Chloroform-soluble extractives: polymeric and resinous coatings (21 CFR 175.300)
Laboratory service for determining the net chloroform-soluble extractives from polymeric and resinous coatings intended for food contact. The applicable regulatory reference is the US FDA's 21 CFR 175.300. The regulation applies to materials for both single and repeated use.
The limits for extractables enforced by the regulation (corrected for zinc extractives as zinc oleate):
Volume of the article | Single use / repeated use | Limit |
---|---|---|
≤1 gallon | Single use | 0.5 mg/inch^2 |
>1 gallon | Single use | 1.8 mg/inch^2 |
All volumes | Repeated use | 18 mg/inch^2 |
Depending on the intended use, as defined in Table 1 and Table 2 of the regulation, testing is done with one or more of the following simulants:
Water
8% ethanol
n-heptane
Testing can be performed under various conditions of use (A-H). The cost includes testing with the three above-mentioned simulants.
- Suitable sample matrices
- Coated metals, coated ceramics, plastics
- Required sample quantity
- 6 x A4-size sheets
- Typical turnaround time
- 3 – 4 weeks after receiving the samples
- Available quality systems
- Accredited test method
- Standard
- Method expert
Price
We also charge a 97 € service fee per order.
Large batches of samples are eligible for discounts.
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