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SAFEGUARDS | Consumer Products NO. 022/17

SafeGuardS Baby Bottles

The CEN has published EN 12868:2017 for the release of n-nitrosamines and n-nitrosatable substances from elastomer or rubber teats and soothers. Conflicting national standards are to be withdrawn by July 2017 at the very latest.

In April 1993, the European Union (EU) published Directive 93/11/EEC [1] to restrict the release of n-nitrosamines and n-nitrosatable substances from elastomer or rubber teats and soothers. This Directive also provided basic rules for determining the release of these substances and criteria for the analytical method to be adopted.

In August 1999, the Comité Europeén de Normalisation (CEN, European Committee for Standardization) published EN 12868:1999 as a standard method for compliance with Directive 93/11/EEC. This standard provides a detailed procedure for the extraction and analytical processes for n-nitrosamines and n-nitrosatable substances in teats and soothers.

In October 2016, the CEN approved EN 12868:2017, a new standard relating to the release of n-nitrosamines and n-nitrosatable substances in elastomer or rubber teats and soothers. This new standard is now available on a commercial basis at national standards organizations, such as the British Standards Institution (BSI [2]).

EN 12868:2017 contains a number of important changes to the 1999 version, which include:

  • A completely new definition for ‘n-nitroamine’ and ‘ready to use product’

  • A revision to the definitions for ‘elastomer’ and ‘rubber’

  • Requirement for two migration tests and two determinations to be carried out

  • A revision to procedures, including a defined temperature for nitrosation and requiring a minimum quantity of elastomer or rubber samples for testing

  • Inclusion of n-nitrosodiisobutylamine (NDiBA, CAS 997-95-5) as one of the n-nitrosamines that has been identified in teats. This is relevant for testing and calibration standards

  • Providing a gas chromatography (GC) chromatogram of a calibration solution of n-nitrosamines and their retention times using a thermal energy analysis (TEA) detector to assist analysis (Annex B)

  • The use of Liquid Chromatography Mass Spectrometry (LC-MSn) as an alternative analytical method for the analysis of n-nitrosamines and n-nitrosatable substances. The settings for this technique are provided in Annex D of the standard

It is noteworthy that the analytical tolerances remain identical between the 1999 and the 2017 versions of EN 12868. These are 0.01 mg/kg for the total quantity of n-nitrosamines and 0.1 mg/kg for the total quantity of n-nitrosatable substances.

Although EN 12868:2017 (or its predecessor) and the toy safety standard EN 71-12 are for n-nitrosamines and n-nitrosatable substances, it is important to note that there are differences between these two methods in terms of extraction and analytical procedures.  

Highlights of Directive 93/11/EEC and the two versions of EN 12868 for determining the release of n-nitrosamines and n-nitrosatable substances from elastomer or rubber teats and soothers are summarized in Table 1.

Citation Method Scope Requirement
Directive 93/11/EEC EN 12868:1999 Elastomer or rubber teats and soothers

≤ 0.01 mg/kg (n-nitrosamines) 

≤ 0.1 mg/kg (n-nitrosatable substances)

EN 12868:2017

Note

  • EN 12868:1999 - Voluntary standard
  • EN 12868:2017 - Conflicting national standards to be withdrawn by July 2017 at the very latest

Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing and consultancy, for n-nitrosamines and n-nitrosatable substances for toys, teats and soothers for the EU and international markets.

For enquiries, please contact:

Hingwo Tsang
Global Hardlines Information and Innovation Manager
t: +852 2774 7420

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