Vedtagne udtalelser og tidligere høringer om ansøgninger om godkendelse

Vedtagne udtalelser og tidligere høringer om ansøgninger om godkendelse

Vedtagne udtalelser og tidligere høringer om ansøgninger om godkendelse

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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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

 

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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
Professional use as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary In Vitro Diagnostic devices (IVDs) including one SERELISA, six ProFLOK, six WITNESS and five VetScan. The use is carried out by professional users in diagnostic laboratories and veterinary clinics to detect certain diseases in pets and farm animals
Broad information on use applied for (conditions of use and function)
The Applicant produces veterinary IVD kits in the EU and imports veterinary IVD kits into the EU. The IVD products are distributed to veterinary practices and analytical laboratories for professional end use. The Applicant is applying on behalf of its EU professional end users. Professional end use of the substance within the final IVD test kits is carried out for the purpose of detection of disease and health conditions in pets and livestock animals.
The veterinary IVD test kits use two immunoassay techniques, namely Rapid immunochromatography and ELISA (Enzyme Linked Immunosorbent Assays). 4-tert-OPnEO is present in sample diluents, control solutions and other buffers and also coated on the test kit card/strip or on the wells of ELISA tests.
4-tert-OPnEO is used as a surfactant across all kits within their end use. It prevents non-specific binding (NSB) within all kits and depending on the kit component, it allows for other key functionalities needed to produce correct results within the IVDs. Other applications of the surfactant in the various kit components include: cell lysis to release the intracellular components allowing for their detection in the assay, maintaining the stability of the proteins of interest, preventing aggregation of antigens and/or a wetting agent.
The identification of possible alternatives and the substitution process is currently ongoing to identify an alternative and must take account of these additional advantageous characteristics of the surfactant. The Applicant has identified potential alternative surfactants that could be technically feasible alternatives. However, technical feasibility cannot be concluded upon until laboratory and field studies and regulatory approvals are completed.
The use is primarily carried out by professional laboratory and veterinary practitioners within veterinary clinics and dedicated testing laboratories. The veterinary professional or laboratory technician uses the IVD kit in conjunction with an animal sample to produce a test result. Most test types are relatively quick to allow for early detection of disease; for example in an animal herd where the risk of cross infection is high, e.g. Bovine Viral Diarrhoea Virus.
The Applicant is requesting a review period of 12 years to allow for the substitution process from its range of IVDs and the subsequent change over by its EU customers.
Annual use: 1-5 kg
Number of sites: > 1 000
Review period requested: 12 years
Use applied for number in application for authorisation
3
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 20
Environmental release category (ERC): 8a
Process category (PROC): 15
Product category (PC): 21
Article category related to subsequent service life (AC): N/A
Technical Function: Surfactant
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
0201-03
Applicant(s)
Zoetis Belgium S.A.
Application type
Initial
Status
Commission decided
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)
Link
Authorisation decision
Final decision