Abstract
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of locust bean gum as a technological feed additive (functional group: emulsifiers, gelling agents, stabilisers and thickeners) for all animal species. Owing the lack of sufficient data, no conclusions could be drawn on the safety of the additive for the target species or the user. The use of locust bean gum in animal nutrition under the proposed conditions of use is of no concern for consumer safety and the environment. The Panel concluded that the additive has potential to be efficacious as gelling agent, thickener and contributes to stabilise canned pet feed when used in synergy with another hydrocolloid (carrageenan). In the absence of data, the Panel could not conclude on the efficacy of the locust bean gum as an emulsifier.
Keywords: technological additives, emulsifiers, gelling agents, stabilisers, thickeners, locust bean gum, safety
1. Introduction
1.1. Background and Terms of Reference
Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 10(2) of that Regulation also specifies that for existing products within the meaning of Article 10(1), an application shall be submitted in accordance with Article 7, at the latest one year before the expiry date of the authorisation given pursuant to Directive 70/524/EEC for additives with a limited authorisation period, and within a maximum of 7 years after the entry into force of this Regulation for additives authorised without a time limit or pursuant to Directive 82/471/EEC. In particular, Article 10(2) of that Regulation specifies that for existing products within the meaning of Article 10(1), an application shall be submitted in accordance with Article 7, within a maximum of 7 years after the entry into force of this Regulation.
The European Commission received a request from Danisco A/S2 for the re‐evaluation of the authorisation of the additive consisting of locust bean gum, when used as a feed additive for target species (category: technological additives; functional group: emulsifiers, gelling agents, stabilisers and thickeners).
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 10(2) (re‐evaluation of an authorised feed additive). The particulars and documents in support of the application were considered valid by EFSA as of 24 April 2014.
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 locust bean gum, when used under the proposed conditions of use (see Section 3.1.5).
1.2. Additional information
Locust bean gum is currently listed in the EU Register of Feed Additives as a technological additive (functional group: emulsifiers, gelling agents, stabilisers, thickeners) for use in feed for all animal species.
Locust bean gum is currently authorised as a food additive in accordance with Annex II to Regulation (EC) No 1333/20083. Specific purity criteria on locust bean gum (E 410) have been defined in Commission Regulation (EU) No 231/20124.
Locust bean gum has not been previously assessed by EFSA as a feed additive. It has been assessed by the Scientific Committee for Food (SCF) (SCF 1991, 1994, 1999, 2003) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1975a,b, 1980a,b, 1981a,b, 2008, 2016) and considered safe for use in food with an acceptable daily intake (ADI) ‘not specified’. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) delivered an opinion on the re‐evaluation of locust bean gum (E410) as a food additive reaching similar conclusions (EFSA ANS Panel, 2017).
2. Data and methodologies
2.1. Data
The present assessment is based on data submitted by the applicant in the form of a technical dossier5 in support of the authorisation request for the use of locust bean gum as a feed additive.
The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, peer‐reviewed scientific papers, other scientific reports, to deliver the present output.
EFSA has verified the European Union Reference Laboratory (EURL) report as it relates to the methods used for the control of the locust bean gum in animal feed. The Executive Summary of the EURL report can be found in Annex A.6
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety and the efficacy of an active substance (trade name of the product) is in line with the principles laid down in Regulation (EC) No 429/20087 and the relevant guidance documents: Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017a), Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017b), Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017c), Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, 2012), Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018) and Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019).
3. Assessment
The additive locust bean gum is a natural polysaccharide extracted from the endosperm of the seeds of the carob tree, Ceratonia siliqua. Locust bean gum is intended to be used as a technological feed additive (functional groups: emulsifiers, stabilisers, thickeners and gelling agents) in feedingstuffs for all animal species.
3.1. Characterisation
3.1.1. Characterisation of the additive
The additive consists of locust bean gum, also called carob bean gum. Locust bean gum (CAS number 9000‐40‐2, EINECS number 232‐541‐5) is a white to yellowish‐white, nearly odourless powder.
Locust bean gum is the ground endosperm of the seeds of the strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae), consisting mainly of high molecular weight (ca. 50,000–3,000,000 g/mol) hydrocolloidal polysaccharides composed of galactomannans with a mannose:galactose ratio of about 4:1 (JECFA 2008, Regulation (EU) 231/2012)8.
