When the FDA releases its final rule on labeling of food as gluten free, testing protocols and testing methods for manufacturers will not be included. Manufacturers will be on their own to determine how to go about ensuring their labeled gluten-free products truly are gluten free as defined by FDA. Similar to the proposed rule, FDA in their preamble to the final rule will likely advise manufacturers about the test(s) they are considering using in their enforcement program. Currently the standard sandwich R5 (Mendez) ELISA and the sandwich Morinaga wheat protein ELISA are the only two commercially available ELISAs validated at the levels used for regulatory purposes and official governmental methods. These two ELISAs are included in the FDA’s proposed gluten-free labeling rule as possible methods for rule enforcement.
Sometimes it is helpful for manufacturers just learning the gluten-free ropes to see how other gluten-free manufacturers are making sure their products are gluten free (as defined by the FDA’s proposed gluten-free labeling rule). Schar (www.schar.com) graciously agreed to share some information with GlutenFreeDietitian.Com.
Schar is an Italian-based manufacturer of gluten-free foods. Since 1981 this company has been producing a variety of products, including breads, pasta, crackers, and cookies. What follows is a summary of the information provided by the corporate office in Italy.
1. Before raw ingredients are allowed into the Schar production facility they are tested for gluten using the standard sandwich R5 (Mendez) ELISA.
Author comment: Why is this important? Testing of raw ingredients before they enter the production facility helps ensure that if an ingredient is cross contaminated with wheat, barley, or rye it does not contaminate other ingredients. Using the standard sandwich R5 (Mendez) ELISA ensures that barley contaminated ingredients are not allowed into the facility. Remember, the omega-glaidin (Skerritt) ELISA does not adequately test for barley. Using this assay also ensures that ingredients have been tested using the best available validated ELISA–currently the standard sandwich R5 (Mendez) ELISA.
2. Ingredients must test below 20 parts per million of gluten to enter the facility.
Author comment: Why is this important? Testing of raw ingredients to this level helps ensure that the final product will contain less than 20 parts per million of gluten. If a manufacturer tests only final food product for gluten and the level comes back high, they will have no idea during what stage of production the product may have become contaminated.
3. The Schar production facility is dedicated gluten free.
Author comment: Why is this important? This step helps ensure that ingredients will not become contaminated during the manufacturing process.
4. Every finished batch of every product is tested for gluten using the standard sandwich R5 (Mendez) ELISA.
Author comment: Why is this important? To some this step may seem like overkill for a manufacturer like Schar who tests raw ingredients and maintains a dedicated gluten-free facility. BUT batch testing of every single product using the best available validated ELISA is the most important step a manufacturer can take to ensure gluten-free status of final product.
Thank you Schar!
I have heard some rumblings in the gluten-free community that gluten-free products must be “certified” to be safe. While the programs run by GIG and CSA are certainly helpful, they serve as starting points for conversations with manufacturers. Regardless of label designations, contact manufacturers. Call them up. Email them. Ask them what they are doing to ensure their food products are gluten free. Most importantly ask them if they are testing their labeled gluten-free products and what test they are using. But please remember, we are all in this together and manufacturers are learning right along with the rest of us.