Safety evaluation of the food enzyme triacylglycerol lipase from the pregastric tissues of calves, kids and lambs

TL;DR

This paper evaluates the safety of a food enzyme derived from young animal tissues and concludes it is safe for use in food production.

Contribution

The study confirms the safety of triacylglycerol lipase from pregastric tissues under intended food manufacturing conditions.

Findings

No safety concerns were identified from the enzyme's manufacturing process.

Dietary exposure from the enzyme is lower than from its natural source tissues.

Allergenic potential is considered low, though not entirely ruled out.

Abstract

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is prepared from the pregastric tissues of calves, kids and lambs by DSM Food Specialties B.V. No issue of concern was identified from the food enzyme manufacturing process. The food enzyme is intended to be used in two food manufacturing processes. As cheese production is a traditional use of this food enzyme, dietary exposure was not calculated. For the use in the production of flavouring preparations from dairy products, dietary exposure was estimated to be up to 0.001 mg total organic solids/kg body weight per day in European populations, which is lower than the intake of the corresponding fraction from pregastric tissues. The Panel considered toxicological testing unnecessary. A search for the homology of the amino acid sequences of the triacylglycerol lipases to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the origin of the food enzyme being edible animal tissues and a dietary exposure to the food enzyme comparable to its source in regular diet, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Tables

TABLE 1. Composition of the food enzyme preparation triacylglycerol lipase from the pregastric tissues of calves.

Parameters	Unit	Batches
		1	2	3
Triacylglycerol lipase activity	ILU/g a	20.1	18.9	57.4
Protein	%	NA b	NA	NA
Ash	%	95.0	95.06	92.16
Water	%	0.89	0.75	1.03
Excipient (■■■■■)	%	3.14	2.64	3.40
Total organic solids (TOS) c	%	0.97	1.55	3.41
Triacylglycerol lipase activity/TOS ratio	ILU/mg TOS	2.1	1.2	1.7

TABLE 2. Composition of the food enzyme preparation triacylglycerol lipase from the pregastric tissues of kids.

Parameters	Unit	Batches
		1	2	3
Triacylglycerol lipase activity	ILU/g a	18.6	91.4	51.5
Protein	%	NA b	NA	NA
Ash	%	98.98	88.55	93.35
Water	%	0.19	1.40	0.92
Excipient (■■■■■)	%	0.61	6.47	3.76
Total organic solids (TOS) c	%	0.22	3.58	1.97
Triacylglycerol lipase activity/TOS ratio	ILU/mg TOS	8.5	2.6	2.6

TABLE 3. Composition of the food enzyme preparation triacylglycerol lipase from the pregastric tissues of lambs.

Parameters	Unit	Batches
		1	2	3
Triacylglycerol lipase activity	ILU/g a	13.5	16.1	16.1
Protein	%	NA b	NA	NA
Ash	%	98.37	98.01	98.28
Water	%	0.33	0.36	0.33
Excipient (■■■■■)	%	0.86	1.02	1.0
Total organic solids (TOS) c	%	0.44	0.61	0.39
Triacylglycerol lipase activity/TOS	ILU/mg TOS	3.1	2.6	4.1

TABLE 4. Intended uses and recommended use levels of the food enzyme as provided by the applicant. 33

Food manufacturing process a	Raw material (RM)	Recommended use level (mg TOS/kg RM) b
Processing of dairy products
Production of cheese	Milk	0.1–2.1 c
Production of flavouring preparations from dairy products	Milk fat, curd, cheese	0.5–20.6

TABLE 5. Summary of the estimated dietary exposure to the food enzyme–TOS in the production of flavouring preparations from dairy products in six population groups.

Population group	Estimated exposure (mg TOS/kg body weight per day)
	Infants	Toddlers	Children	Adolescents	Adults	The elderly
Age range	4–11 months	12–35 months	3–9 years	10–17 years	18–64 years	≥ 65 years
Min–max mean (number of surveys)	0–0 (14)	0–0.001 (17)	0–0 (21)	0–0 (23)	0–0 (23)	0–0 (25)
Min–max 95th percentile (number of surveys)	0–0.001 (13)	0–0.001 (16)	0–0.001 (21)	0–0.001 (22)	0–0 (23)	0–0.001 (24)

TABLE 6. Summary of estimated dietary exposure to the SMT‐Equivalent, resulting from the consumption of animal tongue‐derived foods in six population groups.

