Start here: three distinctions that decide everything else
1. A substance is not a device
FIFRA defines a pesticide as a substance or mixture of substances intended to prevent, destroy, repel or mitigate a pest, and a device as an instrument or contrivance that does the same thing by physical or mechanical means. EPA’s test, stated in its 1976 policy and repeated since, is exactly that: if the article works by physical means it is a device; if it incorporates a substance or mixture of substances to do the work, it is a pesticide and requires registration.
This matters because the two are regulated on entirely different terms. Devices are not registered and EPA reviews neither their safety nor their efficacy — but the establishment that produces them must be registered, and every claim made for them must still be truthful and not misleading. Registered pesticides, by contrast, carry a registration number backed by efficacy data EPA has reviewed.
2. Generated solution is not the same regulatory object as a registered product
Onsite-generated hypochlorous acid is used as a cleaner and sanitiser. Where a protocol, an insurer, an auditor or an inspector specifies an EPA-registered disinfectant with named public-health claims, the generated solution is not the answer to that question — a registered product is. Most of our customers run both: generated solution for the volume work, HOCl-AS200 where the claim has to be documented on a label.
Where claims are made matters as much as what they say
Under 40 CFR 152.15 a substance becomes a pesticide requiring registration if the person selling it claims, states or implies — by labelling or otherwise — that it can be used as a pesticide. “Or otherwise” reaches websites, brochures, specification sheets and sales conversations. Keeping a kill claim off the machine and putting it in the marketing does not solve the problem.
3. Food contact and hard-surface disinfection rest on different statutes
Treating food or food-processing water is an FDA matter, authorised by a food additive regulation or a Food Contact Notification, with USDA FSIS adding its own suitability review for meat, poultry and egg products. Sanitising hard surfaces and equipment with a pesticidal claim is an EPA matter under FIFRA. They authorise different things, and an authorisation under one is not an authorisation under the other. Conflating them is the most common compliance error in this category.
EPA — FIFRA and the registered product
EPA regulates pesticides under the Federal Insecticide, Fungicide and Rodenticide Act. A product sold with claims to kill named pathogens on surfaces is a pesticide, and must be registered before it is distributed or sold.
HOCl-AS200 registration
| Field | Detail |
|---|---|
| EPA Registration Number | 101112-1 |
| EPA Establishment Number | 101112-FL1 |
| Product | HOCL-AS200 — disinfectant, cleaner and deodorizer |
| Registrant | EcoloxTech Inc., 160 Elaine Rd, West Palm Beach, FL 33413 |
| Active ingredient | Hypochlorous acid, 0.0174% |
| Organisms | 21 — 8 bacteria, 13 viruses |
| Contact time | 5 minutes, every listed organism |
| Minimum available chlorine | 149 ppm — do not use below this |
| Signal word | CAUTION |
| Label accepted | 10 December 2025 (label version 3, dated 1 August 2025) |
| Label document | EPA-accepted label (PDF, epa.gov) |
What the registration certifies
That EPA reviewed and accepted data supporting the specific organisms and contact times on the approved label. For public-health claims, product performance data must be submitted with the application under 40 CFR 158 subpart W; 40 CFR 158.2220 requires the applicant to establish through testing that the product is efficacious when used according to label directions.
It is not an endorsement, and saying so is not modesty — 40 CFR 156.10(e) prohibits presenting a registration number in a manner that suggests EPA recommends the product.
Emerging viral pathogens
The AS200 label carries a claim under EPA’s Guidance to Registrants: Process for Making Claims Against Emerging Viral Pathogens not on EPA-Registered Disinfectant Labels (19 August 2016). The policy is a two-stage mechanism: a registrant is pre-approved on existing efficacy data against hard-to-kill viruses, and the claim then becomes available only once CDC has identified an emerging pathogen and recommended environmental surface disinfection.
| If the emerging pathogen is a… | Follow the directions for |
|---|---|
| Enveloped virus | Feline calicivirus (strain F9, ATCC VR-782) |
| Large, non-enveloped virus | Feline calicivirus (strain F9, ATCC VR-782) |
| Small, non-enveloped virus | Feline calicivirus (F9) and rhinovirus type 14 (strain 1059, ATCC VR-284) |
Two constraints are easy to miss. These statements may appear in technical literature and off-label communications but not on the marketed product label, and they are dormant unless a qualifying outbreak is active.
The label is the law
Using a registered pesticide in a manner inconsistent with its labelling is unlawful under FIFRA section 12(a)(2)(G). The exceptions at section 2(ee) allow applying at a lower dose or frequency than the label specifies, and against a pest not named where the site is named — they do not allow a shorter contact time or a higher concentration than the label permits.
