SGS : EU Expands Restriction of Phthalates Under REACH

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.

SAFEGUARDS | Consumer Products NO. 002/19

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 (Safeguard 54/18 [1]).

On December 18, 2018, the EU published Regulation (EU) 2018/2005 [2] to replace entry 51 to Annex XVII of REACH [3]. The new law contains, inter alia, the following important provisions:

• 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
• Providing a legal definition for 'plasticized material', 'prolonged contact with human skin' and 'childcare article'

According to the definitions in the new law, 'plasticized material', 'prolonged contact with human skin' and 'childcare article' have the following meaning:

• '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' means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day
• 'Childcare article' means a product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children

The new legislation also exempts certain categories of articles from the restriction of these four phthalates. These include the following:

• 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

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) Articles	----
Requirement	< 0.1% (individually or 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 scopes (ii) and (iii) above	In force

Table 1.

Definitions

Item	Acronym	Phthalate	CAS No.
1	DEHP	Bis(2-ethylhexyl)	117-81-7
2	DBP	Dibutyl phthalate	84-74-2
3	BBP	Benzyl butyl	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: [phone]

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