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The EU is proposing to amend the restriction of phthalates under entry 51 to Annex XVII of REACH. The draft amendment is expected to be adopted in late 2018.

SAFEGUARDS | Consumer Products NO. 054/18

SafeGuardS chemicals in beakers

In March 2017, we had informed you [1] that 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 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 [2] and notified under G/TBT/N/EU/564, contains a number of 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, a piece of legislation that amended the RoHS Recast Directive on EEEs. The restriction of these phthalates will be implemented in phases, starting on July 22, 2019 [3].

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 Table 1.

WTO Document no. 18-1935 Draft Regulation to amend entry 51 to Annex XVII of REACH
Entry 51 to Annex XVII of REACH [4]
Scope
(Plasticized Materials)

  • Toys and Childcare Articles
  • Articles
  • Toys and Childcare Articles
Phthalate

DEHP, DBP, BBP and DIBP
DEHP, DBP and BBP

Requirement

≤ 0.1% (individually or in combination)
≤ 0.1% (sum)

Effective Date



  • Potentially late 2018 for toys and childcare articles
  • Potentially early 2020 for articles
In force

Table 1

Footnote

Item Acronym CAS Name
1 BBP 85-68-7 Butylbenzyl phthalate
2 DBP 84-74-2 Di-n-butyl phthalate
3 DEHP 117-81-7

Bis(2-ethylhexyl) phthalate

(Di(2-ethylhexyl) phthalate)
4 DIBP 84-69-5 Diisobutyl phthalate

Table 2

Next step:

Stakeholders are advised to comply with the latest requirements for phthalates under entry 51 to Annex XVII of REACH for the EU market.

For enquiries, please contact:

Hingwo Tsang
Global Information and Innovation Manager
t: +852 2774 7420

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