The Consumer Council has been involved in the elaboration of normative requirements for child resistant packaging for many years. Tests of that kind are usually carried out with children aged between 42 and 51 months. They are given a total of 10 minutes to open the packages. Upon the initiative of industry much younger children were intended to be used in case of a European standard for non-reclosable packages for chemicals. Consumer representatives opposed this and could prevent the impending danger of lowering the safety levels.
Certain dangerous chemicals for household use must be sold in child-resistant containers. These containers are tested by child panels. The children have to try to gain access to the contents within five minutes. In case they do not succeed, a demonstration of a successful opening is given to them. Then they have another five minutes to accomplish the task. Overall, not more than 20 % of the children may succeed. As a rule, children aged between 42 - 51 months are used as test persons. The Consumer Council has been active in standards committees developing the requirements and corresponding test methods for many years: it has also been involved in a good many controversies in this field.
Inadequate standard prevented
Surprisingly, another age range was defined in a draft European standard (prEN 862) for non-reclosable packages for non-pharmaceutical products published in 1992. The intention at that time was to test children aged between 20 and 41 months. This would have entailed a significant lowering of the safety level as these younger children are by far less able to open packages in a test. The apparent primary purpose of this was to protect the packages rather than the children. After many years of debate the Consumer Council, in collaboration with other consumer organisations, could push through its position. The well-tried age range 42 - 51 was not altered. The standard was approved in 1997.
A video produced by the Consumer Council significantly influenced the decision. The film shows the different performance of children of both age groups in tests which were carried out in two Viennese Kindergartens in 1994. The investigation was directed by Prof. R. Gädeke, the former head of the poison information centre in Freiburg/Germany. He represents the Consumer Council at the German Institute of Standardisation (DIN) in the responsible European standardisation committee and has long-term experience in the field of child-resistant packaging.
It could be shown that children in the age range 20 - 41 months often do not understand what they are expected to do and in many cases do not even dare to touch the packages (even if they contain sweets). If they deal with the packages their interest is limited to short periods of time. Consequently the younger children were frequently not even in the position to open “normal” (not child-resistant) packages. The video made it apparent that almost all packages could be considered as “child-resistant” if the age of the test children is reduced. A copy of the film is available upon request.
Lower safety level than in USA
Drugs represent one of the major reasons for childhood poisoning. A draft European standard for non-reclosable child-resistant packages for this type of products was prepared in 2001. However, also this draft had to be judged as insufficient. In concrete terms, the issue is how many units (tablets) are children allowed to open in the test. Following the example of the German standard DIN 55559 it was stipulated that this number should be “not more than eight”. The size or toxicity of the units does not play a role.
US regulations take a different approach. There children are not allowed to gain access to a dosage that may cause serious personal injury or serious illness. This could happen even if only a few units (in an extreme case just one unit) are accessed.
It should be noted though, that previous drafts of the document had taken this problem into account. It contained a classification of child-resistant packages depending on the number of units opened in the child panel test. Upon pressure of the pharmaceutical industry this concept was dropped (three years of work had been to no avail).
The Consumer Council was not willing to accept a lowering of the safety level compared to that valid in US regulations. Upon its initiative the European consumer representation in standardisation (ANEC) financially supported a project on that subject. The study, which was finalised in May 2002, was carried out by the Medical Toxicology Unit, Guy’s and St.Thomas´ Hospital, London. The project was supervised by the Consumer Council. The project was supervised by the Consumer Council. The study is available on the website of ANEC as PDF-file (1248kb): www.anec.org/attachments/ch018-04.pdf
The most relevant findings:
a small number of ingested tablets of some pharmaceuticals (less than 8 units) can seriously damage the health of a child.
in certain cases less than a pill can kill a child.
there is reason to believe that in a large proportion of moderate to severe poisonings less than 8 units could be involved.
The study also contains a guide to determine toxic doses of medications for children and disapproves claims that it is impossible to establish those. Also this document is available on the ANEC website as PDF-file (100kb): www.anec.org/attachments/MTUGuidelinesfinal0205.pd
The consumer organisations have done their utmost to fight against this draft standard (prEN 13475). The CEN working group has admitted the insufficiency of the approach and has also expressed this in a note in the text of the standard, but has nevertheless forwarded it to the formal vote. The lobbying of the consumer advocates was almost successful: the standard was adopted with just 72% of the weighted votes (the minimum percentage required is 71%). One can hardly consider that as a broad consensus.
Irrespective of the future developments within standardisation it is clear that European legislation is needed. The standard is not compulsory. Legal provisions exist only in few countries. The most comprehensive rules have been implemented in Germany. Therefore the consumer organisations have launched a campaign with the aim to adopt a law on this subject in Europe. It should:
Require child-resistant packages for all medications which can harm the health of a child when accidentally ingested.
Rely on the principle that children must not be able to access a toxic dose as in the USA.
Establish rules for the determination of a toxic dose for children.
Foresee a scientific committee that identifies the relevant medications and their toxic dose.
Make use of a test standard (child panel tests) which does not itself contain toxic acceptance criteria.
Maintains a register of approved packages.
For this reason the Consumer Council initiated a conference of the European consumer organisations ANEC and BEUC. It was held in Brussels on 24 September 2004 and was attended by representatives of the Commission, the European Parliament, industry and consumer advocates. The contributions to this conference are available on the ANEC website under: www.anec.org/attachments/Confernce23Sept.htm
As a next step ANEC has proposed to the Commission the conduct of a research project repeating the ANEC study on a wider scale involving more medications and data from different countries. However, there was no reaction in this regard. It is, unfortunately, not to be expected that the Commission will pursue this issue further.
Closures for experimental sets
The European standard EN 71-4 includes requirements for “Experimental sets for chemistry and related activities”. Amongst other things it deals with containers for chemicals and their closures. The 1990 edition contained just a not binding note that the containers should (!) have closures which prevent the access to the contents by small children.
Following a fatal accident in France (a child had swallowed copper sulphate from a chemistry set) the Commission gave a mandate to CEN in 1993 with a view to strengthening the requirements for containers and closures. Child-resistant closures should become compulsory. Corresponding requirements were incorporated in the amendment. However, the closures were not specified. It was left to the subjective discretion of manufacturers and test houses to judge the “child-resistance” of the closures.
Upon initiative of the Consumer Council a second amendment of the standard was prepared subsequently. Alternatively the closures must comply with the standard on child-resistant packaging, must have a bayonet joint or must require a tool to be opened. The standard was developed under the lead of the Consumer Council. The formal vote took place in autumn 2002 and the standard was approved.