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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0203-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. – OR5; Sealants Europe SAS; Wesco Aircraft EMEA Ltd; Boeing Distribution UK, Inc. – [Decision discontinued as of 01/01/2021]; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - [name of the co-applicant in the original application OR23 PPG Industries (UK) Ltd. updated due to a notified appointment of only representative]; HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change];	The formulation of a hardener component containing OPE in Aerospace and Defence (A&D) two-part polysulphide sealants.	Commission decided	Details
0167-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Abbott Ireland	Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems.	Commission decided	Details
0198-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Pfizer Ireland Pharmaceuticals	The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals – Post-Production Cleaning.	Commission decided	Details
0178-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Takeda Manufacturing Austria AG [name of the applicant in the original application: Baxter AG updated due to a change of corporate name]; Baxalta Belgium Manufacturing SA	Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated (as a detergent) for virus inactivation via S/D (Solvent/Detergent) treatment in recombinant and plasma-derived medicinal products.	Commission decided	Details
0186-04	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Beckman Coulter Ireland Inc. Immunotech S.R.O. Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o.; Beckman Coulter UK - [Application void as of 01/01/2021] Beckman Coulter S.L.U Beckman Coulter SPA Italy BC Distribution B.V	Downstream use of OPnEO-containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays.	Commission decided	Details
0189-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Lonza Biologics Porriño, SL. Lonza Biologics, plc. - [Application void as of 01/01/2021]	Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures	Commission decided	Details
0198-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Pfizer Ireland Pharmaceuticals	The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals - Viral Inactivation and associated processes.	Commission decided	Details
0206-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Phadia GmbH; B∙R∙A∙H∙M∙S GmbH	Coating Thyroid Stimulating Hormone Receptor onto articles used as components of IVD reagent systems at B∙R∙A∙H∙M∙S GmbH and Phadia GmbH	Opinions adopted	Details
0203-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. – OR5; Sealants Europe SAS; Wesco Aircraft EMEA Ltd; Boeing Distribution UK, Inc. – [Decision discontinued as of 01/01/2021]; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - [name of the co-applicant in the original application OR23 PPG Industries (UK) Ltd. updated due to a notified appointment of only representative]; HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change];	Mixing, by Aerospace and Defence Companies, and their associated supply chains, including the Applicants, of base polysulfide sealant components with OPE-containing hardener, resulting in mixtures containing < 0.1% w/w of OPE for Aerospace and Defence uses that are exempt from authorisation under REACH Art. 56(6)(a).	Commission decided	Details
0171-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Roche Diagnostics GmbH	Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA.	Commission decided	Details

Showing 71 - 80 of 544 results.

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