Lysozyme Safety

TOXICOLOGY AND SAFETY STATEMENT

Lysozyme is a naturally occurring protein discovered by Fleming in 1922.

Hen egg-white (HEW) Lysozyme is a well known compound, which has been used in pharmaceutical compositions and food since the 1950s. Numerous toxicological studies over the years, including acute, sub-acute and chronic toxicity studies on animals, have demonstrated that HEW Lysozyme is “devoid of toxic effects even after rather prolonged administration”1. Moreover, on the basis of toxicological data obtained in numerous clinical studies by 20-40 day treatments in doses of 1.5 g or more by the oral or parenteral route, “no particular problems of local and systemic tolerance of lysozyme have become apparent”2

The overall results of studies on major vital functions, such as the cardiovascular system, the automatic nervous system and the thermoregulatory system confirm the non toxicity of HEW Lysozyme3.

Lysozyme has been affirmed as GRAS by the FDA4 with its tentative final rule dated March 13, 1998.

The USDA has recently authorized the use HEW Lysozyme as an ingredient in or on processed products labeled as “organic”5.

The JEFCA-Joint FAO/WHO Expert Committee on Food Additives stated in its report that: “Lysozyme is obtained from edible animal tissue commonly used as food and can thus be designed as class I enzyme and regarded as a food. It was therefore considered acceptable for use in food processing when used in accordance with good manufacturing practice.”6

HEW Lysozyme is an egg protein. Therefore, individuals sensitive to egg Lysozyme may experience an allergic reaction when taking HEW Lysozyme, especially systemically (i.e. intra-venous, inhalation, etc.). However, of all egg-white proteins Lysozyme has the least statistical allergenic incidence. 7’8

In fact, the statistical incidence of spontaneous or acquired hypersensitivity episodes to Lysozyme as a pharmaceutical is – according to some published reports – extremely low and much lower than that of other commonly used drugs which also have a protein structure, such as insulin, ACTH and other”.9

In a recent study10 related to processing aids in winemaking, carried out in Germany and France over a 3 year period, only 8 egg-allergic individuals could be recruited out of at least 3,000 food allergic patients screened a year.11 This prompted the researchers to state that “if it is such a problem to find this type of allergy among adults, it poses the question about the scope of the actual problem in the European population”12

Notwithstanding the above, Fordras is extremely receptive to the hypersensitivity issues and is supportive of the regulatory bureaus’ initiatives regarding allergen labeling in food, provided that the reasons for such initiatives are supported, in the interest of objective scientific decision making, by reliable scientific data, such as double blind placebo control tests, and not anecdotal observations.

Indeed, Fordras believes that the benefits of HEW Lysozyme are such that labeling its presence in pharmaceutical compositions or foodstuff should not be seen as merely a mean to inform the concerned consumer, but, also, as a possible marketing tool for the manufacturer. In fact, to indicate the presence of Lysozyme in a food product could be a powerful way to communicate to the consumer that such product is, or has been preserved, processed, and protected with a natural and safe compound13, which, in certain instances, is also known to improve the flavor, color and texture of such foodstuff.


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1Fleming’s Lysozyme Luigi Barbara and Rinaldo Pellegrini. Edizioni Minerva Medica, 1976 pp.53
2 Fleming’s Lysozyme Luigi Barbara and Rinaldo Pellegrini. Edizioni Minerva Medica, 1976 pp.123
3 Ricerche farmacologiche sul lisozima Gialdroni Grassi G. Terapia antibiottici Chemoterapie, 6, 89, 1956
4Direct Food Substances Affirmed As Generally Recognized As Safe Food & Drug Administration. Federal Register, Vol. 63 No.49. March 13, 1998. 21 CFR Part 184 [docket no. 89G-0393]
5 http://www.ams.usda.gov/nop/Newsroom/FedReg09_11_06TM-04-01.pdf
6 http://www.inchem.org/documents/jecfa/jecmono/v30je04.htm
7Update on Food Allergy. Sampson HA. J. Allergy Clin. Immunol 2004; 113:805.-19
8 Prevalence of lysozyme sensitization in an egg-allergic population. Fremont S. et al Allergy. 1997 Feb;52(2):224-8
9 Fleming’s Lysozyme Luigi Barbara and Rinaldo Pellegrini. Edizioni Minerva Medica, 1976 pp.124
10 Allergenicity study of protein concerning processing aids for wine 2006 Aug; part 7 Conclusion
11 “Department of Dermatology and Allergy Biederstein” Allergenicity study of protein concerning processing aids for wine 2006 Aug; 6.3.1.pp 83
12 Allergenicity study of protein concerning processing aids for wine 2006 Aug; part 7, 88
13 See footnotes 4 and 5