Assessment of the feed additives consisting of potassium iodide and calcium iodate anhydrous for all animal species for the renewal of their authorisation (AJAY EUROPE SARL)

TL;DR

This paper evaluates the safety of potassium iodide and calcium iodate anhydrous as animal feed additives for all species.

Contribution

The study confirms the safety of these additives for animals and the environment under current usage conditions.

Findings

Potassium iodide and calcium iodate anhydrous are safe for target species and the environment.

Calcium iodate anhydrous is an eye irritant and a skin and respiratory sensitizer.

Consumer safety could not be assessed due to insufficient data.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium iodide (3b201) and calcium iodate anhydrous (3b202) as nutritional additives (functional group: compounds of trace elements) for all species and categories. The additives are currently authorised for use in all animal species. The applicant has provided evidence that both additives, potassium iodide and calcium iodate anhydrous, comply with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of potassium iodide and calcium iodate anhydrous under the current authorised conditions of use are safe for the target species and the environment. Due to the lack of adequate deposition data to assess the consumer exposure, the FEEDAP Panel is not in the position to conclude on the safety for the consumer. With regard to the safety of users, potassium iodide is not an eye irritant, but calcium iodate anhydrous is. The additives potassium iodide and calcium iodate anhydrous should be considered skin and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Tables

TABLE 1. Data on the batch‐to‐batch variation, impurities and physical properties of the additive potassium iodide.

		Analysis
Parameter	Specification	Average	Range	No. of batches
Batch‐to‐batch variation (1)
Iodine (%) (2)	≥ 69	69.8	69.4–70.2	5
Potassium iodide (%)		91.3	90.8–91.8	5
Potassium (g/kg)		220.2	217.0–223.0	5
Impurities (mg/kg)
Lead			< 0.02	3
Mercury			< 0.05	3
Cadmium			< 0.02	3
Arsenic			0.02–0.03	3
Fluorine			< 40	3
Nickel			0.10–0.23	3
Dioxins and furans (upper bound) (3)
PCDD/Fs (ng WHO2005‐TEQ/kg)		0.13	0.08–0.15	3
PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg)		0.17	0.11–0.20	3
nDL‐PCBs (μg/kg)		1.58		3
Physical properties
Physical form		Solid
Bulk density (kg/m3)		1261	1200–1345	3
Tap density (kg/m3)		1686	1667–1724	3
Dusting potential (Stauber–Heubach) (mg/m3)		5275	3817–6883	3
Particle size distribution (laser diffraction) (% of particles below, v/v)				3
100 μm			82.1–85.6
50 μm			57.8–62.6
10 μm			34.5–37.3

TABLE 2. Data on the batch‐to‐batch variation, impurities and physical properties of the additive calcium iodate anhydrous.

		Analysis
Parameter	Specification	Average	Range	No. of batches
Batch‐to‐batch variation (1)
Iodine (%) (2)	≥ 63.5	64.4	64.1–64.8	5
Calcium iodate (%)		99.0	98.5–99.5	5
Calcium (g/kg)		106.3	101.0–111.0	5
Impurities (mg/kg)
Lead			0.12–0.23	3
Mercury			< 0.05	3
Cadmium			0.04–0.06	3
Arsenic			0.30–0.34	3
Fluorine			< 40	3
Nickel			0.40–0.61	3
Dioxins and furans (upper bound) (3)
PCDD/Fs (ng WHO2005‐TEQ/kg)		0.15		3
PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg)		0.21		3
nDL‐PCBs (μg/kg)		2.92		3
Physical properties
Physical form		Solid
Bulk density (kg/m3)		1709	1645–1822	3
Tap density (kg/m3)		2431	2381–2532	3
Solubility (g/L) (4)		3.3 (at 25°C)		5
Dusting potential (Stauber–Heubach) (mg/m3)		6460	4410–7589	3
Particle size distribution (laser diffraction) (% of particles below, v/v)				3
100 μm			78.1–96.8
50 μm			60.8–86.5
10 μm			21.1–26.9

TABLE 3. Input values (μg I/kg tissue/product) for the calculation of consumer exposure considering the currently maximum authorised levels of total iodine (scenario A) or the recommended maximum use levels for dairy cows and laying hens (scenario B).

