SG 002.19
The EU has added DIBP and expanded the scope from toys and childcare articles to articles in entry 51 to Annex XVII of REACH. The new law will be implemented in phases, starting January 7, 2019.
In March 2018, the World Trade Organization (WTO) announced a proposal from the European Union (EU) to amend the restriction of three phthalates (DEHP, DBP and BBP) under entry 51 to Annex XVII of REACH.
On December 18, 2018, the EU published Regulation (EU) 2018/2005 [1] to replace entry 51 to Annex XVII of REACH [2]. The new law contains, inter alia, the following important provisions:
According to the definitions in the new law, ‘plasticized material’, ‘prolonged contact with human skin’ and ‘childcare article’ have the following meaning:
The new legislation also exempts certain categories of articles from the restriction of these four phthalates. These include the following:
The date of entry into force for the new law is January 7, 2019 (the twentieth day following its publication in the OJEU)
Highlights of entry 51 to Annex XVII of REACH in the new law and a comparison with the same entry under the existing law are summarized in Table 1.
| ENTRY 51 TO ANNEX XVII OF REACH | ||
|---|---|---|
| Regulation (EU) 2018/2005 amending Regulation (EC) 1907/2006 | Regulation (EC) 1907/2006 | |
| Phthalate | DEHP, DBP, BBP and DIBP | DEHP, DBP and BBP |
| Scope (plasticized material) | (i) Used as substances or in mixtures in toys and childcare articles (ii) Placing toys and childcare articles on the market | --- |
| (iii) Placing articles on the market | --- | |
| Requirement | < 0.1% (individually and in combination) | ≤ 0.1% (sum) |
| Effective date | January 7, 2019 for DEHP, DBP, BBP and DIBP for scope (i) above January 7, 2019 for DEHP, DBP and BBP for scope (ii) above July 7, 2020 for DEHP, DBP, BBP and DIBP for scope (ii) and (iii) above | In force |
Table 1.
Definitions
| Item | Acronym | Phthalate | CAS No. |
|---|---|---|---|
| 1 | DEHP | Bis(2-ethylhexyl) phthalate | 117-81-7 |
| 2 | DBP | Dibutyl phthalate | 84-74-2 |
| 3 | BBP | Benzyl butyl phthalate | 85-68-7 |
| 4 | DIBP | Diisobutyl phthalate | 84-69-5 |
Stakeholders are advised to comply with the latest requirements for REACH for the EU market.
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 Information and Innovation Manager
t: +852 2774 7420
© SGS Group Management SA - 2019 - 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.