National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Sodium Lactate and Potassium Lactate

August 25, 2015

Summary of Proposed Action: To add Sodium Lactate and Potassium Lactate to the National List under 

section §205.605(b). This request was made to the National Organic Standards Board to take under 

consideration by the National Organic Program, in a memorandum dated June 25, 2014. The original joint 

petition was submitted on January 5, 2004.

History

On January 5, 2004 the NOP received a combined petition for two substances to be added to the National 

List for use in organic handling, these substances were Sodium Lactate and Potassium Lactate (the salts of 

lactic acid). Lactic acid is listed on the National List at §205.605(a) as an approved non-synthetic material for 

use in products labeled as “organic” or “made with organic (specified ingredients of food group(s)). Lactic 

acid appears in “Acids (Alginic; Citric – produced by microbial fermentation of carbohydrate substances; 

and Lactic)”.

On January 22, 2004, the NOP notified the petitioner that their petition would not be necessary since the 

materials (sodium hydroxide, lactic acid, and/or potassium hydroxide), that these two substances were 

formulated using, were already included on the National List. Eventually, this interpretation was deemed to 

not be consistent with previous NOSB recommendations on the classification of materials and was causing 

some confusion within the organic industry regarding the status of the two materials (Sodium lactate and 

potassium lactate) as well as other lactate salts (example: calcium lactate)(McEvoy 2014). Thus, the NOSB 

(Handling Sub-committee) took up the request for the consideration for inclusion to the National List, for

sodium lactate and potassium lactate on §205.605 (b) Synthetics Allowed.

The original 2004 petition was submitted for the following use: Both sodium lactate and potassium lactate 

are used in meat processing as a pathogen inhibitor that is added to meat as an ingredient for use in 

controlling Listeria monocytogenes in Ready-to-Eat meat and poultry products. Both of these materials 

have been recognized by the USDA-FSIS (Food Safety and Inspection Service) as being two of the few known 

antimicrobials validated through scientific studies to inhibit the growth of Listeria monocytogenes, E.coli, 

Salmonella, and other pathogens. They also control Clostridium Botulinum (botulism) in meats, as well.

Sodium and potassium lactate can replace nitrates/nitrates in meat products and are generally recognized 

as safe (GRAS).

In the February 17th, 2015 Technical Evaluation Report it mentions that both sodium and potassium lactate 

are affirmed as GRAS. Sodium lactate is affirmed GRAS at 21 CFR 184.1768 and Potassium Lactate at 21 CFR 

184.1639. However, the FDA does not authorize their use in infant foods and formulas.

Sodium lactate and potassium lactate come as a liquid and may be added to meat as an ingredient at the 

rate of 1% to 4.8% as prescribed by the USDA-FSIS regulations, depending on the product. Whether a 

handling operation uses sodium lactate or potassium lactate is at the discretion of the processor or by the 

requirements of the specific recipe – i.e. low sodium products (Applegate Farms 2004).
Manufacture:

Lactic acid is produced from the fermentation of natural food sources such as dextrose (from corn) and 

sucrose (from sugarcane or sugar beets) or starch. This substrate is fermented by food grade microorganisms to form lactic acid. Sodium hydroxide (NaOH) is produced by the electrolysis of a concentrated 

sodium chloride (table salt) solution. Potassium hydroxide (KOH) is a synthetic, inorganic compound 

produced by an electrolysis process using only potassium chloride (approved for use in organic foods per 

§205.605(a)) and water.

Sodium and/or potassium lactate are generally produced from natural (fermented) lactic acid, which is then 

reacted with either sodium hydroxide or potassium hydroxide, respectively (Houtsma 1996).

Lactates are naturally produced in the human body.

Discussion:

The original petition asked that sodium and potassium lactate be added to the National List, for use in meat 

processing as a pathogen inhibitor. While the petitioned request for these materials covered a very specific 

usage, it is not completely clear whether or not the intended use is currently the only way that these two 

materials are being utilized in organic handling. This is part of the confusion from the action taken in 2004 

by the NOP’s decision to not accept the need for the petitioner’s request to have sodium lactate and 

potassium lactate added to the National List.

