Proposal for an approach with default values for the protection offered by PPE, under European new or existing substance regulations.

Introduction of personal protective equipment (PPE) in the process of quantitative exposure and risk assessment should be addressed carefully. PPE which have been designed and manufactured according to CE-criteria and have proved to pass relevant test criteria, can be classified as "proper functioning". However, test criteria for PPE are not equal to levels of protection which can be achieved in the workplace, because actual workplace exposure scenarios, fit, maintenance and storage may differ substantially from the test conditions. The proper use of PPE is related to issues which form a part of a PPE-programme. Such a programme should be implemented in a company to ensure selection of proper PPE and information, training and instruction of employees how to wear PPE properly. Assigned protection factors (APFs) for different designs of respiratory protective devices (RPD) have been introduced to quantify effectiveness of RPD in the workplace. Similar APFs are proposed for dermal protection (gloves and clothing). In general biological monitoring studies show lower reduction of internal exposure than estimated by reduction of external exposure. Therefore, conservative estimates of protection by PPE, i.e. the lowest APFs, are proposed for risk assessment purposes if "proper use of proper functioning" PPE as part of a PPE-programme cannot be demonstrated.