The feed additive locust bean gum is manufactured to meet the specifications set for its use as a food additive.8 These specifications are: not less than 75% of galactomannan,9 maximum 7% protein (N × 6.25), maximum 4% of acid‐insoluble matter, maximum 1.2% of ash (at 800°C), maximum 15% loss on drying (105°C, 5 h), starch not detectable, and ethanol and propan‐2‐ol maximum 1% (single or in combination).
Analytical data to confirm the specifications were provided for 10 batches of the additive, showing the following average values: 9% loss on dry (8.0–9.9%), 2.3% acid‐insoluble matter (2.04–2.54%) and 5.3% protein (4.9–5.7%);10 , 11 the galactomannan content was reported to be 83.4% (82.6–84.6%).
Three batches of the additive were analysed for impurities. 10 , 12 Cadmium, mercury and arsenic levels were below the limit of quantification (LOQ) of the analytical method, while lead was 0.072 mg/kg (0.022–0.081 mg/kg).13 The results are in compliance with the specifications set for the use of locust bean gum as a food additive.14 No information on the content of starch, ethanol and propan‐2‐ol were provided.
Polychlorinated dibenzodioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and coplanar dioxin‐like polychlorinated biphenyls (co‐planar PCBs) were analysed in the same three batches and resulted: 43 ng WHO‐PCDD/F‐TEQ/kg (23–83) and 52.3 ng WHO‐PCDD/F‐PCB‐TEQ/kg (28–101).
The analysis of mycotoxins, including aflatoxins (B1, G1, B2, G2), deoxynivalenol, HT‐2 toxin and T‐2 toxin showed values below the LOQ of the analytical method.15
Microbiological contamination was analysed by determination of Escherichia coli and Salmonella spp. with no detection in 10 and 25 g, respectively. Yeasts and filamentous fungi were below the specified maximum content of 500 CFU/g additive.
3.1.2. Physical properties of the additive
The additive has a density of 700–800 kg/m3 and is soluble in hot water. The dusting potential tested on one batch of the additive with the Stauber–Heubach method (in triplicate analysis) showed values of 24–61 mg/m3. 10 No information on the particle size distribution, including nanoparticles, was provided.
3.1.3. Manufacturing process
Locust bean gum is obtained from the kernels of the carob fruit. The endosperm of the kernel is separated and grounded into a fine powder.
In order to obtain the locust bean gum, kernels are pealed out without damaging the endosperm, following two alternative procedures:
Acid process 16: The kernels are treated with sulfuric acid to carbonise the seed coat (temperature not specified). The remaining fragments of the seed coat are removed from the endosperm through a washing and brushing process. After, these are dried and cracked and the more friable germs crushed. The germ parts can be sifted off from the unbroken endosperm halves (Neukom, 1989).
Roasting process 16 : The kernels are roasted in a rotating furnace where the seed coat pops off from the rest. The germ and the endosperm halves are recovered as mentioned above. No sulfuric acid is necessary as processing aid. This process yields a darker end product (Neukom, 1989).
3.1.4. Stability and homogeneity
The shelf‐life of the additive (two batches from each manufacturing process – roasting and acid) was investigated by the chemical analysis of its composition and of the persistence of its technological effect.17 Six samples were collected immediately after manufacturing and stored in polystyrene vials for 12 months at 20 and 40°C. The samples were analysed for water content and viscosity. To measure viscosity, a 1% solution in water at 90°C was prepared and stirred for 10 min at 500 rpm. After cooling, viscosity was measured using a rotating viscosimeter at 20 rpm and 25°C. No substantial changes in water content were observed after 12 months, while loss of viscosity was in a range of 3–10% of the initial value.
For technological additives, the stability in feedingstuffs can be demonstrated by the persistence of the intended technological effect, whereas no demonstration of homogenous distribution is considered necessary if the efficacy of the additive is demonstrated. The applicant provided evidence of the stability and homogenous distribution in feed in the efficacy studies done with several feedingstuffs/feed materials. The studies are described in the efficacy section (see Section 3.3).
