10 Questions You Should to Know about Potassium diformate in livestock nutrition

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Mar. 10, 2025

Chemicals

Safety and efficacy of an additive consisting of potassium diformate ...

. Jun 3;19(6):e. doi: 10./j.efsa..

Safety and efficacy of an additive consisting of potassium diformate (Formi&#; LHS) for piglets (weaned) and pigs for fattening (Addcon GmbH)

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)&#;, Vasileios Bampidis

Vasileios Bampidis

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Giovanna Azimonti

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Maria de Lourdes Bastos

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Henrik Christensen

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Birgit Dusemund

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Mojca Fašmon Durjava

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Maryline Kouba

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Marta López&#;Alonso

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Secundino López Puente

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Francesca Marcon

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Baltasar Mayo

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Alena Pechová

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Mariana Petkova

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Fernando Ramos

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Yolanda Sanz

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Roberto Edoardo Villa

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Ruud Woutersen

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Rosella Brozzi

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Jaume Galobart

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Lucilla Gregoretti

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Gloria López&#;Gálvez

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Maria Vittoria Vettori

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Matteo Lorenzo Innocenti

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Collection date Jun.

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Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium diformate (Formi&#; LHS) as a technological feed additive for piglets (weaned) and pigs for fattening. The FEEDAP Panel concluded that potassium diformate is safe for weaned piglets and for pigs for fattening at the level of 6,000 mg/kg complete feed, with no margin of safety. The use of potassium diformate in weaned piglets and pigs for fattening nutrition under the conditions of use proposed is of no concern for consumer safety. Potassium diformate does not raise concern regarding the effects on respiratory system and the skin but is an eye irritant. The use of potassium diformate as a feed additive is considered safe for the environment. The additive is considered to be efficacious as acidity regulator in feedingstuffs for weaned piglets and pigs for fattening at the minimum proposed concentration of 6,000 mg/kg complete feed.

Keywords: Potassium diformate, technological additive, acidity regulator, piglets (weaned), pigs for fattening, safety, efficacy

1. Introduction

1.1. Background and Terms of Reference

Regulation (EC) No / establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any person seeking authorisation for a feed additive or for a new use of a feed additive shall submit an application in accordance with Article 7.

The European Commission received a request from Addcon GmbH2 for authorisation of the product potassium diformate, when used as a feed additive for piglets (weaned) and pigs for fattening (category: technological additive; functional group: acidity regulators).

According to Article 7(1) of Regulation (EC) No /, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 4(1). The particulars and documents in support of the application were considered valid by EFSA as of 8 July .

According to Article 8 of Regulation (EC) No /, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the product potassium diformate, when used under the proposed conditions of use (see Section 3.1.3).

1.2. Additional information

The subject of the assessment is the feed additive consisting of potassium diformate, intended for use as a technological additive (functional group: acidity regulators) for weaned piglets and pigs for fattening.

The EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued five opinions on Formi&#; LHS (potassium diformate): one on the efficacy and safety for sows, safety for consumers, users and the environment (EFSA, ), one on its safety and efficacy for weaned piglets and pigs for fattening (EFSA, ), one on its re&#;evaluation as feed additive for sows (EFSA FEEDAP Panel, ) and two on the renewal of the authorisation as feed additive for sows (EFSA FEEDAP Panel, a,b).

Potassium diformate was authorised by Commission Regulation (EC) No 184/ as a feed additive for piglets (weaned) and pigs for fattening; this authorisation expired in .3 Potassium diformate is currently authorised by Commission Regulation (EU) No 333/ as a preservative feed additive for all animal species.4 The additive is also authorised by Commission Regulation (EU) No 104/ as feed additive for sows.5

2. Data and methodologies

2.1. Data

The present assessment is based on data submitted by the applicant in the form of a technical dossier6 in support of the authorisation request for the use of potassium diformate as a feed additive.

The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, peer&#;reviewed scientific papers, other scientific reports to deliver the present output.

The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of the active substance in animal feed are valid and applicable for the current application.7

2.2. Methodologies

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of potassium diformate is in line with the principles laid down in Regulation (EC) No 429/ and the relevant guidance documents: Guidance for the preparation of dossiers for technological additives (EFSA FEEDAP Panel, a), Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, b), Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, a), Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, b), Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, c), Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, ) and Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, ).

3. Assessment

Potassium diformate is intended to be used as a technological additive (functional group: acidity regulators) in feed for weaned piglets and pigs for fattening.

3.1. Characterisation

3.1.1. Characterisation of the additive

The active substance of the additive is potassium diformate (KCOOH*HCOOH) which is an association of potassium formate and formic acid. It has the chemical formula C2H3O4K, molecular weight is 130.1 Da, the CAS number is &#;05&#;1 and the EINECS number 243&#;934&#;6. Potassium diformate is produced by mixing formic acid and potassium hydroxide in a reactor at atmospheric pressure at a temperature of 50&#;60°C. The crystal mass and the saturated solution of potassium diformate are separated by centrifugation. Solid potassium diformate is obtained by drying and is mixed with silicon dioxide as an anticaking agent.

