Risk assessment at the BfR: independent and transparent
BfR FAQ, updated on 11 September 2023
Questions and answers on safeguarding the independence of the German Federal Institute for Risk Assessment
The independence of experts from economic, political and social interests is a fundamental requirement for an objective risk assessment based purely on scientific facts. For more than 20 years, the separation of scientific risk assessment from its associated management has proven itself in Germany and at the European level. In keeping with this, the German Federal Institute for Risk Assessment (BfR) is an independent scientific institution within the portfolio of the German Federal Ministry of Food and Agriculture (BMEL). It conducts its own research on the basis of its Establishment Act and advises the German federal government and federal states (“Länder”) on issues regarding food, feed, chemical and product safety. The BfR is independent in its scientific assessment, research and communication.
The BfR exchanges information with all relevant stakeholders (NGOs, consumer associations, industry, government, science, media) to fulfil its legal mandate. If there are conflicting scientific positions on an issue, it is important to involve the various stakeholders in the health assessment discussion process using scientific forums and stakeholder conferences. For reasons of independence, the BfR does not accept funding from industry, nor does it financially in such research projects.
The following rules ensure the independence of the German Federal Institute for Risk Assessment.
This text version is a translation of the original German text which is the only legally binding version.
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How does the German Federal Institute for Risk Assessment perform risk assess-ments?
The risk assessments are carried out by BfR employees. External experts provide the BfR with advice, when necessary, but they do not make risk assessment decisions. The work results and recommendations made by the BfR are used by all interested parties as an important source of information and decision-making tool. Statements made by the BfR follow internationally recognised scientific principles and are presented in a manner that is also transparent for outsiders. To prepare these statements the BfR conducts its own research and evaluates existing scientific studies. It also takes into account previously unpublished reports and data, for example, from authorisation procedures. Relevant opposing scientific views are stated.
Transparency is required at all levels of risk assessment. An opinion must be clear, understandable and reproducible from start to finish, beginning with the its objectives and scope and continuing on with the source, nature and evidence of its underlying data. The same qualities must also hold for the methods and assumption used in the opinion, the uncertainty and variability contained in the opinion and, finally, with the opinion's result and conclusion. For this reason, the BfR has been advocating for transparency in risk assessment procedures and for the disclosure of industry studies in numerous forums around the world for many years.
The individual steps of risk assessment are described in detail in our “Guidelines for health risk assessments in consumer protection” (BfR 2020: Guidelines for health risk assessments ). The BfR guidelines set out how the assessment of possible health risks from food, feed, chemical substances and consumer products is to be performed. The guidelines serve as a reference for the BfR and are, therefore, part of its quality management system.
https://www.bfr.bund.de/cm/350/leitfaden-fuer-gesundheitliche-bewertungen-bf.pdf
The risk assessments are carried out by BfR employees. External experts provide the BfR with advice, when necessary, but they do not make risk assessment decisions. The work results and recommendations made by the BfR are used by all interested parties as an important source of information and decision-making tool. Statements made by the BfR follow internationally recognised scientific principles and are presented in a manner that is also transparent for outsiders. To prepare these statements the BfR conducts its own research and evaluates existing scientific studies. It also takes into account previously unpublished reports and data, for example, from authorisation procedures. Relevant opposing scientific views are stated.
Transparency is required at all levels of risk assessment. An opinion must be clear, understandable and reproducible from start to finish, beginning with the its objectives and scope and continuing on with the source, nature and evidence of its underlying data. The same qualities must also hold for the methods and assumption used in the opinion, the uncertainty and variability contained in the opinion and, finally, with the opinion's result and conclusion. For this reason, the BfR has been advocating for transparency in risk assessment procedures and for the disclosure of industry studies in numerous forums around the world for many years.
The individual steps of risk assessment are described in detail in our “Guidelines for health risk assessments in consumer protection” (BfR 2020: Guidelines for health risk assessments ). The BfR guidelines set out how the assessment of possible health risks from food, feed, chemical substances and consumer products is to be performed. The guidelines serve as a reference for the BfR and are, therefore, part of its quality management system.
https://www.bfr.bund.de/cm/350/leitfaden-fuer-gesundheitliche-bewertungen-bf.pdf
How does BfR conduct its risk assessments?
