Guidance

PRISM: Narrative style risk assessment – non-compliant toy with a detachable part

Published 10 October 2024

Applies to England, Scotland and Wales

1) The product

The product is a musical toy saxophone, marketed at children over 3 years old. The tensile test method as specified within the relevant standard for this toy BS EN 71-1:2014+A1:2018 (as referenced by BS EN 62115), requires the tensile testing machine apparatus to apply a force to at least 90 Newtons (N) (+/-2N). During this test, the saxophone keys from the toy detach and become small parts. Things to consider are the ease in which the small part detaches, the tensile force required, and the size of the small part. If the part detaches after 10N the risk may be greater than a part that detaches at 80N. The packaging has a warning stating this product is not suitable for children under 3 years old as it contains small parts which could be considered a choking hazard; however, the warning is partially covered by a fulfilment house barcode label. There were no visible warnings or markings on the actual product.

It is foreseeable through the nature of children’s play and inquisitive behaviours that brightly coloured, child appealing, and purposeful toys that create music or require buttons to be pressed would attract children under the age of 3 years. ^{[footnote 1]} Researchers at McMaster University in Canada have discovered that very early musical training benefits children even before they can walk or talk. The research found that one-year-old babies who participate in interactive music classes with their parents smile more, communicate better, and show earlier and more sophisticated brain responses to music. ^{[footnote 2]} In addition, musical toys are the second highest toy category available in the home for children under 3 years, dolls and soft toys lead. ^{[footnote 3]} Despite the warnings on the product packaging, it is a reasonable assumption this toy could be played with by children under 3 years old, because the toy is unsophisticated and appears suitable and appropriate for play for a child under 3 given their general dexterity and cognitive skills. The hazard is not necessarily obvious either, so the caregiver may choose to ignore the warnings or age-appropriate label if they seem at odds with the design of the product that makes it appealing for play for under 3-year-olds.

This product is deemed a toy and falls within the scope of the Toys (Safety) Regulations 2011. The product was submitted for formal testing to assess compliance with the principal elements of the safety objectives stated in the Regulations. In relation to the musical toy saxophone, the safety objectives were determined by standard BS EN 71-1:2014+A1:2018 (as referenced by BS EN 62115), and the test house findings were that the product did not meet the safety objectives due to the product failing part 4.11 of the standard, mouth-actuated toys and other toys intended to be put in the mouth. It is essential that such toys as well as removable components and components which become detached when tested according to relevant requirements are not so small that they can be unintentionally swallowed or inhaled. ^{[footnote 4]}

Clause H.2 of BS EN 71-3:2019+A1:2021 details mouthing behaviours of children, and states:

Most studies on mouthing behaviour look at children under three years old. Only 3 studies are known that observe children over three years of age, of which only one presents mouthing duration data. The mean mouthing time on toys for 4 years and 5 years old children was very low (3 min and 1 min per day, respectively) with a maximum observed mouthing time on toys of 20 min and 11 min per day.

By the age of 6 years, children do not mouth their toys to any significant degree.

Note: As this is a worked example further product details are not provided here, but would normally include:

• manufacturer/brand
• model
• batch numbers and any other coding
• quantities supplied and over what time period
• how the matter came to the attention of the market surveillance authority (e.g. complaint, intelligence or ports and borders work)
• details of any reported incidents or injuries
• photographs of the product and packaging that, where possible, capture the hazard and identify the product

2) The hazard

The hazard under assessment is that the musical keys are larger than 6mm and can be gripped in accordance with the test method. The detachment force is less than 90N, however the exact force is not specified within the test report. The parts fit into the small parts cylinder as defined in clause 8.2 of BS EN 71-1:2014+A1:2018 (as referenced by BS EN 62115). Due to the small size and shape of the parts, these have the potential to be inhaled or ingested by persons who are unaware of or unable to appreciate the choking hazard or injuries this might cause, and who might confuse the small parts with something edible or have a propensity to mouth objects.

3) Who could be harmed?

The product is an unsophisticated toy that would be appealing to young children due to its design. Children are considered the intended users of this product and most at risk of harm because of their increased propensity to mouth objects. Whilst the product states unsuitable for under 3 years, it is foreseeable that children under the age of 3 years could be unintended users as the toy is appealing for children of that age category because of its simply design and colourful appearance. Children prefer brighter colours from an early age because their eyes are not fully developed yet. They perceive these colours better than fainter shades. Bright colours and contrasting colours stand out more in their field of vision. As children constantly strive to make sense of their environments, objects that are stark and bright are more stimulating and interesting. One of the first ways they learn to sort things by is colour. ^{[footnote 5]} Humans can perceive colour as early as one month old but have limited sensory capacities which limit their range of colour vision. As the eye develops, the ability to see colour increases. ^{[footnote 6]}

In the following scenario we are considering a choking hazard. Children below the age of 3 years are particularly vulnerable to this type of hazard, but it is still present and there is evidence of occurrence in children over the age of 3 years. NHS guidance on choking confirms children, particularly those aged from 1 to 5, often put objects in their mouth. ^{[footnote 7]} This is a normal part of how they explore the world.

