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Scientific Opinion on the safety and efficacy of anthranilate derivatives (chemical group 27) when used as flavourings for all animal species

The chemical group 27 defined as ‘anthranilate derivatives’ consists of two flavouring substances: methyl anthranilate and methyl-N-methylanthranilate. Both compounds are currently authorised for use as flavours in food, and are naturally found in various fruits and plants. The use of methyl anthranilate and methyl-N-methylanthranilate in avian species was found contra-indicated. The applicant’s proposed use levels of 5 to 25 mg methylanthranilate/kg complete feed are safe in the other species with a margin of safety up to three. For methyl-N-methylanthranilate, the proposed upper use level of 5 mg/kg feed is not safe for piglets, therefore the highest feed concentration safe for all animals species other than avian species is 4 mg/kg complete feed. Considering the absent or very low margin of safety, the simultaneous administration of either substance in feed and water for drinking, and the simultaneous use of both compounds are not considered safe without a proportional reduction in their concentration. No residues of safety concern derived from methylanthranilic acid and methyl-N-methylanthranilic are to be expected in animal tissues or products. Consequently, the use of these two compounds in animal nutrition would not increase consumer exposure resulting from natural occurrence and food use. No data relevant to an assessment of user safety was made available. The applicant considers that both substances are irritants to the respiratory system, the eyes and the skin. The use of the anthranilate derivatives in animal nutrition is not expected to have a significant impact on the environment. Since the function of both compounds in feed is essentially the same as that in food, no further demonstration of efficacy is considered necessary.

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