EU Proposes to Expand Restriction of Phthalates under REACH
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
In March 2017, we had informed you  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  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
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 .
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 
||DEHP, DBP, BBP and DIBP
||DEHP, DBP and BBP
|≤ 0.1% (individually or in combination)
||≤ 0.1% (sum)
Bis(2-ethylhexyl) phthalate(Di(2-ethylhexyl) phthalate)
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:
Global Information and Innovation Manager
t: +852 2774 7420
Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!
Read more articles for the Consumer Goods and Retail industry© SGS Group Management SA - 2018 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.