PACKAGE DESIGN APPROVAL CERTIFICATE SPECIFICATION - HOW SPECIFIC IS SPECIFIC ENOUGH?

The BfS as competent authority for package design approval in Germany is responsible for the specifications given in a package design approval certificate. The package design approval certificate must specify the packaging and its contents as well as instructions to handle and use the package in such a way that it can be demonstrated that any real manufactured and used package of that design complies fully with the certificate and the corresponding safety analysis report. In this regard it seems to be desirable to specify as much as possible of the contents, the design and the instructions in the certificate. On the other hand it must be considered that there is a need for changes/improvements based on experience with the package design which affects the specifications given in the certificate. This can be solved in principle by a revision of the certificate which will be the case if safety related changes are necessary. This process, however, is very often time consuming and complex and not necessary if only non-safety related changes are made. For such cases the introduction of a special design type list will be presented which allows for the specification of changes without revision of the whole certificate. The need to specify instructions for use and repeated testing of the package in the certificate will also be discussed as important elements to assure compliance with the certificate and the transport regulations for each package design in use. Practical applications and experience with approval procedures in Germany will be presented.