Guidance on the review, revision and development of EFSA s cross-cutting guidance documents

SCIENTIFIC OPINION ADOPTED: 1 April 2015 PUBLISHED: 16 April 2015 AMENDED: 20 July 2016 doi:10.2903/j.efsa.2015.4080 Guidance on the review, revision and development of EFSA s cross-cutting guidance documents EFSA Scientific Committee Abstract To increase transparency and harmonisation, EFSA asked the Scientific Committee for advice on how cross-cutting guidance documents should be used across EFSA, reviewed and kept up-to-date. The Committee examined 23 documents that should be applied consistently across EFSA sectors to set a common assessment framework, and identified two categories of compliance: unconditional, with a requirement to follow; and conditional, with a requirement to follow if the recommended approach is chosen. The Committee recommends that each guidance document identifies its target audience and addresses the level of obligation to follow. The Committee concludes that the cross-cutting guidance documents must be regularly screened for their up-to-date scientific relevance, and recommends that this should be done every three years. Prioritisation criteria for updating/revising the guidance documents were identified to allow suitable planning of adequate resources and the availability of expertise necessary for the revisions of cross-cutting guidance. The Scientific Committee concluded that the principle of regular review and subsequent revision should also be extended to all guidance documents produced by EFSA s Panels and Units thus including the sectoral guidance documents specific to EFSA s domains of activity. European Food Safety Authority, 2015 Keywords: guidance documents, revision, cross-cutting, obligation Question number: EFSA-Q-2012-00787 Correspondence: sc.secretariat@efsa.europa.eu www.efsa.europa.eu/efsajournal EFSA Journal 2015;13(4):4080

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, Kristen Sejrsen and Vittorio Silano. Acknowledgements: The Scientific Committee wishes to thank the members of the Working Group on Guidance Review: Diane Benford, Tony Hardy, Christer Hogstrand, Sirpa Karenlampi, Michael Jeger, Claude Lambrè, Robert Luttik, Josef Schlatter, Hans Herman Thulke, Hans Verhagen for the preparatory work on this scientific output and the EFSA staff members: Tilemachos Goumperis, Djien Liem and Daniela Maurici for the support provided to this scientific output. Amendment: In the original scientific opinion, published in April 2015, the names of ten contributors were omitted in error. The revised document, published in July 2016, reflects the contributions of Diane Benford, Tony Hardy, Christer Hogstrand, Sirpa Karenlampi, Michael Jeger, Claude Lambrè, Robert Luttik, Josef Schlatter, Hans Herman Thulke, Hans Verhagen in the acknowledgements section. This editorial correction does not materially affect the contents or outcome of this scientific output. To avoid confusion, the older version has been removed from the EFSA Journal, but is available on request, as is a version showing all the changes made. Suggested citation: EFSA Scientific Committee, 2015. Scientific Opinion: Guidance on the review, revision and development of EFSA s Cross-cutting Guidance Documents. EFSA Journal 2015; 13(4):4080, 11 pp. doi:10.2903/j.efsa.2015.4080 ISSN: 1831-4732 European Food Safety Authority, 2015 Reproduction is authorised provided the source is acknowledged. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. www.efsa.europa.eu/efsajournal 2 EFSA Journal 2015;13(4):4080

Table of contents Abstract... 1 1. Introduction... 4 1.1. Background and Terms of Reference as provided by EFSA... 4 1.2. Interpretation of the Terms of Reference... 4 1.3. Additional information... 4 2. Data and Methodologies... 5 2.1. Data... 5 2.2. Methodologies... 5 3. The level of obligation for EFSA Panels and other target audiences to follow and apply crosscutting guidance... 5 4. Implementation of cross-cutting guidance documents... 6 5. Process and periodicity for reviewing/updating cross-cutting guidance documents... 6 6. Conclusions and recommendations... 7 References... 8 Appendix A Table summarising cross-cutting guidance documents developed by the Scientific Committee and by EFSA, and considered for the purpose of this document.... 10 www.efsa.europa.eu/efsajournal 3 EFSA Journal 2015;13(4):4080

