COMMISSION DIRECTIVE (EU) 2019/1929 adopting specific limit values for chemicals used in certain toys, as regards formaldehyde

2019.11.29
Directive 2009/48/EC establishes certain requirements for chemical substances that are classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council. Appendix C to Annex II to the Directive lays down specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.

Formaldehyde is used as a monomer in the manufacture of polymeric materials. Polymeric materials are often used in toys. Children may, therefore, ingest formaldehyde when mouthing toys containing polymeric materials. The tolerable daily intake (TDI) for formaldehyde was set by the World Health Organisation (WHO) and has been confirmed by the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) of the European Food Safety Authority(5). The TDI is 0,15 mg/kg body weight per day. With an allocation of 10 % of the TDI to the intake of formaldehyde from toys; a child with a bodyweight of 10 kg should therefore not take in more than 0,15 mg formaldehyde per day. Assuming a daily ingestion of 100 ml of mouthing saliva, the subgroup Chemicals recommended, at its meeting on 26 September 2017, a formaldehyde migration limit of 1,5 mg/l in polymeric materials when the migration of formaldehyde is determined in accordance with the test method in standards EN 71-10:2005 and EN 71-11:2005.

Phon Tech manufactures Thermoplastic Elastomers (TPEs) in accordance with the EU regulations for toy and baby products, such as teether, toy car wheel, baby spoons, and bathtub etc.... Our TPEs do not contain any formaldehyde and they are safe for baby. 
The TPEs are flexible, easy to process and can bond with various materials like PP, PE, and PS. 



 
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