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 111/05
Date: 2023-03-27
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, polishing and scouring preparations, veterinary medicine








C_2023111EN.01000501.xml










27.3.2023   


EN


Official Journal of the European Union


C 111/5






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 111/05)

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) 1771


20 March 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.-


Bio-Rad, 3 Boulevard Raymond Poincaré, 92430 Marnes-la-Coquette, France


REACH/23/9/0


Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections
Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections
Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles
Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications
Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application


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/23/9/1


4 January 2033




REACH/23/9/2


4 January 2033




REACH/23/9/3


4 January 2033




REACH/23/9/4


4 January 2028






(1)  OJ L 396, 30.12.2006, p. 1.

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