FDA – Gluten Free Labelling Compliance Requirements Proposed Rule

The U.S. Food and Drug Administration released a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The proposed rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods”, pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers.

In 2013, the FDA issued the gluten-free final rule, which addressed the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods in terms of intact gluten.  Due to this uncertainty, the FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer.

The proposed rule, when finalized, would require these manufacturers to make and keep records demonstrating assurance that:

  • The food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis
  • The manufacturer has adequately evaluated its process for any potential gluten cross-contact
  • Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process

Distilled foods such as distilled vinegars are also included in the proposed rule. Distillation is a purification process that separates volatile components from non-volatile components such as proteins.  Thus, when properly done, gluten should not be present in distilled foods. The proposed rule states that FDA would evaluate compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

The FDA is accepting public comments beginning Wednesday, November 18 (closing date February 2nd, 2016). To electronically submit comments to the docket, visit www.regulations.gov and type docket number “FDA-2014-N-1021” in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number “FDA-2014-N-1021” on each page of your written comments.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information:

Food recalls in EU – Week 29 – 2014

This week on the RASFF database (Rapid Alert System for Food and Feed) we don’t have any recall from consumers in EU in the alert notifications.

Between the information for attention notifications, followed by a recall from consumers, we find:

– Foreign bodies: glass fragments in asparagus, following a consumer complaint. Origin China, notified by Germany;

– Pathogenic micro-organisms: Campylobacter spp. in chilled chicken breast fillets, following an official control on the market. Origin Poland, notified by Denmark;

Pathogenic micro-organisms: Listeria Monocytogenes in heat processed pork sausage “boudin blanc”, following company’s own check. Origin France, notified by France, distributed also to United Kingdom.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

– Allergens: undeclared gluten in gluten free beer, following company’s own check. Origin Germany, notified by Germany, distributed also to Italy, France, Netherlands and Romania;

– Biotoxins: Diarrhoeic Shellfish Poisoning (DSP) toxins in chilled mussels, following an official control on the market. Origin Denmark, notified by Denmark, distributed also to Netherlands;

– Mycotoxins: deoxynivalenol (DON) in organic whole wheat shortbread and organic whole grain cracker, following an official control on the market. Origin Germany, raw material from Poland, notified by Germany, distributed also to Hong Kong and Denmark;

– Pathogenic micro-organisms: Norovirus in froze raspberries, following a food poisoning. Origin Serbia (packaged), notified by Sweden, distributed via Belgium and France;

– Pathogenic micro-organisms: Listeria Monocytogenes in chilled sliced sirloin, following company’s own check. Origin Poland, notified by Poland, distributed also to United Kingdom;

– Pathogenic micro-organisms: Listeria Monocytogenes in gorgonzola cheese, following an official control on the market. Origin Italy, notified by France;

– Pathogenic micro-organisms: Salmonella Spp. in sesame seeds, following company’s own check. Origin India, notified by Netherlands, distributed also to Sweden;

– Pathogenic micro-organisms: Salmonella in minced meat, following company’s own check. Origin Netherlands, notified by Netherlands, distributed also to Denmark and Sweden;

– Pathogenic micro-organisms: Salmonella Brandenburg in processed cheese powder, following company’s own check. Origin Netherlands, notified by Netherlands, distributed also to Hungary and France.

We have also a seizure for Salmonella Saint Paul in frozen poultry and veal kebab, following an official control on the market in Italy; origin Germany.

Amongst border rejections we have aflatoxins in groundnuts from Egypt and from the United States, in pecan nuts from Israel, in raw pistachios in shell from Iran, in peanut candy from India and in unshelled pistachios from the United States; ochratoxin A in pumpkin seeds from China, in dried figs from Turkey, in raisins from Afghanistan and in organic spelt from Ukraine, poor temperature control of frozen whole poultry from Brazil, norovirus in frozen boiled white clams from Vietnam, bacterial contamination and spoilage of frozen cooked shrimps from India, residues above MRL for oxytetracycline in frozen shrimps from Vietnam, benzo(a)pyrene and polycyclic haromatic hydrocarbons in non-refined soybean oil from Ukraine, unauthorised use of colour E 122 – azorubine in pickles from Lebanon, dimethoate in fresh peppers from Turkey, clorpyriphos, cypermethrin, cyhalothrin and dichlorvos in fresh olu beans from Nigeria, cypermethrin and dichlorvos in fresh oloyn beans and in oluyin beans from Nigeria.

For feed, we have an alert notification, followed by a withdrawal from the market for:

Residues of veterinary medicinal product: prohibited substance nitrofuran (metabolite) furazolidone (AOZ) in compound feed, following an official control on the market. Origin Netherlands, notified by Netherlands, distributed also to Germany.

For food contact materials we don’t have any relevant notification this week.

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