The scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) focussed on furan-2,5-dicarboxylic acid (FDCA).
FDCA is a monomer intended to manufacture PEF polymers with ethylene glycol as co-monomer.
Avantium’s partners include The Coca-Cola Company, Danone and ALPLA.
EFSA opinion before EU Commission decision
Before a substance is authorised to be used in food contact materials and is included in a positive list, EFSA's scientific opinion on its safety is required. The European Commission will base their final decision on this.
CEF received a request from the UK Food Standards Agency to assess FDCA following an application from YXY Technologies, The Netherlands.
Nathan Kemeling, director business development at YXY, told FoodProductionDaily.com that it was a very important milestone for the firm and its partners as it was an open question which they needed to answer.
“This supports our EU situation to drive further in commercialisation and it was a box that needed to be checked. Next steps include building a 50 kilotonne PEF plant and the plan is three years from now for mass production,” he said.
“We are doing a lot of work on technical elements such as food contact, regulatory aspects, REACH register application, recycling status and specific applications with partners on products to be used in the commercial launch.
“The scientific opinion of EFSA is the mid-way point in the approval in the EU and it validated our assumptions.”
Avantium said it has delayed its submission to the US Food and Drug Administration (FDA) until 2016 as the agency also requires polymer data, unlike EFSA which is focussed on monomer data, so the firm will file it closer to the date they have the final polymerisation recipe of PEF.
PEF to replace PET
YXY Technologies said its main building block (FDCA) can replace terephthalic acid (TA), a petroleum-based monomer that is used to produce polyethylene terephthalate (PET).
PEF is a biobased polymer developed in 2005 targeted at replacing PET.
PEF has higher mechanical strength permitting lightweighting, improved barrier properties (10 times for oxygen; 4x improved for CO2 and 2x for water) compared to PET, according to the firm.
The PEF polyester will be used with all types of foodstuffs and storage under any condition of time and temperature.
Ate Duursma, team leader for the application development team, told us that the application was filed with the UK FSA as it was the fastest way.
“The UK agency was the fastest way to forward this, we submitted the petition we prepared with (law firm) Keller & Heckman. It is the scientific opinion that the EU Commission will use to base the final approval on,” he said.
“Our view is that it was a normal process, two years of preparation and the result was EFSA got extensive data to base its scientific opinion on.
“The EU Commission will make the final decision in the course of 2015 when its updates it plastics regulation.”
In an interview last year, Kemeling told us that food contact is one of the critical parameters for Coca-Cola on soft drinks, Danone in bottled water and ALPLA on sauces and solid foods.
Migration and assessment
CEF estimated specific migration based on an assumption of 100% mass transfer of the residual content of FDCA in PEF and this provided an estimate of 0.12 mg/kg food.
Overall migration was performed with 3% acetic acid, 10, 20, 50 and 95% ethanol and iso-octane food simulants for 10 days at 60 °C.
All results were below the limit of detection of 6 mg/kg food.
The CEF panel concluded that FDCA does not raise a safety concern when it is used as a monomer in the production of PEF and its migration does not exceed 5 mg/kg food and migration of the oligomers less than 1000 Da does not exceed 50 μg/kg food (expressed as FDCA).
The potential formation of furan was considered as unlikely due to the high thermostability of the substance (FDCA sublimates at greater than 320 °C).
Even if traces of furan were formed, it would be efficiently removed during the thermoprocessing of the polymer due to its low boiling point (32 °C).