PPWR self-assessment

Start now

Technical hexane / n-hexane · CAS 110-54-3

Removed, butnot resolved

Technical hexane helps extract cooking oils and cocoa butter and defats oilseed material used to make protein ingredients. EFSA has modelled potential dietary exposure, but Europe still lacks representative occurrence data for a robust estimate of actual consumer exposure.
The everyday process

Technical hexane helps pull oil from crushed seeds. Heat then recovers most of the solvent for reuse.

The unresolved question is what remains in food and how much reaches consumers.

What the evidence shows

Traces have been detected, and EU law sets maximum residues for oils, cocoa butter and some defatted ingredients. EFSA has also modelled potential dietary exposure using legal maximum residue limits. Some high-percentile estimates for infants, toddlers and other children exceeded the exposure previously assumed by the SCF. Representative occurrence data are still needed to estimate what consumers are actually exposed to.

Why this matters now

EFSA's Food Contact Materials, Enzymes and Processing Aids Panel — the FCM Panel — is reassessing technical hexane. Meanwhile, ECHA added n-hexane to the Candidate List. The Candidate List is REACH's list of substances of very high concern that can trigger supply-chain duties. A French bill proposes warnings, testing and substitution measures, while a General Court case challenges the Candidate List decision. EFSA's mandate deadline is 22 November 2027.

01Identity

One commercial mixture contains one substance of concern

Technical hexane is a variable commercial mixture. n-Hexane is one component and the defined substance at the centre of the REACH hazard decision.

Technical hexane is the commercial solvent mixture used in extraction. EU food rules define it mainly by a 64–70°C distillation range and set limits for residues left in particular foods. n-Hexane is one component of that mixture. REACH identifies it as a defined substance because of its intrinsic hazard — what the substance can do — after repeated exposure. The five acyclic C6H14 isomers in the hero illustrate the molecular family; commercial grades can also contain other hydrocarbons and impurities.

EU extraction-solvent rules controlTechnical hexane

Commercial mixture · distillation range · permitted uses · food residues

one component within the mixture
REACH identifiesn-Hexane

CAS 110-54-3 · repeated-exposure hazard · supply-chain duties

3 notes · 3 sourcesEUR-Lex + 2
  1. 1

    The legal definition uses a distillation range and leaves component percentages unspecified.

  2. 2

    Candidate List status applies to n-hexane as a defined substance. Food-residue safety follows a separate legal and evidence framework.

  3. 3

    EFSA is seeking batch composition, impurities and information on fresh and recycled solvent because food legislation leaves the mixture’s component fractions unspecified.

Commercial grades

One name. Different drums.

Two supplier records show how much the n-hexane share can vary across technical mixtures.
Shell extraction gradeBenzene <3 mg/kg · aromatics <5 mg/kg
46%
Bharat Petroleum food grade2-methylpentane 25–30% · 3-methylpentane 15–17%
>30%
n-Hexane share reported by each supplier. The unfilled field contains a mixture of other C6 hydrocarbons.
2 notes · 2 sourcesShell Chemicals + 1
  1. 1

    One commercial grade; European supply remains unsurveyed.

    Measured
  2. 2

    One supplier grade; composition ranges vary across suppliers and batches.

    Measured

02Routes

Extraction creates three exposure routes

Oil enters food, defatted meal enters the feed chain and vapour enters workplace air. Each route has a different evidence base.

An exposure route is the path a substance takes from its source to a person. One extraction process creates three different routes, and the evidence for one route cannot answer the others.

Three exposure routes from one oilseedOil travels into retail food, meal travels through animal feed into milk, and vapour creates occupational inhalation exposure.ONE OILSEEDREFINED OILRETAIL FOODMEASURED RESIDUEDEFATTED MEALANIMAL FEEDDETECTED IN MILKSOLVENT VAPOURWORKPLACE AIRESTABLISHED HAZARD
Oil → foodFood residues: detected, not representative

Four retail oils in one 2021 Malaysian method study. The results provide a method signal; a European market estimate requires representative sampling.

Meal → feed → milkFeed-to-milk: preliminary evidence

Signals too low to measure reliably were more frequent after the hexane-meal diet in a six-cow analytical subset. This is preliminary evidence; transfer magnitude and consumer exposure cannot be estimated.

Vapour → workerWorker inhalation: well established

NIOSH eight-hour recommended limit. Repeated inhalation can cause peripheral neuropathy.

4 notes · 4 sourcesAssemblée nationale + 3
  1. 1

    Industry-level estimates in a parliamentary report; recovery varies by plant and process.

    Modelled
  2. 2

    Four individual products from one Malaysian market, analysed chiefly to validate a method. Product provenance and refining history were not reported; low-level validation and ambient or procedural contamination controls limit interpretation. The values are illustrative analytical observations, not prevalence estimates. European exposure requires representative occurrence and consumption data.

    Measured
  3. 3

    One pooled milk sample per cow in a six-cow analytical subset of the extreme diets. The study reported no quantified milk concentrations and does not quantify transfer magnitude or consumer exposure. Trace-level method and contamination controls were limited, and health significance remains unresolved.

