On 29 June 2013, Regulation 609/2013 concerning foods intended for special groups (the "FSG Regulation") was published in the EU's Official Journal. The FSG Regulation is designed to control foods intended for infants and young children, foods for special medical purposes and foods intended as a total diet replacement for weight control. The FSG Regulation will repeal and replace 6 EU directives and 2 EU regulations which currently regulate the marketing of these foodsuffs, which are at present known as "foods for particular nutritional uses" ("PARNUTS"). The new rules will apply from 20 July 2016.

A European Commission (the "Commission") review of the PARNUTS regime in 2011 found increasing difficulty in the interpretation and implementation of the rules, creating an inconsistent regulatory approach across the EU Member States. Many of the product specific laws under the PARNUTS regime have been overtaken by the development of horizontal EU rules on food supplements, food fortification, nutritional and health claims and, most recently, the new Food Information Regulation ("FIR"). The detailed rules under the PARNUTS regime were also perceived to have caused a considerable administrative burden for food businesses. More generally, the 2011 review of the PARNUTS regime also favoured a policy shift away from developing more legal categories of dietetic foods and towards a greater emphasis on promoting a healthy and balanced diet based on conventional foods and exercise.

Infant formula and follow–on formula

Rules concerning infant formula and follow-on formula have been streamlined under the FSG Regulation. The specification in relation to protein sources for both products, which currently exists under the PARNUTS regime, will be dropped under the FSG Regulation. The FSG Regulation will also remove detailed restrictions concerning the advertising and marketing of infant formula and follow-on formula, such as point of sale advertising or the use of promotional gifts. There will no longer be a requirement to include a notice on infant formula or follow-on formula referring to the superiority of breast milk or a recommendation that the product only be used on the advice of independent medical professionals.

However, the use of images of infants, or other pictures or text which idealises formula will remain prohibited. However, under the FSG Regulation the Commission does retain the power to develop further rules on promotional and commercial practices in relation to this category of foodstuff before 20 July 2015. It remains to be seen whether the Commission re-introduces many of these restrictions through secondary legislation.

Other Foods for Special Groups

All of the current specific legislation relating to baby food, food for special medical purposes and total diet replacements for weight control will be repealed. However, the regulation of the composition of these products will continue in the form of a detailed EU list of permissible substances for each product type under the new FSG Regulation. However, as with infant formula, the Commission retains the option of introducing further rules on the labelling and presentation of all of these products before 20 July 2015. The Commission is also empowered to adopt extra rules governing the type of nutrition and health claims made on foods for special groups.

In relation to foodstuffs which are total diet replacements for weight control, the existing distinction between products presenting a replacement for the whole of the daily diet and products presenting a replacement for one or more meals of the daily diet will be abolished. In future, meal replacement claims will be regulated by the EU's Regulation on nutrition and health claims Regulation 1924/2006.

Previous attempts to develop a common EU approach to foods for diabetics will be discontinued under the FSG Regulation. A report produced by the European Commission in 2008 found that the scientific basis for setting specific compositional requirements was lacking. Any foods containing claims aimed at diabetics will need to comply with the requirements of the EU's Regulation on nutrition and health claims.

The FSG Regulation will repeal Regulation 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant of gluten. In future, the rules in relation to 'gluten-free' and 'very low gluten' will be contained in the FIR. The Commission will be required to produce legislative proposals to provide for this new arrangement. In particular, the Commission will need to consider the different approaches to regulating foods that are specially produced, prepared and/or processed in order to reduce the gluten content and foods which are made exclusively from ingredients that are naturally free of gluten.

Milk-based Products for Young Children and Food for Sportspeople

The FSG Regulation places a legal obligation on the Commission, in consultation with the European Food Safety Authority, to produce a report by 20 July 2015 on the need for regulation of milk-based drinks and similar products for young children, i.e. growing up milk. A similar legal obligation exists in relation to foods intended for sportspeople, despite the fact that previous efforts to reach agreement among the EU Member States on the regulation of such products failed.

Conclusion

The FSG Regulation thus provides a framework for the development of a more streamlined and simplified approach to foods for specific groups over the next 3 years. With considerable scope given to the Commission to develop further and more comprehensive implementing rules in relation to all of the sectors set out above by 20 July 2015, industry must now be proactive in ensuring its priorities are clearly communicated to national and European policy-makers.

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