EFSA Journal 2014;12(9):3808

SCIENTIFIC OPINION

Guidance on the structure and content of EFSA’s scientific opinions and

statements1
EFSA Scientific Committee2, 3

European Food Safety Authority (EFSA), Parma, Italy

ABSTRACT
The European Food Safety Authority (EFSA) asked the Scientific Committee to prepare a guidance
document revising the structure and content of EFSA’s scientific opinions and statements, to be
implemented across EFSA’s Scientific Committee and Panels. The new structure is proposed herein.

© European Food Safety Authority, 2014

KEY WORDS
template

1
On request from EFSA, Question No EFSA-Q-2012-00786, adopted on 09 July 2014.
2
Scientific Committee members: Jan Alexander, Diane Benford, Qasim Chaudhry, John Griffin, Anthony Hardy, Michael
John Jeger, Robert Luttik, Ambroise Martin, Simon More, Alicja Mortensen, Birgit Nørrung, Bernadette Ossendorp, Joe
Perry, Josef Schlatter, Vittorio Silano, Kristen Sejrsen. Correspondence: scientific.committee@efsa.europa.eu
3
Acknowledgement: The Scientific Committee wishes to thank the members of the Working Group on Guidance Review:
Christer Hogstrand, Claude Lambre, Diane Benford, Hans Verhagen, Josef Schlatter, Robert Luttik, Metka Filipic,
Michael Jeger, Sirpa Karenlampi and Anthony Hardy for the preparatory work and the EFSA staff member Daniela
Maurici for the support provided to this scientific opinion.

Suggested citation: EFSA Scientific Committee, 2014. Guidance on the structure and content of the EFSA scientific opinions
and statements. EFSA Journal 2014;12(9) 3808, 10 pp. doi:10.2903/j.efsa.2014.3808
Available online: www.efsa.europa.eu/efsajournal

© European Food Safety Authority, 2014

 Structure and content of EFSA’s scientific opinions and statements

SUMMARY
The European Food Safety Authority (EFSA) asked the Scientific Committee to prepare a guidance
document revising the structure and content of EFSA’s scientific opinions and statements, to be
implemented across EFSA’s Scientific Committee and Panels. The new structure is proposed as an
annex to this opinion. It will be tested by the EFSA Scientific Committee and Panels for a period of
about one year and after that, amended if necessary.

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 Structure and content of EFSA’s scientific opinions and statements

TABLE OF CONTENTS
Abstract .................................................................................................................................................... 1
Summary .................................................................................................................................................. 2
Table of contents ...................................................................................................................................... 3
Background as provided by EFSA ........................................................................................................... 4
Terms of reference as provided by EFSA ................................................................................................ 4
Assessment ............................................................................................................................................... 5
Conclusions .............................................................................................................................................. 6
References ................................................................................................................................................ 6
Appendix A. Structure and content of EFSA’s scientific opinions and statements ........................... 7
Abstract .................................................................................................................................................... 7
Summary .................................................................................................................................................. 7
Table of contents ...................................................................................................................................... 7
1. Introduction ..................................................................................................................................... 7
1.1 Background and Terms of Reference as provided by the requestor ....................................... 7
1.2 Interpretation of the Terms of Reference (if appropriate) ...................................................... 8
1.3 Additional information (if appropriate) .................................................................................. 8
2. Data and Methodologies .................................................................................................................. 8
2.1 Data ........................................................................................................................................ 8
2.2 Methodologies ........................................................................................................................ 8
3. Assessment ...................................................................................................................................... 9
4. Conclusions ..................................................................................................................................... 9
5. Recommendations (if appropriate) .................................................................................................. 9
Documentation as provided to EFSA (if appropriate) .............................................................................. 9
References .............................................................................................................................................. 10
Appendixes/Annex (if appropriate) ........................................................................................................ 10
Glossary and/or abbreviations and/or acronyms .................................................................................... 10

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 Structure and content of EFSA’s scientific opinions and statements

BACKGROUND AS PROVIDED BY EFSA

As per EFSA’s Founding Regulation (EC) No 178/2002 of the European Parliament and of the
Council, “the EFSA Scientific Committee shall be responsible for the general coordination necessary
to ensure the consistency of the scientific opinion procedure, in particular with regard to the adoption
of working procedures and harmonisation of working methods”. The EFSA Science Strategy 2012-
2016 echoes this key responsibility of the Scientific Committee by setting the development and
harmonisation of methodologies and approaches to assess risks associated with the food chain as one
of the four strategic objectives for EFSA.

