Recently, the EU Commission drafted an amendment to REACH Annex XVII to amend Entry 51-DEHP,DBP,BBP.
The draft Regulation will add a new phthalate DIBP to Entry 51 and will expand the restriction scope of plasticized materials from the original toys and childcare articles to other articles. Below table indicates a comparison of Entry 51 before and after amendment.
|
Entry 51-Current |
Entry 51-Draft |
Restricted substance |
DEHP, DBP, BBP |
DEHP, DBP, BBP, DIBP |
Restriction scope |
- plasticized materials in toys and childcare articles |
- plasticized materials(including toys and childcare articles) |
Limit |
The concentration of one or more of the phthalates(DEHP,DBP,BBP)<0.1%(w/w) |
The concentration of one or more of the phthalates(DEHP,DBP,BBP,DIBP)<0.1%(w/w) |
Exemption |
None |
(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, or motor vehicles within the scope of Directive 2007/46/EEC, placed on the market before [OJ please insert date – 60 months after the date of entry into force], or to articles, whenever placed on the market, for use exclusively in the maintenance or repair of those vehicles or aircraft; (c) articles placed on the market before [OJ please insert date: 18 months after the date of entry into force]; (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 (EC) 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. |
Definition |
"childcare article" shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children |
(a) "plasticised material" means the following homogeneous materials: - polyvinyl chloride (PVC), other polymers such as polyvinylidene chloride (PVDC) and polyvinyl acetate (PVA), as well as any other plastics, except polyolefins, - rubber, except silicone rubber and natural latex coatings, - polyurethanes and any other foam rubber or foam plastic, - 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" shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.” |