3.1.5. Conditions of use
The additive is intended to be used in feedingstuffs for all animal species with a maximum use level of 10,000 mg/kg in complete feed.
3.2. Safety
3.2.1. Safety for the target species
No specific studies or information were submitted on the safety of the product under assessment for the target species.
Locust bean gum was evaluated by the SCF (1991, 1994, 1999, 2003) and by JECFA (JECFA, 1975a,b, 1980a,b, 1981a,b, 2008, 2016) which allocated an acceptable daily intake (ADI) ‘not specified’ owing to the lack of adverse effects in the available toxicity studies.
In 2017, the EFSA ANS Panel delivered an opinion on the ‘Re‐evaluation of locust bean gum (E 410) as a food additive’ (EFSA ANS Panel, 2017) in which it was concluded that ‘locust bean gum is practically undigested, not absorbed intact, but significantly fermented by enteric bacteria in humans’ and that ‘no adverse effects were reported in 90‐day toxicity studies in rodents at the highest doses tested (20,000 mg locust bean gum/kg bw per day in mice, and 4,500 or 9,000 mg locust bean gum/kg bw per day in rats); there is no concern with respect to the genotoxicity of locust bean gum; no carcinogenic effects were reported in carcinogenicity studies in rodents at the highest dose tested, up to 7,500 mg locust bean gum/kg bw per day in mice and 2,500 mg locust bean gum/kg bw per day in rats; oral intake of locust bean gum in doses amounting up to 500 mg/kg bw per day for 8 weeks was tolerated in adolescents and adults without significant side effects’.
Most of the studies on which the ANS Panel evaluation was based (EFSA ANS Panel, 2017) were not made available by the applicant. Therefore, in the absence of sufficient data, the FEEDAP Panel is not in the position to conclude on the safety of locust bean gum in feed for all target animals at the proposed conditions of use.
3.2.2. Safety for the consumer
The additive is not absorbed as such in the gastrointestinal tract of the target animals. Its fermentation products in the gut will be metabolised following the normal metabolic pathways of such substances. Any deposition of the additive or its fermentation by‐products in tissues and products from animal origin is unlikely. Since no exposure of the consumer to the additive or its metabolites is expected, the use of the additive in animal nutrition is considered safe for the consumer.
3.2.3. Safety for the user
No specific information was submitted. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety of locust bean gum for the user.
3.2.4. Safety for the environment
Carob tree is widely distributed in Europe. Locust bean gum, naturally present in the bean of carob tree, is expected to be biodegradable in the environment. The use of the additive in animal nutrition is not expected to increase the concentration of locust bean gum in the environment. Therefore, the use of locust bean gum in animal nutrition does not raise concerns for the environment.
3.3. Efficacy
Locust bean gum is authorised for use as a food additive. The effect seen when used in food could reasonably be expected to be seen when it is used in feed at the recommended inclusion level. The applicant stated that locust bean gum's functionality is optimised when used in synergy with other hydrocolloids. The applicant has provided one study18 to support the efficacy of locust bean gum as gelling agent, stabiliser and thickener. No evidence was provided on the effects of the additive as an emulsifier.
In the study aimed to demonstrate the efficacy of the additive in feedingstuffs, the gel strength of a jelly containing 500 mg carrageenan/kg was measured when supplemented either with 0 (control) or 500 mg locust bean gum/kg. The jelly was further combined with chunks to prepare three canned pet feeds (two for cats and one for dogs).
The two feeds for cats had a moisture content of 88.6% and 85.3%, and the one for dogs 87.7%. The gel strength was tested in the jelly and in the final feeds (with chunks) by penetrometry, measuring the breaking force. Ten cans for each jelly preparation with or without chunks were used for the analysis immediately after preparation, and after 3 and 6 months of storage. No statistical analysis was reported. The results of the analysis of the jelly and feeds are reported in Table 1.
Table 1.
