On 18 December 2018, the EU
Commission published a new regulation (EU) 2018/2005, amending Entry 51 of
Annex XVII to REACH regulation (EC) 1907/2006 as regards DEHP, DBP, BBP and
DIBP.
In accordance with the
revised regulations, a new phthalate DIBP was added to Entry51, and the
restriction scopes of DEHP, DBP, BBP, DIBP were expanded from the original toys
and childcare articles to other articles containing plasticized materials. EEE,
FCM, etc. regulated by other Union legislations are exempted from the ban.
This amendment shall enter
into force on 7 July 2020. Below more details about this amendment:
|
Entry
51-Before amendment
|
|
Restricted substance
|
DEHP, DBP, BBP
|
|
Restriction
scope
|
- plasticized materials in toys and childcare articles
|
|
Limit
|
Individually or in any combination of DEHP, DBP, BBP<0.1%(w/w)
|
|
Definition
|
"childcare article" shall mean any product intended to
facilitate sleep, relaxation, hygiene, the feeding of children or sucking on
the part of children
|
|
Exemption
|
NA
|
|
Entry 51-After
amendment
|
|
Restricted substance
|
DEHP, DBP, BBP, DIBP
|
|
Restriction
scope
|
- plasticized materials (including toys and childcare
articles)
|
|
Limit
|
Individually or in any combination of DEHP, DBP, BBP, DIBP<0.1%(w/w)
|
|
Definition
|
(a)¡®plasticised
material¡¯ means any of the following homogeneous materials:
¡ªpolyvinyl
chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA),
polyurethanes,
¡ªany
other polymer (including, inter alia, polymer foams and rubber material)
except silicone rubber and natural latex coatings,
¡ªsurface
coatings, non-slip coatings, finishes, decals, printed designs,
¡ªadhesives, sealants, paints and inks.
(b)
¡®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.
(c)
¡®childcare article¡¯ shall mean any product intended to facilitate sleep,
relaxation, hygiene, the feeding of children or sucking on the part of
children.
|
|
Exemption
|
(a)articles
exclusively for industrial or agricultural use, or for use exclusively in the
open air, provided that no plasticised material comes into contact with human
mucous membranes or into prolonged contact with human skin;
(b)aircraft, placed on the market before 7 January 2024, or articles, whenever
placed on the market, for use exclusively in the maintenance or repair of
those aircraft, where those articles are essential for the safety and
airworthiness of the aircraft;
(c)motor vehicles within the scope of Directive 2007/46/EC, placed on the market
before 7 January 2024, or articles, whenever placed on the market, for use
exclusively in the maintenance or repair of those vehicles, where the
vehicles cannot function as intended without those articles;
(d)measuring devices for laboratory use, or parts thereof;
(e)materials and articles intended to come into contact with food within the scope
of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/2011;
(f)medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or
98/79/EC, or parts thereof;
(g)electrical and electronic equipment within the scope of Directive 2011/65/EU;
(h)the immediate packaging of medicinal products within the scope of Regulation
(EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC;
|
Further Information: (EU) 2018/2005
|