Child Safe Packaging Group

Child Resistant Flexible Packs in the European Union - The Technology and the Regulations

Date of page: Sat 11 Aug 2001 at 8:51pm

Child Resistant Flexible Packs in the European Union - The Technology and the Regulations

Section 1 The History, Regulations & Technology

Child resistant packaging emerged in the United States with the Poisons Prevention Packaging Act of 1970. The 1975 Medicines (Child Safety) Regulations in the United Kingdom specified child resistant packaging for some pharmaceuticals, initially solid dose children's aspirin and paracetamol and subsequently adult versions of these drugs. The UK was the first European Union country to utilise CR packaging, and the second country after the United States. Indeed even today standards for CR packaging and a legal duty to use the product exists only in the United States, Canada, New Zealand, Australia, United Kingdom, Germany and Italy. But more of that later.

What makes a product child resistant? The definitive test is in fact a protocol test where a sample of children is used and asked quite simply to open the pack being tested. The sample is allowed two sessions; five minutes, and then a silent demonstration then a further five minutes. The pack fails, that is, is not considered child resistant, if fifteen percent of the sample open it, prior to demonstration, or twenty percent open it post demonstration.

Sequential testing is used, in other words because each result is plotted on a rising curve with tolerances, a pack can pass or fail using considerably less than the full quota sample.

In the United Kingdom the standards for CR packaging have been BS 5321 (1975), BS 6652 (1985), BS EN 28317 (1989) and subsequently ISO 8317, this was revised in 2000.

The standards differed primarily in sample size, sample composition and stringency. Adult tests were incorporated as the concept of adult openability assumed increasing importance. For example the latest version of ISO 8317 (2000) has changed the adult age range from 45 to 65 years inclusive to 50-70 years inclusive. This brings the standard into line with the United States protocol and mirrors the advancing age of the population.

In the United Kingdom the only pharmaceutical products requiring to be packed in CR containers were children's aspirin and paracetamol, and subsequently adult versions of these preparations. Non pharmaceuticals, for example household products, toiletries and garden products, were subject to separate regulations where two classifications, 'hazardous' and 'very hazardous' required CR packaging. In the United Kingdom these are CHIPS II.

All of the standards to which I have referred cover reclosable child resistant packaging. But non-reclosables blister and strip packs, were accorded the ascription of child resistance if 'designed with a view to being child resistant.' (1975 Medicines (Child Safety) Regulations) This was a classic 'begging of the question' whereby a proposition itself subject to proof was held up as proof.

The situation differed in the United States, thence Canada, Australia, New Zealand and Germany about which more later.

Reverting to the United Kingdom and other EU countries, in an effort to bring blister packs within the ambit of child protocol testing, BS EN 862 was published in 1997, this standard covered blister packs and other non-reclosables, but excluded those which contained pharmaceuticals.

I now refer to the technology.

Reclosable child resistant packaging solutions obtain their child resistance by either asking the user to undertake two opposing actions simultaneously, thus creating a barrier of dexterity. Examples are push down & turn - the classic Clik Lok or KidloK, squeeze & turn, or procedures for lining up the arrows and then opening; this is a barrier of cognisance as well as dexterity

Non-reclosable products usually contain a barrier of cognisance, in other words 'fold at 45degrees and thus reveal a hidden tear start.' Or 'peel back and push' a two stage opening procedure.

A problem though emerges because the definition of child resistant packaging is

'packaging that is difficult for a child to open within a reasonable period but that presents no difficulty for an adult to use properly.'

And flexible packs with hidden tear starts or peel back and push blister packs did and still do present problems for elderly or handicapped people to use properly.

This is less of a problem in the United States because blister packs have very little penetration. But it is a problem here in Europe.

Before I leave this introduction, I have to stress the importance of openability of CR packs by adults, particularly elderly or handicapped ones.

If adult users are not confident of being able to open their medicine packaging they will decant into convenient containers, like cream jugs, and the whole 'raison d'tre' of child resistant packaging of a potentially harmful product is immediately compromised.

Section 2 Bringing blister packs into line; a campaign catalysed by the Patient Pack Initiative

The Child-Safe Packaging Group was formed by the greater part of the supply industry for reclosable pharmaceutical packaging in the United Kingdom.

Since formation in early 1995 membership has expanded and presently the group consists of 15 member organisations; 12 in the UK and 3 in North America and Canada.

The group has developed its objective. Initially it was

'to create a level playing field of testing for child resistance for all products that could contain harmful substances, reclosable and non-reclosable.'

The objective is now

'The promotion, specification and success of child resistant packaging solutions for all products whose ingestion or other exposure could cause serious distress to a child.'

But why the formation of this group? After all child resistant packaging was then in its twentieth year in the UK and could be called a mature product.

