Abstract
Liderfeed® is intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed of chickens for fattening to increase the performance. The additive contains eugenol as an active ingredient with some excipients and has not been authorised in the EU for use in food or feed. In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Liderfeed® as a zootechnical additive for chickens for fattening. In that opinion, the Panel could not conclude on the efficacy of the additive because only two out of the three efficacy studies considered showed a significant effect on the performance of chickens for fattening as a result of the supplementation with the additive. The Commission gave the applicant the possibility of submitting additional information to allow the FEEDAP Panel to complete its assessment. For this reason, additional data have been provided related to the efficacy of the additive for the target species and this new information is the subject of this opinion. The new efficacy study on chickens for fattening is the subject of this assessment; the results of this study indicate an improvement in performance parameters with the use of the additive at 100 mg/kg complete feed. Considering the results of the current study, along with the two efficacy studies already assessed in the previous FEEDAP Panel opinion of 2015, the Panel concludes that Liderfeed® at 100 mg/kg complete feed has the potential to improve the growth of chickens for fattening.
Keywords: zootechnical additives, other zootechnical additives, Liderfeed® , eugenol, efficacy
Summary
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of Liderfeed® (eugenol) for chickens for fattening.
Liderfeed® is intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed of chickens for fattening to increase the performance. The additive contains eugenol as an active ingredient with some excipients and has not been authorised in the European Union (EU) for use in food or feed.
In 2015, the FEEDAP Panel adopted an opinion on the safety and efficacy of Liderfeed® as a zootechnical additive for chickens for fattening. In that opinion, the Panel could not conclude on the efficacy of the additive because only two out of the three efficacy studies considered showed a significant effect on the performance of chickens for fattening as a result of the supplementation with the additive. The Commission gave the applicant the possibility of submitting additional information to allow the FEEDAP Panel to complete its assessment. For this reason, additional data have been provided related to the efficacy of the additive for the target species and this new information is the subject of this opinion.
The new efficacy study on chickens for fattening is the subject of this assessment; the results of this study indicate an improvement in performance parameters with the use of the additive at 100 mg/kg complete feed. Considering the results of the current study, along with the two efficacy studies already assessed in the previous FEEDAP Panel opinion of 2015, the Panel concludes that Liderfeed® at 100 mg/kg complete feed has the potential to improve the growth of chickens for fattening.
1. Introduction
1.1. Background and Terms of Reference as provided by the European Commission
Regulation (EC) No 1831/20031 establishes rules governing the Community authorisation of additives for animal nutrition and, in particular, Article 9 defines the terms of the authorisation by the Commission.
The applicant, Lidervet S.L., is seeking a Community authorisation of Liderfeed® (Clove oil, eugenol) as a zootechnical additive for chickens for fattening (Table 1).
Table 1.
Description of the substances2
| Category of additive | Zootechnical additive |
|---|---|
| Functional group of additive | Other zootechnical additives |
| Description | Clove oil (eugenol) |
| Target animal category | Chickens for fattening |
| Applicant | Lidervet S.L. |
| Type of request | New Opinion |
In its opinion on the safety and efficacy of the product, adopted on 21 October 2015, the Panel on Additives and Products or Substances used in Animal Feed of the European Food Safety Authority (‘Authority’) concluded that only two out of the three efficacy studies considered showed a significant effect on the performance of chickens for fattening as a result of the supplementation with the additive. Therefore, the European Food Safety Authority (EFSA) Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was unable to conclude on the efficacy of Liderfeed® in chickens for fattening.
On 23 May 2016, the Commission has received new data on efficacy for Liderfeed® in chickens for fattening. The supplementary data are sent to the Authority by applicant.
In view of the above, the Commission asks the Authority to deliver a new opinion on the efficacy of Liderfeed® as a feed additive for chickens for fattening based on the additional data submitted by the applicant.
2. Data and methodologies
2.1. Data
The present assessment is based on data submitted by the applicant in the form of additional information3 to a previous application of the same product.4
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety of Liderfeed® is in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents: Guidance on zootechnical additives (EFSA FEEDAP Panel, 2012), Technical guidance: Tolerance and efficacy studies in target animals (EFSA FEEDAP Panel, 2011).
3. Assessment
Liderfeed® is intended as a zootechnical additive (functional group: other zootechnical additives) for use in feed for chickens for fattening to increase performance. The additive contains eugenol (5%) as the active ingredient with some excipients (56% glyceryl polyethyleneglycol ricinoleate (E 484), 33% silica amorphous and 6% acrylic polymers (Eudragit L 30 D‐55) as a coating agent).
Liderfeed® was initially formulated with clove oil as a source of eugenol. Subsequently, the applicant replaced the clove oil with purified eugenol at the same concentration as in the original formulation. The FEEDAP Panel considers that the efficacy studies made with the original and subsequently modified formulation are equivalent (EFSA FEEDAP Panel, 2015). Liderfeed® is intended to be used in feed for chickens for fattening during the whole life of the animals at the dose of 100 mg/kg complete feed equivalent to 5 mg eugenol/kg complete feed.
The FEEDAP Panel adopted, in 2015, an opinion on the safety and efficacy of the product as a zootechnical additive for chickens for fattening (EFSA FEEDAP Panel, 2015). In that opinion, the FEEDAP Panel could not conclude on the efficacy of the additive because only two out of the three efficacy studies considered showed a significant effect on the performance of chickens for fattening as a result of the supplementation with the additive.
