CEN Issues EN 12868:2017 for N-Nitrosamines and N-Nitrosatable Substances in Teats and Soothers

The Comité Europeén de Normalisation (CEN, European Committee for Standardization) has published a new standard, EN 12868:2017, for the release of n-nitrosamines and n-nitrosatable substances from elastomer or rubber teats and soothers.

EN 12868:2017 contains several important changes to the previous 1999 version. These 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

Stakeholders should be aware the analytical tolerances have not altered in the new 2017 version of EN 12868. As with EN 12868:1999, they remain:

• 0.01 mg/kg for the total quantity of n-nitrosamines
• 0.1 mg/kg for the total quantity of n-nitrosatable substances

The European Union (EU) first addressed the release of n-nitrosamines and n-nitrosatable substances from elastomer or rubber teats and soothers in April 1993 with the publishing of Directive 93/11/EEC. The Directive introduced basic rules for determining the release of these substances and conditions for the analytical method to be used. EN 12868 was then adopted in August 1999 as the standard method for compliance with Directive 93/11/EEC. It provided a more detailed procedure for the extraction and analytical processes involved with looking at n-nitrosamines and n-nitrosatable substances in teats and soothers.

With the approval, in October 2016, of EN 12868:2017 by the CEN, it is expected that conflicting national standards will be withdrawn by July 2017.

This new standard is now available on a commercial basis at national standards organizations, such as the British Standards Institution (BSI).

SGS Juvenile Products & Childcare Article Services
SGS’s global network of laboratories and experts 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. Learn more about SGS’s Juvenile Products & Childcare Article Services (www.sgs.com/en/consumer-goods-retail/toys-and-juvenile-products/juvenile-products-and-childcare-articles)

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For further information contact:

Hing Wo Tsang
Global Hardlines Information and Innovation Manager
Tel:(+852) 2774 7420
Email: cts.media@sgs.com
Website: www.sgs.com/hardlines

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This release was published on openPR.