Scientific Opinion on the safety and efficacy of sodium bisulphate (SBS) for all species as preservative and silage additive 1

EFSA Journal 2014;12(6):3731 SCIENTIFIC OPINION Scientific Opinion on the safety and efficacy of sodium bisulphate (SBS) for all species as preservative and silage additive 1 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3 ABSTRACT European Food Safety Authority (EFSA), Parma, Italy In 2011, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sodium bisulphate (SBS) for all species as a preservative and silage additive; for pets and other non-food-producing animals (non-food fur animals) as an acidity regulator; and for pets as a flavouring at a maximum recommended inclusion level for complete feed of 1 %. The Panel concluded that SBS is safe for all animal species at concentrations of 0.8 % in fresh forages for ensiling and for pets and other nonfood-producing animals at concentrations of 0.5 % complete feed. The efficacy of SBS as a silage additive could not be demonstrated. The applicant has provided complementary information on the safety and new arguments to support the efficacy of SBS. Based on newly submitted data, the maximum concentration of SBS in complete feed considered safe for chickens for fattening and piglets was 4 000 mg/kg complete feed. Considering also that 8 000 mg SBS/kg fresh ensiling forage is safe for dairy cows, the FEEDAP Panel concluded that 4 000 mg SBS/kg complete feed is safe for all animal species. The concentration of 20 000 mg SBS/kg complete feed recommended for pets and non-food-producing animals was considered safe for cats, with a margin of safety of at least 1.5. For minks, a concentration of 10 000 mg SBS/kg complete feed was considered safe. Since no new data have been presented to demonstrate the efficacy of SBS in improving silage production, the FEEDAP Panel confirmed its previous conclusions that SBS is not efficacious as a silage additive at the concentrations tested (0.4 % and 0.8 %). European Food Safety Authority, 2014 KEY WORDS technological additive, sodium bisulphate, SBS, safety, efficacy, silage additive 1 On request from the European Commission, Question No EFSA-Q-2013-00781, adopted on 22 May 2014. 2 Panel members: 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. Correspondence: FEEDAP@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Technological Additives, including Jurgen Gropp, Georges Bories, Carlo Nebbia and Anne-Katrine Lundebye, for the preparatory work on this scientific opinion. Suggested citation: EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2014. Scientific Opinion on the safety and efficacy of sodium bisulphate (SBS) for all species as preservative and silage additive. EFSA Journal 2014;12(6):3731, 10 pp. doi:10.2903/j.efsa.2014.3731 Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2014

SUMMARY In 2011, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sodium bisulphate (SBS) for all species as a preservative and silage additive; for pets and other non-food-producing animals (non-food fur animals) as an acidity regulator; and for pets as a flavouring. The applicant recommended use levels for SBS as a technological additive (functional group: preservative) of 0.5 to 3 %, as a silage additive of 0.1 to 0.8 %, as an acidity regulator for pets and non-food fur animals of 0.5 to 2.5 % and as a flavouring substance for pets of 0.15 to 1 %. The highest inclusion level recommended for complete feed was 1 %. The Panel has concluded that a concentration of 0.8 % SBS added to fresh ensiling forage is safe for all animal species, and a concentration of 0.5 % complete feed can be considered safe for pets and other non-food-producing animals. Owing to the lack of data, this conclusion could not be extended to food-producing animals. No convincing evidence on the safety of SBS as a preservative in all animal species at the recommended maximum concentration of 1 % in complete feed was provided. The efficacy of SBS as a silage additive could not be demonstrated by the studies provided by the applicant. The applicant has submitted new studies to support the safety of the additive for the target species and new argumentations to support the studies on the effects of SBS as a silage additive already considered in the previous assessment. The applicant proposes new maximum contents of 4 000 mg/kg complete feedingstuffs for food-producing animals and 20 000 mg/kg complete feedingstuffs for pets and nonfood-producing animals. Based on newly submitted data, the maximum concentration in complete feed recommended for foodproducing animals (4 000 mg SBS/kg complete feed) is considered safe for chickens for fattening and piglets. Considering