Diisopentylphthalate was included in Annex XIV of REACH on 14th June 2017. It will be banned in Europe from 4 January 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.

Phtalate de diisopentyle et autorisation REACH : ce qu'il faut savoir

Identity of Diisopentylphthalate

Name Diisopentylphthalate
IUPAC name bis(3-methylbutyl) benzene-1,2-dicarboxylate
CAS number 605-50-5
EC number 210-088-4
Chemical formula C18H26O4

Classification de danger du Diisopentylphthalate

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

Diisopentylphthalate in annex XIV of REACH

Key regulatory information
Intrinsic property for which it was included in Annex XIV of REACH Toxic for reproduction (category 1B), skin sensitizer
Sunset date 4 July 2020
Latest date to submit the authorisation dossier to ECHA 4 January 2019
Who is concerned by REACH authorisation?
Main industries concerned Polymers, propellants

EcoMundo’s advice to succeed in your authorisation application

Recommendations for your authorisation dossier

  • The substance entered Annex XIV of REACH for its toxic for reproduction properties
  • As the substance does not have a threshold, the "Socio-economic Analysis" route will be chosen. This analysis will have to show that the benefits related to the granting of the authorisation outweigh the risks associated.
  • Whether the substance works with a threshold or not is not determined for these endocrine disruptors.
  • In addition to the CSR and Analysis of Alternatives, the applicant will have to conduct a socio-economic analysis for the dossier.
  • The preferred methodology to conduct the socio-economic analysis of the authorisation application is the cost/benefit analysis.
  • 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
    • The “applied for use” and “non-use” scenarios are essential for the relevance of the socio-economic analysis

Recommandations de planning

  • 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.
  • The Latest Application date for this substance is 04/01/2019, the last submission window is on November 2018.
  • It is therefore recommended to start the creation of the dossier immediately (september 2017).

You want to know more on the Candidate List substances?

 

For more information on SVHCs, do not hesitate to contact our expert Rémi Escola on +33 9 72 26 09 56 for Europe or +1 (778) 234 1607 for North America or via email at [email protected]

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