Population group	Estimated exposure (mg/kg body weight per day)
	Infants	Toddlers	Children	Adolescents	Adults	The elderly
Age range	3–11 months	12–35 months	3–9 years	10–17 years	18–64 years	≥ 65 years
Min–max mean (number of surveys)	0–0 (14)	0–25.574 (17)	0–4.377 (21)	0–16.377 (23)	0–38.410 (23)	0–43.082 (25)
Min–max 95th (number of surveys)	Could not be calculated, due to the low number of actual consumers

TABLE 7. Qualitative evaluation of the influence of uncertainties on the dietary exposure estimate in the production of flavouring preparations from dairy products.

Sources of uncertainty	Direction of impact
	Exposure to FE–TOS	Exposure to SMT–equivalent
Model input data
Consumption data: different methodologies/representativeness/underreporting/misreporting/no portion size standard	+/−	+/−
Use of data from food consumption surveys of a few days to estimate long‐term (chronic) exposure for high percentiles (95th percentile)	+	+
Possible national differences in categorisation and classification of food	+/−	+/−
Model assumptions and factors
Exposure to food enzyme–TOS always calculated based on the recommended maximum use level	+	NA
Selection of broad FoodEx categories for the exposure assessment	+	+
Use of recipe fractions to disaggregate FoodEx categories	+/−	+/−
Use of technical factors in the exposure model	+/−	+/−
Selection of FoodEx categories containing animal tongue for the intake assessment of SMT‐equivalent	NA	+/−
The applied yield factor was the mean value	NA	+/−

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 EU 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 European Union (EU) Community 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 1332/2008^1^ on food enzymes.

Five applications have been introduced by the companies “Novozymes A/S”, “DSM Food Specialties B.V", “Advanced Enzyme Technologies Ltd” and the “Association of Manufacturers and Formulators of Enzyme Products (AMFEP)” for the authorisation of the food enzymes Pullulanase from a genetically modified strain of Bacillus subtilis (strain NZYM‐AK), Glucoamylase from a genetically modified strain of Aspergillus niger (strain NZYM‐BW), Chymosin from a genetically modified strain of Kluyveromyces lactis (strain CHY), Pectin lyase from a genetically modified strain of Aspergillus niger (strain FLOSC) and Triacylglycerol lipase from pregastric tissues of cattle, goat and sheep respectively.

Following the requirements of Article 12.1 of Regulation (EC) No 234/20113 implementing Regulation (EC) No 1331/20082, the Commission has verified that the application falls within the scope of the food enzyme Regulation and contains all the elements required under Chapter II of that Regulation.

Terms of Reference

1.1.2

The European Commission requests the European Food Safety Authority to carry out the safety assessments on the food enzymes Pullulanase from a genetically modified strain of Bacillus subtilis (strain NZYM‐AK), Glucoamylase from a genetically modified strain of Aspergillus niger (strain NZYM‐BW), Chymosin from a genetically modified strain of Kluyveromyces lactis (strain CHY), Pectin lyase from a genetically modified strain of Aspergillus niger (strain FLOSC) and Triacylglycerol lipase from pregastric tissues of cattle, goat and sheep in accordance with Article 17.3 of Regulation (EC) No 1332/2008 on food enzymes.

Interpretation of the Terms of Reference

1.2

The present scientific opinion addresses the European Commission's request to carry out the safety assessment of triacylglycerol lipase from the pregastric tissues of calves, kids and lambs submitted by DSM Food Specialties B.V.

The application was submitted initially as a joint dossier4 and identified as the EFSA‐Q‐2015‐00131. During the risk assessment phase, it was found that the technical dossier is too generic to be evaluated. During an ad hoc meeting between EFSA, the European Commission and the Association of Manufacturers and Formulators of Enzyme Products (AMFEP),5 it was agreed that joint dossiers will be split into individual data packages.

