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Safety and efficacy of a feed additive consisting of tartrazine for its use in baits for freshwater fish (GIFAP)

Authors:

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tartrazine as sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). Tartrazine is intended to be incorporated in fishing baits up to a maximum of 30 mg/kg in complementary feed in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture. Tartrazine is already authorised for use with cats and dogs, ornamental fish, grain‐eating ornamental birds and small rodents. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of tartrazine in the preparation of baits for freshwater fish under the proposed conditions of use is of no concern for the target animals. The use of tartrazine as a feed additive under the proposed conditions of use is considered safe for the consumer and the environment. Regarding the user safety, the additive should be considered a dermal and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the irritation potential of the additive. In absence of data, no conclusion can be reached on the efficacy of tartrazine in freshwater fish baits.
EFSA Journal. 2024;22:e9021.
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https://doi.org/10.2903/j.efsa.2024.9021
efsa.onlinelibrary.wiley.com/journal/1831-4732
SCIENTIFIC OPINION
Safety and efficacy of a feed additive consisting of tartrazine
for its use in baits for freshwater fish (GIFAP)
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
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 | Katerina Theodoridou | Gabriele Aquilina |
Maria Bastos | Georges Bories | Paul Brantom | Jurgen Gropp | Kettil Svensson |
Luca Tosti | Antonio Finizio | Anna Dioni | Maria Dulak- Lis | Jaume Galobart |
Orsolya Holczknecht | Paola Manini | Alberto Navarro- Villa | Daniel Pagés Plaza |
Fabiola Pizzo | Anita Radovnikovic | Maria Vittoria Vettori | Angelica Amaduzzi
Adopted: 17 Septemb er 2024
DOI: 10. 2903/j.ef sa.2024.9 021
This is an ope n access article under th e terms of the Creative Commons Attribution-NoDerivs License, whi ch permits use and distr ibution in any medium, pr ovided the
original work is properly cited and no modifications or adaptations are made.
© 2024 European Food S afety Authority. EFSA Jo urnal published by W iley-VCH GmbH on behalf of Eu ropean Food Safet y Authority.
Correspondence: feedap@efsa.europa.eu
Abstract
Following a request from the European Commission, EFSA was asked to deliver a
scientific opinion on the safety and efficacy of tartrazine as sensory additive (func-
tional group: (a) colourants: (i) substances that add or restore colour in feeding-
stuffs). Tartrazine is intended to be incorporated in fishing baits up to a maximum
of 30 mg/kg in complementary feed in order to colour them and attract fish in
freshwater (ponds, rivers), for both recreational and competitive fishing. The ad-
ditive is not intended for use in aquaculture. Tartrazine is already authorised for
use with cats and dogs, ornamental fish, grain- eating ornamental birds and small
rodents. The EFSA Panel on Additives and Products or Substances used in Animal
Feed (FEEDAP) concluded that the use of tartrazine in the preparation of baits for
freshwater fish under the proposed conditions of use is of no concern for the tar-
get animals. The use of tartrazine as a feed additive under the proposed conditions
of use is considered safe for the consumer and the environment. Regarding the
user safety, the additive should be considered a dermal and respiratory sensitiser.
Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not
conclude on the irritation potential of the additive. In absence of data, no conclu-
sion can be reached on the efficacy of tartrazine in freshwater fish baits.
