Due to today’s hectic lifestyles, bakeries are taking the place of preparing homemade baked goods for everyday meals, school functions, and special occasions. Baked goods may range from those prepared in manufacturing facilities and sold at retail stores to specialty baked items prepared and sold in the stores themselves. Both manufacturing facilities and bakery stores share common food safety challenges and require the proper design of food safety programs to minimize the risks inherent in bakery products and their production environment.

Food Safety Challenges of Baked Goods
There are several factors to consider when evaluating food safety risks in retail bakery products. First, product assortment and storage conditions must be understood. Generally, most bakery items have low water activity (aw), pH, and a validated kill step within the baking process, which will prevent the growth of microorganisms and enable safe storage at ambient temperatures. Some items, like custard/cream-filled pies/pastries, cheesecakes, and focaccia breads topped with cheese and fresh vegetables, need further evaluation to understand the food safety storage conditions, shelf life, and general food safety risks. For example, products with pH and aw above 4.6 and 0.85, respectively, may be considered time-temperature control for safety (TCS) products and will require shelf-stability validation through a microbial challenge study if ambient storage is desired.

Several bakery products have been implicated in foodborne illnesses involving Salmonella spp., Listeria monocytogenes, Staphylococcus aureus, and Bacillus cereus, so it is necessary to design food safety controls into products to prevent subsequent pathogen growth and toxin formation. Applying Hazard Analysis principles will help you understand the potential biological, chemical, and physical hazards in the product and in all steps of the production process, from raw material purchasing, production, distribution, and sale. Once the hazards are determined and risk level assessed, Critical Control Points and/or preventive controls can be developed, including the product formulation, processing, and storage/handling controls, to mitigate those risks; for example, preservatives/pH/aw in formulation, time/temperature of baking, and storage temperature/shelf life.

Safety Begins with Suppliers
Secondly, it is important to know your suppliers and to evaluate their food safety and quality programs. What are the hazards to be controlled in the raw materials they supply, the critical limits, and actions to be taken if a deviation occurs? Hazard Analysis and Critical Control Points and the Food Safety Modernization Act are examples of such preventive controls. Some other parameters to consider in evaluating the risk posed by your suppliers include:

•    Is the supplier certified against one of the audit schemes recognized by the Global Food Safety Initiative?

•    How does the supplier control foreign material in their manufacturing facility?

•    How are allergens controlled in their facility? For example, do they store allergens separately from other ingredients? Is there an allergen matrix/production sequencing schedule to prevent cross-contact of allergens during production? How are they ensuring adequate cleaning between allergen/allergen-free production runs?

•    Does the supplier have a system to ensure correct labels are in use at each product/label changeover?

Suppliers also need to evaluate the effectiveness of their cleaning and sanitation programs, be able to assess the overall microbial cleanliness of the manufacturing environment, and to monitor the production environment for pathogenic bacteria. Monitoring effectiveness of sanitation processes and procedures is essential to minimize the risk of product contamination by pathogens and/or spoilage microorganisms, especially in the postbaking environment.

Traceability of ingredients and finished product is critical within the supply chain. Batch sheets should record all lot codes of ingredients being used during the manufacturing process. This information should be stored in such a way that during a recall event, all impacted product containing the impacted ingredient/lot code can be identified accurately and in a timely manner. The most common reason for recalls in the bakery is undeclared allergens. Having a reliable allergen control program within the manufacturing plant, as well as ensuring that your suppliers have an adequate allergen control program, can help prevent recalls.

Knowing your supply chain is important. Procedures need to be in place to guarantee that product safety is maintained during storage and transportation. Some questions to ask are: Is the product temperature being maintained? Is the product being transported in a clean vehicle? Are there any signs of dirt, pests, damage, or moisture? Has the load been properly secured to avoid tampering?

Knowing the specific food safety needs of each product and ensuring each step is traceable—from ingredient selection and production through the supply chain to the retail bakery and consumer—are key to an effective retail bakery food safety program.

Proper Labeling for Consumer Safety
Once production of the items is complete, it’s time to package them for sale. Manufactured items need to have accurate label information. The primary purpose of food labels is to inform the consumer regarding nutrition, ingredients, claims, or allergen information. When foods are labeled incorrectly, or an allergen warning is not properly declared, this can make a food product dangerous to sell to certain sensitive individuals. Improperly labeled food can cause someone to become ill and/or trigger a costly recall of your bakery products.

While you might not always be able to provide nutritional information on a label of your bakery product due to the size of the label or variations in a specially created product, providing an accurate list of all ingredients is vital. To provide a list of ingredients to the consumer, it is important to know the makeup of the components going into your product. In retail bakeries, providing standard recipes or product builds is key. This not only drives some consistency when making the product, but it also ensures the proper ingredients are used. Once all the ingredients that make up a product are identified, it is easy to combine them and list them on a food label.  

