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HEXANE CURRENT AND FUTURE REGULATIONS fr

What’s changing and why?

Regulatory agencies worldwide are becoming increasingly concerned about health and safety issues with Hexane. This page outlines key regulations in Europe and the United States that influence its use, along with potential future developments.

The summary below allows you to quickly navigate the different sections: you can scroll through the full content or click directly on the topics that interest you.

Key Active European Regulations

Additional European Regulations

United States Regulations

This section outlines the major active regulations in the European Union impacting hexane use, particularly in worker safety, toxic waste management, and product ingredients.

Key regulations include:

Impact: These regulations may lead to restrictions, mandatory authorizations, increased compliance costs, and the need for supply chain adaptations, potentially phasing out certain uses of hexane.

As regulatory changes take effect, other European laws could evolve, further restricting hexane usage.

These include:

Impact: Increased scrutiny, industry adaptation, and potential phase-out of hexane in multiple sectors.

Regulatory awareness is increasing in the U.S., with various agencies potentially reassessing hexane in response to European changes.

Key areas include:

Impact: U.S. industries may face increased regulatory scrutiny and a shift toward safer alternatives, mirroring European trends.

Regulations are categorized here in three key areas:

Worker Safety

Toxic Waste

Product Ingredients

Some regulations cover more than one category.

European Union Regulations

Key Active Regulations

REACH

(Registration, Evaluation, Authorization and Restriction of Chemicals)

August 20, 2024, Germany’s Federal Institute for Occupational Safety and Health (BAuA) recommended listing n-hexane as a Substance of Very High Concern (SVHC) in Europe due to its proven neurotoxic effects on human health.

  • Reasons for Concern

    This recommendation could lead to its inclusion in Annex XIV (authorization), restricting its use and requiring specific authorizations for continued usage with the following consequences:

    • Ban on “Placing on the Market” or Use: Once a « sunset date » is reached, companies can no longer place the substance on the market or use it in the EU unless they have been granted an authorization for specific uses.
    • Application for authorization: To continue using the substance after the sunset date, companies must submit an application to the European Chemicals Agency (ECHA). This application must demonstrate:
      • The risks associated with the use of the substance are adequately controlled.
      • There are no suitable alternatives available.
      • Socio-economic benefits outweigh the risks.
    • Encouragement to Replace: By listing a substance in Annex XIV, the EU aims to promote substitution with safer, more sustainable alternatives. This may lead to innovation in processes or materials to avoid the need for authorization.
    • Supply Chain Impact: The regulation affects not just the manufacturer, but also downstream users, as all companies involved in the supply chain must comply with the authorization requirement or stop using the substance.
    • Increased Scrutiny and Cost: Companies using substances in Annex XIV face increased regulatory scrutiny and significant costs related to the authorization process, including time and resources for preparing detailed dossiers, risk assessments, and socio-economic analyses.
    • Limited Duration of Authorizations: authorizations are granted for a limited period and need to be regularly reviewed. If alternative substances or technologies become available, the authorization may not be renewed.

    This process is designed to progressively phase out the most hazardous chemicals in Europe by pushing industries to adopt safer alternatives.

  • Regulatory History of n-Hexane Under REACH

    Regulatory History of n-Hexane Under REACH

    The regulatory process for n-hexane under REACH has been evolving since 2012, resulting in progressively tightened restrictions.

    Consumer uses of n-hexane in Europe have been effectively discontinued since 2017. After reviewing risk management proposals, the German Federal Institute for Occupational Safety and Health (BAuA) accepted measures for industrial and professional uses but found those for consumer uses insufficient. As a result, registrants decided to stop providing the necessary data and regulatory filings to keep consumer uses of n-hexane approved under REACH. Without this support, these uses could no longer meet REACH requirements and were effectively discontinued in Europe.

    The classification of n-hexane as a proven neurotoxicant (STOT RE 1) was first highlighted in 2017 and officially recognized in 2024. This timeline highlights a steady regulatory shift, signaling potential further restrictions.

