Lignosulfonate Regulatory Status: FDA, EFSA, REACH, JECFA

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Lignosulfonate Regulatory Status: FDA, EFSA, REACH, JECFA

Lignosulfonates have specific approvals for food and feed uses in several jurisdictions. In the US, 21 CFR 573.600 permits lignin sulfonates in animal feed (for example up to 4% of finished pellets as a pelleting aid) and 21 CFR 172.715 permits calcium lignosulfonate as a dispersant in certain pesticide uses on bananas. In the EU, lignosulphonate is authorised as a feed binder (1g565) by Regulation (EU) 2024/749. JECFA has set an ADI of 0–20 mg/kg body weight for calcium lignosulfonate (40-65).

Overview by Use and Jurisdiction

UseJurisdiction / bodyStatus and key conditions
Animal feedUSA, 21 CFR 573.600Ammonium, calcium, magnesium or sodium salts of spent sulfite liquor extract. Pelleting aid ≤4% of finished pellets; binding aid in flaked grain ≤4%; surfactant in molasses ≤11% of the molasses; source of metabolizable energy ≤4% of finished feed (all dry basis)
Animal feedEU, Regulation (EU) 2024/749Technological additive, binder, 1g565. Calcium, sodium or magnesium lignosulphonate ≥55%, reducing sugars ≤20% (DM). Max 10,000 mg/kg complete feed for weaned piglets, pigs for fattening, chickens for fattening, laying hens and cattle for fattening; 8,000 mg/kg for other species. Authorised until 21 March 2034
Food additiveJECFA (FAO/WHO), 69th meeting, 2008Calcium lignosulfonate (40-65): ADI 0–20 mg/kg bw; specification includes Mw 40,000–65,000, reducing sugars ≤5.0%, lead ≤2 mg/kg, arsenic ≤1 mg/kg
Food additiveUSA, 21 CFR 172.715Calcium lignosulfonate as a dispersing agent and stabilizer in pesticides for pre- or post-harvest use on bananas, at the minimum needed
Chemical registrationEU, REACHLignosulfonates are produced by sulfite treatment of lignin. Whether a given product needs registration or is exempt depends on its identity and manufacture; check the ECHA database for the specific substance and producer
Summary only. Always read the current legal text; limits apply to the exact uses and species named.

Feed: The Points That Are Most Often Misquoted

  • The EU limit is expressed in mg per kg of complete feed at 12% moisture, not per kg of premix.
  • The EU 10,000 mg/kg level applies only to the five named categories; all other species are limited to 8,000 mg/kg.
  • The EU authorisation covers calcium, sodium and magnesium lignosulphonate. Ammonium lignosulfonate is listed in the US regulation but not in the EU entry.
  • The US regulation sets moisture limits for the additive itself: up to 50% for liquid and up to 6% for dry forms.

Food: Why JECFA Specifies One Particular Product

The JECFA specification “calcium lignosulfonate (40-65)” describes a purified, ultrafiltered material from softwood sulfite pulping, used as a carrier. The numbers 40-65 refer to its weight-average molecular weight range in thousands. The ADI applies to material meeting that specification, not to every calcium lignosulfonate. Industrial grades with higher sugar or ash content do not meet it. Background: JECFA chemical characterization of calcium lignosulfonate.

Safety Data and Labelling

Most lignosulfonate powders are not classified as hazardous under GHS, but dust can irritate the eyes and airways and fine organic dust can form explosive mixtures in air. The EU feed authorisation requires users of the solid form to apply operational measures and, where risks remain, breathing protection. See sodium lignosulfonate safety and environment.

Frequently Asked Questions

Is lignosulfonate approved in animal feed?

Yes. In the US, 21 CFR 573.600 permits lignin sulfonates, for example up to 4% of finished pellets as a pelleting aid. In the EU, Regulation (EU) 2024/749 authorises lignosulphonate as a binder (1g565) up to 8,000 or 10,000 mg/kg complete feed depending on species.

What is the ADI of calcium lignosulfonate?

JECFA established an ADI of 0–20 mg/kg body weight in 2008 for calcium lignosulfonate (40-65) meeting its specification.

Is ammonium lignosulfonate allowed in EU feed?

The EU authorisation 1g565 names calcium, sodium and magnesium lignosulphonate only. Ammonium salts are listed in the US feed regulation 21 CFR 573.600.

References

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