Principle Healthcare Regulatory Update, October 2010

EFSA – Approval of community health claims

Recent changes affecting Food Supplements include news that EFSA-approved community health claims will no longer be passed into EU Regulation in batches. Instead, with the exception of claims relating to botanical materials, the remaining claims currently under submission will be reviewed, and those that are approved will all be passed into EU Regulations once the reviews are completed. EFSA opinions on submissions they review will continue to be published, but technically they remain opinions until passed into the EU Regulation at a later date, at which time they can be used. The adoption of any positive opinions into regulations is unlikely to be before April 2011. This change in the regulation process represents a pragmatic approach in that it will prevent any further claims being “approved” ahead of others, which risked a continual stream of packaging updates as further claims were passed into legislation in each batch. In the meantime a number of health claim submissions continue to receive unfavourable opinions from EFSA.

Recent EU food supplement withdrawals

Recent withdrawals of a number of Food Supplement products across many EU member states was apparently due to the presence of undeclared GMO-derived ingredients. Presence of undeclared GM-derived material in EU Foods is not permitted, and it is also important to remember that only materials derived from a limited number of well-defined GM-species are permitted in EU Foods. No other GM-derivatives are currently permitted. Principle Healthcare remains vigilant in seeking to avoid the use of any GM-derived materials in its products, and continues to work with Council for Responsible Nutrition (UK) to ensure we follow best practices in this area.

New food additive directive

A number of EU Food additive categories, including colorants and sweeteners, is under review as legislation is streamlined under a new Food Additive Directive. The process is largely one of rationalisation, and aims to remove additives from food categories where they are no longer used. No major impact on Principle Healthcare products is expected, as customers tend to request use of well established, often natural, colorants, so few of the materials under review by EU are present in products supplied by Principle Healthcare. It is noted that one outcome of the changes in colorant legislation may be a reduction in use of Aluminium lake ingredients across all food categories, as the EU seeks to reduce dietary intake of aluminium in line with EFSA recommendations.

Guidelines on sampling and testing

As a result of discussions initiated by the UK Food Standards Agency, Guidelines on the sampling and testing of food products to detect the presence of irradiated ingredients have now been published. The guidelines are the result of numerous discussions involving the FSA and interested parties, and represent the consensus opinion on how best to test for the presence of irradiated components. The UK Council for Responsible Nutrition, of which Principle Healthcare is a member, is hosting the Guidelines document on its website as the FSA website is under review.



Food labelling legislation

EU continues to review Food Labelling legislation, and although Food Supplements are expected to remain exempt for some areas of Nutritional labelling, some general rules regarding minimum font size on packs may represent a challenge to the industry. While legibility is essential, the imposition of a minimum font size may make it difficult to incorporate all the statutory information on a typical Food supplement retail pack. The situation is being monitored, and Principle will continue to seek a practical resolution, that provides the best option for the end-consumer, as the review progresses.

EU Novel Foods legislation

The review of EU Novel Foods legislation is still underway, but progress is slow. Whilst any changes may seem to be detrimental to innovation in the food supplement industry, the regulators seek to ensure consumer safety remains the primary purpose of the legislation.

Herbal medicines product directive

The long publicised ‘Traditional Herbal Medicines Product Directive’ cut–off date draws closer, with April 30th being the last date upon which formerly license-exempt Section 12(2) herbal medicines can be delivered into the retail chain. Beyond that date only herbal medicines holding suitable authorisation (now called THMR Traditional Herbal Medicines Registration) by MHRA can be sold into, or first placed onto, the market. Stocks of existing unlicensed products already delivered into customers prior to April 30th 2011 should be allowed to sell through up until their marked best before date, though MHRA may seek proof of delivery dates if they find such products on sale beyond April 2011. Principle Healthcare is actively managing stocks of any products affected by this cut off date.