    Emerging
  4. 4

    A dietary-residue threshold requires route-specific oral-exposure evidence.

    EstablishedView source text

03Evidence

What the evidence shows — and what it cannot yet answer

Studies have detected residues in oils, meals and milk. A representative European occurrence and exposure picture is still missing.

Evidence at a glance

A detection is not an exposure estimate.

A result below a detection or quantification limit means the method cannot report a reliable amount; molecules may still be present.
QuestionWhat the evidence showsWhat remains unknown
What remains in food?Small studies have detected residues in individual oils. EU law sets food-specific maximum residue levels.Representative public European occurrence data — measurements across enough foods, places and times to estimate consumer exposure.
Can residues move from feed to milk?A six-cow analytical subset — the smaller group whose samples were analysed — produced preliminary signals below the quantification limit, the level above which the method can report a reliable amount.A quantified transfer rate, representative occurrence, consumer exposure or health significance.
What is established for workers?Repeated inhalation of n-hexane in workplace air can damage peripheral nerves, and occupational air limits exist.This evidence does not answer the separate question of dietary exposure from residues in food.
What mixture enters the plant?Supplier records show that the n-hexane fraction varies between commercial grades.A representative European picture of fresh and recycled technical-hexane composition and impurities.
4 notes · 4 sourcesEuropean Food Safety Authority + 3
  1. 1

    EFSA’s data calls closed on 30 June 2026; publication of submitted records and the final assessment remains pending.

    Unknown
  2. 2

    One pooled milk sample per cow in a six-cow analytical subset of the extreme diets. The study reported no quantified milk concentrations and does not quantify transfer magnitude or consumer exposure. Trace-level method and contamination controls were limited, and health significance remains unresolved.

    Emerging
  3. 3

    A dietary-residue threshold requires route-specific oral-exposure evidence.

    EstablishedView source text
  4. 4

    EFSA is seeking batch composition, impurities and information on fresh and recycled solvent because food legislation leaves the mixture’s component fractions unspecified.

Four retail oils · Malaysia · 2021

The method reported one result above the EU oil limit.

The study tested an analytical method on four individual products. Their provenance and refining history were not reported; European compliance and prevalence were outside its scope.
EU limit · 1 mg/kg
Sunflower
2.688
Sesame
0.602
Corn
0.358
Palm
0.126
0123 mg/kg
3 notes · 2 sourcesInternational Journal of Analytical Chemistry + 1
  1. 1

    Four individual products from one Malaysian market, analysed chiefly to validate a method. Product provenance and refining history were not reported; low-level validation and ambient or procedural contamination controls limit interpretation. The values are illustrative analytical observations, not prevalence estimates. European exposure requires representative occurrence and consumption data.

    Measured
  2. 2

    Method sensitivity is part of the finding and limits comparison across studies.

    Measured
  3. 3

    Older national retail sampling provides historical context. Current European occurrence requires new representative data.

    Measured
Representative public evidence gapStill open

EFSA's submission window closed on 30 June. Validation and acceptance for the broader ChemMon collection closes on 31 August. The resulting hexane records and an occurrence-based exposure assessment remain unpublished.

3 notes · 2 sourcesEuropean Food Safety Authority + 1
  1. 1

    Upper scenarios use maximum-residue assumptions and model dietary intake.

    Modelled
  2. 2

    The submission window is closed; publication of the resulting dataset and conclusion remains pending.

    Established
  3. 3

    This date closes data processing for the annual occurrence call. The opinion and publication follow separate timetables.

    Established
Established routeVapour → lungs → nerves

Repeated occupational inhalation can cause peripheral neuropathy. NIOSH names numb extremities and muscle weakness.

Workplace air limits

NIOSH recommended
50ppm
Current US federal OSHA
500ppm
Unresolved routeFood → ingestion → dietary risk?

EFSA has modelled potential exposure from legal maximum residues. Estimating actual dietary exposure still needs representative occurrence, consumption and dose evidence for the relevant mixture.

Different measures. Different exposure routes.Workplace limits measure n-hexane in inhaled air. Food limits measure residue in food. A direct comparison would combine different media, units and exposure routes.
2 notes · 1 sourceNIOSH
  1. 1

    A dietary-residue threshold requires route-specific oral-exposure evidence.

    EstablishedView source text
  2. 2

    These limits govern workplace air. Food safety uses separate residue and dietary-exposure evidence.

04Regulation

Food residues and chemical hazards follow different rules

EU food law sets residue limits for technical hexane. REACH duties apply to n-hexane as a defined hazardous substance.

Current EU food law

The permitted residue depends on the food.

The extraction-solvent rules permit technical hexane and set a maximum residue for each listed food or ingredient. They do not require a universal zero residue.
Extracted fats, oils and cocoa butter1 mg/kg
Food containing defatted protein or flour10 mg/kg
Defatted soya sold to consumers30 mg/kg
Defatted cereal germs5 mg/kg
1 note · 1 sourceEUR-Lex
  1. 1

    Directive 2009/32/EC sets maximum hexane residues of 1 mg/kg in extracted fats, oils and cocoa butter; 10 mg/kg in food containing defatted protein products or flour; 30 mg/kg in defatted soya sold to consumers; and 5 mg/kg in defatted cereal germs.

