Definitions of EFSA Scientific Outputs and Supporting Publications

A. EFSA scientific outputs

EFSA’s scientific outputs can be classified in broad categories: ‘Opinions of Scientific Committee/Panel’; and ‘Other Scientific Outputs’. They all are published in the EFSA Journal . The described scientific outputs find their legal basis in Chapter III of the Founding Regulation, specifically in Article 28 to Article 40.

A.1. Scientific Opinions of Scientific Committee/Scientific Panel

EFSA can issue Scientific Opinions at the request of the European Commission, European Parliament, Member States, or on its own initiative or as foreseen in relevant sectoral legislation. Scientific Opinions are prepared by the Scientific Committee or a Scientific Panel. These scientific outputs are adopted by the Scientific Committee or one or more of the Scientific Panels.

A.1.1 Opinion of the Scientific Committee/Scientific Panel

Requests for an Opinion are defined by ‘terms of reference’ including background information for the request, which together form the mandate for the Scientific Committee or Scientific Panel to work with. Opinions include for example risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment.

A.1.2 Statement of the Scientific Committee /Scientific Panel

A Statement of the Scientific Committee or Scientific Panel is a scientific output in the form of a concise document that does not go into the same level of detail as an Opinion. It may be developed for instance in response to a request for a fast-track response in order to address an urgent matter, provide a provisional scientific view or address a previous risk assessment published by EFSA.

A.1.3 Guidance of the Scientific Committee/ Scientific Panel

Guidance of the Scientific Committee or Scientific Panel explains the principles behind EFSA’s procedures and approaches to scientific risk assessments to risk assessors (including the Scientific Committee or Scientific Panels), risk managers and/or applicants of dossiers submitted for evaluation. Guidance documents may also specify the information and data which industry must provide when submitting applications to EFSA for evaluation prior to their authorisation by risk managers.

A.2 Other Scientific Outputs of EFSA

EFSA can issue other Scientific Outputs at the request of the Commission, on its own initiative or as foreseen in relevant sectoral legislation. Requests for these outputs are defined in mandates received by Commission, or internal mandates[1] approved by the Executive Director. The other Scientific Outputs of EFSA are, as a general rule, prepared by an EFSA working group and/or by EFSA scientific staff. Their content and publication are approved by the Executive Director of EFSA.

Some reports may also be produced jointly with another European Union Agency, such as the European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA).

A.2.1 Statement of EFSA

A Statement of EFSA is a document addressing an issue of concern and prepared as advice or factual statement for consideration by the European Commission, European Parliament, Council of the European Union, Member States or stakeholders. A Statement of EFSA is prepared normally within a relatively short time frame. EFSA may consult the Scientific Committee, a Scientific Panel, or an EFSA network during the process.

A.2.2 Guidance of EFSA

Guidance of EFSA explains to risk assessors, risk managers and/or applicants of dossiers submitted for evaluation, the principles of scientific aspects of the procedural issues or assessment practices and approaches. The Guidance may also explain scientific guiding principles on the best practices for the monitoring, reporting and analysis of data related to food and feed safety and animal or plant health to Member States.

A.2.3 Conclusion on Pesticides Peer Review

An EFSA Conclusion is a comprehensive scientific evaluation providing the conclusions from the peer review process of the risk assessment on whether the active substance used in a plant protection product is expected to meet the approval criteria, as foreseen in the relevant legislative framework.

A.2.4 Reasoned Opinion

A Reasoned Opinion[2], a term introduced in Regulation 396/2005, describes the comprehensive scientific evaluation of, and subsequent conclusions from, the consumer exposure assessment and the risk assessment of pesticide residues resulting from the use of pesticides.

A.2.5 Scientific Report of EFSA

A Scientific Report of EFSA is a scientific document whose main purpose is, for example, to describe original research results that pertain for example to a literature review, statistical data analysis, the compilation of scientific evidence - compilation/collation/ assessment of survey or monitoring results, specifications for the design thereof - or a data collection report. In special cases Scientific Reports of EFSA may be endorsed by the Scientific Committee or the respective Panel.

B. Supporting publications

In addition to the Scientific Outputs, EFSA can publish supporting publications on its website. These publications are not published in the EFSA Journal.

B.1 Technical Report[3]

EFSA can issue a Technical Report at the request of the Commission, on its own initiative or as foreseen in relevant sectoral legislation. Requests on these reports are defined in mandates received from the Commission, internal mandates[4] or internal project mandates[5] approved by the Executive Director. Technical Reports are, as a general rule, prepared by an EFSA working group and/or by EFSA scientific staff. The content and publication of a Technical Report is approved by the Executive Director.

A Technical Report is a document that describes the nature, state of the art, progress, or results of a technical process and pertains for example to: (i) the collection and analysis of comments received via public consultation; (ii) an Overall Opinion on GMO applications[6]; (iii) the collection and analysis of experiences and approaches in EFSA, Member States and wider; (iv) an annual report of network activities; (v) a final report from an EFSA project; (vi) administrative guidance; (vii) a note for guidance; (viii) a manual for the use of reporting applications and for reporting of data through EFSA data collection systems; (ix) or technical specifications to developed IT-based reporting systems.

B.2 External Scientific Report

An External Scientific Report is a document that describes, for example, data collection, literature review or the development of models used in risk assessment. The views contained in External Scientific Reports may not necessarily reflect the official position of EFSA.

EFSA can request a beneficiary of a grant (in accordance with Article 36 of EFSA’s Founding Regulation) or a contractor (in accordance with EU and EFSA public procurement rules) to produce an External Scientific Report. Requests for these reports are defined in internal mandates approved by the Executive Director and in more details within the calls for outsourcing of scientific work. They are prepared by the beneficiary of a grant or by a contractor.

EFSA can also request a joint working group consisting of experts proposed by EFSA’s Advisory Forum and Scientific Committee and Panels (so called ESCO groups) together with staff members to produce an External Scientific Report. Such work aims to enhance EFSA collaboration with Member States. Requests for these reports are defined in internal mandates approved by the Executive Director, taking into account comments from the Advisory Forum and the Scientific Committee. These kind of External Scientific Reports are prepared by the ESCO group.

The External Scientific Report is accepted by the Head of the relevant Scientific Unit and the relevant Director. Publication of the External Report is a decision of the Executive Director.

B.3 Event Report

EFSA can organise an event and thereafter issue an Event Report. An Event Report can be prepared by EFSA staff or by a contractor upon request of the Executive Director. The views contained in Event Reports may not necessarily reflect the official position of EFSA.

Event Reports can arise from EFSA Scientific Colloquia, EFSA scientific events or workshops. They may contain the presentations given at the event as well as summaries of the events’ discussions, outcomes and conclusions. Event Reports can also be available as printed books with an ISBN reference.

Background

These definitions have been in place since December 2010. They replaced a previous version of EFSA scientific definitions implemented in 2008 which is available for reference only.

In the new definitions, the category “scientific or technical reports” has been reclassified into “scientific reports” and “technical reports”. As publications that support EFSA’s scientific work, from January 2011 onwards, technical reports will not be included in the EFSA Journal anymore. Moreover, a new scientific output type has been created, “event report”.

Following the introduction of the new definitions in December 2010, some previously published outputs have been reclassified and are now available under these new categories in the Publications section of the website.

 


[1] Internal Mandates are the internal decisions to allocate scientific tasks in order for EFSA to issue an output within its remit
[2] The Reasoned Opinion is an exception to the rule that the legislation reserves the term ‘opinion’ to output of Scientific Panel/Scientific Committee.
[3] Technical reports were published in EFSA Journal until 2010
[4] Internal Mandates are the internal decisions to allocate scientific tasks in order for EFSA to issue an output within its remit.
[5] Internal Project Mandates are the internal decisions to allocate tasks which are not primarily of a scientific nature.
[6] The overall opinion on GMO applications is an exception to the rule that the legislation reserves the term ‘opinion’ to output of Scientific Panel/Scientific Committee.