Efficacy of a feed additive consisting of guanidinoacetic acid (Creamino®) for weaned piglets and pigs for fattening in water for drinking (Alzchem Trostberg GmbH)

TL;DR

This study evaluates the effectiveness of a feed additive containing guanidinoacetic acid (Creamino®) for improving the performance of weaned piglets and fattening pigs when used in drinking water.

Contribution

The study confirms the potential efficacy of guanidinoacetic acid in water for drinking to improve zootechnical performance in weaned piglets and fattening pigs.

Findings

Guanidinoacetic acid (GAA) is safe for use in feed and water for chickens and pigs.

GAA in water for drinking can improve zootechnical performance in weaned piglets and fattening pigs.

The proposed conditions of use (600–1200 mg/kg feed; 200–600 mg/L water) are supported for efficacy.

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 efficacy of guanidinoacetic acid (GAA; Creamino®), intended for use as zootechnical additive (functional group: other zootechnicals – improvement of performance parameters) for weaned piglets and pigs for fattening in water for drinking. The additive is already authorised for use in feed and water for chickens for fattening and chickens reared for laying/breeding and only for feed in weaned piglets and pigs for fattening. In the previous opinion, the Panel concluded that the additive is safe for chickens for fattening, chickens reared for laying/breeding, piglets and pigs for fattening, the consumer, users and the environment under the proposed conditions of use. In the current submission, the applicant submitted considerations to support the authorisation of GAA in water for drinking for weaned piglets and pigs for fattening. The FEEDAP Panel reiterates it previous conclusion that the use of GAA in feed and water for drinking of weaned piglets and pigs for fattening has the potential to be efficacious in improving the zootechnical performance of the target animals under the proposed conditions of use (600–1200 mg GAA/kg complete feed; 200–600 mg GAA/L water).

Tables

TABLE 1. Description of the substances.

Category of additive	Zootechnical additives
Functional group of additive	Other zootechnical additives (improvement of performance parameters)
Description	Guanidinoacetic acid (GAA) and preparation of GAA (Creamino®)
Target animal category	Weaned piglets and pigs for fattening
Applicant	Alzchem Trostberg GmbH
Type of request	New opinion ‐ Request for scientific opinion pursuant to Article 29(1)(a) of Regulation (EC) No 178/2002

Full text

INTRODUCTION

1

Background and Terms of Reference as provided by the requestor

1.1

Regulation (EC) No 1831/2003 establishes the rules governing the Union authorisation of additives for use in animal nutrition; in particular, Article 9 defines the terms of the authorisation by the Commission.

The applicant is seeking a Union authorisation of the feed additive described in Table 1.

On 28 September 2022 the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), in its opinion on safety and efficacy of a feed additive consisting of guanidinoacetic acid for all animal species (AlzchemTrostberg GmbH) stated the following: “the applicant requested the authorisation of GAA as a nutritional additive, functional group of amino acids, their salts and analogues. In the view of the FEEDAP Panel, this functional group describes substances which finally enter the metabolism of the body as amino acids and as such take part in the protein synthesis pathways. GAA does not play a comparable role. Although resulting from the amino acid metabolism, GAA is exclusively converted to creatine and cannot be converted back to an amino acid. Therefore, the Panel considers that to support the efficacy of this product as a novel nutritional additive, relevant evidence of its efficacy should be provided at least in poultry, pigs, ruminants and fish, covering both growing and reproductive animals”.

In the light of the conclusions of the opinion, the additives could have been classified as nutritional additives, but this would have required the prior inclusion of a new functional group in Annex I to Regulation (EC) No 1831/2003 to allocate the additives in a functional group covering this new nutritional effect (not yet demonstrated according to the last EFSA opinion).

Therefore, as an alternative, the Commission suggested that the additives may be allocated under the category “Zootechnical additives” and under the functional group “Other zootechnical additives” as they have the potential to improve the zootechnical performance. However, the Commission also highlighted that, in that case, studies would need to be provided to demonstrate the efficacy of these additives categorised as “Zootechnical additives” in weaned piglets and pigs for fattening for their use in water, and that these studies would have to be in line with the requirements laid down for zootechnical additives in Regulation (EC) No 429/2008 and in the EFSA guidance.

The European Commission gave the possibility to the applicant to submit supplementary information and data along that line, to complete the assessment and to allow a revision of the EFSA's opinion.

The new supplementary information and data have been transmitted by the applicant using the E‐Submission Food Chain Platform (application number FEED‐2025‐33540).

