Safety Profile
Known Safety Concerns
- MILK allergen (full dairy protein profile — casein, whey); not vegan; WADA monitoring history for IGF-1 (athletes confirm status); contraindicated in milk allergy and galactosaemia
Contraindications
- MILK allergen (full dairy protein profile — casein, whey); not vegan; WADA monitoring history for IGF-1 (athletes confirm status); contraindicated in milk allergy and galactosaemia
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Colostrum is the first milk produced by mammals in the 24–72 hours after parturition, before regular milk begins. Bovine colostrum supplements are standardised for immunoglobulin G (IgG; 10–40%). Key bioactives: IgG, IgA, IgM; IGF-1 and IGF-2; TGF-β; lactoferrin; proline-rich polypeptides (PRPs/colostrinin); growth hormone; oligosaccharides. Applications: immune support; gut barrier integrity (tight junction support); athletic recovery; upper respiratory infection prevention. Clinical evidence: modest positive RCTs for reducing upper respiratory infection incidence in athletes; gut barrier support plausible but requires more data. MILK ALLERGEN: bovine colostrum contains all dairy proteins (casein, whey, lactalbumin, lactoglobulin) — CONTRAINDICATED in IgE-mediated milk allergy; caution in lactose intolerance. Not vegan. WADA: bovine colostrum is WADA-permitted but was historically on monitoring list due to IGF-1 content — athletes in tested sports should confirm current regulatory status. IGF-1 oral bioavailability is limited (GI digestion). Ethical sourcing concerns regarding newborn calf welfare. Avoid in galactosaemia. Pregnancy/nursing: insufficient data at supplement doses.
Biological and Chemical Classification
- Scientific Name
- Bos taurus (bovine colostrum)
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Specialty
- Evidence consistency: High consistency across studies (100%)
- MILK allergen (full dairy protein profile — casein, whey); not vegan; WADA monitoring history for IGF-1 (athletes confirm status); contraindicated in milk allergy and galactosaemia
The available scientific evidence for Colostrum indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 06 აპრ 2026, 12:08
Evidence Distribution
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Observational / other LOW evidence YELLOWThe Expanding Dairy-Beef Calf Industry: Challenges and Opportunities in Pre-Feedlot Nutrition, Health and Welfare. ↗McCarthy HR et al.. The Expanding Dairy-Beef Calf Industry: Challenges and Opportunities in Pre-Feedlot Nutrition, Health and Welfare.. J Dairy Sci. 2026. PMID:41937078.PMID 41937078 ↗Journal J Dairy SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41937078/
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Observational / other LOW evidence YELLOWRandomized Clinical Trial Evaluating the Practical and Biological Limits of Single-Feed Colostral IgG Dosing in Australian Holstein and Angus x Holstein calves. ↗Hapukotuwa DA et al.. Randomized Clinical Trial Evaluating the Practical and Biological Limits of Single-Feed Colostral IgG Dosing in Australian Holstein and Angus x Holstein calves.. J Dairy Sci. 2026. PMID:41937077.PMID 41937077 ↗Journal J Dairy SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41937077/
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Observational / other LOW evidence YELLOWFactors Associated with Preweaning Morbidity, Lung Consolidation, and Mortality in Preweaned Holstein Calves in Ontario, Canada. ↗Edwards KY et al.. Factors Associated with Preweaning Morbidity, Lung Consolidation, and Mortality in Preweaned Holstein Calves in Ontario, Canada.. J Dairy Sci. 2026. PMID:41937066.PMID 41937066 ↗Journal J Dairy SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41937066/
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Observational / other LOW evidence YELLOWColostral fat content modulates glucose homeostasis and lipid metabolism in neonatal calves exposed to cold temperature. ↗Erkinger H et al.. Colostral fat content modulates glucose homeostasis and lipid metabolism in neonatal calves exposed to cold temperature.. J Dairy Sci. 2026. PMID:41937061.PMID 41937061 ↗Journal J Dairy SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41937061/
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Observational / other LOW evidence YELLOWDeep and High-Throughput Proteomic Atlas of Chinese Bovine Colostrum Reveals Regional Signatures. ↗Wang X et al.. Deep and High-Throughput Proteomic Atlas of Chinese Bovine Colostrum Reveals Regional Signatures.. J Dairy Sci. 2026. PMID:41937056.PMID 41937056 ↗Journal J Dairy SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41937056/
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Observational / other LOW evidence YELLOWColostrum somatic cell counts and their association with the bacterial microbiota at udder quarter level in Simmental cows. ↗Kroboth C et al.. Colostrum somatic cell counts and their association with the bacterial microbiota at udder quarter level in Simmental cows.. Res Vet Sci. 2026. PMID:41936224.PMID 41936224 ↗Journal Res Vet SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41936224/
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Observational / other LOW evidence YELLOWMaternal hemoglobin during late gestation and neonatal hemoglobin are associated with piglet oxygenation and early survival in hyper-prolific sows under tropical conditions. ↗Thu PPP et al.. Maternal hemoglobin during late gestation and neonatal hemoglobin are associated with piglet oxygenation and early survival in hyper-prolific sows under tropical conditions.. Theriogenology. 2026. PMID:41934868.PMID 41934868 ↗Journal TheriogenologyYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41934868/
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Observational / other LOW evidence YELLOWColostrum and calf management: does farmers' view match the practices? ↗Costa A et al.. Colostrum and calf management: does farmers' view match the practices?. Animal. 2026. PMID:41932209.PMID 41932209 ↗Journal AnimalYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41932209/
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Observational / other LOW evidence YELLOWEnvironmental and lifestyle factors affecting nickel concentrations in human colostrum: A cross-sectional study in Poznau0144, Poland. ↗Piet M et al.. Environmental and lifestyle factors affecting nickel concentrations in human colostrum: A cross-sectional study in Poznau0144, Poland.. Midwifery. 2026. PMID:41931934.PMID 41931934 ↗Journal MidwiferyYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41931934/
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Observational / other LOW evidence YELLOWRisk Factors for and Prevalence of Failure of Passive Transfer of Immunity in Calves on Dairy Farms in Tu00fcrkiye. ↗Sau011flam N et al.. Risk Factors for and Prevalence of Failure of Passive Transfer of Immunity in Calves on Dairy Farms in Tu00fcrkiye.. Vet Med Sci. 2026. PMID:41930913.PMID 41930913 ↗Journal Vet Med SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41930913/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Colostrum. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Low classification for Colostrum
A score of 2.0 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.