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Publication Date Thursday, February 9, 2017





EN 71–12:2016 Safety of toys — N-Nitrosamines and N-Nitrosatable Substances has been published by CEN (European Committee for Standardization).

The 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.

The standard contains changes, which includes among others:

  • Requirements for elastomers now contain four products type with specific limits. One products type (toys intended for use by children under 36 months and intended or likely to be placed into the mouth) now contains more stringent limits than those provided within the Directive 2009/48/EC, in line with German Legislation. However it should be noted that an A-Deviation (informative) is still present since the migration time under German Legislation is different from the one included in EN 71–12:2016.
  • Limits of detection (LOD) and Limit of Quantification (LOQ) have been improved
  • Definition of elastomer and related rationale have been modified to better clarify the field of application of the standard
  • Technical changes have been included in the test method procedures (e.g. in the sample preparation for other toys or parts of toys than balloons)

According to EN 71–12:2016, this standard shall be given the status of a national standard at the latest by June 2017 and conflicting national standards shall be withdrawn by this date.

This standard is expected to be harmonized under Directive 2009/48/EC by publication in the Official Journal of the European Union.

Source: CEN Publishes EN 71–12:2016 for n-nitrosamines and n-nitrosatable substances


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