While the health food industry in the UK is prepared to go all the way to the European Court of Justice to block the 2002 food supplements directive, their counterparts in Spain see it as a major opportunity to finally recognize a number of products currently outside of the country's dated legislation.
Europe's food supplements directive must be enforced throughout all member states from 1 August 2005. But UK trade associations are hoping that the European court will find it restrictive to trade through its threat to a significant number of nutrients currently available in products on the British market.
Further south however, health food associations in Spain have welcomed the directive as the first legal recognition of food supplements. And they are also lobbying national authorities to expand the scope of the directive, brought into Spanish law in October last year, to allow for a whole range of products not currently recognized there.
Spain's supplement market lags far behind that of France, Germany, Italy and the UK and just 8.2 per cent of the adult population uses vitamins and supplements, according to Mintel. This compares to around 40 per cent in Germany.
While this can be partly blamed on a lower interest in health issues - the Spanish are less inclined to take great care of their health and will visit the doctor for advice and treatment of minor ailments - the current regulatory framework has significantly stifled new product development and product launches.
Current laws fail to recognize a number of herbals and functional food ingredients that have in fact previously been allowed on the market.
The complex laws governing herbals in Spain date to 1973 when the country first established a list of medicinal plant preparations that did not need to file for drug registration. The 100-odd products, excluded all plant extracts and other active plant parts as well as combinations.
Excluded products, such as ginseng, were initially permitted on the market under a far-reaching dietetic foods law from around the same time but this was then replaced by Europe's Parnuts regulation, creating a much stricter definition of 'dietetic' foods.
It left numerous ingredients like taurine, CoQ10, carnitine and isoflavones, in a legal grey area. Those on the market prior to Parnuts are legal; those introduced later are not because no current law recognizes them.
In addition, Spanish authorities have since 2002 decided to enforce a later regulation, published in 1990, to regulate herbals.
This law sought to create a 'traditional plants' category as distinct from registration drug products. But having no references for 'traditional plants', the regulators have looked to the herbal preparations listed on the annex to the 1973 law, despite no mention of 'traditional' under this list.
The large gaps in herbals law have led to numerous product recalls in the last two years. Consultant Anthony Garcia estimates that more than 1000 products have been taken off the market between 2002-2004. This includes around 100 herbal products in April and a further 12 sports supplements last month. They included glucosamine, ginseng, ginkgo biloba, valerian and dandelion.
"For a rational person it is very difficult to understand why ginseng can be on the market if registered under an older law, but not introduced under a different brand name because of application of a newer law," Garcia told NutraIngredients.com.
"Companies have accepted the risk but it is like a game of Russian roulette," he added. "And it certainly impacts the dynamics of the market."
But since February, the trade association AFEPADI (Asociacion Espanola de Fabricantes de Preparados Alimenticios Especiales, Dieteticos y Plantes Medicinales) has been in discussions with Spain's food agency, requesting that it widen the annex of the food supplements directive to include some of the many ingredients currently not permitted under national law.
"It will take a long time but could be faster than changes to the medicinal laws," said Garcia.
For herbals (under medicine law), the industry can only hope that the Commission moves fast on adding these to the supplement directive's list of permitted nutrients, which so far only includes vitamins and minerals.
"We have had assurance from the Commission that herbals will pass before other ingredients like amino acids."
The Spanish industry will need to maintain pressure on both national and European authorities if it wants to curb the ongoing recalls and sluggish growth.
In a report on the vitamins and minerals sector last year, Mintel said Spain's VMS sector "should offer much potential. Take up of products is low and Spanish society is changing, with the growth in a young urban population who lead a busy lifestyle and who are more aware and concerned about their diet."
"However, despite this, the market has struggled to grow significantly, with the market only reaching €101 million in 2002 and has not made much headway since. Indeed, the forecast…shows that the market will remain at approximately this level for the next four years."