Safety assessment of the substance fatty acid‐coated nano precipitated calcium carbonate for use in plastic food contact materials
Meta data
Competing interests: R. Franz declared that Fraunhofer institute at which he is employed provides advisory services to private business operators active in the sector on food contact materials. In line with EFSA’s Policy on Independence (https://www.efsa.europa.eu/sites/default/files/corporate_publications/f…) and the Decision of the Executive Director on Competing Interest Management (https://www.efsa.europa.eu/sites/default/files/corporate_publications/f…), a waiver was granted to R. Franz regarding his participation to the EFSA’s Working Group on Food Contact Materials (FCMWG) in accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management. Pursuant to Article 21(6) of the above‐mentioned Decision, the involvement of R. Franz is authorised as a member in the FCM WG, allowing him to take part in the discussions and in the drafting phase of the scientific output, but he is not allowed to be, or act as, a chairman, a vice‐chairman or rapporteur of the working group.
Note: The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. The following information have been provided under confidentiality and they are redacted awaiting the decision of the Commission: the manufacturing details, the identities and levels of impurities and some of the information on the particle and agglomerate sizes.
Legal notice: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission).
Abstract
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 CaCO3/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.