Scientific Opinion on the safety and efficacy of aliphatic and aromatic hydrocarbons (chemical group 31) when used as flavourings for all animal species

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Article
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal
EFSA Journal 2015;13(3):4053 [22 pp.].
doi
10.2903/j.efsa.2015.4053
Panel members at the time of adoption
Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Feed Flavourings, including Paul Brantom, Andrew Chesson and Anne-Katrine Lundebye, for the preparatory work on this scientific opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2010-00816
Adopted
10 March 2015
Published
31 March 2015
Last Updated
20 July 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Chemical group 31 consists of aliphatic and aromatic hydrocarbons, of which 17 are currently authorised for use as flavours in food. This opinion concerns nine compounds from this group. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is unable to perform an assessment of 1,4(8),12-bisabolatriene [01.016] due to the lack of data on its purity. The Panel concludes that d-limonene [01.045] is safe for all animal species, except for male rats, at the proposed maximum dose level (25 mg/kg feed). 1-Isopropyl-4-methylbenzene [01.002] is safe for all target species, except cats, at the proposed maximum dose level (25 mg/kg feed), with a margin of safety ranging from 1-fold (no margin of safety) to 3.2-fold. For cats the calculated maximum safe concentration is 14 mg/kg complete feed. For the compounds belonging to Cramer Class I, terpinolene [01.005], alpha-phellandrene [01.006], 1-isopropenyl-4-methylbenzene [01.010], alpha-terpinene [01.019], gamma-terpinene [01.020] and l-limonene [01.046], the calculated safe use level is 1.5 mg/kg complete feed for cattle, salmonids and non-food-producing animals and 1 mg/kg complete feed for pigs and poultry. The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of these substances. Overall, the FEEDAP Panel is not in the position to conclude on the use of these additives in water for drinking. No safety concern would arise for the consumer from the use of these compounds up to the highest safe levels in feeds. All compounds should be considered irritant to skin, eyes and respiratory tract and as skin sensitisers. No risk for the safety for the environment is foreseen. Since all of the compounds under assessment are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

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 17 compounds (aliphatic and aromatic hydrocarbons belonging to chemical group 31) when used as flavourings for all animal species. All additives are currently authorised for use as flavours in food and all have been detected in plant materials, fruits and processed foods; however, reports of their distribution vary greatly. The current application has been divided during the course of the assessment, and the present opinion concerns only nine of the compounds, namely 1-isopropyl-4-methylbenzene [01.002], terpinolene [01.005], alpha-phellandrene [01.006], 1-isopropenyl-4-methylbenzene [01.010], 1,4(8),12-bisabolatriene [01.016], alpha-terpinene [01.019], gamma-terpinene [01.020], d-limonene [01.045] and l-limonene [01.046]. The remaining eight compounds are currently under assessment by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) in a separate opinion.

The FEEDAP Panel is unable to perform an assessment of 1,4(8),12-bisabolatriene [01.016] due to the lack of data on its purity. The Panel concludes that d-limonene [01.045] is safe for all animal species, except for male rats, at the proposed maximum dose level (25 mg/kg feed). 1-Isopropyl-4-methylbenzene [01.002] is safe for all target species, except cats, at the proposed maximum dose level (25 mg/kg feed), with a margin of safety ranging from 1-fold (no margin of safety) to 3.2-fold. For cats the calculated maximum safe concentration is 14 mg/kg complete feed. For the compounds belonging to Cramer Class I, terpinolene [01.005], alpha-phellandrene [01.006], 1-isopropenyl-4-methylbenzene [01.010], alpha-terpinene [01.019], gamma-terpinene [01.020] and l-limonene [01.046], the calculated safe use level is 1.5 mg/kg complete feed for cattle, salmonids and non-food-producing animals and 1 mg/kg complete feed for pigs and poultry. The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of these substances. Overall, the FEEDAP Panel is not in the position to conclude on the use of these additives in water for drinking.

No safety concern would arise for the consumer from the use of these compounds up to the highest safe levels in feeds.

All compounds should be considered irritant to skin, eyes and respiratory tract and as skin sensitisers.

No risk for the safety for the environment is foreseen.

Since all of the compounds under assessment are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

Keywords
sensory additives, aliphatic and aromatic hydrocarbons, chemical group 31
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Number of Pages
22