Animal products	Scenario A (1) Maximum authorised use levels	Scenario B (2) Maximum recommended use levels
Mammals liver	250	250
Mammals meat	100	100
Mammals offals and slaughtering products (other than liver)	450	450
Milk	760	280
Eggs	1300	825

TABLE 4. Chronic human dietary exposure to iodine considering deposition data at the maximum authorised levels of iodine in feed (Scenario A).

	Maximum HRP (μg/kg per bw per day)	Default body weight (EFSA Scientific committee, 2012)	Exposure (μg/day)	UL (μg/day)	% UL
Infants	96.27	5	486.3	–	–
Toddlers	93.37	12	1120.4	200	560.2
Other children	123.06	23	2830.4	300	943.5
Adolescents	46.94	52.4 (1)	2459.6	500	491.9
Adults	25.46	70	1782.2	600	297
Elderly	22.8	70	1596	600	266
Very elderly	25.08	70	1755.6	600	292.6

TABLE 5. Chronic human dietary exposure to iodine considering deposition data at the recommended maximum levels of iodine in feed for dairy cows and laying hens (Scenario B).

	Maximum HRP (μg/kg per bw per day)	Default body weight (EFSA scientific committee, 2012)	Exposure (μg /day)	UL (μg /day)	% UL
Infants	36.45	5	182.2	–	–
Toddlers	34.53	12	414.4	200	207.2
Other children	45.47	23	1045.8	300	348.6
Adolescents	17.58	52.4 (1)	921.2	500	184.2
Adults	9.54	70	667.8	600	113.3
Elderly	8.63	70	604.1	600	100.7
Very elderly	9.29	70	650.3	600	108.4

Full text

INTRODUCTION

1

Background and Terms of Reference

1.1

Regulation (EC) No 1831/20031 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 AJAY EUROPE SARL2 for the renewal of the authorisation of the additives potassium iodide (3b201) and calcium iodate anhydrous (3b202), when used as a feed additive for all species (category: nutritional additives; functional group: compounds of trace elements).

According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 14(1) (renewal of the authorisation). The dossier was received on 15 April 2024 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2024‐00223. The particulars and documents in support of the application were considered valid by EFSA as of 31 May 2024.

According to Article 8 of Regulation (EC) No 1831/2003, 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 additives consisting of potassium iodide (3b201) and calcium iodate anhydrous (3b202), when used under the proposed conditions of use (see Section 3.1.3.3).

Additional information

1.2

The additives potassium iodide (3b201) and calcium iodate anhydrous (3b202) are currently authorised for use in feed for all animal species.3 EFSA issued an opinion on the use of iodine in animal feed (EFSA, 2005). Later, EFSA issued several opinions on the safety and efficacy of the compounds under assessment (potassium iodide and/or calcium iodate anhydrous) when used in animal feed (EFSA FEEDAP Panel, 2013a, 2013b, 2013c, 2013d).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of a technical dossier4 in support of the authorisation request for the use of potassium iodide or calcium iodate anhydrous as feed additives.

The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 5 June 2024 to 5 September 2024; the comments received were considered for the assessment.

In accordance with Article 38 of the Regulation (EC) No 178/20025 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation, and of the Decision of EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality,6 a non‐confidential version of the dossier has been published on Open.EFSA.

According to Article 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 22 November to 13 December 2024 for which no comments were received.

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 and experts' (elicitation) knowledge, 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

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of potassium iodide and calcium iodate anhydrous is in line with the principles laid down in Regulation (EC) No 429/20088 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021).

ASSESSMENT

3

The additives potassium iodide (3b201) and calcium iodate anhydrous (3b202) are currently authorised as nutritional feed additives (functional group: compounds of trace elements) for all animal species. The present application concerns the renewal of their authorisations.

Characterisation

3.1

Characterisation of potassium iodide

3.1.1

The additive potassium iodide is currently authorised as an additive consisting of potassium iodide and calcium stearate in powder form with a minimum content of 69% of iodine. The current authorisation states that potassium iodide may be placed in the market and used as an additive consisting of a preparation. The applicant stated that no changes have been introduced in the manufacturing process or in the composition of the additive since the last authorisation.

The active substance potassium iodide with the chemical formula KI; molecular weight: 166.01 g/mol and Chemical Abstract Service (CAS) number 7681‐11‐0 has a theoretical content of iodine of 76.5%.

The data provided by the applicant on the batch‐to‐batch variation,9 impurities10 and physical properties11 of the additive potassium iodide are summarised in Table 1.

