4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) was included in Annex XIV of REACH on 14th June 2017. It will be banned in Europe from 4 July 2019, unless a REACH authorisation application has been drafted. What must you know before starting such application? Our experts give you key information on this substance, as well as advice to follow before going ahead.

4-(1,1,3,3-tétraméthylbutyl)phénol, éthoxylé et autorisation REACH : ce qu'il faut savoir

Identity of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

Name 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
IUPAC name 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues
CAS number -
EC number -
Chemical Formula (C2H4O)nC14H22O

The following table gives the substances covered by this entry in annexe XIV (non exhaustive):

Hazard classification of 4-(1,1,3,3-tetrameethylbutyl) phenol, ethoxylated

CORROSIVE H314: Causes severe skin burns and eye damage
HAZARDOUS TO THE AQUATIC ENVIRONMENT H400 : Very toxic to aquatic life
H412 : Harmful to aquatic life with long lasting effects
VERY HAZARDOUS TO HEALTH H350: May cause cancer
H340: May cause genetic defects
H360: May damage fertility or the unborn child
H371: May cause damage to organs
H304: May be fatal if swallowed and enters airways
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
HAZARDOUS TO THE OZONE LAYER EUH 059: Hazardous to the ozone layer

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in Annex XIV of REACH

Key regulatory information
Intrinsic property for which it was included in Annex XIV of REACH endocrine disrupting properties [article 57, point f) — environment]
Sunset date 4 January 2021
Latest date to submit the authorisation dossier to ECHA 4 July 2019
Who is concerned by REACH authorisation?
Main industries concerned Polymers, pharmaceutical, metallurgy, aeronautics, water treatment

EcoMundo’s advice to succeed in your authorisation application

Recommendations for your authorisation dossier

  • The substance entered Annexe XIV of REACH for its endocrine disrupting properties.
  • In addition to the CSR and Analysis of Alternatives, the applicant will have to conduct a socio-economic analysis for the dossier.
  • Whether the substance works with a threshold or not is not determined for these endocrine disruptors.
  • This means that the chosen route for the creation of the dossier is not set in stone. The European Commission specifies that if an applicant decides to take the risk management route, it will be the applicant’s responsibility to demonstrate the existence of threshold effects and their level. The RAC will then assess this demonstration.
  • Whichever authorisation route chosen, "risk management" or "socio-economic analysis" (SEA), EcoMundo recommends to create an SEA dossier in case the relevance of the threshold demonstration is questioned by the committee assessors.
  • Another challenge could be the possible exemption of the activity involving "Scientific Research and Development" activities, particularly for the Pharmaceutical and In Vitro diagnostic industries.
  • To assess the impacts for health and the environment, EcoMundo recommends to double the approaches through modelling and data monitoring
  • Key elements of a successful authorisation dossier:
    • A specific request with the most elements possible in relation to your activity
    • Transparence and realism of the hypotheses and data as all elements produced will be challenged by the committees or stakeholders
    • Underlining the exposure for man and the environment with associated emission measures
    • The choice of the monetary assessment methodology is key for this dossier

Planning recommendations

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