing on the market of synthetic polymer microparticles (SPMs) unless a specific derogation applies. Derogations exist for essential uses such as:
Ethyl 7,7,7-trifluoro-3-hydroxy-3-methylheptanoate is a fluorinated aliphatic hydroxy ester. The presence of the trifluoromethyl group imparts enhanced metabolic stability, lipophilicity, and unique physicochemical properties compared with non-fluorinated analogues. This compound is primarily used as a synthetic intermediate in pharmaceutical and agrochemical research.
2-Chloro-1,1,1-trimethoxyethane is an organochlorine orthoester compound commonly used as a versatile synthetic intermediate in organic and pharmaceutical chemistry. It is a colorless to pale yellow liquid with good reactivity toward nucleophilic substitution and cyclization reactions, making it valuable in the preparation of heterocyclic and bioactive molecules.