National Organic Standards Board

Handling Subcommittee Discussion Document

Reclassification of L-Malic Acid

February 19, 2020

Introduction:

The Handling Subcommittee is considering a change to the classification of L-malic acid from a nonagricultural 

(nonorganic) non-synthetic allowed substance to a nonagricultural synthetic allowed substance and move the 

substance from §205.605(a) to §205.605(b). This consideration responds to recommendations made in a number 

of comments submitted during the substance’s sunset review at the Spring and Fall 2019 NOSB meetings. 

Additionally, this responds to the 2019 L-malic acid Technical Report (TR), which found that most commercial 

quantities of L-malic acid are derived in part via a process of enzymatic conversion of synthetic fumaric acid. 

Background: 

L-malic acid was first added to the National List in 2006 and its listing has been renewed at each subsequent

sunset review. The substance underwent its most recent 5-year sunset review in 2019, during which it received

support from stakeholders for continued inclusion on the National List. Several commenters opposed the relisting;

these comments are addressed in the discussion section below. At its Fall 2019 meeting, the Board voted 13 in

favor, with one member absent, to relist L-malic acid.

However, during the sunset review the Board acknowledged the many comments suggesting most commercial 

sources of L-malic are synthetic and that the listing for L-malic acid should be at §205.605(b). Because a listing 

cannot be changed nor can an annotation be added during sunset review, the Board noted it would address the 

placement of the substance outside of sunset review.

Relevant areas in the Regulation: 

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: L-malic acid (CAS # 97-67-6).

Discussion: 

L-malic acid occurs naturally in many fruits and vegetables, including apples and cherries and can be obtained by

enzymatic conversion of fumaric acid and by fermentation of glucose and other carbohydrates. It is not

economical to extract L-malic acid from natural foodstuffs such as apple juice.

In the first round of the sunset review in Spring 2019, a number of commenters questioned whether commercially 

available L-malic acid is indeed from nonsynthetic sources, as this listing restricts. Commenters noted that while 

supporting documentation may state L-malic acid is produced naturally via enzymatic fermentation, this 

statement refers to only the second half of the process.

Industrial quantities of L-malic acid are made using biological processes, with the major industrial process to 

produce L-malic acid being a two-step procedure:

1. Production of fumaric acid either synthetically from petroleum or by fermentation of carbohydrates; and

2. Enzymatic conversion of fumaric acid to L-malic acid by immobilized microbes producing the enzyme

fumarase.

There are two options for obtaining the fumaric acid in the first step in this process; more detailed information on 

the two-step process can be found in Appendix A of the 2019 Technical Report.

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1. The fumaric acid precursor is obtained through the fermentation of carbohydrates (i.e., Rhizopus spp.)

2. The fumaric acid precursor is obtained as a synthetic product from maleic acid of petroleum origin

Commercial quantities of nonsynthetic L-malic acid may also be produced using a one-step fermentation process 

through biological methods such as microbial fermentation using Aureobasidium pullulans and Penicillium 

vitacola, though it is not believed that this process is occurring on a scale that would accommodate the needs of 

the current market. The major commercial source of L-malic acid is enzymatic conversion of synthetic fumaric acid 

to L-malic acid by immobilized microbes (Chibata et al. 1983; Chi et al. 2016a; Dai et al. 2018). If the malic acid 

produced by this method is synthetic, most if not all, of the L-malic acid on the market is therefore synthetic 

(Goldberg et al. 2006; Chibata et al. 1983; Engel et al. 2008; Chi et al. 2016a; Dai et al. 2018).

A number of commenters noted that while there may have been nonsynthetic versions available in the past, it is 

unlikely that commercially available nonsynthetic quantities exist. As certifiers, material review organizations, and 

the 2019 TR attest, applying NOP Guidance 5033 and 5033-1 to this full production method would result in 

classifying L-Malic acid as a synthetic material. Until this material is reclassified, certifiers have been verifying the 

following for L-malic acid: that it is not made using the “big 3” (genetic modification, sewage sludge, irradiation); 

that it is L-malic acid (not DL- or D-); and that it is the form with the same CAS# as is identified on the National List.

Commenters opposing the relisting of L-malic acid during the 2019 sunset review believe it should be removed 

from the National List and then repetitioned for inclusion at §205.605(b), or listed at §205.605(a) with an 

annotation limiting use to forms produced through nonsynthetic fermentation methods. The Handling 

Subcommittee is keenly aware of the negative environmental and climate impacts of petroleum use and supports 

alternatives to its use in organic production. However, as noted by commenters during the 2019 sunset review 

and indicated in the 2019 TR, it does not appear that commercial quantities of nonsynthetic L-malic acid are 

sufficient to meet current demand.

Questions:

The Subcommittee is seeking feedback on the following questions to help inform its decision regarding the 

reclassification of L-malic acid and to gather further information on some of the comments expressed during the 

2019 sunset review.

1. There still appears to be some disagreement whether the process described in this document results in a 

synthetic form of L-malic acid. Is the determination that the two-step process described in this document 

and in the 2019 TR results in a synthetic form of L-malic acid accurate?

2. Would classification of L-malic acid when manufactured from synthetic fumaric acid as a synthetic 

substance affect the classification of other substances currently on 205.605(a)?

3. If the Subcommittee recommends an annotation that limits sources of fumaric acid used in the 

production of L-malic acid to non-petroleum sources, are there sufficient quantities to meet current 

demand in organic production?

4. How much time would be required for the industry to meet current and expected commercial demand of 

nonsynthetic L-malic acid produced using a one-step fermentation process through biological methods 

such as microbial fermentation using Aureobasidium pullulans and Penicillium vitacola? 

Subcommittee Vote:

Motion to accept the discussion document on reclassification of L-Malic Acid

Motion by: Scott Rice

Seconded by: Steve Ela

Yes: 6 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

Approved by Asa Bradman, Handling Subcommittee Chair, to transmit to NOSB, February 19, 2020

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