Pedidos de autorização

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

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.

Apresentação de 10 resultados.