European-based consumer and natural health industry group, the Alliance for Natural Health (ANH), claims today that the European Commission has moved the â€˜goalpostsâ€™ on the procedure that aims to standardise allowed generic health claims on foods in the European Union by 2010. In addition, the ANH claims that the Commission has not met its obligations with regard to sound administration in providing adequate guidance to interested parties making applications for health claims, which are to be evaluated by the European Food Safety Authority (EFSA) over the next two years.
These grave concerns come less than three years after the European Commission was heavily criticised firstly by Advocate-General Geelhoed and then by the European Court of Justice (ECJ) itself in the ANHâ€™s case on food supplements in Europeâ€™s highest court.Â The Advocate-General and the ECJ complained about a lack of adequate transparency or guidance over the procedure required to admit sources of vitamins and minerals to the positive list of the Food Supplements Directive in 2005.
The EU Nutrition and Health Claims Regulation, which came into effect Europe wide on 1 July 2007, but is still in a transition phase, aims to ensure consumers are protected from unsubstantiated claims made on food or food supplement packaging or even verbally, while being given sufficient information to allow informed choice. It also harmonises the varying approaches presently allowed by national authorities so offering, it is claimed, conditions of fairer competition for companies trading in Europeâ€™s nearly 30 Member States.
On 27th March 2008, the UK national authority, the Food Standards Agency (FSA), held an urgent conference with interested parties, including the ANH, to inform them of new information received by the European Commission on its proposed approach to handling the several thousands of health claims submitted by applicants across Europe. At this meeting, the FSA informed stakeholders that the European Commission would reject any health claims, before forwarding them to EFSA for evaluation, that did not rely on human studies as primary substantiating evidence.
Dr Robert Verkerk, Executive & Scientific Director of the ANH, said, â€œGuidance from the Commission on how to complete applications for Article 13 health claims was very limited and non-transparent. Now the applications are in, suddenly the Commission seems to have found a way of culling huge numbers of claims.Â Itâ€™s very much another case of Geelhoedâ€™s black box.Â Moving the goalposts is not acceptable if itâ€™s being done primarily as a means of making the European institutionsâ€™ job more manageableâ€.
The ANH has today submitted to the FSA, at the FSAâ€™s request, detailed comments on a wide range of problems emanating from the Commissionâ€™s newly indicated approach. It includes the fact that the Commission seems to wish to exclude evidence from authoritative bodies such as the World Health Organization.
Meleni Aldridge, Development Manager for the ANH, commented, â€œThis Regulation is meant to help consumers, not make life for them more confusingâ€.
The Commissionâ€™s approach appears to fly in the face of recent statements made by President JosÃ© Manuel Barroso and Commissioner for Consumer Protection, Meglena Kuneva, where, in a joint article penned less than a month ago for European Consumer Day, President Barroso supported Mrs Kunevaâ€™s plea for empowered consumers.Â This was swiftly followed by European Commission Vice-President, Margot WallstrÃ¶mâ€™s statement that the Commission was â€œlistening better, explaining better and going localâ€.
Ms Aldridge added: â€œconsumers now need to voice their concerns as the Commissionâ€™s lack of transparency cannot foster empowermentâ€.
The ANH has asked the FSA to establish under what legal basis the Commission has been able to now reject health claims applications based on evidence from representative animal or in vitro models. Importantly, it may not be ethically acceptable to carry out certain types of study on humans and, ironically, animal studies have, historically, been pivotal to the elucidation of health relationships associated with licensed drugs.