Release of N-nitrosamines and N-nitrosable substances
N-nitrosamines and N-nitrosatable substances are present, usually in trace quantities, in various environmental media, certain food products, cosmetics, and rubber products. In particular, those found in rubber products are thought to originate from certain additives used in the vulcanization of rubber.
Regulatory reference / standard | Applicable materials | Compliance limits | Applicable reference method |
---|---|---|---|
Commission Directive 93/11/EEC | Elastomer or rubber teats and soothers | N-nitrosamines released: 0.01 mg/kg N-nitrosatable substances released: 0.1 mg/kg | EN 12868 |
EN 14350 | Drinking accessories made of rubber and other elastomers | ||
BfR recommendation XXI/1 | Commodities based on natural and synthetic rubber in contact with food | N-nitrosamines: not detected above 1 µg/dm2 (sum of substances) | - |
N-nitrosamines and N-nitrosatable substances are controlled by Commission Directive 93/11/EEC. In addition, recommendation XXI by Germany’s Federal Institute for Risk Assessment (BfR) has set the migration limit of N-nitrosamines from elastomers to food at ≤ 1.0 µg/dm2.
The test package covers analysis of the release of the following N-nitrosamines (free and after nitrosation) into artificial saliva simulant or a food simulant:
Substance | Abbreviation | CAS No |
---|---|---|
N-Nitrosodimethylamine | NDMA | 62-75-9 |
N-Nitrosodi-n-propylamine | NDPA | 621-64-7 |
N-Nitrosodi-n-butylamine | NDBA | 924-16-3 |
N-Nitrosopiperidine | NPIP | 100-75-4 |
N-Nitrosopyrrolidine | NPYR | 930-55-2 |
N-Nitrosomorpholine | NMOR | 59-89-2 |
N-Nitrosobenzylamine | NDBzA | 937-32-6 |
N-Nitrosodi-n-amylamine | NDiNA | 2050-92-2 |
N-Nitroso-methylphenylamine | NMPhA | 937-35-9 |
N-Nitrosoethylphenylamine | NEPhA | 612-64-6 |
- Suitable sample matrices
- Natural and synthetic rubbers, elastomers
- Required sample quantity
- 40 g
- Typical turnaround time
- 3 – 4 weeks after receiving the samples
- Detection limit
- N-nitrosamines: 0.003 mg/kg; N-nitrosatable substances: 0.003-0.005 mg/kg
- Available quality systems
- Accredited test method
- Device types
- Standard
- Method expert
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