The plasticizer, DEHP [Di(2-ethylhexyl) phthalate], accounts for about 17% of all plasticizer usage in Western Europe and approximately one-third of plasticizer use worldwide, mainly for making PVC soft and pliable. REACH, the regulation on Registration, Evaluation, Authorization and Restriction of Chemicals, entered into force on June 1, 2007 and was supposed to streamline and improve the former legislative framework on chemicals used in the EU. Some suppliers, especially small-to-medium sized companies, have complained that the cost and effort required by additional paperwork and tracking for REACH registration may mean that SMEs will be unable to compete for some substances.
For DEHP, the registration was driven by a consortium of European suppliers of the chemical. These have collated data and shepherded it through the submission process. The members of the DEHP consortium include Arkema (lead registrant), Oxea, Perstorp, Polynt SPA, Zak S.A., Deza a.s., Oltchim S.A. and Boryszew S.A.
With the registration complete, DEHP has been registered for all current uses including medical devices. The registration enables the continued manufacturing and use of DEHP. However, because DEHP is classified in Europe as a Substance of Very High Concern (SVHC), its uses beyond January 2015 will eventually need to be authorized. The EU Risk Assessment Reports for DEHP can be found on the DEHP Information Centre website.
Those suppliers are expected to begin seeking the necessary approvals for its continued uses beyond January 2015 as soon as the European Chemicals Agency (ECHA) has finalized details of the process. —[email protected]
