# C_2023111EN.01000501.xml

| 27.3.2023 | EN | Official Journal of the European Union | C 111/5 |
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27.3.2023

EN

Official Journal of the European Union

C 111/5

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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 111/05)

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) 1771 | 20 March 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.- | Bio-Rad, 3 Boulevard Raymond Poincaré, 92430 Marnes-la-Coquette, France | REACH/23/9/0 | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections
  Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections
  Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles
  Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications
  Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application | 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/23/9/1 | 4 January 2033 |
| REACH/23/9/2 | 4 January 2033 |
| REACH/23/9/3 | 4 January 2033 |
| REACH/23/9/4 | 4 January 2028 |

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) 1771

20 March 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.-

Bio-Rad, 3 Boulevard Raymond Poincaré, 92430 Marnes-la-Coquette, France

REACH/23/9/0

Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections

Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections

Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles

Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications

Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application

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/23/9/1

4 January 2033

REACH/23/9/2

4 January 2033

REACH/23/9/3

4 January 2033

REACH/23/9/4

4 January 2028

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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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