SCIENTIFIC OPINION. EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3

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1 EFSA Journal 2012;10(5):2681 SCIENTIFIC OPINION Scientific Opinion on safety and efficacy of sodium benzoate, propionic acid and sodium propionate for pigs, poultry, bovines, sheep, goats, rabbits, horses 1 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3 ABSTRACT European Food Safety Authority (EFSA), Parma, Italy The feed additive is a mixture of sodium benzoate 140 g/kg, propionic acid 370 g/kg and sodium propionate 110 g/kg and is intended to be used as a preservative for cereals high with a high moisture content. The applicant has now resubmitted the studies already considered, seeking a reassessment of the data on efficacy for all cereals with a broad range of moisture content. The FEEDAP Panel concluded, on the basis of the evidence provided, that the additive is efficacious in preserving high-moisture grains other than maize kernels at a minimum dose of mg/kg cereal and maize kernels at a minimum dose of mg/kg. For complete feed containing cereals with a moisture content greater than 12 %, the minimum effective dose is mg/kg. The Panel also considered that the currently authorised maximum concentration for cereal grain of mg/kg (equivalent to mg/kg complete feed) should be retained for all cereals to preserve target animal safety. The FEEDAP Panel recognised that the effective dose of the additive depends largely on the initial moisture content of the cereal at harvest, the form (whole grain vs. ground) and the intended storage period. For this reason, the actual effective dose may lie between the minimum and maximum concentration authorised under present legislation. European Food Safety Authority, 2012 KEY WORDS Technological additive, preservative, sodium benzoate, propionic acid, sodium propionate, efficacy, highmoisture cereals 1 On request from the European Commission, Question No EFSA-Q , adopted on 24 April 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. Correspondence: FEEDAP@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Organic Acids, including Atte von Wright and Pieter Wester, for the preparatory work on this scientific opinion. Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific Opinion on safety and efficacy of sodium benzoate, propionic acid and sodium propionate for pigs, poultry, bovines, sheep, goats, rabbits, horses. EFSA Journal 2012;10(5):2681. [7 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2012

2 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 an opinion on the efficacy of a feed additive, containing sodium benzoate 140 g/kg, propionic acid 370 g/kg and sodium propionate 110 g/kg, intended to be used as a preservative for cereals with a high moisture content. The applicant has now resubmitted the studies already considered, seeking a reassessment of the data on efficacy for all cereals with a broad range of moisture content. The FEEDAP Panel concluded, on the basis of the evidence provided, that the additive is efficacious in preserving high-moisture grains other than maize kernels at a minimum dose of mg/kg cereal and maize kernels at a minimum dose of mg/kg. For complete feed containing cereals with a moisture content greater than 12 %, the minimum effective dose is mg/kg. The Panel also considered that the currently authorised maximum concentration for cereal grain of mg/kg (equivalent to mg/kg complete feed) should be retained for all cereals to preserve target animal safety. The FEEDAP Panel recognised that the effective dose of the additive depends largely on the initial moisture content of the cereal at harvest, the form (whole grain vs ground) and the intended storage period. For this reason, the actual effective dose may lie between the minimum and maximum concentration authorised under present legislation. EFSA Journal 2012;10(5):2681 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background... 4 Terms of reference... 4 Assessment Introduction Efficacy... 5 Conclusions and recommendations... 6 Documentation provided to EFSA... 6 References... 6 EFSA Journal 2012;10(5):2681 3

4 BACKGROUND Regulation (EC) No 1831/ establishes the rules governing the Community authorisation of additives for use in animal nutrition and in particular defines the conditions that a substance/product should meet to be granted the authorisation. The European Commission received from the company ADDCON EUROPE GmbH an application requesting the authorisation/re-evaluation of the product sodium benzoate 140 g/kg, propionic acid 370 g/kg, sodium propionate 110 g/kg, when used as a feed additive for pigs, bovines, poultry, sheep, goats, rabbits, horses (category: technological additive; functional group: preservative). The European Food Safety Authority (EFSA) in its opinion adopted on 6 September 2011 (Scientific Opinion on the safety and efficacy of sodium benzoate, propionic acid and sodium propionate for pigs, poultry, bovines, sheep, goats, rabbits, horses), concluded that the additive is effective in the preservation of high moisture cereals at a minimum application rate of mg/kg, as evidenced by the data on maize (moisture content > 38.3 %), but was not able to give a conclusive opinion on the efficacy of the additive as preservative for high moisture cereals (other than maize) due to the lack of data provided by the company. Therefore, the Commission gave the possibility to the company to submit complementary information to complete the assessment. The Commission has now received a supplementary dossier from the applicant ADDCON Europe GmbH containing data on the efficacy of sodium benzoate 140 g/kg, propionic acid 370 g/kg, sodium propionate 110 g/kg as preservative for high moisture cereals when used as feed additive under requested conditions. TERMS OF REFERENCE In view of the above, the Commission asks to the European Food Safety Authority (EFSA) to deliver an opinion on the efficacy of sodium benzoate 140 g/kg, propionic acid 370 g/kg, sodium propionate 110 g/kg as preservative for high moisture cereals when used as feed additive under requested conditions. 4 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. OJ L 268, , p. 29. EFSA Journal 2012;10(5):2681 4

