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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. 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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. The table below will be updated at a later stage.

 

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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
The formulation of a hardener component containing OPE in Aerospace and Defence (A&D) two-part polysulphide sealants.
Broad information on use applied for (conditions of use and function)
OPE is used during formulation of the hardener component of a two-part polysulphide sealant. OPE historically served as a surfactant to assist in evenly dispersing the curing agent in the hardener. A thorough review of performance against relevant aerospace and defence sector requirements is needed to determine whether it is possible to achieve the same dispersion and sealant performance across a range of requirements (such as adhesion, strength, insulating properties, chemical resistance, long-term stability, etc.) when OPE is eliminated from the formulation.

The hardener is formulated in a batch process involving storage, decanting, transfer and charging of chemicals to a mixing vessel, transfer to containers, filling, maintenance and cleaning of equipment, transfer of waste and laboratory activities.

The Applicants state that there is no use of water and no release to wastewater, air or soil during formulation. OPE contaminated waste generated during formulation is managed as hazardous waste by licensed third party waste management contractors. The waste is processed in line with the applicable local, regional, and national regulations. Compliance with these regulations precludes release to the environment and generally involves incineration.

This use of OPE addresses only the formulation of the hardener component by a stand-alone formulator at two sites. On-site mixing (at industrial sites, including the Applicants) of the OPE-containing hardener with the base is not included in this use but in use 2.

Annual tonnage used: <1 tonne
Number of sites: 2
Review period requested: 4 years
Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 0: Other: Aerospace and Defence
Environmental release category (ERC): 2
Process category (PROC): N/A
Product category (PC): 1
Article category related to subsequent service life (AC): AC1b Other vehicles
Technical Function: Surfactant / Dispersant
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
0203-01
Applicant(s)
PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. – OR5; Sealants Europe SAS; PPG Industries (UK) Ltd.; Boeing Distribution, Inc. – [Decision discontinued as of 01/01/2021]; Aviall UK Inc.; Wesco Aircraft EMEA Ltd (Poland); HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change]
Application type
Initial
Status
Opinions adopted
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)
Authorisation decision

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