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Beta-Carotene — supplement ingredient
Fat-soluble vitamins · Gummies

Beta-Carotene

Beta-Carotene is used in private-label supplement manufacturing. Sourcing, dose anchors and target-market documentation are reviewed per project.

Type
Vitamin
Family
Fat-soluble vitamins
Measured in
mg
Research on file
24 studies

At a glance

Format suitability
Reviewed for gummies — confirmed per project.
Why brands use it

Why brands use Beta-Carotene

Beta-Carotene is an essential vitamin commonly considered for daily-wellness ranges, sitting in the fat-soluble vitamins family. On DAT Supply briefs the positioning is set by the brand brief and reviewed against the target market’s claim rules — we do not pre-position an active for any single benefit. Editorial framing uses only EU 432/2012- or DSHEA-compatible wording — we never promote unauthorised claims, even when the active has consumer-side momentum. Format-wise we have considered Beta-Carotene for gummies; the per-format formulation notes below describe the live constraints (taste, payload, stability, packaging) we tune in the formulation pass. Sourcing form (extract ratio for botanicals, salt or chelate form for minerals, free-form vs ester for amino acids) is reviewed against the brief, with documentation matched to the target market’s import rules. Inclusion rate and claim wording are reviewed per project — we don’t publish off-the-shelf doses.

Formulation

How we use Beta-Carotene in formulas

A public-safe formulation reference — how this active behaves in our formats, common pairings and handling notes. Final formulation, dose and on-pack copy are confirmed per project.

Heat stable
Limited — use coated forms
Soluble in matrix
Conditional
Vegan supply
Project-specific
Claim wording

EU-authorised health claims

EU-authorised wording for this ingredient is reviewed per project against Reg. 1924/2006 and the authorised list under Reg. 432/2012. No final claim wording is implied by this page.

Across the EU and UK markets Beta-Carotene is treated as a vitamin: any on-pack benefit wording must come from the EU 432/2012 register (UK retains the same wording post-Brexit), and the inclusion rate has to meet the minimum thresholds tied to the chosen claim. For the US market, label benefit copy follows DSHEA structure-function rules with the standard "not intended to diagnose, treat, cure or prevent any disease" disclosure. We never reuse a market’s wording as if it carried over — claim copy is rewritten per market and reviewed per project. Country-level rules (e.g. France, Italy, Belgium for the EU; California Prop 65 for the US) layer on top, and the back-of-pack nutritional table is built against the market’s reference intake framework.

EU-authorised health claims

Authorised at ≥15% NRV per daily serving. Claim wording must appear verbatim on consumer packaging. DAT reviews final pack copy per project against EU 1924/2006 and the authorised list under EU 432/2012.

Formats

Formats we review Beta-Carotene in

DAT Supply's live catalogue covers gummy, powder sachet, functional jelly, pet soft chew and oral strip formats. Each row is a format this active is reviewed for and what changes when it is delivered that way.

Delivery formats Beta-Carotene is reviewed for, and what changes in each
Format What changes in this format
Gummies Develop in gummies →
  • Taste masking and aroma load against the cooked-base flavour — confirmed per project.
  • Heat exposure during cooking; coated or encapsulated forms may be required — confirmed per project.
  • Pectin matrix formulation and its effect on ingredient stability — confirmed per project.
  • Per-gummy dose and serving count needed to hit the label claim — confirmed per project.
Serving

Typical serving and reference level

Where the serving level for Beta-Carotene is set, and who sets it. The figure that reaches your label is fixed against the specification for your formula and your market — not read off this page.

Measured in
mg
Reference level

Typical anchor: mg per serving — confirmed per project.

Beta-Carotene is measured by weight (mg) per serving on DAT Supply briefs. The working anchor — the inclusion rate against which target-market claim wording is reviewed — is set during the formulation pass for each project rather than published as a fixed number on the public page. Final per-serving load depends on the chosen format (gummy payload window, capsule fill weight, softgel oil load, sachet or powder scoop size, oral-liquid bottle geometry) and the claim wording the brand needs to support against the target market. Sourcing form (extract ratio, standardised marker, micronised vs granular, salt or chelate form) is reviewed in the same pass. Country-level upper limits (France, Italy, Belgium for the EU; California Prop 65 for the US) are checked before any inclusion rate is finalised. Dose is confirmed per project — we don’t publish off-the-shelf dose tables for any active in the catalogue.

Research library

The evidence behind Beta-Carotene

24 studies relevant to Beta-Carotene, strongest evidence first. Peer-reviewed sources and regulatory opinions. Citations only — DAT cites the science, it does not endorse the publishers. Studies are on the ingredient, not on any finished product.

  1. Beta-Carotene

    Beta Carotene (USP-NF)

    Studied dose
    not applicable

    Defines identity, purity (≥96% beta-carotene), assay by HPLC, and limits for impurities.

  2. Beta-Carotene

    Beta-Carotene – EFSA Scientific Opinion on Tolerable Upper Intake Level

    Studied dose
    not applicable

    Establishes that supplemental beta-carotene (≥20 mg/day) may increase lung cancer risk in smokers; no UL set for food sources.

  3. Beta-Carotene

    Beta-Carotene – JECFA Specification

    Studied dose
    not applicable

    Establishes purity criteria: synthetic beta-carotene ≥96%, natural extracts ≥20% beta-carotene. Assay by spectrophotometry.

  4. Beta-Carotene

    Beta-Carotene (Ph. Eur.)

    Studied dose
    not applicable

    Specifies assay (≥96% all-trans beta-carotene), identification by UV and HPLC, and related substances.