As recommended by its Scientific Committee, EFSA is developing a guidance document review

framework for the implementation of activities in relation to the development and harmonisation of
risk assessment approaches. The framework shall include three pillars:

1. Establishing an inventory of guidance documents for risk assessment, which would allow the
identification of commonalities and differences in the legislative data requirements and
guidance documents for risk assessment, among the different areas within EFSA’s mandate,
covering food and feed safety, nutrition, animal health and welfare, plant protection and plant
health, and environmental protection.

2. Based on the above, developing and executing a work plan aimed at updating/revision of
existing guidance documents and the development of new guidance documents, considering as
well trends and developments in risk assessment and the relevant scientific areas for EFSA.
This will result in:
a. better harmonisation of the risk assessment methods used within EFSA as well as
between EFSA and other scientific advisory bodies carrying out risk assessment at
European and/or international level;
b. the possibility to develop and implement new concepts and approaches in EFSA’s risk
assessment practices.

3. The development and implementation of training programmes for experts and staff
contributing to the scientific work of EFSA, with a view to ensure the correct implementation
and use of EFSA’s guidance documents.

TERMS OF REFERENCE AS PROVIDED BY EFSA

EFSA requests its Scientific Committee to prepare the following outputs:

1. a scientific opinion on the priority for the development of guidance documents (completed in
2013);

2. a guidance document revising the structure and content of EFSA’s scientific opinions and
statements, to be implemented across EFSA’s Scientific Committee and Panels (completed);

3. an opinion on the Scientific Committee guidance documents lifecycle. This will revise how its
guidance documents should be used, reviewed, prioritised and kept up-to-date. The advice
should include the procedure and periodicity for reviewing or updating the guidance
documents and criteria to prioritise subjects for guidance development;

4. an opinion explaining reasons for possible differences in risk assessments of the same
compound or class/group of compounds (e.g. based on different legal framework etc).

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 Structure and content of EFSA’s scientific opinions and statements

All the outputs will be presented to the Scientific Committee for possible endorsement/adoption.

Action Plan:

During its 56th Plenary Meeting in July 2012, the EFSA Scientific Committee identified the need for a
Standing Working Group on Guidance Review to ensure the implementation of the guidance
document framework as described above.
The Scientific Committee Standing Working Group will serve as an expert judgment platform for
identifying needs for the work plan related to the development and implementation of EFSA’s
guidance documents, in particular in relation to key strategic objective (3) of EFSA’s Science Strategy
2012-2016 (develop and harmonise methodologies and approaches to assess risks associated with the
food chain). A mandate has been approved: M-2012-0267.

The objectives of the Standing Working Group on Guidance Review are to perform the following
tasks:

to provide recommendations to the EFSA Scientific Committee to set priorities for the review
of existing guidance documents, or for the preparation of new EFSA guidance documents;

to provide guidance on relevant information (structure and content) to be included in EFSA’s

opinions and statements to ensure the transparency of the risk assessments carried out by
EFSA’s Scientific Committee and Panels.

to assist in the implementation of the EFSA guidance documents framework across EFSA,
providing support to the panels on the appropriate use of existing guidance and to contribute to
the overall objective of transparency in the risk assessment process performed by EFSA.

In order to fulfil its objectives, the above mentioned Standing Working Group should consist of
members with expertise in the various scientific areas covered by EFSA. As such, all EFSA Panels
should be represented in the Standing Working Group.
Work is already ongoing as agreed in the mandate M-2012-0267 and the output addressing the first
term of reference has been published in 2013 (EFSA-Q-2012-00785).

ASSESSMENT
The scientific assessments carried out by EFSA’s Scientific Committee and Panels should always be
based on scientifically accepted standards of best practice, and be transparent with regard to the data,
methods and assumptions that are used in the risk assessment process. They should identify
uncertainties and use harmonised terminology, where possible, based on internationally accepted
terms.

The purpose of this document is to revise the structure and content of opinions and statements (but not
guidance) of the Scientific Committee and Panels, first published by EFSA in 2003 and, where
possible, further harmonise its scientific outputs.

