24 Mar Do You Need a Process Authority Letter for Candy?
Candy manufacturers often navigate complex food regulations to ensure their products are safe and compliant. One question that arises is whether a Process Authority Letter (PAL) is required for certain types of candy. While traditional sugar-based candies typically do not require a PAL, some specialty confections may fall under regulatory scrutiny. This blog post explores when a PAL may be necessary for candy production.
What Is a Process Authority Letter?
A Process Authority Letter is an expert-reviewed document that verifies a food product’s formulation and processing method to ensure it meets safety standards. It is often required for low-acid and acidified foods regulated under 21 CFR Part 113 (Thermally Processed Low-Acid Foods) and 21 CFR Part 114 (Acidified Foods) to prevent foodborne illnesses like botulism.
Does Candy Require a Process Authority Letter?
Most traditional candies, such as hard candy, gummies, caramels, and chocolate, do not require a PAL because:
- They have low water activity (aw), which inhibits microbial growth.
- They contain high sugar concentrations, creating an inhospitable environment for bacteria.
- They are not classified as low-acid or acidified foods.
However, certain specialty candies may require a PAL, including:
1. Marshmallows and Nougats with Dairy or Egg
- If these products contain significant moisture and perishable ingredients like dairy or egg, they may require validation to ensure microbial safety.
- Some states or third-party certifications may request a PAL for these products.
2. Reduced-Sugar or Sugar-Free Candies
- Sugar acts as a natural preservative, so reducing or replacing it with alternative sweeteners (e.g., allulose, erythritol) may impact water activity.
- If the final product has a water activity level above 0.85, it may need evaluation to confirm its stability.
3. Cannabis-Infused or Functional Candies
- Infused edibles with CBD, THC, or functional additives (probiotics, vitamins) may fall under stricter regulations depending on state laws.
- Some regulatory agencies may request a PAL to verify ingredient safety and stability.
4. Acidified Confections
- If a candy product incorporates acidification (e.g., pH-controlled fruit fillings, sour gummies with liquid centers), it may need validation to ensure it meets 21 CFR 114 guidelines.
When to Obtain a Process Authority Letter
A PAL is typically required when:
- A food product has high moisture content and perishable ingredients.
- The product falls into a regulatory gray area requiring validation.
- A co-packer, retailer, or regulatory agency requests it for compliance.
Conclusion
For most standard candies, a Process Authority Letter is not necessary due to their low water activity and sugar-based formulation. However, if your candy contains perishable ingredients, reduced sugar, or specialized additives, it may be wise to consult a process authority to determine if additional validation is needed.
If you need assistance with a Process Authority Letter or product safety evaluation, contact United Food Labs for expert guidance.