Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (foods for specific groups – “FSG Regulation”) applies as of 20 July 2016. The Regulation simplifies and harmonises the rules governing the compositional and information requirements for food intended for vulnerable groups of people, namely: infant formulae and follow-on formulae, processed cereal-based foods and baby foods, foods for special medical purposes, and foods intended for total diet replacement for the purpose of weight control. To date, these products qualified as “foodstuffs for particular nutritional uses” (“PARNUTs”) under EU law. As of 20 July 2016, the FSG Regulation replaces the PARNUTs framework and transfers certain foods under the umbrella of the EU framework applicable to normal food.

1. BACKGROUND: FROM THE PARNUTS DIRECTIVE TO THE FSG REGULATION

Historically, PARNUTs have been regulated by Directive 89/398/EEC on foodtuffs intended for particular nutritional uses, completed by recast Directive 2009/39/EC (“PARNUTs Directive”). The PARNUTs Directive establishes general rules to ensure the safety, suitability and appropriate consumer information of PARNUTs, which are characterised as “foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability”. PARNUTs are particularly addressed to cover the nutritional needs of infants (under the age of 12 months) and young children (between one and three years old), people with specific medical conditions, and people undertaking energy-restricted diets to reduce their weight.

• The main provisions adopted under the umbrella of the PARNUTs Directive include:

• Directive 2006/141/EC on infant formulae and follow-on formulae;

• Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children;

• Directive 1999/21/EC on dietary foods for special medical purposes;

• Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction; and

• Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten.

The transposition of the PARNUTs Directive into national law led to legal uncertainty regarding product classification due to diverging interpretations by the EU Member States. In some instances, food business operators have been able to avoid the application of the general EU rules concerning normal food by notifying certain products as PARNUTs in those Member States that would classify them as such. As a result, similar foods have been marketed as PARNUTs in certain Member States and as foods for normal consumption which are aimed at the general public or at specific groups of the population in others. The European Commission (“Commission”) expressed concerns about this form of “legislative shopping”, arguing that it led to market distortions affecting competition among food business operators in the EU market. Furthermore, the Commission was of the view that, due to the array of specialist foods available, the PARNUTs concept no longer reflected market reality. These factors, among others, called for a revision of the PARNUTs framework. Importantly, the new FSG regime was introduced in the form of a Regulation, in order to ensure the application of uniform rules across the EU.

2. THE FSG REGULATION

2.1 Scope and main changes introduced by the FSG Regulation

The FSG Regulation simplifies the harmonised framework governing the compositional and information requirements of food products that constitute the partial or sole source of nourishment for infants and young children, people with specific medical conditions, and people undertaking energy-restricted diets to reduce their weight. The FSG Regulation applies as of 20 July 2016. Its main rules can be summarised as follows:

• The FSG Regulation abolishes the PARNUTs concept, yet retains the objective that the composition of FSG must be appropriate to satisfy the nutritional requirements of, and be suitable for, the persons for whom FSG are intended.

• The FSG Regulation repeals the PARNUTs framework and each of the resulting specific Directives. It exclusively places within a single framework the compositional and information requirements for the following categories of food:

- Infant formulae and follow-on formulae intended for healthy infants;

- Processed cereal-based foods and other baby foods intended for healthy infants and young children;

- Food for special medical purposes intended for people with specific medical conditions (such as people with metabolism disorders); and

- Total diet replacement for weight control for healthy overweight or obese adults.

In addition, the FSG Regulation foresees the adoption of delegated acts incorporating detailed compositional and information requirements concerning FSG. Between 20 July 2016 and the dates of application of the delegated acts, the criteria set out in the specific PARNUTs Directives will continue to apply. In the case of conflict between the FSG Regulation and the specific PARNUTs Directives, the Regulation shall prevail.

• The FSG Regulation establishes a single list of substances that can be added to FSG, such as vitamins and minerals, and replaces the lists contained in the various PARNUTs Directives. It also lays down specific rules to update the list that will apply from the date of application of the appropriate delegated acts.

• The FSG Regulation strengthens certain provisions which are designed to improve the protection of the groups for which FSG are intended.

• One of the particularities of the PARNUTs Directive is the requirement that PARNUTs bear an indication of their suitability for the nutritional purposes being claimed. The FSG Regulation requires food business operators, in more general terms, to “provide information for the appropriate use of such food”. In line with the Directive, the Regulation prohibits the attribution of medicinal claims to FSG, while allowing companies to disseminate information or recommendations exclusively intended for healthcare professionals active in medicine, nutrition or pharmacy. The FSG Regulation extends this possibility in relation to healthcare professionals responsible for maternal care and childcare.

• The FSG Regulation excludes certain foods from its scope, such as gluten-free foods, on grounds that they can adequately be regulated under the EU framework applicable to normal food (such as the Fortified Foods Regulation, Food Supplements Directive, Regulation on the provision of Food Information to Consumers (“FIC Regulation”), and Nutrition and Health Claims Regulation).