1. Introduction 1.1. Background and Terms of Reference 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 scientific assessment approaches. EFSA requested its Scientific Committee to prepare the following outputs: 1.2. a. a scientific opinion on the priority for the development of guidance documents (completed in 2013); b. a guidance document revising the structure and content of EFSA scientific opinions and statements, to be implemented across EFSA Scientific Committee and Panels (completed in 2014); c. an opinion on the Scientific Committee guidance documents lifecycle. This will review how EFSA s cross-cutting guidance documents should be used, reviewed, prioritised and kept upto-date. The advice should include the procedure and periodicity for reviewing or updating the guidance documents and criteria to prioritise subjects for guidance development (this opinion). Interpretation of the Terms of Reference Terms of reference for this particular activity: To increase transparency and harmonisation, in 2013 EFSA asked the Scientific Committee for advice on how cross-cutting guidance documents should be used across EFSA, reviewed and kept up-to-date. The advice should describe the different types of such guidance documents and the levels of obligation for EFSA, applicants and others to follow the guidance. The guidance should include the procedure and periodicity for reviewing, identifying the need for update, and the criteria to prioritise revision. 1.3. Additional information EFSA s Scientific Committee focuses on providing scientific advice in the area of new and harmonised approaches for the risk and safety assessment of food and feed. It deals with issues affecting more than one Panel and develops a range of horizontal and methodological guidance to EFSA and the wider scientific community. The current guidance document concerns the life cycle of such crosscutting guidance documents and includes examples of those cross-cutting guidance documents which have been developed by EFSA. In terms of outputs, EFSA can issue Scientific Opinions that are prepared by the Scientific Committee or a Scientific Panel upon the request of the European Commission, European Parliament or Member States, or on its own initiative. These scientific documents are adopted by the Scientific Committee or by a Scientific Panel. There are three types of published Scientific Opinions: an opinion (e.g. a risk assessment on general scientific issues, an evaluation of an application for the authorisation of a product, substance or claim); a statement (e.g. a concise document that does not go into the same level of detail as an opinion and that may be developed in response to a request for a fast-track response in order to address an urgent matter); guidance (e.g. to explain the approaches to scientific assessments to risk assessors, 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 for pre-authorisation evaluation by EFSA. These may also explain to Member www.efsa.europa.eu/efsajournal 4 EFSA Journal 2015;13(4):4080

States the guiding scientific principles on the best practices to be adopted for the monitoring, reporting and analysis of data related to food and feed safety and animal or plant health. EFSA may also issue other scientific documents including cross-cutting guidance prepared by EFSA scientific staff and approved by the Executive Director. They are not adopted by the Scientific Committee or Panels, although cross-cutting guidance produced by this mechanism might be endorsed by the Scientific Committee. 2. Data and Methodologies 2.1. Data General cross-cutting guidance documents General cross-cutting guidance documents developed by the Scientific Committee and by EFSA were selected and used as the basis for the analysis made in the current document (see Appendix). Guidance documents prepared by individual Panels are excluded from this evaluation, since either they are related to a specific aspect in relation to the scientific assessment practice in one panel or they are related to administrative issues for the submission of dossiers for market authorisation. 2.2. Methodologies Analysis of general cross-cutting guidance documents For each of the cross cutting guidance documents developed by EFSA or by the Scientific Committee (see Appendix) the following aspects were identified: the target audience: EFSA; applicants; the level of obligation of the target audience to follow the guidance: unconditional or conditional; the current status: e.g. in use; in use but revision ongoing etc. 3. The level of obligation for EFSA Panels and other target audiences to follow and apply cross-cutting guidance Cross-cutting guidance aims to improve the harmonisation, scientific consistency and transparency across EFSA s Panels and Units. However, the current guidance documents developed so far do not always state clearly who the guidance is aimed at, and the required level of obligation to follow. Furthermore, the guidance documents published so far have been categorised variously as guidance, opinion, or statement (see also chapter 1.3 above). Thus the heading does not always indicate that a particular document provides guidance. In order to facilitate the efficient retrieval and electronic searching of published documents, it is important to indicate clearly whether or not a document contains some kind of guidance. The Scientific Committee considers that the obligation for the target audience, including EFSA s Panels or other relevant bodies, to follow the cross-cutting guidance can be either unconditional or conditional. Unconditional guidance is denoted in the text by the use of the term must, which specifies a requirement that is compulsory. In these cases, the guidance may refer to a set of standards (e.g. guidelines). An example of such cross-cutting guidance in this category are the opinions on Transparency in risk assessment, covering scientific principles (EFSA SC, 2009a). The alternative level of guidance is conditional where the word should is used in the text. In these cases, conformity is expected unless circumstances justify deviation from the guidance, which should be clearly recorded in the opinions. Such an approach allows for flexibility, while providing the highest clarity and transparency. An example of cross-cutting guidance in this category is the Scientific www.efsa.europa.eu/efsajournal 5 EFSA Journal 2015;13(4):4080

