4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated, used in the production of various medical devices


Summary

The European Chemicals Agency (ECHA) has launched a consultation on alternative substances or technologies on 8 applications for authorisation covering 10 uses of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated, used in the production of various medical devices (e.g. in vitro diagnostic kits / reagents) and medicinal / biopharmaceuticals (e.g. Active Pharmaceutical Ingredients).

Submit your comments by 8 April 2020 (23:59 Helsinki time).


Description

ECHA has launched a public consultation on alternative substances or technologies on 8 applications for authorisation covering 10 uses of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated, used in the production of various medical devices (e.g. in vitro diagnostic kits / reagents) and medicinal / biopharmaceuticals (e.g. Active Pharmaceutical Ingredients).

More information about the uses that authorisation is applied for, including the description of the function of the substance, exposure scenarios, possible alternatives identified by the applicants, together with socio-economic information, is available on ECHA's website.

Submit your comments by 8 April 2020 (23:59 Helsinki time).

More about the applications for authorisation process

The purpose of public consultations is to gather additional relevant and meaningful information on possible alternatives for the uses applied for. It offers the opportunity for public engagement in the regulatory process.

The information submitted will be taken into account in the development of the opinion for the relevant applications for authorisation by ECHA’s Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC).Each public consultation on alternatives lasts eight weeks.

About ECHA

ECHA is the driving force among regulatory authorities in implementing the EU's ground-breaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern.


Alternative should replace

4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated, used in the production of various medical devices (e.g. in vitro diagnostic kits / reagents) and medicinal / biopharmaceuticals (e.g. Active Pharmaceutical Ingredients).


European Chemicals Agency
Company
European Chemicals Agency
Contact
Adam Elwan

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