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

Price

Typical price range (Excl. VAT):
327–397 €per sample

We also charge a 97 € service fee per order.

Large batches of samples are eligible for discounts.

Questions? We're happy to help.

Questions? We're happy to help.

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