Soap bubbles
“BUBBLE KID”



- Číslo případu
- 1894/10
- Kategorie
- Toys
- Typ / Model
- Code No: B0019;
- Čárový kód
- 8021029900586 (supplied by importer) Code on label: ITEM NO. 6388A
- Cílová skupina
- Consumer
- Notifikující země
- 🇮🇹 Itálie
- Země původu
- 🇨🇳 Čína
- Zveřejněno
- 2010-12-24
⚠️ Riziko
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.
Opatření
Type of economic operator to whom the measure(s) were ordered: OtherCategory of measure(s): Seizure of the products and withdrawal from the market ordered by the authorities.Date of entry into force: Unknown