16 February 2007- Potential fees by the European Food Safety Authority’s for processing authorisation files could hamper future innovation in some already financially stretched SME’s, insists trade association EHPM.
Responding to the European Commission consultation document on whether companies should have to pay EFSA for its processing of authorisation files, the European Federation of Associations of Health Product Manufacturers (EHPM) claims the fee system would have serious negative repercussions on innovation in nutrition and health, insisting that the financial impact on SME’s must be taken into account.
The organisation, which represents more than 2000 specialist health product manufacturers in Europe, believes the lack of financial resources for EFSA is due to a cut in its budgetary funds voted by the Council and the Parliament last year. EHPM argues that the lack of funding should be resolved through an increase in the general Community budget rather than a general indiscriminate fee system set at industry’s door.
“Around eighty-five per cent of the European food supplements industry is made up of SME’s and the industry relies on innovation to reflect emerging science in the areas of nutrition, dietetics and health,” said Peter van Doorn, Chairman of EHPM. “These fees are simply an 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. Our sector supports of an overall EFSA budget increase through the general Community budget, but we believe an indiscriminate fee structure would severely hamper industry innovation.”
The consultation paper envisages that EFSA could raise fees for assessing nutrients for addition to the positive lists of the Food Supplement Directive, the Directives on foods for particular nutritional uses (PARNUTS), and Regulation on the addition of vitamins, minerals and certain other substances to foods. It could also charge for assessing the scientific substantiation of health claims and referrals from the European Commission or member state competent authorities regarding the authorisation of novel foods or novel food ingredients.
The Commission claims the fees would entail a financial risk to applicants, therefore deterring them from submitting frivolous applications. EHPM however, disagrees, stating that file preparation already entails a serious financial risk for SME’s. It insists these companies would be further penalised if EFSA were to add a charge for its review.
“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.”
EHPM accepts that some applicants could be considered as falling into a fee-paying category such as those who stand to gain a monopolistic advantage, but insists that as many applicants are innovative SME’s, these fees should remain low.
Stakeholders were required to submit their comments on the consultation paper by February 15. The Commission will now use the feedback in its discussions with EFSA and member states to address how to match EFSA’s financial resources with its growing workload.
• EHPM represents 26 associations from 22 European countries including large pan-European companies and many SME’s.
• For more information contact Lorène Courrège, Director of Regulatory Affairs, EHPM, email [email protected], tel + 32 2 209 11 45, or visit www.ehpm.org.