Opposition is mounting to fees the cash-strapped and understaffed European Food Safety Authority (EFSA) has proposed to process nutrient dossiers submitted by European, American and international food manufacturers and ingredients suppliers. EFSA is charged by the European Commission to review dossiers for possible addition to the positive list of approved ingredients for use in supplements and food stuffs as outlined in the 2002 Food Supplements Directive.
Some 500 dossiers have been submitted to EFSA or are in composition and are in themselves expensive to compile. The food and ingredients industry believes extra bureaucratic costs may discourage companies — especially smaller ones — from preparing the safety data required.
The Belgium-based European Federation of Associations of Health Product Manufacturers (EHPM) said EFSA fees could push companies beyond the financial tipping point and thwart innovation.
"Around 85 per cent of the European food supplements industry is made up of small and medium enterprises (SMEs) and the industry relies on innovation to reflect emerging science in the areas of nutrition, dietitics and health," said EHPM chairman Peter van Doorn. Additional fees "added financial burden to the already challenging cost of compliance some SMEs face with the various legislative changes and the newly adopted regulations for food supplements".
He called on EFSA's budget to be increased and dismissed the Commission's claim that dossier fees would discourage companies from submitting dossiers that had little chance of gaining approval.
"Most SME's are already forced to pay for external expertise in preparing files as they lack the necessary procedural expertise to prepare dossiers for submission to EFSA," said Lorène Courrège, EHPM director of regulatory affairs. "We cannot accept that all applicants must pay a fee, especially when, in most cases, submissions are of a general nature and their approval benefits all operators. Frivolous dossiers can easily be prevented by clear guidance on what information to submit and how to present it."
The Commission will now discuss the feedback it has received on the issue with EFSA and Member States to address how to fund EFSA's growing workload.