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SAFEGUARDS | Consumer Products NO. 047/17

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The RAC and SEAC support the proposed restriction of four phthalates in articles. The restriction could become effective in 2020/2021.

On March 21, 2017, the European Chemicals Agency (ECHA) published ECHA/NA/17/05 [1] announcing the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) were in support of a proposal [2] by the ECHA and Denmark to restrict four phthalates (BBP, DBP, DEHP and DIBP) in articles containing plasticized materials.

According to the Annex XV Restriction Report dated April 2016 [3], these articles mainly include:

  • Coated fabrics and paper

  • Flooring, footwear

  • Mattresses

  • Office supplies and equipment

  • Recreational gear and equipment

  • Other articles molded from or coated with plastic 

The proposal in this Annex XV Restriction Report contains a number of exemptions. Some of these include:

  • Articles covered by Directive 2011/65/EU (RoHS Recast)

  • Food contact materials governed by Regulations (EC) 1935/2004 and (EU) 10/2011

  • Immediate packaging of medicinal products (Regulation (EC) 726/2004, Directives 2001/82/EC or 2001/83/EC)

  • Measuring devices for laboratory use

  • Medical devices (Directives 90/385/EEC, 93/42/EEC or 98/79/EC)

  • Toys and childcare articles governed by entry 51 to Annex XVII of REACH (BBP, DBP and DEHP)

The restriction will apply three years from the date of entry into force upon acceptance by the European Commission (EC) and by publication in the Official Journal of the European Union (OJEU).  This could be in 2020/2021.

Highlights of the conditions of the restriction proposed by SEAC [4] are summarized in Table 1. This proposal would amend entry 51 to Annex XVII of REACH by including DIBP in its scope and will include products falling under the scope of Directive 2011/65/EU (RoHS Recast) in the list of exemptions.

Table 1

Conditions of the restriction proposed by SEAC
RAC and SEAC ‘Opinion on an Annex XV dossier proposing restrictions on four phthalates (DEHP, BBP, DBP, DIBP)’, ECHA,
Agreed, March 16 2017
Substance Scope Requirement Effective date
  • BBP
  • DBP
  • DIBP
  • DEHP
  • Articles whose phthalate containing material may be mouthed or is in prolonged contact with human skin or any contact with mucous membranes, and
  • Phthalate containing articles that are used (including stored) in an interior space where people are present under normal and reasonable conditions and potentially exposed by inhalation. This does not apply to articles that are used only in industrial or agricultural workplaces by workers.
≤ 0.1%
(individually or sum)
3 Years from date of entry into force
(Could be in 2020/2021)

Table 2: Definitions

Item Name Acronym CAS EC
1 Bis(2-ethylhexyl) phthalate DEHP 117-81-7 204-2111-0
2 Benzyl butyl phthalate BBP 85-68-7 201-622-7
3 Dibutyl phthalate BDP 84-74-2 201-557-4
4 Diisobutyl phthalate DIBP 84-69-5 201-553-2

SGS will follow up and inform interested parties as developments on REACH regulation occur. Our expertise combined with consultancy services and experience in consumer product supply chains provides a central point of contact for global solutions. If you would like to learn more about how SGS can support your REACH compliance activities please visit www.sgs.com/reach.

For enquiries, please contact:

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

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