4) Harm scenario

The scenario details how the musical saxophone toy is appealing to children under 3 years so a caregiver gives it to a child to play with and this play may not always be thoroughly supervised as the product may look like it is suitable for younger children despite the warning on the packaging. From the evidence supplied, and the test report, the primary risk arises from the small parts which can be generated by easily removing the saxophone keys.

Whilst children within this age category are generally under close carer supervision, this scenario details that carers do not notice in time. It could also be hypothesised that the toy is given to a child as the hazard is not an obvious one with this particular musical toy, or given to a child whilst travelling in a car, in a highchair or in a front facing push chair where the caregiver assumes the child is safe playing with the toy in that environment and is subsequently distracted. Young children have narrow airways and are still learning to master the sequencing and relationship between chewing, breathing and swallowing. In addition, they are mastering making sounds or trying to talk whilst mouthing objects which can sometimes lead to choking. ^{[footnote 8]}

The steps leading to the fatality are as follows:

Step 1: The product is appealing to children under 3 years, so a parent or carer gives it to a child under 3 years to play with.

Step 2: The child detaches the small part.

Step 3: The child mouths the small part, and it becomes lodged in the windpipe.

Step 4: The parents or carers do not notice in time.

Step 5: A level 4 injury occurs. The small part goes into the child’s airways, blocks passage of air to the lungs leading to death or brain damage.

5) Severity of harm

There is clear evidence that choking on a small part if not removed quickly can lead to a fatality, therefore it is considered that the most severe type of harm that is plausible is at level four.

6) Probability of harm

The following probabilities can be estimated using the available data and knowledge of human behaviour:

Step 1: The product is appealing to children under 3 years, so a parent or carer gives it to a young child to play with.

The musical saxophone toy has brightly coloured buttons and makes a noise which is appealing to young children. The parent or carers give the toy to a small child or leave it in the presence of a small child. Based on best judgement, a conservative probability of 0.5 is given to the likelihood of a child under 3 years having access to the toy based on a common-qualitative event.

Probability: 0.5

Step 2: The child detaches the small part.

The keys detach under a tensile force of less than 90N as specified within the test standard, which results in a failure of the product. The specific force is not stated within the test report; therefore, a cautiously moderate probability is applied based on 90N. The toy is intended to be played with; the keys are an intrinsic part of the toy that the child needs to repeatedly touch in order to create sound. The child detaches the small part through play. A probability of 0.1 is given.

Probability: 0.1

Step 3: The child mouths the small part, and it becomes lodged in the windpipe.

Oral sensory seeking behaviour (or mouthing items) is a normal behaviour of young children. ^{[footnote 9]} In 2019 The Organisation for Economic Co-operation and Development (OECD) ^{[footnote 10]} conducted a study which considered the frequency at which mouthing behaviour was performed. ^{[footnote 11]} The mouthing time was moderated by age group and per item and ranged between 4.2 minutes/day to 7.7 hours/day. The highest typical exposure duration was 3.6 hours/day. It is not uncommon for children to swallow foreign bodies (non-food items). Swallowing may be accidental or deliberate following the child sucking or gagging on the small part. The child might have the small part in their mouth and due to the smoothness of the part, accidentally swallows it when running or falling. However, mouthing will not automatically lead to a swallowing action.

Considering the high tendency towards mouthing behaviour by young children, and the frequency with which it occurs, the probability the small part will be mouthed and results in the blocking of the airway is estimated to be 0.1.

Probability: 0.1

Step 4: The parents or carers do not notice in time.

An article by Schwebel DC and Kendrick D (2009) ^{[footnote 12]} notes that previous studies of coroners and death panel reviews found that most children were unsupervised when injured. It is common for a young child to be momentarily unsupervised whilst the parent is distracted either through answering the phone or multi-tasking with household chores. Also, this toy could be given to a child whilst in an environment that the parent or carer considers safe, such as whilst the child is in a car seat, highchair or push chair.

Other studies on injuries found that between 26% (pedestrian injuries) and 62% (poisonings) occurred when the child was unaccompanied or alone. However, given the age range of children at risk, it is assumed they would have a higher degree of supervision, including checks when left in a safe but unsupervised context, such as in a play pen or in a cot. Accordingly, a probability of 0.1 is given.

