CEN Publishes EN 71–12:2016 for Safety of Toys
EN 71-12:2016 Safety of toys — N-Nitrosamines and N-Nitrosatable Substances has been published by CEN (European Committee for Standardization) on December 21, 2016. 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shall be given the status of a national standard at the latest by June 2017 and conflicting national standards shall be withdrawn by this date. EN 71-12:2016 also superseded EN 71-12:2013 and is expected to be harmonized under Directive 2009/48/EC by publication in the Official Journal of the European Union.
The main changes in EN 71-12:2016 conclude:
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Alignment of language for the definition of ‘finger paint’ for consistency with the language used in EN 71-7:2014 (Finger Paints – Requirements and Test Methods);
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The use of a modified definition for ‘elastomer’ from ISO 472:2013 (Plastics – Vocabulary);
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The use of porous graphitic carbon (PGC) reversed phase (C18) high performance liquid chromatography (HLPC) columns as an additional option for analysis;
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Modify the procedure for the extraction process for toys and parts of toys other than balloons;
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An additional set of multiple reaction monitoring-transitions (MRM-transitions) for quantification and identification.
EN 71-12 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 and finger paints for children under 36 months. No changes for scope in EN 71-12:2016.
An important and notable change in the 2016 version of the standard is the completely new set of four toy categories and their limit values for n-nitrosamines and n-nitrosatable substances in elastomers. This includes one set of more stringent limits for elastomers in toys intended for children under 36 months and intended or likely to be placed in the mouth.
Highlights of the requirements for finger paints and elastomers between the 2016 and 2013 versions of EN 71-12 are summarized as below:
Material
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EN 71-12:2016
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EN 71-12:2013
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Product type
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N-Nitrosamines
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N-Nitrosatable Substances
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Product type
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N-Nitrosamines
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N-Nitrosatable Substances
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Finger paints
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Finger paints intended for children under 36 months
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≤0.02 mg/kg
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≤1.0 mg/kg
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Finger paints intended for children under 36 months
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≤0.02 mg/kg
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≤1.0 mg/kg
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Elastomers
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Toys intended for children under 36 months and intended or likely to be placed into the mouth
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≤0.01 mg/kg
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≤0.1 mg/kg
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Toys intended for children under 36 months or in other toys or parts of toys intended to be placed in the mouth
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≤0.05 mg/kg
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≤1.0 mg/kg
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Toys intended for children under 36 months and not covered by above
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≤0.05 mg/kg
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≤1.0 mg/kg
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Toys intended for children of 36 months and over and intended to be placed into the mouth
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≤0.05 mg/kg
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≤1.0 mg/kg
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Balloons
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≤0.05 mg/kg
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≤1.0 mg/kg
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