Polymer production aid for fluoropolymers poses no safety concern, says EFSA

EFSA published a scientific opinion on the risks originating from the migration into food of the substance 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether.

The panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) found there are no safety concerns as long as it is only used as a polymer production aid (PPA) in the polymerisation of fluoropolymers under certain conditions.

However, the watchdog told the European Commission that the substance is a polyfluoro compound, a class of persistent, widespread environmental pollutants.

The panel received the application from Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany following a corresponding application submitted on behalf of DYNEON GMBH, from the same country.

Chemical use​

A safety evaluation was requested for use as a PPA for manufacturing sintered and non-sintered (processed) fluoropolymers.

The sintered fluoropolymers are used to produce non-stick coatings and kitchen utensils like pans and other articles that come into contact with foodstuffs for repeated use.

Solid non-sintered fluoropolymers are used to produce items like films, bags, tubing, gaskets, seals, pipes, conveyor belts, liners, plates and sheets.

Films may be used to wrap meat, cheese or vegetables or for food heating in the microwave, bags for storing food in the deep freezer and sheets may be used in contact with butter, cheese and milk.

Potential migration​

This was the first time EFSA or SCF has evaluated the substance and specific migration was not tested but worst case and modelled migrations were calculated based on the residual content determined in fluoropolymers after sintering and processing (non-sintered).

Worst case migration was calculated to be 13 μg/kg food and up to 3.4 μg/kg food respectively.

It was concluded that the substance is non-genotoxic.

EFSA said the conditions of use would lead to negligible migration of perfluorinated compounds with conservative assumptions of exposure of less than 1 μg/person/day estimated.

The panel concluded that there is no safety concern if the substance is only used as a polymer production aid in the polymerisation of fluoropolymers intended for:

• repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360°C for at least 10 minutes or at higher temperatures for equivalent shorter times,
• repeated use materials and articles only when processed (non-sintered) at temperatures from 300°C and up to 360°C for at least 10 minutes.

 The full opinion can be read HERE​