Probability: 0.1

Step 5: A level 4 injury occurs. The small part goes into the child’s airways, blocks passage of air to the lungs leading to death or brain damage. This probability will depend upon the shape, taste, size and surface of the small part.

Just because a small part releases from the toy and is mouthed, it does not always automatically lead to a choking incident or fatality. Most of the time the child’s natural gag reflex is expected to expel the item, however RoSPA indicate that on average, a child dies in the UK every month from choking, ^{[footnote 13]} and hundreds more require hospital treatment. It can happen quickly, and the effects can be devastating.

Statista reports that in 2021 there were approximately 2,096,594 children under3 years within the UK. ^{[footnote 14]} Considering the numbers of children within the UK and the number of fatalities within children reported, the probability is calculated to be 0.002 which uses the current rate of child fatalities from choking to act as a baseline that will be increased by the presence of the unsafe product.

Probability: 0.002

Compound probability = 0.5 x 0.1 x 0.1 x 0.5 x 0.002 = 0.000005

7) Level of risk

The steps to harm are summarised in the table below.

Steps	Probability
1: The product is appealing to children <3 years so a parent or carer gives it to a child <3 years to play with.	0.5
2: The child detaches the small part.	0.01
3: The child cannot free themselves from the source of entrapment, and the parents or carers do not notice in time	0.1
4: A level 4 injury occurs. The child is strangled leading to death or brain damage.	0.1

The compound probability is the sum of the probabilities at each step, which equates to 0.0000020 (or 1 in 500,000). For a level 4 injury, this is a medium-risk outcome (see PRISM guidance Table 3 in Part 1, section 2.2(vii)).

8) Uncertainty

There is a medium level of uncertainty in relation to this assessment. This injury scenario takes into consideration consumer behaviour, even though some behaviours can be predicted it is challenging to directly attribute human behaviour to this specific product. Although data is available to support some of the steps there is still a level of uncertainty and judgement used, particularly for steps 1, 3, and 4 where subjective probabilities have been applied. The harm scenario is largely based on predicting the behaviour of young children and of adult caregivers, both of which come with uncertainty.

Sensitivity analysis

The probability associated with step four is an area of uncertainty. Whilst reports indicate that this probability is proportionate, there is limited injury data from hospitals to validate the claims these reports make. The outcome of the risk assessment is somewhat sensitive to changes in these probabilities, which would need increasing by a factor of 10 or more to move the risk level outcome from medium to high. Multiple steps would need to be increased by a factor of 10 or more to increase the risk level to serious.

9) Risk evaluation

This product poses a medium risk of a level 4 injury. The subjects primarily at risk in this scenario are children under 3 years of age. The public has a low tolerability of non-compliant products that can cause avoidable injury to children, particularly very young children. This includes the risk from cords on blinds which has utility, and an effective means of mitigating the risk with cord breaks and tie backs. Decorative cords and drawstrings on clothing do not offer utility other than a decorative quality, and are not considered necessary on children’s clothing, therefore it is considered there will be a very low tolerance of harm from cords in children’s clothing. The highly distressing nature of the potential injury and the circumstances in which it can arise are such that there is potential for psychological impact on the parent or carer, the child’s family, and anyone involved in dealing with the incident.

In addition, the nature of the risk in this case is low probability and high severity, and such risks tend towards low tolerability, compared to high probability and low severity. It is unlikely that a product presenting these hazards left in the hands of consumers would be considered tolerable. This low-level risk is therefore considered intolerable, and action will be required to reduce the risk to a tolerable level.

10) Footnotes

1. Age Determination Guidelines – United States Consumer Product Safety Commission ↩

2. Babies’ benefit from music lessons, even before they can walk and talk – Science Daily ↩

3. Toys and Games in the UK – Statista ↩

4. EN71-1:2014+A1:2018- Part A15 ↩

5. How do bright colors appeal to kids? – Sciencing ↩

6. Colour and children’s play – Michigan State University ↩

7. How to stop a child from choking – NHS ↩

8. Baby Choking Guidance – National Childbirth Trust ↩

9. Frequency of mouthing behaviour in young children – Journal of Exposure Science & Environmental Epidemiology ↩

10. OECD is an intergovernmental organisation in which representatives of 36 industrialised countries in North and South America, Europe and the Asia and Pacific region, as well as the European Commission ↩

11. Mouthing Exposure in Children – OECD ↩

12. Caregiver supervision and injury risk to young children: time to re-examine the issue – Journal of the Society for Child and Adolescent Injury Prevention ↩

13. Choking – RoSPA ↩

14. Population of Young Children – Statista ↩