4-Nonylphenol and REACH authorisation: what you must know

Published 
October 11, 2017

Identity of 4-Nonylphenol, branched and linear, ethoxylated

Name Triton or 4-Nonylphenol, branched and linear, ethoxylated IUPAC name 4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof] CAS number - EC number - Formule chimique C15H24O

Hazard classification of 4-Nonylphenol, branched and linear, 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-Nonylphenol, branched and linear, 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 2019Who is concerned by REACH authorisation? Main industries concerned Pharmaceutical, chemical, paint, metallurgy, agriculture

EcoMundo’s advice to succeed in your authorisation application

Recommendations for your authorisation dossier

  • The substance entered Annex 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

  • The Latest Application date for this substance is 4 July 2019, the last submission window is on May 2019.
  • The creation of a dossier is usually between 6 and 18 months depending on the complexity of the dossier (intrinsic properties of the substance, complexity of the applicants’ value and production chain.
  • It is therefore recommended to start the creation of the dossier immediately (september 2017).
  • You want to know more on the Candidate List substances?
Encore +

Articles similaires

Tous
Biocides
3
/
13
/
2024

Approval of the substance "Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate)": Major Impact on the Biocides Industry

Upcoming approval of Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate): Impact on the biocides industry. Learn how EcoMundo can assist you in this process.
Cosmetics
2
/
15
/
2024

Intentional Microplastic Ban in Cosmetics

The European Union (EU) Commission's decision on September 25th 2023 to amend Annex XVII of the REACH Regulation (EC) No 1907/2006 has far-reaching implications for the cosmetics industry. The amendment specifically targets intentional microplastics in cosmetic products, aiming to address the environmental and health concerns associated with these tiny plastic particles.
REACH Registration
1
/
29
/
2024

Understanding the REACH regulation n°1907/2006 on chemical substances

Manufacturers, importers and downstream users of chemical substances are required to comply with the European REACH regulation, which came into force in 2007. EcoMundo gives you an update on the different aspects of the regulation that concern you.