EN 71-12 N-nitrosamines and N-nitrosatable substances updated to version 2016

On 21 December 2016, the European Committee for Standardisation (CEN) updates EN 71-12:2016 N-nitrosamines and N-nitrosatable substances, which will be transposed to standards of Member States before June 2017 at the latest. By the time, the new version will supersede EN 71-12:2013 and cancel conflicting standards.

Major amendments in EN 71-12:2016:

1. Revise the definition for “finger paint” so that it is in line with that in the European Standard Finger paints - Requirements and test methods;

2. Revise the definition of “elastomers” by citing that from the ISO standard Plastics- Vocabulary.

3. Allow the use of porous graphitic carbon (PGC) reversed phase (C18) high performance liquid chromatography (HLPC) columns as an additional option for analysis

4. Add a new extraction procedure for toys and parts thereof other than balloons.

5. Include multiple reaction monitoring-transitions (MRM-transitions) for quantification and identification.

The scope falling under EN 71 part 12 includes:

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.

In the updated standard, the limits for N-nitrosamines and N-nitrosatable substances remain unchanged. However, it details the categories of toys made of elastomers with new limits. In general, more stringent requirements are posed for toys and parts of toys made from elastomers and intended for use by children under 36 months. See the table below for more details.

Version	Restricted substances	Scope and Limits
		Finger paints for children under 36 months	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 for use by children of or above 36 months	Balloons
			Intended to be placed in the month	Other
EN 71-12:2016 (* New)	N-nitrosamines	≤0.02 mg/kg	≤0.01 mg/kg	≤0.05 mg/kg	≤0.05 mg/kg	≤0.05 mg/kg
	N-nitrosatable substances	≤1.0 mg/kg	≤0.1 mg/kg	≤1.0 mg/kg	≤1.0 mg/kg	≤1.0 mg/kg
EN 71-12:2013	N-nitrosamines	≤0.02 mg/kg	≤0.05 mg/kg
	N-nitrosatable substances	≤1.0 mg/kg	≤1.0 mg/kg

C&K Testing advises exporters should comply with new requirements to avoid economic losses. It is also noteworthy that the formamide restriction becomes effective by May.

|Further Information:

Formamide restriction in EU toy safety directive effective on 24 May

|Our Services: Toys & Children's Products Toy Safety Directive 2009/48/EC&EN 71