KEYWORDS
colourant, ef ficacy, freshwater fish, safety, sensory additive, tartrazine
The declar ations of interest of all sci entific
exper ts active in EFSA’s work are available
at https://ess.efsa.europa.eu/doi/doiweb/
doisearch
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CONTENTS
Abstract................................................................................................................................................................................................................................1
1. Introduction ..............................................................................................................................................................................................................3
1.1. Background and terms of reference .....................................................................................................................................................3
1.2. Additional information ..............................................................................................................................................................................3
2. Data and methodologies ......................................................................................................................................................................................3
2.1. Data ...................................................................................................................................................................................................................3
2.2. Methodologies..............................................................................................................................................................................................4
3. Assessment ................................................................................................................................................................................................................4
3.1. Characterisation ...........................................................................................................................................................................................4
3.1.1. Characterisation of the additive ..............................................................................................................................................4
3.1.2. Stability and homogeneity .......................................................................................................................................................5
3.1.3. Conditions of use ..........................................................................................................................................................................5
3.2. Safety ................................................................................................................................................................................................................5
3. 2.1. Absorption, distribution, metabolism and excretion and residues ...........................................................................5
3.2.2. Toxicological profile ....................................................................................................................................................................6
3.2.3. Safety for the target species .....................................................................................................................................................6
3.2.4. Safety for the consumer .............................................................................................................................................................7
3.2.5. Safety for the user ........................................................................................................................................................................7
3.2.6. Safety for the environment .......................................................................................................................................................7
3.3. Efficacy .............................................................................................................................................................................................................7
4. Conclusions ................................................................................................................................................................................................................7
Abbreviations ....................................................................................................................................................................................................................8
Acknowledgements ........................................................................................................................................................................................................8
Requestor ............................................................................................................................................................................................................................8
Question number .............................................................................................................................................................................................................8
Copyright for non- EFSA content.................................................................................................................................................................................8
Panel members .................................................................................................................................................................................................................8
References...........................................................................................................................................................................................................................8
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1 | INTRODUCTION
1.1 | Background and Terms of Reference
Regulation (EC) No 1831/2003 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 feed additive shall submit an application in accordance with Article 7.
The European Commission received a request from GIFAP1 for the authorisation of the additive consisting of tartrazine,
when used as a feed additive for freshwater fish (category: sensory additives; functional group: (a) colourants: (i) substances
that add or restore colour in feedingstuffs).
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 4(1) (authorisation of a feed additive or new use of a feed ad-
ditive). 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 31st March 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 con-
ditions 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 tartrazine, when used under the proposed conditions
of use (see Section3.1.3).
1.2 | Additional information
Tartrazine is authorised as a feed additive for cats and dogs, ornamental fish, grain- eating ornamental birds and small ro-
dents (2a102).2 The EFSA FEEDAP Panel issued in 2016 an opinion on the safety of this additive when used in feed for cats
and dogs, ornamental fish, grain- eating ornamental birds and small rodents (EFSA FEEDAP Panel,2016).3
2 | DATA AND METHODOLOGIES
2.1 | Data
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 tartrazine as a feed additive. The dossier was received on 7 November 2022 and the
general information and supporting documentation is available at https:// open. efsa. europa. eu/ quest ions/ EFSA-Q- 2022-
00779 .
The confidential version of the technical dossier was subject to a target consultation of the interested Member States
from 31 March 2023 to 30 June 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.
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 30 January to 20 February 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' knowl-
edge, 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 tartrazine in animal feed are valid and applica-
ble for the current application.7
1GIFAP, BP 25 Saint- Laurent Mé doc - France , France.
2Commission Im plementing Regulati on (EU) 2020/157 of 5 February 2020. OJ L 34, 6 .2.2020, p. 15.
3Commission R egulation (EU) No 231/2012. OJ L 83, 22.3. 2012, p. 1.
4Dossier reference: FEED- 2022- 7830.
5Regulatio n (EC) No 178/2002 of the Euro pean Parliament and of the Co uncil of 28 January 2002 lay ing down the general pri nciples and requireme nts of food law,
establish ing the European Food Saf ety Authority and l aying down procedures in m atters of food safe ty. OJ L 31, 1.2.2002, p. 1–48.
6Decision av ailable at: https://www.efsa.europa.eu/en/corporate- pubs/transparency- regulation- practical- arrangements.
7Evaluation re port received on 14/3/2019 and availabl e on the EU Science Hub https:// joint- resea rch- centre. ec. europa. eu/ eurl- fa- eurl- feed- addit ives/ eurl- fa- autho risat
ion/ eurl- fa- evalu ation- repor ts_ en.
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2.2 | Methodologies
The approach followed by the FEEDAP Panel to assess the safety and the efficacy of tartrazine is in line with the principles
laid down in Regulation (EC) No 429/20088 and the relevant guidance documents: Guidance on the assessment of the
safety of feed additives for the consumer (EFSA FEEDAP Panel,2017a), Guidance on the identity, characterisation and condi-
tions of use of feed additives (EFSA FEEDAP Panel,2017b), Guidance on the assessment of the safety of feed additives for
the target species (EFSA FEEDAP Panel,2017c), Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP
Panel,2018), Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel,2019) and
Guidance on the assessment of the safety of feed additives for the users (EFSA FEEDAP Panel,2023).
