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Adopted opinions and previous consultations on applications for authorisation

Adopted opinions and previous consultations on applications for authorisation

 

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. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

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Substance Details

Name
4-Nonylphenol, branched and linear, ethoxylated
EC Number
-
CAS Number
-
Entry Nr in Annex XIV
43
Use name
Industrial use of emulsifiers containing nonylphenols ethoxylated for the manufacture of chromatography resins used by the biopharmaceutical industry, food & beverage sector and academia
Broad information on use applied for (conditions of use and function)

4-Nonylphenol, branched and linear, ethoxylated (NPE) is present as a critical process agent in four different emulsifiers used in the manufacturing of intermediate resins for the further production of more than 120 chromatography resins. The use takes place at one site in Sweden. The chromatography resins produced by the applicant are used in biopharmaceutical applications for the manufacture and purification of active pharmaceutical ingredients (APIs) and for research and development activities, in analytical applications for the characterization and development of analytical methods for biomolecules and polymers, in the food and beverages industry (e.g. to detect food additives), and in nutraceuticals and nutritional chemistry.

During the production of intermediate resins, NPE-containing emulsifiers are added in the emulsification step to aid in the formation of aqueous droplets dispersed in a solvent phase. A subsequent reduction of temperature triggers solidification of the droplets and thereby formation of porous polysaccharide-based particles. A series of washing steps follows to remove all residuals of emulsifiers and solvents from the particles. The washed particles correspond to the intermediate resin product, which is then further used for down-stream processing. The size, shape and physical properties of these particles determine the characteristics of the different chromatography end-products.

The NPE-containing emulsifiers are considered processing aids that are removed during the manufacturing process and are thus not part of the final chromatography resins. The emulsifiers fulfil the following key functionalities which an alternative emulsifier must meet as well:

  • Reduction of interfacial tension to facilitate emulsion droplet formation with low defect contents
  • Facilitation of droplet size reduction to reach the targeted drop size distribution
  • Droplet stabilization during cooling and particle formation to minimize particle defects
  • Low interference with process conditions and other processing aids

Annual tonnage used: < 1 tonne

Review period requested: 12 years

Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 9
Environmental release category (ERC): 4
Process category (PROC): 1, 4, 8b, 9, 15, 28
Product category (PC): 20
Article category related to subsequent service life (AC): n/a
Technical Function: Processing aid
Summary table of RMMs and OCs (non confidential)
Section 9 and 10 of the CSR (original and updated, if available) (non confidential)
Analysis of Alternatives (non confidential report)
Substitution Plan (non confidential summary)
Socio-Economic Analysis (non confidential report)
Joint Analysis of Alternatives and Socio-Economic Analysis (non confidential report)
Explanatory note
Additional information
ID
0172-01
Applicant(s)
Cytiva Sweden AB [name of applicant in the original application: GE Healthcare Bio-Sciences AB updated due to a notified change of corporate name]
Application type
Initial
Status
Opinions adopted
Other consultations on the same/ similar use
Comments submitted to date
No comments received
Response to comments by applicant
Responses to RAC and SEAC requests by Applicant(s) (non confidential)
Compiled RAC and SEAC opinions
Minority positions
Adopted commission decision (OJ summary)
Authorisation decision

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