The data provided by the applicant showed compliance with the specifications set by the authorising regulation. The FEEDAP Panel considers that the amounts of the detected impurities do not raise safety concerns, except for nickel (see Section 3.2.3).

The feed additive potassium iodide appears as an odourless solid crystalline powder or granules.

No new data have been submitted regarding the stability and homogeneous distribution of the additive in feed. Considering that the manufacturing process and the composition of the additive have not been modified, the FEEDAP Panel considers that the conclusions reached in the previous opinion still apply (EFSA FEEDAP Panel, 2013a).

Characterisation of calcium iodate anhydrous

3.1.2

The additive calcium iodate anhydrous is currently authorised as a powder with a minimum content of 63.5% of iodine. The current authorisation states that potassium iodide may be placed in the market and used as an additive consisting of a preparation. The applicant stated that no changes have been introduced in the manufacturing process of the additive since the last authorisation.

Calcium iodate anhydrous has a molecular formula Ca(IO_3_)2 molecular weight 389.9 g/mol and CAS number 7789‐80‐2.

The data provided by the applicant on the batch‐to‐batch variation,12 impurities13 and physical properties14 of calcium iodate anhydrous are reported in Table 2.

The data provided by the applicant showed compliance with the specifications set by the authorising regulation for calcium iodate anhydrous. The FEEDAP Panel considers that the amounts of the detected impurities do not raise safety concerns, with the exception of nickel (see Section 3.2.3).

The feed additive calcium iodate anhydrous appears as a solid white‐cream powder with a slightly pungent odour.

The current authorisation states that calcium iodate anhydrous may be placed in the market and use as an additive consisting of a preparation. No data on any preparation was submitted by the applicant.

The applicant provided a scanning electron microscopy (SEM) analysis.15 Due to shortcomings identified in the methodology (e.g. the dispersion protocol applied was not in line with the Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles (EFSA Scientific Committee, 2021)), this study is not further considered.

No new data have been submitted regarding the stability and homogeneous distribution of the additive in feed. Considering that the manufacturing process and the composition of the additive have not been modified, the FEEDAP Panel considers that the conclusions reached in the previous opinion still apply (EFSA FEEDAP Panel, 2013a).

Conditions of use

3.1.3

Potassium iodide and calcium iodate anhydrous are currently authorised as sources of iodine for all animal species and categories up to the following maximum total iodine content in complete feed (mg iodine/kg complete feed with a moisture content of 12%):

• –Equines, 4;
• –Ruminants for milk production and laying hens, 5;
• –Fish, 20;
• –Other species or categories of animals: 10;

For both additives, the following is stated under other provisions:

1. The additive shall be incorporated into a compound feed in form of a premixture.
2. Potassium iodide/calcium iodate anhydrous may be placed on the market and used as an additive consisting of a preparation.
3. Protective measures shall be taken according to national regulations implementing Union legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC and 98/24/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
4. In the directions for use of the additive and premixture indicate the storage and stability conditions.
5. The recommended maximum content of total iodine in complete feed for:

• –Equines is 3 mg/kg,
• –Dogs is 4 mg/kg,
• –Cats is 5 mg/kg,
• –Ruminants for milk production is 2 mg/kg and.
• –laying hens 3 mg/kg.

The applicant did not request any change in the current conditions of the authorisation.

Safety

3.2

In the previous assessment (EFSA FEEDAP Panel, 2013a), the FEEDAP Panel considered that potassium iodide and calcium iodate anhydrous as sources of iodine were safe for all animal species/categories and for the environment when used up to the maximum authorised iodine levels in complete feed. Also, the Panel identified a potential risk for the consumer (adults and toddlers), primarily due to the consumption of milk and eggs, where the tolerable upper intake level (UL) for adults (600 μg I/day) would be exceeded by a factor of two and for toddlers (200 μg I/day) by a factor of four. Thereafter, a recommendation to reduce the maximum authorised iodine concentration for dairy cows (from 5 to 2 mg I/kg feed) and for laying hens (from 5 to 3 mg I/kg feed) was made to ensure the exposure of iodine was below the UL for adults (although the iodine intake for toddlers would still be above the UL by 1.6‐fold). With regard to the safety of users in the absence of data, potassium iodide and calcium iodate anhydrous were considered irritant to the eyes, skin and respiratory tract and dermal sensitisers.

