# C_2023243EN.01000201.xml

| 10.7.2023 | EN | Official Journal of the European Union | C 243/2 |
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10.7.2023

EN

Official Journal of the European Union

C 243/2

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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 243/02)

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) 4320 | 3 July 2023 | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (‘4-tert-OPnEO’)
  EC No.-; CAS No.-
  4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO)
  EC No.-; CAS No.- | Roche Diagnostics GmbH, Sandhoferstrasse 116, 68305 Mannheim, Germany | REACH/23/16/0 | 4-tert-OPnEO in the formulation and filling of in vitro diagnostic (IVD) assays as specified in Table 1 of the Annex | 4 January 2028 | 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/23/16/1 | 4-NPnEO in the formulation and filling of in vitro diagnostic (IVD) assays as specified in Table 1 of the Annex |
| REACH/23/16/2 | 4-tert-OPnEO in in vitro diagnostic (IVD) assays as specified in Table 2 of the Annex |
| REACH/23/26/3 | 4-NPnEO in in vitro diagnostic (IVD) assays as specified in Table 2 of the Annex |
| REACH/23/16/4 | 4-tert-OPnEO in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other analytical applications, as specified in Table 3 of the Annex |
| REACH/23/16/5 | 4-NPnEO in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other analytical applications, as specified in Table 3 of the Annex |

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) 4320

3 July 2023

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

EC No.-; CAS No.-

4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO)

EC No.-; CAS No.-

Roche Diagnostics GmbH, Sandhoferstrasse 116, 68305 Mannheim, Germany

REACH/23/16/0

4-tert-OPnEO in the formulation and filling of in vitro diagnostic (IVD) assays as specified in Table 1 of the Annex

4 January 2028

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/23/16/1

4-NPnEO in the formulation and filling of in vitro diagnostic (IVD) assays as specified in Table 1 of the Annex

REACH/23/16/2

4-tert-OPnEO in in vitro diagnostic (IVD) assays as specified in Table 2 of the Annex

REACH/23/26/3

4-NPnEO in in vitro diagnostic (IVD) assays as specified in Table 2 of the Annex

REACH/23/16/4

4-tert-OPnEO in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other analytical applications, as specified in Table 3 of the Annex

REACH/23/16/5

4-NPnEO in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other analytical applications, as specified in Table 3 of the Annex

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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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