The risk assessments are made by BfR personnel. External experts merely advise the BfR, they do not make any official decisions. The work results and recommendations of the BfR serve all interested parties as an important decision-making aid for taking the necessary measures. The statements made by BfR are based on internationally recognised principles and are justified in a way that outsiders can also understand. Existing knowledge is always taken sufficiently into account and presented in a clear and straightforward manner. Relevant scientific opposite views are also mentioned.
Transparency is necessary on all levels of risk assessment. From the objective and area of application of the statement through the source, type and evidence of the basic data, the methods used along with the assumptions, uncertainty and variability to the result and conclusions, the assessments have to be clear, understandable and reproducible.
The BfR has published a guideline for health assessments in the field of consumer protection (BfR 2010: Guidance document for Health Assessments[1] ). The BfR guideline is the template for the assessment of possible health risks from foods, chemical substances and consumer products and the guidance document for the BfR within the scope of its quality management system.
[1] http://www.bfr.bund.de/cm/364/guidance_document_for_health_assessments.pdf
The risk assessments are made by BfR personnel. External experts merely advise the BfR, they do not make any official decisions. The work results and recommendations of the BfR serve all interested parties as an important decision-making aid for taking the necessary measures. The statements made by BfR are based on internationally recognised principles and are justified in a way that outsiders can also understand. Existing knowledge is always taken sufficiently into account and presented in a clear and straightforward manner. Relevant scientific opposite views are also mentioned.
Transparency is necessary on all levels of risk assessment. From the objective and area of application of the statement through the source, type and evidence of the basic data, the methods used along with the assumptions, uncertainty and variability to the result and conclusions, the assessments have to be clear, understandable and reproducible.
The BfR has published a guideline for health assessments in the field of consumer protection (BfR 2010: Guidance document for Health Assessments[1] ). The BfR guideline is the template for the assessment of possible health risks from foods, chemical substances and consumer products and the guidance document for the BfR within the scope of its quality management system.
[1] http://www.bfr.bund.de/cm/364/guidance_document_for_health_assessments.pdf
How is the independence of BfR employees ensured?
All BfR employees must comply with federal legislation in their work and decisions. Each employee expressly undertakes to do so by signing their employment contract or receiving the status of civil servant. The legal norms of the public service apply to them, for example, with regard to objectivity, effectiveness, expertise as well as impartiality, incorruptibility and corruption prevention. The relevant regulations are the result of laws and implementing provisions from the Federal Ministry of the Interior (see e.g. the Federal Civil Servants Act, Section 10 Administrative Procedures Act and other regulations).
All BfR employees must comply with federal legislation in their work and decisions. Each employee expressly undertakes to do so by signing their employment contract or receiving the status of civil servant. The legal norms of the public service apply to them, for example, with regard to objectivity, effectiveness, expertise as well as impartiality, incorruptibility and corruption prevention. The relevant regulations are the result of laws and implementing provisions from the Federal Ministry of the Interior (see e.g. the Federal Civil Servants Act, Section 10 Administrative Procedures Act and other regulations).
How is the independence of BfR personnel ensured?
The criteria stipulated in the legal regulations of the federal parliament are authoritative for BfR personnel. By signing an employment contract or being awarded civil servant status, every BfR employee is obliged to comply with the obligations contained therein. All of the civil servants and salaried public service employees at BfR must comply with the legal provisions of the civil service. These include official regulations on impartiality, effectiveness, specialised knowledge and corruption protection as prescribed by German law and the implementing provisions of the Federal Ministry of the Interior (see German Civil Service Act, Art. 10 Administrative Procedures Act, and other regulations).
The criteria stipulated in the legal regulations of the federal parliament are authoritative for BfR personnel. By signing an employment contract or being awarded civil servant status, every BfR employee is obliged to comply with the obligations contained therein. All of the civil servants and salaried public service employees at BfR must comply with the legal provisions of the civil service. These include official regulations on impartiality, effectiveness, specialised knowledge and corruption protection as prescribed by German law and the implementing provisions of the Federal Ministry of the Interior (see German Civil Service Act, Art. 10 Administrative Procedures Act, and other regulations).