There does not appear to be any human health concerns associated with either of these two materials 

according to the information provided in the Technical Evaluation Report. Both materials are considered to 

be GRAS by the FDA according to this same report. There was an environmental issue raised about the 

amount of gypsum created in the manufacturing of lactic acid. This concern seems to have been mitigated 

by utilizing this by-product material (gypsum) as a soil additive (Gypsoil and ADM 2011) and by research 

being implemented to look at other ways to produce lactic acid. According to a report published by the EPA 

lactic acid and its salts are readily biodegradable and have low potential to persist in the environment 

(Environmental Protection Agency 2008).

In the Technical Evaluation Report from February 17, 2015 it does state that no additional ingredients (e.g., 

stabilizers, preservatives, carriers, anti-caking agents, or other materials) are added to the commercially 

available forms of these materials. Thus, it would stand to reason that there are no ancillary substances 

associated with either of these two materials. However, the TR does mention that sodium diacetate (below 

2%) sometimes may be combined with either of these two materials to help lower the pH of the surface 

meat products and therefore decrease microbial growth. Sodium diacetate is GRAS, contains 60% sodium 

acetate and 40% acetic acid (Miller 2010). 

Both sodium lactate and potassium lactate have been allowed for use in organic handling since the January 

22, 2004 decision was rendered by the National Organic Program (McEvoy 2014). This decision (to not 

require a petition for sodium and potassium lactate for inclusion to the National List) was originally based 

on the fact that all three of the materials used to produce sodium lactate and potassium lactate were 

already approved and on the National List. That decision was not consistent with previous NOSB 

Recommendations on classification of materials. The intent of this proposal is to correct that previous 

decision and go through the appropriate process (Petitioned Material Proposal) to see whether or not these 

two materials should in fact be added to the National List of Allowed Substances. It is the intent of the 

subcommittee and ultimately that of the entire National Organic Standards Board by moving forward with 

this proposal we can clear up the confusion, re-establish a concise and transparent process by which these 

two materials shall be reviewed and ultimately voted on.
Sodium Lactate

There are three mechanisms by which sodium lactate can have an antimicrobial affect. The first is by 

changing water activity (it lowers the water activity of meat and thereby slows microbial growth). The 

second occurs as sodium lactate passes through the cell membrane and lowers intracellular pH. The third 

takes place as sodium lactate affects cellular metabolism by inhibiting ATP generation (ATP- adenosine

triphosphate, a nucleoside triphosphate which transports chemical energy within cells for metabolism 

(Biology Online 2010)). The lactic acid portion of sodium lactate has antimicrobial properties, as it can be 

incorporated into the microbial cell. The lactic acid then interferes or slows down the normal metabolic 

process that generates cell energy in the cell. (Miller 2010).

Potassium Lactate

Potassium lactate has a potassium ion rather than the sodium ion found in sodium lactate. It has been 

shown to decrease microbial growth and to limit the growth of some major meat pathogens with similar 

capabilities to those of sodium lactate. Potassium lactate can be used as a substitute for sodium lactate as a 

non-meat ingredient, with similar functionality, but does not have the salty taste (Miller 2010).

Again, the original petitioned use for these materials was for use in Ready-to-Eat meat and poultry products 

as an ingredient to function as a pathogen inhibitor, especially for use in controlling Listeria 

monocytogenes. 

It should be noted that in the TR it states that meat products that contain sodium and potassium lactates 

can no longer be labeled as “natural” without a case-by-case assessment of what function these materials 

are serving in the product, and at what levels (USDA FSIS 2005).

It would assist the NOSB in our consideration of these two petitioned materials if the appropriate organic 

stakeholders and/or certifiers could provide any additional information regarding the extent that these two 

materials are being used. Furthermore, are there any additional ways that these materials are currently

being used other than the original petitioned use that we should be aware of? Finally, between sodium 

lactate and potassium lactate is one more commonly used than the other?

Evaluation Criteria (see attached checklist for criteria in each category)

Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No ☒ N/A

as Organic (only for §205.606)

Substance Fails Criteria Category: NA

Subcommittee Action & Vote:

Classification Motion:

Motion to classify both Sodium Lactate and Potassium Lactate as synthetic.