In view of the above and in accordance with Article 29(1)(a) of Regulation (EC) No 178/2002, the European Commission requests EFSA to deliver a new scientific opinion on the efficacy of guanidinoacetic acid (GAA) and preparation of GAA (Creamino®), under the functional group “other zootechnical additives (improvement of performance parameters)”, in weaned piglets and pigs for fattening for their use in water, under the conditions of Regulation (EC) No 1831/2003 and based on the supplementary information and data submitted by the applicant.

Additional information

1.2

The additive is currently authorised for use in feed under the category of zootechnical (functional group other zootechnical additives (improvement of performance parameters)) for chickens for fattening and reared for laying/breeding, weaned piglets and pigs for fattening.1 The authorisation covers the use of the additive in feed and water for drinking for chickens for fattening/reared for laying or breeding. The use of GAA in weaned piglets and pigs for fattening is authorised in complete feed only.

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA issued three opinions on the safety and efficacy of guanidinoacetic acid: two opinions for the use of the additive in chickens for fattening and for pigs (EFSA, 2009; EFSA FEEDAP Panel, 2016) and one for the use in all animal species (EFSA FEEDAP Panel, 2022).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of supplementary information2 to a previous application on the same product.3 The dossier was received on 28/1/2025 and the general information and supporting documentation are available on Open.EFSA at https://open.efsa.europa.eu/questions/EFSA‐Q‐2025‐00121.

In accordance with Article 38 of the Regulation (EC) No 178/20024 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,5 a non‐confidential version of the dossier has been published on Open.EFSA.

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.

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the efficacy of guanidinoacetic acid (GAA) and a preparation of GAA (Creamino®) is in line with the principles laid down in Regulation (EC) No 429/20086 and the relevant guidance documents: Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2024).

ASSESSMENT

3

The additive guanidinoacetic acid (GAA) and a preparation of 96% GAA (Creamino®) are currently authorised as zootechnical additives (functional group: other zootechnical additives) in feed for chickens for fattening and reared for laying/breeding, weaned piglets and pigs for fattening at a minimum use level of 600 mg/kg complete feed and a maximum use level of 1200 mg/kg complete feed. In the original application, the applicant also requested the use of the additives in water for drinking, at the minimum and maximum use levels of 200 and 600 mg/L, respectively, but this use was only authorised for chickens for fattening and reared for laying/breeding at a range of 300–600 mg/L.

In the previous opinion, the Panel concluded that the additive is safe for chickens for fattening, chickens reared for laying/breeding, piglets and pigs for fattening, the consumer, users and the environment under the proposed conditions of use.

The FEEDAP Panel also concluded that GAA ‘has the potential to improve zootechnical performance of growing avian, Suidae, ruminant (except pre‐ruminants) species, in growing fin‐fish other than salmonids and in frogs’ when used under the proposed conditions of use.

In the current submission, the applicant submitted arguments to support the authorisation of GAA in water for drinking for weaned piglets and pigs for fattening.

Efficacy

3.1

In the previous opinion, the FEEDAP Panel concluded, that GAA has the potential to be efficacious in improving the zootechnical performance of growing porcine species under the proposed conditions of use (600–1200 mg GAA/kg complete feed; 200–600 mg GAA/L water). This conclusion was based on three studies in weaned piglets and pigs for fattening, in which dietary supplementation with GAA at levels ranging 300–1200 mg GAA/kg complete feed resulted in improvement of the performance (EFSA FEEDAP Panel, 2022).

The Panel acknowledges that in all the studies assessed, GAA was supplemented via feed and not via water. However, the Panel notes that both oral administration routes are, in principle, considered bioequivalent for additives intended for use in feed and water. Therefore, the conclusions reached for the use in feed apply to the use in water, considering that water intake is 2–3 times the dry matter feed intake (EFSA FEEDAP Panel, 2024).

CONCLUSIONS

4

The FEEDAP Panel reiterates its previous conclusion that the use of guanidinoacetic acid (as such or as a preparation) in feed and water for drinking of weaned piglets and pigs for fattening has the potential to be efficacious in improving the zootechnical performance of the target animals under the proposed conditions of use (600–1200 mg GAA/kg complete feed; 200–600 mg GAA/L water).ABBREVIATIONSFEEDAPPanel on Additives and Products or Substances used in Animal FeedGAAguanidinoacetic acid

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2025‐00121

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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, Ilen Röhe, and Katerina Theodoridou.