3 | ASSESSMENT
Tartrazine is intended to be used as a sensory additive (functional group: (a) colourants: (i) substances that add or restore
colour in feedingstuffs) in baits for freshwater fish. Tartrazine is intended to be incorporated in fishing baits in order to
colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not
intended for use in aquaculture.
3.1 | Characterisation
3.1.1 | Characterisation of the additive
Tartrazine is a disulfonated mono azo dye and consists of trisodium- 5- hydroxy- 1- (4 sulfonatophenyl)- 4- (4-
sulfonatophenylazo)- H- pyrazole- 3- carboxylate (chemical formula C16H9N4Na3O9S2, Chemical Abstracts Service (CAS) num-
ber 1934- 21- 0, molecular weight 534.37) and subsidiary colouring matters together with sodium chloride and/or sodium
sulfate as the principal uncoloured components. Tartrazine is described as the sodium salt.
Tartrazine is produced by chemical synthesis.9 It is prepared from 4- amino benzenesulfonic acid, which is diazotised
using hydrochloric acid and sodium nitrite. The resulting diazo compound is then coupled with 4,5- dihydro- 5- oxo- 1- (4- su
lfophenyl)- 1H- pyrazole- 3- carboxylic acid or with the methyl ester, the ethyl ester or a salt of the carboxylic acid. The result-
ing dye is purified and isolated as the sodium salt.
The applicant states that the specifications of tartrazine comply with those of the additive already authorised for use in
dogs, cats and ornamental fish, grain- eating ornamental birds and small rodents10: colouring matter calculated as the so-
dium salt ≥ 85%, subsidiary colouring matter ≤ 1%, organic compounds other than colouring matters110.5%, unsulfon-
ated primary aromatic amines ≤ 0.01% and ether extractable matter under neutral conditions ≤ 0.2%. These specifications
are also in line with those set for the use of tartrazine as a food additive.12
Five batches of tartrazine were analysed for their specified components.13 They all complied with the specifications as fol-
lows: 91.1% total colouring matter (range 90.7%–91.6%); 0.1% subsidiary colouring matter; 0.30% sum of organic compounds
other than colouring matters (0.05%–0.34%), < 0.01% unsulfonated primary aromatic amines and < 0.20% ether extractable
matter.
The applicant has set specifications for arsenic (< 3 mg/kg), lead (< 2 mg/kg), mercury and cadmium (< 1 mg/kg), which
align with the established limits for tartrazine when used as a food additive. The levels analysed in the same five batches
above were: 0.01 mg arsenic/kg (0.005–0.029), 0.44 mg lead/kg, (0.005–0.77), 0.006 mg mercury/kg (0.005-0.008) and
0.05 mg cadmium 0.04–0.10.
The additive is an odourless light orange powder, with a bulk density of 500–700 kg/m3. Tartrazine is freely soluble14 in
water; a solubility test in accordance with the OECD Test Guideline (TG) 105 was submitted,15 resulting in 200–1000 g/L.
The dusting potential, as determined by the Stauber- Heubach method, was evaluated in two independent batches,
yielding results of 1658 mg/m3 and 7375 mg/m3, respectively.16 For a third batch, the measurement was unfeasible due to
the inability to retrieve all the dust from the filter.17
8Commission R egulation (EC) No 429/2008 of 25 A pril 2008 on detaile d rules for the implemen tation of Regulation (EC ) No 1831/2003 of the European Par liament and of
the Council as re gards the preparatio n and the presentation of ap plications and the asse ssment and the authoris ation of feed additives . OJ L 133, 22.5.2008 , p. 1.
9Technical dossier/Annex_11.
10Commissi on Implementing Regu lation (EU) 2020/157 of 5 Februar y 2020 concerning the authori sation of tartrazi ne as a feed additive for d ogs, cats, ornament al fish,
grain- eating ornamental birds and small rodents. OJ L 34, 6.2.2020, p. 15.
114- hydrazinobenzene sulfonic acid, 4- aminobenzene- 1- sulfonic acid, 5- oxo- 1- (4- sulfophenyl)- 2- pyrazoline- 3- carboxylic acid, 4.4- diazoaminodi(benzene sulfonic acid),
Tetrahydroxysuccinic acid.
12Commissi on Regulation (EU) No 231/2012. OJ L 83, 22.3.2012, p. 1.
13Technical dossier/Annex_3, Annex_4, Annex_ 5, Annex_6 and Annex _7.
