ANH-Intl responds to EFSA consultation on its proposed revision of guidance for positive list applications
For those who’ve watched closely the issue of EU regulation of nutrients over the last decade and a half, you’ll recall that dozens of vitamin and mineral sources were effectively banned as food supplements by the passage of the EU Food Supplements Directive back in 2002. The reason? They didn’t make their way onto a positive list of permitted nutrients. In true, ‘boil the frog slowly’ EU style, it took a further 8 years for the ban to be implemented. Among the nutrients that disappeared were all forms of vanadium and silver, the majority of forms of boron and big slather of many mineral amino acid chelates including the forms used as intermediates most directly by the Krebs cycle in our all-important energy-producing organelles, our mitochondria.
Saving natural sources from the EU abyss
By taking a case to the High Court in London and then to the European Court of Justice, we established acceptance by the European Commission, but not until 2007, that natural sources of vitamins and minerals were outside of the scope of this EU law. In the process, these natural sources of ingredients were rescued from the EU’s abyss, and that’s very good both for freedom of choice and for public health, given these types of nutrients are increasingly being demonstrated as among the most beneficial as they are derived directly from food sources. Examples of these ‘rescued’ vitamins and minerals include B vitamins from meat sources, and various forms of calcium, magnesium or iodine from seaweeds.
EU obstacles to freedom of choice
While the European Commission has always upheld it didn’t impose any bans, what it did do is present an obstacle to additional nutrients being admitted to the positive list of permitted nutrients that effectively acted as a barrier, especially to smaller companies with less resources. The obstacle has existed since 2001 as a guidance document that provides information on the data requirements for any company wanting to have a new vitamin or mineral form added to the positive list. The guidance was produced not by the European Food Safety Authority (EFSA) which evaluates the dossiers, but by its predecessor, the Scientific Committee on Food (SCF) of the European Commission.
It’s therefore wholly appropriate EFSA puts out a public consultation asking for inputs from interested parties on how a revision to the guidance should be made. Whether it listens to concerns is of course another matter. The deadline for submissions was today, and ANH-Intl has made a submission. It was a perfect opportunity for ANH-Intl to make EFSA again aware of the relevance of the work in which we commissioned the Dutch research organisation, TNO, to develop a new risk/benefit model for micronutrients.
Trying to dismantle barriers to freedom of choice
Among the key points which we have raised in our consultation response are the following:
The safety of the intact source must take into account, where appropriate, the food matrix with which the nutrient might be consumed. If an ingredient can be made safe by consuming it with food, the maximum permitted dose of the nutrient should not be limited to a dose that might give rise to an adverse reaction if the ingredient was consumed on an empty stomach.
Bioavailability should be part of the safety assessment, not a separate part. In our own case in the European Court of Justice, the court ruled that the only factors relevant to assessing whether or not a nutrient should be available for sale were its safety and bioavailability. The minimum requirements should be clarified for each of these, and these procedures should not be in any way onerous as that would pose unnecessary restrictions on trade and consumer freedoms.
There should be no requirement for animal studies. Where adequate human data are available, these are all the data that should be required. Animal data are not only less reliable than human data given physiological differences between animal species and humans and associated translational difficulties, animal studies are increasingly viewed as unethical and wasteful.
There should be an opportunity to provide data on the risk/benefit profile of the nutrient, where applicable. This is because without consideration of benefit, EFSA evaluations end up centring on the most sensitive risk factor among the most sensitive groups of people, this being a major feature which we exposed in our 2010 Toxicology papers, as follows: