Bis(2-methoxyethyl) phthalate and REACH authorisation: what you must know

Identity of Bis(2-methoxyethyl) phthalate

Name Bis(2-methoxyethyl) phthalate

IUPAC name 1,2-bis(2-methoxyethyl) benzene-1,2-dicarboxylate

CAS number 117-82-8

EC number 204-212-6

Chemical formula C₁₄H₁₈O₆

Hazard classification of Bis(2-methoxyethyl) phthalate

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

Bis(2-methoxyethyl) phthalate 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)

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

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 is on November 2018.
• It is therefore recommended to start the creation of the dossier immediately (september 2017).

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