04 from the editor
Herbal Shambles?
The European Commission’s recent opinion, stating that the harmonization of ingredients such
as amino acids, ginseng, essential fatty acids, enzymes, and pre- and probiotics would not be
appropriate at this point, has a number of implications for the functional food sector.
P
ieter Lagae, Regulatory Adviser at EAS, said in a recent podcast views on how they would implement the regulation. In the UK, for example,
interview that while the opinion means vastly differing regulations we tend to “gold plate” things and stick to the letter of the law quite a bit
would remain in place in the 27 Member States, harmonization more than some other countries. It’s very much a matter of interpretation.
would, in reality, be difficult to achieve. “Entering all EU markets with At LFI, we find that people are asking whether a certain point of legislation
a single formula would be the easiest option for manufacturers. Harmonization is being applied all across Europe. And, although you could apply mutual
could be the way forward into markets that are currently reluctant to accept recognition on a continental basis, I don’t think it’s fully bedded in. What we
herbal extracts, for example, and it would entail more transparency and legal try to do is to help people formulate things that comply with the law in as
certainty for companies,” said Mr Lagae. “However, the scientific demands many countries as they want. They might ask, for example, for something
for EU-wide rules might also result in harmonization for only a minimum that satisfies the regulations in France, Italy, the UK, Australia, America
number of substances.” These substances are ingredients with a nutritional or and Japan, which becomes slightly more challenging. As such, we’d do
physiological effect for which no harmonized legal framework exists. They do a full sweep of all those regulations and pick out the additives that comply
not include vitamins and minerals — which are already harmonized by the EU in all those areas, the levels of ingredients that comply with the maximum
Food Supplement Directive — food additives, processing aids and flavourings. permitted levels, and so on. It’s a tricky area and I think it’ll be a while before
The Commission’s opinion stated that rules could only be introduced for a few we get to a situation of totally free trade because of different preferences in
substances owing to the vastly differing national markets; and because there the various countries.”
are existing legal instruments that might, with time, result in harmonization, When asked about the EC’s comment that the harmonization of
such as the fortified foods and novel foods regulations and the recently ingredients such as ginseng and probiotics was inappropriate, Paul
adopted mutual recognition regulation. suggested that what they probably meant was that the process is not
To dig a little deeper and find out more about the implications of the so much “inappropriate” but very difficult. “We’ve all seen how long it’s
decision, I spoke with some members of NBT’s editorial advisory panel taking to get these nutrition and health claims — Article 13 and Article
to examine the pros and cons. Dr Paul Berryman, Chief Executive of 14 — through EFSA. Thousands have been submitted and thousands
Leatherhead Food International (LFI), is well aware of the complexities of have come back because they weren’t completed properly. Only a
formulating for a pan-European market, and beyond, but also believes that handful of claims have actually been signed off,” he added. Perhaps the
a softly, softly approach may reap greater dividends in the future. “In terms EC is postponing the issue and hoping to address such matters when
of mutual recognition,” he said, “in principle it’s an excellent idea. It means its current burden of work