The applicant has submitted additional information related to the efficacy of the additive for the target species and this new information is the subject of this opinion.
3.1. Efficacy for chickens for fattening
The applicant provided an additional efficacy study with chickens for fattening.5 A total of 144 one‐day‐old male Ross 308 chickens were allotted to two treatments, each with 12 pens of 6 birds. The animals were fed a basal maize‐soybean meal diet supplemented with Liderfeed® at either 0 or 100 mg/kg. Broilers were fed a starter diet (analysed: 5.5 mg eugenol/kg feed) from day 1 until day 21 and a grower diet (analysed: 5.5 mg eugenol/kg feed) from day 22 until day 35. Feed was provided ad libitum. Body weight and feed intake were weekly recorded and average daily gain, cumulative feed intake per bird, average daily feed intake and feed‐to‐gain ratio were calculated. Mortality and health incidences were daily checked. Data were subjected to analysis of variance considering the pen as the experimental unit. Statistical significance was declared at p < 0.05.
No deaths or health incidences occurred during the study period. Supplementation with Liderfeed® resulted in a significant improvement in final body weight, average daily gain and feed‐to‐gain ratio over the whole study period compared to the control group (Table 2). There were no differences between control and treated groups in cumulative or average daily feed intake.
Table 2.
Effect of Liderfeed® on mortality and performance of chickens in three efficacy studies
| Trial Duration (days) | Total number of birds (birds/pen × pens/treatment) | Liderfee® (mg/kg feed) | Feed intake (g) | Average weight gain (g/day) | Final body weight (g) | Feed to gain | Mortality (%) |
|---|---|---|---|---|---|---|---|
| 1 (35) | 247 (13/14 × 9) | 0 | 2,932 | 55.3 | 1,981 | 1.51 | 3.2 |
| 100 | 2,880 | 57.3a | 2,048a | 1.44a | 0.8 | ||
| 2 (35) | 216 (9 × 12) | 0 | 3,510 | 60.0 | 2,146 | 1.64 | 4.8 |
| 100 | 3,569 | 62.4a | 2,230a | 1.60a | 4.8 | ||
| 3 (35) | 144 (6 × 12) | 0 | 3,527 | 65.3 | 2,324 | 1.54 | 0.0 |
| 100 | 3,490 | 68.7a | 2,442a | 1.46a | 0.0 |
Means of treated and controls within the same trial are significantly different (p < 0.05).
Results of the two positive studies (studies 1 and 2) assessed in the previous opinion of the FEEDAP Panel (EFSA FEEDAP Panel, 2015) together with the newly submitted study (study 3) are shown in Table 2.
Considering the results of the current study, along with the two efficacy studies already assessed in the previous opinion of the FEEDAP Panel, in which the performance of chickens for fattening was positively affected as a result of the supplementation with the additive at 100 mg/kg complete feed, the FEEDAP Panel concludes that Liderfeed® has the potential to improve the growth of chickens for fattening at the supplementation level of 100 mg/kg complete feed.
4. Conclusions
Liderfeed® has the potential to improve the growth of chickens for fattening when used at 100 mg/kg complete feed.
Documentation provided to EFSA
Clove oil eugenol (Liderfeed®). May 2016. Submitted by Lidervet S.L.
Clove oil eugenol (Liderfeed®). Supplementary information. March 2017. Submitted by Lidervet S.L.
Clove oil eugenol (Liderfeed®). March 2011. Submitted by Lidervet S.L.
Abbreviation
- FEEDAP
EFSA Panel on Additives and Products or Substances used in Animal Feed
Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) , Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Martelli G, Renshaw D and López Puente S. Scientific opinion on efficacy of Liderfeed® (eugenol) for chickens for fattening. EFSA Journal 2017;15(7):1, 7 pp. 10.2903/j.efsa.2017.4931
Requestor: European Commission
Question number: EFSA‐Q‐2016‐00394
Panel members: Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López‐Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Acknowledgements: The FEEDAP Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last name): Jaume Galobart, Lucilla Gregoretti and Jordi Tarrés‐Call.
Adopted: 4 July 2017
Amendment: This scientific opinion has been revised following the adoption of the decision of the Commission on confidentiality claims submitted by the applicant, in accordance with Article 8(6) and Article 18 of Regulation (EC) No 1831/2003.
Amended: 12 July 2018
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
The FEEDAP Panel notes that the Description of the additive ‘Clove oil (eugenol)’ does not correspond to the latest indicated by the applicant and it should be ‘Eugenol’.
FEED dossier reference: FAD‐2016‐0034.
EED dossier reference: FAD‐2010‐0396.
Technical Dossier/Supplementary Information.
References
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2011. Technical guidance: tolerance and efficacy studies in target animals. EFSA Journal 2011;9(5):2175, 15 pp. 10.2903/j.efsa.2011.2175 [DOI] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2012. Guidance for the preparation of dossiers for zootechnical additives. EFSA Journal 2012;10(1):2536, 14 pp. 10.2903/j.efsa.2012.2536 [DOI] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2015. Scientific Opinion on the safety and efficacy of Liderfeed® (eugenol) for chickens for fattening. EFSA Journal 2015;13(11):4273, 16 pp. 10.2903/j.efsa.2015.4273 [DOI] [Google Scholar]