Assessment of the feed additive consisting of coated granulated cobalt(II) carbonate for ruminants with functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals for the renewal of its authorisation (Dox‐al Italia SpA)

TL;DR

This paper assesses the safety and efficacy of a cobalt additive for various animals, confirming its effectiveness but raising concerns about some coating agents.

Contribution

The paper evaluates a modified manufacturing process for a cobalt additive and its safety implications.

Findings

The cobalt component is safe for target species and the environment.

The additive is effective as a cobalt source for the specified animals.

Safety of coating agents remains uncertain 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 coated granulated cobalt(II) carbonate as nutritional feed additive for ruminants with functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals. The additive is already authorised for use for these animal species. The applicant has provided evidence that, in essence, the additives under assessment comply with the conditions of the authorisation. In addition, a modification in the manufacturing process (i.e. addition of 0.2% sepiolite) is proposed. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the cobalt component from the additive (cobalt(II) carbonate) remains safe for the target species and the environment. However, due to the absence of adequate data on some of the coating agents used in the manufacture of the additive, the Panel cannot conclude on the safety of coated granulated cobalt(II) carbonate for the target species and the environment. Due to the lack of adequate cobalt deposition data and information on the safety of some of the coating agents listed by the applicant, the FEEDAP Panel cannot conclude on the safety for the consumer. With regards to the safety for the users, the additive should be considered as irritant to the skin and eyes and a dermal and respiratory sensitiser. Any exposure is considered a risk and should be minimised. The FEEDAP Panel concludes that the additive is an efficacious source of cobalt in feeds for ruminants with functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals.

Tables

TABLE 1. Data on the batch‐to‐batch variation and impurities of the coated granulated cobalt(II) carbonate 5% with and without anticaking agent. The data presented are average values and (range) for batch‐to‐batch variation, and ranges for all other parameters. The number of batches analysed per parameter, or group of parameters are indicated within squared brackets.

Parameter	Additive as authorised	Additive with anticaking agent
Specifications
Cobalt (%) (1)	1–5	1–5
Batch‐to‐batch variation	[5]	[5]
Cobalt (%) (2)	4.97 (4.55–5.50)	4.95 (4.77–5.20)
Impurities (mg/kg)	[5]	[5]
Lead	0.11–0.13	0.12–0.65
Mercury	< 0.01	< 0.01
Cadmium	0.07	< 0.01–0.19
Arsenic	0.39–0.43	0.36–0.63
Fluorine (as fluoride)	40.2–43.1	37.5–43.8
Nickel	1.88–2.99	2.02–2.39
Dioxins and furans (upper bound) (3)	[3]	[3]
PCDD/Fs (ng WHO2005‐TEQ/kg)	0.085–0.141	0.043–0.157
PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg)	0.089–0.163	0.051–0.183
nDL‐PCBs (μg/kg)	0.012–0.047	0.016–0.086

TABLE 2. Data on the physical properties of the coated granulated cobalt(II) carbonate 5% with and without anticaking agent. The number of batches analysed per parameter, or group of parameters are indicated in squared brackets.

Parameter	Additive as authorised	Additive with anticaking agent
Specifications
Particles below 50 μm (%)	< 1	< 1
Physical properties	[3]	[3]
Physical form	Solid granules	Solid granules
Bulk density (kg/m3)	1290	1510
Dusting potential (Stauber Heubach) (mg/m3)
Before compression	5	5
After compression	20–30	15–20
Particle size (laser diffraction)
Particles below 50 μm (% v/v)	0.04–0.65	0.90–0.94
Mean particle size (μm)	763–889	791–794

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 13(3) of that Regulation lays down that if the holder of an authorisation proposes changing the terms of the authorisation by submitting an application to the Commission, accompanied by the relevant data supporting the request for the change, the Authority shall transmit its opinion on the proposal to the Commission and the Member States. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest 1 year before the expiry date of the authorisation.

The European Commission received a request from Dox‐al Italia SpA2 for the renewal of the authorisation and the modification of the terms of the authorisation of the additive consisting of coated granulated cobalt(II) carbonate, when used as a feed additive for ruminants with functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals (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 13(3) (modification of the authorisation of a feed additive) and under Article 14(1) (renewal of the authorisation). The dossier was received on 21 October 2022 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2022‐00745. The particulars and documents in support of the application were considered valid by EFSA as of 15 May 2023.

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 additive consisting of coated granulated cobalt (II) carbonate, when used under the proposed conditions of use (see Section 3.1.3).