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 Structure and content of EFSA’s scientific opinions and statements

The key components of the scientific assessments (which may address specific or more generic
questions) are identified as separate chapters and their content is indicated as appropriate. It is fully
recognised that not all chapter headings, or the extent of detailed description within, are appropriate to
every Opinion or Statement issued. However, whilst the structure proposed allows flexibility to choose
headings and content fit for the purpose of individual Opinions and Statements, it is recommended that
the information content of both types of output should be as complete as possible.

The proposed structure of opinions and statements is presented in Appendix A. Detailed guidance for
authors will be developed to allow smooth implementation of the new structure of opinions and
statements by all EFSA Panels. The Scientific Committee was requested by EFSA to provide guidance
on relevant information to be included in EFSA opinions and statements to ensure the transparency of
the risk assessments carried out by EFSA’s Scientific Committee and Panels.

The Scientific Committee developed a new proposal that was tested with a series of already published
opinions. The comments of the different EFSA Units involved in the exercise were considered and a
revised version of the document was produced and finally endorsed by the Scientific Committee in its
plenary meeting in July 2014. The Scientific Committee proposes to test the appropriateness and the
applicability of the revised structure with new Opinions and Statements that will be produced by
EFSA as soon as possible. At the end of the testing phase, comments and experience will be collected
and the structure reviewed for adoption by the Scientific Committee in 2015 before full
implementation.

CONCLUSIONS
The current proposed structure and content for Opinions and Statements was discussed and endorsed
by the Scientific Committee at its Plenary in July 2014. The Scientific Committee concluded that the
proposed structure should be used for new Opinions and Statements for a trial period. The experience
of Panels and Units will be reviewed by the Scientific Committee in 2015 and the present guidance
re-considered for adoption and implementation.

REFERENCES

EFSA (European Food Safety Authority), 2003. Advice from the EFSA Scientific Committee on a
general format for scientific opinions of the EFSA. Available online: http://www.
efsa.europa.eu/en/efsajournal/pub/13r.htm

EFSA (European Food Safety Authority), 2012. EFSA Science Strategy 2012-2016, available online:
http://www.efsa.europa.eu/en/ corporate/pub/sciencestrategy12.htm

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 Structure and content of EFSA’s scientific opinions and statements

Appendix A. Structure and content of EFSA’s scientific opinions and statements

TITLE OF THE OPINION

(There is no need to repeat the type of output in the title)

Example:

Title: “Olive leaf extract and reduction of post-prandial glycaemic response: Evaluation of a health
claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006”.

Short title (e.g. Olive leaf extract and post-prandial glycaemic response), to be used as running title
and the main link on the EFSA Journal landing page.

ABSTRACT

KEY WORDS

SUMMARY

The summary should not include tables, footnotes, graphs or pictures or references.

A summary should reflect the full scope of the opinion. It should include:

o the requestor;
o the request and the questions;
o the methodologies and the data used;
o the assessment and its results;
o the main conclusions and, if appropriate, recommendations.

In case the summary does not contain any additional information compared to the abstract, it can be
omitted.

TABLE OF CONTENTS

1. INTRODUCTION

1.1 Background and Terms of Reference as provided by the requestor

Mandate as agreed between EFSA and the requestor i.e. the European Parliament, the European
Commission, EU Member State(s), or EFSA (if self tasking), and the terms of reference provided to
the panel/SC.

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1.2 Interpretation of the Terms of Reference (if appropriate)

This chapter may include an explanation of how the Panel/SC interprets the Terms of Reference and
how it answer the questions . If appropriate, the following information should be provided:

o Objectives of the assessment

o Target population
o Specific hazard/s of concern and route/s of exposure
o Disclaimer
o (Other information if needed) ………..

1.3 Additional information (if appropriate)

This chapter could provide additional background information (e.g. other historical data or opinions
issued by bodies/committees within and/or outside EFSA) relevant to the assessment.

Information about the compound/biological organism under assessment can also be given.

2. DATA AND METHODOLOGIES

The steps and methodologies to be followed in the assessment should be described or cited in order to
enhance transparency. This should include the strategy and methodology used to acquire, process and
integrate the data.

2.1 Data

The decision on the type of evidence (e.g. individual data, summary data or expert knowledge) to be
used in each step of the assessment, is taken on the basis of evidence availability, regulatory
framework (e.g. for dossiers) or established approaches (e.g. EFSA Guidance documents).