Committee (SC) opinion on the use of the Benchmark Dose approach in risk assessment (EFSA, 2009b), where the application of the approach is optional but when chosen, this SC guidance must be followed. Another example is the guidance on the application of systematic review methodology to food and feed safety assessments to support decision making (EFSA, 2010). Whilst increased harmonisation and conformity between EFSA s Panels is desirable, transparency will also be improved by the consistency with which deviations from conditional guidance are justified in the text of the assessments. Some cross-cutting guidance documents have been produced by EFSA scientific staff and not by the Scientific Committee (some examples are included in Appendix). In order to improve cohesion and harmonisation across EFSA, the Scientific Committee is of the opinion that all cross-cutting guidance documents developed by EFSA should be brought under the ownership and endorsement of the Scientific Committee. When a Panel discusses a new mandate for the development of sectoral guidance, consideration should be given to the potential for it being cross cutting and this should be brought to the attention of the Scientific Committee by the Panel chair. 4. Implementation of cross-cutting guidance documents Following the adoption or endorsement by the Scientific Committee, it is important that the documents are effectively implemented and used. To achieve this, it is necessary that EFSA ensures that: the documents are included in the organisation s management system (see Appendix for a list of guidance documents to be included in the first instance). In this regard, effective management of the documents through their life cycle including status and version control are considered important; cross-cutting guidance documents should be clearly identified as such and easily located and publicly available on the EFSA website, and also efficiently retrievable from a central repository; cross-cutting guidance documents should be presented to the panels; implementation is supported by effective training for experts and staff on existing and newly developed guidance documents. 5. Process and periodicity for reviewing/updating cross-cutting guidance documents The Scientific Committee recognises that the regularity of updating cross-cutting guidance documents is a pragmatic balance of the need to update the science without continually revising the guidance, which has implications for Panels and for applicants applying the EFSA guidance. However crosscutting guidance documents should regularly be screened and reviewed and to assess their status and identify whether they need updating. If guidance is not already recently updated, this screening could be done in the last year of each mandate period of the Scientific Committee. The relevant EFSA Unit must take the responsibility to ensure regular screening of guidance documents and follow up action. There are several reasons why cross-cutting guidance documents might need to be updated, such as when: new relevant, reliable and consistent scientific information/insight in hazard and/or exposure assessments becomes available. For instance, if new research results clearly indicate that the current guidance is based on wrong assumptions; if there are new exposure routes to be considered for the scientific assessment; if there is a newly identified group of sensitive individuals; if new methodologies become available and should be considered for the guidance; www.efsa.europa.eu/efsajournal 6 EFSA Journal 2015;13(4):4080

