# C_2023204EN.01002101.xml

| 12.6.2023 | EN | Official Journal of the European Union | C 204/21 |
| --- | --- | --- | --- |

12.6.2023

EN

Official Journal of the European Union

C 204/21

---

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 204/05)

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) 3532 | 5 June 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.- | Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland |
| Immunotech S.R.O., Radiova 1, 10227 Prague 10, Czech Republic |
| Immunotech S.A.S, 130, Avenue de Lattre de Tassigny 13009 Marseille, France |
| Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland |
| Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland |
| Immunotech S.R.O., Radiova 1, 10227 Prague 10, Czech Republic |
| Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France |
| Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic |
| Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain |
| Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy |
| BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands |
| Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland |
| Immunotech S.R.O., Radiova 1, 10227 Prague 10, Czech Republic |
| Immunotech S.A.S, 130, Avenue de Lattre de Tassigny 13009 Marseille, France |
| Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France |
| Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic |
| Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain |
| Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy |
| BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands |
| Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland |
| Immunotech S.R.O., Radiova 1, 10227 Prague 10, Czech Republic |
| Immunotech S.A.S, 130, Avenue de Lattre de Tassigny 13009 Marseille, France |
| Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France |
| Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic |
| Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain |
| Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy |
| BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands |
| Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland |
| Beckman Coulter GmbH, Europark Fichtenhain B13 47807 Krefeld, Germany |
| Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland |
| Beckman Coulter GmbH, Europark Fichtenhain B13 47807 Krefeld, Germany |
| Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France |
| Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic |
| Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain |
| Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy |
| BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands |
| Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland |
| Beckman Coulter GmbH, Europark Fichtenhain B13 47807 Krefeld, Germany |
| Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France |
| Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic |
| Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain |
| Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy |
| BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The 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) 3532

5 June 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.-

Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland

Immunotech S.R.O., Radiova 1, 10227 Prague 10, Czech Republic

Immunotech S.A.S, 130, Avenue de Lattre de Tassigny 13009 Marseille, France

Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland

Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland

Immunotech S.R.O., Radiova 1, 10227 Prague 10, Czech Republic

Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France

Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic

Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain

Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy

BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands

Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland

Immunotech S.R.O., Radiova 1, 10227 Prague 10, Czech Republic

Immunotech S.A.S, 130, Avenue de Lattre de Tassigny 13009 Marseille, France

Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France

Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic

Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain

Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy

BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands

Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland

Immunotech S.R.O., Radiova 1, 10227 Prague 10, Czech Republic

Immunotech S.A.S, 130, Avenue de Lattre de Tassigny 13009 Marseille, France

Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France

Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic

Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain

Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy

BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands

Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland

Beckman Coulter GmbH, Europark Fichtenhain B13 47807 Krefeld, Germany

Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland

Beckman Coulter GmbH, Europark Fichtenhain B13 47807 Krefeld, Germany

Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France

Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic

Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain

Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy

BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands

Beckman Coulter Ireland Inc, Lismeehan, O'Callaghan's Mills, Clare, Ireland

Beckman Coulter GmbH, Europark Fichtenhain B13 47807 Krefeld, Germany

Beckman Coulter France S.A.S, 130 Avenue de Lattre de Tassigny - BP 177, 13276 Marseille Cedex 9, France

Beckman Coulter Ceská republika s.r.o., Radiová 1, 102 27 Prague, Czech Republic

Beckman Coulter, S.L.U., Plaza Europa 41-43 L'Hospitalet de Llobregat 08902 Barcelona, Spain

Beckman Coulter SPA Italy, Via Roma 108 20060 Cassina de' Pecchi, Italy

BC Distribution B.V., Bijsterhuizen 3140 6604 LV Wuchen, The Netherlands

REACH/23/15/0

REACH/23/15/1

REACH/23/15/2

REACH/23/15/5

REACH/23/15/6

REACH/23/15/7

REACH/23/15/8

REACH/23/15/9

REACH/23/15/10

REACH/23/15/11

REACH/23/15/12

REACH/23/15/20

REACH/23/15/21

REACH/23/15/22

REACH/23/15/23

REACH/23/15/24

REACH/23/15/25

REACH/23/15/26

REACH/23/15/27

REACH/23/15/35

REACH/23/15/36

REACH/23/15/37

REACH/23/15/38

REACH/23/15/39

REACH/23/15/40

REACH/23/15/41

REACH/23/15/42

REACH/23/15/3

REACH/23/15/4

REACH/23/15/13

REACH/23/15/14

REACH/23/15/15

REACH/23/15/16

REACH/23/15/17

REACH/23/15/18

REACH/23/15/19

REACH/23/15/28

REACH/23/15/29

REACH/23/15/30

REACH/23/15/31

REACH/23/15/32

REACH/23/15/33

REACH/23/15/34

Formulation of 4-tert-OPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use

In-process production use of 4-tert-OPnEO as a washing buffer used in the creation of in vitro diagnostic immunoassay particles

Downstream use of 4-tert- OPnEO containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays

Downstream use of 4-tert-OPnEO containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development

Phase out of 4-tert-OPnEO-containing laboratory products from the market due to obsolescence or next generation formulations

Formulation of 4-NPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use

Downstream use of 4-NPnEO containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays

Downstream use of 4-NPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development

4 January 2033

4 January 2033

4 January 2033

4 January 2028

4 January 2026

4 January 2033

4 January 2033

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.

---

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

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

---