Assessment of the feed additive consisting of sodium propionate for all terrestrial animal species for the renewal of its authorisation (BASF SE)

TL;DR

This paper confirms the safety of sodium propionate as a feed additive for all terrestrial animals, supporting its authorization renewal.

Contribution

The study provides updated safety confirmation for sodium propionate under current usage conditions.

Findings

Sodium propionate is safe for target species, consumers, and the environment.

The additive is corrosive to skin, eyes, and respiratory tract but not a skin sensitiser.

No efficacy assessment was needed for the authorization renewal.

Abstract

Sodium propionate is authorised containing at least 98.5% of sodium propionate. The applicants requested for the renewal of the authorisation of sodium propionate when used as a feed additive for all terrestrial animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of sodium propionate under the current authorised conditions of use is safe for the target species, the consumers and the environment. Considering the user safety, the additive is corrosive to skin, eyes and respiratory tract, but is not a skin sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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 BASF SE2 for the renewal of the authorisation of the additive consisting of sodium propionate, when used as a feed additive for all animal species (category: technological additives; functional group: silage additives). During the assessment, the applicant requested a change in the target species excluding from the application for authorisation all the aquatic animals; therefore, the current assessment covers only all terrestrial animals.3

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 21 December 2022 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2022‐00880. The particulars and documents in support of the application were considered valid by EFSA as of 26 April 2023.

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 sodium propionate, when used under the proposed conditions of use (see Section 3.1.2).

Additional information

1.2

The additive, sodium propionate, is currently authorised as a silage for use in feed for all animal species (1k281).4 The FEEDAP Panel issued several opinions on the safety and efficacy of sodium propionate when used in feed for all animal species (EFSA FEEDAP Panel, 2011, 2012).

DATA AND METHODOLOGIES

2

Data

2.1

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 sodium propionate as a feed additive.

The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 26 April 2023 to 26 July 2023 for which the received comments were considered for the assessment.

In accordance with Article 38 of the Regulation (EC) No 178/20026 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,7 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 9 August to 30 August 2023 for which no comments were received.

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 the sodium propionate in animal feed are valid and applicable for the current application.8

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of sodium propionate is in line with the principles laid down in Regulation (EC) No 429/20089 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021).

ASSESSMENT

3

Sodium propionate is currently authorised as a technological additive (functional group: silage additive) for all animal species. This assessment regards the renewal of the authorisation of sodium propionate as a silage additive for all terrestrial animal species.

Characterisation

3.1

Characterisation of the additive

3.1.1

Sodium propionate is authorised containing at least 98.5% of sodium propionate in the dried matter, a loss on drying ≤ 4% (2 h at 105°C) and a content of water insoluble ≤ 0.1%. Its Chemical Abstracts Service (CAS) number is 137‐40‐6, its molecular formula is C_3_H_5_O_2_Na and the molecular weight is 96.06 g/mol. The additive is produced by chemical synthesis. The applicant states that the manufacturing process has not been modified since the original authorisation.

Analytical data to confirm the specifications were provided for five batches of the additive,10 showing the following average values: 100.1% (100.1%–100.2%) sodium propionate, 0.1% loss on drying and < 0.1% water insoluble matter for all the batches.

The results are in compliance with the specifications of the current authorisation.

Three additional batches of the additive were analysed for impurities.11 Cadmium, fluorine, lead, mercury and arsenic levels were below their respective limit of quantification (LOQ).12

Polychlorinated dibenzo‐p‐dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) were analysed in three batches.13 All values were below the corresponding LOQ. The calculated upper bound (UB) concentration was 0.156 ng WHO2005‐TEQ/kg for the sum of PCDD/Fs and 0.222 ng WHO2005‐TEQ/kg for the sum of PCDD/Fs and DL‐PCBs.14

The FEEDAP Panel considers that the amounts of the detected impurities do not raise safety concerns.

The solubility of sodium propionate in water is of 995 g/L at 20°C.15 The dusting potential of three batches of the additive was determined using the Stauber‐Heubach method (two measurements/batch) and showed values on average of 1253 mg/m^3^ (range 580–1845 mg/m^3^) (mg airborne dust per m^3^ of air).16

Particle size of the additive was analysed in five batches showing 3.5% of particles < 100 μm, 3% < 50 μm and 1.5% < 10 μm.17

No new data on stability and homogeneity have been provided by the applicant in the current dossier. Considering that the manufacturing process has not been changed since the previous authorisation, the data available in the first assessment (EFSA FEEDAP Panel, 2011) still apply.

