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What is a Batch Number and Why Does it Matter for Product Labeling?

Thousands of businesses all over the world rely on batch numbers and batch management to handle and track their products as they move through different stages of the production and distribution process. Let’s discuss batch numbers, the type of information they include, why they’re important, best practices, and how you can add them to labels.

Understanding Batch Numbers

According to the FDA’s Code of Federal Regulations, a product batch number is a distinct combination of numbers, letters and symbols detailing a product’s manufacturing, processing, and distribution history.

With batch numbers, you assign a code to a group of products that were manufactured together during a single production run.The data in a batch number allows manufacturers and distributors to keep track of products as they move through the supply chain.

Information That Batch Numbers Typically Include

Your batch number should contain information that allows distributors and manufacturers to uniquely identify products in one production run. That means each code needs to include information like:

Manufacturing Date: When was the product manufactured? Most batch numbers use the Julian Date format, which is written as YYDD. This helps you trace when the product was manufactured, which is important to know during recalls.
Production Time: Some industries, like the food and beverage industry, mention the production time in batch numbers. This detail allows them to maintain better quality control while managing shelf life and expiration dates.
Location: Companies that have different production sites commonly include the location in batch numbers. Adding this information allows precise traceability for product batches at different stages of the manufacturing process.
Product Code: Batch numbers often include a product code, which corresponds to a specific Stock Keeping Unit (SKU). It helps distributors distinguish between different product varieties and types, such as regular and sugar-free versions.
Serial Number: In industries where several batches are made in a single day, serial numbers are added to batch numbers. It helps manufacturers and distributors distinguish batches produced on the same day or during the same shift.
Expiration Date Or Shelf Life Code: Batch numbers in some industries like cosmetics and food and beverage often include codes for shelf-life and expiration dates.

Why Batch Numbers Matter For Labeling Products

So, why add batch numbers to your product labels? The ISO 9001:2015 lays out best practices for traceability. It requires businesses to use batch numbers to track products and ensure quality control across different production stages.

Here are some of the reasons to use batch numbers:

Improves Traceability

When you’re adding batch numbers to product labels, you get precise traceability for your products. You can trace the lifecycle of an entire batch from manufacturing and processing to distribution and store shelves.

Ensures Regulatory Compliance

When you operate in an industry that’s exposed to strict regulations, such as food and pharmaceuticals, you need precise record-keeping. Not to mention, regulatory bodies like the FDA require batch numbers for food products, beverages, infant formula, and pharmaceuticals.

Allows Better Inventory Management

Your business can keep an accurate track of current inventory and anticipate demand. This reduces the risk of stockouts or overstocking.

Efficient Product Recalls

In the event of defects or safety concerns, your business can quickly identify the issue affecting a specific batch. You’ll be able to implement recalls much faster.

Best Practices For Batch Number Placement And Printing

Regulations surrounding the placement and printing of batch numbers can depend on your industry. However, guidelines usually include printing the batch number in a clear and prominent location. For instance, the FDA requires that you print the batch number somewhere it’s accessible, like the information panel on the label. The font size should be big enough to ensure readability, so about 1/16th of an inch for smaller labels, as detailed by 21 CFR §201.15.

Creating And Managing Batch Numbers

Whether you’re managing operations at a small or large scale, most companies leave managing batch numbers to specialized software.

For smaller-scale operations, common options include Craftbase, Unleashed Software, and QuickBooks Enterprise. For larger-scale operations, common options include NetSuite, SAP’s ERP suite, BatchMaster ERP, and Inciflo.

Integrating Different Batch Numbers Into One Label Run

For businesses that print batch numbers onto labels, integrating different batch numbers into a label run is a common scenario. That’s where labeling solutions like variable data printing comes in.

Variable data printing allows you to change elements like graphics or text for labels quickly adding several different batch numbers into a single run for a cost-effective and efficient solution.

Add Batch Numbers to Labels for Better Traceability and Compliance

Ready to put together a strategy for printing batch numbers in a single label run? Our experts can help. Learn more about variable data printing, get a sample pack, or request a quote!

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What You Need to Know About FDA Health Claims on Food Labels and Dietary Supplements

For something that can’t talk, labels say a whole lot about your product. A good label should be able to communicate a whole story to consumers, including what your product is, how it can help them, and why they should choose your goods instead of someone else’s. These messages are critical to the success of your products, but you need to be careful that what your label says doesn’t get you in trouble.

