Dr Pat O'Mahony, chief specialist in Biotechnology at the FSAI, said that many companies are investing considerable resources in the development of functional foods.
"This leaflet will assist the industry to understand the legal parameters currently governing such products and any claims made," he said.
Crucially, food labels cannot refer to the prevention or potential cure of a disease, as this would mean they would be classified as medicines, which come under the jurisdiction of the Irish Medicines Board.
The leaflet defines functional foods as foodstuffs "that may provide added health benefits following the addition/concentration of a beneficial ingredient, or the removal/substitution of an ineffective or harmful ingredient".
The leaflet comes not in response to awareness of many products with inappropriate labelling, but rather the FSAI has noticed that more and more products are coming to market that would be classified as functional foods. The FSAI wanted to ensure that information on appropriate labelling and regulatory approval was freely available.
In December 2004 the National Functional Foods Forum was set up in Ireland to pool industry and scientific resources and drive the sector forward. At the time, sales for the sector were approximately €100 million. The forum set out to increase this to more than €250 million in five years.
Heavyweight players in the Irish functional foods market include Glanbia Nutritionals, which has a range of specialty whey proteins and other nutritional ingredients bourne out of its R&D activities in Ireland and the US; and Kerry Foods, whose dedicated Bio-Science business unit with a clear focus on health, nutrition and food safety.
A FSAI spokesperson told NutraIngredients.com that there is a fine line between novel foods - that is, foods or food ingredients that have not hitherto been used for human consumption - and functional foods. Companies need to be aware of the differences, and the correct procedures for launching both.
While the regulatory procedures for novel foods are already in place, since the EU Novel Foods Directive was introduced in 1997, health claims regulation is expected to be forthcoming this year.
However the precise form this will take is a hotly debated issue, with the EU Parliament largely in favour of a notification procedure allowing manufacturers to put a product on the market with a specific health claim without receiving authorization in advance. If doubts were raised over scientific basis on the claim, the European Food Standards Agency would then be called on to make a decision.
The EU Council, on the other hand, prefers full pre-market authorization. This is likely to be more time consuming, and entail food manufacturers compiling costly scientific dossiers.
It is no surprise, then, that the industry would prefer the notification route, which lobbyists say would maintain consumer protection whilst also giving flexibility to food manufacturers.
There are fears that authorization would stymie innovation, and force smaller companies out of the market since they would not be able to afford the costs of compiling dossiers.
However the FSAI spokesperson said that authorization would give another level of consumer protection, and enhance consumer trust that the products they are taking are safe and effective. The authority would prefer full authorization, so that products would be checked by itself before entering the Irish market.
The FSAI leaflet on functional foods is available online