Drinking water
Under the Safe Drinking Water Act, 40 CFR 141.65 sets maximum residual disinfectant levels for public water systems: 4.0 mg/L for chlorine as Cl₂, 4.0 mg/L for chloramines, and 0.8 mg/L for chlorine dioxide. This governs drinking water and livestock drinker applications. It is not a general limit for HOCl and it does not apply to surface sanitation.
FDA — food contact, and everything you put on a person
Food-contact surfaces — 21 CFR 178.1010
Sanitising solutions containing sodium, potassium or calcium hypochlorite may provide not more than 200 ppm of available halogen determined as available chlorine. The provision’s operative condition is worth quoting exactly, because it is the origin of the no-rinse claim: such solutions are used “followed by adequate draining” before contact with food.
Draining, not rinsing. The claim holds at or below 200 ppm, on food-contact surfaces. Electrolytically generated HOCl is not separately named in this section; it qualifies as available chlorine.
Produce washing — 21 CFR 173.315
A different provision with the opposite requirement. Sodium hypochlorite may be used to wash or assist in the lye peeling of fruits and vegetables, with no numerical limit stated — but its use must be followed by rinsing with potable water to remove residues so far as possible. The two sections are routinely conflated; they are not interchangeable.
Our Food Contact Notification — FCN 1811
FDA accepted a Food Contact Notification for hypochlorous acid (CAS No. 7790-92-3) filed by IET, Inc. DBA EcoloxTech, effective 2017.
| Field | Detail |
|---|---|
| Notification | FCN 1811 |
| Substance | Hypochlorous acid, CAS No. 7790-92-3 |
| Limit | Free available chlorine not to exceed 60 ppm |
| Covered uses | Process water or ice contacting whole or cut meat and poultry; processed and preformed meat and poultry; fish and seafood; fruits and vegetables; and shell eggs |
| Condition | For product consumed raw, treatment is followed by a drain step or a potable water rinse |
Why an FCN is not the same as a CFR listing
A food additive regulation in 21 CFR is generic — anyone may rely on it. An FCN is effective only for the manufacturer or supplier named in it, and FDA states that persons who purchase the substance from that manufacturer may rely on the notification for the use it covers, within its limitations. If you buy from us, FCN 1811 is available to you. A competitor generating its own HOCl cannot rely on it.
Retail and foodservice — the FDA Food Code
The Food Code sets chlorine sanitiser requirements as a relationship between concentration, temperature and pH rather than a single number — a 25–49 mg/L solution requires a higher minimum temperature than a 100 mg/L one — together with minimum contact times. Because states adopt different editions on different timetables, confirm the edition and section numbering your jurisdiction has actually adopted rather than citing the current federal edition.
Wound care and skin — a caution worth reading
Hypochlorous acid wound products are regulated as devices and reach the market by 510(k) clearance, not as drugs. The important nuance is what those clearances cover: the cleared indications are typically cleansing, irrigating, moistening and debriding — physical actions. A clearance of that kind is not a clearance for antimicrobial action, infection prevention or wound healing, and marketing copy claiming it is exceeds the clearance.
Cosmetics — relevant to white-label production
FDA does not pre-approve cosmetic products or ingredients, with the narrow exception of certain colour additives. Responsibility for safety and labelling sits with the firm marketing the product. There is therefore no such thing as an “FDA-approved cosmetic”.
What decides the category is the claim. An HOCl facial mist claiming cleansing, refreshing or hydration is a cosmetic. Claim acne treatment, antibacterial action or eczema relief and it becomes a drug requiring an approved application or monograph compliance; claim surface disinfection and it becomes a pesticide requiring EPA registration. Our white-label programme works to that line deliberately.
USDA FSIS — meat, poultry and egg products
FSIS maintains a list of substances that are safe and suitable for use in the production of meat, poultry and egg products, published as Directive 7120.1. The directive itself now carries only recent changes; the operative list is its Table 2, which FSIS revises several times a year — check the current table rather than a cached copy.
Aqueous hypochlorous acid is listed there, and the entry rests on FCN 1811.
| Use | Limit |
|---|---|
| Process water or ice contacting whole or cut meat and poultry — spray, wash, rinse, dip, chiller water, scalding water | Free chlorine not to exceed 50 ppm |
| Process water, ice or brine for washing, rinsing or cooling processed and preformed meat and poultry products | Free chlorine not to exceed 50 ppm |
| Process water for washing or rinsing shell eggs | Free chlorine not to exceed 60 ppm |
For comparison, calcium hypochlorite and chlorine gas are limited to 5 ppm free available chlorine in recirculated poultry chiller water. The aqueous HOCl entry is materially more permissive.
