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EFSA journal. European Food Safety Authority2020; 18(4); e06069; doi: 10.2903/j.efsa.2020.6069

Safety and efficacy of propyl gallate for all animal species.

Abstract: 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 safety and efficacy of propyl gallate as feed additive for all animal species. Propyl gallate is neither genotoxic nor carcinogenic. Propyl gallate a is safe for veal calves, cattle for fattening, dairy cows, sheep, goats, sows, horses and salmonids at the proposed maximum use level of 40 mg/kg and for ornamental fish at the proposed maximum use level of 100 mg/kg. The following concentrations (mg/kg complete feed) are considered safe for the other target species: 15 for chickens for fattening; 20 for turkeys for fattening, laying hens and rabbits; 27 for piglets and pigs for fattening and 71 for dogs. The Panel cannot conclude on a safe level for cats. The exposure of the consumer to propyl gallate and its metabolites cannot be estimated owing to the absence of reliable data on residues of propyl gallate and its metabolites in edible tissues and products. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for the consumer of propyl gallate, when used as a feed additive for all food-producing animal species. Propyl gallate is irritant to skin and eyes and a dermal sensitiser. Exposure via inhalation is possible and it is considered a hazard. The use of the additive in animal nutrition does not pose a risk for the environment. The FEEDAP Panel concludes that propyl gallate has the potential to act as an antioxidant in feedingstuffs. The Panel did not see a reason for the use of propyl gallate as an antioxidant in water for drinking.
Publication Date: 2020-04-30 PubMed ID: 32874281PubMed Central: PMC7447890DOI: 10.2903/j.efsa.2020.6069Google Scholar: Lookup
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  • Journal Article

Summary

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The research article deals with the study of the safety and efficacy of using propyl gallate as a feed additive for various animal species, facilitated by the European Commission’s FEEDAP panel. While it was deemed safe for several species, the lack of reliable data on residual propyl gallate in edible tissues made it difficult to estimate consumer exposure and to consequently establish its safety for humans.

Introduction

  • The research was conducted at the request of the European Commission by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), focusing on the safety and usefulness of propyl gallate as a feed additive for all kinds of animals.
  • The study explored the genotoxic and carcinogenic potential of propyl gallate, in addition to mapping its safe levels for different animal types.

Findings

  • The research determined that propyl gallate is neither genotoxic nor carcinogenic.
  • It is safe for consumption by various animals including veal calves, cattle for fattening, dairy cows, sheep, goats, sows, horses, salmonids, and ornamental fish.
  • Safe concentrations for other target species were also established, with different maximum use levels proposed for different animals.
  • However, the research was unable to conclude on a safe level of propyl gallate for cats due to lack of reliable data.

Impact on Humans and Environmental Concerns

  • Another crucial issue was the impact on human consumers due to residual propyl gallate and its metabolites in edible animal tissues and products. The absence of reliable data made it impossible to estimate consumer exposure, preventing the Panel from concluding its safety for human consumption.
  • Propyl gallate was found to cause irritation to skin and eyes and is considered a dermal sensitiser. Its possible inhalation might be hazardous.
  • On an environmental level, the research found that propyl gallate used in animal nutrition does not pose a risk to the environment.

Efficacy of Propyl Gallate

  • FEEDAP panel highlights the potential of propyl gallate as an antioxidant in animal feed.
  • The panel, however, did not see a compelling reason to employ propyl gallate as an antioxidant in drinking water for animals.

Cite This Article

APA
Bampidis V, Azimonti G, de Lourdes Bastos M, Christensen H, Dusemund B, Kos Durjava M, Kouba M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Aquilina G, Bories G, Gropp J, Nebbia C, Innocenti ML. (2020). Safety and efficacy of propyl gallate for all animal species. EFSA J, 18(4), e06069. https://doi.org/10.2903/j.efsa.2020.6069

Publication

ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 18
Issue: 4
Pages: e06069
PII: e06069

Researcher Affiliations

Bampidis, Vasileios
    Azimonti, Giovanna
      de Lourdes Bastos, Maria
        Christensen, Henrik
          Dusemund, Birgit
            Kos Durjava, Mojca
              Kouba, Maryline
                López-Alonso, Marta
                  López Puente, Secundino
                    Marcon, Francesca
                      Mayo, Baltasar
                        Pechová, Alena
                          Petkova, Mariana
                            Ramos, Fernando
                              Sanz, Yolanda
                                Villa, Roberto Edoardo
                                  Woutersen, Ruud
                                    Aquilina, Gabriele
                                      Bories, Georges
                                        Gropp, Jürgen
                                          Nebbia, Carlo
                                            Innocenti, Matteo Lorenzo

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