Safer sweets

Michael Walker and Kirstin Gray of LGC discuss choking risks from jelly confectionery and technical appeals to the Government Chemist in this area.

Introduction

A child choking must be one of the most frightening experiences for any parent or carer. Foreign body aspiration continues to be a common paediatric problem, with food a major cause, especially in the under-fives, the main at-risk population. A second incidence peak typically occurs in the age range 8 – 11 years, when more non-food items are implicated. Although many choking episodes resolve spontaneously, when they do not, the consequences can be severe – from immediate death to brain injury owing to hypoxia^[1].

A typical incident in the media illustrates the tragic consequences. Toddler Adam Milner died in 2009 after choking on a piece of chipolata sausage, with his parents making the agonising decision to turn off his life support four days after he was hospitalised. The inquest revealed he had suffered oxygen starvation and a heart attack. An intensive care consultant gave expert evidence that airway clearance and resuscitation within minutes of him choking would have been required for Adam to have made a full recovery^[2].

There are key provisions in toy safety legislation and standards to address choking risks but for food, guidance is preferred (Table 1). The American Academy of Pediatrics (AAP), noting that legislation on reducing the risk of choking on food by children was introduced, but never enacted, in the US Congress, made a number of recommendations in 2010^[3]. These included avoiding characteristics that increase choking risk to children to the extent possible in new product development. AAP also recommended that the FDA (Food and Drug Administration) should establish a systematic process of risk assessment on food-related choking, followed by surveillance and public education.

But if regulation seemed a step too far in the US, in the EU, the deaths from jelly mini-cup aspiration prompted a change to food additives law, which now contains specific provisions addressing choking risks by ‘jelly mini-cups’. How did this come about and what are the current issues?

Adapted from Lluna, et al., 2017. Recommendations for the prevention of foreign body aspiration. Anales de Pediatría (English Edition), 86(1), pp.50-e1.

Jelly mini-cups

Jelly confectionery, known as jelly cups or jelly mini-cups, first came to prominence in 2001^[4]with instances worldwide of children and elderly people choking to death on soft slippery dome-shaped jellies that were designed to be placed in the mouth in one bite (Figure 1). A UK fatality occurred in 2003 in Bolton, when an 18-month-old boy died. The original small dome-shaped products contained a core of hard material, ‘konjac’ E425, a glucomannan that forms gels that are difficult to dissolve. The inclusion of konjac in such products was banned and manufacturers reformulated jelly mini-cups with gums other than konjac with the intention that the sweets could be dissolved in the mouth more easily.

However, the European Food Safety Authority (EFSA) considered these also gave rise to the formation of firm gels that did not solubilise easily and would be unlikely to initiate a coughing reaction if they were ingested as a whole and became lodged in the human airway. EFSA therefore considered these types of products also constituted a risk of choking^[5]. As a consequence, the European Commission went on to propose a ban on a range of gel-forming additives in jelly minicups. This is currently given effect by food additive legislation that also includes a definition of jelly mini-cups. Annex II of Regulation 1333/2008 of the European Parliament and of the Council on food additives implemented in the UK by the Food Additives, Flavourings, Enzymes and Extraction Solvents Regulations 2013, made separately in each of the home countries, lists the food additives approved for use in foods and their conditions of use. Part C contains the relevant listed additives each with an attached condition reading ‘May not be used in jelly mini-cups’. The prohibition of the relevant additives in jelly mini-cups is reinforced in Part E of Annex II, which also provides the definition of a jelly mini-cup:

‘The substances listed under numbers E 400, E 401, E 402, E 403, E 404, E 406, E 407, 407a, E 410, E 412, E 413, E 414, E 415, E 417, E 418, E 425 and E 440 may not be used in jelly mini-cups, defined, for the purpose of this Regulation, as jelly confectionery of a firm consistence, contained in semi rigid mini-cups or mini-capsules, intended to be ingested in a single bite by exerting pressure on the mini-cups or mini-capsule to project the confectionery into the mouth; E 410, E 412, E 415 E 417 may not be used to produce dehydrated foods intended to rehydrate on ingestion. E425 may not be used in jelly confectionery.’

Figure 1: Example of jelly mini cups

Difficulties with the definition

Although at first sight the definition of a jelly mini-cup seems straightforward, it contains several elements that pose difficulties. What does ‘firm consistence’ mean? And how can we interpret ‘intended to be ingested in a single bite…’? No further guidance has been issued by the European Commission or the Food Standards Agency.

