The end of PARNUTS and changes to the "gluten free" rules

Posted by John Mitchell on
On 20 July 2016, Directive 2009/39/EC on food for particular nutritional uses (PARNUTS) is repealed and replaced by a new regime under Regulation (EU) 609/2013 on food for specific groups (FSG). I have already written about the implications of this change for sports foods. This article examines the framework of the new regime.

PARNUTS established a common definition of food for particular  nutritional uses, laid down general compositional and labelling requirements, envisaged the development of specific standards for particular types of foods and obliged member states to set up procedures for manufacturers to notify the entry of new foods falling within the definition on to the market.

Harmonised rules were developed for foods intended for use in energy-restricted diets for weight reduction, dietary foods for special medical purposes, processed cereal-based foods and baby foods for infants and young children, infant formulae and follow-on formulae and the composition and labelling of foodstuffs suitable for people intolerant to gluten.

Over time, member states applied differing interpretations to the definition, leading to a disparity in the range of notifications across the EU, and manufacturers took advantage of the looseness of the regime to make quasi-health claims that could not pass the authorisation procedures under the health and nutrition claims regulation.

The EU decided, therefore, that the concept of food for particular nutritional uses should be abolished and replaced with a framework aimed at foods for specific groups of people. The new Food for Specific Groups Regulation (FSG) establishes that framework. All food that no longer comes within that framework will now fall under general food law (safety, additives, labelling, health claims, supplements etc.) and food that does come within the framework will be subject not only to general food law, but also to FSG and to additional subsidiary legislation setting out specific requirements for each category of food that falls within its scope.


FSG defines four categories of food:

  • Infant formula and follow-on formula;
  • Processed cereal-based food and baby food;
  • Food for special medical purposes;
  • Total diet replacement for weight control.

The first two are self-explanatory (although tightly defined in FSG).

Food for special medical purposes means in effect food specially processed or formulated with the intention of it being used under medical supervision for feeding patients who have a reduced ability to take, digest, absorb, metabolise or excrete ordinary food or nutrients.

Total diet replacement for weight control means food specially formulated for use in energy restricted diets for weight reduction, which replaces the whole daily diet when used in accordance with the manufacturer's instructions.

The European Commission is given the power to declare, by subsidiary legislation, whether a particular food falls within FSG and if so to which of the four categories it should be assigned.

The following is a summary of the general FSG rules which apply to any food falling within the four categories:

  • It may not be placed on the market if it does not comply with the requirements of FSG.
  • It may only be sold as pre-packed food.
  • Substances such as vitamins and minerals may be added to it, but only provided that they meet any conditions of use and purity criteria specified in the Annex to FSG.
  • Member states may not restrict food which is FSG compliant from being placed on the market.

Specific rules have been set out in subsidiary legislation for infant formula and follow on formula and for food for special medical purposes.

Both sets of rules contain detailed requirements for:

  • Composition
  • Pesticide residues
  • The name of the food
  • Information to be given with the food
  • The nutrition declaration
  • Notification of a new product upon placing on the market

The rules on infant formula and follow on formula have additional requirements in relation to:

  • Suitability of ingredients
  • Statements regarding lactose and DHA
  • Promotional and commercial practices.

Nutrition and health claims may not be made in relation to either product.

Specific rules for processed cereal-based food and baby food and for total diet replacement for weight control are awaited. In the meantime the general FSG rules apply and general food law apply.

Rules on indications of gluten content

The legal requirements relating to the voluntary indication of the absence or reduced presence of gluten in food, formerly controlled by PARNUTS and by a Commission Directive, have been moved to the Food Information for Consumers Regulation (FIC).

Subsidiary legislation made under FIC now provides that from 20 July 2016 the only statements that can be used to indicate the absence or reduced presence of gluten in a food or a meal are "gluten free" and "very low gluten". The legislation defines the meaning of the statements by reference to gluten content.

The phrases "suitable for people intolerant to gluten", "suitable for coeliacs" may appear on the label, but only if the phrase "gluten free" or "very low gluten" also appears on the labelling.

The phrases "specifically formulated for people intolerant to gluten" and "specifically formulated for coeliacs" can also be used but only if:

  • The phrase "gluten free" or "very low gluten" also appears on the labelling; and
  • The food is specially produced, prepared and/or processed to reduce the gluten content of one or more gluten-containing ingredients or to substitute the gluten-containing ingredients with other ingredients naturally free of gluten.

The phrase "no gluten containing ingredients" and the acronym "NGCI" are no longer permitted.

About the Author

John specialises in risk and compliance, advising businesses in those areas of commercial life where the criminal law or penal sanctions are used to regulate business.

John Mitchell
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