5 ASSESSMENT 1. Introduction The product is a feed additive (category: technological additive; functional group: preservative) consisting of a mixture of sodium benzoate, propionic acid and sodium propionate. This product is authorised for the preservation of cereals with a moisture content of more than 15 %, at an inclusion rate of mg/kg cereal, for use as feed for pigs and dairy cows 5 and cattle for fattening. 6 The Scientific Committee on Animal Nutrition (SCAN) issued an opinion on the additive Kofa Grain ph5 (a trade name used to describe the mixture under consideration) for pigs, cattle for fattening and dairy cows (EC, 2002). SCAN concluded that the product had been shown to be efficacious for the preservation of cereal grains (wheat, barley, rye) other than maize when used under the conditions described by the applicant (intended dose range for the preservation of cereal grains: mg/kg, depending on the moisture content of the grain at harvest and intended period of storage). However, insufficient data were presented to determine whether the product is equally efficacious when applied to maize kernels with moisture contents higher than that usually found in the other cereal grains examined. The European Food Safety Authority (EFSA) subsequently issued an opinion on the safety and efficacy of Kofa Grain ph5 as a feed additive for cattle for fattening (EFSA, 2006). Based on a laboratory study 7 and a farm survey 8 the FEEDAP Panel concluded that the efficacy of Kofa Grain has been demonstrated through preventing fungal growth in maize kernels with high moisture content (> 30 %) at mg Kofa Grain/kg for one month of storage and at mg/kg for up to 11 months in storage. EFSA issued an opinion on the safety and efficacy of sodium benzoate, propionic acid and sodium propionate for pigs, poultry, bovines, sheep, goats, rabbits and horses (EFSA, 2011), concluding that the additive is effective in the preservation of high-moisture cereals at a minimum application rate of mg/kg, as evidenced by the data on maize (moisture content > 38.3 %). No data on other cereals were presented. The FEEDAP Panel had reservations about the effectiveness of the product as a preservative in complete feedstuffs with a typical moisture content of 12 %. However, it was recognised that under practical storage conditions the moisture content of all or part of the feed may rise above that level. Under these circumstances, the data presented indicated that the additive would be effective in preventing deterioration at concentrations between and mg/kg complete feed The applicant has now resubmitted the studies already considered in the previous assessments, including those assessed by SCAN, seeking a reassessment of the data on efficacy for all cereals with a broad range of moisture content. 2. Efficacy After reviewing (i) a series of three laboratory tests with spring barley and three with winter wheat with moisture content adjusted to 17.5 %, 20.0 % 22.5 % and 25.0 %, a dose range of mg/kg storage duration of 12 months, and (ii) a series of five laboratory tests with wheat and barley with a moisture content range of %, a dose range of mg/kg and a storage duration range of weeks, the FEEDAP Panel confirmed the conclusions reached by SCAN that the product is efficacious at a minimum dose of mg/kg in cereals other than maize kernels. 5 Commission Regulation (EC) No 1876/2006 of 18 December 2006 concerning the provisional and permanent authorisation of certain additives in feedingstuffs. OJ L 360, , p Commission Regulation (EC) No 757/2007 of 29 June 2007 concerning the permanent authorisation of certain additives in feedingstuffs OJ L 172, , p Technical dossier/annex C. 8 Technical dossier/annex B. EFSA Journal 2012;10(5):2681 5

6 Based on a laboratory study already assessed in 2011, the FEEDAP Panel concluded that the effective dose for the preservation of maize kernels is mg/kg maize. No new data on maize kernels have been submitted by the applicant. A field study summarising data from a farm survey (26 farms) monitored the mycological quality of a range of cereals (whole or ground grain) for a period up to 11 months. 9 The study confirmed the potential of Kofa Grain to stabilise the mycological quality of barley, wheat and triticale at a dose range of mg/kg and of maize kernels at a dose range of mg/kg. The applicant did not provide any new data on the efficacy of the additive in preserving complete feedingstuffs. The FEEDAP Panel reiterates its reservations about the effectiveness of the product as a preservative for complete feedingstuffs with a typical moisture content of 12 %. Based on the data previously submitted (see EFSA, 2011) for complete feed with a higher moisture content, the effective dose range is mg/kg. CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The FEEDAP Panel summarises earlier and current conclusions. The additive is efficacious in preserving: grains with a high moisture content, other than maize kernels, at a minimum dose of mg/kg cereals maize kernels with a high moisture content at a minimum dose of mg/kg maize complete feed with a moisture content greater than 12 % at a minimum dose of mg/kg complete feed. The FEEDAP Panel recognises that the effective dose of the additive depends largely on the initial moisture content of the cereal at harvest, the form (whole grain vs. ground) and the intended storage period. The maximum safe concentrations are mg/kg cereal grain and mg/kg complete feedstuff. RECOMMENDATIONS The minimum moisture content for cereals, as specified in the Commission Regulation (EC) No 1876/2006, should be retained. DOCUMENTATION PROVIDED TO EFSA 1. Sodium benzoate, propionic acid and sodium propionate as technological additive for pigs,. March Submitted by ADDCON EUROPE GmbH. REFERENCES EC (European Commission), 2002, online. Opinion of the Scientific Committee for Animal Nutrition on the use of Kofa Grain ph5 (a mixture of sodium benzoate, propionic acid and sodium propionate) in feedingstuffs for pigs, cattle for fattening and dairy cows. Available from: 9 Technical dossier/annex B. EFSA Journal 2012;10(5):2681 6

7 EFSA (European Food Safety Authority), Opinion of the Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of Kofa Grain ph 5 (a mixture of sodium benzoate, propionic acid and sodium propionate as a feed additive for cattle for fattening. EFSA Journal 408, EFSA (European Food Safety Authority), Scientific opinion on safety and efficacy of sodium benzoate, propionic acid and sodium propionate for pigs, poultry, bovines, sheep, goats, rabbits, horses. EFSA Journal 9, EFSA Journal 2012;10(5):2681 7