EU proposes fees for food safety authorisations
Food Safety Agency (EFSA) would impose too heavy of a financial
burden on companies, says an industry consultant.
Consultant Christopher Whitehouse says the proposal, which was submitted for public consultationyesterday by the European Commission, would allow EFSA to charge companies "potentially verysubstantial amounts" for processing the dossiers which EU legislation requires food productmanufacturers to submit for consideration.
"This is a very important paper in our view and could impose substantial burdens uponindustry -- burdens which the smaller and medium-sized businesses which make up the majority of thespecialist product sector would find it hard to bear," he said. "The introductionof such charges seems to us not that different in principle to the practice of the Chineseauthorities sending a bill for the bullet to the families of those it executes by shooting."
Whitehouse operates a consultancy under his own name in London. The EU consultation on feesrelates to the dossiers and studies food companies submit to EFSA when applying for marketingauthorisations for products or substances used in their processes. EFSA then makes a risk assessmentand issues recommendations.
"In such cases, public money is used partly for private interests, and alegislative system for charging fees can be justified," stated the consultation document.
The Commission noted that a fee-based system in such situations has certain limitations,including the implication that the EFSA service provides would only be supplied separately to clearly differentiated users, instead of to a group as a whole.
The Commission noted that regulatory agencies in various member states currently charge fees for processing authorisation files for medicinal products for human use, for veterinary medicinal products and for pesticides. In the health field, fees may also be charged for inspections.
For example, some member states charge companies fees ranging from €1, 000 to €15, 000 for assessments of novel foods and ingredients such as genetically modified organisms, depending on the product.
The European Medicines Agency's fees range from €58,000 up to €232,000 for a complete assessmentof a medicinal product for human use.
Some member states also charge authorisation fees of active substances used as a basis for plant protectionproducts such as pesticides. These range from €100,000 to €300,000.
Under option one of the proposals made in the consultation document, the Commission proposes thatall applicants for an authorisation must pay a fee.
"The simplest approach would be to regard all applicants for an authorisation as submitting an authorisation file, since they have an interest inthis," the document stated. "Given the high cost of compiling most authorisation files, it can be assumed thatthose who submit such files do so only when they expect to profit economically from the authorisation.The potential disadvantage of this approach would be to add to the costs of obtaining an authorisation and therefore possibly to discourage applicantswho have little economic interest in meeting the cost of an authorisation file."
Such a case might arise when an authorisation could also benefit other operators. The reportsuggests interested operators in this situation could pool their resources in order to submit an authorisation file.
Option two suggests that only applicants with profits specifically vested in the authorisation mustpay fees.
The deadline for comment is 15 February 2007.