In the current application, the applicant stated that no adverse effects or incidents/accidents have been reported from the use of potassium iodide16 or calcium iodate anhydrous17 since the first authorisation of the products.

Extensive literature searches (ELS)

3.2.1

Two literature searches to support the safety for the target species, consumer, user and the environment were provided. The first literature search covered the period from 2015 to 2024 and several databases were consulted (Google Scholar, Base, Mendely, PubMed, ResearchGate); the search presented a number of limitations and/or missing information (e.g. full list of search terms, a priori inclusion/exclusion criteria, complete description of the search strategy, flow‐chart describing the review process, copies of the retrieved articles) and was not further considered in the assessment. The second literature search18 was conducted on two databases (PubMed and Cochrane) and other sources (Google Scholar and citation searches) covering the period from 2015 to 2025. The search included terms relative to the safety of either potassium iodide or calcium iodate anhydrous. The search strategy as well as the inclusion/exclusion criteria were properly described. A total of 25 articles for potassium iodide and 18 articles for calcium iodate anhydrous were selected as potentially relevant for the safety of the additive. These papers were screened by the FEEDAP Panel and those relevant for the current assessment are quoted below in the corresponding chapter.

Safety for the target species

3.2.2

As a result of the ELS, a total of 17 publications were considered relevant for the safety for the target species. These papers were screened by the FEEDAP Panel and it was considered that none of them provided new information relative to the potential of adverse effects associated with the supplementation of iodine in the target animals at the current authorised maximum use levels.

Considering the fact that the manufacturing process and the composition of the additive have not been modified since the previous authorisation and that no new information has been found in the ELS that would indicate a safety concern, the FEEDAP Panel concludes that the additive remains safe for the target species under the current conditions of the authorisation.

Safety for the consumer

3.2.3

The toxicological profile of iodine and the consumer exposure assessment were evaluated in the previous assessment (EFSA FEEDAP Panel, 2013a).

A tolerable upper intake level (UL) of 600 μg/day has been established for adults (including pregnant and lactating women) and ranges between 200 and 500 μg/day for other population groups (SCF, 2003).

In the previous consumer exposure assessment, the iodine deposition values used were not based on specific studies on the deposition of iodine, but on studies published in the literature (EFSA FEEDAP Panel, 2013a). In that opinion, the FEEDAP Panel considered that the iodine content in products from animals receiving the authorised maximum contents of total iodine in complete feed for dairy cows and laying hens, would represent a substantial risk to consumers, mainly for high‐consuming (95th percentile) adults and toddlers. The ULs would be exceeded for adults by a factor of 2 (1230 vs 600 μg I/day), and for toddlers by a factor of 4 (840 vs 200 μg I/day). The Panel considered that the exposure of adult consumers to iodine from foods of animal origin would be below the UL (480 vs 600 μg I/day) if the maximum iodine concentrations in feed for dairy cows and laying hens were reduced to 2 and 3 mg I/kg feed, respectively. However, iodine intake would remain above the UL (1.6‐fold) for high‐consuming toddlers (320 vs 200 μg I/day). Based on that, the FEEDAP Panel recommended to modify some of the authorised maximum iodine contents in complete feed (EFSA FEEDAP Panel, 2013a). Although the currently authorisation did not reduce the maximum contents of iodine in feed, a provision was added under “other provisions” to recommend lower maximum levels for several species (see Section 3.1.3).

The ELS identified 18 publications of potential interest for the safety for the consumer. These papers were screened by the FEEDAP Panel, and it was considered that none of them provided new information relative to the safety for the consumer except for one paper that reported iodine deposition in eggs. This paper is described below.

Reassessment of the consumer exposure

3.2.3.1

The FEEDAP Panel notes that the dataset of deposition values used in the previous opinion (EFSA FEEDAP Panel, 2013a) does not fully comply with the current requirements according to the EFSA FEEDAP Panel Guidance (EFSA FEEDAP Panel, 2017). Data were not available for all target species (e.g. fish), the residue values were not always obtained from animals receiving the additives at the maximum authorised supplementation level of iodine (e.g. chickens for fattening were supplemented at 5 mg I/kg feed and pigs at 8 mg/kg feed) and some data were obtained based on regression calculations (e.g. deposition data in milk and eggs).

