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 (OJ L 396, 30.12.2006 , p. 1)) (Text with EEA relevance) 2023/C 204/05
Date: 2023-06-12
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical product, health control, health risk, market approval, marketing standard, medical device, medical diagnosis








C_2023204EN.01002101.xml










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






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)