EFSA - European Food Safety Authority
EFSA - European Food Safety Authority
02/01/2023 | Press release | Distributed by Public on 02/01/2023 07:26
Safety assessment of ‘waxes, paraffinic, refined, derived from petroleum‐based or synthetic hydrocarbon feedstock, low viscosity’ for use in food contact materials
Metadata
EFSA Journal 2023;21(2):7761
DOI:
https://doi.org/10.2903/j.efsa.2023.7761
Keywords:
waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstock, low viscosity, FCM No. 93, food contact materials, safety assessment, evaluation
On request from:
Ministry of Health, Welfare and Sport, the Netherlands
Question Number:
EFSA‐Q‐2018‐00558
Contact:
fip[at] efsa.europa.eu
Panel members at the time of adoption
José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn.
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 (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.
Abstract
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the 'waxes, paraffinic, refined, derived from petroleum‐based or synthetic hydrocarbon feedstock, low viscosity' (FCM No. 93), for which the uses were requested to be extended for articles in contact with fatty foods. Migration from low‐density polyethylene samples containing 1% w/w of a representative wax was tested in food simulants. In fatty food simulants, the migration of mineral oil saturated hydrocarbons (MOSH) ≤ C35 was 142 mg/kg food, exceeding the overall migration limit for plastic FCM. Mineral oil aromatic hydrocarbons (MOAH) with at least two rings are largely removed during the manufacturing process. Based on various lines of evidence, the Panel concluded that any concern for the potential presence of MOAH with two or more conjugated aromatic rings can be ruled out. Based on the genotoxicity studies and on the content of polycyclic aromatic hydrocarbons (PAHs), the substance does not raise a concern for genotoxicity. Available toxicokinetic data showed a limited accumulation of MOSH. No adverse effects were observed up to the highest tested dose of 9 g/kg body weight per day in a 90‐day repeated oral toxicity study in Sprague-Dawley rats. The available results showed that FCM No. 93 is devoid of endocrine activity. The provided information on chronic toxicity and carcinogenicity was limited and inadequate to reach conclusions on these endpoints. Therefore, the CEP Panel concluded that under the intended and tested conditions of uses, the substance does not raise safety concern for the consumer if used to a level ensuring that its migration into food is no more than 5 mg/kg.
© European Food Safety Authority