Food contact compliance testing of single-use nitrile gloves (BfR XXI/1)
Test package for single-use nitrile gloves to assess food contact compliance (for all foodstuffs) according to Germany's BfR XX1/1 "Commodities based on natural and synthetic rubber in contact with food (as of 01.09.2024)" and Regulation (EC) No 1935/2004.
Test package covers selected general requirements for nitrile rubber as well as analysis for specific migration of nitrile rubber monomers (i.e., acrylonitrile and 1,3-butadiene). The substances have specific migration reference (SMR) values defined in Table 1 of BfR XXI.
Table below lists covered parameters, test methods, and applied requirements:
Test parameter | Simulant(s) | Test method | Requirement |
---|---|---|---|
Overall migration | 10% ethanol, 3% acetic acid, olive oil | EN 1186-1, -2, -3 | ≤ 10 mg/dm2 |
Sensory analysis | Water | DIN 10955 | No transfer of taste or odor |
Total transfer of zinc | 3% acetic acid | In-house ICP-MS | ≤ 25 mg/kg of food |
Total transfer of aluminium | 3% acetic acid | In-house ICP-MS | ≤ 1 mg/kg of food |
Total transfer of lead | 3% acetic acid | In-house ICP-MS | ≤ 0.01 mg/kg of food |
Extractable primary aromatic amines | 3% acetic acid | In-house LC-MS/MS | ≤ 0.002 mg/l of extract (per substance) |
Total transfer of formaldehyde | 3% acetic acid | In-house method | ≤ 6 mg/kg of food |
Specific migration of butadiene | olive oil | In-house GC-MS/FID | ≤ 0.01 mg/kg of food |
Specific migration of acrylonitrile | 10% ethanol, 3% acetic acid, olive oil | In-house GC-MS/FID | ≤ 0.01 mg/kg of food |
Not included in the package, but can be analyzed separately:
Colorfastness
Release of N-nitrosamines and nitrosatable substances
Release of secondary aliphatic amines
Transfer of antimicrobial components (EN 1104)
- Suitable sample matrices
- Nitrile gloves
- Required sample quantity
- 100 gloves
- Typical turnaround time
- 4 weeks after receiving the samples
- Available quality systems
- Accredited test method
- Device types
- Standard
- Method expert
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