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EU REACH: WTO draft restriction on amendment of phthalate restriction

april 2018 - Relevant for: Hardlines, Softlines, Toys & children's products INDUSTRY

On 28 March 2018, the European Commission (EC) submitted a draft amendment to the World Trade Organization (WTO)1, to amend the REACH Annex XVII entry 51 – 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. In 2016, European Chemicals Agency (ECHA) in cooperation with Denmark prepared a restriction report to propose a restriction on four phthalates, DEHP, DBP, BBP and diisobutyl phthalate (DIBP) under REACH Annex XVII. After 1st and 2nd public consultation, ECHA submitted the opinions4 to the EC. Based on these opinions, the EC concluded that the four phthalates pose an unacceptable risk to human health when present in any plasticized material in articles, and the risk should be addressed on a EU-wide basis, and REACH Annex XVII entry 51 should be amended accordingly. Meanwhile, the EC revised the original restriction conditions which were proposed by ECHA, e.g. newly provided the definition for “plasticised material”, changed the general transition period from 36 to 18 months.

The new restriction is expected to be published in the 2nd half of 2018. It will set a general 18-month transition period, and aircraft or motor vehicles will have a 60-month transition period.

Please refer to Table A for the comparison of current entry 51 and proposed amendment.

Parameter

Current entry 51

Proposed amendment of entry 51

Restricted substances

  • DEHP, DBP, BBP

  • DEHP, DBP, BBP, DIBP

Scope of restriction

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

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

  • Articles containing plasticised materials which come into contact with human mucous membranes or prolonged contact with human skin (including toys and child care articles)

Limit

  • DEHP, DBP, BBP: ≤ 0.1% by weight of plasticised material

  • DEHP, DBP, BBP, DIBP: < 0.1% by weight of plasticised material

Definition

Childcare articlemeans any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children

Childcare articlemeans any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children

Plasticised materialmeans the following homogeneous materials:

  • Polyvinyl chloride (PVC), other polymers such as polyvinylidene chloride (PVDC) and polyvinyl acetate (PVA), as well as any 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

Prolonged contact with human skinmeans continuous contact of more than 10 minutes or intermittent contact over a period of 30 minutes per day

Exemption

None

  • Article placed on the market before the date of 18 months after the date of entry into force;

  • 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 with human skin;

  • Aircraft or motor vehicles within the scope of Directive 2007/46/EC, placed on the market before the date of 60 months after the date of entry into force;

  • Articles for use exclusively in maintenance or repair of aircraft or motor vehicles;

  • 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

Table A. Comparison of current entry 51 and proposed amendment

[1] EC Notification sent to WTO 
[2] Draft text sent to WTO (Part 1)
[3] Draft text sent to WTO (Part 2)
[4] The opinions submitted by ECHA

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