Five regulatory files

Different rules answer different parts of the same problem.

FileWhat it seesStatusDecision ahead
Extraction Solvents DirectiveTechnical mixture + food residueBindingRetain, revise or narrow uses and limits
EFSA reassessmentFCM Panel · composition + hazard + dietUnder reviewCan current uses be supported?
REACH Candidate Listn-Hexane’s repeated-exposure hazardBindingSupply-chain duties; possible later authorisation
French bill no. 3023Disclosure + testing + substitutionProposedWill warnings and records become law?
Occupational safetyWorker inhalationEstablishedControl vapour and reduce exposure

EFSA reassessment

Exposure depends on three linked datasets.

Composition records describe what enters the plant. Occurrence data are measurements of what remains in foods across a defined sample. Consumption data then connect those measurements to consumer exposure — the amount people may take in through what they eat.

1 note · 1 sourceEuropean Food Safety Authority

Safety demonstration

A benchmark first. Actual exposure second.

The reassessment needs a defensible toxicological reference point for the material used, followed by representative occurrence and consumption data to test consumer exposure against it. Codex says the supplier or user should demonstrate processing-aid safety. EU food law makes operators responsible for ensuring and verifying that food under their control is safe and compliant.

2 notes · 2 sourcesEUR-Lex + 1
  1. 1

    The regulation establishes safety and operator-responsibility duties. It does not prescribe a universal processing-aid dossier or place an exclusive burden on the solvent supplier.

    Binding
  2. 2

    Codex is an international guideline. Its supplier-or-user wording does not create an exclusive EU-law burden on one party.

    Established
Other markets

One solvent.Four legal architectures.

Each system answers permission, residue and disclosure differently. Population exposure still requires occurrence, consumption and dose evidence.

United States

Use-specific rules and conclusions

Federal rules expressly cover some uses, including spice oleoresins, hops and specified defatted cottonseed flour. EPA also regulates hexane-based oilseed extraction as an air-emissions source; that environmental rule does not authorise food use.

Canada

Product-specific table

Hexane is listed for vegetable fats, oils and oilseed meals at 10 ppm, with separate limits for hops and natural extracts.

Australia / New Zealand

One processing-aid ceiling

Hexanes may be used in all foods at 20 mg/kg. Ingredient statements may omit a compliant processing aid.

Japan

Removal rule

The use standard permits extraction during edible-fat and oil manufacture and requires removal before the final food is completed.

8 notes · 8 sourcesElectronic Code of Federal Regulations + 7
  1. 1

    This narrow permission covers spice oleoresins and hops extract. The official-source review left the legal basis for routine oilseed extraction unresolved.

    Binding
  2. 2

    This permission is specific to the cottonseed products and specifications in 21 CFR 172.894. It is not a general authorisation for every oilseed or food use.

    Binding
  3. 3

    This EPA rule establishes an environmental emissions boundary and evidence of industrial practice. It does not authorise a food use or establish food safety.

    Binding
  4. 4

    The list also specifies different limits for hop extracts, pre-isomerised hop extract, natural extractives and spice extracts.

    Binding
  5. 5

    This broad all-food ceiling is a different regulatory architecture from the EU product-specific table.

    Binding
  6. 6

    The exemption covers ingredient declaration. Permission and residue compliance remain separate questions.

    Binding
  7. 7

    The official English standard states a removal condition and leaves a numerical general residue ceiling unspecified. A Japanese food-law specialist should check the translation and current legal application before publication.

    Binding
  8. 8

    JECFA supplies an international scientific benchmark; national law controls market permission. The official sources reviewed leave the next review undated as of 10 August 2026.

    Established

United States

Would a new EFSA opinion change the evidence?

Not automatically. It would not amend US law or invalidate a GRAS conclusion. The question is whether EFSA's underlying hazard and exposure evidence weakens the scientific basis or specifications for a particular US use. That question matters because EPA's IRIS assessment has no oral reference dose, while ATSDR's 2025 profile derived an intermediate oral screening value and found no chronic oral studies from which to derive one.

3 notes · 3 sourcesElectronic Code of Federal Regulations + 2
  1. 1

    The standard applies to the particular substance, specifications and intended conditions of use. It is not a blanket FDA approval of technical hexane extraction.

    Binding
  2. 2

    The absence of an IRIS oral reference dose is an assessment gap, not evidence that a particular authorised food use is unsafe.

    Established
  3. 3

    An ATSDR minimal risk level is a screening value for public-health assessment. It is not a food-law limit or an automatic finding on a GRAS conclusion.

    Established

French bill no. 3023

Production use can remain absent from the label.

EU food-information law excludes residues from the ingredient definition and can permit substances used like processing aids to be omitted when the legal conditions are met.

French proposal

May contain hexane residues

Bill no. 3023 would add warnings, testing and records across food and feed pathways, backed by a proposed €75,000 penalty. Introduced on 7 July 2026, it remains before committee.

2 notes · 2 sourcesEUR-Lex + 1
  1. 1

    Application depends on the finished product and the legal role of the substance.

