Foods for special medical purposes

SUMMARY OF:

Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 — the specific compositional and information requirements for food for special medical purposes

WHAT IS THE AIM OF THE REGULATION?

• It modifies labelling requirements for foods for special medical purposes, and introduces a ban on making nutrition and health claims for such foods.
• It extends the rules for infant and follow-on formula on labelling, presentation, advertising and marketing to cover foods for special medical purposes intended for infants.
• It also extends the rules on pesticides to foods for special medical purposes intended for infants and young children.

KEY POINTS

The directive repeals Directive 1999/21/EC. It is a delegated act that supplements Regulation (EU) No 609/2013 on foods for specific groups.

Food for special medical purposes:

• may only be placed on the market if it complies with this regulation;
• falls within 3 categories:
  • nutritionally complete food with a standard nutrient formulation, which could constitute the sole source of nourishment, or be used as a partial replacement or supplement;
  • nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition, which could constitute the sole source of nourishment, or be used as a partial replacement or supplement;
  • nutritionally incomplete food which is not suitable to be used as the sole source of nourishment.

Pesticides

Food for special medical purposes developed for infants and young children must not contain pesticide residues exceeding 0.01 mg/kg per active substance.

Food information labelling

Food for special medical purposes must comply with Regulation (EU) No 1169/2011 on the labelling of foodstuffs and these statements or warnings (the first 4 points preceded by the words ‘important notice’ or equivalent) must appear on labelling:

• product must be used under medical supervision;
• whether the product is suitable for use as the sole source of nourishment;
• whether the product is intended for a specific age group;
• whether the product poses a health hazard for persons who do not have the condition for which the product is intended;
• the statement ‘For the dietary management of (the disease, disorder or medical condition for which the product is intended)’;
• precautions and contra-indications;
• a description of what makes the product useful in relation to the disease, disorder or medical condition, relating to the special processing and formulation, the nutrients and the product rationale;
• warning that the product is only to be taken by mouth;
• instructions for the preparation, use and storage of the product after opening.

Nutritional declaration

• The mandatory nutrition declaration, with some specific exceptions, must include the amount (where appropriate) of minerals, vitamins, protein (including its source and nature), carbohydrate, fat and other nutrients and their components.
• Nutrition and health claims must not be made on food for special medical purposes.

Specific requirements for food for special medical purposes developed for infants

• Mandatory information must be in a language easily understood by the consumers.
• Labelling must not include pictures of infants, or other pictures or text which may idealise the use of the product, with the exception of graphics for easy identification or illustrating preparation methods.
• Labelling must be designed so that consumers can make a clear distinction between such products and infant formula.
• Advertising must be restricted to publications specialising in baby care and scientific publications.
• There must be no point-of-sale advertising, free samples or any other promotional device directly to the consumer at the retail level.
• Manufacturers and distributors must not directly provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts.

Food business operators must notify the competent authority of each EU country, where the product is being placed on the market, by sending a model of the label used for the product, and any other information requested to establish compliance with this regulation.

FROM WHEN DOES THIS REGULATION APPLY?

It has applied since 22 February 2019, except in respect of food for special medical purposes developed for infants, for which it applies from 22 February 2020.

BACKGROUND

For more information, see:

• Food for special medical purposes (European Commission)
• FAQ: foods for special medical purposes (European Food Safety Authority).

MAIN DOCUMENT

Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (OJ L 25, 2.2.2016, pp. 30-43)

RELATED DOCUMENTS

Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35-56)

Successive amendments to Regulation (EU) No 609/2013 have been incorporated into the original document. This consolidated version is of documentary value only.

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, pp. 18-63)

See consolidated version.

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, pp. 71-86)

See consolidated version.

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, pp. 1-33)

See consolidated version.

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, pp. 9-25)

See consolidated version.

Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (Codified version) (OJ L 339, 6.12.2006, pp. 16-35)

Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, pp. 29-36)

See consolidated version.

last update 24.05.2019