14For solu bility terms, see Table2 of th e Guidance on technical re quirements for regul ated food and feed pro duct applications to e stablish the presenc e of small particles
including nanoparticles (EFSA Scientific Committee, 2021).
15Technical dossier/Annex_50.
16Technical dossier/Annex_50 and Annex_52.
17Technical dossier/Annex_76.
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3.1.2 | Stability and homogeneity
The shelf life of the additive stored for 8 years at 15–45°C and 40%–90% relative humidity was evaluated in three batches
for their colour content by measuring the extinction coefficient.18 After 9 years, average losses in pure dye content was
3.7%, moisture content increased by 4.1% and total dye content increased by 0.6% in two batches and decreased by 0.5%
in the third one.
No data were submitted on the stability of the additive when incorporated in feed. The applicant states that tartrazine
is generally unstable in the presence of oxidising or reducing agents (e.g. sugars and acids).
3.1.3 | Conditions of use
The additive tartrazine is intended to be incorporated in fishing baits for freshwater fish up to a maximum of 30 mg/kg in
complementary feed. The applicant stated that it can be used either as small fish baits of approximately 4 g attached to the
hooks or fishing lines or as small pellets (ground bait) which are cast in water to attract fish to the fishing area. It is not in-
tended for use in aquaculture feed.19
3.2 | Safety
Tartrazine is intended to be used in the preparation of baits for freshwater fish only. According to the proposed conditions
of use, it can be used either as small fish baits of approximately 4 g attached to the hooks or fishing lines or as small pellets
(ground bait) which are cast in water to attract fish to the fishing area (Section3.1. 3). Therefore, the FEEDAP Panel considers
that the safety assessment of this additive should consider this peculiar use, which will likely result in an occasional expo-
sure of the target animals to tartrazine, and not to a continuous exposure during their whole life, as it is normally the case
with other feed additives.
The safety of tartrazine was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives in 1966
and 2016 (JECFA,1966 , 2016), by the Scientific Committee on Food (SCF) (European Commission,1975, 1984), by EFSA in
2009 when re- evaluating tartrazine as a food additive (EFSA ANS Panel, 2009) and in 2016 as a feed additive for cats, dogs,
ornamental birds, ornamental fish and small rodents (EFSA FEEDAP Panel,2016).
No new studies were submitted in support of the safety of the additive, but the applicant performed a literature search
on the safety of tartrazine for the target species, consumers and users, covering the period up to October 2023 and for
the safety for the environment up to November 2022, to identify any relevant information that might be available since
the previous evaluations. The literature search was conducted using the Google Scholar, PubMed and EFSA publications
databases. A total of 53 publications were retrieved (20 on the safety for the target species, 27 for the consumer, four for
the users and two for the environment).
3. 2.1 | Absorption, distribution, metabolism and excretion and residues
No data on absorption, distribution, metabolism, excretion (ADME) and residues of tartrazine in fish was made available to
the FEEDAP Panel.
The ADME of tartrazine in laboratory animals have been previously reviewed by EFSA (EFSA ANS Panel, 2009; EFSA
FEEDAP Panel,2016) and JECFA (JECFA,2016) which considered that the absorption of tartrazine in humans and laboratory
animals is typically less than 5%. Once absorbed, tartrazine is primarily excreted unchanged in the urine. The unabsorbed
portion undergoes reductive metabolism by the intestinal microbiota. Small amounts of some metabolites (e.g. sulfanilic
acid and 4- amino- 3- carboxy- 5- hydroxy- 1- (4- sulfophenyl)pyrazole (SCAP) and aniline derivates are then absorbed by the
intestine and excreted via urine.
The applicant provided a literature search (see Section2.2) to support that the anatomical organisation of the intestine,
the gene expression regulated by gut microbes and the core gut microbiota assembly are similar in fish and mammals
(Tyagi & Shukla,2002; Rawls et al.,2004; Roeselers et al., 20 11; Wu etal.,2012; Turnbaugh & Gordon,2009; Turnbaugh
etal.,2009, cited in Li etal.,2014). Although these findings might suggest a commonality of the enteric metabolism in fish
and mammals, the FEEDAP Panel considered that the information provided by the applicant is of limited relevance for the
characterisation of the ADME profile of tartrazine in fish.