The current opinion addresses one data package originating from the joint dossier EFSA‐Q‐2015‐00131. This data package, identified as EFSA‐Q‐2023‐00016, concerns the food enzyme triacylglycerol lipase from the pregastric tissues of calves, kids and lambs and submitted by DSM Food Specialties B.V.

DATA AND METHODOLOGIES

2

Data

2.1

The applicant has submitted a dossier in support of the application for authorisation of the food enzyme triacylglycerol lipase from the pregastric tissues of calves, kids and lambs.

Additional information was requested from the applicant during the assessment phase on 25 April 2023, 23 April 2024 and 23 September 2025, and they were received on 26 September 2023, 14 May 2024 and 26 September 2025, respectively (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, 2009b) and following the relevant guidance documents of the EFSA Scientific Committee.

The ‘Guidance on the submission of a dossier on food enzymes for safety evaluation’ (EFSA, 2009a) has been followed for the evaluation of the application. Additional information was requested in accordance with the updated ‘Scientific Guidance for the submission of dossiers on food enzymes’ (EFSA CEP Panel, 2021) and the guidance on the ‘Food manufacturing processes and technical data used in the exposure assessment of food enzymes’ (EFSA CEP Panel, 2023).

ASSESSMENT

3

IUBMB nomenclatureTriacylglycerol lipaseSystematic nameTriacylglycerol acylhydrolaseSynonymsLipase; triglyceride lipaseIUBMB NoEC 3.1.1.3CAS No9001‐62‐1EINECS No232‐619‐9

Triacylglycerol lipases catalyse, in the presence of water, the hydrolysis of the ester linkages in triacylglycerols, resulting in the generation of glycerol, free fatty acids, diacylglycerols and monoacylglycerols. The food enzyme under assessment is intended to be used in two food manufacturing processes as defined in the EFSA guidance (EFSA CEP Panel, 2023): processing of dairy products for the production of (1) cheese and (2) flavouring preparations from dairy products.

Source of the food enzyme

3.1

The triacylglycerol lipase is obtained from the pregastric tissues of calves, kids and lambs from certified European suppliers, surveyed and approved by the competent authorities. The food enzyme is exclusively obtained from healthy animals slaughtered under the supervision of official health authorities, following the requirements of the relevant EU hygiene regulations, the Food Hygiene Regulation (EC) No 852/20046 and Regulation (EC) No 853/2004.7

In EU, according to Regulation (EC) 1774/2002,8 pregastric tissues of calves, kids and lambs are considered fit for human consumption. It is an edible offal as defined in Regulation (EC) No 853/2004.9

No issues of concern arising from the source material were identified by the panel.

Production of the food enzyme

3.2

The food enzyme is manufactured according to the Food Hygiene Regulation (EC) No 852/2004,10 with food safety procedures based on Hazard Analysis and Critical Control Points, and in accordance with good manufacturing practice.11

The food enzyme is extracted from the pregastric tissues of calves, kids and sheep. The frozen tissues are thawed and then trimmed and ground. The ground tissue is then mixed with acid and pH controlling agent, milled and homogenised. The obtained extract is filtered and further concentrated by an ultrafiltration step in which enzyme protein is retained, while most of the low molecular mass material passes the filtration membrane and is discarded.12

Around ■■■■■ of pregastric tissues is needed to produce 1 kg of liquid food enzyme (■■■■■),13 corresponding to a yield factor of ■■■■■.

The applicant provided information on the identity of the substances used in the extraction and in the subsequent downstream processing.14

The Panel considered that sufficient information has been provided on the manufacturing process and the quality assurance system implemented by the applicant to exclude issues of concern.

Characteristics of the food enzyme

3.3

Properties of the food enzyme

3.3.1

The triacylglycerol lipase from the tongue of calves is a single polypeptide chain containing between 428 and 469 amino acids.15 The molecular masses of the mature protein, calculated from the above amino acid sequences, are between 48 and 53 kDa.16

The triacylglycerol lipase from the tongue of kids is a single polypeptide chain of 378 amino acids.17 The molecular mass of the mature protein, calculated from the amino acid sequence, is 42.7 kDa.18

The triacylglycerol lipase from the tongue of lambs is a single polypeptide chain of 399 amino acids.19 The molecular mass of the mature protein has been reported to be 50 kDa.20

The food enzyme was analysed by sodium dodecyl sulfate‐polyacrylamide gel electrophoresis.21 A consistent protein pattern was observed across all batches.