Motion by: Harold V. Austin IV 

Seconded by: Ashley Swaffar

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0

Listing Motion: 
Motion to list Sodium Lactate and Potassium Lactate on section 205.605(b) with the following 

annotation: for use as an antimicrobial agent only. 

Motion by: Harold V. Austin IV 

Seconded by: Ashley Swaffar

Yes: 4 No: 1 Abstain: 2 Absent: 0 Recuse: 0

 Approved by Tom Chapman, Subcommittee Chair, to transmit to NOSB August 25, 2015
NOSB Evaluation Criteria for Substances Added To the National List - Handling

Category 1. Adverse impacts on humans or the environment? Sodium and Potassium Lactate 

Question Yes No N/A

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use or 

misuse of the substance?

[§205.600(b)(2), [§6518(m)(3)]

X The EPA Screening-Level Hazard 

Characterization of High Production Volume 

Chemicals report for Lactic Acid and its salts 

(2008) concluded that the manufacture and 

use of natural lactic acid constitutes a low 

potential risk to human health or the 

environment. According to the data assessed 

in the report, lactic acid and its salts are 

readily biodegradable and have low potential 

to persist in the environment. Further, the 

potential acute hazard of lactic acid to 

aquatic organisms is low (Environmental 

Protection Agency 2008). February 17, 2015 

TR Lines: 770-774.

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the substance?

[§6518(m)(3)]

X During the fermentation process to make 

lactic acid, the pH is stabilized by adding 

calcium carbonate (lime) which neutralizes 

the acid and results in the formation of 

calcium lactate. A by-product of the 

purification process of the calcium lactate 

during the production of lactic acid is 

insoluble calcium sulfate (gypsum). In the TR 

(Feb. 17, 2015) lines782-784 states about 

gypsum: It is a by-product in the process and 

is produced at a rate of 1 ton per 1 ton of 

lactic acid produced (Pal 2012). Gypsum 

disposal can be a problem. Lines 792-794 

states: One of the main commercial lactic 

acid manufacturers, Archer Daniels Midland 

Company (ADM), has partnered with a 

fertilizer company to sell and distribute much 

of the gypsum by-product to growers 

(Gypsoil and ADM 2011). Lines 800-802 

states that: another commercial 

manufacturer, Corbin (Purac): The company 

is investing in the development of a 

proprietary gypsum-free technology that 

does not rely on the use of calcium 

carbonate or sulfuric acid in the acidification 

and purification processes. This technology 

appears to be in the initial stages of 

development, and more information on the 

details of this technology is needed.
3. Are there any adverse impacts on 

biodiversity? (§205.200)

X

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X

5. Is there undesirable persistence or 

concentration of the material or breakdown 

products in the environment? [§6518(m)(2)]

X According to the February 17, 2015 TR, lactic 

acid and its salts are readily biodegradable 

and have low potential to persist in the 

environment. Further, the potential acute 

hazard of lactic acid to aquatic organisms is 

low (Environmental Protection Agency, 

2008).

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added to it? 

[§6517(c))(1)(A)(i); 6517 (c)(2)(A)(i); 

§6518(m)(4), 205.600(b)(3)]

X In the TR (February 17,2015) lines 815-817 

states: Lactates have been reported to have 

low oral toxicity, with a lack of adverse 

effects in feeding studies in which up to 

3,900 mg/kg body weight/day was 

administered to rats for 2 years. Likewise, 

lactates were proven to be non-genotoxic 

and non-mutagenic (Purac 2008). TR lines 

828-830, As described in other sections of 

this report, the use of lactic acid and its 

sodium and potassium salts in certain food 

applications may reduce risk of foodborne 

pathogens because of their antimicrobial 

properties.

However, the FDA does not authorize its

(sodium or potassium lactate) use in infant 

foods and formulas.

7. Is the substance, and any ancillary 

substances, GRAS when used according to 

FDA’s good manufacturing practices? 

