Part 2: Wheat vs Gluten – Regulatory Perspective

4 July 2022. By FACTS in Allergen Management, Regulatory & Nutrition

FACTS receives many inquiries about the ‘significant’ cereal group, also called ‘gluten-containing’ cereals elsewhere in the world. We sympathetically refer to this as ‘Wheat vs Gluten confusion’. The goal of this four-part series is to help you go from confusion to clarity.
In part 2, we look at the regulatory requirements that pertain to the significant cereal group

The South African regulations relating to the labelling and advertising of foodstuffs (R. 146/2010) regard ‘significant cereals’ as common allergens; thus, they must be identified on a food label if they are present in the product. Additionally, there are specific requirements that must be met when products carry claims such as ‘gluten-free’ or ‘wheat-free’.

What if a product contains a significant cereal as an ingredient?

According to regulation 43, if a food product contains an ingredient derived from wheat, rye, barley or oats, the presence of the significant cereal must be included in the name of the ingredient, with the word ‘gluten’ added in parenthesis – e.g. ‘wheat flour (gluten)’, or ‘barley malt extract (gluten)’.

For example, the ingredient list and allergen declaration statement for oatmeal crunchies that contain oats, flour and malt extract might look like this:

OATMEAL CRUNCHIES
Ingredients: Sugar, rolled oats (gluten), wheat flour (gluten), barley malt extract (gluten), desiccated coconut, animal fat [butter (cream, salt)], glucose syrup, egg, raising agent, salt.
Contains: Wheat, gluten, cow’s milk, egg.

What if a significant cereal might be in a product due to cross-contact?

In line with regulation 45, if it’s possible that a significant cereal may be present in a food product due to allergen cross-contact (also called cross-contamination), then first, due diligence must be exercised and appropriate allergen controls implemented, to eliminate or reduce the risk of cross-contact.

If it is found that cross-contact persists (i.e. it cannot be eliminated), then the risk, the procedure for assessing the risk, and the steps taken to avoid the risk of allergen cross-contamination must be documented. To determine whether precautionary allergen labelling (PAL) – a ‘may contain <allergen>’ statement – is required, a risk-assessment tool such as the VITAL^® (Voluntary Incidental Trace Allergen Labelling) Program can be used. If the risk assessment indicates that the cross-contact holds a significant risk to sensitive individuals, a PAL should be applied; if it does not, the PAL may be omitted. While VITAL^® (developed by the Australia/New Zealand Allergen Bureau) is not part of the regulations, it is a scientifically robust and consistent approach to PAL.

For example, if a risk assessment concludes that rice cakes may be contaminated with significant levels of wheat due to cross-contact, the PAL statement could look like this:

RICE CAKES
Ingredients: White rice, salt
May contain: Wheat, gluten

What are the requirements for making wheat- and gluten-free claims?

According to the requirements set out in regulation 46, for a producer to make a ‘gluten-free’ claim, the product must be tested to prove it contains no more than 20mg gluten per kilogram product (20ppm). For a ‘wheat-free’ claim, the product may not contain any wheat proteins whatsoever.

In Australia and New Zealand, for a product to carry a gluten-free claim it may not contain any detectable gluten, or contain an ingredient derived from a gluten-containing cereal.

In many other parts of the world – including North America, the EU, and those countries that adopt Codex Alimentarius standards – a product must contain less than 20ppm gluten to make a gluten-free claim, the same as our regulations.

The EU also permits the claim ‘very low gluten’, which applies to foods that consist of or contain one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been specially processed to reduce the gluten content. To qualify for the claim, the product may not contain more than 100mg/kg gluten in the food as sold to the final consumer.

Canada’s regulations do not mention a specific threshold for making a ‘gluten-free’ claim; they refer to the best currently available scientific evidence, which currently means 20ppm.

There are many gluten-free certification schemes – for example, the Brand Reputation Compliance Global Standards (BRCGS) has voluntary modules that can be included in your company’s food-safety system if they apply to your operations. It has developed a gluten-free module against which you can be audited, and which will be noted on your audit report and certificate.

This article outlines the fundamental regulatory requirements, and does not deep dive into the nuanced regulatory interpretation – what our Regulatory and Nutritional team refers to as ‘50 shades of regulatory grey’! – required to answer some of the questions we know our clients are faced with from time to time.

THE SOUTH AFRICAN REGULATIONS RELATING TO THE LABELLING AND ADVERTISING OF FOODSTUFFS (R. 146/2010)

IMPORTANT DEFINITIONS

‘significant cereal’ means any one of the following cereals:

Wheat, meaning any species belonging to the genus Triticum, including varieties such as kamut and spelt;
Rye, meaning any species belonging to the genus Secale;
Barley, meaning any species belonging to the genus Hordein;
Oats; or
Crossbred hybrids of wheat, rye or barley (e.g. triticale, which is a cross between wheat and rye).

‘common allergen’ means egg, cow’s milk, crustaceans and molluscs, fish, peanuts, soya beans, tree nuts and any significant cereals, as well as any ingredient derived from these foodstuffs that has retained its allergenicity in the final product.

IMPORTANT REGULATIONS

43(1) Where a product or its packaging contains a “common allergen”, its presence shall be indicated:
a) in parenthesis after the name of such ingredient in the list of ingredients, if not self evident from the name of the ingredient
b) in close proximity to ingredient list in a list or block with the words: “Contains: (allergen(s))”

43(2) the name of the specific significant cereal shall be specified in the list of ingredients with the word “gluten” in parenthesis.

45. If there is a risk for cross-contamination of a common allergen in a food processing facility:
a) due diligence shall be exercised to prevent the occurrence of such contamination and an allergen control policy (ACP) shall be implemented in accordance with the guidelines; and
b) in the case where precautionary labelling is utilised, this shall not be utilised to circumvent the implementation of GMPs and an effective allergen control policy (ACP); and
c) in the case where precautionary labelling is utilised, the risk, the manner of assessing the risk, and the steps taken to avoid the risk of allergen cross-contamination, shall be documented.

46 (1) a) The claim “gluten-free” shall only be permitted on a foodstuff if the foodstuff does not contain any of the following:
i. an ingredient that is any species of the significant cereals;
ii. an ingredient that is derived from any of the aforementioned significant cereals and that has not been processed to remove gluten;
iii. an ingredient that is derived from any of the aforementioned significant cereals which has been processed to remove gluten so that the use of that ingredient results in the presence of more than 20 mg/kg (ppm) gluten in the end product; or
iv. More than 20 mg/kg gluten, where the level of gluten is determined by the R5 Mendez Enzyme-Linked Immunosorbent Assay (ELISA) for gluten (as described in the Guidelines), or other Codex recommended methods.

b) A cereal which, by its nature, is suitable for use as part of a gluten-free diet, shall not be designated “special dietary”, “special dietetic” or any other equivalent term, but may bear a statement on the label that “this cereal product is by its nature gluten-free” provided that it complies with Regulation 47(1)(a)* and such a statement does not mislead the consumer.
* 46(1)(a)

46 (2) No claim shall be made that a foodstuff –
a) neither a single ingredient foodstuff nor a compound foodstuff, is “hypoallergenic ” or “nonallergenic” or similar wording, unless the foodstuff is modified by chemical or genetic means so as to reduce the quantity of endogenous allergens in such a way that it is not possible to detect the presence of any possible allergen with testing suitable for the specific allergen; or
b) is free from any common or uncommon allergen or similar wording, unless the foodstuff has been tested to confirm the absence of the particular allergen(s), using suitable testing for the specific allergen(s).