N-pentyl-isopentylphtalate and REACH authorisation: what you must know

Identity of N-pentyl-isopentylphtalate

Name N-pentyl-isopentylphtalate IUPAC name N-pentyl-isopentylphtalate CAS number 776297-69-9 EC number - Chemical formula C₁₈H₂₆O₄

Hazard classification of N-pentyl-isopentylphtalate

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

HAZARDOUS TO THE AQUATIC ENVIRONMENT ● H400: Very toxic to aquatic life

N-pentyl-isopentylphtalate in annex XIV of REACH

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

EcoMundo’s advice to succeed in your authorisation application

Recommendations for your authorisation dossier

• As the substance does not have a threshold, the Socio-Economic Analysis route will be chosen. This analysis will demonstrate that the benefits related to the granting of the authorisation outweigh the risks associated.
• The applicant will thus have to conduct a socio-economic analysis as well as the CSR and Analysis of Alternatives.
• The preferred methodology to conduct the socio-economic analysis of the authorisation application is the cost/benefit analysis.
• 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.
• 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

Planning recommendations

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