There shonld also be guidance on situations where in-use testing would not be considered necessary. For example, products packaged in containers permeable to oxygen with an intentional head-space should be excluded from in-use testing as any potential for the oxidative degradation of an active ingredient or preservative would be readily evident during normal stability studies. It is also suggested that fuller account should be taken of the Ph Eur's preservative efficacy test results; no additional preservation testing should be required for products which are shown to meet the Ph Eur's 'A' criteria in the normal stability tests. If regulators consider that such tests are required, there is a special need for advice on how they would wish the test to be conducted (e.g the types of organism to be used ,the inoculum level and whether or not the testing should be conducted in the container)