In adopting the new EU Directive on Food Supplements last week the European Parliament laid the foundations for a period of developing legislative stability for companies involved in food and health ingredients. Considered by some as far reaching and others as not far enough, the directive certainly stirred up some strong opinions and intense lobbying.
In a bid to unravel the bureaucratic text of the new directive we spoke with Stefanie Geiser, Regulatory Affairs Manager at the European Advisory Services in Brussels. The service has just published a comprehensive report that summarises the directive and examines the impact on the food industry. Geiser explained the implications the text would have on the food and health ingredients slice of the food industry.
FN: What are the key points of the food supplement directive passed by the European Parliament this week? SG: The key impact of this new directive is that it provides a framework for food supplement regulations at a European level. It is a positive step which has opened up some significant opportunities for cross border trade.
But generally it is still not easy for companies to market food supplements across Europe.
FN:The new legislation brings a much needed harmonisation of national laws to the marketplace. For years cries of change have been heard from companies wishing to trade between Member States. A fleet of different laws from one country to the next has made the effective marketing and selling of products far from efficient and a positive juggling act.
SG: Soon companies will be able to sell pure vitamin and mineral products that conform to the list across the borders of existing Member States, without the need for reformulation. Currently due to diversified laws at a national level, ingredients companies may sell one product in one European country and are then obliged to reformulate this same product in order to sell it to a different member state. The new directive will open up the market.
A crucial point to bear in mind is the opening up of previously "restrictive countries".Some European countries have legislation that forbids the use of a certain vitamin and/or mineral that is actually allowed elsewhere in Europe. These countries will now be forced to open their arms to products on the list. A good example is selenium - there are many Member States who do not permit it now but who will be obliged to do so very shortly.
FN: When will it be law? SG: The Parliament passed the directive on Wednesday and it will now return to the Council of Ministers. Although the Council has in fact already approved the text because the Parliament amended one aspect of the directive it must shuttle back to the Ministers for a final approval. It's a co-decision procedure - the parliament and council need to adopt it together - but this is only bureaucratic. So, we have estimated that it could be May, or perhaps earlier - it all depends how quickly they work.
Once approved the directive becomes law twenty days after publication in the Official Journal. The directive must be introduced into the national law of Member States after one year of publication in the OJ.
For the moment the directive only covers vitamins and minerals but companies working with food and health ingredients are keen to see amino acids and fatty acids swiftly included. The Commission has hinted that they will be next on the list. In fact the Commission has five years to develop the lists of other ingredients categories and substances for inclusion in the Directive.
The list of permitted vitamins and minerals included in the EU directive was in fact directly lifted from the PARNUTS (foods for particular nutritional uses) list. The Commission used this as a basis.
Any vitamins and mineral substances that do not feature on this list have up to three years to submit a safety dossier. It is certainly in the interest of the ingredients companies to get their dossiers in within the three years because, although the SCF will always accept the dossiers, they will take those received within three years as a priority. The SCF has a total of seven years to complete the first review of vitamin and mineral substances. For an ingredients company keen to market its product the delays could be significant if prompt action does not occur.
FN: And National Authorities? SG:National authorities have the option to provide an exemption of 7 years for companies wanting to use and market their products that are not included on the EU list but who have submitted a dossier. The reaction from different governments is varied. The more liberal UK has agreed to the exemption and will allow companies to go ahead and market/use the products whereas Germany is unlikely to allow the exemption.
FN:How will it work? SG:One of the most significant aspects of this new directive lies in the definition. The definition of food supplements includes substances with a nutritional or physiological effect. The 'physiological' aspect opens up the definition to herbals and is henceforth a platform for recognition.
The next step? The European Scientific Committee on Food (SCF) is currently studying the upper safe levels for the consumption of vitamins and minerals. They must evaluate the level at which no adverse effect occurs. The SCF results should be ready by end of the year, beginning of next year. The European Commission and Member States will then need to do a risk management analysis and develop final maximum limits for vitamins and minerals in food supplements.
FN: What about the future for health claims? SG:Eight European countries have recently developed national guidelines on health claims. These include Austria, the Netherlands, Finland, Spain, Sweden, Switzerland, Belgium and the UK.
Most countries have now recognised the use of nutrient function claims and claims related to the maintenance and promotion of good health (so -called "enhanced function claims").
The relatively new concept of disease risk reduction claims (eg. "may help lower cholesterol levels") has also started to appear in the national guidelines of Belgium and the UK. Significantly there are currently discussions going on within the Council of Europe [advisory body that provides guidelines, composed of 15 Member States plus 25 other European states] and the Codex Alimentarius. The Council of Europe has already issued health claim guide that includes disease risk reduction claims. But essentially the issue is a policy question - food or medicinal? This is the heart of the debates.
The food supplement industry looks set to enter a dynamic period of change. In Stefanie Geiser's words: "This is a platform for the functional food and food supplement industries for regulatory recognition across Europe. The Directive represents an important step forward and a framework at European level to start more discussions."