    Binding
  2. 2

    Introduced on 7 July 2026 and referred to committee; the text remains a proposal.

05Decision

Measure, disclose or replace?

The next decisions span data validation, supply-chain duties, legislation, litigation, scientific assessment and possible substitution.
Forward watch

What to watch next.

Fixed dates, conditional dates and unscheduled decisions require different action. The first item is already due; the later rows are the forward watch.

  1. Already due

    Check REACH duties triggered by Candidate List inclusion

    The six-month article-notification point has passed. Companies should check the relevant 0.1% article threshold, one-tonne annual total, supply-chain communication, safety-data-sheet and SCIP conditions; not every duty applies to every product.

  2. Confirmed window

    ChemMon data validation and acceptance closes

    This closes validation for the broader 2026 ChemMon collection, which includes submitted hexane records. It is not a hexane opinion deadline.

  3. UnscheduledFrench bill no. 3023

    First committee action

    The bill remains with the Social Affairs Committee. Rapporteur, hearing, debate and vote dates have not been announced.

  4. Conditional

    Article 2 contribution could start

    Only the Article 2 contribution carries this proposed date, and only if Parliament enacts the bill. The date does not apply to every measure in the proposal.

  5. UnscheduledCase T-237/26

    General Court review

    The challenge seeks annulment of ECHA's SVHC decision and removal of n-hexane from the Candidate List. Hearing and judgment dates have not been announced.

  6. Mandate deadline

    EFSA's scientific opinion is due

    The mandate covers technical-hexane composition, consumer exposure through food, toxicology and current residue limits. Adoption and publication can follow later.

  7. UnscheduledAfter EFSA

    European Commission risk-management response

    The Commission can consider changes to permitted uses or residue limits after the scientific opinion. No response timetable has been announced.

7 notes · 6 sourcesEuropean Chemicals Agency + 5
  1. 1

    Companies must check the applicable article concentration, annual tonnage, communication, safety-data-sheet and SCIP conditions. The duties do not apply identically to every company, mixture or article.

    Binding
  2. 2

    This date closes data processing for the annual occurrence call. The opinion and publication follow separate timetables.

    Established
  3. 3

    The proposed 1 January 2027 commencement becomes operative only if Parliament enacts the bill.

    Proposed
  4. 4

    The date applies only to the Article 2 contribution. It is not a commencement date for the bill's other proposed disclosure, testing or feed-information measures.

    Proposed
  5. 5

    The case is pending; publication of a hearing or judgment date remains outstanding as of 10 August 2026.

    Disputed
  6. 6

    The mandate deadline sets the timetable for the work. Adoption and publication may follow later.

    Established
  7. 7

    The scientific opinion informs, but does not predetermine, any later decision on permitted uses or residue limits.

    Unknown
What public records prove

Two useful signals.Two firm limits.

Industrial trials and organic production show that other routes exist. Neither establishes an easy, universal or €1 million conversion for conventional commodity plants.

UK plant trial

10 tonnes/day

EcoXtract partners reported 2-methyloxolane campaigns in an existing Crown hexane unit in 2021 and 2022. The public abstract confirms further modifications, but not their detailed scope, duration or cost.

EU organic production

Restrictive positive list

EU organic rules list authorised processing aids. They specify ethanol for defined extraction uses but not technical hexane. That excludes deliberate hexane use in the relevant certified processes; it does not prove retrofit economics.

4 notes · 4 sourcesEuropean Commission CORDIS + 3
  1. 1

    The project record establishes the participant, location and project period. It does not disclose a plant-conversion cost or detailed engineering scope.

    Established
  2. 2

    This is an industry-authored conference abstract. It does not provide the detailed modifications, conversion duration or capital cost, and it is not independent proof of retrofit economics.

    Established
  3. 3

    This is an organic-production boundary. It does not prohibit technical hexane across conventional EU food production.

    Binding
  4. 4

    The list supports the organic process restriction. It does not show that conventional commodity plants can convert easily or economically.

    Binding

Substitution options

Every alternative changes the process.

Removing hexane can shift yield, energy demand, capital cost and operating risk. The trade-offs vary by oilseed and plant. There is no simple switch that fits every crop, product and factory.

03

2-methyloxolane

EU-authorised, bio-based production is possible, and some studies report yields close to hexane.

+35% heat

Full-scale commodity use remains limited. Cost, flammability, peroxide control, crop performance and higher modelled heat demand matter.

1 note · 1 sourceOCL
  1. 1

    Driven by the modelled solvent-removal system, retention and water presence; operating values vary by plant and process.

    Modelled
04

Supercritical CO₂

Non-flammable and removed by depressurisation; useful where selective extraction can justify the process.

≥7.38 MPa

High-pressure equipment, capital cost and throughput can make it unsuitable for high-volume commodity oilseeds.

1 note · 1 sourceProcesses
  1. 1

    Commercial suitability depends on feedstock, required yield, co-products, throughput and capital cost.

    Established
Most of the solvent is recovered in the factory. The evidence still has to follow what remains through food, feed and workplace air.
Continue in Foresight

See the n-hexane file as it changes.