No data on possible residues of tartrazine in fish was made available to the FEEDAP Panel. Considering the conditions
of use of tartrazine in freshwater fish (as described in Section 3.1. 3), the Panel considers that the use of the additive for
recreational or sportive fishing would result in a limited consumption of baits before the animals are caught. Therefore,
considering the limited amount ingested by the animals over a short period of time, the deposition of tartrazine in fish
flesh is considered unlikely.
18Technical dossier/Annex_13, Annex_45 and Annex_51.
19Technical dossier/Conditions_of_use.pdf.
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3.2.2 | Toxicological profile
Based on the results from long- term carcinogenicity studies and in vivo genotoxicity studies, described in the above-
mentioned assessments (EFSA ANS Panel, 2009; EFSA FEEDAP Panel,2016; JECFA, 2016), tartrazine was considered not
carcinogenic nor genotoxic and not a reproductive/developmental toxicant. In 2009, the ANS Panel confirmed the existing
acceptable daily intake (ADI) for tartrazine of 7.5 mg/kg body weight (bw) which was previously established by JECFA based
on a no observed adverse effect level (NOAEL) of 1.5% (corresponding to 750 mg/kg bw per day), which was the highest
dose tested in a repeated dose study in (Mannell etal.,1958). In 2016, JECFA updated the safety evaluation of tartrazine
(J ECFA , 2016) and withdrew the previous ADI and established a new one of 0–10 mg/kg bw, which was derived from a
NOAEL of 984 mg/kg bw per day, based on the reduction in body weight observed in a chronic study in rats and applying
an uncertainty factor (UF) of 100.
The literature search retrieved five papers (Ai- Mashhedy & Fijer,2016; Boussada etal.,2017; de Souza etal.,2022; Ghonimi
& Elbaz,2015; Ismail & Rashed,2022) which were not considered in the previous assessments. Three papers describe toxico-
logical studies with oral administration in rats and report adverse effects in liver, testes (including sperm quality and testos-
terone levels), brain, kidney, stomach over a repeated dose exposure (Boussada etal.,2017; Ghonimi & Elbaz,2 015; Ismail &
Rashed,2022). However, given the specific use of the additive in fishing bait, which likely results in an occasional exposure
of the animals, the FEEDAP Panel considers that the effects of repeated dose exposure to tartrazine described in these pub-
lications are not relevant for the current assessment. One paper (De Souza etal.,2022) reported positive genotoxicity results
obtained testing a tartrazine of unknown purity. However, the relevance of the test item used in this study for the additive
under assessment is not established and therefore, this paper was not further considered for the current assessment.
The paper by Ai- Mashhedy and Fijer(2016) evaluated the acute oral toxicity of tartrazine (E102) in male mice. The me-
dian lethal dose (LD50) of tartrazine was found to be greater than 6250 mg/kg bw, with no observed mortality following
single- dose administration across all dosage groups (ranging from 125 to 6250 mg/kg bw). The FEEDAP Panel considers the
results of this study relevant for the assessment of the safety of the additive for the target species. The FEEDAP Panel also
noted that a LD50 of 6375 mg/kg bw for tartrazine, when orally administered in rats, was reported in the paper by Boussada
etal.(2017). This result is in line with the study by Ai- Mashhedy and Fijer(2016).
3.2.3 | Safety for the target species
Tartrazine is intended to be used only in the preparation of fishing baits for freshwater fish. The Panel considers that this
use will likely result in an occasional exposure of the animals to the additive, and not to a continuous exposure during the
whole life. In addition, for those fish that are caught and killed after capture, the assessment of the safety of the additive is
irrelevant. Therefore, the Panel considers that the assessment of the safety for the target species is relevant only for those
fish that are either caught and released in the water, or those that eat the ground baits and are not caught. In both cases,
it is not possible to make an accurate estimate of the actual consumption of the additive, which, as mentioned before, is
going to be occasional, in a very short time and not continuous during long periods of the life of the animals. In addition,
the number of baits ingested represents a small fraction of the total feed intake of fish during a given day.