“USDA approved” is not a thing
FSIS lists substances and conditions of use, not products or brands. The defensible statement is that a solution meets the conditions FSIS lists for aqueous hypochlorous acid under FCN 1811 — not that a particular machine or brand is USDA approved.
The mechanism behind the listing is FDA-first: safety is established with FDA through GRAS, a food additive regulation or an FCN, and FSIS then evaluates suitability — that the substance performs its intended technical effect and does not conceal damage or mislead — before adding it with stated conditions.
USDA National Organic Program
Hypochlorous acid is permitted in organic production and handling, and is named explicitly rather than inferred.
| Citation | Scope | Listing |
|---|---|---|
| 7 CFR 205.601(a)(2)(iii) | Crop production | Hypochlorous acid — generated from electrolyzed water |
| 7 CFR 205.603(a)(10)(iii) | Livestock production | Hypochlorous acid — generated from electrolyzed water |
| 7 CFR 205.605(b)(12)(iii) | Handling | Hypochlorous acid — generated from electrolyzed water |
The annotation limits the source to generation from electrolyzed water, which is what was petitioned and reviewed.
The 4 ppm figure, stated the right way round
The National List sections contain no number of their own; they refer to the maximum residual disinfectant limit under the Safe Drinking Water Act, which is 4.0 mg/L for chlorine at 40 CFR 141.65. What the handling annotation actually says is that chlorine materials in water in direct food contact are permitted at levels approved by FDA or EPA — provided the use is followed by a potable water rinse at or below that limit. The 4 ppm caps the rinse, and chlorine used as an ingredient. It is not a cap on the intervention itself. Most industry write-ups get this backwards.
The crop rule at 205.601 is structured differently and is stricter. Do not carry the handling reading across to it.
If a certifier cites the 2014 memo
An NOP policy memo from June 2014 stated that electrolyzed water was not then permitted, and it is still findable online. It predates the 2019 listing and no longer reflects the regulation. Current NOP guidance on chlorine materials lists hypochlorous acid generated from electrolyzed water across crops, livestock and handling. Cite the CFR sections and the current guidance.
One genuinely unsettled point, worth knowing before an audit: current NOP guidance directs operators to monitor chlorine where the water last contacts the organic product, but an NOSB technical review has acknowledged that the regulation’s own text does not state whether compliance is measured at the point of application, contact or discharge. Certifier practice can vary.
CDC — guidance, not regulation
CDC approves nothing and registers nothing. It issues evidence-based recommendations. There is no such thing as a CDC-approved or CDC-recommended disinfectant, and any supplier claiming one is telling you something false.
What CDC does provide is the framework almost every healthcare protocol is built on. Its Guideline for Disinfection and Sterilization in Healthcare Facilities organises instruments and surfaces by infection risk — the Spaulding classification.
| Category | What it contacts | Required processing |
|---|---|---|
| Critical | Sterile tissue or the vascular system | Sterilisation |
| Semicritical | Mucous membranes or non-intact skin | High-level disinfection |
| Non-critical | Intact skin | Low-level disinfection |
CDC’s guideline does discuss electrolytically generated solutions, under the heading of superoxidized water, describing a solution containing hypochlorous acid intended to be generated fresh at the point of use. Beyond that discussion CDC has no standalone recommendation for hypochlorous acid as a product category, and it would be an overstatement to suggest otherwise.
The limits on one page
| Application | Limit | Authority |
|---|---|---|
| Food-contact surfaces, no rinse | 200 ppm available chlorine, followed by adequate draining | FDA, 21 CFR 178.1010 |
| Meat and poultry process water, including chiller water | 50 ppm free chlorine | USDA FSIS 7120.1 Table 2, on FCN 1811 |
| Shell egg wash water | 60 ppm free chlorine | USDA FSIS 7120.1 Table 2, on FCN 1811 |
| Process water and ice, food contact | 60 ppm free available chlorine | FDA, FCN 1811 |
| Produce washing | No numerical limit stated; potable rinse required | FDA, 21 CFR 173.315 |
| Organic handling, direct food contact | FDA- or EPA-approved levels, then a potable rinse at or below 4.0 mg/L | USDA NOP, 7 CFR 205.605(b)(12) |
| Public drinking water | 4.0 mg/L as Cl₂ | EPA, 40 CFR 141.65 |
| Registered surface disinfection | Per label; 5-minute contact time | EPA Reg. No. 101112-1 |
Substance identity
Hypochlorous acid, CAS No. 7790-92-3. Listed in the EPA Substance Registry.
