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The European Union (EU) published a new regulation on December 18, 2018, which adds diisobutyl phthalate (DIBP) and expands the scope of restrictions relating to phthalates under Annex XVII of REACH.

Among other provisions, the new regulation – (EU) 2018/2005:

  • Adds DIBP to the list of restricted phthalates. The others being:
    • Bis(2-ethylhexyl) phthalate (DEHP)
    • Dibutyl phthalate (DBP)
    • Benzyl butyl phthalate (BBP)
  • Expands the scope from plasticized materials in toys and childcare articles to plasticized materials in articles
  • Provides a legal definition for:
    • ‘Plasticized material’ – means the following homogeneous materials:
      • Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethanes (PUs)
      • Other polymer (including, among other things, polymer foams and rubber materials) except silicone rubber and natural latex coatings
      • Surface coatings, non-slip coatings, finishes, decals, printed designs
      • Adhesives, sealants, paints and inks
    • ‘Prolonged contact with human skin’ is defined as continuous contact of more than 10 minutes duration or intermittent over a period of minutes, per day
    • ‘Childcare article’ – product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children

The new regulation requires articles to contain less than 0.1% (individually or in combination) of the four phthalates.

The regulation has two enforcement dates. These are:

  • January 7, 2019 for:
    • DEHP, DBP, BBP and DIBP in using these as substances or mixtures in toys and childcare articles
    • DEHP, DBP and BBP in placing toys and childcare articles on the market
  • July 7, 2020 for DEHP, DBP, BBP and DIBP in placing toys and childcare articles as well as other articles on the market

Exemptions for (other) articles include:

  • Articles for industrial or agricultural use (under certain conditions)
  • Motor vehicles (Directive 2007/46/EC) and aircraft placed on the market before January 7, 2024
  • Articles for the maintenance of aircraft and motor vehicles
  • Articles placed on the market before July 7, 2020
  • Measuring devices for laboratory use
  • Food contact materials and articles under Regulations (EC) 1935/2004 or food contact plastics under (EU) 10/2011
  • Medical devices under Directives 90/385/EEC, 93/42/EEC or 98/79/EC
  • Electrical and electronic equipment (Directive 2011/65/EU)
  • Immediate packaging of medicinal products

Regulation (EU) 2018/2005 replaces the current entry 51 to Annex XVII of REACH and stakeholders are advised to now check their products are compliant.

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For further information contact:

Hingwo Tsang

Global Information and Innovation Manager

Tel:(+852) 2774 7420

Email: crs.media@sgs.com

Website: www.sgs.com/hardlines

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