Definitions of EFSA scientific outputs

EFSA’s scientific output can be classified in two broad categories: "Opinions of Scientific Committee/Panels" and "other scientific outputs". The described scientific outputs find their legal basis in Chapter III of the Founding Regulation, specifically in Article 28 to Article 40.

1. Scientific Opinions of Scientific Committee/Scientific Panel

1.1 Opinion of the Scientific Panel/Scientific Committee

The EFSA can issue an Opinion at the request of the Commission, the Members States, the European Parliament, on its own initiative or as foreseen in other relevant sectoral legislation. Requests for an opinion are defined by ‘terms of reference’ including background information, which together form the mandate for the Scientific Committee or Scientific Panel to work with.

An Opinion is a scientific output adopted by the Scientific Committee or one or more of the Scientific Panels. An Opinion is structured in accordance with ‘EFSA’s guidance for the drafting of scientific opinions’ and comprises a generic or applications-specific risk assessment or an evaluation of a risk assessment.

1.2 Statement of the Scientific Committee or Scientific Panel

The EFSA may a issue a statement of the Scientific Committee or scientific Panel which is a scientific output in the form of a concise document adopted by the Scientific Committee or one or more of the Scientific Panels. It may deal with a multitude of subjects within the remit of EFSA and addresses a risk assessment or an evaluation of a risk without providing a full risk assessment. It may be of a provisional or preliminary nature.

A Scientific Committee or Panel Statement may be developed in response to a request for: (i) a fast-track response in order to address an urgent matter or (ii) a provisional scientific view.

1.3 Guidance of the Scientific Committee or Scientific Panel

The EFSA may issue a Guidance at the request of the Commission, the Members States, the European Parliament or on its own initiative.

A Guidance is a generic scientific output adopted by the Scientific Committee or one or more of the Scientific Panels. A Guidance provides guiding principles on procedural or assessment practices and approaches for risk assessors (including the Scientific Committee or Scientific Panels), risk managers and/or applicants of dossiers submitted for evaluation.

2. Other scientific outputs of EFSA

These scientific outputs are not prepared by the Scientific Panels/Scientific Committee.

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, Member States or stakeholders.

A Statement of EFSA is prepared as a general rule by an EFSA Expert Group, other than the Scientific Committee or Scientific Panel, or by EFSA scientific staff, normally, within a relative short time frame. EFSA may consult the Scientific Committee, a Scientific Panel, or an EFSA network during the process.

2.2 Guidance of EFSA

A Guidance of EFSA provides guiding principles on procedural issues or assessment practices and approaches for risk assessors, risk managers and/or applicants of dossiers submitted for evaluation. The guidance documents may also provide guiding principles on the best practices for monitoring, reporting and analysing data related to food and feed safety and animal health for the Member States.

A Guidance of EFSA is prepared, as a rule, by an EFSA Network or an EFSA Expert Group other than the Scientific Committee or Scientific Panel or by EFSA scientific staff.

2.3 Conclusion on Pesticides Peer Review

An EFSA Conclusion provides the comprehensive scientific evaluation of, and subsequent conclusions from, the peer review process of the risk assessment for any plant protection product at EU level as foreseen in the relevant legislative framework. Conclusions are prepared by EFSA staff.

2.4 Reasoned Opinion

A Reasoned Opinion, a term introduced in Regulation 396/2005 to describe the comprehensive scientific evaluation of, and subsequent conclusions from, the peer review process of the MRL for any plant protection product at EU level may be prepared by EFSA staff. The reasoned opinion is an exception to the rule that the legislation reserves the term “opinion” to output of Scientific Panel/Scientific Committee.

2.5 Scientific or Technical Report of EFSA

A Report can be: (i) a background document annexed to an Opinion of Panel or scientific Committee, or (ii) a stand-alone document. It pertains to a (literature) review, statistical data analysis, compilation of scientific evidence, such as a compilation / collation / interpretation of survey or monitoring results or a data collection report (iii) a report on the outcome of an EFSA public consultation.

A scientific or Technical Report can be produced by the working group of the Scientific Committee or a Scientific Panel, an EFSA Network or by EFSA staff.