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 Personnel Buildings and facilities Equipment and utensils Production and process controls Warehousing and distribution Defect action levels SSOPs 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 Sanitation Pest control Additional PRPs Microbiological control and environmental monitoring 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 HACCP 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 specifications Difficult to conduct when a physical audit cannot be performed ; prioritize for the most critical raw materials Rely upon strong specifications , third party audits and accurate information ; for example regulatory websites for pesticides ( fda.gov and epa.gov ) English Spanish Mandarin French Russian http://www.gmaonline.org/publications/index.cfm 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 nd or 3 rd 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 Moisture Mold Infestation 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 processes 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 products 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 environment Once contaminated , chocolate products cannot be reprocessed to render them safe ; they must be destroyed HACCP for Milk Chocolate HACCP for Milk Chocolate Sanitation 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 Salmonella 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 result 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 used Code dates must be recorded to identify the customers to which products were shipped Recall 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., BAM , AOAC 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 Questions