The additive is specified to contain minimum 98% potassium diformate, with a maximum of 1.5% silicon dioxide (as an anticaking agent) and a maximum of 0.5% water.9 The analysis of ten batches of the additive, showed that the additive meets those specifications: potassium diformate 98.3% (range 98.2&#;98.5%), anticaking agent 1.5% (range 1.4&#;1.5%), water 0.2% (range 0.1&#;0.3%).10

Analytical data of heavy metals (cadmium, lead and mercury) and arsenic, content in three independent batches was provided.11 Values reported were below the limits of detection (LODs) or limits of quantification (LOQs)12 and are considered of no concern. Dioxins (polychlorinated dibenzo&#;p&#;dioxins and dibenzofurans (PCDD/F)) measured in three batches13 amounted to < 0.09 ng Bioanalytical Equivalents (BEQ)/kg (LOQ), and the sum of dioxins and dioxin&#;like polychlorinated biphenyls (DL&#;PCBs) was < 0.2 ng BEQ/kg (LOQ). Non&#;DL&#;PCBs were 1.2 ng/g. The values are of no concern.

Due to its chemical nature, it is not expected that the additive supports microbiological growth.

The additive is described as a dry, white and free flowing crystalline product, with a bulk density of 900&#;1,000 kg/m3.14 The dusting potential of the additive was measured in three independent batches showing an average of 348 mg/m3 (range: 254&#;415 mg/m3).15

3.1.2. Stability and homogeneity

The shelf&#;life of the product was tested in two studies, in which three batches each of the additive were stored in polyethylene bags at 25°C and 55&#;60% relative humidity (RH) or at 40°C and 75&#;90% RH for 6 months, or at room temperature for 24 months.16 No substantial losses in the content of potassium diformate were observed during storage.

The stability of the additive (three batches) in pre&#;starter and starter piglet mash feeds was studied for eight months storage at room temperature.17 Recovery at the end of the storage was 95.0&#;98.3 (pre&#;starter feed) and 98.9% (starter feed). Although the applicant claims that potassium diformate is stable to feed processing temperatures up to 110°C, no data to support this claim was provided.

The capacity of potassium diformate to homogeneously distribute was studied in mash and pelleted pig feed at two different inclusion levels (0.5% and 1.8%).18 The coefficients of variation (n = 10) in mash feed were 6.1% and 10.4% for the 0.5% and 1.8% inclusion levels, respectively. The coefficients of variation (n = 10) in pelleted feed were 7.7% and 15.5% for the 0.5% and 1.8% inclusion levels, respectively.

3.1.3. Conditions of use

Potassium diformate is intended to be used in feed for weaned piglets and pigs for fattening at a minimum inclusion level of 6,000 and a maximum level of 18,000 mg/kg complete feed (0.6&#;1.8%). The use in premixtures is not foreseen for this product.

3.2. Safety

The safety of use of potassium diformate in feed for weaned piglets (up to 18,000 mg/kg) and pigs for fattening (up to 12,000 mg/kg feed) was first considered by the FEEDAP Panel in (EFSA, ), following a previous assessment by the Scientific Committee for Animal Nutrition (SCAN) (European Commission, ). In , in the framework of the re&#;evaluation of the additive Formi&#; LHS for sows, the Panel re&#;assessed the safety for the consumer, user and the environment (EFSA FEEDAP Panel, ).

In the present application, the applicant has submitted a new tolerance study in weaned piglets, and the same studies already assessed in by the FEEDAP Panel for the safety for the consumer, user and environment. The FEEDAP Panel has re&#;assessed all the data submitted in the present dossier, which is summarised in the following sections.

3.2.1. Safety for the target species

To support the safety for the target species, the applicant submitted three old studies (two in pigs for fattening and one in piglets) previously assessed by SCAN (European Commission, ; European Commission, respectively) and by the FEEDAP Panel (EFSA, ).

Considering the current standards and the limitations in the three studies (poor trial set up, poor reporting, and no statistical report), these studies cannot further be considered to assess the safety of the additive for pigs for fattening and piglets (weaned), at the maximum proposed inclusion level of 1.8%.

The applicant also submitted one recent tolerance study in piglets (weaned).