The catalyst was the Patient Pack Initiative, which grew to prominence in 1994/5. The Patient Pack Initiative, which advocated original pack dispensing, was a result of European Directive 92/27/EEC. Amongst other things this directive called for two very laudable improvements to pharmaceutical packaging. These were clear labelling and the inclusion of a patient information leaflet.

The then Department of Health in the UK embraced this EU directive with unaccustomed vigour and so did the pharmaceutical industry.

It does not require too much guesswork to imagine the reason behind the enthusiasm of the pharmaceutical industry. Clearly original pack dispensing gave rise to greater complexity and thus greater room to move prices for products, which were already a commodity.

It is easy to find sympathy with 'Big Pharma'. As a sector it needs to spend vast sums on research and development, and society constantly makes demands for cures to more and more diseases, and yet what can fund these large research budgets but its Cash Cow? Thus an opportunity to manipulate prices can almost be equated to 'pennies from heaven'.

It is more difficult to try to ascribe motives to the UK Department of Health, keep in mind it was that department which drove the Patient Pack Initiative, notwithstanding the fact that the cost that would impact on the Department of Health was anything from 9M. to ?Bn.

Various of my colleagues in the United Kingdom have ascribed it to the garbage can decision syndrome. There was a government in its fourth term running out of ideas, there was no real reason to make a decision anyway, 'but lets make one to show that we are doing something.'

The new administration in 1997 was quick to distance itself from the Patient Pack Initiative which effectively 'bit the dust,' but the pharmaceutical industry was then, and still is, too committed to original pack dispensing to abandon the concept.

The question might be asked where did we come in? Well, blister packs then produced in the UK and still produced now, are simply not child resistant. They consist of foil laminated to PVC blisters, they are cheap and very openable indeed, particularly by the elderly and even more particularly by children.

In early summer 1995 the Child-Safe Packaging Group tested a series of blister packs then and now widely used in the United Kingdom. The protocol was the then current US standard. Using sequential testing a sample of forty children was employed. The results were disturbing but predictable.

  • 92.5% of the sample of forty children accessed at least three tablets from the blister pack prior to demonstration.
  • 45% accessed all fifteen tablets, again prior to demonstration.
  • 90%, after ten minutes testing, had accessed all fifteen tablets.
  • Only one child had accessed less than three tablets.

These results were worrying in view of the fact that three adult paracetamol tablets could be fatal to a child.

There is a standard to which blister packs need to apply, that is BS 7752, this specifies materials and dimensions, particularly lack of rattle, and is based upon research undertaken in 1987 by H.M. Wiseman, G, Volans and others. This standard does not include any child testing or mechanical testing.

The Wiseman, Volans work did avoid a number of questions and indeed its findings were subsequently discredited by Wilbur & Barone published by the Consumer Product Safety Commission in the United States (CPSC- 1998).

However, the Wiseman, Volans work did, at the time, anchor, then totally untested blister packs into the firmament of child resistant packaging and effectively gave brand owners and packer/fillers licence to manufacture and use that system with no real fear from the UK's Consumer Protection Act 1987 or subsequent European Union product liability directives.

Section 3. objections to testing non-reclosables for child resistance

This paper is not a political tract, so I shall not spend too much time on this section, which I would have called the 'power of fudge' or 'how to make untruths half truths and guesses seem like the truth'.

My views expressed now may seem to be reactionary. But let us explore them for a moment.

Initially objections to increasing child panel testing to cover non-reclosables for pharmaceuticals could be classified under three headings and these were;

1. Firstly it is impossible.
2. Secondly it is unethical.
3. And thirdly it unnecessary.

Let us explore them.

The impossible lobby said that every blister pack from every line was different and therefore unlike reclosable packaging systems it was impossible to test a blister with any certainty that the test results could be applied to other blisters of similar or indeed identical specification. The argument was advanced that if we were to test using panels of children we would eventually and quickly run out of children! This of course is nonsense and taken to its logical conclusion would turn the whole science of statistical sampling onto its head.

Clearly type testing was a solution and if the blister pack of a specific type; materials, design, dimensions and contents were tested, clearly a blister pack equal in all respects would exhibit the same qualities of child resistance, at least within the parameters of the standard.

Thus the impossible argument was overturned.

The Unethicals said that it was wrong to use panels of children to test for child resistance because in doing so the tester would teach those children how to open child resistant packaging and thus place them in danger.

There are a number of built in safeguards here.

The first one being that the panel consists of children of 42 to 51 months who are in any event on the downswing from the peak age of ingestion which is 30 to 36months

Secondly, in the UK all testing had been undertaken in Berkshire, an area approximately forty miles west of London, and in twenty years of testing no abnormality of ingestions had been observed there. In addition in twenty-five years of testing, using panels of children in the United States, no abnormalities, spikes or outliers had been observed despite annual monitoring of all child poisonings and ingestions.

