EU Proposes to Expand Restriction of Phthalates under REACH Regulation

In March of 2017, the Committee for Risk Assessment (RAC) and the Committee for Social-Economic Analysis (SEAC) were in support of a proposal by the European Chemicals Agency (ECHA) and Denmark to restrict four phthalates (BBP, DBP, DEHP and DIBP) in articles containing plasticized materials.

In March of 2018, the World Trade Organization (WTO) circulated a notification announcing a draft regulation from the European Union (EU) to amend entry 51 to Annex XVII of REACH. The proposed amendment, attached to WTO document number 18-1935 and notified under G/TBT/N/EU/564, contains several important changes to entry 51 under Annex XVII of REACH. These include the following:

  • Expanding the number of restricted phthalates from three (DEHP, DBP and BBP) to four (DEHP, DBP, BBP and DIBP)
  • Expanding the scope from plasticized materials in toys and childcare articles to plasticized materials in articles.

The proposal also exempts certain product categories from the scope. These include the following:

  • Articles for industrial use that are subject to certain conditions
  • Aircrafts or motor vehicles (are exempt) for 5 years
  • Articles for the maintenance or repair of aircrafts or motor vehicles
  • Articles placed on the market before the new restrictions become effective
  • Measuring devices for laboratory use
  • Food contact materials and articles
  • Medical devices
  • Electrical and electronic equipment (EEE)
  • Immediate packaging materials for medicinal products

It is important to note that DEHP, DBP, BBP and DIBP are regulated under Directive (EU) 2015/863; this is a piece of legislation that amended the RoHS Recast Directive on EEEs. The restriction of these phthalates will be implemented in phases, starting July 22, 2019.

According to the WTO notification, the draft regulation is expected to be adopted in the second half of 2018.

According to the draft document, the regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union (OJEU). The provision to restrict the four phthalates in articles other than toys and childcare articles will become effective 18 months after the date of entry into force

Major highlights of the proposed amendment and a comparison with entry 51 to Annex XVII of REACH are summarized in the following table.


Restriction of Phthalates under REACH Regulation