State of the union

It's probably one of the most notorious 'euro-myths' of them all: the European Union (EU) banana directive. The hoax, perpetuated by various British tabloids, was that EU officials had issued a law that imposed draconian regulations governing the shape of bananas coming into the EU. It was hailed as a classic example of out-of-touch 'eurocrats' making petty rules about an issue that didn't need to be addressed.

In reality, there was little truth to the tale, the story stemming from a misreading of European Commission legalese, but it goes to the show the extent to which the EU's 'harmonisation' attempts - bringing the complex, and sometimes contradictory world of European regulation of the food industry under one roof - has been met with incredulity, and resistance, by naysayers.

But harmonisation is taking place in response to the strong differences in how the rules work across Europe. Some member states take a more laissez-faire approach, opting to let supranational bodies take the lead, while many others choose to impose strict rules in addition to those decided by Brussels.

"It can be very, very different between member states," says Patrick Coppens, who works for Food Supplements Europe, a trade body based in Brussels, at the heart of the regulatory system. "For some, there are no rules at all and no specific legislation," he says. "This means companies can just enter these countries with any product they want, provided it's in conformity with legislation on a European level that exists, and are free to formulate their products in any way they want."

Coppens has been navigating this world for a while now. An expert in international food and health law, with a particular focus on scientific issues, he advises industry clients on how best to work within the complex rules that govern the safety and security of supplements and botanicals across Europe. These industry clients come in a number of forms, from national industry associations representing businesses on a country-by-country basis to individual companies interested in getting an edge over competitors.

"These can be companies involved in one or more aspects of food supplements," he says. "Some of them are end-product or food-supplement manufacturers, others are sellers of food supplements and some are the companies that supply food supplements with raw materials."

"It is a significant task for companies who want to market food supplements throughout the whole EU to navigate through all this national legislation."

The feeding's mutual

This disparity in the rules a government might choose to impose on its food industry can seriously compromise the EU's central principle of free trade between member states, Coppens argues, which is why it has become such a priority. While in theory the EU is supposed to operate an open border system with no restrictions on interstate commerce, a product coming from the UK, where there's complete freedom to formulate it in any way, could find it hard to get on the market for sale in stricter countries such as Belgium, France, Italy or Spain.

"The UK, the Netherlands or Sweden, for instance, are examples of countries with no legislation on food supplements," says Coppens. "That's one extreme; the other is countries where you have very strict legislation."

This presents real legal challenges. Protectionism is anathema to the principles of the EU - founded, after all, as a free trade area for steel and coal - and it's in situations such as this where the European Commission is, occasionally, forced to intervene. But there's only so much it can do, says Coppens, and the top-down approach faced strong opposition from business and workers organisations.

"At the start, the European Commission had the intention of harmonisomg everything, which led to a lot of criticism," he explains. "The Commission realised this approach was an illusion and that it would be far better to leave national legislation in place in some instances."

This led to a change of tack, one that recognised the variety of the EU but also, through a clause in the regulation known as the principle of mutual recognition, that member states are, in most instances, obliged to accept any product that is lawfully manufactured or marketed in another member state.

"There are still barriers to trade," says Coppens. "Member states can be very reluctant to allow these products, and they often hide behind safety to not apply mutual recognition. For companies, that can be very difficult, and it's tedious to try to challenge that.

"But in principle, today, mutual recognition for food works quite well, and there are, at least in the area of general foods, not so many barriers to trade anymore."

Supplemental difficulties

However, this isn't strictly the case when it comes to supplements - Coppens's area of expertise - which have, in theory at least, been harmonised since 2002 through the rules that govern their labelling, the nutrients that can be used in them and what chemical forms are allowed. The EU's authority ends there, however, and the complexity of the supply chains involved means that some regulation is consistent across the free trade area and some isn't.

"For dietetic foods, the EU has tried to harmonise them completely, and they have succeeded to a certain degree," Coppens says. "But a lot of aspects of food supplements have not been standardised. Aspects like the maximum levels of nutrients allowed, what other substances and non-nutrients can be used, or which botanicals can be used - these are still subject to national legislation; they are not harmonised, and the rules are often divergent between member states."

Crucial to understanding the regulation and how it has developed in recent years is the food supplements regulation directive passed by the European Commission in 2002. This, and associated legislation, established the European Food Safety Authority, a body, completely independent of the Commission, tasked with risk assessment of food and ingredients.

"It also lays down responsibility with food operators, so it covers the whole food chain, and each link is responsible for the safety of the product it is producing," Coppens adds. "There are also requirements that if a product is thought to be unsafe, then authorities must be informed, and companies must have systems for traceability, and for recall or withdrawal of these products from the market."

A lot of these regulations were already in place in various member states, and Coppens points to the EU's 1997 rules on novel foods, which ruled that any new product substantially different from one that already exists has to undergo important pre-market authorisation procedures and safety assessments, and then requires a decision by the Commission and member states about whether the food is accepted on to the market.

A dose of reality

The supplements business offers plenty of its own unique challenges not usually faced by other members of the food industry, too.

"We're in a very specific category; we are regulated as food, which we are of course not," Coppens says. "These products are not food like you would eat in the morning, at noon or in the evening, so that means that they have some specificities."

A major concern lies in their multiple formats, which range from pills to tablets, capsules, powders and liquids. This variety presents distinct challenges, and in many instances, the specificities of the different forms are not taken into consideration by regulators, according to Coppens.

His industry faces real issues with legislation relating to the classification of products, which is crucial because it dictates what kinds of additives are allowed to be added. Another issue the sector faces is that the products are concentrated sources to be taken in very small dosages, typically of only a few grams. This poses challenges when it comes to transposing values as, by regulation, everything is expressed by 100g or 100ml.

Food Supplements Europe often finds itself facing these problems head on, working with regulators at the policymaking levels and offering advice. A hot topic at the moment is the issue of the regulation of botanical supplements, another area where there are strong discrepancies between what the EU and national governments say.

"That is something we are now working very hard on to ensure that a legal framework is being established that is appropriate for that kind of product," Coppens says, "and the framework is adopting more or less the same principles that have already been accepted under medicinal law and are used in medicinal products."

Supplements can be a contentious subject, and a new wave of illegal, and dangerous, supplements flooding the EU market is driving worries about their safety. Sold primarily over the internet from outside the union, a number of these products are adulterated and of very low quality, likely to be totally ineffective.

"This undermines the credibility of the genuine food supplement manufacturers in the EU," says Coppens. "This is an effort that should be stepped up in order to try to chase these products and manufacturers, and keep them from the market."

The whole food industry is concerned with safety, and the illegal supplements issue makes it all the more important. Harmonised safety assessments are becoming the standard, which means that any issue with an ingredient within a product is ultimately going to end up before the European Food Safety Authority, where standards are rigorous. This poses real organisational and logistical challenges for companies.

"In these instances, a lot of data and a lot of information on the current uses is required," Coppens says. "This is not always immediately available, so we are increasingly trying hard to collect data and information to put that into the process."

Creating a single market from the myriad traditions and economic perspectives that exist within the

EU was never going to be easy, and the ways in which food and food supplements are regulated across Europe can be complicated - but the harmonisation that was accomplished in the past few years has already changed a lot. From businesses and regulators to customers - who can increasingly enjoy standardised consumer protection standards across the entire region - it has made life easier for everyone.