Child Resistant Packaging

WHAT IS CHILD-RESISTANT PACKAGING?

Child-resistant packaging is packaging that is difficult for a child younger than 52 months to open (or gain access to the contents) in a reasonable period but not difficult for an adult — up to and including seventy years old — to use properly.

These packs may be split into reclosable and non-reclosable and each may use one of a variety of ways to achieve child resistance. A reclosable pack defined by the international standard BS EN ISO 8317:2004 is “ (A) package which, after it has been initially opened, is capable of being reclosed with a similar degree of security and is capable of being used a sufficient number of times to dispense the total contents without loss of security.”

Reclosable packs employ a number of different methods to ensure child resistance. All are based on the fact that children younger than 52 months are unable to accomplish two simultaneous actions. The three most popular child resistant mechanisms are, push and turn, a two-piece moulding that has the added advantage of presenting the child with a false affordance. Squeeze and turn packs, usually single piece mouldings are extremely popular for household products. Finally, ‘line up the arrows’ packaging, where two fixed points on the container and closure must be aligned for the pack to open. All reclosable child resistant packs consist of a container and closure, in other words the complete pack. Hence there are child resistant packs but never child resistant closures or child resistant containers.

A non-reclosable child-resistant pack is defined by the European standard BS EN 14375:2003 as: “ (A) child resistant package or part of a child resistant package which, when all or part of the contents have been removed, cannot be properly closed again.” Typical non-reclosable packs are blister and strip packs, popular for packaging medicines and single use household products. Blister packs consist of a polymer tray whose open side is sealed to aluminium lidding foil during the filling process. Designing child resistance into a non-reclosable pack is usually accomplished by making opening a two step process for example, ‘peel and push’ or using a paper label, impervious to children’s soft fingernails, which is applied to the lidding foil.

Child resistant packaging is invariably made from plastic or has a high plastic content. Reclosable packs may include a glass container and blister packs often incorporate aluminium foil and paper lidding material; however plastic, PP, HDPE, LDPE or PVC are the major materials used. Hence this type of packaging is important to the plastics industry.

WHEN DID CHILD-RESISTANT PACKAGING APPEAR IN THE UK AND EU?

Child-resistant reclosable packs were first introduced into the UK in the mid 1970s. They were an American import and over the past forty years have achieved increasing acceptance in the UK and other EU member states. In the UK, non-reclosable child resistant packs were slow to emerge, being standardized only in 2001. As well as being subject to international, European or American standards, the use of child-resistant packs for certain products has been set out in various regulations. These include the Human Medicines Regulations 2012 and GHS/CLP, which became fully effective in 2015.

Since its introduction, child-resistant packaging has been improved and made more effective not only in levels of resistance to opening by children but in ease of use by adults. In addition, increasing and ongoing efforts have been made to create more lightweight packaging generally and this is true also of child-resistant packs.

HOW IS A PACK CERTIFIED TO BE CHILD-RESISTANT?

To be child resistant a pack must comply with one of the following four standards:

• BS EN ISO 8317:2004 an international standard which covers reclosable packaging for any contents.
• BS EN 14375:2003 a European standard which covers non reclosable packaging for medicines.
• BS EN 862:2005 a European standard which covers non reclosable packaging for non medicines.
• 16 CFR 1700.20 an American regulation which covers both reclosable and non-reclosable packaging for both medicines and non-medicines. This regulation is mandatory in the United States and has been adopted by a number of other countries.

Although they differ in detail all of these standards are very similar. They are type testing standards as opposed to quality management tools and they each consist of two tests a child test and an adult test.

The child test specifies that the pack be tested by a panel of up to 200 children aged 42-51 months, that is three-and-a-half to four-and-a-quarter years. Each child is given a pack and asked to open it, after five minutes they watch a silent demonstration and then they try to open the pack for a further five minutes. For the pack to pass the test, 85% of the panel must fail to open it before the demonstration and 80% must fail to do so after it.

In practice, the full panel of 200 children is never used: to do so would be expensive and tedious. Instead the standards specify sequential testing where results are plotted as they occur and the resulting curve moves into an acceptance or rejection zone between the X and Y axes. In this way a negative result may be observed after as few as six trials and a positive one after thirty trials. A child may only test two packs under the ISO and EN standards and then they must have different opening systems and a week or a month, depending on the standard, must elapse between tests.

Critics of child-resistant packaging, or of the standards, have expressed the view that testing packaging with panels of children will be ethically suspect because it will expose those children to the packaging and teach them to open it. They are quite wrong. There are safeguards built into the test, participating children receive two warnings and promise never to try to open such a pack again, but to hand it to their parent if they ever find one. Most importantly though, the panel at 42-51 months old are a clear six months older than the danger age group, which peaks at 36 months. In addition, ongoing testing and the resulting observations are vital in designing packs that resist opening by our increasingly intelligent and dexterous child population.

The adult test employs a panel of 100 adults aged 50-70 — 70% female, half evenly spread between 50-59 and the other half not necessarily evenly spread but aged between 60-70. After a period of familiarization 90% of the panel must open and properly reclose the pack in one minute or extract one unit in one minute depending on the type of pack and the standard. The adult test has developed over time to more accurately reflect the population. Initially the panel was aged 18-45 then 18-60 then 18-65 and only since 2004 the more realistic 50-70.

However, child-resistant packaging remains the only type of packaging that is routinely and mandatorily tested for openability by adults.

Children can open them but adults cannot.

Simply not true. Certainly some adults have difficulty and up to 15% of the test panel can open a pack and it will still comply with the standard. But testing ensures that children in the ‘danger age group’ cannot open the packaging.

We don’t need them. They’re a solution looking for a problem.

Again, this isn’t true. In its 2008  World report on child injury prevention, the World Health Organisation (WHO) with UNICEF said amongst other things that child-resistant packaging was one of “the best documented successes in preventing child poisoning in the developed world”. In the same report, the WHO said that non-child-resistant blister packs for medicines, common in many EU countries, represented a real hazard to children.

BENEFITS AND ACCEPTANCE OF CHILD-RESISTANT PACKAGING

Reference has been made to the contribution of child-resistant packaging to prevention of child poisoning. This packaging also prevents many thousands of domestic traumas of suspected poisoning, minor spills or ingestions that are non fatal but nonetheless worrying.

The regulatory structure for the use of child-resistant packaging is, unremarkably, open to criticism. But the industry, packaging, consumer products and healthcare have in many cases stepped up and specified packaging over and above that required by regulation. Non-regulated products like mouthwash are routinely packed in child resistant packs and in many cases blister packs are tested to a higher level of child resistance than that laid down as a minimum in EN 14375.

The benefits of ongoing pack testing are varied. Observations of adults opening the packaging has proved a catalyst in the development of standards of accessible design and the design of easier opening packaging generally. At the other end of the spectrum, as new child resistant packs are developed, regard is paid to the most recent testing observations. Quite simply, what would resist being opened by a child in 1975 may cause little trouble to a modern child as they have been exposed to markedly different learning experiences.

References

1. Child resistant packaging-Requirements and testing procedures for reclosable packages. BS EN ISO 8317:2004.
2. Child-resistant non-reclosable packaging for pharmaceutical products-Requirements and testing BS EN 14375:2003.
3. Packaging-Child resistant packaging-Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products BS EN 862:2005.
4. Code of Federal Regulation ch. 16 sec. 1700.20.
5. World report on Child injury prevention 2008 World Health Organisation/UNICEF.
6. Packaging-child resistant packaging- Mechanical test methods for reclosable child resistant packaging systems BS EN ISO 13127:2012
7. EU regulation 1272/2008 including GHS.