Safety evaluation of an extension of use of the food enzyme acylglycerol lipase from the genetically modified Penicillium sp. strain AE‐LGS

TL;DR

This paper evaluates the safety of extending the use of a food enzyme produced by a genetically modified fungus, but insufficient data prevents a full assessment.

Contribution

The paper provides an updated safety evaluation for an extended use of a food enzyme, highlighting ongoing data gaps.

Findings

The safety evaluation could not be completed due to insufficient data on the production strain.

The extension of use for the food enzyme was not assessed due to the same data limitations as before.

The application for extended use remains pending further information.

Abstract

The food enzyme acylglycerol lipase (glycerol‐ester acylhydrolase, EC 3.1.1.23) is produced with the genetically modified Penicillium sp. strain AE‐LGS by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which the Panel could not complete the safety assessment due to insufficient data to characterise the production strain and the composition of the food enzyme. In the current application, the applicant requested to extend the use of the food enzyme to include two additional food manufacturing processes. For the same reasons as stated in the previous assessment, the Panel could not complete the evaluation of the extension of use.

This publication is linked to the following EFSA Journal article: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9228

Full text

INTRODUCTION

1

Article 3 of the Regulation (EC) No 1332/20081 provides definition for ‘food enzyme’ and ‘food enzyme preparation’.

‘Food enzyme’ means a product obtained from plants, animals or microorganisms or products thereof including a product obtained by a fermentation process using microorganisms: (i) containing one or more enzymes capable of catalysing a specific biochemical reaction; and (ii) added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods.

‘Food enzyme preparation’ means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution.

Before January 2009, food enzymes other than those used as food additives were not regulated or were regulated as processing aids under the legislation of the Member States. On 20 January 2009, Regulation (EC) No 1332/2008 on food enzymes came into force. This Regulation applies to enzymes that are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food, including enzymes used as processing aids. Regulation (EC) No 1331/20082 established the European Union (EU) procedures for the safety assessment and the authorisation procedure of food additives, food enzymes and food flavourings. The use of a food enzyme shall be authorised only if it is demonstrated that:

• it does not pose a safety concern to the health of the consumer at the level of use proposed;
• there is a reasonable technological need;
• its use does not mislead the consumer.

All food enzymes currently on the European Union market and intended to remain on that market, as well as all new food enzymes, shall be subjected to a safety evaluation by the European Food Safety Authority (EFSA) and approval via an EU Community list.

Background and Terms of Reference as provided by the requestor

1.1

Background as provided by the European Commission

1.1.1

Only food enzymes included in the Union list may be placed on the market as such and used in foods, in accordance with the specifications and conditions of use provided for in Article 7(2) of Regulation (EC) No 1332/2008 on food enzymes.

Acylglycerol lipase from a genetically modified strain of Penicillium camemberti (strain AE‐LGS) is a food enzyme included in the Register of food enzymes3 to be considered for inclusion in the Union list and thus subject to a risk assessment by the European Food Safety Authority (EFSA).

On 29 September 2023, a new application has been introduced by the applicant “Amano Enzyme Inc.” for an extension of the condition of the use of the food enzyme acylglycerol lipase from a genetically modified strain of Penicillium camemberti (strain AE‐LGS).

Terms of Reference

1.1.2

The European Commission requests the European Food Safety Authority to carry out the safety assessment and the assessment of possible confidentiality requests of the extension of use for the following food enzyme: acylglycerol lipase from a genetically modified strain of Penicillium camemberti (strain AE‐LGS), in accordance with Regulation (EC) No 1331/2008 establishing a common authorization procedure for food additives, food enzymes and food flavourings.4

Interpretation of the Terms of Reference

1.1.3

The present scientific opinion addresses the European Commission's request to carry out the safety assessment of an extension of the conditions of use for the acylglycerol lipase from the genetically modified Penicillium camemberti strain AE‐LGS.

The production microorganism was reclassified as Penicillium sp. at the species level in the previously published scientific opinion (EFSA FEZ Panel, 2025). Therefore, EFSA continued to use the name Penicillium sp. (instead of P. camemberti) also in the present opinion.

DATA AND METHODOLOGIES

2

Data

2.1

The applicant has submitted a dossier in support of the application for the authorisation of the extension of use of the food enzyme acylglycerol lipase from a genetically modified Penicillium camemberti strain AE‐LGS.

Additional information, requested from the applicant during the assessment process on 7 February 2024, was received on 28 February 2024 (see ‘Documentation provided to EFSA’).

Methodologies

2.2

The assessment was conducted in line with the principles described in the EFSA ‘Guidance on transparency in the scientific aspects of risk assessment’ (EFSA, 2009) and following the relevant existing guidance documents of EFSA Scientific Committee.

The ‘Scientific Guidance for the submission of dossiers on food enzymes’ (EFSA CEP Panel, 2021) and the ‘Food manufacturing processes and technical data used in the exposure assessment of food enzymes’ (EFSA CEP Panel, 2023) have been followed for the evaluation of the application.

Public consultation

2.3

According to Article 32c(2) of Regulation (EC) No 178/20025 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 October to 01 November 2024.6 No comments were received.

ASSESSMENT

3

IUBMB nomenclatureAcylglycerol lipaseSystematic nameGlycerol‐ester acylhydrolaseSynonymsMonoacylglycerol lipase; monoacylglycerolipase; monoglyceride lipase; monoglyceride hydrolase; fatty acyl monoester lipase; monoacylglycerol hydrolase; monoglyceridyl lipase; monoglyceridaseIUBMB NoEC 3.1.1.23CAS No9040‐75‐9EINECS No679‐517‐4

Acylglycerol lipases catalyse, in the presence of water, the hydrolysis of acyl‐glycerols into free fatty acids and glycerol. At very low concentrations of water, interesterification, i.e. the exchange of fatty acids between acylglycerols, may occur.

All aspects concerning the safety of this food enzyme were evaluated in January 2025, when used in two food manufacturing processes. In that application, the Panel was unable to complete the safety assessment of the food enzyme due to insufficient data regarding the production strain and the food enzyme composition. Since it was not possible to calculate the TOS value for the food enzyme preparation batches, the Panel could not apply the provided use levels to calculate the dietary exposure (EFSA FEZ Panel, 2025).

In this application, the applicant requested to update the intended uses (adding two food manufacturing processes). However, the reasons that impeded the previous assessment remain unresolved for the current application. Therefore, the Panel could not evaluate the extension of uses for the same food enzyme.

CONCLUSIONS

4

Previously, the Panel could not complete the safety evaluation of the food enzyme acylglycerol lipase produced with the genetically modified Penicillium sp. strain AE‐LGS. For the same reasons as stated in the previous assessment, the Panel could not complete the evaluation of the extension of use.

DOCUMENTATION AS PROVIDED TO EFSA

5

Technical dossier “Extension of use of the acylglycerol lipase from a genetically modified strain of Penicillium camemberti AE‐LGS”. September 2023. Submitted by Amano Enzyme Inc.

Additional information. February 2024. Submitted by Amano Enzyme Inc.

ABBREVIATIONSCASChemical Abstracts ServiceCEPEFSA Panel on Food Contact Materials, Enzymes and Processing AidsECEuropean CommissionEINECSEuropean Inventory of Existing Commercial Chemical SubstancesEUEuropean UnionFEZEFSA Panel on Food EnzymesIUBMBInternational Union of Biochemistry and Molecular Biology

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2023‐00652

COPYRIGHT FOR NON‐EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.

PANEL MEMBERS

José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize de Lourdes Marzo Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, and Holger Zorn.