Europe - REACH | New phthalates restriction and scope expansion under REACH Annex XVII (Entry 51)
New phthalates restriction and scope expansion under REACH Annex XVII (Entry 51)
On 18th December 2018, Commission Regulation (EU) 2018/2005 was published in the Official Journal of the European Union.
This new regulation amends Entry 51 of Annex XVII to REACH Regulation (EC) No 1907/2006 as regards bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP).
Previously, only three phthalates (DEHP, DBP, BBP) were restricted in plasticised materials in toys and childcare articles under this Entry 51.
The new amendment introduces the following 2 major changes:
- Inclusion of Diisobutyl phthalate (DIBP) restriction, in addition to DEHP, DBP and BBP, in toys and childcare articles
- Scope expansion: not only toys and childcare articles are included in the scope of the restriction of these 4 phthalates (DEHP, DBP, BBP, DIBP), but also any plasticised materials in articles. List of articles excluded from this restriction is included in Paragraph 4 of this new amended Entry 51, within which we can find:
- Measuring devices for laboratory use
- 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
- Medical Devices
- Electrical and electronic equipment within the scope of RoHS Directive 2011/65/EU
As indicated in the new Entry: ‘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
These additional restrictions under REACH Annex XVII Entry 51 will become effective from 7 July 2020.