Which regulations specifically ensure that BfR employees carry out assessments sole-ly on a scientific basis, uninfluenced by other interests?
As set out in the relevant legal provisions, BfR employees are generally required to declare secondary employment or to obtain permission for secondary employment, depending on the type of employment contract they have with the BfR (employee covered by a collective wage agreement or civil servant). The BfR checks any planned secondary employment for conflicts of interest. If there are indications that a BfR employee’s secondary employment might impair their legally intended independence, then the secondary employment is strictly prohibited by the BfR. In this way, BfR employees cannot have an inadmissible conflict of interest due to a parallel activity in industry. Through these rules and procedures, the legislator ensures that the federal government receives objective advice from its scientific institutions.
As set out in the relevant legal provisions, BfR employees are generally required to declare secondary employment or to obtain permission for secondary employment, depending on the type of employment contract they have with the BfR (employee covered by a collective wage agreement or civil servant). The BfR checks any planned secondary employment for conflicts of interest. If there are indications that a BfR employee’s secondary employment might impair their legally intended independence, then the secondary employment is strictly prohibited by the BfR. In this way, BfR employees cannot have an inadmissible conflict of interest due to a parallel activity in industry. Through these rules and procedures, the legislator ensures that the federal government receives objective advice from its scientific institutions.
Are BfR employees allowed to work for foundations, institutions, networks or associa-tions funded by industry on a voluntary basis or in addition to their primary work?
Generally, it is one of the tasks of BfR employees to communicate with stakeholders as part of their duties. To this end, they are involved in working groups and bodies of foundations or institutions as well as in interest groups in industry or consumer protection associations. This is then part of their main job. BfR employees perform their duties impartially and independently in accordance with their legal or collective agreement obligations. They are expressly obliged to do so when they are hired or appointed and are regularly made aware of this.
Generally, it is one of the tasks of BfR employees to communicate with stakeholders as part of their duties. To this end, they are involved in working groups and bodies of foundations or institutions as well as in interest groups in industry or consumer protection associations. This is then part of their main job. BfR employees perform their duties impartially and independently in accordance with their legal or collective agreement obligations. They are expressly obliged to do so when they are hired or appointed and are regularly made aware of this.
Which rules apply to the selection of assessors?
Members of the BfR commissions and scientific advisory board are selected in line with objective and transparent criteria purely on the basis of their scientific excellence, competence and specialised skills and knowledge. The concept of the BfR commissions recognises scientific excellence as the decisive criterion rather than membership or non-membership in certain social groups. The honorary positions are awarded in accordance with a public tendering process in which every expert in the world is at liberty to apply on the basis of his or her professional self-assessment. The process is openly structured and deliberately does not only address specialists from universities and research institutions but also representatives of consumer protection and environmental conservation organisations, industry and public authorities, in order to cover the scientific consultancy needs of the BfR in sufficient width and depth. The process is structured as follows: to begin with, all of the experts interested in getting involved in a BfR commission are requested to submit their applications in a public call. Thereafter, an appointment panel set up especially for this purpose selects suitable experts from the group of applicants. The appointment panel comprises members of the BfR Scientific Research Council, the chair persons of the Senate Commissions on Food Safety and on Substances and Resources in Agriculture of the German Research Foundation (DFG) and a member of the Governing Board of the Senate of Federal Research Agencies.
Members of the BfR commissions and scientific advisory board are selected in line with objective and transparent criteria purely on the basis of their scientific excellence, competence and specialised skills and knowledge. The concept of the BfR commissions recognises scientific excellence as the decisive criterion rather than membership or non-membership in certain social groups. The honorary positions are awarded in accordance with a public tendering process in which every expert in the world is at liberty to apply on the basis of his or her professional self-assessment. The process is openly structured and deliberately does not only address specialists from universities and research institutions but also representatives of consumer protection and environmental conservation organisations, industry and public authorities, in order to cover the scientific consultancy needs of the BfR in sufficient width and depth. The process is structured as follows: to begin with, all of the experts interested in getting involved in a BfR commission are requested to submit their applications in a public call. Thereafter, an appointment panel set up especially for this purpose selects suitable experts from the group of applicants. The appointment panel comprises members of the BfR Scientific Research Council, the chair persons of the Senate Commissions on Food Safety and on Substances and Resources in Agriculture of the German Research Foundation (DFG) and a member of the Governing Board of the Senate of Federal Research Agencies.
