EU: Recent Updated Standards – EN 71-12 & EN 12868 related to N-nitrosamines and N-nitrosatable substances

23/02/17

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08h00 - 16h30

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The CEN has recently published a new version of Toy Safety Standard EN 71-12:2016 for nitrosamines and n-nitrosatable substances in December 2016 and a new version of  EN 12868:2017 for n-nitrosamines and n-nitrosatable substances in teats and soothers in January 2017.

 

EN 71-12:2016


The CEN has published toy safety standard EN 71-12:2016 for n-nitrosamines and n-nitrosatable substances. Conflicting national standards will be withdrawn at the latest by June 2017. This standard is expected to be harmonized under Toy Safety Directive 2009/48/EC by publication in the Official Journal of the European Union (OJEU).

The major changes in the 2016 version of the standard include:
• Requirements for elastomers now divided into four product types with specific limits
• More stringent limits of n-nitrosamines and n-nitrosatable substances for toys intended for use by children under 36 months and intended or likely to be placed into the mouth than those in current Toy Safety Directive (2009/48/EC) [same limits as German Federal Law with deviation of migration time]
• Definition of elastomer and related rationale have been modified to give better clarity
• Sample preparation for other toys or parts of toys other than balloon has been changed

Overview of Requirements

This standard is applicable to:
• Toys and parts of toys made from elastomers and intended for use by children under 36 months
• Toys and parts of toys made from elastomers and intended to be placed in the mouth
• Finger paints for children under 36 months

Download Bulletin to view table with requirements in 2016 version compared to previous 2013 version.

EN 12868:2017

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 will be removed at the latest by July 2017. This standard is used for determining n-nitrosamines and n-nitrosatable substances released from elastomer or rubber teats in contact with artificial saliva salt solution for testing compliance with Directive 93/11/EEC.

The major changes in the 2017 version of the standard include:
• New terms and definitions, “n-nitrosamine” and “ready to use product” have been added and some terms and definitions have been revised to give better clarity
• Pre-boiling and migration steps have been separated for the determination of n-nitrosamines and n- nitrosatable substances
• Sampling procedure has been revised such as requiring a minimum quantity of elastomer or rubber samples for testing
• Temperature for nitrosation has been defined
• N-nitrosodiisobutylamine (NDiBA) has been included as one of the nitrosamines as this has been identified in teats and is relevant for testing and calibration standards

Download Bulletin to view table with overview of requirements.

How Does This Change Impact You? Contact Us:
To find out how we can assist you, visit www.bureauveritas.de/cps , www.bureauveritas.co.uk/cps, www.bureauveritas.fr, or email: cps-hamburg@de.bureauveritas.com

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