10 July 2019,ECHA proposed a recommendation to the European Commission to amend Authorization List (Annex XIV of REACH) entries by adding the endocrine disrupting properties of four phthalates。 Once the Commission decides on the amendment, some previously exempted uses will require authorization。
The four phthalates are:
- bis(2-ethylhexyl) phthalate (DEHP) (EC 204-211-0, CAS 117-81-7)
- benzyl butyl phthalate (BBP) (EC 201-622-7, CAS 85-68-7)
- dibutyl phthalate (DBP) (EC 201-557-4, CAS 84-74-2)
diisobutyl phthalate (DIBP) (EC 201-553-2, CAS 84-69-5)
These four phthalates had already been identified as SVHCs in 2008 and 2009, and subsequently added to the Authorization List in 2011 and 2012 due to their classification as toxic for reproduction.
ECHA also recommends removing an exemption for the chemical in medicinal product packaging and suggests that authorization should be required for mixtures containing any of the four phthalates at concentrations above or equal to 0。1% by weight。
The agency has also requested that the Commission now reviews an existing exemption for uses of BBP and DBP in medicinal product packaging.