1. The Foods Supplements Directive (FSD)
Dossiers
Under this directive there is a published list (Annex II) of vitamin and minerals which can be used as food supplements. The directive also allowed other vitamins and minerals, not on this list, to be continued to be sold until the end of 2009 as long a dossier on the composition, bio-availability and safety was submitted to the FSA in the UK and then onto EFSA. EFSA would assess these dossiers before the end of 2009 and give an opinion on whether the products are suitable or not to stay on the market. Many of the original dossiers were only of one page and all of these products will not be allowed after the end of 2009. Some dossiers were incomplete and EFSA could not give an opinion. These products will also be lost at the end of 2009. The products affected by this are those highlighted in brown in the attached pdf. listing. The listing also includes the Annex II products and those given a favourable opinion (shown in green). The rest of the products (in white) are still being assessed but it is likely that the majority will be lost. In addition the hydrolysed protein based amino acid chelates of Magnesium , Iron, Calcium, Zinc and Copper will be lost as the dossiers submitted were under the name of Mineral Bisglycinates and it is the Bisglycinate form that will be put on to the Annex II list. The most recent amendment of the list has approved Inositiol Hexaniacinate but with a limit of not more than 10mg per day of niacin.
The EC were obliged to report on the extension of the FSD to other products (not just vitamins and minerals) but in the report decided not to extend the directive. However one member state, Germany, has objected and so an extension may be back on the agenda.
Maximum Permitted Levels
The EC are still discussing the setting of maximum permitted limits (MPL’s) for Vitamins and Minerals which is a requirement under the food supplement directive. In the UK we have traditionally been allowed to use high potency Vitamins and Minerals which is not the case for other European countries. Therefore there is a fear that the EC will propose limits that are much lower than currently allowed in the UK. The UK industry have been advocating the setting of limits based on the safety of the products with some special cases to allow higher levels together with advisory statements in case there is some health risk. The latest situation is that it is unlikely that the EC will now publish the draft MPL’s before the autumn as the European Parliament elections are in June and there is another Irish referendum in the autumn and the EC don’t want to make this issue part of these political processes. So it is very unlikely that any levels will come into force in 2009
2. Nutrition & Health Claims Regulation
This regulation requires that all health claims made for food and food supplement products are approved by EFSA. A list of about 4000 generic (article 13) health claims have been submitted to EFSA for approval which should be completed by the end of 2009. Products currently making these claims can stay on the market until January 2010. The end of 2009 deadline is unlikely to be met and thus there is likely to be an extension of the January 2010 deadline. In addition there are certain disease risk reduction and children’s health claims that require a special dossier to be submitted. The majority of these dossiers have been rejected by EFSA who are using a very stick pharmaceutical type criteria for looking at the data to assess whether the claims are justified. EFSA have reported that they will use the same criteria on the 4000 generic claims and thus there is a fear that most claims for the products we sell will be lost and thus our customers will no longer be able to make such health claims The EU industry is lobbying very hard with the EC and EFSA on this issue and there could well be legal action if the generic claims are dealt with on the same basis as the
Disease risk reduction and children’s health claims. Meetings have taken place with industry bodies and EFSA and the EC but it seems that they are going ahead with the strict pharmaceutical type assessments of the generic claims.
3. The Traditional Herbal Medicinal Products Directive
This directive requires that all new herbal finished products are registered before they are put on the market and that herbal products already on the market before April 2004 are registered before April 2011. If they are not registered they will have to come off the market. Registration involves the submission of a pharmaceutical type dossier by our customers for which we would have to supply a Drug Master File for the herbal ingredient which also needs to be produced to pharmaceutical GMP standards. This legislation will affect herbs that are considered to be medicinal of which there are hundreds on our product range but can be different in different countries. In the UK some of the main medicinal herbs which we sell are Echinacea, Devils Claw, St John’s Wort, Milk Thistle and Wild Lettuce. Very few of our customers for medicinal herbs have been asking us if we could supply Drug Master Files and since it can take up to 2 years to get a product registered we have to assume that they will not be registering to meet the April 2011 deadline. So far in the UK on 24 products have been registered and none with ingredients supplied by us.
4. Heavy Metals Regulations
The EU have added food supplements as a separate category to the general food contaminants legislation and have set limits for Lead, Cadmium and Mercury in the finished food supplement. This legislation comes into force on the 1st of July 2009 and applies to the finished product of our customer. Any product the customer puts on the market after this date must comply with the legislation. We have being checking the status of our top 300 selling products for compliance and in the main all but about 15 products comply. For these non-complying products they still can be used depending on how much the customer uses in their formulation. The main product of issue for us is the Magnesium Amino Acid Chelate 20% from Kelatron.
5. Novel Foods
Any food that was not on the market in the EU in substantial quantities before May 1997 is considered to be Novel and a special dossier has to be submitted before they can be sold. This is a time consuming and expensive process and for all but the wealthiest of companies it is not a practical option. The regulators (FSA) apply a very strict criteria when checking the Novel status. E.g. although milk is not a Novel food a new ingredient extracted from Milk would be. Also if a particular product was on the market before May 1997 and you wanted to sell a similar product from another supplier then unless your product was identical to the original it would also be Novel. The regulations are currently under review and it is possible that they may allow ingredients that have had use out side of the EU for a generation (could be 70 years) to forgo the Novel food approval process.