3.2.1.1. Tolerance study in piglets (weaned)

A total of 128 piglets (Topigs Stambo HBI Dalland 40, 28 days of age, mean body weight 7.8 kg; equal number of males and females) distributed in four treatments with eight replicate pens of four piglets each were fed with diets (based on barley, wheat, maize and soy protein concentrate; pre&#;starter, from day 0 to 14; starter, from day 15 to 42) supplemented with 0, 6,000 (0.3× the maximum content), 18,000 (1×), or 72,000 (4×) mg potassium diformate/kg feed (confirmed by analysis).19 Feed in mash form and water were offered ad libitum. Health status and mortality were monitored daily. Feed intake and body weight were recorded at the beginning (day 1), and at days 14, 28 and 42 of the experiment. Average daily body weight gain and feed to gain ratio were calculated. At day 1 and at the end of the experiment (day 42), 32 piglets (1 per replicate pen) were selected and blood samples were taken for haematology20 and blood biochemistry.21 The data were analysed by repeated measurements ANOVA with treatment and time and their interaction, and a Tukey test was used for the comparison of the group means. The pen was considered as the experimental unit. Significance level was set at 0.05.

No mortality or culling occurred. The main results are reported in Table 1. No differences in the zootechnical parameters were observed between the groups fed 0.3× or 1× the maximum content compared to the control group. The group fed 4× potassium diformate showed a statistically lower feed intake and body weight gain compared to the control group. Feed to gain ration was similar among all four groups. Haematocrit, haemoglobin and red blood cells (RBC) at day 42 were lower in a dose dependent manner in the groups receiving potassium diformate compared to the control group; the values were significantly different compared to control from the level 1× of the additive for haematocrit and haemoglobin and at 4× for RBC. Also, serum chloride was lower compared to the control group at 4×. No other relevant effects were observed for any other haematological and biochemical parameters.

Table 1.

Groups (mg potassium diformate/kg feed) 0 6,000 18,000 72,000 Feed intake (g) 683b 681b 679b 505a Final body weight (kg) 25.53b 26.45b 25.60b 20.03a Average daily gain (g) 436b 437b 438b 291a Feed to gain ratio 1.56 1.46 1.57 1.78 Haematocrit (%) 31.6a 27.2ab 24.0b 23.1b Haemoglobin (g/dL) 9.95a 8.80ab 7.95b 8.16b Red blood cells (×10 6 /μL) 6.01a 5.47ab 5.23ab 5.14b Serum chloride (mmol/L) 98.4a 97.8ab 96.5ab 95.1b

The results of this study showed a lower performance of the piglets in the group that received 72,000 mg potassium diformate/kg feed with decreases in RBC counts and haematocrit, and lower haemoglobin content. The effects on haematocrit and haemoglobin content were also seen at the level of 18,000 mg/kg complete feed. These effects are considered as adverse effects and consequently the FEEDAP Panel concludes that the additive is not safe at the level of 18,000 mg/kg complete feed or above in piglets.

Based on the data from this tolerance trial in piglets, the FEEDAP Panel concludes that the additive is safe for weaned piglets at the level of 6,000 mg/kg complete feed with no margin of safety and the same conclusion is extended to pigs for fattening.

3.2.2. Safety for the consumer

3.2.2.1. Absorption, distribution, metabolism and excretion

Potassium diformate remains in the diformate form under acidic conditions and dissociates into formate and potassium ions under neutral or alkaline conditions. Therefore, diformate, present as the salt in the stomach, is likely to dissociate in the neutral conditions prevailing in the intestine and after eventual absorption, in plasma and tissues. Formate is a normal endogenous metabolite (EFSA FEEDAP Panel, ).

Formic acid partially enters the one&#;carbon pool of the body or is further oxidised to carbon dioxide and water in the liver and in the erythrocytes. The residual unmetabolised formic acid and other minor metabolites are excreted via urine, faeces or expired air. No significant increase in the presence of formate per se is expected in the animal products, although carbon derived from formate may be incorporated into tissues as a consequence of normal anabolism (Hanzlik et al., ). This assumption was confirmed by the residue studies provided by the applicant (see Section 3.2.2.2).

3.2.2.2. Residue studies

The applicant submitted data on residues of potassium diformate in tissues in pigs for fattening from a study already assessed by the SCAN (European Commission, , , respectively) and by the FEEDAP Panel (EFSA, ) (see Section 3.2.1), and data from the tolerance study in piglets (see Section 3.2.1.1).

In the study with pigs for fattening, the animals were fed with diets supplemented with potassium diformate at concentrations of 0, 12,000, 24,000 or 60,000 mg/kg. Two animals were killed at the beginning of the study (day 0) and at days 30, 60 and 90 and samples of muscle, liver, kidney, heart, lung and plasma were analysed for formate concentration. Notwithstanding the low number of samples, no increase in tissues&#; concentrations of formate as observed in the animals fed up to 24,000 mg potassium diformate/kg feed compared with the control animals in any of the sampling points, nor overall.

