Low- and Non-Alcoholic Beers: The Role of a Process Authority and Testing Considerations
by: Martha Kimber, M.S.
The demand for low- and non-alcoholic beverages is booming, driven by evolving consumer preferences for healthier, more mindful drinking options. But behind this innovation lies a complex challenge: without alcohol’s natural antimicrobial properties, these beverages face a higher risk of spoilage and contamination. Ensuring product safety, shelf stability, and regulatory compliance requires more than careful brewing—it calls for the expertise of a qualified process authority. Here is a look at the key risks, essential testing protocols, and proven strategies to keep your low- and no-alcohol products safe, high-quality, and market-ready.
Understanding the Risks for Low-Alcohol and NA Beers
Developing low-alcohol and NA beers introduces several microbiological challenges:
- Reduced Microbial Hurdles: Ethanol is the primary antimicrobial agent in traditional beers. To produce low-alcohol and NA beers, the ethanol content is either eliminated or severely reduced, thereby removing an important microbial hurdle. Additionally, some low-alcohol and NA beers may lack hop bittering compounds, depending upon their formulation. Hops are a common ingredient in traditional beers and are known for their antimicrobial activity, and when eliminated or added at lower levels another microbial hurdle is diminished.
- More Favorable Environment: In many cases, the fermentation process in the production of low-alcohol or NA beers may be abbreviated or skipped altogether. This often results in higher residual levels of fermentable sugars in the product and potentially a higher product pH compared to traditional alcoholic beer products, creating a more favorable environment allowing for the growth of microorganisms.
- Unusual Ingredients: New recipes may include unique ingredients that introduce microorganisms to the batch and increase spoilage risks.
- Inadequate Processes: Thermal techniques acceptable for traditional beers may not be suitable for thermal processing of lower alcohol variants.
For these reasons, evaluating product formulations and implementing proper preservation methods, considering thermal pasteurization, sterile filtration, and the use of preservatives, is essential.
Regulatory Concerns of the Low- and Non-Alcoholic Brewer
All breweries that qualify as a food manufacturing facility under FDA regulations (most breweries, with some exceptions) must comply with subparts A, B, D, E, and F of 21 CFR 117, including current GMPs and recordkeeping requirements1. In addition, if the brewery’s NA beverage production (<0.5% alcohol by volume) makes up more than 5% of gross revenue, then the brewery must comply with all aspects of 21 CFR 117, including Hazard Analysis and Risk-Based Preventive Controls (subpart C) and Supply Chain Program requirements (subpart G). As part of these requirements, NA beers must have a food safety plan that identifies and addresses any microbiological hazards, making the support of a process authority an integral part of production.
Key Pathogens and Spoilage Organisms
When producing low-alcohol and NA beers, controlling both pathogens and spoilage organisms is critical for safety and quality. Below is a description of pathogenic and spoilage organisms that are relevant to this beverage category and which a process authority must consider when designing an appropriate scheduled process for a product.
Pathogens
Acid-tolerant bacteria like Escherichia coli O157:H7, Listeria monocytogenes, and Salmonella have a low infectious dose and can survive for extended periods in acidic environments, potentially causing illness even if they are not capable of growing. Therefore, they must be addressed with a minimum 5-log reduction. Established thermal processes from the FDA, or other available literature sources, can be applied to beverages to target these pathogens.
Spoilage Organisms
Fermentative and oxidative yeasts are a significant concern due to their ability to grow under carbonated/anaerobic conditions at relatively low pH. Some yeast are capable of forming ascospores and demonstrate relatively high heat resistance compared to other spoilage organisms. Lactic acid bacteria are also a concern as they are capable of growth in anaerobic conditions at relatively low pH. Thermal processing or additional hurdles like preservatives or sterile filtration can help mitigate spoilage risks.
The Role of a Process Authority
A process authority is a qualified expert or team of experts who works to assess and validate that your product is microbiologically safe and meets regulatory requirements. Their responsibilities include:
- Assessing product formulations to prevent microbial growth or survival.