2.2 Main rules established in the FSG Regulation

(a) Foods for infants and young children: infant formulae and follow-on formulae; processed cereal-based foods and other baby foods (weaning foods)

The FSG Regulation sets out general compositional and information requirements for infant formulae and follow-on formulae, as well as processed cereal-based foods and other baby foods (weaning foods) intended for healthy infants and young children, applicable as of 20 July 2016.

Infant and follow-on formulae are currently covered by Directive 2006/141/EC and characterised as follows: •

• “Infant formula” is food intended for use by healthy infants during the first months of their life and satisfying the nutritional requirements of such infants until the introduction of appropriate complementary feeding; and

• “Follow-on formula” is food intended for use by healthy infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in a progressively diversified diet of such infants.

In this respect, Directive 2006/141/EC lays down the compositional and information requirements of infant formulae and follow-on formulae (including a list of vitamins, minerals and other substances). Commission Delegated Regulation (EU) 2016/127 supplementing the FSG Regulation updates such requirements. In contrast to the Directive, the Delegated Regulation forbids the use of nutrition and health claims in infant formulae. The Delegated Regulation shall apply as of 22 February 2020, except in respect of infant formulae and follow-on formulae manufactured from protein hydrolysates to which it shall apply as of 22 February 2021. Between 20 July 2016 and the application dates set out in the Delegated Regulation, the requirements established in Directive 2006/141/EC will apply.

The FSG Regulation extends the existing restriction on the use of written or pictorial information which may idealise the use of formulae (e.g. pictures of infants) to the labelling of follow-on formulae. These restrictions were only applicable to the labelling, presentation and advertising of infant formulae. Notwithstanding this, graphic representations for easy identification and clear distinction of the formulae and for illustrating methods of preparation shall be permitted.

Processed cereal-based foods and other baby foods (weaning foods) are covered by Directive 2006/125/EC. They are designed to satisfy the specific nutritional requirements of healthy infants and young children, and are intended for use by infants while they are being weaned and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food. The Directive lays down the criteria for the labelling and composition of weaning foods (including a list of vitamins, minerals and other substances). It does not apply to milk-based drinks intended for young children. The Directive will cease to apply from the date of application of the delegated act regulating specific compositional and information requirements for processed cereal-based foods and other baby foods. In January 2016, the European Parliament objected to a Commission proposal for a Delegated Regulation setting out such specific compositional and information requirements. The Parliament called, among other things, for the Commission to review the proposed compositional requirements on sugar content as well as certain information requirements in line with the recommendations of the World Health Organisation.

(b) Food for special medical purposes

Directive 1999/21/EC lays down the rules for the composition and labelling of foods which are intended for the dietary management, under medical supervision, of individuals who suffer from certain diseases, disorders or medical conditions and whose nutritional requirements cannot be met by normal food. In particular, the Directive provides guidance on the vitamins and minerals that can be used in such specific foods, known as "food for special medical purposes" or “FSMP”.

The FSG Regulation sets out general compositional and information requirements applicable to FSMP foods as of 20 July 2016. Commission Delegated Regulation (EU) 2016/128 supplementing the FSG Regulation updates the compositional and information requirements for FSMP, including the list of vitamins and minerals. The Delegated Regulation explicitly forbids the use of nutrition and health claims in FSMP: in this respect, the mandated description of the characteristics that make the product useful for the dietary management of a disease, disorder or medical condition should neither be considered as nutrition or health claims nor as medicinal claims. The Delegated Regulation shall apply as of 22 February 2019, except in respect of FSMP developed to satisfy the nutritional requirements of infants, to which it shall apply as of 22 February 2020. Between 20 July 2016 and the application dates set in the Delegated Regulation, the criteria set in the FSMP Directive will apply.

(c) Foods intended for energy-restricted diets for weight reduction

Directive 96/8/EC lays down compositional and labelling requirements for foods intended to be used in energy-restricted diets for weight reduction intended for healthy overweight or obese adults; namely, total diet replacement products for weight control, and meal replacement products for weight control.

As of 20 July 2016, the FSG Regulation sets general compositional and information requirements for total diet replacement products for weight control, including very low calorie diets. Notwithstanding this, Directive 96/8/EC will cease to apply in practice to total diet replacement products from the date of application of the delegated acts foreseen in the FSG Regulation.

For its part, as of 20 July 2016, the compositional and information requirements governing meal replacement products are to be governed by the EU food framework applicable to normal food (such as the Fortified Foods Regulation and the Nutrition and Health Claims Regulation).