In the UK, the Government Chemist is required to act as the national focus of technical appeal where there is an actual or potential dispute between food businesses and a regulator in the agrifood sector. The Laboratory of the Government Chemist (LGC) was involved in the original work for EFSA in 2004 on jelly mini-cups. Since then, disputes in this area and requests for advice from food businesses and regulators have been a regular feature of our work. This led us to publish a paper in 2012 setting out how we approach the issues^[6]. The paper remains the only publically available advice on jelly mini-cups and is regularly used by Public Analysts and trade laboratories to assess submitted samples.

Technical appeals follow a well-developed work flow (Table 2). LGC has developed a battery of tests to assess whether jelly confectionary products meet the legislative definition.

Gel-forming additives

The presence or otherwise of gel-forming additives listed in the definition is usually a matter of agreement between the parties based on the specification and ingredients list.

Physical characteristics of the product

The physical characteristics are important to the definition and the potential of the product to represent a choking risk.

In the laboratory, the products are described, photographed, weighed, measured and tested for size in relation to a ‘Small Parts Cylinder’ (SPC)^[7] (Figure 2). The SPC originates from the American Code of Federal Regulations, CFR Title 16, Part 1000, §1501 and is included in the toy standard EN71-1 to ensure toys and toy components have a minimum size to avoid the hazards of asphyxiation and choking as described in the section on particular safety requirements in the European Directive 2009/48/ EC on the safety of toys. Toy items, which fit completely within the SPC without the application of pressure, are deemed not suitable for children less than 3 years of age. The dimensions of the SPC mimic those of a child’s mouth and pharynx. However, containment or otherwise within the SPC is a useful but not a definitive aspect in assessing size and shape in relation to choking risk.

When introduced tip first, some products fit into the SPC but not when introduced base first. The slippery nature of some products and their cone shape might lodge one in the human airway if it went down the throat tip first. But clearly if a product is too large to fit at all into the SPC, it is unlikely to present a choking risk.

The behaviour under compression and when bitten into are telling characteristics. Thus, items are tested using a Hounsfield H10K-S Materials Testing Instrument. The data obtained includes the force required to penetrate the end seal of the products and the jellies themselves with a tooth-shaped indentor (Figure 3). How the products behave under compression with a flat surfaced disc is also investigated.

The konjac material originally used in jellies was very hard, some requiring forces up to 170 Newtons to penetrate. By way of comparison, the maximum mean vertical biting forces for children 18 months of age are 111 N, rising to 222 N for children 36 months of age and 445 N for children 3-8 years of age.

Non-konjac products can be penetrated with forces much less than 1 N. Many of the products we examine simply squeeze out from under the flat disc at forces around 30 N without appreciable damage or distortion, something that goes towards the assessment of firmness (Figure 4).

Figure 2: Small parts cylinder

Figure 3: Force required to penetrate a jelly with a tooth-shaped indentor

Figure 4: A jelly mini-cup squeezes out undamaged from under the compression disc

Solubility characteristics

Solubility is another key characteristic. If the jelly confectionery does not dissolve quickly and becomes lodged in the airway, bronchospasm or laryngospasm may be induced, exacerbating the possibility of asphyxiation.

Thus, the products are tested for solubility by immersion in artificial saliva^[8]at 37°C in a 500mL glass conical flask with the addition of 10 glass balls and mechanically shaken by a wrist action shaker in a water bath maintained at 37°C (Figure 5).

Figure 5: Solubility test

The four questions

In the final assessment four questions need to be addressed:

(1) Are the products jellyconfectionery?

This is usually self-evident.

(2) Are the products contained in semi rigid mini-cups or mini-capsules?

Again, this is usually self-evident.

(3) Are the products intended to be ingested in a single bite by exerting pressure on the mini-cups to project the confectionery into the mouth?

This aspect depends on the size, shape and packaging. For most products, the pressures required to eject the product from its container without separately breaking the end seal are too great to be exerted by children.

The end seals of the products may be easy or difficult to tear off – often beyond the strength of a child.

But the seals are always easy to bite through and it is probably best to assume a child will get access to the jelly by a variety of means.

Any labelling advice must be carefully considered. Some products are labelled with cautions, such as ‘Must be chewed thoroughly or cut into small pieces …’ or ‘Not recommended for children under 5 years old without adult supervision'. But reasonably foreseeable use should also be taken into account, e.g. the unpredictable behaviour of children.

The European Commission’s view on labelling at the time the legislation on jelly mini-cups was introduced was that safety labelling is not enough to protect children’s health.

(4) Do the products have a firm consistence?

This is really the crux of the problem. The indentor, compression and solubility characteristics must all be considered. LGC views ‘firm’ as representing a choking risk either (a) by being hard, so that it requires considerable force to bite into (the original konjac products) or (b) not being readily disrupted or brought into solution by saliva (or its simulants) in a time of two minutes.

