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Ripping the red tape

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Related tags: European union, Efsa

They say that patience is a virtue. But when it comes to the
regulatory process on both sides of the Atlantic, patience too
often results in dust gathering in the "to do" box on some
regulator's desk.

Calls for improvements to the approvals process in the EU and the US are getting ever louder, but industry butting heads with regulators is not the answer. Talking and listening will get the results we all need. When Portugal took over the reins of the EU presidency in the summer, the Confederation of Food and Drink Industries of the EU (CIAA) released a memo outlining the group's lobbying agenda. Top of the list was reform to cut red tape. Nine months earlier the Alliance for a Competitive European Industry (ACEI), which counts the CIAA as one of its 11 sector associates, issued a statement calling for better regulation. One assumes better​ means more efficient. So is anyone listening? Of course they are. The root cause of the problem is resources. Regulatory bodies across the globe are crying out that they are understaffed, under-funded, and over-worked. They do however manage to react quickly when an 'emergency' pops up, like first aspartame kerfuffle in 2005. In this case, the EU regulatory body, European Food Safety Authority (EFSA), said it was prioritising the issue, and promptly issued a verdict. Something similar is now occurring in response to the study linking certain food additives to hyperactivity in children. A verdict is expected in January 2008. If the regulatory bodies can react quickly to such issues, why are people still moaning? And why does 'cleaning up' regulation still top the wish list of many in the industry? The reason is that, despite fast reaction to these high-profile issues, the everyday hum-drum of the approvals process is a long, drawn-out process, which continues to frustrate many in industry. This is not a criticism of the workings of regulatory bodies such as EFSA or US Food and Drug Administration (FDA) because their work is a necessary and commendable part of the food industry. The food industry cannot function without regulation. Self-regulation is one thing but the public wants and needs an independent body overseeing everything. A strong, efficient and independent regulatory body is worth more to everyone than a weak and watered down agency, or self-regulation. Consumer confidence in food, whether that being the health claims on labels or the safety of ingredients, is key. Indeed, regaining the public's trust after the BSE and dioxin scares was the raison d'être behind EFSA's creation in 2002. However, it is increasingly clear that the current structures in place are not working as well as they should be. If it's broken, strap on the tool belt and fix it! Take, for example, the recent decision by the UK's Food Standards Agency (FSA) to refer Cargill's vegetarian glucosamine hydrochloride ingredient to further review by EFSA prior to granting novel food status. Europe's novel foods regulation (EC No 258/97) was introduced in 1997 and requires that any food not commonly consumed in the European Union prior to May 1997 be subject to rigorous safety assessment before it can be brought to market. At present this requirement is applicable even for traditional food for which there is information on safe use outside the EU. Applications can be made to either national agencies or EFSA. The vegetarian glucosamine ingredient is approved for use in the US, with FDA approving its self-affirmed GRAS (Generally Recognized As Safe) status in March this year for certain food and beverage applications. It has also been widely used in dietary supplements since 2004. But since no evidence was apparently presented as to how the ingredient affects glucose metabolism, a concern for diabetics, the FSA has asked EFSA to review it further. This will put approval back - for how long? No-one knows. One company, in attempting to carve out a new market for its apparently unique ingredient, will now see its ingredient weighed down in red-tape in Europe, while in the US the innovative step into food and beverage applications will continue. So should we relax the novel foods regulations? Well, if you listen to various industry experts, relaxing the regulation will drive trade, increase competition, and boost innovation. A proposal has been made by the European Commission itself to ease regulations in an attempt to do just that. The news has been welcomed by many in the industry as the first breath of the winds of change. In the US, the situation is the same but different. Approval can take years, producing similar frustrations as experienced in Europe, but GRAS (Generally Recognized As Safe) approval is relatively fast in arrival. However, the FDA's make-up has been criticised by some as being more susceptible to political and lobby/industrial pressure. Regardless of how much truth there is behind such statements, comments of this sort can only undermine confidence. Another proposal being mooted is the charging of fees for processing dossiers. This is a step in the wrong direction. When people start paying for approval, they usually expect a positive reply. Financial gain or assistance for the regulatory authority is not the way to do it. Others feel the same. The times they are a changing however. According to EFSA, recruitment is going ahead to bring up staffing levels to the full complement of 400 employees. This should, in theory, result in improvements. Increased scrutiny of the workings of FDA should also improve the process. Both sides are aware of the problem. By working together both sides can get closer to the kind of system they feel is needed. For the moment, we must leave it up to those in the driving seat. Have patience, change is coming. Stephen Daniells is the Science Editor for NutraIngredients.com and FoodNavigator.com. He has a PhD in Chemistry from Queen's University Belfast and has worked in research in the Netherlands and France. If you would like to comment on this article please contact stephen.daniells'at'decisionnews.com

Related topics: Regulation

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