“BUBBLE KID” soap bubbles — microbiological risk

Hazard

The product poses a chemical risk because the liquid exceeds the limit values for the total aerobic microbial count (TAMC) (aerobic mesophilic bacteria) laid down by the European Pharmacopoeia for the microbiological quality of non-sterile pharmaceutical preparations (5.1.4), for which cutaneous, nasal or oromucosal contact is envisaged; we consider that the same limit (10²) should apply, since there is equivalence between the exposure experienced by children using the soap bubble toy (this actually occurs through cutaneous contact, through indirect inhalation and through frequent accidental introduction into the mouth during use) and the exposure envisaged for the preparations referred to above. The liquid also returns a positive result for gram-negative bacteria, among which Burkholderia cepacia has been identified; this is highly resistant to antibiotics and is capable of causing infections, including serious infections, in vulnerable subjects such as children with cystic fibrosis or immunodeficiciency disorders.

Measures taken

• Seizure of the products and withdrawal from the market ordered by the authorities — Other

Product description

The product is a container for soap solution made of smooth, luminous orange plastic with a white cap. The cap is topped off with a clear green plastic dome containing a metallic ball (puzzle). There is an orange label around the product. The front shows four cartoon characters, a ram, a tiger cub, a chick and a puppy - coloured pink, orange, yellow and blue, respectively - and the name of the product appears in red outlined in black. The characters are surrounded by soap bubbles. The following text appears in a white rectangle at the top right: 'WARNING: Choking hazard - Small parts, not for children under 3 years.' The following text appears to the left: '12PCS' and the CE mark appears at the bottom. On the back the product's name appears at the top. To the right there are two diagrams with instructions for use, and lower down the following text in a white box: 'PRECAUCIONES peligro de ahogarse. Contiene partes pequenas. No recomendado para ninos menores de 3 anos.' That text also appears in other languages, namely English and Arabic.