Lipases from animal

sources

Ad hoc meeting on plant and animal derived enzymes Joint

Dossiers18th September 2020

Summary

• Lipase enzymes from the “gullet” of kid goat/lamb/calf have been used for >70 years in cheese production

• Lipase (triacylglycerol) is found in the pregastric tissues (gullet) of ruminants, especially of calf (bovine), kid goat (caprine), and lamb (ovine)

• 1. Commercial lipase products exist in two major forms

– A) Extracted from the gullet; B) Directly dried/grinded gullet

• In 2019 the amounts lipase produced in the EU were:

– Ca. 40 tons

• Generating an estimated amount of cheese:

– Ca. 36,400 tons (used at ca. 110 g commercial lipase/ton milk)

• 2. Separately, the gullet is present in the “tongue long cut” and is prepared and eaten

• The amount of bovine origin tongue produced in France in 2019 was about 3 million pieces

• A literature search, and general market knowledge, do not indicate adverse effects, eating either said cheeses or cuts of tongue

• Thus, taking 1 and 2 together, we consider that lipases from gullet have a record of safe consumption

– Thus, in our view, not requiring toxicity studies for EU approval

– Thereby saving EU companies from additional costs

– And not unnecessarily harming animals for testing

Contents

• 1) Animal source

• 2) Production process of lipases

• 3) Uses of lipases in food production– In cheese making– A cut of meat (tongue long cut)

• 4) Overall safety

• 5) Conclusion

1) Animal source

• The main physiological role of lipases, released from the gullet, is the hydrolyzation of the fat from globules in the milkin “kid mammals”– During ingestion of for example milk, the lipases are released

– Thus, mammal lipases is something naturally related to food/digestion

• Lipase (triacylglycerol) is found in the pregastric tissues of ruminants, especially of calf (bovine), kid goat (caprine), and lamb (ovine)

Schematic of the gullet

• The richest area is the intraparietal glands of the mucosa of the "gullet"

– The gullet is the region which is bordered anteriorly by the vallatepapillae of the tongue and posteriorly by the pharyngeal end of the esophagus

– The gullet includes the soft palate, the root of the tongue, the glosso-epiglottic region, the epiglottis, the larynx, and the apex of the arytenoids cartilage

2) Production process of lipases(Triacylglycerol lipase)

Gullets are a raw

material for the

production of lipase

3) Uses of lipases in food production

• On the following slides we describe different uses (or presence) of the lipases / gullet in food production

In cheese production• Lipases can release fatty acids from the fat globules in milk

(lipolysis)– The fatty acids can be further metabolized generating various volatile

compounds

• This gives a strong definite flavor found in for example these cheeses:– Provolone

– Pecorino

– Feta (traditional)

– …

• Commercial lipase products exists in two major forms

– A) Extracted from the gullets (ca. 30% of market)

– B) Directly dried/grinded gullets (ca. 70%)

– … in both cases from kid goat/lamb/calf

In cheese production

• Amount of lipase produced in the EU in 2019: ca. 40 tons

– About 95% of this total is excipients

• Commercial lipase is used at ca. 110g / ton milk

• Thus in the EU, it is added to ca. 364,000 tons of milk

• Generating ca. 36,400 tons of cheese

– (Ca. of 90% the milk becomes whey)

• Assuming a cheese “portion size” of 50g

– The “lipase intake” is ca. 2-3mg

– (55mg incl. excipients)

A cut of meat (tongue long cut)

• Historically, almost all parts of slaughtered animals have been eaten

• And it is still very common to for example eat the tongue of calves

• Specifically, in for example France, there is a common cut of meat of tongue (“tongue long cut”) derived from the gullet

• The tongues of bovine origin produced in France in 2019: about 3 million pieces

• The main quantity of gullets produced in EU are exported to Africa for human consumption, used in the preparation of soup;

• People of African origin in the EU have kept this tradition; consuming gullets as food

https://www.unece.org/fileadmin/DAM/trade/agr/meetings/ge.11/2007/2007_i09_f_FancyMeats_FR.pdf

Gullets in pet food

• A minor quantity of gullets produced in the EU is used for pet food

– For this, it must be approved for human consumption

• According to Regulation (EC) N. 1069/2009, articles 10 and 14 below

Overall safety• Although studies have shown that cheese can have effects on

general health, both

– A) positive (e.g. Ca++, protein) and potentially

– B) negative (e.g. saturated fatty acids, cholesterol)

– We are not aware* of any documented health issues relating to the lipases

– The same can be said about the cut of meat (tongue)*

• *See the following slide for literature search method

• Please note that the present document does not specifically discuss the compounds used in the extraction and formulation of lipases

– Naturally, different producers use different compounds

– These compounds are safe, suitable, and in compliance with relevant EU regulations

Literature search method• Searches were done on http://pubmed.gov. The “hits” were screened manually. Selected

examples of searches are shown below:

– lipase AND cheese: 106 hits (would also include articles about “toxicity” etc.)

• The publication from this search that is most “related” (but not relevant) to the topic at hand can be found here: https://pubmed.ncbi.nlm.nih.gov/31331094/, with the title:

• Prevalence and toxicity characterization of Bacillus cereus in food products from Poland

– lipase AND tongue: 94 hits (again, nothing relevant)

– tongue AND (bovine OR calf OR cow) AND (eat OR intake): 24 hits

• The most “related” (but not relevant) publication can be found here: https://pubmed.ncbi.nlm.nih.gov/28962453/, with the title:

• Human health risks associated with residual pesticide levels in edible tissues of slaughtered cattle in Benin City, Southern Nigeria

• Overall, there appears to be no published work about “toxic effects” of lipase in cheese, or eating calf tongue

• Further, general knowledge of the “cheese market”:

– Not aware of any adverse effects

Conclusion• Taking the information within, i.e.:

– The ingestion of lipases / gullets for many decades through consumption of:

• Certain types of cheeses

• Certain cuts of meat (tongue)

• Apparently, no documented adverse health effects attributed to this consumption

– We consider that lipases / gullets have a record of safe consumption

• Thus, in our view, not requiring toxicity studies for EU approval:

• a) Will save EU companies from additional costs

• b) Not unnecessarily harming animals for testing

• Proposed action

– Data packages will be submitted by each manufacturer

• Covering the points EFSA raised, March 2020

– We trust the data will show all products are made with substantially equivalent processes

• As mentioned in the Commission implementing regulation 562/2012

– To avoid disturbing the market, and to maintain the current situation in most member states, we anticipate that lipase will be covered by a generic entry

Thank you for your attention!