Sector frameworks
- Food processing — HACCP, FSMA preventive controls, GFSI schemes (BRCGS, SQF, FSSC 22000)
- Meat and poultry — USDA FSIS performance standards and permitted antimicrobial interventions
- Seafood — Seafood HACCP under 21 CFR 123
- Juice and beverage — Juice HACCP under 21 CFR 120 where applicable
- Produce — FSMA Produce Safety Rule agricultural water provisions
- Organic — USDA National Organic Program, 7 CFR part 205
- Healthcare — CMS conditions of participation, Joint Commission environment of care
- Marine — USPH / VSP inspection criteria for vessels calling at US ports
- Foodservice — FDA Food Code and local health department criteria
Building a defensible file
- System specification and commissioning records
- Written SOPs by application and zone
- Concentration verification logs at your scheme’s required frequency
- Baseline and ongoing environmental monitoring, trended rather than filed
- Training records for every operator
- Safety data sheets, and the registered label where the registered product is used
- Supporting citations from the research hub
This page is orientation, not legal advice
Regulations differ by jurisdiction, and the federal documents cited here are revised on their own schedules — FSIS Table 2 several times a year, the National List through sunset review, the Food Code by edition. Verify the current requirement applicable to your facility and product with your own regulatory advisor, and always follow the label supplied with any registered product.
Questions
Is onsite-generated HOCl an EPA-registered disinfectant?
No, and the distinction is the single most important one on this page. Onsite-generated hypochlorous acid is used as a cleaner and sanitiser. A product sold with claims to kill named pathogens is a pesticide under FIFRA and must be registered. Where your protocol requires a registered disinfectant, our HOCl-AS200 carries EPA Reg. No. 101112-1 and its own accepted label.
What does an EPA registration number actually certify?
That EPA reviewed and accepted efficacy data supporting the specific organisms and contact times printed on that label, alongside chemistry and toxicology data. Product performance data are required for public health claims under 40 CFR 158.2220. It is not a general endorsement — 40 CFR 156.10(e) expressly forbids presenting the number in a way that implies EPA recommends the product.
Can we rely on your FDA Food Contact Notification?
Yes, if you buy the substance from us. FDA states that persons who purchase a food contact substance from a manufacturer identified in an effective notification may rely on that notification for the use it covers, subject to its limitations. This is the practical difference between an FCN and a food additive regulation: an FCN is specific to its notifier, while a 21 CFR listing is generic.
What is the food-contact surface limit?
200 ppm available chlorine, under 21 CFR 178.1010. Note the exact wording of the provision: such sanitising solutions are used “followed by adequate draining” before contact with food. Draining, not rinsing — which is where the no-rinse claim comes from, and it holds only at or below 200 ppm and only for food-contact surfaces.
Is it allowed in organic processing?
Yes, and by name. “Hypochlorous acid — generated from electrolyzed water” is listed on the National List at 7 CFR 205.605(b)(12)(iii) for handling, 205.601(a)(2)(iii) for crops and 205.603(a)(10)(iii) for livestock. Note that an older NOP policy memo from 2014 saying electrolyzed water was not permitted predates the 2019 listing and no longer reflects the regulation.
Is the 4 ppm organic limit a cap on the wash itself?
Usually stated backwards. Under the handling annotation, chlorine in water in direct food contact is permitted at FDA- or EPA-approved levels, provided the use is followed by a potable water rinse at or below the Safe Drinking Water Act maximum residual disinfectant limit — 4.0 mg/L for chlorine, per 40 CFR 141.65. The 4 ppm figure caps the rinse water and chlorine used as an ingredient. The crop rule at 205.601 is structured differently and is stricter; do not carry the handling reading across to it.
What is the potable water limit?
4.0 mg/L as Cl₂, the maximum residual disinfectant level at 40 CFR 141.65. That is a Safe Drinking Water Act rule for public water systems. It is not a general exposure limit for HOCl and it does not govern surface sanitation.
Does a sanitiser claim differ from a disinfectant claim?
Yes. They are defined regulatory claims with different efficacy thresholds and different registration consequences, not interchangeable marketing words. What you may claim depends on the product and its registration status, not on the chemistry alone.
Can we shorten the contact time if we raise the concentration?
No. Using a registered pesticide in a manner inconsistent with its labelling is unlawful under FIFRA section 12(a)(2)(G). The statutory exceptions at section 2(ee) permit applying at a lower dose than the label specifies; they do not permit shortening the contact time. For HOCl-AS200 the five minutes is the claim.
What documentation should we keep?
System specification and commissioning records, written SOPs by application and zone, concentration verification logs at your scheme’s required frequency, environmental monitoring results, training records, safety data sheets, and the registered label where the registered product is used. That set satisfies most GFSI, FSIS and health department reviews.