Lysozyme
Egg white lysozyme · LYSOZYME · E1105 · 1105 · Egg white lysozyme · Lysozyme · Lisozim · Lisozima · lizocim · Lizocimas · Lizocīms · LIZOZIM · Lizozym · Lysotsyymi · Lysozym · Lysozyme · Lyzozým · Lüsosüüm · Λυσοζύμη · ЛизоцимE number E1105INS 1105CAS 12650-88-3
Listed as a preservative by Codex and the US.
Listed as preservatives (US, Codex) · enzymes (US)
- United States: Antimicrobial agent — FDA, Substances Added to Food: EGG WHITE LYSOZYME
- Codex Alimentarius: Preservative — CXS 192-1995 Table One, INS 1105
- United States: Enzyme — FDA, Substances Added to Food: EGG WHITE LYSOZYME
Lysozyme is an antibacterial enzyme from egg white, used to stop late blowing in hard cheeses and as a preservative in wine. It is not vegan, and because it comes from egg it is an allergen that must be declared.
Where it is and isn’t permitted
| Jurisdiction | Status | Scope and limits | Citation |
|---|---|---|---|
| Australia and New Zealand | Permitted, with conditions | 54 food categories no numerical limit (good manufacturing practice) Show every food category
| Food Standards Code, Schedule 15, S15—5and 53 further provisionsretrieved 2026-10-17 |
| Canada | No listing matchedHealth Canada’s lists name additives without E or INS numbers, so this site matches them by exact name. A substance listed there under a name this site does not recognise has no row here. | ||
| European Union | Permitted, with conditions | 5 food categories Show every food category
| Regulation (EC) No 1333/2008, Annex IIand 4 further provisionsretrieved 2026-10-18 |
| Great Britain | Permitted, with conditions | 5 food categories Show every food category
| Assimilated Regulation (EC) No 1333/2008and 4 further provisionsretrieved 2026-10-18 |
| Japan | No listing matchedThis site imports only Japan’s list of designated additives (Appended Table 1 to the Regulations for Enforcement of the Food Sanitation Act), matched by English name. Existing additives, natural flavouring agents and ordinary foods used as additives are permitted outside that list and are not imported, so an empty row does not show that Japan does not permit the substance. | ||
| South Korea | Permitted, with conditions | Designated food additive: Standards and Specifications for Food Additives, Part III, 2. …Designated food additive: Standards and Specifications for Food Additives, Part III, 2. 가공보조제 (processing aids), 리소짐 (“Lysozyme”, the English the Code prints beside it). Main use (주용도) of 리소짐: 효소제. Standard for use (사용기준) of 리소짐: (1) [to be used under the general standard for use in II. 2. 1), the minimum amount that achieves the technical effect, with no limit set for this additive in particular] “II. 2. 1)의 규정에 따라 사용하여야 한다.” The Korean is the standard as published. There is no official English translation of the current Code (the English version on MFDS’s website is the 2020 edition and has no legal effect); the English in square brackets is this site’s description of what each sentence does, not a translation of the foods or the levels. Compositional specifications (Part IV) are not imported, nor are the general standards in Part II, which apply to every additive. | Standards and Specifications for Food Additives (식품첨가물의 기준 및 규격), MFDS Notification, Part III (Standards for use, by item)retrieved 2026-10-18 |
| United States | Not listedDoes not appear on this jurisdiction’s permitted list. That is not the same as being prohibited. | ||
| Codex Alimentarius | Permitted, with conditions | 3 food categories highest permitted level 500 mg/kg Show every food category and its notes
| CXS 192-1995 Table One, INS 1105and 2 further provisionsretrieved 2026-09-07 |
How much is permitted
A listing usually limits the quantity as well as the food. Only one of the forms that takes is a figure: quantum satis and good manufacturing practice permit the amount the technological effect requires and no more, which is a limit rather than the absence of one. Figures below are the range across every food category this page is listed in, and categories differ between regulators — see how much is permitted.
| Australia and New Zealand | — | 54 GMP |
|---|---|---|
| European Union | — | 5 quantum satis |
| Great Britain | — | 5 quantum satis |
| South Korea | — | 1 no quantity stated |
| Codex Alimentarius | 500 mg/kg | 2 numeric limit, 1 GMP |
What FDA’s inventory records
This page holds no listing for Lysozyme in the parts of 21 CFR this site reads. FDA’s Substances Added to Food inventory does carry it, as EGG WHITE LYSOZYME, pointing at no regulation at all.
Technical effects FDA records: antimicrobial agent, enzyme.