In the study with piglets (weaned), eight animals from each group (0, 18,000 and 72,000 mg potassium diformate/kg feed) were killed at the end of the study and samples of muscle, skin, fat, spleen, lung, liver and kidney were analysed for formate concentration.22 In none of the tissues analysed an increase of formate was observed in the animals fed 18,000 mg potassium diformate compared to the control animals.

3.2.2.3. Toxicological studies

The applicant provided a series of toxicological studies that were already evaluated by the FEEDAP Panel in (EFSA FEEDAP Panel, ). This included studies on genotoxicity (bacterial mutagenicity tests (Salmonella Typhimurium, Escherichia coli), in vitro mouse lymphoma assay and chromosome aberration test in human peripheral blood lymphocytes, and an in vivo bone marrow micronucleus test in rats). The FEEDAP Panel concluded that no potential genotoxicity was observed.

Regarding laboratory animal toxicity studies, the following data were available:

&#;
A subchronic toxicity study in mice, which did not cause adverse effects even in the highest dose tested (3,000 mg/kg diet).
&#;
Chronic studies in mice and rats, in which no treatment&#;related increase in tumours was seen in either species. NOAELs of 400 and 50 mg/kg body weight (bw) per day in mice and rats, respectively, were identified.

The FEEDAP Panel concluded that the additive is not genotoxic and of low toxicity (EFSA FEEDAP Panel, ).

The Panel is not aware of any new information that would lead to reconsider the previous conclusions, in line with the recent opinion on the same product for use in sows (EFSA FEEDAP Panel, b).

3.2.2.4. Conclusions on the safety for the consumer

Considering the negative outcome of the genotoxicity testing, the low toxicity of potassium diformate and the lack of an increased consumer exposure to formate, the FEEDAP Panel considers that the use of potassium diformate as a feed additive in piglets and pigs for fattening at the maximum inclusion level of 1.8% is safe for the consumer.

3.2.3. Safety for the user

All the data presented in this dossier were previously evaluated by SCAN (European Commission, , ) and by the FEEDAP Panel (EFSA, ; EFSA FEEDAP Panel, ). Based on skin23 and eye irritation studies (rabbit),24 skin sensitisation test (Magnusson&#;Kligman test with Guinea pigs)25 and an acute inhalation toxicity test (rats)26 the Panel concludes that the additive does not raise concern regarding the effects on respiratory system and the skin, but is an eye irritant.

3.2.4. Safety for the environment

Since the excretion products, formic acid and formate, are naturally occurring metabolites, the use of potassium diformate is not expected to increase the natural concentrations of formate (and potassium ions) in the environment. The FEEDAP Panel concludes that the use of potassium diformate as feed additive in piglets (weaned) and pigs for fattening under the proposed conditions of use is safe for the environment.

3.3. Efficacy

To support the efficacy of potassium diformate as an acidity regulator, four in vitro studies were provided; these studies included three trials with complete feed for piglets (weaned) and three with complete feed for pigs for fattening. The four studies shared the same methodology, only potassium diformate inclusion levels varied in the studies. In all the studies, three 10 g subsamples of the feedingstuffs treated with each of concentration of potassium diformate were taken, grounded and added to 100 mL of distilled deionized water. The solution was mixed with a magnetic stirrer for 15 minutes and the pH was measured. The results were statistically analysed by an ANOVA and a Tukey test for group comparison.

The first study included two trials in which one commercial feed for pigs for fattening and one for piglets (weaned) were supplemented with potassium diformate at concentrations of 0, 2,000, 4,000, 6,000, 8,000, 10,000 or 12,000 mg/kg.27 , 28 In the second study, two commercial feeds for weaned piglets (pre&#;starter and starter) were supplemented with potassium diformate at concentrations of 0, 6,000 or 18,000 mg/kg.29 In the third study, one commercial feed for pigs for fattening was supplemented with potassium diformate at concentrations of 0, 5,000, 6,000 or 18,000 mg/kg.30 In the fourth study, one commercial feed for pigs for fattening was supplemented with potassium diformate at concentrations of 0, 6,000 or 18,000 mg/kg.31

In the four studies, the supplementation of feeds with potassium diformate reduced the pH in a dose dependent manner, starting from the lowest supplementation applied. The lowest concentration common in the four studies was 6,000 mg/kg feed. The results of the studies are summarised in Table 2.

Table 2.

Trial Potassium diformate inclusion level (mg/kg feed) 0 2,000 4,000 5,000 6,000 8,000 10,000 12,000 18,000 pH Trial 1 Piglets 5.50a 5.28b 5.22c &#; 5.17d 5.12e 5.06f 5.01g &#; Pigs for fattening 5.84a 5.59b 5.51c &#; 5.42d 5.32e 5.23f 5.15g &#; Trial 2 Piglets (pre&#;starter) 6.19a &#; &#; &#; 5.82b &#; &#; 5.25c Piglets (starter) 6.06a &#; &#; &#; 5.64b &#; &#; 5.12c Trial 3 Pigs for fattening 5.82a &#; &#; 5.46b 5.36c &#; &#; &#; 5.08d Trial 4 Pigs for fattening 6.10a &#; &#; &#; 5.70b &#; &#; 5.31c

3.3.1. Conclusions on efficacy

Based on the four studies, the FEEDAP Panel concludes that potassium diformate is an effective acidity regulator in feedingstuffs for piglets (weaned) and pigs for fattening at the minimum proposed concentration of 6,000 mg/kg complete feed.

