Presentation of the EEC Regulation on Coeliac Disease

The definition and identification of gluten-free food products is rather complex because, until now, definitions and terminology that are not always unambiguous have been used on labels. In an attempt to bring clarity, as of 1 January 2012 the Ministry of Health ordered the application of EC Regulation 41/2009 on the composition and labelling of foodstuffs suitable for people intolerant to gluten (O.J.E.C. L 16 of 21 January 2009). Under the measure, only the following wordings are permitted: a. "very low gluten content", if the gluten content does not exceed 100 mg/kg; b. "gluten-free", if the gluten content does not exceed 20 mg/kg. In order to clarify some concepts of the regulation, the Ministry of Health published the circular of 5 November 2009. In particular, annex 3 “Gluten-free products”, which states: 1. Any product, for which companies can guarantee the absence of gluten (gluten < 20 ppm), may bear the wording “gluten-free”. The wording: “contains no sources of gluten” is to be replaced with the wording “gluten-free”. The use of this indication is voluntary in nature. 2. Gluten-free dietary products remain subject to the notification procedure (legislative decree 111/92). 3. The gluten limit of 100 ppm is permitted only for dietary products based on ingredients purified of gluten. Such products must compulsorily bear the wording “very low gluten content”. 4. Dietary products “with very low gluten content” are not admitted to the National Register for the purposes of provision at the expense of the National Health Service (SSN). 5. Products that are “naturally gluten-free”, that is, those not containing gluten and unprocessed, such as fruit, vegetables, meat, fish, milk, eggs, may not use the “gluten-free” claim. 6. For foods in everyday use, the use of the wording “gluten-free” on the label is permitted only where the producing company is able to guarantee both the absence of ingredients derived from gluten-containing cereals and the absence of potential sources of contamination during the production process. 7. The wording “may contain traces of gluten” is used by companies to indicate a potential presence of gluten through accidental contamination. This wording is not, however, contemplated among the obligations of the current legislation. The Ministry of Health is also carrying out a review of the products notified and included in the National Register so far, with the aim of removing from the regime of free provision at the expense of the SSN those non-essential products in favour of essential ones.