Introduction
With the European Union’s recent restrictions on Synthetic Polymer Microparticles (microplastics) under REACH Regulation (EU) 2023/2055, many formulators are in a state of panic.
We frequently receive urgent emails asking:
“Is Polysorbate 20 considered a microplastic?” “Do I need to remove Polysorbate 80 from my export formulas?”
The short answer is: NO.
Polysorbates (including Polysorbate 20, 60, and 80) are exempt from the EU microplastic ban. They do not meet the definition of a microplastic set by the European Chemicals Agency (ECHA).
In this guide, we explain the regulatory logic behind this exemption so you can confidently continue using these essential emulsifiers in your global formulations.
The ECHA Definition: What Actually Counts as a “Microplastic”?
To understand why Polysorbates are safe, we must look at what the law actually bans. According to ECHA, a “microplastic” generally refers to Synthetic Polymer Microparticles that are:
- Solid (solid particles).
- Insoluble in water.
- Non-biodegradable.
The ban targets ingredients like polyethylene microbeads (used in scrubs) or encapsulated fragrances that persist in the environment.
Why Polysorbates Are NOT Microplastics (The Technical Breakdown)
Polysorbates fall under specific exemptions within the REACH restriction text. Here is the technical breakdown you can present to your regulatory team:
1. The Solubility Exemption (Crucial) The primary definition of a microplastic requires it to be a solid particle.
- Polysorbate 20 & 80 are viscous liquids at room temperature.
- Polysorbate 60 is a soft paste/waxy solid, BUT it is water-soluble.
The regulation explicitly exempts polymers that are soluble in water. Since the primary function of Polysorbates is to act as solubilizers (dissolving oils into water), they pass the solubility criteria outlined in Appendix X of the restriction.
2. The Biodegradability Exemption Polysorbates are biodegradable. They are esters derived from sorbitol and fatty acids. In the environment, they break down into their base components, which do not persist like traditional plastics (PE/PP).
Regulatory Conclusion: Because Polysorbates are soluble/liquid surfactants and biodegradable, they are NOT “Synthetic Polymer Microparticles” and are NOT restricted for sale or use in the EU.
Addressing Specific Product Concerns
Is Polysorbate 20 a Microplastic? No. Polysorbate 20 (Tween 20) is a clear, water-soluble liquid used to solubilize fragrances. It is fully compliant with EU REACH microplastic regulations.
Is Polysorbate 80 (E433) a Microplastic? No. Polysorbate 80 is a liquid emulsifier. It is widely used in pharmaceuticals and food (E433) and is exempt from the ban.
A Note for German Markets (Mikroplastik) For our clients exporting to Germany, you may see inquiries regarding “Mikroplastik.” Please be assured that our Polysorbate series does not fall under the Mikroplastik-Verbot regarding synthetic polymers.
The FoodEmul Compliance Guarantee
At FoodEmul, we understand that regulatory documentation is just as important as the product itself.
When you source from us, you aren’t just buying a drum of surfactant; you are buying supply chain security. We provide:
- REACH Compliance Statements
- Non-Microplastic Declarations
- Biodegradability Data
Don’t let regulatory confusion disrupt your production. Ensure your raw materials are backed by clear technical dossiers.
