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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
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
0204-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Biokit S.A.	Professional use of 4-tert-OPnEO as a detergent during the final use of latex-based, ELISA and CLIA In-Vitro-Diagnostic kits.	Opinions adopted
0204-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Biokit S.A.	Industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA In-Vitro-Diagnostic kits.	Opinions adopted
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; PPG Industries (UK) Ltd.; Boeing Distribution, Inc. – [Decision discontinued as of 01/01/2021]; Aviall UK Inc.; Wesco Aircraft EMEA Ltd (Poland); 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
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; PPG Industries (UK) Ltd.; Boeing Distribution, Inc. – [Decision discontinued as of 01/01/2021]; Aviall UK Inc.; Wesco Aircraft EMEA Ltd (Poland); 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
0202-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Merckle-GmbH-Ulm	The use of 4-OPnEO as an emulsifier in a silicone oil emulsion for siliconization of pre-filled syringes in a medicinal product	Opinions adopted
0201-04	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Zoetis Belgium S.A.	Industrial use as a viral inactivating agent in the manufacture of two veterinary biologic drugs for treatment of osteoarthritis in cats and dogs	Commission decided
0201-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Zoetis Belgium S.A.	Professional use as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary In Vitro Diagnostic devices (IVDs) including one SERELISA, six ProFLOK, six WITNESS and five VetScan. The use is carried out by professional users in diagnostic laboratories and veterinary clinics to detect certain diseases in pets and farm animals	Commission decided
0201-02	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 in formulation of kits, kit reagents and buffer solutions in two WITNESS and three SERELISA veterinary In Vitro Diagnostic devices (IVDs) used for detecting certain diseases in pets and farm animals	Commission decided
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

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