As per the European Union additions published in December 2018, the scope of Entry 51 of Annex XVII to REACH Regulation (EC) No 1907/2006 has some changes starting on 7th July 2020. The changes include an increase in the number of restricted phthalates from three to four, and an extension of the scope of restrictions as per below:
Scope of Restriction
Current Entry 51
DEHP, DBP and BBP:
Plasticized materials in toys and childcare articles
Revised Entry 51 as of 7th July 2020
DEHP, DBP, BBP and DIBP: <0.1% by weight of plasticized material (individually or in combination)
All articles containing plasticized materials*
DIBP was frequently used as a replacement for DBP for lots of plasticized materials. With the new restrictions in place, manufacturers will need to look for alternative options to comply with the normative.
With the extension of phthalates requirements (entry 51), all articles containing plasticized materials* will be affected.
These can include:
(As included in Annex XVII to REACH – Conditions of Restriction)
(a) 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;
(b) aircraft, placed on the market before 7 January 2024, or articles, whenever placed on
the market, for use exclusively in the maintenance or repair of those aircraft, where those
articles are essential for the safety and airworthiness of the aircraft;
(c) motor vehicles within the scope of Directive 2007/46/EC, placed on the market before 7
January 2024, or articles, whenever placed on the market, for use exclusively in the
maintenance or repair of those vehicles, where the vehicles cannot function as intended
without those articles;
(d) articles placed on the market before 7 July 2020;
(e) measuring devices for laboratory use, or parts thereof;
(f) materials and articles intended to come into contact with food within the scope of
Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/20111;
(g) medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC, or
(h) electrical and electronic equipment within the scope of Directive 2011/65/EU;
(i) the immediate packaging of medicinal products within the scope of Regulation (EC) No
726/2004, Directive 2001/82/EC or Directive 2001/83/EC;
(j) toys and childcare articles covered by paragraphs 1 or 2.
With the new restrictions in place, brands, retailers and manufacturers must ensure that the products placed in the market do not contain any of the restricted substances. At API, we can provide technical advice and adapted chemical product testing for your affected product categories to ensure your products comply with the new REACH requirements. Our combined expertise in chemistry x manufacturing x household goods and toys allows our experts to provide tailor-made solutions suited to your needs.