EU member countries are concerned about the feasibility of companies paying fees to the European Food Safety Authority (EFSA) for vetting ingredients, packaging and food contact materials for use in the bloc.
The details are revealed in an European Commission review of comments submitted in response to a public consultation of the proposal to charge fees for EFSA work. The reservations back up EFSA's own submission to the consultation that a fee-based system should take into account its independence.
The majority of member states that responded are not, in principle, against a fee-system, but expressed concerns on its feasibility, the Commission reported yesterday. Meanwhile the "vast majority" of respondents do not support a fee-based system.
Such widespread opposition could lead to the Commission putting the proposal on ice. The proposal, if approved, would have led to an additional cost for companies, which also have to pay for the scientific studies and investigations they must submit to EFSA.
EFSA was established two years ago as part of a package to co-ordinate food safety procedures throughout the bloc. It is meant to serve as an independent body providing science-based risk assessments relating to food and feed safety.
However the body has been underfunded, leading to delays in hiring staff and in vetting applications.
One of the major aims of the consultation was to ask industry and the public whether all applicants should pay fees, or only those with profits vested in the authorisation. Submissions were also asked to give opinions on the advantages and disadvantages of charging fees.
"The analysis of the contributions shows that the vast majority of the respondents do not support the establishment of fees and that a system for the collection of fees would be complex and difficult to put in place," the Commission stated.
A total of 16 member states commented on the consultation paper, the Commission reported.
"Most of them pointed out that they were not, in principle, opposed to a fee-system, but expressed concerns on its feasibility," the Commission stated.
The main concerns were to safeguard EFSA's independence, the difficulty of identifying beneficiaries, and the creation of an additional administrative and financial burden for small and medium sized businesses (SMEs), the Commission reported.
The main arguments put forward by EU members in favour of fees include the funding of a more professional service, and a more secure source of funding for EFSA's work.
Member states also stressed that it would be unfair to establish fees for all applicants. Some suggested an impact assessment that would allow identification of additional costs and
administrative burdens for companies.
They also suggested a sector-by-sector analysis is necessary to determine if fees would hinder companies from being competitive.
"The impact of fees on innovation and the competitiveness of individual businesses, especially SMEs, must be taken into consideration," the Commission stated in summarising the comments.
Overall commentators said the authorisation procedures for certain foods or substances are
mainly aimed at giving general approvals to the benefit of all operators and provide little
proprietary data protection.
Such benefits would add to the complexity of establishing a fee-system given the difficulty in identifying those liable to pay fees.
In the consultation document the EFSA consultants argue that the regulator is underfunded and understaffed in relation to the work it is responsible for doing.
"EFSA is now at crossroads," the document states. "It must expand, develop, consolidate and build on its first success. Therefore, it must ensure that its structures, organisation, procedures and systems are fit for the challenges ahead."
EFSA has noted that the agency's 2005 budget was €36 million, below the €44 million originally promised and that introducing fees might ease the financial squeeze.
"The collection of fees by EFSA for opinions requested by legislation could ease the constraints but the idea needs some time to gain political acceptance and to be accepted by the interested stakeholders who are so far opposed," the consultants stated. "It is important that the relatively low level of current EFSA expenditures be not interpreted as 'EFSA does not need more'."
EFSA has issued relevant opinions with a reasonable cost in financial terms but with significant overtime work, a situation that is not sustainable, the board argues. A proper staffing level would be about 350 employees.
EFSA last year had about 70 permanent staff. Another 150 members make up the expert panels that issue scientific opinions.
"Timeliness of opinions can be improved, notably through more formalised negotiating procedures, as well as productivity thanks to recruitment and organisational measures," the consultants stated.
One way of getting more money and speeding up the process would be to charge fees for registering authorisations on ingredients such as genetically modified organisms, pesticides and feed additives.
The consultants noted that some people fear that this would change the nature of EFSA as a public institution. People might perceive EFSA as less independent after having authorised substances such as GMOs due to a potential conflict of interest.
Several of those interviewed in the drafting of the document believe that fees will not affect the independency of EFSA.
"But it will take some time to come to a political acceptance of a fee system, notably as the public might have less trust in EFSA," the consultants stated.
A fee system has several advantages. The fees would clarify the performance and resources of the two types of services offered by EFSA. One is services to the private sector, the other is to the European parliament and to member states.
The increase in funds from fees would help EFSA to issue opinions faster. About 17 per cent of opinions do not meet their legal deadline. Recently there has been a dramatic increase of deadlines not met, but this increase seems so far at least partly attributable to a change of reporting system, the consultants noted.
Extensions of deadlines and delays are related primarily to the understaffing of EFSA, as well as to internal organisation and coordination procedures.
Still with 76 per cent of the forecasted staff and 66 per cent of the forecasted budget, EFSA provides 80 per cent of the forecasted scientific opinions requested.
"This efficiency is however not sustainable," the consultants stated. "People are overstretched and, due to lack of time, they are not able to implement tools and procedures, to recruit, to train new colleagues and to ensure the continuity of the service. Incidents like burn outs of key persons might have severe impacts."
Another problem that EFSA needs to address is its location in Parma, Italy rather than in Brussels, the EU's headquarters.
EFSA estimates that the location in Parma is more expensive than Brussels has led to higher staff and travel expenses. More importantly the Parma location has led to a lengthier travel time for those attending meetings.
The consultation document was issued by Bureau van Dijk Management Consultants and Arcadia International.