Legislation and gluten-free labeling in EU and US

“Gluten-free" labelling reviewed Lately there has been great movement around the gluten-free labeling legislation: let’s have a look about what’s going on in EU and US with Cesare Varallo.

During the last year we registered great movement around gluten-free products, not only because of the increasing market share, but also on the regulatory side.

In EU, in the context of the revision of the legislation on foodstuffs intended for particular nutritional uses Regulation (EU) n. 609/2013 of the European Parliament and of the Council repealed the pre-existing Regulation1 and the new rules, recently adopted2, will enter into force on 20th July 2016.

It was considered appropriate to ensure that, in accordance with the requirements of the upcoming general rules about food labeling3 - who has expressly provided for the adoption of specific standards for the "Gluten-free" category - the information provided about the absence of gluten or its presence to a limited extent in foods continue to be based on relevant scientific information and are not misleading or confusing for the consumers.

It is also relevant to stress that the adoption of a Regulation (and not a simple Directive) should be guarantee of uniform conditions of application in all the 28 Member States of the Unions. The new conditions provided reflect significantly what was already provided in Regulation (EC) n. 41/2009.

The main rules, contained in Annex I, shall provide that, where consumers are informed about the absence of gluten or about its presence to a limited extent in foods by adding text, the information is provided exclusively by the terms and conditions that follow: • GLUTEN-FREE: The statement ‘gluten-free’ may only be made where the food as sold to the final consumer contains no more than 20 mg/kg - ppm of gluten.

• VERY LOW GLUTEN: The statement ‘very low gluten’ may only be made where the food, consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been specially processed to reduce the gluten content, contains no more than 100 mg/kg – ppm of gluten in the food as sold to the final consumer.

Most people with intolerance to gluten can include oats in their diet without adverse effect on their health.

This is an issue of ongoing study and investigation by the scientific community in EU: therefore, despite some worries about potential cross-contaminations, additional requirements for foods containing oats are established: “Oats contained in a food presented as gluten-free or very low gluten must have been specially produced, prepared and/or processed in a way to avoid contamination by wheat, rye, barley, or their crossbred varieties and the gluten content of such oats cannot exceed 20 mg/kg.”

Food information referred to above may be accompanied by the words 'suitable for people intolerant to gluten' or 'suitable for coeliacs', and may be also completed by the words 'specifically formulated for people

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Reg. (EC) n. 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten Reg. (EU) n. 828/2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food 3 Reg. (EU) n. 1169/2011 on the provision of food information to consumers 2

intolerant to gluten" or ‘specifically formulated for coeliacs' if the food has been specifically produced, prepared and/or processed in order to: a) reduce the gluten content of one or more ingredients containing gluten; OR b) replace the gluten containing ingredients with other ingredients naturally free of gluten.

A food containing ingredients that are naturally gluten-free should be able to bear labels indicating the absence of gluten, in accordance with the provisions of the Regulations, provided that the general conditions of fair information practices set out in Regulation (EU) No. 1169/2011 are met. In particular, the food information should not be misleading by suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics (i.e. the discussed category of foods ‘naturally gluten-free’).

In the US, in the meantime, the Food & Drug Administration (FDA) issued a final rule defining the term ‘gluten-free’ for voluntary use in the labeling of foods on 5th August 2013. The compliance date for the final rule was 5th August 2014, date from which they started to be applied.

The final rule defines "gluten-free" as meaning that the food either is inherently gluten free or does not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.

Also, any unavoidable presence of gluten in the food must be less than 20 ppm.

While the limit of 20 ppm is the same as in EU, differences stand on other grounds.

About oats, for instance, FDA’s Q&A4 clarifies that oats should not have been certified as gluten-free to be labeled as such; they have just to meet the limit of 20 ppm.

Finally, on the side of foods by nature free of gluten (e.g. bottled spring water) the FDA position is far clearer than the European one: such products may bear a gluten-free labeling claim if it meets all FDA requirements for a gluten-free food, because the claim is basically made on voluntary basis.

Cesare Varallo Food Lawyer and founder of www.foodlawlatest.com

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Questions and Answers: Gluten-Free Food Labeling Final Rule