5.2.7 Allergen Claims - Gluten Free

We are making a gluten free claim on multiple products.  We are performing testing using the Neogen swabs on equipment before the product is produced.  We use ATP testing to validate cleaning.  We also have raw material controls in place.  We currently test finished product twice per year by sending it to the FARP lab at the Univeristy of Nebraska.  Is finished product testing for each product required every time we produce?  Thank you!

It depends - there is no regulatory requirement that I am aware of in the US, and BRC expects that you have a defensible program. How robust is your program? How willing are you to have a failure between testing sets? Do your customers have any specific requirements? What is your risk of cross-contamination before/during/aftger production from other processes in your plant? Your Risk Assessment will answer these questions and help provide direction as to how tight a program you should have.

Are you looking to obtain gluten-free certification? If so, the certification body may have requirements you need to meet.

We also produce gluten free products. We test all the equipment prior to use for traces of gluten and then test a sample of each finished product, based on lot code prior to packaging. Annually, we choose one product and have it sent out to an independent lab and have it tested for gluten. We are GFCO certified and this program fulfilled all requirements for our recent BRC certification. 

We also produce gluten free products and are GF certified. We use the kits for testing our own product in house, that way its not very expensive and we test every lot.

Producing a gluten free (or anything free) product brings with it a whole additional layer of controls and you need to get it right. Bottom line - the product needs to be free of traces of the allergen you are claiming it is free from. Obvious I know, but the product as shipped to the market must meet the claims and internal testing and swabbing of surfaces in my experience is just part of the picture. The risks are influenced by a number of factors including dedicated plant, shared plant, dedicated line, shared line, the allergen, detection method and limits of detection, machine design, cleaning program design etc etc. 

In addition to surface testing post washing, final product testing of each batch is important until you are absolutely certain that internal controls, sanitizing programs and verification/validation testing programs are capable of picking up traces if they may remain and contaminate the product. Then the final product testing and positive release program can be reduced based on historical data.

I say this based on real experience. In short do not take short cuts to save money. It is a false economy. Indeed free from can be an expensive businesses.

George

We produce a few products that include the term "gluten-free".  We have controls in place that address cross contamination such as:

• Allergen segregation,
• Sanitation cleaning and validation,
• Preoperational and changeover cleaning and inspection,
• allergen cleaning validation,
• ATP food contact surface verification and supplier approval and verification programs.

During a BRC audit, these programs were reviewed though we received a minor non-compliance because we did not validate each lot of production of a product that claimed "gluten free". We responded to this non-conformance by having retained samples tested for the presence of gluten. For the following year’s re-certification audit we initiated a program that required testing of each lot of finished product of this item for the presence of gluten and all were negative. The auditor's interpretation of this program is that such tesing is a requirement (each lot of finished product shall be tested) and would need to continue.

Now, we are producing additional products that include a label claim of "gluten-free". If the auditor's interpretation continues, we will be required to continue to test each lot.  My question is: Is this actually necessary?  My interpretation is that we must have in place controls that provide assurances and should be able to present them as due diligence for assuring a product is indeed gluten-free.  Compliance to them should present adequate evidence of our control rather than testing each lot.  I understand that we should establish a history that these controls are effective but can this be in the form of routine validation rather than required “per-lot” testing.  Is this acceptable reasoning for satisfying the BRC requirement for product identity claims?