  5. Beta-Carotene

    Beta-Carotene and Lung Cancer Risk: A Systematic Review and Meta-Analysis

    Studied dose
    20-30 mg/day

    Supplemental beta-carotene at high doses (≥20 mg/day) increased lung cancer risk in smokers and asbestos-exposed individuals. No increased risk in non-smokers.

  6. Beta-Carotene

    Beta-carotene and lung cancer: a systematic review of randomized controlled trials

    Studied dose
    20-30 mg/day

    Increased lung cancer risk in smokers and asbestos workers

  7. Beta-Carotene

    Beta-Carotene as a Food Additive (E160a) – EU Specification

    Studied dose
    not applicable

    Defines purity criteria for beta-carotene used as a colour (E160a): ≥96% total colouring matter (synthetic), ≥20% (natural extract).

  8. Beta-Carotene

    Beta-Carotene Beadlet Specification (DSM)

    Studied dose
    not applicable

    Typical specification: 10% beta-carotene content (minimum), with added antioxidants (tocopherols, ascorbyl palmitate) and starch/maltodextrin matrix.

  9. Beta-Carotene

    Beta-Carotene Powder (BASF)

    Studied dose
    not applicable

    Specification: 10% beta-carotene (minimum), encapsulated in modified starch, with tocopherols as antioxidant.

  10. Beta-Carotene

    Beta-carotene supplementation and age-related macular degeneration: the Age-Related Eye Disease Study (AREDS)

    Studied dose
    15 mg/day

    Reduced risk of advanced AMD in patients with intermediate AMD

  11. Beta-Carotene

    Beta-Carotene Supplementation and Cancer Risk: A Meta-Analysis of Randomized Controlled Trials

    Studied dose
    15-50 mg/day

    Supplemental beta-carotene increased lung cancer risk in smokers (RR 1.18, 95% CI 1.04-1.33). No effect on other cancers. No increased risk in non-smokers.

  12. Beta-Carotene

    Beta-carotene supplementation and cognitive function: a randomized controlled trial in older adults

    Studied dose
    50 mg every other day

    Modest benefit on verbal memory in long-term supplementation

  13. Beta-Carotene

    Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study

    Studied dose
    50 mg every other day

    No effect on cancer or cardiovascular disease incidence

  14. Beta-Carotene

    Beta-carotene supplementation and risk of cardiovascular disease: a meta-analysis of randomized controlled trials

    Studied dose
    20-50 mg/day

    No significant benefit on cardiovascular events; possible increase in mortality in smokers

  15. Beta-Carotene

    Beta-carotene supplementation and risk of lung cancer in smokers: the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study

    Studied dose
    20 mg/day

    Increased incidence of lung cancer in smokers

  16. Beta-Carotene

    Beta-carotene supplementation and skin protection against UV-induced erythema

    Studied dose
    24 mg/day

    Reduced UV-induced erythema after 10 weeks

  17. Beta-Carotene

    Dietary beta-carotene intake and risk of cardiovascular disease: a prospective cohort study

    Studied dose
    dietary intake (not supplement)

    Inverse association with CVD risk

  18. Beta-Carotene

    EFSA Scientific Opinion on the Tolerable Upper Intake Level of Beta-Carotene

    Studied dose
    Not applicable (review of literature)

    EFSA established an acceptable daily intake (ADI) of 0–5 mg/kg bw for beta-carotene as a food additive. For supplemental beta-carotene, a tolerable upper intake level (UL) of 7 mg/day for adults was proposed based on lung cancer risk in smokers. No UL for dietary beta-carotene from food.

  19. Beta-Carotene

    European Commission Regulation on Health Claims for Beta-Carotene

    Studied dose
    Not applicable

    EFSA approved health claim: 'Beta-carotene contributes to the maintenance of normal skin' and 'Beta-carotene contributes to the maintenance of normal vision' when used at doses providing at least 2 mg/day. No adverse effects at recommended intakes.

  20. Beta-Carotene

    FDA Generally Recognized as Safe (GRAS) Notification for Beta-Carotene

    Studied dose
    Not applicable

    Beta-carotene is GRAS as a food additive and nutrient supplement. No specific UL set by FDA; use is self-limiting.

  21. Beta-Carotene

    FDA Guidance on Beta-Carotene as a Nutrient Supplement

    Studied dose
    Not applicable

    Beta-carotene is permitted as a dietary supplement ingredient. No specific UL; recommended daily intake for vitamin A activity is 900 mcg RAE for men and 700 mcg RAE for women (1 mcg RAE = 12 mcg beta-carotene).

  22. Beta-Carotene

    HPLC Assay of Beta-Carotene in Dietary Supplements (AOAC 2012.10)

    Studied dose
    not applicable

    Validated method for quantification of all-trans beta-carotene in supplements; applicable to powder and beadlet forms.

  23. Beta-Carotene

    JECFA Evaluation of Beta-Carotene as a Food Additive

    Studied dose
    Not applicable

    JECFA established an ADI of 0–5 mg/kg bw for beta-carotene as a food additive. No safety concerns at current usage levels.

  24. Beta-Carotene

    Subchronic Toxicity of Beta-Carotene in Rats

    Studied dose
    0, 100, 500, 1000 mg/kg bw/day

    No adverse effects at doses up to 1000 mg/kg bw/day. NOAEL established at 1000 mg/kg bw/day.

Formulas

Formulas using Beta-Carotene

Private-label options where Beta-Carotene is in the formula — a ready starting point for your brand.

The formulas above sit in this private-label range:

Adjacent actives

Ingredients that sit alongside this one

Start

Build a formula around Beta-Carotene

Explore the private-label options that use Beta-Carotene — review formula, format and packaging on each product before you commit.

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