Health claims on food labels are one major way to help communicate the benefits of your product to your intended audience. However, the FDA is very particular about exactly what businesses try to claim. The FDA has strict guidelines for what is and isn’t acceptable on product labels to prevent consumers from being swindled by false or misleading promises. One claim may be fine, but another could result in recalls, seized products, and criminal prosecution.

As you may have guessed by now, health claims are serious business. Unfortunately, the FDA’s various definitions and rules of health claim usage are a bit difficult to understand without some help. That’s why we wanted to break down the different health claims with examples to see what it takes to ensure that what your labels say is okay with the FDA.

The Different Types of Label Claims

In general, health claims on food labels are statements made on food product labels or dietary supplements that boast some type of health benefit. This may seem simple, but the FDA doesn’t treat every claim the same way. Label claims come in multiple forms:

Health claims (which comprise of authorized health claims and qualified health claims)
Nutrient content claims
Structure/function claims

While they all have the same goal, there are distinct differences for each type of claim. In turn, the FDA has different guidelines that you need to follow depending on which claim you use.

A food product label with health claims being handled by a label printing expert.

What are health claims?

A health claim is a statement that creates a relationship between a product and some type of health benefit. For example, a specific ingredient may be tied to reduced risk for heart disease or some other condition. These claims can be represented in a few different ways:

Written statement
Symbols
Vignettes
Third-party statements

No matter how they’re represented, they still need to meet certain standards. Health claims require scientific evidence to be deemed acceptable for use. However, there are two different levels of health claims that dictate just what evidence is necessary:

Authorized health claims
Qualified health claims

Authorized health claims must meet the Significant Scientific Agreement (SSA) standard. Essentially, experts create a consensus of whether there’s enough publicly-available evidence that a certain health claim is accurate. For example, you can make the connection that diets that are low in sodium “may” or “might” reduce the risk of high blood pressure.

Qualified health claims aren’t quite as strict as their authorized compatriots. These claims don’t need to meet SSA standards, but still requires some significant scientific evidence. For example, scientific evidence suggests that including whole grains as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2 .

Of course, you need to be careful with the specific wording of statements. Fortunately, the FDA does provide approved lists of both approved health claims and qualified health claims online.

What are nutrient content claims?

While health claims dictate a certain relationship between certain ingredients or products and a health condition, nutrient content claims involve statements about specific nutrients found in your products. These include, but are not limited to:

Calories
Sugars
Cholesterol
Saturated fat
Sodium

Essentially, nutrient content claims showcase how the level of certain ingredients relate to typical products. However, your products must meet certain FDA standards to do so. For example, your label can make the claim that it’s “100 percent fat free” if it contains 0.5 g fat per 100 g. Whether you want to market that your product is an excellent source of something or contains a small amount of something else, make sure you check the FDA’s guideline for content claim criteria on page 87 of the Food Labeling Guide.

It’s also important to note that the FDA cares about not only what you claim, but also how that claim is presented on your label. The FDA mandates that any nutrient content claims should be no more than twice as prominent as the name of your food or dietary supplement. In general, that means you should make sure your claim’s type size isn’t more than twice as big as your product name. If your claim is too big or too bold in comparison to your statement of identity, the FDA will probably want to have a word with you.

What are structure/function claims?

According to the FDA, structure/function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.” In short, these claims cover any statements about how a certain nutrient generally impacts the human body, as long as it doesn’t make a connection to preventing disease.

A good example of a structure/function claims is that “calcium helps create strong bones.” As long as the claim is truthful, the FDA is fine with using structure/function claims on food products.

However, the FDA is more particular about these claims if you plan to use them on dietary supplements. In that case, you need to meet the following three requirements to use these claims on your packaging.

You must have substantiation that the claims are truthful and not misleading before you make any claims
You must notify the FDA that you’re using the claim within 30 days of first marketing your product
The claim must include a mandatory disclaimer statement that is provided for in the law

Employees at a label printing company reviewing labels with health claims.

Stake Your Claim with Quality Product Labels

Health claims on food labels can help you attract customers, but it’s only one piece of the packaging puzzle. A good label needs to balance compliance and quality, which means that it’s important to work with the right label printing company.

Blue Label Packaging Company offers the right combination of printing technology and expertise to bring out the best in your label designs. In addition to offering a variety of custom label printing capabilities, we’re committed to customer service as well. We work with you throughout the process to ensure a quality product and turnaround times of three to five business days after proofs are approved.

When you’re in need of eye-catching product labels, we’re ready to help. Contact us today the next time you need custom labels for your products.