Safety assessment of the substance fatty acid-coated nano precipitated calcium carbonate for use in plastic food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance identified by the applicant as 'fatty acid-coated nano precipitated calcium carbonate'. It is intended to be used as a filler in all plastics at up to 5% for contact with acidic food and at up to 40% for contact with all other types of food. Articles made with the substance are intended for long-term storage over 6 months at room temperature and below. No information was provided on the mechanism of coating as to whether there is chemical modification of the surface and/or physical adsorption. The substance was not properly characterised, either as pristine material or when incorporated into plastic. Contrary to the non-coated material, data show that the coated material does not dissolve fully and quickly under pH conditions simulating gastrointestinal tract. Surface analysis with electron microscopy of low-density polyethylene (LDPE) samples before and after migration experiments showed major differences that indicate release of the substance from the surface after the tests with 3% acetic acid and to a lesser extent with 10% ethanol. This is consistent with measurable migrations that were up to 39 mg CaCO/kg when using an LDPE sample made with 5% of the substance in contact with acetic acid for 64 days at 40°C. The required data on the release of nanoparticles and on the potential toxicity of the substance in nanoform were not provided. Therefore, the Panel could not conclude on the safe use of the substance.