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)

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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

Price

Price per sample (Excl. VAT):
268 €

We also charge a 97 € service fee per order.

Large batches of samples are eligible for discounts.

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