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:

Veterinary Agreement to boost EU-New Zealand trade in animal products

Technical amendments to the EU-New Zealand Agreement on sanitary measures in live animals and animal products have recently been made to boost existing trade relations. This updated agreement, which has been in place since 1996, is the most advanced international bilateral agreement in the area of animal health, animal welfare and food safety systems.

Key innovative features that will lead to further trade opportunities whilst reducing costs for exporters are:

  • Enhanced equivalence provisions including EU standards for raw milk products;
  • Mutual recognition of microbiological controls and chemical testing standards for seafood;
  • Trade conditions to permit trade in certain products with agreed treatments during disease outbreaks;
  • Reduced physical inspection rates on products;
  • Resumption of fresh pig meat exports to New Zealand; and
  • Simplified certification and a move to electronic certification in 2016.

Worth €427 million in 2014, EU agricultural exports to New Zealand have increased significantly with a 20% annual average growth over the last five years. Several key commodities have also experienced high growth over recent years including pork products and cheese. New Zealand has authorised imports of high value raw milk products, such as Roquefort, Camembert and Emmental and fresh pig meat, from the EU. Both these products have significant potential for growth.  New Zealand was also the very first country in the world to re-authorise exports of EU beef following the BSE crisis.

Other important benefits of cooperation between the EU and New Zealand are:

  • The EU and New Zealand are complementary suppliers of high-quality products.  Because New Zealand is in the southern hemisphere, their production and exports peak in a way that is counter-cyclical to EU pastoral producers.  This means products from New Zealand complement those from the EU, maintaining year round availability of certain products.
  • The EU is New Zealand’s largest source of imported goods and services.
  • Through the mutual recognition of regionalisation under the Agreement, trade in animal products such as pork to continue, despite recent EU outbreaks of African Swine Fever, from regions that remain unaffected by the disease.

These benefits bring substantial economic incentives and maintain sustainable trade flows between both parties.

For more details:

Commission Implementing Decision (EU) 2015/1084 of 18 February 2015 approving on behalf of the European Union certain amendments to Annexes II, V, VII and VIII to the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products (notified under document C(2015) 797), OJ L 175, 4.7.2015, p. 45–123.

(Source: DG Sante website)