Consumer safety
Identifying nitrosamines in elastomer, latex rubber, toys
and cosmetics
Focus on nitrosamine compounds
Nitrosamines have been identified as presenting a potential risk
to human health. These substances are prohibited by regulatory
requirements in cosmetic products/raw materials, toys, teats and
soothers which have been manufactured with elastomer or latex
rubber.
How are these chemicals used?
Nitrosamines are substances that are not added to cosmetic
formulations or during the production of teats and soothers.
They are the reaction products of amines or amine derivatives with
nitrosating agents.
Some common nitrosamines include the following:
N-nitrosodimethylamine (NDMA)
N-nitrosomorpholine (NMorph)
N-nitrosodiethanolamine (NDELA)
Why are nitrosamines harmful?
Some nitrosamines pose a risk to human health owing to their
toxicity.
What are the EU regulatory requirements for nitrosamines?
- Commission Directive 93/11/EEC concerning the release of
nitrosamines and nitrosatable substances from elastomer or rubber
teats and soothers
- Nitrosamines are listed in ANNEX II of Cosmetic Directive
76/768/EC as substances which must not form part of the composition
of cosmetic products
- Nitrosamines and nitrosatable substances are prohibited for use
in toys intended for use by children under 36 months or in other
toys intended to be placed in the mouth if the migration of the
substances is equal to or higher than 0.05 mg/kg for nitrosamines
and 1 mg/kg for nitrosatable substances under Annex III of the toy
safety Directive 2009/48/EC.
Services include:
- ASTM and CEN standardised methods for determining specific
nitrosamines
- Methods for apparent total N-nitroso compounds (ATNC) in
cosmetic formulations
- Specific determination of N-nitrosodiethanolamine (NDELA).
Why choose LGC?
- Certified to ISO 9001: 2000
- Accredited to ISO 17025
- Considerable experience - LGC actively participates in EC
working groups and is involved with international committees to
test and collaboratively trial methodologies for regulated
substances as specified by EU toy and cosmetic
Directives.
For more information, please contact:
Andy.Earls@lgc.co.uk; tel:
+44(0)20 8943 7576 or
Ian.Axford@lgc.co.uk;
tel: +44(0)20 8943 7578