Patent Blue V (E131) β€” What You Need to Know

Caution(5/10)Synthetic

The score is an eNumbers.org editorial summary, not an official agency rating or medical advice. Start with the regulatory status and primary sources below.

What Is Patent Blue V?

Patent Blue V is a synthetic triarylmethane dye used primarily in the EU as a blue food coloring. It is also used in medical applications as a surgical dye for sentinel lymph node detection during breast cancer and melanoma surgery.

What Is It Used For?

Produces blue and blue-green shades in confectionery, beverages, and processed foods. Also used as a diagnostic dye in surgical procedures.

Function: Blue synthetic food coloring (triarylmethane dye)
0.1 mg
Dataset exposure estimate
350 mg
ADI-derived reference (70 kg)
0%
of ADI (typical diet)

Exposure figures are population-level references, not personal limits. Actual intake varies by diet, product and jurisdiction.

Regulatory & Editorial Context

πŸ“Š
Acceptable Daily Intake (ADI)
5 mg/kg bw/day
πŸ›οΈ
Regulatory Status
πŸ‡ͺπŸ‡Ί EU: Authorized
πŸ‡ΊπŸ‡Έ US: Not approved
πŸ‡―πŸ‡΅ JP: Not approved
πŸ‡¦πŸ‡Ί AU: Approved
πŸ‡¨πŸ‡¦ CA: Not approved
⚠️ Key Concerns

Can cause allergic reactions including urticaria and anaphylaxis in rare cases. Used as a surgical dye for sentinel lymph node detection, where anaphylactic reactions have been documented (incidence ~1 in 2,000). Not approved for food use in the US, Australia, or Norway. EFSA re-evaluated in 2013 and maintained ADI.

Editorial context score

eNumbers.org currently assigns Patent Blue V an editorial context label of Caution with a score of 5/10. This is 0.8 points below the database average for colorings (5.8/10). Dataset reference year: 2013. The dataset's population estimate equals about 0% of the listed ADI.

This score is not issued by EFSA, FDA, WHO or another regulator.

Commonly Found In

Scotch eggsConfectioneryCanned vegetables (EU)Beverages (EU)
Example brands:
Haribo (EU varieties)Dr. Oetker (EU products)

Always check the label for E131 or 'Patent Blue V'

β–ΆChemical Information
Formula: C27H31N2NaO7S2
Molecular Weight: 582.67 g/mol
CAS Number: 3536-49-0
INS Number: 131
Also known as: E131, CI Food Blue 5, Acid Blue 3, INS 131

Frequently Asked Questions about Patent Blue V

Current dataset status: FDA β€” Not approved in US; EFSA/EU β€” Approved in EU with ADI of 5 mg/kg bw/day (re-evaluated 2013). Reported concerns: Can cause allergic reactions including urticaria and anaphylaxis in rare cases. Used as a surgical dye for sentinel lymph node detection, where anaphylactic reactions have been documented (incidence ~1 in 2,000). Not approved for food use in the US, Australia, or Norway. EFSA re-evaluated in 2013 and maintained ADI. Regulatory status and individual risk are not the same; check the primary sources and permitted conditions of use.

Quick Facts

E-Number
E131
INS Number
131
Category
Colorings
Origin
Synthetic
FDA Status
Not approved in US
EFSA Status
Approved in EU with ADI of 5 mg/kg bw/day (re-evaluated 2013)
ADI
5 mg/kg bw/day
Dataset Review
2013
Ingredient-level Dietary Notes
Vegan: βœ… YesHalal: βœ… YesKosher: βœ… YesGluten-Free: βœ… Yes

Carriers, processing aids and product certification can change suitability. Verify the final label and certifier.

Disclaimer: This information is for educational purposes only and is not medical advice. Always consult a healthcare professional for health-related decisions.

Related Additives

Other colorings in the same family