EU - EN 71-12:2013 – N-Nitrosamines and N-Nitrosatable Substances in Toys Has Been Published and Harmonised
Vol. 724 | July 19, 2013
EN 71-12 has been published to provide test methods in support of the EU requirements for N-nitrosamines and N-nitrosatable substances in certain types of toys. A reference to this standard has also been published in the EU’s Official Journal, such that compliance will offer a presumption of conformity to the new chemical requirements for toys that take effect from 20 July 2013 under the EU Toys Safety Directive 2009/48/EC.
Elastomers (e.g. rubbers, silicones and thermoplastic elastomers (TPEs)) may contain N-nitrosamines, which are believed to arise from precursor additives such as accelerators. N-nitrosamines may be formed in finger paints under certain acidic conditions if they include N-nitrosatable substances (e.g. secondary amines) and a nitrosating agent (e.g. nitrite). For example, N-nitrosodiethanolamine (NDELA) can be produced if diethanolamine (DEA, a secondary amine), or even triethanolamine which could decompose to DEA, is present with certain preservatives such as bronopol (nitrite source).
Some N-nitrosamines are carcinogenic (Category 1B). The EN 71-12 migration limits are shown in Table 1.
Table 1 – EN 71-12 Requirements for N-Nitrosamines and N-Nitrosatable Substances
Types of Materials and Toys
Sum of all N-nitrosamines/ mg/kg
Sum of all N-nitrosatable substances/ mg/kg
Elastomers in toys and parts of toys intended for use by children under 36 months (e.g. teethers)
Elastomers in toys and parts of toys intended to be placed in the mouth (e.g. balloons)
These limits for elastomers are from the Directive and are based on ingestion by mouth. However the EN 71-12 migration limit for N-nitrosamines in finger paints has been reduced from 0.05 mg/kg in the Directive to 0.02 mg/kg. This lower limit takes into account the relatively high rate at which some N-nitrosamines, such as NDELA, are absorbed through the skin. Hence the child’s ingestion of NDELA from finger paint is likely to be greater through the skin than by mouth.
Each type of toy material is tested in a different manner. Elastomers are extracted with a saliva solution containing nitrite, as ingestion will be primarily via the mouth. This test solution is then divided, with one portion used for the direct analysis of N-nitrosamines, while the other is acidified to facilitate the conversion of N-nitrosatable substances to further N-nitrosamines.
Finger paints are extracted with two test solutions. Water is used to extract N-nitrosamines, taking into account skin absorption. However, the conversion of N-nitrosatable substances to N-nitrosamines requires acidic conditions (e.g. in the stomach) water is replaced by a saliva solution containing nitrite.
N-nitrosamines are analysed using high performance liquid chromatography (HPLC) coupled with tandem mass spectrometry (HPLC-MS/MS). EN 71-12 requires testing of elastomers for those N-nitrosamines (13 in total) that have been found in toy materials, along with NDELA in finger paints, as listed in Tables 2 and 3, respectively. Please note as the EN 71-12 migration limits apply to the sum of all N-nitrosamines and N-nitrosatable substances any other N-nitrosamines detected will be included.
Table 2 – N-Nitrosamines to be Tested in Elastomers
Table 3 – N-Nitrosamines to be Tested in Finger Paints
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