The four phthalates DEHP, BBP, DBP and DIBP are recognised as having endocrine disrupting properties that may affect human health. DEHP also impacts on the environment. ECHA has proposed to add endocrine disrupting properties of the substances to the REACH Authorisation List entry.
The proposal includes removing some of the previous exemptions for uses, including medical devices, food contact materials and immediate packaging for medicinal products. These uses have been exempted until now but will require authorisation as a result of the amendment.
In combination with the requirements in the EU Medical Devices Regulation (MDR) for labelling and justification of medical devices containing substances classified as CMR or endocrine disrupting, this adds another reason for the medical device industry to avoid or substitute these phthalates.
Read more in the news release from ECHA
For more information on endocrine disruptors, please contact:
Lise Lyck
lly@dhigroup.com
Tel +45 4516 9307
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