Special Nutrition Food

The increasing overlap between foodstuffs intended for particular nutritional uses (“PARNUTs”), including sports foods or “foods intended for the expenditure of intense muscular effort” and other categories of food, including food supplements, is at the origin of the abolition of the whole category of PARNUTs and its replacement by Regulation 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control ("Food for Specific Groups"), which entered into force on July 20, 2016.

Weight management foods

Commission Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction lays down compositional and labelling requirements for foods presented for use in energy restricted diets that are total daily diet replacement or individual meal replacement for weight control. The claims that may be made on these types of products are very limited.

Regulation 609/2013 entered into force on July 20, 2016, and applies only to products on the total diet replacement for weight control (also known as low calorie and very low calorie diets). The Commission also adopted specific measures detailing compositional and labelling rules for these products through Regulation 2017/1798, which enters into force in October 2022.

Foods for special medical purposes

These foods are intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods.

Regulation 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (“Food for Specific Groups”) sets out rules for the composition and labelling of foods that are specifically formulated, processed and intended for the dietary management of diseases, disorders or medical conditions of individuals who are being treated under medical supervision.

Success Stories

We represented the world's top dairy producer in a high profile application for the use of the term "probiotic"; in the EU, coordinating the work in several EU countries

We represented one of the global leaders in the life science markets refuting a forthcoming Spanish policy directly affecting one of their top-grossing ingredients, by filing a complaint before the European Commission

We represented one of Japan's largest food-processing companies in the impact of new GMO rules for their products in Poland and Russia

We advised one of the world's leading companies in the healthcare and medical products industry with their communication strategy on health claims on their flagship line of products

We performed the regulatory due diligence in a multi-million dollar acquisition of a food ingredients producer by an animal by-products processing company

We represented one of the world's fruit and fruit juice manufacturers on the conformity of the labelling of their new products in several jurisdictions

We advised the world's number one online food supplement store in their expansion in the EU with their own line of products

We analyzed composition and labelling of their products, classified them and placed them on several EU countries

We represented a publicly traded pharmaceutical company based on several food policy issues such as advertising claims, withdrawals and recalls and the placing on the market of novel food

We advised one of the world's largest food ingredients companies on a high profile, highly confidential issue with one of their top-grossing products in a EU country

We assisted a food sector association in advocating a policy revision by the European Commission in relation to health claims

We helped one of the world's leading pharmaceutical companies with the negotiation with the authorities in connection with the withdrawal of one of their flagship products from the market

We helped several governments to draft several food safety policies

01 / 13

Latest
Local News

Food additive occurrence data in food and beverages intended for human consumption

European Union

Mar 30, 2023

Canarium indicum L. dried nuts authorized as a novel food

European Union

Mar 24, 2023

Roasted and popped kernels from the seeds of Euryale ferox Salisb (makhana) authorized as a novel food

European Union

Mar 22, 2023

Health claim referring to the reduction of disease risk authorized

European Union

Mar 22, 2023

Protein requirements for infant and follow-on formula manufactured from protein hydrolysates published

European Union

Mar 22, 2023

See all news

FREQUENTLY ASKED QUESTIONS ON WEIGHT MANAGEMENT FOODS IN THE EU

What products fall into the category of weight management foods?

According to Article 1(2) of Commission Directive 96/8/EC, weight management foods, also called foods for use in energy-restricted diets for weight reduction, are products presented as a replacement for the whole of the daily diet and as a replacement for one or more meals of the daily diet.

These products can be presented under various forms such as shakes, soups, custards, ready to drink shakes and snacks. However, the form chosen does not involve the rules that the product must abide by.

Should these products be sold under certain names?

Yes, pursuant to Article 5(1) of Commission Directive 96/8/EC, products intended to replace the whole of the daily diet must be named “total diet replacement for weight control”. Likewise, products intended to replace one or more meals of the daily diet shall be designated as “meal replacement for weight control”.

Is the composition of these products regulated?

Yes, according to Article 5(2) of Commission Directive 96/8/EC, they contain mandatory particulars like the available energy value expressed in kJ and kcal and the average quantity of each mineral and vitamin listed in Annex I of the Directive.

Annex I also details their maximum and minimum energy, macronutrient, dietary fibre and vitamins and minerals requirements.

May these products be used for an unlimited period of time?

No, Article 5(2) of Commission Directive 96/8/EC stresses that for total diet replacement products must bear a statement saying that they should not be used for more than three weeks without medical advice.

On the other hand, individual meal replacement products are not subjected to a specific period of use.

May these products set references to the rate or amount of weight loss resulted from their use?

No, Article 5(3) of Commission Directive 96/8/EC forbids such endeavour. It means that neither the labelling, advertising nor presentation of the products may make such references.

6. Does Regulation 609/2013 apply to individual meal replacements?

No, Article 1(1)(d) of Regulation 609/2013 specifically includes total diet replacement for weight control and de facto excludes individual meal replacements.

Are there restrictions in place to prevent to the use of specific substances in total diet replacement products?

Yes, Article 15 (1) of Regulation 609/2013 restrains the categories of substances that may be used in these products. These substances are vitamins, minerals, amino acids, carnitine and taurine, nucleotides, choline and inositol.

The Annex of Regulation 609/2013 also establishes the Union list of permitted substances that may be used for these products.

However, this list does not apply to individual meal replacements.

Are there further specific rules applicable to total diet replacement products?

Yes, Delegated Regulation 2017/1798 lays down compositional requirements, requirements for labelling, presentation and advertising and notification requirements for placing the product on the market applicable to these products.

However, pursuant to Article 9 of Delegated Regulation 2017/1798 this regulation will only apply from 27 October 2022. It means that meanwhile the rules specified in Regulation 609/2013 remains applicable.

Are there specific rules applicable to individual meal replacement products?

Yes, Delegated Regulation 2016/1413 imposes additional conditions for the use of the two claims related to weight loss and weight maintenance for meal replacements.

These claims are the following:

“Substituting one of the main daily meals of an energy restricted diet with a meal replacement”; and
“Substituting two of the main daily meals of an energy restricted diet with meal replacements contributes to weight loss”.

May weight control management products be notified automatically notified in all Member States?

No, pursuant to Regulation 609/2013 these products are to be notified in each Member States where the food business operators intend to place them.

Special Nutrition Food

Success Stories

Latest Local News

FREQUENTLY ASKED QUESTIONS ON WEIGHT MANAGEMENT FOODS IN THE EU

Get in touch

Latest
Local News