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 206/05
Date: 2023-06-13
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








C_2023206EN.01000701.xml










13.6.2023   


EN


Official Journal of the European Union


C 206/7






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 206/05)

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) 3517


6 Jun 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.-







QIAGEN GmbH, Qiagenstr. 1, 40724, Hilden, Germany;




STAT-Dx Life S.L., Carrer de Baldiri Reixac 4, 08028, Barcelona, Spain;




QIAGEN Distribution B.V., Hulsterweg 82, 5912 PL, Venlo, Netherlands.






REACH/23/17/0
REACH/23/17/1


Formulation and filling of buffer solutions containing 4-tert-OPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing


4 January 2031


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/23/17/2


Formulation and filling of buffer solutions containing 4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing


4 January 2031




REACH/23/17/3


Industrial use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing


4 January 2031




REACH/23/17/4


Industrial use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing


4 January 2031




REACH/23/17/5
REACH/23/17/6
REACH/23/17/7


Professional downstream use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing and immunoassay


4 January 2031




REACH/23/17/8
REACH/23/17/9


Professional downstream use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing


4 January 2031




REACH/23/17/10
REACH/23/17/11


Professional downstream use of 4-tert-OPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing


4 January 2026




REACH/23/17/12
REACH/23/17/13


Professional downstream use of 4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing


4 January 2026






(1)  OJ L 396, 30.12.2006, p. 1.

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