Principle Healthcare Regulatory update - December 2010

After the long awaited publication of the third batch of Health Claims assessments by EFSA in October, November was relatively quiet in terms of Regulatory news. It was confirmed that all remaining Health Claims still to be assessed would be completed by June 2011, however, health claims relating to botanical materials are still seen as an area of concern given the risk of possible overlap or conflict between Health Claims Legislation and Traditional Herbal Medicines Regulations. Current concerns focus on the differing level of evidence needed to support a potentially similar claim if presented for assessment under each area of Legislation. At present it would appear possible that very similar claims could be approved for use on a Food Supplement under Health Claims Legislation, and for Traditional Herbal Medicine product under THR, even though the level of evidence provided, and the requirements surrounding manufacture and control of the final product could be very different.



In UK, the Council for Responsible Nutrition are seeking clarification as to how the minimum 15% of RDA limit (as per EC Health Claims Regulation No.1924/2008) is being interpreted, some local authorities seem to interpret the level in such a way that they will not permit inclusion of nutrients at less than 15% of RDA, others seem to permit inclusion, but not allow them to be quantified, others allow them to be included and quantified on labels, so long as no other reference to them is made on pack or in product names etc. CRN are asking for a definitive answer from UK Department of Health as to how the legislation should be interpreted.



Within European Commission work continues towards a new Food Additive Directive, and current estimates hope for adoption in Summer 2011, with it being fully in force Summer 2012. Various additives are under scrutiny for matters such as level of use, categories where used, and safety, with a view to modifying Annex II to reflect current working practices across the Food Industry – including supplements. It is not yet clear which, if any, changes may have an impact on food additives (including colours, sweeteners and other miscellaneous additives) used in Food Supplements. The new Directive, once finalised, is intended to supersede the existing individual directives covering sweeteners, colours miscellaneous directives with one harmonised document.



Two mineral sources were reviewed by EFSA, and Ferrous ammonium phosphate and Chromium (III) have been approved for use in Food supplements as well as in other food categories.



Oat-derived Beta Glucans had an Article 14 health claim approved relating to reduction of blood cholesterol, and Water soluble tomato extract had existing health claims relating to platelet aggregation/healthy blood flow extended into other food categories, including food supplements. Both claims carry associated conditions of use related to levels that must be present before claims can be made.