No other enzyme activities were reported.22

The triacylglycerol lipase activity is determined according to the official method ISO 13082/IDF 218 (2011) that is based on the hydrolysis of tributyrin (reaction conditions: pH 6.2, 42°C). The enzyme activity is determined by titration of the butyric acid released from tributyrin using sodium hydroxide. The enzyme activity is expressed as International Lipase Units (ILU) per mL or ILU per g. One ILU is defined as the amount of lipase activity that releases butyric acid at a rate of 1.25 μmol/min under the conditions of the assay.23

The triacylglycerol lipase activity has a pH optimum around pH 5.5 (30°C) and a temperature optimum around 40°C (pH 5.5). Enzyme activity decreased above 50°C showing no residual activity above 72°C after 15 s of pre‐incubation.24

Chemical parameters

3.3.2

Data on the chemical parameters of the food enzyme preparation were provided for three batches from calves (Table 1), three from kids (Table 2) and three from lambs (Table 3).25 The mean total organic solids (TOS) from calves, kids and lambs were 2.0%, 1.9% and 0.5%, respectively, and the mean enzyme activity/mg TOS ratios were 1.7, 4.6 and 3.3 ILU/mg TOS, respectively.

Purity

3.3.3

The lead content in all commercial batches was below 0.01 mg/kg26 ^,^ 27 which complies with the specification for lead as laid down in the general specifications and considerations for enzymes used in food processing (FAO/WHO, 2006).

The microbiological analyses of all batches were reported. The food enzyme preparation complies with the microbiological criteria for total coliforms, Escherichia coli, Salmonella, Campylobacter including C. jejuni and C. coli, as laid down in the general specifications and considerations for enzymes used in food processing (FAO/WHO, 2006).28 The absence of Shiga toxin‐producing E. coli was also demonstrated in 25 g of each of the batches.29

The Panel considered that the information provided on the purity of the food enzyme is sufficient to exclude safety concern.

Toxicological data

3.4

According to the Commission Implementing Regulation (EU) No 562/2012,30 an application for the safety evaluation of a food enzyme does not need to include toxicological data if the food enzyme is obtained from edible parts of animals intended or reasonably expected to be ingested by humans.

According to the EFSA Guidance on the submission of a dossier on food enzymes for safety evaluation, the justification for not supplying toxicological data may include a documented history on the safety of the source of the food enzyme, the composition and the properties of the food enzyme, as well as its use in foods, demonstrating no adverse effects on human health when consumed in a comparable way (EFSA CEP Panel, 2021).

The Panel considers that these requirements are fulfilled, because:

• triacylglycerol lipases obtained from the pregastric tissues of calves, kids and lambs have been safely used in the production of cheese and related products for centuries (Nelson et al., 1977);
• the tongue from cattle is consumed throughout the EU and elsewhere in the world;
• the manufacturing process of the food enzyme is not considered to introduce substances that could raise safety concerns;
• the dietary exposure to the food enzyme–TOS for the flavouring preparations from dairy products was lower compared to the intake from tongue (see Section 3.5).

The Panel considered that sufficient information has been provided on the animal source, its history of safe use and consumption as well as the manufacturing process. Therefore, the need for toxicological data is waived.

Allergenicity

3.4.1

The allergenicity assessment considered only the food enzyme and not additives, carriers or other excipients that may be used in the final formulation.

