ECHA has recommended that the European Commission should amend the REACH authorisation list to include endocrine disrupting properties for four phthalates: DEHP, BBP, DBP, and DIBP.
If these changes are brought about, some previously exempted uses will require authorisation. These include the use of DEHP in food contact materials or medical devices.
Further recommendations from ECHA are that the exemption for DEHP in medicinal product packaging be removed and that authorisation should be required for any of the four phthalates present in mixtures at concentration above or equal to 0.1% by weight
Consistent with better regulation, and in the interests of the circular economy, European Plasticisers calls on the European Commission not to adopt this recommendation from ECHA.
It should be noted that DEHP, DBP, BBP and DIBP are already listed on Annex XIV due to Category 1B reproductive effects, and further listings as endocrine disruptors are based on these same adverse effects.
Since the substances have already been extensively regulated and phased out by this first listing on Annex XIV (and the Candidate List), the added value of second and third listings is very questionable given the limited benefits.
We therefore question the efficiency and potential of this amendment to protect health and the environment since proper disposal and/or recycling are the appropriate risk management measures with respect to the environment, and health aspects are already addressed via the first Annex XIV listing which has led to the phase out and broad restriction of DEHP, DBP, BBP and DIBP in REACH related applications.
Additionally, this amendment would further undermine the efforts of PVC recycling (see VinylPlus) and the potential for a circular economy with respect to flexible PVC made with these plasticisers (mainly past use).