CEN Issues New Toy Safety Standard for N-Nitrosamines and N-Nitrosatable Substances

The Comité Europeén de Normalisation (CEN, European Committee for Standardization) has published a new standard relating to the use of n-nitrosamines and n-nitrosatable substances in toys.

The new standard, EN 71-12:2016, has several important background, editorial and technical changes, including:

• 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)
• The use of a modified definition for ‘elastomer’ from ISO 472:2013 (Plastics – Vocabulary, for better clarity)
• The use of porous graphitic carbon (PGC) reversed phase (C18) high performance liquid chromatography (HLPC) columns as an additional option for analysis
• A new procedure for the extraction process for toys and parts of toys other than balloons
• An additional set of multiple reaction monitoring-transitions (MRM-transitions) for quantification and identification

Stakeholders should be aware that the 2016 version of the standard contains also one other important change from the 2013 version – the creation of four new toy categories and limit values for n-nitrosamines and n-nitrosatable substances in elastomers. Previously, elastomers intended for children under 36 months or in other toys or parts of toys intended to be placed in the mouth had the following limit restrictions:

• n-nitrosamines – no more than 0.05 mg/kg
• n-nitrosatable substances – no more than 1.0 mg/kg

The new standard requires “Toys intended for children under 36 months and intended or likely to be placed into the mouth” to now comply with the much lower levels of:

• n-nitrosamines – no more than 0.01 mg/kg
• n-nitrosatable substances – no more than 0.1 mg/kg

The other three new categories: for balloons, toys intended for children of 36 months or older and intended to be placed in the mouth, and toys not covered by the under 36-month-old category, retain the same limits as the original version.

The new strengthened limits are stricter than those contained within the Toy Safety Directive 2009/48/EC (TSD) but match those in the German Federal Law for nitrosamines and n-nitrosatable substances. It should also be noted that there is still a deviation for Germany’s duration of the migration process for toys made of natural or synthetic rubber designed for children up to 36 months and intended or likely to be placed in the mouth. This is 24 hours rather than 240 + or - 5 minutes as specified in EN 71-12:2016 or 240 + or - 3 minutes as specified in EN 71-12:2013.

The new standard, published in December 2016, is expected to be given the status of a national standard by June 2017, with conflicting standards being withdrawn before this date. It is anticipated that the new standard will be harmonized under the TSD upon official acceptance by the European Commission (EC) and by publication in the Official Journal of the European Union (OJEU).

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

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This release was published on openPR.