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 243/02
Date: 2023-07-10
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical compound, chemical product, health control, health risk, market approval, marketing standard, medical diagnosis








C_2023243EN.01000201.xml










10.7.2023   


EN


Official Journal of the European Union


C 243/2






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






(1)  OJ L 396, 30.12.2006, p. 1.

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