Gel strength of the jelly and canned chunks feeds
| Type of feed | Chunks | Locust bean gum (mg/kg) | Force (g) Average (±SD) | ||
|---|---|---|---|---|---|
| Time (months) | |||||
| 0 | 3 | 6 | |||
| Cat 1 | No | 0 | 157.6 (±12) | 154.0 (±9.7) | 155.5 (±9.1) |
| No | 500 | 357.8 (±22.5) | 350.2 (±14.6) | 343.3 (±15.8) | |
| Yes | 0 | 58.5 (±4.3) | 61.2 (±9.3) | 61.6 (±3.4) | |
| Yes | 500 | 117.4 (±5.3) | 130.9 (±18.8) | 130.9 (±4.7) | |
| Cat 2 | No | 0 | 172.8 (±17.4) | 168.5 (±19.1) | 169.7 (±16.1) |
| No | 500 | 337.5 (±16.7) | 354.4 (±9.1) | 331.1 (±10.2) | |
| Yes | 0 | 74.6 (±3.8) | 76.7 (±3.4) | 75.0 (±6.9) | |
| Yes | 500 | 157.4 (±9.4) | 146.4 (±7.8) | 156 (±7) | |
| Dog | No | 0 | 120.6 (±14.1) | 120.2 (±14.3) | 126.6 (±13.6) |
| No | 500 | 224.3 (±29.1) | 247.3 (±20.6) | 250.7 (±15.7) | |
| Yes | 0 | 61.4 (±4.3) | 61.5 (±7.8) | 52.6 (±6.2) | |
| Yes | 500 | 146.8 (±6.7) | 148.8 (±7) | 151.8 (±4.7) | |
During the whole storage period, jellies on carrageenan basis (with or without chunks) showed about twice the values of gel strength when supplemented with 500 mg locust bean gum/kg compared to the controls (0 mg locust bean gum/kg).
The FEEDAP Panel concludes that the additive is efficacious as gelling agent, thickener and contributes to stabilise canned pet feed when simultaneously used with another hydrocolloid (carrageenan). No conclusion can be drawn on the efficacy of the additive as an emulsifier.
4. Conclusions
Owing the lack of sufficient data, no conclusions can be drawn on the safety of the additive for the target species or the user.
The use of locust bean gum in animal nutrition under the proposed conditions of use is of no concern for consumer safety.
The use of locust bean gum as a feed additive is considered safe for the environment.
The FEEDAP Panel concludes that locust bean gum is efficacious as gelling agent, thickener and contributes to stabilise canned pet feed, when simultaneously used with another hydrocolloid (carrageenan). In the absence of data, the Panel cannot conclude on the efficacy of the locust bean gum as an emulsifier.
5. Documentation provided to EFSA/chronology
| Date | Event |
|---|---|
| 08/11/2010 | Dossier received by EFSA. Locust bean gum. Submitted by Danisco A/S currently Dupont Nutrition and Health |
| 11/12/2013 | Reception mandate from the European Commission |
| 24/04/2014 | Application validated by EFSA – Start of the scientific assessment |
| 25/06/2014 | Reception of the Evaluation report of the European Union Reference Laboratory for Feed Additives |
| 25/07/2014 | Comments received from Member States |
| 08/10/2014 | Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: characterisation of the additive |
| 02/09/2016 | Reception of supplementary information from the applicant – Scientific assessment re‐started |
| 30/09/2016 | Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: safety |
| 28/02/2017 | Reception of supplementary information from the applicant ‐ Scientific assessment re‐started |
| 13/09/2021 | Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: characterisation and safety |
| 29/06/2022 | Opinion adopted by the FEEDAP Panel. End of the Scientific assessment |
Abbreviations
- AFC
EFSA Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food
- ANS
EFSA Scientific Panel on Additives and Nutrient Sources added to Food
- bw
body weight
- CAS
Chemical Abstracts Service
- CFU
colony forming unit
- CV
coefficient of variation
- EINECS
European Inventory of Existing Chemical Substances
- EURL
European Union Reference Laboratory
- FAO
Food Agricultural Organization
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- IUPAC
International Union of Pure and Applied Chemistry
- JECFA
The Joint FAO/WHO Expert Committee on Food Additives
- LOD
limit of detection
- LOQ
limit of quantification
- MRL
maximum residue limit
- NOAEL
no observed adverse effect level
- OECD
Organisation for Economic Co‐operation and Development
- PCB
polychlorinated biphenyl
- PCDD
polychlorinated dibenzodioxin
- PCDF
polychlorinated dibenzofuran
- SCAN
Scientific Committee on Animal Nutrition
- SCF
Scientific Committee on Food
- WHO
World Health Organization
Appendix A – Executive Summary of the Evaluation Report of the European Union Reference Laboratory for Feed Additives on the Method(s) of the Analysis for Locust bean gum