Additional information

1.2

The additive is a coated granulated preparation of cobalt (II) carbonate. EFSA issued an opinion on the safety and efficacy of this product when used in feed for all animal species (EFSA FEEDAP Panel, 2012).

The additive is currently authorised for use in feed for ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals (3b304).3

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 coated granulated cobalt (II) carbonate as a feed additive.

The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 15 May to 15 August 2023 for which the received comments 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 28 July to 18 August 2023 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/agent in animal feed/marker residue in tissues 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 coated granulated cobalt (II) carbonate 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 additive coated granulated cobalt(II) carbonate (3b304) is currently authorised as a nutritional feed additive (functional group: compounds of trace elements) for ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals. The applicant requested the renewal of the above authorisation.

Characterisation

3.1

Characterisation of the additive

3.1.1

The additive is currently authorised as a coated granulated preparation of cobalt(II) carbonate with a cobalt content of 1%–5%. The authorisation also specifies that the additive contains 2.3%–3.0% of coating agents and dispersants (choice of polyoxyethylene sorbitan monolaurate, glycerol polyethyleneglycol ricinoleate, polyethyleneglycol 300, sorbitol and maltodextrin).9 In addition, the particles below 50 μm should be below 1%.

In addition to the above, the additive is mainly constituted by carriers, i.e. calcium magnesium carbonate, calcium carbonate and corn cobs.

The applicant requested a small modification in the manufacturing process to include up to 0.2% of sepiolite (1g562) as a binder/anticaking agent, to reduce the variability of the particle size between batches.

Although the authorisation foresees the possibility of different preparations with a cobalt content ranging from 1% to 5%, the applicant provided data only on a preparation containing 5% cobalt. The data on the batch‐to‐batch variation and impurities of coated granulated cobalt(II) carbonate manufactured with and without sepiolite specified to contain 5% cobalt is given in Table 1.10

The analytical data showed compliance with the specifications set in the authorising regulation for both the currently authorised additive and the one with the proposed addition of sepiolite. The proposed addition of the anticaking agent did not affect the content of cobalt in the additive from an analytical point of view. The FEEDAP Panel considers that the amounts of the detected impurities do not raise safety concerns, except for nickel (see Section 3.2.5).

Data on the physical properties of coated granulated cobalt(II) carbonate manufactured with and without sepiolite specified to contain 5% cobalt is given in Table 2.11

The applicant provided data in order to investigate the presence of small/nano particles in the additive with anticaking agent.12 Based on the qualitative scanning electron microscopy (SEM) analysis provided, no firm conclusion can be drawn on the level of small/nano particles present in the formulated material due to the presence of aggregates. Furthermore, energy dispersive X‐ray spectroscopy data were not provided to indicate the chemical nature of the particles. The FEEDAP Panel notes that the active substance is insoluble in water. Although it is expected that the solubility increases with decreasing pH,13 no data on dissolution rate following 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) was made available.

The homogenous distribution of the additive in feed was previously demonstrated (EFSA FEEDAP Panel, 2012). It is not expected that the proposed change by the addition of the binder/anticaking agent will have an effect on the homogeneous distribution of the additive in feed.

Characterisation of the active substance

3.1.2

The applicant stated that the source of the active substance used in the manufacturing of the additive is cobalt(II) carbonate complying with the purity conditions (minimum content of 46% cobalt) set for the currently authorised cobalt(II) carbonate (3b302).

The identity of the cobalt(II) carbonate was confirmed via X‐ray diffraction analysis.14 The cobalt content in three batches was in the range of 48.3%–48.4%;15 water content was in the range of 2.78%–2.92%.16

Conditions of use

3.1.3

The additive is currently authorised for ruminants with a functional rumen, equidae, lagomorphs, rodents, herbivore reptiles and zoo mammals up to a maximum (total) concentration in complete feed of 1 mg Co/kg.

Under other provisions it is stated:

• The additive shall be incorporated into feed in the form of a premixture.

• Protective measures shall be taken according to national regulations implementing EU 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.

• Declarations to be made on the labelling of the additive and premixture, if applicable:

• —Cobalt content

• —It is recommended to limit the supplementation with Cobalt to 0.3 mg/kg in complete feed. In this context, the risk for cobalt deficiency due to local conditions and the specific composition of the diet should be taken into account.

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

Safety

3.2

The safety of the additive was assessed by the FEEDAP Panel in a previous opinion (EFSA FEEDAP Panel, 2012). In that opinion, the Panel concluded that the additive is safe when supplemented up to the maximum authorised level of cobalt in feed for the target animals, the consumers and the environment. The additive was considered as a skin and eye irritant and as a dermal and respiratory sensitiser, and exposure by inhalation must be avoided.

