Non-Phthalate Plasticizers: Medical, Toy & Food Guide

Medical devices and food-contact articles share a key characteristic: the plasticizer is evaluated on the finished product, not on the raw material drum. A grade that meets a supplier's declaration may still fail migration testing for a tube, blood bag, or cling film because the contact category, duration, temperature, and the specific food or body-fluid simulant all factor into the assessment. This note outlines how to structure your selection process and clarifies what documentation a plasticizer supplier can and cannot provide.

Four non-phthalate options and when to use each

All critical values — purity, acid value, color, volatile loss, and epoxy oxygen for ESBO — are listed on the COA per batch, not in this table.

The applicable standard is defined by the article, not additively.

ISO 10993-1 defines the biological evaluation pathway for medical devices and references ISO 10993-12 for extraction and testing conditions, including the specific endpoint coverage. This evaluation is a risk-management process: a device with brief contact to intact skin is assessed differently from one with indirect blood contact over 30 days. Plasticizers enter as leachables; therefore, the compound and manufacturing process—not just the additive—determine the extraction results.

For food-contact articles, the approach differs. In the EU, Regulation 10/2011 assigns simulants based on food type (aqueous, acidic, alcoholic, fatty) and specifies contact time and temperature. In the US, 21 CFR 175.300 covers resinous and polymeric coatings intended for repeated use. Both frameworks test the finished article.

What a plasticizer supplier can and cannot provide

A supplier can provide: grade TDS, a batch COA covering identity and purity, a REACH SVHC screening statement limited to the substance supplied, and a statement confirming no phthalates are intentionally added. A supplier cannot provide migration or biocompatibility certificates for your device, as results depend on the final article. Exercise caution with any vendor offering such certificates without reviewing your compound.

A qualification sequence that eliminates wasted trials

1. Confirm the contact category and applicable standard with your regulatory colleague before sampling.
2. Sample the grade using TDS and COA; verify identity and purity against specifications.
3. Run a trial compound at the target hardness and process it on the intended equipment.
4. Send the completed article to a laboratory for required tests: extraction, migration, or biological endpoints.
5. Only after the article is approved, update the grade in the specification and issue the customer declaration.

Formulation notes for these grades

• DINCH and DOTP are typically dosed at similar parts per hundred (phr) levels as the phthalates they replace. ATBC is more efficient in some compounds but more volatile, so heat history determines the maximum dosage limit.
• ESBO is added at low phr as a co-stabilizer with Ca/Zn systems; it reduces the risk of zinc chloride formation but does not replace the primary plasticizer.
• Color and clarity matter in medical tubing. Specify APHA color standards and verify them per batch, as yellowed tubes are rejected even if they pass mechanical tests.
• Avoid adding components with unknown restriction status late in the project; it invalidates the documentation set.

FAQ

Yes, DINCH is phthalate-free.

Yes. DINCH is a cyclohexanoate ester, not a phthalate. This statement should apply at the substance level: the supplied grade contains no phthalates, while the finished article must be evaluated based on its own composition.

Do you include migration test reports with the sample?

No. A 1 kg sample ships with the grade TDS and a batch COA. Migration and biocompatibility testing is performed on the finished product by the device or food-contact manufacturer, or by an accredited laboratory acting on their behalf.

Which simulants are used for fatty foods?

EU Regulation 10/2011 defines fatty-food simulants and specifies time and temperature based on intended use; 21 CFR 175.300 determines the extracting solvent by food category. Verify the current text for your market before booking the test.

Can ATBC replace DINCH in medical tubing?

ATBC is used in sensitive applications, but its higher volatility makes it less suitable for long-term or heat-sterilized devices. Test the finished product instead of relying solely on the datasheet.