Drowning in a sea of rules

One of the biggest costs for small businesses trying to get to grips with the Nutrition and Health Claims Regulation was the initial failure of the European Food Safety Authority (EFSA) to provide regulatory guidance for submissions under article 13 of the Regulation (which covers claims supported by generally accepted science).

This lack of official guidance has driven companies to source alternative guidance on submission issues. The European Federation of Health Product Manufacturers (EHPM) has been one such organisation that has helped to develop a template for health claim submissions to EFSA. The deadline set for EHPM to submit dossiers to EFSA is September 21, but the cut-off for submissions to the EHPM from pan-European manufacturers was late June. These dossiers can cost £15,000 or more depending on the complexity, with no guarantee of success.

In principle, this route was suitable for some businesses, but following months of work on the creation of health claims dossiers, the European Commission then requested that EFSA provide guidance for the preparation of applications for health claims under article 14 of the Regulation (which covers disease risk reduction claims and children's health and development claims).

The problem here is that many people believe the guidance about article 14 provides the best framework for submissions under article 13. As such, companies could now be hit with further bills to amend their dossiers from the EHPM framework to match that of article 14. Furthermore, just to make the whole process more complicated, local guidance being afforded by regulatory bodies differs significantly between Member States.

Questions also remain over the relationship between article 13 claims and health claims made for foods for particular nutritional uses, which are covered by a specific piece of legislation known as PARNUTS. Will these ingredients be exempt from some of the legislative rules used in article 13? The approach to inclusion of nutrients for health claims by EFSA is that of nutrient profiling, where set criteria define whether a food is classed as healthy or not. However, nutrient profiles will not be published until 2009, by which time dossiers for article 13 will already have been submitted.

One class of foods and ingredients that is currently accepted and approved by PARNUTS is food for use in situations of "intense muscular efforts" such as sports foods and drinks. The composition of many of these products includes high doses of nutrients such as sodium and sugars for hydration.

Yet, for the general population, high dose sodium may be classed as "non-healthy" and under the nutrient profiling system, these products would not be allowed to make any health claims. So the general consumer may get restricted advice vital for well-being during intense exercise.

Other nutrients that may be affected include those high in fats such as medium-chain triglycerides, which are often used to boost carbohydrate levels in muscle during exercise, thereby enhancing the duration an athlete can exercise before exhaustion.

Finally, we have The Human Medicinal Products (Pharmaceuticals) Directive (2004/27/EC), controlling the use and sale of pharmaceutical products across the EU. The big issues here could be the inclusion of ingredients such as glucosamine or fish oils if their use is deemed to be medicinal following review by EFSA. If this proves to be the case, then applications for additional product marketing licences will have to be applied for.

So, some huge issues remain relating to article 13, many of which may stifle innovation and the growth of the nutrition industry as a whole if product health claims are not accepted. The larger companies with one or two products sold primarily into mass markets with years of scientific research behind them will come out of the process very well. But the smaller companies with very little money to invest may be significantly damaged by the legislation.

Clearly, EFSA will have a huge workload on its hands and it will be very interesting to see what developments are forthcoming as the submission deadlines approach.

Dr Mark Tallon is a consultant and co-founder of dietary supplements firm CR-Technologies. Email him at: oxygenix2004@aol.com. Much of this article is from the author's market report: Dietary supplements outlook 2007: Business Insights Ltd, London UK.