Documents considered by the committee on 10 November 2010, including the following recommendation for debate: Safety of offshore oil and gas activities - European Scrutiny Committee Contents

11   Fees chargeable by the European Food Safety Authority



COM(10) 496

Commission Report on the advisability and feasibility of presenting a legislative proposal enabling the EFSA to receive fees

Legal base
Document originated23 September 2010
Deposited in Parliament4 October 2010
DepartmentFood Standards Agency
Basis of considerationEM of 28 October 2010
Previous Committee ReportNone
To be discussed in CouncilNo date set
Committee's assessmentPolitically important
Committee's decisionCleared


11.1  In establishing the European Food Safety Authority (EFSA), Regulation (EC) No 178/2002[23] also required the Commission to publish within three years a report on the feasibility and advisability of putting forward a legislative proposal which would enable the Authority to charge fees for services rendered. The Commission has now sought to fulfil that remit in the current document, which has been prepared in the light of comments made on an earlier consultation paper.

The current document

11.2  In presenting its report, the Commission says that this has been based on a longer period than originally envisaged because initially the EFSA was still in its developmental phase, and it was important to take into account its experience over a longer period, particularly in the light of new challenges over recent years (including a significant increase in the work involved in processing applications for product authorisations). The Commission then looks in turn at the advisability and feasibility of establishing a fee system.


11.3  The Commission notes that the majority of Member States are not in principle against charging fees to applicants, on the grounds that this could achieve more secure funding, a more professional service, increased cooperation between the Authority and national agencies, a reduction in authorisation delays, and a greater harmonisation of various agency procedures at European level. However, there is also recognition that the establishment of a fee system in the case of the EFSA would be complex, and of the consequent need to identify the conditions and specific cases where this might be done. On the other hand, the Commission says that most industry stakeholders have reservations, arising from concerns that fees could damage both the Authority's actual and perceived independence; that the EFSA was established to protect public health, and that its financing is therefore a public responsibility, where any shortfall should not be met by funding from private industry; and that the burden imposed by fees would be contrary to the Lisbon agenda and detrimental to innovation. The EFSA itself has not taken a view either for or against fees, commenting only that funding may not be an issue, provided a number of conditions are met, particularly as regards its independence and accountability.

11.4  In presenting its own views, the Commission says that, as effective and transparent mechanisms are in place, it does not believe that the establishment of fees would diminish the EFSA's independence, or the perception of it, suggesting that this has not proved to be the case with either the European Medicines Agency or the European Chemicals Agency. It adds that most the EFSA's tasks are of general interest and financed by the public budget,[24] and that only those related to the assessment of authorisation dossiers, where private interest would be served, could be subject to fees, though it points out that the distinction between general and private interest is not always straightforward. Finally, the Commission says that its commitment to the better regulation approach means that fees would not be established without a meaningful cost-benefit ratio having been established after a full analysis.


11.5  The Commission notes that two main concerns have been raised — the difficulty of identifying beneficiaries, and the extent to which a fee system might lead to instabilities in the EFSA's budget.

Identification of beneficiaries

The Commission says that the main problem identified by Member States and stakeholders is the extent to which authorisation procedures for certain foods are aimed mainly at giving general approvals for the benefit of all operators, and rarely protect proprietary data or offer exclusivity to the applicant, as compared with the arrangements for medicinal products. This means that it would be difficult to identify beneficiaries, and that it would be unfair to make an applicant pay a fee for a generic authorisation in cases which benefit the whole sector. The Commission adds that it recognises the difficulty of identifying beneficiaries in the food and feed sectors, and that the impact of fees would therefore give rise to difficulties not encountered for medicines and chemicals. However, it suggests that a sector-by-sector approach might be adopted, in that specific authorisation holders can be identified in the areas such as genetically modified food and feed, pesticides, flavourings and additives, nutritional and health claims, and novel foods.

EFSA budgetary stability

The Commission says that Member States have pointed out that fees may not always guarantee a stable annual budget for the EFSA as the number of dossiers for assessment can vary from year to year, and that the introduction of a fee system may provide grounds for reducing public funding, possibly leading to a decrease in the Authority's budget. However, it suggests that it should be possible to guarantee a number of fixed costs by public funding in order to stabilise the budget, though it also recognises that, as the establishment of fees can only be based on a stable workload, this issue needs to be explored further.


11.6  The Commission says that four possible options have emerged from the comments it has received. These are

  • a flat rate fee for all applicants for authorisation;
  • graduated fees for all applicants for authorisation;
  • graduated fees for all applicants who are authorisation holders;
  • maintaining the existing system without fees.

It says that, although this is not an exhaustive list, it provides a good basis for further work, in which it proposes to look at the costs of the services which could be subject to fees (and to refine these further); to examine the relationship with the national fees which EU legislation permits for plant protection products; and to consider whether any special arrangements are needed for small and medium sized enterprises (SMEs).

11.7  At this stage, the Commission says that it is not possible to draw any definitive conclusions without further consideration being given to the various issues which arise, including the preparation of an impact assessment. However, it suggests that consideration should in any case be given to the option of graduated fees for applicants who are already authorisation holders, and to the introduction of fees for the authorisation of genetically modified organisms, feed additives, claims, novel foods, active substances used in plant protection products, and smoke flavourings.

The Government's view

11.8  In her Explanatory Memorandum of 28 October 2010, the Parliamentary Under-Secretary of State (Public Health) at the Department of Health (Anne Milton) says that the UK can see merit in the EFSA charging for some of its work on authorisations, for example where an application is specific to commercial products or companies, and believes that it would in those cases be appropriate for fees to be set at a European level (for example by a central authorisation body, as in the case of medicines). However, she adds that fees should be set for work exclusive to the EFSA's role, and should not duplicate charges for work already charged by national authorities, as for example in the case of plant protection products.

11.9  The Minister also says that, in response to the Commission's earlier consultation, the UK flagged the need to consider how to deal with charges for the approval of generic products for use by more than one person or business, and also noted the need for clarity on how fees would be introduced and how the money raised by them would be used by the EFSA. She stresses that it is important that any fee system did not stifle innovation and growth or have a disproportionate impact of on small and medium sized enterprises, but notes that the report takes account of these concerns, which will be explored further in the proposed impact assessment.


11.10  This document simply identifies the extent to which it would be advisable and feasible for the European Food Safety Authority to charge fees for some of the work it carries out, and this issue will be the subject of further work by the Commission, including the preparation of an impact assessment of the various options which have been identified. In view of this, we see no need to withhold clearance, but, as any measures which might arise from this report could have implications for an important area of activity, both economically and as regards food safety, we think it right to draw it to the attention of the House.

23   OJ No. L.31, 1.2.02, p.1. Back

24   Such tasks account for 69% of the EFSA's budget. Back

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