also that 8 000 mg SBS/kg fresh ensiling forage is safe for dairy cows, the FEEDAP Panel concludes that 4 000 mg SBS/kg complete feed is safe for all animal species. The maximum concentration of 20 000 mg SBS/kg complete feed recommended for pets and nonfood-producing animals is considered safe for cats, with a margin of safety of at least 1.5. For minks, only about 10 000 mg SBS/kg complete feed is considered safe (corresponding to about 5 100 mg SBS/kg mink feed with a typical dry matter content of 45 %). Testing with higher doses (about 20 000 mg/kg complete feed and more) affected weight gain and significantly decreased the feed intake. No new data have been presented to demonstrate the efficacy of SBS in improving silage production, other than an expert report that did not lead the FEEDAP Panel to modify the conclusion expressed in its previous opinion, that is that SBS is not efficacious as a silage additive at the concentrations tested (0.4 % and 0.8 %). EFSA Journal 2014;12(6):3731 2

TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by the European Commission... 4 Terms of reference as provided by the European Commission... 4 Assessment... 5 1. Introduction... 5 2. Safety for the target species... 6 2.1. Chickens for fattening... 6 2.2. Weaned piglets... 6 2.3. Cats... 7 2.4. Minks... 8 2.5. Ruminants... 9 2.6. Conclusions on the safety for the target species... 9 3. Efficacy... 10 Conclusions... 10 Documentation provided to EFSA... 10 References... 10 EFSA Journal 2014;12(6):3731 3

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION Regulation (EC) No 1831/2003 4 establishes the rules governing the Community authorisation of additives for use in animal nutrition and in particular, Article 9 defines the terms of the authorisation by the Commission. The applicant, Grillo-Werke AG., 5 is seeking a Community authorisation of sodium bisulphate to be used as technological additive (Table 1). Table 1: Description of the substance Category of additive Technological additives Functional group of Preservative and silage additive additive Trade name - Description Sodium bisulphate Target animal category All animal species Applicant Grillo-Werke AG. Type of request Update opinion On 13 th October 2011, the Panel on Additives and Products or Substances used in Animal Feed of the European Food Safety Authority ( Authority ) published an opinion on the safety and efficacy of the product. The Panel was not able to conclude on the safety as preservative and the efficacy as silage additive of sodium bisulphate from the data provided by the applicant. The Commission gave the possibility to the applicant to submit complementary information to complete the assessment on safety and efficacy, to allow a revision of that opinion. The Commission has now received additional dossier on sodium bisulphate with supplementary information, concerning the safety as preservative and efficacy as silage additive. The Commission, in order to give the appropriate follow-up to the applications, asks the European Food Safety Authority to issue an updated opinion on the safety and the efficacy of the product under the terms of reference specified in the Annex. The data generated by the applicant and compiled in the above-mentioned supplementary reports have been sent directly to Authority by the applicant. 6 TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION In the view of the above, the Commission asks to the European Food Safety Authority to deliver an opinion on safety and efficacy of sodium bisulphate as technological additive submitted by Grillo- Werke AG. 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, 18.10.2003, p. 29. 5 Joint application of Grillo-Werke AG and Jones-Hamilton Co., represented in the EU by Grillo-Werke AG, Weseler Straße 1, 47169 Duisburg, Germany. 6 EFSA Dossier reference: FAD-2013-0024. EFSA Journal 2014;12(6):3731 4

ASSESSMENT 1. Introduction The additive sodium bisulphate (SBS) is currently authorised for use as a technological additive (functional group (j), acidity regulators) and as a sensory additive (functional group (b), flavouring compound) for pets and other non-food-producing animals, with a maximum content of 5 000 mg/kg complete feedingstuffs. 