# C_2023243EN.01000401.xml

| 10.7.2023 | EN | Official Journal of the European Union | C 243/4 |
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10.7.2023

EN

Official Journal of the European Union

C 243/4

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Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

(Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (1)
  )

(Text with EEA relevance)

(2023/C 243/03)

Decision granting an authorisation

| Reference of the decision (2) | Date of decision | Substance name | Holder of the authorisation | Authorisation number | Authorised use | Date of expiry of review period | Reasons for the decision |
| --- | --- | --- | --- | --- | --- | --- | --- |
| C(2023) 4355 | 3 July 2023 | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (‘4-tert-OPnEO’)
  EC No.-; CAS No.- | ABBOTT Ireland, Ballytivnan, ROI Sligo, Connaught, Ireland;
  ABBOTT GmbH, Max Planck Ring 2, D-65205 Wiesbaden, Germany;
  ABBOTT Diagnostics GmbH, Max Planck Ring 2, D-65205 Delkenheim, Germany | REACH/23/13/0
  REACH/23/13/1 | Industrial use as a surfactant in the formulation of in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems | 4 January 2033 | In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and there are no suitable alternative substances or technologies. |
| REACH/23/13/2
  REACH/23/13/3
  REACH/23/13/4 | Professional use as a surfactant in the final use of in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems | |
| REACH/23/13/5 | Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with in-vitro diagnostic devices on ARCHITECT and Alinity automated analyser system | 4 January 2025 |
| REACH/23/13/6 | Industrial use as a surfactant in the extraction and purification of antigens for incorporation into in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems | 4 January 2033 |

Reference of the decision (2)

Date of decision

Substance name

Holder of the authorisation

Authorisation number

Authorised use

Date of expiry of review period

Reasons for the decision

C(2023) 4355

3 July 2023

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (‘4-tert-OPnEO’)

EC No.-; CAS No.-

ABBOTT Ireland, Ballytivnan, ROI Sligo, Connaught, Ireland;

ABBOTT GmbH, Max Planck Ring 2, D-65205 Wiesbaden, Germany;

ABBOTT Diagnostics GmbH, Max Planck Ring 2, D-65205 Delkenheim, Germany

REACH/23/13/0

REACH/23/13/1

Industrial use as a surfactant in the formulation of in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems

4 January 2033

In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and there are no suitable alternative substances or technologies.

REACH/23/13/2

REACH/23/13/3

REACH/23/13/4

Professional use as a surfactant in the final use of in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems

REACH/23/13/5

Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with in-vitro diagnostic devices on ARCHITECT and Alinity automated analyser system

4 January 2025

REACH/23/13/6

Industrial use as a surfactant in the extraction and purification of antigens for incorporation into in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems

4 January 2033

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(1)  OJ L 396, 30.12.2006, p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu).

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