Capsicum extract, broadly encompassing Capsicum annuum and Capsicum frutescens extracts—most notably capsaicin-rich oleoresins—is used globally in food, cosmetics, OTC medicines, supplements, and animal feed. While valued for color, flavor, and counterirritant properties, regulatory agencies carefully assess its safety to ensure public health protection. This article provides an in-depth look at its chemical composition, safety profile, regulatory approvals, restrictions, and emerging scientific findings across major international markets.

Chemical Composition and Definitions

• Paprika oleoresin (paprika extract; E 160C) is a lipid-soluble concentrate derived from red bell peppers, standardized to ~7% total carotenoids, including capsanthin and capsorubin.
• Capsicum oleoresin (OC) typically contains capsaicinoids—capsaicin and dihydrocapsaicin—which contribute the "heat". As a product category it can be food-grade (low heat) or irritant-grade (high purity).
• Capsaicin (8-methyl-N-vanillyl-trans-6-nonenamide) is the main pungent compound responsible for pepper heat. It is used in medicinal (topical analgesics, irritating formulas) and food-grade contexts.

Toxicity and Safety Assessments

Genotoxicity & Carcinogenicity

• Paprika extract (E 160C): Evaluated by JECFA (1974-2014) with 90-day and chronic rodent studies showing no evidence of carcinogenicity; a no-observed-adverse effect level (NOAEL) calculated in long-term studies equated to a NOAEL of 153 mg/kg bw-day (as carotenoids).
• EFSA re-evaluation (2015): No genotoxic or carcinogenic concerns with paprika extract; derived ADI of 1.7 mg carotenoids/kg bw-day (~24 mg extract/kg bw-day) based on sub-chronic histopathology findings.
• Capsaicin: EFSA and EMA acknowledged potential genotoxic signals in early data (e.g., SCF 2002), but more recent risk assessments (e.g., EFSA feed additive in animals) did not find genotoxic risk at typical exposure levels.

NOAEL and Acceptable Intakes

Local Effects, Irritation, Sensitization

• Skin/Eye/Irritant: Capsicum extracts are recognized skin and respiratory irritants. Occupational exposure (e.g., manufacturing plants) can produce cough, sneezing, wheezing, and dermatitis.
• Dermal Sensitization: Generally not systemically sensitizing; dermatological patch tests at low concentrations (0.1-1.0%) mostly negative.
• Gastrointestinal irritation: High chili consumption has been linked to gastric tissue irritation, though causality remains inconclusive.

Regulatory Status by Region

Exposure Assessment & Risk Characterization

• Dietary Intake: JECFA's 95th percentile exposure estimates (scaled to 60 kg bw) of 0.1–0.2 mg carotenoids/day (~0.002–0.003 mg/kg bw/day) are well-delineated below the ADIs (1.5–1.7 mg/kg bw/day).
• Non-Dietary Exposure: Industrial and consumer exposure (e.g., pepper spray, topical gels) can cause local dermal or respiratory effects; classified as irritant, with users required to take precautions.
• Cumulative Safety Margin: The substantial difference between conservative ADIs and expected intake shows strong safety margin for human dietary exposure.

Labeling and Usage Requirements

• In formulated foods and cosmetics, capsicum derivatives (e.g., paprika extract, Capsicum annuum extract, capsaicin) must be listed as specified by regulations (CFR part 73, EC 1333/2008, INCI names).
• For OTC drugs, monograph compliance includes concentration limits, external-use warnings, and no application to broken skin.
• Animal feed additives labeled with inclusion levels and safety statements at manufacturing stage.
• Plant protection substances are unapproved; vendor warnings reflect non-approval as per EU regulation.

Occupational and Consumer Safety Concerns

• Industrial Hygiene Hazards: Capsicum extracts are documented irritants; manufacturing plants require protective equipment, ventilation, work-practice limits to prevent respiratory/cutaneous damage.
• Spray & Product Misuse Risks: High-concentration oleoresin capsicum sprays can cause acute respiratory distress and corneal injury if misused.
• Contaminants and Nitrosamines: Historical concerns about n-nitroso compounds in chili peppers warrant attention when extracting capsicum—residual nitrates or nitrosylation by-products may pose carcinogenic risk if not adequately controlled

High-Profile Case Studies

• Paprika Extract (E 160C) Re-evaluation: EFSA's 2015 assessment—updating data, aligning with GLP-compliant studies—raised ADI from JECFA's earlier values, reinforcing safety and resolving genotoxic questions.
• Capsaicin in Animal Feed: Feed-use opinions (2015, 2025) examined safety in multiple species; set safe inclusion levels (~6.5 mg/kg feed) and noted irritant risk, but concluded consumer safety unaffected.
• EU Non-Approval for Plant Protection: 2021's non-approval highlighted need for complete environmental, toxicological data and recognized eye/skin hazard at higher product concentrations.

Emerging Research & Future Considerations

• Phenylcapsaicin: EFSA-approved as novel food in 2019; early safety evaluation supports low-dose supplement use.
• Nitrosamine Risks: Ongoing studies investigating nitrosamine formation in chili products; may prompt enhanced monitoring or manufacturing controls.
• Genotoxicity Data: Capsaicin remains evaluated; earlier red flags (SCF 2002) largely resolved by recent data.
• Innovative Applications: Capsicum extracts continue to appear in nutraceuticals, antimicrobial sprays, flavor-enhanced feed, and cosmetic irritants. Each new application must undergo its sector-specific regulatory review.

Capsicum extracts—ranging from mild coloring agents to potent irritants—are tightly regulated globally. Robust scientific reviews by JECFA, EFSA, FDA, EMA, and others support their safe use in permitted applications. Nevertheless, as with any bioactive compound, manufacturing purity, exposure context, and sectoral usage (e.g., food vs. pesticides) dictate regulatory acceptance. Ongoing surveillance, especially regarding occupational hazards, nitrosamine content, and high-purity usage forms, remains essential to ensure long-term consumer and worker safety.

At Creative Enzymes, we provide high-purity capsicum extract and capsicum oleoresin that meet global regulatory standards. Our products are trusted for safe use across food, nutraceutical, and industrial applications—delivering both performance and compliance. Contact us today for more information!