7 The additive SBS is also listed in the European Union Register of Feed Additives as a technological additive (functional group (k) silage additives). The European Food Safety Authority (EFSA) issued an opinion on the safety and efficacy of SBS for all species as a preservative and silage additive; for pets and other non-food-producing animals (nonfood fur animals) as an acidity regulator; and for pets as a flavouring (EFSA FEEDAP Panel, 2011). For all uses, no minimum and maximum doses were specified. The recommended use levels proposed by the applicant were 0.5 to 3 % as a preservative, 0.1 to 0.8 % as a silage additive, 0.5 to 2.5 % as an acidity regulator for pets and non-food fur animals and 0.15 to 1 % as a flavouring substance for pets. The highest inclusion level recommended for complete feed was 1 %. In its opinion (EFSA FEEDAP Panel, 2011), the FEEDAP Panel concluded that the additive is safe for the consumer, the user and the environment when used at the proposed maximum content of 1 % in complete feedingstuffs. No convincing evidence for the safety of SBS as a preservative in all animal species at the recommended maximum concentration of 1 % in complete feed was provided. A concentration of 0.8 % SBS added to fresh forages for ensiling was considered safe for all animal species, and a concentration of 0.5 % complete feed was considered safe for pets and other non-foodproducing animals. Owing to the lack of data, this conclusion could not be extended to food-producing animals. The additive was considered efficacious as a preservative, an acidity regulator and a flavouring compound. The efficacy of SBS as a silage additive could not be demonstrated based on the studies provided by the applicant. The applicant has submitted new studies to support the safety of the additive for the target species and new argumentations to support the studies on the effects of SBS as a silage additive already considered in the previous assessment. Moreover, the applicant is proposing new conditions of use, as follows. Sodium bisulphate is proposed to be used: - up to 4 000 mg/kg complete feed in food-producing animals (preservative and acidity regulator); - up to 8 000 mg/kg fresh forage as a silage additive for all animal species; - up to 20 000 mg/kg complete feed for pets and non-food-producing animals (acidity regulator, preservative and flavouring). In its previous assessment (EFSA FEEDAP Panel, 2011), the FEEDAP Panel assessed the safety for the consumer, user and environment. No changes in the product identity or manufacturing process that would lead to a revision of the previous conclusions were reported. Therefore, in the present opinion, the FEEDAP Panel has assessed only the safety of SBS for the target species and its efficacy as a silage additive. 7 Commission Implementing Regulation (EU) No 136/2012 of 16 February 2012 concerning the authorisation of sodium bisulphate as feed additive for pets and other non-food-producing animals. OJ L 46, 17.2.2012, p. 33. EFSA Journal 2014;12(6):3731 5

2. Safety for the target species 2.1. Chickens for fattening A total of 2 100 male and female one-day-old (Ross 308) chickens for fattening were divided into six groups (10 replicates per treatment (five male and five female pens), 35 broilers per replicate) and fed, for 35 days, mash diets (based on maize and soybean) supplemented with SBS at intended levels of 0, 4 000, 8 000, 12 000, 20 000 and 40 000 mg/kg complete feed (confirmed by analysis). 8 Zootechnical parameters (live weight, feed intake) were recorded per pen on days 0, 21 and 35; average daily gain and feed-to-gain ratio were calculated for each interval. At the end of the experimental period (day 35), blood samples were taken from one bird per replicate (10 per treatment) for routine haematology and clinical biochemistry. 9 Mortality was recorded. Dead and culled animals were subjected to necropsy. The results were analysed using analysis of variance (ANOVA) as the main statistical test; a Tukey test was used for treatment comparison. The pen was the basic experimental unit, except for blood parameters, in which the individual animal was the experimental unit. The main results are listed in Table 2. Table 2: Results of the tolerance study with sodium bisulphate (SBS) in chickens for fattening SBS intended (mg/kg feed) SBS analysed (mg/kg feed)* Final body weight (kg/pen) Average daily weight gain(kg/pen) Average daily feed intake (kg/pen) Feed-togain ratio 0 61.67 bc 1.76 cd 2.77 bc 1.58 a 4 000 4 005 66.43 c 1.90 d 2.99 c 1.58 a 8 000 7 935 65.88 c 1.86 cd 2.93 c 1.57 a 12 000 10 815 61.29 bc 1.73 bc 2.80 bc 1.62 ab 20 000 18 285 56.63 b 1.59 b 2.62 b 1.65 bc 40 000 35 720 45.95 a 1.29 a 2.20 a 1.71 c *Values reported are means of starter and grower feeds. a,b,c,d Values in the same column with different superscript are statistically different (P 0.05). No differences in mortality were observed between the treatments (average mortality 1 %). It should be noted that body weight gain in the tolerance study is low when compared with the Broiler Performance Objectives given by the breeder company for the Ross 308 broiler. A reduction in final body weight, average daily weight gain and feed-to-gain ratio in comparison with the control was observed at 20 000 mg/kg and above. However, a significant reduction in average daily weight gain was observed at 12 000 mg/kg in comparison with the recommended dose. None of the other endpoints, including haematological and biochemical parameters, showed treatment-related changes. Therefore, 4 000 mg SBS/kg complete feed is considered safe for chickens for fattening, with a margin of safety of approximately 2. 