[§205.600(b)(5)]

X Sodium Lactate is affirmed as GRAS at 21 CFR 

184.1768 for use in food with no limitation 

other than current good manufacturing 

practice. (Feb. 17, 2015 TR Lines: 203-204)

Potassium Lactate is affirmed as GRAS at 21 

CFR 184.1639 for use in food with no 

limitation other than current good 

manufacturing practice. (Feb. 17, 2015 TR 

Lines 209-210) In the TR Lines 204 and 210 it 

states (pertaining to the GRAS statements for 

these two lactates) However, the FDA does 

not authorize their use in infant foods and 

formulas.

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 (b)(5)]

X
Category 2. Is the Substance Essential for Organic Production? Sodium and Potassium Lactate

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X See answer below for Cat. 2, question 3 and 

4.

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

X According to the TR (Lines 612-615) Sodium 

lactate and potassium lactate are produced 

by combining non-synthetic lactic acid and 

sodium hydroxide or potassium hydroxide, 

respectively. 

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X According to the TR (Lines 601-602) Lactic 

acid, produced from fermentation, is 

currently listed on the National List, 

205.605(a) as a non-synthetic material with 

no restrictions on use. However, to form 

either sodium lactate or potassium lactate 

either sodium hydroxide or potassium 

hydroxide is added, which both of these 

materials are on the National List as 

synthetics allowed.

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X TR line 615-616 states “There does not 

appear from the literature to be a nonsynthetic version of sodium lactate or 

potassium lactate.

6. Is there an organic substitute? 

[§205.600(b)(1)]

X TR lines 1,042-1,043 says “research into the 

use of natural antimicrobials in organic and 

natural meat products is being done with 

promising results. Research is also being 

done to look at agricultural antimicrobial 

alternatives such as: cranberry, cherry, lime 

and vinegar powders. Lines 1,092-1094 

states: According to the research, the 

addition of the antimicrobials appeared to 

improve control of L.monocytogenes, but 

these products demonstrated a slight 

variation of inhibitory activity, suggesting 

that other inhibitory factors are involved. 

Essential Oils (oily mixes of volatile and 

complex compounds that are extracted from 

different parts of aromatic plants) are also 

under going research as possible alternatives 

as an antimicrobial. Multi-barrier 

Preservation Systems is another potential 

alternative, which uses multiple substances 
to give control of L. monocytogenes.

7. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600(b)(6)]

X TR (Feb. 17,2015) Lines 913-917 states: There 

is concern that organic meat products could 

potentially pose a food safety hazard if they 

do not contain antimicrobials that are 

comparable to formulated sodium nitrate 

(NaNO2) in concentrations known to be 

highly effective in inhibiting the growth of 

many food borne pathogens such as Listeria 

monocytogenes (Niebuhr, et al.2010) 

However, more research into natural 

antimicrobials in organic and natural meat 

products is being done with promising 

results.

8. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

X Sodium nitrate is commonly used in curing 

non-organic meat and poultry products, 

except for bacon. Vinegar, essential oils and 

vegetable and fruit juice powders are 

possible natural/agricultural alternatives that 

researchers are currently looking at.

Campops, et al. (2011) TR lines 936-938 , 

looked at the effectiveness of organic acids in 

controlling L. monocytogenes. The results of 

these studies were promising; Lactic Acid 

cultures also can be used for dry sausage and 

ham. Bacteriophages (micro-organisms) are 

utilized as an antimicrobial to control 

bacteria during the production of foods on 

the farm, on perishable foods post-harvest, 

and during food processing. Bacteriophage 

products are typically sprayed directly on 

food products prior to packaging (GRN 468; 

GRN 218; (OMRI 2014b)). TR 984 & 985.

9. Are there any alternative substances? 

[§6518(m)(6)]

X Lactic Acid Cultures can be used for dry 

sausage and ham.

Bacteriophages (micro-organisms) are 

utilized as an antimicrobial to control 

bacteria and control the growth of pathogens 

such as Listeria monocyogenes, Salmonella, 

and Campyloabacter jejuni in refrigerated 

foods (TR 983-984) also phage preparations 

are sprayed onto the surface of RTE meat 

and poultry products. According to the 

product data information for LISTEXTM 

product, phages are considered processing 

aids and do not have to be declared on the 

finished product label (Micreos B.V. 2012). 