In this submission, the applicant was requested to provide additional deposition data in line with the requirements of the above guidance, but these data were not provided.19 In the absence of such information and despite the limitations identified in the previous dataset, the FEEDAP Panel estimated consumer exposure using the deposition data available from the previous assessment but following the methodology described in the guidance on the safety for the consumer (EFSA FEEDAP Panel, 2017).

Deposition data for meat, liver and kidney were available for cattle for fattening at the currently maximum authorised level of 10 mg I/kg complete feed. Data in milk and eggs were available for both currently maximum authorised and recommended levels. These data were obtained supplementing with iodine diets intended for dairy cows and laying hens containing either low or high glucosinolate levels (from rapeseed). Glucosinolates are known to influence the iodine deposition, as reported already by EFSA FEEDAP Panel (2013a). For both milk and eggs, the residue data used to estimate the consumer exposure were calculated as the average of the results obtained for the two glucosinolate contents, to take into account the variability in the composition of the diets (EFSA FEEDAP Panel, 2013a). One paper found in the literature search conducted by the applicant reports deposition data of iodine in eggs. In this study, hens were fed diets (with no rapeseed) supplemented with 2.5 or 5 mg I/kg feed. The corresponding iodine concentrations in whole eggs were 1022 μg I/kg egg and 1128 μg I/kg egg, respectively (Bakhshalinejad et al., 2018). The FEEDAP Panel notes that the deposition data observed in this study are in line with those used in the previous assessment for eggs from hens fed diets with low glucosinolate content (EFSA FEEDAP Panel, 2013a) and, therefore, does not deem necessary to modify the assumptions considered in the previous assessment and the deposition data used in the consumer exposure.

The FEEDAP Panel notes that deposition data are available for chickens for fattening, however, these data were obtained following a supplementation level of iodine below (5 mg/kg feed) the currently authorised level for this category (10 mg/kg feed). Similarly, data on meat and liver of pigs were available, however the levels of iodine in feed were lower (8 mg/kg feed) compared to that currently authorised for this species (10 mg/kg feed). Therefore, these data were considered not adequate for the consumer exposure assessment by the FEEDAP Panel.

Based on the authorisation currently in place for the additives under assessment, the FEEDAP Panel considered appropriate to calculate the consumer exposure considering both the maximum authorised levels (Scenario A) and the recommended maximum use levels (Scenario B). Deposition data used for both scenarios are described in Table 3.

The results of the dietary exposure to iodine (from the additives under assessment) for the different population categories are reported in Table 4 (Scenario A) and in Table 5 (Scenario B).

The limited data available would indicate that the exposure of consumers exceeds the UL in all age classes highlighting a concern for consumer safety, in line with the previous conclusions (EFSA FEEDAP Panel 2013a). The UL would also be exceeded when the consumer exposure is calculated based on the maximum recommended levels of iodine in feed (scenario B). The Panel notes that these calculations did not consider exposure via food products from pigs, fish or poultry (other than eggs). It is therefore likely that when the additional exposure via food products from all animal species is considered, the UL would be further exceeded.

However, considering the limitations described above, the Panel considers that additional data on iodine deposition following the current requirements is needed to allow a proper assessment of consumer exposure and a conclusion on consumer safety. Therefore, in the lack of adequate data, the FEEDAP Panel cannot conclude on the safety for the consumer of potassium iodide and calcium iodate anhydrous, under the approved conditions of use.

Safety for the user

3.2.4

In the previous assessment, the FEEDAP Panel, in absence of data, concluded that potassium iodide and calcium iodate anhydrous were considered irritant to the eyes, skin and respiratory tract, and dermal sensitisers. Exposure by inhalation should be avoided (EFSA FEEDAP Panel, 2013a).

Based on the highest dusting potential measured (Section 3.1), the FEEDAP Panel considers that the exposure of users through inhalation is likely.

The FEEDAP Panel notes that the additive contains nickel (Section 3.1). The European Directive 2022/431^4^ sets an occupational exposure limit (OEL) of 0.01 and 0.05 mg/m^3^ for both respirable and inhalable fraction, respectively, as nickel meets the criteria for classification as carcinogenic (category 1A). Therefore, to reduce the risk, the FEEDAP Panel considers that the exposure of the users should be minimised.

The eye irritation potential of potassium iodide was tested in a study performed according to OECD Testing Guideline 437, which showed that the additive is not an eye irritant.20

Based on the information present in the safety data sheet,21 calcium iodate anhydrous is irritant to the eye.

