Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
 
0265-02 Initial Trixylyl phosphate 246-677-8 25155-23-1 EDF S.A. Industrial use as a hydraulic fluid in closed systems to drive and control main steam isolation valves Opinions adopted Details
0265-01 Initial Trixylyl phosphate 246-677-8 25155-23-1 EDF S.A. Industrial use as a hydraulic fluid in closed systems to drive and control the steam inlet valves of turbines Opinions adopted Details
0021-01 Initial Trichloroethylene 201-167-4 79-01-6 Grupa Azoty S.A. Industrial use as a process chemical in caprolactam purification Commission decided Details
0077-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Eli Lilly Kinsale Limited [application transferred from original Applicant: Eli Lilly S.A. - Irish Branch due to a notified legal entity change] Industrial use as a reaction medium and a solvating agent in mediating subsequent chemical transformation reactions leading to the manufacture of an Active Pharmaceutical Ingredient, Raloxifene Hydrochloride Commission decided Details
0060-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 BASF SE Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane Commission decided Details
0080-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 H&R Ölwerke Schindler GmbH
H&R Chemisch-Pharmazeutische Spezialitäten GmbH
Industrial use as a solvent and anti-solvent of the feedstock and intermediate product streams in the combined de-waxing and de-oiling of refining of petroleum vacuum distillates for the production of base oils and hard paraffin waxes Commission decided Details
0078-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2
  • Specialty Electronic Materials Italy srl [name of lead applicant in the original application: DOW ITALIA S.R.L. updated due to a notified legal entity change]
  • DSP S.A.S. [name of co-applicant in the original application: Dow France SAS updated due to a notified legal entity change]
Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins 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
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
0167-01 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]
Industrial use as a surfactant in the formulation of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. Commission decided Details