FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB)

TO THE NATIONAL ORGANIC PROGRAM (NOP)

Date: 11/05/2009 ____

Subject: Egg White Lysozyme Sunset Review ___

Chair: __Jeff Moyer ______________

Recommendation

The NOSB hereby recommends to the NOP the following:

Rulemaking Action: ___X __

Guidance Statement: ________

Other: ________

Summary Statement of the Recommendation (including Recount of Vote):

Egg White Lysozyme was reviewed for sunset by the NOSB at the November 2009 meeting. A 

summary of the Handling committee’s recommendation is attached. No comments were received 

during the meeting that disagreed with the committee’s recommendation. 

The NOSB voted to recommend relisting of Egg White Lysozyme on §205.605(a) with 13 voting 

yes, 0 no votes and 2 absent.

NOSB Vote: Motion: DeMuri Second: Weisman

Board vote: Yes - 13 No- 0 Abstain- 0 Absent - 2 

Summary Rationale Supporting Recommendation (including consistency with OFPA and 

NOP):

Response by the NOP:
National Organic Standards Board

Handling Committee Recommendation for §205.605(a)

Sunset of Egg White Lysozyme 

August 28, 2009

I. List: 

National Organic Program Subpart G: The National List of Allowed and Prohibited 

Substances. §205.605 Nonagricultural (nonorganic) substances allowed as ingredients 

in or on processed products labeled as “organic” or “made with organic (specified 

ingredients or food group(s)).”

a. Nonsynthetics allowed 

II. Committee Summary: 

Egg white lysozyme was added to the National List (Federal Register Vol. 71, No. 175) 

§205.605(a) on September 11, 2006. This addition was based on a re-assessment of egg 

white lysozyme by the NOSB at their May 13-14, 2003 meeting. This is the first time that egg 

white lysozyme has been reviewed through the sunset process. Egg white lysozyme is a 

purified enzyme preparation extracted from hen egg white. Lysozyme is a natural antimicrobial. The food applications for egg white lysozyme include cheese and wine.

The April 1, 2003 TAP reviewed “Enzymes, Plant and Fungal” and included these findings: 

The substance is used in handling and is non-synthetic but is not organically produced (7 

USC 6517 (b)(c)(iii)). Enzymes contained in various ingredients have been used to prepare 

foods since before recorded history. Enzymes have been used in a broad number of 

applications by organic food processors for as long as organic processed food has been on 

the market. The TAP did not address any unacceptable risks to the environment, human or 

animal health resulting specifically from the use or manufacture of egg white lysozyme. The 

petitioner describes the manufacturing process thusly: “The food-lysozyme that is the subject 

of the petition is naturally derived from chicken egg whites. A food-grade inert material (a 

polymer resin) that specifically binds to lysozome is used to extract the enzyme from the egg 

whites. After the binding process, the lysozyme is stripped from the resin, concentrated, 

purified, and dried. The extraction process requires the use of the following chemicals: citric 

acid, salt (NaCl), and hydrochloric acid / sodium hydroxide for pH adjustment. There are no 

solvents used in the manufacturing of the enzyme and the final dry product is nearly 100% 

pure egg white lysozyme.” Alternatives to this material in food handling are generally 

considered to be more harsh preservatives such as formaldehyde, nitrate, nisin, or hydrogen 

peroxide.

The NOSB has received seven public comments in support of, and no public comments 

opposed to, the relisting of egg white lysozyme in response to the Federal register notice of 

the sunset of egg white lysozyme (AMS-TM-07-0136). No public comments have been 

received opposing the continued use of egg white lysozyme in organic handling.

III. Committee Recommendations

The Handling Committee recommends the re-listing of egg white lysozyme on §205.605(a). 

Moved: Tracy Miedema Second: Joe Smillie

Committee Vote: Yes- 5 No- 0 Absent- 1 Abstain- Recuse- 0