Total extractables: rubber articles intended for repeated use (21 CFR 177.2600)

Determination of total extractives from rubber articles intended for repeated use in accordance with U.S. regulation 21 CFR 177.2600. The regulation applies to both natural and synthetic rubber as well as elastomers (such as silicone) intended for food contact.

The applicable limits for the total extractables are:

Food type

Food simulant

Test conditions

Limit

Aqueous

Distilled water

9 hours at reflux

≤ 20 mg/inch^2 (during the first 7 hours of extraction)

≤ 1 mg/inch^2 (during the last 2 hours of extraction)

Fatty

Hexane

9 hours at reflux

≤ 175 mg/inch^2 (during the first 7 hours of extraction)

≤ 4 mg/inch^2 (during the last 2 hours of extraction)

The test package includes testing with both distilled water and hexane.

Suitable sample matrices
Rubbers and elastomers
Required sample quantity
6 x A4 or 40 g
Typical turnaround time
3 – 4 weeks after receiving the samples
Available quality systems
Accredited testing laboratory

Price

Typical price range (Excl. VAT):
327–398 €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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