The inventory is an information resource: a row means FDA holds information about the substance’s use in food, not that the substance is listed for that use. It is shown apart from the permissions above and is not counted as a US permission anywhere on this site.
GRAS notices to the FDA
A GRAS notice is a company’s conclusion that a substance is generally recognised as safe for the use it describes. FDA’s letter responds to that conclusion, for that notifier and that use. It is not a listing in 21 CFR, and it is not counted as a US permission above. The substance and use are as FDA’s inventory words them; this site matched the notice to this page by exact name.
GRN No. 64 · Egg white lysozyme · Rhodia, Inc.
Intended use: Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent
FDA’s response (2001-04-02): FDA has no questions
What it is made from
Extracted from hen egg white, where it occurs naturally as part of the egg's own defence against bacteria.
- Not vegan
- Vegetarian
Compare other additives on the dietary indexes.
Allergen labelling
- From eggs. Extracted from hen egg white.
The EU’s list of allergens an ingredients list must emphasise is Regulation (EU) No 1169/2011, Annex II (consolidated text of 1 April 2025). Whether a product must declare one depends on what its additive was actually made from, which the label may not show; see the allergen origin index.
- CAS registry number
- 12650-88-3
The two specifications, compared
The European Union sets identity and purity by regulation; JECFA publishes its own through FAO, advisory until a country adopts it. Both documents are below in full. These are the parameters each puts a number on.
| Parameter | European Union | JECFA |
|---|---|---|
| Assay | stated in prose | stated in prose |
| Lead | no more than 5 mg/kg | no more than 2 mg/kg |
| Arsenic | no more than 1 mg/kg | — |
| Mercury | no more than 1 mg/kg | — |
One parameter differs between the two documents. A difference is not a disagreement about safety: the two are revised on their own cycles, and an assay or a drying loss can be measured against a different preparation of the substance, which is why only the contaminant ceilings are marked. Within the EU the EU's figure is the one that binds.
How the EU defines it
The legal specification an additive must meet to be sold as this E number in the EU — what it is, how it may be made, and the purity it must reach. From Commission Regulation (EU) No 231/2012.
E 1105 Lysozyme
Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride
Synonyms: Lysozyme hydrochloride; Muramidase
Assay, identification and purity criteria
Description and assay
- Einecs
- 232-620-4
- Enzyme Commission No
- EC 3.2.1.17
- Molecular weight
- About 14 000
- Assay
- Content not less than 950 mg/g on the anhydrous basis
- Description
- White, odourless powder having a slightly sweet taste
Identification
- Isoelectric point
- 10,7
- pH
- Between 3,0 and 3,6 (2 % aqueous solution)
- Spectrophotometry
- Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm
Purity criteria
- Water content
- Not more than 6,0 % (Karl Fischer method) (powder form only)
- Residue on ignition
- Not more than 1,5 %
- Nitrogen
- Not less than 16,8 % and not more than 17,8 %
- Arsenic
- Not more than 1 mg/kg
- Lead
- Not more than 5 mg/kg
- Mercury
- Not more than 1 mg/kg
- Microbiological criteria: Total bacterial count
- Not more than 5 × 10⁴ colonies per gram
- Microbiological criteria: Salmonella spp.
- Absent in 25 g
- Microbiological criteria: Staphylococcus aureus
- Absent in 1 g
- Microbiological criteria: Escherichia coli
- Absent in 1 g
How JECFA defines it
The international specification for identity and purity, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by FAO. It is a different document from any above, written by a different body and revised on its own cycle; it is advisory, and a country adopts it or does not.
INS 1105 Lysozyme Hydrochloride
A polypeptide obtained from hen's egg whites consisting of 129 amino acids and having a molecular weight of about 14,000 and an isoelectric point of 10.7; possesses enzymatic activity in its ability to hydrolyze the ß(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular Gram-positive organisms; usually obtained in the hydrochloride form for food use; must conform to the General Specifications for Enzyme Preparations used in Food Processing .
