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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
 
0274-02 Initial Sodium dichromate 234-190-3 10588-01-9 ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) Opinions adopted Details
0041-01 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Akzo Nobel Pulp and Performance Chemicals AB
Akzo Nobel Pulp and Performance Chemicals Oy
Akzo Nobel Pulp and Performance Chemicals S.A.S.
Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide. Commission decided Details
0072-06 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Souriau sas;
TE UK Ltd – [Decision discontinued as of 01/01/2021]
Industrial use of a mixture containing hexavalent chromium compounds for the conversion of cadmium coated circular and rectangular connectors in order to achieve a higher level of performances than the requirements of international standards as well as to withstand harsh environments and high safety applications (such as in the military, aeronautic, aerospace, mining, offshore and nuclear industries or for the application in safety devices for road vehicles, rolling stock and vessels). Commission decided Details
0040-01 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
CAFFARO BRESCIA S.r.l Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorite Commission decided Details
0072-07 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Souriau sas
“Amphenol Limited – [Decision discontinued as of 01/01/2021]
AMPHENOL SOCAPEX
Industrial use of a mixture containing hexavalent chromium compounds in conversion coating and passivation of circular and rectangular connectors in order to meet the requirements of international standards and special requirements of industries subject to harsh environments. Commission decided Details
0043-02 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Brenntag Chemicals Distribution (Ireland) Ltd [application transferred from original Applicant: Brenntag UK Ltd due to a notified legal entity change]
Henkel AG & Co. KGaA
AD International BV
Use of Sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites and sealings of anodic films Commission decided Details
0137-01 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
SOCIETA' CHIMICA BUSSI S.P.A. Use of sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacturing of sodium chlorite. Commission decided Details
0079-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Lanxess Deutschland GmbH Industrial use as a swelling agent and reaction medium during the phthalimidomethylation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of anion exchange and chelating resins Commission decided Details
0107-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 emp Biotech GmbH Use as a solvent in manufacture of polymeric particles for pharmaceutical and research purification processes Commission decided Details
0108-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 ORGAPHARM Use as a process solvent in the manufacture of an Active Pharmaceutical Ingredient: Flecainide acetate Commission decided 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
0076-01 Initial 1,2-dichloroethane (EDC) 203-458-1 107-06-2 BASF SE Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO) Commission decided Details
0076-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 BASF plc - [Decision discontinued as of 01/01/2021; application transferred from original Applicant: BASF SE due to a notified legal entity change] Industrial use as solvent and crystallisation medium in the synthesis of the EU biocide flocoumafen (ISO) Discontinued as of 01 January 2021 Details
0082-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Cytiva Sweden AB [name of applicant in the original application: GE Healthcare Bio-Sciences AB updated due to a notified change of corporate name] Industrial use of 1,2-dichloroethane as an emulsifying solvent in the manufacture of porous particles for beaded chromatography and cell culture media. 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
0029-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Laboratoires Expanscience Use as process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients Commission decided Details
0109-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Akzo Nobel Chemicals SpA The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant Commission decided Details
0111-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 OLON Spa The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient for epirubicin. Commission decided Details
0111-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 OLON Spa The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient prednisolone steaglate. 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
0110-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Bayer AG [application transferred from original applicant: Bayer Pharma AG, due to a notified legal entity change] Use as an industrial solvent in the manufacture of the high-grade pure final intermediate of Iopromide, the Active Pharmaceutical Ingredient for the X-ray contrast medium Ultravist® 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
0108-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 ORGAPHARM Use as an process solvent in the manufacture of an Active Pharmaceutical Ingredient: Nefopam hydrochloride Commission decided Details
0223-01 Review report 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Lanxess Deutschland GmbH Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins. Commission decided Details
0224-01 Review report 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 EURENCO Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives. Commission decided Details
0083-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 EURENCO Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives Commission decided Details
0079-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Lanxess Deutschland GmbH Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins Commission decided Details
0120-01 Initial 1,2-dichloroethane (EDC) 203-458-1 107-06-2 Microbeads AS Industrial use as a swelling agent during the sulfonation reaction of crosslinked polystyrene beads in the manufacture of ion exchange resins for purification of radioactive waste 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
0088-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (in-house processes). Commission decided Details
0217-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (in-house processes) Commission decided Details
0091-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Merck KGaA Industrial use of diglyme as solvent in the manufacturing process of cryptand intermediates for further conversion into cryptand 221 and cryptand 222 Commission decided Details
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
0217-02 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (downstream user processes) Commission decided 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
0088-02 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (downstream user processes). Commission decided Details
0125-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 N.V. Ajinomoto OmniChem S.A. Use of diglyme as a solvent for the synthesis of the anti-HIV active pharmaceutical ingredient (API) dapivirine. Commission decided Details
0086-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Bracco Imaging s.p.a Use of bis(2-methoxyethyl) ether (diglyme) as a processing aid in the purification of 5-amino-2,4,6-triiodoisophthalic acid dichloride (EC 417- 220-1; CAS 37441-29-5) by precipitation Commission decided Details
0085-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Life Technologies AS Use of diglyme as a process chemical in the manufacture of Dynabeads. Commission decided Details
0061-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Novartis Ringaskiddy Limited Use of diglyme as solvent in the manufacturing process of an intermediate for further conversion into a pharmaceutical compound used in medicinal products for treatment of respiratory diseases Commission decided Details
0087-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 MAFLON S.P.A. Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity. Commission decided Details
0084-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Roche Diagnostics GmbH Use of diglyme as a process chemical in the manufacture of one specific type of Dynabeads® used in immunodiagnostic assays (in vitro diagnostic) 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
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
0352-02 Initial Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd Use of DEHP-containing plastics for immediate packaging of medicinal products Opinion development Details
0122-02 Review report Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 VINYLOOP
FERRARA
S.p.A.
Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrials workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. Withdrawn Details
0352-03 Initial Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd Use of DEHP-based mixtures as a lubricating/sealing agent for the insertion of port closures into empty bags and assembly/connection of parts, that are used in immediate packaging of medicines Opinion development Details
0352-01 Initial Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd; Colorite Europe Ltd. Formulation of DEHP mixtures for application in immediate packaging of medicines and medical devices Opinion development Details
0122-01 Review report Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 VINYLOOP
FERRARA
S.p.A.
Formulation of recycled soft PVC containing DEHP in compounds and dry-blends Withdrawn Details
0123-02 Review report Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Plastic Planet srl Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrial workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. Opinions adopted Details