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Aangenomen adviezen en eerdere raadplegingen over autorisatieaanvragen

Aangenomen adviezen en eerdere raadplegingen over autorisatieaanvragen

 

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-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
EC Number
-
CAS Number
-
Entry Nr in Annex XIV
42
Use name
Use of Octoxynol-9 for virus splitting and inactivation step in the manufacturing of influenza vaccines
Broad information on use applied for (conditions of use and function)

Sanofi Pasteur produces seasonal influenza vaccines that protect the public against either three or four strains of influenza as well as single strain vaccines when an influenza pandemic occurs. The production of Sanofi Pasteur’s seasonal influenza vaccines takes place at Val de Reuil, France. Production at the facility shifts to pandemic vaccines when the need arises.

During production, Octoxynol‑9 is an essential component used to split the influenza virus and recover the viral antigens that are the main ingredients of the vaccines. The virus splitting step uses Octoxynol-9 at a concentration of 0.5% (v/v). Virus splitting also contributes to virus inactivation because split viruses are not infectious anymore. Additional virus inactivation steps are also needed to meet safety standards from health authorities, including treatment with other substances. Part of the Octoxynol-9 is then removed from the harvested medium in the following filtration steps. The remaining Octoxynol-9 intentionally present in the vaccine contributes to the stabilization of the viral antigens in the final vaccine, preserving these and thus ensuring its potency and efficacy. The final vaccine product is formulated with additional components necessary for its administration and is then filled into a syringe or a vial, checked for quality and packaged for distribution.

The use of Octoxynol‑9 has the following key functionalities in the vaccine manufacturing process that must also be met by a suitable alternative:

  • It splits the influenza virus by disrupting its lipid bilayer and solubilizes the virus antigens without damaging them or compromising their integrity.
  • It inactivates influenza viruses and a wide range of enveloped viruses that may be present as adventitious agents, and thus ensures the safety of the final vaccines.
  • It stabilizes the antigens in the final vaccine, ensuring its potency up to the expiration date and minimizing activity loss due to temperature excursions.

Annual tonnage used: 10-100 kg/year

Review period requested: 21 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, 20
Environmental release category (ERC): 4
Process category (PROC): 15, 0: Other: Antigen production
Product category (PC): 0: Other: Detergent
Article category related to subsequent service life (AC): n/a
Technical Function: Surfactant
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
0156-01
Applicant(s)
Sanofi Pasteur
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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