The applicant stated that no adverse effects in target species and users have been reported since the previous authorisation.

For the current assessment, the applicant provided extensive literature searches to support the safety of the additive.

Safety of the carriers and coating agents

3.2.1

The additive coated granulated cobalt (II) carbonate is manufactured by mixing the active substance in the form of cobalt (II) carbonate with coating agents (polyoxyethylene (20) sorbitan monolaurate (E432), glycerol polyethyleneglycol ricinoleate (E484), polyethyleneglycol 300, sorbitol (E420ii), maltodextrin), an anticaking agent (sepiolite 1g562) and carriers (calcium magnesium carbonate, calcium carbonate, corn cobs).

The Panel notes that the carriers, sorbitol and maltodextrin are feed materials, that sepiolite is currently authorised as a feed additive for use in feed of all animal species at levels up to 20,000 mg/kg complete feed, several orders of magnitude higher than its inclusion level in the current additive and that the coating agent glycerol polyethyleneglycol ricinoleate (E484) is an authorised feed additive currently under re‐evaluation.

The Panel notes that the other coating agents (polyoxyethylene (20) sorbitan monolaurate (E432) and polyethyleneglycol 300), are not authorised feed additives and that in the previous opinion, the assessment of the coating agents was based on the specific purity criteria of the compounds used, which was either based on its specifications as food additives or in the European Pharmacopeia (EFSA FEEDAP Panel, 2012). No information in support of the safety of the above‐mentioned coating agents was submitted. In the absence of such information, the Panel is not in the position to conclude on their safety in the context of the present assessment.

Extensive literature searches

3.2.2

The applicant performed a series of literature searches to provide evidence that in the light of the current knowledge, the additive remains safe for the target species, consumers, users and the environment under the approved conditions. A first ELS was not considered as several shortcomings were identified (e.g. number of databases used, incomplete search terms, lacking details of the inclusion/exclusion criteria). The second ELS was conducted on Web of Science, PubMed and Google Scholar covering the period 2012–2024, with one ELS for each safety aspect (target species, consumer, users and the environment). A third literature search was performed on Scopus, Web of Science and the meta database of Wageningen University covering the period 2009–2025 with the aim to identify papers providing data on Co deposition in food products. In all cases, the search strategy as well as the inclusion and exclusion criteria applied were described. No relevant papers were identified in any of the literature searches indicating an adverse effect of cobalt.

Safety for the target species

3.2.3

In its previous opinions (EFSA FEEDAP Panel, 2012), the Panel concluded that the coated cobalt(II) carbonate is safe for the target species when used at the maximum authorised total cobalt content in complete feed, which at that time was 2 mg/kg complete feed. The current maximum authorised level of cobalt is 1 mg/kg complete feed.

The ELS did not identify any papers that would indicate an adverse effect of cobalt under the authorised conditions of use for the target species.

Therefore, and considering that the manufacturing process and composition of the additive have not been significantly changed, the Panel considers that there are no reasons to revise its previous conclusions with regards the cobalt (II) carbonate component of the additive, which is considered to remain safe for the target species under the approved conditions.

However, considering that the safety of some of the coating agents (polyoxyethylene (20) sorbitan monolaurate (E432) and polyethyleneglycol 300) could not be established in the context of this application (see Section 3.2.1), the Panel cannot conclude on the safety of the additive coated granulated cobalt (II) carbonate for the target species.

Safety for the consumer

3.2.4

The toxicological profile of cobalt and the consumer exposure were evaluated in the previous assessments (EFSA FEEDAP Panel, 2009; EFSA FEEDAP Panel, 2012). Cobalt(II) cations are considered genotoxic under in vitro and in vivo conditions and have CMR (carcinogen, mutagen and reproduction toxicant) properties. No data were available on the potential carcinogenicity of cobalt(II) following oral exposure either in humans or in experimental animals. However, oral exposure may potentially entail a number of adverse effects in humans (cardiac effects, effects on erythropoiesis, effects on thyroid, developmental effects and allergic dermatitis). For these threshold effects, the FEEDAP Panel developed a health‐based guidance value of 0.0016 mg/kg body weight (bw) per day for oral cobalt calculated based on the lowest observed adverse effects level (LOAEL) of about 1 mg/kg bw per day (based on polycythaemia) observed in a 22‐day study on volunteers and applying an uncertainty factor (UF) of 600. Based on the exposure calculation, no safety concern for the consumer was expected for threshold effects of oral cobalt (EFSA FEEDAP Panel, 2012). No studies were identified in ELS that would lead to a modification of the health‐based guidance value of 0.0016 mg/kg bw per day as established in the previous FEEDAP opinion.

