BS EN 71-12 2016 pdf free download.Safety of toys Part 1 2: N-Nitrosamines and N-nitrosatable substances
This European Standard specifies the requirements and test methods for N-nitrosamines and Nnitrosatable substances for:
— 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.
EXAMPLE Examples of toys made from elastomers are balloons and teethers.
NOTE With regard to elastomers, up to now N-nitrosamines and N-nitrosatable substances have mainly been detected in vulcanized materials.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 3696, Water for analytical laboratory use – Specification and test methods (ISO 3696)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 finger paint
aqueous semi-solid or liquid, coloured mixture specially designed for children to apply directly to suitable surfaces with the fingers and hands
[SOURCE: EN 71-7:2014, definitio 3.1]
3.2 elastomer
flexible cross-linked macro-molecular material which returns rapidly to approximately its initial dimensions and shape after substantial deformation by stress and release of the stress at room temperature
Note 1 to entry: Not all elastomers are likely to contain N-nitrosamines and N-nitrosatable substances. For further guidance on possible sources of N-nitrosamines and N-nitrosatable substances in elastomers the term elastomer and other related aspects see A.1.
[SOURCE: EN ISO 472:2013, 2.327, modified: the phrases “flexible cross-linked”, “approximately” and “at room temperature” and note 1 to entry added and the phrase “a weak” deleted]
3.3 N-nitrosamine
substance characterised by the -N-N=O functional group, usually formed by the reaction of an amine with a nitrosating agent at acidic pH
Note 1 to entry: The reacting amines primarily are secondary amines.
Note 2 to entry: An example for a nitrosating agent is nitrite
3.4 N-nitrosatable substance
substance which when released into the test solution undergoes nitrosation to form a N-nitrosamine under specified conditions
4 Requirements
4.1 Requirements for finger paints
The concentration of N-nitrosamines in finger paints shall not exceed 0,02 mg/kg when tested in accordance with 7.2 and Clause 8, calculated as sum of all detected N-nitrosamines according to 9.1.
The migration of N-nitrosatable substances from finger paints shall not exceed 1 mg/kg of toy material,calculated as sum of all detected N-nitrosamines after nitrosation.
At least the substance in Table 1 shall be determined in finger paint. If there are indications of the presence of other N-nitrosamines, they shall also be determined.
4.2 Requirements for elastomers
The migration of N-nitrosamines (calculated as sum of all detected N-nitrosamines according to 9.2) andof N-nitrosatable substances (calculated as sum of all detected N-nitrosamines after nitrosation) from toys or parts of toys shall not exceed the limit values specified in Table 2 when tested in accordance with 7.3 and Clause 8.
5 Principle
N-nitrosamines and N-nitrosatable substances migrate into a test solution. N-nitrosatable substances are converted to N-nitrosamines by acidification. The final test solutions are analysed for N-nitrosamines by a suitable validated analytical technique. The N-nitrosamines and N-nitrosatable substances are expressed in mg/kg of sample.
The test solution for N-nitrosamines in finger paints is water. The test solution for N-nitrosatable substances in finger paints and for N-nitrosamines and N-nitrosatable substances in elastomers is saliva test solution.
6 Reagents and apparatus
6.1 Reagents
Unless otherwise specified, all reagents shall be of analytical grade and distilled water, or water of equivalent purity conforming to at least grade 3 of EN ISO 3696.
6.1.1 Sodium hydrogen carbonate (CAS 144-55-8)
6.1.2 Sodium chloride (CAS 7647-14-5)
6.1.3 Potassium carbonate (CAS 584-08-7)
6.1.4 Sodium nitrite (CAS 7632-00-0)
6.1.5 Hydrochloric acid (CAS 7647-01-0), aqueous solution, c(HCL) = 0,1 mol/l.BS EN 71-12 pdf download.