The unecessary's went back to begging the question, they said effectively 'that if blister packs were made with a view to child resistance, they would be child resistant.' Notwithstanding that this argument ignored empirical testing by Wilbur and Barone in the USA and the Child-Safe Packaging Group here in the UK.

Section 4 The tipping point

Malcolm Gladwell, who worked on the Washington Post and subsequently the New Yorker, published his seminal work the Tipping Point in early 2000. He examined how little things can make a big difference, and he drew on numerous of his observations and those that he had extracted from history. For example Paul Revere's Night ride which mobilised the colonial army prior to the American war of Independence. And more up to date, the success of 'Sesame Street' and 'Blues Clues' children's programming, initially from the USA but subsequently adopted throughout Europe.

Using the paradigms set out by Gladwell, the Tipping Point, which moved UK thinking from complacency to concern to action for child resistant packaging of flexible packs for pharmaceuticals, was the sad death of a small boy in West Yorkshire. His name was Yaqoob Lookman.

In the UK an unexplained or suspicious death is investigated by means of an ancient court procedure called an inquest and this is presided over by a judicial officer called the Coroner.

The West Yorkshire Coroner Roger Whittaker for many years ran his own firm of lawyers. He is a crusading individual and was not prepared to accept the fact that it was normal or indeed acceptable for a three-year-old small boy to extract 44 ferrous sulphate tablets from supposedly child resistant blister packs. He went public in the UK media and wrote to the executive authority responsible in the United Kingdom the Medicines Control Agency. We, the Child-Safe Packaging Group wrote to every relevant member of parliament and requested that they seek action from the Department of Health.

In the UK members of parliament the legislative assembly, may or may not be part of the executive, in some cases, because the Child-Safe Packaging Group is widely spread the relevant members of parliament were also executives, and I believe a fine flurry was created.

The upshot was that the Department of Health Executive The Medicines Control Agency, began to look very hard at the then lackadaisical situation.

The British Standards Institute was considering a CEN standard TC 261 due to be published in the very distant future and requiring sixteen votes in favour, there was a DIN standard in Germany operational since 1980, there were clearly standards in the United States, Canada, Australia and New Zealand.

The British Standards Institute was asked to fast track a standard operational in the UK, which should, in the view of the Department of Trade & Industry and the Medicines Control Agency, take them six months. This was originated in November last year, and as time was of the essence the six months should expire on the 31st May this year two weeks time.

There were three hundred objections from members of the pharmaceutical and related industries.

The vast majority of these objections were spurious revolving around the unnecessary, impossible and unethical arguments. But it was clear that the proposed CEN standard could not be fast tracked into a British Standard.

The importance of a standard remember cannot be overstated. If one exists failure to comply with it renders a brand owner, packer/filler or even a retailer not only liable under the consumer protection legislation but open to action in the civil courts.

Section 5. CR Packaging the Crux in 2001

The British Standards Institute has been forced into a compromise and by September of this year (2001) will publish a standard based very much on the existing German standard DIN 55 559.

DIN 55 559 has been operational since the early 1980's. It is a rigorous standard, and a random sample of non-reclosable products tested under that standard in late 1999, showed that of 29 tests 11 failed and 14 passed; the test was abandoned in the remaining 4 cases. Conversely, in the same location during the same period, 29 random reclosable packs were tested under DIN EN 28317 or ISO 8317, 23 were accepted and only 6 rejected.

The results are obvious. At face value reclosables are more child resistant but non-reclosables can be made child resistant and can pass tests for child resistance.

Subject to bringing the standard up to date with the new 2000 ISO 8317, the British Standards Institute proposes to publish, under its own banner, the DIN standard, and make pharmaceutical products, packed in non-reclosables, liable to protocol testing for child resistance.

This though is not a threat to 'Big Pharma' or Baby Biotech, it is not the removal of a neat way of manipulating prices. And neither is it a compulsion to use rigid packs as opposed to flexible ones.

The new standard is a tremendous opportunity. It represents an opportunity for competitive advantage.

But more than anything else it represents a design opportunity. Now why am I saying this when flexible packs that are child resistant have been available in the United States for many, many years?

The reason is simple. And let us take it apart piece by piece.

Firstly, Big Pharma needs to pack to the highest world standard. As the pharmaceutical industry globalises its products will be called upon anywhere in the world. They may sit in a West London warehouse but they could be shipped to West coast USA and be there the same day, Australia or New Zealand the following day. Germany a couple of hours thence, Italy likewise.

It is crazy to pack high value products in a low value packing system to avoid a few pence.

Baby BioTech is increasingly disease centric and its remedies will be shipped all over the world wherever the disease they are designed to overcome manifests itself.

