The European Chemicals Agency’s (ECHA) committee for risk assessment committee (RAC) has published information on the authorisation process that will be used to evaluate two phthalates: DEHP and DBP, as per prw.com.
It said that the setting of “reference Derived No Effect Levels (DNEL)” for substances is part of a trial exercise which aims to improve the efficiency of RAC’s work and provide guidance for applicants in a transparent manner. DEHP has been used as a plasticiser in medical devices such as intravenous tubing and bags, catheters, nasogastric tubes, dialysis bags and tubing, and blood bags and transfusion tubing, and air tubes. Concern has been expressed about leachates being transported into the patient, especially for those requiring extensive infusions. The use of DBP has been restricted in the European Union for use in children's toys since 1999.