EFSA said the petitioner, Evonik Industries, had requested the authorisation for basic methacrylate copolymer under Directive 95/2/EC of the European Parliament and of the Council on food additives other than colours and sweeteners.
Glazing agents are a functional class of food additives which are regulated under this regulation.
According to the applicant the substance is to be used to provide moisture protection and to mask the taste of various nutrients. And Evonik added in its submission that BMC is a fully polymerised cationic copolymer based on dimethylaminoethyl methacrylate and neutral methacrylic esters.
The Panel on Food Additives and Nutrient Sources added to Food, in its scientific opinion, said that BMC does not raise concern with respect to genotoxicity. It noted that no studies on reproductive toxicity were available and that the database on developmental toxicity was limited, and thus the Panel said it was unable to derive an ADI for BMC.
According to the Panel's opinion, basic methacrylate copolymer is virtually not absorbed from the gastrointestinal tract after oral administration, which is in keeping with the fact that it is a stable high-molecular compound.
The Panel estimated the combined exposure for heavy users to BMC with a normal maximum coating level of 30 mg/tablet, from both its proposed use in food supplements and from its approved use in pharmaceuticals to 7 mg/kg bw/day for a 60 kg adult and to 4.8 mg/kg bw/day for a child.
It added that the respective estimates by the petitioner, in its submission, for these user groups were 6 mg/kg bw/day and 4.8 mg/kg bw/day.
EFSA stated that the NOAELs derived from the available studies are 1000 mg/kg bw/day from a developmental study in the rat (the only dose level tested) and 2000 mg/kg bw/day from a 26-week feeding study in the rat (highest dose tested).
“Using this range of NOAELs and assuming a coating level of 100 mg/tablet and a combined exposure from food supplements and pharmaceuticals, the Panel calculates a margin of safety (MOS) for heavy users varying from at least 43 to 85 for adults and from 63 to 125 for children,” it continued.
Furthermore, states the opinion, if only the exposure from food supplements is considered the MOS ranges from 85 to 171 for adults and from 125 to 250 for children: “In the light of the high molecular weight of the substance, its lack of absorption and its low toxicity profile, the Panel considers these margins of safety adequate.”