Principle Healthcare Regulatory update - November 2010
The main EU Regulatory news in October was the outcome of the third set of EFSA Health Claim Assessments (Article 13(2)). As before the vast majority of claims submitted for assessment were rejects on various grounds, most often due to lack of clear evidence to support the claims. However, some 80+ claims were considered valid and thus approved by EFSA, and now await formal adoption into EU Regulation. A number of additional claims for Vitamins and Minerals were approved in areas including energy release, reduction of fatigue, psychological function, plus claims related to fatty acids such as DHA including maintenance of normal brain function, blood pressure, cardiac function etc. Other approved claims related to blood cholesterol levels, fibre/gastrointestinal transit etc. As ever, the claims are qualified in that each claim applies to specific defined nutrients or materials, and they are qualified by specific terms of use relating to the level of that ingredient that must be provided to a permit the claim.
The EU continues to review Food Additive ingredient legislation, particularly focussing on permitted levels of use for existing additives, and on updating the list of approved additives to remove any that are no longer required, or to add a few new additives. For example the possible inclusion of sweeteners derived from Stevia (steviosides) is under consideration, as is the possible deletion of erythrosine colorant in some food categories. The colorant review has suggested new lower levels of use for some of the 6 “Southampton” artificial colorants, yet others, such as Tartrazine seem likely to remain unchanged. Scientific opinion concluded that current levels of use in adult products was unlikely to trigger allergic responses. The debate continues, and the overall impact on Food Supplements remains unclear, though the EU Supplement industry is being asked to comment on any propose changes and hopes to retain additives that are required to produce supplements. Concerns have also been raised over the levels of aluminium present in some aluminium lake colorants, and discussions are underway with a view to reducing daily intake of aluminium via this route.
The EU is also working on Flavouring compounds, and a list of EU-approved flavour components is expected late in 2010, or early 2011. This will detail components that have been assessed and authorised as suitable for use. However there is a further group of some 400 compounds believed to be in current use in EU Food products that are not included in the first EU list. It is unclear how that second group of compounds will be handled – the EU has said they will be assessed not later than 2014, but it is unclear what status they will have in the interim – they may be granted a derogation to allow continued use up until they are assessed, or until the 2014 cut-off. Impact on the flavour industry, and thus on all areas of foods is still unclear.