    • The German Federal Institute for Occupational Safety and Health (BAuA) started its evaluation of n-hexane for the European Chemicals Agency (ECHA) in 2012, indicating early regulatory concerns. In 2014, BAuA released an initial report requesting additional data from REACH registrants to further assess risk management measures for n-hexane.
    • In 2017, BAuA published a second report assessing registrants’ risk management proposals. It accepted measures proposed for industrial and professional uses but considered those for consumer uses inadequate.
    • Given this outcome, n-hexane registrants (suppliers) decided not to submit further studies or maintain support for consumer uses of n-hexane in Europe. Without an active REACH registration for consumer applications, n-hexane has effectively been excluded from consumer use since 2017.
    • Additionally, in the same 2017 report, BAuA highlighted that n-hexane should be classified as STOT RE 1, acknowledging its proven neurotoxic effects in humans. This assessment initiated a reclassification process, culminating in the official implementation of STOT RE 1 in September 2024.

CLP

(Classification, Labelling and Packaging)

The CLP regulation mandates the labelling of products containing hexane.

  • Reasons for Concern

    This requirement can potentially affect several industries, particularly in food and cosmetics, in terms of regulatory compliance and risk communication.

    Note that based on the current harmonized classification of hexane under STOT RE 1 (H372) it is probable that increased restrictions are likely.

Regulation on Food Extraction Solvents

EFSA decided that the safety of hexane as a food extraction solvent must be reevaluated.

  • Reasons for Concern

    If the evaluation concludes that hexane no longer meets current safety requirements, this could lead to a ban or severe restrictions on its use in food processing, impacting industries such as vegetable oils, natural flavors, additives, and food proteins.

Subsequent impact on other Regulations

European Chemical Strategy 

This initiative aims to replace hazardous substances with safer and more sustainable alternatives.

  • Reasons for Concern

    Hexane, being a fossil fuel-derived solvent with significant risks to health and the environment, is directly affected by this strategy.This could promote its substitution with alternative solutions such as gaseous or biobased solvents.

Farm to Fork Strategy

The European Green Deal and associated initiatives, such as the « Farm to Fork » strategy, emphasize reducing dangerous substances in agriculture and food production chains.

  • Reasons for Concern

    A ban or restriction on hexane would align with this goal of creating a healthier, more sustainable, and environmentally friendly food system.

Packaging and Packaging Waste Directive

This directive affects materials used in food packaging.

  • Reasons for Concern

    Hexane may be present in the manufacturing processes of food packaging or their components (inks, adhesives etc.). Any reclassification of hexane could necessitate a reevaluation of the safety of these materials and force companies to adopt safer alternatives in the packaging supply chain.

European Cosmetics Regulation

This regulation governs the safety of ingredients used in cosmetic products sold in Europe.

  • Reasons for Concern

    Hexane, as a solvent, can be present as residue in cosmetic natural ingredients (essential oils, fragrances, etc.). As hexane is officially classified as STOT RE 1 H372 (nervous system) and suspected reprotoxic, it could be restricted or banned in cosmetics due to its potential danger to human health.

    For cosmetic products certified COSMOS, n-hexane is not allowed because it is a petroleum-derived solvent and does not meet the standard’s requirements for natural and sustainable cosmetics. Instead, COSMOS-certified products must use safer, eco-friendly extraction methods like steam distillation or cold pressing to ensure ingredient purity and environmental responsibility.

    Article 3: Safety of Cosmetic Products states that any cosmetic product placed on the market must be safe for human health, particularly regarding long-term exposure to hazardous ingredients like hexane.

    Adding hexane to the SVHC list under REACH could influence its use in cosmetics, potentially leading to a ban or restrictions.

Detergents Regulation

The Detergents Regulation aims to ensure the safety and environmental impact of ingredients used in cleaning products.

  • Reasons for Concern

    Hexane can be present as a residual solvent in various chemical processes used to create surfactants and other components of detergents, its possible presence could be questioned.

    Article 10 of the regulation focuses on the environmental impact of substances in detergents, and hexane, being a volatile organic compound (VOC), may be subject to stricter restrictions regarding its use in industrial cleaning product formulations.

    If hexane is classified as SVHC or subject to new restrictions, products containing this ingredient could face enhanced labeling and safety requirements or even bans.

Toy safety Regulation

The toy safety directive imposes strict restrictions on substances and mixtures that can be used in the manufacturing of toys, particularly CMR substances (carcinogenic, mutagenic, or reprotoxic).

  • Reasons for Concern

    Residues of hexane, which is neurotoxic and suspected reprotoxic, could be present in the finished product.

    Due to exposure risks to children, a particularly vulnerable population, its use in toys could be banned or severely limited.

Biocidal Products Regulation

This regulation controls the use biocide compounds.