What ensures that the participation of BfR employees in industry-funded bodies and institutions does not jeopardise the BfR’s independence?
Employees are obliged to report secondary employment. The secondary employment of a BfR employee is to be prohibited as soon as this employment could have an impact on the professional interests of the employee.
Furthermore, employees are generally obliged to maintain secrecy about matters that they have become aware of as part of their work in public service, even after the termination of their civil servant or employment contract.
Employees are obliged to report secondary employment. The secondary employment of a BfR employee is to be prohibited as soon as this employment could have an impact on the professional interests of the employee.
Furthermore, employees are generally obliged to maintain secrecy about matters that they have become aware of as part of their work in public service, even after the termination of their civil servant or employment contract.
What rules apply to the work of the commissions?
The BfR commissions all work in accordance with a binding agenda. The commissions advise the BfR in open scientific matters and are expressly encouraged to critically reflect the state of each art and technology in the current assessment work of the BfR, while also marking out future work areas of risk assessment. Due to their restricted mandate, however, the commissions do not reach any official decisions by themselves. The members of the commissions come from universities and other research institutions, federal and state authorities, commercial and consumer associations, private laboratories and industry.
The BfR commissions all work in accordance with a binding agenda. The commissions advise the BfR in open scientific matters and are expressly encouraged to critically reflect the state of each art and technology in the current assessment work of the BfR, while also marking out future work areas of risk assessment. Due to their restricted mandate, however, the commissions do not reach any official decisions by themselves. The members of the commissions come from universities and other research institutions, federal and state authorities, commercial and consumer associations, private laboratories and industry.
Which rules apply to the participation of BfR employees in conferences and scientific events?
The participation of BfR staff in conferences and other scientific events is part of the BfR’s scientific work. Any participation on behalf of the BfR must be approved by BfR management. As part of the approval procedure, an assessment is made as to whether participation in the event in question would create a conflict of interest with regard to the Institute’s tasks and independence. Scientific events may also be organised by stakeholders with whom the BfR communicates regularly. A list of these stakeholders can be found in BfR background information no. 033/2014 “BfR Risk Communication in Practice” on the BfR website.
The participation of BfR staff in conferences and other scientific events is part of the BfR’s scientific work. Any participation on behalf of the BfR must be approved by BfR management. As part of the approval procedure, an assessment is made as to whether participation in the event in question would create a conflict of interest with regard to the Institute’s tasks and independence. Scientific events may also be organised by stakeholders with whom the BfR communicates regularly. A list of these stakeholders can be found in BfR background information no. 033/2014 “BfR Risk Communication in Practice” on the BfR website.
How are possible conflicts of interest between members of BfR commissions documented?
Any possible conflicts of interest among the members of the commissions must be recorded in writing. To this end, the experts sign a corresponding declaration which is published on the BfR website. In addition to this, oral inquiries about possible conflicts of interest concerning the topics dealt with in the commission are made at the beginning of each meeting in order to check the suitability of each member to participate in the consultations and decision-making process. A note to this effect is made in the summary minutes which can also be viewed at the BfR website. Because BfR employees are deliberately debarred from voting in the commissions, the consulting work of the commissions is completely separate from the official assessment processes.
Any possible conflicts of interest among the members of the commissions must be recorded in writing. To this end, the experts sign a corresponding declaration which is published on the BfR website. In addition to this, oral inquiries about possible conflicts of interest concerning the topics dealt with in the commission are made at the beginning of each meeting in order to check the suitability of each member to participate in the consultations and decision-making process. A note to this effect is made in the summary minutes which can also be viewed at the BfR website. Because BfR employees are deliberately debarred from voting in the commissions, the consulting work of the commissions is completely separate from the official assessment processes.
Which rules apply when selecting experts?