4. Conclusions

Potassium diformate is safe for weaned piglets and for pigs for fattening at the level of 6,000 mg/kg complete feed, with no margin of safety.

The use of potassium diformate in feed for weaned piglets and pigs for fattening under the conditions of use proposed is of no concern for consumer safety.

Potassium diformate does not raise concern regarding the effects on respiratory system and the skin but is an eye irritant.

The use of potassium diformate as a feed additive is considered safe for the environment.

The additive is considered to be efficacious as acidity regulator in feedingstuffs for weaned piglets and pigs for fattening at the minimum proposed concentration of 6,000 mg/kg complete feed.

5. Documentation provided to EFSA/Chronology

Date Event 02/04/ Reception mandate from the European Commission 12/04/ Dossier received by EFSA. Formi LHS (potassium diformate) submitted by Addcon GmbH 08/07/ Application validated by EFSA &#; Start of the scientific assessment 10/10/ Comments received from Member States 17/09/ Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No / &#; Scientific assessment suspended. Issues: characterisation and safety for the target species, consumers, users and environment 22/11/ Reception of supplementary information from the applicant &#; Scientific assessment re&#;started 20/12/ Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No / &#; Scientific assessment suspended. Issues: Safety for the target species and consumers 06/02/ Reception of supplementary information from the applicant &#; Scientific assessment re&#;started 05/05/ Opinion adopted by the FEEDAP Panel. End of the Scientific assessment

Abbreviations

BEQ: Bioanalytical Equivalents
bw: body weight
CAS: Chemical Abstracts Service
CFU: colony forming unit
DL&#;PCB: dioxin&#;like polychlorinated biphenyl
EINECS: European Inventory of Existing Chemical Substances
EURL: European Union Reference Laboratory
FCR: feed conversion ratio
FEEDAP: EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
LOQ: limit of quantification
MCHC: mean corpuscular haemoglobin concentration
MCV: mean corpuscular volume
MIC: minimum inhibitory concentration
PCDD/F: polychlorinated dibenzo&#;p&#;dioxins and dibenzofurans
SCAN: Scientific Committee on Animal Nutrition

Suggested citation: EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis V, Azimonti Giovanna, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López&#;Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brozzi R, Galobart J, Gregoretti L, López&#;Gálvez G, Vettori MV and Innocenti ML, . Scientific Opinion on the safety and efficacy of an additive consisting of potassium diformate (Formi&#; LHS) for piglets (weaned) and pigs for fattening (Addcon GmbH). EFSA Journal ;19(6):, 11 pp. 10./j.efsa..

Requestor: European Commission

Question number: EFSA&#;Q&#;&#;

Panel members: Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López&#;Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.

Declarations of interest: The declarations of interest of all scientific experts active in EFSA's work are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch.

Acknowledgements: The Panel wishes to thank the following for the support provided to this scientific output: Jordi Ortuño Casanova.

Adopted: 5 May

Notes

Regulation (EC) No / of the European Parliament and of the Council of 22 September on additives for use in animal nutrition. OJ L 268, 18.10., p. 29.

Addcon GmbH, Parsevalstrasse 6, Bitterfeld&#;Wolfen, Germany.

Commission Regulation (EC) No 184/ of 20 February concerning the authorisation of potassium diformate (Formi LHS) as a feed additive, OJ L 291, 5.11., p. 8.

Commission Regulation (EU) No 333/ of 19 April concerning the authorisation of a preparation of potassium diformate as a feed additive for all animal species and amending Regulation (EC) No 492/, OJ L 89, 28.3., p.6.

Commission Regulation (EU) No 104/ of 5 February concerning the authorization of potassium diformate as a feed additive for sows (holder of authorization BASF SE) and amending Regulation (EC) No /, OJ L 35, 6.2., p. 4, amended by Commission Implementing Regulation (EU) /410 of 8 March , OJ L 63, 9.3., p. 98.

FEED dossier reference: FAD&#;&#;.

The full report is available on the EURL website: https://ec.europa.eu/jrc/sites/jrcsh/files/FinRep-FormateGroup.pdf

Commission Regulation (EC) No 429/ of 25 April on detailed rules for the implementation of Regulation (EC) No / of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5., p. 1.

Technical dossier/Section II/Annex_II_2.

Technical dossier/Supplementary information_Nov19/Annex_1.

