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)
Date: 2023-12-08
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_202301425EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2023/1425


8.12.2023






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)
(C/2023/1425)


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) 8143


1 December 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.-


Prionics Lelystad B.V., Platinastraat 33, 8211AR, Lelystad, Flevoland, the Netherlands


REACH/23/34/0


4-tert-OPnEO as component of buffer solutions with the following purposes: (1) for antigen production (to achieve cell extraction, cell lysis, coating of biological antigens onto articles, inactivation of microorganisms that produce targeted antigen and solvent exchange) and (2) to carry out in-process and final quality control of antigens intended for use as veterinary and human health laboratory reagents in scientific research and development and in vitro diagnostic applications


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/23/34/1


4-NPnEO as component of buffer solutions with the following purposes: (1) for antigen production (to achieve cell extraction, cell lysis, coating of biological antigens onto articles, inactivation of microorganisms that produce targeted antigen and solvent exchange) and (2) to carry out in-process and final quality control of antigens intended for use as veterinary and human health laboratory reagents in scientific research and development and in vitro diagnostic applications






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

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


ELI: http://data.europa.eu/eli/C/2023/1425/oj
ISSN 1977-091X (electronic edition)