Reassessment of consumer exposure

3.2.4.1

The FEEDAP Panel notes that the dataset of deposition values used in the previous opinion (EFSA FEEDAP Panel, 2012) does not fully comply with the current requirements according to the EFSA FEEDAP Panel Guidance on consumer safety (EFSA FEEDAP Panel, 2017a).

In the previous assessment (EFSA FEEDAP Panel, 2012) some deposition data of cobalt in animal tissues and products were derived from surveys rather than animal studies. These data were used for the exposure assessment and the FEEDAP Panel concluded that no safety concern for the consumer was expected for threshold effects, considering that the exposure to cobalt was about 4–10 times lower than the health‐based guidance value established (0.0016 mg/kg bw per day).

Considering the limitations above, during the present assessment, the applicant was requested to provide additional deposition data in line with the requirements of the above‐mentioned guidance. No cobalt deposition studies were conducted, but an extensive literature search was performed (see Section 3.2.2), aimed at providing information on the levels of cobalt in milk and edible tissues from dairy cows and cattle and/or other mammals, which were considered by the FEEDAP Panel as the main source of exposure of consumers to cobalt.

No relevant data was identified by the applicant from the ELS. The Panel however, identified one paper (Akins et al., 2013) which is considered relevant for the current assessment. This paper was already assessed by the FEEDAP Panel in a recent opinion on the renewal of the authorisation of cobalt compounds (EFSA FEEDAP Panel, 2025). In that opinion, the Panel noted that ‘The limited data available would indicate that the exposure of consumers exceeds the health‐based guidance values in all population categories, highlighting a concern for consumer safety’, with exposures ranging between 194% and 1075% of the health‐based guidance value for cobalt. The FEEDAP Panel noted that these calculations did not consider exposure via food products from mammals other than milk (e.g. cattle, rabbits, horses). It is therefore likely that, when the additional exposure via food products from all animal species is considered, the health‐based guidance value would be further exceeded.

Considering the limitations described above, the Panel considers that additional data on cobalt deposition in tissues (muscle, liver, kidney and fat) and milk following the requirements of the guidance on consumer safety (EFSA FEEDAP Panel, 2017a) are needed to allow a proper assessment of consumer exposure and a conclusion on consumer safety.

Therefore, due to the lack of adequate data in cobalt deposition and the lack of information on the safety of some of the coating agents (i.e. polyoxyethylene (20) sorbitan monolaurate (E432) and polyethyleneglycol 300), the FEEDAP Panel cannot conclude on the safety of additive coated cobalt(II) carbonate for the consumer, under the approved conditions of use.

Safety for the user

3.2.5

In its previous opinion, the Panel concluded that the additive should be considered as a skin and eye irritant and as a dermal and respiratory sensitiser, and exposure by inhalation must be avoided (EFSA FEEDAP Panel, 2012).

No new experimental studies have been provided by the applicant on the safety of the user.

The FEEDAP Panel further notes that Committee for Risk Assessment (RAC) of the European Chemical Agency (ECHA) issued an opinion on scientific evaluation of occupational exposure limits for cobalt and inorganic cobalt compounds (ECHA, 2012). OELs of 0.0005 mg Co/m^3^ (respirable fraction) and 0.001 mg Co/m^3^ (1 μg Co/m^3^; inhalable fraction) have been identified. In addition, a notation for skin and respiratory sensitisation have been added.

Cobalt is classified under the Classification, Labelling and Packaging (CLP) Regulation^54^ as ‘Carc. 1B’, ‘Muta. 2’, ‘Repr. 1B’, ‘Resp. Sens. 1’ and ‘Skin Sens. 1’.

The additive contains nickel. The Directive (EU) 2022/43137 set an occupational exposure limit (OEL) of 0.01 and 0.05 mg/m^3^ for both respirable and inhalable fractions, respectively, as nickel meets the criteria for classification as carcinogenic (category 1A). Due to the presence of nickel, it should be considered as a skin and respiratory sensitiser.

Based on the safety data sheet, the additive should also be considered as irritant to skin and eyes.

Therefore, based on the above, the FEEDAP Panel concludes that the additive should be considered as irritant to the skin and eyes and a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk and should be minimised.