2.2. Weaned piglets A total of 128 male and female (Large White Landrace) three- to four-week-old piglets (average body weight 8 kg) were divided into four groups (eight replicates per treatment, four piglets (two males and two females) per replicate) and fed, for 42 days, pelleted diets (based on cooked wheat, porridge oats, full-fat soybean, whey powder and fish meal) supplemented with SBS, at intended levels of 0, 4 000, 8 000 and 12 000 mg SBS/kg complete feed (confirmed by analysis). 10 Zootechnical 8 Technical dossier/annex III_1_7. 9 Haematology: red blood cell, haemoglobin, packed cell volume, mean corpuscular volume, mean corpuscular haemoglobin concentration, heterophils, white blood cell, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Biochemistry: urea, creatinine, calcium, phosphorus, magnesium, glucose, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, triglycerides, cholesterol, uric acid acid. 10 Technical dossier/annex III_1_8. EFSA Journal 2014;12(6):3731 6

parameters (live weight, feed intake) were recorded per pen on days 0, 14 and 42; average daily gain and feed-to-gain ratio were calculated for each interval. At the end of the experimental period (day 42), blood samples were taken from one piglet per replicate and sex (16 per treatment) for routine haematology and clinical biochemistry. 11 The results were analysed using ANOVA as the main statistical test; a Tukey test was used for treatment comparison. The pen was the basic experimental unit, except for blood parameters, in which the individual animal was the experimental unit. The main results are listed in Table 3. Table 3: Results of the tolerance study with sodium bisulphate (SBS) in weaned piglets SBS intended (mg/kg feed) SBS analysed (mg/kg feed)* Average daily weight gain (kg/piglet) Average daily feed intake (kg/piglet) Feed-to-gain ratio 0 0.46 0.82 1.79 a 4 000 3 595 0.43 0.79 1.82 ab 8 000 6 600 0.42 0.78 1.84 ab 12 000 10 605 0.43 0.81 1.89 b *Values reported are means of prestarter and starter pelleted feeds. a,b Values in the same column with different superscript are statistically different (P 0.05). No mortality was observed during the experiment. No significant differences were found for total weight gain and feed intake between the groups. Significantly, more feed per kg gain was required in the group administered 12 000 mg SBS/kg feed than in the control group. None of the other endpoints, including haematological and biochemical parameters, showed treatment-related changes. It is therefore concluded that the recommended SBS concentration of 4 000 mg/kg complete feed is safe for piglets, with a margin of safety of approximately 2. 2.3. Cats A total of 30 male and female adult domestic cats were divided into three groups (10 replicates per treatment) and fed, for 28 days, diets (based on chicken by-product, maize, brewer s rice and chicken fat) supplemented with SBS, at intended levels of 0, 20 000 and 30 000 mg SBS/kg complete feed (confirmed by analysis), without balancing the diets for energy and sodium. 12 On days 0, 14 and 28, the cats were individually weighed and blood samples for routine haematology and clinical biochemistry were individually collected. 13 Feed intake and cat behaviour and health were recorded daily. On days 14 and 28, individual faecal samples were collected for the analysis of faecal moisture content and individual stools were scored. The results were analysed using ANOVA. The main results are listed in Table 4. 11 Haematology: red blood cell, haemoglobin, packed cell volume, mean corpuscular volume, platelet, white blood cell, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Biochemistry: urea, creatinine, sodium, potassium, glucose, total protein, albumin, total bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and creatine kinase. 12 Technical dossier/annex III_1_9. 13 Haematology: red blood cell, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, white blood cell, neutrophils, lymphocytes, monocytes and eosinophils. Biochemistry: urea nitrogen, creatinine, sodium, potassium, chloride, bicarbonate, calcium, phosphorus, glucose, total protein, albumin, total bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, triglycerides, cholesterol and gamma-glutamyltransferase. EFSA Journal 2014;12(6):3731 7

