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

On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid.

Substance Details

Name: Bis(2-methoxyethyl) ether
EC Number: 203-924-4
CAS Number: 111-96-6
Entry Nr in Annex XIV: 25
Use name: Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (downstream user processes)
Broad information on use applied for (conditions of use and function): Bis(2-methoxyethyl)ether (diglyme) is used as a solvent for sodium naphthalide to produce an etchant for the surface modification of , especially perfluoropolymers such as polytetrafluoroethylene (PTFE), by reductive defluorination in order to increase the surface adhesion properties of such polymers.
Etchants formulated using diglyme as the solvent are used in the surface modification of fluoropolymer components in a range of industrial and medical applications, where the bonding of the fluoropolymer, and polytetrafluoroethylene (PTFE) in particular, provides the final bonded manufactured product with the critical non-reactive properties of the virgin fluoropolymer surface, and where the specific structural integrity of the components must be maintained, as failure of the bonded fluoropolymer surface is both expensive and would subject the end user to high risk. Some key examples of these uses include:
- medical tubing for use in heart catheters and stroke-treatment catheters
- automotive crankshaft sealing applications,
- aerospace components
- fire-resistant data cable (used to prevent fire-spreading in commercial buildings).

The following properties of diglyme are considered critical for this use:
- sufficient solvation of the radical anion salt to generate the active chemical species in order to promote this reductive defluorination
- relatively high flash point reducing the physico-chemical hazard during use
- a viscosity similar to that of water, enabling surface modification of complex fluoropolymer article
- good chemical stability over a range of process temperatures (20 - 60°C)
- stability during storage and solvent recovery.

These properties allow to produce an etchant that can be handled with reduced process risk in a number of process configurations (batch and continuous) to process a range of physical forms of polymer articles (e.g. sheets, seals, tubes etc).
Annual tonnage used: 5-10 tonnes per annum
Review period requested: 12 years
Use applied for number in application for authorisation: 2
Broad information on use applied for (Use descriptor system): Sector of end use (SU): 12
Environmental release category (ERC): 4
Process category (PROC): 1, 8b, 13
Product category (PC): N/A
Article category related to subsequent service life (AC): N/A
Technical Function: Solvent
Summary table of RMMs and OCs (non confidential)
Chemical Safety Report (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: 0217-02
Applicant(s): Acton Technologies Limited
Application type: Initial
Status: Commission decided
Other consultations on the same/ similar use
Comments submitted to date: Link
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): Link
Authorisation decision: Link