Synonyms: Lysozyme, INS No. 1105 Lysozyme
Assay, identification and purity criteria
Description and assay
- Specification history
- LYSOZYME HYDROCHLORIDE Prepared at the 39th JECFA (1992), published in FNP 52 Add 1 (1992). Metals and arsenic specifications revised at the 63rd JECFA (2004). Acceptable for use in food processing in accordance with GMP established at the 39th JECFA (1992)
- C.A.S. number
- 9066059-5
- Assay
- Not less than 950 μg/mg, as lysozyme hydrochloride, calculated on the anhydrous basis
- DESCRIPTION
- White, odourless powder
- FUNCTIONAL USES
- Processing aid for cheese production
- METHOD OF ASSAY
- Turbidimetric determination - The method is based on the changes in turbidity of a suspension of Micrococcus luteus ATCC 4698 induced by the lytic action of lysozyme. In appropriate experimental conditions these changes are proportional to the amount of lysozyme in the medium. Substrate - Suspend a suitable quantity (40-60 mg) of dry powdered Micrococcus luteus ATCC 4698 (Boehringer) in a few ml of M/15 pH 6.6±0.1 phosphate buffer solution to obtain a homogeneous suspension and dilute to 100 ml with the same buffer (use manual agitation or ultrasonic bath; do not use electromagnetic agitator). (The exact quantity of Micrococcus to be used depends on the type of spectrophotometer available). Prepare a control consisting of 5 ml of buffer solution and of 5 ml of M. luteus suspension and measure the absorbance of this suspension with a suitable spectrophotometer at 450 nm against a blank consisting of phosphate buffer. The reading should be not less than 0.800. If the reading does not correspond, adjust the initial suspension so as to obtain the desired absorbance (The absorbance values 0.800 -0.900 of the solution prepared as mentioned before, are obtained using a spectrophotometer with suitable sensitivity. Apparatuses with lower sensitivity give lower absorbances even when using the same suspension (0.500 - 0.600). In this case it is not correct to increase the quantity of substrate to obtain the initial absorbance values 0.800 - 0.900 as the reproducibility and linearity of the dosage could be unreliable). Standard solution - Dissolve about 50 mg of lysozyme hydrochloride working standard (Wst) (available from Federation International Pharmacetique, International Commission on Pharmaceutical Enzymes, Centre for Standards, Harelbekestraat 72, B-9000 Ghent, Belgium), accurately weighed, in water and dilute to 100 ml in a volumetric flask. Dilute 5 ml of this solution to 50 ml in a volumetric flask with water and then 2 ml of the last solution to 100 ml in a volumetric flask with M/15 phosphate buffer to obtain a solution containing 1 μg/ml of lysozyme (standard solution). Sample solution - Proceed as for the standard solution. Procedure In 180 x 80 nm test-tubes, prepare the following solutions: Standard soln. M/15 buffer Lysozyme conc. 2.0 ml 3.0 ml 0.4 μg/ml 2.8 ml 2.2 ml 0.56 μg/ml 4.0 ml 1.0 ml 0.8 μg/ml It is advisable to prepare three replications for each dilution of the standard and of the sample solutions. Separately prepare two test-tubes with 5 ml of buffer as control of the Micrococcus suspension. Use the first tube of the control at the beginning and the second at the end of the assay. At exactly 30 sec intervals, to each test-tube, randomly add 5 ml of the suspension of Micrococcus luteus (maintained under manual agitation to avoid decantation). Agitate rapidly and place the test-tubes to incubate in a water bath at 37±0.5o for exactly 12 min. The final quantities of lysozyme contained in the test-tubes are therefore 0.2 - 0.28 - 0.4 μg/ml. After incubation, remove the test-tubes from the water bath in the same order as they were put it and at 30 sec intervals. Agitate and read the absorbances with a suitable spectrophotometer at 450 nm against a blank of buffer. Normally the assay is acceptable when the difference between the absorbances of the two control tubes is not more than 5%. Calculate the result of the assay by standard statistical methods or by the following calculation: prepare the standard curve plotting on a graph the average of values of absorbance obtained for each dilution (on the ordinates) against the concentrations of lysozyme (on the abscissa) in logarithmic scale. Do the same with the solutions of the sample. Draw a straight line through the points obtained for the standard and another straight line through the points obtained for the sample. The two lines must be parallel otherwise the dosage is not valid. Then draw a line parallel to the axis of the abscissa so as to intersect the two lines at about half-way between the end limits of the dosage. At the two intersection points correspond two concentration on the abscissa (Cs the concentration of the standard curve and Cx the concentration of the sample curve). Calculate the microbiological assay (potency) of the sample under test as follows: C s × W st × P st 𝑃𝑜𝑡𝑒𝑛𝑐𝑦 ( 𝜇 𝑔 / 𝑘𝑔 ) = C x × W x where C s = concentration of the lysozyme hydrochloride working standard C x = concentration of the sample P st = potency of the lysozyme hydrochloride working standard W st = weight in mg of the lysozyme hydrochloride working standard W x = weight in mg of the sample under test Calculate the potency of the anhydrous basis as follows: Potency ( 𝜇 𝑔 / 𝑘𝑔 ) × 100 100 − water where water = determined as described above
Identification
- Solubility (Vol. 4)
- Soluble in water, insoluble in organic solvents and in concentrated saline solutions 3.0 - 3.6 (2 in 100 soln)
- pH (Vol. 4)
- An aqueous solution containing 25 mg/100 ml shows an ultraviolet absorbance
- Spectrophotometry (Vol. 4)
- maximum at 281 nm and a minimum at 252 nm
- PURITY
- Not more than 6% (Karl Fischer Method) Not
- Water (Vol. 4)
- more than 1.5%
- Residue on ignition (Vol. 4)
- Between 16.8 and 17.8%
- Chlorides
- Between 3.2 and 4.2% See description under TESTS
- Sodium
- Not more than 0.6% See description under TESTS
- Microbiological criteria (Vol. 4)
- Total bacterial count: not more than 5 x 10 4 col/g Salmonella spp.: absent in 25 g Staphylococcus aureus : absent in 1 g E. coli : absent in 1 g
- Lead (Vol. 4)
- Not more than 2 mg/kg Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4, “Instrumental Methods.”
