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SAFEGUARDS | Toys & Juvenile Products NO. 017/17

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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 Conflicting national standards are to be withdrawn by June 2017 at the very latest.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 1). 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 1.

EN 71-12 ‘Safety of Toys: N-nitrosamines and N-nitrosatable Substances’
Version 2016 2013
Scope
  • Toys and parts of toys made from elastomers and intended for 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
Requirement

Finger paints intended for children under 36 months
≤ 0.02 mg/kg (n-nitrosamines)
≤ 1.0 mg/kg (n-nitrosatable substances)

Elastomers:
Toys intended for children under 36 months and intended or likely to be placed into the mouth

≤ 0.01 mg/kg (n-nitrosamines)
≤ 0.1 mg/kg (n-nitrosatable substances)

Toys intended for children under 36 months and not covered by above
≤ 0.05 mg/kg (n-nitrosamines)
≤ 1.0 mg/kg (n-nitrosatable substances)

Toys intended for children of 36 months and older and intended to be placed into the mouth
≤ 0.05 mg/kg (n-nitrosamines)
≤ 1.0 mg/kg (n-nitrosatable substances)

Balloons
≤ 0.05 mg/kg (n-nitrosamines)
≤ 1.0 mg/kg (n-nitrosatable substances)

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)
≤ 1.0 mg/kg (n-nitrosatable substances)

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)

  • Duration of migration process for natural or synthetic rubber intended for children under 36 months or in other toys or parts of toys intended to be placed in the mouth is 24 hours
  • Requirements for natural or synthetic rubber intended for children under 36 months or in other toys or parts of toys intended to be placed in the mouth are:
    ≤ 0.01 mg/kg (n-nitrosamines)
    ≤ 0.1 mg/kg (n-nitrosatable substances)
               

Throughout our global network, SGS offers consultation and comprehensive testing services (physical/mechanical, chemical, flammability, electrical safety, etc.) covering the full spectrum of international product safety and regulatory standards for a wide range of toys. Our laboratories are internationally recognized by major industry associations, accreditation bodies and authorities. With the largest global network of toy experts and testing facilities around the world (including 3 EU Notified Bodies and about 40 CPSC-Accepted Testing Laboratories), SGS is the partner to trust. Please do not hesitate to contact us for further information or http://www.sgs.com/toys

For enquiries, please contact:

Hing Wo Tsang
Global Toys and Juvenile Products
 t: +852 2774 7420

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