The FEEDAP Panel noted that the literature search performed by the applicant identified two papers reporting adverse
effects in fish after exposure to tartrazine. Wu etal.(2021) fed crucian carp with various tartrazine concentrations (1.4, 5.5
and 10 mg/kg bw) for 2 months, noting alterations in intestinal and liver structure, oxidative stress and microbiota compo-
sition; Athira and Ds(2022) exposed carp to tartrazine concentrations of 5 and 10 mg/L for 75 days, observing behavioural
changes, decreased body weight, mucosal coating and altered enzyme activity. Due to the specific use of tartrazine as fish-
ing bait and the brief interval between ingestion and capture, these findings were considered not relevant for the current
assessment by the FEEDAP Panel.
The FEEDAP Panel considered appropriate to make an estimation of the potential exposure to tartrazine from its use in
baits. In that regard, the applicant proposed as a worst- case scenario for the consumer safety assessment that a 300 g fish
might eat 20 baits (total of 80 g). The FEEDAP Panel considers this scenario can be appropriate for the assessment of the
safety for the target animals. Under these conditions, considering the maximum use level of 30 mg tartrazine/kg comple-
mentary feed, a single fish would ingest approximately 2.4 mg tartrazine. Considering an average weight of the fish of 300
g, that would result in an exposure of 8 mg tartrazine/kg bw.
The FEEDAP Panel also noted that tartrazine is already authorised in feed for ornamental fish at 1924 mg/kg complete
feed.
Considering that tartrazine is of low acute toxicity in mammalian species (LD50, rats and mice), and the peculiarity of the
conditions of use which would likely result in an occasional exposure, the FEEDAP Panel concludes that the use of tartra-
zine in the preparation of baits for freshwater fish under the proposed conditions of use (maximum use level of 30 mg/kg
complementary feed) is of no concern for the target animals.
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3.2.4 | Safety for the consumer
Considering that tartrazine is already authorised for use as food additive in several food categories and the conditions of
use of the feed additive as proposed by the applicant, the FEEDAP Panel considers that the exposure to residue of tartra-
zine from fish for recreational or sportive fishing would not significantly contribute to the overall exposure to tartrazine via
food for the consumers (EFSA ANS Panel, 2009). Therefore, the FEEDAP Panel concludes that the use of tartrazine under the
proposed conditions of use is safe for the consumers.
3.2.5 | Safety for the user
The highest dusting potential measured was 7375 mg/m3. Therefore, the FEEDAP Panel considered that the exposure of
users by inhalation is likely.
For the current dossier, the applicant submitted two papers (Kalender,2000; Safford & Goodwin,1985) which suggest
that tartrazine is a skin sensitiser. In addition, the applicant referred to eye and skin irritation studies submitted to the
European Chemicals Agency (ECHA). However, since the full reports of these studies were not made available, the FEEDAP
Panel could not conclude on the eye and skin irritation potential.
The additive should be considered a dermal and respiratory sensitiser. Inhalation and dermal exposure are considered a
risk. The FEEDAP Panel could not conclude on the eye irritation potential of the additive.
3.2.6 | Safety for the environment
Tartrazine is intended to be used only in fishing baits for freshwater fish, and the additive will not be used in aquaculture
operation involving the use of cages. Therefore, surface water is considered the environmental compartment potentially
at risk.
In line with the requirements of the FEEDAP Panel guidance on the safety of the additive for the environment (EFSA
FEEDAP Panel,2019) the applicant calculated the predicted environmental concentration for surface water (PECsw) using
the FERA calculation tool,20 assuming that 100% of the ingested dose is excreted as the parent compound.
At the maximum concentration of tartrazine used in fishing baits (30 mg/kg complementary feed), the PECsw does not
exceed the threshold value of 0.1 μg/L for aquaculture from land- based fish farms. Thus, the use of tartrazine in the feed
of freshwater fish does not present a risk of contamination of surface waters and the assessment stops in Phase I of the
FEEDAP guidance on the safety of the additive for the environment (EFSA FEEDAP Panel,2019). The FEEDAP Panel considers
that the use of tartrazine, according to the proposed conditions of use, is not expected to pose a risk for the environment.
3.3 | Efficacy
Tartrazine is intended to be used to colour the fishing baits of freshwater fish. Tartrazine is authorised as a food additive.
In principle, where the function requested for feed is the same as that used in food, no further demonstration of efficacy
is necessary, provided that the effect seen when used in food could reasonably be expected to be seen when used in feed
at the recommended concentration, and that food and feed matrices are of comparable nature. However, considering the
uncertainty in the equivalence of the food and feed matrices and the use levels, efficacy demonstration for this use as feed
additive was considered necessary.