With such high value medicines it is again crazy to pack in anything but universally acceptable packaging systems this of course means packing to the highest world standards

The new British Standard, matching the German DIN Standard the acceptance of child resistance in Italy and subsequently the whole European Union, is not a revolution it is an acceptance.

It is an acceptance by those who have been in denial of a need that has always been there.

The need is that medicines potentially harmful to children need to be packed in child resistant containers, need to be acceptable the world over and that the only true test of child resistance is a protocol test.

It is only the Department of Health in the UK that seems so oblivious to safety. In the United Kingdom the Department of Health, through its Medicines Control Agency, is responsible for consumer safety in connection with medicines and their packaging. All other elements of consumer safety in the UK are the responsibility of the Department of Trade & Industry. Whilst over twenty five years the medicines control agency has resisted child safe blister packs and over the last five years has resisted extreme pressure by my organisation, the CSPG, to introduce such packs. Let me quote from a Department of Trade & Industry press release dated 26th March 2001.

'More than 60,000 people a year receive hospital treatment as a result of packaging accidents that's 2% of all accidents in the home, at a cost to the Health service of over 12M.'

The Department went on to quote a number of case studies, here they are

  • Woman, 66, opening a bottle of wine cut her fingers on the metallic wrapping.
  • Man, 71, trying to get wrapping off packet of tea bags with a knife cut finger.
  • Man, 68, opening plastic bag to get mini kievs bent thumb awkwardly in the process.
  • Woman, 47, taking the plastic wrapping off soft drinks bottle sprained her hand.

The remaining cases are equally trivial. The is example is not reported here only to show the difference in priorities in the UK between the Department of Health and the Department of Trade & Industry. It is to show that there is an increasingly robust attitude to consumer safety even though the Department of Health in the UK has some catching up to do.

Last year our research indicated that there were 45,000 child ingestions of harmful products in the UK. There was one death. When three adult paracetamol tablets or nine ferrous sulphate, or 3 barbiturates can be life threatening to an 11kilo child it is impossible to under-estimate, in the face of this data and these attitudes, the importance of child resistant packaging.

Here today we have a large element of the design industry for packaging for pharmaceuticals and today I am throwing out a challenge. We in the United Kingdom in the Child-Safe Packaging Group as far back as 1996 when we were being accused of being self centred, commercially interested and even luddite, sponsored the patent application and subsequent development of a blister pack for pharmaceuticals that was child resistant.

Glaxo-SmithKline took up our sponsored patent as did Pago label printers and label printing machine manufacturers who subsequently became members of the Child-Safe Packaging Group. The product is still at the development stage. It endeavours to overcome problems of opening by the elderly whilst being child resistant.

In the United States blister packs enjoy less than 10% market penetration. Elderly citizens or those handicapped can demand, as of right, rigid packs with standard non-child resistant closures should they feel they need them. The culture in the UK is such that individuals accept what they are given and rarely ask for an alternative that may better suit their needs; although in pharmacies across the UK the right to have the packaging you require is offered free of charge.

In Europe the situation could well be different.

Try to imagine what it is like to be an elderly or handicapped person.

  • Wear cracked spectacles to simulate cataracts.
  • Coat your fingers in talcum powder to simulate reduced tactile sensitivity.
  • Imagine a kilo of sand strapped to your left ankle to simulate the symptoms of a stroke.
  • Imagine children's armbands or buoyancy aids attached to your elbows to simulate the effects of arthritis.

And now try and open some pharmaceutical packaging.

Clearly peel back & push child resistant blister packs do not fall within the ambit of easy openability by the elderly.

Here in Europe we need to either abandon flexible packs, and this would be very wrong because such packaging exhibits real value to both manufacturer, brand owner, packer/filler and user. Or we make them child resistant.

My challenge here today to the design industry is let us meet this requirement, this need for child resistant flexible packs head on by designing better packs. There is nothing to be proud of in fudging the issue, in pretending that a non-child resistant packs can be made to qualify under a modified standard. There are no prizes for creating a standard whose sole benefit is that it is easy to comply with.

What is required in the European Union is a sea-change in packaging technology to ensure that as we in Europe become the biggest consumer, we are also the biggest and the best, the most effective, the most efficient and the most elegant producer.

In its short life the Child-Safe Packaging Group has amassed a substantial volume of research data and empirical evidence. This is available to members.

Those who would seek to design or endeavour to design CR packs will derive real competitive advantage from so doing. Our research information is available not only to our members but to designers on a pro bono basis.

At the Closure Manufacturers Association's Technical Conference in Chicago, Illinois, October 1999, I quoted from one of those airport bookstall publications 'Great products of the 20th Century Century Makers,' that the Child resistant cap was one of the most important products of to emerge during the last century. I wonder if it is possible that this event will be the tipping point that ensures universally applicable child resistant flexibles are one of this century's most important products.


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