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
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information:

FVO report – Eggs and egg products in UK

This report describes the outcome of an audit carried out by the Food and Veterinary Office in the United Kingdom, from 3 to 13 March 2015. The objective of the current audit was to assess the control system in place concerning the production and placing on the market of eggs and egg products destined for human consumption.

The report concludes that the official control system in place meets the main elements of Regulation (EC) No 882/2004. It includes regular and risk based controls, covering all stages of production and placing on the market of eggs and egg products. However, there are no guarantees that means of transport used for eggs and egg products are under official control, as no documented evidence of official controls carried out on such vehicles was provided by the central competent authority.

The report concludes also that in the areas where the Local Authorities are responsible for official controls, in particular in liquid egg and egg products establishments, there are weaknesses as regards: approval of establishments, respecting inspection frequency, detection and follow-up of non-compliances during official controls, verification of food business operator compliance with microbiological/analytical criteria, identification marking and labelling of unpasteurised liquid egg.

The official control system is supported by a network of official laboratories which meet EU requirements and can provide guarantees concerning the reliability of results.

Concerning traceability and labelling of eggs (including the method of production i.e. free range/organic) the official controls have ensured compliance with the relevant EU legislation.

The report includes a number of recommendations addressed to the United Kingdom competent authorities, aimed at rectifying the shortcomings identified and enhancing the implementation of the official control system in place.

(Source: FVO website)