# C_2023206EN.01000701.xml

| 13.6.2023 | EN | Official Journal of the European Union | C 206/7 |
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13.6.2023

EN

Official Journal of the European Union

C 206/7

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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 206/05)

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) 3517 | 6 Jun 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.- | QIAGEN GmbH, Qiagenstr. 1, 40724, Hilden, Germany; |
| STAT-Dx Life S.L., Carrer de Baldiri Reixac 4, 08028, Barcelona, Spain; |
| QIAGEN Distribution B.V., Hulsterweg 82, 5912 PL, Venlo, Netherlands. |

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) 3517

6 Jun 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.-

QIAGEN GmbH, Qiagenstr. 1, 40724, Hilden, Germany;

STAT-Dx Life S.L., Carrer de Baldiri Reixac 4, 08028, Barcelona, Spain;

QIAGEN Distribution B.V., Hulsterweg 82, 5912 PL, Venlo, Netherlands.

REACH/23/17/0

REACH/23/17/1

Formulation and filling of buffer solutions containing 4-tert-OPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing

4 January 2031

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/23/17/2

Formulation and filling of buffer solutions containing 4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing

4 January 2031

REACH/23/17/3

Industrial use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing

4 January 2031

REACH/23/17/4

Industrial use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing

4 January 2031

REACH/23/17/5

REACH/23/17/6

REACH/23/17/7

Professional downstream use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing and immunoassay

4 January 2031

REACH/23/17/8

REACH/23/17/9

Professional downstream use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing

4 January 2031

REACH/23/17/10

REACH/23/17/11

Professional downstream use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing

4 January 2026

REACH/23/17/12

REACH/23/17/13

Professional downstream use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing

4 January 2026

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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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