See how Foresight connects new evidence, substance status and policy decisions to the products and markets they affect.

Book a demoFollow the EFSA reassessment, the French proposal and the n-hexane substance record in one traceable watch.
How this investigation was assembled

Different routes.Different standards of proof.

01 · Source hierarchy

We prioritised legislation, regulators, supplier specifications and published measurement records. Interested-party evidence is identified by role.

02 · Separation

Occupational hazard remains separate from dietary risk. Modelled upper scenarios remain distinct from measured intake. Political proposals stay in the policy record. Medical guidance sits outside this investigation.

03 · Review boundary

Evidence reviewed 19 August 2026. This page is an editorial investigation. Food-safety and medical guidance sit outside its scope.

Evidence fileRead the whole record.

48 cleared claims · 38 sources · 3 open questions

Binding

Current legal or regulatory status.

Established

Supported by mature, route-specific evidence.

Measured

Observed directly, with the stated sampling limits.

Emerging

Observed in recent work that still needs replication.

Modelled

Calculated scenario or process estimate based on stated assumptions.

Proposed

Non-binding policy text or recommendation.

Disputed

A material challenge to method or interpretation remains.

Unknown

The representative evidence needed to answer is absent.

01

One commercial mixture contains one substance of concern

  1. Binding

    EU food law defines hexane as a commercial product consisting essentially of saturated acyclic six-carbon hydrocarbons distilling between 64°C and 70°C.

    The legal definition uses a distillation range and leaves component percentages unspecified.
  2. Measured

    One Shell extraction-grade specification reports 46% n-hexane, benzene below 3 mg/kg and total aromatics below 5 mg/kg.

    One commercial grade; European supply remains unsurveyed.
  3. Measured

    One Bharat Petroleum food-grade safety data sheet describes more than 30% n-hexane alongside major fractions of 2-methylpentane and 3-methylpentane.

    One supplier grade; composition ranges vary across suppliers and batches.
  4. Binding

    ECHA added n-hexane to the REACH Candidate List on 4 February 2026 for specific target organ toxicity after repeated exposure.

    Candidate List status applies to n-hexane as a defined substance. Food-residue safety follows a separate legal and evidence framework.
  5. Unknown

    EFSA is seeking batch composition, impurities and information on fresh and recycled solvent because food legislation leaves the mixture’s component fractions unspecified.

02

Extraction creates three exposure routes

  1. Modelled

    The French parliamentary report describes mechanical pressing as recovering about 80% of an oilseed’s oil and solvent extraction as bringing total recovery towards 97%.

    Industry-level estimates in a parliamentary report; recovery varies by plant and process.
03

What the evidence shows — and what it cannot yet answer

  1. Measured

    A 2021 method study reported residual hexane of 2.688 mg/kg in sunflower oil, 0.602 in sesame, 0.358 in corn and 0.126 in palm oil.

    Four individual products from one Malaysian market, analysed chiefly to validate a method. Product provenance and refining history were not reported; low-level validation and ambient or procedural contamination controls limit interpretation. The values are illustrative analytical observations, not prevalence estimates. European exposure requires representative occurrence and consumption data.
  2. Measured

    The four-oil study found that changing the calibration range materially changed the reported result.

    Method sensitivity is part of the finding and limits comparison across studies.
  3. Measured

    A 2005 Korean survey detected residual hexane in nine of 87 vegetable-oil samples bought on the local market.

    Older national retail sampling provides historical context. Current European occurrence requires new representative data.
  4. Disputed

    Greenpeace France reported 0.04–0.08 mg/kg in selected refined oils and higher concentrations in selected oilseed meals.

    Advocacy-commissioned, non-representative testing; industry challenged laboratory accreditation and interpretation.
  5. Emerging

    Controlled dairy-cow research reported n-hexane signals below the 10 ng/g quantification limit in five of six milk samples after the hexane-meal diet and one of six after the 2-methyloxolane-meal diet.

    One pooled milk sample per cow in a six-cow analytical subset of the extreme diets. The study reported no quantified milk concentrations and does not quantify transfer magnitude or consumer exposure. Trace-level method and contamination controls were limited, and health significance remains unresolved.
  6. Unknown

    A representative public European dataset connecting commercial-solvent composition, food occurrence and consumer exposure is still missing.

    EFSA’s data calls closed on 30 June 2026; publication of submitted records and the final assessment remains pending.
  7. Modelled

    EFSA’s screening scenarios estimated high-percentile exposure using foods at their legal maximum residue limits.

    Upper scenarios use maximum-residue assumptions and model dietary intake.
  8. Established

    EFSA’s dedicated composition call and 2026 occurrence-data window closed on 30 June 2026.

    The submission window is closed; publication of the resulting dataset and conclusion remains pending.
  9. Established

    Repeated occupational inhalation of n-hexane can cause peripheral neuropathy, including numb extremities and muscle weakness.

    A dietary-residue threshold requires route-specific oral-exposure evidence.
  10. Binding

    NIOSH recommends an eight-hour limit of 50 ppm; the current US federal OSHA limit shown by NIOSH is 500 ppm.