No data on efficacy were submitted by the applicant. Therefore, no conclusion on the efficacy of tartrazine to be used
in freshwater fish baits can be reached.
4 | CONCLUSIONS
The FEEDAP Panel concludes that the use of tartrazine in the preparation of baits for freshwater fish under the proposed
conditions of use (maximum use level of 30 mg/kg complementary feed) is of no concern for the target animals.
The use of tartrazine as a feed additive under the proposed conditions of use is considered safe for the consumer and
the environment.
Regarding the user safety, the additive should be considered a dermal and respiratory sensitiser. Inhalation and dermal
exposure are considered a risk. The FEEDAP Panel could not conclude on the irritation potential of the additive.
In absence of data no conclusion can be reached on the efficacy of tartrazine in freshwater fish baits.
20FERA calculation tool available online: https:// www. efsa. europa. eu/ en/ appli catio ns/ feeda dditi ves/ tools .
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ABBREVIATIONS
ADI acceptable daily intake
ADME absorption, distribution, metabolism and excretion
ANS EFSA Scientific Panel on Additives and Nutrient Sources added to Food
BW body weight
CAS Chemical Abstracts Service
ECHA European Chemicals Agency
EURL European Union Reference Laboratory
FAO Food and Agricultural Organization
FEEDAP EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
JECFA The Joint FAO/WHO Expert Committee on Food Additives
LD50 median lethal dose
NOAEL no observed adverse effect level
OECD Organisation for Economic Co- operation and Development
SCF Scientific Committee on Food
UF uncertainty factor
WHO World Health Organization
ACKNOWLEDGEMENTS
The Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last
name): Montserrat Anguita, Matteo L. Innocenti, the experts of the FEEDAP Working Group on Animal nutrition, Working
Group on Toxicology and Working Group on Environment
REQUESTOR
European Commission
QUESTION NUMBER
EFSA- Q- 2022- 00779
COPYRIGHT FOR NON EFSA CONTENT
EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright
holder and users should seek permission to reproduce the content from the original source.
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.
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How to cite this article: EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal
Feed), Villa, R. E., Azimonti, G., Bonos, E., Christensen, H., Durjava, M., Dusemund, B., Gehring, R., Glandorf, B., Kouba,
M., López- Alonso, M., Marcon, F., Nebbia, C., Pechová, A., Prieto- Maradona, M., Röhe, I., Theodoridou, K., Aquilina, G.,
Bastos, M., … Amaduzzi, A. (2024). Safety and efficacy of a feed additive consisting of tartrazine for its use in baits for
freshwater fish (GIFAP). EFSA Journal, 22(10), e9021. https://doi.org/10.2903/j.efsa.2024.9021
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Food dyes, or color additives, are often added into foods, cosmetics and beverages during processing to improve the sensory attributes of the final products. However, the toxicity of tartrazine (TZ), one of the most common azo-dyes, is still unclear, and needs to be ascertained by further study. Hence, in the present study, we aimed to evaluate the effects of TZ consumption on health by using a teleost, crucian carp (Carassius auratus) as the experimental fish. TZ consumption (1.4, 5.5 and 10 mg/kg bwt/day) could cause severe histopathological and cellular alterations in intestine and liver. The height of intestinal villus, thickness of intestinal muscle, and microvilli density were also affected. With the increasing of TZ concentrations, the activities of antioxidant enzymes (CAT, SOD and GSH-Px), exhibited a decreasing trend, while the contents of MDA elevated. Upregulations of pro-inflammatory cytokines (il6 and tnfα), anti-inflammatory cytokines (il8, and il10) and other immune related genes (complement component 3 (c3), lysozymes (lyz), β-defensin 3 (defb3)), were observed after TZ uptake. In addition, TZ consumption also affected the community structure of the microbiota in the intestine of crucian carp. The amount of some probiotic bacteria (Roseomonas, Rhodococcus and Bacillus) and the bacteria (Bacteroides and Clostridium), producing short chain fatty acids, were significantly reduced, and some pathogenetic microorganisms (e.g. Bdellovibrio and Shewanella) were significantly increased after TZ uptake. In summary, the data in the present study indicate that TZ consumption, even at a low concentration, may lead to adverse effects on fish health. Therefore, in aquaculture, it is necessary to be informed about the hazardous effects of TZ, and more attentions should be focused on using natural substitutes.