Lead: 0.06 mg/kg (LOQ); Cadmium: 0.02 mg/kg (LOD); Mercury: 0.01 mg/kg (LOD); Arsenic: 0.03 mg/kg (LOD).

Technical dossier/Supplementary information_Nov19/Annex_2.

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Technical dossier/Section II/Annex_II_5.

Technical dossier/Supplementary information_Nov19/Annex_3.

Technical dossier/Section II/Annex_II_11.

Technical dossier/Section II/Annex_II_12.

Technical dossier/Section II/Annex_II_13.

Technical dossier/Supplementary information_Nov19/Annex_4 and Supplementary information February /annex 5.

Red blood cells (RBC), haemoglobin, haematocrit, platelets, mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), mean corpuscular volume (MCV), red cell distribution width (RCDW), white blood cells (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils.

Glucose, cholesterol, total protein, urea, albumin, bilirubin tot., creatinine, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), calcium, phosphorus, chloride, potassium, sodium, magnesium.

Ion&#;chromatography, limit of quantification: 1 mg/kg.

Technical dossier/Section III/Annex_III_21.

Technical dossier/Section III/Annex_III_22.

Technical dossier/Section III/Annex_III_23.

Technical dossier/Section III/Annex_III_19.

Technical dossier/Section IV/Annex_IV_1a.

Technical dossier/Section IV/Annex_IV_1b.

Technical dosser/Section IV/Annex_IV_2a.

Technical dossier/Section IV/Annex_IV_3a.

Technical dossier/Section IV/Annex_IV_4a.

References

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Assessment of the feed additive consisting of potassium diformate ...

. Mar 3;20(3):e. doi: 10./j.efsa..

Assessment of the feed additive consisting of potassium diformate for all animal species for the renewal of its authorisation (Addcon GmbH)

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)&#;, Vasileios Bampidis

Vasileios Bampidis

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Collection date Mar.

PMCID: PMC PMID:

Abstract

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 assessment of the application for renewal of authorisation of potassium diformate for all animal species. The additive was initially evaluated in and re&#;evaluated by the Panel in , with the conclusion that the additive (i) was safe for the target species, the consumer and the environment when used under the proposed conditions; (ii) was an eye irritant and (iii) had the potential to increase the storage time of raw fish and fish by&#;products for feed use in a dose&#;dependent manner at low temperature. The FEEDAP Panel considered that the use of potassium diformate under the approved conditions of use remains safe for consumers and the environment, and that it is an eye irritant. Due to the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be a skin irritant or a respiratory or dermal sensitiser. Regarding the safety for the target species, the FEEDAP Panel considered that the mixture of different sources of potassium diformate remains safe for use in sows&#; feed under the approved conditions of use (12,000 mg/kg complete feed). However, based on a tolerance trial, the Panel concluded that the maximum safe level of potassium diformate in weaned piglets should be reduced to 6,000 mg/kg complete feed and the same conclusion was extended to pigs for fattening. Owing to the lack of information provided, the Panel could not conclude on the safety of the additive for species other than pigs under the approved conditions. The present application does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive.

Keywords: potassium diformate, all animal species, safety, efficacy, renewal

1. Introduction

1.1. Background and Terms of Reference

Regulation (EC) No / establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest one year before the expiry date of the authorisation.

The European Commission received a request from Addcon GmbH2 for renewal of the authorisation of the product potassium diformate when used as a feed additive for all animal species (category: technological additive; functional group: preservative).

According to Article 7(1) of Regulation (EC) No /, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 14(1) (renewal of the authorisation). EFSA received directly from the applicant the technical dossier in support of this application. The particulars and documents in support of the application were considered valid by EFSA as of 15 July .

According to Article 8 of Regulation (EC) No /, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the feed additive consisting of potassium diformate, when used under the proposed conditions of use (see Section 3.1.2).

1.2. Additional information

EFSA issued two opinions on the safety and efficacy of this product when used as a preservative in raw fish and fish by&#;products for feed uses for all animal species (EFSA, ; EFSA FEEDAP Panel, ).

Potassium diformate is currently authorised by Commission Regulation (EU) No 333/ as a technological feed additive (functional group: preservative) for all animal species (1a237a).3 The active substance potassium diformate is also authorised as a zootechnical feed additive (functional group: acidity regulator) for sows (4d800).4

2. Data and methodologies

2.1. Data

The present assessment is based on data submitted by the applicant in the form of a technical dossier5 in support of the authorisation request for the use of potassium diformate as a feed additive.

The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies and peer&#;reviewed scientific papers, to deliver the present output.

2.2. Methodologies

3. Assessment

The additive potassium diformate in liquid form (50:50 diluted in water) is authorised as a technological additive (functional group: preservatives) for use in raw fish and fish by&#;products for feed use with a maximum content of 9,000 mg potassium diformate as active substance per kg of raw fish.