    These limits govern workplace air. Food safety uses separate residue and dietary-exposure evidence.
04

Food residues and chemical hazards follow different rules

  1. Binding

    Directive 2009/32/EC sets maximum hexane residues of 1 mg/kg in extracted fats, oils and cocoa butter; 10 mg/kg in food containing defatted protein products or flour; 30 mg/kg in defatted soya sold to consumers; and 5 mg/kg in defatted cereal germs.

  2. Binding

    EU food-information law excludes residues from the ingredient definition and permits omission of substances used like processing aids where the Article 20 conditions are met.

    Application depends on the finished product and the legal role of the substance.
  3. Binding

    EU General Food Law requires food business operators to ensure and verify that food under their control meets the food-safety requirements relevant to their activities.

    The regulation establishes safety and operator-responsibility duties. It does not prescribe a universal processing-aid dossier or place an exclusive burden on the solvent supplier.
  4. Established

    Codex says the supplier or user should demonstrate the safety of a processing aid, including unavoidable residues under good manufacturing practice.

    Codex is an international guideline. Its supplier-or-user wording does not create an exclusive EU-law burden on one party.
  5. Binding

    The reviewed US direct-food rule permits hexane residues from extracting spice oleoresins at no more than 25 ppm and hops extract at no more than 2.2% by weight.

    This narrow permission covers spice oleoresins and hops extract. The official-source review left the legal basis for routine oilseed extraction unresolved.
  6. Binding

    US food-additive rules permit n-hexane in the manufacture of specified defatted cottonseed flour, subject to composition requirements and a maximum residue of 60 ppm.

    This permission is specific to the cottonseed products and specifications in 21 CFR 172.894. It is not a general authorisation for every oilseed or food use.
  7. Binding

    US air-emissions rules recognise commercial hexane grades in solvent-extraction plants processing major oilseeds, including soybean, canola, sunflower and safflower.

    This EPA rule establishes an environmental emissions boundary and evidence of industrial practice. It does not authorise a food use or establish food safety.
  8. Binding

    A US GRAS conclusion based on scientific procedures requires general recognition among qualified experts and evidence of the same quantity and quality required for food-additive approval.

    The standard applies to the particular substance, specifications and intended conditions of use. It is not a blanket FDA approval of technical hexane extraction.
  9. Established

    EPA's IRIS assessment for n-hexane does not provide an oral reference dose.

    The absence of an IRIS oral reference dose is an assessment gap, not evidence that a particular authorised food use is unsafe.
  10. Established

    ATSDR's 2025 profile derived an intermediate-duration oral minimal risk level of 0.1 mg/kg/day and no chronic oral minimal risk level because it located no chronic oral studies.

    An ATSDR minimal risk level is a screening value for public-health assessment. It is not a food-law limit or an automatic finding on a GRAS conclusion.
  11. Binding

    Canada lists hexane as an extraction solvent for vegetable fats and oils and vegetable oilseed meals, with a maximum residue of 10 ppm, alongside separate permissions for hops and natural extracts.

    The list also specifies different limits for hop extracts, pre-isomerised hop extract, natural extractives and spice extracts.
  12. Binding

    Australia and New Zealand permit hexanes as an extraction-solvent processing aid in all foods at a maximum permitted level of 20 mg/kg.

    This broad all-food ceiling is a different regulatory architecture from the EU product-specific table.
  13. Binding

    Australia and New Zealand permit the ingredient statement to omit a substance used as a processing aid in accordance with Standard 1.3.3.

    The exemption covers ingredient declaration. Permission and residue compliance remain separate questions.
  14. Binding

    Japan's use standard permits hexane for extracting fats and oils during the manufacture of edible fats and oils and requires its removal before the final food is completed.

    The official English standard states a removal condition and leaves a numerical general residue ceiling unspecified. A Japanese food-law specialist should check the translation and current legal application before publication.
  15. Established

    JECFA recommended re-evaluating hexanes because commercial composition and resulting residues might differ from the material covered by its earlier assessment.

    JECFA supplies an international scientific benchmark; national law controls market permission. The official sources reviewed leave the next review undated as of 10 August 2026.
  16. Proposed

    French bill no. 3023 proposes a 'May contain hexane residues' warning across directly extracted foods, foods containing extracted ingredients and specified animal-product pathways.

    Introduced on 7 July 2026 and referred to committee; the text remains a proposal.
  17. Unknown

    EFSA is seeking solvent composition and variability, actual applications, occurrence, consumption, toxicokinetics, neurotoxicity, reproductive and developmental toxicity, and infant-relevant evidence.

    These inputs are needed to connect the material used in plants to consumer exposure.
05

Measure, disclose or replace?

  1. Established

    Mechanical pressing generally leaves more oil in the meal and changes yield and economics. The process eliminates extraction-solvent residue.

    Performance varies by oilseed, pretreatment, press design and product specification.
  2. Established

    CORDIS records New Holland Extraction in Hull as a participant in the EU-funded EcoXtract project, which ran from May 2021 to April 2024.

    The project record establishes the participant, location and project period. It does not disclose a plant-conversion cost or detailed engineering scope.
  3. Established

    EcoXtract partners reported using an existing 10-tonne/day Crown hexane plant in the UK for 2-methyloxolane campaigns, first with soy in 2021 and then soy, rapeseed and sunflower after further modifications in 2022.

