Child Safe Packaging Group

CEN Moves Closer to a Non-Reclosable Pharmaceutical Child-Resistant Packaging Standard

Date of page: Mon 11 Oct 1999 at 9:36pm

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CEN (Comit?? Europ??en de Normalisation) Moves Closer to a Non-Reclosable Pharmaceutical Child-Resistant Packaging Standard

The CEN (a committee consisting of members of the European Union) met in Basel, Switzerland on August 9 and August 10, 1999 to further their work on a new draft standard for testing non-reclosable pharmaceutical packages for child-resistance and senior-use effectiveness. Richard Ward, of Perritt Laboratories, also attended the meeting by way of an invitation from CEN to represent ASTM and the United States' position on child-resistant packaging. This invitation to a United States representative was as an "observer," since the United States has no voting rites in the European Union. However, Mr. Ward's expertise in child-resistant packaging was called upon many times throughout the meetings and his influence swayed many of the draft standard positions towards the current United States Consumer Product Safety Commission's (CPSC) protocol standards.

Initially there was a 3 minutes/demo /3 minutes test period proposed for the child portion of test protocol, but that was changed to 5 minutes/demo/5 minutes, as the CPSC and the ISO 8317 (for reclosable package) standards are written today.

On the senior side, the test will use panelists 50 to 70 years old, but it will be limited to one five-minute test period, rather than the five-minutes/one minute test periods utilized by the CPSC. Also, sequential testing will no longer be an option as in past CEN standards, since it is not feasible to keep an accurate age/sex ratio in sequential testing. One hundred senior adults will be utilized for the test.

CSA Nearing Approval of Non-Reclosable Child-Resistant Packaging Standard
The Canadian Standards Organization is in the final phases of approval of a non-reclosable child-resistant packaging standard. This standard will be nearly identical to the U.S. CPSC standard, with the main difference being the option of using a different sequential child test procedure.
CSA is revising the reclosable standard to exclude the option of using a sequential senior adult test panel, since it proved to not be feasible to keep accurate age/sex ratios in a sequential test pattern.
It is likely that the CSA will require testing agencies to be approved by their auditors, and will then begin to require retesting of previously tested packages.

The Child-Safe Packaging Group says ???
???It is clear now that Europe is keen to gain both the expertise and, most importantly, the standards that the United States apply to their testing of child resistant packaging. This suggests that if the United States and Europe are packaging to similar protocols, the rest of the world must follow; as indeed Canada already is, not only to allow their products to be sold globally, particularly in the USA and Europe, but also to gain competitive advantage.???


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