EU RoHS Directive Phthalates

Commission Delegated Directive (EU) 2015/863 amended RoHS Annex II to add four phthalates to the restricted-substance list: Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP), and Diisobutyl phthalate (DIBP).

The current consolidated Directive 2011/65/EU lists each of those four phthalates with a maximum concentration value of 0.1% by weight in homogeneous materials, equivalent to 1,000 mg/kg in the material being assessed. RoHS defines a homogeneous material as a uniform material, or a combination of materials that cannot be separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, or abrasive processes. A product-level average can therefore hide a non-compliant plastic, cable jacket, insulation layer, adhesive, coating, or other material.

Member States were required to apply the provisions introduced by Delegated Directive (EU) 2015/863 from 22 July 2019. Annex II gives a later phthalate date for medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments: 22 July 2021.

Annex II also narrows how the phthalate restrictions apply to certain cables and spare parts. The restriction of DEHP, BBP, DBP, and DIBP does not apply to cables or spare parts used for repair, reuse, updating functionalities, or upgrading capacity of EEE placed on the market before 22 July 2019, or of medical devices and monitoring and control instruments placed on the market before 22 July 2021.

A useful phthalate file should let a reviewer trace every conclusion from the homogeneous material to the placed-on-market product. Start with the bill of materials, polymer and plasticised-material declarations, supplier declarations, material risk screening, and any test reports used to support the DEHP, BBP, DBP, and DIBP conclusion. Record whether the evidence covers all four RoHS phthalates; a laboratory panel may report additional phthalates without answering every Annex II question.

Directive 2011/65/EU requires manufacturers to draw up technical documentation, carry out internal production control, draw up an EU declaration of conformity when compliance is demonstrated, affix CE marking, and keep the technical documentation and EU declaration of conformity for 10 years after the EEE has been placed on the market. Importers must keep a copy of the EU declaration of conformity for 10 years after placing the EEE on the market and ensure that technical documentation can be made available on request.

Do not treat a RoHS exemption as a blanket permission for phthalates. Article 5 exemption logic is application-specific, limited in time, and tied to Annex III or Annex IV wording. The Commission implementation page states that exemption renewal applications must be filed no later than 18 months before expiry and that existing exemptions with a timely renewal application remain valid until the Commission decides.

For phthalates, the first screening question is still Annex II: which homogeneous materials contain DEHP, BBP, DBP, or DIBP, at what concentration, and under which product timing rule? Only after that should the team assess whether a cable, spare-part, toy, or Annex III/IV exemption pathway changes the conclusion.