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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
 
0278-01 Review report Bis(2-methoxyethyl) ether 203-924-4 111-96-6 PMC ISOCHEM Use as a process solvent in one step of manufacturing of an active pharmaceutical ingredient used in an anti-protozoal drug Opinions adopted Details
0089-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 PMC ISOCHEM [application transferred from original Applicant: ISOCHEM due to a notified legal entity change] Use of diglyme as a process solvent in one step of the manufacturing of an Active Pharmaceutical Ingredient used in an anti-protozoal drug Commission decided Details
0090-02 Initial Formaldehyde, oligomeric reaction products with aniline 500-036-1 25214-70-4 Polynt Composites France Industrial use of an epoxy resin hardener containing technical MDA aimed at immobilising spent ion exchange resins in a high containment matrix Commission decided Details
0090-01 Initial Formaldehyde, oligomeric reaction products with aniline 500-036-1 25214-70-4 Polynt Composites France Formulation of an epoxy resin hardener containing technical MDA Commission decided Details
0047-02 Initial Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - OR23 [application transferred from original Applicant: “PPG Industries (UK) Ltd” due to a notified change of Only Representative]; Finalin GmbH; PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative]; PPG Coatings SA; Boeing Distribution Deutschland GmbH [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name] Use of potassium hydroxyoctaoxodizincatedichromate in paints, in primer, sealants, and coatings (including as wash primers) Commission decided Details
0047-01 Initial Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - OR23 [application transferred from original Applicant: “PPG Industries (UK) Ltd” due to a notified change of Only Representative]; Finalin GmbH; PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative]; PPG Coatings SA; Boeing Distribution Deutschland GmbH [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name] Formulation of Mixtures Commission decided Details
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
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
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
0350-02 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. Mixing, by Airbus, and their associated supply chains, including the Applicant, 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) Opinion development Details
0239-01 initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Prionics Lelystad B.V Use as component of buffer solutions to produce antigens (Cell extraction, cell lysis, coating of biological antigens onto articles, inactivation of microorganisms that produce targeted antigen and solvent exchange) and in-process and final Quality Control of antigens intended for use as veterinary and human health laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications Commission decided Details
0239-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Prionics Lelystad B.V. Use as component of buffer solutions to produce antigens (Cell extraction, cell lysis, coating of biological antigens onto articles, inactivation of microorganisms that produce targeted antigen and solvent exchange) and in-process and final Quality Control of antigens intended for use as veterinary and human health laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications Commission decided Details
0200-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH Industrial use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Commission decided Details
0200-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Commission decided Details
0200-04 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH Industrial use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Commission decided Details
0200-07 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing Commission decided Details
0200-08 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing Commission decided Details
0200-06 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only) Commission decided Details
0200-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L. Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Commission decided Details
0200-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L.; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only) Commission decided Details
0257-01 Initial Chromium trioxide 215-607-8 1333-82-0 QUALIPAC Aurillac; Etablissements R.GRAINDORGE Industrial use of chromium trioxide for the etching of polypropylene (PP) substrates, as a pre-treatment step of the electroplating process, for the luxury sector and other applications Opinions adopted Details
0081-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Rafineria Gdańska Sp. z o.o. [name of applicant in the original application: GRUPA LOTOS S.A. updated due to a notified legal entity change] Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes. Commission decided Details
0027-01 Initial Trichloroethylene 201-167-4 79-01-6 RAG Aktiengesellschaft, RAG Anthrazit Ibbenbüren GmbH Use of Tricholoroethylene-containing vulcanising and bonding agents for endless connections and repair of chloroprene rubber coated conveyor belts in underground hard coal mining Authorisation expired Details
0152-02 Initial Anthracene oil 292-602-7 90640-80-5 Rain Carbon bvba Use of AO for manufacture of formulations for various industrial uses Commission decided Details
0152-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 Rain Carbon bvba Use of CTPht for manufacture of formulations for various industrial uses Commission decided Details
0151-02 Initial Anthracene oil 292-602-7 90640-80-5 Rain Carbon Germany GmbH [name of applicant in the original application: RÜTGERS Germany GmbH updated due to a notified change of corporate name] Use of AO for manufacture of formulations for various industrial uses Commission decided Details