In the current application authorisation is sought under article 10(2) for Locust Bean Gum under the category/functional groups 1(c), 1(d), 1(e) and 1(f) ‘technological additives’/‘emulsifiers’, ‘stabilisers’, ‘thickeners’, ‘gelling agents’ according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, authorisation is sought for the use of the feed additive for all animal species. Locust Bean Gum is white‐to‐brown powder consisting of a minimum of 75% of galactomannan with a galactose/mannose ratio close to 1:3.9. The feed additive is intended to be incorporated directly into feedingstuffs with proposed maximum inclusion level of 1% (10 g/kg) of Locust Bean Gum in the complete feedingstuffs. For the characterisation of Locust Bean Gum in the feed additive the Applicant proposed the internationally recognised FAO JECFA monographs for food additives, recommended by Commission Directive 2008/84/EC, where identification is based on: – positive test for galactose and manose; − microscopic examination; − solubility; − loss on drying; − protein content; and – acid insoluble matter content, while the quantification of the galactomannan content is determined substracting the values of loss on drying, protein and acid insoluble matter contents from the initial weight of the feed additive. Even though no performance characteristics are provided, the EURL recommends for official control the methods described in the FAO JECFA monographs – as recommended by Commission Directive 2008/84/EC – to characterise Locust Bean Gum in the feed additive. The Applicant provided no experimental data or any analytical methods for the quantification of Locust Bean Gum in feedingstuffs, as the accurate determination of Locust Bean Gum in feedingstuffs is not achievable experimentally. Therefore the EURL cannot evaluate nor recommend any method for official control to quantify Locust Bean Gum in feedingstuffs. Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005) is not considered necessary.
Suggested citation EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López‐Alonso M, Puente SL, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brantom P, Brozzi R, Galobart J, Innocenti ML, Vettori MV, and Amaduzzi A, 2022. Scientific Opinion on the safety and efficacy of a feed additive consisting of locust bean gum for all animal species (Dupont Nutrition and Health). EFSA Journal 2022;20(8):7435, 11 pp. 10.2903/j.efsa.2022.7435
Requestor: European Commission
Question number: EFSA‐Q‐2013‐01023
Panel members: Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Declarations of interest: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.
Acknowledgments: The Panel wishes to thank the following for the support provided to this scientific output: Jordi Ortuño.
Adopted: 29 June 2022
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the council of 22 September 2003 on the additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
Currently Dupont Nutrition and Health, Langebrogade 1, 1,001, Copenhagen, Denmark.
Regulation (EC) no 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives.
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012R0231&from=EN
FEED dossier reference: FAD‐2010‐0360.
The full report is available on the EU Hub Science website: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5.2008, p. 1.
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) no 1333/2008 of the European Parliament and of the Council. OJ L 83, 22.3.2012, p. 1.
Determined by subtracting the values of loss on drying, protein and acid insoluble matter contents from the initial weight of the feed additive.
Technical dossier/FAD‐2010‐0360_SIn_Sep16/Annexes.
Technical dossier/Section II/Annexes/2.1.3 b.
Technical dossier/Section II/Annexes/2.1.4.a.
Limit of quantification (LOQ) of arsenic, cadmium and mercury = 0.005 mg/kg.
Impurities: < 3 mg/kg As, < 2 mg/kg Pb, < 1 mg/kg Hg, < 1 mg/kg Cd.
Limit of quantification (LOQ) for aflatoxins (B1, G1, B2, G2) = 0.050 μg, deoxynivalenol (DON) = 50 μg, HT‐2 toxin = 20 μg, T‐2 toxin = 10 μg.
Technical dossier/Section_II_Identity.
Technical dossier/FAD‐2010‐0360_SIn_Sep16/Annexes and Report LBG feed additive re‐authorisation_additional data.
Technical dossier/FAD‐2010‐0360_SIn_Sep16/Report LBG feed additive re‐authorisation_additional data.
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