CEF clears BASF FCM safety evaluation request

By Joseph James Whitworth contact

- Last updated on GMT

The opinion was republished after amendments from a version earlier this year
The opinion was republished after amendments from a version earlier this year

Related tags: Food contact materials, Food safety, European food safety authority

A panel of the European Food Safety Authority (EFSA) has given the all-clear after BASF requested the safety of a food contact material (FCM).

The panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) said adipic acid dihydrazide is not of safety concern but migration should not exceed 0.050 mg/kg food​.

It is for use as a crosslinker for acrylic polymer with keto side groups for non-self-supporting coatings on polyolefins and adhesives in laminates made from plastics.

The coating is not for direct food contact but used in inner layers of plastics laminates used for foodstuffs at all time-temperature conditions applicable according to the laminate’s properties.

The substance has not previously been evaluated by the Scientific Committee on Food (SCF) or EFSA.

EFSA received an application from the Bundesamt für Verbraucherschutz und ebensmittelsicherheit, Germany on a dossier submitted by BASF.

It is highly hydrophilic and largely soluble in water and acetic acid. It is thermostable up to 200 °C which is higher than the maximum process temperature.

Migration conditions

Specific migration was measured from a coated low-density polyethylene (LDPE) film with a thickness of 0.16mm with the non-coated LDPE side in contact with the food simulants 3% acetic acid, 10% ethanol, 95% ethanol for 10 days at 40°C and isooctane for 2 days at 20°C.

The substance is not stable in 95% ethanol, under the migration test conditions due to the reaction with traces of aldehydes.

However, due to the high hydrophilic character, the specific migration values in 10% ethanol and 3% acetic acid can be considered to represent a realistic migration value.

Under these conditions the substance was not detectable in any of the food simulants at a limit of 0.019 mg/kg food simulant.

The substance could not be detected at a limit of 0.025 mg/g coated LDPE film. This supports that it has fully reacted and it is not detected in specific migration test, said the scientific opinion.

Overall migration into 95% ethanol and isooctane was measured against a blank LDPE sample which was not coated on the non-contact side.

No significant differences between the test samples and the blank were found for any of the tested simulants, which means the coating layer did not influence the overall migration value. 

To verify no oligomers or other reaction products penetrated the LDPE layer and migrated into food, LC-MS analysis was performed on the iso-octane overall migration solution. No additional oligomers compared to the blank LDPE were detected. 

This can be explained by the coating consisting of a crosslinked acrylic polymer which is expected to contain only little or no LMWF oligomers, said the panel. 

Related topics: Food Safety & Quality

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