EU RoHS Directive: Review of Exemptions for Four Phthalates (DEHP, BBP, DBP, DIBP), 2025–2026
ENFORCEMENT TIMELINE
Restrictions in force since July 2019 (medical devices and monitoring/control instruments since July 2021); current exemption review ongoing
Overview
The EU RoHS Directive (2011/65/EU) limits the combined content of four phthalates — DEHP, BBP, DBP, and DIBP — in electrical and electronic equipment (EEE) to 0.1% by weight each.
As alternative technologies for rubber and resin parts, wire insulation, and adhesives have matured, the European Chemicals Agency (ECHA) is now reviewing several exemptions previously granted for medical devices and specific industrial equipment, working toward their technical evaluation and eventual expiry.
Enforcement Timeline
June 2015: Delegated Directive (EU) 2015/863 adds the four phthalates to the list of restricted substances.
July 22, 2019: The restriction on the four phthalates enters into application for general EEE categories (1–7, 10, 11).
July 22, 2021: The restriction enters into application for medical devices (category 8) and monitoring and control instruments (category 9).
2025–2026: ECHA conducts technical review of existing phthalate-related exemptions ahead of their expiry or renewal.
Business Impact
Suppliers of components and materials — such as cables, PVC molded parts, and sealants — need to maintain evidence (precision analytical data and RoHS declarations of conformity) confirming the absence of the four phthalates in resin and rubber parts. Manufacturers of medical and industrial equipment must validate designs using alternative plasticizers (such as DINCH or ATBC) and strengthen supply-chain-wide screening.