The additives should be considered skin and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. Potassium iodide is not an eye irritant, but calcium iodate is considered an eye irritant.

Safety for the environment

3.2.5

The assessment of the safety of both additives for the environment is focused on iodine only.

The applicant provided an environmental risk assessment according to the EFSA FEEDAP Panel guidance to evaluate the safety of the feed additive for the environment (EFSA FEEDAP Panel, 2019). The conditions of use indicate that for terrestrial animals, pigs for fattening are the worst‐case scenario. At a total maximum level of iodine of 10 mg I/kg feed, the predicted environmental concentration in soil (PEC_soil_) would correspond to 201.5 μg/kg soil dw (PEC_soil plateau_ 901.4 μg/kg soil dw). This value is lower than the 10% of the natural background concentration in soil, based on the 90th percentile for topsoil of 1.12 mg/kg soil dw from the FOREGS database (2005)22. Therefore, no safety concerns are expected when both additives are used in the terrestrial target species.

Considering aquatic species, for land‐based aquaculture, the maximum authorised level in fish of 20 mg I/kg feed results in PEC in surface water (land‐base aquaculture; PEC_swaq_) (range 0.023–0.050 μg/L) below both the trigger value of 0.1 μg/L and the natural background concentration in water (90th percentile) of the FOREGS database (2005)23. Therefore, no safety concerns are expected when both additives are used for aquatic species (land‐based aquaculture).

When the additives are used in marine aquaculture, the compartment considered more at risk is marine sediment (EFSA FEEDAP Panel, 2019). A use level of 20 mg I/kg feed results in a PEC for marine sediment (PEC_marine sediment_) of 44.1 mg/kg marine sediment dw. No background concentration of iodine in marine sediment is available. However, the FEEDAP Panel considers that, due to the high solubility of iodide and iodate in water, iodine would not represent a safety concern for marine sediment.

Conclusions on safety for the environment

3.2.5.1

The use of both additives in animal nutrition, according to the proposed conditions of use, will not significantly alter the concentration of iodine in the concerned environmental compartments. The FEEDAP Panel concludes that the use of potassium iodide and calcium iodate anhydrous under the current authorised conditions remains safe for the environment.

Efficacy

3.3

The present application for the 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 nutritional additive, functional group: compounds of trace elements. Therefore, there is no need to assess the efficacy of the additive in the context of the renewal of the authorisation.

Post‐market monitoring

3.4

The FEEDAP Panel considers that there is no need for specific requirements for a post‐market monitoring plan other than those established in the Feed Hygiene Regulation24 and Good Manufacturing Practice.

CONCLUSIONS

4

The applicant provided evidence that the additives potassium iodide and calcium iodate anhydrous currently on the market comply with the conditions of the authorisation.

The use of potassium iodide and calcium iodate anhydrous in animal nutrition remains safe for the target species and the environment under the approved conditions of use.

The limited data available indicate that the exposure of consumers exceeds the UL in all age classes highlighting a concern for consumer safety. In the lack of adequate data, the FEEDAP Panel cannot conclude on the safety for the consumer of potassium iodide and calcium iodate anhydrous, under the approved conditions of use.

Potassium iodide is not an eye irritant, but calcium iodate anhydrous is an eye irritant. Both additives should be considered skin and respiratory sensitisers. Inhalation and dermal exposure are considered a risk.

There is no need to assess the efficacy of the additives in the context of the renewal of the authorisation.ABBREVIATIONSADIacceptable daily intakebwbody weightCASChemical Abstracts ServiceDMdry matterdwDry weightEURLEuropean Union Reference LaboratoryFAOFood Agricultural OrganizationFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedHRPmaximum highest reliable percentileIUPACInternational Union of Pure and Applied ChemistrynDL‐PCBsnon‐dioxin‐like PCBsPCBpolychlorinated biphenylPCDDpolychlorinated dibenzo‐p‐dioxinPCDFpolychlorinated dibenzofuranPECPredicted environmental concentrationOECDOrganisation for Economic Co‐operation and DevelopmentOELoccupational exposure limitRHrelative humiditySCANScientific Committee on Animal NutritionTEQToxic equivalent factors for dioxins, furans and dioxin‐like PCBs established by WHO in 2005ULtolerable upper levelWHOWorld Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00223

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PANEL MEMBERS

Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe, and Katerina Theodoridou.