Adopted opinions and previous consultations on applications for authorisation

Adopted opinions and previous consultations on applications for authorisation

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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. 

 

There are currently no ongoing consultations.
 
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 Details
0167-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland
Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name]
Abbott Diagnostics GmbH
Professional use as a surfactant in the final use of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. Commission decided Details
0168-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Diagnostics GmbH Professional use as a surfactant, in wash buffer components used in conjunction with Fluorescence In Situ Hybridisation (FISH) test kits and/or their Laboratory Developed Test (LDT) equivalents, in clinical diagnostic use for medical analysis of human tissue and blood samples to identify characteristic genetic abnormalities related to specific disease conditions. Commission decided Details
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. Commission decided Details
0012-12 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR2 [application transferred from “DCL Corporation (NL) B.V. OR” due to a notified legal entity change. Name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking Authorisation expired Details
0012-11 Initial Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-2 DCL Corporation (NL) B.V. OR2 [application transferred from “DCL Corporation (NL) B.V. OR” due to a notified legal entity change. Name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking Authorisation expired Details
0167-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland Professional use of system solutions (Pre-Trigger and Trigger) in the final use of the In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. Withdrawn Details
0012-06 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCL Corporation (NL) B.V. OR2 [application transferred from “DCL Corporation (NL) B.V. OR” due to a notified legal entity change. Name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking Authorisation expired Details
0012-05 Initial Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-2 DCL Corporation (NL) B.V. OR2 [application transferred from “DCL Corporation (NL) B.V. OR” due to a notified legal entity change. Name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking Authorisation expired Details
0350-01 Review report 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc.; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. Repackaging hardener formulations containing OPE as a surfactant in a concentration above 0.1%, to be used within two-part polysulphide sealants by Airbus and their associated supply chains Opinion development Details