Members of BfR committees and of the Scientific Advisory Board are selected using objective and transparent criteria. They are chosen solely on the basis of their scientific excellence, competence and expertise.
The concept of the BfR committees intends for scientific excellence to be the decisive criterion, not the affiliation or non-affiliation with certain social groups. Volunteer positions are awarded following a public tender procedure in which every expert around the world is free to apply on the basis of their professional self-assessment. The procedure is open and explicitly addresses not only experts from universities and research institutions, but also representatives from consumer and environmental protection organisations, industry and authorities, in order to cover the BfR’s scientific advisory needs in terms of technical breadth and depth. The procedure is as follows: first, all experts interested in participating in a BfR committee are asked in a public invitation to apply. The specially established Appointment Board then selects suitable experts from among the applicant pool. The Appointment Board is composed of the members of the BfR’s Scientific Advisory Board, one representative each from the Federal Ministry of Food and Agriculture (BMEL) and the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV), a representative from the “Senate Commissions on Food Safety” and a representative from one of the BMEL’s departmental research institutions.
Members of BfR committees and of the Scientific Advisory Board are selected using objective and transparent criteria. They are chosen solely on the basis of their scientific excellence, competence and expertise.
The concept of the BfR committees intends for scientific excellence to be the decisive criterion, not the affiliation or non-affiliation with certain social groups. Volunteer positions are awarded following a public tender procedure in which every expert around the world is free to apply on the basis of their professional self-assessment. The procedure is open and explicitly addresses not only experts from universities and research institutions, but also representatives from consumer and environmental protection organisations, industry and authorities, in order to cover the BfR’s scientific advisory needs in terms of technical breadth and depth. The procedure is as follows: first, all experts interested in participating in a BfR committee are asked in a public invitation to apply. The specially established Appointment Board then selects suitable experts from among the applicant pool. The Appointment Board is composed of the members of the BfR’s Scientific Advisory Board, one representative each from the Federal Ministry of Food and Agriculture (BMEL) and the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV), a representative from the “Senate Commissions on Food Safety” and a representative from one of the BMEL’s departmental research institutions.
Which rules apply to committee work?
The BfR committees all work according to binding rules of procedure. The committees advise the BfR on open scientific specialist issues and are asked specifically to adopt a critical approach, to bring the current state of science and technology to bear on the latest assessment work of the BfR and also to identify future fields of activity for risk assessment. The advice resulting from the committees’ work is addressed to the BfR and is only intended to be understood as a recommendation. The BfR takes note of these opinions and makes decisions independent of the committees. Committee members come from universities and other research institutions, federal and state authorities, business and consumer associations, private laboratories and industry.
The BfR committees all work according to binding rules of procedure. The committees advise the BfR on open scientific specialist issues and are asked specifically to adopt a critical approach, to bring the current state of science and technology to bear on the latest assessment work of the BfR and also to identify future fields of activity for risk assessment. The advice resulting from the committees’ work is addressed to the BfR and is only intended to be understood as a recommendation. The BfR takes note of these opinions and makes decisions independent of the committees. Committee members come from universities and other research institutions, federal and state authorities, business and consumer associations, private laboratories and industry.
How are possible conflicts of interest of BfR committee members documented?
Potential conflicts of interest of committee members are already recorded and documented in writing during the appointment process.
In addition, members are prompted verbally at the beginning of each meeting to state any conflicts of interest in relation to the topics discussed within the committee. If a conflict of interest is identified, the committee member in question is excluded from the deliberations on the relevant topics. This is noted in the minutes of the meeting. All BfR committee meeting minutes can be viewed on the BfR website. BfR employees explicitly have no voting rights in the committees, so that the committees’ advisory work is completely separated from the official assessment processes.
Potential conflicts of interest of committee members are already recorded and documented in writing during the appointment process.
In addition, members are prompted verbally at the beginning of each meeting to state any conflicts of interest in relation to the topics discussed within the committee. If a conflict of interest is identified, the committee member in question is excluded from the deliberations on the relevant topics. This is noted in the minutes of the meeting. All BfR committee meeting minutes can be viewed on the BfR website. BfR employees explicitly have no voting rights in the committees, so that the committees’ advisory work is completely separated from the official assessment processes.
