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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

EFSA Journal 2011;9(12):2441[13 pp.]. doi:10.2903/j.efsa.2011.2441
  EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel Members Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Reinhard Kroker, Lubomir Leng, Secundino López Puente, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf Acknowledgment The Panel wishes to thank the members of the Working Group on Feed Flavourings including Paul Brantom, Joaquim Brufau, Gérard Pascal and Guido Rychen for the preparatory work on this scientific opinion. Contact FEEDAP@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2010-00990 Adopted: 15 November 2011 Published: 02 December 2011 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

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.

© European Food Safety Authority,2011

Summary

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of methyl anthranilate and methyl-N-methylanthranilate when used as flavour compounds for all animal species. Both compounds belonging to chemical group 27 are currently authorised for use as flavours in food, and are naturally found in various fruits and essential oil plants.

Because of the neurotoxic effects in birds, the use of methyl anthranilate and methyl-N-methylanthranilate as a flavour in avian species is contra-indicated.

A calculation based on the lowest NOAEL for each compound showed that the applicant’s proposed use levels of 5 to 25 mg methylanthranilate/kg complete feed are safe in the remaining 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 animal species other than avian species is 4 mg/kg complete feed.

Considering the absent or very low margin of safety, (i) the simultaneous administration of either substance in feed and water for drinking, and (ii) 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 FEEDAP Panel considers that 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.

Keywords

Sensory additives, flavourings, anthranilate derivatives, chemical group 27, methyl anthranilate, methyl-N-methylanthranilate