Table 4: Results of the tolerance study with sodium bisulphate (SBS) in cats Dietary SBS intended concentration (mg/kg feed) SBS analysed values (mg/kg feed) Initial body weight (kg/cat) Final body weight (kg/cat) Average daily feed intake (g/cat) Faecal moisture content (%) 0 4.51 4.48 47.5 70.31 20 000 16 450 4.52 4.51 44.3 69.99 30 000 25 090 4.11 3.96 47.5 68.90 No mortality or abnormal behaviour was observed during the experimental period. No treatmentrelated changes have been observed during the course of the study for body weight, daily feed intake or any of the other endpoints considered. The recommended dose of 20 000 mg SBS/kg complete feed is considered safe for cats, with a margin of safety of at least 1.5. 2.4. Minks In its previous opinion (EFSA FEEDAP Panel, 2011), the FEEDAP Panel, based on two studies on minks, concluded that 10 000 mg SBS/kg complete feed (5 000 mg/kg diet) is safe for minks. In the first study, 129 minks of four weeks of age received wet diets (dry matter (DM) content 47.4 %) with 9 300 mg SBS/kg diet or 9 300 mg phosphoric acid/kg diet, for 82 days. The SBS concentration corresponds to approximately 17 000 mg/kg standardised complete feed (DM content 88 %). A group of 41 females and 25 males was fed diets supplemented with SBS, while a group of 39 females and 24 males was fed diets supplemented with phosphoric acid. Weight gain was reduced from 121 g and 33 g in the control to 100 g and 10 g in the SBS-treated females and males, respectively. Faecal DM (n = 16/treatment) was significantly reduced by the SBS treatment (30.7 % vs. 25.4 %). In the second study, groups of 47 male kits (initial body weight 849 g) received wet diets (DM content 43.0 %) containing no acidity regulator, 5 000 mg SBS/kg diet and 2 000 mg ammonium chloride/kg diet. Study duration was somewhat longer than four months (until pelting). The SBS concentration corresponds to approximately 10 000 mg/kg standardised complete feed. Mortality was recorded and, in the control group, four animals died and, in the SBS group, two animals died. SBS lowered the ph value of feed consistently (three measurements), from 5.8 of the unsupplemented control feed to 5.3, and that of urine in most periods (monthly measurements). The average final body weight of all three groups was 2 607 g/mink without differences between the groups. In addition, pelt length and skin quality remained unaffected. To support the recommended maximum SBS concentration of 20 000 mg/kg wet diet, the applicant provided a new tolerance study, in which a total of 30 male adult minks were divided into three groups (10 replicates per treatment) and fed, for 28 days, fresh wet diets (based on cereals, chicken, liver, eggs and cheese) supplemented with SBS, at intended levels of 0, 20 000 and 30 000 mg SBS/kg fresh wet diet. 14 The three diets had an average DM content of 43.6, 43.8 and 45.8 %, respectively. Therefore, the intended SBS concentrations were 40 180 and 57 600 mg/kg complete feed (standardised DM content of 88 %). On days 0, 14 and 28, the minks were individually weighed. Blood samples for routine haematology and clinical biochemistry were individually collected on days 0 and 28. 15 Feed intake, mink health and behaviour and stool scores were recorded daily. On day 28, individual faecal samples from beneath the cages were collected for the analysis of faecal moisture content. The results were analysed using ANOVA as the main statistical test. The main results are listed in Table 5. 14 Technical dossier/annex III_1_10. 15 Haematology: red blood cell, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, cell haemoglobin concentration mean, red blood cell distribution width, haemoglobin distribution width, platelet, mean platelet volume, white blood cell, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Biochemistry: urea nitrogen, creatinine, sodium, potassium, chloride, total CO 2, anion gap, sodium/potassium ratio, osmolarity, calcium, phosphorus, magnesium, iron, glucose, total protein, albumin, globulin, total bilirubin, direct bilirubin, indirect bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, amylase, creatine kinase, triglycerides, cholesterol and bile acid. EFSA Journal 2014;12(6):3731 8