Purity criteria
- Test: Chlorides
- Accurately weigh about 0.5 g of the sample and dissolve in 20 ml of water. Adjust the pH to 2.5 with 0.1 N nitric acid, add 20 ml of water and 15 drops of indicator (dissolve 0.125 g of diphenylcarbazone and 0.0125 g of bromophenol blue in 25 ml of 95% dry ethyl alcohol) and titrate with 0.025 N mercuric nitrate solution until a violet colour is produced. Prepare a blank and titrate as described above. Calculate the chloride content from (𝑚𝑙𝑥 − 𝑚𝑙𝑏) × 35.45 × 0.025 × 100 𝐶𝑙 = 𝑊 where mlx = ml of 0.025 N mercuric nitrate solutions used for sample mlb = ml of 0.025 N mercuric nitrate solutions used for blank W = weight of the sample (mg)
- Test: Sodium
- Determine the sodium content of a 1.0% solution of the sample by means of an ion analyzer equipped with a sodium detection electrode. Calibrate the apparatus using solutions of sodium chloride containing exactly 100 mg/l, 50 mg/l and 10 mg/l of sodium. Read the concentration of sodium in the sample solution from the calibration curve or directly from the digital display of the apparatus in units of mg/kg. The value found for the sample solution is not more than 60 mg/kg, equivalent to not more than 0.6% of sodium.
Every name it appears under
20 recorded names. A label may use any of them.
E number
- E1105
INS number
- 1105
As it appears in regulation
- Egg white lysozyme
- Lysozyme
Other names
- Egg white lysozyme
- LYSOZYME
The EU re-evaluation programme
Every additive authorised in the EU before 20 January 2009 was put back through EFSA by Commission Regulation (EU) No 257/2010, and this one is named in it. What the Regulation required is below; whether the opinion has since been published is not something this site records.
- To be evaluated by 31 December 2016. Named in Annex II, Part II, point 3 as “Lysozyme”, among the additives given priority within its class.
Hazard reference values
| Type | Value | Population | Assessed by | Opinion |
|---|---|---|---|---|
| ADI | not specified | — | JECFA | 1992 |
Evidence and how bodies read it
Studies, and the differing conclusions regulators drew from them, are curated rather than machine-read, and none has been written for this substance yet.
Common questions
Assembled from what is above, in the words the questions are usually asked in. Each answer is the same statement the relevant section makes, with the same citations behind it.
- What is E 1105?
- E 1105 is Lysozyme. Lysozyme is an antibacterial enzyme from egg white, used to stop late blowing in hard cheeses and as a preservative in wine. It is not vegan, and because it comes from egg it is an allergen that must be declared.
- What is Lysozyme used for in food?
- It is listed as a preservative — the role Codex and the US assign it. This page shows every function each regulator records, with the citation for each.
- Where is Lysozyme permitted?
- Of the seven regulators this site reads, Australia and New Zealand, the EU, Great Britain, South Korea and the Codex standard permit it. Each permission is for named foods at named levels, not a blanket one; the table on this page gives them with citations.
- Is Lysozyme vegan?
- No. Lysozyme is animal-derived, though it is generally accepted as vegetarian. This page says what it is made from.
Sources for this page
- anz retrieved 2026-10-17
- eu retrieved 2026-10-18
- gb retrieved 2026-10-18
- kr retrieved 2026-10-18
- gsfa retrieved 2026-09-07
- euspecs retrieved 2026-10-18
- jecfaspecs retrieved 2026-09-23
Full licence terms and publisher details on Sources. How this page is built and updated: Method.
Machine-readable: a JSON record of this additive is given on request —how to ask for access.
Follow changes to Lysozyme:Atom feed — regulatory events, and any change the weekly refresh detects in its provisions.