Proposed Restricting Four Phthalates in Plasticised Materials at all Product under Annex XVII to REACH Regulation
The European Commission has proposed to restrict four phthalates (DIBP, DEHP, DBP and BBP) in plasticised materials under Annex XVII to REACH Regulation (EC) No 1907/2006. Here are the highlights of the proposal:
1.The Commission proposed to restrict DIBP content in plasticised materials, and the restricted phthalates under Entry 51 of Annex XVII to REACH Regulation shall become:
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Bis(2-ethylhexyl) phthalate (DEHP)
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Dibutyl phthalate (DBP)
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Benzyl butyl phthalate (BBP)
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Diisobutyl phthalate (DIBP)
2. In addition to toys and childcare articles, the phthalate content of plasticised materials in other articles shall also be restricted.
3. Toys, childcare articles, and other articles shall not be placed on the market if they contain the 4 phthalates in a concentration equal to or greater than 0.1 % by weight individually or in any combination of the plasticised materials. This restriction is expected to be applied 18 months after entry into force.
4. The phthalate restriction shall not apply to:
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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
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Aircraft or motor vehicles within the scope of Directive 2007/46/EEC, or articles for use exclusively in the maintenance or repair of those vehicles or aircraft
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Articles placed on the market within 18 months after the date of entry into force
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Measuring devices and their parts for laboratory use
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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
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Medical devices and their parts within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC
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Electrical and electronic equipment within the scope of Directive 2011/65/EU
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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 the following homogeneous materials:
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Polyvinyl chloride (PVC), other polymers such as polyvinylidene chloride (PVDC) and polyvinyl acetate (PVA), as well as any other plastics, except polyolefins
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Rubber, except silicone rubber and natural latex coatings
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Polyurethanes and any other foam rubber or foam plastic
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Surface coatings, non-slip coatings, finishes, decals, printed designs
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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.
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