On 16 February 2009 was updated for the Annex XI of the REACH Regulation.


In particular three different criteria for exemption from testing based on the information on exposure have been identified .

The first criterion requires that both demonstrated and documented that the exposure in all scenarios is much less appropriate DNEL (derived no-effect level) or PNEC (Predicted No Effect Concentration) derived under specific conditions.

The second criterion requires that both proven and documented the conditions of strictly controlled throughout the life cycle of the substance.

The third criterion requires that, where the substance is incorporated in an article, this will be incorporated in order to avoid exposure, is not released during the life cycle and is handled in strictly controlled conditions during manufacturing and production.