Regulation (EC) No 1272/2008 of the European Parliament and of the Council defines specific requirements for chemical substances that are designated as carcinogenic, mutagenic, or hazardous for reproduction. These requirements are set forth in Directive 2009/48/EC. Specific limit values for chemicals used in toys intended for use by children under 36 months of age or in other toys meant to be put in the mouth are set forth in Appendix C of Annex II to the Directive.
A monomer utilized in the production of polymeric polymers is formaldehyde. Toys frequently contain materials made of polymers. Therefore, when mouthing toys made of polymeric materials, kids could consume formaldehyde. The World Health Organization (WHO) established the tolerated daily intake (TDI) for formaldehyde, and the European Food Safety Authority’s Scientific Panel on Food Additives, Flavourings, Processing Aids, and Materials in Contact with Food (AFC) has since confirmed it(5). The daily TDI is 0.15 mg/kg body weight. A child weighing 10 kg should not consume more than 0.15 mg of formaldehyde per day, with formaldehyde from toys accounting for 10% of the total daily intake (TDI). The subgroup Chemicals recommended a formaldehyde migration limit of 1.5 mg/l in polymeric materials when the migration of formaldehyde is determined using the test method in standards EN 71-10:2005 and EN 71-11:2005, assuming a daily ingestion of 100 ml of mouthing saliva.
Thermoplastic Elastomers (TPEs) are produced by Phon Tech in compliance with EU requirements for toys and infant products, including teethers, toy vehicle wheels, baby spoons, and bathtubs, among others. Our TPEs are safe for babies and contain no formaldehyde.
The TPEs may connect with a variety of materials, including PP, PE, and PS, and are flexible and simple to produce.