new regulation or new legal instruments are published that impact several EFSA Scientific Panels; a request comes from the Commission or a Member State; mistakes (other than small errata) or ambiguity have been identified that directly influence the outcome of the scientific assessment; ambiguity resulting in different interpretations of the guidance by different Panels. Prioritisation criteria to update/revise the guidance documents to allow suitable planning of adequate resources and the availability of expertise for the necessary revisions of cross cutting guidance include: the degree of impact of the proposed revision on the scientific assessments; improving the consistency in the way scientific assessment is carried out by the EFSA Panels; the obligation for EFSA/applicants to apply the guidance (when the guidance is classified as unconditional, revision is to be consider as high priority); the number of EFSA Panels for which the guidance is relevant. 6. Conclusions and recommendations The Scientific Committee examined 23 documents classified as guidance, opinions or technical reports which are considered to have cross-cutting relevance and that have been published up to the end of 2014 (by the SC and by Units within EFSA e.g. Assessment and Methodological Unit, see Appendix) and concluded that there is a need to harmonise and strengthen the processes to review, update and disseminate such guidance to Units and Panels in EFSA and the wider international risk assessment community. Cross-cutting guidance should be applied consistently across EFSA sectors to set a common assessment framework to increase scientific harmonisation and transparency. The Scientific Committee identified two categories of compliance: unconditional (compulsory), with a requirement to follow; and conditional (not compulsory), with a requirement to follow if the recommended approach is chosen (deviations should be clearly justified and documented). In the past the cross-cutting guidance documents have variously been published as guidance of EFSA or guidance/opinion/statement of the Scientific Committee. Cross-cutting guidance documents should be clearly identified as such and easily located and publicly available on the EFSA website, and also efficiently retrievable from a central repository. The Scientific Committee recommends that each guidance document published in the future identifies its target audience, its application area(s) and clearly addresses the level of obligation to follow for EFSA Units, the Panel/Scientific Committee and applicants (i.e. as being unconditional or conditional). To improve cohesion and harmonisation, all cross-cutting guidance documents developed by EFSA must be presented to the Scientific Committee for endorsement. In order to increase the use of cross-cutting guidance in the development of EFSA s outputs, an agreed implementation plan would assist the communication, dissemination and uptake by Panels and units across EFSA s domains. EFSA must take responsibility for disseminating the cross-cutting guidance documents to the relevant Panels and their experts. The Scientific Committee recognises that the regularity of updating is a pragmatic balance of the need to update the science without continually revising the guidance, which has implications for Panels and applicants. However, the Scientific Committee concludes that the cross-cutting guidance documents must be periodically and regularly screened. The Scientific Committee recommends that unless there is more urgent scientific need (or request) to update cross-cutting guidance documents, they should be screened every 3 years for their up to date scientific relevance and to identify the need for revision (updating). Ideally this could be close to the end of the mandate period of the Scientific Committee. The relevant EFSA Unit must take the responsibility to ensure regular screening of guidance documents and follow up action. www.efsa.europa.eu/efsajournal 7 EFSA Journal 2015;13(4):4080

Prioritisation criteria for updating/revising the guidance documents were identified to allow suitable planning of adequate resources and the availability of expertise necessary for the revisions of crosscutting guidance. The EFSA Units should take responsibility to initiate the revisions of the guidance documents upon request from the Scientific Committee/Panels or when the need is identified. The Scientific Committee concluded that the principle of regular review and subsequent revision where appropriate should also be extended to all guidance documents produced by EFSA s Panels and Units thus including the sectoral guidance documents specific to EFSA s domains of activity. References EFSA (European Food Safety Authority), 2005a. Opinion of the Scientific Committee on a request from EFSA related to A Harmonised Approach for Risk Assessment of Substances Which are both Genotoxic and Carcinogenic. The EFSA Journal 2005, 282, 1 31. doi:10.2903/j.efsa.2005.282 EFSA (European Food Safety Authority), 2005b. Opinion of the Scientific Committee on a request from EFSA related to Exposure Assessments. The EFSA Journal 2005, 249, 1 26. EFSA (European Food Safety Authority), 2006. Opinion of the Scientific Committee related to Uncertainties in Dietary Exposure Assessment. The EFSA Journal 2006, 438, 1 54. doi:10.2903/j.efsa.2006.438 EFSA (European Food Safety Authority), 2007. Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee. The EFSA Journal 2007, 587, 1 16. doi:10.2903/j.efsa.2007.587 EFSA (European Food Safety Authority), 2009. Guidance of the Scientific Committee on Use of the benchmark dose approach in risk assessment. The EFSA Journal 2009, 1150, 1 72. doi:10.2903/j.efsa.2009.1150 EFSA (European Food Safety Authority), 2010. Application of systematic review methodology to food and feed safety assessments to support decision making. EFSA Journal 2010;8(6):1637, 90 pp. doi:10.2903/j.efsa.2010.1637 EFSA (European Food Safety Authority), 2014a. Indicative timelines for submitting additional or supplementary information to EFSA during the risk assessment process of regulated products. EFSA Journal 2014;12(1):3553, 37 pp. doi:10.2903/j.efsa.2014.3553 EFSA (European Food Safety Authority), 2014b. Guidance on Statistical Reporting. EFSA Journal 2014;12(12):3908, 18 pp. doi:10.2903/j.efsa.2014.3908 EFSA (European Food Safety Authority), 2014c. Explanatory statement for the applicability of the Guidance of the EFSA Scientific Committee on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed for GMO risk assessment. EFSA Journal 2014;12(10):3871, 25 pp. doi:10.2903/j.efsa.2014.3871 EFSA (European Food Safety Authority), 2014d. Guidance on Expert Knowledge Elicitation in Food and Feed Safety Risk Assessment. EFSA Journal 2014;12(6):3734, 278 pp. doi:10.2903/j.efsa. 2014.3734 EFSA SC (EFSA Scientific Committee), 2009a. Guidance of the Scientific Committee on Transparency in the Scientific Aspects of risk assessments carried out by EFSA. Part 2: General Principles. The EFSA Journal 2009, 1051, 1 22. doi:10.2903/j.efsa.2009.1051 EFSA SC (EFSA Scientific Committee), 2009b. Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements. EFSA Journal 2009;7(9):1249. 19 pp. doi:10:2903/j.efsa.2009.1249 EFSA SC (EFSA Scientific Committee), 2010. Guidance on human health risk-benefit assessment of foods. EFSA Journal 2010;8(7):1673, 41 pp. doi:10.2903/j.efsa.2010.1673 EFSA SC (EFSA Scientific Committee), 2011a. Statistical Significance and Biological Relevance. EFSA Journal 2011;9(9):2372, 17 pp. doi:10.2903/j.efsa.2011.2372 www.efsa.europa.eu/efsajournal 8 EFSA Journal 2015;13(4):4080

