Natural health campaigners to design new methods for regulating supplements
that it has commissioned independent experts to develop a new
approach to regulating food supplements to replace that proposed by
the 2002 European directive, already challenged by the group in
court, writes Dominique Patton.
ANH, which took the Commission to the European court in January over the directive, said the new €75,000 research will focus in particular on developing a new and appropriate scientific risk assessment methodology for vitamins, minerals and other micro-nutrients.
The ANH, along with other trade associations, has argued that the list of nutrients and nutrient forms allowed in supplements under the new law (called the 'positive list') is based on outdated evidence and older lists for other directives. Many ingredients being used safely in supplements on the market have been left off the list.
Moreover there are concerns that the setting of maximum levels of vitamins and minerals on the list - to be carried out after the directive comes into force on 1 August - will result in much lower levels than those currently allowed in markets like the UK and Netherlands.
The new study commissioned by ANH, whose members include consumers, doctors and innovative supplement makers and suppliers, is designed to influence the shape of a new directive, if the court recommends next month that the current version should be altered.
The advocate general hearing the case said in April that the directive was invalid under EU law and noted that the procedure for adding ingredients to the 'positive list' had the "transparency of a black box", suggesting that it needed to be amended. A European court ruling follows the opinion of the advocate general in the majority of cases although the rewriting of a directive remains rare.
"It is essential that the issue of food supplements regulation is looked at by a leading independent group of risk analysis scientists with a blank sheet of paper, before any amendment to the directive is finalised," said Dr Robert Verkerk, executive director of the ANH.
"In our opinion, and that of medical doctors practising clinical nutrition and other scientists around the world who have endorsed our proposal, the existing risk assessment systems being used by regulators are deeply flawed. We badly need a new model that takes into account both risks and benefits of food supplements," he added.
The study will be led by Dr Jaap Hanekamp and Professor Aalt Bast, of the Heidelberg Appeal Nederland (HAN) Foundation, which has previously provided risk assessment studies to governments on health issues such as nitrates in food and drinking water and antibiotic growth promoters in livestock. The €75,000 in funding is being provided by the Netherlands-based International Nutritional Company.
Dr Verkerk is also keen to shape the international guidelines on vitamin and mineral food supplements being finalised by the UN's Codex Alimentarius Commission in July.
The ANH previously submitted a report to the Food & Agriculture Organisation and the World Health Organisation of the UN, which are developing a so-called "nutrient-appropriate risk assessment" system for food supplements likely to be adopted by the Codex Alimentarius Commission.
In an interview with NutraIngredient.com earlier this year, Dr Verkerk said: "Risk management is about focusing energy on high risk problems. We should focus specifically on the 30-40 high risk nutrient forms, such as the fat-soluble vitamins and some potentially toxic mineral forms like selenium and zinc, and develop a risk assessment system for these as the first move forward."
The HAN Foundation study is expected in around nine months time and ANH believes regulators should await the results before any further laws or guidelines are finalised.
The UK's health food manufacturer's association (HFMA), which brought a parallel challenge to the European court in January, is however continuing to work on dossiers for ingredients not on the directive's positive list, in the event that the court decision goes with the Commission.
European Court of Justice issues its final decision on the case on 12 July, also the deadline for submitting dossiers to support the addition of a new ingredient to the positive list.
