Authorisation List

Authorisation List

Authorisation List

List of substances included in Annex XIV of REACH ("Authorisation List").

Companies that want to continue using a substance included in the Authorisation List after the sunset date need to prepare an application for authorisation, submit it before the latest application date and have a positive authorisation decision by the European Commission. The latest application date and the sunset date are specified in the Authorisation List.

Please be reminded that this list is provided for information purposes only. Only the text of Annex XIV as published in the Official Journal of the EU is authentic and produces legal effects.

Bis(2-ethylhexyl) phthalate (DEHP)

EC No.: 204-211-0 CAS No.: 117-81-7
Entry No.
04
Latest application date
21-Aug-2013
1 September 2021 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.

By way of derogation:
14/06/2023 for uses in:
- food contact materials within the scope of Regulation (EC) No 1935/2004,
- immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC,
- mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight;

01/01/2029 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746

Sunset Date
21-Feb-2015
1 March 2023 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without those spare parts and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products, where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.

By way of derogation:
14/12/2024 for uses in:
- food contact materials within the scope of Regulation (EC) No 1935/2004,
- immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC,
- mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight;

01/07/2030 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746.

Exempted (categories of) uses
Intrinsic property(ies) referred to in Article 57
Toxic for reproduction (Article 57c)
Endocrine disrupting properties (Article 57(f) - environment)
Endocrine disrupting properties (Article 57(f) - human health)
Review Periods
Date of inclusion in Authorisation List
17-Feb-2011
Regulation amending Annex XIV
Remarks
First published
11-Jan-2016