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On 18 December 2018, Commission Regulation (EU) 2018/2005 was published to amend the restriction of phthalates under Entry 51 to Annex XVII of REACH. The number of restricted phthalates is expanded by including Diisobutyl phthalate (DIBP) and the scope is expanded to include plasticised materials in articles. These additional restrictions of phthalates will apply to articles placed on the EU market after 7 July 2020.
By Bureau Veritas Technical Services 5 minute read
Overview of Requirement
The European Commission has adopted the decision to amend Entry 51 by:
• 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 all articles with certain exemptions
Requirement
| Current Requirement | New Requiremen | |
| Scope | • Toys and childcare articles | • Toys and childcare articles |
| Restricted Phthalate | DEHP, DBP, BBP | DEHP, DBP, BBP, DIBP |
| Material | Plasticised material | Plasticised material |
| Requirement | = 0.1 % by weight (sum) | < 0.1 % by weight (individual or sum) |
Exemption
Certain articles are exempted for the new restriction of four phthalates such as:
• 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
• Article placed on the market before July 7, 2020
• Measuring devices for laboratory use
• Food contact materials and articles; Medical device; Electrical and electronic equipment; Immediate packaging of medicinal products
Definition:
"plasticised material" means the following homogeneous materials:
• Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC) and 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.
“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 any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.”
Additional Information: Commission Regulation (EU) 2018/2005
