Adopted opinions and previous consultations on applications for authorisation

This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. Its decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid.

ID	Application type	Name	EC Number	CAS Number	Applicant(s)	Use name	Status
0174-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Hospira Zagreb d.o.o., a Pfizer company	The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of one biopharmaceutical protein, a biosimilar product, used to prevent infection and neutropenic fevers.	Commission decided
0177-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Rentschler Biopharma SE	Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated in a washing buffer applied during a purification step in the manufacture of the monoclonal antibody Dinutuximab beta	Commission decided
0181-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	DiaSorin Italia S.p.A [name of applicant in the original application: DiaSorin S.p.A. updated due to a notified legal entity change]	Industrial use, as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology.	Commission decided
0200-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	QIAGEN GmbH; STAT-Dx Life S.L.	Formulation and filling of buffer solutions containing 4-tert-OPnEO/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	Opinions adopted
0205-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Becton Dickinson Distribution Center NV	Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)) as a processing aid in imported Diagnostics	Commission decided
0247-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Boehringer Ingelheim RCV GmbH & Co KG	Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification of lipidated OspA protein subsequently used for manufacturing of Lyme disease vaccine candidate.	Opinions adopted
0154-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Siemens Healthcare Diagnostics Products GmbH	Use of OPE in formulation of IVD- wash solutions	Opinions adopted
0155-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Kedrion S.p.A	Use of 4-tert-OPnEO as Triton X-100 as detergent for virus inactivation in the manufacturing process of the human plasma-derived medicinal products Plasmagrade/Plasmasafe and Resusix, as well as Plasminogen (pre-commercialization name) and any subsequent commercialization brand	Commission decided
0159-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Nuova Ompi S.r.l. unipersonale	Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for one specific medicinal product (NeoRecormon®) of one pharmaceutical company.	Commission decided
0160-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Roche Diagnostics GmbH	Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®).	Commission decided

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