In accordance with Regulation (EU) No 828/2014, a food product can be labelled as “gluten-free” if it contains less than 20 mg of gluten per kilogram (20 ppm). This threshold is based on scientific evidence and is considered safe for individuals with coeliac disease.

It is important to understand:

• the use of the term “gluten-free” is voluntary, not mandatory,

• a product is not required to have a gluten-free label to be considered safe for coeliacs,

• it is mandatory to clearly label allergens in accordance with Regulation (EU) No 1169/2011.

If grains containing gluten (wheat, barley, rye, oats) are present as ingredients, they must be clearly stated and highlighted. If there is a real risk of cross-contamination, the manufacturer must assess the risk and inform consumers accordingly, for instance by stating “may contain traces”.

Labelled gluten-free vs. certified gluten-free

This is where most misunderstandings often occur.

Labelled gluten-free

A product labelled as “gluten-free”:

• meets the legal requirement (less than 20 ppm of gluten),

• is based on internal controls, documentation, and food safety assurance systems,

• does not necessarily mean it has been independently tested or certified by a coeliac society.

The manufacturer is legally responsible for the truthfulness of the claim and must prove it if requested by relevant authorities.

Certified gluten-free

Certification is separate and voluntary.

In most European countries:

• the main coeliac society holds the licence to certify products (in Slovenia, this is the Slovene Coeliac Society),

• the process involves inspections of manufacturing facilities, monitoring of raw materials and suppliers, checking HACCP systems, and continuous monitoring,

• often includes regular testing of final products.

The process is lengthy and financially demanding, particularly for smaller manufacturers. Certified products usually carry a special symbol (crossed grain symbol) and are included in national registers.

The certificate provides an additional level of assurance, but is not a legal requirement.

Why do some manufacturers not label their product as gluten-free even if it is?

There are multiple reasons which are entirely legitimate.

Psychological and marketing reasons

Some consumers associate the term “gluten-free” with a higher price, inferior taste, or special diet products. For naturally gluten-free foods (e.g., yoghurts, chocolate, crisps, legumes), manufacturers sometimes consciously choose not to use the label.

Costs and administrative burden

Using a gluten-free label, especially certification, involves additional controls, documentation, certification body fees, and ongoing compliance costs. For smaller companies, this is often a significant financial burden.

Coordination for multiple markets

Many products are sold in multiple EU countries. In some countries, particularly Italy, gluten-free labelling is widespread due to national registers. Elsewhere, manufacturers only follow general EU legislation. The product is the same, but the labelling strategy differs.

Legal clarity

EU legislation does not require a product to be labelled as gluten-free if it does not contain gluten. Some manufacturers therefore choose to limit themselves only to mandatory declarations.

Italy: a special case, not a European standard

Italy is often cited as an example of a country where everything is “gluten-free”. The reason is the national register managed by the Italian Coeliac Association (AIC).

To be included in the register, manufacturers must complete additional procedures and label their product as “senza glutine”. This system is specific to Italy and exists alongside EU legislation.

Thus, an exact same product can be:

• labelled as gluten-free in Italy,

• yet not labelled as such in Slovenia or elsewhere in the EU, but still equally safe when the declaration is read correctly.