Reported risk: The amount of N-nitrosatable substances released by the balloons is too high (measured value up to 1.647 mg/kg). Nitrosatable compounds can be converted into nitrosamines, which are genotoxic carcinogens via inhalation, ingestion or dermal exposure. A child can get exposed to them by putting the balloon in the mouth. The product does not comply with the requirements of the Toy Safety Directive and the relevant European standard EN 71-12.
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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.