The potential allergenicity of the food enzyme triacylglycerol lipase from the pregastric tissues of calves, kids and lambs was assessed by comparing their amino acid sequences with those of known allergens as described in the EFSA GMO Scientific Opinion (EFSA GMO Panel, 2010). Using higher than 35% identity in a sliding window of 80 amino acids as the criterion, no match was found in the AllergenOnline database.31

No reports on oral or respiratory sensitisation or elicitation reactions of the triacylglycerol lipase under assessment have been published.32

Respiratory allergic reactions following occupational inhalation of triacylglycerol lipase have been reported (Budnik et al., 2017; Elms et al., 2003; Lindstedt et al., 2005; Loureiro et al., 2009; Martel et al., 2010; Shin et al., 2008). Several studies have shown that individuals respiratorily sensitised to a food enzyme are usually able to ingest the corresponding enzyme without acquiring clinical symptoms of food allergy (Armentia et al., 2009; Cullinan et al., 1997; Poulsen, 2004). Adverse reactions upon dietary exposure to triacylglycerol lipases in individuals sensitised through the respiratory route have not been reported.

The Panel considered that the results of the sequence homology search and the available literature do not indicate a risk of allergic reactions upon dietary exposure to the triacylglycerol lipase under assessment.

In addition, allergic reactions upon dietary exposure to proteins from meat of calves, kids and lambs, the sources of the food enzyme, are rare.

In conclusion, the Panel considered that, under the intended conditions of use, a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is low.

Dietary exposure

3.5

intended use of the food enzyme

3.5.1

The food enzyme is intended to be used in two food manufacturing processes at the recommended use levels summarised in Table 4.

TABLE 4: Intended uses and recommended use levels of the food enzyme as provided by the applicant. 33

In the production of cheese, the triacylglycerol lipase is added to milk together with starter culture during coagulation.34 The free fatty acids released by hydrolysis of the triacylglycerols enhance cheese flavour. After coagulation, the food enzyme–TOS partition into the whey and the curd.35

In the production of flavouring preparations from dairy products, the food enzyme is added to a variety of dairy ingredients (e.g. curd and cheese) prior to pasteurisation.36 The hydrolysis of milk fat by triacylglycerol lipases results in the release of free fatty acids, which intensify the flavour of the enzymatically modified dairy ingredients. The food enzyme–TOS remain in the final products.

Based on data provided on thermostability (see Section 3.3.1), and the downstream processing steps applied in the respective food manufacturing processes, the Panel considered that the food enzyme is inactivated during the production of flavouring preparations from dairy products. However, it may remain in its active form in cheese, depending on the processing conditions.

Dietary exposure estimation

3.5.2

The estimation was made only for the production of flavouring preparations from dairy products, but not for the production of cheese.

The technology of extracting enzymes from pregastric tissues and the technology of using the food enzyme for cheese making have remained traditionally the same over many years and remain the major source of human exposure to the food enzyme. Cheese and by‐products of cheese making have been consumed by humans in Europe and many other parts of the world for millennia. In addition, tongues from ruminants are consumed in European countries, which contributes to the overall exposure to the food enzyme in the EU. Consequently, the Panel considered that a dietary exposure estimation to the production of cheese was not required.

The use of the food enzyme to produce enzymatically modified dairy ingredients is not a traditional use of animal tongue. Therefore, the Panel performed a dietary exposure calculation for this food manufacturing process.

Following the EFSA guidance document on food enzymes (EFSA CEP Panel, 2021), a comparison was made between the chronic exposures:

• dietary exposure to the food enzyme–TOS, resulting from the production of flavouring preparations from dairy products (herein referred as ‘FE‐TOS’) and
• dietary exposure to a fraction of pregastric tissues comparable to the food enzyme–TOS, resulting from the consumption of pregastric tissue‐derived foods (herein referred to as source material TOS equivalent, ‘SMT‐Equivalent‘).

In both cases, chronic exposure to the food enzyme–TOS was calculated using the FEIM webtool37 by combining the maximum recommended use level with individual consumption data (EFSA CEP Panel, 2021). The estimation involved selection of relevant food categories and application of technical conversion factors (EFSA CEP Panel, 2023).