Safety for the environment

3.2.6

In previous opinions, the FEEDAP Panel concluded that the use of cobalt from any source at the authorised maximum content in feed does not pose a risk to the environment (EFSA FEEDAP Panel, 2012). It is noted that, at the time of these assessments, the maximum authorised dietary level of cobalt was 2 mg/kg complete feed. The literature search conducted by the applicant did not provide data that would lead to the revision of the previous conclusions on the safety of cobalt compounds for the environment.

To assess the environmental risk of cobalt from the additive, the Panel compared the worst‐case predicted environmental concentrations (PECs), calculated at the maximum authorised level of cobalt (1 mg Co/kg complete feed), with the natural background concentration considered as the 90th percentile value from the FOREGS database. If the predicted concentrations (PECs) fall below 10% of this value, no further risk assessment is needed. The 90th percentile concentration of cobalt in soil based on 837 topsoil samples collected throughout Europe for the FOREGS survey was 17 mg Co/kg (FOREGS database 200517). As regards the use of the additive in terrestrial farm animals, cattle for fattening were considered the worst‐case scenario with a PEC_soil_ of 17 μg/kg. This value is well below 10% of the natural background concentration of cobalt in soil (1.7 mg Co/kg soil dry weight). Therefore, it is concluded that no concerns are expected for the environment.

From the five possible coating agents, three are either feed materials and/or are authorised feed additives under re‐evaluation; and the remaining two need an environmental risk assessment (polyoxyethylene (20) sorbitan monolaurate (E432) and polyethyleneglycol 300). The information provided in support of the safety of these two coating agents for the environment is not considered adequate (reference to an ECHA dossier or a scientific publication (Rogers et al., 2019) not considered relevant for the present assessment). In the absence of such information, the Panel is not in the position to conclude on their safety in the context of the present assessment.

Overall, the use of cobalt from cobalt(II) carbonate up to the maximum recommended level does not represent a safety concern for the environment. However, in the absence of adequate data on some of the coating agents used (polyoxyethylene (20) sorbitan monolaurate (E432) and polyethyleneglycol 300), a final conclusion on the safety of the environment of the additive using these coating agents cannot be reached.

Efficacy

3.3

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. Therefore, there is no need to re‐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 Regulation18 and Good Manufacturing Practice.

CONCLUSIONS

4

The applicant provided evidence that the additive currently in the market complies with the existing conditions of the authorisation. In addition, the applicant proposed a small modification in the manufacturing process of the additive (i.e. addition of 0.2% sepiolite) which does not have an impact on its composition.

The Panel concludes that, considering only the cobalt component, the additive remains safe for the target species. However, in the absence of adequate data on some of the coating agents used in the manufacture of the additive, the Panel cannot conclude on the safety of coated granulated cobalt(II) carbonate for the target species.

The FEEDAP Panel cannot conclude on the safety of additive coated cobalt(II) carbonate for the consumer, under the approved conditions of use due to the lack data in cobalt deposition and the lack of information on the safety of some of the coating agents.

With regards to user safety, the additive should be considered as irritant to the skin and eyes and a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk and should be minimised.

The use of cobalt from cobalt(II) carbonate up to the maximum authorised total cobalt level does not represent a safety concern for the environment. However, in the absence of adequate data on some of the coating agents used, the FEEDAP Panel cannot conclude on the safety for the environment of the additive.

There is no need to re‐assess the efficacy of the additive in the context of the renewal of the authorisation.

ABBREVIATIONSBWbody weightCASChemical Abstracts ServiceCDCommission DecisionCDGchemically defined groupCGchemical groupCLPClassification, Labelling and PackagingCVcoefficient of variationDMdry matterECHAEuropean Chemicals AgencyEINECSEuropean Inventory of Existing Chemical SubstancesEURLEuropean Union Reference LaboratoryFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedFL‐noFLAVIS numberLODlimit of detectionLog Kowlogarithm of octanol–water partition coefficientLOQlimit of quantificationMWmolecular weightnDL‐PCBsnon‐dioxin‐like PCBsNOAELno observed adverse effect levelOECDOrganisation for Economic Co‐operation and DevelopmentOELoccupational exposure limitPCBspolychlorinated biphenylsPCDDspolychlorinated dibenzo‐p‐dioxinsPCDFspolychlorinated dibenzofuransPECspredicted environmental concentrationsRACCommittee for Risk AssessmentSEMscanning electron microscopyTEQtoxic equivalent factors for dioxins, furans and dioxin‐like PCBsUFuncertainty factor

REQUESTOR

European Commission

QUESTION NUMBERS

EFSA‐Q‐2022‐00745

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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, and Katerina Theodoridou.