February 1, 2023
The assessment report for this studies are mentioned below.
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. During the manufacturing process, mineral oil aromatic hydrocarbons (MOAH) with at least two rings are largely removed.
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 use, the substance does not raise a safety concern for the consumer if used to a level ensuring that its migration into food is no more than 5 mg/kg.
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