The Office for Product Safety and Standards (OPSS) was recently made aware of the death of 5-year-old Karlton Noah Donaghey, who died in June 2022 following an accident involving a helium-filled foil balloon. We understand from the coroner’s report that the child was able to pull the inflated balloon over his head while playing at his home and suffered a fatal brain injury after inhaling helium in the dinosaur-shaped balloon. He passed away in hospital.

Sadly, an 8-year-old child from Dublin also died in April 2021 in similar circumstances involving a helium-filled foil balloon in the shape of a figure 8, and there are, unfortunately, examples of several other fatalities over recent years in the UK, Republic of Ireland and USA.

Retailers will know that the Toys (Safety) Regulations 2011 (TSR) requires all toys to be safe before they can be placed on the market. It establishes essential safety requirements that toys must meet to be considered safe, and where there are foreseeable risks or hazards associated with a toy, the Regulations require warnings to be provided on the product, its packaging, or an affixed label as well as in any instructions.

Helium-filled balloons that are designed or intended for use in play by children are toys governed by the TSR and therefore, when they are placed on the market, need to meet the essential safety requirements. This includes not jeopardising health or safety when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children. The inhalation of helium contained within a helium-filled balloon, intentionally or accidentally, is a foreseeable risk, and there is evidence the harm can be fatal.

To comply with essential safety requirements of the Regulations, retailers selling helium-filled balloons must ensure products warn of the dangers of inhaling helium (where it is, or will be, contained within the toy). Those supplying such balloons must verify that any warning, instructions or other information required to accompany a toy are supplied.

OPSS has also written to the British Standards Institution to ask that it considers updating the Toy Safety Standard EN71 to require that warnings be provided on toys that are (or will be) filled with helium. OPSS is currently reviewing the designation of this standard to determine whether a restriction may be necessary as without warnings, such helium balloons that have been manufactured and tested to the requirements of EN71 may still fail to meet the requirements of the TSR.