Table 5: Results of the tolerance study with sodium bisulphate (SBS) in minks Dietary SBS intended concentration (mg/kg wet diet) SBS analysed values (mg/kg wet diet) Initial body weight (kg/mink) Final body weight (kg/mink) Average daily feed intake (g/mink) Faecal moisture content (%) 0 1.92 1.92 208.7 b 70.95 a) 20 000 16 360 1.90 1.85 177.1 a 78.20 b 30 000 23 920 1.90 1.84 173.1 a 81.04 b a,b Values in the same column with different superscript are statistically different (P 0.05). The analysis of SBS in the diets showed concentrations of 16 360 and 23 920 mg SBS/kg diet (corresponding to approximately 33 000 and 46 000 mg/kg complete feed); these concentrations are somewhat lower than intended (20 000 and 30 000 mg SBS/kg diet (40 180 and 57 600 mg SBS/kg complete feed). No mortality or abnormal behaviour was observed during the experimental period. The groups receiving SBS showed a significant reduction in feed intake that was apparent even at the lowest dose tested. However, body weight was not significantly influenced. The control group maintained initial body weight (1.9 kg), whereas, within 28 days, animals in the groups receiving 20 000 and 30 000 mg SBS/kg lost an average of 50 and 70 g respectively. After 28 days, faecal moisture in the 20 000 mg SBS/kg diet group was significantly higher than in the control. All the other endpoints did not show differences related to the treatment. The newly submitted study does not support the safety of 40 000 mg SBS/kg complete feed (corresponding to about 20 000 mg SBS/kg wet diet). Therefore, the FEEDAP Panel confirms its previous conclusion that 10 000 mg SBS/kg complete feed (5 000 mg/kg wet diet) is safe for minks. A margin of safety could not be identified. 2.5. Ruminants In the previous opinion (EFSA FEEDAP Panel, 2011), based on a study of 40 dairy cows fed for 103 days a clover timothy silage treated with 0 mg or 8 000 mg SBS/kg fresh forage, the FEEDAP Panel concluded that 0.8 % SBS added to fresh ensiling forages is safe for dairy cows. Considering that under European feeding conditions in high-yielding cows silage contributes about half of the daily ration, the conclusion is approximately in line with the safe use of SBS in pets and other non-foodproducing animals. The conclusion on the safety of 0.8 % SBS as silage additive can be extended to all animal species. No new data have been provided by the applicant. 2.6. Conclusions on the safety for the target species The maximum concentration in complete feed recommended for food-producing animals (4 000 mg SBS/kg complete feed) is considered safe for chickens for fattening and piglets. Considering also that 8 000 mg SBS/kg fresh ensiling forage is safe for dairy cows, the FEEDAP Panel concludes that 4 000 mg SBS/kg complete feed is safe for all animal species. The maximum concentration of 20 000 mg SBS/kg complete feed recommended for pets and nonfood-producing animals is considered safe for cats, with a margin of safety of at least 1.5. However, the recommended dose of 20 000 mg SBS/kg could not be confirmed as safe for minks. Only about 10 000 mg SBS/kg complete feed is considered safe (corresponding to about 5 100 mg SBS/kg mink feed with a typical DM content of 45 %). EFSA Journal 2014;12(6):3731 9

3. Efficacy No new data have been presented to demonstrate the efficacy of SBS in improving silage production, other than an expert report that did not lead the FEEDAP Panel to modify the conclusion expressed in its previous opinion (EFSA FEEDAP Panel, 2011), that is that SBS is not efficacious as a silage additive at the concentrations tested (0.4 % and 0.8 %). CONCLUSIONS The FEEDAP Panel concludes, based on studies in chickens, piglets and dairy cows, that SBS is safe for all animal species at a level of 4 000 mg SBS/kg complete feed. The Panel also concludes that SBS is safe for cats at a level of 20 000 mg/kg complete feed, but is safe only at 10 000 mg/kg complete feed in minks. In the absence of new data, the FEEDAP Panel confirms its previous conclusion that SBS is not efficacious as a silage additive at the concentrations tested (0.4 % and 0.8 %). DOCUMENTATION PROVIDED TO EFSA 1. Supplementary information SBS (sodium bisulphate 1j514ii), technological/sensory (acidity regulator, preservative, silage additive, flavour) feed additive. May 2013. Submitted by Grillo- Werke AG. and Jones-Hamilton Co. 2. Supplementary information SBS (sodium bisulphate 1j514ii), technological/sensory (acidity regulator, preservative, silage additive, flavour) feed additive. Supplementary information. March 2014. Submitted by Grillo-Werke AG. and Jones-Hamilton Co. REFERENCES EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2011. Scientific Opinion on the safety and efficacy of sodium bisulphate (SBS) for all animal species as preservative and silage additive, for pets and other non food-producing animals (non-food fur animals) as acidity regulator and for pets as flavouring. EFSA Journal 2011;9(11):2415, 16 pp. doi:10.2903/j.efsa.2011.2415 EFSA Journal 2014;12(6):3731 10