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:

EU – Breaking news on allergens labelling

Last week we had great movement around this topic.

DG Sanco opened a public consultation on Guidelines relating to the provision of information on substances or products causing allergies or intolerances as listed in Annex II of Regulation (EU) No 1169/2011 on the provision of food information to consumers.

The consultation aim is to gather opinions from consumers and stakeholders about the draft document. The consultation will be closed on 4th January 2015.

For the pre-packed foods the rules are quite clear and the main topic is around gluten: the Commission suggest to emphasize not the word “gluten” but the name of the cereal (i.e. wheat, barley, …).

For non pre-packed food, the following Q&A give an idea of what is the line of the Commission and the space given to Member States legislation (see 44.2 FIC Reg.).

Can Member States allow, through national measures, the provision of information on substances or products causing allergies or intolerances used in the manufacture or preparation of a non-prepacked food, only and simply upon request by the consumer?

The provision of allergen information “upon request” is not to be considered as a “means of providing information’. However, in a spirit of a pragmatic approach, indicatively, national measures may stipulate that detailed allergen/intolerance information regarding the manufacture or preparation of a non-prepacked food may be given upon request by the consumer, provided that the food business operator indicates in a conspicuous place and in such a way as to be easily visible, 11 clearly legible and, where appropriate, indelible, that such information can be obtained upon request. This combination would already indicate to the consumer that the non-prepacked food
concerned raises issues relating to allergen/intolerances and that such information is available and easily accessible.

The guidelines should be read in conjunction with the legislation itself. The examples it contains are given for illustration only. The guidelines and examples given in the document cannot be regarded as official interpretation of
the legislation, this being the exclusive reserve of the Court of Justice of the European Union. Moreover it is not a final document, but is better than nothing for our food business operators  in light of the fact that in a week from now the FIC Regulation will enter in application.

Few days before the European Food Safety Authority (EFSA) released a Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes.

The Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) updated its previous opinions relative to food ingredients or substances with known allergenic potential listed in Annex IIIa of 2003/89/EC, as amended. These include cereals containing gluten, milk and dairy products, eggs, nuts, peanuts, soy, fish, crustaceans, molluscs, celery, lupin, sesame, mustard and sulphites. The opinion relates to immunoglobulin (Ig)E- and non-IgE-mediated food allergy, to coeliac disease and to adverse reactions to sulphites in food, and it does not address non-immune-mediated adverse reactions to food. It includes information on the prevalence of food allergy in unselected populations, proteins identified as food allergens, cross-reactivities, the effects of food processing on the allergenicity of foods and ingredients, methods for the detection of allergens and allergenic foods, doses observed to trigger adverse reactions in sensitive individuals and risk assessment methodologies that have been used to derive individual and population thresholds for selected allergenic foods.

The huge opinion (286 pages) has many interesting point, but cannot cut clear two of the main issues linked to the possibility to establish thresholds for labelling purposes: which doses trigger adverse reactions (too many variables) and which methods use to detect allergens.