✓ Safety Confirmed: The EFSA’s 2017 comprehensive safety re-evaluation established an ADI of 25 mg/kg body weight per day for E476—a 3-fold increase from the previous ADI. Regulatory authorities concluded E476 is safe at permitted uses and levels. The compound has been extensively studied since the 1950s with no safety concerns identified.

The EFSA’s 2017 Comprehensive Safety Re-evaluation

The European Food Safety Authority’s thorough 2017 re-evaluation provides authoritative reassurance about E476’s safety.

Key findings:

– Safe at permitted uses and levels – No safety concern identified
– ADI increased to 25 mg/kg body weight per day (from previous 7.5 mg/kg)
– NOAEL: 2,500 mg/kg body weight per day – No observed adverse effect level from animal studies
– No carcinogenic effects – Animal studies found no carcinogenicity
– Metabolism: E476 metabolizes to free polyglycerols and ricinoleic acid, which are safe
– Ricinoleic acid: Safe as an edible oil; not of toxicological concern
– No metabolic interference: No evidence of interference with normal fat metabolism
– Digestion: Approximately 98% digested by animals, utilized as energy source

Safety Studies and Toxicity Data

E476 has been extensively studied since the 1950s with consistently reassuring results.

Acute toxicity: Low acute oral toxicity. Animal studies show E476 is tolerated at high doses without adverse effects.

Long-term toxicity: A 1998 comprehensive review of studies from the late 1950s and early 1960s concluded that “PGPR does not constitute a human health hazard.”

Carcinogenicity: A 1998 study found no carcinogenic effects when 120 rats were fed for 2 years and 50 mice for 80 weeks with diets containing 5% E476—an extremely high dose.

Organ weight changes: At very high doses, increased kidney and liver weights were observed in animal studies. However, EFSA determined these were adaptations to increased consumption levels, not toxic effects.

How E476 Is Made

E476 is synthesized through a multi-step chemical process combining glycerol and castor oil components.

Manufacturing process:

1. Polyglycerol production: Glycerol is heated to above 200°C in a reactor in the presence of an alkaline catalyst to create polyglycerol
2. Fatty acid preparation: Castor oil fatty acids are separately heated to above 200°C to create interesterified ricinoleic fatty acids
3. Combination: The polyglycerol and interesterified ricinoleic fatty acids are mixed to create PGPR
4. Result: A semisynthetic emulsifier combining glycerol (from plant sources or animal sources) with castor oil components

Potential Side Effects

At approved food use levels, no adverse effects are documented.

E476 is safe for consumption. Regulatory agencies have identified no toxic endpoints at food-use levels. The compound is well-digested (98% in animal studies) and utilized as an energy source.

Rare allergic reactions have been theoretically possible but are extremely rare in practice. General population consumption occurs without documented health concerns.

Important note: The EFSA noted that studies on other emulsifiers have observed potential issues such as changes in gut bacterial communities and increased intestinal inflammation risk. However, these specific findings have not been confirmed for E476 itself and are areas of ongoing research for the broader emulsifier class.

Vegan, Vegetarian, and Dietary Status

E476 status depends on its source of glycerol:

– Vegan-friendly: Usually yes, when derived from plant-based glycerol and castor oil (no animal products in manufacturing)
– Vegetarian: Usually yes, when sourced from plants
– Exception: Glycerol can alternatively be sourced from animal fats/oils; vegetarians should verify source
– Gluten-free: Yes, complies with FDA gluten-free definition
– Halal: Yes, complies with Muslim dietary policy
– Kosher: Yes, certified as kosher pareve
– Natural: No, semisynthetic; made from chemical combination of glycerol and fatty acids

Approved Use Levels

E476 is approved at specific maximum levels depending on food category:

– Chocolate and cocoa products: 0.5% (5,000 mg/kg)
– Chocolate coatings: 0.5% (5,000 mg/kg)
– Cocoa-based confectionery: 5,000 mg/kg
– Spreads and margarine: 4,000 mg/kg
– Salad dressings: 4,000 mg/kg
– Emulsified sauces: 4,000 mg/kg
– Baked goods: Varies by category
– Ice cream (via chocolate coating): ~750 mg/kg assumed level

These levels are carefully controlled to ensure both efficacy and safety.

Where You Might Find It (Not Always Labeled)

An important note: E476 is sometimes used in food production in ways not always visible on labels.

According to regulatory sources, E476 is used as an adjuvant in the food industry to protect chocolate and cakes from mold during production. In these cases, the emulsifier may not need to be declared on the label, depending on regulatory jurisdiction.

Additionally, E476 serves as an ingredient in other food additives, particularly in food colorings like curcumin (E100), cochineal (E120), and anthocyanins (E163).

Regulatory Approval Across Regions

E476 is approved for use virtually worldwide:

– United States (FDA): Generally Recognized as Safe (GRAS) at ≤0.3% in chocolate products
– European Union (EFSA): Authorized food additive per Commission Regulation (EU) No 231/2012
– International (JECFA): FAO/WHO approved as emulsifier
– Australia/New Zealand: Approved with code number 476
– United Kingdom (FSA): Categorized as emulsifier, stabilizer, thickener, and gelling agent

This near-universal approval reflects confidence in its safety and efficacy.

Recent Regulatory Updates

In 2022, the EFSA issued a follow-up assessment addressing additional data gaps identified in the 2017 re-evaluation.

The Panel on Food Additives and Flavouring concluded that:

– Proposed extension of use in edible ices would not give rise to safety concern
– Revision of maximum levels in emulsified sauces is acceptable
– Impurity limits for toxic elements (arsenic, lead, mercury, cadmium) should be lowered based on actual commercial levels
– New specification requirements for purity to prevent glycidyl esters and 3-monochloropropanediol contamination

Overall, the regulatory trend is toward confirmed safety at current and proposed use levels.

Comparison with Similar Emulsifiers

E476 is part of a family of polyglycerol ester emulsifiers:

– E475: Polyglycerol esters of fatty acids (PGE)
– E476: Polyglycerol polyricinoleate (PGPR) ← This product
– E477: Propane-1,2-diol esters of fatty acids

All three are approved by EFSA and FDA when used within regulated limits. E476 is distinguished by its specific use of ricinoleic acid from castor oil.

The Bottom Line

E476 (polyglycerol polyricinoleate or PGPR) is a semisynthetic emulsifier made from glycerol and castor oil fatty acids, used primarily in chocolate to improve flow and reduce cocoa butter requirements.

It allows chocolate manufacturers to maintain quality while reducing costs, making it economically valuable for the industry.

Regulatory authorities worldwide (FDA, EFSA, JECFA) classify E476 as safe for food use at approved levels.

The EFSA’s 2017 comprehensive safety re-evaluation found it “even more harmless than previously assumed,” leading to a 3-fold increase in the Acceptable Daily Intake (ADI) from 7.5 to 25 mg/kg body weight per day.

Extensive toxicological studies dating back to the 1950s have identified no safety concerns. The compound is well-digested and utilized as an energy source by the body.

At food-use levels, no adverse effects are documented.

E476 is typically plant-derived and vegan-friendly (when sourced from plant-based glycerol), and is gluten-free, halal, and kosher.

Most people eating chocolate and confectionery products regularly consume E476 without any documented health concerns.

As always, food labels must declare E476 when used as a direct food additive, enabling informed consumer choice.