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: 2023-11-22
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 device, medical diagnosis








C_202300917EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2023/917


22.11.2023






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/2023/917)


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) 7574


15 November 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.-


Phadia GmbH,
Munzinger Strasse 7, 79111 Freiburg, Germany
Thermo Fisher Scientific Baltics UAB V.A.Graiciuno 8, LT-02241 Vilnius, Lithuania


REACH/23/32/0
REACH/23/32/1


4-tert-OPnEO as components of buffer solutions with the following purposes: (1) production of purified proteins (to achieve cell extraction, chromatographic purification and solvent exchange); and (2) in-process and final quality control testing; intended for use as 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.




 


 


 


Thermo Fisher Scientific Baltics UAB V.A.Graiciuno 8, LT-02241 Vilnius, Lithuania


REACH/23/32/2


4-NPnEO as components of buffer solutions with the following purposes: (1) production of purified proteins (to achieve cell extraction, chromatographic purification and solvent exchange); and (2) in-process and final quality control testing; intended for use as laboratory reagents in scientific research and development and in vitro diagnostic applications


 


 




 


 


 


Phadia GmbH,
Munzinger Strasse 7, 79111 Freiburg, Germany
Brahms GmbH, Neuendorfstrasse 25, 16761 Hennigsdorf, Germany


REACH/23/32/3
REACH/23/32/4


4-tert-OPnEO in coating thyroid stimulating hormone receptor onto articles used as components of in vitro diagnostic reagent systems


 


 






(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/2023/917/oj
ISSN 1977-091X (electronic edition)