Assessment of the feed additive consisting of benzoic acid (4d210) (VevoVitall®) for weaned piglets, pigs for fattening, sows and minor porcine species for fattening and for reproduction for the renewal of its authorisation (DSM Nutritional Products Ltd)

TL;DR

This paper assesses the safety of benzoic acid (VevoVitall®) as a feed additive for pigs and related species, confirming its safety under approved conditions.

Contribution

The study provides a renewed safety evaluation of benzoic acid for use in animal feed, confirming its continued approval.

Findings

Benzoic acid (4d210) is safe for target animals, consumers, and the environment under approved conditions.

The additive is irritant to skin, eyes, and respiratory system but not a skin sensitiser.

Assessment of efficacy was not required for the renewal of authorisation.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of benzoic acid (4d210) (VevoVitall®) as a zootechnical feed additive for weaned piglets, pigs for fattening, sows and minor porcine species for fattening and for reproduction. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of benzoic acid (4d210) remains safe for the target animals, consumer and for the environment under the approved conditions of the authorisation. Regarding user safety, the additive was considered irritant to skin, eyes and respiratory system and was not considered a potential skin sensitiser. Exposure by any route was considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Tables

TABLE 1. Data on the batch‐to‐batch variation and impurities of benzoic acid. The data presented are average values and (range) for batch‐to‐batch variation, and ranges for all other parameters. The number of batches analysed per parameter or group of parameters is indicated in [].

Specifications 1
Benzoic acid (%)	≥ 99.9
Phthalic acid (mg/kg)	≤ 100
Biphenyls (mg/kg)	≤ 100
Batch‐to‐batch variation	[5]
Benzoic acid (%) 2	99.99 (99.99–99.99)
Phthalic acid (mg/kg)	20.60 (11–33)
Biphenyls (mg/kg)	43.20 (33–61)
Water (%)	0.01–0.08
Impurities	[5]
Elemental impurities 3 (mg/kg)	< 10
Arsenic (mg/kg)	< 0.01
Sulfated ash (%)	< 0.01
Dioxins and furans (upper bound) 4
PCDD/Fs (ng WHO2005‐TEQ/kg)	0.19–0.25
PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg)	0.29–0.37
nDL‐PCBs (μg/kg)	1.20–1.50
Residual solvents (mg/kg)
Toluene	< 14 [3]

Full text

INTRODUCTION

1

Background and Terms of Reference

1.1

Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest 1 year before the expiry date of the authorisation.

The European Commission received a request from DSM Nutritional Products Ltd.2, represented in the EU by DSM Nutritional Products Sp. z o.o, for the renewal of the authorisation of the additive consisting of benzoic acid (VevoVitall®), when used as a feed additive for weaned piglets, pigs for fattening, sows and minor porcine species for fattening (category: zootechnical additives; functional group: other zootechnical additives).

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 14(1) (renewal of the authorisation). The dossier was received on 07 July 2025 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2025‐00426. The particulars and documents in support of the application were considered valid by EFSA as of 11 September 2025.

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 benzoic acid (VevoVitall®), when used under the proposed conditions of use (see Section 3.1.2).

Additional information

1.2

The additive consisting of benzoic acid (VevoVitall®) is currently authorised for use in feed for weaned piglets, pigs for fattening, sows and minor porcine species for fattening and for reproduction (4d210).3 The FEEDAP Panel issued five opinions on the safety and efficacy of this product (EFSA FEEDAP Panel, 2012, 2015, 2017a, 2017b, 2019).

DATA AND METHODOLOGIES

2

Data

2.1

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 benzoic acid (4d210) (VevoVitall®) as a feed additive.

The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 16 September 2025 to 16 December 2025; the comments received 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 39–39e 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 has been published on Open.EFSA.

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 11 November to 02 December 2025 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' (elicitation) knowledge, 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 benzoic acid (4d210) in animal feed are valid and applicable for the current application.7

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of benzoic acid (4d210) (VevoVitall®) is in line with the principles laid down in Regulation (EC) No 429/20088 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021).

ASSESSMENT

3

The additive benzoic acid (4d210) (VevoVitall®) is currently authorised as a zootechnical additive (functional group: other zootechnical additives) for use in feed for weaned piglets, pigs for fattening, sows and minor porcine species for fattening and for reproduction. The specific functions under which the authorisations are granted are:

• for weaned piglets, ‘improvement of performance parameters: weight gain or feed to gain ratio’;
• for pigs for fattening, ‘improvement of performance parameters: weight gain or feed to gain ratio’ and ‘urinary pH decrease’ and
• for sows and minor porcine species for fattening and for reproduction, ‘urinary pH decrease’.

The applicant is asking for the renewal of these authorisations.

Characterisation

3.1

Characterisation of the additive

3.1.1

Benzoic acid has the Chemical Abstracts Service (CAS) number 65‐85‐0, the EU number 200‐618‐2 and a molecular weight of 122.12 g/mol.

The additive is a free‐flowing powder and is currently authorised with a minimum purity of 99.9% and maximum levels of phthalic acid and biphenyl of 100 mg/kg each.

The applicant states that the manufacturing process remains the same since the previous authorisations.9

The data provided by the applicant on the batch‐to‐batch variation10 and impurities11 of the additive are reported in Table 1.

