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 45/2015

This week on the EU RASFF (Rapid Alert System for Food and Feed) we can find the following notifications:

1. Alerts followed by a recall from consumers:

2. Information for attention/for follow up followed by a recall from consumers:

3. Alerts followed by a withdrawal from the market:

4. Seizures:

5. Border rejections:

  • acetamiprid (0.836 mg/kg – ppm) in fresh sweet peppers from Turkey
  • aflatoxins (B1 = 1.9; Tot. = 4.5 / B1 = 33; Tot. = 36 / B1 = 22; Tot. = 23 µg/kg – ppb) in groundnuts from Bolivia
  • aflatoxins (B1 = 54.3; Tot. = 98.6 / B1 = 39.6; Tot. = 70.1 µg/kg – ppb) in dried figs, hazelnuts kernels (B1 = 13.9; Tot. = 48 µg/kg – ppb) and in pistachio kernels (B1 = 2.8; Tot. = 3 / B1 = 23.6; Tot. = 24.5 µg/kg – ppb) from Turkey
  • aflatoxins (B1 = 19 µg/kg – ppb) in melon seeds from Togo
  • aflatoxins (B1 = 3.14 / B1 = 2.56 µg/kg – ppb) in groundnut kernels and blanched groundnuts (B1 = 6.8 / B1 = 6.7 µg/kg – ppb) from Brazil
  • aflatoxins (B1 = 49.1 µg/kg – ppb) in peanut halva from Ukraine
  • aflatoxins (B1 = 6.4; Tot. = 27 µg/kg – ppb) in groundnut kernels from Argentina
  • attempt to illegally import (invalid health certificate) organic dried figs from Turkey
  • bifenthrin (0.13 mg/kg – ppm) and unauthorised substances carbendazim (0.82 mg/kg – ppm) and chlorfenapyr (0.1 mg/kg – ppm) in green tea from China
  • E 407 – carrageenan unauthorised in jelly mini cups from Malaysia
  • FEED: improper health certificate(s) for dried pet food (chicken and rice and lamb flavor with rice) from South Africa
  • fenitrothion (0.026 mg/kg – ppm) in olives in brine from Egypt
  • FCM (Food Contact Materials): migration of chromium (0.4; 0.6 mg/kg – ppm) from kitchen scissors from China
  • FCM (Food Contact Materials): migration of chromium (9; 0.5 mg/kg – ppm), of nickel (0.2 mg/kg – ppm) and of manganese (0.4 mg/kg – ppm) and too high level of overall migration (27 mg/dm²) from kitchen knives from China
  • FCM (Food Contact Materials): migration of formaldehyde (< 19 mg/kg – ppm) and of melamine (3.31; 6.61; 6.17 mg/kg – ppm) from melamine dinner plate from China
  • FCM (Food Contact Materials): migration of manganese (0.120 mg/kg – ppm) from steel grill from China
  • fosthiazate (0.047 mg/kg – ppm) in fresh sweet peppers from Turkey
  • missing import declaration for frozen flatbread dough from Pakistan infested with moulds
  • peanuts in shell from China infested with insects (Pyralidae(moths), cocoons, live pests and frass)
  • poor temperature control (-11; -10; -14 °C) of frozen sardines (Sardina pilchardus) from Morocco
  • Salmonella (presence /25g) in frozen poultry meat preparations from Argentina
  • too high content of sulphite (2429 mg/kg – ppm) in dried apricots from Turkey