Conditions of use

3.1.2

The additive is currently authorised for use in feed for pigs and poultry at a maximum content of 30,000 mg/kg for pigs and 10,000 mg/kg for poultry species, expressed as propionic acid. It is also authorised in ruminants and all animal species other than pigs and poultry with no minimum and maximum content in feed.

Under ‘other provisions’, it is stated:

1. The simultaneous use of other organic acids at the maximum permitted doses is contraindicated.
2. The additive shall be used in easy to ensile materials.
3. Simultaneous use with other sources of the active substance shall not exceed the authorised maximum content.
4. For safety, breathing protection, eye protection, gloves and protective clothing shall be used during handling.

The applicant did not request to change the current conditions of the authorisation except for the request to exclude aquatic species from the authorisation.18

Safety

3.2

In the opinion adopted by the FEEDAP Panel in 2011 (EFSA FEEDAP Panel, 2011), it was concluded that the maximum safe level of sodium propionate is 10,000 mg/kg complete feed for poultry and 30,000 mg/kg complete feed for pigs. The corresponding maximum concentrations in water for drinking would be 4000 mg/L for poultry and 10,000 mg/L for pigs. In the same opinion, it was concluded that the use of sodium propionate as a silage additive, without a quantitative restriction of supplementation, would not affect the safety of target animals and that the additive is not a skin sensitiser, but is corrosive to skin, eyes and mucous membranes, and that any exposure is considered a risk. The use of sodium propionate in animal nutrition was considered of no concern for the safety of consumers and no safety concern for the environment was identified from the use of sodium propionate at typical use levels in animal nutrition.

The applicant stated that no adverse effects or incidents/accidents have been reported from the use of the feed additive since the first authorisation of the product.19

In line with the requirements established in the EFSA Guidance on the renewal (EFSA FEEDAP Panel, 2021), the applicant performed an automatic extensive literature search (ELS) to support that the additive remains safe for target species, consumers, users and the environment, under the approved conditions.20 The literature search focused on propionates with the aim to generate one joint literature search for propionic acid, sodium propionate and ammonium propionate. The timeframe considered was from 2012 to 2022 and the strategy followed was reported. The applicant searched in several relevant databases.21 In addition to the automatic ELS, an independent manual search of relevant articles for the safety for the target species was conducted.

The ELS and the manual search identified a total of 62 publications potentially relevant for the safety for the target species (39 out of the 172 found in the ELS and 23 out of the 60 hits from the manual search). Four of the 62 relevant publications were EFSA opinions (EFSA ANS Panel, 2014, 2016; EFSA FEEDAP Panel, 2011, 2012).

Moreover, the literature search highlighted 11 potentially relevant publications for the safety for the consumer, two of which were EFSA opinions (EFSA ANS Panel, 2014, 2016) and four publications for the safety for the environment and four publications for the safety for the user, two of which were a EFSA opinion (EFSA FEEPAP Panel, 2011).

None of the papers reviewed provided information relevant to the safety for the target species, consumers, user and the environment that would lead the Panel to modify its previous conclusions. Therefore, considering the above and the fact that the manufacturing of the additive, specifications and conditions of use have not been modified, the FEEDAP Panel concludes that sodium propionate remains safe for the target species (all terrestrial animal species), consumers and the environment under the current conditions of authorisation. The FEEDAP Panel also concluded that sodium propionate is not a skin sensitiser, but it is corrosive to skin, eyes and mucous membranes, and that any exposure 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.

CONCLUSIONS

4

The applicant provided evidence that the additive currently in the market complies with the existing conditions of the authorisation.

The FEEDAP Panel concludes that the use of sodium propionate under the current authorised conditions of use remains safe for the target species (all terrestrial animal species), the consumers and the environment.

Regarding the user safety, the additive is corrosive to skin, eyes and respiratory tract, but is not a skin sensitiser. Any exposure is considered a risk.

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

ABBREVIATIONSANSEFSA Scientific Panel on Additives and Nutrient Sources added to FoodBWbody weightCASChemical Abstracts ServiceCDCommission DecisionCVcoefficient of variationDMdry matterECHAEuropean Chemicals AgencyEINECSEuropean Inventory of Existing Chemical SubstancesEMAEuropean Medicines AgencyEURLEuropean Union Reference LaboratoryFAOFood Agricultural OrganizationFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedIUPACInternational Union of Pure and Applied ChemistryJECFAThe Joint FAO/WHO Expert Committee on Food AdditivesLODlimit of detectionLOQlimit of quantificationNOAELno observed adverse effect levelOECDOrganisation for Economic Co‐operation and DevelopmentWHOWorld Health Organization

CONFLICT 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.

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2022‐00880

COPYRIGHT FOR NON‐EFSA CONTENT

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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.