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Our Verdict: SAFE

Tomato Lycopene

E-numberE160dCAS502-65-8

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Tomato Lycopene — food additive

Tomato lycopene is a naturally occurring carotenoid pigment responsible for the red color in tomatoes and tomato products. It is used as a flavoring agent and color adjuvant in food products, derived from tomato concentrates or synthesized through chemical processes.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
ApprovedMHLW
South Korea
ApprovedMFDS
Brazil
ApprovedANVISA
China
ApprovedNHC / GB 2760
India
ApprovedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Tomato Lycopene?

Tomato lycopene (CAS Number 502-65-8) is a carotenoid compound belonging to the class of natural pigments found abundantly in tomatoes and tomato-based foods. Lycopene is a 40-carbon tetraterpene that exists in multiple geometric isomers, with the all-trans form being the most common naturally occurring variant. This compound gives tomatoes their characteristic red color and can be extracted from tomato processing byproducts or synthesized chemically for use as a food additive.

Common Uses

Tomato lycopene is utilized in the food industry primarily as a flavoring agent and color adjuvant. It appears in various food products including beverages, dairy products, confectionery, and processed foods where a tomato flavor profile or red coloration is desired. As a naturally derived ingredient, it appeals to manufacturers seeking clean-label alternatives to synthetic colorants and flavorings. Lycopene extracts are also incorporated into functional food products marketed for their antioxidant properties, though health claims are subject to regulatory limitations.

Safety Assessment

Tomato lycopene has a favorable safety profile based on available data. The FDA reports zero adverse events associated with this additive and zero recalls, indicating no documented safety incidents in the U.S. food supply. As a naturally occurring compound present in commonly consumed tomatoes and tomato products, lycopene has a long history of safe consumption in the human diet.

The toxicological data on lycopene shows low systemic toxicity. Studies have demonstrated minimal absorption when consumed orally, with most lycopene passing through the gastrointestinal tract. The compound is fat-soluble and accumulates in adipose tissue and certain organs, but no adverse health outcomes have been established at dietary levels. No genotoxicity or carcinogenicity has been identified in preclinical studies.

Individuals with tomato allergies would theoretically need to avoid lycopene products, though such allergies are relatively uncommon. Lycopene does not appear to interact significantly with common medications, though fat-soluble vitamin absorption may be theoretically affected at very high supplemental doses.

Regulatory Status

Tomato lycopene is not listed on the FDA's Generally Recognized as Safe (GRAS) list, meaning it has not undergone the formal GRAS affirmation process. However, this designation does not indicate the ingredient is unsafe; rather, it reflects that formal regulatory review through the GRAS petition process has not been completed. The ingredient is permitted for use in the United States under FDA regulations for food colorants and flavoring agents derived from natural sources.

In the European Union, lycopene is regulated under food additive regulations, though specific authorization varies by intended use and application. The EFSA has evaluated lycopene in various contexts and has not identified significant safety concerns at typical food use levels.

Key Studies

Preclinical research on lycopene absorption and metabolism has shown that dietary fat enhances its bioavailability. Studies examining lycopene's antioxidant properties in vitro demonstrate its ability to neutralize free radicals, though in vivo effects are more modest due to limited absorption.

No chronic toxicity studies specific to food-additive lycopene were identified in recent literature, though the long history of lycopene consumption through tomato products provides substantial safety data. The lack of adverse event reports and recalls in the FDA database supports a favorable safety profile under current conditions of use in food applications.

Real products containing Tomato Lycopene

See where it shows up on American shelves.

Data: Open Food Facts
  • One a day Men’s 50+ — contains Tomato LycopeneSAFE

    One a day Men’s 50+

    Bayer

  • Similac Advance — contains Tomato LycopeneSAFE

    Similac Advance

    Abbott

  • DAILY MULTI — contains Tomato LycopeneSAFE

    DAILY MULTI

    Kirkland

  • women's multi — contains Tomato LycopeneSAFE

    women's multi

    vitafusion

  • Multivitamin — contains Tomato LycopeneSAFE

    Multivitamin

    Bayer

  • Hot Sauce — contains Tomato LycopeneSAFE

    Hot Sauce

    TRUFF

  • Men Multivitamin/Multi mineral Supplement — contains Tomato LycopeneSAFE

    Men Multivitamin/Multi mineral Supplement

    Centrum

  • Men’s multivitamin — contains Tomato LycopeneSAFE

    Men’s multivitamin

    One a day

Photos and product data from Open Food Facts (ODbL license). Product formulations change — always verify on current packaging.

Brands that use Tomato Lycopene

8 brands in our database list Tomato Lycopene as an ingredient in at least one product.

Frequently Asked Questions

What is Tomato Lycopene?

Tomato lycopene is a naturally occurring carotenoid pigment responsible for the red color in tomatoes and tomato products. It is used as a flavoring agent and color adjuvant in food products, derived from tomato concentrates or synthesized through chemical processes.

Is Tomato Lycopene safe?

Tomato Lycopene is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Tomato Lycopene banned in any country?

Tomato Lycopene is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.

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