  • Reasons for Concern

    Although hexane is not directly used as a biocide, it can be used as a solvent in certain biocidal formulations. Any reclassification of hexane could lead to restrictions on its use in biocidal products and require the approval of alternative solvents.

Waste Framework Directive

The waste framework directive imposes management measures to limit hazardous substances in waste.

  • Reasons for Concern

    Hexane, as a solvent, can be present in industrial residues and waste streams. If hexane is recognized as an SVHC or hazardous, companies will need to strengthen the management processes for waste containing hexane and comply with recycling and recovery objectives.

Industrial Emissions Directive

This Regulation sets limits on VOC Emissions (Volatile Organic Compounds).

  • Reasons for Concern

    Hexane, as a volatile organic compound (VOC), may be subject to stricter restrictions regarding air emissions in industrial facilities. Specific measures may be imposed to limit hexane emissions, particularly in the food extraction and industrial solvent sectors.

Air Quality Directive

This regulation sets limits on VOC emissions.

  • Reasons for Concern

    Hexane contributes to air pollution as a VOC. A stricter classification under REACH or CLP could influence the measures taken at the European level to reduce air pollution.

    Member States may be encouraged to monitor and limit hexane emissions into the air, especially in industrial areas.

Seveso III Directive

This directive concerns risk management related to dangerous substances at industrial sites.

  • Reasons for Concern

    Hexane is a flammable substance classified under physical hazards in addition to its toxicity. Depending on the quantities stored on site, storage and use of hexane can trigger a Seveso classification. The Seveso thresholds are:

    • 10 tons of Highly Flammable liquids for a lower tier: implementation of risk management measures required
    • 50 tons of Highly Flammable liquids for an upper tier: full safety management system required

    Any change in its classification under REACH or CLP could affect companies that store or handle large quantities of hexane, necessitating risk management and industrial accident prevention measures.

Directive on Worker Protection

The use of hazardous substances such as hexane in the workplace is governed by this directive.

  • Reasons for Concern

    The STOT RE 1 (H372) classification strengthens employers’ obligations to protect workers, requiring stricter measures to minimize employee exposure to hexane in solvent-using sectors. Failure to adequately protect employees can lead to fines and legal actions from employees.

Conclusion

These regulations demonstrate the cross-cutting impact that evolving restrictions on hexane could have across various sectors. Industries using hexane in their processes will need to closely monitor these developments to anticipate potential further restrictions. Given the time and costs associated with being forced by new regulations to change manufacturing methods – It would be prudent for them to proactively consider safer alternatives. [link to alternative technologies] These changes could result in more sustainable practices and safer alternatives, aligning with the EU’s priorities for chemical safety and sustainability.

UNITED STATES Regulations

Just as occured in Europe, the awareness and scrutiny related to hexane’s health and environmental risks in the US could influence U.S. regulators. Below are some U.S. federal regulations that could be affected by these developments:

Food and Drug Administration Regulations

The US FDA regulates a wide range of products, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products.

  • Reasons for Concern

    Food Contact and Processing: The FDA regulates hexane’s use as an extraction solvent in food processing, but only for cotton oil, some food additives and protein isolates. However no maximum residue limit is set by FDA on hexane residue in soy, rapeseed, sunflower and other oils. EFSA’s decision to reassess hexane’s safety could prompt the FDA to revisit the status for hexane in food extraction.

    Any revision or new safety data might result in changes to the allowable residual levels of hexane in food products.

    Hexane may be reevaluated under 21 CFR Part 173, which covers secondary direct food additives permitted in food for human consumption.

Consumer Product Safety Commission

The Consumer Product Safety Commission (CPSC) protects the public from unreasonable risks of serious injury or death from thousands of types of consumer products under its jurisdiction, including products that pose a fire, electrical, chemical, or mechanical hazard or can injure children.

  • Reasons for Concern

    If hexane is used in consumer products such as adhesives, paints, or solvents, the CPSC could reevaluate its safety guidelines for products containing hexane.

    Particularly in light of the STOT RE 1 classification and concerns over chronic exposure risks in non-occupational settings.

US State Regulations

As of June 2024, 40 states have adopted 368 policies to protect people from toxic chemicals, and 35 states have introduced 484 policies.

  • Reasons for Concern

    Certain U.S. states, particularly California, may react to hexane’s new classification more quickly than federal authorities.

