Half of health claims applications ‘incomplete’
Half of the applications to make health claims under article 13.1 of the EU Nutrition and Health Claims Regulation do not include sufficient information for scientists to evaluate them properly, it has emerged.
In order to ensure the mountain of applications (4,185) is processed efficiently, European Food Safety Authority (EFSA) scientists have spent weeks pre-screening them. “This exercise revealed that for around 50% of claims, more clarification or information is needed before EFSA can evaluate them,” said EFSA executive director Catherine Geslain-Lanéelle. This means that the European Commission will have to go back to the Member States and secure the relevant information from applicants before EFSA can process them, she said. In the meantime, EFSA has committed to evaluating 1,000 of the claims it is able to process by July 31. A second tranche will be processed in November followed by a final tranche just before the January 2010 deadline by which the European Commission is required to publish approved claims.
Professor Albert Flynn, who chairs the panel tasked with analysing the claims, has also criticised the quality of applications received under article 14 of the Regulation (which cover disease risk reduction and children’s claims). He said: “We’ve received some excellent applications and some very bad dossiers. The range of quality has been incredibly wide.” A large number were also incomplete, which meant EFSA had to waste a lot of time going back to applicants and requesting more information, he said.
As for quality, major problems included a failure to properly characterise the ingredients in question, a failure to demonstrate a causal relationship between the ingredient and the claimed health benefit and mismatch between the age and nature of the volunteers used in the scientific studies provided as evidence and the target groups for the proposed health claims.
According to the timetable laid out by EFSA, Flynn’s panel will not assess most of the controversial botanicals claims applications until the end of the process. The finalised list of applications, which will be published in full in January 2009, includes 328 claims about probiotics, 1,900 about botanicals and 128 about fibres. Other claims relate to diets, vitamins, minerals, macronutrients, foods and ‘other substances’
Article 13.1 claims refer to the role of a nutrient/substance in growth, development and the functions of the body; psychological and behavioural functions; and weight control claims. Claims that have been approved will become available for any company to use, provided that they adhere to the conditions of use.
While it is impossible to predict how many article 13.1 claims will be approved, applicants following the process for scrutinising article 14 claims will not be feeling optimistic given the large percentage that have been rejected to date.