Beyond the basic labeling requirements of ingredients, nutritional, and allergen information, manufacturers may choose to make claims highlighting product attributes. There are many examples of claims in the marketplace today. Examples include, but are not limited to, nutrient content and ingredient attribute claims. Some common claims found on bakery products are “low fat,” “0 grams of trans fat,” “organic,” and “no genetically modified organisms.” If a manufacturer chooses to make a product claim, documentation is needed for substantiation. In addition to documentation, manufacturers need to ensure the claim is truthful and not misleading. State and federal regulatory agencies scrutinize product labels and may collect samples to monitor accuracy. Enforcement action can be taken against the manufacturer if product claims or other label information is not accurate or within specified tolerances. Some of the risks of noncompliance are consumer illness, product recalls, lost consumer faith, agency warning letters, increased regulatory surveillance, and consumer litigation.

When it comes to claims, growing in demand on baked goods are “allergen-free” claims or “gluten-free” claims. More frequently, schools are requesting that students bring treats that are “peanut free” or “nut free.” Substantiating these claims comes at a high risk. While gluten is not one of the eight major allergens, “gluten free” is one of the only “free from” claims that has been defined by the U.S. Food and Drug Administration (FDA) with established testing thresholds. In general, allergen-free claims are unregulated, and there is no standard across the industry.

Once all the ingredients in the product have been identified, you can determine what allergens need to be declared on the label. The Food Allergen Labeling and Consumer Protection Act of 2004 requires food manufacturers to label food products that contain an ingredient that is, or contains, protein from a major food allergen in one of two ways:

The first option for food manufacturers is to include the name of the food source in parentheses following the common or usual name of the major food allergen in the list of ingredients. This can be done in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement. For instance, Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), sugar, hydrogenated soybean oil, and/or cottonseed oil, whey (milk), eggs, vanilla, natural and artificial flavoring, salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono- and diglycerides (emulsifier).

The second option is to place the word “Contains,” followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients. For instance, Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), sugar, hydrogenated soybean oil, and/or cottonseed oil, whey, eggs, vanilla, natural and artificial flavorings, salt, leavening (sodium acid pyrophosphate, monocalcium phosphate). Contains Wheat, Egg, and Milk.

The FDA food allergen labeling policy does not require that labels have a supplemental allergen statement, such as a “may contain” statement, although they are common within the bakery industry due to the nature of the bakery environment in which common manufacturing lines are used throughout the production day. While supplemental allergen statements can be helpful for the consumer, this type of labeling should not substitute for Good Manufacturing Practices (GMPs). They should be considered only if the presence of a major food allergen is unavoidable even when current GMPs are followed.

Nutritional information, ingredient lists, claims, or allergen information may be provided to the consumer in other formats that supplement regulatory labeling requirements, for instance, supplemental in-store information provided at the point of sale or access to this information on websites. Food product information provided on your company website is viewed as an extension of the label and falls under the same jurisdiction as the physical labels themselves. Consequently, it is important to provide accurate information especially around ingredients, nutritional, and allergen information.

Shelf-Life Testing/Challenge Studies for Safety and Quality
Most finished products in a bakery setting are able to be stored and sold under ambient conditions. While many bakery assortments do not require refrigeration, consideration should be taken when temperature-sensitive ingredients are used in the production of an item. You should think about the number of refrigeration units that will be needed for storage and display of goods, as well as temperature regulation devices for the equipment.

Whether it is a TCS ingredient or finished product, both the temperature and shelf life need to be controlled for safety from pathogens. This includes having the proper study design to evaluate risk, temperature control monitoring devices, and appropriate protocols and procedures for production, transport, storage, and display.

Conducting shelf-life studies of all items being produced in the bakery is integral, not only from a safety perspective for nonambient items but also from a quality perspective. Due to the low aw of many bakery items, the most common indicator of shelf life is mold growth. By conducting shelf-life studies on your products, you can determine how long after production the items can be stored before they exhibit mold growth. Based on the amount of time you want the consumer to store the item before this happens, these studies will determine the “best by” date(s) for the item.

For items that have a complex interface, challenge studies should always be considered, especially if these items will be marketed at ambient temperatures. Additions of toppings and particulate ingredients to bakery items change the aw, and this new, finished product state needs to be considered. Fruit and vegetable toppings, cheese, chocolate, and meats all change the water activity level of a finished bakery product.

Conducting a challenge study with an accredited laboratory is essential to ensure that products are not potentially hazardous. Challenge studies are conducted by inoculating a finished food item with any potential pathogens that could grow at the product’s pH and aw. Once the choice is made for the organisms that will be tested, the item is inoculated and the bacteria are given the opportunity to grow.

Comparing results with an uninoculated sample, the outcomes of growth levels and where a spike or unsafe level occurs become the pass/fail of the challenge study results. It is not enough to simply test the item at one interface. It is critical when testing to ensure all interfaces of the product are challenged. An example of item interfaces that would need inoculation for a lemon meringue pie would be the crust, where the crust meets the lemon filling, and where the filling meets the meringue pie topping.