Data can be derived from several sources: (peer reviewed) scientific publications (white literature),
reports on websites of agencies (governmental, non-governmental, intra-governmental, etc.; grey
literature), and confidential reports (black literature). Grey and black literature may or may not have
been peer reviewed. White and grey literature are in the public domain but can differ in the ease of
being found. Black literature is typically presented in confidential reports owned by the company that
performed or commissioned the work. EFSA should consider all categories of literature for its risk
assessment processes as appropriate.

When literature review is performed, the search string and the period covered by the data searching
should be provided.

The sources of all data considered must be described. The inclusion/exclusion criteria applied should
be explained and described within the assessment (e.g. systematic literature review). Personal
communications should only be cited in specific instances where the information provided is highly
pertinent to the issue in question.

2.2 Methodologies

The methods applied should be explained. When the assessment methods follow an established
approach (e.g. in the case of regulated products), it may be sufficient to refer to other documents
where details are provided (e.g. guidance documents/guidelines, previous assessments, accepted
referenced models). Deviation from such methods must be documented and the rationale for doing so
explained.

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Whenever different methods are applied, they should be described in detail (e.g. expert knowledge
elicitation, weight of evidence).

EFSA has developed, or is in the process of developing, a number of horizontal guidance documents,
which should be followed (e.g. default values used by EFSA Units and Panels, statistical reporting,
genotoxicity testing strategies, use of the benchmark dose approach, uncertainty in risk assessment,
weight of evidence in scientific assessment). Deviation from such guidance documents must be
documented and the rationale for doing so explained.

Assumptions (e.g. extrapolation factors) made at any stage of the assessment must be documented and
justified. It can be done either in this section or in the assessment section.

For the assessment, the accepted methodology (e.g. CODEX, OIE, IPPC) consisting of hazard
identification, hazard characterisation, exposure assessment and risk characterisation is expected to be
followed, as appropriate. It is not always necessary to perform all four steps, in certain cases only part
of the full risk assessment may be requested.

For human and animal nutrition, animal health and welfare, plant health and the environment, the
assessment concepts are similar in principle but terminology and specific procedures may differ,
especially when regulatory prescriptions have to be followed.

3. ASSESSMENT

This chapter may be the most variable across EFSA due to differences in the Terms of Reference and
type of assessment (e.g. number of substances, number and type of organisms etc.). The outcome of
the individual steps of the assessment should be clearly documented. The final output should be the
logical and transparent result of integrating these steps.

In quantitative assessments (deterministic and probabilistic), results are based, at least partly, on
calculations or mathematical models. In qualitative assessments (including weight of evidence), results
are expressed in a narrative way. In both cases, transparency requires that every element of the
reasoning and/or calculation, and/or mathematical modelling should be communicated and justified.

Uncertainty and variability should be described and quantified to the extent possible at the most
appropriate place(s) in the assessment.

4. CONCLUSIONS

Conclusions should provide answers to the Terms of Reference.

When appropriate, key scientific information underpinning the assessment should be outlined,
including uncertainties. Conclusions should only be drawn from data and reasoning described in the
main text.

5. RECOMMENDATIONS (IF APPROPRIATE)

Recommendations may be provided, if applicable.

DOCUMENTATION AS PROVIDED TO EFSA (IF APPROPRIATE)

e.g.: Dossier name. Month YYYY. Submitted by [name of company]; PhD thesis of…..was provided
and considered for this assessment…..…; Data submitted by companies on request of “call for data”
can be mentioned here.

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 Structure and content of EFSA’s scientific opinions and statements

REFERENCES

All publications that are used and/or cited in the scientific output, including cross-references to other
relevant scientific opinions and documents provided to EFSA, should be reported. In the case of
systematic literature reviews, it may be appropriate to list the references either in a technical report or
in an annex to the scientific output.

APPENDIXES/ANNEX (IF APPROPRIATE)

An appendix and an annex are different forms of addenda to the main document and should be cited in
the text.

An appendix may contain data and analyses that are considered too detailed to be included in the main
text of the document.

An annex is usually a stand-alone document that offers additional information to the main document.

GLOSSARY AND/OR ABBREVIATIONS AND/OR ACRONYMS

The scientific outputs should contain a list of abbreviations and a glossary of technical terms, or refer
to an accessible glossary.

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