Estimated dietary exposure to the food enzyme–TOS in the production of flavouring preparations from dairy products

3.5.2.1

Table 5 provides an overview of the derived exposure estimates across all surveys. Detailed mean and 95th percentile exposure to the food enzyme–TOS per age class, country and survey, as well as contribution from each FoodEx category to the total dietary exposure are reported in Appendix A – Tables 1 and 2. For the present assessment, food consumption data were available from 51 dietary surveys (covering infants, toddlers, children, adolescents, adults and the elderly), carried out in 27 European countries (Appendix B). The highest dietary exposure was estimated to be 0.001 mg TOS/kg bw per day in infants, toddlers, children, adolescents and the elderly at the 95th percentile.

Estimated dietary exposure to the SMT–equivalent

3.5.2.2

The chronic dietary exposure to the SMT–Equivalent was calculated by estimating the intake of pregastric tissue‐derived foods from all dietary sources (applying recipe and conversion fractions reported in Appendix C). Among the tissues that constitute the pregastric material, actual consumption data are available for tongues from bovines, pigs and horses. The intake of animal tongues was converted into a fraction comparable to the food enzyme–TOS via the application of a yield factor provided by the applicant (■■■■■)38 to take into account the yield of the food enzyme–TOS from the pregastric tissues (Section 3.2).

Table 6 provides an overview of the estimated exposure to the SMT–Equivalent. The absolute number of actual consumers of tongue‐derived foods is limited in each survey, and therefore, the 95th percentile could not be calculated. Consequently, only the detailed mean exposure to the SMT–Equivalent per age class, country and survey, as well as contribution from each FoodEx category to the total dietary exposure are reported in Appendix A – Tables 3 and 4. For the present assessment, food consumption data were available from 51 dietary surveys (covering infants, toddlers, children, adolescents, adults and the elderly), carried out in 27 European countries (Appendix B). The highest mean dietary exposure was estimated to be 43.082 mg/kg bw per day in the elderly.

Comparison of the two exposure estimates

3.5.2.3

The intake of the SMT‐Equivalent (Table 6) is three or four orders of magnitude greater than the dietary exposure to the food enzyme‐TOS via the consumption of foods containing flavouring preparations from dairy products (Table 5) for all the age classes, except for the infants. However, the consumption of animal tongue by infants is not expected.

Uncertainty analysis

3.5.2.4

In accordance with the guidance provided in the EFSA opinion related to uncertainties in dietary exposure assessment (EFSA, 2006), the following sources of uncertainties have been considered and are summarised in Table 7.

Both estimates are derived using the same food consumption data and exposure model and, hence, share a number of uncertainties, which do not have an effect on the comparison of the two estimates.

Margin of exposure

3.6

A margin of exposure was not calculated, because the Panel considered toxicological tests unnecessary as indicated in Section 3.4.

CONCLUSION

4

Based on the data provided, the origin of the food enzyme being edible animal pregastric tissues and a dietary exposure to the food enzyme comparable to its source in regular diet, the Panel concluded that the food enzyme triacylglycerol lipase obtained from the pregastric tissues of calves, kids and lambs does not give rise to safety concerns under the intended conditions of use.

DOCUMENTATION AS PROVIDED TO EFSA

5

Triacylglycerol lipase from pregastric tissues of calves, kids and lambs. December 2022. Submitted by DSM Food Specialties.

Additional information. September 2023. Submitted by DSM Food Specialties.

Additional information. May 2024. Submitted by DSM Food Specialties.

Additional information. September 2025. Submitted by DSM Food Specialties.

ABBREVIATIONSCASChemical Abstracts ServiceCEFEFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing AidsCEPEFSA Panel on Food Contact Materials, Enzymes and Processing AidsEINECSEuropean Inventory of Existing Commercial Chemical SubstancesFAOFood and Agricultural Organization of the United NationsIDFInternational Dairy FederationILUInternational Lipase UnitISOInternational Organization for StandardizationIUBMBInternational Union of Biochemistry and Molecular BiologyJECFAJoint FAO/WHO Expert Committee on Food AdditiveskDakiloDaltonLoDlimit of detectionNANot analysedTOStotal organic solidsWHOWorld Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2023‐00016

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, Henk Van Loveren, Laurence Vernis, and Holger Zorn.

NOTE

The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.

Supporting information

APPENDIX A: Dietary exposure estimates to the food enzyme–TOS and to the SMT‐equivalent in detail