Possible derogation for certain pharmaceutical products | REACH restriction on PFOA | Consultation following ECHA’s Executive Director Requests

The Commission has received a request for re-examination of the existing restriction on PFOA and related substances (entry 68 of Annex XVII) in view of including a derogation for the use of PFOB for the manufacturing of certain pharmaceutical products using pressurised metereddose inhalers for the treatment of pulmonary diseases.

The companies concerned have informed the Commission that the relevant products contain low-density phospholipid porous particles as a functional component indispensable for the efficient delivery of the medicine to the lungs. The manufacture of the porous particles uses PFOB as a processing aid and unavoidable traces of PFOI are present in the PFOB at around 200 ppm. Whereas PFOB is not restricted, PFOI is a PFOA-related substance covered by the REACH PFOA restriction under entry 68 of Annex XVII. 

More information available on ECHA website

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