16 Feb 2017
CEN Publishes EN 71-12:2016 for Toy Safety
The CEN has published toy safety standard EN 71-12:2016 for n-nitrosamines and n-nitrosatable substances. Conflicting national standards are to be withdrawn by June 2017 at the very latest.
In December 2016, the Comité Europeén de Normalisation (CEN, European Committee for Standardization) published [1] EN 71-12:2016, a new standard relating to n-nitrosamines and n-nitrosatable substances in toys. This new standard is now available on a commercial basis at the national standards organizations such as the British Standards Institution (BSI [2]).
EN 71-12:2016 contains a number of important background, editorial and technical changes, which include:
- 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
An important and notable change in the 2016 version of the standard is the completely new set of four toy categories and their limit values for n-nitrosamines and n-nitrosatable substances in elastomers (table below). This includes one set of more stringent limits for elastomers in toys intended for children under 36 months and intended or likely to be placed in the mouth. This set of strengthened limits is stricter than those in the Toy Safety Directive 2009/48/EC (TSD [3]) but identical to those in the German Federal Law for nitrosamines and n-nitrosatable substances [4]. It is also noteworthy 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 ± 5 minutes as specified in EN 71-12:2016 or 240 ± 3 minutes as specified in EN 71-12:2013.
According to EN 71-12:2016, this standard shall be given the status of a national standard by June 2017 and conflicting standards shall be withdrawn by this date at the very latest. This standard is expected to 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).
Highlights of the requirements for finger paints and elastomers between the 2016 and 2013 versions of EN 71-12 are summarized in table below.
| EN 71-12 "Safety of Toys: N-nitrosamines and N-nitrosatable Substances" | ||
| Version | 2016 | 2013 |
| Scope |
| |
| Requirement | Finger paints intended for children under 36 months ≤ 0.02 mg/kg (n-nitrosamines) ≤ 1.0 mg/kg (n-nitrosatable substances) | |
Elastomers: ≤ 0.01 mg/kg (n-nitrosamines) ≤ 0.05 mg/kg (n-nitrosamines) ≤ 0.05 mg/kg (n-nitrosamines) ≤ 0.05 mg/kg (n-nitrosamines) | Elastomers intended for children under 36 months or in other toys or parts of toys intended to be placed in the mouth ≤ 0.05 mg/kg (n-nitrosamines) | |
| Effective date for demonstrating presumption of conformity with the TSD | Expected to be cited in the OJEU (Becomes a national standard by June 2017 and conflicting national standards to be withdrawn by June 2017 at the very latest) | June 2013 [5] |
| Note German Consumer Goods Ordinance (Bedarfsgegenständeverordnung [6], BedGgstV, 1992)
≤ 0.01 mg/kg (n-nitrosamines) | ||
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