(d) Use of presticides

The FSG includes provisions to ensure that the use of pesticides and pesticide residues in FSG be restricted as much as possible. It foresees the adoption of delegated acts incorporating specific requirements concerning the use of pesticides in products intended for the production of FSG and pesticide residues in such food. To date, the Commission has set up specific requirements in respect of pesticides in infant formulae and follow-on formulae intended for healthy infants in Delegated Regulation (EU) 2016/127; as well as in FSMP intended for infants and young children in Delegated Regulation (EU) 2016/128.

3. SPECIFIC FOOD GROUPS FALLING UNDER THE EU FRAMEWORK APPLICABLE TO NORMAL FOOD

3.1 Young-child formulae

The FSG Regulation required the Commission to present by 20 July 2015 two reports on the necessity, if any, of developing specific provisions regarding compositional and information requirements for young-child formulae and foods for sportspeople.

The report on milk-based drinks and similar products intended for young children (young-child formulae, also known as growing-up milks and toddler milks) was adopted by the Commission on 31 March 2016. It concludes that there are no reasons justifying a particular role of young-child formulae when compared with foods included in the normal diet of young children who are being weaned.

This implies that, as of 20 July 2016, young-child formulae are subject to the EU framework applicable to normal food. Consequently, one can expect legislative developments in those Member States that still classify young-children formulae as PARNUTs. The Commission will monitor such developments to ensure compliance with EU law.

3.2 Food for sportspeople

Similarly, the report on food intended for sportspeople, adopted on 15 June 2016, confirms that there is no need for specific provisions for food intended for sportspeople, in that sportspeople can hardly be characterised as a specific vulnerable group of consumers but rather as a target group within the general population.

Therefore, as of 20 July 2016, food for sportspeople is to be exclusively governed by the EU framework applicable to normal food, especially by the food supplements or fortified foods regime. That being said, the Commission acknowledges that sport foods may have specific characteristics and it will monitor developments to ensure that such specificities can adequately be addressed in the application and implementation of EU food law.

3.3 Meal replacement products for weight control

As mentioned, the EU framework for normal food regulates the compositional and information requirements governing meal replacement products for weight control as of 20 July 2016.

3.4 Diabetic food

The PARNUTs Directive foresaw the possibility of adopting a Directive for foods for persons suffering from carbohydrate metabolism disorders (diabetes). A Report from the Commission dated 26 June 2008 concluded that there is no scientific basis for setting specific compositional requirements for “diabetic” food products. The FSG confirms this position and does not include “diabetic” food products within its scope. These food products are, therefore, regulated under the EU framework applicable to normal food.

3.5 Gluten-free food products

Likewise, the original PARNUTs Directive foresaw the adoption of rules for the use of terms concerning the absence of gluten. As a result, Regulation (EC) No 41/2009 was adopted. The Regulation governs the composition and labelling of foodstuffs suitable for people intolerant to gluten and regulates the conditions for use of “gluten-free” and “very low gluten” statements.

The FSG Regulation repeals Regulation (EC) No 41/2009 as of 20 July 2016. As of this date, the EU framework applicable to normal food – in particular, the FIC Regulation and Regulation (EU) No 828/2014 which lays down the specific requirements for the provision of information to consumers on the absence or reduced presence of gluten in food – regulates the information pertaining to food intended for coeliac and gluten-intolerant people. Consequently, the rules will also apply to non-pre-packed food, in contrast to Regulation (EC) No 41/2009 which only applied to pre-packed food.

Regulation (EU) No 828/2014 maintains the substantial requirements related to the use of “gluten-free” and “very low gluten” statements. It also allows the possibility of accompanying such products with a reference to their suitability (“suitable for people intolerant to gluten” or “suitable for coeliacs”, “specifically formulated for people intolerant to gluten” or “specifically formulated for coeliacs”), provided certain conditions are met.

3.6 Lactose-free food products

The FSG Regulation calls for the harmonisation of the compositional and labelling rules indicating the absence or reduced presence of lactose in food products under the FIC Regulation. To date, Commission Delegated Regulation (EU) 2016/127 supplementing the FSG has harmonised the rules for the use of the statements “lactose only” and “lactose free” in infant formulae and follow-on formulae.

4. TRANSITIONAL PERIOD

Foods in compliance with the PARNUTs rules and which are placed on the market or labelled before 20 July 2016 may continue to be marketed until stocks are exhausted.

5. CONCLUSION

The FSG Regulation simplifies the regulatory framework applicable to the composition and marketing of specific foods intended for vulnerable groups of consumers, namely: infant formulae and follow-on formulae, processed cereal-based foods and baby foods, foods for special medical purposes, and foods intended for total diet replacement for weight control. It also strengthens certain provisions to improve the protection of such groups of consumers for which FSG are intended, while reclassifying other foods under the legal framework applicable to normal food. The next few months will prove challenging as implementing rules concerning certain provisions applying to FSG are still expected to be adopted, and as the “reclassification” of certain PARNUTs as normal food may result in burdensome administrative and business costs for the food industry (related e.g. to reformulation and labelling changes).