    This is an industry-authored conference abstract. It does not provide the detailed modifications, conversion duration or capital cost, and it is not independent proof of retrofit economics.
  4. Binding

    EU organic rules restrict processing aids for organic food and feed to substances authorised for those uses.

    This is an organic-production boundary. It does not prohibit technical hexane across conventional EU food production.
  5. Binding

    The implementing positive lists specify ethanol for defined extraction uses but do not list technical hexane, excluding its deliberate use in the relevant certified organic food and feed processes.

    The list supports the organic process restriction. It does not show that conventional commodity plants can convert easily or economically.
  6. Modelled

    One process comparison estimated higher heat requirements for optimised ethanol and isopropanol systems than for hexane.

    Process-model estimates; values vary by plant, oilseed and operating conditions.
  7. Modelled

    One process comparison estimated that 2-methyloxolane would require about 35% more heat than hexane.

    Driven by the modelled solvent-removal system, retention and water presence; operating values vary by plant and process.
  8. Established

    Supercritical carbon dioxide is non-flammable and readily removed by depressurisation. High-pressure equipment and commodity-scale throughput remain constraints.

    Commercial suitability depends on feedstock, required yield, co-products, throughput and capital cost.
  9. Established

    EFSA’s validation and acceptance period for 2026 chemical-contaminant occurrence data closes on 31 August 2026.

    This date closes data processing for the annual occurrence call. The opinion and publication follow separate timetables.
  10. Established

    Open EFSA gives 22 November 2027 as the mandate deadline for the scientific opinion reassessing technical hexane as a food extraction solvent.

    The mandate deadline sets the timetable for the work. Adoption and publication may follow later.
  11. Proposed

    French bill no. 3023 remains referred to the Assemblée nationale’s Social Affairs Committee; committee examination, debate and vote dates remain unannounced.

    The proposed 1 January 2027 commencement becomes operative only if Parliament enacts the bill.
  12. Disputed

    Case T-237/26 seeks annulment of ECHA’s n-hexane SVHC decision and removal of n-hexane from the Candidate List.

    The case is pending; publication of a hearing or judgment date remains outstanding as of 10 August 2026.
  13. Binding

    The six-month REACH article-notification point following n-hexane's Candidate List inclusion fell on 4 August 2026.

    Companies must check the applicable article concentration, annual tonnage, communication, safety-data-sheet and SCIP conditions. The duties do not apply identically to every company, mixture or article.
  14. Proposed

    If French bill no. 3023 is enacted, the contribution created by Article 2 is proposed to apply from 1 January 2027.

    The date applies only to the Article 2 contribution. It is not a commencement date for the bill's other proposed disclosure, testing or feed-information measures.
  15. Unknown

    The European Commission can consider risk-management action after EFSA delivers its scientific opinion; no response timetable has been announced.

    The scientific opinion informs, but does not predetermine, any later decision on permitted uses or residue limits.
Open questions

What the reassessment still needs to answer.

  1. How many occurrence records and composition dossiers did EFSA receive by 30 June 2026?
  2. What n-hexane ranges and recycled-solvent changes are seen in current European extraction plants?
  3. How should the sub-quantification-limit milk signals be interpreted, and will the work be replicated with trace-level analytical controls?
Source index

38 records

EUR-LexDirective 2009/32/EC on extraction solvents used in food productionEUR-LexRegulation (EU) No 1169/2011 on food information to consumersEUR-LexRegulation (EC) No 178/2002 — General Food LawEUR-LexRegulation (EU) 2018/848 on organic production and labellingEUR-LexImplementing Regulation (EU) 2021/1165 — authorised inputs for organic productionCodex AlimentariusCXG 75-2010 — Guidelines on Substances Used as Processing AidsElectronic Code of Federal Regulations21 CFR 173.270 — HexaneElectronic Code of Federal Regulations21 CFR 172.894 — Modified cottonseed products intended for human consumptionElectronic Code of Federal Regulations40 CFR 63.2872 — Vegetable-oil production definitionsElectronic Code of Federal Regulations21 CFR 170.30 — Eligibility for GRAS classificationHealth CanadaList of permitted carrier or extraction solventsFederal Register of LegislationAustralia New Zealand Food Standards Code — Schedule 18Federal Register of LegislationAustralia New Zealand Food Standards Code — Standard 1.2.4Ministry of Health, Labour and Welfare, JapanStandards for use of food additives — HexaneWorld Health OrganizationJECFA database entry — HexanesEuropean Food Safety AuthorityTechnical report on the need for re-evaluation of technical hexaneEuropean Food Safety AuthorityCall for data for the re-evaluation of technical hexane used as an extraction solventEuropean Food Safety Authority2026 annual call for chemical-contaminant occurrence data in food and feedEuropean Food Safety AuthorityRe-evaluation of technical hexane, EFSA-Q-2025-00358European Chemicals AgencyECHA adds n-hexane to the REACH Candidate ListShell ChemicalsindustryHexane Extraction grade product specificationBharat PetroleumindustryHexane Food Grade material safety data sheetInternational Journal of Analytical ChemistryOptimization of residual hexane in edible oils analysis using static headspace gas chromatographyFood Science and BiotechnologyHeadspace analysis for residual hexane in vegetable oilGreenpeace FranceadvocacyNos aliments contaminés à l’hexaneAssemblée nationaleMission flash sur l’incidence économique de l’utilisation d’hydrocarbures dans la production d’huiles alimentairesAssemblée nationaleProposition de loi visant à renforcer la transparence sur la présence d’hexane dans l’alimentation, no. 3023Assemblée nationaleLegislative dossier for bill no. 3023 on hexane in food and feedOfficial Journal of the European UnionAction brought on 14 April 2026 — Case T-237/26INRAE / Wageningen University & ResearchReplacing hexane with 2-methyloxolane for defatting soybean meal fed to dairy cowsNIOSHPocket Guide to Chemical Hazards: n-HexaneUS Environmental Protection Agencyn-Hexane — IRIS Chemical Assessment SummaryAgency for Toxic Substances and Disease RegistryToxicological Profile for n-HexaneFoodsTowards substitution of hexane as extraction solvent of food products and ingredients with no regretsEuropean Commission CORDISDelivering a new, efficient and biobased plant oil and protein extraction systemAOCS Annual MeetingindustryExtraction at industrial scale of soy, rapeseed and sunflower with methyloxolaneOCLSolvent solutions: comparing extraction methods for edible oils and proteins — impacts on energy consumptionProcessesExtraction methods of oils and phytochemicals from seeds and their environmental and economic impacts

