The European Commission has published Regulation (EU) 2018/2005 to restrict four phthalates (DIBP, DEHP, DBP and BBP) in plasticised materials for all articles under Annex XVII entry 51 to REACH Regulation (EC) No 1907/2006. The regulation shall be effective on 7 January 2019. Here are the highlights of the regulation:
1. DIBP shall be added to Entry 51 of Annex XVII to REACH Regulation. So the restricted phthalates under this entry shall become:
Bis(2-ethylhexyl) phthalate (DEHP)
Dibutyl phthalate (DBP)
Benzyl butyl phthalate (BBP)
Diisobutyl phthalate (DIBP)
2. The phthalate restrictions under Entry 51 are summarised as follows:
|
Conditions of restriction |
Phthalate restriction |
Effective Date |
|
Place on the market of toys and childcare articles containing the 3 phthalates |
DEHP, DBP, BBP (individually or in any combination) < 0.1 % by weight of plasticised material |
Already
in force |
|
Use of the 4 phthalates in toys and childcare articles |
DEHP, DBP, BBP, DIBP (individually or in any combination) < 0.1 % by weight of plasticised material |
7 January 2019 |
|
Place on the market of toys and childcare articles containing the 4 phthalates |
DEHP, DBP, BBP, DIBP (individually or in any combination) < 0.1 % by weight of plasticised material |
7 July 2020 |
|
Place on the market of any article (except those listed in Point 3)containing the 4 phthalates |
DEHP, DBP, BBP, DIBP (individually or in any combination) < 0.1 % by weight of plasticised material |
7 July 2020 |
3. The phthalate restriction on articles (other than toys and childcare articles) shall not apply to:
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 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. Articles placed on the market before 7 July 2020
e. Measuring devices and their parts for laboratory use
f. Materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EC) No 10/2011
g. Medical devices and their parts within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC
h. Electrical and electronic equipment within the scope of Directive 2011/65/EU
i. Immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC
Note:
a. "Plasticised material" means any of the following homogeneous materials:
Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethanes
Any other polymer, (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings
Surface coatings, non-slip coatings, finishes, decals, printed designs
Adhesives, 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” means any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.