Although there are some instances of people surviving hypoxia for longer periods of time, the two-minute limit was decided in the light of medical advice and in discussion with a forensic pathologist with experience of choking fatalities.

Foreign body aspiration continues to be a common paediatric problem with food a major cause, especially in the under-fives, the main at-risk population.'

Recommendations summary for laboratory examination

Laboratories asked to examine jelly confectionery for compliance with Regulation 1333/2008 should consider the following work flow:

• Record details of labelling and appearance of the unopened items and weigh all intact items.

• Remove items from their containers by pulling on the end seal, noting the subjective ease/difficulty of doing this and measure the force required if equipment is available.

• Note the appearance of the unpacked item, e.g. fluid present and nature of surface (slippery, elastic, malleable), subjectively how compressible the item is and its standing attitude (whether or not upright and self-supporting).

• Weigh the items after patting dry with paper tissues and/or weigh the dried empty container and any liquid released, obtaining the item weight by difference.

• Record the shape and measure the base diameter and height of three items as a minimum. Apply at least three items to a small parts cylinder and note whether or not and at what attitude the items are contained.

• Investigate the solubility of an item by observing its behaviour submerged in saliva simulant maintained at 37°C (±0.5°C) in a 500mL Erlenmeyer flask in a wrist action shaker running at a medium setting with 10 glass balls (diameter around 8mm) included to mimic a mouthing effect. The experiment must be closely observed for the first 10 minutes, every 5 minutes thereafter and may be discontinued after 30 minutes. On completion of the test, if dissolution has not taken place, recover the item, pat dry with paper tissues and weigh.

At this stage, LGC believes it is possible to form an opinion on the product under test. If it has a slippery surface and does not dissolve in artificial saliva in two minutes and largely fits into a small parts cylinder in any attitude, then it can be regarded as a choking risk.

Conclusions

Many food items are capable of choking us if accidentally aspirated into the airway. Most such events resolve spontaneously, but some have tragic consequences.

Only jelly mini-cups have attracted the attention of European legislators and in some instances the courts, where in the US, substantial damages have been awarded against firms that sold jelly mini-cups that resulted in the death of children.

The tests developed should enable a conclusion to be arrived at on the question of whether or not any particular product conforms to the legal definition of a ‘jelly mini-cup’. If a product conforms to the definition and contains any of the banned gel-forming additives, it is non-compliant and constitutes a choking risk.

Importers, in particular, are recommended to ensure representative samples of any consignment destined for the UK are forwarded in advance of shipping for testing in the UK by a laboratory familiar with the tests described.

Further experimental details are included in our 2012 paper, which is currently being updated. LGC would welcome any comments from readers of FS&T.

Michael Walker& Kirstin Gray, Laboratory of the Government Chemist, LGC, Teddington, TW11 0LY, UK.

Email Michael.Walker@lgcgroup.comTel +44 (0) 289096 8732

Webhttps://www.gov.uk/government/organisations/government-chemist

References

1. Lluna, J., Olabarri, M., Domènech, A., Rubio, B., Yagüe, F., Benítez, M.T., Esparza, M.J. and Mintegi, S., 2017. Recommendations for the prevention of foreign body aspiration. Anales de Pediatría (English Edition), 86(1), pp.50-e1.

2. Daily Telegraph, 05 March 2011, Child died choking on a sausage at nursery,  http://www.telegraph.co.uk/news/uknews/8362418/Child-died-choking-on-a-sausage-at-nursery.html  (accessed 14.07.2017)

3. American Academy of Pediatrics, 2010. Policy Statement--Prevention of Choking Among Children. Pediatrics, 125(3), pp.601-607.

4. http://www.telegraph.co.uk/news/uknews/1365379/Sweet-alert-after-16-choke-to-death.html

5. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a Request from the Commission related to the use of certain food additives in Jelly mini cups, Question number EFSA-Q-2004-054, adopted on 12 July 2004, The EFSA Journal (2004) 82, 1-11 https://www.efsa.europa.eu/en/efsajournal/pub/82

6. Michael J. Walker, Peter Colwell, Derek Craston, Ian P. Axford and Jack Crane, 2012, Analytical Strategy for the Evaluation of a Specific Food Choking Risk, a Case Study on Jelly Mini-Cups, Food Analytical Methods,  5, 54-61

7. BS EN 71-1:2014- Safety of toys - Part 1: Mechanical and physical properties under Section 8.6 ‘Small parts cylinder’

8. NaCl 4.5 g, KCl 0.3 g, Na₂SO₄ 0.3 g, NH₄Cl 0.4 g, urea 0.2 g, lactic acid 3.0 g dissolved in water, adjusted to pH between 4.5 and 5.0 with 5 M NaOH,  0.29 g α-amylase added and made up to 1,000 mL