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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
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
0192-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Pfizer Manufacturing Belgium NV	The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant within a lubricant used in the manufacture of pharmaceutical drug products.	Commission decided	Details
0167-05	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name]	Industrial use as a surfactant in the extraction and purification of antigens for incorporation into In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems.	Commission decided	Details
0240-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Alexion Pharma International Operations Unlimited Company	Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation in the manufacture Andexanet alfa for treatment of adult patients treated with a direct factor Xa (FXa) inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding	Commission decided	Details
0201-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Zoetis Belgium S.A.; Aguettant Diagnostics [name of co-applicant in the original application: “Delpharm Biotech” updated due to a notified corporate name change]	Industrial use as a surfactant in a lysis buffer for the release of proteins and antigens from biological material used in the manufacture of three SERELISA veterinary In Vitro Diagnostic devices (IVDs) for detecting infectious disease in farm animals.	Commission decided	Details

Showing 51 - 60 of 544 results.

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