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Chocolate Manufacturing Safety

GMPs for Cocoa & Chocolate

The industry is currently regulated by FDA
Good Manufacturing Practices , 21 CFR
Part 110
The manufacturing confectioner must be
aware of FDA , State , and local regulations
In addition to regulations , there are
guidance documents that require attention
GMP Components
Buildings and facilities
Equipment and utensils
Production and process controls
Warehousing and distribution
Defect action levels
Sanitation Standard Operating Procedures
Not currently mandated for cocoa or
chocolate processing
FDA requirements to establish HACCP
Required to be written
Apply to all areas of the manufacturing
environment and process control
Each plant must determine their controls
Quality Management System
The QMS will support food safety programs
Management commitment
Documentation control
Internal and external auditing
Corrective and preventative actions
Management Review process
Continuous improvement
Prerequisite Programs
Prerequisite programs underpin HACCP
PRPs cover all areas of GMPs
Facilities and equipment
Personnel and training
Raw materials and packaging control
Pest control
Additional PRPs
Microbiological control and environmental
Chemical control
Allergen Management Program
Foreign object control
Product labeling , traceability and recall
Receiving , storage and distribution
Focus on Primary Hazards
Microbiological : Salmonella ; assume all raw
cocoa beans are contaminated with pathogens
Chemical : food allergens , pesticides and heavy
metals ( lead ) ; level of hazards are typically
source specific , dependent on growing
conditions and regional agricultural practices
Physical : metal ; primarily a result of equipment
used for cocoa bean processing
Cover the Pipeline
Start with raw materials and follow them through
the process to the consumer ; from farm to fork
Conduct a risk assessment to understand where
the product and process are vulnerable to the
primary hazards
Control the areas of risk by Prerequisite
Programs or by a Critical Control Point , applying
Chocolate Pipeline
The chocolate pipeline begins in the origins
with the supply of cocoa beans
Cocoa beans present a variety of hazards
representing biological , chemical and
physical categories
The source of cocoa beans may determine
the level of pesticide risk
Supplier Assurance
A Prerequisite Program designed to verify a raw
material supplier will provide a product that meets
Difficult to conduct when a physical audit cannot
be performed ; prioritize for the most critical raw
Rely upon strong specifications , third party audits
and accurate information ; for example regulatory
websites for pesticides ( fda.gov and epa.gov )
Available in:
Supplier Management
Build in prevention via close interaction
with suppliers
Establish supplier approval protocols
Source only from approved suppliers
whenever possible
Implement a more stringent oversight
process when sourcing from a new
supplier or unapproved supplier
Supplier Audits
May be second or third party audits or both,
depending on risk of ingredient.
Conduct follow up audit to verify deficiencies have
been corrected.
Conduct audit (2
or 3
party) when testing
indicates there may be deficiencies in the
suppliers control programs.
Ensure auditor is knowledgeable about the
ingredient being provided by the supplier.
