# Presentation: 203951

## Allergensand the Confectionery Industry

- Alison Bodor
- Vice President Regulatory and Scientific Affairs

## National Confectioners Association

- Over 300 manufacturing confectionery company members
- Interest in allergens for past 15 years
- Participant in Food Allergy Issues Alliance
- Goal is to best protect the consumer

## Topics to Cover

- Industry Overview
- Circumstances that influence use of advisory labeling
- Guidance for industry
- Relevance of company size
- Unique challenges

## Industry Overview

## Major Food Allergens used in candy

- Peanuts
- Milk
- Eggs
- Soy (lecithin)
- Wheat
- Fish (gelatin, omega-3 fa)

- Almonds
- Walnuts
- Macadamia Nuts
- Pecans
- Cashews
- Hazelnuts
- Pistachios
- Coconut

## What manufacturing circumstances prompt manufacturers to place advisory statements on a food label? 

## Influencing Factors

- Ingredient procurement
- Physical characteristics of allergen
- Manufacturing one or more allergens in the same facility
- Manufacturing one or more allergens on the same equipment
- Chocolate GMPs

## Particulate Matter vsReadily Dispersible Proteins

- _Particulate_
- Peanuts, Tree nuts
- Particulate matter gets caught in equipment
- No certainty of cleaning technique, testing not appropriate
- Risk of significant quantity of protein reaching consumer in small serving

- _Dispersible Proteins_
- Milk, whey, soy, egg, etc
- Residual levels affected by type of candy, time, equipment
- Bound by chocolate; impossible to rid from some systems

## Shared Facility

- Very few candy companies in the industry have dedicated facilities that isolate allergens
- Many allergens often used in same facility
- Barriers to cross contact not foolproof
- Risk of human error, even with employee education and allergen control plans in place

**Dedicated facility is not a realistic expectation****.**

## Shared Equipment

- Most confectioners use the same equipment to produce many different candies
- Constraints include space, cost, efficiencies
- Those who use shared equipment have an allergen clean-up strategy and are more likely to use advisory labeling.

**Dedicated equipment is not a realistic expectation****.**

## Unavoidable Cross-contact:

- Inaccessible Equipment
- Equipment not intended to be dismantled.
- Many systems or components of systems are closed
- Shared equipment that cannot be wet cleaned
- For chocolate operations, carbon steel equipment often used. Can be corrosive with water system.

**Difficult to achieve certainty**
**that allergens are eliminated. **

## Chocolate

- Manufacturing in a Dry Environment

## Water and Pathogens

- Chocolate is very viscous and adheres in thick layers to machinery, pipes
- Flushing is very difficult
- Chocolate + water = stiffness
- These pockets of water can foster microbial growth
- Cannot guarantee dryness in system

**Basic GMP principle:**
**Avoid water-cleaning systems for most *****chocolate***** equipment**

**Notes:**
The uptake of moisture in chocolate can make the product unusable.  Chocolate and moisture do not mix.  A long standing practice with chocolate manufacturers is that all possible precautions are taken to prevent moisture from getting into the chocolate processing system.  Dry cleaning is typically used in many areas of a chocolate plant.  Even a trace amount of water will go directly to the sugar particles, form a microscopic syrup film, and cause the chocolate to seize up in a consistency like fudge. In manufacturing, there is a great risk of pockets of wet product to adhere to the inside of piping or tanks causing growth niches for mold and bacteria.

## Dry Clean and Flush

- _Dry Clean_
- Depends on accessibility of equipment
- Extremely labor intensive
- Not able to rid many systems of allergen proteins

- _Flush_
- Chocolate clings to pipes
- Flushed chocolate must be reworked. Introduces new risk.
- Does not eliminate risk of allergen protein.
- Does not eliminate need for advisory labeling.

## Mixing and Pre-refining Room

## Liquid Phase Conching

## Chocolate Feed to Enrober

## Typical Points of Cross Contact:Chocolate and Other Confections

- Ingredient feed systems, pipes
- Conveyors, tunnels
- Mixing Equipment
- Release agent reservoirs
- Tempering units
- Depositors
- Vacuum cook kettles

- Cutting equipment
- Wire belts
- Rework vessels, grinders
- Enrobers
- Extruders
- Panners
- Utensils, gloves, clothes
- Wrapping equipment

## Ingredient Procurement

- Reliance on operations of suppliers
- Carry-forward principle for labeling, if verified
- Multiple peanuts and tree nuts processed by same suppliers
- Dark chocolate with milk protein

## Testing

- Use visual inspection and analytical testing to facilitate the design of the clean-up procedure
- Used to validate a sanitation procedure
- Doesn’t measure “hung-up” product that can later dislodge
- Cannot guarantee safety
- Need analytical methods for some allergens and validation of other methods.
- Industry needs FDA to establish thresholds

## Guidance for Industry:Advisory Allergen Labeling

## Food Allergen Issues Alliance Labeling Guidelines

- Recommend using advisory statements for unavoidable cross contact when all of the following exist:
- Allergen presence is documented - visual, analytical, etc.
- Risk is unavoidable even when current GMPs followed
- Allergen present in some, but not all, products
- Presence is potentially hazardous

## Relevance of Company Size

- Similar proportion of shared facilities and shared manufacturing lines
- Labeling criteria and considerations of small companies similar to medium and large companies
- Frequency of advisory labeling is similar, based on limited NCA survey data
- Small companies possibly less likely to document presence of allergen via analytical or visual testing
- Issue of resources, expertise?

**Small companies ****	****= 100 employees or less**
**Medium companies ****	****= 101 to 500 employees**
**Large companies ****	****= 500 to 1000+ employees**

## Additional “Alliance” Guidelines:

- Advisory statements should be accurate and conspicuous.
- Advisory statements should be placed at the end of, or in close proximity to, the ingredient declaration.
- When using an ingredient that utilizes an advisory statement, the food processor should carry that statement forward to the label of its food, when risk verified.
- Food processors should strive to label the same product consistently, even if produced in different locations or in different package sizes.

**Candy companies support...**

## Typical Common Advisory Label Approaches for Confectionery

- May contain X. (or May contain traces of X.)
- Manufactured on equipment that also processes X.
- Manufactured in a facility that processes X.

## What do advisory statementson candy mean?

- No confectionery industry agreement on levels of risk associated with different statements
- An advisory statement is intended to indicate **risk** to the allergic consumer
- An advisory statement -of any kind- means that allergic consumers should not eat the product.

## Challenges

- Is it possible to convey a level of risk to the consumer?
- Industry needs FDA to establish thresholds/action levels.
- How do we communicate risk of a particulate allergen?
- Need to account for variability in allergen levels, depending on allergen characteristic, processing system and sanitation capabilities.
- Companies will err on the side of over protecting the consumer.

## Additional Confectionery Concerns

- Label carryover from ingredient suppliers
- Chocolate with milk or nut proteins
- Peanuts and tree nuts are often processed in same facility
- Limited label space / smaller formats
- Recommend same labeling for brand manufactured in different plants regardless of manufacturing conditions and size variations.

## Summary:

- Advisory labeling is important tool that confectionery manufacturers use to help allergic consumers make an informed choice.