Table 3 German proposal for refinement of default MO sentence

for the label

“May have the potential to cause skin and/or respiratory sensitization”.

This phrase shall always be assigned as a precautionary statement (i.e., as a non-specific risk mitigation measure) to a PPP containing a microorganism; personal protective measures must be specified in these cases.

“May cause skin and/or respiratory sensitization”.

This phrase shall be assigned to a PPP containing a micro-organism where there is clear evidence from experimental systems, documented human exposure or available scientific literature that the PPP may show sensitizing effects; if the attribution criteria is fulfilled for this second phrase, the first phrase will not apply. Personal protective measures must be specified in these cases.

for the active substance in the DAR/RAR

MAY HAVE THE POTENTIAL TO CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION.

German colleagues are proposing to use in RAR/DAR templates for the active substance and the product (and not on the label) the following sentences to distinguish between the type of information on sensitization in the APPL/RMS assessment box of the DAR/RAR.

The advantage is that the information from the study evaluation in the DAR/RAR is presented in a uniform and condensed way in the corresponding chapter.

MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase “and there is evidence from animal studies (e.g., XY, 20XX) that the microorganism … is a skin /respiratory sensitizer”.

MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase “and there is evidence from human observations (e.g., XY, 20XX) that the microorganism … is a skin / respiratory sensitizer”.

MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase “and there is evidence from animal studies (e.g., XY, 20XX) and human observations (e.g., XY, 20XX) that the microorganism … is a skin / respiratory sensitizer”.