COMMISSION DELEGATED DIRECTIVE (EU) .../… of 11.8.2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic resonance imaging (MRI) detector coils
Following an application for this exemption the EU launched an in-depth study which included a consultation. The assessment concluded that the development of alternatives and substitutes would need more time. Given the lack of sufficient appropriate alternatives not granting an exemption would likely result in shortage of supply for health services. This would cause health impacts for many patients linked to the lack of relevant diagnosis and treatment facilities.