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On December 18th, the European Commission published Regulation 2018⁄2005 which amends REACH Annex XVII entry 51 related to certain phthalates.

Some of the main changes introduced are:

  • The restrictions will apply to every article (unless specifically exempted), NOT only for toys and childcare articles.
  • One additional phthalate, DIBP (CAS N°84–69–5), is added to the list (current restricted phthalates: DEHP, DBP, BBP).
  • Clarifications have been added to better define the meaning of “plasticised materials”, “prolonged contact with human skin” and “childcare articles.”

Plasticised material means any of the following homogeneous materials:

  • Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), and polyurethanes
  • Any other polymer (including, inter alia, polymer foams, and rubber materials) except for silicone rubber and natural latex coatings
  • Surface coatings, non-slip coatings, finishes, decals, and printed designs
  • Adhesives, sealants, paints, and inks.

The restriction shall not apply to certain articles, such as:

  • Articles exclusively for industrial or agricultural use or for use exclusively in the open air provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin.
  • Materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935⁄2004 or Commission Regulation (EU) No 10/2011.
  • Electrical and electronic equipment within the scope of Directive 2011/65/EU.

The regulation was entered into force on 7 January 2019. The amended restrictions for:

  • DIBP in toys or childcare articles (entry 51.2)
  • DEHP, DBP, BBP, DIBP in other articles (entry 51.3)

will apply from 7 July 2020.

Source URL: Commission Regulation (EU) 20182005