This is a different situation from sodium 

lactate and potassium lactate, which are 
added to meat as ingredients at the rate of 

1% to 4.8% as prescribed by USDA-FSIS 

regulations, depending on the product 

(Applegate Farms 2004). TR lines 1011-1015.

10. Is there another practice (in farming or 

handling) that would make the substance 

unnecessary? [§6518(m)(6)]

X The TR mentions 3 possible alternatives 

listed in the USDA – FSIS, Listeria Rule for 

Ready-To-Eat products. (Lines 853 – 870) 

discusses these alternatives: (1) a postlethality treatment and the use of an 

antimicrobial agent (either of the lactates 

could be used for this). Example: deli or 

hotdog products that are steam pasteurized 

after packaging and have lactates added in 

the formulation. (2) either a post-lethality 

treatment or an antimicrobial agent, or 

antimicrobial process is applied. Under this 

alternative, sodium lactate and potassium 

lactate could be used or the post-lethality 

treatment or the antimicrobial process. 

Example: a hotdog or deli product that is 

treated with a post pasteurization treatment 

after packaging, such as a steam treatment, 

and does not contain lactates or any 

antimicrobial agents. And (3) none of the 

other options are applied and instead the 

establishment relies on its sanitation 

program to control Lm. Example: refrigerated 

chicken nuggets that are not treated with a 

post lethality treatment or antimicrobials. 

Additional verification testing requirements 

for establishments that produced deli or 

hotdog products are enforced. (Lethality 

step: defined as cooking or another process 

such as fermentation or drying that results in 

a product that is safe for human 

consumption without further preparation. 

(USDA FSIS 2012).

11. Have the ancillary substances associated 

with the primary substance been reviewed? 

Describe, along with any proposed 

limitations. 

x
Category 3. Is the substance compatible with organic handling practices? Sodium and Potassium Lactate

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

handling? [§6517(c)(1)(A)(iii); 

6517(c)(2)(A)(ii)]

X Materials (both sodium lactate and 

potassium lactate) have been allowed for use 

in organic handling, but are now needing to 

be petitioned for inclusion to the National 

List, due to the Memo from the NOP to the 

NOSB dated June 25th, 2014.

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible with 

organic handling? [§205.600(b)(2)]

X

3. Is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

X

4. Are the ancillary substances reviewed 

compatible with organic handling [?

X

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

X In the original petition from Purac America & 

Trumark Co.’s in 2004, both sodium lactate 

and potassium lactate were petitioned for 

use in organic meat processing as a pathogen 

inhibitor. In the TR (Lines 670 – 671) it states: 

“ One of the primary uses of sodium lactate 

and potassium lactate is as a preservative in 

meat. As stated above, sodium (and 

potassium) lactate has the ability to extend 

shelf-life of meat products. The petitioner 

stated that their targeted use of these two 

materials was as a pathogen inhibitor 

primarily to control Listeria monocytogenes.

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law)? [§205.600(b)(4)]

X TR (lines 721-723) says: Similar to lactate 

acid, sodium and potassium lactates do not 

recreate or replace flavors, colors, textures, 

or nutritive values lost in processing, but are 

often used to improve or enhance flavors 

and textures of food products, especially 

meat. Sodium lactate is known to enhance 

meat flavor due to the salty taste that it 

provides, potassium lactate offers similar 

attributes but is less salty. Sodium lactate 

results in enhanced overall flavor and beef 

flavor intensity (TR line 729-730).
Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially 

unavailable? [§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Sodium and Potassium Lactate

Question Yes No N/A Comments/Documentation. (TAP; petition;

regulatory agency; other)

1. Is the comparative description as to why the 

non-organic form of the material /substance 

is necessary for use in organic handling

provided? 

X

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling? 

X

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling? 

X

4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

X

5. Does the industry information about 

unavailability include (but is not limited to) 

the following?

a. Regions of production (including factors 

such as climate and number of regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

X

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

X

e. Other issues which may present a 

challenge to a consistent supply?

X