EFSA SC (EFSA Scientific Committee), 2011b. Scientific Opinion on genotoxicity testing strategies applicable to food and feed safety assessment. EFSA Journal 2011;9(9):2379, 69 pp. doi:10.2903/j.efsa.2011.2379 EFSA SC (EFSA Scientific Committee), 2011c. Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed. EFSA Journal 2011;9(12):2438, 21 pp. doi:10.2903/j.efsa.2011.2438 EFSA SC (EFSA Scientific Committee), 2011d. Scientific Opinion on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA Journal 2011;9(5):2140, 36 pp. doi:10.2903/j.efsa.2011.2140 EFSA SC (EFSA Scientific Committee), 2012a. Scientific Opinion on Risk Assessment Terminology. EFSA Journal 2012;10(5):2664, 43 pp. doi:10.2903/j.efsa.2012.2664 EFSA SC (EFSA Scientific Committee), 2012b. Scientific Opinion on Exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC). EFSA Journal 2012;10(7):2750, 103 pp. doi:10.2903/j.efsa.2012.2750 EFSA SC (EFSA Scientific Committee), 2012c. Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data. EFSA Journal 2012;10(3):2579, 32 pp. doi:10.2903/j.efsa.2012.2579 EFSA SC (EFSA Scientific Committee), 2012d. Scientific Opinion on the applicability of the Margin of Exposure approach for the safety assessment of impurities which are both genotoxic and carcinogenic in substances added to food/feed. EFSA Journal 2012;10(3):2578, 5 pp. doi:10.2903/j.efsa.2012.2578 EFSA SC (EFSA Scientific Committee), 2014e. Guidance on the structure and content of EFSA s scientific opinions and statements. EFSA Journal 2014;12(9)3808, 10 pp. doi:10.2903/ j.efsa.2014.3808 EFSA SC (EFSA Scientific Committee), 2014f. Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations. EFSA Journal 2014;12(3):3593, 38 pp. doi:10.2903/j.efsa.2014.3593 www.efsa.europa.eu/efsajournal 9 EFSA Journal 2015;13(4):4080