EUR-Lex · Annex I, Part II, footnote 1

How EU food law defines hexane

Our reading

The legal object is a commercial mixture defined by its hydrocarbons and boiling range. The n-hexane percentage remains unspecified.

Exact source text
Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C.

Checked against Directive 2009/32/EC on extraction solvents used in food production on 10 Aug 2026.

Open original source ↗

EUR-Lex · Annex I, Part II, Hexane

The binding residue limits for hexane

Our reading

The permitted residue changes with the extracted food or ingredient.

Exact source text
Conditions of use (summary description of extraction)Maximum residue limits in the extracted foodstuff or food ingredient
Production or fractionation of fats and oils and production of cocoa butter1 mg/kg in the fat or oil or cocoa butter
Preparation of defatted protein products and defatted flours10 mg/kg in the food containing the defatted protein products and the defatted flours
Preparation of defatted protein products and defatted flours30 mg/kg in the defatted soya products as sold to the final consumer
Preparation of defatted cereal germs5 mg/kg in the defatted cereal germs

Checked against Directive 2009/32/EC on extraction solvents used in food production on 10 Aug 2026.

Open original source ↗

European Chemicals Agency · Candidate List entry for n-hexane

Why ECHA listed n-hexane

Our reading

This classification concerns repeated-exposure effects on human health. Dietary residue limits follow a separate legal framework.

Exact source text
FieldCandidate List entry
Date of inclusion04-Feb-2026
Reason for inclusionSpecific target organ toxicity after repeated exposure (Article 57(f) - human health)
N-hexane is identified as a substance of very high concern in accordance with Article 57(f) of Regulation (EC) 1907/2006 (REACH) because it is a substance with neurotoxic properties for which there is scientific evidence of probable serious effects to human health which gives rise to an equivalent level of concern to those substances listed in points (a) to (e) of Article 57 of REACH.

European Food Safety Authority · Call for data, Technical hexane and Toxicological dataset

What EFSA says the reassessment still needs

Our reading

EFSA is asking for representative composition and toxicology evidence before it concludes on safety.

Exact source text
Compositional data are sought for each relevant step of the extraction process, i.e. for ‘fresh’ technical hexane and for that recycled during the extraction process.
The EFSA report also considered that the toxicological information considered by the SCF is no longer sufficient to adequately conclude on the risk of technical hexane.

Checked against Call for data for the re-evaluation of technical hexane used as an extraction solvent on 10 Aug 2026.

Open original source ↗

Assemblée nationale · Article 1, proposed Article L. 2133-1-1, II(1)

The warning proposed in French bill no. 3023

Our reading

The article uses an English translation. The bill's exact proposed wording remains French, and binding status awaits enactment.

Exact source text
Un avertissement sanitaire apposé sur l’emballage et lisible comportant la mention « peut contenir des résidus d’hexane »

Checked against Proposition de loi visant à renforcer la transparence sur la présence d’hexane dans l’alimentation, no. 3023 on 10 Aug 2026.

Open original source ↗

NIOSH · Exposure Limits and Symptoms

The workplace limits and symptoms reported by NIOSH

Our reading

The two numbers are workplace-air limits from different authorities. Food residue requires separate measurements.

Exact source text
LimitPocket Guide text
NIOSH RELTWA 50 ppm (180 mg/m³)
OSHA PELTWA 500 ppm (1800 mg/m³)
irritation eyes, nose; nausea, headache; peripheral neuropathy: numb extremities, muscle weak; dermatitis; dizziness; chemical pneumonitis (aspiration liquid)