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Pareri adottati e consultazioni precedenti sulle domande di autorizzazione

Pareri adottati e consultazioni precedenti sulle domande di autorizzazione

 

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 Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for two specific medicinal products (NutropinAq® and Lucentis®) of one pharmaceutical company.
Broad information on use applied for (conditions of use and function)

This dossier covers the siliconisation process of glass containers for two medicinal products that are commercialized in pre-filled syringes (PFS) and cartridges for injection pens, respectively.

The inner surface of PFS and cartridges are siliconized to allow the movement of a plunger stopper along the inner side of the glass containers, while at the same time allowing for a tight connection between the glass container and the plunger stopper. During the production of the PFS for the two affected medicinal products, Vetter currently uses a silicone oil emulsion which contains the substance Octylphenolethoxylates (OPnEO) as emulsifier of the silicone oil in the aqueous phase for the siliconisation of the glass containers.

For an alternative silicone oil emulsion to be considered as an appropriate replacement of the OPnEO-containing emulsion, the following conditions should be fulfilled:

  • The physicochemical behaviour of the silicone oil emulsion must be appropriate for the manufacturing process. This behaviour determines if the content and distribution of the silicone oil on the glass container can be achieved within the specified ranges.
  • The functionality of the PFS must be fulfilled, i.e. the closing as well as the gliding properties of the plunger stopper must be within the specified range (i.e. Break Loose and Gliding Forces).
  • The components of the silicone oil emulsion must be compatible with the medicinal product, i.e. stability studies have to demonstrate that the medicinal product meets the specified requirements at the end of shelf life.

An alternative silicone oil emulsion has been proposed by the manufacturer. First experiments regarding physicochemical properties as well as machinability behaviour of the alternative were promising. However, the process required for the substitution of the OPnEO containing silicone oil emulsion requires extensive testing and generation of stability data of each medicinal product. Since medicinal products are subject to extensive regulation by the health authorities all over the world, change notifications have to be submitted to competent health authorities when any change is introduced in their production process. As substitution with an alternative silicone oil emulsion is a change in manufacturing process, the substitution can only be completed after approvals from health authorities have been received.

Annual tonnage used: max. of 0.306 kg/a OPnEO

Review period requested: 5 years

Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 20
Environmental release category (ERC): 4
Process category (PROC): 5, 7, 8a, 9
Product category (PC): 0: Other: Surfactant
Article category related to subsequent service life (AC): n/a
Technical Function: Emulsifier
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
0161-01
Applicant(s)
Vetter Pharma-Fertigung GmbH & Co. KG
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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