- Evaluating processing technologies for their effectiveness in killing microorganisms.
- Providing regulatory guidance and facilitating interactions with regulatory bodies like the Food and Drug Administration (FDA).
Getting Started with a Process Authority
To work effectively with a process authority, you will need to provide detailed information about your product formulation and processing capabilities, such as:
- Product Formulation:
- pH, IBU, Brix, ABV, carbonation level
- Ingredient percentages within formulation and additional information about quality specifications of any high-risk ingredients, such as fresh juices or powders
- Processing Capabilities:
- Description of production steps
- Description of processing equipment, if applicable (flash pasteurizer, tunnel pasteurizer, kettle cook, etc.)
- Details on all batching steps to identify potential spoilage risks
- Filling and Packaging:
- Sterilization methods (aseptic, hot-fill-hold, ambient)
- Packaging type, finished product storage conditions (shelf-stable or refrigerated), and anticipated shelf life
Deliverables from a Process Authority
After this information is gathered, the process authority can start designing a “scheduled process” that is specific to your product formulation and processing parameters. The scheduled process authority letter will summarize details such as:
- Product formulation
- Procedures to prepare the product
- Processing method
- Critical factors for product and process, based upon existing published literature or laboratory studies
Testing Considerations to Validate and Verify your Product and Process
Process Validation Studies
Validation studies are particularly valuable when the proposed thermal process is less stringent than those recommended in the published literature or when a novel process is being introduced. These types of studies can be conducted either in a laboratory benchtop setting or onsite at the production facility where the primary objective is to determine whether a specific process can achieve the desired reduction of relevant microorganisms. Validation studies are especially beneficial for breweries with specific goals related to product quality, packaging requirements, or carbonation levels, all of which may necessitate less severe thermal processes.
Inoculated Challenge Studies
Breweries often explore the use of preservatives as a hurdle to control pathogenic and spoilage microorganisms in low-alcohol and NA beers. The gold standard for evaluating preservative efficacy is conducting inoculated challenge studies. In these studies, microorganisms are intentionally introduced into the product, in a laboratory setting, and then stored under specific conditions. By assessing microbial growth, survival, or inactivation over time, these studies help determine whether the product formulation effectively mitigates microbial risks. Challenge studies are particularly valuable for evaluating the effectiveness of natural preservatives against vegetative pathogens or ensuring microbial stability during storage.
The Importance of Routine Testing for Finished Products
Routine testing of finished products is a critical step in ensuring the quality, safety, and consistency of low-alcohol and NA beers. Regular monitoring includes testing for the presence of spoilage organisms, which helps verify that processing controls are operating as expected and confirms that contamination did not occur during production. Additionally, key parameters such as pH, alcohol content, and carbonation levels are measured to ensure that each batch meets the specified standards and aligns with product expectations. These tests not only safeguard product quality but also serve as a valuable tool to confirm that the brewing and packaging processes are functioning as intended. Implementing a robust routine testing program provides breweries with the data needed to maintain regulatory compliance, uphold brand integrity, and ensure consumer satisfaction.
Takeaways
To ensure the microbiological safety of low-alcohol and NA beers, a well-defined strategy is essential:
- Work with an experienced process authority to develop an appropriate thermal process based on FDA guidance or published scientific literature.
- In lieu of published literature, conduct challenge studies or process validations specific to your product/process to confirm that your product formulation and process meet your performance criteria.
- Use a trusted lab partner for routine testing of your finished product batches.
If you are ready to bring your low-alcohol or NA beer to market, expert microbiology labs like Eurofins offer tailored solutions, including process validation and regulatory guidance. With decades of experience, they can help ensure your product is safe, stable, and ready for distribution.
For more information or specific testing needs,
References
- Leinhart, P., Radke, B., Riccio, Z., Torres, L., & Walker, J. (2022). Non-Alcohol Beer: A Review and Key Considerations. Brewers Association Educational Publications: Boulder, CO USA.
- Office of Food Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 2016. Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry. Appendix 3, Table 3-D.