The applicant has applied for the renewal of this authorisation under the same conditions of use currently authorised.

3.1. Characterisation

3.1.1. Characterisation of the additive

The additive is an aqueous solution (specific weight at 20°C: 1,225&#;1,325 kg/m3, pH 4.0&#;4.5) containing 45&#;55% of potassium diformate (potassium hydrogen diformate, CAS No &#;05&#;1, EINECS number 243&#;934&#;6, molecular weight 130.12, molecular formula C2H3O4K). At pH > 4, the product dissociates to formate and potassium ions.

The applicant stated that there have been no changes in the manufacturing process since the additive was authorised.

The applicant provided data on the batch&#;to&#;batch variation of eleven recent batches of the additive,8 showing an average value of potassium diformate of 49.7 (47.8&#;51.5)% (w/w).

Five batches of the additive were analysed for chemical impurities.9 Heavy metals (cadmium, lead and mercury), fluorine and arsenic levels were below the limit of quantification (LOQ) of the analytical methods.10

Polychlorinated dibenzodioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and coplanar dioxin&#;like polychlorinated biphenyls (co&#;planar PCBs) were analysed in three batches and found below the corresponding LOQ.11 The calculated (upper bound) levels of dioxins and the sum of dioxins and dioxin&#;like&#;PCBs were 0.15 ng WHO&#;PCDD/F&#;TEQ/kg and 0.096 ng WHO&#;PCDD/F&#;PCB&#;TEQ/kg, respectively (in all three batches).

No new data have been provided regarding the physico&#;chemical properties or stability of the additive. Since no changes have been introduced in the additive or its manufacturing process, the data described in the previous opinions still apply (EFSA, ; EFSA FEEDAP Panel, ).

3.1.2. Conditions of use

Potassium diformate is authorised as a preservative for raw fish and fish by&#;products for feed use for all animal species.

The authorising regulation under other provisions states that:

&#;
Only permitted in raw fish and fish by&#;products for feed use with a maximum content of 9,000 mg potassium diformate as active substance per kg of raw fish.
&#;
For use in feed for pigs, the mixture of different sources of potassium diformate shall not exceed the permitted maximum level in complete feedingstuffs of 18,000 mg/kg complete feedingstuffs for weaned piglets and 12,000 mg/kg complete feedingstuffs for sows and pigs for fattening.
&#;
Indicate in the instructions for use: &#;The simultaneous use of other organic acids at the maximum permitted doses is contraindicated&#;.
&#;
&#;For safety: breathing protection, eye protection and gloves shall be used during handling&#;.

The applicant has not requested to modify the current conditions of use.

3.2. Safety

The safety of the additive for the target species, the consumers, the users and the environment has already been assessed by the FEEDAP Panel (EFSA, ; EFSA FEEDAP Panel, ). The FEEDAP Panel concluded that the additive is safe for the target species, the consumers and the environment when used under the proposed conditions, and is an eye irritant.

In the current application, the applicant submitted a tolerance study to support the safety for weaned piglets, which had already been assessed in a previous opinion (EFSA FEEDAP Panel, ). Based on the results from that tolerance trial, the Panel concluded that potassium diformate as the active substance is safe for weaned piglets at the level of 6,000 mg/kg complete feed with no margin of safety and the same conclusion was extended to pigs for fattening.

3.2.1. Extensive literature search

The applicant conducted a literature search covering the period &#; in the databases TOXCENTER, BIOSIS, AGRICOLA, HCAPLUS, PQSCITECH, MEDLINE, ESBIOBASE, EMBASE and CABA; a single concept search strategy (i.e. search for CAS number and the chemical names) was applied. Studies in certain target species (restricted to pigs, piglets and sows), consumers and users were considered for the scope of the present assessment. In total, 147 records were retrieved from bibliographic databases and were screened for relevance by expert reviewers. Based on the evaluation of the summary of the records (titles/abstracts), 144 publications were assessed and were considered not relevant; three full&#;text documents were assessed in detail and it was concluded that these publications did not provide relevant information regarding adverse effects in target animals (pigs, piglets and sows), consumers and users. The Panel notes that this literature search was limited to pigs as target species and did not address any other target species covered by the current authorisation.

Owing to the nature of the active substance and its metabolism, the FEEDAP Panel considers that there is no need for additional information on the safety for the environment in the context of the renewal of authorisation of this additive.

3.2.2. Conclusions on safety

Based on the information provided by the applicant and the fact that the manufacturing and composition of the additive have not been modified, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in the previous opinion. Therefore, the additive is regarded safe under the approved conditions for consumers and the environment, and it is an eye irritant. Due to the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin irritant or a respiratory or dermal sensitiser.