While bakery products are typically viewed as low risk in terms of pathogens, recent contamination events have illustrated the importance of conducting a thorough risk assessment of all bakery products where the potential for a TCS hazardous food could occur.

Sanitation Basics
Sanitation in bakery settings can be quite challenging. Since the environment in bakeries faces constant dust buildup of flour and other dry ingredients, adding liquid cleaners to this environment can be precarious. Furthermore, adding water to the environment can cause harborage sites for formation of pathogens, such as Salmonella, which is inherent in raw flour. The recent Escherichia coli O121 and O26 recalls on flour have added further concerns to the possible pathogens that are present in a bakery environment.

Many bakeries have historically relied on dusting, scraping, and spot cleaning to clean equipment. However, all equipment in the bakery needs to have a thorough inspection and risk assessment performed to understand if the equipment poses a risk to the overall function of the facility. If the food contact areas of the equipment can’t be disassembled and cleaned, replacement of antiquated equipment should be considered. Newer bakery equipment should be designed according to sanitary design specifications to allow belts, formers, slicers, and scoring equipment to be properly disassembled and cleaned.

Wet washrooms where bowls, bins, containers, and pans are cleaned can also pose a hazard to the bakery environment. These areas need to be enclosed with adequate ventilation to prevent the aerosolization of mist/spray into or onto the production line. These areas also need extra monitoring and diligence to ensure harborage sites and pathogens are not present.

It is important to partner with a chemical supplier that can help develop an adequate chemical sanitation program for the facility. These partners are instrumental in recommendations for cleaning and sanitation chemicals that are effective in the bakery setting. Furthermore, their expertise can be utilized to train staff on monitoring the limits of these chemicals and the steps to take when these chemicals fall outside the established limits. Based on the chemicals identified for use in your facility, your chemical vendor can help you establish what the optimal water temperature is to ensure efficacy of detergents and sanitizers.

Food Safety Basics for Employees
All bakery employees should be taught the basics of food safety and their role in producing safe food. Especially, they should be taught why their behaviors are needed to keep food safe, in addition to being taught how and when to perform their required tasks. Teaching employees why a behavior is important ensures that they continue to make good food safety decisions when unsupervised. Supervisors should be diligent in rewarding employees practicing good food safety behaviors and coaching employees whose behaviors do not meet expectations.

Practicing proper employee health and hygiene requirements is key to food safety success. Employees cannot work while ill and need to regularly wash their hands thoroughly. Wearing hair restraints and not wearing jewelry help keep physical contaminants out of products. Wearing gloves to prevent bare-hand contact and wearing clean uniforms help prevent cross-contamination of bacteria or allergens.

With common bakery ingredients including eggs, milk, peanuts, tree nuts, and wheat (five of the major eight allergens), allergen management is key. While labeling and signage, mentioned above, are necessary elements of an allergen food safety program, bakeries might also:

•    Segregate ingredients by storing allergens below and separate from other

•    Produce products working from those containing the least amount of allergens to the most allergens, with thorough cleaning and sanitization steps in between

•    Use separate equipment such as pans, knives, and cutting boards that are color coded to indicate which allergen they are to be used with

•    Ensure that employees know how to effectively use, clean, and store equipment

In any event, it is important to train employees to know the eight major allergens, symptoms of an allergic reaction, and what to do in response to a customer having an allergic reaction. It is important that employees understand that there is always a risk of cross-contact within a bakery setting and that they need to remain vigilant to minimize these risks.

Whether it is proper equipment use, health and hygiene practices, allergen control, proper cleaning, reduction of cross-contamination, proper labeling, or any other food safety basic, it is essential that employees understand and follow good food safety practices at all times.

Bakery food safety programs minimize the risk of bacterial, physical, and chemical contaminants in the final bakery products. Working with suppliers that have good food safety programs and perform risk assessments on the products being sold is a foundational element of any bakery food safety program. Designing and conducting shelf-life and challenge studies with a reputable laboratory determine appropriate shelf-life, storage, and production practices for TCS products. Proper labeling and signage of ingredients, nutritional, and allergen information help guide customers in choosing the best products for their health and well-being. Employees that understand the basics of food safety principles, and practice them in their daily behaviors, help ensure the safety of the baked goods produced. When combined, these program elements will provide safe, high-quality products for your bakery customers.   

Patricia Marden, B.Sc., is a food safety scientist at Target, specializing in vendor management.
Jennifer Forester, B.Sc., M.Ed., is a nutrition, labeling, and regulatory compliance scientist at Target. 
Becky Swayne, B.Sc., is a recall program lead at Target.
Sadie Pulk, M.A., M.B.A., REHS, is a senior business partner in the food safety division of Target.  
Ann Marie McNamara, Ph.D., is the vice president of Target’s foods and essentials safety and quality assurance division.

All authors of this article are members of Target’s foods and essentials safety and quality assurance division. This division is responsible for the food safety and regulatory compliance programs of over 1,800 stores, distribution centers, vendors, labeling, data management, and regulatory compliance activities.