Appendix A Table summarising cross-cutting guidance documents developed by the Scientific Committee and by EFSA, and considered for the purpose of this document. Indication on the status is given: e.g. in use; in use and revision ongoing etc. The target audience is also specified: EFSA; applicants submitting dossier for market authorisation. In the last column, the level of compliance is indicated: U= unconditional; C= conditional; (for more explanation see Section 6); NA= not applicable Title of the guidance Status Target audience Intended level of compliance at the time of publication: unconditional (U) or conditional (C) EFSA Applicants EFSA Applicants Harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic (2005) http://www.efsa.europa.eu/it/efsajournal/pub/282.htm Opinion of the Scientific Committee on a request from EFSA related to Exposure Assessments (2005) http://www.efsa.europa.eu/en/efsajournal/doc/c_op_ej249_exposure_en2.pdf Opinion of the Scientific Committee related to Uncertainties in Dietary Exposure Assessment (2006) http://www.efsa.europa.eu/it/efsajournal/pub/438.htm Introduction of the Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA (2007, latest update 2013) http://www.efsa.europa.eu/it/efsajournal/pub/587.htm Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements (2009) http://www.efsa.europa.eu/de/search/doc/1249.pdf Transparency in risk assessment Scientific Aspects (2009; Part 2: general principles) http://www.efsa.europa.eu/fr/scdocs/doc/1051.pdf Use of the benchmark dose approach in risk assessment (2009) http://www.efsa.europa.eu/it/efsajournal/pub/1150.htm Application of systematic review methodology to food and feed safety assessments to support decision making (2010) http://www.efsa.europa.eu/en/efsajournal/pub/1637.htm Guidance on human health risk-benefit assessment of foods (2010) http://www.efsa.europa.eu/it/search/doc/1673.pdf Scientific opinion on Statistical significance and Biological Relevance (2011) http://www.efsa.europa.eu/en/search/doc/2372.pdf In use X X U NA Obsolete replacement envisaged X X U NA In use and revision ongoing X X C NA In use (appendices listing microorganisms regularly updated) X X C C In use X X U NA In use and revision ongoing X X C C In use X X C NA In use X NA C NA In use and development of complementary guidance on biological relevance ongoing X X U U www.efsa.europa.eu/efsajournal 10 EFSA Journal 2015;13(4):4080

Title of the guidance Status Target audience Intended level of compliance at the time of publication: unconditional (U) or conditional (C) EFSA Applicants EFSA Applicants Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment (2011) http://www.efsa.europa.eu/en/efsajournal/doc/2379.pdf Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed (2011) http://www.efsa.europa.eu/en/efsajournal/pub/2438.htm Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain (2011) http://www.efsa.europa.eu/it/search/doc/2140.pdf Scientific opinion of risk assessment terminology (2012) http://www.efsa.europa.eu/en/efsajournal/doc/2664.pdf Scientific Opinion on Exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (2012) http://www.efsa.europa.eu/en/efsajournal/pub/2750.htm Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data (2012) http://www.efsa.europa.eu/en/efsajournal/pub/2579.htm Applicability of the margin of exposure approach for the safety assessment of impurities which are both genotoxic and carcinogenic added to food and feed (2012) http://www.efsa.europa.eu/en/efsajournal/pub/2578.htm Guidance on the structure and content of EFSA s scientific opinions and statements (2014) http://www.efsa.europa.eu/en/efsajournal/pub/3808.htm Guidance on statistical reporting (2014) http://www.efsa.europa.eu/en/efsajournal/pub/3908.htm Guidance on Expert Knowledge Elicitation in Food and Feed Safety Risk Assessment (2014) http://www.efsa.europa.eu/en/efsajournal/pub/3734.htm Indicative timelines for submitting additional or supplementary information to EFSA during the risk assessment process of regulated products (2014) http://www.efsa.europa.eu/en/efsajournal/pub/3553.htm Qualified presumption of safety approach for the safety assessment of botanicals and botanical preparations (2014) http://www.efsa.europa.eu/en/efsajournal/pub/3593.htm Explanatory statement for the applicability of the Guidance of the EFSA Scientific Committee on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed for GMO risk assessment (2014) http://www.efsa.europa.eu/en/efsajournal/doc/3871.pdf In use X NA C NA In use, possible revision being considered X X C C In use X X C NA In use X NA U NA In use X NA C NA In use X X NA C In use X X C C www.efsa.europa.eu/efsajournal 11 EFSA Journal 2015;13(4):4080