On 10 January 2022, the European Commission (EC) has updated EC-type approval protocol No. 21 which intends to specify microbiological requirements for toys containing aqueous media such as bubble solutions, finger paints, colouring sets, slime, modelling clays and squeezable toys.

In this revision, the limit parameter “Enterobacteriaceae” is changed to “bile-salts tolerant gram-negative bacteria”. The Enterobacteriaceae are part of the group “bile-salts tolerant gram-negative bacteria”, but there are a few more in this group.

If pathogenic micro-organisms are present in toys, they may present a risk of microbial infection. As no specific microbiological requirements for toys exist, the EU Notified Body toys group has developed this harmonised protocol based on requirements that are applicable for cosmetic products.