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EU REACH Annex XVII: Amendment of phthalate restriction published 

DEcember 2018- Relevant for: electrical & electronics, hardlines, softlines, toys & children's products

On 18 December 2018, the Official Journal of the European Union (OJEU) published a Regulation (EU) 2018/20051, amended the REACH Annex XVII entry 51 of phthalates restriction.

Currently REACH Annex XVII entry 51 restricts three phthalates, (bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) in plasticised materials of toys and childcare articles. The new amendment expands the restricted phthalates by newly adding diisobutyl phthalate (DIBP) and the scope of the products. Besides toys and childcare articles, articles containing plasticised materials will also be restricted, including. indoor environments or used in the open air which come into contact with human mucous membranes or prolonged contact with human skin.

This amendment will complement the existing restriction on three phthalates in toys and other childcare articles. The new amendment sets a general 18-month transition period and will apply from 7 July 2020.

Please refer to Table A for the comparison of current entry 512 and new entry 51 for toys and childcare articles. Table B lists the requirements for newly included products.

Parameter

Current entry 51

Revised entry 51

Restricted substances 

DEHP, DBP, BBP 

DEHP, DBP, BBP, DIBP

Scope of restriction

Plasticised materials (substances, mixtures, articles) in toys and childcare articles 

Limit

DEHP, DBP, BBP (combination or individual):

≤ 0.1% by weight of the plasticised material

From 7 January 2019:
Use as substances and mixtures in toys and child care articles: DEHP, DBP, BBP, DIBP (combination or individual): < 0.1% by weight of the plasticised material

Before 7 July 2020:
Articles in toys and child care articles
DEHP, DBP, BBP (combination or individual): < 0.1% by weight of the plasticised material

From 7 July 2020:
DEHP, DBP, BBP, DIBP (individually or in any combination): < 0.1% by weight of the plasticised material

Table B. Requirements for newly included products

Restricted substances 

DEHP, DBP, BBP, DIBP  

Scope of restriction

Articles containing plasticised materials including.

  • used in indoor environments or

  • used in the open air which come into contact with human mucous membranes or prolonged contact with human skin

Limit

From 7 July 2020:
DEHP, DBP, BBP, DIBP (individually or in any combination): < 0.1% by weight of the plasticised material 

Exemption

 

  • Articles placed on the market before 7 July 2020;

  • Articles exclusively for industrial or agricultural use, or for use exclusively in the open air, provided that no plasticized material comes into contact with human mucous membranes or prolonged with human skin;

  • Aircraft or motor vehicles within the scope of Directive 2007/46/EC, placed on the market before 7 January 2024;

  • Articles for use exclusively in maintenance or repair of aircraft or motor vehicles, placed on the market before 7 January 2024;

  • Measuring devices or parts for laboratory use;

  • Food contact materials within the scope of Regulation (EC) No 1935/2004 or Regulation (EC) No 10/2011;

  • Medical devices or parts within the scope of Directive 90/385/EEC, 93/42/EEC or 98/79/EC;

  • Electrical and electronic equipment within the scope of Directive 2011/65/EU;

  • The immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC;

  • Toys and child care articles

Definitions:

  • Childcare article means any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children
  • Plasticised material means 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
  • Prolonged contact with human skin means continuous contact of more than 10 minutes or intermittent contact over a period of 30 minutes per day

[1] Legal text of Regulation (EU) 2018/2005
[2] Current REACH Annex XVII entry 51

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