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Lupahakemukset

Lupahakemukset

The application for authorisation process includes a period of consultation. It lasts for eight weeks.

 

Instructions for providing comments

Anyone can provide information on alternative substances or technologies for the uses of Annex XIV substances included in applications for authorisation. Those most likely to be interested are companies, organisations representing industry or civil society, individual citizens, as well as public authorities.

The following documents describe the consultation process:

 

Document Description  
Submission of information on alternatives Instructions of how interested third parties can submit information for the consultation on alternatives for applications for authorisation. Download
Format for "Public version" Download
Format for "Complete version" Download

 

 

Provide your comments

In order to facilitate the work of ECHA's Committees in reviewing the comments received, you are kindly invited to provide your comments in English preferably. By clicking on a link in the table below, you will get access to the full broad information on the use applied for, and to the related commenting form. Comments are welcomed from the EU or beyond.

Consultations close at 23:59 Helsinki time (EET).

Adopted opinions and previous consultations on applications for authorisation

 

Related Links

 

ID
Application type
Name
EC Number
CAS Number
Deadline for consultation
Applicant(s)
Use name
 
0192-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 Pfizer Manufacturing Belgium NV The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant within a lubricant used in the manufacture of pharmaceutical drug products.
0193-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 Yposkesi Use of 4-tert-OPnEO for its non-ionic detergent properties for the cell membrane lysis and viral clearance during the development and manufacturing of viral vectors in medicinal products dedicated to human use (Investigational and Authorized Advanced Therapy Medicinal Product).
0194-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 Instrumentation Laboratory SpA Use as a lysing agent for red blood cells in blood analysis diagnostic device.
0195-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 RSI ChemRep Europe Ltd (O002) OR for OraSure Technologies Inc Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as surfactant in in –vitro diagnostic device developer solution.
0196-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 Vetter Pharma-Fertigung GmbH & Co. KG Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers (syringes and cartridges) used as primary packaging material for 44 medicinal products of several pharmaceutical companies listed in the confidential Appendix 1 to the AoA. These products cover several therapeutic areas, and approx. 40 % of them are listed on the WHO Model List of Essential Medicines (EML).
0197-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 MERCK MILLIPORE LIMITED Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surface-active ingredient for the production of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes).
0197-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 MERCK MILLIPORE LIMITED Downstream use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as component of mixed cellulose ester membranes.
0198-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 Pfizer Ireland Pharmaceuticals The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals - Viral Inactivation and associated processes.
0198-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 Pfizer Ireland Pharmaceuticals The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals – Post-Production Cleaning.
0199-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/04/2020 Sanquin Reagents B.V. Use of Triton™ X-100 (4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated) in formulation of components for IVD kits.
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