Supplier Certificates of Analysis
Require testing and COAs where
necessary and meaningful
Remember the limitations of testing
Supplier COAs should not be the sole
means of verifying compliance for high risk
or important ingredients
Cocoa Bean Specifications
General absence of harmful pesticides or
compliance to established regulatory limits
DALs for foreign materials ( rodent excreta )
Color and organoleptic quality
Chocolate Material Specs
Processed chocolate materials such as
liquor , cocoa powder and finished
chocolates should be expected to be
microbiologically safe , i.e.,Salmonella free
Heavy metals should comply to regulatory
limits , e.g., for lead
Pesticides must be in compliance
Unintended food allergens to be absent
Other Critical Ingredients
Milk products including milkfat
Peanuts and nut products
Emulsifiers such as soy lecithin
Natural flavors such as vanilla
Flour and baked products
Allergen Control Plan
Cross contact is sometimes considered
unavoidable ; for example with chocolate
Some equipment may be dedicated for
allergen control ; some may be shared
Some maintenance and cleaning tools /
equipment may need to be dedicated
Rework management is a critical component
of all Allergen Control Plans
Material Management
In addition to Specifications and Supplier
Assurance , raw materials and packaging items
require a Material Management Program
Source control ; use only approved vendors
Usage control ; shelf life management
Storage and process control ( batching )
Waste and rework conrol
Change management
Storage and Handling
Raw cocoa beans must be segregated from
areas of the plant that handle processed
Cocoa bean silos for large operations
Off site storage rooms / containers
Separate receiving docks and dedicated
unloading equipment
Isolated areas for sampling and testing
Process Areas
Controlled traffic patterns for movement of raw
cocoa beans to process equipment
Operator(s) dedicated to handling raw cocoa
beans ; not permitted to handle processed
products without change / disposal of clothing,
e.g., shoe coverings and effective hand washing
Physical barriers between raw cocoa bean
handling and processed products ; walls ,
partitions , air handling control ( neg. pressure )
Process Control
Control of the thermal process steps is critical to
Salmonella control ; all parameters of a validated heat
step must be maintained ; e.g. , belt speed , time ,
temperature , bed depth , chamber volumes
Control of cracking winnowing is critical to assure heavy
metals ( lead ) will be below regulatory limits in finished
chocolates ( excess shell will potentially result in higher
levels ) ; note that higher liquor content has increased risk
A strong Preventive Maintenance program will minimize
the generation of metal from ball mills and other process
equipment ; properly placed rare earth magnets and metal
detectors will assist in protecting finished products
Process Control
Once past the critical heat step , the
product must be protected from post
process contamination
Chocolate products are low moisture and
low water activity foods ; if pathogens
survive the heat treatment or if the product
is contaminated after the heat step , the
bacteria can persist well past the shelf life
of the products
Microbial Contamination
Risk assessment of the process facility must be
conducted to establish a food safety program ;
the HACCP approach is strongly suggested
Microbes require moisture for growth , so water
control is key to maintaining a pathogen free
Once contaminated , chocolate products cannot
be reprocessed to render them safe ; they must
be destroyed
HACCP for Milk
HACCP for Milk
Enforce a dry clean only policy ; keep water away
from all process environments and equipment
If water is required ( e.g. , glass breakage ) ,
shutdown the process , isolate the area during the
cleaning , and thoroughly dry the area /
equipment prior to start up
Conduct a thorough swab survey of the cleaned
area to confirm there is no spread of Salmonella
Environmental Sampling
Conduct regular environmental swabs for
Focus on areas around the barriers separating
raw cocoa beans and processed products ( dirty
vs. clean )
Sample around traffic patterns used for people
and equipment movement
Test air filters , and monitor the effectiveness of
air handling systems
Product Testing
Sample product after the process to verify control
of the critical kill step ; e.g., roaster , D-Bac , etc.
Sample finished products to verify all steps in
production are controlled
Control all product implicated by the product
sample , i.e., do not ship to customer during test
Maintain records of all product sampled and
tested to be able to quickly react to a positive
Lot Coding
Traceability must be in place for all raw materials
and packaging used in production
All intermediate products must be traceable ; e.g.,
any product pulled off line , and rework
Finished products must be code dated with a
designated lot number to be able to trace back
through the process and identify the raw materials
Code dates must be recorded to identify the
customers to which products were shipped
In the event that a hazardous contaminant
has been identified in finished product , a
recall plan must be enacted
A recall team should be in place to control
the recall process
The recall process should be regularly
challenged using mock recall drills
( recommended twice per year )
Sampling and Testing
Microbiological and chemical testing should be
done according to standardized methods , e.g.,
Sampling should be done to represent a focused
point in the process or the environment , or a
specific batch / lot of finished product
Approved laboratories must be used to conduct
analyses ; whether labs are internal or external
Regulatory requirements must be considered for
analytical testing and records of results