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Regulation on food for special medical purposes

Delegated Regulation (EU) 2016/128 of 15 September 2015 applies as of 22 February, except for the provisions for food for special medical purposes developed to meet nutritional needs of infants (for which the Regulation will apply as of 22 February 2020).

Regulation 2016/128 integrates Regulation (EU) no. 609/2013 regarding specific prescription on composition and information for  food for special medical purposes.

Regulation 609/2013 is a novelty in the norms of this sector and has gradually abrogated all previous national regulations for the different classes of products (infant formula, follow-on formula, processed cereal-based foods and baby foods, food for special medical purposes and total diet replacement products for weight control).

A regulation was required to ensure the correct functioning of the internal market and greater consistency in the management of this kind of products in all European countries.

Regulation 2016/128 includes specific prescriptions on food for special medical purposes.

In particular, this food is classified into three categories depending on their composition and whether they partially replace or integrate the patient’s nutrition or represent the only source of nutrition for the people they are intended for.

The Regulation also specified that, considering the special type and purpose of these products, it is necessary that food for special medical purposes comply with the other regulations on food and food safety, and report specific indications in the label that can be useful for a correct use by consumers.

The labelling must mandatorily indicates that the product should be used only under medical control along with a description of the characteristics that make it useful for the specific issue of the patients.

The nutritional statement should be reported for all food for special medical purposes, regardless the size of the packaging, and should include specific details along with those expected for food.

Moreover, no nutritional or health indications can be given on food for special medical purposes; therefore, both the label and the promotional materials must be drafted appropriately.

The Regulation also provides for the minimum and maximum values of vitamins and minerals that can be used in the composition.

Finally, the Regulation specifies that the food business operator responsible for the marketing of a food for special medical purposes should notify the label to the competent authority of each Member State where the product is marketed along with any other useful information confirming the compliance of the product with the Regulation.

Written by: Federica Montozzi