    Under California Proposition 65, chemicals known to cause cancer or reproductive toxicity must be listed and warned about. Hexane’s toxicity profile is confirmed as neurotoxic and suspected reprotoxic, it may lead to new warning label requirements under Prop 65.

    Other states with strong chemical safety regulations, such as Washington or New York, may also enact specific measures to restrict or monitor hexane usage.

Toxic Substances Control Act

The TSCA, administered by the Environmental Protection Agency (EPA), regulates the use of chemicals in commerce.

  • Reasons for Concern

    Hexane is already listed on the TSCA Chemical Substance Inventory. If the new European classification and recommendations trigger further safety concerns, the EPA could:

    • Reassess hexane’s safety and enforce additional reporting requirements.
    • Consider restrictions or risk management rules for its use under Section 6 of TSCA, especially if it is found to pose unreasonable risks to human health.
    • Prioritize hexane for a risk evaluation or chemical action plan.

Clean Air Act

The Clean Air Act (CAA) is a US federal law that regulates air emissions from both mobile and stationary sources to improve air quality and protect the ozone layer.

  • Reasons for Concern

    Hexane as a Hazardous Air Pollutant (HAP): Hexane is already listed as a hazardous air pollutant (HAP) under Section 112 of the Clean Air Act.

    The new health concerns could push for stricter emissions controls or reductions on facilities that release hexane into the air, such as oil extraction plants and chemical processing facilities.

    The National Emission Standards for Hazardous Air Pollutants (NESHAPs) may also be updated to include more stringent limits on hexane emissions.

Resource Conservation and Recovery Act

The Resource Conservation and Recovery Act (RCRA) gives EPA the authority to control hazardous waste from cradle to grave.

  • Reasons for Concern

    Under the RCRA, hexane is classified as a hazardous waste when discarded. Stricter classification and restrictions under European regulations could prompt the U.S. EPA to tighten the rules on how hexane waste is managed, particularly in the context of its neurotoxic and environmental impacts.

Regulation of Volatile Organic Compounds (VOC)

The U.S. EPA regulates VOCs at Federal level in 40 CFR 59, which is the National Volatile Organic Compound Emission Standards For Consumer And Commercial Products.

  • Reasons for Concern

    As hexane is classified as a volatile organic compound (VOC), stricter classification in Europe might lead to increased scrutiny and potential tightening of VOC emission standards under both US federal and state environmental regulations.

    This could affect industries that use hexane for extraction or as a solvent, leading to additional compliance burdens.

Occupational Safety and Health Administration

OSHA’s Hazard Communication Standard (HCS) (🌐 29 CFR 1910.1200) requires employers to classify and label hazardous chemicals in the workplace.

  • Reasons for Concern

    The new classification of hexane as STOT RE 1 for nervous system toxicity may lead to updates in the Safety Data Sheets (SDS) and hazard labeling for hexane in the U.S. workplace.

    • Permissible Exposure Limits (PELs): Although OSHA already has a PEL for hexane (500 ppm for an 8-hour workday), the new evidence on chronic toxicity could lead to a reassessment of PELs for occupational exposure, especially in industries where hexane is widely used (e.g., printing, extraction processes).
    • OSHA Process Safety Management (PSM): Hexane is flammable, and while it’s not classified as an extremely hazardous chemical under the PSM regulations, stricter measures might be imposed in industries using large quantities of hexane.

National Institute for Occupational Safety and Health

NIOSH, provides research and recommendations on workplace safety.

  • Reasons for Concern

    If new research suggests heightened risks of long-term exposure to hexane, NIOSH could update its guidelines regarding safe handling practices for hexane.

Conclusion

While the new European classifications of hexane and EFSA’s reassessment do not directly change U.S. regulations, the cumulative weight of international concern could lead to a reconsideration of hexane’s use and regulation across several U.S. federal frameworks. U.S. agencies like the EPA, FDA, and OSHA may need to reevaluate hexane’s safety profile, especially concerning chronic exposure, occupational hazards, and environmental impacts. Industry stakeholders should remain vigilant, as regulatory shifts in the U.S. often follow developments in other regions like the EU.

American manufacturers using hexane would be wise to think proactively . Given the time and costs associated with being forced by new regulations to change manufacturing methods, it would be prudent for them to proactively consider safer alternatives. These changes could result in more sustainable practices and safer alternatives, aligning with the United States priorities for chemical safety and sustainability.

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