0151-01 Initial Pitch, coal tar, high temp. 266-028-2 65996-93-2 Rain Carbon Germany GmbH [name of applicant in the original application: RÜTGERS Germany GmbH updated due to a notified change of corporate name] Use of CTPht for manufacture of formulations for various industrial uses Commission decided Details
0363-01 Initial Chromium trioxide 215-607-8 1333-82-0 Ramboll Belgium BVBA (Indestructible Paints) Treatment of components used in industrial gas turbines and associated components using slurry coating products containing chromium trioxide to enhance corrosion resistance, chemical resistance, high temperature oxidation resistance, adhesion to components which produce a smooth finish and enhance the technical performance of turbines. Opinion development Details
0121-02 Initial Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Ramboll Belgium BVBA [application transferred from: “Indestructible Paint Ltd.” due to a notified legal entity change] Use of pentazinc chromate octahydroxide in stoved epoxy primer for corrosion protection of aircraft engine components in aerospace and aeroderivative applications Commission decided Details
0254-02 Initial Chromium trioxide 215-607-8 1333-82-0 RATIER-FIGEAC Industrial use of chromium trioxide for the chromic acid anodizing of aluminium spars as critical surface preparation phase for bonding with aircraft safety critical propeller blades to secure reliable bonding performance and enhance spars corrosion resistance Opinions adopted Details
0254-01 Initial Chromium trioxide 215-607-8 1333-82-0 RATIER-FIGEAC Industrial use of chromium trioxide for functional chrome plating of aircraft safety critical steel ball screws used in airplane's actuators, to decrease friction ratio, and enhance wear, corrosion, and endurance resistance, enabling targeted service life Opinions adopted Details
0094-01 Initial 2,2'-dichloro-4,4'-methylenedianiline (MOCA) 202-918-9 101-14-4 REACHLaw Ltd in its legal capacity as Only Representative of Suzhou Xiangyuan Special Fine Chemical Co., Ltd Industrial use of MOCA as a curing agent/chain extender in cast polyurethane elastomer production Withdrawn Details
0095-04 Initial Chromium trioxide 215-607-8 1333-82-0 REGARTIS s.r.o. in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” [application transferred from: “REACHLaw” in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” due to a notified legal entity change] Surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering Commission decided Details
0095-02 Initial Chromium trioxide 215-607-8 1333-82-0 REGARTIS s.r.o. in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” [application transferred from: “REACHLaw” in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” due to a notified legal entity change] Functional Chrome Plating Commission decided Details
0095-01 Initial Chromium trioxide 215-607-8 1333-82-0 REGARTIS s.r.o. in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” [application transferred from: “REACHLaw” in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” due to a notified legal entity change] Formulation of mixtures of chromium trioxide for functional chrome plating, functional chrome plating with decorative character and surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering Commission decided Details
0095-03 Initial Chromium trioxide 215-607-8 1333-82-0 REGARTIS s.r.o. in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” [application transferred from: “REACHLaw” in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” due to a notified legal entity change] Functional chrome plating with decorative character Opinions adopted Details
0177-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Rentschler Biopharma SE Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated in a washing buffer applied during a purification step in the manufacture of the monoclonal antibody Dinutuximab beta Commission decided Details
0026-02 Initial Trichloroethylene 201-167-4 79-01-6 Richard Geiss GmbH Use of tricholoroethylene in packaging Commission decided Details
0026-01 Initial Trichloroethylene 201-167-4 79-01-6 Richard Geiss GmbH Use of tricholoroethylene in formulation Commission decided Details
0272-01 Initial Chromium trioxide 215-607-8 1333-82-0 RIGHI S.p.A. Electroplating of metal substrates using chromium trioxide to achieve functional surfaces for the sanitary sector Opinions adopted Details
0056-01 Initial Chromium trioxide 215-607-8 1333-82-0 Rimex Metals (UK) Ltd – [Decision discontinued as of 01/01/2021] Use of chromium trioxide as an oxidising and hardening agent in the manufacture of coloured stainless steel Discontinued as of 01 January 2021 Details
0053-01 Initial Chromic acid
231-801-5
236-881-5
13530-68-2
7738-94-5
Robert Bosch GmbH Hard chrome plating for gasoline and diesel injection applications Commission decided Details
0236-01 Initial Sodium dichromate 234-190-3
7789-12-0
10588-01-9
Robur S.p.A Use of sodium dichromate as an anticorrosion agent of the carbon steel in sealed circuit of gas absorption appliances up to 1.05% w/w (corresponding to 0.42% w/w as Cr VI) in the refrigerant solution Opinions adopted 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
0160-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®). Commission decided Details
0171-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) Commission decided Details
0171-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Commission decided Details
0171-04 Initial 4-Nonylphenol, branched and linear, 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
0171-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Commission decided Details
0171-06 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) Commission decided Details