The data provided by the applicant showed compliance with the specifications set in the authorisations. The FEEDAP Panel considers that the amounts of the detected impurities do not raise safety concerns, and the levels of the residual solvent are below the limits set by VICH (2023).

No new data have been provided on the physical properties, stability and homogeneity of the additive. Considering that the manufacturing process and the composition of the additive have not been changed, the data described in the previous opinion are still valid (EFSA FEEDAP Panel, 2017b).

Conditions of use

3.1.2

The additive is currently authorised for use in feed, for weaned piglets at the maximum use level of 5000 mg/kg complete feed, pigs for fattening at the minimum use level of 3000/5000 mg/kg complete feed (improvement of zootechnical parameters/urinary pH decrease) and at the maximum use level of 10,000 mg/kg complete feed, sows at the minimum use level of 5000 mg/kg complete feed and at the maximum use level of 10,000 mg/kg complete feed and minor porcine species for fattening and for reproduction at the minimum and maximum use level of 5000 mg/kg complete feed.

Under other provisions of the authorisations,12 it is specified that:

• –The directions of use shall be indicated:

‘Complementary feedingstuffs containing benzoic acid shall not be fed to weaned piglets or pig for fattening/sows/minor porcine species for fattening and for reproduction as such. Complementary feedingstuffs shall be thoroughly mixed with other feed materials of the daily ration’. For piglets, pigs for fattening and minor porcine specie

• – In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
• – The additive shall not be used with other sources of benzoic acid or benzoates.
• – For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes and skin protection.

For piglets

• – Recommended minimum dose: 5000 mg/kg of complete feed.
• – For use in weaned piglets up to 35 kg of body weight.

For sows

• – For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eye contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

The applicant did not request any change in the current conditions of the authorisation.

Safety

3.2

In the previous assessments (EFSA FEEDAP Panel, 2012, 2015, 2017a, 2017b, 2019), the FEEDAP Panel concluded that the use of benzoic acid (VevoVitall®) is safe for weaned piglets, pigs for fattening, sows, gilts, boars and minor porcine species for fattening and for reproduction at levels ranging 5000–10,000 mg/kg complete feed. Regarding consumer and environment, the Panel concluded that there is no safety concern at the authorised doses. For user safety, the FEEDAP Panel concluded that the additive is a skin irritant and a severe eye irritant but is not a skin sensitiser and there is no concern for the exposure by inhalation.

The applicant stated that no adverse effects have been reported for the target species, consumers, users and the environment since the previous authorisations.

Extensive literature search

3.2.1

The applicant conducted an extensive literature search (ELS)13 to support the safety of VevoVitall® for all target species, consumers, environment and users under the authorised conditions of use. The ELS covered the period from 2014 until January 2025 and the following databases were used for the search: MEDLINE, AGRICOLA, EMBASE and CAPLUS. The search terms and the inclusion/exclusion criteria were provided. The search resulted in a total of 11 publications considered relevant for the safety by the applicant. The FEEDAP Panel assessed all of them and considered that no new information was provided that would lead to reconsider its previous conclusions on the safety for the target species, consumers and the environment.

Safety for the target species, consumer and environment

3.2.2

Considering that the manufacturing process and the composition of the additive have not been modified since the previous authorisations and no relevant new information was found in the literature search, the Panel concludes that the additive benzoic acid remains safe for the target species, consumer and the environment under the current conditions of the authorisations.

Safety for the user

3.2.3

In the previous opinions (EFSA FEEDAP Panel, 2017a, 2017b, 2019) the FEEDAP Panel concluded that VevoVitall® is not a skin sensitiser and does not pose a risk by inhalation. However, it is a skin irritant and a severe eye irritant.

Benzoic acid is classified under the Classification, Labelling and Packaging (CLP) Regulation as STOT RE 1 (Specific target organ toxicity – repeated exposure, Category 1, Lungs), Eye Damage 1 and Skin Irritant 2.

Additionally, no new evidence has been identified that would change the previous conclusion that the additive is not a skin sensitiser.

The Panel concludes that benzoic acid should be considered a skin, eye and respiratory irritant. Exposure of users by any route is considered a risk.

Efficacy

3.3

The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Post‐market monitoring

3.4

The FEEDAP Panel considers that there is no need for specific requirements for a post‐market monitoring plan other than those established in the Feed Hygiene Regulation14 and good manufacturing practice.

CONCLUSIONS

4

The applicant provided evidence that the additive benzoic acid (4d210) (VevoVitall®) currently in the market complies with the existing conditions of the authorisation.

The FEEDAP Panel concludes that the use of the feed additive benzoic acid in animal nutrition remains safe for the target animals, consumers and for the environment under the approved conditions of the authorisation.

Regarding user safety, benzoic acid should be considered a skin, eye and respiratory irritant. Exposure of users by any route is considered a risk.

There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

ABBREVIATIONSCASChemical Abstracts ServiceCLPClassification, Labelling and PackagingELSExtensive Literature SearchEURLEuropean Union Reference LaboratoryFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedICPInductively Coupled PlasmanDL‐PCBsnon‐dioxin‐like PCBsPCBspolychlorinated biphenylsPCDDspolychlorinated dibenzo‐p‐dioxinsPCDFspolychlorinated dibenzofuransTEQtoxic equivalentVICHInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal ProductsWHOWorld Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2025‐00426

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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, and Katerina Theodoridou.