EN 71-12 Safety of N-Nitrosamines and N-Nitrosatable Substances

In the field of toy chemical safety, in addition to heavy metals, certain specific organic compounds are also strictly regulated due to their potential carcinogenicity. N-nitrosamine compounds are among them. The BS EN 71-12:2016 standard, "Safety of toys - N-nitrosamines and N-nitrosatable substances," specifically establishes strict control measures for these high-risk substances that may exist in toys, with a particular focus on toys made from elastomeric materials (such as rubber).

Substances Regulated by the Standard

This standard primarily controls two categories of substances:

• N-Nitrosamines: A group of chemicals classified by the International Agency for Research on Cancer (IARC) as carcinogenic to animals, with some being probably carcinogenic to humans. They may exist as impurities in certain rubber and elastomeric materials.

• N-Nitrosatable Substances: These substances themselves may not be nitrosamines, but they can react with nitrites in the human body (especially in the acidic environment of the stomach) to form nitrosamines. Therefore, they are referred to as "nitrosatable substances" or nitrosamine precursors.

Children may face a risk of long-term ingestion by sucking or chewing on toys containing these substances (such as balloons, pacifiers, teethers, etc.). EN 71-12 aims to minimize this risk.

1.1 Key Standard

Scope of Application and Limit Requirements

This standard applies to all toys that may contain elastomeric parts, particularly:

• Toys intended for use by children under 36 months of age.

• Toys intended to be placed in the mouth (regardless of age group).

The standard sets extremely strict migration limits:

• For N-Nitrosamines: The total amount must not exceed 0.01 mg/kg (for toys intended for children under 36 months or intended to be placed in the mouth) or 0.1 mg/kg (for other toys).

• For N-Nitrosatable Substances: The total amount must not exceed 0.1 mg/kg (for toys intended for children under 36 months or intended to be placed in the mouth) or 1.0 mg/kg (for other toys).

These limits are exceedingly low, placing extremely high requirements on raw material purity and production processes.

Test Methods

EN 71-12 specifies complex methods for sample preparation and chemical analysis:

• Sample Preparation and Migration Simulation: The elastomeric parts of the toy are cut into small pieces and soaked in an artificial saliva simulant at a specific temperature to simulate the child's sucking process.

• Extraction and Analysis:

• Direct extraction and concentration are performed for N-nitrosamines in the migration solution, typically using a Gas Chromatography-Thermal Energy Analyzer (GC-TEA) or Gas Chromatography-Mass Spectrometry (GC-MS) for high-sensitivity detection.

• For N-nitrosatable substances in the migration solution, they must react with sodium nitrite under acidic conditions to convert them into corresponding nitrosamines, and then the total amount of generated nitrosamines is detected.

The standard references method standards such as EN ISO 3696 (Standard for laboratory water) and DIN 32645 (Determination of the limit of quantification for chemical analysis), and harmonizes its relationship with EN 71-7 (Finger paints) and EN 71-10 (Sample preparation).

Mandatory Testing: For high-risk products, conducting EN 71-12 testing is a prerequisite for obtaining the ce mark and entering the European Union market.

JJR LAB provides a one-stop, highly efficient combined testing solution for chemical tests such as en 71-3 (Heavy Metals), EN 71-12 (Nitrosamines), and en 71-9/10/11 (Organic Compounds), ensuring your products meet all chemical requirements of the EU Toy Safety Directive (TSD).