Safety assessment of the substance (triethanolamine‐perchlorate, sodium salt) dimer, for use in food contact materials
Competing interests: R. Franz declared that Fraunhofer institute at which he was employed provides advisory services to private business operators active in the sector on food contact materials. In line with EFSA's Policy on Independence (http://www.efsa.europa.eu/sites/default/files/corporate_publications/fil...) and the Decision of the Executive Director on Competing Interest Management (http://www.efsa.europa.eu/sites/default/files/corporate_publications/fil...), a waiver was granted to R. Franz regarding his participation to the EFSA's Working Group on Food Contact Materials (FCM WG) 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 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.
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance (triethanolamine‐perchlorate, sodium salt) dimer, FCM substance No 1080, intended to be used as a thermal stabiliser at up to 0.15% w/w in rigid poly(vinyl chloride) (PVC) for repeated use bottles in contact with water. No thermal degradation of the substance is expected during the manufacture of the PVC articles. In water, the substance fully dissociates into triethanolamine, sodium (cations) and perchlorate. Therefore, migration would lead to exposure to triethanolamine and perchlorate and not to the substance itself. Specific migration of perchlorate, ethanolamine, diethanolamine and triethanolamine was tested under repeated use conditions covering the requested uses. After the second and third contacts, perchlorate was detected at ca. 0.3 μg/kg food. Ethanolamine, diethanolamine and triethanolamine were not detected in any of the three contacts at an estimated limit of detection of 0.03 mg/kg food. The available in vitro studies on the substance confirmed the lack of concern for genotoxicity, as anticipated by the dissociation of the substance into authorised non‐genotoxic substances. Therefore, the CEP Panel concluded that the substance is not of safety concern for the consumer if used, under the condition requested by the applicant, as an additive at up to 0.15% w/w in rigid PVC for repeated use bottles intended for contact with water. Additionally, the migration of triethanolamine and perchlorate should not exceed the specific migration limits (SMLs) of 50 μg/kg food and 2 μg/kg food, respectively, set in the Regulation (EU) 10/2011. This evaluation also covers acidic foods such as fruit juices that can reasonably be foreseen to be in contact.