With regard to the target species, the Panel concludes that potassium diformate remains safe for sows at a maximum level of 12,000 mg/kg complete feed. For weaned piglets, potassium diformate is safe at a maximum level of 6,000 mg/kg complete feed with no margin of safety and the same conclusion is extended to pigs for fattening. The FEEDAP Panel notes that the maximum safe level in piglets and pigs for fattening is not aligned with the current authorisation, which indicates that the mixture of different sources of potassium diformate shall not exceed the permitted maximum level in complete feedingstuffs of 18,000 mg/kg complete feedingstuffs for weaned piglets and 12,000 mg/kg complete feedingstuffs for sows and pigs for fattening.

Considering that no new information was provided, the Panel cannot conclude whether the additive remains safe under the approved conditions for species other than pigs.

3.3. Efficacy

The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive as a preservative in raw fish and fish by&#;products for feed use. Therefore, there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

4. Conclusions

The FEEDAP Panel considers that the use of potassium diformate under the approved conditions of use is safe for consumers and the environment. The additive is an eye irritant. The FEEDAP Panel cannot conclude on the potential of the additive to be irritant to the skin or a respiratory or skin sensitiser.

Regarding the safety for the target species, the FEEDAP Panel considers that the maximum potassium diformate level in feed for sows (12,000 mg/kg) remains safe under the approved conditions of use. However, the Panel considers that the maximum safe level for weaned piglets and pigs for fattening is 6,000 mg/kg complete feed, which is lower than the one included in the current authorisation. Owing to the lack of information, the Panel cannot conclude on whether the additive remains safe under the approved conditions for the other species for which it is authorised.

5. Documentation provided to EFSA/Chronology

Date Event 26/01/ Reception mandate from the European Commission 19/02/ Dossier received by EFSA. FAD&#;&#;. Potassium diformate (KDF preservative) for all animal species. Submitted by Addcon GmbH 15/07/ Application validated by EFSA &#; Start of the scientific assessment 29/09/ Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No / &#; Scientific assessment suspended. Issues: general/purity/safety 18/10/ Comments received from Member States 04/11/ Reception of supplementary information from the applicant &#; Scientific assessment re&#;started 27/01/ Opinion adopted by the FEEDAP Panel. End of the Scientific assessment

Abbreviations

CAS: Chemical Abstracts Service
EINECS: European Inventory of Existing Chemical Substances
EURL: European Union Reference Laboratory
FAO: Food Agricultural Organization
FEEDAP: EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
LOD: limit of detection
LOQ: limit of quantification
OECD: Organisation for Economic Co&#;operation and Development
PCB: polychlorinated biphenyl
PCDD: polychlorinated dibenzodioxin
PCDF: polychlorinated dibenzofurans
SCAN: Scientific Committee on Animal Nutrition
TEQ: toxic equivalent
WHO: World Health Organization

Suggested citation: EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López&#;Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Anguita M, Galobart J and Ortuño J, . Scientific Opinion on the assessment of the feed additive consisting of potassium diformate for all animal species for the renewal of its authorisation (Addcon GmbH). EFSA Journal ;20(3):, 8 pp. 10./j.efsa..

Requestor: European Commission

Question number: EFSA&#;Q&#;&#;

Declarations of interest: The declarations of interest of all scientific experts active in EFSA&#;s work are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch.

Adopted: 27 January

Notes

Regulation (EC) No / of the European Parliament and of the council of 22 September on the additives for use in animal nutrition. OJ L 268, 18.10., p. 29.

Addcon GmbH, Parsevalstrasse 6, , Bitterfeld&#;Wolfen (Germany).

COMMISSION IMPLEMENTING REGULATION (EU) No 333/ of 19 April concerning the authorisation of a preparation of potassium diformate as a feed additive for all animal species and amending Regulation (EC) No 492/. OJ L 108, 20.4., p.3.

COMMISSION IMPLEMENTING REGULATION (EU) No 104/ of 05 February concerning the authorisation potassium diformate as a feed additive for sows (holder of authorisation BASF SE) and amending Regulation (EC) No /. OJ L 35, 6.2., p.4. COMMISSION IMPLEMENTING REGULATION (EU) No /410 of 8 March amending Regulations (EC) No 184/ and (EU) No 104/, as regards the name of the holder of the authorisation of potassium diformate. OJ L 63, 9.3., p.98.

FEED dossier reference: FAD&#;&#;.

The full report is available on the EURL website: https://ec.europa.eu/jrc/en/eurl/feed&#;additives/evaluation&#;reports/fad&#;&#;

Technical dossier/Section II/Annex II_1 to 6 and SIn_/Annexes 1 to 5.

Technical dossier/SIn_/Annexes 1 to 5.

LOQ (mg/kg): As=0.1; Cd=0.1; F=5; Hg=0.01; Pb=0.1.

Technical dossier/Section II/Annex II_10.

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