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
- Articles should be in finished form. Articles with < 100 cm2 surface area: 12 articles; articles with >100 cm2 surface area: 6 articles. In case of very small articles (e.g. O-rings), please consult us before sending the samples. Other formats: at least 600 cm2.
- Typical turnaround time
- 3 – 4 weeks after receiving the samples
- Available quality systems
- Accredited testing laboratory
- Standard
- Method expert
Price
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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