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News - Food Supplements Directive - New Year - new rules!

By Karen Wilson BSc(Hons) MSc NutMed

Back in 2005, the Food Supplements Directive was published and, for the first time, supplements were legislated for separately to food. The European Food Safety Authority (EFSA) sought to ensure that only safe nutrients were used in supplements. What we got was something much worse!

The original directive contained two lists, one of vitamins and minerals considered essential and one of acceptable sources, which EFSA considered safe. Most minerals listed were inorganic oxides and carbonates.

There were many notable omissions from these lists: boron and vanadium on the essential nutrient list plus many hundreds of sources, mostly organic and bio-available such as chromium polynicotinate, all vanadium sources and all the mineral amino acid chelates.

The health food industry was invited to submit dossiers for those ingredients not on the list and these were given derogation until 31.12.09. Hundreds of dossiers were optimistically submitted to EFSA in 2005 and, for nearly four years, all went quiet!

During 2009, EFSA finally published its opinions on these dossiers. Many of the mineral sources were not given the approval we had all hoped for.  But there were some positives, such as calcium ascorbate.

EFSA wanted to be able to characterise the minerals in purely chemical terms and also considered safety evidence in its criteria.

Food cannot be characterised by a chemical formula and so the amino acid chelates derived from food proteins, such a soya, were not given approval. Tradition of safe use was not considered as evidence for safety. I suspect if you presented them with an orange as a source of vitamin C it would be rejected because it could not be chemically characterised in the way ascorbic acid can!

Chromium polynicotinate was rejected on safety grounds, but it is hoped that the manufacturers will challenge this. Vanadium was also given the thumbs down on safety concerns. Not good news for those of us who value these nutrients for optimising health. The only glimmer of good news is that boron has been accepted as essential but with less than ideal sources - sodium borate and boric acid.

It is a sad fact that many nutrients, not given a positive opinion, will cease to be legal at the end of the derogation period and will disappear from the shelves in the early part of 2010.

The loss of amino acid chelates will be a major concern to many. These were a favoured mineral source because of the body’s ability to absorb more efficiently the minerals bonded to amino acids in proteins. Inorganic sources of minerals are no substitute for those whose digestive systems have poor absorption capacity.

Food-based nutrients are the obvious alternative and will still be available from Higher Nature under the True Food® label.

Even More Regulation?

The next phase of the Food Supplements Directive is the setting of maximum permitted levels for vitamins and minerals, which is being considered at the same time as the addition of vitamins and minerals to foods. The outcome of EFSA’s deliberations on this will be known in the early part of 2010 but, if based on safety as we think likely, should not affect Higher Nature supplements, with the possible exception of those containing vitamin B6. The lobbying, which we all did back in the 1990s, has fallen on deaf ears and this vital vitamin will almost certainly be restricted to minimal daily intakes within a year or so.

No other nutrients groups are likely to be looked at by EFSA in the way they have the vitamins and minerals so, thankfully, we will not have lists of approved amino acids, antioxidants and phytonutrients to contend with.

There are new regulations; introducing new RDAs, new labelling rules, new definitions for fibre - the list is endless. However, these have little real impact on the end user. But 2010 will also bring significant restrictions, as a result of Nutrition and Health Claims Regulation. This dictates what can and cannot be said about the function and use of products on labels and in consumer publications. The stated aim of this Regulation is to protect the consumer from outrageous claims but will effectively remove 70% of all health claims from products during 2010/11, if it is not revoked as a result of industry pressure.

The lack of claims on labels will leave the average person unable to make informed choices on which supplements to take.

The current situation is a huge cause for concern because so many of the established claims have been rejected by EFSA, as not proven. A good example is joint health and glucosamine, which has not been approved because all studies are in people with joint disease and EFSA feels this evidence cannot be extended to include the effect on healthy individuals.

The same Regulation also limits what health professionals can say about products and will limit product recommendations to the public.

Nutrition claims will also be regulated and, once again, EFSA has failed to understand what is required to inform the general public. A typical example is ‘high in omega 3’:

The EU ruling allows ‘high in omega 3 fatty acids’ on pack if a product contains a minimum of 0.6g alpha linolenic acid (ALA) or 80mg EPA / DHA per 100g. This will allow margarine and other processed foods to claim ‘high in omega 3’ when, in reality, there is hardly any omega 3 present. In comparison, Higher Nature’s fish oil capsules contain 275mg EPA / DHA per 1,000mg capsule (equivalent to 27,500mg per 100g).

Omega Excellence Organic Flax Seed Oil contains 57.8g (57,800mg) ALA per 100g (2.9g per teaspoon).

This is just the tip of the iceberg - some nutrition claims, such as ‘low GI’ have not even made it onto the list!

Higher Nature will be working hard to overcome the limitations these regulations place on product information, by informing and educating through its publications, seminars and websites.

I would urge you to add your name to the numerous petitions against EU legislation on food and food supplements, as there are more rules in the pipeline aimed at restricting our industry even further. www.consumersforhealthchoice.com has a strong lobbying voice.

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