Made in Italy
To get your bearings

The regulatory framework

Here's a plain-language summary of the EU regulations that define each product class. They don't replace legal advice: for an assessment of your specific project, write to us.

Class I

Food supplements

Directive 2002/46/EC

The EU rule that first harmonised the definition of "food supplement" across all member states: a food product intended to supplement the normal diet, a concentrated source of nutrients (vitamins, minerals) or other substances with a nutritional or physiological effect, sold in dosed forms such as capsules, tablets, sachets, vials or similar.

  • Sets closed lists of permitted vitamins and minerals, and the chemical forms in which they can be used.
  • Prohibits attributing to supplements any property of preventing, treating or curing disease.
  • Requires specific labelling, with recommended daily dose and a warning not to exceed it.
🔗 Read the full text on EUR-Lex
Class II

Food for infants and young children

Regulation (EU) 609/2013

A regulation that brings together in a single text the rules on infant and follow-on formulae, cereal-based foods and other foods for infants and young children. It replaced several earlier directives, harmonising requirements across the whole European market.

  • Applies to products designed for healthy infants during weaning and for young children, to supplement their diet or gradually accustom them to normal food.
  • Sets strict composition and safety requirements, given the particularly sensitive age group it addresses.
🔗 Read the official summary on EUR-Lex
Class III

Food for special medical purposes

Regulation (EU) 609/2013 · Delegated Reg. (EU) 2016/128

Governs so-called FSMPs: foods specially processed for the dietary management of patients, to be used under medical supervision, intended for people with a limited or impaired capacity to take, digest, absorb or metabolise ordinary food.

  • Delegated Regulation 2016/128 sets specific composition and labelling requirements for this category.
  • Prohibits promotional nutrition and health claims: these are clinical products, not marketing ones.
🔗 Read the official summary on EUR-Lex
Class IV

Total diet replacement for weight control

Regulation (EU) 609/2013

Same regulatory framework as Class II and III (Regulation 609/2013 covers all three categories in a single text): this class covers total diet replacement products, i.e. products designed to completely replace one or more meals as part of a weight-control programme.

  • Sets the minimum nutritional requirements a meal replacement must guarantee, to avoid nutritional deficiencies during use.
🔗 Read the official summary on EUR-Lex
Class V

Food fortified with vitamins and minerals

Regulation (EC) 1925/2006

Governs the voluntary addition of vitamins, minerals and other specific substances to "ordinary" foods (drinks, baked goods, milk, meals, etc.), aiming to harmonise rules across the EU internal market and ensure a high level of consumer protection.

  • Lists in an annex which vitamins and minerals can be added, and in which chemical forms.
  • Allows minimum and maximum amounts to be set for specific foods or food categories.
  • Prohibits labelling that implies a balanced diet cannot already provide adequate amounts of nutrients.
🔗 Read the official summary on EUR-Lex
Class VI

Food for athletes

No dedicated EU regulation · Italian Ministry of Health guidelines

Until 2016 there was a specific EU directive for "foods intended for sportspeople", later repealed: today these products formally fall under the general category of food supplements (Class I, Dir. 2002/46/EC).

  • The Italian Ministry of Health publishes guidelines and specific guidance over time on nutrients, dosages and permitted claims for products aimed at people who practise sport.
  • Anyone launching a line for athletes must therefore follow the general rules on supplements, plus the sector-specific ministerial guidance in force at the time of notification.
We help you find your way through this class case by case: the guidance is updated more often than actual regulations.

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